Medicines can treat diseases and improve your health. If you are like most people, you need to take medicine at some point in your life. You may need to take medicine every day, or you may only need to take medicine once in a while. Either way, you want to make sure that your medicines are safe, and that they will help you get better. In the United States, the Food and Drug Administration is in charge of ensuring that your prescription and over-the-counter medicines are safe and effective.

There are always risks to taking medicines. It is important to think about these risks before you take a medicine. Even safe medicines can cause unwanted side effects or interactions with food, alcohol, or other medicines you may be taking. Some medicines may not be safe during pregnancy. To reduce the risk of reactions and make sure that you get better, it is important for you to take your medicines correctly. You should also be careful when giving medicines to children, since they can be more vulnerable to the effects of medicines.

Analgesics: Drugs that relieve pain. There are two main types: non-narcotic analgesics for mild pain, and narcotic analgesics for severe pain.

Antacids: Drugs that relieve indigestion and heartburn by neutralizing stomach acid.

Antianxiety Drugs: Drugs that suppress anxiety and relax muscles (sometimes called anxiolytics, sedatives, or minor tranquilizers).

Antiarrhythmics: Drugs used to control irregularities of heartbeat.

Antibacterials: Drugs used to treat infections.

Antibiotics: Drugs made from naturally occurring and synthetic substances that combat bacterial infection. Some antibiotics are effective only against limited types of bacteria. Others, known as broad spectrum antibiotics, are effective against a wide range of bacteria.

Anticoagulants and Thrombolytics: Anticoagulants prevent blood from clotting. Thrombolytics help dissolve and disperse blood clots and may be prescribed for patients with recent arterial or venous thrombosis.

Anticonvulsants: Drugs that prevent epileptic seizures.

Antidepressants: There are three main groups of mood-lifting antidepressants: tricyclics, monoamine oxidase inhibitors, and selective serotonin reuptake inhibitors (SSRIs).

Antidiarrheals: Drugs used for the relief of diarrhea. Two main types of antidiarrheal preparations are simple adsorbent substances and drugs that slow down the contractions of the bowel muscles so that the contents are propelled more slowly.

Antiemetics: Drugs used to treat nausea and vomiting.

Antifungals: Drugs used to treat fungal infections, the most common of which affect the hair, skin, nails, or mucous membranes.

Antihistamines: Drugs used primarily to counteract the effects of histamine, one of the chemicals involved in allergic reactions.

Antihypertensives: Drugs that lower blood pressure. The types of antihypertensives currently marketed include diuretics, beta-blockers, calcium channel blocker, ACE (angiotensin- converting enzyme) inhibitors, centrally acting antihypertensives and sympatholytics.

Anti-Inflammatories: Drugs used to reduce inflammation - the redness, heat, swelling, and increased blood flow found in infections and in many chronic noninfective diseases such as rheumatoid arthritis and gout.

Antineoplastics: Drugs used to treat cancer.

Antipsychotics: Drugs used to treat symptoms of severe psychiatric disorders. These drugs are sometimes called major tranquilizers.

Antipyretics: Drugs that reduce fever.

Antivirals: Drugs used to treat viral infections or to provide temporary protection against infections such as influenza.

Barbiturates: See "sleeping drugs."

Beta-Blockers: Beta-adrenergic blocking agents, or beta-blockers for short, reduce the oxygen needs of the heart by reducing heartbeat rate.

Bronchodilators: Drugs that open up the bronchial tubes within the lungs when the tubes have become narrowed by muscle spasm. Bronchodilators ease breathing in diseases such as asthma.

Cold Cures: Although there is no drug that can cure a cold, the aches, pains, and fever that accompany a cold can be relieved by aspirin or acetaminophen often accompanied by a decongestant, antihistamine, and sometimes caffeine.

Corticosteroids: These hormonal preparations are used primarily as anti-inflammatories in arthritis or asthma or as immunosuppressives, but they are also useful for treating some malignancies or compensating for a deficiency of natural hormones in disorders such as Addison's disease.

Cough Suppressants: Simple cough medicines, which contain substances such as honey, glycerine, or menthol, soothe throat irritation but do not actually suppress coughing. They are most soothing when taken as lozenges and dissolved in the mouth. As liquids they are probably swallowed too quickly to be effective. A few drugs are actually cough suppressants. There are two groups of cough suppressants: those that alter the consistency or production of phlegm such as mucolytics and expectorants; and those that suppress the coughing reflex such as codeine (narcotic cough suppressants), antihistamines, dextromethorphan and isoproterenol (non-narcotic cough suppressants).

Cytotoxics: Drugs that kill or damage cells. Cytotoxics are used as antineoplastics (drugs used to treat cancer) and also as immunosuppressives.

Decongestants: Drugs that reduce swelling of the mucous membranes that line the nose by constricting blood vessels, thus relieving nasal stuffiness.

Diuretics: Drugs that increase the quantity of urine produced by the kidneys and passed out of the body, thus ridding the body of excess fluid. Diuretics reduce water logging of the tissues caused by fluid retention in disorders of the heart, kidneys, and liver. They are useful in treating mild cases of high blood pressure.

Expectorant: A drug that stimulates the flow of saliva and promotes coughing to eliminate phlegm from the respiratory tract.

Hormones: Chemicals produced naturally by the endocrine glands (thyroid, adrenal, ovary, testis, pancreas, parathyroid). In some disorders, for example, diabetes mellitus, in which too little of a particular hormone is produced, synthetic equivalents or natural hormone extracts are prescribed to restore the deficiency. Such treatment is known as hormone replacement therapy.

Hypoglycemics (Oral): Drugs that lower the level of glucose in the blood. Oral hypoglycemic drugs are used in diabetes mellitus if it cannot be controlled by diet alone, but does require treatment with injections of insulin.

Immunosuppressives: Drugs that prevent or reduce the body's normal reaction to invasion by disease or by foreign tissues. Immunosuppressives are used to treat autoimmune diseases (in which the body's defenses work abnormally and attack its own tissues) and to help prevent rejection of organ transplants.

Laxatives: Drugs that increase the frequency and ease of bowel movements, either by stimulating the bowel wall (stimulant laxative), by increasing the bulk of bowel contents (bulk laxative), or by lubricating them (stool-softeners, or bowel movement-softeners). Laxatives may be taken by mouth or directly into the lower bowel as suppositories or enemas. If laxatives are taken regularly, the bowels may ultimately become unable to work properly without them.

Muscle Relaxants: Drugs that relieve muscle spasm in disorders such as backache. Antianxiety drugs (minor tranquilizers) that also have a muscle-relaxant action are used most commonly.

Sedatives: Same as Antianxiety drugs.

Sex Hormones (Female): There are two groups of these hormones (estrogens and progesterone), which are responsible for development of female secondary sexual characteristics. Small quantities are also produced in males. As drugs, female sex hormones are used to treat menstrual and menopausal disorders and are also used as oral contraceptives. Estrogens may be used to treat cancer of the breast or prostate, progestins (synthetic progesterone to treat endometriosis).

Sex Hormones (Male): Androgenic hormones, of which the most powerful is testosterone, are responsible for development of male secondary sexual characteristics. Small quantities are also produced in females. As drugs, male sex hormones are given to compensate for hormonal deficiency in hypopituitarism or disorders of the testes. They may be used to treat breast cancer in women, but either synthetic derivatives called anabolic steroids, which have less marked side- effects, or specific anti-estrogens are often preferred. Anabolic steroids also have a "body building" effect that has led to their (usually nonsanctioned) use in competitive sports, for both men and women.

Sleeping Drugs: The two main groups of drugs that are used to induce sleep are benzodiazepines and barbiturates. All such drugs have a sedative effect in low doses and are effective sleeping medications in higher doses. Benzodiazepines drugs are used more widely than barbiturates because they are safer, the side-effects are less marked, and there is less risk of eventual physical dependence.

Tranquilizer: This is a term commonly used to describe any drug that has a calming or sedative effect. However, the drugs that are sometimes called minor tranquilizers should be called antianxiety drugs, and the drugs that are sometimes called major tranquilizers should be called antipsychotics.

Vitamins: Chemicals essential in small quantities for good health. Some vitamins are not manufactured by the body, but adequate quantities are present in a normal diet. People whose diets are inadequate or who have digestive tract or liver disorders may need to take supplementary vitamins.

Have you ever had a problem with your medicines? You are not alone. There are so many things to keep track of. For example, you may have asked yourself:

• When exactly should I take my medicine?
• Is it safe to take vitamins when I take a prescription medicine?
• Now that I feel better, can I stop taking this medicine?

Medicine is prescribed to help you. But it can hurt if you take too much or mix medicines that don't go together. Many people have problems each year, some serious, because of taking the wrong medicine or not taking the right medicines correctly.

You can help yourself get the best results by being a part or your "health care team." Your health care team includes:

• The doctor, physician assistant, nurse practitioner, or other professionals who prescribe your medicine or are in charge of your care.
• A nurse who helps you at home, a doctor's office, or a hospital.
• The pharmacist who fills your prescription and can answer questions about your medicines.

Four Ways To Be Smart and Safe with Medicines

1. Give Your Health Care Team Important Information

Be a partner with your health care team. Tell them about all the medicines, vitamins, herbals, and dietary supplements you're taking. This includes:

• Prescription medicines.
• Medicines you can buy without a prescription, such as aspirin, diet pills, antacids, laxatives, allergy medicine, and cough medicine.
• Vitamins, including multivitamins.
• Dietary or herbal supplements such as St. John's wort or gingko biloba.

Be sure to tell your health care team:

• If you have allergies (including medicine-related allergies) or if you have had problems when taking a medicine.
• About other doctors or health professionals who have prescribed medicine for you or suggested that you take a vitamin or herbal supplement.
• If you are pregnant, may get pregnant, or are nursing.
• About any other illness or medical condition you have, like diabetes or high blood pressure.
• If cost is a concern. There may be another medicine that costs less and will work the same.

2. Get the Facts About Your Medicine

Ask questions about every new prescription medicine. Get the answers you need from your health care team before you take your medicine.

If your doctor writes your prescription by hand, make sure you can read it. If you can't read your doctor's handwriting, your pharmacist might not be able to either. If your doctor submits your prescription directly to the pharmacy, ask for a copy.

Ask your doctor to write down on the prescription why you need the medicine... for example, not just "take once a day" but "take once a day for high blood pressure."

If you have other questions or concerns:

• Talk to your doctor or pharmacist.
• Write questions down ahead of time and bring them to your appointment.

By asking questions now, you may prevent problems later.

• Write your questions down ahead of time. Keep a list of questions you want to ask your health care team. Take the list to your appointment.
• Be sure to write down what your health care team tells you about your medicine so you remember later.
• Bring a friend or family member with you when you visit the doctor. Talking over what to do with someone you trust can help you make better decisions.
• Try to use the same pharmacy so all your prescription records will be in one place.
• Read and save the information that comes with your medicine. It's often stapled to the bag from the pharmacy.
• Keep a list of all the medicines, vitamins, and dietary supplements or herbs you take. Add new medicines to the list when you start taking something new or when a dose changes. Show the list to your doctor and the pharmacist.
• Make a copy of your list. Keep one copy and give the other to a family member or friend
• Store all medicines together in one designated location in a dry and cool place. The kitchen and the bathroom are bad places to store medicine because of heat and moisture.
• Make sure medicine does not freeze if you store it in the refrigerator.
• Throw away any medicine that has expired or that your doctor has discontinued. (Ask your doctor or pharmacist for advice on how to throw away your specific medication.)

3. Stay With Your Treatment Plan

Now that you have the right medicine, you'll want to carry out the treatment plan. That's not always easy. Medicines may cause side effects. Or you may feel better and want to stop before finishing your medicines.

• Take all the antibiotics you were prescribed. If you are taking an antibiotic to fight an infection, it is very important to take all of your medicine for as long as your doctor prescribed even if you feel better. If you don't finish, the infection could come back and be harder to treat.
• Ask your doctor if your prescription needs to be refilled. If you are take medicine for high blood pressure or to lower your cholesterol, you may need your medicine for a long time.
• If you are having side effects or other concerns, tell your doctor. You may be able to take a different amount or type of medicine.
• Your medicine was prescribed only for you. Never give your prescription medicine to anyone else or take prescription medicine that wasn't prescribed for you, even if you have the same medical condition.
• Ask whether you need blood tests, x-rays, or other tests to find out if the medicine is working, if it's causing any problems, and if you need a different medicine. Ask your doctor to tell you what the tests showed.

Many products can help remind you to take your medicine on time and keep track of how much to take. There are containers you can fill with your pills for each day of the week, calendars to check off, and even products that fit on top of a pill bottle. Ask your pharmacist for help finding the right product for you.

You can get help:

• At work, there may be a nurse on site.
• At school, a nurse may be able to help your child take medicines on time and safely.
• At home, a visiting nurse may be able to help you.

Friends and family can help by:

• Going with you to the doctor. Ask them to write down information about your medicines and treatment plan.
• Picking up your medicine. Have them show the pharmacist your list of medicines, vitamins, and supplements. They should ask, "Will this new medicine work safely with the other medicines?"
• Calling regularly to remind you to take your medicine on time. If you are have problems, let them know.
• Keeping a daily record of medicine and the time of day so you won't take it twice.

4. Keep a Record of Your Medicines

Keep a list of all the medicines, vitamins, and dietary supplements or herbs you take. Add new medicines to the list when you start taking something new or when a dose changes.

Medication adherence, or taking medications correctly, is generally defined as the extent to which patients take medication as prescribed by their doctors. This involves factors such as getting prescriptions filled, remembering to take medication on time, and understanding the directions.

Common barriers to medication adherence include

• the inability to pay for medications
• disbelief that the treatment is necessary or helping
• difficulty keeping up with multiple medications and complex dosing schedules
• confusion about how and when to take the medication

Poor adherence can interfere with the ability to treat many diseases, leading to greater complications from the illness and a lower quality of life for patients. Here are some examples of areas in which medication adherence can pose challenges, along with tips for taking medications correctly and talking with health care professionals about your questions and concerns.

Taking Antibiotics

If you feel better and no longer have symptoms, you may think your illness is cured. But if you have a bacterial infection, this can be a dangerous assumption.

If the full course of antibiotics is not taken, a small number of bacteria are likely to still be alive. These surviving germs are likely to have some natural resistance to the antibiotic. As they multiply and spread, a new strain of resistant germs may begin to develop. This may be one way that Methicillin-Resistant Staphylococcus Aureus (MRSA) infections occur. MRSA is a type of bacteria that’s resistant to certain antibiotics.

It’s important to use antibiotics appropriately and to take the medication exactly as directed.

• Take all doses of the antibiotic, even if the infection is getting better.
• Don’t stop taking the antibiotic unless your doctor tells you to stop.
• Don’t share antibiotics with others.
• Don’t save unfinished antibiotics for another time.

Taking HIV/AIDS Medications

People with HIV/AIDS can have a particularly difficult time taking medications as prescribed, according to Richard Klein, the HIV/AIDS program director for the Food and Drug Administration’s (FDA) Office of Special Health Initiatives (OSHI).

Some of the main reasons:

• Multiple drugs may need to be taken at different times, which can be hard to remember.
• The side effects of certain drugs can sometimes make people feel worse instead of better.
• When people feel okay, they may not feel the need to take their drugs. They don’t have the ‘physical reminder’ to take the medications.
• People may not be aware of the risks of drug resistance that can occur if they stop treatment or skip or lower doses.

When you skip doses or stop taking a prescribed medication, you may develop strains of HIV that are resistant to the medications you are taking and even to some medications you haven’t taken yet. This may result in fewer treatment options should you need to change treatment regimens in the future.

FDA has given expedited reviews to several fixed dose combination medications like Atripla (a combination of efavirenz, emtricitabine and tenofovir) and Combivir (a combination of retrovir and epivir) to treat HIV. Fixed dose combination tablets contain two or more anti-HIV medications that can be from one or more drug classes.

“These fixed dose combinations are examples where the constituent drugs were already approved,” says Klein, “but the agency expedited review because the combined formulations simplified dosing, and thus were likely to improve adherence.” A standard drug review time is 10 months, while an expedited review of fixed dose combination tablets is generally completed within 6 months.

Tips for Consumers

Communicate with your health care professional. If medication side effects are bothering you, talk with your doctor or pharmacist about what you can do to lessen the problem. You might be able to switch to a different medication or your doctor may be able to adjust the timing of your dose.

Make sure you understand how long to take the medication. Some questions to ask when you’re prescribed a new medication are:

• Is it necessary to empty the bottle, or can I stop taking this medication once I feel better?
• Will I need to get a refill, or can I stop treatment when the bottle is empty?

Tell your doctor if paying for prescription drugs is a problem. Your doctor may be able to prescribe a generic medication or offer other suggestions to offset the cost of a drug. Generic drugs use the same active ingredients and are shown to work the same way in the body, but they can cost 30 percent to 80 percent less. Generics also have the same risks and benefits as their brand-name counterparts.

You can also shop around your neighborhood or legitimate online pharmacies for the best prices on prescription drugs.

You can also:

• Check to see whether you are eligible for drug assistance programs in your state.
• Check with the pharmaceutical companies that manufacture your medicines to find out whether you qualify for assistance.

Set daily routines to take medication. It can be helpful to connect taking the medication with normal, daily activities such as eating meals or going to bed. You can also keep backup supplies of your medication at your workplace or in your briefcase or purse.

Keep medications where you’ll notice them. For a medication that should be taken with food, place that medication on the dinner table or TV tray, or wherever you eat on a regular basis. If there are medications you need to take in the morning, put those medications in your bathroom, next to your toothbrush or your deodorant, or something else that you use as part of your morning routine.

Use daily dosing containers. These are available at most pharmacies and allow you to keep medications in compartments that are labeled with the days of the week and various dosage frequencies.

Keep a written or computerized schedule. This can cover the medications you take, how often you take them, and any special directions. Thanks to modern technology, there are a number of devices that have been designed to help patients adhere to a prescribed medication schedule. These include medication reminder pagers and wristwatches, automatic pill dispensers, and even voice-command medication managers. Ask your pharmacist for suggestions as to which particular devices may be helpful for you.

What are generic drugs?

A generic drug is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use. These similarities help to demonstrate bioequivalence, which means that a generic medicine works in the same way and provides the same clinical benefit as its brand-name version. In other words, you can take a generic medicine as an equal substitute for its brand-name counterpart.

Do generic medicines work the same as brand-name medicines?

Yes. Any generic medicine modeled after a brand-name medicine must perform the same in the body as the brand-name medicine. This standard applies to all generic medicines. A generic medicine is the same as a brand-name medicine in dosage, safety, effectiveness, strength, stability, and quality, as well as in the way it is taken and the way it should be used. Generic medicines use the same active ingredients as brand-name medicines and work the same way, so they have the same risks and benefits as the brand-name medicines. The FDA Generic Drugs Program conducts a rigorous review to make certain generic medicines meet these standards, in addition to conducting 3,500 inspections of manufacturing plants a year and monitoring drug safety after the generic medicine has been approved and brought to market.

It is important to note that there will always be a slight, but not medically important, level of natural variability—just as there is for one batch of brand-name medicine compared with the next batch of brand-name product. This variability can and does occur during manufacturing, for both brand-name and generic medicines. When a medicine, generic or brand-name, is mass produced, very small variations in purity, size, strength, and other parameters are permitted. FDA limits how much variability is acceptable.

For example, in a very large research study comparing generics with brand-name medicines, it was found that there were very small differences (approximately 3.5%) in absorption into the body between generic and the brand-name medicines. Some generics were absorbed slightly more, some slightly less. This amount of difference is expected and acceptable, whether for one batch of brand-name medicine tested against another batch of the same brand, or for a generic tested against a brand-name medicine. As a rule, the difference for the generic-to-brand comparison was about the same as the brand-to-brand comparison.

Why do brand-name drugs look different from their generic versions?

Trademark laws in the United States do not allow a generic drug or medicine to look exactly like other drugs already on the market. Generic medicines and brand-name medicines share the same active ingredient, but other characteristics, such as colors and flavorings, that do not affect the performance, safety, or effectiveness of the generic medicine, may be different.

Why do generic medicines cost less than brand-name medicines?

Generic drugs or medicines become available only after a rigorous review by FDA and after a set period of time that the brand-name version has been on the market exclusively. This is because new drugs, like other new products, are usually protected by patents that prohibit others from making and selling copies of the same drug. The patent protects the company's investment in the drug's development by giving the company the sole right to sell the drug while the patent is in effect. Because it takes such a long time to bring a new drug to market, this period of exclusivity allows drug companies to recoup the costs associated with bringing a new drug to market. FDA also grants certain periods of marketing exclusivity to brand-name drugs that can prohibit the approval of generic drugs. Once these patents and marketing exclusivities expire (or if the patents are successfully challenged by the generic drug company), the generic drug can be approved.

Generic drugs also tend to cost less than their brand-name counterparts because generic drug applicants do not have to repeat animal and clinical (human) studies that were required of the brand-name medicines to demonstrate safety and effectiveness. This is why the application is called an “abbreviated new drug application.” This, together with competition between the brand-name drug and multiple generic drugs, is a large part of the reason generic medicines cost much less.

In fact, multiple generic companies are often approved to market a single product; this creates competition in the marketplace, typically resulting in lower prices.

The reduction in upfront research costs means that, although generic medicines have the same therapeutic effect as their branded counterparts, they are typically sold at substantial discounts, an estimated 80 to 85% less, compared with the price of the brand-name medicine. According to the IMS Health Institute, generic drugs saved the U.S. healthcare system $1.67 trillion from 2007 to 2016.

What standards must generic medicines meet to receive FDA approval?

Drug companies can submit an abbreviated new drug application (ANDA) for approval to market a generic drug that is the same as (or bioequivalent to) the brand-name version. FDA's Office of Generic Drugs reviews the application to make certain drug companies have demonstrated that the generic medicine can be substituted for the brand-name medicine that it copies.

An ANDA must show the generic medicine is equivalent to the brand in the following ways:

• The active ingredient is the same as that of the brand-name drug/innovator drug.
  • An active ingredient in a medicine is the component that makes it pharmaceutically active — effective against the illness or condition it is treating.
  • Generic drug companies must provide evidence that shows that their active ingredient is the same as that of the brand-name medicine they copy, and FDA must review that evidence.
• The generic medicine is the same strength.
• The medicine is the same type of product (such as a tablet or an injectable).
• The medicine has the same route of administration (such as oral or topical).
• It has the same use indications.
• The inactive ingredients of the medicine are acceptable.
  • Some differences, which must be shown to have no effect on how the medicine functions, are allowed between the generic and the brand-name version.
  • Generic drug companies must submit evidence that all the ingredients used in their products are acceptable, and FDA must review that evidence.
• It lasts for at least the same amount of time.
  • Most medicines break down, or deteriorate, over time.
  • Generic drug companies must do months-long "stability tests" to show that their versions last for at least the same amount of time as the brand-name.
• It is manufactured under the same strict standards as the brand-name medicine.
  • It meets the same batch requirements for identity, strength, purity, and quality.
  • The manufacturer is capable of making the medicine correctly and consistently.
    • Generic drug manufacturers must explain how they intend to manufacture the medicine and must provide evidence that each step of the manufacturing process will produce the same result each time. FDA scientists review those procedures, and FDA inspectors go to the generic drug manufacturer's facility to verify that the manufacturer is capable of making the medicine consistently and to check that the information the manufacturer has submitted to FDA is accurate.
    • Often, different companies are involved (such as one company manufacturing the active ingredient and another company manufacturing the finished medicine). Generic drug manufacturers must produce batches of the medicines they want to market and provide information about the manufacturing of those batches for FDA to review.
• The container in which the medicine will be shipped and sold is appropriate.
• The label is the same as the brand-name medicine's label.
  • The drug information label for the generic medicine should be the same as the brand-name label. One exception is if the brand-name drug is approved for more than one use and that use is protected by patents or exclusivities. A generic medicine can omit the protected use from its labeling and only be approved for a use that is not protected by patents or exclusivities, so long as that removal does not take away information needed for safe use. Labels for generic medicines can also contain certain changes when the drug is manufactured by a different company, such as a different lot number or company name.
• Relevant patents or exclusivities are addressed.
  • As an incentive to develop new medicines, drug companies are awarded patents and exclusivities that may delay FDA approval of applications for generic medicines. FDA must comply with the delays in approval that the patents and exclusivities impose.

The ANDA process does not, however, require the drug applicant to repeat costly animal and clinical research on ingredients or dosage forms already approved for safety and effectiveness. This allows generic medicines to be brought to market more quickly and at lower cost, allowing for increased access to medications by the public.

Is a generic version of my brand-name medicine available?

In addition to asking your local pharmacist for assistance, there are three ways to find out if there is a generic version of your brand-name medicine available:

• Use Drugs@FDA, a catalog of FDA-approved drug products, including their drug labeling.
• Search for generic equivalents by using the online version of the "Orange Book."
  • First, search by proprietary or "brand" name.
  • Second, search again by the active ingredient name.
  • If other manufacturers are listed besides the brand-name manufacturer in result for searches by the "active ingredient," they are the generic product manufacturers.
• For very recent approvals, consult the First Generics List.

If you are unable to locate a generic version of your brand-name medicine, it may be that the brand-name medicine is still within the period of time when it has exclusive rights to the marketplace, to allow drug companies to recoup their costs for the initial research and marketing of the brand-name or innovator drug. It is only after both patent and other periods of exclusivity are resolved that FDA can approve generic versions of the medicine.

Does FDA monitor side effects or safety issues with generic medicines?

Yes. After FDA approves any medicine, including generics, it continues to examine the medicine's safety. FDA takes several actions to ensure safety and quality before and after a new or generic medicine is marketed.

FDA staff continually monitors drug products to make certain the medicines at all levels of the supply chain, from active pharmaceutical ingredients (APIs) to products being sold to consumers, are safe, effective, and high quality.

FDA also monitors and investigates reports of negative patient side effects or other reactions. The investigations may lead to changes in how a product (brand-name and generic counterparts) is used or manufactured.

Due to limited resources, FDA is unable to perform independent clinical studies, and the agency lacks the regulatory authority to require the generic industry to conduct such studies. FDA will, however, continue to investigate these reports to ensure that it has all the facts about these possible treatment failures and will make recommendations to health care professionals and the public if the need arises. Currently, to better understand what may cause problems with certain formulations if, in fact, they are linked to specific generic products, FDA is encouraging the generic industry to investigate whether, and under what circumstances, such problems occur.

Prescription drugs can be pricey, especially if you’re juggling several prescriptions. Buying generic drugs can be one way to save money. Generics have the same active ingredients as the brand-name drugs they’re based on. They cost 20 percent to 70 percent less, according to estimates from the Food and Drug Administration (FDA). If you want to make sure you’re getting generics when possible, talk to your doctor and pharmacist. You can ask your doctor to write a prescription allowing a generic drug product when it’s appropriate.

Getting Generic Drugs Q&A

Do all drugs have generic versions?

No, but a lot do. New drugs are protected by patents, so only the company that came up with the drug can sell it. Patents generally last 17 years, giving companies that put a lot of money into developing and promoting a drug time to recoup those costs. Once the patent expires, however, other companies can get a generic approved and start selling it.

To see what generic drugs FDA has approved lately, and for more information on generic drugs, visit www.fda.gov/drugs.

How can I get generic drugs?

To find out if there’s a generic drug that will work just as well for you as a brand-name drug you’re taking, talk to your doctor or pharmacist. Tell them you want the most effective drug at the best price, and that you want prescriptions for generic drugs when possible.

Each state has a law allowing pharmacists to substitute generic drugs for many brand-name products if your doctor doesn’t specify that the brand-name drug is required.

Will my doctor automatically prescribe generic drugs?

It depends on the doctor. You can ask your doctor to write a prescription allowing substitution of a generic drug when it’s appropriate. You also can ask whether a generic product will be as effective and less costly.

Offers You Get About Low-Cost Prescriptions

If you get emails saying free or low-cost prescription drugs are just a phone call away — or you visit a website that says it can help you get free prescription drugs for a fee — it’s likely to be a scam.

However, many prescription drug companies offer free or low-cost drugs for people who:

• don’t have prescription drug coverage
• can’t afford to pay for medication out of pocket, or
• have used their insurance’s annual allowance

But the programs have qualification standards. Your income and the cost of the drugs you need can affect whether you qualify. Information on these programs is free — and publicly available — from your physician, pharmacists, and the government.

Perhaps you’ve had this experience: You go to your local pharmacy to fill a prescription from your doctor, and the pharmacist confirms there is a generic available.

“If it’s a copy, it must not be as good,” you think.

You would be wrong.

What are generic drugs, and how does the Food and Drug Administration ensure that they are as safe and effective as brand-name drugs?

Rigorous Standards

A brand-name drug is often patented to protect it from competition and thus to help the drug manufacturer recover the development costs. Several years later when the patent expires, other drug companies can copy the brand-name drug and seek FDA’s approval for its generic version.

Today, more than 8 in 10 prescriptions filled in the United States are for generic drugs. The use of generic drugs is expected to grow over the next few years as a number of popular drugs come off patent.

Because generic drug makers are not required to repeat the clinical trials of new drugs and generally do not pay for advertising, marketing and promotion, generics are usually substantially less expensive than brand-name drugs. According to the Congressional Budget Office, generic drugs save consumers an estimated $8 billion to $10 billion a year at retail pharmacies. Billions more are saved when hospitals use generics.

To obtain FDA approval, generic drug makers must prove that their product performs in the same way and is as safe and effective as the brand-name drug. Therefore, health care professionals and consumers can be assured that FDA-approved generic drugs have met the same strict standards as their brand-name counterparts.

The generic drug approval process includes a review of scientific data on manufacturing, ingredients and performance. A generic drug approved by FDA that would be substituted by a pharmacist for a brand name drug will:

• Contain the same active ingredients as the brand-name drug. Active ingredients make the drug effective against the disease or condition it is treating. Inactive ingredients may vary.
• Be identical in strength, dosage form and route of administration. If the brand-name drug is a capsule and is taken orally, so is the generic.
• Treat the same medical condition.
• Be absorbed into the bloodstream at a similar rate and over the same period of time.
• Meet the same requirements for identity, strength, purity and quality.
• Be manufactured under the same strict standards that FDA demands of brand-name drugs.

Testing Generic Drugs

The FDA approval process assures that medicines sold in the United States are safe and effective. But FDA also confirms safety and effectiveness by testing selected drugs—both brand and generic—in its laboratories or through research contracts and grants. This includes the raw ingredients used to make the product, as well as the finished drug.

“If questions are raised about whether a generic drug performs the same as a brand-name product, we perform experiments in FDA laboratories, evaluate data and take a comprehensive scientific look at any possible differences between the products,” says Mansoor Khan, R.Ph., Ph.D., director of FDA’s Division of Product Quality Research.

In rare cases, new evidence emerges indicating that a generic drug may not have the safety or effectiveness as was previously believed. That’s what happened in 2012 with one of the generic forms of Wellbutrin XL 300 mg, a drug to treat depression. FDA sponsored a study comparing Budeprion XL 300 mg, the generic drug, with Wellbutrin XL 300 mg, and concluded that Budeprion XL 300 mg may not be as effective.

FDA encourages consumers and health care professionals to notify FDA of any adverse side effects when using drugs and devices the agency regulates, by reporting them online to MedWatch, FDA’s safety information and adverse event reporting program, or by telephone at 1-800-FDA-1088. Visit FDA’s Drug Quality Sampling and Testing Programs website to learn more.

How Do I Know if a Generic Is Available?

Not every drug has an approved generic. To find out if there is a generic equivalent for your brand-name drug, use Drugs@FDA. You can search for generic equivalents using FDA’s Electronic Orange Book. You can also consult the most recent monthly approvals for First Generics.

If you have chronic kidney disease (CKD), diabetes, or high blood pressure—or if you take certain blood pressure medicines that affect your kidneys—you should take steps to protect your kidneys from harm.

ACE inhibitors and ARBs are two types of blood pressure medicine that may slow the loss of kidney function and delay kidney failure. You can tell if you’re taking one of these medicines by its generic name. ACE inhibitors end in –pril and ARBs have generic names that end in –sartan; for example, lisinopril and losartan.

You may also take a diuretic, sometimes called a water pill, to meet your blood pressure goals.

Manage your medicines with help from your health care providers

At the pharmacy

The next time you pick up a prescription or buy an OTC medicine or supplement, ask your pharmacist how the product may affect your kidneys or react with other medicines you take.

Fill your prescriptions at only one pharmacy or pharmacy chain so your pharmacist can monitor your medicines and supplements, and check for harmful interactions between your medicines.

At your doctor’s office

Keep an up-to-date list of your medicines and supplements in your wallet. Take your list with you, or bring all your medicine bottles, to all health care visits.

Be careful about using over-the-counter medicines

If you take OTC or prescription medicines for headaches, pain, fever, or colds, you may be taking a nonsteroidal anti-inflammatory drug (NSAID). NSAIDs include popular pain relievers and cold medicines that can damage your kidneys if you take them for a long time, or lead to acute kidney injury if you take them when you are dehydrated or your blood pressure is low.

Ibuprofen and naproxen are NSAIDs. NSAIDs are sold under many different brand names, so ask your pharmacist or health care provider if the medicines you take are safe to use.

You also can look for NSAIDs on Drug Facts labels like the one below.

Plan ahead to manage pain, flu, or other illness

Almost everyone gets sick once in a while. Your doctor or pharmacist can help you plan ahead to keep your kidneys safe until you get well. Prepare in advance so you know what to do if you have pain or a fever, diarrhea, nausea, or vomiting, which can lead to dehydration.

Before you get sick, ask your health care provider or pharmacist the following questions

• If I get sick, are there medicines I should not take while I’m sick?
• If I need to stop medicines when I’m sick, when can I restart them?
• What can I take or do to relieve a headache or other pain?
• What can I take to relieve a fever?
• If I have diarrhea or am vomiting, do I need to change how or when I take my blood pressure medicine?

If blood pressure medicines help my kidneys, why all this extra caution?

In normal, everyday circumstances, taking your blood pressure medicines as prescribed helps protect your kidneys. However, certain situations, such as when you’re dehydrated from the flu or diarrhea, can lower the blood flow to your kidneys and cause harm.

Factors that can add up to cause harm

When you get sick from something like the flu or diarrhea, or have trouble drinking enough fluids, the blood pressure in your body may decrease. As a result, the pressure in your kidneys can be low, too.

In most cases, healthy kidneys can protect themselves. However, if you keep taking your blood pressure medicines when you’re dehydrated or have low blood pressure, your kidneys might have a hard time protecting themselves. The pressure within your kidneys might drop so low that your kidneys won’t filter normally.

If you’re dehydrated, NSAIDs can also keep your kidneys from protecting themselves. As a result, taking NSAIDs when you’re sick and dehydrated can cause kidney injury.

Other ways to protect your kidneys

Read about what else you can do to keep your kidneys healthy. If you already have CKD, the steps you take to protect your kidneys also may help prevent heart disease—and improve your health overall.

The liver is a remarkable, if underappreciated, organ. It turns the nutrients in our diets to substances the body can use and converts toxins into harmless substances or makes sure they are removed from the body

When the liver is working well, our metabolism hums along in equilibrium. But drugs and dietary supplements can sometimes wreak havoc with that system, leading to dangerous liver problems. The Food and Drug Administration (FDA) is working to prevent drug-induced liver injuries.

“Any drug may cause dangerous liver problems but, fortunately, such problems only occur rarely,” says John R. Senior, M.D., an FDA gastrointestinal medical reviewer and consultant in hepatology, which includes study of the liver. “It is challenging to predict how drugs will affect the liver because each patient is different in how they respond to a given drug. Our goal is to prevent the toxicity of drugs.”

Acute liver failure is a rapid deterioration of the organ’s ability to function. Data suggest that prescription and over-the-counter drugs (OTC) and dietary supplements cause more acute liver failure cases than all other reasons combined.

FDA has identified several instances of liver damage caused by dietary supplements. For example, the agency has issued public health warnings and sent warning letters to companies marketing supplements for weight loss and muscle building. In one instance, a Texas-based company agreed to recall and destroy certain dietary supplement products after discovering a link between the supplement and cases of liver failure and non-viral hepatitis.

No Easy Way to Identify the Vulnerable

Finding even a few cases of serious liver toxicity in clinical trial subjects exposed to a drug can be a reason for discontinuing the trial. Also, cases of serious liver toxicity have prompted FDA to request sponsors to withdraw their approved drugs from the market.

Senior explains there’s no easy way to identify the people who might be vulnerable. “The drug-disease relationship is not so simple,” he says. “Identifying drugs that may cause liver injury only solves half the problem. The other half: Drugs that appear to be safe in pre-clinical studies still may be harmful to some patients.”

Meanwhile, we have an aging population that is more dependent on drugs. “The more medications you take, the more likely you are to have trouble,” Senior says.

A few drugs are toxic to the liver only when used in excess. One example is acetaminophen.

“Acetaminophen when used as labeled is generally considered to be safe. But overdoses of acetaminophen are the most common cause of drug-related liver injury, whether these occur accidentally or otherwise,” says Mark Avigan, M.D., a medical reviewer at FDA with a background in gastroenterology and hepatology. “With acetaminophen overdoses, some people get a more severe reaction than others.”

Acetaminophen is an active ingredient in hundreds of OTC and prescription medicines commonly used to treat musculoskeletal pain and fever, allergies, coughing, colds, flu, and even sleeplessness. Overdoses leading to serious liver injury have resulted from consumers inadvertently taking both OTC and prescription drugs containing acetaminophen.

Inadvertent overdoses with prescription drugs that contain acetaminophen and a narcotic have been responsible for a significant proportion of all the cases of acetaminophen-related liver failure in the United States, some of which have resulted in liver transplant or death.

FDA has taken steps to keep consumers safe. In early 2014, FDA requested withdrawal of over 120 applications for combination prescription acetaminophen drug products containing more than 325 mg acetaminophen per dosage unit. The agency also has reminded pharmacists and physicians to stop prescribing and dispensing combination prescription acetaminophen products containing more than 325 mg. It is FDA’s understanding that as a result, all manufacturers have discontinued marketing combination prescription drug products that contain more than 325 mg of acetaminophen.

Some antibiotics and nonsteroidal anti-inflammatory medications also have been tied to liver damage.

Hepatitis, a liver inflammation, can have several potential causes. Drugs may induce a form of hepatitis that closely resembles viral hepatitis (liver inflammation caused by viral infection).

Signs and Symptoms

How can you recognize the signs of liver problems?

Avigan says you might feel tired and have a poor appetite. In more extreme cases, your eyes and skin become yellowish (jaundice) and your skin becomes very itchy. “Your skin itches because the liver is not properly clearing toxins from the body,” he says.

When patients taking a drug they have not used before get those symptoms, they should seek immediate medical attention and stop using that drug if it is identified as the cause, Avigan cautions.

If the symptoms surface and the patient has been taking a medication for a long time, there could be another cause. Senior says it’s difficult to be certain that the symptoms were caused by a drug and not something else. Obesity and excessive consumption of alcohol also can damage the liver.

Considering Risks and Benefits

Patients should discuss the risks and benefits of any drug with their doctors when they start treatment, Avigan says. They should also discuss dietary supplements with their clinician before taking them.

Some life-saving drugs are the only options for very sick patients.

“Before approving or denying approval of a drug, we evaluate its risks and work to identify its liver injury potential, even if only one in 10,000 people will be badly affected,” Avigan says. “With some drugs, for example for cancer patients, the benefits of treatment might far outweigh the risks.”

The liver can regenerate even when 65% of it is destroyed or surgically removed, as in a cancer treatment. This versatile organ is often capable of adapting and becoming tolerant of various foreign agents, including drug products. But if the liver isn’t healthy, complications from drug interactions can be even worse.

May 28, 2014

When your medicines are no longer needed, they should be disposed of promptly. Consumers and caregivers should remove expired, unwanted, or unused medicines from their home as quickly as possible to help reduce the chance that others accidentally take or intentionally misuse the unneeded medicine, and to help reduce drugs from entering the environment. Below, we list some options and special instructions for you to consider when disposing of expired, unwanted, or unused medicines.

Your best choices for disposal of unused or expired medicines are:

• Medicine take-back options,
• Disposal in the household trash and
• Flushing certain potentially dangerous medicines in the toilet

How to dispose of unused/expired medicine

Medicine take-back options

Consumers and caregivers should remove expired or unused medicines from their home as quickly as possible to help reduce the chance that others may accidentally take or intentionally misuse the unneeded medicine.

Medicine take-back options are the preferred way to safely dispose of most types of unneeded medicines. There are generally two kinds of take-back options: periodic events and permanent collection sites.

Periodic events

Local law enforcement agencies may also sponsor medicine take-back events in your community. Consumers can also contact their local waste management authorities to learn about events in their area.

Permanent collection sites

In your community, authorized permanent collection sites may be in retail pharmacies, hospital or clinic pharmacies, and law enforcement facilities. Some authorized collection sites may also offer mail-back programs or collection receptacles, sometimes called “drop-boxes,” to assist consumers in safely disposing of their unused medicines.

Disposal in the household trash

If no take-back programs or DEA-registered collectors are available in your area, and there are no specific disposal instructions in the product package insert, such as flushing described below, you can also follow these simple steps to dispose of most medicines in the household trash*:

• Mix medicines (do not crush tablets or capsules) with an unpalatable substance such as dirt, cat litter, or used coffee grounds;
• Place the mixture in a container such as a sealed plastic bag;
• Throw the container in your household trash; and
• Delete all personal information on the prescription label of empty pill bottles or medicine packaging, then dispose of the container.

*Other technologies to provide additional options for patients to use to dispose of medicines in the household trash have been developed.

Flushing certain potentially dangerous medicines in the toilet

A small number of medicines have specific instructions to immediately flush down the toilet when no longer needed and a take-back option is not readily available. These medicines may be especially harmful and, in some cases, fatal with just one dose if they are used by someone other than the person for whom they were prescribed. But as drug take-back programs and sites increase across the country, these could be options too, if one is readily available to you.

Promptly disposing of unneeded medications can help prevent accidental exposure to, including ingestion of, these potentially dangerous medicines by children and others, including pets.

There are some medicines that, when not disposed of properly, can pose significant risks. For example, patients using fentanyl patches should immediately flush their used or unneeded patches down the toilet. When powerful medicines such as these patches are disposed down the toilet, you help to keep others safe by ensuring these medicines are not misused or accidentally ingested or touched.

Some medicines come with disposal instructions. If you received disposal instructions for a medicine, you should dispose of that medicine as directed by those instructions. Otherwise, if your medicine is on the list of medicines recommended for flushing, and you did not receive information containing disposal instructions along with your prescription, you should dispose of any used or unneeded medicine by flushing it down the toilet if a take-back option is not readily available.

Impact of flushing medicines on the environment

FDA believes that the known risk of harm, including death, to humans from accidental exposure to certain medicines, especially potent opioid medicines, far outweighs any potential risk to humans or the environment from flushing these medicines when a take-back option is not readily available. FDA will continue to conduct risk assessments as a part of our larger activities related to the safe use of medicines.

List of medicines recommended for disposal by flushing when take-back options are not readily available

This list from FDA tells you which medicines you should flush when they are no longer needed and take-back options are not readily available.

Is your medicine cabinet full of expired drugs or medications you no longer use? Your medicine is for you. What’s safe for you might be harmful for someone else. You can dispose of your expired, unwanted, or unused medicines through a drug take back program — or you can do it at home.

Drug Take Back Programs

The U.S. Drug Enforcement Administration (DEA) sponsors National Prescription Drug Take Back Day in communities nationwide. Many communities also have their own drug take back programs. Check with your local law enforcement officials to find a location near you or with the DEA to find a DEA-authorized collector in your community.

You can also check with your pharmacist. Some pharmacies have mail-back programs and disposal kiosks for unused medicines.

How to Dispose of Medicines at Home

There are two ways to dispose of medicine, depending on the drug.

Flushing medicines: Because some medicines could be especially harmful to others, they have specific directions to immediately flush them down the sink or toilet when they are no longer needed.

How will you know? Check the label or the patient information leaflet with your medicine. Or consult the U.S. Food and Drug Administration’s list of medicines recommended for disposal by flushing.

Disposing medicines in household trash: Almost all medicines can be thrown into your household trash. These include prescription and over-the-counter (OTC) drugs in pills, liquids, drops, patches, creams, and inhalers.

Follow these steps:

1. Remove the drugs from their original containers and mix them with something undesirable, such as used coffee grounds, dirt, or cat litter. This makes the medicine less appealing to children and pets and unrecognizable to someone who might intentionally go through the trash looking for drugs.
2. Put the mixture in something you can close (a re-sealable zipper storage bag, empty can, or other container) to prevent the drug from leaking or spilling out.
3. Throw the container in the garbage.
4. Scratch out all your personal information on the empty medicine packaging to protect your identity and privacy. Throw the packaging away.

If you have a question about your medicine, ask your health care provider or pharmacist.

Disposing of Fentanyl Patches

Some prescription drugs — such as powerful narcotic pain medicines and other controlled substances — have instructions for flushing to reduce the danger of overdose from unintentional or illegal use.

One example is the fentanyl patch. This adhesive patch delivers a strong pain medicine through the skin. Even after a patch is used, a lot of the medicine remains. That’s why the drug comes with instructions to flush used or leftover patches.

Disposing of Inhaler Products

One environmental concern involves inhalers used by people who have asthma or other breathing problems, such as chronic obstructive pulmonary disease. Read handling instructions on the labeling of inhalers and aerosol products. These products could be dangerous if punctured or thrown into a fire or incinerator. To properly dispose of these products and follow local regulations and laws, contact your trash and recycling facility.

Flushing Drugs and the Water Supply

Some people wonder if it’s okay to flush certain medicines. There are concerns about the small levels of drugs that may be found in surface water, such as rivers and lakes, and in drinking water supplies.

“The main way drug residues enter water systems is by people taking medicines and then naturally passing them through their bodies,” says Raanan Bloom, Ph.D., an environmental assessment expert at the FDA. “Many drugs are not completely absorbed or metabolized by the body and can enter the environment after passing through wastewater treatment plants.”

The FDA and the U.S. Environmental Protection Agency take the concerns of flushing certain medicines in the environment seriously. Still, there has been no sign of environmental effects caused by flushing recommended drugs.

About 50,000 young children end up in emergency rooms each year because they got into medicines while an adult wasn’t looking. These emergency visits can be prevented by always putting every medicine up and away and out of children’s reach and sight every time you use it.

Families take medications and vitamins to feel well and to stay well. However, any medication, including those you buy without a prescription, can cause harm if taken in the wrong way or by the wrong person. Practicing safe medication storage, while at home and when on-the-go, can help keep children safe.

Protect your children. Here’s how:

• Put medicines up and away and out of children’s reach and sight.
  • Children are curious and put all sorts of things in their mouths. Even if you turn your back for less than a minute, they can quickly get into things that could hurt them.
  • Pick a storage place in your home that children cannot reach or see. Different families will have different places. Walk around your house and decide on the safest place to keep your medicines and vitamins.
• Put medicines away every time.
  • This includes medicines and vitamins you use every day. Never leave medicine out on a kitchen counter or at a sick child’s bedside, even if you have to give it again in a few hours.
• Make sure the safety cap is locked.
  • Always relock the cap on a medicine bottle. If the bottle has a locking cap that turns, twist it until you hear the click or cannot twist anymore.
  • Remember, even though many medicines have safety caps, children may be able to open them. Every medicine must be stored up and away and out of children’s reach and sight.
• Teach your children about medicine safety.
  • Teach your children what medicine is and why you or a trusted adult must be the one to give it to them.
  • Never tell children medicine is candy to get them to take it, even if they don’t like to take their medicine.
• Tell your guests about medicine safety.
  • Ask family members, houseguests, and other visitors to keep purses, bags, or coats that have medicine in them up and away and out of sight when they are in your home.
• Be prepared in case of an emergency.
  • Call your poison control center at 800.222.1222 right away if you think your child might have gotten into a medicine or vitamin, even if you are not completely sure.
  • Program the Poison Help number into your home and cell phones so you will have it when you need it.
• Take Action.
  • Visit the Up and Away Campaign’s website to learn more about storing medications safely while at home and when traveling with young children. Share these safe storage tips with family and friends.

Your pharmacist can help you learn how to use your prescription and nonprescription (over-the-counter) medicines safely and effectively. You can also use these tips when talking with your other healthcare providers.

Tell your pharmacist

• Every medicine you use, especially if you use multiple pharmacies, even if it is the same pharmacy chain.
  • Keep a record and give it to your pharmacist. List all the prescription and over-the-counter medicines, vitamins, herbals, and other supplements you use. Tell your pharmacist exactly how you are taking the medicine.
  • Don’t forget to tell your pharmacist about any changes to your medicines. This includes anything you have stopped taking.
• If you've had any allergic reactions or problems with medicines, dietary supplements, food, medical devices or other medical treatments.
  • What kind of reaction did you have? Did your throat swell up? Did you get a rash? Or was it a stomach ache or diarrhea?
• Any medical conditions you have or have had, including any abnormal lab results.
• Anything that could affect your use of medicine, such as trouble with swallowing, reading small labels, understanding English, remembering to take your medicine, distinguishing the look of one medicine from another, paying for medicines, or transportation to the pharmacy. Your pharmacist may be able to help, so just ask!
• If you plan to start or have started something new such as a new medicine, supplement, diet, or exercise regime. Your pharmacist can help you avoid medicines, supplements, foods, and other things that don't mix well with your medicines.
• If you are pregnant, plan to become pregnant, breastfeeding or plan to breastfeed.
• The best phone number to reach you and your current address. . This is in case the pharmacist has any questions for you or if there are any issues. If you prefer to receive text messages instead of phone calls, let your pharmacy know! Many pharmacies have the ability to text.
• If there have been any changes to your insurance plan/policy/card.

Ask your pharmacist

• What is the most important information I should know about this medicine?
• How do I pronounce the name of my medicine? Does it go by any other name(s)? What are the brand and generic (non-brand) names?
• Are there any cheaper options? Is a generic available? Are there any co-pay assistance coupons?
• How does this medicine work and what is it used for?
• How and when should I use it? How much do I use? Should I take it with food or without food, before a meal or after a meal? What time of the day should I use it? How many times a day is it used? Is there a limit on how often I should use it?
• How long should I use it? Can I stop using the medicine or use less if I feel better? In what circumstances should I stop taking this medicine?
• What should I do if I …miss a dose? ….throw up shortly after taking a dose? ….use too much? ….lose the medicine?
• Will this take the place of anything else I am taking?
• When will the medicine start working? How should I expect to feel?
• Are there any special directions for using this?
• Should I avoid any other medicines, dietary supplements, drinks, foods, activities, or other things? Do I have to space this medicine out from any other medicines or food?
• Does this medicine contain any ingredients I am allergic to?
• Is there anything I should watch for, like allergic reactions or side effects? What are the serious side effects? What do I do if I get any?
• Will I need any tests to check the medicine's effects (blood tests, x-rays, other)? When will I need those?
• How and where should I store this medicine? Is it stored at room temperature or refrigerated or frozen? What should I do if I left it in a hot car?
• When should I throw out this medicine? When does it expire?
• Is there a medication guide or other patient information for this medicine?
• Where and how can I get more written information?
• When should I contact my doctor about this medicine? In what situation should I call 911?

Before you leave the pharmacy after picking up your prescription

• Look to be sure you have the right medicine. If you've bought the medicine before, make sure this medicine has the same shape, color, size, markings, and packaging. Anything different? Don’t hesitate to ask your pharmacist. If it seems different when you use it, tell your pharmacist, doctor, or other healthcare professional.
• Be sure you know the right dose for the medicine and you know how to use it. Unsure about anything? Ask your pharmacist.
• For liquid medicines, make sure there is a measuring spoon, cup, or syringe. If the medicine doesn't come with a special measuring tool, ask your pharmacist for one. (Spoons used for eating and cooking may give the wrong dose. Don't use them.)
• Be sure you have any information the pharmacist can give you about the medicine. Read it and save it.
• Get the pharmacy’s phone number and hours, so you can call back for any questions or refills.

Taking out-of-date drugs carries certain risks

Out with the old! Be it the fresh start of a new year or a spring cleaning, consumers are encouraged to take stock of what has surpassed its usefulness. Medicines are no exception.

In 1979, the U.S. Food and Drug Administration began requiring an expiration date on prescription and over-the counter medicines. The expiration date is a critical part of deciding if the product is safe to use and will work as intended.

The expiration date can be found printed on the label or stamped onto the bottle or carton, sometimes following “EXP.” It is important to know and stick to the expiration date on your medicine. Using expired medical products is risky and possibly harmful to your health.

Expired medicines can be risky

Expired medical products can be less effective or risky due to a change in chemical composition or a decrease in strength. Certain expired medications are at risk of bacterial growth and sub-potent antibiotics can fail to treat infections, leading to more serious illnesses and antibiotic resistance. Once the expiration date has passed there is no guarantee that the medicine will be safe and effective. If your medicine has expired, do not use it.

According to the DEA many people don’t know how to properly clean out their medicine cabinets. Failing to safely dispose of old medications, especially opioids, all too often leads to dangerous drugs ending up in the wrong hands. The CDC reports that 50,000 young children end up in emergency rooms each year because they got into medicines while an adult wasn’t looking.

Finally, expired medicines are also not just a risk to the person they were prescribed for and can injure children and pets if taken by mistake. For all these reasons, proper disposal of unneeded medicines is essential.

What to do with expired meds

First, read the medicine’s label and follow any specific disposal instructions that may be included. A drug take-back program, if available, is the preferred way to dispose of expired, unwanted, or unused medicine. For example, the National Prescription Drug Take-Back Day, coordinated by the DEA, addresses a vital public safety and public health issue by focusing attention on this important issue and reminding everyone to get rid of unneeded and outdated medicines. Through this important program many tons of unneeded and out-date drugs have been removed for proper disposal.

When drug take-back programs aren’t available, federal guidelines recommend throwing the medicines away in the household trash after mixing them with a substance like dirt or kitty litter and then sealing the mixture in a container (see graphic at right). However, certain medicines are specifically recommended for flushing down a toilet or sink because they could be especially harmful, even fatal, to a child, pet, or anyone else if taken accidentally. For a list of medicines recommended for disposal by flushing, as well as other information on proper disposal, please see the Disposal of Unused Medicines page.

A place for everything

Proper storage is one way to help make sure your medicines will remain safe and effective up to their expiration date. Be sure to read the label to see if there are specific storage instructions for your medicine. Certain medicines need to be stored in the refrigerator and others cannot be exposed to high temperatures. Improper storage – such as a damp bathroom cabinet – can contribute to decreased effectiveness in medicines that have not reached their posted expiration date. For most medicines, to help ensure the proper shelf life of your medicine, it is better to store medicine in a cool, dry place such as a dresser drawer, storage box, closet shelf, or kitchen cabinet.

When storing medicine in a kitchen cabinet make sure that it is away from hot appliances and the sink due to changing temperatures and humidity, which can affect the medicine. When storing medicine in a high traffic area, like a kitchen, care should be taken to prevent access by children at risk of accidental poisoning or others who may be tempted to take for abuse/misuse.

Remember to store medicines properly and don’t use expired medicines -- it’s not worth the risk!

At some point your healthcare or managed care company may have recommended tablet splitting for reasons such as to adjust the dosing of your medication or to reduce costs. In such cases, it is your healthcare professional’s responsibility to monitor the impact of risks associated with the practice of tablet splitting. You should always talk to your healthcare professional before splitting a tablet and not be afraid to ask him or her questions if you are considering splitting tablets.

When considering whether to split a tablet, you and your healthcare professional should bear in mind the following:

• If a tablet is FDA-approved to be split, this information will be printed in the “HOW SUPPLIED” section of the professional label insert and in the patient package insert. Also, the tablet will be scored with a mark indicating where to split it.
• If a tablet does not include such information in the label, FDA has not evaluated it to ensure that the two halves of a split tablet are the same in weight or drug content or work the same way in the body as the whole tablet. You should discuss with your healthcare professional whether to split this type of tablet.
• If your healthcare professional asks you to split your tablets, do not split the entire supply of tablets at one time and then store them for later use. That is, make sure that both halves are taken before splitting the next tablet. This is important because split tablets may be affected by factors such as heat, humidity and/or moisture content. For example, a split tablet stored in a damp environment such as in a bathroom medicine cabinet could be affected.
• Your healthcare professional may be able to recommend the best method by which to split a tablet. In many cases, a tablet splitter may be appropriate. However, some tablets may not be suitable for this method because of their unique shape and size—even if they appear to be scored. It is important to discuss this issue with your healthcare professional to determine what is best for you.
• Most sustained, controlled, or timed release medications are not meant for splitting. In those rare instances where splitting is recommended for this type of medication, such information will be printed in the “HOW SUPPLIED” section of the professional label insert and in the patient package insert and will be scored.
• When you switch from one brand of medicine to another, you and your healthcare professional should confirm whether the newly prescribed tablet is splitable, even if the original tablet could be split. The same medications can be manufactured differently, thus may not have been developed to be split.

REMEMBER: Tablet splitting should be done only under the supervision of a healthcare professional.

Abbreviated New Drug Application (ANDA)
An Abbreviated New Drug Application (ANDA) contains data that, when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Generic drug applications are called "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, a generic applicant must scientifically demonstrate that its product is bioequivalent (i.e., performs in the same manner as the innovator drug). Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public.

Abbreviated New Drug Application (ANDA) Number
This six-digit number is assigned by FDA staff to each application for approval to market a generic drug in the United States.

Active Ingredient
An active ingredient is any component that provides pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or animals.

Approval History
The approval history is a chronological list of all FDA actions involving one drug product having a particular FDA Application number (NDA). There are over 50 kinds of approval actions including changes in the labeling, a new route of administration, and a new patient population for a drug product.

Application
See New Drug Application (NDA), Abbreviated New Drug Application ANDA), or Biologic License Application (BLA)

Approval Letter
An official communication from FDA to a new drug application (NDA) sponsor that allows the commercial marketing of the product.

Application Number
See FDA Application Number

Biologic License Application (BLA)
Biological products are approved for marketing under the provisions of the Public Health Service (PHS) Act. The Act requires a firm who manufactures a biologic for sale in interstate commerce to hold a license for the product. A biologics license application is a submission that contains specific information on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical affects of the biologic product. If the information provided meets FDA requirements, the application is approved and a license is issued allowing the firm to market the product.

Biological Product
Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living entities such as cells and tissues. Biologics are isolated from a variety of natural sources — human, animal, or microorganism — and may be produced by biotechnology methods and other cutting-edge technologies. Gene-based and cellular biologics, for example, often are at the forefront of biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available.

In general, the term "drugs" includes therapeutic biological products.

Brand Name Drug
A brand name drug is a drug marketed under a proprietary, trademark-protected name.

Chemical Type
The Chemical Type represents the newness of a drug formulation or a new indication for an existing drug formulation. For example, Chemical Type 1 is assigned to an active ingredient that has never before been marketed in the United States in any form.

Company
The company (also called applicant or sponsor) submits an application to FDA for approval to market a drug product in the United States.

Discontinued Drug Product
Products listed in Drugs@FDA as "discontinued" are approved products that have never been marketed, have been discontinued from marketing, are for military use, are for export only, or have had their approvals withdrawn for reasons other than safety or efficacy after being discontinued from marketing.

Dosage Form
A dosage form is the physical form in which a drug is produced and dispensed, such as a tablet, a capsule, or an injectable.

Drug
A drug is defined as:

• A substance recognized by an official pharmacopoeia or formulary.
• A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
• A substance (other than food) intended to affect the structure or any function of the body.
• A substance intended for use as a component of a medicine but not a device or a component, part or accessory of a device.
• Biological products are included within this definition and are generally covered by the same laws and regulations, but differences exist regarding their manufacturing processes (chemical process versus biological process.)

Drug Product
The finished dosage form that contains a drug substance, generally, but not necessarily in association with other active or inactive ingredients.

FDA Action Date
The action date tells when an FDA regulatory action, such as an original or supplemental approval, took place.

FDA Application Number
This number, also known as the NDA (New Drug Application) number, is assigned by FDA staff to each application for approval to market a new drug in the United States. One drug can have more than one application number if it has different dosage forms or routes of administration

Generic Drug
A generic drug is the same as a brand name drug in dosage, safety, strength, how it is taken, quality, performance, and intended use. Before approving a generic drug product, FDA requires many rigorous tests and procedures to assure that the generic drug can be substituted for the brand name drug. The FDA bases evaluations of substitutability, or "therapeutic equivalence," of generic drugs on scientific evaluations. By law, a generic drug product must contain the identical amounts of the same active ingredient(s) as the brand name product. Drug products evaluated as "therapeutically equivalent" can be expected to have equal effect and no difference when substituted for the brand name product.

Label
The FDA approved label is the official description of a drug product which includes indication (what the drug is used for); who should take it; adverse events (side effects); instructions for uses in pregnancy, children, and other populations; and safety information for the patient. Labels are often found inside drug product packaging.

Marketing Status
Marketing status indicates how a drug product is sold in the United States. Drug products in Drugs@FDA are identified as:

• Prescription
• Over-the-counter
• Discontinued
• None - drug products that have been tentatively approved

Medication Guide
A medication guide contains information for patients on how to safely use a drug product.

NDA (see New Drug Application)

New Drug Application (NDA)
When the sponsor of a new drug believes that enough evidence on the drug's safety and effectiveness has been obtained to meet FDA's requirements for marketing approval, the sponsor submits to FDA a new drug application (NDA). The application must contain data from specific technical viewpoints for review, including chemistry, pharmacology, medical, biopharmaceutics, and statistics. If the NDA is approved, the product may be marketed in the United States. For internal tracking purposes, all NDA's are assigned an NDA number.

New Drug Application (NDA) Number
This six digit number is assigned by FDA staff to each application for approval to market a new drug in the United States. A drug can have more than one application number if it has different dosage forms or routes of administration. In Drugs@FDA, you can find the NDA number under the column named "FDA Application."

NME (see New Molecular Entity)

New Molecular Entity (NME)
An NME is an active ingredient that contains no active moiety that has been previously approved by the Agency in an application submitted under section 505 of the Federal Food, Drug, and Cosmetic Act, or has been previously marketed as a drug in the United States.

Over-the-Counter Drugs (OTC)
FDA defines OTC drugs as safe and effective for use by the general public without a doctor's prescription.

Patient Package Insert (PPI)
A patient package insert contains information for patients' understanding of how to safely use a drug product.

Pharmaceutical Equivalents
FDA considers drug products to be pharmaceutical equivalents if they meet these three criteria:

• they contain the same active ingredient(s)
• they are of the same dosage form and route of administration
• they are identical in strength or concentration

Pharmaceutically equivalent drug products may differ in characteristics such as

• shape
• release mechanism
• labeling (to some extent)
• scoring
• excipients (including colors, flavors, preservatives)

Prescription Drug Product
A prescription drug product requires a doctor's authorization to purchase.

Product Number
A product number is assigned to each drug product associated with an NDA (New Drug Application). If a drug product is available in multiple strengths, there are multiple product numbers.

Reference Listed Drug (see RLD)

Review
A review is the basis of FDA's decision to approve an application. It is a comprehensive analysis of clinical trial data and other information prepared by FDA drug application reviewers. A review is divided into sections on medical analysis, chemistry, clinical pharmacology, biopharmaceutics, pharmacology, statistics, and microbiology.

Review Classification
The NDA and BLA classification system provides a way of describing drug applications upon initial receipt and throughout the review process and prioritizing their review. (List of Review Classifications and their meanings)

RLD (Reference Listed Drug)
A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.

Strength
The strength of a drug product tells how much of the active ingredient is present in each dosage.

Supplement
A supplement is an application to allow a company to make changes in a product that already has an approved new drug application (NDA). CDER must approve all important NDA changes (in packaging or ingredients, for instance) to ensure the conditions originally set for the product are still met.

Supplement Number
A supplement number is associated with an existing FDA New Drug Application (NDA) number. Companies are allowed to make changes to drugs or their labels after they have been approved. To change a label, market a new dosage or strength of a drug, or change the way it manufactures a drug, a company must submit a supplemental new drug application (sNDA). Each sNDA is assigned a number which is usually, but not always, sequential, starting with 001.

Supplement Type
Companies are allowed to make changes to drugs or their labels after they have been approved. To change a label, market a new dosage or strength of a drug, or change the way it manufactures a drug, a company must submit a supplemental new drug application (sNDA). The supplement type refers to the kind of change that was approved by FDA. This includes changes in manufacturing, patient population, and formulation.

Tentative Approval
If a generic drug product is ready for approval before the expiration of any patents or exclusivities accorded to the reference listed drug product, FDA issues a tentative approval letter to the applicant. The tentative approval letter details the circumstances associated with the tentative approval. FDA delays final approval of the generic drug product until all patent or exclusivity issues have been resolved. A tentative approval does not allow the applicant to market the generic drug product.

Therapeutic Biological Product
A therapeutic biological product is a protein derived from living material (such as cells or tissues) used to treat or cure disease.

Therapeutic Equivalence (TE)
Drug products classified as therapeutically equivalent can be substituted with the full expectation that the substituted product will produce the same clinical effect and safety profile as the prescribed product. Drug products are considered to be therapeutically equivalent only if they meet these criteria:

• they are pharmaceutical equivalents (contain the same active ingredient(s); dosage form and route of administration; and strength.)
• they are assigned by FDA the same therapeutic equivalence codes starting with the letter "A." To receive a letter "A", FDA
• designates a brand name drug or a generic drug to be the Reference Listed Drug (RLD).
• assigns therapeutic equivalence codes based on data that a drug sponsor submits in an ANDA to scientifically demonstrate that its product is bioequivalent (i.e., performs in the same manner as the Reference Listed Drug).

Therapeutic Equivalence (TE) Codes
The coding system for therapeutic equivalence evaluations allows users to determine whether FDA has evaluated a particular approved product as therapeutically equivalent to other pharmaceutically equivalent products (first letter) and to provide additional information on the basis of FDA's evaluations (second letter). Sample TE codes: AA, AB, BC (More on TE Codes)

• FDA assigns therapeutic equivalence codes to pharmaceutically equivalent drug products. A drug product is deemed to be therapeutically equivalent ("A" rated) only if:
• a drug company's approved application contains adequate scientific evidence establishing through in vivo and/or in vitro studies the bioequivalence of the product to a selected reference listed drug.
• those active ingredients or dosage forms for which no in vivo bioequivalence issue is known or suspected.
• Some drug products have more than one TE Code.
• Those products which the FDA does not deem to be therapeutically equivalent are "B" rated.

Over-the-counter drugs are not assigned TE codes.