Drug Safety FAQs

Get answers to the most common questions about prescription drug use, safety, and recalls.

Prescription Drug Questions

  • What is a prescription?

    A prescription is a medicine ordered by a doctor or medical professional to benefit a patient, based on their symptoms. The length of time for which the prescription is valid varies based on the individual’s needs, and what the physician determines is necessary and most beneficial. A prescription is a controlled substance, and must be ordered for a legitimate illness or condition by a registered physician.

  • How do doctors know what prescription(s) you need?

    Doctors are required to go to medical school for years to make sure that they are educated on dozens of treatment options and medications. In addition, many doctors take ongoing education and training, read academic literature, and attend conferences and other professional gatherings to make sure they know about new drugs and new uses of existing drugs. All of this training and information helps them determine the best medication to treat a particular illness or condition.

    A doctor may prescribe you a medication if they think your condition is treatable, and if they believe that it is safe for you to take the particular drug they are prescribing. Since there are thousands of medications on the market, the prescription a doctor writes will depend on the your symptoms, preferences, any allergies you may have, and sometimes even the cost of the prescription.

  • What questions should I ask my doctor about prescriptions?

    The U.S. Food & Drug Administration (FDA) recommends asking the following questions about your prescription:

    • What is the name of the medicine?
    • What is the medicine supposed to do?
    • How and when do I need to take the prescription?
    • How much time should pass between each dose?
    • For how long do I need to take the prescription?
    • Do I need to take the prescription with food, water, or at the same time as another medication?
    • What foods, drinks, other medicines, dietary supplements, or activities should I avoid while taking this prescription?
    • Can this prescription be taken with over-the-counter medicines?
    • Is there a less expensive alternative?
    • What should I do if I miss or forget a dose?
    • Are there any other special instructions to follow?
    • What are the possible side effects, and what should I do if they occur?
    • When should I expect the medicine to start working?
    • How will I know if the medication is working?

    These questions can also be asked of your pharmacists when you go to pick up the prescription.

  • How should I store my prescriptions?

    Always read the directions on your prescription and follow storage directions indicated. If you have any questions about how to store your prescription, talk to your doctor or pharmacist.

    In most cases, prescriptions should be stored in a clean, dry area, such as a cabinet. It’s important to not store out in the open, like countertops or windowsills, where they can be accessed by others, especially children. Because medications are sensitive to light, temperature, and moisture, it’s best to keep them in a place where they can be stored at room temperature.

    Some prescriptions may need to be kept cool, such as in a refrigerator. This includes some types of medicines that are held in suspension, insulin, and certain other liquid or gel medications.

  • I found an old prescription — how can I dispose of it responsibly?

    Since medications have expiration dates, it’s important to dispose of old prescriptions appropriately when they expire. The best method, if possible, is to return unused prescriptions through what’s called a take-back program. DEA-authorized collectors or local law enforcement may be able to provide materials to collect unused medications.

    If take-back programs aren’t available in your area, most medicines can be mixed with a grainy substance, such as kitty litter, used coffee grounds, or dirt, and then placed in the trash. When disposing of old prescription bottles, be sure to remove or scratch out any personal information on the bottle.

    A very small number of prescriptions are not recommended to be thrown away by the FDA. These medications, such as fentanyl patches, should be flushed down the toilet. This is to make sure that there is no chance for a pet or person to accidentally take the medication, because with these select few prescriptions, even one dose can cause death.

  • What is the difference between generic drugs and brand name drugs?

    There is not much difference between generic drugs and brand name drugs besides the price. Brand name drugs hit the market first, because it’s owned by a pharmaceutical company who has patent rights to the medication. Once the FDA determines that the drug is safe, the company can sell the medication exclusively as long as they have rights to it.

    After a drug patent expires, a generic drug manufacturer is able to make a cheaper version of the drug, which means more people are able to buy it at an affordable price. The generic drug must contain the same active ingredient, the same dose and concentration, and be able to be taken the same way (as a pill, for example).

    The difference in the prescriptions may be that they look different in shape, color, or packaging. Generic versions may also have different inactive ingredients or preservatives than a brand name drug. The vast majority of doctors agree, however, that a generic medication is just as good as a brand name one.

  • Can I take someone else’s prescription if it’s the same drug?

    It is never a good idea to take someone else’s prescription. Even if you believe you are taking the same drug in the same dosage, there may be a difference that you are not aware of. Also, some drugs that have similar names may have very different effects on the body. Finally, if you take someone else’s prescription, that means they may not have enough medicine for their own needs, which can cause harm or force them to pay more to purchase a refill.

    For all of these reasons, it is extremely important to only take medications prescribed to you by a doctor who has considered your specific medical needs.

  • What is “off-label” drug use?

    Off-label drug use is the use of a prescription for something other than its intended use. When a prescription goes on the market, the FDA must approve that the drug is safe, and what condition(s) it is intended to treat. This is called the indications for use.

    When a drug is used off-label, it is being used in a way not indicated on the label. This could be using it as a treatment for a different medical condition, taking a different dose, or taking the medication in a different way (injecting it versus swallowing it, for example.) Some off-label drug uses are studied as part of clinical trials, and if the off-label use is determined to effectively treat a new condition, it may be approved by the FDA as a new indication to be added to the label.

    Off-label drug use is not prohibited in the U.S.. The only exception is with pain medications, which can only be prescribed in the United States for intended use.

Drug Safety Questions

  • Why are some prescriptions considered unsafe?

    Even though prescription medications are regulated by the FDA, many carry serious side effects that can be dangerous to some patients. These can include everything from muscle aches to heart problems, which may even lead to death. Each year, about 4.5 million Americans visit the emergency room because of side effects from their medications.

    For prescriptions that carry the risk of a number of problems, the FDA requires the manufacturer to put a warning label on the bottle. Some prescriptions are also considered more unsafe because of the risk that patients may become addicted, such as with opioid pain medications.

  • Are prescription drugs addictive?

    Some prescription drugs can become addictive. When taking a medication, it works by either creating or restricting chemical reactions in the brain. Based on the personality of the individual, as well as the type of drug, it is very possible to become dependent on your prescription. Three classes of prescriptions that are more likely to be addictive are:

    • Stimulants – drugs that increase attention
    • Opiates – drugs that reduce pain
    • Sedatives – drugs that treat anxiety or sleep disorders

    Signs of prescription drug abuse may include:

    • More frequent refills or refill requests
    • Unapproved methods of preparation (such as crushing) or ingestion (such as snorting)
    • Stealing or “borrowing” prescriptions or pills from others
    • A change in buying habits, such as purchasing prescriptions online instead of a retail pharmacy

    Symptoms of drug addiction may include:

    • Mood swings and irritability
    • Increased consumption of alcohol
    • Changes in sleep patterns
  • Is it safe to take prescription drugs while pregnant?

    Most likely not, since the effects of many prescriptions on fetuses are not widely known. Many studies on animals have shown that taking most prescriptions during pregnancy can pose a danger to both mother and child.

    Because of this, every drug is assigned to an alphabetical “pregnancy category” by the FDA based on its safety to take while pregnant. The only drugs in the A category, which are determined completely safe to take during pregnancy, are prenatal vitamins and thyroid medication. All other drugs are considered unsafe for women who are pregnant.

  • Are generic drugs safe?

    In the vast majority of instances, generic drugs are as safe to take as their brand name counterparts. They have been found no more likely to cause risks or side effects than brand name drugs. They contain the same active ingredient as brand name drugs, which are tested for years with a patent, before a generic brand can go on the market. This means that generic drugs are just as safe to take, and are usually cheaper.

  • Can people die from a prescription drug?

    If a person takes too much of a prescription drug (i.e., overdose), they can die if they don’t get proper medical attention right away. In fact, the class of drugs that most result in an overdose, which can cause death, are prescription medications. According to the Foundation for a Drug-Free World, certain classes of prescription medication (opioids, depressants, and antidepressants) lead to more deaths by overdose than do the most dangerous illegal drugs (amphetamines, cocaine, heroin, and methamphetamine). This is why it’s important to be very careful and serious with your prescriptions, and make sure that you are always taking the correct dosage.

    The number of deaths caused by overdosing on prescription medication has grown drastically in the last several years based on figures from the National Center for Health Statistics. In 2001, the number of deaths caused by prescription drugs was 10,000 in the United States. In 2014, the number of deaths has risen to over 25,000.

  • What should I do if I take the wrong dosage?

    Many Americans make mistakes with their medications daily, including not taking the correct prescription or dosage. If you accidentally take a little more than you meant to, you will probably be safe, but you should review the medication bottle for emergency numbers, and contact your doctor if you feel that it’s an emergency.

    For some individuals, it is possible to continuously take the wrong dose, which can result in worsening conditions that may lead to more complications and side effects, as well as a worse overall health. Severe cases may lead to permanent disability, comas, or death.

    Given the potential for taking the wrong dosage, it is extremely important to make sure you understand what medication you’re taking and how much is needed. Conversations with your doctor or pharmacist are critical to making sure you stay educated about your health.

  • What should I do if I miss a dose?

    Life gets busy and sometimes it’s easy to forget to take your medication. Many people think that they can just “double up” on their dose with no negative side effects. Some medications can result in an immediate, dangerous health reaction. Your body may become overwhelmed and speech slurring, nausea, dizziness, and even unconsciousness are possible, depending on the specific drug.

    In other cases, some patients may successfully take two or more doses without feeling worse. However, this could lead to severe effects down the road, especially if the patient continues to self-medicate with the incorrect dosage.

    If you miss a dose of your medication, read the label to see whether it provides instructions about what to do if you miss a dose. If you still need help, contact your doctor or pharmacist for advice. Additional, it may be beneficial to work out a plan with your doctor to determine what to do if you miss a dose. This way, you will be prepared if you do miss a dose, rather than panicking and trying to “make up for it” by taking two doses or more.

  • How long can prescription drugs be stored?

    While some medication may be good for a long time, The National Institutes of Health (NIH) recommend throwing out prescriptions that have passed the expiration date. Also, the NIH recommends getting rid of medication if it is damaged in any way (e.g., crushed pills, broken capsules, etc.) or has changed in color, smell, or texture.

  • How can you tell when a prescription has expired?

    On the label of a prescription bottle, there is an expiration date. For many states, this date defaults to one year after the date of sale. There is also another date on many bottles, which is usually two years after the date of sale. This is the manufacturer’s expiration date, and this means how long the prescription is “good” when stored in wet, hot temperatures.

  • Is it safe to buy medicine in bulk?

    In an effort to save money, some patients are interested in buying their medication in bulk. However, before buying in bulk, make sure the individual taking the medicine has been on the medication for at least three months to make sure that there are no negative side effects.

    The advantage to buying in bulk is the potential for saving a significant amount on the long-term cost of the medication. Generally, it is advisable not to purchase more than a 90 day supply so that the medication doesn’t expire before used, or in case you end up going off the prescription sooner than expected – for example, if you have bad side effects or if the medication stops working for you. Pay attention to the labels and, as always, follow the directions on the packaging for storing the medicine.

  • Is it safe to buy medication online?

    There are many legitimate online pharmacies that allow you to buy your medication, even in bulk. However, fake websites and companies certainly exist. The risks of buying from a scam website may be that they send a patient unsafe or ineffective drugs. It is always important to make sure that the website is safe and credible before making any purchases.

    To ensure that a website is legitimate:

    • Look for contact information
    • Make sure that the company is located within the United States
    • Make sure the site is licensed by the state board of pharmacy
    • Check for a VIPPS seal, which means that a website has been verified as an internet pharmacy site by the National Association of Boards of Pharmacy

    Safe online pharmacies should also verify that you have a prescription before making a purchase and have a pharmacist available  who answer your questions.

  • Is it safe to buy medicine from other countries?

    In recent years, the idea of buying medicine from other countries to save money has become more popular. Neighboring countries like Canada and Mexico have cheaper medications, in part due to regulatory differences and price controls, so many websites will try to sell them to United States patients without a prescription. This is a huge red flag!

    No legitimate doctor or pharmacist will give you medicine without a prescription. Other countries can then sell these drugs without regulating them for safety. It is illegal for any person to import prescription drugs into the U.S. – which is essentially what buying prescriptions from other countries is.

    Play it safe and only purchase prescriptions from within the U.S.

  • What should I do if I think I have an unsafe drug?

    Although medications are studied by researchers, approved by the FDA, and prescribed by your doctor, some drugs cause negative reactions. If the drug creates dangerous or persistent symptoms, call your doctor or pharmacist and make sure you can take yourself off of the medication. Some drugs may require a weaning period to avoid withdrawal symptoms. In other cases, your doctor or pharmacist may tell you to stop taking the drug immediately.

    Once you have safely stopped taking a medication under supervision of your doctor, you can dispose of the drug properly.

    Another problem with the safety of prescription drugs is that some effects are delayed in appearing. This happens because even though the FDA reviews the prescription for years before approving, some side effects may take longer to show themselves, or may only exist in some patients who were not included in the study sample. The more medications that are on the market, the higher chance there is of danger. As always, have a detailed conversation with your doctor about any concerns.

Drug Side Effect Questions

  • What is a side effect?

    A side effect is a reaction that your body produces when some active ingredient(s) in the drug interferes with your body’s ability to function. Side effects can be caused by any medication, including a prescription drugs, over-the-counter medicines, or even dietary supplements.

    Side effects can be acute, lasting only a short time as your body gets used to a particular medication, or chronic, meaning they occur for as long as you take the medication. Minor side effects can include nausea, muscle aches, dizziness, fatigue, and more. Unfortunately, more serious side effects also are a possibility with many medications. These include the risk of a stroke, heart condition, severe pain, and even death.

    If you start to feel very ill after starting a new prescription, contact your doctor or call 911 immediately.

  • Do all medications have side effects?

    Most medical professionals and scientists agree that all medications can cause side effects in users. Even over-the-counter drugs, commonly thought of as completely safe, can pose risks to patients who don’t read the label and take too many doses.

    It’s important to follow the instructions for use for all medications, whether they are prescription drugs, over-the-counter medications, or dietary supplements.

  • Is a drug interaction different than a side effect?

    While drug interactions and side effects are two different things, they can be experienced at the same time in some patients.

    A side effect is a response that your body produces when a drug negatively interacts with one or more systems in your body. A drug interaction is what happens when a drug is taken that negatively interacts with one of three things: another drug, a food or beverage, or an existing condition.

    For example, taking a medication to help you sleep may cause side effects of nausea and dizziness. If you are taking a sleep medication and an allergy medication, you may feel physically slowed down. This is what is known as a drug-drug interaction.

    It is extremely important to consider everything when discussing starting a new medication with your doctor. Notify your doctor of all existing medical conditions such as high blood pressure, and of any important lifestyle factors, such as alcohol consumption. These factors can make a drug react differently and may pose a serious threat to your health.

  • Should I stop taking a drug if I experience a side effect or interaction?

    Some side effects are minor and short lived. These include brief episodes of nausea, mood swings, and fatigue. These side effects usually fix themselves as your body gets used to the medication, and many patients do not feel the need to stop the drug or call their doctor.

    If you experience a serious side effect or interaction, you may want to immediately stop taking it, and not tell your doctor. Unless you are experiencing a severe allergic reaction or other life threatening emergency, do not just stop taking the drug.

    Many medications can cause serious side effects when stopped abruptly, so it’s important to work with your doctor to make a slow, withdrawal plan. It’s also important to know warning signs before they happen, so you are prepared on whether a side effect is very serious or not.

  • Are there any ways to avoid or manage side effects?

    Being honest with your doctor about your health will help them prescribe you a medication that is least likely to cause side effects. They will also tell you the risk of side effects with that particular drug, so that you are aware and may be able to avoid some or even all of them.

    For example, if you know that you have a sensitive stomach, and that this new medication carries a risk of nausea, take the medication with food or milk, as long as your doctor says that this is okay. Other helpful hints for nausea are to avoid spicy foods, heavy meals, and drink a lot of water.

    Other side effects such as diarrhea and constipation can be avoided by not drinking caffeine, or food/drink high in fiber, acidity, or spice. Discuss appropriate strategies for avoiding and managing side effects with your doctor or pharmacist.

  • For what side effects should I call my doctor?

    If a side effect feels severe, do not wait to call your doctor. This could include intense physical pain, to the point where you can barely move, or dizziness so extreme that you almost pass out. If side effects persist for days or weeks at a time, it’s also important to contact your doctor immediately, as something more serious may be going on.

    Other dangerous side effects which should be reported to a doctor include bleeding that will not stop, coughing up blood, hallucinations, blue lips or fingernails, long periods of crying or anger, and more.

    The bottom line is that you know your body the best, and if a side effect feels serious, do not wait to call your doctor.

Drug Recall Questions

  • Why can a drug be recalled?

    The FDA is responsible for making sure that drugs on the market are safe for users to take. When a bad experience is reported by a patient, either from a side effect or drug interaction, a recall may be issued. This is more likely if a high number of patients report problems, or if more research is done and shows that the drug poses a serious risk for users.

    Another reason a drug may be recalled is if there is a manufacturing or packaging problem with the drug. If the drug is contaminated while being made, or if a packaging error makes the drug become unsealed before it reaches the patient, it may be unsafe to take. Once again, if a large number of patients report these problems, a drug may be recalled. Companies can also voluntarily recall drugs if they discover a manufacturing defect or contamination.

  • Who issues drug recalls?

    It is usually the drug manufacturer’s responsibility to issue a voluntary recall for an unsafe drug. Many times the FDA requires the manufacturer to take the drug off the market. The FDA will then add the recall to its database, along with information about the seriousness of the problem, so that consumers can see when the drugs are removed from the market.

    For your convenience, ConsumerSafety.org pulls together important recall information from the FDA and other regulatory agencies in one place, to help you find the information you need to keep you safe.

  • Who should I contact if I think a drug should be recalled?

    You can contact the drug manufacturer and the FDA to notify them that that you think the drug should be recalled. Patients are encouraged to contact the FDA with information about drug problems, so that they can act quickly in taking them off the market, before they hurt anyone seriously.

    Be sure to include enough information to make an effective report, including your contact information, the contact information of any other persons affected, and clearly state the problem and its history. Also include any identifying information on the label or container, and the store’s name, address, and date of the purchase.

  • What should I do if a drug I’m taking is recalled?

    If you become aware that a drug you are taking has been recalled, immediately contact your doctor to discuss the recall and the next steps you need to take. They will be able to educate you on the seriousness of the recall and what prescription may be more appropriate for you to take in the meantime.

  • How can I find information about specific drug recalls?

    For your convenience, ConsumerSafety.org pulls together important recall information from the FDA and other regulatory agencies in one place, to help you find the information you need to keep you safe.

  • Where can I find information about legal actions related to drug recalls?

    ConsumerSafety.org provides substantial information about recalls and legal actions related to prescription drugs. To find information about a specific device, visit the Drugs section of our site and search for the device you want to know more about.

    If you are looking for information about the rights you have as a user of medical devices, visit our Legal Rights page.