How to Read a Package Insert
When you pick up a prescription, the pharmacy usually gives you a short handout about the medicine. You may also get a longer document called a package insert, which explains how the medicine is used, what risks to watch for, and other details that can help answer your questions. The U.S. Food and Drug Administration (FDA) approves the information in this insert based on studies in people. Every FDA-approved prescription medicine has one. You can also find package inserts online, including on drug company websites.
To read a package insert, start with the parts that matter most to you, such as what the medicine is used for, how to take it, major warnings, side effects, and drug interactions. The sections below explain what the main parts mean and where to look for the information you need.
What’s included in package inserts?
Important Safety Information
This section shows key safety warnings about the medicine, often in a boxed format. You can find more details in other sections.
Indications and Usage
This section lists the uses the FDA has approved for the medicine. In this example, it lists the types of epilepsy that were studied before the medicine was approved.
Doctors sometimes use medicines for problems not listed here, so it may not list your type of epilepsy. This is called “off-label use”. It is common and legal for a clinician to prescribe a medicine for a condition that is not included in the indication if, in the best judgement of the clinician, the medication may help. Off-label prescribing may happen with less commonly seizure types or in children. In those cases, the prescriber may use other studies, experience, and expert advice to decide if the medicine may help.
Some insurance plans may not cover a medication for an off-label use. They may also pay only part of the cost, so you may have to pay more. If you need help paying for medication, learn about patient assistance programs.
Some seizure medicines are also used for other health problems, such as pain, migraine, or mood disorders. If you need treatment for another condition, your doctor may consider a medicine that could help with both.
Dosage and Administration
This section gives the recommended dose. It explains how to start the medicine and how to raise the dose over time. Your doctor may tell you to start at a lower dose or go more slowly to lower the chance of side effects.
If the medicine is approved for more than one use, you may see separate dosing instructions for each use. There may also be special directions for children, older adults, or people with certain health conditions.
If your doctor tells you to take the medicine in a different way, ask why. The right dose may change based on:
- Age
- Health problem
- Other medicines
Keep following your doctor’s instructions and tell them if you feel any side effects.
Dosage Strength and Forms
This section tells you what forms the medicine comes in, such as tablets, capsules, or liquid, and how much medicine is in each one.
Contraindications
Contraindications are reasons not to use a medicine. For example, you should not take a medication if you had an allergic reaction to it or a similar medicine before, or if it could mix badly with another medicine you take.
This section may also warn doctors not to prescribe the medicine for people with certain health conditions because of a higher risk of serious side effects. For example, the package insert for Depakote says it should not be used in people with liver disease. If you have other health problems, review this section with your doctor.
Warnings and Precautions
This section explains serious side effects that may happen. If there is a boxed warning, this section gives more detail. Read it so you know what signs to watch for. Do not assume these problems will happen to you. Ask your doctor what the warning means for you.
Precautions explain:
- How to use the medicine as safely as possible.
- Who needs closer checkups.
- Lab tests that are needed.
- Activities that need extra care, such as driving.
- Information about pregnancy.
This section may also say that you should not take the medicine with certain foods, other medicines, or products such as antacids. It is a good idea to check this section for anything you use often.
Adverse Reactions
This section lists the side effects reported by people who took the medicine during clinical studies. The side effects are often grouped by body system and sometimes by how often they happen.
A side effect called common or frequent may still have happened in only a small number of people. Inserts often compare people who took the medicine with people who took a placebo, which is an inactive treatment. They may also list side effects reported after the medicine was sold.
These lists can look scary because they include many problems, from mild to serious. Keep in mind that this section lists everything reported by people taking the medicine, even if the medicine may not have caused it.
You may have some side effects, or none at all. Even the most common side effects do not affect everyone. Also, seizure medicines are often tested in people who take other seizure medicines too, so your experience may be different.
Some side effects are rare and may never be a problem for you. But if they are also listed under Warnings or Precautions, review them with your doctor.
Drug Interactions
This is one of the most important parts of the insert. It lists how this medicine may affect other prescriptions and over-the-counter medicines, and how other medicines may affect it. If you take any medicines listed here, review all of your medicines with your doctor and pharmacist.
Use in Specific Populations
This section may explain possible problems if the medicine is used during pregnancy or while breastfeeding. If you are planning a pregnancy or become pregnant, it is important to talk with your doctor about your medicine. Your doctor may also know about pregnancy registries that track seizure medicines. Keep in mind that most women have healthy babies no matter which medicine they use.
It may also explain how the medicine is used in children, older adults, and people with certain health conditions.
Drug Abuse and Dependence
This section says whether the medicine could be misused or could cause emotional or physical dependence. Most seizure medicine inserts say there is no clear evidence of misuse or dependence, or that this has not been studied in people. Some seizure medicines, such as barbiturates or benzodiazepines, can cause dependence.
If you have a history of dependence or substance use disorder, review this section with your doctor. If you have been taking a medicine that can cause dependence, never stop it suddenly. A doctor should help you lower the dose slowly.
Overdosage
This section explains what may happen if too much medicine is taken and how it may be treated. This information is mostly for medical professionals. If you think someone took too much medicine, call poison control or go to the emergency room right away.
Description
This section gives the chemical name of the medicine and may show a diagram of it. It also lists the forms it comes in, such as tablets, capsules, or liquid, and the available doses. You may also see inactive ingredients like fillers, colors, or flavors. If you have allergies or sensitivities, this section may help.
Clinical Pharmacology
This section may be hard to read. In simple terms, it explains how the medicine works in the body, how the body takes it in, how it may be changed or broken down when in the body, how it leaves the body, and how it works at different doses. It may also explain whether it works differently in children, older adults, or people with kidney or liver disease.
Nonclinical Toxicology
This section sums up animal studies that may help doctors understand how the medicine could affect people. It may include problems that are hard to study in people, such as cancer risk, fertility problems, or other long-term health concerns.
Clinical Studies
This section describes study results. It shows how well the medicine works and what risks or side effects may happen. It can help doctors compare the medicine with a placebo, see how it works by itself, or see how it works with other seizure medicines.
Supplied, Storage, and Handling
This section lists the forms of the medicine, such as tablets, capsules, or liquid. It may describe each one by color, shape, and markings so you can make sure you have the right product. If you use a liquid, it may tell you whether to shake it first.
This section also gives storage instructions. It tells you whether the medicine should be kept in the refrigerator or away from heat, light, or moisture. For example, some medicines should not be left in a hot car.
Patient Counseling Information
This section is written in simpler language and shares key information about how to use the medicine, possible side effects, and important warnings. It reminds prescribers what to tell patients, but it may not include everything you need to know. The drug maker may also provide a Medication Guide with more patient-friendly information.
Resources
Epilepsy Centers
Epilepsy centers provide you with a team of specialists to help you diagnose your epilepsy and explore treatment options.
Epilepsy Medication
Find in-depth information on anti-seizure medications so you know what to ask your doctor.
Epilepsy and Seizures Helpline
Call our Epilepsy and Seizures Helpline and talk with an epilepsy information specialist or submit a question online.
Tools & Resources
Get information, tips, and more to help you manage your epilepsy.
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