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  4. 7 Things to Know About How You Can Find CDER’s Drug Safety Information
  1. News & Events for Human Drugs

7 Things to Know About How You Can Find CDER’s Drug Safety Information

In this Internet Age, we often go online for medical and health-related information. But not all this information is reliable, including information about medications. There are many false statements and conclusions shared online. The popularity of social media platforms has helped to broadly and rapidly spread false, inaccurate, and/or misleading information about drugs. Making medical decisions based on inaccurate information can have negative consequences. It can lead you to choose drugs that are not safe and effective, or to forgo treatments that are. 

An older woman reviewing a prescription bottle while researching on her laptop at home.

CDER’s role in providing timely, accessible, evidence-based information on a drug's safety is crucial. This drug safety information helps you and health care professionals understand the potential risks and benefits of medications. CDER provides information proactively in a variety of ways, such as through drug safety communications and notifications, to help keep you informed of drug safety issues.

CDER drug safety resources are not, however, a substitute for talking with your health care professional. 

Here are 7 Things to Know About How You Can Find CDER’s Drug Safety Information:

  1. Drug labeling is CDER’s primary tool for communicating drug information and is required for all FDA-approved prescription medicines. The drug labeling is the most complete source of information on a prescription drug. It contains important information on the safety and effectiveness of the drug. Drug labeling lists the active ingredients and inactive substances in a drug and provides information for patient safety and medication administration. 

    Labeling for prescription medicines are typically paper documents your pharmacist provides when you pick up your prescription. Prescription drug labeling lists:

  • Prescribing Information (labeling also called patient package insert or Medication Guides), and
  • Carton and container labeling (cartons and containers are outside packaging that contain information about prescription medicines).

  1. When a drug is FDA-approved, the known safety issues are included in the labeling at that time. However, some safety issues are identified after drugs are approved and being used. In these cases, the agency can require manufacturers to add new information to prescription labeling. You can search online for the current labeling information of FDA-approved drugs. 

    CDER provides online labeling resources, which are useful in finding information on new drug warnings, updated safety information, and drug labeling changes. 

  2. The agency requires a standard label for all nonprescription (or over-the-counter (OTC)) medicines known as the Drug Facts Label. The Drug Facts Label is intended to make it easier for you to read and understand nonprescription labeling and use nonprescription medicines safely and effectively. The Drug Facts Label tells you what a medicine is supposed to do, who should or should not take it, and how to use it.
  3. CDER will notify the public of safety concerns of drugs through Drug Safety Communications, or public alerts including CDER Alerts and Press Announcements. Drug Safety Communications provide clinically important information about new safety issues with FDA-approved drugs so you can make more informed decisions about treatment. You can get new safety information on drugs by signing up for email alerts about Drug Safety Communications.

  4. The FDA Adverse Event Reporting System (FAERS) database contains adverse event (or any unintended experience connected to the use of a medical product) reports, medication error reports and product quality complaints resulting in an adverse event that were submitted to CDER. The database supports CDER's work to monitor the safety of drug and therapeutic biologic products once they are approved. 

    The FAERS Public Dashboard is a highly interactive web-based tool that allows you to find information on a specific drug. The FAERS Public Dashboard does not contain all the data fields that are available internally to CDER staff because certain data fields, such as a narrative description of the adverse event, are not publicly available to protect patient privacy.

    While FAERS contains reports on a particular drug or biologic, this does not mean that the drug or biologic caused the adverse event. Importantly, the FAERS data by themselves are not an indicator of the safety profile of the drug or biologic. 

  5. A drug recall is an effective way to protect you from defective or potentially harmful drugs. A recall is a voluntary action taken by a company to remove a defective drug from the market or warn about a potential risk. The agency publishes drug company recall notifications when there are concerns with drugs, including safety issues. All recalls are listed on FDA.gov. 

  6. MedWatch is CDER’s safety information and adverse event reporting program. MedWatch receives reports from the public and when appropriate, publishes safety alerts for FDA-regulated drugs. 

    If you think you or someone in your family has experienced and unintended reaction to a drug, or medication error, or has concerns with the quality of a drug, you are encouraged to ask your health care professional to report it to MedWatch. Your health care professional can provide clinical information based on your medical record to include on the form that can help CDER evaluate your report. But keep in mind, your health care professional is NOT required to report to MedWatch.

    You can help improve the quality of data CDER receives by submitting detailed and complete reports of adverse events and medication errors. Complete and detailed reports are helpful to the agency when identifying safety concerns. You may complete the Online Reporting Form for yourself or a family member or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. 

Resources

Understanding CDER’s Postmarket Safety Surveillance Programs and Public Data

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