Your Side Effects May IncludeYou don't have to be a doctor to report a side effect to the FDA. Patients, family members and caregivers can report one directly, and those reports help the FDA spot problems that clinical trials missed.
How to report
- Online: use the FDA's MedWatch program. There's a consumer form written in plain language.
- By phone: call 1-800-FDA-1088 (1-800-332-1088).
- Through the drug maker: you can also contact the company that makes the drug, usually through the phone number on the label. Drug makers are required to send the reports they receive to the FDA.
What to have ready
- The name of the medicine, the dose and how long it was taken.
- What happened, when it started and how it turned out.
- Other medicines and supplements taken at the same time.
- Basic facts like age and relevant health conditions. You can report without being a medical expert.
What happens to your report
Reports go into the FDA Adverse Event Reporting System, known as FAERS. FDA staff review the reports to look for patterns, such as a side effect appearing far more often than expected. That can lead to label changes, new warnings or other safety actions.
The counts you see after each quiz answer come from this same database, through the FDA's public openFDA service. Read more about what those numbers mean.
Tell your doctor too
A report to the FDA doesn't reach your own doctor. If you've had a side effect, tell the person who prescribed the medicine so they can help you decide what to do next.
Sources
This article is general information, not medical advice. Talk to your doctor or pharmacist about your own medicines.