How to Report Adverse Events to the FDA

The FDA tracks adverse events to identify patterns and take action when medications cause harm. Your report—even if it's just one data point—contributes to a larger picture that protects everyone.

Reporting is free, takes about 10 minutes, and can be done online. You don't need proof that the medication caused your issue; you just need to describe what happened.

What Counts as an Adverse Event?

An adverse event is any undesirable experience associated with a medication. This includes:

• Serious or unexpected side effects
• Allergic reactions
• Hospitalization related to medication use
• Medication that seemed ineffective or didn't work as expected
• Product quality issues (discoloration, particles, contamination)
• Labeling or packaging problems

For compounded medications specifically, quality issues are especially important to report—like inconsistent potency or products that look different than expected.

How to Submit a Report

Option 1: Online (Recommended)

1. Go to FDA.gov/MedWatch
2. Click "Report a Problem"
3. Select "Human Drug Products (for patients)"
4. Fill out the online form with details about your experience
5. Submit—you'll receive a confirmation number

The online form guides you through each section and only takes about 10 minutes to complete.

Option 2: Phone

Call 1-800-FDA-1088 during business hours. A representative will help you file your report over the phone.

Option 3: Mail

Download FDA Form 3500 from the MedWatch website, fill it out, and mail it to the address provided on the form. This option takes longer but works if you prefer paper.

What Information to Gather

Before starting your report, gather:

• Medication details: Name, dose, concentration, pharmacy name
• Lot number: Found on your vial label
• Timeline: When you started the medication, when the issue occurred
• Description: What happened, symptoms, severity
• Medical care: Did you see a doctor, go to the ER, get hospitalized?
• Outcome: Are you recovered, still experiencing symptoms?

What Happens After You Report

Your Report Enters the Database

The FDA maintains a database called FAERS (FDA Adverse Event Reporting System) where all reports are stored and analyzed. Analysts look for patterns—multiple reports about the same issue from the same manufacturer, for example.

The FDA May Follow Up

For serious events, an FDA representative might contact you for more information. This is rare but possible, especially if your report involves hospitalization or severe harm.

Reports Drive Action

When enough reports show a pattern, the FDA takes action. This might include warning letters to manufacturers, recalls of specific lots, public safety communications, or regulatory changes.

The FDA's September 2025 warning letters to telehealth companies were partly informed by consumer reports about misleading marketing and product quality issues.

Other Places to Report

Depending on your issue, you may also want to report to:

Your State Board of Pharmacy

State boards regulate compounding pharmacies. If you have concerns about a specific pharmacy's practices, your state board can investigate. Find yours at NABP.pharmacy.

Your Provider

Always let your healthcare provider know about adverse events. They may need to adjust your treatment and can help evaluate whether the medication caused the issue.

The Telehealth Platform

If you used a telehealth provider, report issues to their customer service. Reputable providers want to know about problems and may offer replacements or refunds.

Better Business Bureau

For customer service complaints (not medical issues), the BBB tracks business practices and can help resolve disputes.

Common Questions

Will my report be confidential?

Yes. The FDA keeps your personal information confidential. Public versions of the FAERS database remove identifying information.

What if I'm not sure the medication caused it?

Report anyway. The FDA doesn't expect you to prove causation—that's their job. If you suspect a connection, it's worth reporting. Analysts look at patterns across many reports to identify real signals.

Can I report for someone else?

Yes. Family members, caregivers, and healthcare providers can all submit reports on behalf of patients.

Will the FDA contact the company?

Your individual report is confidential, but if the FDA identifies a pattern of problems, they may investigate the manufacturer or pharmacy.

When to Seek Immediate Medical Attention

Reporting to the FDA is not a substitute for medical care. Seek emergency help immediately if you experience severe allergic reaction (difficulty breathing, swelling, hives), chest pain or heart palpitations, severe abdominal pain, signs of pancreatitis (severe pain radiating to back, vomiting), or thoughts of self-harm.

Get medical care first, then file your FDA report when you're stable.

Quick Steps

1. Gather information: medication name, lot number, dates, symptoms
2. Visit FDA.gov/MedWatch
3. Click "Report a Problem"
4. Complete the online form (about 10 minutes)
5. Submit and save your confirmation number

Your report makes a difference. Thank you for contributing to medication safety.