Firm-Wide blog

How to Report a Drug-Related Injury to the FDA

By Burg Simpson
December 5, 2019
2 min read

While pharmaceutical drugs can save lives, they can also cause significant injuries if defectively manufactured, poorly designed, or improperly labeled. If you or a loved one have been harmed by a drug, you should not suffer in silence. It is important that you speak with a product liability attorney right away. You may also consider reporting your injury to the FDA.

The FDA is responsible for regulating drugs (prescription and over-the-counter) and human biologic products (e.g., blood, gene therapies). FDA is also responsible for tracking and monitoring drug safety.

To report a drug-related injury to the FDA, submit a report to MedWatch, an FDA safety monitoring system. MedWatch collects reports of injuries related to drugs and human biologics. These submissions, made by healthcare providers and consumers, can be very helpful in alerting the FDA about drug safety issues.


Fill Out a MedWatch Form (online form or printable form):

  1. Fill in your personal information
  2. Describe what happened
  3. Identify drug
  4. Provide your contact information
  5. Indicate whether or not you wish to be contacted by the drug manufacturer

Submit a MedWatch Form:

  1. If using an online form, review and submit your report online.
  2. If using a printed form, review and follow directions for submission:
  • To send by Fax: 1-800-FDA-0179
  • To send by Mail (no postage necessary):


The FDA Safety Information and Adverse Event Reporting Program

Food and Drug Administration

5600 Fishers Lane

Rockville, MD 20852-9787

If you want to see if others have had similar experiences to what you are going through, you can review previously submitted MedWatch reports of drug-related injury. Reports are maintained in a publicly available system called the FAERS database. In FAERS, you can search for injuries or experiences similar to yours. To learn more about searching the FAERS database, see our previous post, “How to Search FDA’s Adverse Event Databases.”

If you suspect that you or your loved one has been harmed by a drug or human biologic product contact one of our experienced product liability attorneys at Burg Simpson’s Cincinnati office today. Our award-winning, compassionate attorneys would be happy to discuss your potential claim. Call (513)852-5600 or fill out our contact form for a FREE no-obligation consultation today.

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