Click to go to DrugInjuryLaw Home


Legal information and news about prescription drug side effects
NuvaRing Case Evaluation Ortho Evra Case Evaluation Fosamax Case Evaluation Avandia Case EvaluationKetek Case Evaluation Zelnorm Case Evaluation Meridia Case Evaluation Zocor Case Evaluation
Vytorin Case EvaluationZetia Case Evaluation Yasmin Case Evaluation Ocella Case EvaluationYAZ Case Evaluation Levaquin Case Evaluation Byetta Case Evaluation Gianvi Case Evaluation


Free Case Evaluation

FDA Adverse Event Reporting System

Report Adverse Drug Reactions and Drug-Drug Interactions to FDA

The United States Food and Drug Administration (US FDA) has established a drug safety database known as the Adverse Event Reporting System (AERS).

The basic information stored in the AERS is taken from the Individual Safety Report (ISR), which contains all of the information contained on the MedWatch form (FDA Form 3500 or FDA Form 3500A). ISRs can be submitted to the FDA by consumers, health care providers, and drug manufacturers. A real limitation to the database, however, is under-reporting. One study found that only 1% of serious adverse events are reported to the FDA.

If you are interested in getting the facts of your possible drug injury claim reviewed by our law firm, click here for a free legal case evaluation.


  • US FDA advises that you should not stop taking any prescription medication before talking to your doctor.
  • Reports of serious drug side effects should be made to the US FDA MedWatch program.
  • The prescription drug names are registered trademarks of the respective drug companies.
  • DrugInjuryLaw.com is not affiliated with any of the drug companies, nor US FDA.
Law Offices of Thomas J. Lamb, P.A.
Lumina Station Suite 225
1908 Eastwood Road
Wilmington, NC 28403
Tel: (910) 256-2971   Fax: (910) 256-2972
Toll Free: (800) 426-9535
email: ThomasJLamb@DrugInjuryLaw.com

Disclaimer