Frequently Asked Questions for Pharmacists on Reporting Adverse Drug Effects
A: Yes. Effective January 1, 2008, pharmacists are required to distribute with all prescriptions information alerting patients that they may call a toll-free telephone number to report adverse drug effects to the FDA. The final rule provides a number of ways by which this requirement can be accomplished. The text of the rule may be found here.
To report a problem to the FDA, call 1-800-332-1088.
Submit your report online here: http://www.fda.gov/safety/medwatch/howtoreport/default.htm or here: https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm.