Reporting Adverse Events

Reporting Adverse Events – Health care providers are required to report all medication errors, serious adverse events, and clinical outcomes involving the use of hydroxychloroquine and chloroquine distributed from the Strategic National Stockpile for the treatment COVID-19 patients under the FDA Emergency Use Authorization (EUA).  In addition, health care providers are encouraged to submit report on medication errors, serious adverse events involving all other treatments for COVID-19. When reporting these events indicate that the product was being used to treat COVID-19 to ensure rapid review of the report. Both health professionals and patients can submit Adverse Event reports online to FDA MedWatch www.fda.gov/medwatch/report.htm, by postage-paid Form FDA 3500 (available at http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM163919.pdf), by fax (1-800-FDA-0178), or by calling 1-800-FDA-1088 to request a reporting form.