How to Report a Suspected Medication Side Effect

Start with the level of urgency

If symptoms may be a medical emergency, call 911. An FDA report, customer-support message, or routine telehealth message is not emergency care.

For non-emergency concerns, contact the licensed clinician or dispensing pharmacist responsible for the medicine. They can assess the situation using the product information and your health history.

Record the details while they are available

• Product name, active ingredient, strength, and dosage form
• When the product was used and when the problem began
• A description of the symptoms or product-quality issue
• Other medicines or supplements being used
• Lot number, photos, or packaging details when relevant

Know what MedWatch accepts

FDA's MedWatch program accepts voluntary reports from consumers and healthcare professionals about suspected serious reactions, product-quality problems, therapeutic failure, and product-use errors involving human medical products.

A report describes a suspected problem and does not by itself show that a product caused the event. FDA explains that reports, along with follow-up investigations, can help identify important safety concerns.

Use the official reporting route

FDA provides an online voluntary reporting form and downloadable consumer forms. Include contact information if you are willing to answer follow-up questions, and keep a copy of what you submit.

Also follow the prescriber's and pharmacy's instructions for reporting a product or care concern so the organizations responsible for the prescription and product are informed.