The FDA Safety Information and Adverse Event Reporting Program

“Your FDA gateway for finding clinically important safety information and reporting serious problems with human medical products.”

Consumers and the Food and Drug Administration (FDA)

Consumers play an important public health role by reporting to the FDA any adverse events (unexpected side effects) after using a medical product, or other problems with any products that the agency regulates. Timely reporting allows the agency to take prompt action. There are a number of ways you can report problems to the agency, depending on the type of problem and product.

What is MedWatch?

MedWatch is the Food and Drug Administration's (FDA) program for reporting serious reactions, product quality problems, therapeutic inequivalence/failure, and product use errors with human medical products, such as drugs and medical devices.

FDA-regulated products include:
    * human drugs (both prescription and over-the-counter)
    * medical devices (ex. contact lenses, glucose tests, pacemakers, and medical x-rays)
    * blood products, human cell and tissue products, and other biologics (except vaccines)
    * special nutritional products (dietary supplements, infant formulas, and medical foods such as nutritional supplements used under medical supervision)
    * cosmetics.

What types of problems should you report to MedWatch?

MedWatch is for reporting four types of problems with human health care products. Examples of each type of problem are shown here:

1. Serious adverse event
    * death
    * life-threatening situation
    * requires admission to hospital or longer-than-expected hospital stay
    * permanent disability
    * birth defect, miscarriage, stillbirth, or birth with serious disease
    * requires medical care to prevent permanent damage

2. Product quality problem
    * suspected counterfeit product
    * potentially contaminated product indicated by suspicious odor or unusual color
    * inaccurate or unreadable product labeling

3. Product use error
    * mixing up products with similar drug names or packaging
    * taking wrong dose of a drug because of confusing dosing instructions on label

4. Problem with different manufacturer of same medicine
    * not getting same results from a generic drug as a brand name drug, or from another generic

What is an adverse drug reaction?

An adverse drug reaction, also called a side effect, is any undesirable experience associated with the use of a medicine in a patient. Adverse events can range from mild to severe. Serious adverse events are those that can cause disability, are life-threatening, result in hospitalization or death, or are birth defects.