What is MedWatch used for?

An important FDA program called “MedWatch” allows health care professionals and consumers to report serious problems that they believe may be associated with the medical products they prescribe, dispense, or use. These reports, along with follow-up investigations, can help to identify important safety concerns.

What are Type B adverse drug reactions?

Type B reactions — Type B reactions represent hypersensitivity reactions. They make up 10 to 15 percent of adverse drug reactions, occur in a susceptible subgroup of patients, and have signs and symptoms that are different from the pharmacologic actions of the drug.

What is ADRs in medical terms?

Adverse drug reactions (ADRs) – unintended, harmful events attributed to the use of medicines – occur as a cause of and during a significant proportion of unscheduled hospital admissions.

What do you need to know about MedWatch?

MedWatch, the FDA’s medical product safety reporting program for health professionals, patients and consumers. MedWatch receives reports from the public and when appropriate, publishes safety alerts for FDA-regulated products such as:

Who is the medical director of the FDA MedWatch program?

As the medical director of the FDA’s MedWatch program, I can report that the FDA, as a public health agency, has an increased capacity and commitment to making timely, science-based and actionable new safety information available to busy practitioners across America.

Where can I find the MedWatch precertification form?

You have accessed the MedWatch precertification form. Please enter as much information as possible in the spaces provided, even if you do not have all the information requested on this form.

How to report an adverse event to MedWatch?

Reporting can be done through our online reporting portal or by downloading, completing and then submitting FDA Form 3500 (health professional) or 3500B (consumer/patient) to MedWatch:The FDA Safety Information and Adverse Event Reporting Program, For use by healthcare professionals, consumers, and patients.

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