Get Medwatch

MedWatch forms are not public documents. The information you provide is kept confidential to protect your privacy. However, the FDA uses data collected through MedWatch to create public safety alerts and improve drug and device regulation. This means your report plays a critical role in promoting safety without compromising individual identities.

Anyone can report to MedWatch, including healthcare professionals, patients, and caregivers. It provides a platform for individuals to share their experiences with medications and medical devices. By reporting through MedWatch, you contribute to safer healthcare practices for everyone. Your information helps the FDA monitor product safety effectively.

To submit to MedWatch, you can visit the FDA's official website and access the online reporting form. Filling out the form is straightforward, and you will be guided through each step. If you prefer, you can submit your report via mail or fax using a downloadable form. By taking this action, you help enhance patient safety and inform regulators about potential risks.

The United States prominently uses the MedWatch program to gather reports on adverse events and product safety issues. This system is crucial for maintaining effective health regulations and ensuring safety for all Americans. Other countries may have similar reporting systems, but MedWatch specifically serves the needs of U.S. consumers. By participating, you contribute to a safer medical environment.

The MedWatch form can be completed by healthcare professionals, patients, and caregivers who observe an adverse event. Each party plays a vital role in reporting their experiences to improve the safety of medical products. If you're a patient or caregiver, sharing your observations can significantly contribute to product evaluations. This collective effort supports the FDA's mission to ensure product safety.

You should submit a MedWatch form to the FDA when you experience adverse events related to medical products, such as drugs or devices. This ensures that the FDA receives crucial information about potential safety issues. Submitting this form allows the FDA to monitor product safety and take necessary actions, benefiting all users. Timely reporting is essential to enhance safety standards.

There are two types of MedWatch forms: MedWatch Form 3500 and MedWatch Form 3500A. MedWatch Form 3500 represents a voluntary reporting form and should be used by consumers, healthcare professionals and patients to report serious adverse events.

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: Prescription and over-the-counter medicines.

More than 25% of the names of reported suspect products were inaccurate, and 31% of suspect product start dates were inaccurate. Higher levels of completion and accuracy were associated with reports filed closer to the date when the adverse event was observed.