What types of adverse events should be reported to MedWatch?

Asked 2 years ago
Adverse events that should be reported to MedWatch encompass a wide range of incidents associated with the use of medical products, including medications and devices. Specifically, any unexpected or unusual reactions that occur following the administration of a drug or the use of a medical device are of particular concern. These may include severe allergic reactions, significant changes in health status, and new or worsening symptoms that are not consistent with the product's labeling. Additionally, events categorized as serious must also be reported. Serious adverse events are those that result in death, are life-threatening, require hospitalization, cause disability or permanent damage, or result in a birth defect or congenital anomaly. It is also important to report any product quality issues, such as defects in the product or issues related to its manufacturing. Should there be any uncertainties regarding what constitutes an adverse event, individuals are encouraged to consult the information available on the current web page associated with MedWatch. It is essential to ensure that all relevant events are reported to maintain the safety and efficacy of medical products, ultimately protecting public health.
Jeff Whelpley is the editor / author responsible for this content.
Answered Jun 27, 2025

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