Serious adverse event

Serious adverse event or SAE refers to an undesirable experience associated with the use of a medical product in a patient. The term is often used in clinical trials to refer to any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect.

Definition

The Food and Drug Administration (FDA) defines a serious adverse event as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability or incapacity, or is a congenital anomaly or birth defect.

Reporting

In the United States, the FDA requires that serious adverse events be reported within 15 days of their discovery. In the European Union, the European Medicines Agency (EMA) requires that all serious adverse reactions be reported within 15 days as well.

Examples

Examples of serious adverse events include death, life-threatening disease, hospitalization (initial or prolonged), disability or permanent damage, congenital anomaly or birth defect, or the need for medical or surgical intervention to prevent one of these outcomes.

See also

• Adverse event
• Adverse drug reaction
• Pharmacovigilance
• Clinical trial

Serious adverse event Resources
Need Help Finding a Doctor? Need help finding a doctor or specialist anywhere in the world? Explore our world directory. WikiMD's DocFinder can assist you in locating millions of physicians.	Medical Knowledge Access the latest research - Most recent articles Ongoing trials.

Translate to: East Asian 中文, 日本, 한국어, South Asian हिन्दी, Urdu, বাংলা, తెలుగు, தமிழ், ಕನ್ನಡ,
Southeast Asian Indonesian, Vietnamese, Thai, မြန်မာဘာသာ, European español, Deutsch, français, русский, português do Brasil, Italian, polski