Adverse Event (AE)

Similar or Alternative Terms Meaning the Same Thing	NA
Related Term(s)	Adverse Event Report (AER)

The definition of "adverse event" for both prescription drugs and dietary supplements is "any health-related event associated with the use of a that is adverse". This could include any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease, and, more seriously, death.

FDA defines an Adverse drug experience as "Any adverse event associated with the use of a drug in humans, whether or not considered drug related, including the following: An adverse event occurring in the course of the use of a drug product in professional practice; an adverse event occurring from drug overdose whether accidental or intentional; an adverse event occurring from drug abuse; an adverse event occurring from drug withdrawal; and any failure of expected pharmacological action."

FDA's MedWatch Form, which is used by physicians and consumers to report adverse events, includes the following outcomes attributed to adverse events:

• Death
• Life-threatening
• Hospitalization
• Disability or permanent damage
• Congenital abnormality
• Required intervention to prevent permanent impairment or damage

The FDA requires pharmaceutical companies to monitor and report all adverse events it learns about relating to its products. The agency expects "entities responsible for reporting will promptly review all adverse event information received or otherwise obtained, which potentially includes information from the Internet and social media tools."

Such events should be reported to FDA if there is knowledge of the four basic elements for submission of an individual case safety report, namely:

1. An identifiable patient
2. An identifiable reporter
3. A suspect drug or biological product
4. An adverse experience or fatal outcome suspected to be due to the suspect drug or biological product

FDA guidance states that those entities should review any Internet sites sponsored by them for adverse experience information, but are not responsible for reviewing any Internet sites that they do not sponsor; however, if they become aware of an adverse experience on an Internet site that they do not sponsor, they should review the adverse experience and determine if it should be reported to FDA.

Where to find more information:

• Source: CFR - Code of Federal Regulations Title 21
• Source: FDA Regulatory Procedures Manual March 2010
• Blog Post: New FDA Data: Adverse Event Reporting Increases Dramatically
• Article: Social Media Adverse Event Reporting Safe Harbors