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Traditional Chinese Herbal Medicine (TCHM)
Mild Adverse Event (AE) Database Reporting Tool 

Reporting Information

AE definitions according to:  Dietary Supplement and Non-prescription Drug Consumer Protection Act  PUBLIC LAW 109–462—DEC. 22, 2006


SERIOUS ADVERSE EVENT

The term ‘serious adverse event’ is an adverse event that:

—‘‘(A) results in—

‘‘(i) death;

‘‘(ii) a life-threatening experience;

‘‘(iii) inpatient hospitalization;

‘‘(iv) a persistent or significant disability or incapacity; or

‘‘(v) a congenital anomaly or birth defect; or

—‘‘(B) requires, based on reasonable medical judgment, a medical or surgical intervention to prevent an outcome described under subparagraph (A).
STOP and click here to report to FDA! 

ADVERSE EVENT

.—The term ‘adverse event’ means any health-related event associated with the use of a nonprescription drug that is adverse, including—

‘‘(A) an event occurring from an overdose of the drug, whether accidental or intentional;

‘‘(B) an event occurring from abuse of the drug;

‘‘(C) an event occurring from withdrawal from the drug;

and

‘‘(D) any failure of expected pharmacological action

of the drug.

To report use the form on the right 

Mild AE Report Form

This NON FDA reportable mild Adverse Events (AE) -  reporting tool is intended for interprofessional data collection purposes. 
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