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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


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! 


.—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;


‘‘(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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