Classification of Adverse Drug Events

Adverse Drug Events are classified on the basis of severity:

1. Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose:

• Results in death
• Is life-threatening (subject was at risk of death at the time of the event. It does not refer to an event that hypothetically might have caused death if it is more severe)
• Requires inpatient hospitalization or prolongation of existing hospitalization
• Results in persistent or significant disability/incapacity
• Results in a congenital anomaly/birth defect
• Results in suspected transmission of any infectious agent via the medicinal product
• Is medically important

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2. Non-serious Adverse Drug Reaction (ADR) Associated with the Use of Drugs: Any adverse drug reaction that does not meet the above criteria to be a serious AE and is considered associated with the use of the drug .

4. Life-threatening: Any event in which the patient was at risk of death at the time of the event; but does not refer to an event, which hypothetically might have caused death if it were more severe.

5. Associated with Use of the Drug: An adverse event is considered associated with use of the drug if the attribution is possible, probable or very likely.

Resources

• Guidelines for Programmatic Management of Drug Resistant Tuberculosis in India, March 2021
• Ready Reckoner for Medical Officer - Adverse Drug Reactions Associated with Anti-TB Drugs Identification and Management, 2019 
• WHO - A Practical Handbook on the Pharmacovigilance of Medicines Used in the Treatment of Tuberculosis, 2012
• Technical and Operational Guidelines for TB in India, 2016

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