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Classification of Adverse Drug Reactions

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Severity	Description	Examples
Mild	No antidote or treatment is required; hospitalization is not prolonged.	ACE inhibitor: Cough Antidepressants: Dry mouth Antihistamines (some): Drowsiness
Moderate	A change in treatment (eg, modified dosage, addition of a medication), but not necessarily discontinuation of the medication, is required; hospitalization may be prolonged, or specific treatment may be required.	Hormonal contraceptives: Venous thrombosis NSAIDs: Hypertension and edema Opioids: Constipation
Severe	An ADR is potentially life threatening and requires discontinuation of the medication. Specific treatment of the ADR and extended hospitalization stay often is required.*	ACE inhibitors: Angioedema Macrolide antibiotics: Abnormal heart rhythm
Lethal	An ADR directly or indirectly contributes to a patient’s death.	Acetaminophen overdosage: Liver failure Anticoagulants: Major hemorrhage
* Komagamine J. Prevalence of urgent hospitalizations caused by adverse drug reactions: a cross-sectional study. Sci Rep. 2024 Mar 13;14(1):6058. doi: 10.1038/s41598-024-56855-z. PMID: 38480855; PMCID: PMC10937656.