Classification of Adverse Drug Reactions (ADRs)

Severity

Description

Example

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 drug or medication and specific treatment of the ADR.

ACE inhibitors: Angioedema

Macrolide antibiotics: Abnormal heart rhythm

Lethal

An ADR directly or indirectly contributes to a patient’s death.

Anticoagulants: Hemorrhage

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