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. 2018 Winter;17(Suppl):53–63.

Table 4.

Food and drug administration (FDA) classification of severity of adverse drug reactions

Type of ADR (%) Severity of ADRs
Mild Moderate Severe Very severe
Chest pain 62.1% 16.2 21.7
Hypotension 65.4% 15.7 18.5 0.5
Coughing 87.1% 4.6 8.3
Ecchymose 89.9% 3.2 8.3
Pain in the extremities 89.9% 3.7 6.4
Nausea and vomiting 89.9% 4.6 5.5
Bronchospasm 90.1% 1.9 4.2 3.8
Bradycardia 90.3% 4.6 4.6 0.5
Sweating 90.3% 9.7
Tachycardia 91.2% 4.2 4.6
Fever and chill 91.6% 1.9 6.5
Ventricular fibrillation 92.6% 2.3 5.1
Headache 94% 2.3 3.7
Hypertension 94.9% 2.8 2.3
Bleeding 94.9% 2.3 0.9 1.9
Agitation 95.4% 4.6
Back pain 95.7% 1.5 2.8
Abdominal cramp 95.8% 1.4 2.8
Gastrointestinal bleeding 95.8% 2.8 1.4
Pulmonary edema 96.3% 3.2 0.5
Epigastric pain 96.3% 2.3 1.4
Constipation 96.3% 0.9 2.8
Hematuria 96.7% 0.5 0.9 1.9
Hemoptysis 96.7% 0.5 2.8
Allergy and erythema 97.2% 0.9 1.9
Phlebitis 97.2% 0.5 2.3
Cardiogenic shock 97.2% 0.5 2.3
Atrial fibrillation 97.6% 0.5 1.9
Swelling and edema in the extremities 98.1% 1.9
Dry mucosa 98.6% 1.4
Itching 98.6% 1.4
Stroke 98.6% 1.4
Hypoxic encephalopathy 99% 0.5 0.5
Diarrhea 99.1% 0.4 0.5