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. 2023 Oct 2;46(11):1161–1172. doi: 10.1007/s40264-023-01348-7

Table 3.

Characteristics of the most commonly reported adverse drug events (n ≥ 5) among the top 10 most commonly reported culprit drugs

Top 10 culprit drugs ADE type(s) Symptoms/diagnoses Reports/drug, n (%)
Hydrochlorothiazide (n = 120) Adverse Drug Reaction Hyponatraemia 60 (50.0)
Hypokalaemia 10 (8.3)
Hypokalaemia and hyponatraemia 8 (6.7)
Dizziness and hyponatraemia 5 (4.2)
Ramipril (n = 113) Adverse Drug Reaction Angioedema 20 (17.7)
Cough 15 (13.3)
Acute kidney injury 12 (10.6)
Hyperkalaemia 9 (8.0)
Acute kidney injury and hyperkalaemia 6 (5.3)
Hypotension 6 (5.3)
Apixaban (n = 99) Adverse Drug Reaction Gastrointestinal haemorrhage 14 (14.1)
Haematuria 10 (10.1)
Epistaxis 7 (7.1)
Chronic gastrointestinal bleeding 5 (5.1)
Furosemide (n = 99) Adverse Drug Reaction Acute kidney injury 11 (11.1)
Hyponatraemia 6 (6.1)
Hypokalaemia 5 (5.1)
Non-adherence Cardiac failure congestive 7 (7.1)
Acetylsalicylic acid (n = 95) Adverse Drug Reaction Gastrointestinal haemorrhage 28 (29.5)
Chronic gastrointestinal bleeding 7 (7.4)
Haematuria 5 (5.3)
Warfarin (n = 88) Adverse Drug Reaction Laboratory test abnormal 8 (9.1)
Gastrointestinal haemorrhage 7 (8.0)
Supratherapeutic Dose International normalised ratio increased 5 (5.7)
Rivaroxaban (n = 83) Adverse Drug Reaction Gastrointestinal haemorrhage 11 (13.3)
Epistaxis 9 (10.8)
Haematuria 7 (8.4)
Hemoptysis 6 (7.2)
Lower gastrointestinal haemorrhage 5 (6.0)
Empagliflozin (n = 68) Adverse Drug Reaction Euglycemic diabetic ketoacidosis 34 (50.0)
Diabetic ketoacidosis 12 (17.6)
Spironolactone (n = 66) Adverse Drug Reaction Hyperkalaemia 15 (22.7)
Acute kidney injury and hyperkalaemia 7 (10.6)
Sulfamethoxazole/trimethoprim (n = 58) Adverse Drug Reaction Hyperkalemia 8 (13.8)
Rash 6 (10.3)

ADE adverse drug event