Table 4.
The most commonly reported ADEs (n ≥ 5) among 1590 patients with 1800 serious adverse drug events
| ADE culprit drugs | ADE type | Symptom/diagnosis | Report frequency, n | Proportion of reports/drug | Proportion of all reports (N = 1800) |
|---|---|---|---|---|---|
| Hydrochlorothiazide (n = 77) | Adverse Drug Reaction | Hyponatraemia | 38 | 49.4 | 2.1 |
| Hypokalemia & hyponatremia | 7 | 9.1 | 0.4 | ||
| Acetylsalicylic acid (n = 67) | Adverse Drug Reaction | Gastrointestinal hemorrhage | 25 | 37.3 | 1.4 |
| Chronic gastrointestinal bleeding | 6 | 9.0 | 0.3 | ||
| Furosemide (n = 67) | Adverse Drug Reaction | Acute kidney injury | 8 | 11.9 | 0.4 |
| Non-adherence | Cardiac failure congestive | 6 | 9.0 | 0.3 | |
| Apixaban (n = 65) | Adverse Drug Reaction | Gastrointestinal hemorrhage | 12 | 18.5 | 0.7 |
| Hematuria | 6 | 9.2 | 0.3 | ||
| Empagliflozin (n = 58) | Adverse Drug Reaction | Euglycemic diabetic ketoacidosis | 29 | 50.0 | 1.6 |
| Diabetic ketoacidosis | 12 | 20.7 | 0.7 | ||
| Warfarin (n = 56) | Adverse Drug Reaction | Gastrointestinal hemorrhage | 6 | 10.7 | 0.3 |
| Laboratory test abnormal | 5 | 8.9 | 0.3 | ||
| Ramipril (n = 53) | Adverse Drug Reaction | Acute kidney injury | 8 | 15.1 | 0.4 |
| Angioedema | 8 | 15.1 | 0.4 | ||
| Rivaroxaban (n = 47) | Adverse Drug Reaction | Gastrointestinal hemorrhage | 6 | 12.8 | 0.3 |
| Insulin glargine (n = 37) | Adverse Drug Reaction | Hypoglycemia | 7 | 18.9 | 0.4 |
| Non-adherence | Diabetic ketoacidosis | 8 | 21.6 | 0.4 | |
| Hyperglycemia | 5 | 13.5 | 0.3 | ||
| Spironolactone (n = 37) | Adverse Drug Reaction | Acute kidney injury & hyperkalemia | 6 | 16.2 | 0.3 |
| Metformin (n = 35) | Adverse Drug Reaction | Lactic acidosis | 11 | 31.4 | 0.6 |
| Candesartan cilexetil (n = 33) | Adverse Drug Reaction | Acute kidney injury | 7 | 21.2 | 0.4 |
| Hyperkalemia | 6 | 18.2 | 0.3 | ||
| Acute kidney injury & hyperkalemia | 5 | 15.2 | 0.3 | ||
| Ibuprofen (n = 32) | Adverse Drug Reaction | Gastrointestinal hemorrhage | 6 | 18.8 | 0.3 |
| Clopidogrel (n = 29) | Adverse Drug Reaction | Gastrointestinal hemorrhage | 6 | 20.7 | 0.3 |
| Naproxen (n = 29) | Adverse Drug Reaction | Gastrointestinal hemorrhage | 8 | 27.6 | 0.4 |
| Chlorthalidone (n = 26) | Adverse Drug Reaction | Hyponatraemia | 17 | 65.4 | 0.9 |
| Escitalopram (n = 23) | Adverse Drug Reaction | Hyponatraemia | 8 | 34.8 | 0.4 |
| Perindopril (n = 19) | Adverse Drug Reaction | Hyponatraemia | 7 | 36.8 | 0.4 |
| Pantoprazole (n = 17) | Adverse Drug Reaction | Gastrointestinal hemorrhage | 5 | 29.4 | 0.3 |
| Glyburide (n = 15) | Adverse Drug Reaction | Hypoglycemia | 10 | 66.7 | 0.6 |
| Gliclazide (n = 14) | Adverse Drug Reaction | Hypoglycemia | 8 | 57.1 | 0.4 |
| Aripiprazole (n = 13) | Non-adherence | Acute psychosis | 5 | 38.5 | 0.3 |
| Indapamide (n = 13) | Adverse Drug Reaction | Hyponatraemia | 6 | 46.2 | 0.3 |
| Cyclophosphamide (n = 8) | Adverse Drug Reaction | Febrile neutropenia | 5 | 62.5 | 0.3 |
| Empagliflozin/metformin (n = 6) | Adverse Drug Reaction | Euglycemic diabetic ketoacidosis | 6 | 100.0 | 0.3 |
| Doxorubicin (n = 5) | Adverse Drug Reaction | Febrile neutropenia | 5 | 100.0 | 0.3 |
ADE adverse drug event
Serious ADEs are those with an outcome of fetal defect, permanent disability, hospitalisation, extended hospitalisation, life threatening, or death