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

Table 2.

Descriptive statistics of included ADE reports, by severity

Overall (N = 3174) Serious ADEsa (N = 1800)
ADE types, n (%)
 Adverse drug reactionb 2340 (73.7) 1362 (75.7)
 Non-adherence 357 (11.3) 257 (14.3)
 Allergyb 249 (7.8) 58 (3.2)
 Supratherapeutic dose 90 (2.8) 52 (2.9)
 Drug–drug interaction 44 (1.4) 22 (1.2)
 Drug misuse 28 (0.9) 14 (0.8)
 Subtherapeutic dose 24 (0.8) 11 (0.6)
 Other (e.g., drug-disease interaction) 14 (0.4) 9 (0.5)
 Treatment failure 14 (0.4) 9 (0.5)
 Drug withdrawal 10 (0.3) Suppressed
 Incorrect drug Suppressed Suppressed
Most common ADE drugs, n (%)
 Hydrochlorothiazide 120 (3.8) 77 (4.3)
 Ramipril 113 (3.6) 53 (2.9)
 Apixaban 99 (3.1) 65 (3.6)
 Furosemide 99 (3.1) 67 (3.7)
 Acetylsalicylic acid 95 (3.0) 67 (3.7)
 Warfarin 88 (2.8) 56 (3.1)
 Rivaroxaban 83 (2.6) 47 (2.6)
 Empagliflozin 68 (2.1) 58 (3.2)
 Spironolactone 66 (2.1) 37 (2.1)
 Sulfamethoxazole/trimethoprim 58 (1.8) 26 (1.4)
Most common ADE symptoms/diagnoses, n (%)
 Hyponatremia 223 (7.0) 157 (8.7)
 Acute kidney injury 174 (5.5) 126 (7.0)
 Rash 169 (5.3) 36 (2.0)
 Gastrointestinal hemorrhage 127 (4.0) 103 (5.7)
 Hyperkalemia 88 (2.8) 45 (2.5)
 Hypotension 86 (2.7) 51 (2.8)
 Hypoglycemia 83 (2.6) 49 (2.7)
 Bradycardia 72 (2.3) 43 (2.4)
 Confusion 71 (2.2) 53 (2.9)
 Nausea 70 (2.2) 26 (1.4)
ADE certainty, n (%)
 Certain 502 (15.8) 291 (16.2)
 Probable 1791 (56.4) 1081 (60.1)
 Possible 862 (27.2) 419 (23.3)
 Unlikely 19 (0.6) 9 (0.5)
Most serious ADE outcome reported, n (%)
 Unknown 249 (7.8) 0
 Other (e.g., change in medication therapy) 347 (10.9) 0
 Worsened pre-existing condition 84 (2.7) 0
 Emergency visit 694 (21.9) 0
 Hospitalisation extended 177 (5.6) 177 (9.8)
 Hospitalisation 1393 (43.9) 1393 (77.4)
 Permanent disability 10 (0.3) 10 (0.6)
 Life threatening 211 (6.7) 211 (11.7)
 Fetal defect 0 0
 Death 9 (0.3) 9 (0.5)

ADE adverse drug event, ED emergency department, GP general practitioner

aSerious ADEs are those with an outcome of fetal defect, permanent disability, hospitalisation, extended hospitalisation, life threatening, or death

bOf the 2589 adverse drug reactions (ADRs) and allergies in the final cohort, 570 were not sent to PharmaNet because they were reported before the start of the randomised control trial and 606 reports were for drugs not eligible to be listed in PharmaNet (e.g., non-prescription drugs). Patients under 19 years old or with ADE outcomes of life threatening, fetal defect, or death were also excluded from the trial. 1129 patients with 1286 ADRs/allergies were included in the trial, of whom 538 patients with 648 ADRs/allergies were randomised to the control group where the ADR/allergy record was not sent to PharmaNet leaving 591 patients with 638 ADRs/allergy reports in PharmaNet as a part of the trial