Attributes of the More Prevalent Patient-Reported ADEs
| ADEa | Patients Self-Reporting ADE, No. (%) | Main Therapeutic Drug Group Associated With ADE | No. (%) of Therapeutic Drug Group With ADEb | Severity | Bothered, No. (%) | Reported to Physician, No. (%) | Sensitivity, % | Specificity, % |
|---|---|---|---|---|---|---|---|---|
| Bruise easily | 266 (31) | Antithrombotic agents (eg, aspirin, warfarin) | 249 (49) | Mild | 55 (21) | 74 (28) | 53 | 90 |
| Difficulty stopping a small cut from bleeding | 101 (12) | Antithrombotic agents (eg, aspirin, warfarin) | 97 (19) | Mild | 26 (26) | 22 (22) | 73 | 72 |
| Up at night to urinate | 153 (18) | Diuretics (eg, furosemide, bendroflumethiazide) | 147 (44) | Mild | 43 (28) | 33 (22) | 18 | 95 |
| Dizziness or lightheadedness | 117 (14) | Diuretics (eg, furosemide, bendroflumethiazide) | 19 (6) | Mild | 71 (61) | 73 (62) | 28 | 84 |
| Beta-blocking agents (eg, bisoprolol, atenolol, metoprolol) | 32 (13) | |||||||
| Analgesics (eg, codeine combinations, tramadol, buprenorphine, oxycodone) | 32 (31) | |||||||
| Psychoanaleptics (eg, amitriptyline, doxepin) | 10 (15) | |||||||
| Psycholeptics (eg, benzodiazepine derivatives, trifluoperazine) | 15 (31) | |||||||
| Unsteadiness while standing | 75 (9) | Analgesics (eg, codeine combinations, tramadol, buprenorphine, oxycodone) | 28 (27) | Mild | 39 (52) | 33 (44) | 4 | 100 |
| Psychoanaleptics (eg, amitriptyline, doxepin) | 10 (15) | |||||||
| Psycholeptics (eg, benzodiazepine derivatives, trifluoperazine) | 20 (42) | |||||||
| Constipation | 137 (16) | Calcium channel blockers (eg, amlodipine, lercanidipine, diltiazem) | 28 (21) | Mild | 69 (50) | 73 (53) | 22 | 89 |
| Analgesics (eg, codeine combinations, tramadol, buprenorphine, oxycodone) | 40 (39) | |||||||
| Psychoanaleptics (eg, amitriptyline, doxepin) | 11 (17) | |||||||
| Indigestion or heartburn | 115 (13) | Antithrombotic agents (eg, aspirin, warfarin) | 92 (18) | Mild | 38 (33) | 57 (50) | 12 | 89 |
| Anti-inflammatory and antirheumatic products (eg, diclofenac, ibuprofen, etoricoxib) | 23 (32) | |||||||
| Fatigue or unusual tiredness | 87 (10) | Beta-blocking agents (eg, bisoprolol, atenolol, metoprolol) | 38 (15) | Mild | 43 (49) | 24 (28) | 17 | 92 |
| Analgesics (eg, codeine combinations, tramadol, buprenorphine, oxycodone) | 30 (29) | |||||||
| Dry mouth | 84 (10) | Diuretics (eg, furosemide, bendroflumethiazide) | 50 (15) | Mild | 28 (33) | 17 (20) | 33 | 77 |
| Psychoanaleptics (eg, amitriptyline, doxepin) | 12 (18) | |||||||
| Ankle swelling | 68 (8) | Calcium channel blockers (eg, amlodipine, lercanidipine, diltiazem) | 68 (52) | Mild | 25 (37) | 44 (65) | 27 | 90 |
| Cough | 66 (8) | Agents acting on the renin-angiotensin system (eg, ramipril, perindopril, lisinopril) | 62 (52) | Mild | 35 (53) | 37 (56) | 18 | 90 |
| Muscle pain or weakness | 57 (7) | Serum lipid–reducing agents (eg, atorvastatin, pravastatin, rosuvastatin, simvastatin) | 48 (43) | Mild | 43 (75) | 27 (47) | 18 | 96 |
ADE = adverse drug effect.
↵a ADE is a patient-reported symptom that was established as an ADE per independent clinician review.
b The proportion of patients with an ADE to this therapeutic drug group as a percentage of the overall number of patients prescribed medication from this therapeutic group during the study period.