Table 2.
Most frequently reported adverse drug reactions (MedDRA preferred terms)
| All patients | Elderly patients (≥ 65 years) | Patients < 65 years | |
|---|---|---|---|
| Spontaneous reports (global database) | |||
| All adverse drug reactions | 18,028 (100%) | 3569 (100%) | 8130 (100%) |
| Drug ineffective | 1237 (6.9%) | 181 (5.1%) | 492 (6.1%) |
| Nausea | 888 (4.9%) | 198 (5.6%) | 346 (4.3%) |
| Dizziness | 644 (3.6%) | 177 (5.6%) | 245 (3%) |
| Headache | 472 (2.6%) | 55 (1.5%) | 222 (2.7%) |
| Hallucination | 336 (1.9%) | 64 (1.8%) | 122 (1.5%) |
| Vomiting | 335 (1.9%) | 81 (2.3%) | 148 (1.8%) |
| Somnolence | 321 (1.8%) | 76 (2.1%) | 148 (1.8%) |
| Feeling abnormal | 297 (1.7%) | 33 (0.9%) | 140 (1.7%) |
| Hyperhidrosis | 248 (1.4%) | 46 (1.3%) | 108 (1.3%) |
| Fatigue | 245 (1.4%) | 53 (1.5%) | 114 (1.4%) |
| Confusional state | 244 (1.4%) | 110 (3.1%) | 81 (1%) |
| Constipation | 228 (1.3%) | 81 (2.3%) | 83 (1%) |
| Dyspnea | 218 (1.2%) | 47 (1.3%) | 114 (1.4%) |
| Pain | 245 (1.4%) | 44 (1.2%) | 127 (1.6%) |
| All subjects | Elderly subjects (≥ 65 years) | Subjects < 65 years | |
|---|---|---|---|
| Interventional clinical trial database | |||
| All adverse drug reactions | 21,312 (100%) | 5214 (100%) | 16,098 (100%) |
| Nausea | 3429 (16.1%) | 640 (12.3%) | 2789 (17.3%) |
| Dizziness | 2338 (11%) | 542 (10.4%) | 1796 (11.2%) |
| Vomiting | 1689 (7.9%) | 316 (6.1%) | 1373 (8.5%) |
| Somnolence | 1567 (7.4%) | 343 (6.6%) | 1224 (7.6%) |
| Constipation | 1512 (7.1%) | 560 (10.7%) | 952 (5.9%) |
| Headache | 1096 (5.1%) | 169 (3.2%) | 927 (5.8%) |
| Fatigue | 706 (3.3%) | 191 (3.7%) | 515 (3.2%) |
| Dry mouth | 602 (2.8%) | 183 (3.5%) | 419 (2.6%) |
| Pruritus | 549 (2.6%) | 109 (2.1%) | 440 (2.7%) |
| Hyperhidrosis | 432 (2%) | 110 (2.1%) | 322 (2%) |
| Decreased appetite | 300 (1.4%) | 116 (2.2%) | 184 (1.1%) |
| All patients | Elderly patients (≥ 65 years) | Patients < 65 years | |
|---|---|---|---|
| Non-interventional trial database | |||
| All adverse drug reactions | 1659 (100%) | 886 (100%) | 773 (100%) |
| Nausea | 268 (16.2%) | 152 (17.2%) | 116 (15%) |
| Dizziness | 143 (8.6%) | 77 (8.7%) | 66 (8.5%) |
| Fatigue | 78 (4.7%) | 39 (4.4%) | 39 (5.1%) |
| Vomiting | 67 (4%) | 33 (3.7%) | 34 (4.4%) |
| Constipation | 51 (3.1%) | 34 (3.8%) | 17 (2.2%) |
| Hyperhidrosis | 50 (3%) | 23 (2.6%) | 27 (3.5%) |
| Somnolence | 49 (3%) | 28 (3.2%) | 21 (2.7%) |
| Headache | 45 (2.7%) | 11 (1.2%) | 34 (4.4%) |
| Diarrhea | 40 (2.4%) | 20 (2.3%) | 20 (2.6%) |
| Restlessness | 40 (2.4%) | 23 (2.6%) | 17 (2.2%) |
| Abdominal pain upper | 28 (1.7%) | 18 (2%) | 10 (1.3%) |
Data are number of adverse drug reactions (%). Information about age was not available for all reports