Table 5.
In the postmarketing safety database, reporting rate of common adverse drug reactions for which the first total daily dose was 50 or 100 mg
| First total daily dose |
||
|---|---|---|
| Disorder system Event, n (%)* | 50 mg N = 12,843 reports† | 100 mg N = 5,066 reports† |
| Cardiac | ||
| Myocardial infarction | 273 (2.1) | 95 (1.9) |
| Palpitation | 236 (1.8) | 48 (0.9) |
| Tachycardia | 165 (1.3) | 36 (0.7) |
| Eye disorders | ||
| Cyanopsia | 233 (1.8) | 189 (3.7) |
| Vision blurred | 244 (1.9) | 89 (1.8) |
| Visual disturbance | 149 (1.2) | 74 (1.5) |
| Gastrointestinal | ||
| Dyspepsia | 415 (3.2) | 174 (3.4) |
| Nausea | 276 (2.2) | 82 (1.6) |
| General and administration site | ||
| Chest pain | 220 (1.7) | 59 (1.2) |
| Drug interaction | 248 (1.9) | 121 (2.4) |
| Feeling hot | 202 (1.6) | 47 (0.9) |
| Malaise | 130 (1.0) | 40 (0.8) |
| Injury, poisoning and procedural complications | ||
| Intentional drug misuse | 85 (0.7) | 66 (1.3) |
| Intentional overdose | 153 (1.2) | 121 (2.4) |
| Overdose | 154 (1.2) | 65 (1.3) |
| Nervous system | ||
| Dizziness | 502 (3.9) | 167 (3.3) |
| Headache | 1929 (15.0) | 574 (11.3) |
| Reproductive system | ||
| Priapism and related events‡ | 305 (2.4) | 132 (2.6) |
| Respiratory | ||
| Dyspnoea | 163 (1.3) | 54 (1.1) |
| Nasal congestion | 530 (4.1) | 156 (3.1) |
| Skin and subcutaneous tissue | ||
| Erythema | 304 (2.4) | 59 (1.2) |
| Vascular | ||
| Flushing | 1367 (10.6) | 409 (8.1) |
| Hot flush | 183 (1.4) | 26 (0.5) |
*
Events constituting ≥ 1% of reported events in ≥ 1 of the two dosage groups are listed.
†
50 mg = > 25–50 mg; 100 mg = > 50–100 mg.
‡
Priapism and erection increased.