All-causality, treatment-emergent adverse events (AE) among subjects receiving varenicline
| Varenicline (n=332) No (%) | |
|---|---|
| Any adverse event | 80 (24.1) |
| Most frequent AE | |
| Gastrointestinal disorders | 42 (12.7) |
| Nausea | 32 (9.6) |
| Dry mouth | 1 (0.3) |
| Flatulence | 8 (2.4) |
| Diarrhoea | 1 (0.3) |
| Psychiatric disorders | 9 (2.7) |
| Abnormal dreams | 2 (0.3) |
| Sleep disorder | 2 (0.3) |
| Insomnia | 5 (1.5) |
| Nervous system disorders | |
| Dizziness | 9 (3.3) |
| Cardiovascular system disorders | |
| Palpitation | 8 (2.4) |
| Respiratory system disorders | |
| Cough | 2 (0.6) |
| General disorders | |
| Itching | 7 (2.1) |
| Serious adverse events | 5 (1.5) |
| Quitting discontinuation due to AE | 26 (7.8) |
| Dose reduction or temporary discontinuation due to AE | 15 (4.5) |