Adverse events (safety population)
| . | Placebo . | Topiramate CR 175 mg/day . |
|---|---|---|
| n | 57 | 54 |
| Patients with ≥1: | ||
| Adverse event | 42 (74) | 49 (91) |
| Serious adverse event | 2 (4) | 1 (2) |
| Adverse event resulting in discontinuation | 4 (7) | 5 (9) |
| Common treatment-emergent adverse events* | ||
| Gastrointestinal system disorders | 21 (37) | 19 (35) |
| Constipation | 4 (7) | 7 (13) |
| Dyspepsia | 3 (5) | 4 (7) |
| Gastroenteritis | 2 (4) | 3 (6) |
| Body as a whole: general disorders | 18 (32) | 17 (31) |
| Fatigue | 2 (4) | 6 (11) |
| Pain | 3 (5) | 3 (6) |
| Central and peripheral nervous system disorders | 12 (21) | 23 (43) |
| Paresthesia | 0 | 15 (28) |
| Dizziness | 2 (4) | 8 (15) |
| Neuropathy | 1 (2) | 3 (6) |
| Hypoesthesia | 0 | 3 (6) |
| Respiratory system disorders | 15 (26) | 13 (24) |
| Upper respiratory tract infection | 8 (14) | 9 (17) |
| Sinusitis | 1 (2) | 4 (7) |
| Psychiatric disorders | 6 (11) | 18 (33) |
| Anxiety | 2 (4) | 4 (7) |
| Difficulty with memory | 0 | 4 (7) |
| Insomnia | 1 (2) | 3 (6) |
| Somnolence | 0 | 4 (7) |
| Appetite increased | 0 | 3 (6) |
| . | Placebo . | Topiramate CR 175 mg/day . |
|---|---|---|
| n | 57 | 54 |
| Patients with ≥1: | ||
| Adverse event | 42 (74) | 49 (91) |
| Serious adverse event | 2 (4) | 1 (2) |
| Adverse event resulting in discontinuation | 4 (7) | 5 (9) |
| Common treatment-emergent adverse events* | ||
| Gastrointestinal system disorders | 21 (37) | 19 (35) |
| Constipation | 4 (7) | 7 (13) |
| Dyspepsia | 3 (5) | 4 (7) |
| Gastroenteritis | 2 (4) | 3 (6) |
| Body as a whole: general disorders | 18 (32) | 17 (31) |
| Fatigue | 2 (4) | 6 (11) |
| Pain | 3 (5) | 3 (6) |
| Central and peripheral nervous system disorders | 12 (21) | 23 (43) |
| Paresthesia | 0 | 15 (28) |
| Dizziness | 2 (4) | 8 (15) |
| Neuropathy | 1 (2) | 3 (6) |
| Hypoesthesia | 0 | 3 (6) |
| Respiratory system disorders | 15 (26) | 13 (24) |
| Upper respiratory tract infection | 8 (14) | 9 (17) |
| Sinusitis | 1 (2) | 4 (7) |
| Psychiatric disorders | 6 (11) | 18 (33) |
| Anxiety | 2 (4) | 4 (7) |
| Difficulty with memory | 0 | 4 (7) |
| Insomnia | 1 (2) | 3 (6) |
| Somnolence | 0 | 4 (7) |
| Appetite increased | 0 | 3 (6) |
Data are n (%).
Occurring in at least 5% of topiramate-treated patients and at a greater incidence than in placebo-treated patients, n (%).