Table 3

Adverse events reported by patients on tolcapone with incidences >5% higher than reported by patients on placebo

Treatment group (n (%))
Placebo (n=58)Tolcapone
100 mg tid (n=60)200 mg tid (n=59)
Dyskinesia3-150 12  (21)22  (37)31  (52.5)
Nausea3-150 8 (14)16 (27)17 (29)
Insomnia3-150 10 (17)15 (25)12 (20)
Orthostatic complaints3-150 6 (10)16 (27)12 (20)
Muscle cramps3-150 6 (10)13 (22)10 (17)
Excessive dreaming3-150 8 (14)14 (23)5 (8.5)
Diarrhoea2 (3)9 (15)15 (25)
Somnolence3-150 5 (9)12 (20)7 (12)
Vomiting3-150 2 (3)7 (12)5 (8.5)
Headache2 (3)6 (10)2 (3)
Akathisia/restlessness0 (0)3 (5)4 (7)
Abdominal pain1 (2)1 (2)4 (7)
Dyspnoea1 (2)0 (0)4 (7)
Hypotension0 (0)2 (3)3 (5)
  • 3-150 Corresponding to levodopainduced symptom check list used by investigators during the study; tid = three times daily.