Table 3.
Side effects of tetrabenazine, threshold dose and exposure time.
| Adverse events | n (%) total AEs | Subtypes | Threshold TBZ dose/ exposure time at the time of AE |
|
|---|---|---|---|---|
| Threshold dose (mg) | Threshold time (months) | |||
| All AEs | 56 (100%) | 25 (43.1; 6.25–162.5) |
12 (29.7; 1–132) |
|
| Parkinsonism | 29 (51.8%) | 37.5 (51.5; 6.25–162.5) |
28 (35.6; 3–132) |
|
| Psychiatric disorders | 14 (25%) |
Depression (n = 6) Anxiety (n = 4) Worsening of pre-existing psychiatric disorder (=6) |
26.3 (45.7; 12.5–150) |
24 (30.5; 3–94) |
| Other movement disorders | 2 (3.6%) |
Akathisia (n = 2) Dystonia (n = 1) Postural tremor (n = 1) |
50 (50; 50) |
48 (48; 12–84) |
| Other AEs | 11 (19.6%) |
Somnolence (n = 6) Mental confusion (n = 1) Nausea/vomiting (n = 1) Headache (n = 1) Rash (n = 1) Dizziness (n = 1) Elevated transaminase levels (n = 1) |
18.8 (26.1; 11–75) |
3 (12.4; 1–87.5) |
AEs, adverse events; TBZ, tetrabenazine.