Table 5

All-cause adverse events

Placebo

N = 248

Pregabalin

N = 250


Adverse events

175 (70.6)a

225 (90.0)

Serious adverse events

1 (0.4)

3 (1.2)

Severe adverse events

0

2 (0.8)

Discontinuations due to adverse events

9 (3.6)

24 (9.6)

Dose reductions/temporary discontinuations due to adverse events

11 (4.4)

30 (12.0)

Frequent adverse eventsb

Somnolence

45 (18.1)

116 (46.4)

Dizziness

15 (6.0)

74 (29.6)

Nasopharyngitis

45 (18.1)

45 (18.0)

Increased weight

9 (3.6)

39 (15.6)

Constipation

17 (6.9)

36 (14.4)

Feeling abnormal

3 (1.2)

20 (8.0)

Peripheral edema

3 (1.2)

18 (7.2)

Headache

15 (6.0)

15 (6.0)

Vision blurred

3 (1.2)

13 (5.2)


aNumber (%) of patients. bReported by ≥5% of patients in any group.

Ohta et al. Arthritis Research & Therapy 2012 14:R217   doi:10.1186/ar4056

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