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Table 5 All-cause adverse events

From: A randomized, double-blind, multicenter, placebo-controlled phase III trial to evaluate the efficacy and safety of pregabalin in Japanese patients with fibromyalgia

 

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)

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