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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.