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Table 2 Adverse events by treatment group (all causalities) in the double-blind trial

From: Safety and efficacy of pregabalin in adolescents with fibromyalgia: a randomized, double-blind, placebo-controlled trial and a 6-month open-label extension study

  Pregabalin (N = 54) Placebo (N = 53)
AEs, n 167 132
Patients with AEs, n (%) 38 (70.4) 34 (64.2)
Patients with serious AEs, n (%) 1 (1.9) 0
Patients with severe AEs, n (%) 3 (5.6) 3 (5.7)
Discontinuations due to AEs, n (%) 4 (7.4) 4 (7.5)
Common AEsa, n (%)   
 Dizziness 16 (29.6) 7 (13.2)
 Nausea 12 (22.2) 5 (9.4)
 Headache 10 (18.5) 10 (18.9)
 Weight increased 9 (16.7) 0 (0.0)
 Fatigue 8 (14.8) 4 (7.5)
 Somnolence 5 (9.3) 2 (3.8)
 Oropharyngeal pain 4 (7.4) 2 (3.8)
 Pain in extremity 4 (7.4) 0 (0.0)
 Pyrexia 4 (7.4) 3 (5.7)
 Back pain 3 (5.6) 5 (9.4)
 Upper respiratory tract infection 3 (5.6) 4 (7.5)
 Vomiting 3 (5.6) 4 (7.5)
  1. AE adverse event
  2. a Occurring in at least 5 % of subjects taking pregabalin