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Table 7 Adverse events (AEs) in pediatric patients with epilepsy treated with cannabidiol

From: Pharmacokinetics and Tolerability of Multiple Doses of Pharmaceutical-Grade Synthetic Cannabidiol in Pediatric Patients with Treatment-Resistant Epilepsy

AE, n (%)a Cannabidiol oral solution
All doses (N = 61) 10 mg/kg/day (n = 20) 20 mg/kg/day (n = 20) 40 mg/kg/day (n = 21)
Any AE 39 (63.9) 13 (65.0) 9 (45.0) 17 (81.0)
 Somnolence 13 (21.3) 3 (15.0) 3 (15.0) 7 (33.3)
 Anemia 11 (18.0) 2 (10.0) 5 (25.0) 4 (19.0)
 Diarrhea 10 (16.4) 1 (5.0) 2 (10.0) 7 (33.3)
 Flatulence 5 (8.2) 0 2 (10.0) 3 (14.3)
 Psychomotor hyperactivity 5 (8.2) 0 2 (10.0) 3 (14.3)
 Abdominal pain upper 4 (6.6) 2 (10.0) 1 (5.0) 1 (4.8)
 Catheter site pruritus 3 (4.9) 0 2 (10.0) 1 (4.8)
 Decreased appetite 3 (4.9) 2 (10.0) 0 1 (4.8)
 Seizure 3 (4.9) 1 (5.0) 1 (5.0) 1 (4.8)
 Vomiting 3 (4.9) 2 (10.0) 1 (5.0) 0
 Weight increased 3 (4.9) 0 1 (5.0) 2 (9.5)
 Ataxia 2 (3.3) 0 0 2 (9.5)
 Cough 2 (3.3) 1 (5.0) 1 (5.0) 0
 Contact dermatitis 2 (3.3) 0 2 (10.0) 0
 Dehydration 2 (3.3) 0 0 2 (9.5)
 Ecchymosis 2 (3.3) 0 1 (5.0) 1 (4.8)
 Insomnia 2 (3.3) 0 1 (5.0) 1 (4.8)
 Metabolic acidosis 2 (3.3) 0 0 2 (9.5)
 Pyrexia 2 (3.3) 1 (5.0) 0 1 (4.8)
  1. aReported in ≥ 2% of patients in overall population regardless of causality