Table 1.

Main ADRs occurring in AUD patients treated with high dose baclofen.

	Occurrence rates in RCTs (HDB vs. placebo)a	Proportion of all ADRs reported in the FPVDb
Sedation/Dizziness/Fatigue	38.0 to 46.6% vs. 17.7 to 25%	24.5%
Insomnia/Sleep Disorders	32.1 to 38.8% vs. 14.3 to 30.8%	7%
Headache	26.7% vs. 15.0%	–
Paraesthesia	14.4 to 16.6% vs. 3.6 to 4.4%	–
Restlessness/Fasciculations	10.8 to 14.3% vs. 3.6 to 3.8%	3.8%
Headache	24 (15.0%) 42 (26.7%)
Dry mouth	7.6 to 20.7% vs. 1.6 to 5.0%	10%

^a(15, 16, 18).

^b(20).

ADRs, adverse drug reactions; AUD, alcohol use disorder; RCTs, randomized controlled trials; HDB, high-dose baclofen; FPVD, French Pharmacovigilance Database.