Mebeverine Hydrochloride Dosing in Children
Mebeverine is not recommended for routine use in children, as the available evidence shows no statistically significant benefit over placebo in pediatric populations, and there is no established safe and effective dosing regimen for children under 12 years of age.
Evidence from Pediatric Studies
The most recent high-quality pediatric trial demonstrates that mebeverine lacks efficacy in children:
A 2025 randomized controlled trial in adolescents (ages 12-17 years) with IBS and functional abdominal pain used a dose of 200 mg twice daily for 8 weeks, but found no significant difference between mebeverine and placebo (23.4% vs 22.0% treatment success, P=0.81). 1
An earlier 2014 pediatric trial tested 135 mg twice daily in children aged 6-18 years for 4 weeks, showing a non-significant trend toward benefit (54.5% response vs 39.5% placebo, P=0.117), but this did not reach statistical significance and the study was underpowered. 2
Critical Limitations for Pediatric Use
There is no FDA-approved pediatric indication or dosing for mebeverine, and the drug has only been studied in limited pediatric trials with inconsistent results. The 2025 trial—the largest and most rigorous pediatric study—definitively showed no benefit over placebo in the target age group. 1
Age-Specific Concerns:
Children under 12 years: No adequate safety or efficacy data exists. The 2014 trial included children as young as 6 years but failed to demonstrate statistical benefit. 2
Adolescents 12-17 years: The 2025 trial used 200 mg twice daily but showed no therapeutic advantage, with adverse events being mild and infrequent. 1
Adult Dosing (For Reference Only)
In adults, the standard dose is 135 mg three times daily before meals, as demonstrated in adult IBS trials. 3 However, this adult dosing should not be extrapolated to children without proper pediatric studies demonstrating safety and efficacy.
Clinical Recommendation
Given the lack of proven efficacy in the most recent and highest-quality pediatric trial, mebeverine should not be prescribed to children for functional abdominal pain or IBS. 1 Alternative management strategies, including dietary modifications, behavioral interventions, and other evidence-based therapies for pediatric functional gastrointestinal disorders, should be prioritized instead.
If a clinician is considering mebeverine in an adolescent despite the negative evidence, the only studied dose in this age group is 200 mg twice daily, though this showed no benefit over placebo. 1