Evigrade

Mebeverine

AEMPS

Antispasmodics (myotropic)

ATC code: A03AA04

Brand names: Colofac, Duspatalin

Updated · Methodology

Indications

B

Irritable bowel syndrome

Individual decision

Per 2021 and Rome IV, myotropic antispasmodics are first-line pharmacotherapy for abdominal pain in irritable bowel syndrome. Mebeverine dose 200 mg twice daily 20 minutes before meals. Effect on abdominal pain is moderate (NNT 7), on overall QoL – small. 2021 grades antispasmodic recommendations as 'conditional, low-quality evidence'. If no benefit after 4 weeks, reassess diagnosis and switch to peppermint oil, eluxadoline, rifaximin, or psychotropic agents.

ICD-10: K58.8 · ICD-11: DD91.0Z

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

D

Biliary dyskinesia

Not recommended

Mebeverine is an antispasmodic that relaxes the smooth muscle of the gut, and it's sometimes prescribed for biliary dyskinesia too. Convincing benefit for this particular condition hasn't been shown, and there's no solid evidence base for the use. Gallbladder and sphincter dysfunction usually calls for clarifying the diagnosis, adjusting diet, and follow-up with a gastroenterologist who can match the approach to the actual cause of symptoms.

ICD-10: K82.8 · ICD-11: DC14.2

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

Direct myotropic antispasmodic on GI smooth muscle. Blocks sodium channels, reduces muscle tone, and suppresses spastic contractions without affecting normal peristalsis. Unlike atropinic antispasmodics, mebeverine has no anticholinergic effects — no dry mouth, accommodation disturbance, or urinary retention.

Safety

Contraindications

  • Hypersensitivity
  • Age under 18 (extended-release forms)
  • Pregnancy (per manufacturer)

Serious adverse effects

  • Anaphylaxis (very rare)
  • Angioedema (very rare)

Common adverse effects

  • Allergic skin reactions
  • Dizziness (rare)
  • Dyspepsia

Pregnancy: can you take Mebeverine?

Manufacturer label contraindicates first-trimester use. Data on second/third-trimester risk are limited. In pregnant IBS patients, non-pharmacological measures and the FODMAP diet are preferred.

Breastfeeding: can you take Mebeverine?

Data on breast milk transfer are limited. Manufacturer label advises against breastfeeding.

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Timing and administration

Take 20 minutes before meals twice daily. Swallow the capsule whole — modified release. Effect develops over 1–2 weeks of regular use; no benefit after 4 weeks warrants reassessment.

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Frequently asked

What is Mebeverine used for?

Mebeverine is evaluated for the following indications with varying evidence strength: Abdominal smooth muscle spasm (evidence tier B), Irritable bowel syndrome (evidence tier B), Biliary dyskinesia (evidence tier D). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Mebeverine?

Common side effects of Mebeverine (≥ 1 in 100): Allergic skin reactions, Dizziness (rare), Dyspepsia. See the Safety section for uncommon and serious reactions.

Is Mebeverine safe during pregnancy?

Manufacturer label contraindicates first-trimester use. Data on second/third-trimester risk are limited. In pregnant IBS patients, non-pharmacological measures and the FODMAP diet are preferred.

Is Mebeverine compatible with breastfeeding?

Data on breast milk transfer are limited. Manufacturer label advises against breastfeeding.

Who should not take Mebeverine?

Mebeverine is contraindicated in: Hypersensitivity; Age under 18 (extended-release forms); Pregnancy (per manufacturer). Full list in the Safety section.

Official sources

Direct links to regulator labels. Open in a new tab.

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