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Trimebutine

GI motility regulator, peripheral opioid receptor agonist

ATC code: A03AA05

Updated · Methodology

Indications

C

Irritable bowel syndrome

Second line

Used in irritable bowel syndrome with mixed or variable bowel pattern. Evidence is modest: the 2011 Cochrane meta-analysis showed moderate benefit over placebo for symptom relief (RR 1.32, 95% CI 1.07–1.64), with low-quality studies. International guidelines ( 2021, 2022) do not include it; it is used mostly in Spain, France, and Eastern Europe.

Sources

  1. AEMPS: Ficha técnica de Trimebutina (2024)
  2. AEG: Guía AEG sobre síndrome del intestino irritable (2022)

ICD-10: K58.8 · ICD-11: DD91.0Z

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

An agonist of peripheral enkephalinergic μ, κ, and δ receptors within the enteric nervous system. Modulates motility according to baseline state: increases it in hypokinesia and decreases it in hyperkinesia. No central opioid effect – does not cross the blood-brain barrier and produces no dependence or analgesia.

Safety

Contraindications

  • Trimebutine hypersensitivity
  • Age under 3 years (tablets)

Serious adverse effects

  • Allergic reactions, angioedema (rare)

Common adverse effects

  • Dry mouth
  • Nausea
  • Hearing disturbances (rare)
  • Skin rash

Pregnancy: can you take Trimebutine?

Limited pregnancy data. Avoid in T1 where possible.

Breastfeeding: can you take Trimebutine?

Milk excretion data are limited. Prefer alternatives with more data when feasible.

Calculate RID

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

Practical notes

Timing and administration

Standard dose 100–200 mg three times daily before meals. Course 4 weeks with reassessment. No evidence supports continuous use beyond 12 weeks.

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Frequently asked

What is Trimebutine used for?

Trimebutine is evaluated for the following indications with varying evidence strength: Irritable bowel syndrome (evidence tier C), Functional dyspepsia (evidence tier D). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Trimebutine?

Common side effects of Trimebutine (≥ 1 in 100): Dry mouth, Nausea, Hearing disturbances (rare), Skin rash. See the Safety section for uncommon and serious reactions.

Is Trimebutine safe during pregnancy?

Limited pregnancy data. Avoid in T1 where possible.

Is Trimebutine compatible with breastfeeding?

Milk excretion data are limited. Prefer alternatives with more data when feasible.

Who should not take Trimebutine?

Trimebutine is contraindicated in: Trimebutine hypersensitivity; Age under 3 years (tablets). Full list in the Safety section.

Other drugs in this group

Cinitapride, Cisapride, Domperidone, Drotaverine, Mebeverine, Otilonium bromide, Hyoscine butylbromide, Metoclopramide