Trimebutine has been commercialised since the 1970s as a treatment for pains associated with irritable bowel syndrome. It has no proven efficacy beyond a placebo effect; any benefits are modest.

There is little available evidence of its adverse effects. There have been reports of trimebutine addiction since the 1990s. Most patients had no known history of drug addiction and dependence is reported most frequently with the injectable form.

Between 1974 and 2011, French poison and toxicovigilance centres recorded 366 cases of voluntary or accidental overdose. The vast majority of cases were dosage errors in children, or suicidal behaviour with oral timebutine. The symptoms were mainly gastrointestinal (pains, vomiting), neurological (loss of consciousness, coma, drowsiness, convulsions), and more rarely cutaneous or cardiocirculatory (cardiac arrhythmia, arterial hypertension). These effects appeared very rapidly, i.e. within under 3 hours of the drug being taken. The patients recovered, except for one adolescent girl found dead after committing suicide by taking a cocktail of drugs.

Trimebutine has no proven efficacy beyond the placebo effect. Available evidence shows that trimebutine is not harmless, particularly in children. The benefits of taking this drug should be carefully weighed up.

©Prescrire 1 October 2013

"Trimebutine: abuse, addiction and overdose" Prescrire Int 2013; 22 (142): 241-242. (Pdf, subscribers only).