Trimebutine

Although teratological studies have not shown any drug related adverse effects on the course and outcome of pregnancy in laboratory animals by both oral and parenteral routes, the use of trimebutine in pregnant women is not recommended.

Mutagenicity

No teratogenic abnormalities were found during the course of these studies and trimebutine maleate had no adverse effects on fertility, reproduction, course and outcome of pregnancy and offspring development during lactation.

In vivo, a mutagenicity study in mice at dose levels of 3,000-12,000 mg/kg and in vitro mutagenicity and carcinogenicity studies failed to show any evidence of bone marrow toxicity or mutagenic and carcinogenic potential of trimebutine maleate.

In clinical studies, adverse effects of mild to moderate nature occurred in 7% of the patients treated with trimebutine. No single side effect occurred in more than 1.8% of the patients and some of these might have been related to the patients' condition rather than the medication.

The commonly reported adverse effects are as follows:

Gastrointestinal: dry mouth, foul taste, diarrhea, dyspepsia, epigastric pain, nausea and constipation were reported in a total of 3.1% of the patient population;

CNS: drowsiness, fatigue, dizziness, hot/cold sensations and headaches were reported in 3.3%;

Allergic reactions: rash in 0.4% of the patients; and

Miscellaneous effects: menstrual problems, painful enlargement of breast, anxiety, urine retention and slight deafness were also infrequently reported.