Motilium Adverse Reactions

The safety of Motilium was evaluated in 1275 patients with dyspepsia, gastro-oesophageal reflux disorder (GERD), Irritable Bowel Syndrome (IBS), nausea and vomiting or other related conditions in 31 double-blind, placebo-controlled studies. All patients were at least 15 years old and received at least one dose of Motilium (domperidone base). The median total daily dose was 30 mg (range 10 to 80 mg), and median duration of exposure was 28 days (range 1 to 28 days).
Studies in diabetic gastroparesis or symptoms secondary to chemotherapy or parkinsonism were excluded.
The following terms and frequencies are applied: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), and very rare (<1/10,000). Where frequency can not be estimated from clinical trials data, it is recorded as "Not known". (See table.)

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In 45 clinical studies where domperidone was used at higher dosages, for longer duration and for additional indications including diabetic gastroparesis, the frequency of adverse events (apart from dry mouth) was considerably higher. This was particularly evident for pharmacologically predictable events related to increased prolactin. In addition to the reactions listed previously, akathisia, breast discharge, breast enlargement, breast swelling, depression, hypersensitivity, lactation disorder, and irregular menstruation were also noted.
In postmarketing experience, there were no differences in the safety profile of adults and children with the exception of extrapyramidal disorder which occurred primarily in neonates and infants (up to one year of age) and other central nervous system-related effects of convulsion and agitation which were primarily reported in infants and children.
An increase in the risk of serious ventricular arrhythmias and sudden cardiac death have been reported in some epidemiology studies (see Precautions).
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.