Motilium Adverse Reactions





Zuellig Pharma
Full Prescribing Info
Adverse Reactions
Throughout this section, adverse reactions are presented. Adverse reactions are adverse events that were considered to be reasonably associated with the use of domperidone based on the comprehensive assessment of the available adverse event information. A causal relationship with domperidone cannot be reliably established in individual cases. Further, because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Clinical Trial Data: The safety of MOTILIUM was evaluated in 1221 patients with gastroparesis, dyspepsia, gastro-oesophageal reflux disorder (GERD), or other related conditions in 45 clinical trials included in the safety database. All patients were ≥15 years old and received at least one dose of oral domperidone base. Slightly fewer than one-half (553/1221) of patients were diabetic. The median total daily dose was 80 mg (range 10 to 160 mg), with 230 patients receiving a dose greater than 80 mg. Median duration of exposure was 56 days (range 1 to 2248 days).
ARs reported by ≥1% of patients treated with domperidone in these 45 clinical trials are shown in Table 4. (See Table 4.)

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ARs that occurred in <1% of domperidone-treated patients in the 45 clinical trials (n=1221) are listed as follows in Table 5. (See Table 5.)

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The following adverse reaction has been reported with over-the-counter use: dry mouth.
Postmarketing: In addition to the ARs reported during clinical studies and listed previously, the following ARs have been reported during postmarketing experience (Table 6). In the table, the frequencies are provided according to the following convention: Very common ≥ 1/10; Common ≥ 1/100 and < 1/10; Uncommon ≥ 1/ 1,000 and < 1/100; Rare ≥1/10,000 and < 1/1,000; Very rare <1/10,000, including isolated reports.
In Table 6, ARs are presented by frequency category based on spontaneous reporting rates. (See Table 6.)

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Pediatric population: In postmarketing experience, there were no differences in the safety profile of adults and children.
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