Cisapride Side Effects
Applies to cisapride: oral suspension, oral tablet
Generally cisapride is well tolerated. Many of the side effects reported in clinical trials occurred with similar frequency in the placebo groups.[Ref]
Gastrointestinal side effects are often due the pharmacologic actions of cisapride. These effects appear to be dose-related, as 20 mg doses are associated with an increased incidence of diarrhea, abdominal pain, and flatulence compared to 10 mg doses.
In a study of 1500 patients, approximately 2.5% discontinued cisapride therapy, usually due to abdominal pain and intolerable diarrhea.[Ref]
Gastrointestinal side effects have been reported the most frequently. These have included diarrhea or loose stools (14.2%), abdominal cramping (10.2%), nausea (7.6%), flatulence (3.5%), borborygmi (rumbling bowel sounds), and dry mouth.[Ref]
While cisapride lacks antidopaminergic properties, extrapyramidal effects have been reported to the manufacturer. However, the incidence of cisapride-induced movement disorders would be expected to be significantly less than with metoclopramide, an antidopaminergic, gastrokinetic agent.
In addition, somnolence and fatigue are reported with lesser frequency during cisapride therapy (1.6%) than with metoclopramide (15.2%).
Worsening of tremor has been reported in two patients with parkinsonism who were treated with cisapride.[Ref]
Cardiovascular effects have reported rarely. These have included palpitations, tachycardia, and edema. Rare but potentially serious cardiac arrhythmias, including ventricular arrhythmias and torsades de pointes have also been reported.[Ref]
Syncope associated with QT interval prolongation and nonsustained ventricular tachycardia occurred in a 64-year-old male taking cisapride 40 mg by mouth four times a day for diabetic gastroparesis. A baseline electrocardiogram was normal 6 days earlier. Gradual reduction in dosage to 5 mg four times a day resolved the prolonged QT interval. High dosages of cisapride may lead to a risk of ventricular arrhythmia and torsades de pointes.[Ref]
Hepatic side effects have included elevations in liver function test results, and hepatitis.[Ref]
Urinary symptoms usually begin within 48 hours of starting treatment with cisapride. Urinary frequency and incontinence generally resolve completely upon withdrawal of therapy and may recur during rechallenge with the drug.[Ref]
Ocular side effects have included visual changes (1.4%).[Ref]
Endocrine side effects have been rarely reported. These have included gynecomastia in males, female breast enlargement, hyperprolactinemia, and galactorrhea.[Ref]
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Some side effects may not be reported. You may report them to the FDA.
More about cisapride
- Cisapride Side Effects
- During Pregnancy or Breastfeeding
- Drug Interactions
- Support Group
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- Drug class: GI stimulants
Other brands: Propulsid