Propulsid Side Effects
Generic Name: cisapride
Note: This document contains side effect information about cisapride. Some of the dosage forms listed on this page may not apply to the brand name Propulsid.
Some side effects of Propulsid may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to cisapride: oral suspension, oral tablet
Along with its needed effects, cisapride (the active ingredient contained in Propulsid) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking cisapride:Rare
- Blurred vision or other changes in vision
- convulsions (seizures)
- fainting or feeling faint
- fast or racing heartbeat
- pounding or irregular heartbeat
- swelling of face, hands, lower legs, and/or feet
- unusual weight gain
Some side effects of cisapride may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:Less common or rare
- Abdominal pain or cramping
- dryness of mouth
- heartburn or indigestion
- runny nose
- unusual tiredness or weakness
For Healthcare Professionals
Applies to cisapride: oral suspension, oral tablet
Generally cisapride (the active ingredient contained in Propulsid) is well tolerated. Many of the side effects reported in clinical trials occurred with similar frequency in the placebo groups.
Gastrointestinal side effects are often due the pharmacologic actions of cisapride (the active ingredient contained in Propulsid) 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.
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.
Nervous system side effects have included headache (19.3%), dizziness, somnolence, and fatigue. In addition, seizures and extrapyramidal symptoms have been reported rarely.
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.
Hematologic side effects have rarely included thrombocytopenia, leukopenia, aplastic anemia, pancytopenia, and granulocytopenia.
Syncope associated with QT interval prolongation and nonsustained ventricular tachycardia occurred in a 64-year-old male taking cisapride (the active ingredient contained in Propulsid) 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.
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.
Hepatic side effects have included elevations in liver function test results, and hepatitis.
Psychiatric side effects have rarely included insomnia, anxiety, nervousness, and depression.
Urinary symptoms usually begin within 48 hours of starting treatment with cisapride (the active ingredient contained in Propulsid) Urinary frequency and incontinence generally resolve completely upon withdrawal of therapy and may recur during rechallenge with the drug.
Genitourinary side effects have included urinary frequency, urinary incontinence, and vaginitis.
Ocular side effects have included visual changes (1.4%).
Respiratory side effects have included bronchospasm and wheezing in asthma patients. Rechallenge with cisapride (the active ingredient contained in Propulsid) led to reoccurrence of bronchospasm in one patient.
Hypersensitivity side effects have included allergic reactions, including bronchospasm, urticaria, and angioedema.
Endocrine side effects have been rarely reported. These have included gynecomastia in males, female breast enlargement, hyperprolactinemia, and galactorrhea.
More about Propulsid (cisapride)
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