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

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using cisapride (the active ingredient contained in Propulsid) and call your doctor at once if you have a serious side effect such as:

• fast or irregular heartbeats; or

• feeling like you might pass out.

Less serious side effects of cisapride may include:

• stomach pain, nausea, diarrhea; or

• increased urination.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to cisapride: oral suspension, oral tablet

General

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

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

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

Hematologic side effects have rarely included thrombocytopenia, leukopenia, aplastic anemia, pancytopenia, and granulocytopenia.

Cardiovascular

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

Hepatic side effects have included elevations in liver function test results, and hepatitis.

Psychiatric

Psychiatric side effects have rarely included insomnia, anxiety, nervousness, and depression.

Genitourinary

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

Ocular side effects have included visual changes (1.4%).

Respiratory

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

Hypersensitivity side effects have included allergic reactions, including bronchospasm, urticaria, and angioedema.

Endocrine

Endocrine side effects have been rarely reported. These have included gynecomastia in males, female breast enlargement, hyperprolactinemia, and galactorrhea.

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