Cisapride Side Effects

Not all side effects for cisapride may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to cisapride: oral suspension, oral tablet

In addition to its needed effects, some unwanted effects may be caused by cisapride. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking cisapride:

Rare
  • Blurred vision or other changes in vision
  • convulsions (seizures)
  • dizziness
  • 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 of the side effects that can occur with cisapride may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common or rare
  • Abdominal pain or cramping
  • constipation
  • diarrhea
  • drowsiness
  • dryness of mouth
  • gas
  • headache
  • heartburn or indigestion
  • nausea
  • runny nose
  • tremor
  • unusual tiredness or weakness

For Healthcare Professionals

Applies to cisapride: oral suspension, oral tablet

General

Generally cisapride is well tolerated. Many of the side effects reported in clinical trials occurred with similar frequency in the placebo groups.[Ref]

Gastrointestinal

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]

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.[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]

Hematologic

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

Cardiovascular

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

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

Psychiatric

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

Genitourinary

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]

Genitourinary side effects have included urinary frequency, urinary incontinence, and vaginitis.[Ref]

Ocular

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

Respiratory

Respiratory side effects have included bronchospasm and wheezing in asthma patients. Rechallenge with cisapride led to reoccurrence of bronchospasm in one patient.[Ref]

Hypersensitivity

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

Endocrine

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

References

1. Bennett JR "How safe and acceptable is cisapride?" Scand J Gastroenterol Suppl 165 (1989): 59-61

2. McCallum RW, Prakash C, Campoli-Richards DM, Goa KL "Cisapride. A preliminary review of its pharmacodynamic and pharmacokinetic properties, and therapeutic use as a prokinetic agent in gastrointestinal motility disorders." Drugs 36 (1988): 652-81

3. Wiseman LR, Faulds D "Cisapride - an updated review of its pharmacology and therapeutic efficacy as a prokinetic agent in gastrointestinal motility disorders." Drugs 47 (1994): 116-52

4. Castell DO, Sigmund C, Patterson D, Lambert R, Hasner D, Clyde C, Zeldis JB "Cisapride 20 mg b.i.d. provides symptomatic relief of heartburn and related symptoms of chronic mild to moderate gastroesophageal reflux disease." Am J Gastroenterol 93 (1998): 547-52

5. "Product Information. Propulsid (cisapride)." Janssen Pharmaceutica, Titusville, NJ.

6. Richter JE, Long JF "Cisapride for gastroesophageal reflux disease: a placebo-controlled, double-blind study." Am J Gastroenterol 90 (1995): 423-30

7. Sempere AP, Duarte J, Cabezas C, Claveria LE, Coria F "Aggravation of parkinsonian tremor by cisapride." Clin Neuropharmacol 18 (1995): 76-8

8. Bucci KK, Haverstick DE, Abercrombie SA "Dystonic-like reaction following cisapride therapy." J Fam Pract 40 (1995): 86-8

9. Bran S, Murray WA, Hirsch IB, Palmer JP "Long QT syndrome during high-dose cisapride." Arch Intern Med 155 (1995): 765-8

10. Hill SL, Evangelista JK, Pizzi AM, Mobassaleh M, Fulton DR, Berul CI "Proarrhythmia associated with cisapride in children." Pediatrics 101 (1998): 1053-6

11. Gray VS "Syncopal episodes associated with cisapride and concurrent drugs." Ann Pharmacother 32 (1998): 648-51

12. Lewin MB, Bryant RM, Fenrich AL, Grifka RG "Cisapride-induced long QT interval." J Pediatr 128 (1996): 279-81

13. Pillans PI, Wood SM "Cisapride increases micturition frequency." J Clin Gastroenterol 19 (1994): 336-8

14. Boyd IW, Rohan AP "Urinary disorders associated with cisapride." Med J Aust 160 (1994): 579-80

15. Pillans P "Bronchospasm associated with cisapride." BMJ 311 (1995): 1472

16. Nolan P, Phillips M, Williamson B "Cisapride and brittle asthma." Lancet 336 (1990): 1443

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