Recommended Topic Related To:

Propulsid

"FDA is recommending health care professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 milligrams (mg) of acetaminophen per tablet, capsule or other dosage unit. There are no"...

Propulsid

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Propulsid

Propulsid Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Propulsid (cisapride) is used to treat gastric reflux (the regurgitation of stomach acid into the esophagus), which is usually experienced as heartburn. It is a "prokinetic" agent that increases muscle contractions of the lower esophagus and the lower esophagus sphincter. The brand name Propulsid is no longer available in the U.S. Generic versions may be available. Common side effects include abdominal pain, nausea, or diarrhea, or increased frequency of urination.

The starting dose of cisapride is one 10 mg tablet or 10 ml of the suspension 4 times daily at least 15 minutes before meals and at bedtime. Cisapride may interact with antibiotics, antidepressants, antifungal medications, phenothiazines, antihistamines, blood pressure medications, heart medications, HIV medications, clidinium, dicyclomine, hyoscyamine, belladonna, propantheline, cimetidine, warfarin, or benzodiazepines. Tell your doctor all medications you use. During pregnancy, cisapride should be taken only if prescribed. Cisapride passes into breast milk. It is unknown if this drug will harm a nursing infant. Consult your doctor before breast-feeding.

Our Propulsid (cisapride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Propulsid in Detail - Patient Information: Side Effects

If you experience any of the following serious side effects, stop taking cisapride and seek emergency medical attention or notify your doctor immediately:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
  • fainting; or
  • fast or irregular heartbeats.

Other, less serious side effects may be more likely to occur. Continue to take cisapride and talk to your doctor if you experience

  • abdominal pain, nausea, or diarrhea; or
  • increased frequency of urination.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Read the entire detailed patient monograph for Propulsid (Cisapride (Removed from US Market)) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Propulsid FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

In the U.S. clinical trial population of 1728 patients (comprising 506 with gastroesophageal reflux disorders, and the remainder with other disorders) the following adverse experiences were reported in more than 1% of patients treated with cisapride and at least as often on cisapride as on placebo. (See TABLE 1.)

TABLE 1
System/Adverse Events Cisapride N=1042 Placebo N=686
 Central & Peripheral Nervous Systems
19.3% 17.1%
 Gastrointestinal

    Diarrhea

14.2 10.3

    Abdominal pain

10.2 7.7

    Nausea

7.6 7.6
6.7 3.4

    Flatulence

3.5 3.1

    Dyspepsia

2.7 1.0
 Respiratory System

    Rhinitis

7.3 5.7

    Sinusitis

3.6 3.5

    Coughing

1.5 1.2
 Resistance Mechanism

    Viral infection

3.6 3.2

    Upper respiratory tract infection

3.1 2.8
 Body as a Whole

    Pain

3.4 2.3

    Fever

2.2 1.5
 Urinary System
2.4 1.9

    Micturition frequency

1.2 0.6
 Psychiatric

    Insomnia

1.9 1.3

    Anxiety

1.4 1.0

    Nervousness

1.4 0.7
 Skin & Appendages

    Rash

1.6 1.6

    Pruritus

1.2 1.0
 Musculoskeletal System

    Arthralgia

1.4 1.2
 Vision

    Abnormal vision

1.4 0.3
 Reproductive, Female

    Vaginitis

1.2 0.9


The following adverse events also reported in more than 1% of cisapride patients were more frequently reported on placebo: dizziness, vomiting, pharyngitis, chest pain, fatigue, back pain, depression, dehydration, and myalgia.

Diarrhea, abdominal pain, constipation, flatulence, and rhinitis all occurred more frequently in patients using 20 mg of cisapride than in patients using 10 mg.

Additional adverse experiences reported to occur in 1% or less of patients in the U.S. clinical studies are: dry mouth, somnolence, palpitation, migraine, tremor, and edema.

In other U.S. and international trials and in postmarketing experience, there have been rare reports of seizures and extrapyramidal effects. Also reported have been tachycardia, elevated liver enzymes, hepatitis, thrombocytopenia, leukopenia, aplastic anemia, pancytopenia, and granulocytopenia. The relationship of cisapride to the event was not clear in these cases.

Cardiac arrhythmias, including ventricular tachycardia, ventricular fibrillation, torsades de pointes, and QT prolongation, in some cases resulting in death, have been reported. (See CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and DRUG INTERACTIONS.)

Postmarketing Reports

In addition to the cardiovascular adverse events, the following events have been identified during post-approval use of cisapride in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion in this product information due to a combination of their seriousness, frequency of reporting, or potential causal connection to cisapride: allergic reactions, including bronchospasm, urticaria, and angioedema; possible exacerbation of asthma; psychiatric events, including confusion, depression, suicide attempt, and hallucinations; extrapyramidal effects including akathisia, Parkinson-like symptoms, dyskinetic and dystonic reactions; gynecomastia, female breast enlargement, urinary incontinence, hyperprolactinemia, and galactorrhea.

The Following Events Were Specifically Reported in the Pediatric Population: Antinuclear antibody (ANA) positive, anemia, hemolytic anemia, methemoglobinemia, hyperglycemia, hypoglycemia with acidosis, unexplained apneic episodes, confusion, impaired concentration, depression, apathy, visual changes accompanied by amnesia, and severe photosensitivity reaction.

There have been rare cases of sinus tachycardia reported. Rechallenge precipitated the tachycardia again in some of those patients.

Read the entire FDA prescribing information for Propulsid (Cisapride (Removed from US Market)) »

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.

Related Supplements
advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations