What are the possible side effects of Cisapro?
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 Cisapro and call your doctor at once if you have a serious side effect such as:
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fast or irregular heartbeats; or
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feeling like you might pass out.
Less serious side effects may include:
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stomach pain, nausea, diarrhea; or
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increased urination.
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.
Side effects of Cisapro in details
may cause extrapyramidal symptoms (usually acute dystonic reactions); these are more common in children and young adults, especially if female, and at daily doses above 500 micrograms/kg. Parkinsonism and tardive dyskinesia have occasionally occurred, usually during prolonged treatment in elderly patients.
Other adverse effects include restlessness, drowsiness, and diarrhoea. Hypotension, hypertension, dizziness, headache, and depression may occur and there are isolated reports of blood disorders, hypersensitivity reactions (rash, bronchospasm), and neuroleptic malignant syndrome. Disorders of cardiac conduction have been reported with intravenous metoclopramide.
it may also
stimulates prolactin secretion and may cause galactorrhoea or related disorders. Transient increases in plasma-aldosterone concentrations have been reported.
What is the most important information I should know about Cisapro?
You should not take Cisapro if you are allergic to it, or if you have bleeding or an obstruction in your stomach, heart disease or hardening of the arteries, congestive heart failure, slow heart rate or a heart rhythm disorder, a personal or family history of "Long QT syndrome," a structural heart defect, heart block or other conduction disorders, severe dehydration, malnutrition, an eating disorder, kidney failure, or severe lung problems or advanced cancer.
There are many other drugs that can cause serious or life-threatening medical problems if you take them together with Cisapro. The following drugs should not be used while you are taking Cisapro:
Drinking alcohol can increase certain side effects of Cisapro.
Do not consume grapefruit or grapefruit juice while taking Cisapro. Grapefruit products may increase amount of Cisapro available in your body, which could lead to dangerous side effects.
Cisapro contraindications
The concomitant oral or parenteral use of the following potent cytochrome P450 3A4 inhibiting drugs may lead to elevated Cisapro blood levels and is contraindicated.
Antifungals: oral or i.v. fluconazole, itraconazole, ketoconazole.
Antibiotics: oral or i.v. erythromycin, clarithromycin.
Protease Inhibitors: ritonavir, indinavir (in vitro studies suggest that saquinavir is only a weak inhibitor).
Antidepressants: nefazodone.
Cisapro is also contraindicated for patients with: history of prolonged electrocardiographic QT intervals; renal failure; history of ventricular arrhythmias, ischemic heart disease, and congestive heart failure; uncorrected electrolyte disorders (hypokalemia, hypomagnesemia or in patients who might experience rapid reduction of plasma potassium such as those administered potassium-wasting diuretics and/or insulin in acute settings); respiratory failure; and concomitant medications known to prolong the QT interval and increase the risk of arrhythmia, such as certain antiarrhythmics, certain antipsychotics, certain antidepressants, astemizole and terfenadine.
The preceding lists of drugs are not comprehensive.
Cisapro is contraindicated in prematurely born infants (born at gestational age of less than 36 weeks), from 0 through 3 months after the delivery date.
Cisapro is contraindicated in patients with known sensitivity or intolerance to the drug.
Cisapro is contraindicated whenever gastrointestinal stimulation might be dangerous, i.e., gastrointestinal hemorrhage, mechanical obstruction or perforation.
Manufacturers’ Warnings In Clinical States: Serious cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation, torsades de pointes, and QT prolongation have been reported in patients taking Cisapro with other drugs that inhibit cytochrome P450 3A4. Cisapro is contraindicated in patients taking any of these drugs. Some of these contraindicated drugs are listed in the Contraindications section. Some of these patients did not have cardiac disease. However, most had been receiving multiple other medications and had pre-existing cardiac disease or risk factors for arrhythmias. QT prolongation, torsades de pointes (sometimes with syncope), cardiac arrest and sudden death have been reported in patients taking Cisapro without the above-mentioned contraindicated drugs. Most patients had disorders that may have predisposed them to arrhythmias with Cisapro. Some of these events have been fatal.
Cisapro is contraindicated in patients with the following risk factors for cardiac arrhythmia: uncorrected electrolyte disturbances (hypokalemia, hypomagnesemia such as seen in patients taking potassium-wasting diuretics, severe dehydration, vomiting, malnutrition, or in patients who might experience a rapid reduction of plasma potassium, such as insulin administered in acute settings), renal failure (particularly when on chronic dialysis), chronic obstructive pulmonary disease, respiratory failure, conditions associated with QT prolongation (such as congenital long QT syndrome, idiopathic QT prolongation, QT prolongation associated with diabetes mellitus, combination with medications known to prolong the QT interval), prolonged QT interval at baseline and history of significant cardiac disease (including serious ventricular arrhythmia, torsades de pointes, second or third degree AV block, congestive heart failure, ischemic heart disease and sinus node dysfunction).
Additionally, concomitant medications known to prolong the QT interval risk of arrhythmia, such as certain antiarrhythmics, including those of Class 1A (such as but not limited to quinidine and procainamide) and Class III (such as but not limited to amiodarone and sotalol); tricyclic antidepressants (such as but not limited to amitriptyline); certain tetracyclic antidepressants (such as but not limited to maprotiline); certain antipsychotic medications (such as but not limited to certain phenothiazines); astemizole and terfenadine should also be avoided.
The preceding lists of drugs are not comprehensive.
Potential benefits should be weighed against risks prior to the administration of Cisapro to patients who have, or may develop prolongation of cardiac conduction intervals, particularly QTc. In addition, patients with or suspected of having the above risk factors should be evaluated prior to the administration of Cisapro. An ECG should be considered as part of this evaluation to exclude a prolonged QT interval.
References
- European Chemicals Agency - ECHA. "cisapride: The European Chemicals Agency (ECHA) is an agency of the European Union which is the driving force among regulatory authorities in implementing the EU's groundbreaking chemicals legislation for the benefit of human health and the environment as well as for innovation and competitiveness.". https://echa.europa.eu/ (accessed September 17, 2018).
- HSDB. "CISAPRIDE". https://toxnet.nlm.nih.gov/cgi-bin/s... (accessed September 17, 2018).
- NCIt. "Cisapride: NCI Thesaurus (NCIt) provides reference terminology for many systems. It covers vocabulary for clinical care, translational and basic research, and public information and administrative activities.". https://ncit.nci.nih.gov/ncitbrowser... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Cisapro are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Cisapro. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported side effects
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Information checked by Dr. Sachin Kumar, MD Pharmacology
