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Propulsid (Cisapride) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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 PROPULSID® (cisapride) and at least as often on PROPULSID® as on placebo.

System/Adverse Event PROPULSID ®
N=1042
Placebo
N=686
Central & Peripheral Nervous Systems
Headache19.3%17.1%
Gastrointestinal
Diarrhea14.210.3
Abdominal pain10.27.7
Nausea7.67.6
Constipation6.73.4
Flatulence3.53.1
Dyspepsia2.71.0
Respiratory System
Rhinitis7.35.7
Sinusitis3.63.5
Coughing1.51.2
Resistance Mechanism
Viral infection3.63.2
Upper respiratory tract infection3.12.8
Body as a Whole
Pain3.42.3
Fever2.21.5
Urinary System
Urinary tract infection2.41.9
Micturition frequency1.20.6
Psychiatric
Insomnia1.91.3
Anxiety1.41.0
Nervousness1.40.7
Skin & Appendages
Rash1.61.6
Pruritus1.21.0
Musculoskeletal System
Arthralgia1.41.2
Vision
Abnormal vision1.40.3
Reproductive, Female
Vaginitis1.20.9

The following adverse events also reported in more than 1% of PROPULSID® 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 PROPULSID® 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 PROPULSID® 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.)

Ongoing Postmarketing Surveillance: Serious cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation, torsades de pointes, and QT prolongation have been reported in patients taking PROPULSID ® . From July 1993 through May 1999, more than 270 such cases have been spontaneously reported, including 70 fatalities. In approximately 85% of these cases the events occurred when PROPULSID ® was used in patients with known risk factors. These risk factors included the administration of other drugs which caused QT prolongation, inhibited the cytochrome P450 3A4 enzymes that metabolize cisapride, or depleted serum electrolytes; or the presence of disorders that may have predisposed patients to arrhythmias. In approximately 0.7% of these cases, the events occurred in the absence of identified risk factors; in the remaining cases, risk factor status was unknown. Because the cases were reported voluntarily from a population of unknown size, estimates of adverse event frequency cannot be made. (See Boxed Warning, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and Drug Interactions.) PROPULSID®-induced serious ventricular arrhythmias and death may not correlate with the degree of drug-induced prolongation of the QT interval detected by 12-lead ECG.

In addition to the cardiovascular adverse events, the following events have been identified during post-approval use of PROPULSID® 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 insert due to a combination of their seriousness, frequency of reporting, or potential causal connection to PROPULSID®: 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.



REPORTS OF SUSPECTED PROPULSID SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Propulsid. The information is not vetted and should not be considered as verified clinical evidence.

Possible Propulsid side effects / adverse reactions in 54 year old male

Reported by a physician from United States on 2012-01-17

Patient: 54 year old male weighing 93.4 kg (205.6 pounds)

Reactions: Electrocardiogram QT Prolonged

Suspect drug(s):
Propulsid
    Indication: Product Used FOR Unknown Indication

Propulsid



Possible Propulsid side effects / adverse reactions in 20 year old male

Reported by a consumer/non-health professional from United States on 2012-03-12

Patient: 20 year old male

Reactions: Intestinal Obstruction

Adverse event resulted in: hospitalization

Suspect drug(s):
Propulsid
    Indication: Product Used FOR Unknown Indication
    Start date: 2002-01-01

Propulsid



See index of all Propulsid side effect reports >>

Drug label data at the top of this Page last updated: 2006-10-10

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