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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

    Headache

19.3% 17.1%
 Gastrointestinal

    Diarrhea

14.2 10.3

    Abdominal pain

10.2 7.7

    Nausea

7.6 7.6

    Constipation

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

    Urinary tract infection

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.