Drug Information for PEPCID (Salix Pharmaceuticals, Inc): ADVERSE REACTIONS

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  • The adverse reactions listed below have been reported during domestic and international clinical trials in approximately 2500 patients. In those controlled clinical trials in which PEPCID Tablets were compared to placebo, the incidence of adverse experiences in the group which received PEPCID Tablets, 40 mg at bedtime, was similar to that in the placebo group.

    The following adverse reactions have been reported to occur in more than 1% of patients on therapy with PEPCID in controlled clinical trials, and may be causally related to the drug: headache (4.7%), dizziness (1.3%), constipation (1.2%) and diarrhea (1.7%).

    The following other adverse reactions have been reported infrequently in clinical trials or since the drug was marketed. The relationship to therapy with PEPCID has been unclear in many cases. Within each category the adverse reactions are listed in order of decreasing severity:

    Body as a Whole: fever, asthenia, fatigue

    Cardiovascular: arrhythmia, AV block, palpitation

    Gastrointestinal: cholestatic jaundice, liver enzyme abnormalities, vomiting, nausea, abdominal discomfort, anorexia, dry mouth

    Hematologic: rare cases of agranulocytosis, pancytopenia, leukopenia, thrombocytopenia

    Hypersensitivity: anaphylaxis, angioedema, orbital or facial edema, urticaria, rash, conjunctival injection

    Musculoskeletal: musculoskeletal pain including muscle cramps, arthralgia

    Nervous System/Psychiatric: grand mal seizure; psychic disturbances, which were reversible in cases for which follow-up was obtained, including hallucinations, confusion, agitation, depression, anxiety, decreased libido; paresthesia; insomnia; somnolence. Convulsions, in patients with impaired renal function, have been reported very rarely.

    Respiratory: bronchospasm, interstitial pneumonia

    Skin: toxic epidermal necrolysis/Stevens Johnson syndrome (very rare), alopecia, acne, pruritus, dry skin, flushing

    Special Senses: tinnitus, taste disorder

    Other: rare cases of impotence and rare cases of gynecomastia have been reported; however, in controlled clinical trials, the incidences were not greater than those seen with placebo.

    The adverse reactions reported for PEPCID Tablets may also occur with PEPCID for Oral Suspension.

    Pediatric Patients

    In a clinical study in 35 pediatric patients <1 year of age with GERD symptoms [e.g., vomiting (spitting up), irritability (fussing)], agitation was observed in 5 patients on famotidine that resolved when the medication was discontinued.

  • Drug Information Provided by National Library of Medicine (NLM).
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