Famotidine side effects

List of side effects
Overview Occurrence in > 1% of patients Occurrence in < 1% of patients Pediatric patients

Overview
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 Famotidine tablets were compared to placebo, the incidence of adverse experiences in the group which received Famotidine tablets, 40 mg at bedtime, was similar to that in the placebo group. The adverse reactions reported for Famotidine tablets may also occur with Famotidine for oral suspension and Famotidine orally disintegrating tablets Return to top

Occurrence in > 1% of patients
The following adverse reactions have been reported to occur in more than 1% of patients on therapy with Famotidine 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%). Return to top

Occurrence in < 1% of patients
The following other adverse reactions have been reported infrequently in clinical trials or since the drug was marketed. The relationship to therapy with Famotidine has been unclear in many cases. Within each category the adverse reactions are listed in order of decreasing severity: Return to top
 * 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
 * Respiratory: bronchospasm
 * Skin: toxic epidermal necrolysis (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.

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. Return to top