SIDE EFFECTS

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 famoti-dine 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 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%).

The following other adverse reactions have been reported infrequently in clinical trials or since the drug was marketed.The relationship to therapy with famotidine hasbeen 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 agranulocyto-sis, pancytopenia, leukopenia, thrombocy-topenia

Hypersensitivity: anaphylaxis, angioedema, orbital or facial edema, urticaria, rash, conjuc-tival 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 inci-dences were not greater than those seen with placebo.

The adverse reactions reported for famotidine tablets may also occur with famotidine for oral suspension, famotidine orally disintegrating tablets, famotidine injection preservative free in plastic container or famotidine injection.

Read the entire FDA prescribing information for Famotidine Injection (Famotidine Injection) »