FDA label c30bc729-75b0-ea95-deca-25921e8b50ce

BOXED WARNING 2 mL Single Dose Vial 50 mL Pharmacy Bulk Package – Not for Direct Infusion

ADVERSE REACTIONS 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 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 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 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. 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. In addition, transient irritation at the injection site has been observed with famotidine injection. 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.