Pepcid (Famotidine) - Side Effects and Adverse Reactions

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 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

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 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.

REPORTS OF SUSPECTED PEPCID SIDE EFFECTS / ADVERSE REACTIONS

Possible Pepcid side effects / adverse reactions in 58 year old male

Reported by a pharmacist from Japan on 2011-10-10

Patient: 58 year old male

Reactions: Blood Creatine Phosphokinase Increased, Rhabdomyolysis

Suspect drug(s):
Pepcid
    Start date: 2011-08-18

Pepcid
    Start date: 2011-08-14
    End date: 2011-08-14

Omeprazole
    Start date: 2011-08-15

Possible Pepcid side effects / adverse reactions in 79 year old male

Reported by a pharmacist from Japan on 2011-10-12

Patient: 79 year old male

Reactions: Hypoglycaemia

Adverse event resulted in: hospitalization

Suspect drug(s):
Tizanidine HCL

Celecoxib
    Administration route: Oral
    Start date: 2011-09-22
    End date: 2011-10-04

Toughmac E

Pepcid
    Administration route: Oral
    End date: 2011-10-05

Myonal
    End date: 2011-10-04

Possible Pepcid side effects / adverse reactions in 66 year old male

Reported by a physician from Japan on 2011-10-12

Patient: 66 year old male weighing 98.0 kg (215.6 pounds)

Reactions: Vasculitis, Eosinophilia

Adverse event resulted in: hospitalization

Suspect drug(s):
Pepcid
    Start date: 2011-06-24
    End date: 2011-07-04

FOY
    Start date: 2011-06-24
    End date: 2011-06-29

Cefmetazole Sodium
    Start date: 2011-06-24
    End date: 2011-06-29

Meropenem
    Start date: 2011-06-29
    End date: 2011-07-04

Miraclid
    Dosage: 50 kiu
    Start date: 2011-06-24
    End date: 2011-06-29