Famotidine Side Effects

Brand Names: Pepcid , Pepcid

Please note - some side effects for Famotidine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Famotidine - for the Consumer

Famotidine

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Famotidine:

Constipation; diarrhea; dizziness; headache.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); convulsions (seizures).

Famotidine/Calcium Carbonate/Magnesium Hydroxide

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Famotidine/Calcium Carbonate/Magnesium Hydroxide:

Constipation; diarrhea; dizziness; headache.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); loss of appetite; muscle weakness; nausea; seizures; slow reflexes; vomiting.

Famotidine Chewable Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Famotidine Chewable Tablets:

Constipation; diarrhea; dizziness; headache.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); convulsions (seizures).

Famotidine Solution

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Famotidine Solution:

Constipation; diarrhea; dizziness; headache.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); convulsions (seizures).

Famotidine Suspension

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Famotidine Suspension:

Constipation; diarrhea; dizziness; headache.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); convulsions (seizures).

Famotidine Side Effects - for the Professional

Famotidine Injection

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. 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 Famotidine Tablets may also occur with Famotidine for Oral Suspension 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.

Famotidine Injection Bedford

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 followup 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 preservative free in plastic container and Famotidine injection. In addition, transient irritation at the injection site has been observed with Famotidine injection.

Side Effects by Body System

Gastrointestinal

Gastrointestinal side effects including diarrhea (1.7%) and constipation (1.2%) have been reported. Vomiting, nausea, abdominal discomfort, anorexia, and dry mouth have been reported infrequently. Hypergastrinemia of uncertain clinical significance has also been reported.

Nervous system

Nervous system side effects have included headache (1% to 4.7%) and dizziness (1.3%). Grand mal seizures, paresthesia, and somnolence have been reported infrequently. Lethargy, confusion, psychosis, and agitation have been reported. Delirium has been reported, which reversed upon drug withdrawal. Convulsions, in patients with impaired renal function, have been reported very rarely.

Confusion, lethargy, delirium, psychosis, agitation, seizures and somnolence have been reported, particularly in elderly patients and patients with multiple medical problems. The frequency of such reactions may be greater than previously believed. The FDA has accumulated 72 reported cases of such central nervous system reactions. All H2-blockers cross the blood-brain barrier and are found in the cerebrospinal fluid.

Hepatic

Hepatic side effects have included mild elevations of liver function tests. The clinical significance of these elevations is unknown. Jaundice and cholestatic jaundice have been reported infrequently. Cases of drug-induced hepatitis have also been reported.

Cardiovascular

Cardiovascular side effects have included decreases in stroke volume and cardiac output and may be clinically significant in patients with preexisting cardiac dysfunction. A variety of arrhythmias, including bradycardia, tachycardia, AV conduction defects (including AV block), and palpitations have also been reported rarely. Acquired long QT syndrome has been reported in at least three cases including a man with decompensated cirrhosis.

A 92-year-old male with a history of diabetes mellitus, hypertension, coronary artery disease, and pacemaker implantation for sick sinus syndrome experienced acquired long QT syndrome coincident with famotidine therapy. The patient was admitted with fever, periurethral abscess, and enterococcal sepsis. He was treated with several medications including famotidine. He was administered famotidine at 20 mg per nasogastric tube twice a day after admission. He developed an acute myocardial infarction 10 hours after famotidine therapy. The admission 12-lead electrocardiogram revealed a ventricular paced rhythm at a rate of 60 beats/min and a QTc of 439 ms. After two 20 mg doses of famotidine, the QTc became markedly prolonged at 618 ms. Four days after famotidine was discontinued, the QTc returned close to baseline at 445 ms.

Hypersensitivity

Hypersensitivity side effects have infrequently included anaphylaxis, angioedema, orbital or facial edema, urticaria, rash, conjunctival infection, toxic epidermal necrolysis (very rare), erythema multiforme, and Stevens-Johnson syndrome (very rare).

Renal

Renal side effects have included rare cases of interstitial nephritis.

Endocrine

Endocrine side effects have included anti-androgen effects of reversible hyperprolactinemia and gynecomastia.

Dermatologic

Dermatologic side effects have infrequently included alopecia, acne, pruritus, dry skin, and flushing. At least one case of contact dermatitis in a worker handling famotidine has been reported.

A 22-year-old man reported painful, erythematous macules on his chest five days after starting famotidine. These progressed to hemorrhagic, painful erosions of the oral, conjunctival, and urogenital mucosal areas. A lymphocyte transformation test (LTT) was positive indicating an antigenic response to famotidine. The lesions completely resolved in 4 weeks after stopping famotidine and administering prednisolone, tobramycin, oxacillin, cefotaxime, and fluconazole.

Hematologic

Hematologic side effects including neutropenia have been reported. Rarely, reversible thrombocytopenia, agranulocytosis, pancytopenia, and leukopenia have been reported.

A case report of agranulocytosis eight days after the initiation of famotidine therapy has been reported in a 87-year-old male. After discontinuation of famotidine, initiation of empiric antibiotic use for the treatment of neutropenic fever, and administration of granulocyte-colony stimulating factor, the patient's white blood cell count and granulocyte count improved.

Respiratory

Respiratory side effects including bronchospasm and interstitial pneumonia have been reported infrequently.

Psychiatric

Psychiatric side effects including depression, anxiety, insomnia, hallucinations, and decreased libido have been reported.

Musculoskeletal

Musculoskeletal side effects have infrequently included musculoskeletal pain including muscle cramps and arthralgia.

Other

Other side effects including tinnitus, fever, asthenia, fatigue, and taste disorder have been reported infrequently. At least one case of hyperpyrexia in association with famotidine use has been reported.

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