Famotidine: What to Know Before You Take It
Also sold as Pepcid
What Famotidine Is Used For
1 INDICATIONS AND USAGE Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: • active duodenal ulcer (DU). • active gastric ulcer (GU). • symptomatic nonerosive gastroesophageal reflux disease (GERD). • erosive esophagitis due to GERD, diagnosed by biopsy. Famotidine tablets are indicated in adults for the: • treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias). • reduction of the risk of duodenal ulcer recurrence. Famotidine tablets are a histamine-2 (H 2 ) receptor antagonist indicated ( 1 ): In adult and pediatric patients 40 kg and greater for the treatment of: • active duodenal ulcer (DU). • active gastric ulcer. • symptomatic nonerosive gastroesophageal reflux disease (GERD). • erosive esophagitis due to GERD, diagnosed by biopsy. In adults for the: • treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias). • reduction of the risk of DU recurrence.
Warnings
5 WARNINGS AND PRECAUTIONS • Central Nervous System (CNS) Adverse Reactions: Elderly patients and patients with renal impairment at increased risk; reduce the dosage. ( 2.2 , 5.1 , 8.5 , 8.6 ) • GI Malignancy: Absence of GI symptoms does not preclude the presence of gastric malignancy; evaluate prior to initiating therapy. ( 5.2 ) 5.1 Central Nervous System Adverse Reactions Central nervous system (CNS) adverse reactions, including confusion, delirium, hallucinations, disorientation, agitation, seizures, and lethargy, have been reported in elderly patients and patients with moderate and severe renal impairment treated with famotidine. Since famotidine blood levels are higher in patients with renal impairment than in patients with normal renal function, dosage adjustments are recommended in patients with renal impairment [see Dosage and Administration ( 2.2 ), Clinical Pharmacology ( 12.3 )]. 5.2 Concurrent Gastric Malignancy In adults, symptomatic response to therapy with famotidine does not preclude the presence of gastric malignancy. Consider evaluation for gastric malignancy in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with famotidine.
Contraindications
4 CONTRAINDICATIONS Famotidine tablets are contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other histamine-2 (H 2 ) receptor antagonists. History of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other H 2 receptor antagonists. ( 4 )
Famotidine Drug Interactions (6)
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Most-Reported Side Effects
Based on 115,334 reports in the FDA Adverse Event Reporting System (FAERS). Reports do not prove the drug caused the effect.
Explore full Famotidine safety data in our free FDA Safety Explorer
FDA Recalls (10)
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Recalling firm: Fresenius Kabi USA, LLC
Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.
Recalling firm: Ascend Laboratories, LLC
Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton indicating strength as 10 mg.
Recalling firm: Glenmark Therapeutics, Inc.
Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg.
Recalling firm: Aurobindo Pharma USA Inc.
TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state.
Recalling firm: HF Acquisition Co. LLC
Failed impurities/degradation specifications: Famotodine has an out of specification result for an individual related substance observed during routine stability testing of a batch for related substances -impurity 8 at 24 month stability interval.
Recalling firm: Dr. Reddy's Laboratories, Inc.
Failed Tablet/Capsule Specification; out of specification for tablet weight
Recalling firm: Teva Pharmaceuticals USA
CGMP Deviations
Recalling firm: Lupin Pharmaceuticals Inc.
Failed Impurity/Degradation Specification; 12-month stability time point
Recalling firm: Novel Laboratories, Inc.
Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting the presence of particulate matter identified as plastic/rubber in famotidine Injection premixed containers.
Recalling firm: Baxter Healthcare Corp.
This information is educational — not medical advice.
This page is provided for general educational purposes and summarizes publicly available data from sources such as the U.S. Food & Drug Administration. It is not a substitute for the judgment of a licensed clinician and should not be used to start, stop, or change any medication. It may be incomplete or out of date, and individual circumstances vary. Always talk with your prescriber or pharmacist about your specific medications and health conditions. If you think you may have a medical emergency, call 911.