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Famotidine

Famotidine is a brand of Famotidine.

Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: • active duodenal ulcer (DU). • active gastri.

Checked against the official label · Updated

Prescription medicine Oral Safety alerts on record

How to use Famotidine

What the official label says. If a doctor prescribed it, follow the prescription. Your pack's leaflet comes first if it is different.

Who it is for

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). …

How to take it and how often
  • Indication Recommended Dosage Adult and Pediatric Patients 40 kg and greater Active DU 40 mg once daily; or 20 mg twice daily Active Gastric Ulcer 40 mg once daily GERD 20 mg twice daily Erosive Esophagitis 20 mg twice daily; or 40 mg twice daily
  • Adults Pathological Hypersecretory Conditions 20 mg every 6 hours; adjust to patient needs; maximum 160 mg every 6 hours Risk Reduction of DU Recurrence 20 mg once daily • See full prescribing information for complete dosing information, including dosing in renal impairment, and recommended treatment duration
  • Administration : • Take once daily before bedtime or twice daily in the morning and before bedtime with or without food
  • Recommended Dosage Table 1 shows the recommended dosage of famotidine 20 mg and 40 mg tablets in adult and pediatric patients weighing 40 kg and greater with normal renal function
  • The use of famotidine 20 mg and 40 mg tablets is not recommended
  • In pediatric patients weighing less than 40 kg because the lowest available strength (20 mg) exceeds the recommended dose for these patients
  • Use another famotidine formulation for pediatric patients weighing less than 40 kg. …
Strengths it comes in

• 20 mg tablets: Light yellow, round, biconvex, film-coated tablets debossed with “T” on one side and “11” on the other side. • 40 mg tablets: White, round, biconvex film-coated tablets debossed with “T” on one side and “12” on the other side. Tablets: 20 mg, 40 mg ( 3 )

Children
  • The safety and effectiveness of famotidine have been established
  • In pediatric patients
  • For the treatment of peptic ulcer disease (i.e., duodenal ulcer, gastric ulcer) and GERD (i.e., symptomatic nonerosive GERD, erosive esophagitis as diagnosed by endoscopy)
  • The use of famotidine and the recommended dosage of famotidine in these
  • Pediatric patients is supported by evidence from adequate and well-controlled studies of famotidine
  • In adults and published pharmacokinetic and pharmacodynamic data
  • In pediatric patients [see Dosage and Administration , Clinical Pharmacology ]. …
Older adults

Of the 1442 famotidine-treated patients in clinical studies, approximately 10% were 65 and older. In these studies, no overall differences in safety or effectiveness were observed between elderly and younger patients. In postmarketing experience, CNS adverse reactions have been reported in elderly patients with and without renal impairment receiving famotidine [see Warnings and Precautions ( 5.1 )]. …

While you are taking it
  • Central Nervous System (CNS) Adverse Reactions Advise
  • Elderly patients and those with moderate and severe renal impairment of the risk of CNS adverse reactions, including confusion, delirium, hallucinations, disorientation, agitation, seizures, and lethargy [see Warnings and Precautions ]
  • Report symptoms immediately to a healthcare provider
  • QT Prolongation Advise patients with moderate and severe renal impairment of the risk of QT interval prolongation [see Use in Specific Populations ]
  • Report new cardiac symptoms, such as palpitations, fainting and dizziness or lightheadedness immediately to a healthcare provider. …
Talk to a doctor first if
  • 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
Medicines it may not mix with

• Drugs Dependent on Gastric pH for Absorption: Systemic exposure of the concomitant drug may be significantly reduced leading to loss of efficacy. See full prescribing information for a list of interacting drugs. ( 7.1 ) • Tizanidine (CYP1A2) Substrate: Potential for substantial increases in blood concentrations of tizanidine resulting in hypotension, bradycardia or excessive drowsiness; avoid concomitant use, if possible. ( 7.2 ) 7.1 Drugs Dependent on Gastric pH for Absorption Famotidine can reduce the absorption of other drugs, due to its effect on reducing intragastric acidity, leading to loss of efficacy of the concomitant drug. …

Warnings

• 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. …

Possible side effects

The most common adverse reactions are: headache, dizziness, constipation, and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Annora Pharma Private Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Famotidine was studied in 7 US and international placebo- and active-controlled trials in approximately 2500 patients [see Clinical Studies ( 14 )]. …

Pregnancy and breastfeeding

8.1 Pregnancy Risk Summary Available data with H 2 -receptor antagonists, including famotidine, in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. …

If you take too much

The types of adverse reactions in overdosage of famotidine are similar to the adverse reactions encountered with use of recommended dosages [see Adverse Reactions ( 6.1 )]. In the event of overdosage, treatment should be symptomatic and supportive. Unabsorbed material should be removed from the gastrointestinal tract, the patient should be monitored, and supportive therapy should be employed. Due to low binding to plasma proteins, famotidine is eliminated by hemodialysis. There is limited experience on the usefulness of hemodialysis as a treatment for famotidine overdosage.

If you miss a dose

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.

From the official U.S. FDA label for this active ingredient. Your pack may have a different strength, so always read its leaflet. If a doctor prescribed it, follow the prescription. Ask a pharmacist if you are unsure. Label dated 2025-10-22.

Same medicine, other brands

Products with Famotidine as the active ingredient. Names differ between countries.

Registered products

United States (FDA)

FamotidineFAMOTIDINE 10 mg/1 · Tablet, Film Coated · VKT Pharma Private Limited
NDC 71821-012Label
FamotidineFAMOTIDINE 40 mg/5mL · Powder, For Suspension · Novadoz Pharmaceuticals LLC
NDC 72205-233Label
FamotidineFAMOTIDINE 20 mg/1 · Tablet, Film Coated · Zydus Lifesciences Limited
NDC 70771-1702Label
FamotidineFAMOTIDINE 40 mg/1 · Tablet, Film Coated · Zydus Lifesciences Limited
NDC 70771-1703Label
FamotidineFAMOTIDINE 20 mg/1 · Tablet, Film Coated · VKT Pharma Private Limited
NDC 71821-010Label

Nigeria (NAFDAC)

NAFDACFamotab 40 Tablet 04-4390

Other countries: check your pack's registration number and we point you to your regulator.

Safety alerts and recalls

Famotidine Injection in Sodium Chloride Injection, 20 mg, 50 mL in GALAXY Single Dose Container, Rx Only, Sterile Nonpyrogenic, Baxter International Inc., Baxter Healthcare CorporaU.S. FDA Class II
6 Aug 2026 · Baxter Healthcare Corporation · OngoingCGMP Deviations
Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of sale).U.S. FDA Class I
6 Nov 2025 · Fresenius Kabi USA, LLC · OngoingMicrobial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Ibuprofen and Famotidine Tablets 800mg/26.6mg, Rx Only, 90 Tablets per Bottle, manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC., ParsippanU.S. FDA Class II
29 Dec 2023 · Ascend Laboratories, LLC · OngoingPresence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.
Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed by: Glenmark Therapeutics Inc., USA, Mahwah, NJ 07430, Made in India, NDC 72657-113-20.U.S. FDA Class II
1 May 2023 · Glenmark Therapeutics, Inc. · TerminatedLabeling: 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.

A recall usually affects certain batches only. Compare the lot number on your pack.

Check your pack of Famotidine

Type the registration number on the pack, or scan it with your camera.

Or take photos of the pack
3 free checks left today Official sources: U.S. FDA · EMA (EU) · Health Canada · WHO alerts

Questions about Famotidine

What is in Famotidine?

Famotidine contains Famotidine. Other brands with the same active ingredient work the same way; the dose and strength on your pack are what matter.

What is Famotidine used for?

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 synd (From the official U.S. FDA label.)

How do I take Famotidine?

Follow your prescription or the leaflet in your pack. The official label says: Indication Recommended Dosage ( 2.1 ) Adult and Pediatric Patients 40 kg and greater Active DU 40 mg once daily; or 20 mg twice daily Active Gastric Ulcer 40 mg once daily GERD 20 mg twice daily Erosive Esophagitis 20 mg twice daily; or 40 mg twice daily Adults Pathological Hypersecretory Conditions 20 mg every 6 hours; adjust to patient needs; maximum 160 mg every 6 hours Risk…

Do I need a prescription for Famotidine?

Usually yes. Famotidine is a prescription medicine in most countries. Rules differ by country.

What brands contain Famotidine?

Famotidine is sold under names such as Calmicid, Duexis, Duo Fusion, Pepcid, Zantac Reformulated Aug 2022, Pepcid Complete, Tums Dual Action. Brand names differ between countries.

What are the side effects of Famotidine?

The official label lists: The most common adverse reactions are: headache, dizziness, constipation, and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Annora Pharma Private Limited at 1-866-495-1995 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the… Tell your doctor about any side effect that bothers you or does not go away.

Can children take Famotidine?

The safety and effectiveness of famotidine have been established in pediatric patients for the treatment of peptic ulcer disease (i.e., duodenal ulcer, gastric ulcer) and GERD (i.e., symptomatic nonerosive GERD, erosive esophagitis as diagnosed by endoscopy). The use of famotidine and the recommended dosage of famotidine in these pediatric patients is supported by evidence from… Always use the dose for the child's age or weight on the pack or prescription.

Can I take Famotidine when pregnant or breastfeeding?

8.1 Pregnancy Risk Summary Available data with H 2 -receptor antagonists, including famotidine, in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. … Ask your doctor or midwife first.

What medicines interact with Famotidine?

• Drugs Dependent on Gastric pH for Absorption: Systemic exposure of the concomitant drug may be significantly reduced leading to loss of efficacy. See full prescribing information for a list of interacting drugs. ( 7.1 ) • Tizanidine (CYP1A2) Substrate: Potential for substantial increases in blood concentrations of tizanidine resulting in hypotension, bradycardia or excessive… Use the free interaction checker before combining medicines.

What happens if I take too much Famotidine?

The types of adverse reactions in overdosage of famotidine are similar to the adverse reactions encountered with use of recommended dosages [see Adverse Reactions ( 6.1 )]. In the event of overdosage, treatment should be symptomatic and supportive. Unabsorbed material should be removed from the gast… Get medical help right away.

How can I check that my Famotidine is genuine?

Scan the registration number on your pack with PillVera (NAFDAC number in Nigeria, NDC in the United States, DIN in Canada), check the expiry date and buy only from licensed pharmacies.

Sources

This page shows what official sources say, in plain words. It is not medical advice: your prescription and your doctor or pharmacist come first. Brand names, strengths and rules differ between countries.