Medicine guide

Famotidine

40 mg · Tablet, Film Coated

Prescription only
Histamine-2 Receptor Antagonist

Active substance: Famotidine
Used in: Digestion, stomach, diabetes and nutrition
Made by: Northwind Health Company, LLC
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2025-12-26

What it is

Histamine-2 Receptor Antagonist

Used for

Active duodenal ulcer (DU). active gastric ulcer (GU). symptomatic nonerosive gastroesophageal reflux disease (GERD). erosive esophagitis due to GERD, diagnosed by biopsy.

The label’s usual adult dose

1 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.

Adults Pathological Hypersecretory Conditions 20 mg every 6 hours; adjust to patient needs; maximum 160 mg every 6 hours Risk Reduction of DU Reocurrence 20 mg once daily See full prescribing information for complete dosing information, including dosing in renal impairment, and recommended treatment duration.

Full directions ↓

Do not take it 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.

All warnings ↓

Good to know

Prescription only
FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-01

259other products contain Famotidine — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What 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). 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.

From the official label · 2025-12-26 · DailyMed

How it works

From this product’s own US prescribing label.

Famotidine is a competitive inhibitor of histamine-2 (H 2 ) receptors.
The primary clinically important pharmacologic activity of famotidine is inhibition of gastric secretion.

Half-life2.5–3.5 h

Mostly cleared after≈ 15 hfive half-lives — our arithmetic

How it leaves the body

Famotidine is eliminated by renal (65 to 70%) and metabolic (30 to 35%) routes.

With food

Bioavailability may be slightly increased by food, or slightly decreased by antacids; however, these effects are of no clinical consequence.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-12-26

Do not take it 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.
( 4 )

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

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 Reduction of DU Reocurrence 20 mg once daily See full prescribing information for complete dosing information, including dosing in renal impairment, and recommended treatment duration.
( 2.1 , 2.2 ) A d m inistration ( 2.3 ):
Take once daily before bedtime or twice daily in the morning and before bedtime with or without food.
2.1 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.
Table 1:
Recommended Dosage and Duration of Famotidine Tablets in Adult and Pediatric Patients 40 kg and Greater with Normal Renal Function Indication Recommended Dosage Rec ommended Duration Active duodenal ulcer (DU) 40 mg once daily; or 20 mg twice daily a Up to 8 weeks b,c Active gastric ulcer 40 mg once daily Up to 8 weeks c Symptomatic nonerosive GERD 20 mg twice daily Up to 6 weeks c Erosive esophagitis diagnosed by endoscopy 20 mg twice daily; or 40 mg twice daily a Up to 12 weeks Pathological hypersecretory conditions d Starting dosage:
20 mg every 6 hours; adjust dosage to individual patient needs Maximum dosage 160 mg every 6 hours As clinically indicated Reduction of the risk of DU recurrence d 20 mg once daily 1 year c or as clinically indicated a Both dosages demonstrated effectiveness in clinical trials [see Clinical Studies ( 14 )] . b In clinical trials, the majority of patients healed within 4 weeks.
For patients who do not heal after 4 weeks, consider an additional 2 to 4 weeks of treatment [see Clinical Studies ( 14.1 )]. c Longer treatment durations have not been studied in clinical trials [see Clinical Studies ( 14.1 , 14.2 , 14.3 )] . d In pediatric patients, the safety and effectiveness of famotidine tablets have not been established for the reduction of the risk of duodenal ulcer recurrence or for treatment of pathological hypersecretory conditions [see Use in Specific Populations ( 8.4 )] .
2.2 Dosage in Renal Impairment Dosage adjustments of famotidine tablets are recommended for patients with moderate to severe renal impairment (creatinine clearance less than 60 mL/min) [see Use in Specific Populations ( 8.6 )] .
Table 2 shows the recommended maximum dosage of famotidine 20 mg or 40 mg tablets for patients with renal impairment, by indication.
Use the lowest effective dose.
Some dosage adjustments may require switching to other formulations of famotidine (e.g., oral suspension, lower dose tablet).
Table 2:
Recommended Maximum Dosage of Famotidine Tablets in Adult and Pediatric Patients 40 kg and Greater with Moderate and Severe Renal Impairment Indication Rec o m mended Maximum Dosages Creatinine clearance 30 to 60 mL/minute Creatinine clearance less than 30 mL/minute Active duodenal ulcer (DU) 20 mg once daily; or 40 mg every other day 20 mg every other day a Active gastric ulcer 20 mg once daily; or 40 mg every other day 20 mg every other day a Symptomatic nonerosive GERD 20 mg once daily 20 mg every other day a Erosive esophagitis diagnosed by endoscopy b 20 mg once daily; or 40 mg every other day b 20 mg every other day a,b 40 mg once daily b 20 mg once daily b Pathological hypersecretory conditions c
Avoid use d Reduction of the risk of DU recurrence c 20 mg every other day a (see footnote) e a An alternate dosage regimen is 10 mg once daily.
Since 20 mg or 40 mg tablet strength cannot be used for this dosage regimen, use an alternate famotidine formulation. b Dosage adjustments for renal impairment are provided for both dosing regimens (20 mg twice daily and 40 mg twice daily) which showed effectiveness for the treatment of erosive esophagitis in clinical trials [see Clinical Studies ( 14.4 )] . c In pediatric patients, the safety and effectiveness of famotidine tablets have not been established for the reduction of the risk of duodenal ulcer recurrence or for treatment of pathological hypersecretory conditions [see Use in Specific Populations ( 8.4 )] . d Doses required to treat pathological hypersecretory conditions may exceed the maximum doses evaluated in patients with impaired renal function.
The risk for increased adverse reactions in renally impaired patients treated with famotidine tablets for pathological hypersecretory conditions is unknown. e Recommended dosage regimen is 10 mg every other day.
Since 20 mg or 40 mg tablet strength cannot be used for this dosage regimen, use an alternate famotidine formulation.
2.3 Administration Instructions Take famotidine tablets once daily before bedtime or twice daily in the morning and before bedtime, as recommended.
Famotidine tablets may be taken with or without food [see Clinical Pharmacology ( 12.3 )] .
Famotidine tablets may be given with antacids.

Quoted from the official label, section “Dosage & Administration”.

Other 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 tablets.
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 )].
Concurrent Gastric Malignancy In
adults, symptomatic response to therapy with famotidine tablets 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 tablets.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

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.
In animal reproduction studies, no adverse development effects were observed with oral administration of famotidine at doses up to approximately 243 and 122 times, respectively, the recommended human dose of 80 mg per day for the treatment of erosive esophagitis (se e Data) .
The estimated background risk for major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Data Animal Data Reproductive studies have been performed in rats and rabbits at oral doses of up to 2000 and 500 mg/kg/day, respectively, and in both species at intravenous doses of up to 200 mg/kg/day, and have revealed no significant evidence of impaired fertility or harm to the fetus due to famotidine tablets.
While no direct fetotoxic effects have been observed, sporadic abortions occurring only in mothers displaying marked decreased food intake were seen in some rabbits at oral doses of 200 mg/kg/day (about 49 times the recommended human dose of 80 mg per day, based on body surface area) or higher.
There are, however, no adequate or well-controlled studies in pregnant women.
Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
IN SPECIFIC POPULATIONS Geriatric Use:
Use the lowest effective dose for an elderly patient and monitor renal function.
( 2.2 , 5.1 , 8.5 ) Renal Impairment:
Risk of CNS adverse reactions and QT prolongation in patients with moderate and severe renal impairment; reduce the dosage.
( 2.2 , 8.6 ) See 17 for Patient Counseling Information
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.
In animal reproduction studies, no adverse development effects were observed with oral administration of famotidine at doses up to approximately 243 and 122 times, respectively, the recommended human dose of 80 mg per day for the treatment of erosive esophagitis (se e Data) .
The estimated background risk for major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Data Animal Data Reproductive studies have been performed in rats and rabbits at oral doses of up to 2000 and 500 mg/kg/day, respectively, and in both species at intravenous doses of up to 200 mg/kg/day, and have revealed no significant evidence of impaired fertility or harm to the fetus due to famotidine tablets.
While no direct fetotoxic effects have been observed, sporadic abortions occurring only in mothers displaying marked decreased food intake were seen in some rabbits at oral doses of 200 mg/kg/day (about 49 times the recommended human dose of 80 mg per day, based on body surface area) or higher.
There are, however, no adequate or well-controlled studies in pregnant women.
Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
8.2 Lactation Risk Summary There are limited data available on the presence of famotidine in human breast milk.
There were no effects on the breastfed infant.
There are no data on famotidine effects on milk production.
Famotidine is present in the milk of lactating rats (see Data) .
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for famotidine and any potential adverse effects on the breastfed child from famotidine tablets or from the underlying maternal condition.
Data Animal Data Transient growth depression was observed in young rats suckling from mothers treated with maternotoxic doses of famotidine at least 600 times the usual human dose.
8.4 Pediatric Use The safety and effectiveness of famotidine tablets 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 tablets and the recommended dosage of famotidine tablets in these pediatric patients is supported by evidence from adequate and well-controlled studies of famotidine tablets in
adults and published pharmacokinetic and pharmacodynamic data in pediatric patients [s ee Dosage and Administration ( 2.1 ), Clinical Pharmacology ( 12.2 , 12.3 )] .
In pediatric patients, the safety and effectiveness for the treatment of pathological hypersecretory conditions and reduction of risk of duodenal ulcer recurrence have not been established.
Famotidine 20 and 40 mg tablets are not recommended for use in pediatric patients weighing less than 40 kg because these tablet strengths exceed the recommended dose for these patients [ see Dosage and Administration ( 2.1 )] .
For pediatric patients weighing less than 40 kg, consider another famotidine formulation (e.g., oral suspension, lower dose tablet).
8.5 Geriatric Use Of the 1442 famotidine tablets-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 tablets [ see Warnings and Precautions ( 5.1 )] .
Famotidine is known to be substantially excreted by the kidney, and the risk of adverse reactions to famotidine tablets may be greater in elderly patients, particularly those with impaired renal function [ see Use in Specific Populations ( 8.6 )] .
In general, use the lowest effective dose of famotidine tablets for an elderly patient and monitor renal function [see Dosage and Administration ( 2.2 )].
8.6 Renal Impairment CNS adverse reactions and prolonged QT intervals have been reported in patients with moderate and severe renal impairment [see Warnings and Precautions ( 5.1 )].
The clearance of famotidine is reduced in
adults with moderate and severe renal impairment compared to
adults with normal renal function [see Clinical Pharmacology ( 12.3 )].
No dosage adjustment is needed in patients with mild renal impairment (creatinine clearance greater than or equal to 60 mL/minute).
Dosage reduction is recommended in adult and pediatric patients greater than or equal to 40 kg with moderate or severe renal impairment (creatinine clearance less than 60 mL/minute) [see Dosage and Administration ( 2.2 )].

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

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 ) T izanidine (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.
Concomitant administration of famotidine tablets with dasatinib, delavirdine mesylate, cefditoren, and fosamprenavir is not recommended.
See the prescribing information for other drugs dependent on gastric pH for absorption for administration instructions, including atazanavir, erlotinib, ketoconazole, itraconazole, ledipasvir/sofosbuvir, nilotinib, and rilpivirine.
7.2 Tizanidine (CYP1A2 Substrate) Although not studied clinically, famotidine is considered a weak CYP1A2 inhibitor and may lead to substantial increases in blood concentrations of tizanidine, a CYP1A2 substrate.
Avoid concomitant use with famotidine tablets.
If concomitant use is necessary, monitor for hypotension, bradycardia or excessive drowsiness.
Refer to the full prescribing information for tizanidine.

Quoted from the official label, section “Drug Interactions”.

Side effects

The most common adverse reactions are: headache, dizziness, constipation, and diarrhea.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 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 tablets was studied in 7 US and international placebo- and active-controlled trials in approximately 2500 patients [see Clinical Studies ( 14 )] .
A total of 1442 patients were treated with famotidine tablets, including 302 treated with 40 mg twice daily, 456 treated with 20 mg twice daily, 461 treated with 40 mg once daily, and 396 treated with 20 mg once daily.
The population was 17-91 years old, fairly well distributed between gender and race; however, the predominant race treated was Caucasian.
The following adverse reactions occurred in greater than or equal to 1% of famotidine tablets-treated patients:
headache, dizziness and constipation.
The following other adverse reactions were reported in less than 1% of patients in clinical trials:
Body as a Whole:
fever, asthenia, fatigue Cardiovascular:
palpitations Gastrointestinal:
elevated liver enzymes, vomiting, nausea, abdominal discomfort, anorexia, dry mouth Hematologic:
thrombocytopenia Hypersensitivity:
orbital edema, rash, conjunctival injection, bronchospasm Musculoskeletal:
musculoskeletal pain, arthralgia Nervous System/Psychiatric:
seizure, hallucinations, depression, anxiety, decreased libido, insomnia, somnolence Skin:
pruritus, dry skin, flushing Special Senses:
tinnitus, taste disorder Other:
impotence
6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of famotidine.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Cardiovascular:
arrhythmia, AV block, prolonged QT interval Gastrointestinal:
cholestatic jaundice, hepatitis Hematologic:
agranulocytosis, pancytopenia, leukopenia Hypersensitivity:
anaphylaxis, angioedema, facial edema, urticaria Musculoskeletal:
rhabdomyolysis, muscle cramps Nervous System/Psychiatric:
confusion, agitation, paresthesia Respiratory:
interstitial pneumonia Skin:
toxic epidermal necrolysis/Stevens-Johnson syndrome

Quoted from the official label, section “Adverse Reactions”.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

Bulgaria5 matching products

Every strength and form (13)

France1 matching products

FAMOTIDINE EG 40 mg · comprimé pelliculé

Every strength and form (2)

Canada8 matching products

Every strength and form (31)

Netherlands10 matching products

Every strength and form (22)

Details

Made by	Northwind Health Company, LLC
Active substance	Famotidine
Used in	Digestion, stomach, diabetes and nutrition
Strength	40 mg
Form	Tablet, Film Coated
Route	Oral
Packs	90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC · 30 TABLET, FILM COATED in 1 BOTTLE, DISPENSING
NDC	51655-102

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

Report wrong or outdated information on this page

Other strengths and forms

187 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Tablet, Film Coated100 products
- 10 mg18
  10 mg · 18 companies
  +10 more
- 20 mg56
  20 mg · 56 companies
  +48 more
- 40 mg26
  40 mg · 26 companies
  +18 more
Tablet49 products
- 10 mg9
  10 mg · 9 companies
  +1 more
- 10 mg/10mg
- 20 mg26
  20 mg · 26 companies
  +18 more
- 40 mg13
  40 mg · 13 companies
  +5 more
Powder, for Suspension18 products
- 40 mg/5mL18
  40 mg/5mL · 18 companies
  +10 more
Tablet, Coated7 products
- 20 mg4
  20 mg · 4 companies
- 40 mg3
  40 mg · 3 companies

Show all forms · 8 forms

Injection, Solution6 products
- 4 mg/mL
- 10 mg/mL4
  10 mg/mL · 4 companies
- 20 mg/50mL
Injection3 products
- 10 mg/mL3
  10 mg/mL · 3 companies
For Suspension3 products
- 40 mg/5mL3
  40 mg/5mL · 3 companies
Powder, for Solution1 products
- 40 mg/5mL

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

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See every product with Famotidine