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Famotidine

Famotidine is an acid-reducing medicine (an H2 blocker) used for heartburn and acid indigestion, and for prescription-treated ulcers, GERD and excess stomach acid conditions.

Brand names PepcidPepcid AcFluxidPepcid RPDCalmicid +11 more
Drug class Histamine-2 Receptor Antagonist
Rx/OTC Forms 4
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 304 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 7, 2026 🚨Class I recall on record · 2
Other forms & routes:
Famotidine at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Famotidine (Pepcid) is a decades-old acid reducer (an H2 blocker), available as a generic and over the counter, that cuts both the amount and strength of stomach acid for heartburn, ulcers and GERD (acid reflux), working faster but less powerfully than omeprazole. Most people tolerate it very well, and the side effects that do show up, mainly headache, dizziness, constipation or diarrhea, tend to be mild. Watch for confusion, hallucinations or seizures, mostly in older adults and people with kidney disease, since the drug builds up when the kidneys clear it slowly. Over-the-counter use is meant to be short-term, so see a doctor if you need it past 14 days.

Clinical pearls

  • To prevent heartburn, swallow the over-the-counter tablet whole 10 to 60 minutes before the trigger meal, depending on the product.
  • It can blunt absorption of acid-dependent drugs such as atazanavir, dasatinib, erlotinib and ketoconazole, so mention it to every prescriber.
  • If you take tizanidine, avoid famotidine where possible, since tizanidine levels can climb enough to cause low blood pressure and heavy drowsiness.
  • Feeling better does not rule out stomach cancer, so heartburn that returns quickly or comes with weight loss deserves a check.
How you get itPrescription and over the counter
Comes asTablet, Injection, Oral suspension +1
Earliest FDA record1986
Companies listing it with the FDA136
FDA label last updatedNov 11, 2024
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Famotidine, written from its FDA label.

What Famotidine is used for

▾

Famotidine is used for acid-related problems, depending on the product.

  • Over-the-counter tablets (for example Pepcid AC, Acid Reducer, Acid Controller, Calmicid AC): relieve heartburn from acid indigestion and sour stomach.
  • Those same tablets: prevent heartburn brought on by certain foods and drinks.
  • Prescription tablets (such as Pepcid) in adults and children 40 kg and over: active duodenal ulcer, active gastric ulcer, symptomatic nonerosive GERD, and erosive esophagitis due to GERD.
  • Prescription tablets in adults: pathological hypersecretory conditions (such as Zollinger-Ellison syndrome) and lowering the risk of duodenal ulcer recurrence.
  • Famotidine for oral suspension: the adult uses above, peptic ulcer disease and GERD in children 1 year and older, and GERD from birth to under 1 year.
  • Famotidine Injection (intravenous): some hospitalized patients with pathological hypersecretory conditions or intractable ulcers, or as an alternative to oral forms for short-term use when someone cannot take oral medicine.

How Famotidine works

▾

Famotidine is a competitive blocker of histamine-2 (H2) receptors. By blocking them, it reduces both the acid concentration and the volume of stomach secretions. Less acid means less irritation, which helps ulcers heal and eases reflux and heartburn.

Famotidine dosage

▾

Famotidine comes as tablets, an oral suspension and an intravenous injection. Over-the-counter tablets are swallowed with water, not chewed, and prevention doses are taken shortly before trigger foods or drinks. Do not exceed 2 tablets in 24 hours.

  • Prescription tablets: once daily at bedtime or twice daily, with or without food.
  • Injection: given into a vein by a healthcare team.

Follow your prescriber and the product label for your dose.

Dosing details from the FDA-approved label

From the Famotidine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Active duodenal ulcer (DU) - adult and pediatric patients 40 kg and greater
    • 40 mg once daily
    • Or 20 mg twice daily
    • Up to 8 weeks; renal impairment (CrCl 30 to 60 mL/minute): 20 mg once daily; or 40 mg every other day; CrCl less than 30 mL/minute: 20 mg every other day
  • Active gastric ulcer - adult and pediatric patients 40 kg and greater
    • 40 mg once daily
    • Up to 8 weeks; renal impairment (CrCl 30 to 60 mL/minute): 20 mg once daily; or 40 mg every other day; CrCl less than 30 mL/minute: 20 mg every other day
  • Symptomatic nonerosive GERD - adult and pediatric patients 40 kg and greater
    • 20 mg twice daily
    • Up to 6 weeks; renal impairment (CrCl 30 to 60 mL/minute): 20 mg once daily; CrCl less than 30 mL/minute: 20 mg every other day
  • Erosive esophagitis diagnosed by endoscopy - adult and pediatric patients 40 kg and greater
    • 20 mg twice daily
    • Or 40 mg twice daily
    • Up to 12 weeks; renal impairment: for 20 mg twice daily regimen, CrCl 30 to 60 mL/minute 20 mg once daily or 40 mg every other day, CrCl less than 30 mL/minute 20 mg every other day; for 40 mg twice daily regimen, CrCl 30 to 60 mL/minute 40 mg once daily, CrCl less than 30 mL/minute 20 mg once daily
  • Pathological hypersecretory conditions - adults
    • Starting dosage: 20 mg every 6 hours
    • Adjust dosage to individual patient needs
    • Maximum: 160 mg every 6 hours
    • Avoid use in renal impairment (CrCl less than 60 mL/min); not established in pediatric patients
  • Reduction of the risk of DU recurrence - adults
    • 20 mg once daily
    • 1 year or as clinically indicated; renal impairment: 20 mg every other day (recommended regimen is 10 mg every other day, requires an alternate famotidine formulation)
  • OTC: adults and children 12 years and over - to relieve symptoms
    • Swallow 1 tablet with a glass of water
    • Do not chew
    • Maximum: Do not use more than 2 tablets in 24 hours
  • OTC: adults and children 12 years and over - to prevent symptoms
    • Swallow 1 tablet with a glass of water at any time from 15 to 60 minutes (10 mg tablet
    • 10 to 60 minutes for 20 mg tablet) before eating food or drinking beverages that cause heartburn
    • Maximum: Do not use more than 2 tablets in 24 hours
  • OTC: children under 12 years
    • Ask a doctor
  • Pediatric patients weighing less than 40 kg
    • PEPCID 20 mg and 40 mg tablets not recommended
    • Use another famotidine formulation
    • Lowest available strength (20 mg) exceeds the recommended dose
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Recommended adult dosage by indication (2.1) : Active DU 40 mg once daily; or 20 mg twice daily Active GU 40 mg once daily Symptomatic Nonerosive GERD 20 mg twice daily Erosive Esophagitis due to GERD 20 mg twice daily; or 40 mg twice daily 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 Recommended pediatric dosage by indication (2.2) : Peptic Ulcer Disease 1 year to less than 17 years Starting dosage 0.5 mg/kg once daily; or 0.25 mg/kg twice daily; may increase to 1 mg/kg once daily at bedtime or 0.5 mg/kg twice daily; Maximum of 40 mg per day GERD Birth to less than 3 months Starting dosage 0.5 mg/kg once daily; may increase to 1 mg/kg once daily 3 months to less than 1 year Starting dosage 0.5 mg/kg twice daily; may increase to 1 mg/kg twice daily; Maximum of 40 mg per day GERD with or without esophagitis and ulcerations 1 year to less than 17 years 0.5 mg/kg twice daily Maximum of 40 mg twice daily See full prescribing information for complete dosing information in adults and pediatrics, recommended treatment duration by indication, and dosage adjustment for adult patients with renal impairment. (2.1 , 2.2 , 2.3) Administration (2.3) : Take once daily before bedtime or twice daily in the morning and before bedtime with or without food. 2.1 Recommended Dosage in Adults The recommended dosage and duration of Famotidine for oral suspension in adults with normal renal function is shown in Table 1.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Famotidine side effects

▾

Most people tolerate famotidine well. The most common side effects are:

Common side effects

  • Headache
  • Dizziness
  • Constipation
  • Diarrhea

When to get medical help

  • Get help right away for signs of a serious allergic reaction, such as swelling of the face, hives or trouble breathing.
  • Call your doctor if you notice confusion, hallucinations, agitation, disorientation, severe sleepiness or seizures, especially if you are older or have kidney problems.
  • See a doctor if you have trouble or pain swallowing, vomit blood, or have bloody or black stools.
  • Seek care for chest pain, shortness of breath, sweating, or pain spreading to the arms, neck or shoulders.
  • Report a fast or irregular heartbeat, severe skin rash or blistering, yellowing of skin or eyes, or muscle pain.
  • Stop the over-the-counter product and ask a doctor if heartburn continues or worsens, or if you need it for more than 14 days.

Famotidine warnings and precautions

▾
  • Confusion, hallucinations and seizures have been reported, mainly in older adults and people with moderate or severe kidney impairment. Dose reduction is recommended with kidney problems.
  • Symptom relief does not rule out stomach cancer; poor response or early relapse should be evaluated.
  • Do not self-treat if you have trouble swallowing, vomit blood, or have bloody or black stools.
  • Stop the over-the-counter product and ask a doctor if heartburn continues or worsens, or if you need it for more than 14 days.

Famotidine interactions

▾

Famotidine can change how other medicines work.

  • Drugs needing stomach acid for absorption (such as dasatinib, delavirdine, cefditoren, fosamprenavir, atazanavir, erlotinib, ketoconazole, itraconazole, ledipasvir/sofosbuvir, nilotinib, rilpivirine): less may be absorbed, so they may work less well.
  • Tizanidine: famotidine may raise its levels, causing low blood pressure, slow heartbeat or drowsiness.
  • Other acid reducers and prescription drugs: ask a doctor or pharmacist first.

Interactions listed in the FDA-approved label

From the Famotidine prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Drugs dependent on gastric pH for absorption (dasatinib, delavirdine mesylate, cefditoren, fosamprenavir): Famotidine can reduce the absorption of other drugs by reducing intragastric acidity, leading to loss of efficacy of the concomitant drug. Concomitant administration of famotidine for oral suspension with dasatinib, delavirdine mesylate, cefditoren, and fosamprenavir is not recommended.
  • Atazanavir, erlotinib, ketoconazole, itraconazole, ledipasvir/sofosbuvir, nilotinib, rilpivirine: These drugs are dependent on gastric pH for absorption, so systemic exposure may be reduced. See the prescribing information for these drugs for administration instructions.
  • Tizanidine (CYP1A2 substrate): Famotidine is considered a weak CYP1A2 inhibitor and may substantially increase blood concentrations of tizanidine, resulting in hypotension, bradycardia or excessive drowsiness (not studied clinically). Avoid concomitant use with famotidine for oral suspension. If concomitant use is necessary, monitor for hypotension, bradycardia or excessive drowsiness.
Read the label’s full interactions text

7 DRUG INTERACTIONS 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. Concomitant administration of famotidine for oral suspension 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 for oral suspension. If concomitant use is necessary, monitor for hypotension, bradycardia or excessive drowsiness. Refer to the full prescribing information for tizanidine.

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 for oral suspension with dasatinib, delavirdine mesylate, cefditoren, and fosamprenavir is not recommended.

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

Before taking Famotidine

▾
  • Do not use with a history of serious allergic reaction to famotidine or other H2 blockers.
  • Kidney disease: a lower dose is recommended for moderate or severe impairment.
  • Older adults: use the lowest effective dose and monitor kidney function.
  • Pregnancy: data are insufficient to establish risk; use only if clearly needed, and ask a health professional.
  • Breastfeeding: famotidine may be present in breast milk; discuss with a health professional.
  • Children: over-the-counter tablets are for ages 12 and up; younger children should ask a doctor.

Famotidine overdose

▾

Overdose effects are similar to the usual side effects. Adults with hypersecretory conditions have taken up to 640 mg a day without serious effects. Get medical help or call Poison Control (1-800-222-1222) right away; treatment is symptom-based and supportive.

What Famotidine does in the body

▾

Famotidine lowers basal, nighttime and food-stimulated stomach acid. After oral use it starts working within 1 hour, peaks in 1 to 3 hours, and lasts about 10 to 12 hours. It raises stomach pH and does not affect gastric emptying or pancreatic function. Hormone levels such as testosterone and prolactin were not changed.

How your body processes Famotidine

▾

Oral famotidine is incompletely absorbed (about 40 to 45%). Food may slightly raise absorption and antacids may slightly lower it, with no clinical consequence. Peak levels occur in 1 to 3 hours and the half-life is about 2.5 to 3.5 hours. It is cleared by the kidneys (65 to 70%) and by metabolism (30 to 35%), so kidney problems can cause it to build up.

How to store Famotidine

▾

Store famotidine for oral suspension dry powder and constituted suspension at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) . Protect from freezing. Dispense in a USP tight, light-resistant container.

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

41

Supplements & herbs that interact with Famotidine

41 supplements and herbal products have documented interactions with Famotidine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 1
  • Moderate · 19
  • Minor · 21
Every supplement checked against Famotidine — ranked by severity The full interaction hub: 1 major · 19 moderate · 21 minor · every one linked to its full report. Check Famotidine against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

6

Nutrient depletion considerations

Famotidine has been associated with lower levels of 6 nutrients in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

Evidence & significance mix
  • Higher significance · 4
  • Moderate · 1
  • Unrated · 1
See the full Famotidine nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Famotidine: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Famotidine — the kind of thing our pharmacy team would talk through with you at the counter.

What is famotidine for?

▾
It reduces stomach acid. Over-the-counter versions relieve and prevent heartburn from acid indigestion and sour stomach. Prescription versions treat ulcers, GERD and erosive esophagitis, and some excess-acid conditions.

How do I take it?

▾
With the over-the-counter tablets, swallow one with water and do not chew it. To prevent heartburn, take it shortly before a food or drink that triggers it. Do not take more than 2 tablets in 24 hours. For prescription use, follow your prescriber's directions; it can be taken with or without food.

What side effects should I expect?

▾
Headache, dizziness, constipation and diarrhea are the most common, and they are usually mild. Call your doctor if you have confusion, hallucinations, seizures, a rash with swelling or trouble breathing.

Can I take it with my other medicines?

▾
Not always. Famotidine can lower absorption of some drugs that need stomach acid and can raise tizanidine levels. Tell me or your doctor everything you take before you start.

I have kidney problems or am older. Is it safe?

▾
It can be used, but you are at higher risk of confusion and other nervous system effects because the drug stays in your body longer. Your doctor may lower your dose, so check before using it.

How long can I use the over-the-counter version?

▾
Stop and see a doctor if your heartburn continues or worsens, or if you need it for more than 14 days. See a doctor sooner for trouble swallowing, bloody vomit, bloody or black stools, or chest pain.

Is Famotidine available over the counter?

▾
Both. Some Famotidine products are sold over the counter and others need a prescription. According to their FDA listings, the tablet form is sold both ways, at different strengths or package sizes and the injection, oral suspension and oral solution forms need a prescription. The package says which kind you have. Your pharmacist can tell you which product is right for you.

When was Famotidine first available?

▾
The earliest FDA record we hold for Famotidine is from 1986: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Famotidine was first used.

Who makes Famotidine?

▾
136 companies currently list Famotidine products in the FDA's NDC Directory, including Bryant Ranch Prepack, Proficient Rx LP, A-S Medication Solutions. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Famotidine on HelloPharmacist

Detailed data & references for Famotidine Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Famotidine forms and strengths (how it comes)

Famotidine is available in 4 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Famotidine inactive ingredients by manufacturer.

Tablet

By mouth
Brands Acid Controller Acid Reducer Acid Relief Basic Care Acid Reducer CareOne Acid Relief Equaline Heartburn Prevention Equate Famotidine Heartburn Relief Pepcid Pepcid Ac TopCare Acid Reducer Zantac 360
How this form is used
What it may be used for
  • Acid Reducer, Acid Controller, basic care acid reducer, Amazon Basic Care Acid Reducer and Calmicid AC tablets relieve and prevent heartburn from acid indigestion and sour stomach.
Important instructions
  • Acid Reducer and Acid Controller labels: adults and children 12 and over swallow 1 tablet with water and do not chew.
  • These labels: to prevent heartburn, take 1 tablet about 10 to 60 minutes (15 to 60 for some strengths) before trigger foods or drinks.
  • These labels: do not use more than 2 tablets in 24 hours; children under 12 should ask a doctor.
Available strengths 4 strengths
568 FDA-listed product records ⓘ

Injection

Into a vein
How this form is used
What it may be used for
  • Famotidine Injection is used in some hospitalized patients with pathological hypersecretory conditions or intractable ulcers.
  • Famotidine Injection is an alternative to oral forms for short-term use in patients unable to take oral medicine for conditions such as active duodenal ulcer and active benign gastric ulcer.
Important instructions
  • Famotidine Injection is for intravenous use only.
Available strengths 3 strengths
34 FDA-listed product records ⓘ

Oral suspension

By mouth
How this form is used
What it may be used for
  • Famotidine for oral suspension is used in adults for active duodenal ulcer, active gastric ulcer, GERD and erosive esophagitis due to GERD.
  • Famotidine for oral suspension is used in children 1 year and older for peptic ulcer disease and GERD, and from birth to under 1 year for GERD.
Available strengths 1 strength
34 FDA-listed product records ⓘ

Oral solution

By mouth
How this form is used
What it may be used for
  • Famotidine for oral solution/suspension is used in adults for active duodenal ulcer, active gastric ulcer, GERD and erosive esophagitis due to GERD.
  • Famotidine for oral solution/suspension is used in adults for pathological hypersecretory conditions and to reduce duodenal ulcer recurrence.
  • Famotidine for oral solution/suspension is used in children 1 year and older for peptic ulcer disease and GERD, and from birth for GERD.
Available strengths 1 strength
1 FDA-listed product record ⓘ

Famotidine on the U.S. market: products, makers and brands

How Famotidine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

136 companies list 350 Famotidine product records with the FDA, mostly as tablet, injection, oral suspension; the earliest marketing or approval year on record is 1986. Brand names on the directory include Pepcid, Pepcid Ac, Fluxid and 13 more; the rest are generics.

4
Dose forms ⓘ
136
Labelers (makers, repackagers, distributors)
40
Brand names
350
FDA-listed product records ⓘ
1986
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (22) · Granule (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bryant Ranch Prepack5%
Proficient Rx LP4%
A-S Medication Solutions4%
PD-Rx Pharmaceuticals, Inc.2%
Preferred Pharmaceuticals Inc.2%
NuCare Pharmaceuticals,Inc.2%
Other makers80%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Famotidine is used (Medicaid data)

A general measure of how commonly Famotidine is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Famotidine is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

6,721,162
Medicaid prescriptions filled (Q1–Q4 2025)
$90.2M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Famotidine prescribed? Of the 1,601 medications we measure, Famotidine ranks #23 by Medicaid prescriptions — more than 99% of them.

Where Famotidine ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Famotidine product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 20 mg oral tablet is the most-dispensed Famotidine product — about 54% of these Medicaid prescriptions.

famotidine 20 MG Oral Tablet Most dispensed

3,603,936 Medicaid prescriptions (Q1–Q4 2025) 54% of Famotidine prescriptions shown $33.5M gross reimbursement (before rebates) ≈ $9.31 per prescription (gross)

Summed across the 46 of 801 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 310273

famotidine 40 MG Oral Tablet

1,970,473 Medicaid prescriptions (Q1–Q4 2025) 29% of Famotidine prescriptions shown $18.3M gross reimbursement (before rebates) ≈ $9.30 per prescription (gross)

Summed across the 32 of 271 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 284245

famotidine 8 MG/ML Oral Suspension

913,418 Medicaid prescriptions (Q1–Q4 2025) 14% of Famotidine prescriptions shown $28.7M gross reimbursement (before rebates) ≈ $31 per prescription (gross)

Summed across the 15 of 26 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 310274

2 ML famotidine 10 MG/ML Injection

114,979 Medicaid prescriptions (Q1–Q4 2025) 2% of Famotidine prescriptions shown $6.4M gross reimbursement (before rebates) ≈ $56 per prescription (gross)

Summed across the 6 of 17 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1743833

famotidine 10 MG Oral Tablet

86,697 Medicaid prescriptions (Q1–Q4 2025) 1% of Famotidine prescriptions shown $946,809 gross reimbursement (before rebates) ≈ $11 per prescription (gross)

Summed across the 17 of 180 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 199047

famotidine 10 MG/ML Injectable Solution

22,818 Medicaid prescriptions (Q1–Q4 2025) <1% of Famotidine prescriptions shown $1.3M gross reimbursement (before rebates) ≈ $58 per prescription (gross)

Summed across the 7 of 21 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 204441

50 ML famotidine 0.4 MG/ML Injection

8,841 Medicaid prescriptions (Q1–Q4 2025) <1% of Famotidine prescriptions shown $913,589 gross reimbursement (before rebates) ≈ $103 per prescription (gross)

Summed across the 1 of 1 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 199739

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Famotidine, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 124 of 1,317 listed Famotidine NDCs with Medicaid activity.

Compare Famotidine products

A representative set of FDA-listed product records for Famotidine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 200 of 350 products — FDA National Drug Code Directory. See every product, package size and price: browse all 350 Famotidine NDCs →

Famotidine side effects reported to the FDA (FAERS)

After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Famotidine — a signal of what to watch for, not proof the drug caused it.

The effects most often named in FDA reports that mention Famotidine are nausea, fatigue, diarrhoea; about 63% of the reports were classed as serious. These are voluntary reports, so they show what people report, not how often it happens.

118,942
Reports mentioning it
63%
Reported as serious
12
Distinct effects shown
Most reported effects
Nausea
7,889
Fatigue
7,401
Diarrhoea
7,086
Chronic Kidney Disease
6,794
Dyspnoea
5,644
Headache
5,422
Pain
4,914
Vomiting
4,805
Acute Kidney Injury
4,802
Dizziness
4,589
Age groups
Adult · 12,580Elderly · 9,977Child · 587Adolescent · 415Infant · 183Neonate · 58

Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Famotidine in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.

Famotidine FDA approval history

How Famotidine went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.

Famotidine was first approved by the FDA in 1986 (Brand: PEPCID · Bausch); the first generic version was approved in 2001. It remains available in U.S. pharmacies today.

1986
Brand approved
Brand: PEPCID · Bausch
2001
First generic approved
Lower-cost ANDA competition begins
2026
Available today
Active in U.S. pharmacies

Source: Drugs@FDA.

Famotidine recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list 3 Famotidine recalls since July 2021. Two of them are still ongoing or began in the last six months and are listed first. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class II Aug 6, 2026 · Baxter Healthcare Corporation
CGMP Deviations
  • Famotidine Injection in Sodium Chloride Injection, 20 mg, 50 mL in GALAXY Single Dose Container, Rx Only, Sterile Nonpyrogenic, Baxter International Inc., Baxter Healthcare Corporation, Deerfield, IL… Lots: Lot # NC188586, Exp Date: 02/28/2027; Lot # NC188913, Exp Date: 3/9/2027. FDA record D-0809-2026 →
Ongoing Class I Nov 6, 2025 · Fresenius Kabi USA, LLC
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
  • 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). Lots: Lot #: 6133156, 6133194, Exp Date: 08/2026; 6133388, Exp Date: 10/2026. FDA record D-0182-2026 →
Class II May 1, 2023 · Terminated · Glenmark Therapeutics, Inc.
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.
  • 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. Lots: FA2022001B, Exp 03/2025 FDA record D-0939-2023 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Famotidine RxCUI 4278 6 dose forms · 13 strengths
  1. Dose form (SCDF) Chewable Tablet RxCUI 372138 No current FDA listing
    Clinical drug / strength (SCD) 10 MG RxCUI 310272 20 MG RxCUI 799049
  2. Dose form (SCDF) Disintegrating Oral Tablet RxCUI 374596 In current FDA listings
    Clinical drug / strength (SCD) 20 MG RxCUI 197690 40 MG RxCUI 197691
  3. Dose form (SCDF) Injectable Solution RxCUI 374391 In current FDA listings
    Clinical drug / strength (SCD) 4 MG/ML RxCUI 2727402 10 MG/ML RxCUI 204441
  4. Dose form (SCDF) Oral Suspension RxCUI 372139 In current FDA listings
    Clinical drug / strength (SCD) 8 MG/ML RxCUI 310274
  5. Dose form (SCDF) Oral Tablet RxCUI 372140 In current FDA listings
    Clinical drug / strength (SCD) 10 MG RxCUI 199047 20 MG RxCUI 310273 40 MG RxCUI 284245

Look up RxCUI 4278 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Famotidine costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet, Film Coated · Oral 20 mg $0.138–$0.148 per tablet NDC details & price history
Tablet, Film Coated · Oral 40 mg $0.048 per tablet NDC details & price history
Tablet, Film Coated · Oral 10 mg $0.095 per tablet NDC details & price history
Tablet · Oral 10 mg $0.095 per tablet NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Famotidine brand names

Famotidine is sold under 16 brand names in the FDA directory — Pepcid, Pepcid Ac, Fluxid, Pepcid RPD and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Pepcid Pepcid Ac Fluxid Pepcid RPD Calmicid Zantac Reformulated Aug 2022 Acid Controller Acid Reducer heartburn relief CareOne Acid Relief acid relief Equate Famotidine equaline heartburn prevention Zantac 360 basic care acid reducer TopCare Acid Reducer

Who makes Famotidine: manufacturers and labelers

136 companies list Famotidine products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, Proficient Rx LP, A-S Medication Solutions. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Bryant Ranch Prepack 18 Proficient Rx LP 15 A-S Medication Solutions 14 PD-Rx Pharmaceuticals, Inc. 8 Preferred Pharmaceuticals Inc. 8 NuCare Pharmaceuticals,Inc. 7 Amazon.com Services LLC 6 Chain Drug Marketing Association INC 6 Aurohealth LLC 5 Remedyrepack Inc. 5 Ascend Laboratories, LLC 4 CVS Pharmacy, Inc. 4 Dr.Reddy's Laboratories Limited 4 H E B 4 Northwind Health Company, LLC 4 Redpharm Drug 4 Rite Aid Corporation 4 Safeway 4 Sagent Pharmaceuticals 4 Walgreen Co. 4 Wal-Mart Stores Inc 4 Aphena Pharma Solutions - Tennessee, LLC 3 Aurobindo Pharma Limited 3 Better Living Brands Llc. 3

…and 112 more on the FDA NDC directory.

Famotidine drug class (RxNorm)

Famotidine belongs to the Histamine-2 Receptor Antagonist class.

Pharmacologic class Histamine-2 Receptor Antagonist
Drug family (ATC) H2-receptor antagonists
How it works Histamine H2 Receptor Antagonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Famotidine page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Nov 11, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Famotidine.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Famotidine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
304
Finished products in the current FDA directory
350
Companies listing them (makers, repackagers, distributors)
136
FDA labeler codes behind them ⓘ
142
Linked representative label ⓘ
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
Linked label effective
Nov 11, 2024
Composite sections available
27
Linked SPL Set ID
2854047f-c5c4-43c3-8ef2-5c0a84a307f2
Linked SPL Document ID
21af0de6-18c5-b8e8-e063-6394a90af51f
Open the linked representative label on DailyMed ↗
NDC package records associated with this linked SPL 25
16837-0855-02 PEPCID AC Maximum Strength Famotidine 20 mg/1 TABLET, FILM COATED Kenvue 16837-0855-05 PEPCID AC Maximum Strength Famotidine 20 mg/1 TABLET, FILM COATED Kenvue 16837-0855-09 PEPCID AC Maximum Strength Famotidine 20 mg/1 TABLET, FILM COATED Kenvue 16837-0855-12 PEPCID AC Maximum Strength Famotidine 20 mg/1 TABLET, FILM COATED Kenvue 16837-0855-13 PEPCID AC Maximum Strength Famotidine 20 mg/1 TABLET, FILM COATED Kenvue 16837-0855-14 PEPCID AC Maximum Strength Famotidine 20 mg/1 TABLET, FILM COATED Kenvue 16837-0855-15 PEPCID AC Maximum Strength Famotidine 20 mg/1 TABLET, FILM COATED Kenvue 16837-0855-16 PEPCID AC Maximum Strength Famotidine 20 mg/1 TABLET, FILM COATED Kenvue 16837-0855-17 PEPCID AC Maximum Strength Famotidine 20 mg/1 TABLET, FILM COATED Kenvue 16837-0855-18 PEPCID AC Maximum Strength Famotidine 20 mg/1 TABLET, FILM COATED Kenvue 16837-0855-19 PEPCID AC Maximum Strength Famotidine 20 mg/1 TABLET, FILM COATED Kenvue 16837-0855-20 PEPCID AC Maximum Strength Famotidine 20 mg/1 TABLET, FILM COATED Kenvue 16837-0855-24 PEPCID AC Maximum Strength Famotidine 20 mg/1 TABLET, FILM COATED Kenvue 16837-0855-40 PEPCID AC Maximum Strength Famotidine 20 mg/1 TABLET, FILM COATED Kenvue 16837-0855-49 PEPCID AC Maximum Strength Famotidine 20 mg/1 TABLET, FILM COATED Kenvue 16837-0855-50 PEPCID AC Maximum Strength Famotidine 20 mg/1 TABLET, FILM COATED Kenvue 16837-0855-51 PEPCID AC Maximum Strength Famotidine 20 mg/1 TABLET, FILM COATED Kenvue 16837-0855-52 PEPCID AC Maximum Strength Famotidine 20 mg/1 TABLET, FILM COATED Kenvue 16837-0855-65 PEPCID AC Maximum Strength Famotidine 20 mg/1 TABLET, FILM COATED Kenvue 16837-0855-67 PEPCID AC Maximum Strength Famotidine 20 mg/1 TABLET, FILM COATED Kenvue

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →