famotidine
Pharmaranks rates Famotidine 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Famotidine is a histamine-2 receptor antagonist used to treat Duodenal Ulcer, Dyspepsia, Peptic Esophagitis, Gastroesophageal Reflux.
Histamine-2 Receptor Antagonist · by Micro Labs
Generic of Pepcid Ac
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Famotidine
- Drug class
- Histamine-2 Receptor Antagonist
- Form
- Injectable, Solution, Powder, Tablet
- Strength
- Famotidine 40MG/5ML
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- May treat
- duodenal ulcer, dyspepsia, peptic esophagitis
- Manufacturer
- Micro Labs
- Half-life
- 2.5 to 3.5 hours (how long it stays in your system)
- What the pharmacy pays
- ~$1.54 for 30 — not your price
- FDA application
- ANDA217842
What is Famotidine?
From the FDA label:The active ingredient in famotidine for oral suspension, USP is a H 2 -receptor antagonist. Famotidine is N' -(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio]propanimidamide. The empirical formula of famotidine is C 8 H 15 N 7 O 2 S 3 and its molecular weight is 337.45. Its structural formula is: Famotidine, USP is a white to pale yellowish white crystalline powder that is freely soluble in glacial acetic acid and dimethylformamide, slightly soluble in methanol, very slightly soluble in water, and practically insoluble in acetone, in alcohol, in chloroform, in ether and in ethyl acetate. Each 5 mL of famotidine for oral suspension when prepared as directed contains 40 mg of famotidine, USP and the following inactive ingredients: citric acid monohydrate, flavors (strawberry, orange), powdered cellulose, sucrose and xanthan gum. Added as preservatives are sodium benzoate, sodium methylparaben and sodium propylparaben. famotidine-str.jpg
How to use
Famotidine is sold in more than one form (Injectable, Solution, Powder and Tablet), and each is dosed differently. The instructions below come from the FDA label for application ANDA217842 — follow the label that came with the product you were actually prescribed.
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 ( 2.4 ): Take once daily before bedtime or twice daily in the morning and before bedtime with or without food. 2.1 Recommended…
Side effects
The most common adverse reactions are: headache, dizziness, constipation, and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Micro Labs USA Inc. at 1-855-839-8195 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. The safety of famotidine for oral suspension has been established based on adequate and well-controlled studies of another oral famotidine product [see Clinical Studies ( 14 )]. The following is a summary of the adverse reactions reported in those studies. Oral famotidine was studied in 7 U.S. and international placebo- and active-controlled trials in approximately 2500 patients [see Clinical Studies ( 14 )] . A total of 1442 patients were treated with famotidine, 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 to 91 years old, fairly well distributed between sex and race; however, the predominant race was White. The following adverse reactions occurred in greater than or equal to 1% of famotidine-treated patients: headache, dizziness…
Warnings
Important safety information
Central Nervous System (CNS) Adverse Reactions : Elderly patients and patients with renal impairment at increased risk; reduce the dosage. ( 2.1 , 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 for oral suspension 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 for oral suspension.
Who should not take Famotidine
Famotidine for oral suspension is contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other H 2 -receptor antagonists. History of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other H 2 -receptor antagonists. ( 4 )
Overdose — what happens 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.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Drugs Dependent on Gastric pH for Absorption : Systemic exposure of the concomitant drug may be significantly reduced leading to loss of efficacy. ( 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.
Storing Famotidine, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “Discard unused constituted suspension after 30 days.”
- “Although diluted Famotidine Injection has been shown to be physically and chemically stable for 7 days at room temperature, there are no data on the maintenance of sterility after dilution.”
- “Avoid storage of famotidine tablets at temperatures above 40°C (104°F).”
How long does Famotidine stay in your body?
The elimination half-life of famotidine is 2.5 to 3.5 hours — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the elimination half-life stated in §12.3 of the FDA label for adults with normal organ function; the label reports a single elimination half-life and does not separate a distribution from a terminal phase. Famotidine is not a prodrug, and it has no active metabolite that outlasts it — the label says the only metabolite identified in humans is the S-oxide, and famotidine undergoes minimal first-pass metabolism, with 25-30% of an oral dose recovered in urine unchanged. Kidney impairment: famotidine is cleared mostly by the kidneys (65-70% renal), and clearance falls in kidney impairment, so the drug lingers longer. The current label quantifies this as exposure rather than half-life — AUC increases at least 2-fold with moderate impairment (creatinine clearance 30-60 mL/min) and at least 5-fold with severe impairment (below 30 mL/min) — and it does not state a specific prolonged half-life number, so none is given here. Older adults: the label names no separate half-life, but notes famotidine is substantially excreted by the kidney and that risk of adverse reactions may be greater in elderly patients, particularly those with impaired renal function. Liver impairment: this label states no hepatic pharmacokinetic data and no half-life for liver impairment.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: DailyMed - FAMOTIDINE tablet, film coated (FDA label, revised 11/2021), §12.3 Pharmacokinetics.
Drug class
May treat (source: NIH RxClass)
See how Famotidine ranks — best-rated histamine-2 receptor antagonist for:
Dosage forms
Injectable, Solution, Powder and Tablet
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
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Frequently asked questions
- What does Famotidine treat?
- Famotidine (Famotidine) may be used to treat duodenal ulcer, dyspepsia, peptic esophagitis, gastroesophageal reflux, heartburn, stomach ulcer, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Famotidine rated?
- pharmaranks gives Famotidine a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Famotidine cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $1.54 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Famotidine?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Famotidine. To pay less, Famotidine is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Famotidine?
- Famotidine is marketed by Micro Labs. You can see Micro Labs's full profile, rating, and other products on pharmaranks.
- Is Famotidine a brand-name or generic drug?
- Famotidine is a generic medication; its active ingredient is Famotidine. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Famotidine available over the counter?
- No. Famotidine is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Famotidine come in?
- Famotidine is currently marketed as injectable, solution, powder and tablet, per the FDA's National Drug Code Directory.
- What class of drug is Famotidine?
- Famotidine is classified as histamine-2 receptor antagonist, per the FDA's Established Pharmacologic Class.
- Is Famotidine FDA-registered?
- Famotidine is on record with the U.S. FDA under application number ANDA217842. You can verify this on its official FDA label.
- Has Famotidine been recalled by the FDA?
- Famotidine has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Famotidine safe?
- There's no single safe-or-not verdict. pharmaranks gives Famotidine a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Famotidine?
- Famotidine's side effects are taken directly from its FDA label. From the label: The most common adverse reactions are: headache, dizziness, constipation, and diarrhea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Micro Labs USA Inc. at 1-855-839-8195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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famotidine
70/100