FDA-filed SPL labeling · retrieved through openFDA

Methenamine

Methenamine is an antibacterial medication used to suppress or prevent recurring urinary tract infections, including pyelonephritis and cystitis.

Brand names HiprexUrexMethenamine HippurateMethenamine Mandelate
Rx Forms 2 Route Oral
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 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 20 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 →

At a glance
Linked label effectiveNov 17, 2024
Clinical labels in scope 20
AvailabilityRx
Earliest approval/marketing year 1967
FDA-listed product records 56
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 20, 2026
Methenamine at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Methenamine is a long-term antibacterial used to prevent recurring urinary tract infections — it works in the urine, not the bloodstream, and must be taken after another antibiotic has already cleared the infection. Keeping urine acidic is key to making it work, so follow your prescriber's guidance on diet and any urine-acidifying supplements. It's generally well-tolerated, but it's not right for everyone — particularly those with kidney problems, liver disease, or gout.

📖 Methenamine: Patient Information Guide

A plain-language walkthrough of Methenamine — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Methenamine is used to suppress or prevent recurring urinary tract infections over the long term. It is always started after another antibiotic has already cleared the active infection.

  • Hiprex (tablet): prophylactic or suppressive treatment of frequently recurring urinary tract infections when long-term therapy is needed
  • Methenamine Hippurate (tablet): prophylactic or suppressive treatment of frequently recurring urinary tract infections when long-term therapy is needed
  • Methenamine Mandelate (tablet and oral solution): suppression or elimination of bacteriuria (bacteria in the urine) associated with pyelonephritis (kidney infection), cystitis (bladder infection), and other chronic urinary tract infections
  • Methenamine Mandelate (tablet and oral solution): infected residual urine that can accompany certain neurologic diseases
  • Methenamine Mandelate should not be used alone for acute infections causing systemic symptoms such as fever and chills
⚙️How it works

Methenamine itself is not directly antibacterial in the body. Once it reaches the bladder and mixes with acidic urine, it breaks down into formaldehyde — a substance that kills bacteria on contact. The hippurate or mandelate salt paired with methenamine helps maintain the acidic urine environment needed for this conversion to happen. Because bacteria cannot develop resistance to formaldehyde, methenamine remains effective even against organisms that have become resistant to other antibiotics.

Urea-splitting bacteria such as Proteus and Pseudomonas can raise urine pH, making it less acidic and reducing methenamine's effectiveness. Keeping urine sufficiently acidic is therefore critical to how well this medication works.

💊How it's taken

Methenamine is taken by mouth in tablet or oral solution form. Timing and frequency vary by product — follow your specific product's directions.

  • Hiprex and Methenamine Hippurate tablets: typically taken twice daily, morning and night
  • Methenamine Mandelate tablets and oral solution: typically taken four times daily, after each meal and at bedtime

Keeping urine acidic is essential for this medication to work. Your prescriber may recommend limiting alkalinizing foods and medications, and urine pH may be monitored. If you miss a dose, follow the guidance on your label or ask your pharmacist — do not double up without checking first.

🤒Side effects — in detail

Most people tolerate methenamine well — side effects were reported in fewer than 3.5% of adults in studies. The most common ones include:

  • Nausea
  • Vomiting
  • Itching (pruritus)
  • Skin rash
  • Painful or difficult urination (dysuria)

Contact your doctor if you develop a rash, severe stomach upset, signs of a worsening infection (fever, chills, back pain), or any new symptom that concerns you.

⚠️Warnings & precautions
  • Do not use with sulfonamide antibiotics — formaldehyde produced by methenamine can react with sulfonamides to form a precipitate (solid particles) in the urine, which may cause harm
  • Not for serious acute infections — methenamine is for long-term suppression or prevention only; it should not be used alone when you have fever, chills, or signs of a systemic infection
  • Kidney, liver, or dehydration concerns — methenamine is contraindicated if you have significant kidney problems, severe liver disease, or severe dehydration
  • Gout or uric acid kidney stones — Methenamine Mandelate should be avoided in people with gout or a predisposition to uric acid stones, as it may trigger urate crystal formation in the urine
  • Pregnancy — methenamine crosses the placenta; discuss risks with your prescriber if you are pregnant or planning to become pregnant
🔀What it interacts with

Methenamine has a few important interactions to be aware of before starting it:

  • Sulfonamide antibiotics (e.g., sulfamethizole): must not be combined — formaldehyde from methenamine reacts with sulfonamides to form a harmful precipitate in the urine
  • Salicylates (e.g., aspirin): acidified urine slows salicylate excretion, which can raise salicylate blood levels and increase the risk of salicylate-related effects
  • Alkalinizing foods and medications: anything that makes urine less acidic (higher pH) reduces how well methenamine works; your prescriber may recommend limiting these

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Tell your doctor if you have kidney disease — methenamine is contraindicated with significant kidney impairment (renal insufficiency)
  • Tell your doctor if you have liver disease — severe liver problems (hepatic insufficiency) are a contraindication
  • Tell your doctor if you are severely dehydrated — this is also a contraindication
  • Tell your doctor if you have gout or a history of uric acid kidney stones — Methenamine Mandelate may worsen these conditions
  • Tell your doctor if you take any sulfonamide antibiotic — these must not be combined with methenamine
  • Tell your doctor if you take aspirin or other salicylates regularly — dosing may need to be reviewed
  • Tell your doctor if you are pregnant — methenamine crosses the placenta and reaches the fetus
  • Older adults or those with some degree of kidney impairment may handle the drug differently — your prescriber will take this into account
🚑If you take too much

If too much methenamine is taken, acting quickly can help limit further absorption. The label advises inducing vomiting or using stomach lavage (gastric pumping) if appropriate, followed by activated charcoal. Fluids — either by mouth or intravenously — should be given as much as can be tolerated. Seek emergency medical help immediately if an overdose is suspected.

📡Pharmacodynamics — effects in the body

Methenamine works by releasing formaldehyde in the urine when the urine is acidic. This formaldehyde directly kills a broad range of bacteria. Because the action is nonspecific — meaning it targets bacterial cells through chemistry rather than a specific receptor — bacteria do not develop resistance to it over time. The more acidic the urine, the more formaldehyde is released and the stronger the antibacterial effect.

🔬Pharmacokinetics — how your body processes it

Methenamine is readily absorbed from the gastrointestinal tract after an oral dose. It distributes widely into body fluids but is largely not broken down before reaching the kidneys — meaning very little active formaldehyde is released in the bloodstream, which limits systemic toxicity. Over 90% of the methenamine is excreted in the urine within 24 hours. Antibacterial activity in the urine can be detected within about 30 minutes of a dose, and it remains continuous with regular twice-daily dosing of the hippurate form. The hippurate component reaches the urine through both glomerular filtration and tubular secretion, which may be relevant in older patients or those with mild kidney impairment.

📦How to store it

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) .

📄 Written from Methenamine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

44

Supplements & herbs that interact with Methenamine

44 supplements and herbal products have documented interactions with Methenamine 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 · 33
  • Minor · 10
Every supplement checked against Methenamine — ranked by severity The full interaction hub: 1 major · 33 moderate · 10 minor · every one linked to its full report. Check Methenamine 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.

7

Nutrient depletion considerations

Methenamine has been associated with lower levels of 7 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 · 6
  • Moderate · 1
See the full Methenamine 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.

🩺 Pharmacist Counseling Corner

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

Why do I need to take methenamine if my infection is already gone?
That's a great question. Methenamine isn't used to clear an active infection — it's used to prevent another one from taking hold. Once your other antibiotic has done that job, methenamine works in your urine on an ongoing basis to keep bacteria from growing back. Think of it as long-term maintenance rather than a rescue treatment.
Does it matter what I eat or drink while I'm on this medication?
Yes, it actually does. Methenamine only converts into its active antibacterial form in acidic urine. Foods and medications that make your urine more alkaline — less acidic — can reduce how well it works. Your prescriber may give you specific guidance on what to limit, and in some cases may add a supplement to help keep your urine acidic enough.
What side effects should I watch for?
Most people do well on methenamine — fewer than 3.5% of adults in studies had side effects. The most common ones are nausea, vomiting, a skin rash, itching, or some discomfort when urinating. These are usually mild. If you develop a rash, fever, chills, or signs of a new or worsening infection, call your doctor — those aren't things to wait on.
Can I take my regular aspirin or pain relievers while on this?
Check with your doctor or pharmacist first. Methenamine acidifies your urine, and acidic urine slows the body's ability to clear salicylates — drugs like aspirin. That can lead to higher-than-expected salicylate levels in your blood. It may be fine in your situation, but your prescriber should know you're taking both.
I've heard there's a concern about taking this with certain antibiotics — is that true?
Yes. Methenamine should never be taken at the same time as sulfonamide antibiotics — a class that includes drugs like sulfamethizole. When methenamine converts to formaldehyde in your urine, it can react with sulfonamides to form solid particles. That can be harmful to your urinary tract. Make sure your doctor and pharmacist know all the medications you're taking.
Is this medication safe to take for a long time?
Methenamine is specifically designed for long-term use to prevent recurring UTIs, and the label notes it is considered particularly suitable for long-term therapy because bacteria don't develop resistance to its active ingredient, formaldehyde. That said, whether it's the right long-term option for you depends on your specific health situation — including your kidney and liver function — so keep having those check-ins with your prescriber.
Is Methenamine available over the counter?
Methenamine is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Methenamine first available?
Methenamine has been available in the United States since at least 1967, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Methenamine?
Methenamine is supplied by 37 manufacturers listed in the FDA NDC Directory, including Edenbridge Pharmaceuticals LLC., Chartwell RX, LLC, Alvogen Inc..

💬 Answers drafted from Methenamine’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Methenamine comes

Methenamine is available in 2 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.

Tablet

By mouth
Brands Hiprex Methenamine Hippurate Methenamine Mandelate
How this form is used
What it may be used for
  • Hiprex tablets are indicated for the prophylactic (preventive) or suppressive treatment of frequently recurring urinary tract infections when long-term therapy is needed
  • Methenamine Hippurate tablets are indicated for prophylactic or suppressive treatment of frequently recurring urinary tract infections when long-term therapy is considered necessary
  • Methenamine Mandelate tablets are used to suppress or eliminate bacteriuria associated with pyelonephritis, cystitis, and other chronic urinary tract infections, including infected residual urine in neurologic diseases
Important instructions
  • Hiprex and Methenamine Hippurate tablets are taken twice daily — morning and night
  • Methenamine Mandelate tablets are taken four times daily — after each meal and at bedtime
  • For all tablet forms, restrict alkalinizing foods and medications to maintain the acid urine needed for the drug to work
  • Your prescriber may monitor the effectiveness of therapy with repeated urine cultures
Available strengths 4 strengths
39 FDA-listed product records

Oral solution

By mouth
Brands Methenamine Mandelate
How this form is used
What it may be used for
  • Methenamine Mandelate oral solution is used to suppress or eliminate bacteria in the urine associated with pyelonephritis, cystitis, and other chronic urinary tract infections
  • Methenamine Mandelate oral solution is also used for infected residual urine that can accompany neurologic diseases
Important instructions
  • Methenamine Mandelate oral solution is taken four times daily — after each meal and at bedtime
  • Keeping urine acidic is essential for Methenamine Mandelate to work; limit alkalinizing foods and medications as directed
  • If urine pH testing shows the need, your prescriber may add a urine acidifier alongside Methenamine Mandelate oral solution
Available strengths 1 strength
1 FDA-listed product record

📊 Methenamine across the U.S. market

How Methenamine 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.

2
Dose forms
37
Manufacturers
3
Brand names
56
FDA-listed product records
1967
First marketed

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 (15) · Crystal (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Edenbridge Pharmaceuticals LLC.7%
Chartwell RX, LLC7%
Alvogen Inc.5%
Aurobindo Pharma Limited5%
Bryant Ranch Prepack5%
American Health Packaging4%
Other makers66%

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

📈 How widely Methenamine is used

A general measure of how commonly Methenamine 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 Methenamine 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.

70,440
Medicaid prescriptions filled (Q1–Q4 2025)
$2.5M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Methenamine prescribed? Of the 1,596 medications we measure, Methenamine ranks #564 by Medicaid prescriptions — more than 65% of them.

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

Utilization by Methenamine 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 1000 mg oral tablet is the most-dispensed Methenamine product — about 99% of these Medicaid prescriptions.

methenamine hippurate 1000 MG Oral Tablet Most dispensed

69,581 Medicaid prescriptions (Q1–Q4 2025) 99% of Methenamine prescriptions shown $2.4M gross reimbursement (before rebates) ≈ $34 per prescription (gross)

Summed across the 7 of 18 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 992150

methenamine mandelate 1000 MG Oral Tablet

730 Medicaid prescriptions (Q1–Q4 2025) 1% of Methenamine prescriptions shown $82,026 gross reimbursement (before rebates) ≈ $112 per prescription (gross)

Summed across the 2 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 992153

methenamine mandelate 500 MG Oral Tablet

129 Medicaid prescriptions (Q1–Q4 2025) <1% of Methenamine prescriptions shown $21,765 gross reimbursement (before rebates) ≈ $169 per prescription (gross)

Summed across the 1 of 10 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 992184

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 Methenamine, 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 10 of 37 listed Methenamine NDCs with Medicaid activity.

🔍 Compare Methenamine products

A representative set of FDA-listed product records for Methenamine — 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 56 of 56 products — FDA National Drug Code Directory. See every product, package size and price: browse all 56 Methenamine NDCs →

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) Methenamine RxCUI 6832 4 dose forms · 6 strengths
  1. Dose form (SCDF) Oral Capsule RxCUI 393462 No current FDA listing
    Clinical drug / strength (SCD) hippurate 1000 MG RxCUI 1000025
  2. Dose form (SCDF) Oral Solution RxCUI 2741043 In current FDA listings
    Clinical drug / strength (SCD) mandelate 100 MG/ML RxCUI 2741045
  3. Dose form (SCDF) Oral Suspension RxCUI 372821 No current FDA listing
    Clinical drug / strength (SCD) mandelate 100 MG/ML RxCUI 1000024

Look up RxCUI 6832 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.

🏷️ Sold under these brand names

Hiprex Urex Methenamine Hippurate Methenamine Mandelate

🏭 Manufacturers & labelers

Edenbridge Pharmaceuticals LLC. 4 Chartwell RX, LLC 4 Alvogen Inc. 3 Aurobindo Pharma Limited 3 Bryant Ranch Prepack 3 American Health Packaging 2 Ingenus Pharmaceuticals, LLC 2 Micro Labs Limited 2 Chattem Chemicals, Inc. 2 Westminster Pharmaceuticals, LLC 2 AvPAK 2 ANI Pharmaceuticals, Inc. 2 Zydus Lifesciences Limited 1 Oncora Pharma, LLC 1 Professional Compounding Centers of America 1 Nuray Chemicals Private Limited 1 Seton Pharmaceuticals 1 Siegfried (Nantong) Pharmaceuticals Co, Ltd 1 Siegfried Evionnaz SA 1 Spectrum Laboratory Products, Inc. 1 Sthree Chemicals Private Limited 1 Validus Pharmaceuticals LLC 1 Viona Pharmaceuticals Inc 1 W. R. Grace & Co.-Conn. 1

…and 13 more on the FDA NDC directory.

RxNorm drug class

Methenamine belongs to the Other antibacterials class.

Drug family (ATC) Other antibacterials

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.

🔬 Where this comes from

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 17, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Methenamine.
📈
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 Methenamine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
20
NDC products indexed
56
Distinct labelers/manufacturers represented
37
Linked representative label
Alvogen Inc.
Linked label effective
Nov 17, 2024
Composite sections available
18
Linked SPL Set ID
bc95972d-3db2-122a-0d1c-d7080c251445
Linked SPL Document ID
176aed32-228d-8715-8d16-83ea50343900
Open the linked representative label on DailyMed ↗
NDC package records associated with this linked SPL 1

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 20 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

For canonical ingredient pages, bounded product-attributed indication and administration excerpts may be added to the AI evidence, and the generator is instructed to preserve available product, brand, route, and form qualifiers instead of treating one label as universal. Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Alvogen Inc. is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.