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Methenamine Hippurate 1 g Tablet, 100-count — NDC 72603-816-01 (Billing 72603-0816-01)

by NorthStar Rx LLC · 100 TABLET in 1 BOTTLE

This is a package of 100 tablets of Methenamine Hippurate 1 g Tablet from NorthStar Rx LLC, marketed since Apr 2025 and currently FDA-listed; retail pharmacies pay about $0.3126 per tablet (NADAC). It is this product's only package size.

NDC 72603-0816-01
🏷️ FDA NDC (as labeled) 72603-816-01 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 72603-816-01
Product NDC 72603-816
11-digit billing NDC 72603081601
NCPDP billing unit EA — each (per item)
RxCUI 992150
UNII M329791L57
Application # ANDA205661
SPL Set ID 3c9e5bea-f61d-48c3-8e05-640eccccf2ba
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2025-04-01
Route ORAL
Dosage form TABLET
Substance METHENAMINE HIPPURATE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 16800020200305
GCN Seq No 009457
GCN 41980
HICL code 004101
Ingredient (HICL) Methenamine Hippurate
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W2
Therapeutic class — intermediate (HIC2) Antibacterials
HIC3 code W2G
Therapeutic class — specific (HIC3) Antibiotic, Antibacterial, Misc.
AHFS code 08:36.00.00
AHFS class Urinary Anti-Infectives
FDB label name METHENAMINE HIPP 1 GM TABLET
FDB brand name Methenamine Hippurate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 009457
  • GCN: 41980
  • GPI-14 (Medi-Span): 16800020200305
  • HICL (First Databank): 004101
  • AHFS class code: 08:36.00.00
  • RxCUI (RxNorm): 992150
Why two NDCs? The FDA registers this code as 72603-816-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 72603-0816-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Other antibacterials class.

Drug family (ATC) Other antibacterials
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name METHENAMINE HIPP 1 GM TABLET Ingredient Methenamine Hippurate
📗 Our plain-language guide HelloPharmacist
  • 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, meth...
  • Why do I need to take methenamine if my infection is already gone?
  • 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 re...
  • Does it matter what I eat or drink while I'm on this medication?
📖 Read our full Methenamine guide →
7
Nutrient depletion considerations

Methenamine Hippurate may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Methenamine Hippurate nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.313 $31.26 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.5156 $51.56 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $0.5951 $59.51 / 100 tablets
NADAC price history (per ea) — tap or hover for the price & month
Dec 2025 Mar 2026 Jun 2026 Sep 2026 $0.325 $0.307
▼ Down 4% over the last 10 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
72603-0816-01 You're viewing this Main listing 100 TABLET in 1 BOTTLE 2025-04-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Methenamine Hippurate 1000 mg 42571-0332-01 Micro 100 tablets $0.313 AB Availability likely —
Methenamine Hippurate 1 g 47781-0577-01 Alvogen 100 tablets $0.313 AB Availability likely —
Methenamine Hippurate 1000 mg 50268-0549-15 AvPAK 50 tablets $0.313 AB Availability likely —
Methenamine Hippurate 1 g 50742-0142-01 Ingenus 100 tablets $0.313 AB Availability likely —
Methenamine Hippurate 1 g 59746-0797-01 Jubilant 100 tablets $0.313 AB Availability likely —
Methenamine Hippurate 1000 mg 60687-0694-21 American 30 tablets $0.313 AB Availability likely —
Methenamine Hippurate 1 g 65862-0782-01 Aurobindo 100 tablets $0.313 AB Availability likely —
Methenamine hippurate 1 g 72578-0175-01 Viona 100 tablets $0.313 AB Availability likely —
Methenamine Hippurate 1 gthis 72603-0816-01 NorthStar 100 tablets $0.313 AB Availability likely —
Methenamine Hippurate 1 g 70954-0959-10 ANI 100 tablets $0.313 AB Availability likely —
Methenamine Hippurate 1 g 51407-0880-01 Golden 100 tablets — AB FDA listed —
Methenamine Hippurate 1 g 70685-0050-01 Esjay 100 tablets — AB Discontinued —
Methenamine hippurate 1 g 70771-1919-01 Zydus 100 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2025
On the market since
Apr 2025
📍
2026
Currently FDA-listed
1 year listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII SB8ZUX40TY
    Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.

3 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerNorthStar Rx LLC
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA205661 (ANDA)
Labeler code72603
First marketedApr 2025
Product typeHuman Prescription Drug
Portfolio414 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 121 words ▾

INDICATIONS Methenamine hippurate tablets USP are indicated for prophylactic or suppressive treatment of frequently recurring urinary tract infections when long-term therapy is considered necessary. This drug should only be used after eradication of the infection by other appropriate antimicrobial agents. To reduce the development of drug-resistant bacteria and maintain the effectiveness of methenamine hippurate tablets USP and other antibacterial drugs, methenamine hippurate tablets USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

⏱️ Dosage and Administration 94 words ▾

DOSAGE AND ADMINISTRATION 1 tablet (1 g) twice daily (morning and night) for adults and pediatric patients over 12 years of age. 1/2 to 1 tablet (0.5 to 1 g) twice daily (morning and night) for pediatric patients 6 to 12 years of age. Since the antibacterial activity of methenamine hippurate tablets is greater in acid urine, restriction of alkalinizing foods and medications is desirable.

If necessary, as indicated by urinary pH and clinical response, supplemental acidification of the urine should be instituted. The efficacy of therapy should be monitored by repeated urine cultures.

⛔ Contraindications 40 words ▾

CONTRAINDICATIONS Methenamine hippurate tablets are contraindicated in patients with renal insufficiency, severe hepatic insufficiency, or severe dehydration. Methenamine preparations should not be given to patients taking sulfonamides because some sulfonamides may form an insoluble precipitate with formaldehyde in the urine.

⚠️ Warnings 25 words ▾

WARNING Large doses of methenamine (8 grams daily for 3 to 4 weeks) have caused bladder irritation, painful and frequent micturition, albuminuria, and gross hematuria.

🤒 Adverse Reactions 42 words ▾

ADVERSE REACTIONS Minor adverse reactions have been reported in less than 3.5% of patients treated. These reactions have included nausea, upset stomach, dysuria, and rash. To report SUSPECTED ADVERSE REACTIONS, contact Northstar Rx LLC at 1-800-206-7821 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🧬 Clinical Pharmacology 200 words ▾

ACTIONS Microbiology Methenamine hippurate tablets have antibacterial activity because the methenamine component is hydrolyzed to formaldehyde in acid urine. Hippuric acid, the other component, has some antibacterial activity and also acts to keep the urine acid. The drug is generally active against E. coli , enterococci and staphylococci.

Enterobacter aerogenes is generally resistant. The urine must be kept sufficiently acid for urea-splitting organisms such as Proteus and Pseudomonas to be inhibited. Susceptibility Testing For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC.

Human Pharmacology Within 1/2 hour after ingestion of a single 1 gram dose of methenamine hippurate, antibacterial activity is demonstrable in the urine. Urine has continuous antibacterial activity when methenamine hippurate is administered at the recommended dosage schedule of 1 gram twice daily. Over 90% of methenamine moiety is excreted in the urine within 24 hours after administration of a single 1 gram dose.

Similarly, the hippurate moiety is rapidly absorbed and excreted, and it reaches the urine by both tubular secretion and glomerular filtration. This action may be important in older patients or in those with some degree of renal impairment.

📦 How Supplied / Storage and Handling 79 words ▾

HOW SUPPLIED Methenamine Hippurate Tablets USP , 1 g are white to off-white colored capsule shaped tablets debossed with “E” and “71” on one side and scoreline (functional) on other side. Bottles of 100 NDC 72603-816-01 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in well-closed, light-resistant container with child-resistant closure.

Manufactured for: Northstar Rx LLC Memphis, TN 38141. Manufactured by: Aurobindo Pharma Limited Unit-VII (SEZ) Mahabubnagar (Dt)-509302 India. M.L.No.: 22/MN/AP/2009/F/R Issued: 11/2024

📋 Description 37 words ▾

DESCRIPTION Each white to off-white colored capsule shaped tablet contains 1 g Methenamine Hippurate USP which is the Hippuric Acid Salt of Methenamine (hexamethylene tetramine). The tablet also contains inactive ingredients. Magnesium stearate, povidone, and saccharin sodium.

💬 Information for Patients 111 words ▾

Information for Patients Patients should be counseled that antibacterial drugs including methenamine hippurate should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When methenamine hippurate is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed.

Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by methenamine hippurate or other antibacterial drugs in the future.

⚠️ Precautions ~2 min read ▾

PRECAUTIONS Prescribing methenamine hippurate in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria. 1. Care should be taken to maintain an acid pH of the urine, especially when treating infections due to urea-splitting organisms such as Proteus and strains of Pseudomonas .

2. In a few instances in one study, the serum transaminase levels were slightly elevated during treatment but returned to normal while the patients were still taking methenamine hippurate. Because of this report, it is recommended that liver function studies be performed periodically on patients taking the drug, especially those with liver dysfunction.

3. Use in Pregnancy: In early pregnancy the safe use of methenamine hippurate is not established. In the last trimester, safety is suggested, but not definitely proved.

No adverse effects on the fetus were seen in studies in pregnant rats and rabbits. Methenamine hippurate taken during pregnancy can interfere with laboratory tests of urine estriol (resulting in unmeasurably low values) when acid hydrolysis is used in the laboratory procedure. This interference is due to the presence in the urine of methenamine and/or formaldehyde.

Enzymatic hydrolysis, in place of acid hydrolysis, will circumvent this problem. Geriatric Use Clinical studies of methenamine hippurate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. Methenamine hippurate tablets are contraindicated in patients with renal insufficiency and severe hepatic insufficiency (see CONTRAINDICATIONS ). Information for Patients Patients should be counseled that antibacterial drugs including methenamine hippurate should only be used to treat bacterial infections.

They do not treat viral infections (e.g., the common cold). When methenamine hippurate is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by methenamine hippurate or other antibacterial drugs in the future.

📄 Package Label / Principal Display Panel 36 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 1 g (100 Tablets Bottle) Rx only NDC 72603- 816 -01 Methenamine Hippurate Tablets USP 1 g 100 Tablets NORTHSTAR ® PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 1 g (100 Tablets Bottle)

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q3 2025 – Q4 2025 · 2 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
675
Units reimbursed last 4 qtrs
41.3K
Gross reimbursed last 4 qtrs
$21.3K
Avg / prescription
$31.54
Avg / unit
$0.5156
Latest quarter Q4 2025
513Rx
Medicaid pays / ea
$0.5156
gross reimbursed
vs
NADAC / ea
$0.3126
acquisition cost
=
Spread
+$0.2030
+65% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
43% FFS 57% MCO
Fee-for-service · 288 Rx Managed care · 387 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 7,428 units · 95.1 per 100k residents WA Idaho: 690 units · 35.1 per 100k residents ID Montana: 1,710 units · 151 per 100k residents MT North Dakota: no data reported ND Minnesota: 880 units · 15.3 per 100k residents MN Wisconsin: 897 units · 15.2 per 100k residents WI Michigan: no data reported MI New York: 4,600 units · 23.5 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 3,444 units · 81.4 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 4,036 units · 32.2 per 100k residents IL Indiana: no data reported IN Ohio: 1,792 units · 15.2 per 100k residents OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 7,264 units · 18.6 per 100k residents CA Utah: no data reported UT Colorado: 2,170 units · 36.9 per 100k residents CO Nebraska: no data reported NE Missouri: 880 units · 14.2 per 100k residents MO Kentucky: 2,060 units · 45.5 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: 382 units · 6.2 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 590 units · 7.9 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: 758 units · 24.7 per 100k residents AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: 428 units · 10.6 per 100k residents OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 1,283 units · 4.2 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
4.2151
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Montana 151 /100k
2 Washington 95.1 /100k
3 Oregon 81.4 /100k
4 Kentucky 45.5 /100k
5 Colorado 36.9 /100k
6 Idaho 35.1 /100k
7 Illinois 32.2 /100k
8 Arkansas 24.7 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Methenamine Hippurate — the program that covers self-administered drugs. 7 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Methenamine Hippurate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$18.08M
Claims incl. refills
301K
Beneficiaries
166.6K
Spend / beneficiary
$108.53
Spend / claim
$60.07
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Methenamine hippurate — the ingredient across all brands.

Top reported reactions

Urinary Tract Infection163
Diarrhoea81
Nausea80
Fall74
Fatigue74
Headache65
Dizziness60

Age at onset

Adolescent1
Adult57
Elderly170

Reporter sex

1,210 reports
Male · 19%
Female · 81%
Unknown · 0%

Serious outcomes

Hospitalization335
Death75
Disabling29
Life-threatening7
Reports over time (by year) — tap or hover for the count & year
2023 2024 2025 2026 129 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
← 72603-0815-01 · Northstar 72603-0817-01 · NorthStar →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.