Hippurate

• Methenamine hippurate tablets 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.ICD-10: N39.0

• 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.contraindicated

1 tablet (1.0 g) twice daily (morning and night) for adults and pediatric patients over 12 years of age. 1/2 to 1 tablet (0.5 to 1.0 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.

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

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 Esjay Pharma LLC at 1-800-239-9339 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

• Jul 5, 1967NDANDA016151Quagen
• Sep 9, 1976NDANDA017681Esjay Pharma
• Jul 5, 2016ANDAANDA205661Aurobindo Pharma Ltd
• Aug 1, 2019ANDAANDA212172Micro Labs
• Nov 27, 2020ANDAANDA210068Ingenus Pharms Llc
• Dec 1, 2023ANDAANDA217675Jubilant Cadista
• Mar 10, 2025ANDAANDA219661Zydus Lifesciences

1. 1Urinary Tract Infection15013%
2. 2Diarrhoea756.6%
3. 3Nausea756.6%
4. 4Drug Ineffective736.4%
5. 5Fall716.2%
6. 6Fatigue716.2%
7. 7Headache605.3%
8. 8Dizziness554.8%
9. 9Product Dose Omission Issue514.5%
10. 10Death494.3%
11. 11Off Label Use494.3%
12. 12Pneumonia453.9%
13. 13Vomiting443.9%
14. 14Asthenia433.8%
15. 15Covid-19423.7%

The 10 most recently updated of 30 ClinicalTrials.gov registrations naming Hippurate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Renal Mechanism of SGLT2 Inhibition
  Active not recruiting · Phase 2 · Interventional · 45 enrolled · University of Colorado, Denver
  NCT05507892updated 2026-06-02
• Pathogenesis of Kidney Disease in Type 1 Diabetes: a Modern Kidney Biopsy Cohort (The PANDA Study)
  Active not recruiting · Observational · 100 enrolled · University of Colorado, Denver
  NCT05319990updated 2026-05-22
• A Clinical Trial of Extended (High) Treatment Dose Antibiotics in Combination With Methenamine Hippurate Compared to the Standard of Care (Either Prophylactic (Low) Dose Antibiotic Treatment or Methenamine Hippurate) in Females With Chronic Urinary Tract Infection
  Recruiting · Phase 2 · Interventional · 192 enrolled · University College, London
  NCT07202949updated 2026-04-23
• Physical Exercise and Biomolecular Analysis to Reduce Uremic Toxins in Chronic Kidney Disease: An Exploratory Study
  Enrolling by invitation · Interventional · 1,600 enrolled · Catholic University of Brasília
  NCT06910475updated 2026-03-18
• Efficacy and Mechanism of Action of Methenamine Hippurate (Hiprex™) in Women With Recurring Urinary Tract Infections.
  Terminated · Phase 4 · Interventional · 14 enrolled · University of Texas Southwestern Medical Center
  NCT04709601updated 2026-02-24
• Vitamin C and Hiprex in rUTI
  Not yet recruiting · Early phase 1 · Interventional · 20 enrolled · University Hospitals of North Midlands NHS Trust
  NCT06710899updated 2026-02-11
• Impact of Metabolic Surgery on Pancreatic, Renal and Cardiovascular Health in Youth With Type 2 Diabetes
  Completed · Phase 1 · Phase 2 · Interventional · 24 enrolled · University of Colorado, Denver
  NCT03620773updated 2026-01-12
• MANATEE-T1D: Metformin ANd AutomaTEd Insulin Delivery System Effects on Renal Vascular Resistance, Insulin Sensitivity, and Cardiometabolic Function in Youth With Type 1 Diabetes
  Recruiting · Phase 1 · Interventional · 60 enrolled · Kalie Tommerdahl
  NCT05065372updated 2025-06-13
• Methenamine Hippurate Following Intradetrusor OnabotulinumtoxinA Injection
  Not yet recruiting · Phase 4 · Interventional · 164 enrolled · Women and Infants Hospital of Rhode Island
  NCT06953271updated 2025-05-01
• AMT-PET in Monitoring Telotristat Etiprate Treatment in Participants With MetastaticNeuroendocrine Neoplasm
  Completed · Phase 2 · Interventional · 4 enrolled · Barbara Ann Karmanos Cancer Institute
  NCT03453489updated 2025-04-10

Frequently asked questions

What is Hippurate used for?

According to FDA labeling, Hippurate carries indications including: Methenamine hippurate tablets 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What are the contraindications for Hippurate?

Hippurate labeling lists contraindications including: 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.. Always consult the full prescribing information and a clinician.