pharmacopeia

Methenamine

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/api/v1/drug/methenamine

Indications

Sourced from openFDA
  • Uses Temporarily relieves: pain & burning • frequency and urgency of urination

Dosage & administration

Sourced from openFDA

Directions: Adults and children 12 years and over: take 2 tablets with a full glass of water 3 times a day. Drink plenty of fluids. Children under 12 years: ask a doctor

Warnings & precautions

Sourced from openFDA

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. If changes in behaviour with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Stomach bleeding warning: This product contains an NSAID, which may cause stomach bleeding. The chance is higher if you: • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen or others) • have 3 or more alcoholic drinks every day while using this product • have stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • are age 60 or older • take more or for a longer time than directed Do not use: • if you are on a sodium restricted diet • if you are allergic to salicylates (including aspirin) unless directed by a doctor • if you have stomach problems (such as heartburn, upset stomach, or stomach pain) that persist or recur, or if you have ulcers or bleeding problems unless directed by a doctor Ask a doctor before use if you have • frequent, burning urination for the first time • the stomach bleeding warning applying to you • history of stomach problems, such as heartburn • high blood pressure • heart disease • liver cirrhosis • bleeding problems • diuretic use • ulcers • kidney disease • reached age 60 or older Ask a doctor or pharmacist before use if you are • taking any other drug containing an NSAID (prescription or nonprescription) • taking a blood thinning (anticoagulant), steroid, diabetes, gou…

Approval history

Sourced from openFDA
  • 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

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
2,119 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Urinary Tract Infection2029.5%
  2. 2Fatigue1466.9%
  3. 3Nausea1446.8%
  4. 4Diarrhoea1366.4%
  5. 5Headache1286.0%
  6. 6Drug Ineffective1205.7%
  7. 7Pain1105.2%
  8. 8Fall1085.1%
  9. 9Dizziness1065.0%
  10. 10Off Label Use924.3%
  11. 11Asthenia884.2%
  12. 12Malaise844.0%
  13. 13Arthralgia823.9%
  14. 14Product Dose Omission Issue823.9%
  15. 15Vomiting793.7%

Literature

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Recent PubMed references pinned to Methenamine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 23 ClinicalTrials.gov registrations naming Methenamine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

What is Methenamine used for?
According to FDA labeling, Methenamine carries indications including: Uses Temporarily relieves: pain & burning • frequency and urgency of urination. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Methenamine?
Methenamine is classified as Other antibacterials, Cellular Activity Alteration.
What are the brand names for Methenamine?
Methenamine is marketed under brand names including Azo Urinary Tract Defense, Cystex, Hiprex, Hyophen, Phosphasal, Prosed DS, Urelle, Uretron DS.
Note. Data for methenamine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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