{
 "query": "methenamine",
 "ingredient": "methenamine",
 "slug": "methenamine",
 "rxcui": "6832",
 "brands": [
  "Hiprex",
  "Urex"
 ],
 "names": [
  "methenamine",
  "methenamine hippurate",
  "methenamine mandelate",
  "methenamine sulfosalicylate"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 46,
   "SUBLINGUAL": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of Methenamine Hippurate Tablets and other antibacterial drugs, Methenamine Hippurate Tablets 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. 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.",
  "contraindications": "CONTRAINDICATIONS Methenamine Hippurate Tablets are contraindicated in patients with renal insufficiency, severe hepatic insufficiency, or severe dehydration. It should not be used as the sole therapeutic agent in acute parenchymal infections causing systemic symptoms.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS Patients with pre-existing hepatic insufficiency may suffer adverse effects from the small amounts of ammonia and formaldehyde that are produced. The classical syndrome of acute hepatic failure may be evoked in these patients.",
  "adverse_reactions": "ADVERSE REACTIONS Adverse effects of Methenamine Hippurate Tablets have been reported in fewer than 3.5% of patients treated. These reactions have included the following, in decreasing order of frequency: nausea, vomiting and rarely pruritus, rash, dysuria. Children have received Methenamine Hippurate Tablets at the recommended dosages as a prophylactic/suppressive regimen after initial treatment of acute episodes of pyuria. Side effects were encountered in only 1.1% of these children.",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Information for Patients: Patients should be counseled that antibacterial drugs including Methenamine Hippurate Tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g. the common cold). When Methenamine Hippurate Tablets are 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 Tablets or other antibacterial drugs in the future.",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Methenamine Hippurate",
  "manufacturer": "Alvogen Inc.",
  "application_number": "NDA016151",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20241117",
  "set_id": "bc95972d-3db2-122a-0d1c-d7080c251445",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 2835,
  "serious": 1731,
  "death": 202,
  "hospitalization": 879,
  "primary_suspect": 2827,
  "top_reactions": [
   [
    "Urinary Tract Infection",
    408
   ],
   [
    "Fatigue",
    214
   ],
   [
    "Diarrhoea",
    210
   ],
   [
    "Fall",
    176
   ],
   [
    "Drug Ineffective",
    166
   ],
   [
    "Nausea",
    164
   ],
   [
    "Headache",
    146
   ],
   [
    "Off Label Use",
    135
   ],
   [
    "Asthenia",
    130
   ],
   [
    "Dyspnoea",
    119
   ],
   [
    "Dizziness",
    118
   ],
   [
    "Malaise",
    116
   ],
   [
    "Product Dose Omission Issue",
    112
   ],
   [
    "Pyrexia",
    109
   ],
   [
    "Death",
    106
   ]
  ],
  "by_year": {
   "2019": 238,
   "2020": 224,
   "2021": 202,
   "2022": 219,
   "2023": 268,
   "2024": 264,
   "2025": 355,
   "2026": 210
  },
  "by_year_primary": {
   "2019": 238,
   "2020": 223,
   "2021": 202,
   "2022": 218,
   "2023": 265,
   "2024": 264,
   "2025": 352,
   "2026": 210
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 8,
  "nda": 2,
  "anda": 6,
  "first_approval": "19670705",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 10,
  "labeling_recent": 0,
  "sponsors": [
   "AUROBINDO PHARMA LTD",
   "ESJAY PHARMA",
   "IMPAX LABS INC",
   "INGENUS PHARMS LLC",
   "JUBILANT CADISTA",
   "MICRO LABS",
   "QUAGEN",
   "ZYDUS LIFESCIENCES"
  ],
  "unapproved": false,
  "first_approval_fmt": "07/05/1967"
 },
 "trials": {
  "total": 23,
  "completed": 8,
  "terminated": 7,
  "with_results": 5,
  "industry": 2,
  "phase3": 3,
  "results_share": 0.625,
  "terminated_share": 0.30434782608695654
 },
 "pubmed": {
  "rct": 23,
  "meta": 8,
  "recent_rct": 7,
  "cochrane": [
   {
    "pmid": "23076896",
    "title": "Methenamine hippurate for preventing urinary tract infections",
    "year": "2012"
   },
   {
    "pmid": "17943785",
    "title": "Methenamine hippurate for preventing urinary tract infections",
    "year": "2007"
   },
   {
    "pmid": "11869659",
    "title": "Methenamine hippurate for preventing urinary tract infections",
    "year": "2002"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "methenamine",
   "Hiprex",
   "Urex"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 893800,
  "beneficiaries": 205175,
  "spend": 61457933.43,
  "by_brand": [
   {
    "brand": "Methenamine Hippurate",
    "claims": 887845,
    "per_claim": 68.508042845,
    "is_generic": true
   },
   {
    "brand": "Methenamine Mandelate",
    "claims": 5955,
    "per_claim": 106.36610076,
    "is_generic": true
   }
  ],
  "per_claim": 68.76027459163123
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 826,
  "fills": 893800,
  "per_million": 924.1441038263594,
  "ratio": 0.33375257263563196,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "924 FDA reports naming it as the suspect drug per million Medicare fills, 0.3x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.8x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 40,
   "letter": "F",
   "why": [
    "23 randomized trials and 8 systematic reviews/meta-analyses indexed in PubMed",
    "3 independent Cochrane review(s) exist",
    "30% of registered trials were terminated, withdrawn, or suspended (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 100,
   "letter": "A",
   "why": [
    "No recalls on record since 2016"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 70,
   "letter": "C",
   "why": [
    "Generic versions approved (6 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 82,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are urinary tract infection, fatigue, diarrhoea, fall. How would we recognize and handle those?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}