{
 "query": "phenazopyridine",
 "ingredient": "phenazopyridine",
 "slug": "phenazopyridine",
 "rxcui": "8120",
 "brands": [
  "Pyridium",
  "Azo Urinary Pain Relief",
  "Baridium",
  "Uricalm",
  "Uristat"
 ],
 "names": [
  "phenazopyridine",
  "phenazopyridine hydrochloride"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 104
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS AND USAGE Phenazopyridine Hydrochloride is indicated for the symptomatic relief of pain, burning, urgency frequency, and other discomforts arising from irritation of the mucosa of the lower urinary tract caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. The use of Phenazopyridine Hydrochloride for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. The drug should be used for symptomatic relief of pain and not as a substitute for specific surgery or antimicrobial therapy. Phenazopyridine Hydrochloride is compatible with antimicrobial therapy and can help relieve pain and discomfort during the interval before antimicrobial therapy controls the infection. Treatment of a urinary tract infection with Phenazopyridine Hydrochloride should not exceed 2 days. There is no evidence that the combined administration of Phenazopyridine Hydrochloride and an antimicrobial provides greater benefit than administration of the antimicrobial alone after 2 days. (See Dosage and Administration .)",
  "contraindications": "CONTRAINDICATIONS Phenazopyridine Hydrochloride should not be used in patients who are hypersensitive to the drug or its ingredients. Phenazopyridine Hydrochloride is contraindicated in patients with renal insufficiency, severe liver disease, severe hepatitis or pyelonephritis of pregnancy. It should be used cautiously in the presence of GI disturbances.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS Phenazopyridine Hydrochloride is reasonably anticipated to be a human carcinogen based on sufficient evidence of carcinogenicity in experimental animals (IARC 1980, 1982, 1987, NCI 1978). When administered in the diet, Phenazopyridine hydrochloride increased the incidences of hepatocellular adenomas and carcinomas in female mice and adenomas and adenocarcinomas of the colon and rectum in rats of both sexes. There is inadequate evidence for the carcinogenicity of Phenazopyridine hydrochloride in humans (TARC 1987). In one limited epidemiological study, no significant excess of any cancer was observed among 2,214 patients who received Phenazopyridine hydrochloride and were followed for a minimum of 3 years.",
  "adverse_reactions": "ADVERSE REACTIONS The following adverse events have been reported: CNS: headache. Gastrointestinal: nausea, vomiting and diarrhea. Dermatologic and Hypersensitivity: rash, pruritus, discoloration, anaphylactoid-like reaction and hypersensitivity hepatitis. Hematologic: methemoglobinemia, hemolytic anemia, potential hemolytic agent in G-6-PD deficiency, sulfhemoglobinemia. Other: visual disturbances, renal and hepatic toxicity usually associated with overdose, renal calculi, jaundice, discoloration of body fluids and aseptic meningitis.",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Information for Patients The patient should be advised to take Phenazopyridine Hydrochloride with or following food or after eating a snack to reduce stomach upset. The patients should be aware that Phenazopyridine Hydrochloride causes a reddish orange discoloration of the urine and feces, and may stain clothing. Phenazopyridine Hydrochloride may cause discoloration of body fluids and staining of contact lenses has been reported. There have been reports of teeth discoloration when the product has been broken or held in the mouth prior to swallowing. Patients should be instructed to take Phenazopyridine Hydrochloride for only 2 days if an antibacterial agent is administered concurrently for the treatment of a urinary tract infection. If symptoms persist beyond those 2 days, the patient should be instructed to contact his or her physician.",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Phenazopyridine Hydrochloride",
  "manufacturer": "Proficient Rx LP",
  "application_number": "",
  "pharm_class_epc": [],
  "route": [
   "ORAL"
  ],
  "effective_time": "20240201",
  "set_id": "140a40f8-26ec-46ac-a04b-998ea96e8f93",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 4250,
  "serious": 2765,
  "death": 273,
  "hospitalization": 1242,
  "primary_suspect": 4241,
  "top_reactions": [
   [
    "Chronic Kidney Disease",
    405
   ],
   [
    "Fatigue",
    351
   ],
   [
    "Urinary Tract Infection",
    339
   ],
   [
    "Nausea",
    319
   ],
   [
    "Pain",
    303
   ],
   [
    "Acute Kidney Injury",
    283
   ],
   [
    "Diarrhoea",
    275
   ],
   [
    "Renal Failure",
    249
   ],
   [
    "Off Label Use",
    233
   ],
   [
    "Headache",
    222
   ],
   [
    "Vomiting",
    196
   ],
   [
    "Drug Ineffective",
    174
   ],
   [
    "Anxiety",
    169
   ],
   [
    "Dizziness",
    162
   ],
   [
    "Dyspnoea",
    152
   ]
  ],
  "by_year": {
   "2019": 453,
   "2020": 417,
   "2021": 285,
   "2022": 282,
   "2023": 243,
   "2024": 210,
   "2025": 409,
   "2026": 153
  },
  "by_year_primary": {
   "2019": 453,
   "2020": 417,
   "2021": 284,
   "2022": 281,
   "2023": 238,
   "2024": 210,
   "2025": 408,
   "2026": 153
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20240528",
   "reason": "Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.",
   "firm": "Winder Laboratories, LLC",
   "status": "Completed"
  }
 ],
 "recall_total": 1,
 "drugsfda": {
  "applications": 0,
  "nda": 0,
  "anda": 0,
  "first_approval": "",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 0,
  "labeling_recent": 0,
  "sponsors": [],
  "unapproved": false,
  "first_approval_fmt": ""
 },
 "trials": {
  "total": 24,
  "completed": 14,
  "terminated": 3,
  "with_results": 8,
  "industry": 5,
  "phase3": 6,
  "results_share": 0.5714285714285714,
  "terminated_share": 0.125
 },
 "pubmed": {
  "rct": 15,
  "meta": 0,
  "recent_rct": 3,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "phenazopyridine",
   "Pyridium",
   "Azo Urinary Pain Relief",
   "Baridium",
   "Uricalm",
   "Uristat"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 54740,
  "beneficiaries": 42378,
  "spend": 457545.98,
  "by_brand": [
   {
    "brand": "Phenazopyridine HCl",
    "claims": 54387,
    "per_claim": 7.9519429275,
    "is_generic": true
   },
   {
    "brand": "Pyridium",
    "claims": 353,
    "per_claim": 71.001869688,
    "is_generic": false
   }
  ],
  "per_claim": 8.358530873218852
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "Death share in reports is near or below the FAERS average (0.7x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 27,
   "letter": "F",
   "why": [
    "15 randomized trials and 0 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 97,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 1 Class II, 0 Class III (-3)"
   ],
   "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": 40,
   "letter": "F",
   "why": [
    "No generic version approved: brand-only pricing (-30)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 75,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are chronic kidney disease, fatigue, urinary tract infection, nausea. How would we recognize and handle those?",
  "There is no generic. Is there an older generic in the same class that works as well for my situation?",
  "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.)"
 ]
}