{
 "query": "clotrimazole",
 "ingredient": "clotrimazole",
 "slug": "clotrimazole",
 "rxcui": "2623",
 "brands": [
  "Alevazol",
  "Clotic",
  "Cruex Antifungal",
  "Fungicure Solution",
  "Lasolex Liquid",
  "Lotrimin",
  "Trimazole"
 ],
 "names": [
  "clotrimazole"
 ],
 "classes": [
  {
   "id": "A01AB",
   "name": "Antiinfectives and antiseptics for local oral treatment"
  },
  {
   "id": "D01AC",
   "name": "Imidazole and triazole derivatives"
  },
  {
   "id": "G01AF",
   "name": "Imidazole derivatives"
  }
 ],
 "alternatives": [
  "amphotericin b",
  "benzoxonium chloride",
  "bifonazole",
  "butoconazole",
  "chlorhexidine",
  "chlortetracycline",
  "domiphen",
  "doxycycline",
  "econazole",
  "efinaconazole",
  "fenticonazole",
  "fluconazole",
  "flutrimazole",
  "hexetidine",
  "hydrogen peroxide",
  "isoconazole",
  "ketoconazole",
  "luliconazole",
  "metronidazole",
  "miconazole",
  "minocycline",
  "natamycin",
  "neomycin",
  "octenidine",
  "omoconazole",
  "ornidazole",
  "oxiconazole",
  "oxyquinoline",
  "oxytetracycline",
  "polynoxylin",
  "sertaconazole",
  "sodium perborate",
  "sulconazole",
  "tetracycline",
  "thiabendazole",
  "tibezonium iodide",
  "tinidazole",
  "tioconazole"
 ],
 "label": {
  "route_mode": "TOPICAL",
  "route_counts": {
   "TOPICAL": 213,
   "VAGINAL": 18,
   "ORAL": 3,
   "AURICULAR (OTIC)": 1,
   "CUTANEOUS": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS AND USAGE Prescription Clotrimazole Topical Solution product is indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur . This formulation is also available as a nonprescription product which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes , Epidermophyton fluoccosum , and Microsporum canis .",
  "contraindications": "CONTRAINDICATIONS Topical antifungal agents are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS Clotrimazole Topical Solution is not for ophthalmic use.",
  "adverse_reactions": "ADVERSE REACTIONS The following adverse reactions have been reported in connection with the use of clotrimazole: erythema, stinging, blistering, peeling, edema, pruritius, urticaria, burning, and general irritation of the skin. To report SUSPECTED ADVERSE REACTIONS, contact ScieGen Pharmaceuticals, Inc. at 1-855-724-3436 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Information for Patient This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects. The patient should be advised to: Use the medication for the full treatment time even though the symptoms may have improved. Notify the physician if there is no improvement after 4 weeks of treatment. Inform the physician if the area of application shows signs of increased irritation (redness, itching, burning, blistering, swelling, oozing) indicative of possible sensitization. Avoid sources of infection or reinfection.",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Clotrimazole Topical Solution USP, 1%",
  "manufacturer": "ScieGen Pharmaceuticals, Inc",
  "application_number": "ANDA216569",
  "pharm_class_epc": [
   "Azole Antifungal [EPC]"
  ],
  "route": [
   "TOPICAL"
  ],
  "effective_time": "20260430",
  "set_id": "15368c2a-572f-41fb-a3a1-7b1eb842faa8",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 11298,
  "serious": 8391,
  "death": 802,
  "hospitalization": 3673,
  "primary_suspect": 11221,
  "top_reactions": [
   [
    "Drug Ineffective",
    1439
   ],
   [
    "Macular Degeneration",
    816
   ],
   [
    "Nausea",
    795
   ],
   [
    "Off Label Use",
    793
   ],
   [
    "Headache",
    741
   ],
   [
    "Pain",
    736
   ],
   [
    "Dyspnoea",
    657
   ],
   [
    "Fatigue",
    642
   ],
   [
    "Diarrhoea",
    588
   ],
   [
    "Pyrexia",
    491
   ],
   [
    "Malaise",
    481
   ],
   [
    "Acute Kidney Injury",
    464
   ],
   [
    "Therapeutic Product Effect Incomplete",
    448
   ],
   [
    "Weight Decreased",
    445
   ],
   [
    "Anxiety",
    440
   ]
  ],
  "by_year": {
   "2019": 1194,
   "2020": 1011,
   "2021": 1139,
   "2022": 968,
   "2023": 943,
   "2024": 1048,
   "2025": 1055,
   "2026": 396
  },
  "by_year_primary": {
   "2019": 1191,
   "2020": 1008,
   "2021": 1134,
   "2022": 945,
   "2023": 921,
   "2024": 1036,
   "2025": 1049,
   "2026": 393
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20251031",
   "reason": "cGMP deviations",
   "firm": "Blossom Pharmaceuticals",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20251031",
   "reason": "cGMP deviations",
   "firm": "Blossom Pharmaceuticals",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20201117",
   "reason": "Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.",
   "firm": "Taro Pharmaceuticals U.S.A., Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20201117",
   "reason": "Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.",
   "firm": "Taro Pharmaceuticals U.S.A., Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20201117",
   "reason": "Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.",
   "firm": "Taro Pharmaceuticals U.S.A., Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20201117",
   "reason": "Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.",
   "firm": "Taro Pharmaceuticals U.S.A., Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20201117",
   "reason": "Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.",
   "firm": "Taro Pharmaceuticals U.S.A., Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20201117",
   "reason": "Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.",
   "firm": "Taro Pharmaceuticals U.S.A., Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 8,
 "drugsfda": {
  "applications": 35,
  "nda": 21,
  "anda": 14,
  "first_approval": "19750203",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 55,
  "labeling_recent": 0,
  "sponsors": [
   "BAYER HEALTHCARE LLC",
   "BAYER HLTHCARE",
   "BAYER PHARMS",
   "CARWIN PHARM ASSOC",
   "ENCUBE",
   "FOUGERA PHARMS",
   "GLENMARK PHARMS",
   "HIKMA"
  ],
  "unapproved": false,
  "first_approval_fmt": "02/03/1975"
 },
 "trials": {
  "total": 155,
  "completed": 89,
  "terminated": 17,
  "with_results": 27,
  "industry": 70,
  "phase3": 32,
  "results_share": 0.30337078651685395,
  "terminated_share": 0.10967741935483871
 },
 "pubmed": {
  "rct": 132,
  "meta": 2,
  "recent_rct": 10,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "clotrimazole",
   "Alevazol",
   "Clotic",
   "Cruex Antifungal",
   "Fungicure Solution",
   "Lasolex Liquid",
   "Lotrimin",
   "Trimazole"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 1066616,
  "beneficiaries": 601383,
  "spend": 22032789.76,
  "by_brand": [
   {
    "brand": "Clotrimazole",
    "claims": 1066616,
    "per_claim": 20.656721594,
    "is_generic": true
   }
  ],
  "per_claim": 20.65672159427573
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "clotrimazole",
  "matched": "clotrimazole",
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 2478,
  "fills": 1066616,
  "per_million": 2323.2353536793,
  "ratio": 0.8390312429826513,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 95,
   "letter": "A",
   "why": [
    "2,323 FDA reports naming it as the suspect drug per million Medicare fills, 0.8x the median drug on this site",
    "Death share in reports is near or below the FAERS average (0.8x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 30,
   "letter": "F",
   "why": [
    "132 randomized trials and 2 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "No Cochrane review found (-5)",
    "Only 30% of completed registered trials posted results (-15)",
    "'Drug ineffective' is the single most-reported item about this drug in FAERS (-5)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 94,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 8 Class II, 0 Class III across 14 generic makers (-6)"
   ],
   "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": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (14 applications)",
    "38 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 80,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are macular degeneration, nausea. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "Why this one over amphotericin b, benzoxonium chloride, bifonazole? What would make you pick one of those instead?",
  "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.)"
 ]
}