{
 "query": "minoxidil",
 "ingredient": "minoxidil",
 "slug": "minoxidil",
 "rxcui": "6984",
 "brands": [
  "Regoxidine",
  "Rogaine"
 ],
 "names": [
  "minoxidil",
  "minoxidil sulfate"
 ],
 "classes": [
  {
   "id": "C02DC",
   "name": "Pyrimidine derivatives"
  }
 ],
 "alternatives": [],
 "label": {
  "route_mode": "TOPICAL",
  "route_counts": {
   "TOPICAL": 287,
   "ORAL": 26,
   "CUTANEOUS": 4,
   "EXTRACORPOREAL": 4
  },
  "boxed_warning": "",
  "indications_and_usage": "Use to regrow hair on the top of the scalp (vertex only, see pictures on side of this carton)",
  "contraindications": "",
  "warnings_and_cautions": "",
  "warnings": "Warnings For external use only. For use by men only. Extremely Flammable Avoid fire, flame, or smoking during and immediately following application. Do not Use if you are a woman your amount of hair loss is different than that shown on side of this carton or your hair loss is on the front of the scalp. 5% minoxidil topical foam is not intended for frontal baldness or receding hairline. you have no family history of hair loss your hair loss is sudden and/or patchy you do not know the reason for your hair loss you are under 18 years of age. Do not use on babies and children. your scalp is red, inflamed, infected, irritated, or painful you use other medicines on the scalp Ask a doctor before use if you have heart disease When using this product do not apply on other parts of the body avoid contact with the eyes. In case of accidental contact, rinse eyes with large amounts of cool tap water. some people have experienced changes in hair color and/or texture it takes time to regrow hair. Results may occur at 2 months with twice a day usage. For some men, you may need to use this product for at least 4 months before you see results. the amount of hair regrowth is different for each person...",
  "adverse_reactions": "",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Mens rogaine Minoxidil Unscented Formula",
  "manufacturer": "Kenvue Brands LLC",
  "application_number": "NDA021812",
  "pharm_class_epc": [
   "Arteriolar Vasodilator [EPC]"
  ],
  "route": [
   "TOPICAL"
  ],
  "effective_time": "20241111",
  "set_id": "1b5e2860-6855-4a65-8bbc-e064172a1adf",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 66040,
  "serious": 4493,
  "death": 349,
  "hospitalization": 1719,
  "primary_suspect": 66025,
  "top_reactions": [
   [
    "Drug Ineffective",
    10687
   ],
   [
    "Adverse Drug Reaction",
    8614
   ],
   [
    "Alopecia",
    7594
   ],
   [
    "Product Use Issue",
    5463
   ],
   [
    "Off Label Use",
    5232
   ],
   [
    "Application Site Pruritus",
    3809
   ],
   [
    "Product Use In Unapproved Indication",
    2684
   ],
   [
    "Intentional Product Misuse",
    2583
   ],
   [
    "Pruritus",
    2545
   ],
   [
    "Overdose",
    2435
   ],
   [
    "Hair Texture Abnormal",
    2375
   ],
   [
    "Incorrect Dose Administered",
    2279
   ],
   [
    "Inappropriate Schedule Of Drug Administration",
    2135
   ],
   [
    "Wrong Technique In Product Usage Process",
    2080
   ],
   [
    "Inappropriate Schedule Of Product Administration",
    1996
   ]
  ],
  "by_year": {
   "2019": 4434,
   "2020": 5007,
   "2021": 7299,
   "2022": 9525,
   "2023": 7194,
   "2024": 4864,
   "2025": 3728,
   "2026": 1325
  },
  "by_year_primary": {
   "2019": 4434,
   "2020": 5007,
   "2021": 7295,
   "2022": 9522,
   "2023": 7190,
   "2024": 4862,
   "2025": 3727,
   "2026": 1324
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 37,
  "nda": 4,
  "anda": 28,
  "first_approval": "19791018",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 40,
  "labeling_recent": 3,
  "sponsors": [
   "APOTEX INC",
   "AUROBINDO PHARMA",
   "AUROBINDO PHARMA LTD",
   "AVACOR PRODS",
   "BAUSCH AND LOMB",
   "COPLEY PHARM",
   "HIKMA",
   "KENVUE BRANDS"
  ],
  "unapproved": false,
  "first_approval_fmt": "10/18/1979"
 },
 "trials": {
  "total": 111,
  "completed": 51,
  "terminated": 5,
  "with_results": 11,
  "industry": 41,
  "phase3": 22,
  "results_share": 0.21568627450980393,
  "terminated_share": 0.04504504504504504
 },
 "pubmed": {
  "rct": 151,
  "meta": 35,
  "recent_rct": 47,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "minoxidil",
   "Regoxidine",
   "Rogaine"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 603619,
  "beneficiaries": 178019,
  "spend": 8810706.88,
  "by_brand": [
   {
    "brand": "Minoxidil",
    "claims": 603619,
    "per_claim": 14.596470423,
    "is_generic": true
   }
  ],
  "per_claim": 14.59647042256788
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 9913,
  "fills": 603619,
  "per_million": 16422.610951610204,
  "ratio": 5.930989151799935,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 80,
   "letter": "B",
   "why": [
    "16,423 FDA reports naming it as the suspect drug per million Medicare fills, 5.9x the median drug on this site (-15)",
    "Death share in reports is near or below the FAERS average (0.1x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 46,
   "letter": "F",
   "why": [
    "151 randomized trials and 35 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 22% 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": 96,
   "letter": "A",
   "why": [
    "No recalls on record since 2016",
    "3 label changes approved since 2021 (-4)"
   ],
   "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 (28 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 76,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are adverse drug reaction, alopecia, product use issue. 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?",
  "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.)"
 ]
}