{
 "query": "hydroquinone",
 "ingredient": "hydroquinone",
 "slug": "hydroquinone",
 "rxcui": "5509",
 "brands": [],
 "names": [
  "hydroquinone"
 ],
 "classes": [],
 "alternatives": [],
 "label": {
  "route_mode": "TOPICAL",
  "route_counts": {
   "TOPICAL": 15,
   "ORAL": 1
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS AND USAGE Hydroquinone USP, 4% Skin Bleaching Cream is indicated for the gradual bleaching of hyperpigmented skin conditions such as chloasma, melasma, freckles, senile lentigines, and other unwanted areas of melanin hyperpigmentation.",
  "contraindications": "CONTRAINDICATIONS Prior history of sensitivity or allergic reaction to hydroquinone or to any of the ingredients of the product. The safety of topical hydroquinone use during pregnancy or for children (12 years and under) has not been established.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people. Since this product contains no sunscreen, an effective broad spectrum sun-blocking agent should be used and unnecessary solar exposure avoided, or protective clothing should be worn to cover bleached skin in order to prevent repigmentation from occurring. Hydroquinone may produce exogenous ochronosis, a gradual blue-black darkening of the skin. If this condition occurs, discontinue treatment and consult your physician. The majority of patients developing this condition are Black, but it may also occur in Caucasians and Hispanics.",
  "adverse_reactions": "ADVERSE REACTIONS The following adverse reactions have been reported: dryness and fissuring of paranasal and intraorbital areas, erythema, and stinging. Occasional hypersensitivity (localized contact dermatitis) may develop. If this occurs, the medication should be discontinued and the physician notified immediately.",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Information for Patients Sunscreen use is an essential aspect of hydroquinone therapy because even minimal sunlight sustains melanocytic activity. To prevent repigmentation, during treatment and maintenance therapy, sun exposure on treated skin should be avoided by application of a broad spectrum sunscreen (SPF 15 or greater) or by use of protective clothing. Avoid contact with eyes and mucous membranes. Keep this and all medications out of reach of children. In case of accidental ingestion, call a physician or a poison control center immediately.",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Hydroquinone 4%",
  "manufacturer": "SOHM, Inc.",
  "application_number": "",
  "pharm_class_epc": [
   "Melanin Synthesis Inhibitor [EPC]"
  ],
  "route": [
   "TOPICAL"
  ],
  "effective_time": "20230605",
  "set_id": "47f0cbfb-b73b-4572-95d2-992c7382df3a",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 1415,
  "serious": 352,
  "death": 19,
  "hospitalization": 80,
  "primary_suspect": 1415,
  "top_reactions": [
   [
    "Drug Ineffective",
    383
   ],
   [
    "Acne",
    252
   ],
   [
    "Dry Skin",
    219
   ],
   [
    "Erythema",
    153
   ],
   [
    "Skin Burning Sensation",
    151
   ],
   [
    "Skin Irritation",
    136
   ],
   [
    "Inappropriate Schedule Of Product Administration",
    112
   ],
   [
    "Skin Exfoliation",
    100
   ],
   [
    "Pruritus",
    96
   ],
   [
    "Product Use In Unapproved Indication",
    95
   ],
   [
    "Overdose",
    88
   ],
   [
    "Rash",
    88
   ],
   [
    "Skin Hyperpigmentation",
    67
   ],
   [
    "Condition Aggravated",
    64
   ],
   [
    "Pain Of Skin",
    45
   ]
  ],
  "by_year": {
   "2019": 217,
   "2020": 374,
   "2021": 270,
   "2022": 49,
   "2023": 55,
   "2024": 50,
   "2025": 57,
   "2026": 23
  },
  "by_year_primary": {
   "2019": 217,
   "2020": 374,
   "2021": 270,
   "2022": 49,
   "2023": 55,
   "2024": 50,
   "2025": 57,
   "2026": 23
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20210923",
   "reason": "Finished product specification did not meet USP specifications.",
   "firm": "Monarch PCM, LLC",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20210901",
   "reason": "Subpotency: one product for active ingredient assay and another one for preservative assay",
   "firm": "Monarch PCM, LLC",
   "status": "Terminated"
  }
 ],
 "recall_total": 2,
 "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": 60,
  "completed": 37,
  "terminated": 3,
  "with_results": 4,
  "industry": 25,
  "phase3": 9,
  "results_share": 0.10810810810810811,
  "terminated_share": 0.05
 },
 "pubmed": {
  "rct": 71,
  "meta": 1,
  "recent_rct": 20,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "hydroquinone"
  ],
  "source": "bulk-index"
 },
 "partd": null,
 "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 (0.1x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 23,
   "letter": "F",
   "why": [
    "71 randomized trials and 1 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 11% 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": [
    "Recalls since 2016: 0 Class I, 1 Class II, 1 Class III (-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": 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": 74,
 "grade": "C",
 "questions": [
  "The most-reported problems in FDA's adverse event data are acne, dry skin, erythema. 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.)"
 ]
}