{
 "query": "tretinoin",
 "ingredient": "tretinoin",
 "slug": "tretinoin",
 "rxcui": "10753",
 "brands": [
  "Retin-A",
  "Altreno",
  "Atralin",
  "Avita",
  "Refissa",
  "Renova",
  "Tretin X"
 ],
 "names": [
  "tretinoin",
  "tretinoin microsphere"
 ],
 "classes": [
  {
   "id": "D10AD",
   "name": "Retinoids for topical use in acne"
  },
  {
   "id": "L01XF",
   "name": "Retinoids for cancer treatment"
  }
 ],
 "alternatives": [
  "adapalene",
  "alitretinoin",
  "bexarotene",
  "isotretinoin",
  "trifarotene",
  "vitamin a"
 ],
 "label": {
  "route_mode": "TOPICAL",
  "route_counts": {
   "TOPICAL": 60,
   "ORAL": 5
  },
  "boxed_warning": "",
  "indications_and_usage": "Tretinoin Gel is indicated for topical treatment of acne vulgaris. Tretinoin Gel is a retinoid indicated for topical treatment of acne vulgaris. ( 1 )",
  "contraindications": "None. None ( 4 )",
  "warnings_and_cautions": "\u2022 Tretinoin Gel should not be used on eczematous or sunburned skin due to potential for severe irritation. ( 5.1 ) \u2022 Topical over-the-counter acne preparations, concomitant topical medications, medicated cleansers, topical products with alcohol or astringents: Use with caution, irritation may occur. ( 5.1 ) \u2022 Avoid unprotected exposure to sunlight including sunlamps (UV light) when using Tretinoin Gel due to potential for increased photosensitization. Use sunscreen of at least SPF 15 and protective clothing during exposure. ( 5.2 ) \u2022 Avoid use of Tretinoin Gel with weather extremes, such as wind or cold due to potential for increased irritation. ( 5.2 ) \u2022 Use Tretinoin Gel with caution if allergic to fish due to potential for allergenicity to fish protein. Patients who develop pruritus or urticaria should contact their healthcare provider. ( 5.3 ) 5.1 Skin Irritation The skin of certain individuals may become dry, red, or exfoliated while using Tretinoin Gel. If the degree of irritation warrants, patients should be directed to temporarily reduce the amount or frequency of application of the medication, discontinue use temporarily, or discontinue use all together. Efficacy at reduce...",
  "warnings": "",
  "adverse_reactions": "The most common adverse reactions (incidence \u22655%) with Tretinoin Gel are dry skin, peeling/scaling/flaking skin, skin burning sensation, and erythema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Obagi Cosmeceuticals LLC at 1-800-636-7546 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under prescribing conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two randomized, controlled trials, 674 subjects received treatment for up to 12 weeks with Tretinoin Gel [see Clinical Studies (14) ] .In these studies, 50% of the subjects who were treated with Tretinoin Gel reported one or more adverse reactions; 30% of the subjects reported treatment-related adverse reactions. In the vehicle group, 29% of the 487 randomized subjects reported at least one adverse reaction; 5% of the subjects reported events that were treatment-related. There were no serious, treatment-related adverse reactions reported by subjects in any of the treatment groups. Selected adverse r...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "See FDA-Approved Patient Labeling (Patient Information) Instruct patients to clean the affected areas with an appropriate cleanser before applying Tretinoin Gel. Patients may use moisturizers that are noncomedogenic and should avoid products that could be drying or irritating. Patients may also wear cosmetics while being treated with Tretinoin Gel; however, they should be instructed to remove the cosmetics and clean the area thoroughly before applying Tretinoin Gel. Warn patients of the drying and irritation effects often seen during treatment. Continue use of the medication if these effects are tolerable. Caution patients against application of Tretinoin Gel around the eyes, mouth, paranasal creases, and mucous membranes as the skin is especially prone to irritation. Minimize exposure to sunlight, including sunlamps. Recommend the use of sunscreen products and protective apparel (e.g., hat) when exposure cannot be avoided. Rx only Distributed by: Obagi Cosmeceuticals LLC Long Beach, CA 90806 All products/brand names, whether designated by notice or not (\u00ae/TM), are trademarks of Obagi Cosmeceuticals LLC and/or its affiliates. \u00a92021 Obagi Cosmeceuticals LLC. All rights reserved. www...",
  "spl_medguide": "",
  "clinical_studies": "The safety and efficacy of Tretinoin Gel used once daily before bedtime for the treatment of mild to moderate acne vulgaris were assessed in two 12-week prospective, multi-center, randomized, controlled trials. Subjects in these two trials ranged from 10 to 65 years of age, were approximately 52% female, 48% male, and were 74% Caucasian, 15% Black or African American, 3% Asian, and 8% Other. Efficacy results at Week 12 are presented in Table 3. Success on the 6-point Global Severity Score is defined as a score of 0 (clear) or 1 (very mild). In Trial 2, subjects were also required to have at least two grades reduction from baseline for success. 'Very mild' acne is defined as: skin almost clear; rare non-inflammatory lesions present, with rare non-inflamed papules (papules may be hyperpigmented, though not pink-red, less than 4 lesions). The database was not large enough to assess whether there were differences in effects in age, gender, or race subgroups. Table 3: Efficacy Results at Week 12 in Trials 1 and 2 Trial 1 Tretinoin Gel N=375 Vehicle N=185 Global Severity Score Success Success was defined as 0 (clear) or 1 (very mild) 78 (21%) 23 (12%) Non-Inflammatory Facial Lesions Mean...",
  "brand_name": "Tretinoin",
  "manufacturer": "Obagi Cosmeceuticals LLC",
  "application_number": "NDA022070",
  "pharm_class_epc": [
   "Retinoid [EPC]"
  ],
  "route": [
   "TOPICAL"
  ],
  "effective_time": "20210501",
  "set_id": "c5ee36ac-2ffd-4cca-ad47-b1dae7ebdb3b",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 8324,
  "serious": 4811,
  "death": 806,
  "hospitalization": 1639,
  "primary_suspect": 8311,
  "top_reactions": [
   [
    "Off Label Use",
    1000
   ],
   [
    "Drug Ineffective",
    865
   ],
   [
    "Product Use In Unapproved Indication",
    610
   ],
   [
    "Pain",
    531
   ],
   [
    "Vomiting",
    479
   ],
   [
    "Rash",
    438
   ],
   [
    "Nausea",
    428
   ],
   [
    "Headache",
    421
   ],
   [
    "Diarrhoea",
    412
   ],
   [
    "Paraesthesia",
    389
   ],
   [
    "Abdominal Pain Upper",
    363
   ],
   [
    "Hypoaesthesia",
    358
   ],
   [
    "Fatigue",
    353
   ],
   [
    "Drug Intolerance",
    346
   ],
   [
    "Maternal Exposure During Pregnancy",
    343
   ]
  ],
  "by_year": {
   "2019": 649,
   "2020": 634,
   "2021": 609,
   "2022": 613,
   "2023": 690,
   "2024": 793,
   "2025": 914,
   "2026": 419
  },
  "by_year_primary": {
   "2019": 649,
   "2020": 634,
   "2021": 609,
   "2022": 608,
   "2023": 686,
   "2024": 790,
   "2025": 914,
   "2026": 418
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class III",
   "date": "20260925",
   "reason": "Failed Impurities/Degradation Specifications",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20260925",
   "reason": "Failed Impurities/Degradation Specifications",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20260925",
   "reason": "Failed Impurities/Degradation Specifications",
   "firm": "SUN PHARMACEUTICAL INDUSTRIES INC",
   "status": "Ongoing"
  }
 ],
 "recall_total": 3,
 "drugsfda": {
  "applications": 47,
  "nda": 14,
  "anda": 33,
  "first_approval": "19711020",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 59,
  "labeling_recent": 3,
  "sponsors": [
   "ALEMBIC",
   "ALLERGAN",
   "AMNEAL",
   "AUROBINDO PHARMA LTD",
   "BARR LABS INC",
   "BAUSCH",
   "CHEPLAPHARM",
   "DOW PHARM"
  ],
  "unapproved": false,
  "first_approval_fmt": "10/20/1971"
 },
 "trials": {
  "total": 406,
  "completed": 224,
  "terminated": 51,
  "with_results": 97,
  "industry": 117,
  "phase3": 82,
  "results_share": 0.4330357142857143,
  "terminated_share": 0.12561576354679804
 },
 "pubmed": {
  "rct": 190,
  "meta": 6,
  "recent_rct": 18,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 2158.42,
  "records": 5,
  "by_name": [
   [
    "Altreno",
    2158.42
   ]
  ],
  "names_checked": [
   "tretinoin",
   "Retin-A",
   "Altreno",
   "Atralin",
   "Avita",
   "Refissa",
   "Renova",
   "Tretin X"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 268282,
  "beneficiaries": 131046,
  "spend": 22244034.400000002,
  "by_brand": [
   {
    "brand": "Tretinoin",
    "claims": 235091,
    "per_claim": 89.910786887,
    "is_generic": true
   },
   {
    "brand": "Retin-A",
    "claims": 32166,
    "per_claim": 31.268471678,
    "is_generic": false
   },
   {
    "brand": "Altreno",
    "claims": 1009,
    "per_claim": 91.298622398,
    "is_generic": false
   },
   {
    "brand": "Atralin",
    "claims": 16,
    "per_claim": 557.226875,
    "is_generic": false
   }
  ],
  "per_claim": 82.91288420393468
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 2122,
  "fills": 268282,
  "per_million": 7909.587672672785,
  "ratio": 2.8565298672701727,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 86,
   "letter": "B",
   "why": [
    "7,910 FDA reports naming it as the suspect drug per million Medicare fills, 2.9x the median drug on this site (-9)",
    "Death share in reports is near or below the FAERS average (1.1x)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 50,
   "letter": "D",
   "why": [
    "190 randomized trials and 6 systematic reviews/meta-analyses indexed in PubMed",
    "No Cochrane review found (-5)",
    "Only 43% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 95,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 0 Class II, 3 Class III across 33 generic makers (-1)",
    "3 label changes approved since 2021 (-4)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $2,158 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 (33 applications)",
    "6 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 82,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are product use in unapproved indication, pain. 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 adapalene, alitretinoin, bexarotene? 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.)"
 ]
}