{
 "query": "isotretinoin",
 "ingredient": "isotretinoin",
 "slug": "isotretinoin",
 "rxcui": "6064",
 "brands": [
  "Claravis",
  "Zenatane",
  "Amnesteem",
  "Accutane",
  "Absorica",
  "Myorisan",
  "Sotret"
 ],
 "names": [
  "isotretinoin"
 ],
 "classes": [
  {
   "id": "D10AD",
   "name": "Retinoids for topical use in acne"
  },
  {
   "id": "D10BA",
   "name": "Retinoids for treatment of acne"
  }
 ],
 "alternatives": [
  "adapalene",
  "tretinoin",
  "trifarotene",
  "vitamin a"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 19
  },
  "boxed_warning": "WARNING: EMBRYO-FETAL TOXICITY \u2013 CONTRAINDICATED IN PREGNANCY Isotretinoin capsules can cause severe life-threatening birth defects and is contraindicated in pregnancy. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking any amount of isotretinoin capsules even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining prenatally whether an exposed fetus has been affected. If pregnancy occurs, discontinue isotretinoin capsules immediately and refer the patient to an Obstetrician- Gynecologist experienced in reproductive toxicity for further evaluation and counseling [see Contraindications (4) , Warnings and Precautions (5.1) , and Use in Specific Populations (8.1) ]. Because of the risk of embryo-fetal toxicity, isotretinoin capsules are available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the iPLEDGE REMS [see Warnings and Precautions (5.2) ] . WARNING: EMBRYO-FETAL TOXICITY \u2013 CONTRAINDICATED IN PREGNANCY See full prescribing information for complete boxed warning. Isotretinoin capsules can cause life-thr...",
  "indications_and_usage": "Isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, isotretinoin capsules are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use : If a second course of isotretinoin capsules therapy is needed, it is not recommended before a two-month waiting period because the patient\u2019s acne may continue to improve following a 15 to 20-week course of therapy [see Dosage and Administration (2.2) ]. Isotretinoin capsules are retinoids indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, isotretinoin capsules are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. (1) Limitations of Use: If a second course of isotretinoi...",
  "contraindications": "Pregnancy ( 4.1 , 8.1 ) Hypersensitivity to this product or any of its components ( 4.2 , 5.14 ) 4.1 Pregnancy Isotretinoin capsules are contraindicated in pregnancy [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ]. 4.2 Hypersensitivity Isotretinoin capsules are contraindicated in patients with hypersensitivity to isotretinoin (or Vitamin A, given the chemical similarity to isotretinoin) or to any of its components (anaphylaxis and other allergic reactions have occurred) [see Warnings and Precautions (5.14) ] .",
  "warnings_and_cautions": "Psychiatric Disorders (depression, psychosis, suicidal thoughts and behavior, and aggressive and/or violent behaviors): Prior to and during therapy assess for these conditions; stop if these conditions occur on therapy (5.4) Intracranial Hypertension (Pseudotumor Cerebri) : Avoid use with concomitant tetracyclines (5.5) Serious Skin Reactions : Monitor for Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious skin reactions (5.6) Acute Pancreatitis : If occurs, discontinue treatment (5.7) Lipid Abnormalities (hypertriglyceridemia, low HDL, and elevation of cholesterol): Monitor lipid levels at regular intervals; stop if hypertriglyceridemia cannot be controlled (5.8) Hearing Impairment : Discontinue and refer to specialized care (5.9) Hepatotoxicity : Monitor liver function tests prior to and during therapy (5.10 , 5.15) Inflammatory Bowel Disease : Discontinue for abdominal pain, rectal bleeding, or severe diarrhea (5.11) Musculoskeletal Abnormalities : Arthralgias, back pain, decreases in bone mineral density and premature epiphyseal closure (5.12) Ocular Abnormalities e.g., corneal opacities, decreased night vision: If visual symptoms occur, discont...",
  "warnings": "",
  "adverse_reactions": "The following adverse reactions with isotretinoin capsules or other isotretinoin capsule products are described in more detail in other sections of the labeling: Embryo-Fetal Toxicity [see Warnings and Precautions ( 5.1 )] Psychiatric Disorders [see Warnings and Precautions ( 5.4 )] Intracranial Hypertension (Pseudotumor Cerebri) [see Warnings and Precautions ( 5.5 )] Serious Skin Reactions [see Warnings and Precautions ( 5.6 )] Pancreatitis [see Warnings and Precautions ( 5.7 )] Lipid Abnormalities [see Warnings and Precautions ( 5.8 )] Hearing Impairment [see Warnings and Precautions ( 5.9 )] Hepatotoxicity [see Warnings and Precautions ( 5.10 )] Inflammatory Bowel Disease [see Warnings and Precautions ( 5.11 )] Musculoskeletal Abnormalities [see Warnings and Precautions ( 5.12 )] Ocular Abnormalities [see Warnings and Precautions ( 5.13 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.14 )] The following adverse reactions associated with the use of isotretinoin capsules were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably es...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Advise the patient to read the FDA-approved patient labeling (Medication Guide). Embryo-Fetal Toxicity There is an extremely high risk of severe birth defects when isotretinoin capsules are used in pregnancy [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] . Instruct patients who can become pregnant that they must not be pregnant during or up to one month after isotretinoin capsules therapy. Instruct patients to not donate blood during isotretinoin capsules therapy and for 1 month following discontinuation to avoid blood donation to a pregnant patient. iPLEDGE Isotretinoin capsules are available only through a restricted program called iPLEDGE [see Warnings and Precautions (5.2) ] . Inform patients who can become pregnant of the following notable requirements. These patients must: Sign an informed consent form to be enrolled in the program Comply with the pregnancy testing and contraception requirements [see Use in Specific Populations (8.3) ] Demonstrate comprehension of the safe-use conditions of the program every month Obtain the prescription within 7 days of the pregnancy test collection Inform patients who cannot become pregnant of the following nota...",
  "spl_medguide": "Medication Guide Isotretinoin (EYE so TRET i noyn) Capsules, USP Read the Medication Guide that comes with isotretinoin capsules before you start taking it and each time you get a prescription. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. What is the most important information I should know about isotretinoin capsules? Isotretinoin capsules can harm your unborn baby, including birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby, and early (premature) births. Patients who are pregnant or who plan to become pregnant must not take isotretinoin capsules. Patients must not get pregnant: for 1 month before starting isotretinoin capsules during treatment with isotretinoin capsules for 1 month after stopping isotretinoin capsules If you get pregnant during treatment with isotretinoin capsules, stop taking it right away and call your healthcare provider. Healthcare providers and patients should report all cases of pregnancy during treatment or 1 month after stopping treatment to: FDA MedWatch at 1-800-FDA-1088, and the iPLEDGE Pregnancy...",
  "clinical_studies": "The effectiveness of isotretinoin capsules for the treatment of severe recalcitrant nodular acne in patients 12 years of age and older has been established and is based on a double-blind, randomized, parallel group trial (Study 1) in subjects with severe recalcitrant nodular acne who received isotretinoin capsules or another isotretinoin capsule product under fed conditions. A total of 925 subjects were randomized 1:1 to receive isotretinoin capsules or another isotretinoin capsule product. Study subjects ranged from 12 to 54 years of age (including 397 pediatric subjects 12 to 17 years old); 60% were male, 40% were female; and the racial groups included 87% White, 4% Black, 6% Asian, and 3% Other. Enrolled subjects had a weight of 40 to 110 kg and had at least 10 nodular lesions on the face and/or trunk. Subjects were treated with an initial dose of 0.5 mg/kg/day in two divided doses for the first 4 weeks, followed by 1 mg/kg/day in two divided doses for the following 16 weeks. Change from baseline to Week 20 in total nodular lesion count and proportion of subjects with at least a 90% reduction in total nodular lesion count from baseline to Week 20 are presented in Table 3. Total ...",
  "brand_name": "Isotretinoin",
  "manufacturer": "Sun Pharmaceutical Industries, Inc.",
  "application_number": "NDA021951",
  "pharm_class_epc": [
   "Retinoid [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20240110",
  "set_id": "b44200ba-6672-4ea7-b151-7caec3f53c9c",
  "has_boxed_warning": true,
  "controlled": false,
  "mentions_rems": true
 },
 "faers": {
  "total": 39419,
  "serious": 16523,
  "death": 353,
  "hospitalization": 1815,
  "primary_suspect": 39404,
  "top_reactions": [
   [
    "Depression",
    3242
   ],
   [
    "Exposure During Pregnancy",
    2038
   ],
   [
    "Dry Skin",
    1897
   ],
   [
    "Off Label Use",
    1892
   ],
   [
    "Headache",
    1867
   ],
   [
    "Product Dose Omission Issue",
    1820
   ],
   [
    "Arthralgia",
    1806
   ],
   [
    "Adverse Drug Reaction",
    1556
   ],
   [
    "Mood Altered",
    1511
   ],
   [
    "Drug Ineffective",
    1330
   ],
   [
    "Anxiety",
    1221
   ],
   [
    "Suicidal Ideation",
    1216
   ],
   [
    "Unintended Pregnancy",
    1078
   ],
   [
    "Lip Dry",
    1031
   ],
   [
    "Treatment Noncompliance",
    972
   ]
  ],
  "by_year": {
   "2019": 2687,
   "2020": 3606,
   "2021": 3372,
   "2022": 3888,
   "2023": 3591,
   "2024": 4481,
   "2025": 3822,
   "2026": 1637
  },
  "by_year_primary": {
   "2019": 2687,
   "2020": 3605,
   "2021": 3371,
   "2022": 3884,
   "2023": 3584,
   "2024": 4480,
   "2025": 3821,
   "2026": 1637
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20260406",
   "reason": "Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin",
   "firm": "Teva Pharmaceuticals USA, Inc",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260224",
   "reason": "Failed Dissolution Specifications",
   "firm": "MYLAN PHARMACEUTICALS INC",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260112",
   "reason": "Superpotent and Subpotent",
   "firm": "Teva Pharmaceuticals USA, Inc",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20260112",
   "reason": "Superpotent and Subpotent",
   "firm": "Teva Pharmaceuticals USA, Inc",
   "status": "Ongoing"
  },
  {
   "class": "Class II",
   "date": "20240328",
   "reason": "Superpotent Drug: The 3-month stability result for assay was found to be above specification limit",
   "firm": "Teva Pharmaceuticals USA, Inc",
   "status": "Ongoing"
  },
  {
   "class": "Class III",
   "date": "20191016",
   "reason": "Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.",
   "firm": "Amneal Pharmaceuticals, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class III",
   "date": "20181207",
   "reason": "Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.",
   "firm": "Sun Pharmaceutical Industries, Inc.",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20150626",
   "reason": "Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.",
   "firm": "Ranbaxy Inc.",
   "status": "Terminated"
  }
 ],
 "recall_total": 8,
 "drugsfda": {
  "applications": 19,
  "nda": 3,
  "anda": 16,
  "first_approval": "19820507",
  "rems": true,
  "rems_last": "20261007",
  "labeling_supplements": 46,
  "labeling_recent": 9,
  "sponsors": [
   "ACTAVIS LABS FL",
   "AMNEAL PHARMS NY",
   "AUROBINDO PHARMA",
   "AUROBINDO PHARMA LTD",
   "DR REDDYS LABS LTD",
   "HOFFMANN LA ROCHE",
   "MYLAN PHARMS INC",
   "SUN PHARM"
  ],
  "unapproved": false,
  "first_approval_fmt": "05/07/1982"
 },
 "trials": {
  "total": 214,
  "completed": 124,
  "terminated": 26,
  "with_results": 42,
  "industry": 36,
  "phase3": 34,
  "results_share": 0.3387096774193548,
  "terminated_share": 0.12149532710280374
 },
 "pubmed": {
  "rct": 158,
  "meta": 55,
  "recent_rct": 40,
  "cochrane": [
   {
    "pmid": "30484286",
    "title": "Oral isotretinoin for acne",
    "year": "2018"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "isotretinoin",
   "Claravis",
   "Zenatane",
   "Amnesteem",
   "Accutane",
   "Absorica",
   "Myorisan",
   "Sotret"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 17187,
  "beneficiaries": 6848,
  "spend": 2989306.4400000004,
  "by_brand": [
   {
    "brand": "Isotretinoin",
    "claims": 7711,
    "per_claim": 197.42512126,
    "is_generic": true
   },
   {
    "brand": "Claravis",
    "claims": 4013,
    "per_claim": 147.71268129,
    "is_generic": false
   },
   {
    "brand": "Zenatane",
    "claims": 3444,
    "per_claim": 157.58078978,
    "is_generic": false
   },
   {
    "brand": "Amnesteem",
    "claims": 1519,
    "per_claim": 145.79728111,
    "is_generic": false
   },
   {
    "brand": "Accutane",
    "claims": 476,
    "per_claim": 146.71466387,
    "is_generic": false
   },
   {
    "brand": "Absorica",
    "claims": 24,
    "per_claim": 1674.1604167,
    "is_generic": false
   }
  ],
  "per_claim": 173.92834351544775
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": "",
  "name": "",
  "matched": null,
  "stewardship": []
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 55,
   "letter": "D",
   "why": [
    "Carries an FDA boxed warning, the strongest warning the FDA issues (-30)",
    "Subject to a REMS safety program: FDA requires special controls to use it (-10)",
    "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": 59,
   "letter": "D",
   "why": [
    "158 randomized trials and 55 systematic reviews/meta-analyses indexed in PubMed",
    "1 independent Cochrane review(s) exist",
    "Only 34% of completed registered trials posted results (-15)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 75,
   "letter": "B",
   "why": [
    "Recalls since 2016: 0 Class I, 5 Class II, 2 Class III across 16 generic makers (-7)",
    "REMS program in force (-10)",
    "9 label changes approved since 2021: the safety story is still moving (-8)"
   ],
   "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 (16 applications)",
    "4 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 70,
 "grade": "C",
 "questions": [
  "This drug carries a boxed warning. Which specific risk does it cover, and does it apply to me?",
  "This drug has a REMS safety program. What monitoring does that require from us?",
  "The most-reported problems in FDA's adverse event data are depression, exposure during pregnancy, dry skin. 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, tretinoin, trifarotene? 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.)"
 ]
}