pharmacopeia
GET
/api/v1/drug/isotretinoin

Boxed warning

AND WARNINGS Isotretinoin capsules must not be used by patients who are or may become pregnant. There is an extremely high risk that life-threatening birth defects will result if pregnancy occurs while taking isotretinoin capsules in any amount, even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected. Birth defects which have been documented following isotretinoin capsules exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. Cases of IQ scores less than 85 with or without other abnormalities have been reported. There is an increased risk of spontaneous abortion, and premature births have been reported. Documented external abnormalities include: skull abnormality; ear abnormalities (including anotia, micropinna, small or absent external auditory canals); eye abnormalities (including microphthalmia); facial dysmorphia; cleft palate. Documented internal abnormalities include: CNS abnormalities (including cerebral abnormalities, cerebellar malformation, hydrocephalus, microcephaly, cranial nerve deficit); cardiovascular abnormalities; thymus gland abnormality; parathyroid hormone deficiency.

2D structure
(2Z,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona-2,4,6,8-tetraenoic acid
SMILES CC1=C(C(CCC1)(C)C)/C=C/C(=C/C=C/C(=C\C(=O)O)/C)/C
InChIKey SHGAZHPCJJPHSC-XFYACQKRSA-N

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Receptor Interactions; Unknown Cellular or Molecular Interaction.

Indications

Sourced from openFDA
  • Severe Recalcitrant Nodular Acne Isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater.ICD-10: L70.0

Contraindications

Sourced from openFDA
  • Pregnancy Category X See Boxed CONTRAINDICATIONS AND WARNINGS . Allergic Reactions Isotretinoin capsules are contraindicated in patients who are hypersensitive to this medication or to any of its components (see PRECAUTIONS: Hypersensitivity ).contraindicated

Dosage & administration

Sourced from openFDA

Isotretinoin capsules should be administered with a meal (see PRECAUTIONS: Information for Patients ). The recommended dosage range for isotretinoin capsules are 0.5 to 1 mg/kg/day given in two divided doses with food for 15 to 20 weeks. In studies comparing 0.1, 0.5, and 1 mg/kg/day 8 , it was found that all dosages provided initial clearing of disease, but there was a greater need for retreatment with the lower dosages. During treatment, the dose may be adjusted according to response of the disease and/or the appearance of clinical side effects – some of which may be dose related. Adult patients whose disease is very severe with scarring or is primarily manifested on the trunk may require dose adjustments up to 2 mg/kg/day, as tolerated. Failure to take isotretinoin capsules with food will significantly decrease absorption. Before upward dose adjustments are made, the patients should be questioned about their compliance with food instructions. The safety of once daily dosing with isotretinoin capsules have not been established. Once daily dosing is not recommended. If the total nodule count has been reduced by more than 70% prior to completing 15 to 20 weeks of treatment, the drug may be discontinued. After a period of 2 months or more off therapy, and if warranted by persistent or recurring severe nodular acne, a second course of therapy may be initiated. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth. Long-term use of isotretinoin capsules, even in low doses, has not been studied, and is not recommended.

Warnings & precautions

Sourced from openFDA

Psychiatric Disorders Isotretinoin capsules may cause depression, psychosis and, rarely, suicidal ideation, suicide attempts, suicide, and aggressive and/or violent behaviors. No mechanism of action has been established for these events (see ADVERSE REACTIONS: Psychiatric ). Prescribers should read the brochure, Recognizing Psychiatric Disorders in Adolescents and Young Adults: A Guide for Prescribers of Isotretinoin. Prescribers should be alert to the warning signs of psychiatric disorders to guide patients to receive the help they need. Therefore, prior to initiation of isotretinoin capsules therapy, patients and family members should be asked about any history of psychiatric disorder, and at each visit during therapy patients should be assessed for symptoms of depression, mood disturbance, psychosis, or aggression to determine if further evaluation may be necessary. Signs and symptoms of depression, as described in the brochure ("Recognizing Psychiatric Disorders in Adolescents and Young Adults"), include sad mood, hopelessness, feelings of guilt, worthlessness or helplessness, loss of pleasure or interest in activities, fatigue, difficulty concentrating, change in sleep pattern, change in weight or appetite, suicidal thoughts or attempts, restlessness, irritability, acting on dangerous impulses, and persistent physical symptoms unresponsive to treatment.

Adverse reactions

Sourced from openFDA

Clinical Trials and Postmarketing Surveillance The adverse reactions listed below reflect the experience from investigational studies of isotretinoin , and the postmarketing experience. The relationship of some of these events to isotretinoin therapy is unknown. Many of the side effects and adverse reactions seen in patients receiving isotretinoin are similar to those described in patients taking very high doses of vitamin A (dryness of the skin and mucous membranes, e.g. of the lips, nasal passage, and eyes). Dose Relationship Cheilitis and hypertriglyceridemia are usually dose related. Most adverse reactions reported in clinical trials were reversible when therapy was discontinued; however, some persisted after cessation of therapy (see WARNINGS and ADVERSE REACTIONS ). Body as a Whole allergic reactions, including vasculitis, systemic hypersensitivity (see PRECAUTIONS: Hypersensitivity ), edema, fatigue, lymphadenopathy, weight loss Cardiovascular palpitation, tachycardia, vascular thrombotic disease, stroke Endocrine/Metabolic hypertriglyceridemia (see WARNINGS: Lipids ), alterations in blood sugar levels (see PRECAUTIONS: Laboratory Tests ). Gastrointestinal inflammatory bowel disease (see WARNINGS: Inflammatory Bowel Disease ), hepatitis (see WARNINGS: Hepatotoxicity ), pancreatitis (see WARNINGS: Lipids ), bleeding and inflammation of the gums, colitis, esophagitis/esophageal ulceration, ileitis, nausea, other nonspecific gastrointestinal symptoms.

Use in specific populations

Sourced from openFDA

Pregnancy Category X See Boxed CONTRAINDICATIONS AND WARNINGS .

Pharmacokinetics

Sourced from openFDA
Metabolism
Absorption Due to its high lipophilicity, oral absorption of isotretinoin is enhanced when given with a high-fat meal. In a crossover study, 74 healthy adult subjects received a single 80 mg oral dose (2 × 40 mg capsules) of isotretinoin under fasted and fed conditions.

Overdosage

Sourced from openFDA

The oral LD 50 of isotretinoin is greater than 4000 mg/kg in rats and mice (>600 times the recommended clinical dose of 1 mg/kg/day after normalization of the rat dose for total body surface area and >300 times the recommended clinical dose of 1 mg/kg/day after normalization of the mouse dose for total body surface area) and is approximately 1960 mg/kg in rabbits (653 times the recommended clinical dose of 1 mg/kg/day after normalization for total body surface area). In humans, overdosage has been associated with vomiting, facial flushing, cheilosis, abdominal pain, headache, dizziness, and ataxia. These symptoms quickly resolve without apparent residual effects. Isotretinoin capsules cause life-threatening birth defects at any dosage (see Boxed CONTRAINDICATIONS AND WARNINGS ). Patients who can become pregnant who present with isotretinoin overdose must be evaluated for pregnancy. Patients who are pregnant should receive counseling about the risks to the fetus, as described in the Boxed CONTRAINDICATIONS AND WARNINGS . Non-pregnant patients must be warned to avoid pregnancy for at least one month and receive contraceptive counseling as described in PRECAUTIONS .

Approval history

Sourced from openFDA
  • Nov 8, 2002ANDAANDA075945Mylan Pharms Inc
  • Apr 11, 2003ANDAANDA076356Teva Pharms Usa
  • Apr 11, 2003ANDAANDA076135Teva Pharms Usa
  • Jan 19, 2012ANDAANDA076485Upsher Smith Labs
  • May 25, 2012NDANDA021951Sun Pharm Inds Inc
  • Mar 25, 2013ANDAANDA202099Dr Reddys Labs Ltd
  • Sep 29, 2017ANDAANDA207792Amneal Pharms Ny
  • Nov 5, 2019NDANDA211913Sun Pharm

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
48,237 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Depression5,73812%
  2. 2Inflammatory Bowel Disease5,25311%
  3. 3Colitis Ulcerative3,8017.9%
  4. 4Dry Skin2,3784.9%
  5. 5Suicidal Ideation2,1324.4%
  6. 6Pregnancy2,0764.3%
  7. 7Irritable Bowel Syndrome2,0154.2%
  8. 8Headache1,9624.1%
  9. 9Arthralgia1,9424.0%
  10. 10Unintended Pregnancy1,9053.9%
  11. 11Anxiety1,8993.9%
  12. 12Product Dose Omission Issue1,7463.6%
  13. 13Crohn^s Disease1,6773.5%
  14. 14Exposure During Pregnancy1,6443.4%
  15. 15Lip Dry1,5603.2%

Literature

View JSON

Recent PubMed references pinned to Isotretinoin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 209 ClinicalTrials.gov registrations naming Isotretinoin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Structural analogs

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Ranked by 2D fingerprint (Tanimoto) similarity over PubChem structures. Structural proximity only — not a claim of therapeutic equivalence.

Frequently asked questions

How does Isotretinoin work?
Mechanism-of-action classes: Receptor Interactions; Unknown Cellular or Molecular Interaction.
What is Isotretinoin used for?
According to FDA labeling, Isotretinoin carries indications including: Severe Recalcitrant Nodular Acne Isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Isotretinoin?
Isotretinoin is classified as Retinoids for topical use in acne, Retinoids for treatment of acne, Retinoid, Receptor Interactions, Unknown Cellular or Molecular Interaction, Decreased Sebaceous Gland Activity.
What are the brand names for Isotretinoin?
Isotretinoin is marketed under brand names including Absorica, Accutane, Amnesteem, Claravis, Myorisan, Sotret, Zenatane.
What are the contraindications for Isotretinoin?
Isotretinoin labeling lists contraindications including: Pregnancy Category X See Boxed CONTRAINDICATIONS AND WARNINGS . Allergic Reactions Isotretinoin capsules are contraindicated in patients who are hypersensitive to this medication or to any of its components (see PRECAUTIONS: Hypersensitivity ).. Always consult the full prescribing information and a clinician.
Note. Data for isotretinoin is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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