Tretinoin

Tretinoin induces cytodifferentiation and decreased proliferation of APL cells in culture and in vivo . In APL patients, tretinoin treatment produces an initial maturation of the primitive promyelocytes derived from the leukemic clone, followed by a repopulation of the bone marrow and peripheral blood by normal, polyclonal hematopoietic cells in patients achieving complete remission (CR).

• Tretinoin capsules are indicated for the induction of remission in adults and pediatric patients 1 year of age and older with acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RARα gene expression, and who are refractory to or who have relapsed from anthracycline chemotherapy or for whom anthracycline-based chemotherapy is contraindicated. Tretinoin capsules are a retinoid indicated for induction of remission in adults and pediatric patients 1 year of age and older with acute promyelocytic leukemia (APL), characterized by presence of t(15;17) translocation or presence of PML/RARα gene expression, and who are refractory to or who have relapsed from anthracycline chemotherapy or for whom anthracycline-based chemotherapy is contraindicated.ICD-10: C95.90

• Tretinoin capsules are contraindicated in patients with a known hypersensitivity to tretinoin capsules, any of its components, or other retinoids. Reactions have included rash, pruritus, face edema, and dyspnea [see Adverse Reactions ( 6.1 )].contraindicated

• The recommended dosage of tretinoin capsules is 22.5 mg/m 2 orally twice daily until complete remission. ( 2.2 ) • Discontinue 30 days after achievement of complete remission or after 90 days of treatment, whichever occurs first. ( 2.2 ) 2.1 Important Safety Information Verify pregnancy status in females of reproductive potential prior to initiating tretinoin capsules. Females of reproductive potential must have a negative pregnancy test before initiating tretinoin capsules [see Use in Specific Populations (8.3)] . 2.2 Recommended Dosage The recommended dosage of tretinoin capsules is 22.5 mg/m 2 orally twice daily until complete remission is documented. Discontinue tretinoin capsules 30 days after achievement of complete remission or after 90 days of treatment, whichever occurs first. Discontinue tretinoin capsules if the t(15;17) translocation or PML/RARα fusion has not been identified [see Warnings and Precautions (5.3)] . Take tretinoin capsules with a meal. Swallow tretinoin capsules whole with water. Do not chew, dissolve, or open capsule. Do not take a missed dose of tretinoin capsules unless it is more than 10 hours until the next scheduled dose. If vomiting occurs after tretinoin capsules administration, do not take an additional dose, but continue with the next scheduled dose.

• Patients Without t(15;17) Translocation or PML/RARα Fusion: Tretinoin capsules may be initiated based on morphological diagnosis of APL. Confirm diagnosis by detection of the t(15;17) translocation or PML/RARα fusion. ( 5.3 ) • Leukocytosis: Consider administering cytoreductive chemotherapy (including an anthracycline if not contraindicated or hydroxyurea) with tretinoin capsules in the setting of leukocytosis, as clinically indicated. ( 5.4 ) • Intracranial Hypertension: Tretinoin capsules have been associated with benign intracranial hypertension, especially in pediatric patients. Consider interruption, dose reduction, or discontinuation of tretinoin capsules as appropriate. ( 5.5 ) • Lipid Abnormalities: Patients experienced hypercholesterolemia and/or hypertriglyceridemia, which may be reversible upon completion of treatment. Monitor fasting triglycerides and cholesterol at baseline and periodically during treatment. ( 5.6 ) • Hepatotoxicity: Monitor liver function test results at baseline and during treatment as clinically indicated. ( 5.7 ) • Thromboembolic Events: Venous and arterial events have been reported; these events may occur during the first month of treatment with tretinoin capsules. ( 5.8 , 7.4 ) 5.1 Embryo-Fetal Toxicity Tretinoin capsules can cause embryo-fetal loss and malformations when administered to a pregnant woman. Tretinoin capsules are a retinoid and there is an increased risk of major congenital malformations, spontaneous abortions and premature births following exposure to retinoids during pregnancy in humans.

The following clinically significant adverse reactions are described elsewhere in the labeling: • Differentiation Syndrome [see Warnings and Precautions ( 5.2 )] • Leukocytosis [see Warnings and Precautions ( 5.4 )] • Intracranial hypertension [see Warnings and Precautions (5.5)] • Lipid abnormalities [see Warnings and Precautions ( 5.6 )] • Hepatotoxicity [see Warnings and Precautions ( 5.7 )] • Thromboembolic events [see Warnings and Precautions (5 .8 )] The most common adverse reactions (≥30%) are headache, fever, skin/mucous membrane dryness, bone pain, malaise, shivering, upper respiratory tract disorders, dyspnea, hemorrhage, infections, nausea/vomiting, rash, peripheral edema, leukocytosis, pain, gastrointestinal hemorrhage, chest discomfort, abdominal pain ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Par Health at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying 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. Acute Promyelocytic Leukemia The safety of tretinoin capsules was evaluated in patients with APL who received tretinoin capsules at a dose of 22.5 mg/m 2 orally twice daily [see Clinical Studies ( 14 )] .

Lactation : Advise not to breastfeed. ( 8.2 ) 8.1 Pregnancy Risk Summary Based on findings in animals and its mechanism of action [see Clinical Pharmacology ( 12.1 )], tretinoin capsules can cause embryo-fetal loss and malformations when administered to a pregnant woman. Tretinoin capsules are a retinoid and there is an increased risk of major congenital malformations, spontaneous abortions and premature births following exposure to retinoids during pregnancy in humans. Tretinoin was teratogenic and embryotoxic in mice, rats, hamsters, rabbits and pigtail monkeys at doses less than the human dose on a mg/m 2 basis (see Data) . Advise pregnant women of the potential risk to a fetus. The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data Tretinoin capsules are a retinoid and increased spontaneous abortions and major fetal abnormalities related to the use of retinoids have been documented in humans.

Metabolism

Following the administration of tretinoin capsules 22.5 mg/m 2 orally twice daily, the mean ± SD peak tretinoin concentrations after the first dose was 394 ± 89 and after 1 week of continuous treatment was 138 ± 139 ng/mL, while area under the curve (AUC) after the first dose was 537 ± 191 ng·h/mL and after 1 week of continuous treatment was 249 ± 185 ng·h/mL. Absorption Time to reach peak concentration was between 1 and 2 hours.

In case of overdose with tretinoin capsules, reversible signs of hypervitaminosis A (headache, nausea, vomiting, mucocutaneous symptoms) can appear. Overdosage with other retinoids has been associated with transient headache, facial flushing, cheilosis, abdominal pain, dizziness and ataxia. These symptoms have quickly resolved without apparent residual effects. There is no specific treatment in the case of an overdose; however, it is important that the patient be treated in a special hematological unit.

• Jan 26, 1973NDANDA017340Valeant Pharms North
• Jul 19, 1974NDANDA017522Valeant Bermuda
• Apr 18, 1975NDANDA017579Valeant Intl
• Oct 17, 1978NDANDA017955Bausch
• Sep 16, 1988NDANDA019049Bausch
• Jan 14, 1997NDANDA020404Mylan Pharms Inc
• Feb 7, 1997NDANDA020475Bausch
• Aug 31, 2000NDANDA021108Valeant Pharms North

1. 1Drug Ineffective96311%
2. 2Off Label Use94611%
3. 3Pain5696.6%
4. 4Product Use In Unapproved Indication5246.1%
5. 5Vomiting4795.6%
6. 6Rash4495.2%
7. 7Nausea4375.1%
8. 8Headache4104.8%
9. 9Erythema4044.7%
10. 10Condition Aggravated3874.5%
11. 11Paraesthesia3864.5%
12. 12Diarrhoea3834.5%
13. 13Abdominal Pain Upper3514.1%
14. 14Fatigue3514.1%
15. 15Pruritus3414.0%

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

• Role of retinoic acid in meiosis.
  Current topics in developmental biology · 2026 · Gilbert EA, Geyer CB
  PMID 42236059DOI 10.1016/bs.ctdb.2026.04.003
• Anti-asthma drug montelukast induces autistic behaviors via disrupting neuronal retinoic acid signaling.
  Signal transduction and targeted therapy · 2026 · Hao ZJ, Wu QH, Li YL, et al.
  PMID 42230569DOI 10.1038/s41392-026-02665-w
• Upregulation of GnT-IVa and Its Critical Roles in ATRA-Induced Differentiation of Acute Promyelocytic Leukemia Cells.
  Biomolecules · 2026 · Zhang S, Isaji T, Zheng M, et al.
  PMID 42194104DOI 10.3390/biom16050756
• Imbalance in WNT: retinoic acid signaling dysregulates HOX gene expression: implications for cancer stem cell heterogeneity and CRC patient survival.
  Stem cells translational medicine · 2026 · Osmond B, Zhang C, Kataboh PK, et al.
  PMID 42184974DOI 10.1093/stcltm/szag043
• All-trans retinoic acid and lansoprazole potentiated NKG2D-CAR T for breast cancer treatment.
  International immunopharmacology · 2026 · Lu T, Yu J, Zhou R, et al.
  PMID 42161056DOI 10.1016/j.intimp.2026.116889
• Dual-Phase Barrier-Penetrating Nanomedicine for Early Intervention on Hepatic Stellate Cells to Enhance Liver Fibrosis Treatment.
  ACS applied materials & interfaces · 2026 · Xin D, Huang Y, Zhu J, et al.
  PMID 42157097DOI 10.1021/acsami.6c05537
• [Spontaneous resolution of ATRA-related hearing impairment without symptoms of intracranial hypertension].
  [Rinsho ketsueki] The Japanese journal of clinical hematology · 2026 · Tasaka K, Kawaguchi K, Hashimoto A, et al.
  PMID 42128864DOI 10.11406/rinketsu.67.332
• Optimizing Photobiomodulation for Smooth Muscle Differentiation of Adipose-Derived Stem Cells Using Retinoic Acid and TGFβ in a Two-Dimensional Model.
  Cells · 2026 · Mbuyu C, Abrahamse H, Crous A, et al.
  PMID 42121890DOI 10.3390/cells15090789

The 10 most recently updated of 398 ClinicalTrials.gov registrations naming Tretinoin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma
  Recruiting · Phase 3 · Interventional · 478 enrolled · National Cancer Institute (NCI)
  NCT06172296updated 2026-06-12
• Study to Determine Effect of Gentle Wounding to Stimulate Hair Follicle Neogenesis
  Completed · Early phase 1 · Interventional · 24 enrolled · Johns Hopkins University
  NCT03491267updated 2026-06-12
• Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia
  Recruiting · Phase 3 · Interventional · 150 enrolled · Quetzal Therapeutics
  NCT07504458updated 2026-06-11
• Chemotherapy and Radiation Therapy in Treating Young Patients With Newly Diagnosed, Previously Untreated, High-Risk Medulloblastoma/PNET
  Completed · Phase 3 · Interventional · 379 enrolled · Children's Oncology Group
  NCT00392327updated 2026-06-08
• All-Trans Retinoic Acid for the Treatment of Hemophagocytic Lymphohistiocytosis
  Not yet recruiting · Phase 2 · Phase 3 · Interventional · 30 enrolled · Beijing Anzhen Hospital
  NCT07626398updated 2026-06-04
• Lisaftoclax for Prevention of Differentiation Syndrom in Acute Promyelocytic Leukemia Patients
  Not yet recruiting · Phase 2 · Phase 3 · Interventional · 60 enrolled · The Affiliated People's Hospital of Ningbo University
  NCT07597941updated 2026-06-04
• Clinical and Molecular Biomarker Studies in RAI1 (Retinoic Acid-Induced 1) -Related Disorders
  Recruiting · Observational · 90 enrolled · Baylor College of Medicine
  NCT06274164updated 2026-06-03
• Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma
  Completed · Phase 2 · Interventional · 42 enrolled · National Cancer Institute (NCI)
  NCT03786783updated 2026-06-02
• Study for Patients With Newly Diagnosed, High-risk Acute Promyelocytic Leukemia
  Completed · Phase 3 · Interventional · 133 enrolled · Technische Universität Dresden
  NCT02688140updated 2026-05-29
• Substudy 02B: Safety and Efficacy of Pembrolizumab in Combination With Investigational Agents or Pembrolizumab Alone in Participants With First Line (1L) Advanced Melanoma (MK-3475-02B/KEYMAKER-U02)
  Completed · Phase 1 · Phase 2 · Interventional · 335 enrolled · Merck Sharp & Dohme LLC
  NCT04305054updated 2026-05-28

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

• IsotretinoinRetinoid100%

Frequently asked questions

How does Tretinoin work?

Tretinoin induces cytodifferentiation and decreased proliferation of APL cells in culture and in vivo . In APL patients, tretinoin treatment produces an initial maturation of the primitive promyelocytes derived from the leukemic clone, followed by a repopulation of the bone marrow and peripheral blood by normal, polyclonal hematopoietic cells in patients achieving complete remission (CR).

What is Tretinoin used for?

According to FDA labeling, Tretinoin carries indications including: Tretinoin capsules are indicated for the induction of remission in adults and pediatric patients 1 year of age and older with acute promyelocytic leukemia (APL) characterized by the presence of the t(15;17) translocation or PML/RARα gene expression, and who are refractory to or who have relapsed from anthracycline chemotherapy or for whom anthracycline-based chemotherapy is contraindicated. Tretinoin capsules are a retinoid indicated for induction of remission in adults and pediatric patients 1 year of age and older with acute promyelocytic leukemia (APL), characterized by presence of t(15;17) translocation or presence of PML/RARα gene expression, and who are refractory to or who have relapsed from anthracycline chemotherapy or for whom anthracycline-based chemotherapy is contraindicated.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Tretinoin?

Tretinoin is classified as Retinoids for cancer treatment, Retinoids for topical use in acne, Retinoid, Receptor Interactions, Unknown Cellular or Molecular Interaction, Decreased Epithelial Proliferation, Decreased Sebaceous Gland Activity, Decreased Sebaceous Gland Quantity.

What are the brand names for Tretinoin?

Tretinoin is marketed under brand names including Altreno, Atralin, Avita, Refissa, Renova, Retin-A, Tretin X, Tri-Luma.

What are the contraindications for Tretinoin?

Tretinoin labeling lists contraindications including: Tretinoin capsules are contraindicated in patients with a known hypersensitivity to tretinoin capsules, any of its components, or other retinoids. Reactions have included rash, pruritus, face edema, and dyspnea [see Adverse Reactions ( 6.1 )].. Always consult the full prescribing information and a clinician.