{"shortAnswer":"Tretinoin is FDA-approved by prescription on the skin for acne and fine facial wrinkles, and by mouth for one kind of leukemia. For acne the evidence grade is strong-human. The capsule label warns it can harm an unborn baby. It is not approved to reverse skin ageing.","url":"https://peptideindex.ai/compound/tretinoin","status":"fda-approved","statusCheckedAt":"2026-10-26T13:43:56.890Z","statusStale":false,"regulatoryAsOf":"2026-10-26","verified":"2026-10-26T13:43:56.926Z","primarySourceUrl":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020475","clinicallyReviewed":false,"notice":"Information, not medical advice.","id":"1cf67b1b-48f7-4298-bccf-76c4b93cc3ca","object":"compound","slug":"tretinoin","name":"Tretinoin","attrs":{"name":"Tretinoin","class":"non-peptide","access":[{"type":"approved-product","detail":"Approved by FDA as a prescription gel put on the skin, in four strengths.","indication":"Acne in adults and children 12 years and older.","source_url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020475","brand_names":["Retin-A Micro"],"manufacturer":"Bausch"},{"type":"approved-product","detail":"Approved by FDA as a prescription 0.05% lotion put on the skin.","indication":"Acne in people 9 years and older.","source_url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209353","brand_names":["Altreno"],"manufacturer":"Dow Pharm"},{"type":"approved-product","detail":"Approved by FDA as a prescription 0.02% cream for the face, used with sun protection. Not approved to remove wrinkles or repair sun damage.","indication":"An add-on to soften fine facial wrinkles in people who use full skin care and avoid the sun.","source_url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021108","brand_names":["Renova"],"manufacturer":"Valeant Pharms North"},{"type":"approved-product","detail":"Approved by FDA as a prescription capsule taken by mouth. The brand is discontinued, not for safety or effectiveness reasons.","indication":"To bring acute promyelocytic leukemia into remission, in adults and children 1 year and older, when anthracycline chemotherapy failed, stopped working or cannot be used.","source_url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020438","brand_names":["Vesanoid"],"manufacturer":"Cheplapharm"},{"type":"lawful-compounding","detail":"Pharmacies may compound with a raw substance that meets a USP standard or is part of an FDA-approved drug.","source_url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act"}],"dosing":"From the Retin-A Micro, Altreno, Renova and Vesanoid labels. Retin-A Micro gel: a thin layer on the acne areas once a day in the evening. Altreno lotion: a thin layer on the acne areas once a day. Renova cream: a pearl-sized amount on the face once a day in the evening, with sunscreen in the morning. The labels say using more will not bring faster or better results. Vesanoid capsules for acute promyelocytic leukemia: 22.5 mg/m2 by mouth twice a day with a meal, stopped 30 days after remission or after 90 days, whichever comes first. A negative pregnancy test is required first. The prescriber sets the dose.","trials":[{"nct":"NCT07848568","url":"https://clinicaltrials.gov/study/NCT07848568","phase":"Phase 1/Phase 2","title":"Testing Safe Doses of Anti-Cancer Medicines, 5-Flurouracil (5-FU) and Tretinoin (ATRA), Added to the Usual Cancer Treatment of Ependymoma","status":"not-yet-recruiting","sponsor":"Children's Oncology Group","countries":[],"us_states":[]},{"nct":"NCT07842887","url":"https://clinicaltrials.gov/study/NCT07842887","phase":"Phase 1","title":"Phase 1 Study of ATRA Plus a PD-1 Inhibitor in EGFR-Mutant NSCLC After Third-Generation EGFR-TKI Resistance","status":"not-yet-recruiting","sponsor":"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","countries":["China"],"us_states":[]},{"nct":"NCT07779811","url":"https://clinicaltrials.gov/study/NCT07779811","phase":"Phase 2","title":"Topical Metformin Versus Triple Regimen for Epidermal Melasma","status":"not-yet-recruiting","sponsor":"Combined Military Hospital, Pakistan","countries":["Pakistan"],"us_states":[]},{"nct":"NCT07732192","url":"https://clinicaltrials.gov/study/NCT07732192","phase":"Phase 4","title":"Oral Tranexamic Acid Plus Triple Combination vs Triple Combination Alone in Melasma","status":"not-yet-recruiting","sponsor":"Combined Military Hospital Abbottabad","countries":[],"us_states":[]},{"nct":"NCT07504458","url":"https://clinicaltrials.gov/study/NCT07504458","phase":"Phase 3","title":"Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia","status":"recruiting","sponsor":"Quetzal Therapeutics","countries":["United States","France","Italy","Romania","Spain"],"us_states":["Alabama","California","Georgia","Kentucky","Maryland","Michigan","New York","North Carolina","Ohio","Tennessee","Texas","Virginia"]},{"nct":"NCT07626398","url":"https://clinicaltrials.gov/study/NCT07626398","phase":"Phase 2/Phase 3","title":"All-Trans Retinoic Acid for the Treatment of Hemophagocytic Lymphohistiocytosis","status":"not-yet-recruiting","sponsor":"Beijing Anzhen Hospital","countries":[],"us_states":[]},{"nct":"NCT07597395","url":"https://clinicaltrials.gov/study/NCT07597395","phase":"Phase 3","title":"ATRA for Management of Primary ITP","status":"not-yet-recruiting","sponsor":"Peking University People's Hospital","countries":["China"],"us_states":[]},{"nct":"NCT07348107","url":"https://clinicaltrials.gov/study/NCT07348107","phase":"Phase 1","title":"ATRA and SDK002 in Combination With Chemotherapy and Anti-PD-1 Inhibitor in Patients With Advanced Pancreatic Ductal Adenocarcinoma.","status":"not-yet-recruiting","sponsor":"Daniel Breadner","countries":["Canada"],"us_states":[]},{"nct":"NCT07137130","url":"https://clinicaltrials.gov/study/NCT07137130","phase":"Not applicable","title":"Secretome TGF Beta 3","status":"not-yet-recruiting","sponsor":"Universitas Indonesia","countries":["Indonesia"],"us_states":[]},{"nct":"NCT07355855","url":"https://clinicaltrials.gov/study/NCT07355855","phase":"Phase 2","title":"A Clinical Study on the Efficacy and Safety of All-trans Retinoic Acid Combined With VAC Regimen in the Treatment of Intermediate-to-high-risk Rhabdomyosarcoma","status":"not-yet-recruiting","sponsor":"Fudan University","countries":["China"],"us_states":[]},{"nct":"NCT07296445","url":"https://clinicaltrials.gov/study/NCT07296445","phase":"Phase 3","title":"A Trial to Investigate Whether Oral Arsenic Trioxide Is Similar to Intravenous Arsenic Trioxide in Pharmacokinetics, Safety, and Efficacy (LATITUDE/SDKARS-301)","status":"not-yet-recruiting","sponsor":"SDK Therapeutics, Inc.","countries":[],"us_states":[]},{"nct":"NCT07366229","url":"https://clinicaltrials.gov/study/NCT07366229","phase":"Phase 2","title":"Topical Application of Engineered Lactobacillus Reuteri With a Zinc Sulfate-Tannic Acid MPN Coating for Acne","status":"recruiting","sponsor":"Shenzhen People's Hospital","countries":["China"],"us_states":[]},{"nct":"NCT07586826","url":"https://clinicaltrials.gov/study/NCT07586826","phase":"Phase 2","title":"Romiplostim N01 Plus ATRA for Persistent Isolated Chemotherapy-Induced Thrombocytopenia After Complete Remission of Gynecologic, Breast, or Lung Solid Tumors","status":"recruiting","sponsor":"Peking University People's Hospital","countries":["China"],"us_states":[]},{"nct":"NCT07586813","url":"https://clinicaltrials.gov/study/NCT07586813","phase":"Phase 2","title":"Romiplostim N01 Plus ATRA for Persistent Isolated Chemotherapy-Induced Thrombocytopenia After Complete Remission of Gastrointestinal Solid Tumors","status":"recruiting","sponsor":"Peking University People's Hospital","countries":["China"],"us_states":[]},{"nct":"NCT07278908","url":"https://clinicaltrials.gov/study/NCT07278908","phase":"Phase 2/Phase 3","title":"Avatrombopag Combined With All-trans Retinoic Acid in the Treatment of Primary Immune Thrombocytopenia","status":"not-yet-recruiting","sponsor":"Institute of Hematology & Blood Diseases Hospital, China","countries":[],"us_states":[]},{"nct":"NCT06528769","url":"https://clinicaltrials.gov/study/NCT06528769","phase":"Phase 2","title":"Study of All-Trans Retinoic Acid (ATRA) and Cemiplimab in Patients With Advanced Leiomyosarcoma","status":"recruiting","sponsor":"Gabriel Tinoco","countries":["United States"],"us_states":["Ohio"]},{"nct":"NCT07154030","url":"https://clinicaltrials.gov/study/NCT07154030","phase":"Phase 1","title":"Efficacy Of Combined Microneedling Plus Tretinoin In Treatment Of Stria Rubra","status":"not-yet-recruiting","sponsor":"Sohag University","countries":[],"us_states":[]},{"nct":"NCT07079696","url":"https://clinicaltrials.gov/study/NCT07079696","phase":"Phase 2","title":"Investigating the Therapeutic Efficacy of All-trans Retinoic Acid in Autism Spectrum Disorder Patients With 15q11-13 Duplication Syndrome","status":"not-yet-recruiting","sponsor":"Second Affiliated Hospital, Zhejiang University, School of Medicine","countries":["China"],"us_states":[]},{"nct":"NCT07142070","url":"https://clinicaltrials.gov/study/NCT07142070","phase":"Not applicable","title":"Effect of Systemic Retinoic Acid Use on Micro Ribonucleic Acid (mRNA) Expression","status":"not-yet-recruiting","sponsor":"Medipol University","countries":["Turkey (Türkiye)"],"us_states":[]},{"nct":"NCT07503730","url":"https://clinicaltrials.gov/study/NCT07503730","phase":"Phase 3","title":"Early Use of Realgar-Indigo Naturalis Formula (RIF) Combined With All-trans Retinoic Acid (ATRA) for Treating Acute Promyelocytic Leukemia (APL).","status":"recruiting","sponsor":"First Affiliated Hospital Xi'an Jiaotong University","countries":["China"],"us_states":[]},{"nct":"NCT06925386","url":"https://clinicaltrials.gov/study/NCT06925386","phase":"Phase 2","title":"The Relationship Between Microbioma Balance and Acne Vulgaris as a New Acne Treatment","status":"not-yet-recruiting","sponsor":"Universitas Padjadjaran","countries":["Indonesia"],"us_states":[]},{"nct":"NCT06447480","url":"https://clinicaltrials.gov/study/NCT06447480","phase":"Phase 3","title":"Clinical Trial to Compare Oral Isotretinoin to Standard of Care in Moderate Acne Skin of Color Patients","status":"recruiting","sponsor":"Centre Hospitalier Universitaire de Nice","countries":["France","French Guiana"],"us_states":[]},{"nct":"NCT06698263","url":"https://clinicaltrials.gov/study/NCT06698263","phase":"Phase 4","title":"13-cis Retinoic Acid (Isotretinoin) and Sperm Production","status":"not-yet-recruiting","sponsor":"University Hospital, Strasbourg, France","countries":["France"],"us_states":[]},{"nct":"NCT06706401","url":"https://clinicaltrials.gov/study/NCT06706401","phase":"Phase 3","title":"Lymphocyte-Sparing And Radio-Immunotherapy in Head and Neck Carcinoma","status":"recruiting","sponsor":"Centre Leon Berard","countries":["France"],"us_states":[]},{"nct":"NCT06358677","url":"https://clinicaltrials.gov/study/NCT06358677","phase":"Phase 2","title":"Topical Tretinoin Prophylaxis for Anti-EGFR Induced Skin Toxicity in Patients With Solid Tumors","status":"recruiting","sponsor":"University of Utah","countries":["United States"],"us_states":["Utah"]},{"nct":"NCT06780644","url":"https://clinicaltrials.gov/study/NCT06780644","phase":"Not applicable","title":"Comparison of Effectiveness and Safety of Triple Combination Cream of Fucinolone Acetonide 0.01%, Hydroquinone 4%, Tretinoin 0.05% with Mometasone Furoate 0.1%, Hydroquinone 4%, Tretinoin 0.05% in the Treatment of Melasma","status":"not-yet-recruiting","sponsor":"Universitas Indonesia","countries":["Indonesia"],"us_states":[]},{"nct":"NCT06841952","url":"https://clinicaltrials.gov/study/NCT06841952","phase":"Not applicable","title":"Study of Tretinoin Capsules in Combination With Azacitidine and Venetoclax in Treatment Naïve Participants With Acute Myeloid Leukemia","status":"not-yet-recruiting","sponsor":"The First Affiliated Hospital of Soochow University","countries":["China"],"us_states":[]},{"nct":"NCT06731140","url":"https://clinicaltrials.gov/study/NCT06731140","phase":"Phase 2","title":"Reverse HER2-negative Immune Resistant Breast Cancer","status":"recruiting","sponsor":"Fudan University","countries":["China"],"us_states":[]},{"nct":"NCT06646666","url":"https://clinicaltrials.gov/study/NCT06646666","phase":"Phase 2","title":"ARTA-based Chemo-free Bridging/Maintenance Therapy in CAR-T Treatment for High-Risk R/R B-NHL Ineligible for HDCT and ASCT","status":"not-yet-recruiting","sponsor":"Ruijin Hospital","countries":["China"],"us_states":[]},{"nct":"NCT05474859","url":"https://clinicaltrials.gov/study/NCT05474859","phase":"Phase 1","title":"Subjects With Advanced or Metastatic Solid Tumor Malignancies","status":"not-yet-recruiting","sponsor":"Xenthera, Inc.","countries":[],"us_states":[]},{"nct":"NCT06703047","url":"https://clinicaltrials.gov/study/NCT06703047","phase":"Phase 2","title":"Tislelizumab Combined with Chemotherapy and All Trans Retinoic Acid for Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma","status":"not-yet-recruiting","sponsor":"Fudan University","countries":[],"us_states":[]},{"nct":"NCT06484920","url":"https://clinicaltrials.gov/study/NCT06484920","phase":"Phase 2","title":"A Phase II Study of the Combination of Pembrolizumab and ATRA Combination Treatment of Relapsed HL and B-NHL","status":"recruiting","sponsor":"Rita Assi","countries":["United States"],"us_states":["Indiana"]},{"nct":"NCT06636981","url":"https://clinicaltrials.gov/study/NCT06636981","phase":"Phase 2","title":"All Trans Retinoic Acid Combined with Toripalimab+Chemotherapy for Locally Advanced Inoperable or Metastatic Triple Negative Breast Cancer：a Multi-center, Multi-cohort Phase II Trial","status":"recruiting","sponsor":"Fudan University","countries":["China"],"us_states":[]},{"nct":"NCT06371274","url":"https://clinicaltrials.gov/study/NCT06371274","phase":"Not applicable","title":"A Study on the Efficacy and Safety of Oral All-trans Retinoic Acid Combined With Toripalimab in TNBC.","status":"recruiting","sponsor":"First Affiliated Hospital of Zhejiang University","countries":["China"],"us_states":[]},{"nct":"NCT06536413","url":"https://clinicaltrials.gov/study/NCT06536413","phase":"Phase 1/Phase 2","title":"ATRA and Carfilzomib in Plasma Cell Myeloma Patients","status":"recruiting","sponsor":"The Methodist Hospital Research Institute","countries":["United States"],"us_states":["Texas"]},{"nct":"NCT06439888","url":"https://clinicaltrials.gov/study/NCT06439888","phase":"Phase 1/Phase 2","title":"Lymphocyte Support to SBRT in Patients With Oligo-metastatic Solid Cancer","status":"recruiting","sponsor":"Gustave Roussy, Cancer Campus, Grand Paris","countries":["France"],"us_states":[]},{"nct":"NCT06172296","url":"https://clinicaltrials.gov/study/NCT06172296","phase":"Phase 3","title":"Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma","status":"recruiting","sponsor":"National Cancer Institute (NCI)","countries":["United States","Australia","Canada","New Zealand","Puerto Rico"],"us_states":["Alabama","Arizona","Arkansas","California","Colorado","Connecticut","Delaware","District of Columbia","Florida","Georgia","Hawaii","Illinois","Indiana","Iowa","Kansas","Kentucky","Louisiana","Maine","Maryland","Massachusetts","Michigan","Minnesota","Mississippi","Missouri","Nebraska","Nevada","New Hampshire","New Jersey","New Mexico","New York","North Carolina","North Dakota","Ohio","Oklahoma","Oregon","Pennsylvania","Rhode Island","South Carolina","South Dakota","Tennessee","Texas","Utah","Vermont","Virginia","Washington","West Virginia","Wisconsin"]},{"nct":"NCT06274164","url":"https://clinicaltrials.gov/study/NCT06274164","phase":"Not stated","title":"Clinical and Molecular Biomarker Studies in RAI1 (Retinoic Acid-Induced 1) -Related Disorders","status":"recruiting","sponsor":"Baylor College of Medicine","countries":["United States"],"us_states":["Texas"]},{"nct":"NCT06158412","url":"https://clinicaltrials.gov/study/NCT06158412","phase":"Phase 2","title":"All-trans Retinoic Acid in Combination With a KPD Regimen for the Treatment of Refractory/Relapsed Multiple Myeloma","status":"recruiting","sponsor":"The First Affiliated Hospital of Xiamen University","countries":["China"],"us_states":[]},{"nct":"NCT05553782","url":"https://clinicaltrials.gov/study/NCT05553782","phase":"Early phase 1","title":"Drug Screening Using Novel IMD in Salivary and Head and Neck Cancers","status":"recruiting","sponsor":"Brigham and Women's Hospital","countries":["United States"],"us_states":["Massachusetts"]},{"nct":"NCT06982274","url":"https://clinicaltrials.gov/study/NCT06982274","phase":"Phase 2","title":"Oral Arsenic With ATRA for Newly Diagnosed Patients With Acute Promyelocytic Leukemia","status":"recruiting","sponsor":"Instituto do Cancer do Estado de São Paulo","countries":["Brazil"],"us_states":[]},{"nct":"NCT05881265","url":"https://clinicaltrials.gov/study/NCT05881265","phase":"Phase 2","title":"Treatment of Chidamide and Venetoclax for Retinoic Acid and Arsenic Resistant Acute Promyelocytic Leukemia","status":"recruiting","sponsor":"Shanghai Jiao Tong University School of Medicine","countries":["China"],"us_states":[]},{"nct":"NCT05345002","url":"https://clinicaltrials.gov/study/NCT05345002","phase":"Phase 2","title":"All-Trans Retinoic Acid (ATRA) Plus PD-1 Inhibition in Recurrent IDH-Mutant Glioma","status":"recruiting","sponsor":"Stephen Bagley, MD, MSCE","countries":["United States"],"us_states":["Pennsylvania"]},{"nct":"NCT05384821","url":"https://clinicaltrials.gov/study/NCT05384821","phase":"Phase 1/Phase 2","title":"Metronomic Chemotherapy in Wilms Tumor (MetroWilms-1906)","status":"recruiting","sponsor":"Centre Oscar Lambret","countries":["France"],"us_states":[]},{"nct":"NCT04897490","url":"https://clinicaltrials.gov/study/NCT04897490","phase":"Not stated","title":"RWE of 1st Line Treatment With ATO/ATRA for Adult APL","status":"recruiting","sponsor":"Grupo Argentino de Tratamiento de la Leucemia Aguda","countries":["Argentina"],"us_states":[]},{"nct":"NCT04793919","url":"https://clinicaltrials.gov/study/NCT04793919","phase":"Phase 2","title":"Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia","status":"recruiting","sponsor":"Associazione Italiana Ematologia Oncologia Pediatrica","countries":["Belgium","Czechia","Denmark","France","Germany","Ireland","Israel","Italy","Netherlands","Portugal","Spain","Sweden"],"us_states":[]},{"nct":"NCT03126916","url":"https://clinicaltrials.gov/study/NCT03126916","phase":"Phase 3","title":"Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)","status":"recruiting","sponsor":"Children's Oncology Group","countries":["United States","Canada","Puerto Rico"],"us_states":["Alabama","Arizona","Arkansas","California","Colorado","Connecticut","Delaware","District of Columbia","Florida","Georgia","Hawaii","Idaho","Illinois","Indiana","Iowa","Kentucky","Louisiana","Maine","Maryland","Massachusetts","Michigan","Minnesota","Mississippi","Missouri","Nebraska","Nevada","New Hampshire","New Jersey","New Mexico","New York","North Carolina","North Dakota","Ohio","Oklahoma","Oregon","Pennsylvania","Rhode Island","South Carolina","South Dakota","Tennessee","Texas","Utah","Vermont","Virginia","Washington","West Virginia","Wisconsin"]},{"nct":"NCT01409161","url":"https://clinicaltrials.gov/study/NCT01409161","phase":"Phase 2","title":"Tretinoin and Arsenic Trioxide With or Without Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia","status":"recruiting","sponsor":"M.D. Anderson Cancer Center","countries":["United States"],"us_states":["Texas"]}],"aliases":["all-trans retinoic acid","Retin-A","Vesanoid"],"summary":"A vitamin A substance approved as a prescription skin product for acne and fine facial wrinkles, and as a capsule for one kind of leukemia.","citations":[{"n":1,"url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/020475Orig1s029lbl.pdf","tier":"primary","type":"label","title":"Retin-A Micro (tretinoin) gel label, revised September 2025"},{"n":2,"url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209353s000lbl.pdf","tier":"primary","type":"label","title":"Altreno (tretinoin) lotion label, revised August 2018"},{"n":3,"url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021108s015lbl.pdf","tier":"primary","type":"label","title":"Renova (tretinoin) cream 0.02% label"},{"n":4,"url":"https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020438s009lbl.pdf","tier":"primary","type":"label","title":"Vesanoid (tretinoin) capsules label, revised October 2024"},{"n":5,"url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020475","tier":"primary","type":"regulatory","title":"Drugs@FDA: Retin-A Micro (tretinoin) gel, application 020475"},{"n":6,"url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209353","tier":"primary","type":"regulatory","title":"Drugs@FDA: Altreno (tretinoin) lotion, application 209353"},{"n":7,"url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021108","tier":"primary","type":"regulatory","title":"Drugs@FDA: Renova (tretinoin) cream, application 021108"},{"n":8,"url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020438","tier":"primary","type":"regulatory","title":"Drugs@FDA: Vesanoid (tretinoin) capsules, application 020438"},{"n":9,"url":"https://www.accessdata.fda.gov/drugsatfda_docs/psg/PSG_017340.pdf","tier":"primary","type":"regulatory","title":"FDA draft product-specific guidance on tretinoin cream, December 2025"},{"n":10,"url":"https://api.fda.gov/drug/enforcement.json?search=product_description:tretinoin&limit=20","tier":"primary","type":"regulatory","title":"FDA drug enforcement reports (openFDA): recalls naming tretinoin"},{"n":11,"url":"https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act","tier":"primary","type":"regulatory","title":"FDA: bulk drug substances used in compounding under section 503A"},{"n":12,"url":"https://www.fda.gov/media/94155/download","tier":"primary","type":"regulatory","title":"FDA: 503A bulk drug substances category list"},{"n":13,"url":"https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks","tier":"primary","type":"regulatory","title":"FDA: bulk drug substances that may present significant safety risks (Category 2)"},{"n":14,"url":"https://pubmed.ncbi.nlm.nih.gov/16060712/","tier":"peer-reviewed","type":"rct","title":"Two-year randomized trial: tretinoin 0.05% cream against placebo in sun-damaged facial skin, 2005"},{"n":15,"url":"https://pubmed.ncbi.nlm.nih.gov/31741356/","tier":"peer-reviewed","type":"rct","title":"Analysis of two randomized phase 3 trials: tretinoin 0.05% lotion in acne, by sex and race, 2019"},{"n":16,"url":"https://pubmed.ncbi.nlm.nih.gov/23841729/","tier":"peer-reviewed","type":"rct","title":"Randomized phase 3 trial: retinoic acid with arsenic trioxide against retinoic acid with chemotherapy in acute promyelocytic leukemia, 2013"},{"n":17,"url":"https://pubmed.ncbi.nlm.nih.gov/19153339/","tier":"peer-reviewed","type":"rct","title":"VA randomized trial: topical tretinoin and death from any cause in 1131 veterans, 2009"},{"n":18,"url":"https://pubmed.ncbi.nlm.nih.gov/26215715/","tier":"peer-reviewed","type":"systematic-review","title":"Systematic review: pregnancy outcomes after first-trimester exposure to topical retinoids, 2015"},{"n":19,"url":"https://pubmed.ncbi.nlm.nih.gov/2136048/","tier":"peer-reviewed","type":"animal","title":"Study in pregnant rats: retinoic acid on the skin and fetal outcome, 1990"},{"n":20,"url":"https://clinicaltrials.gov/study/NCT06358677","tier":"primary","type":"reference","title":"ClinicalTrials.gov NCT06358677: topical tretinoin to prevent skin toxicity from anti-EGFR cancer drugs"},{"n":21,"url":"https://clinicaltrials.gov/study/NCT01409161","tier":"primary","type":"reference","title":"ClinicalTrials.gov NCT01409161: tretinoin and arsenic trioxide in acute promyelocytic leukemia"},{"n":22,"url":"https://abcnews.go.com/Health/Healthday/story?id=6720751&page=1","tier":"established-news","type":"reference","title":"HealthDay via ABC News: acne cream not linked to raised death risk, January 2009"}],"known_risks":["The capsule label opens with its strongest warning. Tretinoin by mouth can cause miscarriage and birth defects [^4].","Before starting the capsules, a woman who could become pregnant must have a negative pregnancy test. She must use two kinds of birth control during treatment and for 1 month after [^4].","About 26% of leukemia patients on the capsules got a reaction called differentiation syndrome. It causes fever, trouble breathing and fluid build-up, and it can be fatal [^4].","The capsules can raise pressure inside the skull, mostly in children. They can also raise blood fats, harm the liver and cause blood clots [^4].","On the skin, tretinoin can cause dryness, redness and peeling. It can also cause swelling, itching, blisters, burning or stinging [^1].","Tretinoin on the skin makes sunburn more likely. The labels say to limit sun and use sunscreen of SPF 15 or more [^1] [^3].","Acne can look worse in the first weeks of treatment [^1].","Darker or lighter patches of skin have been reported with repeated use [^1].","The Renova label says not to use it in pregnancy. It lists 30 reports of birth defects after another skin form, with no proven link [^3].","The Altreno lotion holds fish proteins. Its label urges care for people allergic to fish [^2].","A large VA trial of tretinoin cream was stopped early because more people died in the tretinoin group. The authors did not conclude the cream caused the deaths [^17].","FDA recall records list compounded tretinoin creams recalled from 2017 to 2020. Reasons included no assurance the product was sterile [^10]."],"short_answer":"Tretinoin is FDA-approved by prescription on the skin for acne and fine facial wrinkles, and by mouth for one kind of leukemia. For acne the evidence grade is strong-human. The capsule label warns it can harm an unborn baby. It is not approved to reverse skin ageing.","evidence_grade":"strong-human","open_questions":["Daily Renova use for more than 52 weeks has not been studied enough. Its label says the effects past that point are not known [^3].","Some people on a stronger cream for over 48 weeks had unusual changes in skin cells. The label says what this means is unknown [^3].","Some mice given tretinoin on the skin for 91 weeks got skin tumors. Tretinoin may also help UV light cause tumors in mice. The label says the meaning for people is not clear [^1].","It is unclear why more people died on tretinoin in the VA trial. The authors called a direct cause unlikely, but did not rule it out [^17] [^22].","A 2015 review of 654 pregnancies found no clear rise in birth defects after skin use. It was too small to rule out a risk [^18].","In one Renova study of 107 people with darker skin, fewer improved with the cream than with a dummy cream. The study may have been too small to tell [^3]."],"section_routes":"The legal way to get tretinoin is a prescription for an FDA-approved product [^5] [^6] [^7] [^8]. For acne, that includes Retin-A Micro gel and Altreno lotion [^1] [^2] [^5] [^6]. For fine facial wrinkles, it is Renova cream, used with sun protection [^3] [^7]. For one kind of leukemia, it is capsules by mouth [^4] [^8].\n\nPharmacies may compound with a raw substance that is part of an FDA-approved drug [^11].\n\nOne US study in Utah is testing tretinoin on the skin to prevent a rash caused by some cancer drugs [^20]. One US study in Texas gives tretinoin with other drugs for acute promyelocytic leukemia [^21]. The trials block on this page lists open trials with their dates.","regulatory_as_of":"2026-10-26","section_channels":"Some pharmacies mix tretinoin into custom creams. Some mixes add other drugs, such as hydroquinone or clindamycin [^10]. FDA recall records list several of these creams from 2017 to 2020 [^10]. In some, there was no proof the cream was sterile [^10]. Others lacked good process controls [^10].\n\nSome liquids made by pharmacies also mixed tretinoin with minoxidil and fluocinolone. Some added finasteride too [^10]. In 2020, two such formulas were recalled for weak process controls [^10].","section_evidence":"The evidence grade is strong-human for acne [^1] [^2] [^15]. In two 12-week trials, the 0.1% gel cut acne spots by 32% to 45%, against 16% to 23% on a dummy gel [^1]. In two trials of 1,640 people aged 9 and over, the 0.05% lotion helped more than a dummy lotion [^2] [^15]. After 12 weeks, 16.5% on the lotion were clear or almost clear in one trial, against 6.9% on the dummy [^2].\n\nFor fine wrinkles, the support is narrower. In Renova's trials, 25% of lightly pigmented users had mild or moderate gains, against 12% on a dummy cream [^3]. The label says Renova has not shown an effect on deep wrinkles, dark spots or sagging skin [^3]. A two-year trial of a 0.05% cream in 204 people found more gains than a dummy cream for sun-damaged facial skin [^14]. Renova today is a 0.02% cream [^3].\n\nFor acute promyelocytic leukemia, 36% to 80% of patients on the capsules went into remission in the label's studies [^4]. A 2013 trial found retinoic acid with arsenic trioxide did at least as well as retinoic acid with chemotherapy [^16]. In pregnant rats, retinoic acid put on the skin in a solvent harmed the mothers [^19].","regulatory_status":"fda-approved","section_what_it_is":"Tretinoin is a substance the body makes from vitamin A, also called all-trans retinoic acid [^1] [^3]. It is not a peptide. It is the active part of prescription gels and lotions for acne [^1] [^2]. One cream is approved to soften fine facial wrinkles [^3].\n\nTretinoin also comes as a capsule taken by mouth [^4]. The capsule treats acute promyelocytic leukemia, a blood cancer [^4]. Brand names include Retin-A Micro, Altreno, Renova and Vesanoid [^5] [^6] [^7] [^8].","section_is_it_legal":"Tretinoin is FDA-approved: Drugs@FDA lists prescription products put on the skin and capsules taken by mouth [^5] [^6] [^7] [^8]. The skin gel and lotion are approved for acne [^1] [^2]. Renova cream is approved only as an add-on to soften fine facial wrinkles, along with sun protection [^3]. The capsules are approved for one kind of leukemia [^4]. The approval does not cover reversing skin ageing. Renova's label says it does not remove wrinkles or repair sun damage [^3]. Checked 26 October 2026.\n\nThe approved products named here need a prescription [^5] [^6] [^7]. Vesanoid, the brand-name capsule, is listed as discontinued [^8]. Drugs@FDA notes a Federal Register finding that it was not stopped for safety or effectiveness reasons [^8]. In December 2025, FDA posted draft advice for companies that want to make generic tretinoin cream [^9].\n\nPharmacies may compound with a raw substance that meets a USP standard or is part of an FDA-approved drug [^11]. Tretinoin is not on FDA's 503A category list [^12]. 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Trials have strict eligibility rules. Talk to your doctor and read the official record."}}}