Non-peptide
Tretinoin
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.
This page has not been individually reviewed by a clinician.
Fact sheet · 6 facts
every row cites its source and its date| Fact | Value | Tier | Checked | Source |
|---|---|---|---|---|
| Also called | all-trans retinoic acid, Retin-A, Vesanoid | primary | accessdata.fda.gov | |
| Class | non-peptide | primary | accessdata.fda.gov | |
| Regulatory status | fda-approved | primary | accessdata.fda.gov | |
| Status source read | 2026-10-26 | primary | accessdata.fda.gov | |
| Evidence grade | strong-human | our assessment | peptideindex.ai | |
| Label 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. | primary | accessdata.fda.gov |
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.
Our assessment, drawn from the sources below.
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].
Tretinoin 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].
Where it stands legally
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.
The 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].
Pharmacies 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]. It is not among the substances FDA says may present significant safety risks [13].
What the evidence shows
Evidence grade: strong-human · our assessment
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].
For 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].
For 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].
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].
What nobody knows yet
- 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].
Legitimate ways to get it
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].
Pharmacies may compound with a raw substance that is part of an FDA-approved drug [11].
One 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.
Approved product
Approved by FDA as a prescription gel put on the skin, in four strengths.
Brand names: Retin-A Micro
Manufacturer: Bausch
Indication: Acne in adults and children 12 years and older.
Approved product
Approved by FDA as a prescription 0.05% lotion put on the skin.
Brand names: Altreno
Manufacturer: Dow Pharm
Indication: Acne in people 9 years and older.
Approved product
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.
Brand names: Renova
Manufacturer: Valeant Pharms North
Indication: An add-on to soften fine facial wrinkles in people who use full skin care and avoid the sun.
Approved product
Approved by FDA as a prescription capsule taken by mouth. The brand is discontinued, not for safety or effectiveness reasons.
Brand names: Vesanoid
Manufacturer: Cheplapharm
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.
Lawful compounding
Pharmacies may compound with a raw substance that meets a USP standard or is part of an FDA-approved drug.
Recruiting trials
A listing is not a recommendation. Trials have strict eligibility rules. Talk to your doctor and read the official record.
Snapshot of .clinicaltrials.gov
NCT07848568
Testing Safe Doses of Anti-Cancer Medicines, 5-Flurouracil (5-FU) and Tretinoin (ATRA), Added to the Usual Cancer Treatment of Ependymoma
Phase: Phase 1/Phase 2 · Sponsor: Children's Oncology Group · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT07842887
Phase 1 Study of ATRA Plus a PD-1 Inhibitor in EGFR-Mutant NSCLC After Third-Generation EGFR-TKI Resistance
Phase: Phase 1 · Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Status: Not yet recruiting
Countries: China
US states: none listed
NCT07779811
Topical Metformin Versus Triple Regimen for Epidermal Melasma
Phase: Phase 2 · Sponsor: Combined Military Hospital, Pakistan · Status: Not yet recruiting
Countries: Pakistan
US states: none listed
NCT07732192
Oral Tranexamic Acid Plus Triple Combination vs Triple Combination Alone in Melasma
Phase: Phase 4 · Sponsor: Combined Military Hospital Abbottabad · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT07504458
Pivotal Open-label Phase 3 Clinical Study of QTX-2101 in Adult Patients With Acute Promyelocytic Leukemia
Phase: Phase 3 · Sponsor: Quetzal Therapeutics · Status: Recruiting
Countries: United States, France, Italy, Romania, Spain
US states: Alabama, California, Georgia, Kentucky, Maryland, Michigan, New York, North Carolina, Ohio, Tennessee, Texas, Virginia
NCT07626398
All-Trans Retinoic Acid for the Treatment of Hemophagocytic Lymphohistiocytosis
Phase: Phase 2/Phase 3 · Sponsor: Beijing Anzhen Hospital · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT07597395
ATRA for Management of Primary ITP
Phase: Phase 3 · Sponsor: Peking University People's Hospital · Status: Not yet recruiting
Countries: China
US states: none listed
NCT07348107
ATRA and SDK002 in Combination With Chemotherapy and Anti-PD-1 Inhibitor in Patients With Advanced Pancreatic Ductal Adenocarcinoma.
Phase: Phase 1 · Sponsor: Daniel Breadner · Status: Not yet recruiting
Countries: Canada
US states: none listed
NCT07137130
Secretome TGF Beta 3
Phase: Not applicable · Sponsor: Universitas Indonesia · Status: Not yet recruiting
Countries: Indonesia
US states: none listed
NCT07355855
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
Phase: Phase 2 · Sponsor: Fudan University · Status: Not yet recruiting
Countries: China
US states: none listed
NCT07296445
A Trial to Investigate Whether Oral Arsenic Trioxide Is Similar to Intravenous Arsenic Trioxide in Pharmacokinetics, Safety, and Efficacy (LATITUDE/SDKARS-301)
Phase: Phase 3 · Sponsor: SDK Therapeutics, Inc. · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT07366229
Topical Application of Engineered Lactobacillus Reuteri With a Zinc Sulfate-Tannic Acid MPN Coating for Acne
Phase: Phase 2 · Sponsor: Shenzhen People's Hospital · Status: Recruiting
Countries: China
US states: none listed
NCT07586826
Romiplostim N01 Plus ATRA for Persistent Isolated Chemotherapy-Induced Thrombocytopenia After Complete Remission of Gynecologic, Breast, or Lung Solid Tumors
Phase: Phase 2 · Sponsor: Peking University People's Hospital · Status: Recruiting
Countries: China
US states: none listed
NCT07586813
Romiplostim N01 Plus ATRA for Persistent Isolated Chemotherapy-Induced Thrombocytopenia After Complete Remission of Gastrointestinal Solid Tumors
Phase: Phase 2 · Sponsor: Peking University People's Hospital · Status: Recruiting
Countries: China
US states: none listed
NCT07278908
Avatrombopag Combined With All-trans Retinoic Acid in the Treatment of Primary Immune Thrombocytopenia
Phase: Phase 2/Phase 3 · Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT06528769
Study of All-Trans Retinoic Acid (ATRA) and Cemiplimab in Patients With Advanced Leiomyosarcoma
Phase: Phase 2 · Sponsor: Gabriel Tinoco · Status: Recruiting
Countries: United States
US states: Ohio
NCT07154030
Efficacy Of Combined Microneedling Plus Tretinoin In Treatment Of Stria Rubra
Phase: Phase 1 · Sponsor: Sohag University · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT07079696
Investigating the Therapeutic Efficacy of All-trans Retinoic Acid in Autism Spectrum Disorder Patients With 15q11-13 Duplication Syndrome
Phase: Phase 2 · Sponsor: Second Affiliated Hospital, Zhejiang University, School of Medicine · Status: Not yet recruiting
Countries: China
US states: none listed
NCT07142070
Effect of Systemic Retinoic Acid Use on Micro Ribonucleic Acid (mRNA) Expression
Phase: Not applicable · Sponsor: Medipol University · Status: Not yet recruiting
Countries: Turkey (Türkiye)
US states: none listed
NCT07503730
Early Use of Realgar-Indigo Naturalis Formula (RIF) Combined With All-trans Retinoic Acid (ATRA) for Treating Acute Promyelocytic Leukemia (APL).
Phase: Phase 3 · Sponsor: First Affiliated Hospital Xi'an Jiaotong University · Status: Recruiting
Countries: China
US states: none listed
NCT06925386
The Relationship Between Microbioma Balance and Acne Vulgaris as a New Acne Treatment
Phase: Phase 2 · Sponsor: Universitas Padjadjaran · Status: Not yet recruiting
Countries: Indonesia
US states: none listed
NCT06447480
Clinical Trial to Compare Oral Isotretinoin to Standard of Care in Moderate Acne Skin of Color Patients
Phase: Phase 3 · Sponsor: Centre Hospitalier Universitaire de Nice · Status: Recruiting
Countries: France, French Guiana
US states: none listed
NCT06698263
13-cis Retinoic Acid (Isotretinoin) and Sperm Production
Phase: Phase 4 · Sponsor: University Hospital, Strasbourg, France · Status: Not yet recruiting
Countries: France
US states: none listed
NCT06706401
Lymphocyte-Sparing And Radio-Immunotherapy in Head and Neck Carcinoma
Phase: Phase 3 · Sponsor: Centre Leon Berard · Status: Recruiting
Countries: France
US states: none listed
NCT06358677
Topical Tretinoin Prophylaxis for Anti-EGFR Induced Skin Toxicity in Patients With Solid Tumors
Phase: Phase 2 · Sponsor: University of Utah · Status: Recruiting
Countries: United States
US states: Utah
NCT06780644
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
Phase: Not applicable · Sponsor: Universitas Indonesia · Status: Not yet recruiting
Countries: Indonesia
US states: none listed
NCT06841952
Study of Tretinoin Capsules in Combination With Azacitidine and Venetoclax in Treatment Naïve Participants With Acute Myeloid Leukemia
Phase: Not applicable · Sponsor: The First Affiliated Hospital of Soochow University · Status: Not yet recruiting
Countries: China
US states: none listed
NCT06731140
Reverse HER2-negative Immune Resistant Breast Cancer
Phase: Phase 2 · Sponsor: Fudan University · Status: Recruiting
Countries: China
US states: none listed
NCT06646666
ARTA-based Chemo-free Bridging/Maintenance Therapy in CAR-T Treatment for High-Risk R/R B-NHL Ineligible for HDCT and ASCT
Phase: Phase 2 · Sponsor: Ruijin Hospital · Status: Not yet recruiting
Countries: China
US states: none listed
NCT05474859
Subjects With Advanced or Metastatic Solid Tumor Malignancies
Phase: Phase 1 · Sponsor: Xenthera, Inc. · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT06703047
Tislelizumab Combined with Chemotherapy and All Trans Retinoic Acid for Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma
Phase: Phase 2 · Sponsor: Fudan University · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT06484920
A Phase II Study of the Combination of Pembrolizumab and ATRA Combination Treatment of Relapsed HL and B-NHL
Phase: Phase 2 · Sponsor: Rita Assi · Status: Recruiting
Countries: United States
US states: Indiana
NCT06636981
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
Phase: Phase 2 · Sponsor: Fudan University · Status: Recruiting
Countries: China
US states: none listed
NCT06371274
A Study on the Efficacy and Safety of Oral All-trans Retinoic Acid Combined With Toripalimab in TNBC.
Phase: Not applicable · Sponsor: First Affiliated Hospital of Zhejiang University · Status: Recruiting
Countries: China
US states: none listed
NCT06536413
ATRA and Carfilzomib in Plasma Cell Myeloma Patients
Phase: Phase 1/Phase 2 · Sponsor: The Methodist Hospital Research Institute · Status: Recruiting
Countries: United States
US states: Texas
NCT06439888
Lymphocyte Support to SBRT in Patients With Oligo-metastatic Solid Cancer
Phase: Phase 1/Phase 2 · Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Status: Recruiting
Countries: France
US states: none listed
NCT06172296
Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma
Phase: Phase 3 · Sponsor: National Cancer Institute (NCI) · Status: Recruiting
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
NCT06274164
Clinical and Molecular Biomarker Studies in RAI1 (Retinoic Acid-Induced 1) -Related Disorders
Phase: Not stated · Sponsor: Baylor College of Medicine · Status: Recruiting
Countries: United States
US states: Texas
NCT06158412
All-trans Retinoic Acid in Combination With a KPD Regimen for the Treatment of Refractory/Relapsed Multiple Myeloma
Phase: Phase 2 · Sponsor: The First Affiliated Hospital of Xiamen University · Status: Recruiting
Countries: China
US states: none listed
NCT05553782
Drug Screening Using Novel IMD in Salivary and Head and Neck Cancers
Phase: Early phase 1 · Sponsor: Brigham and Women's Hospital · Status: Recruiting
Countries: United States
US states: Massachusetts
NCT06982274
Oral Arsenic With ATRA for Newly Diagnosed Patients With Acute Promyelocytic Leukemia
Phase: Phase 2 · Sponsor: Instituto do Cancer do Estado de São Paulo · Status: Recruiting
Countries: Brazil
US states: none listed
NCT05881265
Treatment of Chidamide and Venetoclax for Retinoic Acid and Arsenic Resistant Acute Promyelocytic Leukemia
Phase: Phase 2 · Sponsor: Shanghai Jiao Tong University School of Medicine · Status: Recruiting
Countries: China
US states: none listed
NCT05345002
All-Trans Retinoic Acid (ATRA) Plus PD-1 Inhibition in Recurrent IDH-Mutant Glioma
Phase: Phase 2 · Sponsor: Stephen Bagley, MD, MSCE · Status: Recruiting
Countries: United States
US states: Pennsylvania
NCT05384821
Metronomic Chemotherapy in Wilms Tumor (MetroWilms-1906)
Phase: Phase 1/Phase 2 · Sponsor: Centre Oscar Lambret · Status: Recruiting
Countries: France
US states: none listed
NCT04897490
RWE of 1st Line Treatment With ATO/ATRA for Adult APL
Phase: Not stated · Sponsor: Grupo Argentino de Tratamiento de la Leucemia Aguda · Status: Recruiting
Countries: Argentina
US states: none listed
NCT04793919
Treatment Study for Children and Adolescents With Acute Promyelocytic Leukemia
Phase: Phase 2 · Sponsor: Associazione Italiana Ematologia Oncologia Pediatrica · Status: Recruiting
Countries: Belgium, Czechia, Denmark, France, Germany, Ireland, Israel, Italy, Netherlands, Portugal, Spain, Sweden
US states: none listed
NCT03126916
Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)
Phase: Phase 3 · Sponsor: Children's Oncology Group · Status: Recruiting
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
NCT01409161
Tretinoin and Arsenic Trioxide With or Without Gemtuzumab Ozogamicin in Treating Patients With Previously Untreated Acute Promyelocytic Leukemia
Phase: Phase 2 · Sponsor: M.D. Anderson Cancer Center · Status: Recruiting
Countries: United States
US states: Texas
How people are getting it anyway
This section describes what happens and is not a recommendation.
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].
Some 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].
Compounding outside the rules
Compounded tretinoin creams and mixes made by pharmacies, sometimes with other drugs such as hydroquinone, clindamycin or minoxidil.
The lawA pharmacy may compound with a substance that meets a USP standard or is part of an FDA-approved drug.fda.gov
Documented riskFDA recall records list compounded tretinoin creams and gels recalled for lack of assurance that they were sterile.api.fda.gov
Enforcement FDA recall records list a recall of compounded tretinoin creams and gels in all strengths for lack of assurance of sterility.api.fda.gov
Enforcement FDA recall records list a recall of compounded formulas mixing minoxidil, tretinoin and fluocinolone, for weak process controls.api.fda.gov
Sources
- [1]Retin-A Micro (tretinoin) gel label, revised September 2025Label · primary
- [2]Altreno (tretinoin) lotion label, revised August 2018Label · primary
- [3]Renova (tretinoin) cream 0.02% labelLabel · primary
- [4]Vesanoid (tretinoin) capsules label, revised October 2024Label · primary
- [5]Drugs@FDA: Retin-A Micro (tretinoin) gel, application 020475Regulatory · primary
- [6]Drugs@FDA: Altreno (tretinoin) lotion, application 209353Regulatory · primary
- [7]Drugs@FDA: Renova (tretinoin) cream, application 021108Regulatory · primary
- [8]Drugs@FDA: Vesanoid (tretinoin) capsules, application 020438Regulatory · primary
- [9]FDA draft product-specific guidance on tretinoin cream, December 2025Regulatory · primary
- [10]FDA drug enforcement reports (openFDA): recalls naming tretinoinRegulatory · primary
- [11]FDA: bulk drug substances used in compounding under section 503ARegulatory · primary
- [12]FDA: 503A bulk drug substances category listRegulatory · primary
- [13]FDA: bulk drug substances that may present significant safety risks (Category 2)Regulatory · primary
- [14]Two-year randomized trial: tretinoin 0.05% cream against placebo in sun-damaged facial skin, 2005Rct · peer-reviewed
- [15]Analysis of two randomized phase 3 trials: tretinoin 0.05% lotion in acne, by sex and race, 2019Rct · peer-reviewed
- [16]Randomized phase 3 trial: retinoic acid with arsenic trioxide against retinoic acid with chemotherapy in acute promyelocytic leukemia, 2013Rct · peer-reviewed
- [17]VA randomized trial: topical tretinoin and death from any cause in 1131 veterans, 2009Rct · peer-reviewed
- [18]Systematic review: pregnancy outcomes after first-trimester exposure to topical retinoids, 2015Systematic review · peer-reviewed
- [19]Study in pregnant rats: retinoic acid on the skin and fetal outcome, 1990Animal · peer-reviewed
- [20]ClinicalTrials.gov NCT06358677: topical tretinoin to prevent skin toxicity from anti-EGFR cancer drugsReference · primary
- [21]ClinicalTrials.gov NCT01409161: tretinoin and arsenic trioxide in acute promyelocytic leukemiaReference · primary
- [22]HealthDay via ABC News: acne cream not linked to raised death risk, January 2009Reference · established-news
Last verified · 6 facts · 8 sources
- api.fda.gov
- clinicaltrials.gov
- peptideindex.ai
- peptideindex.ai
- accessdata.fda.gov
- accessdata.fda.gov
- accessdata.fda.gov
- accessdata.fda.gov
Primary source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=020475
Machine readers: JSON · Markdown · Status history: Change log
Information, not medical advice.
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