Last reviewed 2026-05-19 · How we verify

Retin-A (TRETINOIN)

Retin-A (generic name: TRETINOIN) is a Retinoid [EPC] Small molecule drug developed by Bausch Health. It is currently FDA-approved (first approved 1971) for Acne vulgaris, Acute promyelocytic leukemia, FAB M3, Chloasma.

Tretinoin works by binding to and activating nuclear receptors, which helps to regulate cell growth and differentiation.

Retin-A, also known as isotretinoin, is a small molecule used to treat various conditions, including HIV-1 infection, leukemia, cervical cancer, photoaging, scars, and hypertrophic scars. It is studied in combination with other treatments, such as ATRA, 6-MP, and MTX, for its potential effects on immune activation and other therapeutic outcomes.

At a glance

Mechanism of action

Mode of Action. Although the exact mode of action of tretinoin is unknown, current evidence suggests that the effectiveness of tretinoin in acne is due primarily to its ability to modify abnormal follicular keratinization. Comedones form in follicles with an excess of keratinized epithelial cells. Tretinoin promotes detachment of cornified cells and the enhanced shedding of corneocytes from the follicle. By increasing the mitotic activity of follicular epithelia, tretinoin also increases the turnover rate of thin, loosely-adherent corneocytes. Through these actions, the comedo contents are extruded and the formation of the microcomedo, the precursor lesion of acne vulgaris, is reduced.Additionally, tretinoin acts by modulating the proliferation and differentiation of epidermal cells. These effects are mediated by tretinoins interaction with family of nuclear retinoic receptors. Activation of these nuclear receptors causes changes in gene expression. The exact mechanisms whereby tretino

Approved indications

• Acne vulgaris
• Acute promyelocytic leukemia, FAB M3
• Chloasma
• Facial Fine Wrinkling
• Fine Wrinkling
• Hyperkeratosis
• Kaposi's Sarcoma Skin Lesions
• Mottle Hyperpigmentation
• Severe Recalcitrant Nodular Acne
• Solar Lentigines

Boxed warnings

• WARNING: EMBRYO-FETAL TOXICITY and DIFFERENTIATION SYNDROME • Tretinoin capsules can cause embryo-fetal loss and malformations when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Females of reproductive potential must have a negative pregnancy test before initiating tretinoin capsules. Advise females of reproductive potential to use two effective methods of contraception during treatment with tretinoin capsules and for 1 month after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with tretinoin capsules and for 1 week after the last dose [see Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.3)] . • Differentiation Syndrome, which can be life-threatening or fatal, occurred in about 26% of patients with APL who received tretinoin capsules. At first signs or symptoms of this syndrome, immediately initiate high-dose corticosteroid therapy and hemodynamic monitoring until resolution of signs and symptoms. Consider withholding tretinoin capsules for moderate and severe Differentiation Syndrome until resolution [see Warnings and Precautions (5.2)] . WARNING: EMBRYO-FETAL TOXICITY and DIFFERENTIATION SYNDROME See full prescribing information for complete boxed warning. • Embryo-Fetal Toxicity: tretinoin capsules can cause embryo-fetal loss and malformations when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Females of reproductive potential must have a negative pregnancy test before initiating tretinoin capsules. Advise females of reproductive potential to use two effective methods of contraception during treatment with tretinoin capsules and for 1 month after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with tretinoin capsules and for 1 week after the last dose. (5.1, 8.1, 8.3) • Differentiation Syndrome, which can be life-threatening or fatal, occurred in about 26% of patients with APL who received tretinoin capsules. At first signs or symptoms of this syndrome, immediately initiate high-dose corticosteroid therapy and hemodynamic monitoring until resolution of signs and symptoms. Consider withholding tretinoin capsules for moderate and severe Differentiation Syndrome until resolution. (5.2)

Common side effects

• Excessive redness
• Edema
• Blistering
• Crusting
• Hyperpigmentation
• Hypopigmentation
• Heightened susceptibility to sunlight

Key clinical trials

• Lenalidomide and Dinutuximab With or Without Isotretinoin in Treating Younger Patients With Refractory or Recurrent Neuroblastoma (PHASE1)
• Dinutuximab With Chemotherapy, Surgery and Stem Cell Transplantation for the Treatment of Children With Newly Diagnosed High Risk Neuroblastoma (PHASE3)
• Metronomic Chemotherapy in Wilms Tumor (MetroWilms-1906) (PHASE1,PHASE2)
• A Study Comparing Tretinoin Gel Microsphere, 0.04% and RETIN-A MICRO ® Gel Microsphere, 0.04% in the Treatment of Acne Vulgaris (PHASE1)
• Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma (PHASE3)
• Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL) (PHASE3)
• All-Trans Retinoic Acid (ATRA) Plus PD-1 Inhibition in Recurrent IDH-Mutant Glioma (PHASE2)
• Tretinoin and Arsenic Trioxide in Treating Patients With Untreated Acute Promyelocytic Leukemia (PHASE3)

Patents

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Retin-A CI brief — competitive landscape report
• Retin-A updates RSS · CI watch RSS
• Bausch Health portfolio CI

Frequently asked questions about Retin-A

Related

• Drug class: All Retinoid [EPC] drugs
• Target: All drugs targeting Nuclear receptor ROR-beta
• Manufacturer: Bausch Health — full pipeline
• Therapeutic area: All drugs in Oncology
• Indication: Drugs for Acne vulgaris
• Indication: Drugs for Acute promyelocytic leukemia, FAB M3
• Indication: Drugs for Chloasma

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing