Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Tretinoin
Drug ID BADD_D02270
Description Tretinoin, also known as all-trans-retinoic acid (ATRA), is a naturally occurring derivative of vitamin A (retinol). Retinoids such as tretinoin are important regulators of cell reproduction, proliferation, and differentiation and are used to treat acne and photodamaged skin and to manage keratinization disorders such as ichthyosis and keratosis follicularis. Tretinoin also represents the class of anticancer drugs called differentiating agents and is used in the treatment of acute promyelocytic leukemia (APL).
Indications and Usage For the the induction of remission in patients with acute promyelocytic leukemia (APL), French-American-British (FAB) classification M3 (including the M3 variant); For the topical treatment of acne vulgaris, flat warts and other skin conditions (psoriasis, ichthyosis congenita, icthyosis vulgaris, lamellar icthyosis, keratosis palmaris et plantaris, epidermolytic hyperkeratosis, senile comedones, senile keratosis, keratosis follicularis (Darier's disease), and basal cell carcinomas.); For palliative therapy to improve fine wrinkling, mottled hyperpigmentation, roughness associated with photodamage. Tretinoin is also indicated in combination with [benzoyl peroxide] for the treatment of acne vulgaris in patients aged nine years and older.[L34869]
Marketing Status approved; investigational; nutraceutical
ATC Code D10AD01; L01XF01
DrugBank ID DB00755
KEGG ID D00094
MeSH ID D014212
PubChem ID 444795
TTD Drug ID D02DGU
NDC Product Code 17337-0036; 17337-0045; 42291-870; 0187-5160; 51672-1395; 70518-3223; 0904-6867; 76055-0007; 79572-030; 0187-0005; 51672-1407; 62032-413; 0378-8083; 0378-8090; 0378-8093; 68462-792; 76420-159; 0187-5150; 0187-5172; 53002-8101; 0378-6141; 68084-075; 68682-513; 68682-514; 0555-0808; 0574-2201; 0574-2225; 62032-414; 63629-9123; 63629-9124; 0378-8086; 0574-2205; 55361-0029; 62049-003; 16714-249; 62032-417; 0378-8082; 0378-8084; 49452-6243; 55361-0028; 0187-5140; 0187-5148; 0187-5164; 0187-5170; 51672-1394; 63629-2285; 68682-800; 0574-2301; 51552-0120; 10370-268; 64566-0009; 71052-401; 0187-5146; 0378-8085; 0378-8092; 68634-069; 50090-0651; 0472-0117; 70518-3233; 51927-1270; 62032-412; 68071-2674; 0574-2325; 62991-2057; 0187-5144; 50090-4347; 63629-8752; 38779-0001; 48943-0011; 13548-070; 16714-250; 0187-5162
UNII 5688UTC01R
Synonyms Tretinoin | Retinoic Acid | Acid, Retinoic | Vitamin A Acid | Acid, Vitamin A | all-trans-Retinoic Acid | Acid, all-trans-Retinoic | all trans Retinoic Acid | trans-Retinoic Acid | Acid, trans-Retinoic | trans Retinoic Acid | Retin-A | Retin A | Tretinoin Potassium Salt | Potassium Salt, Tretinoin | Salt, Tretinoin Potassium | Tretinoin Zinc Salt | Salt, Tretinoin Zinc | Zinc Salt, Tretinoin | Vesanoid | beta-all-trans-Retinoic Acid | Acid, beta-all-trans-Retinoic | beta all trans Retinoic Acid | Tretinoin Sodium Salt | Salt, Tretinoin Sodium | Sodium Salt, Tretinoin
Chemical Information
Molecular Formula C20H28O2
CAS Registry Number 302-79-4
SMILES CC1=C(C(CCC1)(C)C)C=CC(=CC=CC(=CC(=O)O)C)C
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.001---
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Abortion spontaneous18.01.04.0010.000107%-
Acidosis14.01.03.002--
Acne23.02.01.0010.000544%-
Acute febrile neutrophilic dermatosis01.02.01.006; 23.03.03.0330.000213%-
Acute myeloid leukaemia01.10.05.001; 16.01.05.0010.000160%-
Acute myocardial infarction02.02.02.001; 24.04.04.0010.000107%-
Acute promyelocytic leukaemia01.10.05.003; 16.01.05.0030.000107%-
Acute respiratory failure14.01.04.004; 22.02.06.0010.000107%-
Agitation17.02.05.012; 19.06.02.001--
Alopecia23.02.02.0010.000416%
Anxiety19.06.02.002--
Aphasia17.02.03.001; 19.21.01.0010.000107%
Application site erythema08.02.01.001; 12.07.01.001; 23.03.06.0050.000598%-
Application site irritation08.02.01.003; 12.07.01.0030.000416%-
Application site oedema08.02.01.020; 12.07.01.020---
Application site pain08.02.01.004; 12.07.01.0040.000960%-
Application site pruritus08.02.01.005; 12.07.01.005; 23.03.12.004---
Application site rash08.02.01.016; 12.07.01.016; 23.03.13.008---
Arrhythmia02.03.02.001---
Arthralgia15.01.02.001--
Ascites02.05.04.002; 07.07.01.001; 09.01.05.003--
Asterixis09.01.03.004; 17.01.06.001---
Asthenia08.01.01.001---
Asthma10.01.03.010; 22.03.01.002---
Atrioventricular block complete02.03.01.0030.000107%
Auditory disorder04.02.03.002---
Back pain15.03.04.005--
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