Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Adapalene
Drug ID BADD_D00042
Description Acne vulgaris is a multifactorial disorder of the pilosebaceous unit involving increased sebum production, inflammation, and hyperproliferation/hyperkeratinization of the follicular infundibulum. It is also associated with _Cutibacterium acnes_ (also known as _Propionibacterium acnes_). Adapalene is a third-generation topical retinoid used for the treatment of acne vulgaris.[A193518] Adapalene has similar efficacy but a superior safety profile compared to tretinoin.[A193521] [Tazarotene] is more efficacious than adapalene but is designated as pregnancy category X and hence is contraindicated in pregnant women.[A193518] Adapalene can also be combined with benzoyl peroxide (BPO), which possesses bactericidal properties[A193524], and either adapalene alone, or adapalene BPO combination products, are commonly used to treat mild-to-severe acne.[A193518] Differin?, produced by Galderma Labs, was first granted FDA approval on May 31st, 1996, as a 0.1% adapalene topical solution. Differin was later made available as 0.1% gel, cream, or lotion, or 0.3% gel products. On December 8th, 2008, Galderma Labs gained FDA approval for Epiduo?, a 0.1% adapalene, 2.5% BPO combination gel.[L12873]
Indications and Usage For the topical treatment of comedo, papular and pustular acne (acne vulgaris) of the face, chest or back.
Marketing Status Prescription; OTC; Discontinued
ATC Code D10AD03
DrugBank ID DB00210
KEGG ID D01112
MeSH ID D000068816
PubChem ID 60164
TTD Drug ID D0JC9N
NDC Product Code 45802-453; 82034-888; 46014-1098; 0299-4910; 53296-0068; 0299-5915; 11673-888; 15308-0716; 68462-403; 51672-1377; 0363-0888; 51672-2143; 49967-591; 0472-0126; 36800-088; 0781-7142; 90027-010; 63629-8791; 71589-008; 24196-138; 70000-0043; 49967-354; 0299-5918; 55910-880; 21130-708; 0299-5912; 66039-801; 62332-549; 22365-120; 50090-2004; 71052-556; 0168-0424; 11410-956; 17337-0006; 66993-884; 42546-720; 41250-288; 59726-888
Synonyms Adapalene | 6-(3-(1-adamantyl)-4-methoxyphenyl)-2-naphthoic acid | CD 271 | 271, CD | CD271 | CD-271 | Adaferin | Differin | Differine
Chemical Information
Molecular Formula C28H28O3
CAS Registry Number 106685-40-9
SMILES COC1=C(C=C(C=C1)C2=CC3=C(C=C2)C=C(C=C3)C(=O)O)C45CC6CC(C4)CC(C6)C5
Chemical Structure
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Pruritus23.03.12.001--
Rash23.03.13.001--Not Available
Rash pustular11.01.12.002; 23.03.10.003--
Rash vesicular23.03.13.009--Not Available
Seborrhoeic dermatitis23.03.04.018--Not Available
Seizure17.12.03.001--
Skin discolouration23.03.03.005--Not Available
Skin discomfort23.03.03.006--Not Available
Skin exfoliation23.03.07.003--Not Available
Skin irritation23.03.04.009--Not Available
Sunburn12.05.02.001; 23.03.09.007--Not Available
Urticaria10.01.06.001; 23.04.02.001--
Excoriation12.01.06.007; 23.03.11.003--Not Available
Eyelids pruritus06.08.03.007; 23.03.12.005--Not Available
Skin swelling23.03.03.039--Not Available
Eyelid irritation06.04.04.007; 23.03.04.023--Not Available
Skin oedema23.06.04.001--Not Available
Foetal disorder18.03.02.001--Not Available
Skin abrasion12.01.06.010; 23.03.11.018--Not Available
Oral herpes07.05.07.002; 11.05.02.005--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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