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)
Acne23.02.01.001--Not Available
Angioedema10.01.05.009; 23.04.01.001--Not Available
Application site pain08.02.01.004; 12.07.01.004--Not Available
Burning sensation08.01.09.029; 17.02.06.001--Not Available
Conjunctivitis06.04.01.002; 11.01.06.012--
Dermatitis23.03.04.002--Not Available
Dermatitis atopic10.01.04.004; 23.03.04.016--Not Available
Dermatitis bullous23.03.01.002--
Dermatitis contact10.01.01.003; 12.03.01.040; 23.03.04.004--Not Available
Dermatitis exfoliative10.01.01.004; 23.03.07.001--
Drug ineffective08.06.01.006--Not Available
Dry skin23.03.03.001--
Eczema23.03.04.006--
Erythema23.03.06.001--Not Available
Erythema of eyelid06.04.04.003; 23.03.06.006--Not Available
Eye pain06.08.03.002--
Eyelid oedema06.04.04.004; 10.01.05.001; 23.04.01.003--Not Available
Face oedema08.01.07.003; 10.01.05.002; 23.04.01.004--
Feeling hot08.01.09.009--Not Available
Hepatitis09.01.07.004--Not Available
Herpes simplex11.05.02.001; 23.09.03.001--Not Available
Hypersensitivity10.01.03.003--
Instillation site pain08.02.01.008; 12.07.01.008--Not Available
Keratitis06.04.02.002--
Lip swelling07.05.04.005; 10.01.05.005; 23.04.01.007--Not Available
Optic neuritis06.04.08.002; 10.04.10.002; 17.04.05.001--Not Available
Pain08.01.08.004--
Pain of skin23.03.03.003--
Papilloedema06.09.02.002; 17.07.02.004; 24.03.07.001--
Photosensitivity reaction23.03.09.003--
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ADReCS-Target
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