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
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
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
Angioedema23.04.01.001; 10.01.05.009--Not Available
Application site pain12.07.01.004; 08.02.01.004--Not Available
Burning sensation17.02.06.001; 08.01.09.029--Not Available
Conjunctivitis11.01.06.012; 06.04.01.002--
Dermatitis23.03.04.002--Not Available
Dermatitis atopic23.03.04.016; 10.01.04.004--Not Available
Dermatitis bullous23.03.01.002--
Dermatitis contact12.03.01.040; 10.01.01.003; 23.03.04.004--Not Available
Dermatitis exfoliative23.03.07.001; 10.01.01.004--
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 oedema23.04.01.003; 10.01.05.001; 06.04.04.004--Not Available
Face oedema10.01.05.002; 23.04.01.004; 08.01.07.003--
Feeling hot08.01.09.009--Not Available
Hepatitis09.01.07.004--Not Available
Herpes simplex23.09.03.001; 11.05.02.001--Not Available
Hypersensitivity10.01.03.003--
Instillation site pain12.07.01.008; 08.02.01.008--Not Available
Keratitis06.04.02.002--
Lip swelling10.01.05.005; 07.05.04.005; 23.04.01.007--Not Available
Optic neuritis17.04.05.001; 10.04.10.002; 06.04.08.002--Not Available
Pain08.01.08.004--
Pain of skin23.03.03.003--
Papilloedema17.07.02.004; 06.09.02.002; 24.03.07.001--
Photosensitivity reaction23.03.09.003--
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