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 Adapalene is indicated for the topical treatment of acne vulgaris in patients aged 12 and over.[L12873]
Marketing Status approved
ATC Code D10AD03
DrugBank ID DB00210
KEGG ID D01112
MeSH ID D000068816
PubChem ID 60164
TTD Drug ID D0JC9N
NDC Product Code 51672-1377; 63629-8791; 0363-0888; 68308-706; 68462-403; 0299-5915; 59726-888; 66993-884; 72559-015; 72657-102; 82034-888; 15308-0716; 22365-120; 0299-5912; 0472-0126; 70000-0043; 36800-088; 0299-4910; 17337-0006; 24196-138; 53296-0068; 90027-010; 0168-0424; 49908-118; 62332-549; 46014-1098; 66039-801; 11410-956; 11673-888; 49967-354; 49967-591; 0316-0143; 71052-556; 73309-390; 45802-453; 0299-5918; 69842-088; 21130-708; 41250-288; 51672-2150
UNII 1L4806J2QF
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
*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)
Optic neuritis10.02.01.097; 17.04.05.001; 06.04.08.002--Not Available
Pain08.01.08.004--
Pain of skin23.03.03.0030.004894%
Papilloedema24.03.07.001; 17.07.02.004; 06.09.02.002--
Photosensitivity reaction23.03.09.003--
Pruritus23.03.12.0010.004253%
Pulmonary embolism24.01.06.001; 22.06.02.0010.000457%Not Available
Rash23.03.13.0010.004116%Not Available
Rash erythematous23.03.13.0290.001555%Not Available
Rash macular23.03.13.0030.001555%Not Available
Rash papular23.03.13.0170.002333%Not Available
Rash pustular23.03.10.003; 11.01.12.002--
Rash vesicular23.03.13.009--Not Available
Seborrhoeic dermatitis23.03.04.018--Not Available
Seizure17.12.03.001--
Skin discolouration23.03.03.0050.001235%Not Available
Skin discomfort23.03.03.006--Not Available
Skin exfoliation23.03.07.0030.010016%Not Available
Skin fissures23.03.03.0080.003110%Not Available
Skin irritation23.03.04.0090.007775%Not Available
Sunburn12.05.02.001; 23.03.09.007--Not Available
Swelling face23.04.01.018; 10.01.05.018; 08.01.03.1000.002790%Not Available
Urticaria23.04.02.001; 10.01.06.0010.003339%
Skin tightness23.03.03.0180.001006%Not Available
Eyelids pruritus23.03.12.005; 06.08.03.007--Not Available
Skin swelling23.03.03.039--Not Available
Skin burning sensation23.03.03.021; 17.02.06.0090.021679%Not Available
Eyelid irritation23.03.04.023; 06.04.04.007--Not Available
Skin oedema23.06.04.001--Not Available
Foetal disorder18.03.02.001--Not Available
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ADReCS-Target
Drug Name ADR Term Target
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