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)
Abortion spontaneous18.01.04.0010.000457%-
Acne23.02.01.0010.010108%-
Angioedema10.01.05.009; 22.04.02.008; 23.04.01.001---
Application site pain08.02.01.004; 12.07.01.004---
Blister12.01.06.002; 23.03.01.0010.001555%-
Burning sensation08.01.09.029; 17.02.06.001---
Conjunctivitis06.04.01.002; 11.01.06.012--
Dermatitis23.03.04.0020.001006%-
Dermatitis atopic10.01.04.004; 23.03.04.016---
Dermatitis bullous23.03.01.002--
Dermatitis contact10.01.01.003; 12.03.01.040; 23.03.04.004---
Dermatitis exfoliative10.01.01.004; 23.03.07.001--
Drug ineffective08.06.01.0060.007455%-
Dry skin23.03.03.0010.016785%
Eczema23.03.04.006--
Erythema23.03.06.0010.020581%-
Erythema of eyelid06.04.04.003; 23.03.06.0060.000457%-
Eye irritation06.04.05.0030.002561%-
Eye pain06.08.03.002--
Eye swelling06.08.03.0030.001235%-
Eyelid oedema06.04.04.004; 10.01.05.001; 23.04.01.0030.001006%-
Face oedema08.01.07.003; 10.01.05.002; 23.04.01.0040.000457%
Feeling hot08.01.09.009---
Hepatitis09.01.07.004---
Herpes simplex11.05.02.001; 23.11.05.004---
Hypersensitivity10.01.03.0030.004665%
Instillation site pain08.02.01.008; 12.07.01.008---
Intracranial pressure increased17.07.02.0020.000457%-
Keratitis06.04.02.002--
Lip swelling07.05.04.005; 10.01.05.005; 23.04.01.007---
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ADReCS-Target
Drug Name ADR Term Target
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