Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Azelaic acid
Drug ID BADD_D00197
Description Azelaic acid is a saturated dicarboxylic acid found naturally in wheat, rye, and barley. It is also produced by _Malassezia furfur_, also known as _Pityrosporum ovale_, which is a species of fungus that is normally found on human skin. Azelaic acid is effective against a number of skin conditions, such as mild to moderate acne, when applied topically in a cream formulation of 20%. It works in part by stopping the growth of skin bacteria that cause acne, and by keeping skin pores clear. Azelaic acid's antimicrobial action may be attributable to inhibition of microbial cellular protein synthesis.
Indications and Usage For the topical treatment of mild-to-moderate inflammatory acne vulgaris.
Marketing Status approved
ATC Code D10AX03
DrugBank ID DB00548
KEGG ID D03034
MeSH ID C010038
PubChem ID 2266
TTD Drug ID D0E4WR
NDC Product Code 0781-7172; 60862-007; 51552-0112; 76003-0026; 50222-303; 71052-638; 50090-4473; 16110-869; 68462-626; 48041-4700; 48041-4701; 51927-5188; 54236-050; 66039-911; 0591-2131; 51672-1389; 0115-1624; 50222-505
UNII F2VW3D43YT
Synonyms azelaic acid | nonanedioic acid | azelaic acid, dilithium salt | azelaic acid, dipotassium salt | monosodium azelate | azelaic acid, monosodium salt | azelaic acid, potassium salt | azelaic acid, sodium salt | Azelex | Finacea | skinoren | azelaic acid, disodium salt
Chemical Information
Molecular Formula C9H16O4
CAS Registry Number 123-99-9
SMILES C(CCCC(=O)O)CCCC(=O)O
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)
Acne23.02.01.0010.004416%-
Application site erythema08.02.01.001; 12.07.01.001; 23.03.06.0050.004907%-
Application site pain08.02.01.004; 12.07.01.0040.004661%-
Application site pruritus08.02.01.005; 12.07.01.005; 23.03.12.0040.002502%-
Application site rash08.02.01.016; 12.07.01.016; 23.03.13.0080.001668%-
Application site reaction08.02.01.006; 12.07.01.006---
Asthma10.01.03.010; 22.03.01.002---
Blister12.01.06.002; 23.03.01.0010.001668%-
Burning sensation08.01.09.029; 17.02.06.0010.013592%-
Cough22.02.03.0010.001325%
Dermatitis23.03.04.002---
Dermatitis contact10.01.01.003; 12.03.01.040; 23.03.04.0040.001914%-
Drug hypersensitivity10.01.01.0010.002502%-
Drug ineffective08.06.01.0060.020020%-
Dry skin23.03.03.0010.004171%
Dyspnoea02.11.05.003; 22.02.01.0040.000736%
Dyspnoea at rest02.11.05.004; 22.02.01.0250.000491%-
Erythema23.03.06.0010.009912%-
Face oedema08.01.07.003; 10.01.05.002; 23.04.01.0040.001079%
Hypersensitivity10.01.03.0030.005005%
Hypertrichosis23.02.04.002--
Iridocyclitis06.04.03.001---
Leukoderma23.05.02.001---
Oedema08.01.07.006; 14.05.06.010---
Pain08.01.08.0040.004073%
Pain of skin23.03.03.0030.002502%
Paraesthesia17.02.06.005; 23.03.03.0940.003337%
Photosensitivity reaction23.03.09.003--
Presyncope02.11.04.013; 17.02.05.009; 24.06.02.0100.000491%
Pruritus23.03.12.0010.007753%
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