Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Pimecrolimus
Drug ID BADD_D01773
Description Pimecrolimus is an immunomodulating agent that was first marketed by Novartis under the trade name Elidel. It is now promoted in Canada by Galderma since early 2007. It is currently available as a topic cream used in the treatment of atopic dermatitis (eczema).
Indications and Usage For treatment of mild to moderate atopic dermatitis.
Marketing Status approved; investigational
ATC Code D11AH02
DrugBank ID DB00337
KEGG ID D05480
MeSH ID C117268
PubChem ID 6447131
TTD Drug ID D0Z4UN
NDC Product Code 55486-1585; 68682-112; 62227-004; 68254-0014; 0187-5102; 0591-2944; 62227-024; 65727-045; 0187-5101; 53296-0115; 0187-5100; 68682-110; 68462-609; 68682-111; 51552-1620; 16436-0115; 0187-5103
UNII 7KYV510875
Synonyms pimecrolimus | 33-epi-chloro-33-desoxyascomycin | SDZ ASM 981 | SDZ-ASM-981 | ASM 981 | Elidel
Chemical Information
Molecular Formula C43H68ClNO11
CAS Registry Number 137071-32-0
SMILES CCC1C=C(CC(CC(C2C(CC(C(O2)(C(=O)C(=O)N3CCCCC3C(=O)OC(C(C(CC1=O)O)C)C(=CC4CCC(C(C 4)OC)Cl)C)O)C)OC)OC)C)C
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)
Depressed level of consciousness17.02.04.0020.000466%
Dermatitis23.03.04.002---
Dermatitis atopic10.01.04.004; 23.03.04.016---
Dermatitis bullous23.03.01.002--
Dermatitis exfoliative10.01.01.004; 23.03.07.001--
Diarrhoea07.02.01.0010.000700%
Drug hypersensitivity10.01.01.0010.001026%-
Drug ineffective08.06.01.0060.003079%-
Dry skin23.03.03.0010.001260%
Dysmenorrhoea21.01.01.002--
Dyspnoea02.11.05.003; 22.02.01.004--
Ear disorder04.03.01.001---
Ear infection04.03.01.006; 11.01.05.001---
Ear pain04.03.01.003--
Eczema23.03.04.0060.001166%
Eczema herpeticum10.01.04.006; 11.05.02.016; 23.03.04.026---
Epistaxis22.04.03.001; 24.07.01.005--
Erythema23.03.06.0010.002752%-
Eye disorder06.08.03.001---
Eye infection06.04.05.007; 11.01.06.001--
Eye irritation06.04.05.0030.001026%-
Eye pain06.08.03.002--
Face oedema08.01.07.003; 10.01.05.002; 23.04.01.004--
Flushing08.01.03.025; 23.06.05.003; 24.03.01.002--
Folliculitis11.02.01.053; 23.11.04.003--
Furuncle11.02.05.008; 23.11.02.009---
Gastroenteritis07.19.03.001; 11.01.07.004---
Gastrointestinal disorder07.11.01.001---
Gastrointestinal pain07.01.05.005--
Hallucinations, mixed19.10.04.0080.000700%-
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