Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Crisaborole
Drug ID BADD_D02450
Description Crisaborole is a novel oxaborole approved by FDA on December 14, 2016 as Eucrisa, a topical treatment of for mild to moderate atopic dermatitis. This non-steroidal agent is efficacious in improving disease severity, reducing the risk of infection and reducing the signs and symptoms in patients 2 years old and older. It reduces the local inflammation in the skin and prevents further exacerbation of the disease with a good safety profile. Its structure contains a boron atom, which facilitates skin penetration and binding to the bimetal center of the phosphodiesterase 4 enzyme. It is currently under development as topical treatment of psoriasis.
Indications and Usage Intended for the topical treatment of mild to moderate atopic dermatitis in patients 2 years of age and older.
Marketing Status approved; investigational
ATC Code D11AH06
DrugBank ID DB05219
KEGG ID D10873
MeSH ID C543085
PubChem ID 44591583
TTD Drug ID D08NWF
NDC Product Code 0009-0211; 11722-066; 57572-0715; 60715-3211; 69037-0041; 51686-0005; 57572-0714; 17337-0546; 46438-0656; 58175-0622; 69575-4035; 69766-043; 55724-211
UNII Q2R47HGR7P
Synonyms crisaborole | Eucrisa | AN2728 | AN-2728 | 5-(4-cyanophenoxy)-2,3-dihydro-1-hydroxy-2,1-benzoxaborole
Chemical Information
Molecular Formula C14H10BNO3
CAS Registry Number 906673-24-3
SMILES B1(C2=C(CO1)C=C(C=C2)OC3=CC=C(C=C3)C#N)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)
Eyelid pain06.08.03.014; 23.03.03.0360.004823%-
Inflammation08.01.05.007; 10.02.01.0890.004008%-
Pigmentation disorder23.05.03.0010.001897%-
Application site hypersensitivity08.02.01.013; 10.01.03.009; 12.07.01.0140.001507%-
Skin haemorrhage23.06.07.001; 24.07.01.1030.001596%-
Application site exfoliation08.02.01.022; 12.07.01.022; 23.03.07.0070.002713%-
Application site burn08.02.01.038; 12.07.01.038; 23.03.11.0130.006508%-
Treatment failure08.06.01.0170.004522%-
Application site haemorrhage08.02.01.040; 12.07.01.040; 24.07.01.0480.000692%-
Application site hypoaesthesia08.02.01.045; 12.07.01.045; 17.02.06.0270.000603%-
Post inflammatory pigmentation change23.05.03.0020.000904%-
Sensitivity to weather change08.01.03.0770.001206%-
Drug effective for unapproved indication08.06.01.037; 12.09.02.0010.024117%-
Drug ineffective for unapproved indication08.06.01.038; 12.09.02.0020.018868%-
Eczema infantile23.03.04.0440.000993%-
Facial discomfort08.01.08.0310.000603%-
Perioral dermatitis23.03.04.0470.000603%-
Reaction to excipient10.01.01.0420.000603%-
Swelling of eyelid06.04.04.018; 10.01.05.026; 23.04.01.0260.000993%-
Therapeutic product effect delayed08.06.01.0510.001206%-
Therapeutic product effect incomplete08.06.01.0520.018354%-
Urticaria contact10.01.06.018; 23.04.02.0180.000603%-
The 4th Page    First    Pre   4    Total 4 Pages