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)
Skin disorder23.03.03.0070.008139%Not Available
Skin erosion23.07.03.0020.000904%Not Available
Skin exfoliation23.03.07.0030.007714%Not Available
Skin fissures23.03.03.0080.001596%Not Available
Skin hyperpigmentation23.05.01.0030.003015%
Skin hypertrophy23.01.04.0020.000603%Not Available
Skin hypopigmentation23.05.02.0030.003316%
Skin irritation23.03.04.0090.010338%Not Available
Skin lesion23.03.03.0100.003103%Not Available
Swelling08.01.03.0150.005426%Not Available
Swelling face08.01.03.100; 23.04.01.018; 10.01.05.0180.006508%Not Available
Swollen tongue23.04.01.014; 10.01.05.015; 07.14.02.0030.000567%Not Available
Systemic lupus erythematosus23.03.02.006; 15.06.02.003; 10.04.03.0040.000177%Not Available
Therapeutic response unexpected08.06.01.0010.004220%Not Available
Urticaria23.04.02.001; 10.01.06.0010.014257%
Musculoskeletal disorder15.03.05.0250.000692%Not Available
Application site vesicles23.03.01.009; 12.07.01.009; 08.02.01.0090.004220%Not Available
Application site dryness12.07.01.011; 08.02.01.011; 23.03.03.0240.002713%Not Available
Application site inflammation12.07.01.024; 08.02.01.0240.003919%Not Available
Application site hyperaesthesia17.02.06.011; 12.07.01.023; 08.02.01.0230.000390%Not Available
Application site paraesthesia08.02.01.026; 17.02.06.012; 12.07.01.0260.002713%Not Available
Application site urticaria23.04.02.002; 12.07.01.028; 10.01.06.002; 08.02.01.0280.003706%Not Available
Madarosis23.02.02.004; 06.06.04.0100.000904%Not Available
Ear discomfort04.03.01.0050.000603%Not Available
Eye pruritus06.04.05.0060.000692%Not Available
Application site swelling12.07.01.027; 08.02.01.0270.010853%Not Available
Skin burning sensation23.03.03.021; 17.02.06.0090.018478%Not Available
Cerebral disorder17.02.10.0170.000177%Not Available
Eyelid irritation23.03.04.023; 06.04.04.0070.006632%Not Available
Application site discolouration23.03.03.023; 12.07.01.030; 08.02.01.0300.005125%Not Available
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