Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Hydroxyurea
Drug ID BADD_D01110
Description An antineoplastic agent that inhibits DNA synthesis through the inhibition of ribonucleoside diphosphate reductase.
Indications and Usage For management of melanoma, resistant chronic myelocytic leukemia, and recurrent, metastatic, or inoperable carcinoma of the ovary and Sickle-cell anemia.
Marketing Status approved
ATC Code L01XX05
DrugBank ID DB01005
KEGG ID D00341
MeSH ID D006918
PubChem ID 3657
TTD Drug ID D07CWD
NDC Product Code 0904-6939; 35369-0006; 49452-3650; 55154-7143; 61269-403; 68084-284; 70518-3615; 51927-0072; 0555-0882; 55154-3554; 69315-164; 38779-1354; 42291-321; 71770-105; 49884-724; 17337-0023; 0003-6335; 0003-6337; 60429-265; 61269-835; 70518-0916; 55512-0003; 61269-402; 71770-120; 0003-0830; 51552-0851; 62049-135; 0003-6336; 61269-404; 10135-702; 71052-323; 17337-0022
UNII X6Q56QN5QC
Synonyms Hydroxyurea | Hydroxycarbamid | Oncocarbide | Hydrea
Chemical Information
Molecular Formula CH4N2O2
CAS Registry Number 127-07-1
SMILES C(=O)(N)NO
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 lesion23.03.03.0100.000112%-
Skin necrosis23.03.03.0110.000224%-
Skin ulcer23.07.03.003; 24.04.03.0070.002295%
Somnolence17.02.04.006; 19.02.05.003--
Speech disorder17.02.08.003; 19.19.02.002; 22.12.03.0270.000168%-
Spermatogenesis abnormal21.03.03.0020.000336%-
Spleen disorder01.09.02.0030.000112%-
Splenic infarction01.09.02.004; 24.04.08.0240.000168%-
Splenomegaly01.09.02.0010.001869%-
Squamous cell carcinoma16.16.01.0020.001343%-
Squamous cell carcinoma of skin16.03.02.005; 23.08.02.0050.001119%-
Stillbirth08.04.01.006; 18.01.02.0020.000112%-
Stomatitis07.05.06.0050.000660%
Subarachnoid haemorrhage12.01.10.011; 17.08.01.010; 24.07.04.0040.000112%-
Systemic lupus erythematosus10.04.03.004; 15.06.02.003; 23.03.02.006---
Tenderness08.01.08.005---
Testicular disorder21.13.01.0020.000112%
Therapeutic response decreased08.06.01.0160.000280%-
Thrombocytopenia01.08.01.0020.002183%-
Thrombocytosis01.08.02.0010.000470%-
Tongue neoplasm malignant stage unspecified07.21.07.003; 16.13.07.0030.000504%-
Tumour lysis syndrome14.05.01.004; 16.32.03.0020.000448%
Ulcer08.03.06.0010.000548%-
Upper gastrointestinal haemorrhage07.12.02.006; 24.07.02.0240.000168%
Ureteric obstruction20.06.01.005---
Urinary incontinence17.05.01.008; 20.02.02.0100.000112%
Uterine cancer16.12.05.001; 21.07.02.0030.000168%-
Vasculitis10.02.02.006; 24.12.04.0270.000168%
Ventricular tachycardia02.03.04.0100.000112%
Vomiting07.01.07.003--
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ADReCS-Target
Drug Name ADR Term Target
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