Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Nilutamide
Drug ID BADD_D01568
Description Nilutamide is an antineoplastic hormonal agent primarily used in the treatment of prostate cancer. Nilutamide is a pure, nonsteroidal anti-androgen with affinity for androgen receptors (but not for progestogen, estrogen, or glucocorticoid receptors). Consequently, Nilutamide blocks the action of androgens of adrenal and testicular origin that stimulate the growth of normal and malignant prostatic tissue. Prostate cancer is mostly androgen-dependent and can be treated with surgical or chemical castration. To date, antiandrogen monotherapy has not consistently been shown to be equivalent to castration.
Indications and Usage For use in combination with surgical castration for the treatment of metastatic prostate cancer involving distant lymph nodes, bone, or visceral organs (Stage D2).
Marketing Status approved; investigational
ATC Code L02BB02
DrugBank ID DB00665
KEGG ID D00965
MeSH ID C021277
PubChem ID 4493
TTD Drug ID D0SN9T
NDC Product Code 59981-030; 76055-0012; 62559-173; 66993-212; 53220-123; 59212-111
UNII 51G6I8B902
Synonyms nilutamide | 5,5-dimethyl-3-(4-nitro-3-(trifluoromethyl)phenyl)- 2,4-imidazolidinedione | RU 23908 | RU-23908 | Anandron | RU 23908-10 | Nilandron
Chemical Information
Molecular Formula C12H10F3N3O4
CAS Registry Number 63612-50-0
SMILES CC1(C(=O)N(C(=O)N1)C2=CC(=C(C=C2)[N+](=O)[O-])C(F)(F)F)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)
Gastrointestinal disorder07.11.01.001--Not Available
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.001--Not Available
Gastrointestinal pain07.01.05.005--
Gynaecomastia05.05.02.003; 21.05.04.003--
Haematuria21.10.01.018; 24.07.01.047; 20.02.01.006--
Haptoglobin increased13.02.03.002--Not Available
Headache17.14.01.001--
Hyperglycaemia14.06.02.002; 05.06.02.002--
Hyperhidrosis23.02.03.004; 08.01.03.028--
Hypertension24.08.02.001--
Hypoaesthesia17.02.06.023; 23.03.03.081--Not Available
Influenza22.07.02.001; 11.05.03.001--Not Available
Insomnia19.02.01.002; 17.15.03.002--
Interstitial lung disease22.01.02.003; 10.02.01.033--Not Available
Leukopenia01.02.02.001--Not Available
Libido decreased21.03.02.005; 19.08.03.001--
Loss of consciousness17.02.04.004--Not Available
Lung disorder22.02.07.001--Not Available
Malaise08.01.01.003--
Melaena24.07.02.013; 07.12.02.004--Not Available
Menopausal symptoms21.02.02.002--Not Available
Nausea07.01.07.001--
Nervousness19.06.02.003--Not Available
Night blindness06.02.10.010; 14.12.03.001--
Nocturia20.02.03.001--Not Available
Oedema14.05.06.010; 08.01.07.006--Not Available
Oedema peripheral14.05.06.011; 08.01.07.007; 02.05.04.007--
Pain08.01.08.004--
Paraesthesia23.03.03.094; 17.02.06.005--
Photophobia17.17.02.006; 06.01.01.004--
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