Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Darolutamide
Drug ID BADD_D02548
Description Darolutamide is a nonsteroidal androgen receptor antagonist for the treatment of castrate-resistant, non-metastatic prostate cancer (nmCRPC). This condition occurs in the majority of patients with advanced prostate cancer who have been treated with androgen receptor antagonists.[A189063] Though prior treatment for prostate cancer has been successful for these patients, the cancer eventually progresses to become resistant to existing therapies. This warrants further treatment. The goal of treatment with darolutamide is to delay the progression of prostate cancer to metastatic disease, increasing quality of life and life expectancy for those with advanced prostate cancer.[A189054,A189063] Darolutamide was developed by Bayer HealthCare Pharmaceuticals Inc. and approved by the FDA on July 30th, 2019.[L10887]
Indications and Usage This drug is indicated for the treatment of patients diagnosed with non-metastatic and castrate-resistant prostate cancer.[L10872]
Marketing Status approved; investigational
ATC Code L02BB06
DrugBank ID DB12941
KEGG ID D11045
MeSH ID C000607739
PubChem ID 67171867
TTD Drug ID D0DV6D
NDC Product Code 54893-0107; 50419-395; 52483-6300
UNII X05U0N2RCO
Synonyms darolutamide | Nubeqa | ORM-16497 | ODM-201 | ORM-16555
Chemical Information
Molecular Formula C19H19ClN6O2
CAS Registry Number 1297538-32-9
SMILES CC(CN1C=CC(=N1)C2=CC(=C(C=C2)C#N)Cl)NC(=O)C3=NNC(=C3)C(C)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)
Muscular weakness15.05.06.001; 17.05.03.0050.000334%
Myocardial infarction24.04.04.009; 02.02.02.0070.000501%
Nephrolithiasis20.04.01.0020.000334%
Neuropathy peripheral17.09.03.0030.000334%Not Available
Oedema14.05.06.010; 08.01.07.0060.001301%Not Available
Oedema peripheral02.05.04.007; 14.05.06.011; 08.01.07.0070.000501%
Pain in extremity15.03.04.0100.002202%
Rash23.03.13.0010.006006%Not Available
Rash pruritic23.03.13.0300.001301%Not Available
Renal failure20.01.03.0050.000334%Not Available
Syncope02.11.04.015; 24.06.02.012; 17.02.04.0080.000334%
Thirst14.03.02.007; 08.01.09.0210.001135%Not Available
Thrombocytopenia01.08.01.0020.000501%Not Available
Urinary retention20.02.02.0110.000334%
Vision blurred17.17.01.010; 06.02.06.0070.000734%
Vomiting07.01.07.0030.002369%
Peripheral swelling08.01.03.053; 02.05.04.0150.001301%Not Available
General physical health deterioration08.01.03.0180.000334%Not Available
Malignant neoplasm progression16.16.01.0050.002069%Not Available
Cognitive disorder19.21.02.001; 17.03.03.0030.000667%
Hot flush24.03.01.005; 21.02.02.001; 08.01.03.0270.001068%
Prostate cancer21.04.02.002; 16.25.01.0010.003837%Not Available
Decreased appetite14.03.01.005; 08.01.09.0280.002536%
Disease progression08.01.03.0380.000501%
Metastasis16.22.01.0010.001068%Not Available
Renal impairment20.01.03.0100.001335%Not Available
Metastases to bone16.22.02.005; 15.09.03.0060.001168%Not Available
Metastases to lymph nodes16.22.02.006; 01.09.01.0150.000667%Not Available
Hormone-refractory prostate cancer21.04.02.007; 16.25.01.0040.006173%Not Available
Illness08.01.03.0910.000334%Not Available
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