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)
Abdominal pain upper07.01.05.0030.000901%
Anaemia01.03.02.0010.001068%
Arrhythmia02.03.02.0010.000334%Not Available
Atrial fibrillation02.03.03.0020.000334%
Bladder cancer20.03.04.001; 16.08.01.0010.000734%Not Available
Cardiac failure congestive02.05.01.0020.000501%Not Available
Cerebral infarction24.04.06.002; 17.08.01.0040.000334%Not Available
Cerebrovascular accident24.03.05.001; 17.08.01.0070.000667%
Constipation07.02.02.0010.000501%
Dehydration14.05.05.0010.000667%
Delirium19.13.02.0010.000334%
Dementia19.20.02.001; 17.03.01.0010.000334%Not Available
Diplopia17.17.01.005; 06.02.06.0020.000334%Not Available
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.0030.003036%
Drug eruption23.03.05.001; 10.01.01.005; 08.01.06.0150.000734%Not Available
Dysphagia07.01.06.0030.003337%
Fatigue08.01.01.0020.009643%
Feeling abnormal08.01.09.0140.000901%Not Available
Haematuria21.10.01.018; 24.07.01.047; 20.02.01.0060.000501%
Head discomfort17.02.05.0270.000334%Not Available
Hemiparesis17.01.04.0010.000334%
Hepatic function abnormal09.01.02.0010.001401%Not Available
Hepatotoxicity12.03.01.008; 09.01.07.0090.000334%Not Available
Hypoaesthesia23.03.03.081; 17.02.06.0230.001301%Not Available
Liver disorder09.01.08.0010.000501%Not Available
Loss of consciousness17.02.04.0040.000501%Not Available
Malaise08.01.01.0030.000834%
Metastases to spine16.22.02.007; 15.09.03.0070.000501%Not Available
Mood altered19.04.02.0070.000334%Not Available
Muscle spasms15.05.03.0040.001468%
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