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darolutamide

Androgen Receptor Antagonist · Antiandrogen; Prostate cancer agent; Androgen receptor binding inhibitor; Adrenal androgen action blocker

Androgen Receptor AntagonistAntiandrogen; Prostate cancer agent; Androgen receptor binding inhibitor; Adrenal androgen action blockerATC null
CDSCO approved
EXCRETION
—
not curated
INTERACTIONS
12 major
SEVERE in our sources
PREGNANCY
X
FDA category + note
Top interactionssee all 12 →
  • ApalutamideSevereDatabaseDDInter
  • BerotralstatSevereDatabaseDDInter
  • CarbamazepineSevereDatabaseDDInter
  • DexamethasoneSevereDatabaseDDInter

Mechanism

Not yet extracted

Indications

Nonmetastatic castration-resistant prostate cancer (CRPC) (in conjunction with ongoing ADT)

Dosing

Adult
Two 300-mg tablets twice daily, should be given with food.

Pharmacokinetics

Onset
Cmax is reached approximately 4 hours after administration of a single 600-mg oral dose.
Half-life
Approximately 20 hours.
Metabolism
Does not induce CYPs (unlike enzalutamide and apalutamide).

Side effects

Common
FatiguePain in extremitiesRash
Serious
  • Ischemic heart disease
  • Heart failure
  • Urinary retention
  • Pneumonia
  • Hematuria

Pregnancy & lactation

Pregnancy

X

Drug interactions

Apalutamide
Severe
Database

Drug interaction classified as: metabolism

Source: DDInter

Berotralstat
Severe
Database

Drug interaction classified as: metabolism

Source: DDInter

Carbamazepine
Severe
Database

Drug interaction classified as: metabolism

Source: DDInter

Dexamethasone
Severe
Database

Clinical effect not specified

Source: DDInter

Eluxadoline
Severe
Database

Clinical effect not specified

Source: DDInter

Enzalutamide
Severe
Database

Clinical effect not specified

Source: DDInter

Fosphenytoin
Severe
Database

Clinical effect not specified

Source: DDInter

Grazoprevir
Severe
Database

Clinical effect not specified

Source: DDInter

Lorlatinib
Severe
Database

Clinical effect not specified

Source: DDInter

Lumacaftor
Severe
Database

Clinical effect not specified

Source: DDInter

Phenobarbital
Severe
Database

Clinical effect not specified

Source: DDInter

Phenytoin
Severe
Database

Clinical effect not specified

Source: DDInter

Related guidelines

Breast cancer
ESMO · Oncology · 2024
Beta-blockers in hypertension
MOHFW · Cardiology · 2024
Cervical cancer screening and management
ICMR · Oncology · 2022
Breast cancer
ICMR · Oncology · 2022
Tobacco-related cancer prevention
ICMR · Oncology · 2021

Other Androgen Receptor Antagonist drugs

nilutamide
0 brands

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Sources: Goodman & Gilman 14e·Verified: 2026-05-10 · House clinical team