Drug reference

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

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

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

Breast cancer

ICMR · Oncology · 2022

Cervical cancer screening and management

ICMR · Oncology · 2022

Tobacco-related cancer prevention

ICMR · Oncology · 2021

Other Androgen Receptor Antagonist drugs

nilutamide

0 brands

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Textbook-sourced·Sources: Goodman & Gilman 14e·Updated: 2026-05-10