What is DAROLUTAMIDE used for?

DAROLUTAMIDE (brand name NUBEQA) is a Androgen Receptor Inhibitor indicated for See full prescribing information.

What are the most common side effects of DAROLUTAMIDE?

Reported side effects vary by individual. The side-effects section on this page lists the events most frequently reported to FDA FAERS for DAROLUTAMIDE. FAERS is voluntary reporting, so it reflects what was reported, not absolute incidence.

Is DAROLUTAMIDE the same as NUBEQA?

NUBEQA is a brand name for DAROLUTAMIDE. They share the same active ingredient and FDA-approved indications. Biosimilars and authorised generics may differ in inactive ingredients such as buffers or preservatives.

DAROLUTAMIDE

Q: How does DAROLUTAMIDE work?

DAROLUTAMIDE works through the following mechanism: 12.1 Mechanism of Action Darolutamide is an androgen receptor (AR) inhibitor. Darolutamide competitively inhibits androgen binding, AR nuclear translocation, and AR-mediated transcription. A major metabolite, ketodarolutamide, exhibited similar in vitro activity to darolutamide. In addition, darolutamide functioned as a progesterone receptor (PR) antagonist in vitro (approximately 1% activity compared to AR). Darolutamide decreased prostate cancer cell proliferation in vitro and tumor volume in mouse xenograft models of prostate cancer..

Androgen Receptor Inhibitor

Brand names: NUBEQA, Nubeqa

Oral

Mechanism of Action

12.1 Mechanism of Action Darolutamide is an androgen receptor (AR) inhibitor. Darolutamide competitively inhibits androgen binding, AR nuclear translocation, and AR-mediated transcription. A major metabolite, ketodarolutamide, exhibited similar in vitro activity to darolutamide. In addition, darolutamide functioned as a progesterone receptor (PR) antagonist in vitro (approximately 1% activity compared to AR). Darolutamide decreased prostate cancer cell proliferation in vitro and tumor volume in mouse xenograft models of prostate cancer.

Indications

See full prescribing information

Contraindications

• 4 CONTRAINDICATIONS None. None. ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Ischemic Heart Disease : Optimize management of cardiovascular risk factors
1 Ischemic Heart Disease Ischemic heart disease, including fatal cases, occurred in patients receiving NUBEQA
Ischemic events led to death in 0
Ischemic events led to death in 0

Known Side Effects

8 documented side effects by frequency

Fatigue

>10%

Weakness

1-10%

Joint Pain

1-10%

Dizziness

1-10%

Diarrhea

1-10%

Nausea

0.1-1%

Shortness of Breath

0.1-1%

Limb Pain

0.1-1%

Community Discussions

4 Reddit threads analysed for DAROLUTAMIDE

Overall Sentiment

Slightly positive

Comparison Threads

Avg Post Score

33 upvotes

Most discussed side effects in community

Brain Fog (1)

Fatigue (1)

Patient Experiences (r/pharmacy, r/AskDocs & more)

2 years ago today…

It was 2 years ago today that I got the email with my ugly prostate MRI results showing a large PIRAD 5 lesion with spread outside the prostate and to regional lymph nodes. (Biopsy later showed Gleason 9 (4+5) in 12/12 cores.) It was the worst day of my life. I was out of the country, working

r/ProstateCancer84432y ago

My Diagnosis of Advanced Prostate Cancer at 52: The Kaiser Permanente "Experience"

I recently "came out" to my larger circle of extended family and friends about having prostate cancer. It feels much better now that more people know. As this is Prostate Cancer Awareness month, I also wanted to let people know to encourage men to get screening. I have been very successful at gettin

r/ProstateCancer20213y ago

Addressing brain fog caused by HRT / low testosterone in trans women

Howdy! I've commented here for a while, but I figured I would make a post because I'm looking for input and thoughts. &#x200B; I have been dealing with an issue where hrt is giving me brain fog, lack of focus, and emotional numbing. It seems counterintuitive because so many people report HRT m

r/DrWillPowers2093y ago

Brain Fog

Looking for advice re my dad (and grandpa to be) with stage iv PCa

Dear community, my 67-year old father has been diagnosed with prostate cancer stage IV (PSA 57, Gleason 4+3=7b; cT4 N1 M1b with mets in pelvis and lower spine). Some context on him and us: He was enjoying his job as a voluntary janitor at our local church, which kept him physically active, as well a

r/ProstateCancer641y ago

Fatigue

Community discussions are sourced from public Reddit threads. Content reflects individual opinions and is not medical advice.

Primary sources

Every figure on this page links back to its primary source. See data sources for full provenance.

DailyMed FDA label search → DAROLUTAMIDE openFDA label JSON → DAROLUTAMIDE FAERS adverse-event reports → DAROLUTAMIDE ClinicalTrials.gov → completed Phase 2+ trials of DAROLUTAMIDE

Compare With

4 available comparisons

Formulations

Dosage Forms

Tablet

Route

Oral