This page contains brief details about the drug , it's indication, dosage & administaration, mechanism of action, related brands with strength, warnings and common side effects.

Background and Date of Approval

Darolutamide is an anti-cancer medication initially approved for use in treating non-metastatic, castration-resistant (cancer that does not spread to other parts of the body and cannot be surgically treated)  prostate cancer. Later, on 05 August 2005 FDA approved Darolutamide for treating metastatic hormone-sensitive prostate cancer. 

Mechanism of Action of undefined

Darolutamide belongs to the class of anti-androgens. It works by inhibiting the activity of androgens (testosterone) which are male sex hormones. Inhibition of these hormones stops the growth, division, and multiplication of cancer cells.

Uses of undefined

Darolutamide is used to treat non-metastatic, castration-resistant prostate cancer (prostate cancer that hasn’t spread to other body parts and does not respond to surgical treatment). It is also indicated to treat hormone-sensitive metastatic prostate cancer (cancer that spreads to other parts of the body) in combination with other anticancer medications.

undefined Drug administaration and Dosage available

Darolutamide is available as an oral tablet. It is a prescription medicine. The tablet should be taken exactly as prescribed by your healthcare provider. Swallow this medication whole with water. It can be taken with food. Do not break, crush, or chew the tablet. Your doctor will decide the frequency of the tablet based on your disease severity and other factors. 

Warnings, Precautions and Side Effects of undefined


Risk of ischemic heart disease is high in patients receiving this medication regularly. Regular monitoring of signs and symptoms of heart attack is necessary. Report symptoms of chest pain, pain in arms, jaw pain, and shoulder pain immediately. Darolutamide is not indicated for women, especially if they are pregnant, because it causes severe birth defects in the baby. Inform your physician if you have seizures, lung disorders, kidney problems, or heart problems, including changes in heart rhythm and hypertension, before starting the treatment with this medicine.  


Inform your physician about all the prescription medicines, over-the-counter medicines, nutritional or vitamin supplements, nasal flu vaccine, and herbal products that you are currently taking or have taken before. It is advised to use contraceptives if you have a female partner with reproducing ability. Use contraceptives during the treatment and for 1 week after the last dose. If you come into contact with this medicine and are pregnant or breastfeeding, it is advisable to discuss it with your physician. Your healthcare professional may advise you to take certain blood tests to monitor the effectiveness and side effects of the therapy. 

Side Effects

The common side effects of darolutamide are fatigue, rash, muscle pain, bone pain, pain in the arms and legs, and broken bones. Serious side effects include chest pain, pain in arms, jaw, neck, and back, lightheadedness or dizziness, shortness of breath, swelling of ankles and legs, and seizures. Even though all medicines have side effects, not everyone gets them. 

Word Of Advice

Do not take this medicine if you are allergic to darolutamide or any other ingredient in it. This medicine should be taken with food. Inform your physician if you are facing any symptoms of seizures, swelling in your legs, ankle, and face, abdominal pain, shortness of breath, and chest pain after taking this medicine. Notify your physician if you are taking any antibiotics, cholesterol medications, and other prescribed medicines. Darolutamide is not indicated in children and adolescents less than 18 years of age. Pregnant and breastfeeding women should not consume this medication since this is used to treat prostate cancer.   

Frequently Asked Question


  1. Bayer (Pty) Ltd, Patient information leaflet, [Revised on 15th March 2022], [Accessed on 8th August 2],
  2. Orion Corporation, Orion Pharma, Electronics Medicine Compendium (emc), [Revised on January 2021], [Accessed on 8th August 2022],
  3. Bayer HealthCare Pharmaceuticals Inc, U.S. Food and Drug Administration, [Revised on July 2019], [Accessed on 8th August 2022],
  4. Goodman & Gilman’s, The Pharmacological Basis of Therapeutics, Natural products in cancer chemotherapy: hormones and related agents, 12th edition, 2011, 1707 - 1709.


The drug information on this page is not a substitute for medical advice. It is meant for educational purposes only. For further details, consult your doctor about your medical condition to know if you can receive this treatment.