Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Nubeqa (Darolutamide). If you are concerned about side effects, discuss the risks and benefits of Nubeqa (Darolutamide) with your doctor.

The following side effects have been reported by at least 1% of people taking Nubeqa (Darolutamide). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• fatigue
• pain in the arms, legs
• rash

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• difficulty starting urine flow
• signs of heart problems (e.g., fast, irregular heartbeat or pulse, chest pain, sudden weight gain, difficulty breathing, leg swelling)

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a Heart Attack (e.g., chest pain or pressure, pain extending through shoulder and arm, nausea and vomiting, sweating)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Nubeqa (Darolutamide).

Each white-to-off-white, film-coated, oval tablet, marked with BAYER on one side and with 300 on the other side, contains 300 mg of Nubeqa (Darolutamide). Nonmedicinal ingredients: calcium hydrogen phosphate, croscarmellose sodium, hypromellose 15 cP, lactose monohydrate, Macrogol 3350, magnesium stearate, povidone K 30, titanium dioxide.

Do not take Nubeqa (Darolutamide) if you are allergic to Nubeqa (Darolutamide) or any ingredients of the medication.

There may be an interaction between Nubeqa (Darolutamide) and any of the following:

• Apalutamide
• azole antifungals (e.g., itraconazole, ketoconazole)
• Cladribine
• clarithromycin
• Clozapine
• Elagolix
• Eluxadoline
• Hepatitis C antivirals (e.g., asunaprevir, grazoprevir)
• Methotrexate
• Pazopanib
• rifampin
• ritonavir
• St. John's wort
• seizure medications (e.g., Carbamazepine, Phenobarbital, Phenytoin)
• "statin" medications (e.g., Atorvastatin, Fluvastatin, Lovastatin, Rosuvastatin)
• Sulfasalazine
• Tacrolimus
• Topotecan
• voxilaprevir

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Nubeqa (Darolutamide). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Nubeqa (Darolutamide).

Birth control: If Nubeqa (Darolutamide) is used by a man whose partner is or may become pregnant, it may affect the unborn baby. A condom should be used while taking Nubeqa (Darolutamide) and for 3 months after stopping the medication. Do not donate sperm while taking Nubeqa (Darolutamide) and for 3 months after the last dose.

Heart problems: Nubeqa (Darolutamide) may worsen symptoms of heart disease or cause heart attack. If you have heart disease such as Angina, Congestive Heart Failure, or arrhythmia, discuss with your doctor how Nubeqa (Darolutamide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Nubeqa (Darolutamide), and whether any special monitoring is needed. Contact your doctor as soon as possible if you develop symptoms of heart problems such as shortness of breath, chest pain, rapid heartbeat, or swollen ankles.

Lactose: Nubeqa (Darolutamide) contains lactose. If you have hereditary problems of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption, discuss this with your doctor before starting the medication.

Liver function: If you have liver problems, discuss with your doctor how Nubeqa (Darolutamide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Nubeqa (Darolutamide), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Nubeqa (Darolutamide).

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Pregnancy: Nubeqa (Darolutamide) is not intended for women. The safety and effectiveness of Nubeqa (Darolutamide) has not been established for pregnant women.

Breast-feeding: Nubeqa (Darolutamide) is not intended for women. Therefore, it should not be used by breast-feeding women.

Children: The safety and effectiveness of using Nubeqa (Darolutamide) have not been established for children.