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 Erleada (Apalutamide). If you are concerned about side effects, discuss the risks and benefits of Erleada (Apalutamide) with your doctor.

The following side effects have been reported by at least 1% of people taking Erleada (Apalutamide). 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.

• changed sense of taste
• decreased appetite
• Diarrhea
• hot flushes
• itching
• joint pain
• nausea
• skin rash
• tiredness
• weight loss

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:

• broken bones
• falls
• high blood pressure
• signs of heart problems (e.g., fast, irregular heartbeat or pulse; chest pain; sudden weight gain; difficulty breathing; leg swelling)
• swelling of hands, ankles, or feet
• symptoms of irregular heartbeat (e.g., chest pain, dizziness, rapid, pounding heartbeat, shortness of breath)
• symptoms of underactive Thyroid gland (e.g., dry skin, Constipation, weight gain, fatigue, aches, pains and stiffness, intolerance to cold, Depression, memory problems)

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

• seizures
• 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 Erleada (Apalutamide).

Each slightly yellowish-to-greyish-green, oblong, film-coated tablet, debossed with "AR 60" on one side, contains 60 mg of Erleada (Apalutamide). Nonmedicinal ingredients: colloidal anhydrous silica, croscarmellose sodium, hydroxypropyl methylcellulose-acetate succinate (HPMC- AS), magnesium stearate, microcrystalline cellulose, and silicified microcrystalline cellulose; tablet coating: iron oxide black (E172), iron oxide yellow (E172), polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide.

Do not take Erleada (Apalutamide) if you:

• are allergic to Erleada (Apalutamide) or any ingredients of the medication
• are female and are or may become pregnant

Erleada (Apalutamide) is not intended to be used by women or children.

There may be an interaction between Erleada (Apalutamide) and any of the following:

• Abiraterone
• Aliskiren
• alpha-blockers (e.g., Alfuzosin, Doxazosin, Silodosin, Tamsulosin)
• antiarrythmics (e.g., amiodarone, Disopyramide, Dronedarone, Propafenone, quinidine)
• anticancer medications (e.g., Cabazitaxel, Docetaxel, Doxorubicin, Etoposide, Ifosfamide, Irinotecan, Vincristine)
• anticoagulants (e.g., Apixaban, Clopidogrel, dabigatran, Edoxaban, Rivaroxaban, Ticagrelor)
• antipsychotics (e.g., Aripiprazole, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• Aprepitant
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• benzodiazepines (e.g., Chlordiazepoxide, Clobazam, Clonazepam, Diazepam, Lorazepam)
• Bisoprolol
• Buprenorphine
• Buspirone
• calcium channel blockers (e.g., Amlodipine, Diltiazem, Nifedipine, Verapamil)
• cannabis
• Carvedilol
• cetirizine
• chloroquine
• ciprofloxacin
• clindamycin
• Colchicine
• conivaptan
• corticosteroids (e.g., Dexamethasone, Hydrocortisone, Prednisone)
• Cyclosporine
• Dantrolene
• Dapsone
• Darifenacin
• Digoxin
• dronedarone
• Eliglustat
• Enzalutamide
• estrogens (e.g., conjugated estrogen, Estradiol, ethinyl estradiol)
• Everolimus
• Exemestane
• fexofenadine
• Flibanserin
• Flutamide
• Gemfibrozil
• "gliptin" Diabetes medications (e.g., Linagliptin, Saxagliptin, Sitagliptin)
• Guanfacine
• Hepatitis C antivirals (e.g., asunaprevir, daclatasvir, dasabuvir, ledipasvir, paritaprevir, ombitasvir, sofosbuvir)
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine, efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• Ivabradine
• Ivacaftor
• lidocaine
• Loperamide
• Losartan
• Lurasidone
• Macitentan
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• maraviroc
• Mefloquine
• Methadone
• mifepristone
• Mirtazapine
• Modafinil
• Nadolol
• Naloxegol
• narcotic pain relievers (e.g., Codeine, Fentanyl, Morphine, Oxycodone)
• nitrates (e.g., isosorbide dinitrate, isosorbide mononitrate)
• Ondansetron
• praziquantel
• Primaquine
• progestins (e.g., Dienogest, Levonorgestrel, medroxyprogesterone, Norethindrone)
• protein kinase inhibitors (e.g., Bosutinib, Dasatinib, imatinib, Nilotinib,)
• proton pump inhibitors (e.g., Lansoprazole, Omeprazole)
• quinine
• Ranitidine
• Repaglinide
• rifabutin
• rifampin
• rilpivirine
• Roflumilast
• Romidepsin
• seizure medications (e.g., Carbamazepine, Oxcarbazepine, Perampanel, Phenobarbital, Phenytoin, primidone)
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Escitalopram, Fluoxetine, Paroxetine, Sertraline)
• Sildenafil
• Sirolimus
• Solifenacin
• "statin" anticholesterol medications (e.g., Atorvastatin, Lovastatin, Simvastatin)
• Stiripentol
• Tacrolimus
• Tadalafil
• Tamoxifen
• Tetracycline
• thyroid replacements (e.g., desiccated thyroid, Levothyroxine)
• Tofacitinib
• Tolterodine
• Tolvaptan
• Tramadol
• Trazodone
• tricyclic antidepressants (e.g., Amitriptyline, Clomipramine, Desipramine, Trimipramine)
• Ulipristal
• Venlafaxine
• vitamin D analogues (e.g., calcifediol, Calcitriol)
• Warfarin
• Zolpidem

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 Erleada (Apalutamide). 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 Erleada (Apalutamide).

Abnormal heart rhythm: Erleada (Apalutamide) can cause changes to the normal rhythm of the heart, called QT prolongation. QT prolongation is a serious life-threatening condition. If you are at risk for heart rhythm problems (e.g., have heart failure, Angina, low potassium or magnesium levels; have congenital long QT syndrome; or are taking medications that can prolong the QT interval, such as quinidine, procainamide, Amiodarone, Sotalol, Flecainide), discuss with your doctor how Erleada (Apalutamide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Erleada (Apalutamide), and whether any special monitoring is needed.

Bone health and fractures: Long-term use of other anti-androgen medications similar to Erleada (Apalutamide) has been shown to cause reduced bone strength and may increase the risk of bone fractures. Erleada (Apalutamide) appears to increase the risk of bone fractures. If you have Osteoporosis or are at increased risk of developing osteoporosis, discuss with your doctor how Erleada (Apalutamide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Erleada (Apalutamide), and whether any special monitoring is needed.

Heart disease: The risk of heart attack or heart failure is increased for people taking Erleada (Apalutamide). If you have a history of heart disease or risk factors for heart disease (Obesity, high blood cholesterol, smoking), discuss with your doctor how Erleada (Apalutamide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Erleada (Apalutamide), and whether any special monitoring is needed.

Seizures: There have been rare reports of seizures occurring with Erleada (Apalutamide) in studies. The safety of using Erleada (Apalutamide) if you have a seizure disorder has not been determined. If you have a history of Epilepsy or medical conditions that increase the risk of seizures, discuss with your doctor how Erleada (Apalutamide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Erleada (Apalutamide), and whether any special monitoring is needed.

Thyroid disease: Erleada (Apalutamide) may cause decreased thyroid gland function. If you have problems with your thyroid gland, Erleada (Apalutamide) may make these problems worse. If you experience symptoms of underactive thyroid, such as unexpectedly feeling cold, depression, constipation, or fatigue, let your doctor know. If you have a history of thyroid disease, discuss with your doctor how Erleada (Apalutamide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Erleada (Apalutamide), and whether any special monitoring is needed.

Pregnancy: Erleada (Apalutamide) is not intended to be used by women. Erleada (Apalutamide) may cause harm to the developing baby and cause loss of pregnancy if the fetus is exposed to the medication. If you have a female partner who is or may become pregnant, it is important to use a condom, as well as a second effective method of birth control while receiving treatment and for 3 months after the last dose of Erleada (Apalutamide).

Breast-feeding: Erleada (Apalutamide) is not intended to be used by women.

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