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 Bicalutamide. If you are concerned about side effects, discuss the risks and benefits of Bicalutamide with your doctor.

The following side effects have been reported by at least 1% of people taking Bicalutamide. 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.

• Constipation
• decrease in appetite
• dizziness
• dry skin
• feeling weak
• flatulence (passing gas)
• hair loss or decreased hair regrowth
• hot flashes
• impotence or reduction in sexual desire
• increased sensitivity of the skin to sun; increased risk of Sunburn
• indigestion
• itching
• nausea
• puffiness
• skin rash
• swelling of breasts with pain or tenderness
• tiredness
• weight gain

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.

Contact your doctor as soon as possible if the following side effects occur:

• abdominal pain
• blood in the urine
• chest pain
• severe itching
• signs of Anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
• signs of Depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• signs of liver problems (e.g., nausea, vomiting, Diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• symptoms of high blood sugar (e.g., frequent urination, increased thirst, excessive eating, unexplained weight loss, poor wound healing, infections, fruity breath odour)
• symptoms of heart failure (e.g., tiredness, shortness of breath especially when lying down, swelling of the feet or ankles)

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

• pain or tenderness in stomach
• signs of a Heart Attack (e.g., chest pain or pressure, pain extending through shoulder and arm, nausea and vomiting, sweating)
• symptoms of lung problems (e.g., shortness of breath, painful breathing, sudden shortness of breath, cough, Fever)
• symptoms of a serious allergic reaction (e.g., Hives, shortness of breath, difficulty swallowing, swelling of the face, lips, tongue or throat)

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 Bicalutamide.

Do not take bicalutamide if you:

• are allergic to bicalutamide or any ingredients of the medication
• have early-stage (localized) prostate cancer and would otherwise undergo watchful waiting

Bicalutamide is not intended to be used by women or children.

There may be an interaction between bicalutamide and any of the following:

• amiodarone
• anti-psychotics (e.g., Chlorpromazine, Clozapine, Haloperidol, Olanzapine, Pimozide, Quetiapine, Risperidone)
• Aripiprazole
• "azole" antifungals (e.g., ketoconazole, fluconazole)
• calcium channel blockers (e.g., Amlodipine, Diltiazem, Nifedipine, Verapamil)
• Disopyramide
• dofetilide
• Dronedarone
• flecainide
• Hydrocodone
• Lomitapide
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• Porfimer
• Propafenone
• quinidine
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, moxifloxacin)
• salbutamol
• salmeterol
• sotalol
• Verteporfin
• Warfarin

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 Bicalutamide. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that 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 Bicalutamide.

Abnormal heart rhythm: Bicalutamide 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 Bicalutamide may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Bicalutamide, and whether any special monitoring is needed.

Anemia: Bicalutamide may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired, or pale skin, contact your doctor as soon as possible.

Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including red blood cells, in your blood.

Diabetes: Bicalutamide may cause an increase in blood sugar levels. People with diabetes may find it necessary to monitor their blood sugar more frequently while using Bicalutamide.

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how Bicalutamide may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Bicalutamide, and whether any special monitoring is needed.

Drowsiness/reduced alertness: Bicalutamide may cause drowsiness. Do not drive, operate machinery, or perform other hazardous tasks until you have determined how Bicalutamide affects you.

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

Liver function: Bicalutamide is broken down by the liver. Liver disease or reduced liver function may cause Bicalutamide to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Bicalutamide may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Bicalutamide, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Bicalutamide.

Bicalutamide may also cause liver problems. Contact your doctor immediately 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.

Lung disease: Rarely, and particularly when higher doses are used, cases of interstitial lung disease have been reported with Bicalutamide. If you experience any symptoms of lung problems such as breathing difficulties, wheezing, cough, fever, or shortness of breath, contact your doctor immediately.

Osteoporosis: Long-term use of bicalutamide has been shown to cause reduced bone strength and may increase the risk of bone fractures. If you have osteoporosis or are at increased risk of developing osteoporosis, discuss with your doctor how Bicalutamide may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Bicalutamide, and whether any special monitoring is needed.

Sensitivity to sunlight: Bicalutamide may increase the sensitivity of the skin to sunlight, increasing the risk of sunburn. Avoid exposure to sunlight for long periods of time, particularly between the hours of 10 am and 2 pm, while you are taking Bicalutamide and for 7 days after completing treatment. Wear a broad-spectrum sunscreen and lip balm with an SPF of 50 or greater. If you notice any unusual skin rash or peeling, contact your doctor immediately.

Children: The safety and effectiveness of Bicalutamide have not been determined for children.