Dutasteride and Tamsulosin (Oral Route)

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Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Chills
• Cold sweats
• Confusion
• Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

• Chest pain
• Cough or hoarseness
• Fever
• Lower back or side pain
• Painful or difficult urination

• Blistering, flaking, or peeling of the skin
• Blurred vision
• Difficulty with breathing
• Fast, irregular, pounding, or racing heartbeat or pulse
• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• Pain or swelling of the treated skin
• Painful or prolonged erection of the penis
• Shortness of breath
• Sweating
• Unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Change or problem with discharge of semen
• Decreased interest in sexual intercourse
• Dizziness
• Enlarged and painful breasts
• Inability to have or keep an erection
• Loss in sexual ability, desire, drive, or performance

• Back pain
• Body aches or pain
• Congestion
• Diarrhea
• Dryness or soreness of the throat
• Headache
• Increased cough
• Lack or loss of strength
• Pain or tenderness around the eyes and cheekbones
• Runny nose
• Shortness of breath or troubled breathing
• Sleepiness or unusual drowsiness
• Sleeplessness
• Sneezing
• Stuffy nose
• Tender, swollen glands in the neck
• Tightness of the chest or wheezing
• Trouble sleeping
• Trouble with swallowing
• Unable to sleep
• Voice changes

• Constipation
• Hives or welts
• Itching
• Redness of the skin
• Skin rash
• Vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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