Tamoxifen (Oral Route)

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Side Effects

Because of the way this medicine acts on the body, there is a chance that it might cause unwanted effects that may not occur until months or years after the medicine is used. Tamoxifen increases the chance of cancer of the uterus (womb) in some women taking it. Tamoxifen may cause blockages to form in a vein, lung, or brain. In women, tamoxifen may cause cancer or other problems of the uterus (womb). It also causes liver cancer in rats. In addition, tamoxifen has been reported to cause cataracts and other eye problems. Discuss these possible effects with your doctor.

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:

• Anxiety
• Blistering, peeling, or loosening of the skin and mucous membranes
• Blurred vision
• Cataracts in the eyes or other eye problems
• Change in vaginal discharge
• Chest pain
• Chills
• Confusion
• Cough
• Dizziness
• Fainting
• Fast heartbeat
• Fever
• Hoarseness
• Lightheadedness
• Lower back or side pain
• Pain or feeling of pressure in the pelvis
• Pain or swelling in the legs
• Pain, redness, or swelling in your arm or leg
• Painful or difficult urination
• Rapid shallow breathing
• Shortness of breath or trouble with breathing
• Skin rash or itching over the entire body
• Sweating
• Weakness or sleepiness
• Wheezing
• Vaginal bleeding
• Yellow eyes or skin

• Bloating
• Constipation
• Darkened urine
• Diarrhea
• Difficulty with breathing
• Indigestion
• Itching
• Joint or muscle pain
• Large, hard skin blisters
• Large hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, and sex organs
• Loss of appetite
• Nausea
• Pain in the stomach or side, possibly radiating to the back
• Red, irritated eyes
• Red skin lesions, often with a purple center
• Sore throat
• Sores, ulcers or white spots in the mouth or on the lips
• Unusual tiredness or weakness
• Vomiting

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:

• Absent, missed, or irregular periods
• Decrease in the amount of urine
• Feeling of warmth
• Menstrual changes
• Noisy, rattling breathing
• Redness of the face, neck, arms and occasionally, upper chest
• Skin changes
• Stopping of menstrual bleeding
• Swelling of the fingers, hands, feet, or lower legs
• Troubled breathing at rest
• Weight gain or loss
• White or brownish vaginal discharge

• Abdominal or stomach cramps
• Black, tarry stools
• Bleeding gums
• Blood in the urine or stools
• Bluish color changes in skin color
• Bone pain
• Decreased interest in sexual intercourse
• Discouragement
• Feeling sad or empty
• Hair loss or thinning of the hair
• Headache
• Inability to have or keep an erection
• Irritability
• Itching in the genital area
• Loss of interest or pleasure
• Loss in sexual ability, desire, drive, or performance
• Nausea or vomiting (mild)
• Pain
• Pinpoint red spots on the skin
• Skin rash or dryness
• Stomach or pelvic discomfort, aching, or heaviness
• Swelling
• Trouble concentrating
• Trouble with sleeping
• Unusual bleeding or bruising

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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