Toremifene (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.

Also, because of the way this medicine acts on the body, there is a chance that it might cause other unwanted effects that may not occur until months or years after the medicine is used. Some patients who have used toremifene have developed cancer of the uterus (womb), although it is not known for sure if it was caused by the medicine. Discuss this possible effect with your doctor.

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

• Abdominal or stomach pain
• Anxiety
• Arm, back, or jaw pain
• Blurred vision
• Change in vaginal discharge
• Changes in skin color
• Changes in vision
• Chest pain or discomfort
• Chest tightness or heaviness
• Confusion
• Constipation
• Cough
• Decreased urine output
• Depression
• Dilated neck veins
• Dizziness or lightheadedness
• Dry mouth
• Extreme fatigue
• Fainting
• Fast, slow, or irregular heartbeat
• Headache
• Inability to speak incoherent speech
• Increased urination
• Irregular breathing
• Irregular heartbeat
• Loss of appetite
• Metallic taste
• Muscle weakness
• Nausea
• Pain or discomfort in the arms, jaw, back, or neck
• Pain or feeling of pressure in the pelvis
• Pain, tenderness, or swelling of the foot or leg
• Seizures
• Severe or sudden headache
• Shortness of breath
• Slurred speech
• Sudden shortness of breath or troubled breathing
• Sweating
• Swelling of the face, fingers, feet, or lower legs
• Temporary blindness
• Tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
• Thirst
• Tightness in the chest
• Troubled breathing
• Unusual tiredness
• Vaginal bleeding
• Vomiting
• Weakness in the arm and/or leg on one side of the body, sudden and severe
• Weight gain
• Weight loss
• Wheezing

• Chest pain

• Black, tarry stools
• Bleeding gums
• Blood in the urine or stools
• Chills
• Clay-colored stools
• Dark urine
• Dizziness
• Fever
• Headache
• Itching
• Painful or difficult urination
• Pinpoint red spots on the skin
• Rash
• Sore throat
• Sores, ulcers, or white spots on the lips or in the mouth
• Swollen glands
• Unpleasant breath odor
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Vomiting of blood
• Yellow eyes or skin

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:

• Blindness
• Decreased vision
• Dry eyes
• Feeling of warmth
• Redness of the face, neck, arms, and occasionally, upper chest
• Sudden sweating
• Sweating
• White or brownish vaginal discharge

• Bone pain
• Changes in vision
• Double vision
• Eye pain
• Tearing

• Blistering, crusting, irritation, itching, or reddening of the skin
• Cracked, dry, or scaly skin
• Depression
• Difficulty having a bowel movement (stool)
• Dizziness or lightheadedness
• Feeling of constant movement of self or surroundings
• Feeling unusually cold
• Hair loss
• Itching skin
• Lack or loss of strength
• Partial or slight paralysis
• Sensation of spinning
• Shakiness in the legs, arms, hands, or feet
• Shivering
• Thinning of the hair
• Trembling or shaking of the hands or feet

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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