Sorafenib (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:

• Abdominal or stomach pain
• Bleeding gums
• Bloating of the abdomen or stomach
• Blood in the urine or stools
• Blurred vision
• Clay-colored stools
• Coughing up blood
• Dark urine
• Difficulty with breathing or swallowing
• Dizziness
• Headache
• Increased menstrual flow or vaginal bleeding
• Light-colored stools
• Nausea and vomiting
• Nervousness
• Nosebleeds
• Paralysis
• Pounding in the ears
• Prolonged bleeding from cuts
• Red or black, tarry stools
• Red or dark brown urine
• Shortness of breath
• Slow or fast heartbeat
• Vomiting of blood
• Yellow eyes or skin

• Bone pain
• Chest pain or discomfort
• Chills
• Clammy skin
• Confusion
• Constipation
• Convulsions (seizures)
• Cough
• Decreased urine production
• Depressed mood
• Difficulty with moving
• Dry skin and hair
• Enlarged pupils
• Feeling cold
• Fever
• Hair loss
• Hearing loss
• Hives
• Hoarseness or husky voice
• Increased sensitivity of the eyes to light
• Increased sweating, possibly with fever or cold
• Increased thirst
• Indigestion
• Itching
• Joint pain
• Loss of appetite
• Lower back or side pain
• Muscle cramps and stiffness
• Muscle pain
• Pain or discomfort in the arms, jaw, back, or neck
• Painful or difficult urination
• Pains in the stomach, side, or abdomen, possibly radiating to the back
• Pale skin
• Pinpoint red spots on the skin
• Reddening of the skin, especially around the ears
• Ringing, buzzing, or other unexplained noise in the ears that continues
• Severe chest pain
• Severe headache
• Sore throat
• Sores, ulcers, or white spots on the lips or in the mouth
• Stiff or sore neck
• Stomach discomfort or upset
• Sweating
• Swelling of the ankles or hands
• Swelling of the eyes, face, or inside of the nose
• Swollen glands
• Swollen joints
• Trouble breathing with exertion
• Unpleasant breath odor
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Weight gain

• Blistering, peeling, or loosening of the skin
• Diarrhea
• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• Red skin lesions, often with a purple center
• Red, irritated eyes

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:

• Blistering, peeling, redness, and/or swelling of the palms of the hands or bottom of the feet
• Burning, tingling, numbness or pain in the hands, arms, feet, or legs
• Numbness, pain, tingling, or unusual sensations in palms of the hands or bottom of the feet
• Sensation of pins and needles
• Stabbing pain
• Thinning of the hair
• Tightness in the chest
• Weight loss

• Acid or sour stomach
• Acne
• Belching
• Blistering, peeling, or loosening of the skin
• Burning feeling in the chest or stomach
• Burning, itching, and pain in hairy areas
• Cracked lips
• Cracks in the skin
• Decreased appetite
• Decreased interest in sexual intercourse
• Discouragement
• Dry mouth
• Fainting
• Feeling of warmth
• Feeling sad or empty
• Flushing or red skin
• Gas
• General feeling of discomfort or illness
• Heartburn
• Inability to have or keep an erection
• Increase in heart rate
• Irritability
• Lack or loss of strength
• Lightheadedness
• Loss in sexual ability, desire, drive, or performance
• Loss of ability to use or understand speech or language
• Loss of heat from the body
• Loss of interest or pleasure
• Mouth pain
• Pus at the root of the hair
• Rapid breathing
• Red face, neck, arms, and occasionally, upper chest
• Red, swollen skin
• Runny nose
• Scaly skin
• Shivering
• Skin rash that is encrusted, scaly, and oozing
• Sunken eyes
• Swelling of the breasts or breast soreness in both men and women
• Swelling or inflammation of the mouth
• Tenderness in the stomach area
• Thirst
• Trouble concentrating
• Trouble sleeping
• Unusually warm skin
• Wrinkled skin

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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