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Sorafenib Side Effects

In Summary

Commonly reported side effects of sorafenib include: alopecia, arthralgia, desquamation, diarrhea, exfoliation of skin, fatigue, headache, hemorrhage, hypertension, hypophosphatemia, increased serum lipase, lymphocytopenia, neutropenia, palmar-plantar erythrodysesthesia, peripheral sensory neuropathy, pruritus, skin rash, weight loss, increased amylase, and xeroderma. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to sorafenib: oral tablet

Along with its needed effects, sorafenib 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 while taking sorafenib:

More common
  • 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
  • slow or fast heartbeat
  • vomiting of blood
  • yellow eyes or skin
Less common
  • 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
Incidence not known
  • 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 of sorafenib 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:

More common
  • 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
Less common
  • 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

For Healthcare Professionals

Applies to sorafenib: oral tablet


Gastrointestinal (GI) side effects including diarrhea (43%), increased lipase (41%), increased amylase (30%), nausea (23%), anorexia (16%), vomiting (16%), and constipation (15%) have been reported. Common side effects have included mucositis, stomatitis, (including dry mouth and glossodynia), dyspepsia, and dysphagia. Uncommon side effects have included pancreatitis, GI reflux, and gastritis. In addition, GI perforation has been reported in less than 1% of patients receiving sorafenib and not always associated with apparent intra- abdominal tumor.[Ref]


Dermatologic side effects including rash/desquamation (40%), Hand-foot skin reaction (30%), alopecia (27%), pruritus (19%), and dry skin (11%) have been reported. Very common side effects have included erythema. Common side effects have included exfoliative dermatitis, acne, and flushing. Scalp dysesthesia and subungual splinter hemorrhages (characterized by straight black or red lines under the nails) have been reported. Uncommon side effects have included folliculitis, eczema, Stevens-Johnson syndrome, and erythema multiforme. Three cases of keratoacanthomas and two cases of sorafenib-induced eruptive melanocytic lesions have been reported. Postmarketing reports of Stevens-Johnson syndrome and toxic epidermal necrolysis have been received.[Ref]


Endocrine side effects have included hyperthyroidism.[Ref]


Cardiovascular side effects including hypertension (17%), angioedema, and congestive heart failure have been reported. Uncommon side effects have included hypertensive crisis, myocardial ischemia, and/or infarction. Cardiac failure, thromboembolism, and arrhythmia have been reported infrequently.[Ref]


Hematologic side effects including Hypoalbuminemia (49%), hemorrhage (15%) (i.e., gastrointestinal, respiratory tract and rarely cerebral hemorrhage) have been reported. Common side effects have included anemia and thrombocytopenia. Uncommon side effects have included abnormal international normalized ratio (INR) results. Cases of erythrocytosis have also been reported.[Ref]


Respiratory side effects including dyspnea (14%) and cough (13%) have been reported. Common side effects have included hoarseness. Uncommon side effects have included rhinorrhea and interstitial lung disease-like events.[Ref]

Nervous system

Nervous system side effects including sensory neuropathy (13%) and headache (10%) have been reported. Common side effects have included tinnitus. Cerebral hemorrhage, transient ischemic attack, and reversible posterior leukoencephalopathy have also been reported infrequently.[Ref]


Musculoskeletal side effects including joint pain (10%) have been reported. Common side effects have included arthralgia and myalgia. Postmarketing reports of rhabdomyolysis and osteonecrosis of the jaw have been received.[Ref]


Immunologic side effects have very commonly included leukopenia and lymphopenia. Common side effects have included neutropenia.[Ref]


Hypersensitivity side effects including skin reactions and urticaria have been reported. Postmarketing reports of angioedema and anaphylactic reaction have been received.[Ref]


Metabolic side effects including hypocalcemia, weight loss (10%), transient increases in transaminases, and hypophosphatemia have been commonly reported. Uncommon side effects have included dehydration, hyponatremia, hypokalemia, transient increases in alkaline phosphatase, increased bilirubin (including jaundice), and hypothyroidism.[Ref]


Psychiatric side effects have commonly included depression.[Ref]


Genitourinary side effects have commonly included erectile dysfunction. Uncommon side effects have included gynecomastia and proteinuria.[Ref]


Renal side effects including acute renal failure and nephrotic syndrome have been reported infrequently.[Ref]


Hepatic side effects including liver dysfunction have been reported in at least 10% of patients. Drug-induced hepatitis, including reports of hepatic failure and death, has been reported during postmarketing surveillance.[Ref]


Other side effects including fatigue (37%) and abdominal pain (11%) have been reported. Very common side effects have included asthenia and pain (including mouth, bone, and tumor pain). Common side effects have included decreased appetite, influenza-like illness, and pyrexia. Uncommon side effects have included infection.[Ref]


1. Amar S, Wu KJ, Tan WW "Sorafenib-induced pancreatitis." Mayo Clin Proc 82 (2007): 516-22

2. "Product Information. Nexavar (sorafenib)." Bayer Pharmaceutical Inc, West Haven, CT.

3. Autier J, Escudier B, Wechsler J, Spatz A, Robert C "Prospective study of the cutaneous adverse effects of sorafenib, a novel multikinase inhibitor." Arch Dermatol 144 (2008): 886-92

4. Kong HH, Cowen EW, Azad NS, Dahut W, Gutierrez M, Turner ML "Keratoacanthomas associated with sorafenib therapy." J Am Acad Dermatol 56 (2007): 171-2

5. Macgregor JL, Silvers DN, Grossman ME, Sherman WH "Sorafenib-induced erythema multiforme." J Am Acad Dermatol 56 (2007): 527-8

6. Kong HH, Sibaud V, Chanco Turner ML, Fojo T, Hornyak TJ, Chevreau C "Sorafenib-induced eruptive melanocytic lesions." Arch Dermatol 144 (2008): 820-2

7. Alexandrescu DT, McClure R, Farzanmehr H, Dasanu CA "Secondary erythrocytosis produced by the tyrosine kinase inhibitors sunitinib and sorafenib." J Clin Oncol 26 (2008): 4047-8

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.