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Sorafenib Side 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

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

Very common (10% or more): Diarrhea (39%), nausea, vomiting, constipation, abdominal pain, mouth pain

Common (1% to 10%): Stomatitis, dry mouth, glossodynia, dyspepsia, dysphagia, gastroesophageal reflux disease, mucosal inflammation

Uncommon (0.1% to 1%): Pancreatitis, gastritis, GI perforations[Ref]

Dermatologic

Very common (10% or more): Pruritus (20%), dry skin (13%), erythema (10%), rash, alopecia, hand foot skin reaction

Common (1% to 10%): Keratoacanthoma/squamous cell cancer of the skin, dermatitis exfoliative, acne, skin desquamation, hyperkeratosis

Uncommon (0.1% to 1%): Eczema, erythema multiforme

Rare (less than 0.1%): Radiation recall dermatitis, Stevens-Johnson syndrome (SJS), leucocytoclastic vasculitis, toxic epidermal necrolysis (TEN)[Ref]

Endocrine

Common (1% to 10%): Hypothyroidism

Uncommon (0.1% to 1%): Hyperthyroidism[Ref]

Cardiovascular

Very common (10% or more): Hypertension (41%)

Common (1% to 10%): Congestive heart failure, myocardial ischemia, myocardial infarction

Rare (less than 0.1%): QT prolongation[Ref]

Hematologic

Very common (10% or more): Lymphopenia, GI hemorrhage, respiratory tract hemorrhage, cerebral hemorrhage, hypertension

Common (1% to 10%): Leukopenia, neutropenia, anemia, thrombocytopenia, flushing

Uncommon (0.1% to 1%): Hypertensive crisis, INR abnormal, prothrombin level abnormal[Ref]

Respiratory

Very common (10% or more): Cough (15%), dysphonia (13%), dyspnea (12%)

Common (1% to 10%): Rhinorrhea, dysphonia, hoarseness, epistaxis

Uncommon (0.1% to 1%): Interstitial lung disease-like events (e.g., pneumonitis, radiation pneumonitis, acute respiratory distress)[Ref]

Nervous system

Very common (10% or more): Headache

Common (1% to 10%): Peripheral sensory neuropathy, dysgeusia, paresthesia, dizziness

Uncommon (0.1% to 1%): Reversible posterior leukoencephalopathy (sometimes fatal)

Frequency not reported: Encephalopathy (sometimes fatal)[Ref]

Musculoskeletal

Very common (10% or more): Pain in extremity (15%), joint pain (10%), arthralgia, bone pain

Common (1% to 10%): Myalgia, muscle spasm

Rare (less than 0.1%): Rhabdomyolysis[Ref]

Immunologic

Common (1% to 10%): Folliculitis, influenza-like illness[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity reactions (e.g., skin reactions, urticaria), anaphylactic reaction

Rare (less than 0.1%): Angioedema[Ref]

Metabolic

Very common (10% or more): Anorexia (11%), hypophosphatemia, weight loss, increased amylase, increased lipase

Common (1% to 10%): Hypocalcemia, hypokalemia, hyponatremia

Uncommon (0.1% to 1%): Dehydration, transient increase in blood alkaline phosphatase[Ref]

Psychiatric

Common (1% to 10%): Depression[Ref]

Genitourinary

Common (1% to 10%): Erectile dysfunction, urinary tract infection

Uncommon (0.1% to 1%): Gynecomastia[Ref]

Hepatic

Common (1% to 10%): Transient increase in transaminases

Uncommon (0.1% to 1%): Bilirubin increased, jaundice, cholecystitis, cholangitis

Rare (less than 0.1%): Drug induced hepatitis (sometimes fatal), nephrotic syndrome[Ref]

Other

Very common (10% or more): Fatigue (17%), pain

fever

Common (1% to 10%): Tinnitus, asthenia[Ref]

References

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

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.

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