Note: This document contains side effect information about sorafenib. Some dosage forms listed on this page may not apply to the brand name Nexavar.

Summary

Common side effects of Nexavar 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. Continue reading for a comprehensive list of adverse effects.

Applies to sorafenib: oral tablet.

Serious side effects of Nexavar

Along with its needed effects, sorafenib (the active ingredient contained in Nexavar) 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

• Bleeding gums
• blistering, peeling, redness, or swelling of the palms of the hands or bottoms of the feet
• 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
• 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
• stomach pain
• tightness in the chest
• vomiting
• vomiting of blood
• yellow eyes or skin

Less common

• Bone pain
• burning feeling in the chest or stomach
• chest pain or discomfort
• chills
• clammy skin
• confusion
• constipation
• cough
• decreased urine production
• depressed mood
• difficulty with moving
• dry skin and hair
• enlarged pupils (black part of the eye)
• fainting
• feeling cold
• fever
• hair loss
• hearing loss
• hives, itching, skin rash
• hoarseness or husky voice
• increase in heart rate
• increased sensitivity of the eyes to light
• increased sweating, possibly with fever or cold
• increased thirst
• indigestion
• joint pain or swelling
• lightheadedness
• loss of appetite
• loss of the ability to use or understand speech or language
• lower back or side pain
• muscle cramps, pain, or stiffness
• 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
• rapid breathing
• reddening of the skin, especially around the ears
• ringing, buzzing, or other unexplained noise in the ears that continues
• seizures
• severe chest pain
• severe headache
• shivering
• skin rash that is encrusted, scaly, and oozing
• 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
• 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 genitals
• red skin lesions, often with a purple center
• red, irritated eyes

Other side effects of Nexavar

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

• 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
• weight loss

Less common

• Acne
• belching
• burning, itching, and pain in hairy areas
• cracked lips
• cracks in the skin
• decreased appetite
• decreased interest in sexual intercourse
• discouragement
• dry mouth
• 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
• irritability
• lack or loss of strength
• loss in sexual ability, desire, drive, or performance
• loss of heat from the body
• loss of interest or pleasure
• mouth pain
• pus at the root of the hair
• red face, neck, arms, and occasionally, upper chest
• red, swollen skin
• runny nose
• scaly skin
• 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]