Sorafenib Side Effects

Brand Names: Nexavar

Please note - some side effects for Sorafenib may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Sorafenib - for the Consumer

Sorafenib

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Sorafenib:

Constipation; diarrhea; dry skin; hair thinning or loss; headache; loss of appetite; mouth, bone, muscle, stomach, or joint pain; nausea; tiredness; vomiting; weakness; weight loss.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); black, tarry stools; chest, jaw, or left arm pain; confusion; coughing or vomiting blood; decreased sexual ability; decreased urination; depression; fainting; fast or irregular heartbeat; fever, chills, or sore throat; mouth sores; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; redness, pain, swelling, numbness, tingling, ulcers, or blisters on the palms of hands or soles of feet; seizures; severe or persistent dizziness, headache, or light-headedness; severe stomach pain, vomiting, or nausea; shortness of breath; speech changes; sudden increased sweating; sudden weight gain; swelling of the ankles, hands, or feet; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, unusual tiredness, yellowing of the eyes or skin); unusual bruising or bleeding; unusual tiredness or weakness; vision changes; vomit that looks like coffee grounds.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

Gastrointestinal

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.

Dermatologic

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.

Endocrine

Endocrine side effects have included hyperthyroidism.

Cardiovascular

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.

Hematologic

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.

Respiratory

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.

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.

Musculoskeletal

Musculoskeletal side effects including joint pain (10%) have been reported. Common side effects have included arthralgia and myalgia.

Immunologic

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

Hypersensitivity

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

Metabolic

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

Psychiatric

Psychiatric side effects have commonly included depression.

Genitourinary

Genitourinary side effects have commonly included erectile dysfunction. Uncommon side effects have included gynecomastia.

Renal

Renal side effects including acute renal failure have been reported infrequently.

Hepatic

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.

Other

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.

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