Sorafenib Side Effects

Medically reviewed by Drugs.com. Last updated on Feb 17, 2025.

Applies to sorafenib: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. It may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Female patients should use effective birth control during treatment with this medicine and for at least 6 months after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 3 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

Your blood pressure should be checked weekly, especially during the first 6 weeks after starting this medicine. Your doctor may need to treat you if you develop high blood pressure while you are using this medicine. Symptoms of high blood pressure include: blurred vision, dizziness, nervousness, headache, pounding in the ears, or a slow or fast heartbeat.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have redness, blistering, peeling, or loosening of the skin, red skin lesions, redness, pain, swelling, or blisters on the palms of your hands or soles of your feet, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.

This medicine may cause serious heart problems, including heart failure or heart attack. Check with your doctor right away if you are having chest pain or discomfort, nausea, pain or discomfort in your arms, jaw, back, or neck, troubled breathing, sweating, or vomiting.

Check with your doctor right away if you have severe burning, cramps, or pain in the stomach area, bloody or black, tarry stools, trouble breathing, heartburn, indigestion, nausea, or vomiting of material that looks like coffee grounds. These could be symptoms of a serious bowel problem.

This medicine may increase your chance of bleeding and cause a delay in wound healing. To help with this problem, stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

This medicine can cause changes in your heart rhythm, such as a condition called QT prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Call your doctor right away if you have any symptoms of heart rhythm problems, such as a fast, pounding, or irregular heartbeat.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver condition called hepatitis.

If you plan to have children, talk with your doctor before using this medicine. Some men using this medicine have become infertile (unable to have children).

Make sure any doctor who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery.

Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.

Serious side effects of sorafenib

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:

Other side effects of sorafenib

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:

For healthcare professionals

Applies to sorafenib: oral tablet.

Gastrointestinal adverse events

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

fever

See also:

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Further information

Sorafenib side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer