Regorafenib Side Effects

Medically reviewed by Drugs.com. Last updated on May 4, 2025.

Applies to regorafenib: oral tablet.

Precautions

If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits for any problems or unwanted effects that may be caused by this medicine. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Men and women should use an effective form of birth control during treatment and for up to 2 months after treatment. If you think you have become pregnant while using this medicine or within 2 months after the last dose, tell your doctor right away.

Your doctor will check your blood pressure on a regular basis while you are taking this medicine. You may also need to monitor your blood pressure at home. Tell your doctor right away if you have a severe headache, lightheadedness, or changes in your vision.

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 skin or eyes. These could be symptoms of a serious liver problem.

This medicine may increase your risk of developing infections. Avoid being near people who are sick or have infections while you are using this medicine. Wash your hands often. Tell your doctor if you have any kind of infection before you start using this medicine. Also tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back.

This medicine may increase your chance of bleeding and cause wounds or injuries to heal more slowly. To help with this problem, stay away from rough sports or 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 may cause serious skin problems, including hand-foot skin reaction or a severe rash. Call your doctor right away if you have skin redness, pain, blisters, bleeding, or swelling of the palms of your hands and soles of your feet.

This medicine may cause serious heart problems. 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, shortness of breath, sweating, or vomiting.

Check with your doctor right away if you have a headache, seizures, confusion, blurred vision or other visual problems. These may be symptoms of a rare and serious brain condition called reversible posterior leukoencephalopathy syndrome (RPLS).

Check with your doctor right away if you have severe burning, cramps, or pain in the stomach area, a high fever, chills, nausea, vomiting, or severe diarrhea. These could be symptoms of a serious stomach or bowel problem.

Make sure any doctor who treats you knows that you are using this medicine. You may need to stop the medicine at least 2 weeks before and after having a surgery.

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 regorafenib

Along with its needed effects, regorafenib 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 regorafenib:

Other side effects of regorafenib

Some side effects of regorafenib 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 regorafenib: oral tablet.

Hepatic adverse events

• Very common (10% or more): Increased AST (93%), hyperbilirubinemia (78%), increased ALT (70%)
• Common (1% to 10%): Acute kidney injury
• Uncommon (0.1% to 1%): Severe liver injury
• Frequency not reported: Hepatic failure^[Ref]

Genitourinary

• Very common (10% or more): Proteinuria (84%)
• Common (1% to 10%): Hyperuricemia^[Ref]

Hematologic

• Very common (10% or more): Anemia (79%), lymphopenia (68%), thrombocytopenia (63%), increased INR (44%), neutropenia (16%)
• Common (1% to 10%): Leukopenia^[Ref]

Metabolic

• Very common (10% or more): Hypophosphatemia (70%), hypocalcemia (59%), decreased appetite and food intake (47%), weight loss (32%), hypokalemia (31%), hyponatremia (30%), hypothyroidism (18%)
• Common (1% to 10%): Hypomagnesemia, hypoalbuminemia^[Ref]

Dermatologic

• Very common (10% or more): Hand-food skin reaction/palmar-plantar erythrodysesthesia syndrome (67%), rash (30%), alopecia (24%)
• Common (1% to 10%): Exfoliative rash, dry skin, nail disorder
• Uncommon (0.1% to 1%): Erythema multiforme
• Rare (less than 0.1%): Stevens-Johnson Syndrome, toxic epidermal necrolysis, keratoacanthoma/squamous cell carcinoma of the skin^[Ref]

Other

• Very common (10% or more): Asthenia/fatigue (64%), pain (60%), infection (32%), fever (28%), mucosal inflammation (17%)
• Common (1% to 10%): Tinnitus, ear discomfort^[Ref]

Cardiovascular

• Very common (10% or more): Hypertension (59%), hemorrhage (21%)
• Uncommon (0.1% to 1%): Myocardial ischemia, myocardial infarction, hypertensive crisis, acute coronary syndrome^[Ref]

Gastrointestinal

• Very common (10% or more): Diarrhea (47%), increased lipase (46%), mucositis (40%), increased amylase (26%), stomatitis (25%), nausea (20%), vomiting (17%)
• Common (1% to 10%): Pancreatitis, gastroesophageal reflux, gastroenteritis, dry mouth
• Uncommon (0.1% to 1%): GI fistula, GI perforation^[Ref]

Respiratory

• Very common (10% or more): Dysphonia (39%)
• Common (1% to 10%): Epistaxis^[Ref]

Nervous system

• Very common (10% or more): Headache (16%)
• Common (1% to 10%): Tremor, taste disorder, peripheral sensory neuropathy, vertigo
• Frequency not reported: Reversible posterior leukoencephalopathy syndrome/posterior reversible encephalopathy syndrome^[Ref]

Musculoskeletal

• Very common (10% or more): Muscle spasms (14%), musculoskeletal stiffness (14%)^[Ref]

Hypersensitivity

• Uncommon (0.1% to 1%): Hypersensitivity reaction^[Ref]

See also:

Further information

Regorafenib 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