See also Warning section.

Diarrhea, pain/sores in the mouth/throat, changes in taste, dry mouth, loss of appetite, hair loss, voice changes, weight loss, or muscle stiffness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Treatment with this drug may sometimes cause your hands/feet to develop a skin reaction called hand-foot skin reaction (palmar-plantar erythrodysesthesia). People of Asian descent are at greater risk. Tell your doctor right away if you experience swelling, pain, redness, peeling, blisters, or tingling/burning of the hands/feet. The symptoms can be made worse by heat/pressure on your hands/feet. Avoid prolonged sun exposure, tanning booths, and sunlamps, as well as unnecessary exposure to heat (for example, hot dishwater, long hot baths). Use a sunscreen and wear protective clothing when outdoors. Avoid pressure on elbows, knees, and soles of feet (such as leaning on elbows, kneeling, taking long walks). Wear loose clothing and comfortable shoes. Depending on how severe your hand-foot reaction is, your doctor may give you an additional medication to reduce the symptoms, or stop or delay your regorafenib treatment.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Your doctor may control your blood pressure with medication.

Tell your doctor right away if you have any serious side effects, including: slow wound healing, signs of dehydration (such as extreme thirst, dizziness, decreased urination), signs of mineral imbalance (such as muscle cramps/weakness, irregular heartbeat, mental/mood changes), signs of infection (such as sore throat that doesn't go away, fever, chills), signs of underactive thyroid (weight gain, cold intolerance, unusual tiredness, slow heartbeat).

This medication can cause serious bleeding. Tell your doctor right away if you have any signs of serious bleeding, including: easy bleeding/bruising, severe stomach/abdominal pain, vomit that is bloody or looks like coffee grounds, black/tarry stool, unusual vaginal bleeding, pink/bloody urine, coughing up blood.

Get medical help right away if you have any very serious side effects, including: signs of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating), sudden/severe back pain, seizure, severe headache, confusion, sudden vision changes, weakness on one side of the body, trouble speaking.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Regorafenib can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Get medical help right away if you develop any rash.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.