Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Stivarga (Regorafenib). If you are concerned about side effects, discuss the risks and benefits of Stivarga (Regorafenib) with your doctor.

The following side effects have been reported by at least 1% of people taking Stivarga (Regorafenib). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• changed sense of taste
• decreased appetite
• Diarrhea
• dry skin
• hair loss
• headache
• muscle stiffness
• pain
• tiredness
• voice changes or hoarseness
• weight loss

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• cough or shortness of breath with no other symptoms
• severe diarrhea
• Fever
• increased blood pressure
• mouth sores
• signs of bleeding (e.g., bloody nose, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
• signs of hand-foot skin reaction (e.g., tingling, burning sensation affecting the hands and feet, blisters on the fingers or feet, callus formation)
• signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• signs of low Thyroid levels (Hypothyroidism; e.g., weight gain, puffy face, Constipation, fatigue, dry skin memory problems)
• signs of a skin reaction on the hands or feet (e.g., redness, pain, swelling, or blistering of palms of hands or soles of feet)
• slow wound healing

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of bleeding in the stomach (e.g., bloody, black, or tarry stools; spitting up of blood; vomiting blood or material that looks like coffee grounds)
• signs of Heart Attack (e.g., sudden chest pain or pain radiating to back, down arm, jaw; sensation of fullness of the chest; nausea; vomiting; sweating; anxiety)
• signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Stivarga (Regorafenib).

40 mg
Each oval, light-pink, film-coated tablet debossed with "BAYER" on one side and "40" on the other side contains 40 mg of Stivarga (Regorafenib). Nonmedicinal ingredients: tablet core: cellulose microcrystalline, croscarmellose sodium, magnesium stearate, povidone, silica colloidal anhydrous. Film-coat: iron oxide red, iron oxide yellow, lecithin (soy), macrogol, polyvinyl alcohol, partially hydrolyzed, talc, and titanium dioxide.

Do not take Stivarga (Regorafenib) if you are allergic to Stivarga (Regorafenib), sorafenib, or any ingredients of the medication.

There may be an interaction between Stivarga (Regorafenib) and any of the following:

• Amiodarone
• Apalutamide
• Aprepitant
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• beta-blockers (e.g., Atenolol, Metoprolol, Propranolol, Sotalol)
• bisphosphonates (e.g., Alendronate, etidronate)
• Bosentan
• calcium channel blockers (e.g., Amlodipine, Diltiazem, Nifedipine, Verapamil)
• Carbamazepine
• Cobicistat
• conivaptan
• Crizotinib
• Cyclosporine
• Dabrafenib
• Dasatinib
• Deferasirox
• Digoxin
• Dronedarone
• Enzalutamide
• grapefruit juice
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delavirdine efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• imatinib
• Irinotecan
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• mifepristone
• Methotrexate
• Modafinil
• Norfloxacin
• Oxcarbazepine
• Phenobarbital
• Phenytoin
• primidone
• rifabutin
• rifampin
• St. John's wort
• siltuximab
• Stiripentol
• Tocilizumab
• Topotecan
• Warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Stivarga (Regorafenib). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Stivarga (Regorafenib).

Anemia: Stivarga (Regorafenib) may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired or pale skin, contact your doctor as soon as possible.

Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including red blood cells, in your blood.

Bleeding: Stivarga (Regorafenib) may cause a reduced number of platelets in the blood, which can make it difficult to stop cuts from bleeding. If you have a medical condition or are taking medication that affects blood clotting, discuss with your doctor how Stivarga (Regorafenib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Stivarga (Regorafenib), and whether any special monitoring is needed. Your doctor will order routine blood tests to make sure potential problems are caught early.

If you notice any signs of bleeding, such as frequent nosebleeds, or unexplained bruising, notify your doctor as soon as possible. If you notice signs of bleeding in the stomach such as black and tarry stools, vomiting material that looks like coffee grounds or passing blood in the stool, contact your doctor immediately.

Fluid and electrolyte balance: Stivarga (Regorafenib) may cause the levels of electrolytes such as potassium, sodium, magnesium, chloride, and calcium in the blood to change while taking Stivarga (Regorafenib). If you experience symptoms of fluid and electrolyte imbalance such as muscle pains or cramps; Dry Mouth; numb hands, feet, or lips; or racing heartbeat, contact your doctor as soon as possible. Your doctor will do blood tests regularly to monitor the levels of these electrolytes in your blood while you are taking Stivarga (Regorafenib).

Gastrointestinal problems: Rarely, Stivarga (Regorafenib) can cause perforation of the stomach or intestines. If you experience severe abdominal pain, fever, vomiting, or nausea, contact your doctor immediately.

Hand-foot skin reaction: Stivarga (Regorafenib) may cause a tingling, burning sensation on the palms of the hands or soles of the feet. This can progress to swelling or thickening of the skin on the hands and feet. In more severe cases, sores develop, sometimes with blisters or shedding the skin. This reaction is not life-threatening but it can be very uncomfortable and is treatable. If you notice any early signs of this reaction, contact your doctor as soon as possible.

Heart disease: Changes in heart rhythm (arrhythmia), decreased heart rate, increased blood pressure, and heart attack may occur with the use of Stivarga (Regorafenib). If you have a history of heart problems, discuss with your doctor how Stivarga (Regorafenib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Stivarga (Regorafenib), and whether any special monitoring is needed.

If you experience signs of a heart attack, such as sudden chest pain or pain radiating to back, down arm, jaw; sensation of fullness of the chest; nausea, vomiting, sweating, or anxiety, get medical help immediately.

Hypersensitivity syndrome: A Anaphylaxis (severe allergic reaction) called hypersensitivity syndrome has occurred for some people with the use of Stivarga (Regorafenib). This reaction involves a number of organs in the body and may be fatal if not treated quickly. Stop taking the medication and get immediate medical attention if you have symptoms of a severe allergic reaction, including fever, swollen glands, yellowing of the skin or eyes, or flu-like symptoms with skin rash or blistering.

Infection: As well as killing cancer cells, Stivarga (Regorafenib) can reduce the number of cells that fight infection in the body (white blood cells). If possible, avoid contact with people with contagious infections.

Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.

Liver function: Stivarga (Regorafenib) may reduce liver function and can cause liver failure. If you have liver problems, discuss with your doctor how Stivarga (Regorafenib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Stivarga (Regorafenib), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Stivarga (Regorafenib).

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Reversible posterior leukoencephalopathy syndrome (RPLS): This is a rare disease of the brain that may occur when using medications like Stivarga (Regorafenib). If you have had a previous episode of RPLS, Stivarga (Regorafenib) may not be an appropriate medication for you. Make sure your doctor knows you have experienced this before. If you experience signs and symptoms of RPLS, such as headache, seizures, change in awareness or consciousness or vision changes, contact your doctor immediately.

Skin rash: Stivarga (Regorafenib) may cause skin rash or itchiness with or without a rash. Rarely, people taking Stivarga (Regorafenib) experience a severe skin reaction that can be life-threatening. If you experience a rash that gets worse, or develops into blisters, sores on the lips or eyes or covers a large area of the body, contact your doctor immediately.

Surgery: Stivarga (Regorafenib) causes changes to the blood and may slow down the healing process for wounds. Make sure anyone involved in your medical care knows you are taking Stivarga (Regorafenib).

Thyroid disease: Stivarga (Regorafenib) may cause decreased thyroid gland function. If you have problems with your thyroid gland, Stivarga (Regorafenib) may make these problems worse. If you experience symptoms of underactive thyroid, such as unexpectedly feeling cold, Depression, constipation, or fatigue, let your doctor know. If you have a history of thyroid disease, discuss with your doctor how Stivarga (Regorafenib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Stivarga (Regorafenib), and whether any special monitoring is needed.

Pregnancy: There is no information about the effect of Stivarga (Regorafenib) on an unborn baby if Stivarga (Regorafenib) is used during pregnancy. Women who may become pregnant while taking Stivarga (Regorafenib) must use an effective form of birth control, even if they have not had their first menstrual period. Effective birth control must be used by both women and men during treatment with Stivarga (Regorafenib), and for at least eight weeks following the discontinuation of treatment. If you become pregnant while taking Stivarga (Regorafenib), contact your doctor immediately.

Breast-feeding: It is not known if Stivarga (Regorafenib) passes into breast milk. If you are a breast-feeding mother and are taking Stivarga (Regorafenib), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Stivarga (Regorafenib) have not been established for children.