Stivarga Side Effects
Generic name: regorafenib
Medically reviewed by Drugs.com. Last updated on May 4, 2025.
Note: This document provides detailed information about Stivarga Side Effects associated with regorafenib. Some dosage forms listed on this page may not apply specifically to the brand name Stivarga.
Applies to regorafenib: oral tablet.
Important warnings
This medicine can cause some serious health issues
Oral route (tablet)
Severe and sometimes fatal hepatotoxicity has occurred with regorafenib therapy.
Monitor hepatic function prior to and during therapy.
Adjust dose or interrupt or discontinue therapy if hepatoxicity occurs.
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 Stivarga
Along with its needed effects, regorafenib (the active ingredient contained in Stivarga) 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:
More common side effects
- bleeding gums
- bloody or cloudy urine
- blurred vision
- cough or hoarseness
- coughing up blood
- difficult, burning, or painful urination
- difficulty with breathing or swallowing
- dizziness
- fever or chills
- frequent urge to urinate
- headache
- increased menstrual flow or vaginal bleeding
- lower back or side pain
- nervousness
- nosebleeds
- painful or difficult urination
- pounding in the ears
- prolonged bleeding from cuts
- rash
- red or black, tarry stools
- redness, swelling, or pain of the skin
- scaling of the skin on the hands and feet
- slow or fast heartbeats
- tingling of the hands and feet
- ulcers on the skin
Less common side effects
- chest pain or discomfort
- dark-colored urine
- general feeling of tiredness or weakness
- light-colored stools
- nausea or vomiting
- pain or discomfort in the arms, jaw, back, or neck
- shakiness in the legs, arms, hands, or feet
- stomach pain that continues
- sweating
- yellow eyes or skin
Rare side effects
- blistering, peeling, or loosening of the skin
- bloody, black, or tarry stools
- chills
- confusion
- diarrhea
- heartburn
- indigestion
- itching
- joint or muscle pain
- red skin lesions, often with a purple center
- severe stomach pain, cramping, or burning
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- trouble breathing
- unusual tiredness or weakness
- vomiting of material that looks like coffee grounds, severe and continuing
Other side effects of Stivarga
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:
More common side effects
- bad, unusual, or unpleasant taste
- hair loss or thinning of the hair
- lack or loss of strength
- muscle or joint stiffness
- weight loss
Less common side effects
- constipation
- depressed mood
- dry skin and hair
- feeling cold
- muscle cramps
- weight gain
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:
Keytruda
Keytruda is used to treat multiple types of cancer such as melanoma, non-small cell lung cancer ...
Avastin
Avastin is used to brain tumors and cancers of the kidney, colon, rectum, or lung. Learn about side ...
Opdivo Qvantig
Opdivo Qvantig is used to treat adults with melanoma, non-small cell lung cancer, renal cell ...
Xeloda
Xeloda is used to treat breast and colorectal cancers. Learn about side effects, interactions and ...
Opdivo
Opdivo is used to treat many cancers, such as melanoma, non-small cell lung cancer, malignant ...
Oxaliplatin
Oxaliplatin (Eloxatin) is a cytotoxic chemotherapy drug used to treat stage III colon cancer and ...
Imatinib
Imatinib is used to treat certain types of leukemia, bone marrow disorders, and skin cancer ...
Nivolumab
Nivolumab (brand name Opdivo) is an immunotherapy treatment that treats many cancers, such as ...
Bevacizumab
Bevacizumab injection is a targeted cancer drug used to treat types of non-small cell lung cancer ...
Fluorouracil
Fluorouracil systemic is used for anal cancer, breast cancer, breast cancer, palliative, cancer ...
References
1. Godfraind T (1972) "[Pharmacology of digitalis receptors]." Bull Acad R Med Belg, 12, p. 403-48
2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
3. Cerner Multum, Inc. "Australian Product Information."
More about Stivarga (regorafenib)
- Check interactions
- Compare alternatives
- Pricing & coupons
- Reviews (10)
- Drug images
- Dosage information
- During pregnancy
- Generic availability
- FDA approval history
- Drug class: multikinase inhibitors
- Breastfeeding
- En español
Patient resources
Professional resources
Related treatment guides
Further information
Stivarga 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.