Stivarga Side Effects

Generic Name: regorafenib

Note: This document contains side effect information about regorafenib. Some of the dosage forms listed on this page may not apply to the brand name Stivarga.

Some side effects of Stivarga may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to regorafenib: oral tablet

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
  • Bleeding gums
  • blurred vision
  • cough or hoarseness
  • coughing up blood
  • difficulty with breathing or swallowing
  • dizziness
  • fever or chills
  • 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
  • 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
  • Confusion
  • heartburn
  • indigestion
  • severe stomach pain, cramping, or burning
  • vomiting of material that looks like coffee grounds

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
  • 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
  • Constipation
  • depressed mood
  • dry skin and hair
  • feeling cold
  • muscle cramps
  • weight gain

For Healthcare Professionals

Applies to regorafenib: oral tablet


The most common side effect resulting in discontinuation was skin toxicity (HFSR/PPE or rash).
The most frequently observed adverse drug reactions (greater than or equal to 30%) were asthenia/fatigue, decreased appetite and food intake, HFSR/PPE, diarrhea, mucositis, weight loss, infection, hypertension and dysphonia.
The most serious adverse drug reactions were hepatotoxicity, hemorrhage, and gastrointestinal perforation.


Very common (10% or more): Hypertension (30%)


Very common (10% or more): HFSR/PPE (45%), rash (26%)
Common (1% to 10%): Alopecia (7.6%)


Very common (10% or more): Increased lipase (46%), increased amylase (26%)
Common (1% to 10%): Hypothyroidism (4.2%)


Very common (10% or more): Diarrhea (43%), mucositis (33%)
Common (1% to 10%): Taste disorder (7.6%), dry mouth (4.8%), gastroesophageal reflux (1.4%)
Uncommon (0.1% to 1%): Gastrointestinal fistula (0.8%)


Very common (10% or more): Anemia (79%), lymphopenia (54%), thrombocytopenia (41%), increased INR (24%), hemorrhage (21%)
Common (1% to 10%): Neutropenia (3%)


Very common (10% or more): Increased AST (65%), increased ALT (45%), hyperbilirubinemia (45%)


Very common (10% or more): Infection (31%)


Very common (10% or more): Hypocalcemia (59%), hypophosphatemia (57%), decreased appetite and food intake (47%), weight loss (32%), hyponatremia (30%), hypokalemia (26%)


Common (1% to 10%): Musculoskeletal stiffness (6.0%)

Nervous system

Very common (10% or more): Pain (29%), headache (10%)
Common (1% to 10%): Tremor (2%)


Rare (less than 0.1%): Keratoacanthoma/squamous cell carcinoma of the skin (0.09%)


Very common (10% or more): Asthenia/fatigue (64%), fever (28%)


Very common (10% or more): Proteinuria (60%)


Very common (10% or more): Dysphonia (30%)

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