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

Summary

Common side effects of Stivarga include: infection, anemia, asthenia, diarrhea, fatigue, fever, hemorrhage, hyperbilirubinemia, hypertension, hypocalcemia, hypokalemia, hyponatremia, hypophosphatemia, increased amylase, increased inr, increased serum alanine aminotransferase, increased serum aspartate aminotransferase, increased serum lipase, lymphocytopenia, mucositis, neutropenia, pain, palmar-plantar erythrodysesthesia, proteinuria, skin rash, thrombocytopenia, voice disorder, weight loss, and decreased appetite. Continue reading for a comprehensive list of adverse effects.

Applies to regorafenib: oral tablet.

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

• 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

• 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

• 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

• 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.

Hepatic

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]