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Regorafenib Side Effects

Medically reviewed by Drugs.com. Last updated on Jan 11, 2024.

Applies to regorafenib: oral tablet.

Warning

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.

Serious side effects of Regorafenib

Along with its needed effects, regorafenib 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

Less common

Rare

Other side effects of Regorafenib

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

Less common

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]

References

1. Godfraind T. [Pharmacology of digitalis receptors]. Bull Acad R Med Belg. 1972;12:403-48.

2. Cerner Multum, Inc. UK Summary of Product Characteristics.

3. Cerner Multum, Inc. Australian Product Information.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.