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
Rare
  • 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

General

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.

Cardiovascular

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

Dermatologic

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

Endocrine

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

Gastrointestinal

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%)

Hematologic

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

Hepatic

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

Immunologic

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

Metabolic

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

Musculoskeletal

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%)

Oncologic

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

Other

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

Renal

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

Respiratory

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

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

Hide
(web3)