Futibatinib Side Effects

Medically reviewed by Drugs.com. Last updated on Jan 19, 2025.

Applies to futibatinib: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests will be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 1 week after your last dose. Males who are taking this medicine, with female partners who can become pregnant must use effective birth control during treatment and for at least 1 week after the last dose of this medicine. If you think you have become pregnant while using the medicine, tell your doctor right away.

Check with your doctor right away if eye pain, dryness, swelling, or a change in vision occurs during treatment. This could be a sign of a serious eye problem. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor) before starting treatment, every 2 months for the first 6 months, and every 3 months during treatment with this medicine. You may use artificial tear substitutes, or hydrating or lubricating eye gels to help prevent to treat dry eyes.

This medicine may cause hyperphosphatemia (high potassium levels in the blood). Check with your doctor right away it you have stomach cramps, confusion, seizures, difficulty in breathing, irregular heartbeat, mood or mental changes, muscle cramps in the hands, arms, feet, legs, or face, numbness and tingling around the mouth, fingertips, or feet, or tremor.

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 or vitamin supplements.

Serious side effects of futibatinib

Along with its needed effects, futibatinib 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 futibatinib:

Other side effects of futibatinib

Some side effects of futibatinib 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:

For healthcare professionals

Applies to futibatinib: oral tablet.

General adverse events

The most common adverse reactions (20% or greater) were nail toxicity, musculoskeletal pain, constipation, diarrhea, fatigue, dry mouth, alopecia, stomatitis, abdominal pain, dry skin, arthralgia, dysgeusia, dry eye, nausea, decreased appetite, urinary tract infection, palmar-plantar erythrodysesthesia syndrome, and vomiting.

Serious adverse reactions were reported in 39% of patients. Serious adverse reactions that occurred in 2% or more patients were pyrexia (3.9%), gastrointestinal hemorrhage (3.9%), ascites (2.9%), musculoskeletal pain (2.9%), and bile duct obstruction (2.9%).

Permanent discontinuation due to an adverse reaction was reported in 4.9% of patients. Adverse reactions leading to discontinuation included esophagitis, oral dysesthesia, bile duct obstruction, dizziness, and anemia.

The most common laboratory abnormalities (20% or greater) were increased phosphate, increased creatinine, decreased hemoglobin, increased glucose, increased calcium, decreased sodium, decreased phosphate, increased alanine aminotransferase, increased alkaline phosphatase, decreased lymphocyte, increased aspartate aminotransferase, decreased platelets, increased activated partial thromboplastin time, decreased leukocytes, decreased albumin, decreased neutrophils, increased creatine kinase, increased bilirubin, decreased glucose, increased prothrombin international normalized ratio, and decreased potassium.^[Ref]

Gastrointestinal

• Very common (10% or more): Abdominal pain (30%), constipation (39%), diarrhea (39%), dry mouth (35%), nausea (24%), stomatitis (30%), vomiting (20%)^[Ref]

Dermatologic

• Very common (10% or more): Alopecia (34%), dry skin (29%), nail toxicity (47%), palmar-plantar erythrodysesthesia syndrome (21%)^[Ref]

Metabolic

• Very common (10% or more): Decreased appetite (23%)^[Ref]

Musculoskeletal

• Very common (10% or more): Arthralgia (25%), musculoskeletal pain (43%)^[Ref]

Ocular

• Very common (10% or more): Dry eye (25%)
• Common (1% to 10%): Retinal pigment epithelial detachment (RPED)^[Ref]

Other

• Very common (10% or more): Fatigue (37%), decreased weight (18%)^[Ref]

Genitourinary

• Very common (10% or more): Urinary tract infection (23%)^[Ref]

Nervous system

• Very common (10% or more): Dysgeusia (25%)^[Ref]

See also:

Further information

Futibatinib 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.

Medical Disclaimer