Balversa Side Effects

Generic name: erdafitinib

Medically reviewed by Drugs.com. Last updated on Sep 13, 2022.

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

Applies to erdafitinib: oral tablet.

Serious side effects of Balversa

Along with its needed effects, erdafitinib (the active ingredient contained in Balversa) 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 erdafitinib:

More common

Bladder pain
bloody or cloudy urine
blurred vision
burning, dry, or itching eyes
chest tightness
confusion
difficult or labored breathing
difficult, burning, or painful urination
discharge
discoloration of the fingernails or toenails
excessive tearing
frequent urge to urinate
increased tearing
irregular heartbeat
loosening of the fingernails
lower back or side pain
mood or mental changes
muscle cramps in the hands, arms, feet, legs, or face
numbness and tingling around the mouth, fingertips, or feet
redness or soreness around the fingernails
redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
redness, swelling, or pain of the skin
scaling of the skin on the hands and feet
seizures
stomach cramps
tremor
ulceration of the skin

Less common

Chest pain or discomfort
nausea
pain or discomfort in the arms, jaw, back, or neck
sweating
vomiting

Rare

Painful skin lesions

Other side effects of Balversa

Some side effects of erdafitinib 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

Bone pain
constipation
decreased appetite
diarrhea
difficulty in moving
dry mouth
dry skin
fever
hair loss or thinning of hair
joint pain
mouth or throat pain
muscle pain or stiffness
stomach pain
swelling or inflammation of the mouth
unusual tiredness or weakness
vomiting
weight decreased

For Healthcare Professionals

Applies to erdafitinib: oral tablet.

Hematologic

Very common (10% or more): Hemoglobin decreased (35%), platelets decreased (19%), leukocytes decreased (17%), neutrophils decreased (10%)^[Ref]

Musculoskeletal

Very common (10% or more): Musculoskeletal pain (e.g., back pain, musculoskeletal discomfort, musculoskeletal pain, musculoskeletal chest pain, neck pain, pain in extremity) (20%), arthralgia (11%)

Ocular

Very common (10% or more): Dry eye (28%), central serous retinopathy/retinal pigment epithelial detachment (CSR/RPED) (25%), dry eye (e.g., dry eye, xerophthalmia, keratitis, foreign body sensation, corneal erosion) (28%), vision blurred (17%), conjunctivitis (11%), lacrimation increased (10%)

Common (1% to 10%): CSR/RPED involving central field of vision^[Ref]

Metabolic

(76%), sodium decreased (40%), decreased appetite (38%), magnesium decreased (30%), phosphate decreased (24%), calcium increased (22%), potassium increased (16%), weight loss (e.g., weight loss, cachexia) (16%), fasting glucose increased (10%)^[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection (17%), hematuria (11%)^[Ref]

Hepatic

Very common (10% or more): Alanine aminotransferase increased (41%), alkaline phosphatase increased (41%), aspartate aminotransferase increased (30%)^[Ref]

Respiratory

Very common (10% or more): Dyspnea (10%)^[Ref]

Other

Very common (10% or more): Fatigue (e.g., asthenia, fatigue, lethargy, malaise) (54%), pyrexia (14%)

Frequency not reported: Embryofetal toxicity^[Ref]

Nervous system

Very common (10% or more): Dysgeusia (37%)^[Ref]

Renal

Very common (10% or more): Creatinine increased (52%)^[Ref]

Dermatologic

Very common (10% or more): Onycholysis (e.g., onycholysis, onychoclasis, nail disorder, nail dystrophy, nail ridging) (41%), dry skin (e.g., dry skin, xerostomia) (34%), palmar-plantar erythrodysesthesia (26%), alopecia (26%), paronychia (17%), nail discoloration (11%)^[Ref]

Gastrointestinal

Very common (10% or more): Stomatitis (56%), diarrhea (47%), dry mouth (45%), constipation (28%), abdominal pain (e.g., abdominal pain, abdominal discomfort, abdominal pain upper, abdominal pain lower) (23%), nausea (21%), vomiting (13%), oropharyngeal pain (11%)^[Ref]