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]
