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Balversa Side Effects

Generic Name: erdafitinib

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

For the Consumer

Applies to erdafitinib: oral tablet

Side effects requiring immediate medical attention

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
  • 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
  • tightness in the chest
  • tremor
  • ulceration of the skin

Less common

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

Side effects not requiring immediate medical attention

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]

References

1. "Product Information. Balversa (erdafitinib)." Janssen Products, LP, Horsham, PA.

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.