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Side Effects | BALVERSA® (erdafitinib)

Side Effects With BALVERSA®

BALVERSA® may cause serious side effects, including:

  • Eye problems. Eye problems are common with BALVERSA® but can also be serious. Eye problems include dry or inflamed eyes, inflamed cornea (front part of the eye), and disorders of the retina, an internal part of the eye. Tell your healthcare provider right away if you develop blurred vision, loss of vision, or other visual changes. You should use artificial tear substitutes, hydrating or lubricating eye gels, or ointments at least every 2 hours during waking hours to help prevent dry eyes. During treatment with BALVERSA®, your healthcare provider will send you to see an eye specialist.
  • High phosphate levels in the blood (hyperphosphatemia). Hyperphosphatemia is common with BALVERSA® but can also be serious. Your healthcare provider will check your blood phosphate level between 14 and 21 days after starting treatment with BALVERSA®, and then monthly, and may change your dose if needed.

Most common side effects were mild to moderate

  • mouth sores
  • feeling tired
  • change in kidney function
  • diarrhea
  • dry mouth
  • nails separate from the bed or poor formation of the nail
  • change in liver function
  • low salt (sodium) levels
  • decreased appetite
  • change in sense of taste
  • low red blood cells (anemia)
  • dry skin
  • dry eyes
  • hair loss
  • redness, swelling, peeling or tenderness, mainly on the hands or feet (“hand-foot syndrome”)
  • constipation
  • stomach (abdominal) pain
  • nausea
  • muscle pain

Call your doctor right away if you experience any of the following side effects:

Icon of a blue eye with green pupil. The pupil has a black circle on its edge

Eye problems

  • Dry or inflamed eyes
  • Blurred vision
  • Loss of vision
  • Any other vision changes
Icon of a blue left hand, a green magnifying glass is over the thumb nail.

Nail or skin changes

  • Nails separating from the nail bed
  • Nail pain, nail bleeding, or nail breaking
  • Nails that have changed color or texture
  • Infected skin around the nails
  • Dry skin or cracks in the skin
  • Itchy skin rash

What are the other possible side effects of BALVERSA®?

BALVERSA® may affect fertility in females who are able to become pregnant. Talk to your healthcare provider if this is a concern for you.

These are not all the possible side effects of BALVERSA®. Side effects that are bothersome or do not go away should be reported to a doctor. The doctor may change the dose or interrupt treatment with BALVERSA® as needed.

BALVERSA® has been associated with serious eye disorders. Your doctor may send you to see an eye specialist (ophthalmologist or optometrist) if you get eye problems with BALVERSA®.

It is important to inform the doctor about any current eye disorders and to test for certain eye disorders.

You should use artificial tear substitutes, hydrating or lubricating eye gels, or ointments frequently, at least every 2 hours during waking hours to help prevent dry eyes. However, any visual changes should be reported to the doctor right away.

For more information, ask your healthcare provider or pharmacist.

You may report side effects to the FDA at 1-800-FDA-1088.

Keep BALVERSA® out of the reach of children.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines and herbal supplements. Taking BALVERSA® with certain other medicines may affect how BALVERSA® works and can cause side effects.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.