Balversa Side Effects

Generic name: erdafitinib

Medically reviewed by Drugs.com. Last updated on May 20, 2024.

Note: This document provides detailed information about Balversa.

Applies to erdafitinib: oral tablet Side Effects associated with erdafitinib. Some dosage forms listed on this page may not apply specifically to the brand name Balversa.

Applies to erdafitinib: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may 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. It may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Female patients should use effective birth control during treatment and for 1 month after the last dose. Male patients who have female partners should use effective birth control during treatment and for 1 month after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

Check with your doctor right away if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).

This medicine may cause hyperphosphatemia (high potassium levels in the blood), which may increase the amount of minerals (eg, calcium) in different tissues in your body. 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, painful skin rash or lump, or tremor.

If you plan to have children, talk with your doctor before using this medicine. Some women using this medicine have become infertile (unable to have children).

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 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:

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:

For healthcare professionals

Applies to erdafitinib: oral tablet.

Hematologic adverse events

• 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]

See also:

Further information

Balversa 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