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Written By
Dr Rakshitha B K
Doctor of Pharmacy

Reviewed By
Dr. Abhishaanth Prabu
MBBS
Last updated : 12 Aug 2026 | 06:30 AM (IST)

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Quick Summary
ERDAFITINIB
Last updated on 12 Aug 2026 | 06:30 AM (IST)
ERDAFITINIB
Background and Date of Approval of Erdafitinib
Erdafitinib is an anticancer medicine used to treat locally advanced or metastatic urothelial carcinoma, a type of cancer that affects the bladder and urinary tract. It is prescribed for patients whose cancer has certain fibroblast growth factor receptor (FGFR) genetic alterations and who have already received prior chemotherapy.
Erdafitinib is a targeted therapy that helps slow down or stop the growth of cancer cells by blocking FGFR proteins involved in tumour development. It is taken orally and requires close monitoring, especially for eye-related side effects and changes in blood phosphate levels.
Patients should inform their healthcare provider if they experience vision changes, eye pain, or dry eyes. Regular eye examinations and blood tests are important during treatment. Patients with a history of eye disorders or kidney problems should consult their doctor before starting this medicine.
Erdafitinib was approved by the U.S. Food and Drug Administration in April 2019 for the treatment of adults with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 or FGFR2 genetic alterations after progression during platinum-containing chemotherapy. Its approval provided a targeted treatment option for patients with specific genetic mutations.
Uses
Erdafitinib is indicated to treat the following conditions:
Locally advanced urothelial carcinoma
Metastatic urothelial carcinoma with FGFR genetic alterations
How IS Erdafitinib Administered?
Erdafitinib is taken orally as a tablet, usually once daily, or as prescribed by the doctor.
Swallow the tablet whole, with or without food.
Do not crush or chew the tablet.
The dosage may be adjusted based on blood phosphate levels and treatment response.
Do not take a double dose if a dose is missed.
Take this medicine exactly as prescribed by your healthcare provider.
Side Effects
Like all medications, Erdafitinib can cause side effects, although not everyone will experience them.
Serious side effects of Erdafitinib are:
Eye disorders such as central serous retinopathy
Severe hyperphosphatemia (high phosphate levels)
Hand-foot syndrome
Severe skin reactions
Nail disorders
Stomatitis (inflammation of the mouth)
Common side effects of Erdafitinib are:
Dry mouth
Fatigue
Diarrhoea
Decreased appetite
Taste changes
Dry skin
Hair thinning
Constipation
Warnings
Erdafitinib should be used carefully because it may cause serious side effects:
Eye problems: Erdafitinib may cause serious eye disorders such as central serous retinopathy or retinal pigment epithelial detachment, which can affect vision.
High phosphate levels: This medicine often raises blood phosphate levels, which may require dietary changes or additional treatment.
Skin and nail disorders: Patients may experience dry skin, hand-foot syndrome, nail separation, or nail damage during treatment.
Mouth sores: Painful sores or mouth inflammation may develop and require supportive care.
Severe allergic reactions: Although rare, allergic reactions such as rash, swelling, or breathing difficulty may occur.
Precautions
Certain precautions are important when using Erdafitinib:
Regular eye examinations: Patients should undergo eye exams before treatment and during therapy to detect any early vision-related side effects.
Monitoring phosphate levels: Blood phosphate levels should be checked regularly, especially during the first weeks of treatment.
Dose adjustments: The dose may need to be reduced or interrupted if severe side effects occur.
Pregnancy prevention: Erdafitinib may harm an unborn baby, so effective contraception should be used during treatment and for the recommended period after therapy.
Breastfeeding caution: Breastfeeding is not recommended during treatment due to the potential risk to the infant.
Liver and kidney monitoring: Patients with liver or kidney impairment should be monitored carefully while taking this medicine.
Expert Tips
Attend regular eye check-ups during treatment.
Drink adequate fluids and maintain good oral hygiene.
Report any vision changes or eye discomfort immediately.
Follow dietary advice to manage phosphate levels.
Avoid self-medication and inform your doctor about all medicines you are taking.
Use effective contraception during and after treatment as advised.
Frequently Asked Questions
Q1.
It is prescribed for patients with advanced urothelial cancer who have specific FGFR genetic mutations and have received prior treatment.
Q2.
This medicine may cause eye problems, so regular eye exams help detect and manage issues early.
Q3.
Yes, it can increase phosphate levels, so regular monitoring is required.
Q4.
No, do not stop the medication without consulting your doctor, as it may affect treatment outcomes.
Q5.
Avoid pregnancy, attend follow-ups, monitor side effects, and follow your doctor’s instructions carefully.
References
Disclaimer
The drug information on this page is not a substitute for medical advice. It is meant for educational purposes only. For further details, consult your doctor about your medical condition to know if you can receive this treatment.






