Erdafitinib
Erdafitinib (sold as Balversa) is a once-daily kinase inhibitor tablet for adults with advanced bladder and urinary tract cancer (urothelial carcinoma) that has a specific FGFR3 gene change.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Erdafitinib (Balversa) is a once-daily specialist cancer medicine, on the market since about 2019, for adults with advanced urothelial carcinoma (bladder and urinary tract cancer) that carries a specific FGFR3 gene change found on tumor testing, used after earlier treatment, usually including immunotherapy, has stopped working; it blocks the FGFR proteins that drive those tumors’ growth. It is a demanding medicine, since high blood phosphate is an expected effect and mouth sores, diarrhea and nail changes are common, often leading to dose changes. Report any change in vision right away, because it can cause central serous retinopathy (fluid buildup under the retina), and keep every scheduled eye exam.
Clinical pearls
- Swallow the tablets whole, with or without food; if you vomit after a dose, skip it and resume the next day.
- Phosphate is checked a few weeks in to guide your dose, so limit high-phosphate foods and start nothing that alters phosphate.
- Antifungals such as fluconazole or itraconazole can raise erdafitinib levels, so make sure every prescriber knows you take it.
- It can harm an unborn baby, so use effective contraception and do not breastfeed while taking it.
Patient information guide A plain-language walkthrough of Erdafitinib, written from its FDA label.
What Erdafitinib is used for
▾
Erdafitinib is used for one type of advanced cancer.
- Balversa (tablet) treats adults with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations.
- The cancer must have progressed on or after at least one earlier systemic therapy.
- An FDA-approved test on the tumor confirms the FGFR3 change.
- Balversa is not recommended for people who are eligible for PD-1 or PD-L1 inhibitor therapy and haven't received it.
How Erdafitinib works
▾
Erdafitinib is a kinase inhibitor. It binds to and blocks FGFR1, FGFR2, FGFR3 and FGFR4, proteins involved in cell growth signaling.
In lab studies, this reduced signaling and decreased the viability of cells carrying FGFR changes, including point mutations, amplifications and fusions. It showed antitumor activity in models of bladder cancer.
Erdafitinib dosage
▾
Balversa is a tablet taken by mouth once a day, with or without food. Swallow the tablets whole.
- Your doctor checks your phosphate level 14 to 21 days after you start and may increase your dose based on that result and how you're tolerating it.
- If you vomit, take the next dose the next day.
- If you miss a dose, take it the same day as soon as you can, then resume normally the next day. Don't double up.
- Treatment continues until the cancer progresses or side effects become unacceptable.
Dosing details from the FDA-approved label
From the Erdafitinib prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations
- Recommended starting dose is 8 mg (two 4 mg tablets) orally once daily, with a dose increase to 9 mg (three 3 mg tablets) once daily based on tolerability, including hyperphosphatemia, at 14 to 21 days
- Increase to 9 mg once daily if serum phosphate level is < 9.0 mg/dL and there are no ocular disorders or Grade 2 or greater adverse reactions
- Swallow tablet
- Assess serum phosphate 14 to 21 days after starting; if 9.0 mg/dL or higher follow Table 2 dose modifications; if vomiting occurs, take the next dose the next day; if a dose is missed, take it as soon as possible on the same day, then resume the regular schedule the next day
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION Confirm the presence of FGFR3 genetic alterations in tumor specimens prior to initiation of treatment with BALVERSA. ( 2.1 ) Recommended initial dosage: 8 mg orally once daily with a dose increase to 9 mg daily if criteria are met. ( 2.2 ) Swallow whole with or without food. ( 2.2 ) 2.1 Patient Selection Select patients for the treatment of locally advanced or metastatic urothelial carcinoma with BALVERSA based on the presence of susceptible FGFR3 genetic alterations in tumor specimens as detected by an FDA-approved companion diagnostic [see Clinical Studies (14.1) ] . Information on FDA-approved tests for the detection of FGFR3 genetic alterations in urothelial cancer is available at: http://www.fda.gov/CompanionDiagnostics. 2.2 Recommended Dosage and Schedule The recommended starting dose of BALVERSA is 8 mg (two 4 mg tablets) orally once daily, with a dose increase to 9 mg (three 3 mg tablets) once daily based on tolerability, including hyperphosphatemia, at 14 to 21 days [see Dosage and Administration (2.3) ]. Swallow tablets whole with or without food. If vomiting occurs any time after taking BALVERSA, the next dose should be taken the next day. Treatment should continue until disease progression or unacceptable toxicity occurs. If a dose of BALVERSA is missed, it can be taken as soon as possible on the same day. Resume the regular daily dose schedule for BALVERSA the next day. Extra tablets should not be taken to make up for the missed dose. Dose Increase based on Serum Phosphate Levels Assess serum phosphate levels 14 to 21 days after initiating treatment. Increase the dose of BALVERSA to 9 mg once daily if serum phosphate level is < 9.0 mg/dL and there are no ocular disorders or Grade 2 or greater adverse reactions. If the phosphate level is 9.0 mg/dL or higher follow the relevant dose modifications in Table 2. Monitor phosphate levels monthly for hyperphosphatemia [see Pharmacodynamics (12.2) ] . 2.3 Dose Modifications for Adverse Reactions The recommended dose modifications for adverse reactions are listed in Table 1.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Erdafitinib side effects
▾
Many people have side effects, and dose changes are common. The most common ones include:
Common side effects
- High phosphate levels in the blood
- Nail problems
- Mouth sores (stomatitis)
- Diarrhea
- Dry mouth and dry skin
- Tiredness
- Decreased appetite and changes in taste
- Hair loss, dry eye, constipation, and hand-foot skin reaction (palmar-plantar erythrodysesthesia syndrome)
- Nail disorders
When to get medical help
- Call your doctor right away if you notice any vision changes or visual symptoms. Balversa can cause a serious eye problem called central serous retinopathy.
- Tell your doctor about eye dryness or discomfort that doesn't improve.
- Report severe or worsening mouth sores, diarrhea, nail problems, or painful hand and foot skin changes. These often lead to dose changes.
- Let your care team know right away about symptoms of infection or blood in your urine. Urinary tract infection and hematuria were reported as serious reactions.
- Seek help for signs of kidney problems or severe illness. Acute kidney injury and fatal reactions occurred in a study.
Call your doctor promptly about vision changes, severe mouth sores, severe diarrhea or skin and nail problems. In a study, 72% of patients had a dose interruption and 69% had a dose reduction because of side effects.
Erdafitinib warnings and precautions
▾
- Eye disorders: Central serous retinopathy can cause vision problems. Regular eye exams are required, and treatment may be paused or stopped.
- High phosphate: Can lead to mineral deposits in soft tissue and vessels. Follow the low-phosphate diet and blood monitoring.
- Pregnancy: Can cause fetal harm. Use effective contraception.
Erdafitinib interactions
▾
Some medicines change how much erdafitinib is in your body or affect other drugs.
- Moderate CYP2C9 or strong CYP3A4 inhibitors raise erdafitinib levels and may increase toxicity.
- Strong CYP3A4 inducers lower levels and may reduce effect, so they should be avoided.
- Moderate CYP3A4 inducers may lower levels, and your doctor may use the higher dose.
- Phosphate-altering agents can interfere with early dose decisions.
- P-gp substrates with a narrow therapeutic index may rise in level. Separate doses by at least 6 hours.
Interactions listed in the FDA-approved label
From the Erdafitinib prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Moderate CYP2C9 or strong CYP3A4 inhibitors: Co-administration increased erdafitinib plasma concentrations, which may lead to increased drug-related toxicity. Consider alternative therapies that are not moderate CYP2C9 or strong CYP3A4 inhibitors. If unavoidable, monitor closely for adverse reactions and consider dose modifications accordingly. If the inhibitor is discontinued, resume the BALVERSA dose before dose modifications in the absence of drug-related toxicity.
- Strong CYP3A4 inducers: Co-administration decreased erdafitinib plasma concentrations, which may lead to decreased activity. Avoid co-administration with BALVERSA.
- Moderate CYP3A4 inducers: Co-administration may decrease erdafitinib plasma concentrations, which may lead to decreased activity. If a moderate CYP3A4 inducer must be co-administered at the start of treatment, administer BALVERSA at a dose of 9 mg daily. When the inducer is discontinued, continue BALVERSA at the same dose in the absence of drug-related toxicity.
- Serum phosphate level-altering agents: Co-administration may increase or decrease serum phosphate levels and may interfere with the serum phosphate levels needed to determine the initial dose increase. Avoid co-administration before the initial dose increase period based on serum phosphate levels (Days 14 to 21).
- P-glycoprotein (P-gp) substrates: Co-administration may increase plasma concentrations of P-gp substrates, which may lead to increased toxicity of the substrates. If unavoidable, separate BALVERSA administration by at least 6 hours before or after administration of P-gp substrates with narrow therapeutic index.
Read the label’s full interactions text
7 DRUG INTERACTIONS Moderate CYP2C9 or strong CYP3A4 inhibitors: Consider alternative agents or monitor closely for adverse reactions. ( 7.1 ) Strong CYP3A4 inducers: Avoid concomitant use with BALVERSA. ( 7.1 ) Moderate CYP3A4 inducers: Administer BALVERSA at a dose of 9 mg. ( 7.1 ) Serum phosphate level-altering agents: Avoid concomitant use with agents that can alter serum phosphate levels before the initial dose modification period. ( 2.3 , 7.1 ) P-gp substrates: Separate BALVERSA administration by at least 6 hours before or after administration of P-gp substrates with narrow therapeutic indices. ( 7.2 ) 7.1 Effect of Other Drugs on BALVERSA Table 7 summarizes drug interactions that affect the exposure of BALVERSA or serum phosphate level and their clinical management. Table 7: Drug Interactions that Affect BALVERSA Moderate CYP2C9 or Strong CYP3A4 Inhibitors Clinical Impact Co-administration of BALVERSA with moderate CYP2C9 or strong CYP3A4 inhibitors increased erdafitinib plasma concentrations [see Clinical Pharmacology (12.3) ]. Increased erdafitinib plasma concentrations may lead to increased drug-related toxicity [see Warnings and Precautions (5) ]. Clinical Management Consider alternative therapies that are not moderate CYP2C9 or strong CYP3A4 inhibitors during treatment with BALVERSA. If co-administration of a moderate CYP2C9 or strong CYP3A4 inhibitor is unavoidable, monitor closely for adverse reactions and consider dose modifications accordingly [see Dosage and Administration (2.3) ]. If the moderate CYP2C9 or strong CYP3A4 inhibitor is discontinued, resume the BALVERSA dose before dose modifications in the absence of drug-related toxicity. Strong CYP3A4 Inducers Clinical Impact Co-administration of BALVERSA with strong CYP3A4 inducers decreased erdafitinib plasma concentrations [see Clinical Pharmacology (12.3) ]. Decreased erdafitinib plasma concentrations may lead to decreased activity.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Erdafitinib
▾
- Confirm your tumor has a susceptible FGFR3 change.
- Tell your doctor if you are pregnant or planning pregnancy.
- Do not breastfeed during treatment.
- Share all medicines and supplements you take.
- Tell your doctor about eye problems.
- Limited data exist for severe liver or kidney impairment.
- The label lists no contraindications.
What Erdafitinib does in the body
▾
Blocking FGFR raises phosphate levels in the blood, which is an expected effect of the drug. In a study of 187 patients with cancer, erdafitinib had no large effect on the QTc interval (a heart rhythm measurement).
How your body processes Erdafitinib
▾
Erdafitinib reaches peak blood levels about 2.5 hours after a dose. A high-fat meal made no clinically meaningful difference in absorption. Steady levels build up after about 2 weeks of daily dosing.
Its average effective half-life is about 59 hours. It is broken down mainly by the liver enzymes CYP2C9 and CYP3A4. Most of a dose leaves through feces, with some in urine.
How to store Erdafitinib
▾
Store at 20 °C to 25 °C (68 °F to 77 °F); excursions permitted between 15 °C to 30 °C (59 °F to 86 °F) .
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Erdafitinib
169 supplements and herbal products have documented interactions with Erdafitinib in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 4
- Moderate · 127
- Minor · 38
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Erdafitinib: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Erdafitinib — the kind of thing our pharmacy team would talk through with you at the counter.
What is Balversa for?
▾
How do I take it?
▾
What side effects should I expect?
▾
Why do I need eye exams?
▾
Why does my doctor check phosphate and limit it in my diet?
▾
Can I take it during pregnancy or while breastfeeding?
▾
Is Erdafitinib available over the counter?
▾
When was Erdafitinib first available?
▾
Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Erdafitinib on HelloPharmacist
Erdafitinib forms and strengths (how it comes)
Erdafitinib is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Need a version that does not list lactose, a gluten source, a dye or gelatin? Inactive ingredients differ by manufacturer: see Erdafitinib inactive ingredients by manufacturer.
Tablet
How this form is used
- Balversa is used for adults with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations after at least one prior systemic therapy.
- Balversa tablets are swallowed whole, once daily, with or without food.
- If you vomit after taking Balversa, take your next dose the next day.
- If you miss a Balversa dose, take it as soon as possible the same day, then resume your usual schedule the next day.
- Do not take extra Balversa tablets to make up for a missed dose.
Erdafitinib on the U.S. market: products, makers and brands
How Erdafitinib appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 3 Erdafitinib product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2019. Brand names on the directory include Balversa; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (2) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Compare Erdafitinib products
A representative set of FDA-listed product records for Erdafitinib — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Tablet | ||||
| 3 mg | Oral | Janssen Products LP | NDA | View NDC → |
| 4 mg | Oral | Janssen Products LP | NDA | View NDC → |
| 5 mg | Oral | Janssen Products LP | NDA | View NDC → |
Showing 3 of 3 products — FDA National Drug Code Directory. See every product, package size and price: browse all 3 Erdafitinib NDCs →
Erdafitinib side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Erdafitinib — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Erdafitinib in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Erdafitinib FDA approval history
How Erdafitinib went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Erdafitinib recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Erdafitinib recalls since July 2021.
✅No Erdafitinib recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 2123125 1 dose form · 3 strengths
-
Dose form (SCDF) Oral Tablet RxCUI 2123130In current FDA listings
Look up RxCUI 2123125 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Erdafitinib supply and shortage status
Whether Erdafitinib is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Erdafitinib brand names
Erdafitinib is sold under one brand name in the FDA directory — Balversa. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Erdafitinib: manufacturers and labelers
One company lists Erdafitinib products with the FDA. By number of product records, the largest are Janssen Products LP. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Erdafitinib drug class (RxNorm)
Erdafitinib belongs to the Kinase Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Erdafitinib page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Janssen Products LP is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →