Erdafitinib side effects: what 1,215 FDA adverse event reports show

Erdafitinib · Balversa · 28 reaction terms · 815 drug–reaction co-reports · data 2026-09-14

Drug class

Kinase Inhibitor

FDA label (Established Pharmacologic Class) · compare the class

Brand names

Balversa

openFDA label

Who reports

1,215 reports · 74% serious · 342 with death outcome · 37% female

openFDA FAERS counts, all years, deduplication not applied

Used for

BALVERSA is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. Select patients for therapy based on an FDA-approved companion diagnostic for BALVERSA .

FDA label, Indications and Usage

What it is

Erdafitinib, the active ingredient in BALVERSA, is a kinase inhibitor.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 18 strongest signals

Labeled adverse reaction 5Labeled (related wording) 3Reporting / coding artifact 3Outcome field, not a reaction 1Not in label — unassessed 6

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 10 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Retinal detachment	24	45.2 30.4–67.1ROR 46.0 · χ² 990 / p 1e-217	43.6 EB05 30.8 · IC025 +3.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 34.0	no trial data cached
Taste disorder	30	25.9 18.2–36.8ROR 26.5 · χ² 692 / p 7e-153	25.5 EB05 18.7 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 35.0 · ♀ 59% (drug 37%)	no trial data cached
Mucosal inflammation	38	25.2 18.4–34.5ROR 26.0 · χ² 859 / p 4e-189	24.9 EB05 18.9 · IC025 +3.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 15.3 · 97% clinician	no trial data cached
Stomatitis (mouth sores)	77	21.9 17.7–27.2ROR 23.3 · χ² 1,520 / p <1e-300	21.8 EB05 18.0 · IC025 +3.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 18.9	no trial data cached
Palmar-plantar erythrodysaesthesia syndrome	26	19.2 13.1–28.1ROR 19.6 · χ² 431 / p 6e-96	18.9 EB05 13.5 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 15.2	no trial data cached
Eye disorder	29	15.3 10.7–21.9ROR 15.6 · χ² 373 / p 2e-83	15.0 EB05 10.7 · IC025 +3.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.0	no trial data cached
Dry eye	41	14.6 10.8–19.7ROR 15.1 · χ² 507 / p 1e-112	14.4 EB05 10.9 · IC025 +3.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 24.2	no trial data cached
Dry mouth	46	9.8 7.4–13.0ROR 10.2 · χ² 356 / p 9e-80	9.4 EB05 7.2 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.8	no trial data cached
Osteomyelitis	10	9.5 5.1–17.7ROR 9.6 · χ² 68 / p 7e-17	7.5 EB05 4.1 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 7.5	no trial data cached
Oral pain	10	7.7 4.1–14.2ROR 7.7 · χ² 52 / p 3e-13	6.0 EB05 3.4 · IC025 +1.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 4.4	no trial data cached
Cataract	26	7.6 5.2–11.1ROR 7.7 · χ² 142 / p 5e-33	6.8 EB05 4.8 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 6.4 · 92% clinician	no trial data cached
Lacrimation increased	12	6.9 3.9–12.2ROR 7.0 · χ² 55 / p 5e-14	5.7 EB05 3.4 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 7.0	no trial data cached
Disease progression	42	6.1 4.6–8.3ROR 6.3 · χ² 177 / p 1e-40	5.8 EB05 4.5 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 5.5 · 90% clinician	no trial data cached
Death	267	5.4 4.8–6.0ROR 6.6 · χ² 980 / p 2e-215	5.3 EB05 4.8 · IC025 +2.2 3/3 methods agree	Outcome field, not a reaction	serious PRR 4.2	no trial data cached
Therapy cessation	15	5.1 3.1–8.4ROR 5.1 · χ² 45 / p 9e-12	4.4 EB05 2.9 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	serious PRR 0.6	no trial data cached
Dry skin	31	4.1 2.9–5.8ROR 4.1 · χ² 69 / p 5e-17	3.9 EB05 2.9 · IC025 +1.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.3	no trial data cached
Bladder cancer	12	3.5 2.0–6.1ROR 3.5 · χ² 19 / p 7e-6	3.1 EB05 1.9 · IC025 +0.7	Not in label — unassessed	serious PRR 2.7	no trial data cached
Malignant neoplasm progression	20	3.4 2.2–5.2ROR 3.4 · χ² 31 / p 1e-8	3.2 EB05 2.2 · IC025 +0.9 3/3 methods agree	Reporting / coding artifact	serious PRR 2.7	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Death	267	5.4 4.8–6.0ROR 6.6 · χ² 980 / p 2e-215	5.3 EB05 4.8 · IC025 +2.2 3/3 methods agree	Outcome field, not a reaction	serious PRR 4.2	no trial data cached
Stomatitis (mouth sores)	77	21.9 17.7–27.2ROR 23.3 · χ² 1,520 / p <1e-300	21.8 EB05 18.0 · IC025 +3.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 18.9	no trial data cached
Dry mouth	46	9.8 7.4–13.0ROR 10.2 · χ² 356 / p 9e-80	9.4 EB05 7.2 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.8	no trial data cached
Disease progression	42	6.1 4.6–8.3ROR 6.3 · χ² 177 / p 1e-40	5.8 EB05 4.5 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 5.5 · 90% clinician	no trial data cached
Dry eye	41	14.6 10.8–19.7ROR 15.1 · χ² 507 / p 1e-112	14.4 EB05 10.9 · IC025 +3.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 24.2	no trial data cached
Mucosal inflammation	38	25.2 18.4–34.5ROR 26.0 · χ² 859 / p 4e-189	24.9 EB05 18.9 · IC025 +3.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 15.3 · 97% clinician	no trial data cached
Dry skin	31	4.1 2.9–5.8ROR 4.1 · χ² 69 / p 5e-17	3.9 EB05 2.9 · IC025 +1.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.3	no trial data cached
Taste disorder	30	25.9 18.2–36.8ROR 26.5 · χ² 692 / p 7e-153	25.5 EB05 18.7 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 35.0 · ♀ 59% (drug 37%)	no trial data cached
Eye disorder	29	15.3 10.7–21.9ROR 15.6 · χ² 373 / p 2e-83	15.0 EB05 10.7 · IC025 +3.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.0	no trial data cached
Cataract	26	7.6 5.2–11.1ROR 7.7 · χ² 142 / p 5e-33	6.8 EB05 4.8 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 6.4 · 92% clinician	no trial data cached
Palmar-plantar erythrodysaesthesia syndrome	26	19.2 13.1–28.1ROR 19.6 · χ² 431 / p 6e-96	18.9 EB05 13.5 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 15.2	no trial data cached
Retinal detachment	24	45.2 30.4–67.1ROR 46.0 · χ² 990 / p 1e-217	43.6 EB05 30.8 · IC025 +3.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 34.0	no trial data cached
Malignant neoplasm progression	20	3.4 2.2–5.2ROR 3.4 · χ² 31 / p 1e-8	3.2 EB05 2.2 · IC025 +0.9 3/3 methods agree	Reporting / coding artifact	serious PRR 2.7	no trial data cached
Therapy cessation	15	5.1 3.1–8.4ROR 5.1 · χ² 45 / p 9e-12	4.4 EB05 2.9 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	serious PRR 0.6	no trial data cached
Bladder cancer	12	3.5 2.0–6.1ROR 3.5 · χ² 19 / p 7e-6	3.1 EB05 1.9 · IC025 +0.7	Not in label — unassessed	serious PRR 2.7	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Taste disorder — n=30, PRR 25.9
Palmar-plantar erythrodysaesthesia syndrome — n=26, PRR 19.2
Cataract — n=26, PRR 7.6

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Erdafitinib?

In FDA FAERS, the most frequently co-reported reaction terms for Erdafitinib are stomatitis, dry mouth, dry eye, mucosal inflammation, dry skin, taste disorder. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Erdafitinib have an FDA boxed warning?

No. The FDA label retrieved for Erdafitinib has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Erdafitinib causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 2a8aa5c0-6c92-4566-8c45-e8f4d1fc20ee, effective 20251024; matched on openfda.generic_name.exact:"ERDAFITINIB")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 28 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.