Pemigatinib side effects: what 820 FDA adverse event reports show

Pemigatinib · Pemazyre · 19 reaction terms · 407 drug–reaction co-reports · data 2026-09-14

Drug class

Kinase Inhibitor

FDA label (Established Pharmacologic Class) · compare the class

Brand names

Pemazyre

openFDA label

Who reports

820 reports · 63% serious · 144 with death outcome · 56% female

openFDA FAERS counts, all years, deduplication not applied

Used for

PEMAZYRE is a kinase inhibitor indicated: for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. ( 1 , 2.1 ) This indication is approved under accelerated approval based on overall response rate and duration of response.

FDA label, Indications and Usage

What it is

Pemigatinib is a kinase inhibitor with the chemical name 3-(2,6-difluoro-3,5-dimethoxyphenyl)-1-ethyl-8-(morpholin-4-ylmethyl)-1,3,4,7-tetrahydro-2 H -pyrrolo[3',2':5,6]pyrido[4,3- d ]pyrimidin-2-one. Pemigatinib has a molecular formula of C 24 H 27 F 2 N 5 O 4 and molecular mass of 487.5 g/mole.

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 16 strongest signals

Labeled adverse reaction 3Labeled (related wording) 3Likely indication confounding 1Reporting / coding artifact 3Not 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.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
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.
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. 3 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
Hospice care	18	46.8 29.6–73.9ROR 47.8 · χ² 760 / p 1e-167	44.6 EB05 29.9 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 20.7	no trial data cached
Retinal detachment	16	44.5 27.4–72.3ROR 45.4 · χ² 637 / p 8e-141	42.4 EB05 27.6 · IC025 +3.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 41.3	no trial data cached
Disease progression	140	30.4 26.1–35.3ROR 36.4 · χ² 3,963 / p <1e-300	30.2 EB05 26.2 · IC025 +4.5 3/3 methods agree	Reporting / coding artifact	serious PRR 31.3 · ♀ 34% (drug 56%) · 92% clinician	no trial data cached
Product availability issue	24	27.4 18.4–40.6ROR 28.2 · χ² 584 / p 3e-129	26.8 EB05 19.0 · IC025 +3.5 3/3 methods agree	Reporting / coding artifact	serious PRR 13.0	no trial data cached
Taste disorder	21	26.8 17.6–40.9ROR 27.5 · χ² 496 / p 4e-110	26.2 EB05 18.1 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 18.8 · 70% consumer	no trial data cached
Palmar-plantar erythrodysaesthesia syndrome	22	24.0 15.9–36.3ROR 24.7 · χ² 463 / p 5e-103	23.6 EB05 16.4 · IC025 +3.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 25.3	no trial data cached
Acute myeloid leukaemia	10	16.4 8.9–30.4ROR 16.6 · χ² 130 / p 2e-30	14.9 EB05 7.5 · IC025 +2.2 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 15.1	no trial data cached
Ageusia (loss of taste)	16	16.3 10.1–26.6ROR 16.7 · χ² 216 / p 4e-49	15.7 EB05 9.7 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 10.3	no trial data cached
Metastases to liver	11	16.0 8.9–28.8ROR 16.2 · χ² 140 / p 1e-32	14.7 EB05 7.7 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 14.8	no trial data cached
Dry eye	30	15.8 11.1–22.5ROR 16.4 · χ² 403 / p 8e-90	15.5 EB05 11.2 · IC025 +3.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 13.2	no trial data cached
Stomatitis (mouth sores)	34	14.3 10.3–19.9ROR 14.9 · χ² 409 / p 3e-91	14.0 EB05 10.3 · IC025 +3.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.0	no trial data cached
Metastases to lung	6	13.3 6.0–29.5ROR 13.4 · χ² 56 / p 3e-14	9.7 EB05 3.9 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 12.3	no trial data cached
Mucosal inflammation	13	12.7 7.4–21.9ROR 12.9 · χ² 129 / p 3e-30	11.3 EB05 6.3 · IC025 +2.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 12.4	no trial data cached
Metastases to bone	6	9.4 4.2–20.8ROR 9.4 · χ² 37 / p 6e-10	6.4 EB05 2.9 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 8.7	no trial data cached
Therapy interrupted	21	7.8 5.1–11.9ROR 8.0 · χ² 118 / p 1e-27	6.9 EB05 4.7 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 10.1	no trial data cached
Drug effective for unapproved indication	8	7.0 3.5–13.9ROR 7.1 · χ² 35 / p 1e-9	5.2 EB05 2.8 · IC025 +1.2 3/3 methods agree	Labeled (related wording) related wording	serious n=3	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
Disease progression	140	30.4 26.1–35.3ROR 36.4 · χ² 3,963 / p <1e-300	30.2 EB05 26.2 · IC025 +4.5 3/3 methods agree	Reporting / coding artifact	serious PRR 31.3 · ♀ 34% (drug 56%) · 92% clinician	no trial data cached
Stomatitis (mouth sores)	34	14.3 10.3–19.9ROR 14.9 · χ² 409 / p 3e-91	14.0 EB05 10.3 · IC025 +3.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.0	no trial data cached
Dry eye	30	15.8 11.1–22.5ROR 16.4 · χ² 403 / p 8e-90	15.5 EB05 11.2 · IC025 +3.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 13.2	no trial data cached
Product availability issue	24	27.4 18.4–40.6ROR 28.2 · χ² 584 / p 3e-129	26.8 EB05 19.0 · IC025 +3.5 3/3 methods agree	Reporting / coding artifact	serious PRR 13.0	no trial data cached
Palmar-plantar erythrodysaesthesia syndrome	22	24.0 15.9–36.3ROR 24.7 · χ² 463 / p 5e-103	23.6 EB05 16.4 · IC025 +3.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 25.3	no trial data cached
Therapy interrupted	21	7.8 5.1–11.9ROR 8.0 · χ² 118 / p 1e-27	6.9 EB05 4.7 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 10.1	no trial data cached
Taste disorder	21	26.8 17.6–40.9ROR 27.5 · χ² 496 / p 4e-110	26.2 EB05 18.1 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 18.8 · 70% consumer	no trial data cached
Hospice care	18	46.8 29.6–73.9ROR 47.8 · χ² 760 / p 1e-167	44.6 EB05 29.9 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 20.7	no trial data cached
Ageusia (loss of taste)	16	16.3 10.1–26.6ROR 16.7 · χ² 216 / p 4e-49	15.7 EB05 9.7 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 10.3	no trial data cached
Retinal detachment	16	44.5 27.4–72.3ROR 45.4 · χ² 637 / p 8e-141	42.4 EB05 27.6 · IC025 +3.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 41.3	no trial data cached
Mucosal inflammation	13	12.7 7.4–21.9ROR 12.9 · χ² 129 / p 3e-30	11.3 EB05 6.3 · IC025 +2.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 12.4	no trial data cached
Metastases to liver	11	16.0 8.9–28.8ROR 16.2 · χ² 140 / p 1e-32	14.7 EB05 7.7 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 14.8	no trial data cached
Acute myeloid leukaemia	10	16.4 8.9–30.4ROR 16.6 · χ² 130 / p 2e-30	14.9 EB05 7.5 · IC025 +2.2 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 15.1	no trial data cached
Drug effective for unapproved indication	8	7.0 3.5–13.9ROR 7.1 · χ² 35 / p 1e-9	5.2 EB05 2.8 · IC025 +1.2 3/3 methods agree	Labeled (related wording) related wording	serious n=3	no trial data cached
Metastases to bone	6	9.4 4.2–20.8ROR 9.4 · χ² 37 / p 6e-10	6.4 EB05 2.9 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 8.7	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=21, PRR 26.8

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 Pemigatinib?

In FDA FAERS, the most frequently co-reported reaction terms for Pemigatinib are stomatitis, dry eye, palmar-plantar erythrodysaesthesia syndrome, taste disorder, hospice care, ageusia. 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 Pemigatinib have an FDA boxed warning?

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

Do FAERS signals prove that Pemigatinib 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 9e1f2222-1d89-4e63-989c-ccebe2ab1eb4, effective 20260609; matched on openfda.generic_name.exact:"PEMIGATINIB")
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, 19 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.