Palifermin side effects: what 389 FDA adverse event reports show

Palifermin · Kepivance · 11 reaction terms · 202 drug–reaction co-reports · data 2026-09-14

Drug class

Mucocutaneous Epithelial Cell Growth Factor

FDA label (Established Pharmacologic Class)

Brand names

Kepivance

openFDA label

Who reports

389 reports · 90% serious · 67 with death outcome · 40% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Kepivance is a mucocutaneous epithelial human growth factor indicated to decrease the incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy in the setting of autologous hematopoietic stem cell support. Kepivance is indicated as supportive care for preparative regimens predicted to result in ≥ WHO Grade 3 mucositis in the majority of patients.

FDA label, Indications and Usage

What it is

Kepivance (palifermin) is a truncated human KGF produced by recominant DNA technology in E coli . Kepivance is a water soluble, 140 amino acid protein with a molecular weight of 16.3 kilodaltons.

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 10 strongest signals

Labeled adverse reaction 1Not in label — unassessed 9

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.
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. 1 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
Mucosal inflammation	56	116.1 91.1–147.9ROR 135.4 · χ² 6,268 / p <1e-300	111.5 EB05 89.1 · IC025 +5.4 3/3 methods agree	Not in label — unassessed	serious PRR 77.2	no trial data cached
Salivary hypersecretion	13	70.2 41.1–119.9ROR 72.6 · χ² 819 / p 2e-180	63.9 EB05 39.7 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 51.4	no trial data cached
Face oedema	14	44.6 26.6–74.6ROR 46.2 · χ² 554 / p 1e-122	42.2 EB05 26.7 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 31.7	no trial data cached
Petechiae	8	41.5 20.9–82.4ROR 42.3 · χ² 277 / p 2e-62	38.0 EB05 20.5 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 32.0	no trial data cached
Febrile neutropenia	39	31.8 23.6–42.8ROR 35.2 · χ² 1,134 / p 6e-249	31.3 EB05 23.9 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 20.3 · 92% clinician	no trial data cached
Stomatitis (mouth sores)	34	30.2 21.9–41.7ROR 33.0 · χ² 934 / p 2e-205	29.8 EB05 22.3 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 27.2 · 100% clinician	no trial data cached
Rash maculo-papular	12	29.2 16.7–51.0ROR 30.1 · χ² 299 / p 2e-67	28.0 EB05 17.0 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 15.5	no trial data cached
Multi-organ failure	8	24.6 12.4–48.8ROR 25.1 · χ² 158 / p 1e-36	22.8 EB05 11.5 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 15.7	no trial data cached
Palmar-plantar erythrodysaesthesia syndrome	9	20.7 10.9–39.6ROR 21.2 · χ² 150 / p 8e-35	19.3 EB05 9.8 · IC025 +2.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 15.6	no trial data cached
Anorexia	5	20.6 8.6–49.3ROR 20.9 · χ² 75 / p 3e-18	16.4 EB05 5.2 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 17.3	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
Mucosal inflammation	56	116.1 91.1–147.9ROR 135.4 · χ² 6,268 / p <1e-300	111.5 EB05 89.1 · IC025 +5.4 3/3 methods agree	Not in label — unassessed	serious PRR 77.2	no trial data cached
Febrile neutropenia	39	31.8 23.6–42.8ROR 35.2 · χ² 1,134 / p 6e-249	31.3 EB05 23.9 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 20.3 · 92% clinician	no trial data cached
Stomatitis (mouth sores)	34	30.2 21.9–41.7ROR 33.0 · χ² 934 / p 2e-205	29.8 EB05 22.3 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 27.2 · 100% clinician	no trial data cached
Face oedema	14	44.6 26.6–74.6ROR 46.2 · χ² 554 / p 1e-122	42.2 EB05 26.7 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 31.7	no trial data cached
Salivary hypersecretion	13	70.2 41.1–119.9ROR 72.6 · χ² 819 / p 2e-180	63.9 EB05 39.7 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 51.4	no trial data cached
Rash maculo-papular	12	29.2 16.7–51.0ROR 30.1 · χ² 299 / p 2e-67	28.0 EB05 17.0 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 15.5	no trial data cached
Palmar-plantar erythrodysaesthesia syndrome	9	20.7 10.9–39.6ROR 21.2 · χ² 150 / p 8e-35	19.3 EB05 9.8 · IC025 +2.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 15.6	no trial data cached
Multi-organ failure	8	24.6 12.4–48.8ROR 25.1 · χ² 158 / p 1e-36	22.8 EB05 11.5 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 15.7	no trial data cached
Petechiae	8	41.5 20.9–82.4ROR 42.3 · χ² 277 / p 2e-62	38.0 EB05 20.5 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 32.0	no trial data cached
Anorexia	5	20.6 8.6–49.3ROR 20.9 · χ² 75 / p 3e-18	16.4 EB05 5.2 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 17.3	no trial data cached
Toxic skin eruption	4	21.3 8.0–56.6ROR 21.6 · χ² 59 / p 1e-14	15.3 EB05 4.1 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 13.7	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.

Mucosal inflammation — n=56, PRR 116.1
Febrile neutropenia — n=39, PRR 31.8
Stomatitis — n=34, PRR 30.2

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 Palifermin?

In FDA FAERS, the most frequently co-reported reaction terms for Palifermin are mucosal inflammation, febrile neutropenia, stomatitis, face oedema, salivary hypersecretion, rash maculo-papular. 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 Palifermin have an FDA boxed warning?

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

Do FAERS signals prove that Palifermin 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 426f6e64-2c20-4a61-6d65-7320426f6e64, effective 20251217; matched on openfda.generic_name.exact:"PALIFERMIN")
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, 11 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.