Drug · FAERS side-effect profile with label screen

Pexidartinib side effects: what 713 FDA adverse event reports show

Pexidartinib Hydrochloride · 36 reaction terms · 1,245 drug–reaction co-reports · data 2026-09-14

Drug class

Kinase inhibitor

FDA label, Indications wording of the closest related product

Label matched

Pexidartinib Hydrochloride (Turalio)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

713 reports · 16% serious · 11 with death outcome · 61% female

openFDA FAERS counts, all years, deduplication not applied

Used for

TURALIO is indicated for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery. TURALIO is a kinase inhibitor indica.

FDA label, Indications and Usage

What it is

Pexidartinib is a kinase inhibitor.

FDA label, Description section

Boxed warning

HEPATOTOXICITY TURALIO can cause serious and potentially fatal liver injury, including vanishing bile duct syndrome [see Warnings and Precautions (5.1) ] . Monitor liver tests prior to initiation of TURALIO and at specified intervals during treatment. Withhold and dose reduce or permanently discontinue TURALIO based on severity of hepatotoxicity.

FDA 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 24 strongest signals

Labeled adverse reaction 3Labeled (related wording) 2Reporting / coding artifact 12Lab value / disease marker 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.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
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. 12 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
Hair colour changes	235	560.0 503.6–622.7ROR 834.8 · χ² 128,171 / p <1e-300	525.7 EB05 471.7 · IC025 +7.8 3/3 methods agree	Not in label — unassessed	serious n=36	no trial data cached
Product dose omission in error	69	75.7 60.5–94.8ROR 83.8 · χ² 5,008 / p <1e-300	74.1 EB05 60.5 · IC025 +5.2 3/3 methods agree	Reporting / coding artifact	serious PRR 93.4 · 80% consumer	no trial data cached
Brain fog	26	52.5 36.0–76.6ROR 54.5 · χ² 1,261 / p 2e-276	50.6 EB05 36.3 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious PRR 83.9 · 88% consumer	no trial data cached
Therapy cessation	81	46.7 38.0–57.3ROR 52.6 · χ² 3,579 / p <1e-300	46.1 EB05 38.3 · IC025 +4.8 3/3 methods agree	Reporting / coding artifact	serious PRR 32.5	no trial data cached
Photosensitivity reaction (sun sensitivity)	20	35.8 23.2–55.1ROR 36.8 · χ² 642 / p 7e-142	34.7 EB05 23.7 · IC025 +3.5 3/3 methods agree	Labeled adverse reaction exact term	♀ 40% (drug 61%) · 70% consumer	no trial data cached
Eye swelling	41	32.6 24.2–44.0ROR 34.6 · χ² 1,227 / p 4e-269	32.2 EB05 24.7 · IC025 +4.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 36.3	no trial data cached
Taste disorder	21	30.8 20.2–47.0ROR 31.8 · χ² 577 / p 9e-128	30.1 EB05 20.7 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 42.5 · 76% consumer	no trial data cached
Therapy change	10	30.5 16.5–56.5ROR 30.9 · χ² 257 / p 4e-58	28.9 EB05 16.6 · IC025 +2.6 3/3 methods agree	Reporting / coding artifact	serious n=1	no trial data cached
Skin discolouration	43	27.5 20.6–36.8ROR 29.2 · χ² 1,075 / p 5e-236	27.2 EB05 21.1 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 23.2 · 72% consumer	no trial data cached
Product dose omission issue	266	27.5 25.0–30.2ROR 43.3 · χ² 6,853 / p <1e-300	27.4 EB05 24.8 · IC025 +4.5 3/3 methods agree	Reporting / coding artifact	serious PRR 63.2	no trial data cached
Blood iron decreased	11	27.5 15.3–49.4ROR 27.9 · χ² 255 / p 1e-57	26.2 EB05 15.5 · IC025 +2.6 3/3 methods agree	Lab value / disease marker	serious PRR 73.4	no trial data cached
Treatment noncompliance	47	25.5 19.3–33.6ROR 27.2 · χ² 1,082 / p 1e-237	25.2 EB05 19.7 · IC025 +3.9 3/3 methods agree	Reporting / coding artifact	serious PRR 18.2	no trial data cached
Insurance issue	12	23.8 13.6–41.7ROR 24.2 · χ² 239 / p 3e-54	22.8 EB05 13.7 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 14.7	no trial data cached
Surgery	36	18.3 13.3–25.1ROR 19.2 · χ² 572 / p 1e-126	18.1 EB05 13.6 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	serious PRR 18.9	no trial data cached
Thirst	10	16.5 8.9–30.5ROR 16.7 · χ² 131 / p 2e-30	15.0 EB05 7.5 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 22.0	no trial data cached
Swelling face	36	16.3 11.8–22.4ROR 17.1 · χ² 503 / p 1e-111	16.1 EB05 12.0 · IC025 +3.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 21.5	no trial data cached
Therapy interrupted	31	13.2 9.4–18.7ROR 13.8 · χ² 339 / p 5e-76	12.8 EB05 9.2 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	serious PRR 17.5	no trial data cached
Laboratory test abnormal	13	13.0 7.6–22.2ROR 13.2 · χ² 132 / p 7e-31	11.6 EB05 6.5 · IC025 +2.2 3/3 methods agree	Reporting / coding artifact	serious PRR 25.6	no trial data cached
Ageusia (loss of taste)	11	12.9 7.2–23.3ROR 13.1 · χ² 110 / p 6e-26	11.2 EB05 5.9 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 18.6	no trial data cached
Illness	42	12.3 9.2–16.5ROR 13.0 · χ² 427 / p 5e-95	12.0 EB05 9.1 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	serious PRR 31.5 · 74% consumer	no trial data cached
Adverse drug reaction	35	11.5 8.3–15.9ROR 12.1 · χ² 327 / p 3e-73	11.0 EB05 8.1 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	serious PRR 17.1	no trial data cached
Intentional dose omission	10	10.8 5.8–19.9ROR 10.9 · χ² 79 / p 3e-19	8.7 EB05 4.5 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious PRR 15.9	no trial data cached
No adverse event	56	9.3 7.2–11.9ROR 10.0 · χ² 409 / p 3e-91	8.9 EB05 7.0 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious PRR 9.8	no trial data cached
Acne	16	6.2 3.8–10.0ROR 6.3 · χ² 65 / p 5e-16	5.3 EB05 3.5 · IC025 +1.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.8	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
Product dose omission issue	266	27.5 25.0–30.2ROR 43.3 · χ² 6,853 / p <1e-300	27.4 EB05 24.8 · IC025 +4.5 3/3 methods agree	Reporting / coding artifact	serious PRR 63.2	no trial data cached
Hair colour changes	235	560.0 503.6–622.7ROR 834.8 · χ² 128,171 / p <1e-300	525.7 EB05 471.7 · IC025 +7.8 3/3 methods agree	Not in label — unassessed	serious n=36	no trial data cached
Therapy cessation	81	46.7 38.0–57.3ROR 52.6 · χ² 3,579 / p <1e-300	46.1 EB05 38.3 · IC025 +4.8 3/3 methods agree	Reporting / coding artifact	serious PRR 32.5	no trial data cached
Product dose omission in error	69	75.7 60.5–94.8ROR 83.8 · χ² 5,008 / p <1e-300	74.1 EB05 60.5 · IC025 +5.2 3/3 methods agree	Reporting / coding artifact	serious PRR 93.4 · 80% consumer	no trial data cached
No adverse event	56	9.3 7.2–11.9ROR 10.0 · χ² 409 / p 3e-91	8.9 EB05 7.0 · IC025 +2.7 3/3 methods agree	Reporting / coding artifact	serious PRR 9.8	no trial data cached
Treatment noncompliance	47	25.5 19.3–33.6ROR 27.2 · χ² 1,082 / p 1e-237	25.2 EB05 19.7 · IC025 +3.9 3/3 methods agree	Reporting / coding artifact	serious PRR 18.2	no trial data cached
Skin discolouration	43	27.5 20.6–36.8ROR 29.2 · χ² 1,075 / p 5e-236	27.2 EB05 21.1 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 23.2 · 72% consumer	no trial data cached
Illness	42	12.3 9.2–16.5ROR 13.0 · χ² 427 / p 5e-95	12.0 EB05 9.1 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	serious PRR 31.5 · 74% consumer	no trial data cached
Eye swelling	41	32.6 24.2–44.0ROR 34.6 · χ² 1,227 / p 4e-269	32.2 EB05 24.7 · IC025 +4.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 36.3	no trial data cached
Swelling face	36	16.3 11.8–22.4ROR 17.1 · χ² 503 / p 1e-111	16.1 EB05 12.0 · IC025 +3.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 21.5	no trial data cached
Surgery	36	18.3 13.3–25.1ROR 19.2 · χ² 572 / p 1e-126	18.1 EB05 13.6 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	serious PRR 18.9	no trial data cached
Adverse drug reaction	35	11.5 8.3–15.9ROR 12.1 · χ² 327 / p 3e-73	11.0 EB05 8.1 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	serious PRR 17.1	no trial data cached
Therapy interrupted	31	13.2 9.4–18.7ROR 13.8 · χ² 339 / p 5e-76	12.8 EB05 9.2 · IC025 +2.9 3/3 methods agree	Reporting / coding artifact	serious PRR 17.5	no trial data cached
Brain fog	26	52.5 36.0–76.6ROR 54.5 · χ² 1,261 / p 2e-276	50.6 EB05 36.3 · IC025 +4.1 3/3 methods agree	Not in label — unassessed	serious PRR 83.9 · 88% consumer	no trial data cached
Taste disorder	21	30.8 20.2–47.0ROR 31.8 · χ² 577 / p 9e-128	30.1 EB05 20.7 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 42.5 · 76% consumer	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.

Hair colour changes — n=235, PRR 560.0
Brain fog — n=26, PRR 52.5
Taste disorder — n=21, PRR 30.8
Skin discolouration — n=43, PRR 27.5

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 Pexidartinib?

In FDA FAERS, the most frequently co-reported reaction terms for Pexidartinib are hair colour changes, skin discolouration, eye swelling, swelling face, brain fog, 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 Pexidartinib have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: HEPATOTOXICITY TURALIO can cause serious and potentially fatal liver injury, including vanishing bile duct syndrome [see Warnings and Precautions (5.1) ] . Monitor liver tests prior to initiation of TURALIO and at specified intervals during treatment. Withhold and dose reduce or permanently discontinue TURALIO based on severity of hepatotoxicity.

Do FAERS signals prove that Pexidartinib 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 7b0ec4bf-b2ac-49ee-96af-7740ad3f2e16, effective 20250116; matched on openfda.generic_name.exact:"PEXIDARTINIB HYDROCHLORIDE")
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, 36 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.