Pralsetinib side effects: what 1,788 FDA adverse event reports show

Pralsetinib · Gavreto · 42 reaction terms · 1,102 drug–reaction co-reports · data 2026-09-14

Drug class

Kinase Inhibitor

FDA label (Established Pharmacologic Class) · compare the class

Brand names

Gavreto

openFDA label

Who reports

1,788 reports · 62% serious · 252 with death outcome · 57% female

openFDA FAERS counts, all years, deduplication not applied

Used for

GAVRETO is a kinase inhibitor indicated for treatment of: Adult patients with metastatic rearranged during transfection (RET ) fusion-positive non-small cell lung cancer as detected by an FDA approved test (NSCLC). ( 1.1 ) Adult and pediatric patients .

FDA label, Indications and Usage

What it is

Pralsetinib is an oral receptor tyrosine kinase inhibitor.

FDA label, Description section

Boxed warning

SERIOUS INFECTIONS, INCLUDING OPPORTUNISTIC INFECTIONS GAVRETO may increase the risk for serious infections, including bacterial, fungal, viral and opportunistic infections, which can lead to hospitalization or death.

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 25 strongest signals

Labeled — boxed warning 3Labeled adverse reaction 5Labeled (related wording) 6Likely indication confounding 1Reporting / coding artifact 5Lab value / disease marker 1Not in label — unassessed 4

What the badges mean

Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
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.
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. 17 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
Product prescribing issue	181	105.2 91.6–120.9ROR 117.0 · χ² 18,434 / p <1e-300	103.2 EB05 91.2 · IC025 +6.1 3/3 methods agree	Reporting / coding artifact	serious PRR 108.9 · 90% consumer	no trial data cached
Pneumonitis	44	19.1 14.3–25.6ROR 19.6 · χ² 737 / p 1e-162	18.9 EB05 14.7 · IC025 +3.5 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 15.6	no trial data cached
Taste disorder	26	15.2 10.4–22.3ROR 15.4 · χ² 332 / p 2e-74	14.8 EB05 10.4 · IC025 +2.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 11.0 · 85% consumer	no trial data cached
Face oedema	20	13.9 9.0–21.4ROR 14.0 · χ² 226 / p 2e-51	13.2 EB05 8.5 · IC025 +2.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 13.0 · 85% consumer	no trial data cached
Hepatic function abnormal	42	13.3 9.9–17.9ROR 13.6 · χ² 466 / p 1e-103	13.0 EB05 9.9 · IC025 +3.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 12.4	no trial data cached
Myelosuppression	38	13.1 9.6–18.0ROR 13.4 · χ² 413 / p 3e-92	12.8 EB05 9.5 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 11.6	no trial data cached
Hypoaesthesia oral	16	12.5 7.7–20.3ROR 12.6 · χ² 157 / p 2e-36	11.4 EB05 6.8 · IC025 +2.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 6.6	no trial data cached
Pneumocystis jirovecii pneumonia	10	11.7 6.3–21.8ROR 11.8 · χ² 88 / p 4e-21	9.7 EB05 5.0 · IC025 +1.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 11.0	no trial data cached
Mouth ulceration	21	11.7 7.7–17.9ROR 11.8 · χ² 195 / p 1e-44	10.9 EB05 7.1 · IC025 +2.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 12.4 · 81% consumer	no trial data cached
Metastases to central nervous system	12	11.0 6.3–19.3ROR 11.1 · χ² 99 / p 1e-23	9.3 EB05 5.1 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 10.3	no trial data cached
Red blood cell count decreased	26	10.7 7.3–15.6ROR 10.8 · χ² 218 / p 1e-49	9.9 EB05 6.8 · IC025 +2.5 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 9.6 · 88% consumer	no trial data cached
Transaminases increased	19	10.0 6.4–15.7ROR 10.1 · χ² 146 / p 7e-34	8.9 EB05 5.8 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 8.4	no trial data cached
Blood test abnormal	12	10.0 5.7–17.6ROR 10.1 · χ² 89 / p 2e-21	8.3 EB05 4.7 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 8.3	no trial data cached
Ageusia (loss of taste)	21	9.9 6.4–15.1ROR 10.0 · χ² 158 / p 1e-36	8.9 EB05 5.9 · IC025 +2.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.8 · 95% consumer	no trial data cached
White blood cell count decreased	85	9.2 7.5–11.3ROR 9.6 · χ² 615 / p 4e-136	8.9 EB05 7.4 · IC025 +2.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 9.6 · 78% consumer	no trial data cached
Disease progression	91	9.1 7.4–11.1ROR 9.5 · χ² 647 / p 4e-143	8.8 EB05 7.4 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	serious PRR 8.8	no trial data cached
Liver injury	16	7.8 4.8–12.6ROR 7.8 · χ² 88 / p 4e-21	6.6 EB05 4.2 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 7.5	no trial data cached
Blood creatine phosphokinase increased	19	7.6 4.9–11.9ROR 7.7 · χ² 103 / p 2e-24	6.6 EB05 4.4 · IC025 +1.9 3/3 methods agree	Lab value / disease marker	serious PRR 7.1	no trial data cached
Interstitial lung disease	31	7.5 5.3–10.7ROR 7.6 · χ² 169 / p 5e-39	6.9 EB05 5.0 · IC025 +2.2 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 6.8	no trial data cached
Dry mouth	50	7.2 5.5–9.5ROR 7.4 · χ² 264 / p 1e-59	6.9 EB05 5.4 · IC025 +2.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.4 · 82% consumer	no trial data cached
Blood pressure increased	90	6.9 5.6–8.4ROR 7.2 · χ² 451 / p 3e-100	6.7 EB05 5.6 · IC025 +2.4 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 5.4 · 90% consumer	no trial data cached
Platelet count decreased	56	6.2 4.8–8.0ROR 6.3 · χ² 238 / p 4e-54	5.9 EB05 4.7 · IC025 +2.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 5.6 · 73% consumer	no trial data cached
Neutrophil count decreased	20	5.8 3.7–9.0ROR 5.8 · χ² 75 / p 3e-18	5.2 EB05 3.5 · IC025 +1.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 4.4	no trial data cached
Drug resistance	10	4.6 2.5–8.5ROR 4.6 · χ² 24 / p 4e-7	3.9 EB05 2.3 · IC025 +0.9 3/3 methods agree	Reporting / coding artifact	serious PRR 4.3	no trial data cached
No adverse event	52	3.4 2.6–4.5ROR 3.5 · χ² 88 / p 3e-21	3.4 EB05 2.7 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	serious PRR 1.0	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 prescribing issue	181	105.2 91.6–120.9ROR 117.0 · χ² 18,434 / p <1e-300	103.2 EB05 91.2 · IC025 +6.1 3/3 methods agree	Reporting / coding artifact	serious PRR 108.9 · 90% consumer	no trial data cached
Disease progression	91	9.1 7.4–11.1ROR 9.5 · χ² 647 / p 4e-143	8.8 EB05 7.4 · IC025 +2.8 3/3 methods agree	Reporting / coding artifact	serious PRR 8.8	no trial data cached
Blood pressure increased	90	6.9 5.6–8.4ROR 7.2 · χ² 451 / p 3e-100	6.7 EB05 5.6 · IC025 +2.4 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 5.4 · 90% consumer	no trial data cached
White blood cell count decreased	85	9.2 7.5–11.3ROR 9.6 · χ² 615 / p 4e-136	8.9 EB05 7.4 · IC025 +2.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 9.6 · 78% consumer	no trial data cached
Platelet count decreased	56	6.2 4.8–8.0ROR 6.3 · χ² 238 / p 4e-54	5.9 EB05 4.7 · IC025 +2.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 5.6 · 73% consumer	no trial data cached
No adverse event	52	3.4 2.6–4.5ROR 3.5 · χ² 88 / p 3e-21	3.4 EB05 2.7 · IC025 +1.3 3/3 methods agree	Reporting / coding artifact	serious PRR 1.0	no trial data cached
Dry mouth	50	7.2 5.5–9.5ROR 7.4 · χ² 264 / p 1e-59	6.9 EB05 5.4 · IC025 +2.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.4 · 82% consumer	no trial data cached
Pneumonitis	44	19.1 14.3–25.6ROR 19.6 · χ² 737 / p 1e-162	18.9 EB05 14.7 · IC025 +3.5 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 15.6	no trial data cached
Hepatic function abnormal	42	13.3 9.9–17.9ROR 13.6 · χ² 466 / p 1e-103	13.0 EB05 9.9 · IC025 +3.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 12.4	no trial data cached
Myelosuppression	38	13.1 9.6–18.0ROR 13.4 · χ² 413 / p 3e-92	12.8 EB05 9.5 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 11.6	no trial data cached
Interstitial lung disease	31	7.5 5.3–10.7ROR 7.6 · χ² 169 / p 5e-39	6.9 EB05 5.0 · IC025 +2.2 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 6.8	no trial data cached
Red blood cell count decreased	26	10.7 7.3–15.6ROR 10.8 · χ² 218 / p 1e-49	9.9 EB05 6.8 · IC025 +2.5 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 9.6 · 88% consumer	no trial data cached
Taste disorder	26	15.2 10.4–22.3ROR 15.4 · χ² 332 / p 2e-74	14.8 EB05 10.4 · IC025 +2.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 11.0 · 85% consumer	no trial data cached
Ageusia (loss of taste)	21	9.9 6.4–15.1ROR 10.0 · χ² 158 / p 1e-36	8.9 EB05 5.9 · IC025 +2.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.8 · 95% consumer	no trial data cached
Mouth ulceration	21	11.7 7.7–17.9ROR 11.8 · χ² 195 / p 1e-44	10.9 EB05 7.1 · IC025 +2.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 12.4 · 81% 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.

Myelosuppression — n=38, PRR 13.1

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 Pralsetinib?

In FDA FAERS, the most frequently co-reported reaction terms for Pralsetinib are blood pressure increased, white blood cell count decreased, platelet count decreased, dry mouth, pneumonitis, hepatic function abnormal. 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 Pralsetinib have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: SERIOUS INFECTIONS, INCLUDING OPPORTUNISTIC INFECTIONS GAVRETO may increase the risk for serious infections, including bacterial, fungal, viral and opportunistic infections, which can lead to hospitalization or death.

Do FAERS signals prove that Pralsetinib 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 16edd46e-28b8-f06d-e063-6394a90ae31b, effective 20251230; matched on openfda.generic_name.exact:"PRALSETINIB")
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, 42 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.