Drug · FAERS side-effect profile with label screen
Pacritinib side effects: what 2,964 FDA adverse event reports show
Brand names
Vonjo
openFDA label
Who reports
2,964 reports · 37% serious · 339 with death outcome · 44% female
openFDA FAERS counts, all years, deduplication not applied
Used for
VONJO is indicated for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF) with a platelet count below 50 × 10 9 /L. This indication is approved under accelerated approval based on spleen volume reduction .
FDA label, Indications and Usage
What it is
VONJO contains pacritinib citrate, a kinase inhibitor with the chemical name (2E,16E)-11-[2-(pyrrolidin-1-yl)ethoxy]-14,19-dioxa-5,7,27-triazatetracyclo[19.3.1.1(2,6).1(8,12)]heptacosa-1(25),2,4,6,8,10,12(26),16,21,23-decaene citrate and a molecular weight of 664.7 as citrate salt and 472.59 as a free base.
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 40 strongest signals
Labeled adverse reaction 6Labeled (related wording) 1Likely indication confounding 2Reporting / coding artifact 9Lab value / disease marker 6Outcome field, not a reaction 1Not in label — unassessed 15
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.
- 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.
- 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:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Splenomegaly | 105 | 64.0 53.0–77.3ROR 66.3 · χ² 6,395 / p <1e-300 | 62.7 EB05 53.3 · IC025 +5.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 37.3 · 86% consumer | no trial data cached |
| Transfusion | 84 | 57.0 46.1–70.4ROR 58.6 · χ² 4,528 / p <1e-300 | 55.8 EB05 46.5 · IC025 +5.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 27.8 · 95% consumer | no trial data cached |
| Platelet count increased | 61 | 33.2 25.9–42.6ROR 33.9 · χ² 1,864 / p <1e-300 | 32.7 EB05 26.4 · IC025 +4.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 15.7 · 82% consumer | no trial data cached |
| Full blood count abnormal | 35 | 23.6 16.9–32.8ROR 23.8 · χ² 731 / p 2e-161 | 23.2 EB05 17.4 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious PRR 19.6 · 94% consumer | no trial data cached |
| Platelet count decreased | 290 | 19.3 17.3–21.5ROR 21.3 · χ² 5,029 / p <1e-300 | 19.2 EB05 17.5 · IC025 +4.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 13.5 · 81% consumer | no trial data cached |
| Hospice care | 26 | 18.7 12.8–27.5ROR 18.9 · χ² 418 / p 4e-93 | 18.4 EB05 13.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Haemoglobin decreased | 206 | 14.2 12.4–16.2ROR 15.2 · χ² 2,520 / p <1e-300 | 14.1 EB05 12.6 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.3 · 83% consumer | no trial data cached |
| Full blood count decreased | 38 | 13.4 9.7–18.3ROR 13.5 · χ² 422 / p 5e-94 | 13.0 EB05 9.7 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious PRR 17.5 · 100% consumer | no trial data cached |
| Red blood cell count decreased | 50 | 12.4 9.4–16.3ROR 12.6 · χ² 511 / p 2e-113 | 12.1 EB05 9.4 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious PRR 10.2 · 90% consumer | no trial data cached |
| Laboratory test abnormal | 42 | 10.1 7.5–13.6ROR 10.2 · χ² 335 / p 4e-75 | 9.6 EB05 7.3 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 12.5 · 93% consumer | no trial data cached |
| Intentional dose omission | 35 | 9.1 6.5–12.6ROR 9.2 · χ² 243 / p 4e-55 | 8.5 EB05 6.2 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 10.9 · 97% consumer | no trial data cached |
| Gout | 22 | 8.7 5.7–13.2ROR 8.7 · χ² 142 / p 6e-33 | 7.7 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 · 86% consumer | no trial data cached |
| Loss of personal independence in daily activities | 57 | 8.5 6.6–11.0ROR 8.6 · χ² 369 / p 1e-82 | 8.1 EB05 6.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 · 95% consumer | no trial data cached |
| Blood iron decreased | 14 | 8.4 5.0–14.2ROR 8.4 · χ² 84 / p 2e-20 | 7.0 EB05 4.3 · IC025 +1.8 3/3 methods agree | Lab value / disease marker | serious PRR 6.4 | no trial data cached |
| Brain fog | 17 | 8.3 5.1–13.3ROR 8.3 · χ² 101 / p 4e-24 | 7.1 EB05 4.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 | no trial data cached |
| White blood cell count increased | 44 | 8.1 6.0–10.9ROR 8.2 · χ² 267 / p 3e-60 | 7.6 EB05 5.9 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 6.6 · 86% consumer | no trial data cached |
| Product dose omission issue | 323 | 8.0 7.2–8.9ROR 8.9 · χ² 2,007 / p <1e-300 | 8.0 EB05 7.3 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 18.3 · 94% consumer | no trial data cached |
| Leukaemia | 10 | 7.5 4.0–13.9ROR 7.5 · χ² 50 / p 7e-13 | 5.9 EB05 3.3 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.7 | no trial data cached |
| Night sweats | 33 | 7.3 5.2–10.2ROR 7.3 · χ² 172 / p 1e-39 | 6.7 EB05 4.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 · 94% consumer | no trial data cached |
| Diarrhoea (diarrhea) | 622 | 6.8 6.4–7.3ROR 8.4 · χ² 3,195 / p <1e-300 | 6.8 EB05 6.4 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 · 91% consumer | no trial data cached |
| Petechiae | 10 | 6.8 3.7–12.6ROR 6.8 · χ² 44 / p 2e-11 | 5.4 EB05 3.1 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Taste disorder | 19 | 6.7 4.3–10.5ROR 6.7 · χ² 87 / p 6e-21 | 5.9 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
| Intentional product misuse | 80 | 6.5 5.3–8.1ROR 6.7 · χ² 370 / p 1e-82 | 6.3 EB05 5.2 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 9.6 · 99% consumer | no trial data cached |
| Product dose omission in error | 24 | 6.3 4.2–9.4ROR 6.4 · χ² 102 / p 2e-24 | 5.7 EB05 4.0 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 8.2 · 100% consumer | no trial data cached |
| Ageusia (loss of taste) | 18 | 5.1 3.2–8.1ROR 5.1 · χ² 55 / p 5e-14 | 4.5 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Blood test abnormal | 10 | 5.0 2.7–9.4ROR 5.1 · χ² 28 / p 5e-8 | 4.2 EB05 2.5 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 4.8 | no trial data cached |
| Off label use (used outside approved label) | 602 | 4.9 4.6–5.3ROR 5.9 · χ² 1,950 / p <1e-300 | 4.9 EB05 4.6 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 4.4 · 87% consumer | no trial data cached |
| Epistaxis (nosebleed) | 48 | 4.5 3.4–6.0ROR 4.6 · χ² 129 / p 3e-30 | 4.4 EB05 3.4 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 · 90% consumer | no trial data cached |
| Emotional disorder | 18 | 4.1 2.6–6.5ROR 4.1 · χ² 39 / p 2e-10 | 3.8 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Illness | 57 | 4.0 3.1–5.2ROR 4.1 · χ² 127 / p 1e-29 | 3.9 EB05 3.1 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 5.0 · 89% consumer | no trial data cached |
| Contusion | 51 | 3.8 2.9–4.9ROR 3.8 · χ² 101 / p 5e-24 | 3.6 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 · 92% consumer | no trial data cached |
| Peripheral swelling | 79 | 3.6 2.9–4.5ROR 3.7 · χ² 150 / p 9e-35 | 3.6 EB05 3.0 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 · 91% consumer | no trial data cached |
| Fatigue (tiredness) | 381 | 3.5 3.2–3.8ROR 3.8 · χ² 693 / p 5e-153 | 3.5 EB05 3.2 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 2.5 · 93% consumer | no trial data cached |
| Bone pain | 26 | 3.1 2.1–4.6ROR 3.2 · χ² 36 / p 1e-9 | 3.0 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 · 88% consumer | no trial data cached |
| Disease progression | 51 | 3.1 2.3–4.0ROR 3.1 · χ² 69 / p 5e-17 | 3.0 EB05 2.4 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 2.3 | no trial data cached |
| Haemorrhage | 44 | 3.0 2.2–4.0ROR 3.0 · χ² 56 / p 3e-14 | 2.9 EB05 2.3 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.2 · 75% consumer | no trial data cached |
| White blood cell count decreased | 45 | 2.9 2.2–3.9ROR 3.0 · χ² 56 / p 4e-14 | 2.9 EB05 2.2 · IC025 +1.0 3/3 methods agree | Lab value / disease marker | serious PRR 2.6 · 82% consumer | no trial data cached |
| Fluid retention | 21 | 2.9 1.9–4.5ROR 2.9 · χ² 25 / p 3e-7 | 2.8 EB05 1.9 · IC025 +0.8 | Not in label — unassessed | serious PRR 4.3 · 100% consumer | no trial data cached |
| Dysgeusia (altered taste) | 29 | 2.7 1.9–3.9ROR 2.8 · χ² 31 / p 2e-8 | 2.7 EB05 2.0 · IC025 +0.8 | Not in label — unassessed | serious PRR 2.5 · 90% consumer | no trial data cached |
| Death | 303 | 2.5 2.2–2.8ROR 2.7 · χ² 280 / p 4e-63 | 2.5 EB05 2.3 · IC025 +1.1 3/3 methods agree | Outcome field, not a reaction | serious PRR 3.9 · 70% consumer | 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 |
|---|---|---|---|---|---|---|
| Diarrhoea (diarrhea) | 622 | 6.8 6.4–7.3ROR 8.4 · χ² 3,195 / p <1e-300 | 6.8 EB05 6.4 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 · 91% consumer | no trial data cached |
| Off label use (used outside approved label) | 602 | 4.9 4.6–5.3ROR 5.9 · χ² 1,950 / p <1e-300 | 4.9 EB05 4.6 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 4.4 · 87% consumer | no trial data cached |
| Fatigue (tiredness) | 381 | 3.5 3.2–3.8ROR 3.8 · χ² 693 / p 5e-153 | 3.5 EB05 3.2 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 2.5 · 93% consumer | no trial data cached |
| Product dose omission issue | 323 | 8.0 7.2–8.9ROR 8.9 · χ² 2,007 / p <1e-300 | 8.0 EB05 7.3 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 18.3 · 94% consumer | no trial data cached |
| Death | 303 | 2.5 2.2–2.8ROR 2.7 · χ² 280 / p 4e-63 | 2.5 EB05 2.3 · IC025 +1.1 3/3 methods agree | Outcome field, not a reaction | serious PRR 3.9 · 70% consumer | no trial data cached |
| Platelet count decreased | 290 | 19.3 17.3–21.5ROR 21.3 · χ² 5,029 / p <1e-300 | 19.2 EB05 17.5 · IC025 +4.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 13.5 · 81% consumer | no trial data cached |
| Haemoglobin decreased | 206 | 14.2 12.4–16.2ROR 15.2 · χ² 2,520 / p <1e-300 | 14.1 EB05 12.6 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.3 · 83% consumer | no trial data cached |
| Splenomegaly | 105 | 64.0 53.0–77.3ROR 66.3 · χ² 6,395 / p <1e-300 | 62.7 EB05 53.3 · IC025 +5.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 37.3 · 86% consumer | no trial data cached |
| Transfusion | 84 | 57.0 46.1–70.4ROR 58.6 · χ² 4,528 / p <1e-300 | 55.8 EB05 46.5 · IC025 +5.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 27.8 · 95% consumer | no trial data cached |
| Intentional product misuse | 80 | 6.5 5.3–8.1ROR 6.7 · χ² 370 / p 1e-82 | 6.3 EB05 5.2 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 9.6 · 99% consumer | no trial data cached |
| Peripheral swelling | 79 | 3.6 2.9–4.5ROR 3.7 · χ² 150 / p 9e-35 | 3.6 EB05 3.0 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 · 91% consumer | no trial data cached |
| Platelet count increased | 61 | 33.2 25.9–42.6ROR 33.9 · χ² 1,864 / p <1e-300 | 32.7 EB05 26.4 · IC025 +4.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 15.7 · 82% consumer | no trial data cached |
| Illness | 57 | 4.0 3.1–5.2ROR 4.1 · χ² 127 / p 1e-29 | 3.9 EB05 3.1 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 5.0 · 89% consumer | no trial data cached |
| Loss of personal independence in daily activities | 57 | 8.5 6.6–11.0ROR 8.6 · χ² 369 / p 1e-82 | 8.1 EB05 6.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 · 95% consumer | no trial data cached |
| Disease progression | 51 | 3.1 2.3–4.0ROR 3.1 · χ² 69 / p 5e-17 | 3.0 EB05 2.4 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 2.3 | 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.
- Hospice care — n=26, PRR 18.7
- Gout — n=22, PRR 8.7
- Loss of personal independence in daily activities — n=57, PRR 8.5
- Night sweats — n=33, PRR 7.3
- Contusion — n=51, PRR 3.8
- Peripheral swelling — n=79, PRR 3.6
- Fatigue — n=381, PRR 3.5
- Bone pain — n=26, PRR 3.1
- Fluid retention — n=21, PRR 2.9
- Dysgeusia — n=29, PRR 2.7
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 Pacritinib?
In FDA FAERS, the most frequently co-reported reaction terms for Pacritinib are diarrhoea, fatigue, platelet count decreased, haemoglobin decreased, splenomegaly, transfusion. 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 Pacritinib have an FDA boxed warning?
No. The FDA label retrieved for Pacritinib has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Pacritinib 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 4b5ab444-0e1a-4984-99db-76ad11a298ee, effective 20260730; matched on
openfda.generic_name.exact:"PACRITINIB") - 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, fieldpatient.drug.openfda.generic_name.exact, 50 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.