Drug · FAERS side-effect profile with label screen
Bosutinib side effects: what 8,928 FDA adverse event reports show
Drug class
Kinase inhibitor
FDA label, Indications wording
Brand names
Bosulif
openFDA label
Who reports
8,928 reports · 56% serious · 782 with death outcome · 51% female
openFDA FAERS counts, all years, deduplication not applied
Used for
BOSULIF is indicated for the treatment of: • Adult and pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), newly-diagnosed or resistant or intolerant to prior therapy .
FDA label, Indications and Usage
What it is
BOSULIF contains bosutinib, a kinase inhibitor. Bosutinib is present as a monohydrate with a chemical name of 3-Quinolinecarbonitrile, 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-piperazinyl) propoxy]-, hydrate (1:1).
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 10Labeled (related wording) 3Likely indication confounding 5Reporting / coding artifact 3Lab value / disease marker 4Not 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.
- 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. 956 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 |
|---|---|---|---|---|---|---|
| Cytogenetic analysis abnormal | 110 | 273.9 225.1–333.4ROR 277.3 · χ² 26,507 / p <1e-300 | 235.1 EB05 200.5 · IC025 +6.5 3/3 methods agree | Reporting / coding artifact | serious n=91 | no trial data cached |
| Philadelphia chromosome positive | 67 | 242.5 188.7–311.6ROR 244.3 · χ² 14,366 / p <1e-300 | 206.7 EB05 168.4 · IC025 +6.0 3/3 methods agree | Likely indication confounding term in indications | serious n=65 | no trial data cached |
| Chronic myeloid leukaemia recurrent | 22 | 98.2 64.1–150.3ROR 98.4 · χ² 1,938 / p <1e-300 | 87.3 EB05 60.8 · IC025 +4.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=21 | no trial data cached |
| Chronic myeloid leukaemia | 146 | 76.5 64.9–90.1ROR 77.7 · χ² 10,456 / p <1e-300 | 73.4 EB05 63.9 · IC025 +5.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=111 | no trial data cached |
| Blast crisis in myelogenous leukaemia | 38 | 74.4 53.9–102.7ROR 74.7 · χ² 2,595 / p <1e-300 | 69.7 EB05 53.0 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious n=38 · 92% clinician | no trial data cached |
| Chronic myeloid leukaemia transformation | 11 | 59.4 32.7–108.0ROR 59.5 · χ² 560 / p 4e-124 | 52.9 EB05 31.5 · IC025 +3.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=11 | no trial data cached |
| Chylothorax | 15 | 50.5 30.3–84.2ROR 50.6 · χ² 665 / p 8e-147 | 46.7 EB05 30.0 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Myopathy toxic | 11 | 44.1 24.3–80.0ROR 44.1 · χ² 413 / p 4e-92 | 40.5 EB05 24.1 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Hydrothorax | 13 | 37.1 21.5–64.2ROR 37.2 · χ² 415 / p 2e-92 | 34.9 EB05 21.7 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Second primary malignancy | 102 | 29.2 24.0–35.4ROR 29.5 · χ² 2,712 / p <1e-300 | 28.7 EB05 24.3 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 29.6 | no trial data cached |
| Neoplasm progression | 373 | 25.2 22.8–27.9ROR 26.3 · χ² 8,568 / p <1e-300 | 24.9 EB05 22.9 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 15.3 | no trial data cached |
| Acquired gene mutation | 13 | 23.3 13.5–40.3ROR 23.4 · χ² 254 / p 2e-57 | 22.3 EB05 13.6 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Full blood count increased | 10 | 19.8 10.6–36.9ROR 19.8 · χ² 159 / p 1e-36 | 18.4 EB05 9.7 · IC025 +2.3 3/3 methods agree | Lab value / disease marker | serious n=5 | no trial data cached |
| Pleural effusion | 455 | 17.7 16.1–19.3ROR 18.6 · χ² 7,103 / p <1e-300 | 17.5 EB05 16.2 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.8 | no trial data cached |
| Acute lymphocytic leukaemia | 19 | 15.8 10.1–24.9ROR 15.9 · χ² 248 / p 4e-56 | 15.2 EB05 9.9 · IC025 +2.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=16 | no trial data cached |
| Gene mutation | 13 | 15.5 9.0–26.7ROR 15.5 · χ² 161 / p 4e-37 | 14.3 EB05 8.1 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Capillary leak syndrome | 13 | 15.0 8.7–25.8ROR 15.0 · χ² 155 / p 8e-36 | 13.7 EB05 7.7 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Intermittent claudication | 10 | 14.8 8.0–27.6ROR 14.8 · χ² 115 / p 5e-27 | 13.0 EB05 6.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Peripheral arterial occlusive disease | 25 | 14.4 9.7–21.3ROR 14.4 · χ² 296 / p 1e-66 | 13.9 EB05 9.5 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious n=24 · ♀ 30% (drug 51%) · 92% clinician | no trial data cached |
| Cytopenia | 72 | 14.2 11.3–17.9ROR 14.3 · χ² 867 / p 6e-191 | 14.0 EB05 11.5 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.0 | no trial data cached |
| Drug resistance | 147 | 13.5 11.5–15.9ROR 13.7 · χ² 1,682 / p <1e-300 | 13.4 EB05 11.6 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 13.7 | no trial data cached |
| Neoplasm recurrence | 18 | 12.5 7.9–19.9ROR 12.5 · χ² 178 / p 6e-41 | 11.5 EB05 7.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Amylase increased | 16 | 10.3 6.3–16.8ROR 10.3 · χ² 125 / p 3e-29 | 9.0 EB05 5.5 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious n=13 | no trial data cached |
| Pericardial effusion | 95 | 9.7 8.0–11.9ROR 9.8 · χ² 733 / p 1e-161 | 9.5 EB05 7.9 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.9 | no trial data cached |
| Haematotoxicity | 37 | 9.4 6.8–13.0ROR 9.4 · χ² 269 / p 1e-60 | 8.8 EB05 6.5 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 · ♀ 77% (drug 51%) · 95% clinician | no trial data cached |
| Loss of therapeutic response | 11 | 8.6 4.7–15.5ROR 8.6 · χ² 66 / p 2e-16 | 6.8 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Tumour marker increased | 17 | 8.3 5.2–13.4ROR 8.3 · χ² 102 / p 3e-24 | 7.1 EB05 4.6 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious n=4 | no trial data cached |
| Autoimmune haemolytic anaemia | 12 | 8.3 4.7–14.6ROR 8.3 · χ² 70 / p 4e-17 | 6.7 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Carotid artery stenosis | 12 | 8.1 4.6–14.2ROR 8.1 · χ² 67 / p 1e-16 | 6.5 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Iron deficiency | 15 | 7.9 4.8–13.2ROR 8.0 · χ² 84 / p 3e-20 | 6.7 EB05 4.2 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Platelet count increased | 44 | 7.9 5.9–10.7ROR 8.0 · χ² 259 / p 2e-58 | 7.4 EB05 5.7 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 8.5 | no trial data cached |
| Drug intolerance | 316 | 7.7 6.9–8.6ROR 8.0 · χ² 1,847 / p <1e-300 | 7.6 EB05 7.0 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 10.2 | no trial data cached |
| Pulmonary hypertension | 68 | 7.7 6.0–9.7ROR 7.7 · χ² 386 / p 3e-86 | 7.3 EB05 6.0 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.9 | no trial data cached |
| Liver function test increased | 69 | 7.6 6.0–9.6ROR 7.7 · χ² 389 / p 6e-87 | 7.3 EB05 5.9 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 | no trial data cached |
| Diarrhoea (diarrhea) | 2,071 | 7.6 7.3–7.9ROR 9.6 · χ² 12,160 / p <1e-300 | 7.5 EB05 7.3 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.5 | no trial data cached |
| Gastrointestinal toxicity | 15 | 7.5 4.5–12.4ROR 7.5 · χ² 78 / p 5e-19 | 6.3 EB05 4.0 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious n=13 | no trial data cached |
| Peripheral vascular disorder | 16 | 7.3 4.4–11.9ROR 7.3 · χ² 80 / p 2e-19 | 6.2 EB05 4.0 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious n=16 | no trial data cached |
| Pulmonary oedema | 138 | 7.2 6.1–8.6ROR 7.3 · χ² 736 / p 2e-162 | 7.1 EB05 6.1 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.2 | no trial data cached |
| Platelet count abnormal | 18 | 7.0 4.4–11.2ROR 7.0 · χ² 87 / p 6e-21 | 6.1 EB05 4.0 · IC025 +1.8 3/3 methods agree | Lab value / disease marker | serious n=17 | no trial data cached |
| Fluid retention | 150 | 6.9 5.9–8.1ROR 7.0 · χ² 757 / p 6e-167 | 6.8 EB05 5.9 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.3 | 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 |
|---|---|---|---|---|---|---|
| Diarrhoea (diarrhea) | 2,071 | 7.6 7.3–7.9ROR 9.6 · χ² 12,160 / p <1e-300 | 7.5 EB05 7.3 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.5 | no trial data cached |
| Nausea | 1,015 | 3.0 2.9–3.2ROR 3.3 · χ² 1,424 / p <1e-300 | 3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 | no trial data cached |
| Fatigue (tiredness) | 726 | 2.2 2.0–2.4ROR 2.3 · χ² 489 / p 1e-108 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.0 | no trial data cached |
| Vomiting | 542 | 2.7 2.5–2.9ROR 2.8 · χ² 599 / p 2e-132 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.1 | no trial data cached |
| Death | 522 | 1.4 1.3–1.5ROR 1.4 · χ² 68 / p 8e-17 | 1.4 EB05 1.3 · IC025 +0.4 | Outcome field, not a reaction | serious PRR 1.4 | no trial data cached |
| Rash | 491 | 2.7 2.4–2.9ROR 2.8 · χ² 517 / p 8e-115 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.4 | no trial data cached |
| Pleural effusion | 455 | 17.7 16.1–19.3ROR 18.6 · χ² 7,103 / p <1e-300 | 17.5 EB05 16.2 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.8 | no trial data cached |
| Neoplasm progression | 373 | 25.2 22.8–27.9ROR 26.3 · χ² 8,568 / p <1e-300 | 24.9 EB05 22.9 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 15.3 | no trial data cached |
| Dyspnoea (shortness of breath) | 364 | 1.5 1.4–1.7ROR 1.5 · χ² 64 / p 6e-16 | 1.5 EB05 1.4 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.6 | no trial data cached |
| Headache | 337 | 1.3 1.1–1.4ROR 1.3 · χ² 19 / p 7e-6 | 1.3 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 1.3 | no trial data cached |
| Off label use (used outside approved label) | 325 | 0.9 0.8–1.0ROR 0.9 · χ² 5 / p 0.010 | 0.9 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.9 | no trial data cached |
| Drug intolerance | 316 | 7.7 6.9–8.6ROR 8.0 · χ² 1,847 / p <1e-300 | 7.6 EB05 7.0 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 10.2 | no trial data cached |
| Malaise (feeling unwell) | 298 | 1.6 1.4–1.8ROR 1.6 · χ² 66 / p 2e-16 | 1.6 EB05 1.4 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.4 | no trial data cached |
| Drug ineffective (drug did not work) | 278 | 0.5 0.4–0.6ROR 0.5 · χ² 152 / p 4e-35 | 0.5 EB05 0.4 · IC025 -1.2 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.0 | no trial data cached |
| Abdominal pain | 266 | 2.7 2.4–3.0ROR 2.7 · χ² 283 / p 8e-64 | 2.7 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.2 | 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.
- Second primary malignancy — n=102, PRR 29.2
- Neoplasm progression — n=373, PRR 25.2
- Haematotoxicity — n=37, PRR 9.4
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 Bosutinib?
In FDA FAERS, the most frequently co-reported reaction terms for Bosutinib are diarrhoea, nausea, fatigue, vomiting, rash, pleural effusion. 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 Bosutinib have an FDA boxed warning?
No. The FDA label retrieved for Bosutinib has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Bosutinib 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 adc84ad5-a04d-4fee-9ba8-91f7abd928e3, effective 20260310; matched on
openfda.generic_name.exact:"BOSUTINIB") - 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, 996 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.