Drug · FAERS side-effect profile with label screen
Dasatinib side effects: what 9,094 FDA adverse event reports show
Drug class
Not stated in label
Who reports
9,094 reports · 91% serious · 1,338 with death outcome · 46% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Dasatinib tablets are indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib.
FDA label, Indications and Usage
What it is
Dasatinib tablets are a kinase inhibitor.
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 2Labeled (related wording) 6Likely indication confounding 13Reporting / coding artifact 4Lab value / disease marker 2Not in label — unassessed 13
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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,081 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 |
|---|---|---|---|---|---|---|
| Philadelphia chromosome positive | 241 | 289.1 247.5–337.6ROR 291.0 · calibrated p 2e-11 ✓ | 188.1 EB05 169.0 · IC025 +6.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=179 | not reported in cached trials |
| Philadelphia positive chronic myeloid leukaemia | 27 | 232.2 148.3–363.7ROR 232.4 · calibrated p 7e-10 ✓ | 147.4 EB05 106.4 · IC025 +4.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=26 · 92% clinician | not reported in cached trials |
| Blast cell proliferation | 14 | 182.0 99.6–332.6ROR 182.1 · calibrated p 2e-8 ✓ | 116.2 EB05 73.5 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=5 | not reported in cached trials |
| Chylothorax | 165 | 171.4 144.0–204.0ROR 172.2 · calibrated p 2e-9 ✓ | 129.5 EB05 113.7 · IC025 +6.3 3/3 methods agree | Labeled adverse reaction exact term | serious n=123 · 95% clinician | not reported in cached trials |
| Cytogenetic analysis abnormal | 213 | 144.0 123.9–167.3ROR 144.8 · calibrated p 7e-9 ✓ | 113.5 EB05 101.3 · IC025 +6.3 3/3 methods agree | Reporting / coding artifact | serious n=177 | not reported in cached trials |
| Philadelphia positive acute lymphocytic leukaemia | 30 | 129.0 86.7–191.8ROR 129.1 · calibrated p 5e-8 ✓ | 98.6 EB05 72.4 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious n=30 · 100% clinician | not reported in cached trials |
| Chronic myeloid leukaemia recurrent | 95 | 119.1 95.4–148.6ROR 119.4 · calibrated p 4e-8 ✓ | 96.5 EB05 81.3 · IC025 +5.7 3/3 methods agree | Labeled (related wording) related wording | serious n=69 | not reported in cached trials |
| Blast cell crisis | 46 | 90.5 66.3–123.6ROR 90.7 · calibrated p 4e-7 ✓ | 75.7 EB05 59.1 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 86% (drug 46%) | not reported in cached trials |
| Primary effusion lymphoma | 11 | 83.1 44.1–156.5ROR 83.1 · calibrated p 4e-6 ✓ | 64.7 EB05 38.6 · IC025 +3.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=5 | not reported in cached trials |
| Blast crisis in myelogenous leukaemia | 148 | 77.1 64.9–91.5ROR 77.4 · calibrated p 9e-7 ✓ | 67.3 EB05 58.7 · IC025 +5.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=117 | not reported in cached trials |
| Large granular lymphocytosis | 40 | 76.8 55.2–106.9ROR 76.9 · calibrated p 1e-6 ✓ | 65.6 EB05 50.3 · IC025 +4.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=38 · 100% clinician | not reported in cached trials |
| Chronic myeloid leukaemia transformation | 52 | 74.9 56.1–100.0ROR 75.0 · calibrated p 1e-6 ✓ | 64.7 EB05 51.2 · IC025 +4.9 3/3 methods agree | Labeled (related wording) related wording | serious n=34 | not reported in cached trials |
| Clonal evolution | 11 | 67.6 36.1–126.3ROR 67.6 · calibrated p 1e-5 ✓ | 55.0 EB05 32.7 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Polymerase chain reaction positive | 33 | 60.1 42.0–86.0ROR 60.1 · calibrated p 8e-6 ✓ | 52.8 EB05 39.3 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious n=13 | not reported in cached trials |
| Central nervous system neoplasm | 15 | 57.8 34.0–98.4ROR 57.8 · calibrated p 2e-5 ✓ | 49.4 EB05 31.8 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious n=15 | not reported in cached trials |
| Acute lymphocytic leukaemia recurrent | 228 | 54.9 47.9–62.9ROR 55.2 · calibrated p 8e-6 ✓ | 49.9 EB05 44.7 · IC025 +5.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=170 | not reported in cached trials |
| Gene mutation identification test positive | 37 | 54.0 38.5–75.7ROR 54.1 · calibrated p 1e-5 ✓ | 48.2 EB05 36.5 · IC025 +4.4 3/3 methods agree | Lab value / disease marker | serious n=24 | not reported in cached trials |
| Lymphoid tissue hyperplasia | 31 | 54.0 37.3–78.0ROR 54.0 · calibrated p 2e-5 ✓ | 48.0 EB05 35.4 · IC025 +4.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=19 | not reported in cached trials |
| Exposure via body fluid | 64 | 49.8 38.6–64.3ROR 49.9 · calibrated p 2e-5 ✓ | 45.3 EB05 36.7 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious n=4 | not reported in cached trials |
| Aspiration pleural cavity | 60 | 47.7 36.7–62.1ROR 47.8 · calibrated p 2e-5 ✓ | 43.5 EB05 35.0 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=7 | not reported in cached trials |
| Central nervous system leukaemia | 27 | 43.4 29.3–64.1ROR 43.4 · calibrated p 6e-5 ✓ | 39.3 EB05 28.4 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious n=22 · 100% clinician | not reported in cached trials |
| Emergency care examination | 47 | 42.3 31.5–56.9ROR 42.4 · calibrated p 5e-5 ✓ | 38.8 EB05 30.4 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | – | not reported in cached trials |
| Chronic myeloid leukaemia | 297 | 38.9 34.6–43.7ROR 39.2 · calibrated p 6e-5 ✓ | 36.3 EB05 33.0 · IC025 +4.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=193 | not reported in cached trials |
| Graft versus host disease in eye | 13 | 33.8 19.3–59.2ROR 33.8 · calibrated p 4e-4 ✓ | 30.6 EB05 19.0 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious n=12 | not reported in cached trials |
| Leukaemia recurrent | 94 | 33.4 27.1–41.1ROR 33.4 · calibrated p 2e-4 ✓ | 31.4 EB05 26.4 · IC025 +4.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=70 | not reported in cached trials |
| Minimal residual disease | 26 | 33.3 22.4–49.4ROR 33.3 · calibrated p 3e-4 ✓ | 30.8 EB05 22.1 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=24 · ♀ 25% (drug 46%) · 100% clinician | not reported in cached trials |
| Enterocolitis haemorrhagic | 81 | 32.6 26.1–40.8ROR 32.7 · calibrated p 2e-4 ✓ | 30.7 EB05 25.5 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=51 · 96% clinician | not reported in cached trials |
| Chromosome analysis abnormal | 14 | 32.5 18.9–55.7ROR 32.5 · calibrated p 4e-4 ✓ | 29.6 EB05 18.7 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious n=7 | not reported in cached trials |
| Pleural effusion | 3,254 | 32.0 30.9–33.1ROR 35.0 · calibrated p 1e-4 ✓ | 30.3 EB05 29.4 · IC025 +4.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 27.2 | NCT02883049: 7/4,714 (0.1%) on Dasatinib (serious AE) |
| Peripheral artery stenosis | 22 | 27.5 17.9–42.2ROR 27.5 · calibrated p 7e-4 ✓ | 25.7 EB05 17.9 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Leukaemic infiltration extramedullary | 10 | 23.8 12.6–44.8ROR 23.8 · calibrated p 0.002 ✓ | 21.7 EB05 12.0 · IC025 +2.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=10 | not reported in cached trials |
| Subdural hygroma | 12 | 23.3 13.1–41.5ROR 23.3 · calibrated p 0.002 ✓ | 21.5 EB05 12.8 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Gene mutation | 78 | 23.2 18.5–29.0ROR 23.2 · calibrated p 0.001 ✓ | 22.2 EB05 18.3 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=55 | not reported in cached trials |
| Bone marrow transplant | 69 | 21.5 16.9–27.3ROR 21.5 · calibrated p 0.002 ✓ | 20.6 EB05 16.9 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Myeloid leukaemia | 17 | 19.7 12.2–32.0ROR 19.7 · calibrated p 0.004 ✓ | 18.6 EB05 12.0 · IC025 +2.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=16 | not reported in cached trials |
| Acute lymphocytic leukaemia | 92 | 19.0 15.5–23.4ROR 19.1 · calibrated p 0.003 ✓ | 18.4 EB05 15.4 · IC025 +3.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=64 · 92% clinician | not reported in cached trials |
| Cytomegalovirus colitis | 70 | 18.1 14.2–22.9ROR 18.1 · calibrated p 0.004 ✓ | 17.5 EB05 14.3 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=62 | not reported in cached trials |
| B-cell type acute leukaemia | 22 | 17.9 11.7–27.4ROR 17.9 · calibrated p 0.005 ✓ | 17.0 EB05 11.6 · IC025 +3.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=17 | not reported in cached trials |
| Acquired gene mutation | 38 | 16.8 12.2–23.2ROR 16.8 · calibrated p 0.005 ✓ | 16.1 EB05 12.2 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=30 · 100% clinician | not reported in cached trials |
| Remission not achieved | 17 | 16.0 9.9–25.9ROR 16.0 · calibrated p 0.008 ✓ | 14.9 EB05 9.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=9 | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Dasatinib as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (1 of 40 signal terms matched).
- NCT02883049 — Combination Chemotherapy in Treating Young Patients With Newly Diagnosed High-Risk B Acute Lymphoblastic Leuke (N=5949, PHASE3; 553 AE terms posted; arms: Non-DS B-ALL; DS B-ALL; Patients Transferred From AALL0932; Non-DS HR B-ALL Arm A)
- NCT00744497 — Randomized Study Comparing Docetaxel Plus Dasatinib to Docetaxel Plus Placebo in Castration-resistant Prostate (N=1930, PHASE3; 427 AE terms posted; arms: Placebo; Dasatinib)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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 |
|---|---|---|---|---|---|---|
| Pleural effusion | 3,254 | 32.0 30.9–33.1ROR 35.0 · calibrated p 1e-4 ✓ | 30.3 EB05 29.4 · IC025 +4.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 27.2 | NCT02883049: 7/4,714 (0.1%) on Dasatinib (serious AE) |
| Fatigue (tiredness) | 2,541 | 1.9 1.8–1.9ROR 1.9 · calibrated p 0.901 | 1.9 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.1 | NCT02883049: 2/73 (2.7%) on Dasatinib (serious AE) |
| Diarrhoea (diarrhea) | 2,172 | 1.9 1.8–2.0ROR 2.0 · calibrated p 0.931 | 1.9 EB05 1.8 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 1.6 | NCT02883049: 2/23 (8.7%) on Dasatinib (serious AE) |
| Nausea | 2,141 | 1.5 1.5–1.6ROR 1.6 · calibrated p 0.690 | 1.5 EB05 1.5 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.2 | NCT02883049: 1/23 (4.3%) on Dasatinib (serious AE) |
| Death | 2,108 | 1.4 1.3–1.4ROR 1.4 · calibrated p 0.584 | 1.4 EB05 1.3 · IC025 +0.4 | Outcome field, not a reaction | serious PRR 0.8 | NCT02883049: 3/23 (13.0%) on Dasatinib; 22/282 (7.8%) control (serious AE) |
| Headache | 2,006 | 1.8 1.7–1.9ROR 1.9 · calibrated p 0.870 | 1.8 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.3 | NCT02883049: 1/23 (4.3%) on Dasatinib (serious AE) |
| Rash | 1,603 | 2.1 2.0–2.2ROR 2.2 · calibrated p 0.976 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.1 | NCT02883049: 1/23 (4.3%) on Dasatinib (serious AE) |
| Drug ineffective (drug did not work) | 1,536 | 0.7 0.6–0.7ROR 0.6 · calibrated p 0.105 | 0.7 EB05 0.6 · IC025 -0.7 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 2.1 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 1,503 | 1.5 1.4–1.6ROR 1.5 · calibrated p 0.662 | 1.5 EB05 1.4 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.4 | NCT02883049: 2/4,714 (0.0%) on Dasatinib (serious AE) |
| Adverse event | 1,477 | 9.2 8.8–9.7ROR 9.6 · calibrated p 0.037 ✓ | 9.1 EB05 8.7 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 1.5 | not reported in cached trials |
| Off label use (used outside approved label) | 1,264 | 0.8 0.8–0.9ROR 0.8 · calibrated p 0.195 | 0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.0 | not reported in cached trials |
| Hospitalisation | 1,217 | 4.6 4.3–4.8ROR 4.7 · calibrated p 0.272 | 4.5 EB05 4.3 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 0.6 | not reported in cached trials |
| Pulmonary oedema | 1,013 | 13.1 12.3–13.9ROR 13.4 · calibrated p 0.011 ✓ | 12.8 EB05 12.2 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.5 | NCT02883049: 2/4,714 (0.0%) on Dasatinib (serious AE) |
| Vomiting | 956 | 1.2 1.1–1.2ROR 1.2 · calibrated p 0.414 | 1.2 EB05 1.1 · IC025 +0.1 | Labeled adverse reaction exact term | serious PRR 1.1 | NCT02883049: 2/23 (8.7%) on Dasatinib (serious AE) |
| Pyrexia (fever) | 890 | 1.5 1.4–1.6ROR 1.5 · calibrated p 0.623 | 1.5 EB05 1.4 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.9 | NCT00744497: 29/761 (3.8%) on Dasatinib; 14/757 (1.8%) control (serious AE) |
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.
- Blast cell crisis — n=46, PRR 90.5
- Aspiration pleural cavity — n=60, PRR 47.7
- Minimal residual disease — n=26, PRR 33.3
- Enterocolitis haemorrhagic — n=81, PRR 32.6
- Peripheral artery stenosis — n=22, PRR 27.5
- Gene mutation — n=78, PRR 23.2
- Bone marrow transplant — n=69, PRR 21.5
- Cytomegalovirus colitis — n=70, PRR 18.1
- Acquired gene mutation — n=38, PRR 16.8
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 Dasatinib?
In FDA FAERS, the most frequently co-reported reaction terms for Dasatinib are pleural effusion, fatigue, diarrhoea, nausea, headache, rash. 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 Dasatinib have an FDA boxed warning?
No. The FDA label retrieved for Dasatinib has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Dasatinib 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 1931e73f-918c-4d69-9543-de9643513d05, effective 20240709; matched on
openfda.generic_name.exact:"DASATINIB") - 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, 1,121 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 - ClinicalTrials.gov API v2 (query
DASATINIB, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. 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.