Drug · FAERS side-effect profile with label screen
Imatinib side effects: what 17,533 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Imatinib Mesylate
openFDA label
Who reports
17,533 reports · 89% serious · 3,103 with death outcome · 46% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Imatinib mesylate tablets are a kinase inhibitor indicated for the treatment of: • Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. ( 1.1 ) • Patients with Philadelp.
FDA label, Indications and Usage
What it is
Imatinib is a small molecule kinase inhibitor. Imatinib mesylate film-coated tablets are supplied as 100 mg or 400 mg tablets for oral administration. Each 100 mg tablet contains 119.5 mg of imatinib mesylate equivalent to 100 mg of imatinib 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 2Labeled (related wording) 7Likely indication confounding 8Reporting / coding artifact 2Lab value / disease marker 3Not in label — unassessed 18
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. 1,049 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 |
|---|---|---|---|---|---|---|
| Hcov-hku1 infection | 10 | 1,072.0 455.3–2,523.7ROR 1,072.6 · χ² 5,057 / p <1e-300 | 271.1 EB05 157.4 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Ankle brachial index decreased | 10 | 737.0 334.5–1,623.8ROR 737.4 · χ² 4,081 / p <1e-300 | 243.3 EB05 141.3 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | serious n=10 | not reported in cached trials |
| Necrotising panniculitis | 16 | 571.7 314.7–1,038.5ROR 572.2 · χ² 5,760 / p <1e-300 | 264.0 EB05 172.3 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Philadelphia chromosome positive | 218 | 525.7 448.4–616.2ROR 532.3 · χ² 78,600 / p <1e-300 | 352.6 EB05 315.0 · IC025 +7.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=214 | not reported in cached trials |
| Chordoma | 31 | 522.2 342.2–796.8ROR 523.1 · χ² 10,818 / p <1e-300 | 296.1 EB05 218.5 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=31 · 100% clinician | not reported in cached trials |
| Carotid intima-media thickness increased | 12 | 428.8 221.5–830.1ROR 429.1 · χ² 3,448 / p <1e-300 | 210.0 EB05 128.0 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Chronic myeloid leukaemia recurrent | 143 | 423.7 350.2–512.6ROR 427.1 · χ² 44,050 / p <1e-300 | 299.4 EB05 260.5 · IC025 +6.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=143 | not reported in cached trials |
| Oral pigmentation | 18 | 416.2 243.2–712.1ROR 416.6 · χ² 5,207 / p <1e-300 | 232.2 EB05 155.4 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | serious n=14 | not reported in cached trials |
| Cytogenetic analysis abnormal | 271 | 415.5 362.1–476.9ROR 422.0 · χ² 82,564 / p <1e-300 | 301.0 EB05 272.1 · IC025 +7.4 3/3 methods agree | Reporting / coding artifact | serious n=258 | not reported in cached trials |
| Amaurosis fugax | 231 | 330.2 285.6–381.7ROR 334.6 · χ² 58,969 / p <1e-300 | 252.8 EB05 226.6 · IC025 +7.2 3/3 methods agree | Not in label — unassessed | serious n=231 · 94% clinician | not reported in cached trials |
| Transdifferentiation of neoplasm | 11 | 301.6 155.6–584.8ROR 301.8 · χ² 2,391 / p <1e-300 | 170.1 EB05 101.3 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Blast crisis in myelogenous leukaemia | 245 | 296.0 257.5–340.2ROR 300.2 · χ² 57,344 / p <1e-300 | 232.5 EB05 209.1 · IC025 +7.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=245 · 91% clinician | NCT00333840: 12/363 (3.3%) on Imatinib (serious AE) |
| Chromosome analysis abnormal | 48 | 273.4 199.8–374.2ROR 274.2 · χ² 10,356 / p <1e-300 | 204.2 EB05 160.1 · IC025 +5.6 3/3 methods agree | Reporting / coding artifact | serious n=47 · 100% clinician | not reported in cached trials |
| Clonal evolution | 17 | 235.8 140.1–396.9ROR 236.1 · χ² 3,120 / p <1e-300 | 161.4 EB05 106.7 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Philadelphia positive chronic myeloid leukaemia | 15 | 229.7 132.1–399.3ROR 229.9 · χ² 2,670 / p <1e-300 | 154.9 EB05 99.6 · IC025 +3.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=15 | not reported in cached trials |
| Gene mutation identification test positive | 64 | 212.0 162.5–276.5ROR 212.8 · χ² 11,213 / p <1e-300 | 170.7 EB05 138.4 · IC025 +5.8 3/3 methods agree | Lab value / disease marker | serious n=60 · 97% clinician | not reported in cached trials |
| Gastrointestinal stromal tumour | 341 | 174.6 156.0–195.4ROR 178.0 · χ² 51,121 / p <1e-300 | 150.9 EB05 138.0 · IC025 +6.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=335 | not reported in cached trials |
| Chronic myeloid leukaemia transformation | 55 | 168.4 127.0–223.4ROR 169.0 · χ² 7,865 / p <1e-300 | 140.4 EB05 111.9 · IC025 +5.5 3/3 methods agree | Labeled (related wording) related wording | serious n=55 | not reported in cached trials |
| Desmoid tumour | 24 | 156.4 102.2–239.3ROR 156.6 · χ² 3,135 / p <1e-300 | 124.7 EB05 88.2 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=24 · ♀ 26% (drug 46%) · 100% clinician | not reported in cached trials |
| Pseudoporphyria | 36 | 141.5 100.2–199.9ROR 141.8 · χ² 4,359 / p <1e-300 | 118.6 EB05 89.5 · IC025 +5.0 3/3 methods agree | Labeled adverse reaction exact term | serious n=35 · 100% clinician | not reported in cached trials |
| Lip scab | 10 | 140.4 72.9–270.4ROR 140.5 · χ² 1,115 / p 9e-245 | 101.8 EB05 59.1 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Chronic myeloid leukaemia | 483 | 139.4 127.0–153.0ROR 143.3 · χ² 59,248 / p <1e-300 | 124.2 EB05 115.2 · IC025 +6.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=479 | NCT00333840: 3/363 (0.8%) on Imatinib (serious AE) |
| Pancreatic toxicity | 12 | 136.1 74.9–247.3ROR 136.1 · χ² 1,324 / p 4e-290 | 102.6 EB05 62.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Blast cell crisis | 34 | 135.4 95.0–193.1ROR 135.7 · χ² 3,950 / p <1e-300 | 114.0 EB05 85.3 · IC025 +4.9 3/3 methods agree | Labeled (related wording) related wording | serious n=34 | NCT00333840: 1/363 (0.3%) on Imatinib (serious AE) |
| Central nervous system neoplasm | 16 | 131.0 78.2–219.6ROR 131.1 · χ² 1,743 / p <1e-300 | 103.7 EB05 67.7 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious n=16 | not reported in cached trials |
| Gastric antral vascular ectasia | 50 | 127.3 95.1–170.4ROR 127.7 · χ² 5,543 / p <1e-300 | 110.3 EB05 86.9 · IC025 +5.3 3/3 methods agree | Labeled adverse reaction exact term | serious n=50 · ♀ 68% (drug 46%) · 92% clinician | not reported in cached trials |
| Drug resistance mutation | 16 | 119.4 71.4–199.6ROR 119.5 · χ² 1,600 / p <1e-300 | 96.4 EB05 62.9 · IC025 +3.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=15 | not reported in cached trials |
| Lactobacillus infection | 15 | 118.7 69.8–201.8ROR 118.8 · χ² 1,485 / p <1e-300 | 95.2 EB05 61.2 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Osteonecrosis of external auditory canal | 17 | 118.6 72.1–195.3ROR 118.7 · χ² 1,696 / p <1e-300 | 96.5 EB05 63.8 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=17 | not reported in cached trials |
| Pituitary apoplexy | 15 | 117.1 68.9–199.1ROR 117.2 · χ² 1,467 / p <1e-300 | 94.2 EB05 60.6 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Philadelphia positive acute lymphocytic leukaemia | 14 | 113.1 65.4–195.6ROR 113.2 · χ² 1,319 / p 5e-289 | 90.8 EB05 57.5 · IC025 +3.6 3/3 methods agree | Labeled (related wording) related wording | serious n=14 | not reported in cached trials |
| Bone marrow necrosis | 19 | 104.7 65.5–167.3ROR 104.8 · χ² 1,698 / p <1e-300 | 88.0 EB05 59.5 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious n=19 | not reported in cached trials |
| Acute lymphocytic leukaemia recurrent | 203 | 102.0 88.5–117.7ROR 103.2 · χ² 18,600 / p <1e-300 | 93.2 EB05 82.9 · IC025 +6.0 3/3 methods agree | Labeled (related wording) related wording | serious n=202 · 91% clinician | not reported in cached trials |
| Polymerase chain reaction positive | 26 | 97.6 65.5–145.6ROR 97.8 · χ² 2,208 / p <1e-300 | 84.8 EB05 60.8 · IC025 +4.4 3/3 methods agree | Lab value / disease marker | serious n=25 | not reported in cached trials |
| Endocarditis noninfective | 11 | 96.1 52.0–177.6ROR 96.1 · χ² 871 / p 1e-191 | 77.4 EB05 46.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Adenovirus reactivation | 10 | 92.8 48.8–176.7ROR 92.9 · χ² 759 / p 2e-167 | 74.4 EB05 43.2 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Graft versus host disease in lung | 33 | 89.2 62.7–127.1ROR 89.4 · χ² 2,596 / p <1e-300 | 79.4 EB05 59.1 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=33 · ♀ 17% (drug 46%) | not reported in cached trials |
| Leukaemia recurrent | 116 | 88.1 73.0–106.3ROR 88.7 · χ² 9,212 / p <1e-300 | 81.0 EB05 69.3 · IC025 +5.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=115 · 93% clinician | not reported in cached trials |
| Chronic graft versus host disease in skin | 62 | 87.3 67.5–113.0ROR 87.7 · χ² 4,847 / p <1e-300 | 79.5 EB05 64.2 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=62 · 90% clinician | not reported in cached trials |
| Chronic graft versus host disease in lung | 11 | 83.1 45.1–153.2ROR 83.2 · χ² 759 / p 2e-167 | 68.8 EB05 41.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=11 | 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 Imatinib 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 (3 of 40 signal terms matched).
- NCT00333840 — Safety and Efficacy of Imatinib Versus Interferon-α Plus Cytarabine in Patients With Newly Diagnosed Philadelp (N=1106, PHASE3; 801 AE terms posted; arms: Imatinib (STI571); IFN-a + Ara-C; Imatinib to IFN-a + Ara-C; IFN-a + Ara-C to Imatinib)
- NCT04129931 — PrecISE (Precision Interventions for Severe and/or Exacerbation-Prone Asthma) Network Study (N=950, PHASE2; 87 AE terms posted; arms: Run-in Period; Cavosonstat; Cavosonstat-Matching Placebo; Broncho-Vaxom)
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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 1,644 | 1.5 1.4–1.6ROR 1.5 · χ² 286 / p 2e-64 | 1.5 EB05 1.4 · IC025 +0.5 | Reporting / coding artifact | serious PRR 2.5 | NCT00333840: 2/363 (0.6%) on Imatinib (serious AE) |
| Drug resistance | 1,047 | 50.8 47.8–53.9ROR 54.0 · χ² 49,018 / p <1e-300 | 48.7 EB05 46.3 · IC025 +5.5 3/3 methods agree | Reporting / coding artifact | serious PRR 33.4 · 94% clinician | not reported in cached trials |
| Death | 1,040 | 1.4 1.4–1.5ROR 1.5 · χ² 148 / p 3e-34 | 1.4 EB05 1.4 · IC025 +0.4 | Outcome field, not a reaction | serious PRR 0.9 | NCT00333840: 1/363 (0.3%) on Imatinib (serious AE) |
| Nausea | 1,017 | 1.5 1.5–1.6ROR 1.6 · χ² 201 / p 7e-46 | 1.5 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.5 | NCT00333840: 4/363 (1.1%) on Imatinib (serious AE) |
| Diarrhoea (diarrhea) | 1,016 | 1.9 1.8–2.0ROR 1.9 · χ² 438 / p 1e-97 | 1.9 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.8 | NCT00333840: 5/363 (1.4%) on Imatinib (serious AE) |
| Drug intolerance | 899 | 11.3 10.6–12.0ROR 11.8 · χ² 8,360 / p <1e-300 | 11.2 EB05 10.6 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 10.6 | NCT00333840: 1/533 (0.2%) on Imatinib (serious AE) |
| Malignant neoplasm progression | 822 | 9.7 9.1–10.4ROR 10.2 · χ² 6,402 / p <1e-300 | 9.6 EB05 9.1 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 6.3 | not reported in cached trials |
| Fatigue (tiredness) | 818 | 1.3 1.2–1.3ROR 1.3 · χ² 45 / p 9e-12 | 1.3 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 1.3 | NCT00333840: 3/363 (0.8%) on Imatinib (serious AE) |
| Off label use (used outside approved label) | 758 | 1.0 1.0–1.1ROR 1.0 · χ² 1 / p 0.114 | 1.0 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.2 | not reported in cached trials |
| Vomiting | 692 | 1.8 1.6–1.9ROR 1.8 · χ² 234 / p 4e-53 | 1.8 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.5 | NCT00333840: 1/551 (0.2%) on Imatinib (serious AE) |
| Dyspnoea (shortness of breath) | 659 | 1.4 1.3–1.5ROR 1.4 · χ² 75 / p 2e-18 | 1.4 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.2 | NCT00333840: 6/363 (1.7%) on Imatinib (serious AE) |
| Disease progression | 648 | 6.6 6.1–7.1ROR 6.8 · χ² 3,075 / p <1e-300 | 6.5 EB05 6.1 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 4.8 · 97% clinician | not reported in cached trials |
| Pleural effusion | 560 | 11.1 10.2–12.0ROR 11.4 · χ² 5,097 / p <1e-300 | 11.0 EB05 10.2 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.1 | NCT00333840: 2/363 (0.6%) on Imatinib (serious AE) |
| Pyrexia (fever) | 540 | 1.9 1.7–2.0ROR 1.9 · χ² 220 / p 5e-50 | 1.9 EB05 1.7 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.5 · 91% clinician | NCT00333840: 12/363 (3.3%) on Imatinib (serious AE) |
| Asthenia (weakness) | 520 | 1.7 1.5–1.8ROR 1.7 · χ² 136 / p 9e-32 | 1.7 EB05 1.5 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.4 | NCT00333840: 3/363 (0.8%) on Imatinib (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.
- Chordoma — n=31, PRR 522.2
- Amaurosis fugax — n=231, PRR 330.2
- Desmoid tumour — n=24, PRR 156.4
- Graft versus host disease in lung — n=33, PRR 89.2
- Chronic graft versus host disease in skin — n=62, PRR 87.3
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 Imatinib?
In FDA FAERS, the most frequently co-reported reaction terms for Imatinib are nausea, diarrhoea, fatigue, vomiting, dyspnoea, 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 Imatinib have an FDA boxed warning?
No. The FDA label retrieved for Imatinib has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Imatinib 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 a1787fad-3612-43e1-98fa-ce62361e0b3c, effective 20260715; matched on
openfda.generic_name.exact:"IMATINIB") - 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, 1,089 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
IMATINIB, results-bearing studies sorted by enrollment)
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.