Drug · FAERS side-effect profile with label screen
Crizotinib side effects: what 12,638 FDA adverse event reports show
Brand names
Xalkori
openFDA label
Who reports
12,638 reports · 73% serious · 3,792 with death outcome · 55% female
openFDA FAERS counts, all years, deduplication not applied
Used for
XALKORI is a kinase inhibitor indicated for the treatment of • adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK) or ROS1-positive as detected by an FDA-approved test. ( 1.1 , 2.1 ) • pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive.
FDA label, Indications and Usage
What it is
Crizotinib is 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 7Labeled (related wording) 3Likely indication confounding 4Reporting / coding artifact 2Lab value / disease marker 3Not in label — unassessed 21
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. 961 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 |
|---|---|---|---|---|---|---|
| Renal cyst infection | 11 | 122.4 66.4–225.9ROR 122.6 · χ² 1,122 / p 2e-246 | 95.6 EB05 57.0 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious n=11 | no trial data cached |
| Non-small cell lung cancer stage iv | 24 | 118.3 78.2–178.9ROR 118.5 · χ² 2,495 / p <1e-300 | 101.7 EB05 71.9 · IC025 +4.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=21 | no trial data cached |
| Lung adenocarcinoma stage iv | 24 | 111.9 74.0–169.1ROR 112.1 · χ² 2,366 / p <1e-300 | 96.9 EB05 68.5 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=23 | no trial data cached |
| Non-small cell lung cancer | 282 | 105.2 93.4–118.5ROR 107.6 · χ² 27,258 / p <1e-300 | 98.3 EB05 89.0 · IC025 +6.2 3/3 methods agree | Likely indication confounding term in indications | serious n=231 | no trial data cached |
| Non-small cell lung cancer metastatic | 51 | 104.6 78.8–138.7ROR 105.0 · χ² 4,821 / p <1e-300 | 94.9 EB05 75.0 · IC025 +5.2 3/3 methods agree | Likely indication confounding term in indications | serious n=40 | no trial data cached |
| Renal abscess | 46 | 100.2 74.5–134.9ROR 100.6 · χ² 4,165 / p <1e-300 | 91.0 EB05 71.0 · IC025 +5.1 3/3 methods agree | Labeled adverse reaction exact term | serious n=46 · ♀ 78% (drug 55%) · 93% clinician | no trial data cached |
| Drug resistance mutation | 10 | 99.8 52.7–188.9ROR 99.9 · χ² 831 / p 5e-183 | 80.2 EB05 46.6 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Lung adenocarcinoma metastatic | 11 | 81.1 44.3–148.5ROR 81.1 · χ² 754 / p 2e-166 | 68.5 EB05 40.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Neoplasm progression | 1,112 | 54.3 51.3–57.5ROR 59.4 · χ² 56,316 / p <1e-300 | 52.5 EB05 50.0 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 35.5 | no trial data cached |
| Acquired gene mutation | 40 | 51.8 37.8–71.0ROR 52.0 · χ² 1,884 / p <1e-300 | 49.2 EB05 37.7 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=40 · 100% clinician | no trial data cached |
| Lung adenocarcinoma | 84 | 47.4 38.2–58.9ROR 47.8 · χ² 3,667 / p <1e-300 | 45.7 EB05 38.1 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=76 | no trial data cached |
| Photopsia | 135 | 36.3 30.6–43.0ROR 36.6 · χ² 4,496 / p <1e-300 | 35.3 EB05 30.6 · IC025 +4.7 3/3 methods agree | Labeled adverse reaction exact term | serious n=71 · ♀ 75% (drug 55%) | no trial data cached |
| Pleural thickening | 14 | 34.8 20.5–59.0ROR 34.8 · χ² 417 / p 5e-93 | 32.7 EB05 20.7 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Vasogenic cerebral oedema | 14 | 33.5 19.7–56.8ROR 33.5 · χ² 401 / p 2e-89 | 31.6 EB05 20.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Cerebral aspergillosis | 12 | 33.1 18.7–58.5ROR 33.1 · χ² 335 / p 4e-75 | 31.0 EB05 18.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Hydrothorax | 16 | 32.4 19.8–53.1ROR 32.4 · χ² 447 / p 1e-99 | 30.7 EB05 20.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Carcinoembryonic antigen increased | 29 | 25.3 17.5–36.5ROR 25.3 · χ² 642 / p 5e-142 | 24.6 EB05 17.9 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious n=29 | no trial data cached |
| Metapneumovirus infection | 11 | 24.4 13.5–44.2ROR 24.4 · χ² 221 / p 3e-50 | 23.0 EB05 13.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Bronchial carcinoma | 11 | 23.3 12.9–42.3ROR 23.3 · χ² 210 / p 6e-48 | 22.0 EB05 12.7 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Myocardial necrosis marker increased | 21 | 21.7 14.1–33.4ROR 21.8 · χ² 390 / p 5e-87 | 21.1 EB05 14.4 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious n=21 | no trial data cached |
| Lymphangitis | 10 | 21.0 11.2–39.1ROR 21.0 · χ² 169 / p 7e-39 | 19.5 EB05 10.5 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Lung cancer metastatic | 35 | 20.4 14.6–28.5ROR 20.5 · χ² 620 / p 4e-137 | 20.0 EB05 15.0 · IC025 +3.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=23 | no trial data cached |
| Lymphangiosis carcinomatosa | 12 | 19.3 10.9–34.1ROR 19.3 · χ² 188 / p 4e-43 | 18.2 EB05 10.4 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Metastases to central nervous system | 138 | 18.1 15.3–21.3ROR 18.2 · χ² 2,184 / p <1e-300 | 17.8 EB05 15.5 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.4 | no trial data cached |
| Disease progression | 1,216 | 17.3 16.4–18.2ROR 19.0 · χ² 18,543 / p <1e-300 | 17.1 EB05 16.3 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 9.5 | no trial data cached |
| Lung neoplasm malignant | 420 | 17.0 15.5–18.7ROR 17.6 · χ² 6,270 / p <1e-300 | 16.9 EB05 15.5 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Oesophagitis | 101 | 15.5 12.7–18.8ROR 15.6 · χ² 1,339 / p 2e-293 | 15.3 EB05 12.9 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.3 | no trial data cached |
| Oesophageal ulcer | 33 | 14.3 10.1–20.1ROR 14.3 · χ² 391 / p 3e-87 | 13.9 EB05 10.1 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious n=32 | no trial data cached |
| Second primary malignancy | 70 | 14.1 11.1–17.8ROR 14.2 · χ² 831 / p 6e-183 | 13.8 EB05 11.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 11.0 | no trial data cached |
| Multiple-drug resistance | 25 | 13.5 9.1–20.0ROR 13.5 · χ² 275 / p 5e-62 | 12.9 EB05 8.8 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious n=25 · 100% clinician | no trial data cached |
| Metastases to meninges | 18 | 13.4 8.4–21.3ROR 13.4 · χ² 193 / p 3e-44 | 12.5 EB05 7.8 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Vitreous floaters | 76 | 13.0 10.4–16.3ROR 13.1 · χ² 827 / p 4e-182 | 12.8 EB05 10.5 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious n=18 | no trial data cached |
| Malignant pleural effusion | 13 | 12.9 7.5–22.3ROR 12.9 · χ² 130 / p 2e-30 | 11.4 EB05 6.4 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Hypoproteinaemia | 14 | 12.6 7.5–21.4ROR 12.6 · χ² 138 / p 5e-32 | 11.2 EB05 6.5 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Gene mutation | 14 | 11.8 7.0–19.9ROR 11.8 · χ² 126 / p 1e-29 | 10.3 EB05 5.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Oesophageal pain | 27 | 11.4 7.8–16.7ROR 11.4 · χ² 245 / p 2e-55 | 10.7 EB05 7.4 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious n=22 · ♀ 88% (drug 55%) | no trial data cached |
| Renal cyst | 54 | 11.3 8.7–14.8ROR 11.4 · χ² 495 / p 6e-110 | 11.0 EB05 8.6 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.1 | no trial data cached |
| Sinus bradycardia | 61 | 10.5 8.2–13.5ROR 10.6 · χ² 512 / p 9e-114 | 10.2 EB05 8.1 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.5 | no trial data cached |
| Hypoalbuminaemia | 48 | 10.5 7.9–13.9ROR 10.5 · χ² 399 / p 4e-89 | 10.0 EB05 7.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | no trial data cached |
| Blood albumin decreased | 49 | 10.3 7.8–13.7ROR 10.4 · χ² 402 / p 1e-89 | 9.9 EB05 7.7 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious PRR 7.8 | 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 |
|---|---|---|---|---|---|---|
| Death | 2,324 | 4.5 4.3–4.7ROR 5.3 · χ² 6,546 / p <1e-300 | 4.5 EB05 4.3 · IC025 +2.1 3/3 methods agree | Outcome field, not a reaction | serious PRR 3.5 | no trial data cached |
| Disease progression | 1,216 | 17.3 16.4–18.2ROR 19.0 · χ² 18,543 / p <1e-300 | 17.1 EB05 16.3 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 9.5 | no trial data cached |
| Nausea | 1,118 | 2.4 2.2–2.5ROR 2.5 · χ² 901 / p 3e-198 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.0 | no trial data cached |
| Neoplasm progression | 1,112 | 54.3 51.3–57.5ROR 59.4 · χ² 56,316 / p <1e-300 | 52.5 EB05 50.0 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 35.5 | no trial data cached |
| Diarrhoea (diarrhea) | 846 | 2.2 2.0–2.3ROR 2.3 · χ² 558 / p 1e-123 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.7 | no trial data cached |
| Vomiting | 795 | 2.8 2.6–3.0ROR 2.9 · χ² 949 / p 9e-209 | 2.8 EB05 2.6 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.2 | no trial data cached |
| Fatigue (tiredness) | 554 | 1.2 1.1–1.3ROR 1.2 · χ² 16 / p 3e-5 | 1.2 EB05 1.1 · IC025 +0.1 | Labeled adverse reaction exact term | serious PRR 1.0 | no trial data cached |
| Off label use (used outside approved label) | 475 | 0.9 0.8–1.0ROR 0.9 · χ² 5 / p 0.017 | 0.9 EB05 0.8 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.0 | no trial data cached |
| Oedema peripheral (swelling of legs/feet) | 445 | 6.1 5.5–6.6ROR 6.2 · χ² 1,877 / p <1e-300 | 6.0 EB05 5.5 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.5 | no trial data cached |
| Constipation | 439 | 3.4 3.1–3.7ROR 3.5 · χ² 736 / p 3e-162 | 3.4 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 | no trial data cached |
| Dyspnoea (shortness of breath) | 430 | 1.3 1.1–1.4ROR 1.3 · χ² 24 / p 6e-7 | 1.3 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 1.1 | no trial data cached |
| Lung neoplasm malignant | 420 | 17.0 15.5–18.7ROR 17.6 · χ² 6,270 / p <1e-300 | 16.9 EB05 15.5 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Visual impairment | 403 | 5.4 4.9–6.0ROR 5.6 · χ² 1,464 / p <1e-300 | 5.4 EB05 5.0 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 | no trial data cached |
| Decreased appetite (loss of appetite) | 380 | 2.7 2.5–3.0ROR 2.8 · χ² 417 / p 5e-93 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.3 | no trial data cached |
| Asthenia (weakness) | 340 | 1.5 1.4–1.7ROR 1.5 · χ² 57 / p 2e-14 | 1.5 EB05 1.4 · IC025 +0.4 | Not in label — unassessed | serious PRR 1.4 | 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.
- Lung adenocarcinoma stage iv — n=24, PRR 111.9
- Neoplasm progression — n=1,112, PRR 54.3
- Acquired gene mutation — n=40, PRR 51.8
- Lung adenocarcinoma — n=84, PRR 47.4
- Lung neoplasm malignant — n=420, PRR 17.0
- Second primary malignancy — n=70, PRR 14.1
- Hypoalbuminaemia — n=48, PRR 10.5
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 Crizotinib?
In FDA FAERS, the most frequently co-reported reaction terms for Crizotinib are nausea, neoplasm progression, diarrhoea, vomiting, fatigue, oedema peripheral. 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 Crizotinib have an FDA boxed warning?
No. The FDA label retrieved for Crizotinib has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Crizotinib 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 2a51b0de-47d6-455e-a94c-d2c737b04ff7, effective 20250722; matched on
openfda.generic_name.exact:"CRIZOTINIB") - 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, 1,001 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.