Drug · FAERS side-effect profile with label screen
Ceritinib side effects: what 2,378 FDA adverse event reports show
Brand names
Zykadia
openFDA label
Who reports
2,378 reports · 81% serious · 552 with death outcome · 55% female
openFDA FAERS counts, all years, deduplication not applied
Used for
ZYKADIA ® is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test . ZYKADIA.
FDA label, Indications and Usage
What it is
Ceritinib is a kinase inhibitor for oral administration.
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) 7Reporting / coding artifact 4Lab value / disease marker 4Not 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.
- 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. 28 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 |
|---|---|---|---|---|---|---|
| Metastases to central nervous system | 172 | 120.0 103.8–138.7ROR 129.3 · χ² 19,918 / p <1e-300 | 116.9 EB05 102.9 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious PRR 84.6 | no trial data cached |
| Neoplasm | 55 | 42.3 32.5–54.9ROR 43.3 · χ² 2,167 / p <1e-300 | 41.5 EB05 33.1 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 32.5 | no trial data cached |
| Malignant neoplasm progression | 427 | 37.1 34.1–40.5ROR 45.0 · χ² 14,979 / p <1e-300 | 36.9 EB05 34.1 · IC025 +5.0 3/3 methods agree | Reporting / coding artifact | serious PRR 26.5 | no trial data cached |
| Metastases to liver | 51 | 25.7 19.6–33.8ROR 26.3 · χ² 1,184 / p 7e-260 | 25.4 EB05 20.1 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 18.3 | no trial data cached |
| Metastases to bone | 45 | 24.3 18.2–32.5ROR 24.8 · χ² 981 / p 1e-215 | 24.0 EB05 18.7 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 17.4 | no trial data cached |
| Metastases to lung | 28 | 21.4 14.8–31.0ROR 21.7 · χ² 524 / p 2e-116 | 21.1 EB05 15.3 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.3 | no trial data cached |
| Brain neoplasm | 22 | 21.2 13.9–32.1ROR 21.3 · χ² 402 / p 1e-89 | 20.7 EB05 14.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 14.5 · ♀ 80% (drug 55%) | no trial data cached |
| Neoplasm progression | 66 | 16.6 13.1–21.1ROR 17.1 · χ² 952 / p 2e-209 | 16.5 EB05 13.4 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 13.3 | no trial data cached |
| Central nervous system lesion | 26 | 16.6 11.3–24.3ROR 16.8 · χ² 365 / p 9e-82 | 16.3 EB05 11.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 17.2 | no trial data cached |
| Pericarditis | 29 | 15.4 10.7–22.1ROR 15.5 · χ² 375 / p 8e-84 | 15.0 EB05 10.8 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.9 | no trial data cached |
| Transaminases increased | 37 | 14.7 10.7–20.3ROR 14.9 · χ² 459 / p 4e-102 | 14.4 EB05 10.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 10.8 | no trial data cached |
| Hepatic function abnormal | 61 | 14.5 11.3–18.6ROR 14.9 · χ² 755 / p 1e-166 | 14.4 EB05 11.5 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 10.5 | no trial data cached |
| Blood alkaline phosphatase increased | 40 | 14.2 10.4–19.3ROR 14.4 · χ² 477 / p 4e-106 | 13.9 EB05 10.5 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious PRR 10.7 | no trial data cached |
| Lung neoplasm malignant | 66 | 14.1 11.1–17.9ROR 14.5 · χ² 791 / p 2e-174 | 14.0 EB05 11.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 | no trial data cached |
| Drug resistance | 41 | 14.1 10.4–19.1ROR 14.3 · χ² 486 / p 6e-108 | 13.8 EB05 10.5 · IC025 +3.1 3/3 methods agree | Reporting / coding artifact | serious PRR 9.3 | no trial data cached |
| Pericardial effusion | 36 | 13.8 10.0–19.1ROR 14.0 · χ² 415 / p 2e-92 | 13.5 EB05 10.0 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.9 | no trial data cached |
| Pneumonitis | 37 | 12.1 8.8–16.6ROR 12.3 · χ² 365 / p 1e-81 | 11.7 EB05 8.6 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.9 | no trial data cached |
| Hepatotoxicity (liver damage) | 30 | 11.9 8.4–17.1ROR 12.1 · χ² 290 / p 2e-65 | 11.4 EB05 8.1 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.0 | no trial data cached |
| Brain oedema | 15 | 10.5 6.3–17.4ROR 10.5 · χ² 119 / p 4e-28 | 9.1 EB05 5.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Aspartate aminotransferase increased | 61 | 10.1 7.9–13.0ROR 10.4 · χ² 494 / p 9e-110 | 9.8 EB05 7.8 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.7 | no trial data cached |
| Therapy partial responder | 16 | 9.4 5.8–15.3ROR 9.4 · χ² 111 / p 2e-26 | 8.1 EB05 5.0 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 8.0 | no trial data cached |
| Alanine aminotransferase increased | 64 | 9.2 7.2–11.7ROR 9.4 · χ² 460 / p 2e-102 | 8.9 EB05 7.1 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.7 | no trial data cached |
| Gamma-glutamyltransferase increased | 22 | 8.8 5.8–13.3ROR 8.8 · χ² 143 / p 2e-33 | 7.8 EB05 5.3 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious PRR 6.2 | no trial data cached |
| Disease progression | 112 | 8.4 7.0–10.0ROR 8.7 · χ² 724 / p 8e-160 | 8.2 EB05 7.0 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 6.3 · ♀ 77% (drug 55%) | no trial data cached |
| Liver disorder | 40 | 8.0 5.9–10.8ROR 8.1 · χ² 237 / p 8e-54 | 7.5 EB05 5.7 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.3 | no trial data cached |
| Pleural effusion | 54 | 7.8 6.0–10.2ROR 8.0 · χ² 315 / p 8e-71 | 7.4 EB05 5.9 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 | no trial data cached |
| C-reactive protein increased | 30 | 7.3 5.1–10.4ROR 7.4 · χ² 156 / p 3e-36 | 6.7 EB05 4.8 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 5.2 | no trial data cached |
| Cerebral infarction | 20 | 7.2 4.7–11.2ROR 7.3 · χ² 101 / p 5e-24 | 6.3 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Generalised oedema | 10 | 7.2 3.9–13.3ROR 7.2 · χ² 47 / p 3e-12 | 5.6 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Blood creatinine increased | 53 | 7.1 5.5–9.3ROR 7.3 · χ² 275 / p 5e-62 | 6.8 EB05 5.4 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.3 | no trial data cached |
| Pulmonary mass | 12 | 7.1 4.0–12.5ROR 7.2 · χ² 57 / p 2e-14 | 5.8 EB05 3.5 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Liver function test increased | 15 | 6.2 3.7–10.3ROR 6.2 · χ² 60 / p 4e-15 | 5.3 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Diarrhoea (diarrhea) | 426 | 5.8 5.4–6.4ROR 6.9 · χ² 1,758 / p <1e-300 | 5.8 EB05 5.4 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.9 | no trial data cached |
| Hepatitis (liver inflammation) | 16 | 5.5 3.4–9.0ROR 5.5 · χ² 55 / p 7e-14 | 4.8 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Hepatic enzyme increased | 42 | 5.5 4.0–7.4ROR 5.5 · χ² 149 / p 2e-34 | 5.2 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.3 | no trial data cached |
| White blood cell count increased | 23 | 5.3 3.5–7.9ROR 5.3 · χ² 75 / p 2e-18 | 4.8 EB05 3.4 · IC025 +1.6 3/3 methods agree | Lab value / disease marker | serious PRR 4.5 | no trial data cached |
| Hepatic failure | 17 | 5.0 3.1–8.0ROR 5.0 · χ² 50 / p 8e-13 | 4.4 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Haemoptysis | 15 | 4.7 2.9–7.8ROR 4.8 · χ² 41 / p 1e-10 | 4.2 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Eating disorder | 11 | 4.5 2.5–8.2ROR 4.6 · χ² 27 / p 1e-7 | 3.9 EB05 2.3 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Interstitial lung disease | 24 | 4.4 2.9–6.5ROR 4.4 · χ² 59 / p 6e-15 | 4.1 EB05 2.9 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.1 · ♀ 32% (drug 55%) | 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 |
|---|---|---|---|---|---|---|
| Malignant neoplasm progression | 427 | 37.1 34.1–40.5ROR 45.0 · χ² 14,979 / p <1e-300 | 36.9 EB05 34.1 · IC025 +5.0 3/3 methods agree | Reporting / coding artifact | serious PRR 26.5 | no trial data cached |
| Diarrhoea (diarrhea) | 426 | 5.8 5.4–6.4ROR 6.9 · χ² 1,758 / p <1e-300 | 5.8 EB05 5.4 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.9 | no trial data cached |
| Death | 281 | 2.9 2.6–3.2ROR 3.1 · χ² 357 / p 6e-80 | 2.9 EB05 2.6 · IC025 +1.3 3/3 methods agree | Outcome field, not a reaction | serious PRR 2.0 | no trial data cached |
| Metastases to central nervous system | 172 | 120.0 103.8–138.7ROR 129.3 · χ² 19,918 / p <1e-300 | 116.9 EB05 102.9 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious PRR 84.6 | no trial data cached |
| Disease progression | 112 | 8.4 7.0–10.0ROR 8.7 · χ² 724 / p 8e-160 | 8.2 EB05 7.0 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 6.3 · ♀ 77% (drug 55%) | no trial data cached |
| Lung neoplasm malignant | 66 | 14.1 11.1–17.9ROR 14.5 · χ² 791 / p 2e-174 | 14.0 EB05 11.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 | no trial data cached |
| Neoplasm progression | 66 | 16.6 13.1–21.1ROR 17.1 · χ² 952 / p 2e-209 | 16.5 EB05 13.4 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 13.3 | no trial data cached |
| Alanine aminotransferase increased | 64 | 9.2 7.2–11.7ROR 9.4 · χ² 460 / p 2e-102 | 8.9 EB05 7.1 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.7 | no trial data cached |
| Aspartate aminotransferase increased | 61 | 10.1 7.9–13.0ROR 10.4 · χ² 494 / p 9e-110 | 9.8 EB05 7.8 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.7 | no trial data cached |
| Hepatic function abnormal | 61 | 14.5 11.3–18.6ROR 14.9 · χ² 755 / p 1e-166 | 14.4 EB05 11.5 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 10.5 | no trial data cached |
| Neoplasm | 55 | 42.3 32.5–54.9ROR 43.3 · χ² 2,167 / p <1e-300 | 41.5 EB05 33.1 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 32.5 | no trial data cached |
| Pleural effusion | 54 | 7.8 6.0–10.2ROR 8.0 · χ² 315 / p 8e-71 | 7.4 EB05 5.9 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 | no trial data cached |
| Blood creatinine increased | 53 | 7.1 5.5–9.3ROR 7.3 · χ² 275 / p 5e-62 | 6.8 EB05 5.4 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.3 | no trial data cached |
| Metastases to liver | 51 | 25.7 19.6–33.8ROR 26.3 · χ² 1,184 / p 7e-260 | 25.4 EB05 20.1 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 18.3 | no trial data cached |
| Metastases to bone | 45 | 24.3 18.2–32.5ROR 24.8 · χ² 981 / p 1e-215 | 24.0 EB05 18.7 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 17.4 | 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.
- Metastases to central nervous system — n=172, PRR 120.0
- Neoplasm — n=55, PRR 42.3
- Metastases to bone — n=45, PRR 24.3
- Brain neoplasm — n=22, PRR 21.2
- Neoplasm progression — n=66, PRR 16.6
- Central nervous system lesion — n=26, PRR 16.6
- Transaminases increased — n=37, PRR 14.7
- Hepatic function abnormal — n=61, PRR 14.5
- Lung neoplasm malignant — n=66, PRR 14.1
- Cerebral infarction — n=20, PRR 7.2
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 Ceritinib?
In FDA FAERS, the most frequently co-reported reaction terms for Ceritinib are diarrhoea, metastases to central nervous system, lung neoplasm malignant, neoplasm progression, alanine aminotransferase increased, aspartate aminotransferase increased. 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 Ceritinib have an FDA boxed warning?
No. The FDA label retrieved for Ceritinib has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Ceritinib 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 fff5d805-4ffd-4e8e-8e63-6f129697563e, effective 20251215; matched on
openfda.generic_name.exact:"CERITINIB") - 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, 68 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.