Drug · FAERS side-effect profile with label screen
Brigatinib side effects: what 3,628 FDA adverse event reports show
Brand names
Alunbrig
openFDA label
Who reports
3,628 reports · 89% serious · 786 with death outcome · 55% female
openFDA FAERS counts, all years, deduplication not applied
Used for
ALUNBRIG is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test . ALUNBRIG is a kinase inh.
FDA label, Indications and Usage
What it is
Brigatinib 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 4Labeled (related wording) 8Likely indication confounding 1Reporting / coding artifact 5Lab value / disease marker 2Not in label — unassessed 20
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. 48 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 | 242 | 111.2 98.4–125.8ROR 119.1 · χ² 25,838 / p <1e-300 | 108.2 EB05 97.2 · IC025 +6.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 71.2 | no trial data cached |
| Blood creatine phosphokinase increased | 222 | 44.2 38.9–50.2ROR 47.0 · χ² 9,265 / p <1e-300 | 43.7 EB05 39.1 · IC025 +5.1 3/3 methods agree | Lab value / disease marker | serious PRR 29.7 | no trial data cached |
| Lung neoplasm malignant | 225 | 31.6 27.9–35.9ROR 33.7 · χ² 6,619 / p <1e-300 | 31.4 EB05 28.1 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 20.5 | no trial data cached |
| Neoplasm progression | 180 | 29.8 25.8–34.3ROR 31.3 · χ² 4,958 / p <1e-300 | 29.5 EB05 26.1 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 25.4 | no trial data cached |
| Metastases to liver | 61 | 20.2 15.7–25.9ROR 20.5 · χ² 1,089 / p 4e-239 | 20.0 EB05 16.1 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 13.1 | no trial data cached |
| Brain neoplasm | 30 | 18.9 13.2–27.0ROR 19.1 · χ² 490 / p 8e-109 | 18.6 EB05 13.6 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 12.4 | no trial data cached |
| Pneumonitis | 74 | 15.9 12.6–19.9ROR 16.2 · χ² 1,013 / p 1e-222 | 15.7 EB05 12.9 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.2 | no trial data cached |
| Photosensitivity reaction (sun sensitivity) | 43 | 15.1 11.2–20.4ROR 15.3 · χ² 552 / p 2e-122 | 14.9 EB05 11.4 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 12.9 | no trial data cached |
| Hypercholesterolaemia | 17 | 10.3 6.4–16.5ROR 10.3 · χ² 133 / p 4e-31 | 9.0 EB05 5.6 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.6 | no trial data cached |
| Metastases to bone | 29 | 10.3 7.1–14.7ROR 10.3 · χ² 233 / p 7e-53 | 9.6 EB05 6.8 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 · ♀ 33% (drug 55%) | no trial data cached |
| Central nervous system lesion | 22 | 9.2 6.1–14.0ROR 9.3 · χ² 153 / p 2e-35 | 8.2 EB05 5.5 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 | no trial data cached |
| Pericardial effusion | 34 | 8.5 6.1–11.9ROR 8.6 · χ² 219 / p 8e-50 | 7.9 EB05 5.8 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Metastases to lung | 17 | 8.5 5.3–13.7ROR 8.6 · χ² 105 / p 5e-25 | 7.3 EB05 4.7 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.5 | no trial data cached |
| Drug resistance | 36 | 8.1 5.9–11.2ROR 8.2 · χ² 217 / p 2e-49 | 7.5 EB05 5.6 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 4.9 | no trial data cached |
| Brain oedema | 16 | 7.3 4.5–12.0ROR 7.4 · χ² 81 / p 1e-19 | 6.2 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Pleural effusion | 77 | 7.3 5.9–9.1ROR 7.4 · χ² 414 / p 3e-92 | 7.0 EB05 5.8 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Hepatotoxicity (liver damage) | 28 | 7.3 5.0–10.6ROR 7.4 · χ² 146 / p 6e-34 | 6.6 EB05 4.8 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 · ♀ 88% (drug 55%) | no trial data cached |
| Hepatic cytolysis | 15 | 7.1 4.3–11.8ROR 7.1 · χ² 73 / p 8e-18 | 6.0 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Liver function test increased | 25 | 6.8 4.6–10.0ROR 6.8 · χ² 117 / p 1e-27 | 6.1 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Neoplasm | 13 | 6.5 3.8–11.2ROR 6.5 · χ² 55 / p 5e-14 | 5.4 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Haemoptysis | 29 | 6.0 4.2–8.6ROR 6.0 · χ² 116 / p 3e-27 | 5.5 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Transaminases increased | 23 | 6.0 4.0–9.0ROR 6.0 · χ² 91 / p 9e-22 | 5.4 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 · ♀ 83% (drug 55%) · 91% clinician | no trial data cached |
| Hepatic function abnormal | 38 | 5.9 4.3–8.1ROR 6.0 · χ² 151 / p 6e-35 | 5.6 EB05 4.2 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.1 · 95% clinician | no trial data cached |
| Disease progression | 120 | 5.9 4.9–7.0ROR 6.1 · χ² 484 / p 2e-107 | 5.8 EB05 4.9 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 4.1 | no trial data cached |
| Aspartate aminotransferase increased | 51 | 5.6 4.2–7.3ROR 5.6 · χ² 186 / p 1e-42 | 5.3 EB05 4.2 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.8 | no trial data cached |
| Taste disorder | 19 | 5.5 3.5–8.6ROR 5.5 · χ² 65 / p 3e-16 | 4.9 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
| Interstitial lung disease | 43 | 5.1 3.8–6.9ROR 5.2 · χ² 140 / p 2e-32 | 4.9 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 | no trial data cached |
| Therapy partial responder | 13 | 5.0 2.9–8.6ROR 5.0 · χ² 38 / p 4e-10 | 4.3 EB05 2.7 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 3.9 | no trial data cached |
| Malignant neoplasm progression | 84 | 4.8 3.9–5.9ROR 4.9 · χ² 247 / p 5e-56 | 4.6 EB05 3.9 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 3.1 | no trial data cached |
| Lung disorder | 40 | 4.7 3.5–6.4ROR 4.8 · χ² 114 / p 7e-27 | 4.5 EB05 3.4 · IC025 +1.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 3.0 | no trial data cached |
| Blood lactate dehydrogenase increased | 12 | 4.3 2.5–7.7ROR 4.4 · χ² 28 / p 7e-8 | 3.8 EB05 2.3 · IC025 +1.0 3/3 methods agree | Lab value / disease marker | serious PRR 3.0 | no trial data cached |
| Pancytopenia (all blood cells low) | 41 | 4.3 3.1–5.8ROR 4.3 · χ² 99 / p 1e-23 | 4.1 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 2.8 · ♀ 12% (drug 55%) | no trial data cached |
| Aphonia | 10 | 4.1 2.2–7.7ROR 4.2 · χ² 21 / p 3e-6 | 3.6 EB05 2.1 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Product dose omission issue | 204 | 4.1 3.6–4.7ROR 4.3 · χ² 489 / p 1e-108 | 4.1 EB05 3.7 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 8.5 | no trial data cached |
| Alanine aminotransferase increased | 44 | 4.1 3.1–5.6ROR 4.2 · χ² 102 / p 3e-24 | 4.0 EB05 3.1 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.8 | no trial data cached |
| Hepatic enzyme increased | 48 | 4.1 3.1–5.4ROR 4.1 · χ² 109 / p 8e-26 | 3.9 EB05 3.1 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.0 | no trial data cached |
| Renal impairment | 57 | 3.9 3.0–5.1ROR 4.0 · χ² 122 / p 1e-28 | 3.8 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 | no trial data cached |
| Blood pressure increased | 104 | 3.9 3.2–4.7ROR 4.0 · χ² 225 / p 4e-51 | 3.9 EB05 3.3 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.1 | no trial data cached |
| Ascites | 19 | 3.7 2.4–5.8ROR 3.7 · χ² 35 / p 1e-9 | 3.5 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.4 | no trial data cached |
| Cerebral haemorrhage | 22 | 3.6 2.3–5.4ROR 3.6 · χ² 38 / p 4e-10 | 3.3 EB05 2.3 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.3 | 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 |
|---|---|---|---|---|---|---|
| Death | 431 | 2.9 2.6–3.2ROR 3.1 · χ² 554 / p 8e-123 | 2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree | Outcome field, not a reaction | serious PRR 1.9 | no trial data cached |
| Metastases to central nervous system | 242 | 111.2 98.4–125.8ROR 119.1 · χ² 25,838 / p <1e-300 | 108.2 EB05 97.2 · IC025 +6.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 71.2 | no trial data cached |
| Lung neoplasm malignant | 225 | 31.6 27.9–35.9ROR 33.7 · χ² 6,619 / p <1e-300 | 31.4 EB05 28.1 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 20.5 | no trial data cached |
| Blood creatine phosphokinase increased | 222 | 44.2 38.9–50.2ROR 47.0 · χ² 9,265 / p <1e-300 | 43.7 EB05 39.1 · IC025 +5.1 3/3 methods agree | Lab value / disease marker | serious PRR 29.7 | no trial data cached |
| Product dose omission issue | 204 | 4.1 3.6–4.7ROR 4.3 · χ² 489 / p 1e-108 | 4.1 EB05 3.7 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 8.5 | no trial data cached |
| Neoplasm progression | 180 | 29.8 25.8–34.3ROR 31.3 · χ² 4,958 / p <1e-300 | 29.5 EB05 26.1 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 25.4 | no trial data cached |
| Disease progression | 120 | 5.9 4.9–7.0ROR 6.1 · χ² 484 / p 2e-107 | 5.8 EB05 4.9 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 4.1 | no trial data cached |
| Blood pressure increased | 104 | 3.9 3.2–4.7ROR 4.0 · χ² 225 / p 4e-51 | 3.9 EB05 3.3 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.1 | no trial data cached |
| Malignant neoplasm progression | 84 | 4.8 3.9–5.9ROR 4.9 · χ² 247 / p 5e-56 | 4.6 EB05 3.9 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 3.1 | no trial data cached |
| Pleural effusion | 77 | 7.3 5.9–9.1ROR 7.4 · χ² 414 / p 3e-92 | 7.0 EB05 5.8 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Pneumonitis | 74 | 15.9 12.6–19.9ROR 16.2 · χ² 1,013 / p 1e-222 | 15.7 EB05 12.9 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.2 | no trial data cached |
| Metastases to liver | 61 | 20.2 15.7–25.9ROR 20.5 · χ² 1,089 / p 4e-239 | 20.0 EB05 16.1 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 13.1 | no trial data cached |
| Seizure | 60 | 3.0 2.4–3.9ROR 3.1 · χ² 80 / p 2e-19 | 3.0 EB05 2.4 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.1 | no trial data cached |
| Renal impairment | 57 | 3.9 3.0–5.1ROR 4.0 · χ² 122 / p 1e-28 | 3.8 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 | no trial data cached |
| Aspartate aminotransferase increased | 51 | 5.6 4.2–7.3ROR 5.6 · χ² 186 / p 1e-42 | 5.3 EB05 4.2 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.8 | 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 neoplasm malignant — n=225, PRR 31.6
- Neoplasm progression — n=180, PRR 29.8
- Metastases to liver — n=61, PRR 20.2
- Brain neoplasm — n=30, PRR 18.9
- Metastases to bone — n=29, PRR 10.3
- Central nervous system lesion — n=22, PRR 9.2
- Pericardial effusion — n=34, PRR 8.5
- Pleural effusion — n=77, PRR 7.3
- Liver function test increased — n=25, PRR 6.8
- Haemoptysis — n=29, PRR 6.0
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 Brigatinib?
In FDA FAERS, the most frequently co-reported reaction terms for Brigatinib are metastases to central nervous system, lung neoplasm malignant, blood creatine phosphokinase increased, neoplasm progression, blood pressure increased, 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 Brigatinib have an FDA boxed warning?
No. The FDA label retrieved for Brigatinib has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Brigatinib 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 0fe9ff20-d402-41f3-bc1e-7002ea7007db, effective 20260112; matched on
openfda.generic_name.exact:"BRIGATINIB") - 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, 88 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.