Drug · FAERS side-effect profile with label screen
Lorlatinib side effects: what 6,976 FDA adverse event reports show
Brand names
Lorbrena
openFDA label
Who reports
6,976 reports · 83% serious · 1,867 with death outcome · 53% female
openFDA FAERS counts, all years, deduplication not applied
Used for
LORBRENA ® 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. LORBRENA is a kinase inhibitor indicated for .
FDA label, Indications and Usage
What it is
LORBRENA (lorlatinib) 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 13Labeled (related wording) 6Reporting / coding artifact 1Lab value / disease marker 4Not in label — unassessed 16
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. 233 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 |
|---|---|---|---|---|---|---|
| Hypercholesterolaemia | 186 | 59.6 51.6–68.7ROR 61.2 · χ² 10,448 / p <1e-300 | 58.1 EB05 51.4 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 41.1 | no trial data cached |
| Neoplasm progression | 621 | 54.1 50.2–58.4ROR 59.3 · χ² 31,796 / p <1e-300 | 53.1 EB05 49.7 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 40.1 | no trial data cached |
| Hyperlipidaemia | 175 | 44.5 38.4–51.6ROR 45.6 · χ² 7,296 / p <1e-300 | 43.7 EB05 38.5 · IC025 +5.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 26.5 | no trial data cached |
| Blood triglycerides increased | 177 | 30.3 26.2–35.1ROR 31.1 · χ² 4,940 / p <1e-300 | 29.9 EB05 26.4 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 29.7 | no trial data cached |
| Metastases to central nervous system | 123 | 29.1 24.4–34.7ROR 29.6 · χ² 3,283 / p <1e-300 | 28.7 EB05 24.7 · IC025 +4.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 20.3 | no trial data cached |
| Blood cholesterol increased | 348 | 22.6 20.4–25.0ROR 23.7 · χ² 7,120 / p <1e-300 | 22.4 EB05 20.5 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 19.2 | no trial data cached |
| Hallucination, auditory | 109 | 20.7 17.2–25.0ROR 21.0 · χ² 2,013 / p <1e-300 | 20.5 EB05 17.5 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 16.5 | no trial data cached |
| Hallucination (hallucinations) | 404 | 16.3 14.8–17.9ROR 17.2 · χ² 5,768 / p <1e-300 | 16.2 EB05 14.9 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 13.6 | no trial data cached |
| Oedema | 269 | 15.0 13.3–16.9ROR 15.6 · χ² 3,494 / p <1e-300 | 14.9 EB05 13.5 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.5 | no trial data cached |
| Hallucination, visual | 96 | 13.8 11.3–16.9ROR 14.0 · χ² 1,124 / p 1e-246 | 13.7 EB05 11.5 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 10.9 | no trial data cached |
| Cognitive disorder | 187 | 12.1 10.5–14.0ROR 12.4 · χ² 1,894 / p <1e-300 | 12.0 EB05 10.6 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.2 | no trial data cached |
| Pericardial effusion | 92 | 12.1 9.8–14.8ROR 12.2 · χ² 919 / p 3e-202 | 11.9 EB05 9.9 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 | no trial data cached |
| Blood thyroid stimulating hormone increased | 36 | 11.8 8.5–16.3ROR 11.8 · χ² 342 / p 9e-77 | 11.3 EB05 8.3 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious n=36 · 94% consumer | no trial data cached |
| Nervous system disorder | 106 | 10.2 8.4–12.3ROR 10.3 · χ² 869 / p 2e-191 | 10.0 EB05 8.5 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.7 | no trial data cached |
| Pleural effusion | 184 | 9.1 7.9–10.5ROR 9.3 · χ² 1,319 / p 5e-289 | 9.0 EB05 7.9 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Brain oedema | 38 | 9.1 6.6–12.5ROR 9.1 · χ² 264 / p 1e-59 | 8.5 EB05 6.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Metastases to liver | 50 | 8.6 6.5–11.3ROR 8.6 · χ² 327 / p 2e-73 | 8.1 EB05 6.4 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 · ♀ 19% (drug 53%) | no trial data cached |
| Psychotic disorder | 83 | 8.5 6.8–10.5ROR 8.6 · χ² 538 / p 2e-119 | 8.2 EB05 6.8 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.9 | no trial data cached |
| Pneumonitis | 75 | 8.4 6.7–10.5ROR 8.4 · χ² 478 / p 3e-106 | 8.1 EB05 6.6 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.6 | no trial data cached |
| Carpal tunnel syndrome | 38 | 8.2 5.9–11.2ROR 8.2 · χ² 231 / p 2e-52 | 7.6 EB05 5.7 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.2 | no trial data cached |
| Full blood count abnormal | 28 | 8.0 5.5–11.6ROR 8.0 · χ² 164 / p 7e-38 | 7.3 EB05 5.2 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious PRR 7.1 · 89% consumer | no trial data cached |
| Malignant neoplasm progression | 239 | 7.1 6.2–8.0ROR 7.3 · χ² 1,242 / p 3e-272 | 7.0 EB05 6.3 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 5.0 | no trial data cached |
| Generalised oedema | 28 | 6.8 4.7–9.9ROR 6.9 · χ² 134 / p 3e-31 | 6.2 EB05 4.5 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 | no trial data cached |
| Mood altered | 61 | 6.8 5.3–8.7ROR 6.8 · χ² 293 / p 5e-66 | 6.5 EB05 5.2 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.3 | no trial data cached |
| Brain fog | 31 | 6.4 4.5–9.1ROR 6.4 · χ² 136 / p 1e-31 | 5.9 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Oedema peripheral (swelling of legs/feet) | 253 | 6.2 5.5–7.0ROR 6.4 · χ² 1,109 / p 2e-243 | 6.2 EB05 5.5 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.1 | no trial data cached |
| Neuropathy peripheral (nerve damage in hands/feet) | 195 | 6.2 5.4–7.1ROR 6.4 · χ² 849 / p 5e-187 | 6.1 EB05 5.4 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 | no trial data cached |
| Nerve compression | 19 | 6.2 4.0–9.7ROR 6.2 · χ² 78 / p 6e-19 | 5.5 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Polyneuropathy | 24 | 6.1 4.1–9.1ROR 6.1 · χ² 97 / p 4e-23 | 5.5 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 · 100% clinician | no trial data cached |
| Neurotoxicity | 35 | 6.1 4.4–8.4ROR 6.1 · χ² 143 / p 3e-33 | 5.6 EB05 4.2 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 | no trial data cached |
| Glycosylated haemoglobin increased | 49 | 5.9 4.4–7.7ROR 5.9 · χ² 192 / p 5e-44 | 5.6 EB05 4.4 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious PRR 9.0 · 82% consumer | no trial data cached |
| Weight fluctuation | 20 | 5.8 3.7–9.0ROR 5.8 · χ² 74 / p 4e-18 | 5.1 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial data cached |
| Speech disorder | 96 | 5.5 4.5–6.7ROR 5.6 · χ² 351 / p 2e-78 | 5.4 EB05 4.5 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.9 | no trial data cached |
| Weight increased (weight gain) | 399 | 5.4 4.9–5.9ROR 5.7 · χ² 1,435 / p <1e-300 | 5.4 EB05 4.9 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.7 | no trial data cached |
| Blood pressure systolic increased | 34 | 5.2 3.7–7.3ROR 5.2 · χ² 112 / p 2e-26 | 4.9 EB05 3.7 · IC025 +1.7 3/3 methods agree | Lab value / disease marker | serious PRR 3.7 · 97% consumer | no trial data cached |
| Mental disorder | 72 | 5.0 3.9–6.3ROR 5.0 · χ² 224 / p 5e-51 | 4.8 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.7 | no trial data cached |
| Metastases to lung | 19 | 5.0 3.2–7.8ROR 5.0 · χ² 56 / p 4e-14 | 4.5 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Hunger | 22 | 4.9 3.2–7.5ROR 4.9 · χ² 65 / p 4e-16 | 4.5 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious n=19 · 91% consumer | no trial data cached |
| Personality change | 15 | 4.8 2.9–8.0ROR 4.8 · χ² 42 / p 5e-11 | 4.2 EB05 2.7 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 | no trial data cached |
| Gait inability | 53 | 4.8 3.7–6.3ROR 4.8 · χ² 157 / p 3e-36 | 4.6 EB05 3.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 · 83% consumer | 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 | 1,304 | 4.6 4.3–4.8ROR 5.4 · χ² 3,765 / p <1e-300 | 4.5 EB05 4.3 · IC025 +2.1 3/3 methods agree | Outcome field, not a reaction | serious PRR 3.2 | no trial data cached |
| Neoplasm progression | 621 | 54.1 50.2–58.4ROR 59.3 · χ² 31,796 / p <1e-300 | 53.1 EB05 49.7 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 40.1 | no trial data cached |
| Off label use (used outside approved label) | 461 | 1.6 1.5–1.7ROR 1.6 · χ² 107 / p 3e-25 | 1.6 EB05 1.5 · IC025 +0.5 | Reporting / coding artifact | serious PRR 1.7 | no trial data cached |
| Hallucination (hallucinations) | 404 | 16.3 14.8–17.9ROR 17.2 · χ² 5,768 / p <1e-300 | 16.2 EB05 14.9 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 13.6 | no trial data cached |
| Weight increased (weight gain) | 399 | 5.4 4.9–5.9ROR 5.7 · χ² 1,435 / p <1e-300 | 5.4 EB05 4.9 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.7 | no trial data cached |
| Blood cholesterol increased | 348 | 22.6 20.4–25.0ROR 23.7 · χ² 7,120 / p <1e-300 | 22.4 EB05 20.5 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 19.2 | no trial data cached |
| Oedema | 269 | 15.0 13.3–16.9ROR 15.6 · χ² 3,494 / p <1e-300 | 14.9 EB05 13.5 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.5 | no trial data cached |
| Oedema peripheral (swelling of legs/feet) | 253 | 6.2 5.5–7.0ROR 6.4 · χ² 1,109 / p 2e-243 | 6.2 EB05 5.5 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.1 | no trial data cached |
| Malignant neoplasm progression | 239 | 7.1 6.2–8.0ROR 7.3 · χ² 1,242 / p 3e-272 | 7.0 EB05 6.3 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 5.0 | no trial data cached |
| Peripheral swelling | 211 | 4.1 3.6–4.7ROR 4.2 · χ² 502 / p 2e-111 | 4.1 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 | no trial data cached |
| Neuropathy peripheral (nerve damage in hands/feet) | 195 | 6.2 5.4–7.1ROR 6.4 · χ² 849 / p 5e-187 | 6.1 EB05 5.4 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 | no trial data cached |
| Memory impairment | 187 | 4.1 3.6–4.7ROR 4.2 · χ² 436 / p 5e-97 | 4.0 EB05 3.6 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.2 | no trial data cached |
| Cognitive disorder | 187 | 12.1 10.5–14.0ROR 12.4 · χ² 1,894 / p <1e-300 | 12.0 EB05 10.6 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.2 | no trial data cached |
| Hypercholesterolaemia | 186 | 59.6 51.6–68.7ROR 61.2 · χ² 10,448 / p <1e-300 | 58.1 EB05 51.4 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 41.1 | no trial data cached |
| Pleural effusion | 184 | 9.1 7.9–10.5ROR 9.3 · χ² 1,319 / p 5e-289 | 9.0 EB05 7.9 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | 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.
- Hypercholesterolaemia — n=186, PRR 59.6
- Neoplasm progression — n=621, PRR 54.1
- Hallucination, auditory — n=109, PRR 20.7
- Hallucination — n=404, PRR 16.3
- Hallucination, visual — n=96, PRR 13.8
- Pericardial effusion — n=92, PRR 12.1
- Pleural effusion — n=184, PRR 9.1
- Brain oedema — n=38, PRR 9.1
- Metastases to liver — n=50, PRR 8.6
- Brain fog — n=31, PRR 6.4
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 Lorlatinib?
In FDA FAERS, the most frequently co-reported reaction terms for Lorlatinib are neoplasm progression, hallucination, weight increased, blood cholesterol increased, oedema, 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 Lorlatinib have an FDA boxed warning?
No. The FDA label retrieved for Lorlatinib has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Lorlatinib 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 004f93d7-a1cd-4b67-9207-31cdcb5c5976, effective 20260213; matched on
openfda.generic_name.exact:"LORLATINIB") - 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, 273 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.