Sotorasib side effects: what 3,319 FDA adverse event reports show

Sotorasib · Lumakras · 52 reaction terms · 2,354 drug–reaction co-reports · data 2026-09-14

Drug class

Inhibitor of the ras gtpase family

FDA label, Indications wording

Brand names

Lumakras

openFDA label

Who reports

3,319 reports · 82% serious · 788 with death outcome · 49% female

openFDA FAERS counts, all years, deduplication not applied

Used for

LUMAKRAS is an inhibitor of the RAS GTPase family indicated for: KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) As a single agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy.

FDA label, Indications and Usage

What it is

Sotorasib is an inhibitor of the RAS GTPase family.

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 33 strongest signals

Labeled adverse reaction 11Labeled (related wording) 3Reporting / coding artifact 3Lab value / disease marker 2Outcome field, not a reaction 1Not in label — unassessed 13

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.
Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
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. 19 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Hepatotoxicity (liver damage)	101	28.9 23.9–35.1ROR 29.8 · χ² 2,684 / p <1e-300	28.6 EB05 24.3 · IC025 +4.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 20.7 · ♀ 73% (drug 49%) · 90% clinician	no trial data cached
Therapy partial responder	60	25.3 19.7–32.5ROR 25.7 · χ² 1,370 / p 4e-300	25.0 EB05 20.1 · IC025 +4.0 3/3 methods agree	Reporting / coding artifact	serious PRR 19.7 · 95% clinician	no trial data cached
Hepatic cytolysis	37	19.2 13.9–26.4ROR 19.4 · χ² 618 / p 1e-136	18.9 EB05 14.3 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 13.5 · 100% clinician	no trial data cached
Disease progression	342	18.4 16.6–20.3ROR 20.4 · χ² 5,616 / p <1e-300	18.3 EB05 16.7 · IC025 +4.0 3/3 methods agree	Reporting / coding artifact	serious PRR 14.8 · 94% clinician	no trial data cached
Metastases to central nervous system	35	17.3 12.4–24.1ROR 17.5 · χ² 520 / p 2e-115	17.1 EB05 12.7 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 12.3	no trial data cached
Hepatic function abnormal	95	16.2 13.3–19.8ROR 16.7 · χ² 1,342 / p 5e-294	16.1 EB05 13.6 · IC025 +3.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 11.4 · 99% clinician	no trial data cached
Liver function test increased	46	13.7 10.2–18.2ROR 13.8 · χ² 526 / p 9e-117	13.4 EB05 10.3 · IC025 +3.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.5	no trial data cached
Lung neoplasm malignant	74	11.3 9.0–14.2ROR 11.6 · χ² 687 / p 9e-152	11.1 EB05 9.1 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 7.9	no trial data cached
Cholestasis (bile flow blockage)	32	10.6 7.5–15.0ROR 10.7 · χ² 269 / p 1e-60	10.0 EB05 7.2 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 7.5 · 97% clinician	no trial data cached
Aspartate aminotransferase increased	79	9.4 7.6–11.7ROR 9.6 · χ² 586 / p 8e-130	9.1 EB05 7.5 · IC025 +2.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.9 · 94% clinician	no trial data cached
Hospice care	13	8.3 4.9–14.4ROR 8.4 · χ² 77 / p 9e-19	6.9 EB05 4.1 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 3.3	no trial data cached
Alanine aminotransferase increased	79	8.1 6.5–10.1ROR 8.3 · χ² 488 / p 2e-108	7.9 EB05 6.5 · IC025 +2.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.0 · 94% clinician	no trial data cached
Pneumonitis	34	8.0 5.7–11.1ROR 8.0 · χ² 200 / p 1e-45	7.4 EB05 5.4 · IC025 +2.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.1	no trial data cached
Blood alkaline phosphatase increased	31	7.9 5.6–11.2ROR 7.9 · χ² 179 / p 3e-41	7.2 EB05 5.3 · IC025 +2.2 3/3 methods agree	Lab value / disease marker	serious PRR 4.7 · 97% clinician	no trial data cached
Gamma-glutamyltransferase increased	25	7.1 4.8–10.5ROR 7.2 · χ² 126 / p 2e-29	6.4 EB05 4.5 · IC025 +2.0 3/3 methods agree	Lab value / disease marker	serious PRR 4.6 · 100% clinician	no trial data cached
Liver disorder	48	6.9 5.2–9.1ROR 6.9 · χ² 234 / p 3e-53	6.5 EB05 5.1 · IC025 +2.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 4.3	no trial data cached
Metastases to bone	16	6.2 3.8–10.1ROR 6.2 · χ² 64 / p 5e-16	5.3 EB05 3.5 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 4.4	no trial data cached
Drug-induced liver injury	30	6.1 4.3–8.8ROR 6.2 · χ² 124 / p 4e-29	5.7 EB05 4.1 · IC025 +1.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.4 · 90% clinician	no trial data cached
Hypocalcaemia (low calcium)	17	5.7 3.5–9.1ROR 5.7 · χ² 61 / p 3e-15	5.0 EB05 3.3 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 4.3	no trial data cached
Blood bilirubin increased	24	5.6 3.8–8.3ROR 5.6 · χ² 86 / p 8e-21	5.1 EB05 3.6 · IC025 +1.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.4 · ♀ 25% (drug 49%) · 96% clinician	no trial data cached
Colitis	30	5.0 3.5–7.2ROR 5.1 · χ² 93 / p 2e-22	4.7 EB05 3.4 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 3.3	no trial data cached
Circumstance or information capable of leading to medication error	26	4.9 3.3–7.2ROR 4.9 · χ² 77 / p 9e-19	4.5 EB05 3.3 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Jaundice (yellowing of skin/eyes)	20	4.7 3.0–7.3ROR 4.7 · χ² 54 / p 8e-14	4.3 EB05 2.9 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 2.8	no trial data cached
Hepatic enzyme increased	48	4.5 3.4–5.9ROR 4.5 · χ² 126 / p 2e-29	4.3 EB05 3.4 · IC025 +1.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 2.3	no trial data cached
Hepatitis (liver inflammation)	16	4.0 2.4–6.4ROR 4.0 · χ² 32 / p 6e-9	3.6 EB05 2.4 · IC025 +1.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.8	no trial data cached
Interstitial lung disease	28	3.7 2.5–5.3ROR 3.7 · χ² 52 / p 3e-13	3.5 EB05 2.5 · IC025 +1.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.6 · ♀ 17% (drug 49%) · 96% clinician	no trial data cached
Transaminases increased	12	3.4 1.9–6.0ROR 3.4 · χ² 18 / p 1e-5	3.1 EB05 1.9 · IC025 +0.7	Labeled adverse reaction exact term	serious PRR 2.1	no trial data cached
Diarrhoea (diarrhea)	325	3.2 2.9–3.5ROR 3.4 · χ² 503 / p 1e-111	3.2 EB05 2.9 · IC025 +1.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.7	no trial data cached
Pericardial effusion	11	3.0 1.7–5.4ROR 3.0 · χ² 13 / p 2e-4	2.8 EB05 1.7 · IC025 +0.4	Not in label — unassessed	serious PRR 2.2	no trial data cached
Death	388	2.8 2.6–3.1ROR 3.1 · χ² 483 / p 3e-107	2.8 EB05 2.6 · IC025 +1.3 3/3 methods agree	Outcome field, not a reaction	serious PRR 1.9	no trial data cached
Adverse event	33	2.3 1.6–3.2ROR 2.3 · χ² 22 / p 1e-6	2.2 EB05 1.7 · IC025 +0.6	Reporting / coding artifact	serious PRR 2.2	no trial data cached
Neoplasm progression	12	2.2 1.2–3.8ROR 2.2 · χ² 6 / p 0.006	2.1 EB05 1.3 · IC025 +0.1	Not in label — unassessed	serious PRR 1.9	no trial data cached
Ill-defined disorder	20	2.1 1.3–3.2ROR 2.1 · χ² 10 / p 7e-4	2.0 EB05 1.4 · IC025 +0.3	Not in label — unassessed	serious PRR 1.9	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	388	2.8 2.6–3.1ROR 3.1 · χ² 483 / p 3e-107	2.8 EB05 2.6 · IC025 +1.3 3/3 methods agree	Outcome field, not a reaction	serious PRR 1.9	no trial data cached
Disease progression	342	18.4 16.6–20.3ROR 20.4 · χ² 5,616 / p <1e-300	18.3 EB05 16.7 · IC025 +4.0 3/3 methods agree	Reporting / coding artifact	serious PRR 14.8 · 94% clinician	no trial data cached
Diarrhoea (diarrhea)	325	3.2 2.9–3.5ROR 3.4 · χ² 503 / p 1e-111	3.2 EB05 2.9 · IC025 +1.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.7	no trial data cached
Hepatotoxicity (liver damage)	101	28.9 23.9–35.1ROR 29.8 · χ² 2,684 / p <1e-300	28.6 EB05 24.3 · IC025 +4.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 20.7 · ♀ 73% (drug 49%) · 90% clinician	no trial data cached
Hepatic function abnormal	95	16.2 13.3–19.8ROR 16.7 · χ² 1,342 / p 5e-294	16.1 EB05 13.6 · IC025 +3.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 11.4 · 99% clinician	no trial data cached
Alanine aminotransferase increased	79	8.1 6.5–10.1ROR 8.3 · χ² 488 / p 2e-108	7.9 EB05 6.5 · IC025 +2.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.0 · 94% clinician	no trial data cached
Aspartate aminotransferase increased	79	9.4 7.6–11.7ROR 9.6 · χ² 586 / p 8e-130	9.1 EB05 7.5 · IC025 +2.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.9 · 94% clinician	no trial data cached
Lung neoplasm malignant	74	11.3 9.0–14.2ROR 11.6 · χ² 687 / p 9e-152	11.1 EB05 9.1 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 7.9	no trial data cached
Therapy partial responder	60	25.3 19.7–32.5ROR 25.7 · χ² 1,370 / p 4e-300	25.0 EB05 20.1 · IC025 +4.0 3/3 methods agree	Reporting / coding artifact	serious PRR 19.7 · 95% clinician	no trial data cached
Hepatic enzyme increased	48	4.5 3.4–5.9ROR 4.5 · χ² 126 / p 2e-29	4.3 EB05 3.4 · IC025 +1.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 2.3	no trial data cached
Liver disorder	48	6.9 5.2–9.1ROR 6.9 · χ² 234 / p 3e-53	6.5 EB05 5.1 · IC025 +2.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 4.3	no trial data cached
Liver function test increased	46	13.7 10.2–18.2ROR 13.8 · χ² 526 / p 9e-117	13.4 EB05 10.3 · IC025 +3.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.5	no trial data cached
Hepatic cytolysis	37	19.2 13.9–26.4ROR 19.4 · χ² 618 / p 1e-136	18.9 EB05 14.3 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 13.5 · 100% clinician	no trial data cached
Metastases to central nervous system	35	17.3 12.4–24.1ROR 17.5 · χ² 520 / p 2e-115	17.1 EB05 12.7 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 12.3	no trial data cached
Pneumonitis	34	8.0 5.7–11.1ROR 8.0 · χ² 200 / p 1e-45	7.4 EB05 5.4 · IC025 +2.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.1	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.

Hepatic cytolysis — n=37, PRR 19.2
Metastases to central nervous system — n=35, PRR 17.3
Lung neoplasm malignant — n=74, PRR 11.3
Cholestasis — n=32, PRR 10.6
Colitis — n=30, PRR 5.0
Circumstance or information capable of leading to medication error — n=26, PRR 4.9
Jaundice — n=20, PRR 4.7
Ill-defined disorder — n=20, PRR 2.1

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 Sotorasib?

In FDA FAERS, the most frequently co-reported reaction terms for Sotorasib are diarrhoea, hepatotoxicity, hepatic function abnormal, alanine aminotransferase increased, aspartate aminotransferase increased, lung neoplasm malignant. 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 Sotorasib have an FDA boxed warning?

No. The FDA label retrieved for Sotorasib has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Sotorasib 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 c80a362c-7ac3-4894-a076-0691e68ef8c1, effective 20250122; matched on openfda.generic_name.exact:"SOTORASIB")
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, field patient.drug.openfda.generic_name.exact, 52 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.