Adagrasib side effects: what 1,059 FDA adverse event reports show

Adagrasib · Krazati · 12 reaction terms · 521 drug–reaction co-reports · data 2026-09-14

Drug class

Inhibitor of the ras gtpase family

FDA label, Indications wording

Brand names

Krazati

openFDA label

Who reports

1,059 reports · 79% serious · 341 with death outcome · 59% female

openFDA FAERS counts, all years, deduplication not applied

Used for

KRAZATI is an inhibitor of the RAS GTPase family indicated for: 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

Adagrasib is an irreversible inhibitor of KRAS G12C and belongs to 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 12 strongest signals

Labeled adverse reaction 2Reporting / coding artifact 1Outcome field, not a reaction 1Not in label — unassessed 8

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.
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.
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. 0 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
Hepatic cytolysis	11	17.8 9.9–32.0ROR 17.9 · χ² 158 / p 2e-36	16.6 EB05 8.9 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 13.0	no trial data cached
Status epilepticus	9	15.7 8.2–30.1ROR 15.8 · χ² 110 / p 6e-26	13.8 EB05 6.5 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 11.5	no trial data cached
Hospitalisation	112	14.5 12.2–17.3ROR 16.1 · χ² 1,404 / p <1e-300	14.4 EB05 12.3 · IC025 +3.5 3/3 methods agree	Reporting / coding artifact	serious PRR 10.8 · 70% consumer	no trial data cached
Respiratory depression	7	11.3 5.4–23.6ROR 11.3 · χ² 56 / p 4e-14	8.3 EB05 3.8 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 8.5	no trial data cached
Toxic epidermal necrolysis (severe skin peeling reaction)	8	10.5 5.2–20.9ROR 10.5 · χ² 59 / p 6e-15	7.9 EB05 3.9 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 7.7	no trial data cached
Neoplasm progression	18	10.1 6.4–16.0ROR 10.3 · χ² 139 / p 2e-32	9.0 EB05 5.7 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 8.5	no trial data cached
Electrocardiogram qt prolonged	17	9.3 5.8–14.9ROR 9.5 · χ² 118 / p 8e-28	8.1 EB05 5.1 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.9	no trial data cached
Unresponsive to stimuli	12	9.2 5.2–16.2ROR 9.3 · χ² 80 / p 2e-19	7.5 EB05 4.3 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 6.9	no trial data cached
Rash maculo-papular	10	8.9 4.8–16.5ROR 9.0 · χ² 63 / p 1e-15	7.0 EB05 3.8 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 7.2	no trial data cached
Pneumonitis	12	8.8 5.0–15.4ROR 8.8 · χ² 75 / p 2e-18	7.1 EB05 4.1 · IC025 +1.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.7	no trial data cached
Agranulocytosis (severe loss of white cells)	7	7.5 3.6–15.6ROR 7.5 · χ² 33 / p 4e-9	5.4 EB05 2.7 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 5.5	no trial data cached
Death	298	6.8 6.2–7.5ROR 9.1 · χ² 1,539 / p <1e-300	6.8 EB05 6.1 · IC025 +2.6 3/3 methods agree	Outcome field, not a reaction	serious PRR 4.7	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	298	6.8 6.2–7.5ROR 9.1 · χ² 1,539 / p <1e-300	6.8 EB05 6.1 · IC025 +2.6 3/3 methods agree	Outcome field, not a reaction	serious PRR 4.7	no trial data cached
Hospitalisation	112	14.5 12.2–17.3ROR 16.1 · χ² 1,404 / p <1e-300	14.4 EB05 12.3 · IC025 +3.5 3/3 methods agree	Reporting / coding artifact	serious PRR 10.8 · 70% consumer	no trial data cached
Neoplasm progression	18	10.1 6.4–16.0ROR 10.3 · χ² 139 / p 2e-32	9.0 EB05 5.7 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 8.5	no trial data cached
Electrocardiogram qt prolonged	17	9.3 5.8–14.9ROR 9.5 · χ² 118 / p 8e-28	8.1 EB05 5.1 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.9	no trial data cached
Pneumonitis	12	8.8 5.0–15.4ROR 8.8 · χ² 75 / p 2e-18	7.1 EB05 4.1 · IC025 +1.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.7	no trial data cached
Unresponsive to stimuli	12	9.2 5.2–16.2ROR 9.3 · χ² 80 / p 2e-19	7.5 EB05 4.3 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 6.9	no trial data cached
Hepatic cytolysis	11	17.8 9.9–32.0ROR 17.9 · χ² 158 / p 2e-36	16.6 EB05 8.9 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 13.0	no trial data cached
Rash maculo-papular	10	8.9 4.8–16.5ROR 9.0 · χ² 63 / p 1e-15	7.0 EB05 3.8 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 7.2	no trial data cached
Status epilepticus	9	15.7 8.2–30.1ROR 15.8 · χ² 110 / p 6e-26	13.8 EB05 6.5 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 11.5	no trial data cached
Toxic epidermal necrolysis (severe skin peeling reaction)	8	10.5 5.2–20.9ROR 10.5 · χ² 59 / p 6e-15	7.9 EB05 3.9 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 7.7	no trial data cached
Agranulocytosis (severe loss of white cells)	7	7.5 3.6–15.6ROR 7.5 · χ² 33 / p 4e-9	5.4 EB05 2.7 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 5.5	no trial data cached
Respiratory depression	7	11.3 5.4–23.6ROR 11.3 · χ² 56 / p 4e-14	8.3 EB05 3.8 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 8.5	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

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 Adagrasib?

In FDA FAERS, the most frequently co-reported reaction terms for Adagrasib are neoplasm progression, electrocardiogram qt prolonged, pneumonitis, unresponsive to stimuli, hepatic cytolysis, rash maculo-papular. 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 Adagrasib have an FDA boxed warning?

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

Do FAERS signals prove that Adagrasib 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 0b8bf078-34c2-4f45-9012-38a8ac082b01, effective 20260325; matched on openfda.generic_name.exact:"ADAGRASIB")
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, 12 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.