Inavolisib side effects: what 521 FDA adverse event reports show

Inavolisib · Itovebi · 14 reaction terms · 353 drug–reaction co-reports · data 2026-09-14

Drug class

Kinase Inhibitor

FDA label (Established Pharmacologic Class) · compare the class

Brand names

Itovebi

openFDA label

Who reports

521 reports · 66% serious · 25 with death outcome · 99% female

openFDA FAERS counts, all years, deduplication not applied

Used for

ITOVEBI, in combination with palbociclib and fulvestrant, is indicated for the treatment of adults with endocrine-resistant, PIK3CA -mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy .

FDA label, Indications and Usage

What it is

ITOVEBI contains inavolisib, 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 11 strongest signals

Labeled adverse reaction 3Labeled (related wording) 3Lab value / disease marker 1Not in label — unassessed 4

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.
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. 3 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
Hyperglycaemia (high blood sugar)	133	146.2 126.2–169.4ROR 195.2 · χ² 19,000 / p <1e-300	142.7 EB05 123.5 · IC025 +6.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 95.7 · 92% clinician	no trial data cached
Diabetic ketoacidosis	26	43.2 29.7–62.9ROR 45.4 · χ² 1,030 / p 2e-226	41.9 EB05 30.1 · IC025 +3.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 37.9	no trial data cached
Haematotoxicity	8	34.4 17.3–68.4ROR 34.9 · χ² 227 / p 2e-51	31.8 EB05 17.1 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 30.9	no trial data cached
Stomatitis (mouth sores)	39	25.6 18.9–34.6ROR 27.6 · χ² 899 / p 7e-198	25.3 EB05 19.3 · IC025 +3.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 16.4	no trial data cached
Neoplasm	7	24.2 11.6–50.5ROR 24.5 · χ² 133 / p 4e-31	22.0 EB05 10.0 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 16.5	no trial data cached
Taste disorder	10	19.9 10.7–36.7ROR 20.2 · χ² 161 / p 4e-37	18.6 EB05 9.9 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 31.5	no trial data cached
Mucosal inflammation	12	18.3 10.5–32.1ROR 18.7 · χ² 180 / p 3e-41	17.4 EB05 9.8 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 11.4	no trial data cached
Blood glucose increased	82	17.3 14.1–21.1ROR 20.3 · χ² 1,250 / p 4e-274	17.2 EB05 14.3 · IC025 +3.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 21.5	no trial data cached
Myelosuppression	12	14.0 8.0–24.6ROR 14.3 · χ² 133 / p 5e-31	12.6 EB05 6.8 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 12.3	no trial data cached
Full blood count decreased	7	13.8 6.6–28.8ROR 14.0 · χ² 71 / p 2e-17	10.8 EB05 4.6 · IC025 +1.6 3/3 methods agree	Lab value / disease marker	serious PRR 10.0	no trial data cached
Diabetes mellitus inadequate control	5	11.2 4.7–26.9ROR 11.3 · χ² 37 / p 6e-10	7.2 EB05 2.9 · IC025 +1.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 11.6	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
Hyperglycaemia (high blood sugar)	133	146.2 126.2–169.4ROR 195.2 · χ² 19,000 / p <1e-300	142.7 EB05 123.5 · IC025 +6.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 95.7 · 92% clinician	no trial data cached
Blood glucose increased	82	17.3 14.1–21.1ROR 20.3 · χ² 1,250 / p 4e-274	17.2 EB05 14.3 · IC025 +3.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 21.5	no trial data cached
Stomatitis (mouth sores)	39	25.6 18.9–34.6ROR 27.6 · χ² 899 / p 7e-198	25.3 EB05 19.3 · IC025 +3.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 16.4	no trial data cached
Diabetic ketoacidosis	26	43.2 29.7–62.9ROR 45.4 · χ² 1,030 / p 2e-226	41.9 EB05 30.1 · IC025 +3.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 37.9	no trial data cached
Myelosuppression	12	14.0 8.0–24.6ROR 14.3 · χ² 133 / p 5e-31	12.6 EB05 6.8 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 12.3	no trial data cached
Mucosal inflammation	12	18.3 10.5–32.1ROR 18.7 · χ² 180 / p 3e-41	17.4 EB05 9.8 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 11.4	no trial data cached
Taste disorder	10	19.9 10.7–36.7ROR 20.2 · χ² 161 / p 4e-37	18.6 EB05 9.9 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 31.5	no trial data cached
Haematotoxicity	8	34.4 17.3–68.4ROR 34.9 · χ² 227 / p 2e-51	31.8 EB05 17.1 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 30.9	no trial data cached
Full blood count decreased	7	13.8 6.6–28.8ROR 14.0 · χ² 71 / p 2e-17	10.8 EB05 4.6 · IC025 +1.6 3/3 methods agree	Lab value / disease marker	serious PRR 10.0	no trial data cached
Neoplasm	7	24.2 11.6–50.5ROR 24.5 · χ² 133 / p 4e-31	22.0 EB05 10.0 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 16.5	no trial data cached
Diabetes mellitus inadequate control	5	11.2 4.7–26.9ROR 11.3 · χ² 37 / p 6e-10	7.2 EB05 2.9 · IC025 +1.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 11.6	no trial data cached
Breast cancer female	4	5.9 2.2–15.7ROR 6.0 · χ² 12 / p 3e-4	3.8 EB05 1.7 · IC025 +0.2	Labeled (related wording) related wording	serious PRR 5.2	no trial data cached
Metastases to central nervous system	4	12.4 4.7–33.0ROR 12.5 · χ² 31 / p 1e-8	7.3 EB05 2.6 · IC025 +0.7 3/3 methods agree	Not in label — unassessed	serious PRR 11.0	no trial data cached
Breast cancer metastatic	4	14.8 5.6–39.4ROR 14.9 · χ² 39 / p 2e-10	9.2 EB05 2.9 · IC025 +0.8 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 13.3	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 Inavolisib?

In FDA FAERS, the most frequently co-reported reaction terms for Inavolisib are hyperglycaemia, blood glucose increased, stomatitis, diabetic ketoacidosis, myelosuppression, mucosal inflammation. 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 Inavolisib have an FDA boxed warning?

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

Do FAERS signals prove that Inavolisib 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 5de59f5b-e5db-410f-b692-658686ef4107, effective 20260421; matched on openfda.generic_name.exact:"INAVOLISIB")
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, 14 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.