Nateglinide side effects: what 1,333 FDA adverse event reports show

Nateglinide · 40 reaction terms · 500 drug–reaction co-reports · data 2026-09-14

Drug class

Glinide

FDA label (Established Pharmacologic Class)

Who reports

1,333 reports · 71% serious · 149 with death outcome · 53% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Nateglinide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use : Nateglinide tablets should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

FDA label, Indications and Usage

What it is

Nateglinide, USP is an oral blood glucose-lowering drug of the glinide class. Nateglinide, USP (-)-N-[(trans-4-isopropylcyclohexane)carbonyl]-D-phenylalanine, is structurally unrelated to the oral sulfonylurea insulin secretagogues.

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 17 strongest signals

Labeled adverse reaction 1Labeled (related wording) 3Lab value / disease marker 3Outcome field, not a reaction 1Not in label — unassessed 9

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.
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. 23 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
Lactic acidosis	37	18.2 13.2–25.0ROR 18.6 · χ² 583 / p 4e-129	18.0 EB05 13.5 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 14.3 · ♀ 94% (drug 53%) · 97% clinician	no trial data cached
Diabetes mellitus inadequate control	14	12.4 7.4–21.0ROR 12.6 · χ² 136 / p 9e-32	11.1 EB05 6.4 · IC025 +2.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 9.3	no trial data cached
Hypoglycaemia (low blood sugar)	36	11.7 8.5–16.1ROR 12.0 · χ² 341 / p 2e-76	11.2 EB05 8.3 · IC025 +2.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.3	no trial data cached
End stage renal disease	13	11.1 6.5–19.1ROR 11.2 · χ² 110 / p 6e-26	9.5 EB05 5.4 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 9.0	no trial data cached
Blood potassium increased	11	10.7 5.9–19.2ROR 10.8 · χ² 87 / p 5e-21	8.8 EB05 4.8 · IC025 +1.9 3/3 methods agree	Lab value / disease marker	serious PRR 10.2	no trial data cached
Proteinuria	12	10.0 5.7–17.6ROR 10.1 · χ² 89 / p 2e-21	8.3 EB05 4.7 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 8.3	no trial data cached
Glycosylated haemoglobin increased	15	9.4 5.7–15.5ROR 9.5 · χ² 104 / p 1e-24	8.0 EB05 4.9 · IC025 +2.0 3/3 methods agree	Lab value / disease marker	serious PRR 16.1	no trial data cached
Chronic kidney disease	41	8.4 6.2–11.4ROR 8.7 · χ² 261 / p 4e-59	7.9 EB05 6.0 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 6.9 · ♀ 81% (drug 53%)	no trial data cached
Blood glucose decreased	22	7.2 4.7–10.9ROR 7.3 · χ² 111 / p 3e-26	6.4 EB05 4.4 · IC025 +1.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 7.1 · ♀ 75% (drug 53%) · 71% consumer	no trial data cached
Renal failure acute	19	6.9 4.4–10.9ROR 7.0 · χ² 91 / p 7e-22	6.1 EB05 4.1 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 5.4	no trial data cached
Cerebral infarction	10	6.4 3.5–11.9ROR 6.5 · χ² 41 / p 9e-11	5.1 EB05 3.0 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 5.2	no trial data cached
Blood glucose increased	76	6.3 5.1–7.9ROR 6.6 · χ² 338 / p 8e-76	6.1 EB05 5.0 · IC025 +2.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 5.8	no trial data cached
Blood creatine phosphokinase increased	11	5.9 3.3–10.7ROR 6.0 · χ² 40 / p 1e-10	4.8 EB05 2.9 · IC025 +1.3 3/3 methods agree	Lab value / disease marker	serious PRR 4.9	no trial data cached
Renal injury	11	5.8 3.2–10.4ROR 5.8 · χ² 39 / p 2e-10	4.7 EB05 2.8 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 4.7	no trial data cached
Interstitial lung disease	17	5.5 3.5–8.9ROR 5.6 · χ² 59 / p 9e-15	4.9 EB05 3.2 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 4.5	no trial data cached
Injection site haemorrhage	14	2.8 1.6–4.7ROR 2.8 · χ² 14 / p 8e-5	2.6 EB05 1.7 · IC025 +0.5	Not in label — unassessed	serious PRR 3.6	no trial data cached
Completed suicide (death by suicide)	11	2.1 1.1–3.7ROR 2.1 · χ² 5 / p 0.013	2.0 EB05 1.2 · IC025 -0.0 PRR-only: not supported by EBGM or IC	Outcome field, not a reaction	serious PRR 1.7	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
Blood glucose increased	76	6.3 5.1–7.9ROR 6.6 · χ² 338 / p 8e-76	6.1 EB05 5.0 · IC025 +2.2 3/3 methods agree	Labeled (related wording) related wording	serious PRR 5.8	no trial data cached
Chronic kidney disease	41	8.4 6.2–11.4ROR 8.7 · χ² 261 / p 4e-59	7.9 EB05 6.0 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 6.9 · ♀ 81% (drug 53%)	no trial data cached
Lactic acidosis	37	18.2 13.2–25.0ROR 18.6 · χ² 583 / p 4e-129	18.0 EB05 13.5 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 14.3 · ♀ 94% (drug 53%) · 97% clinician	no trial data cached
Hypoglycaemia (low blood sugar)	36	11.7 8.5–16.1ROR 12.0 · χ² 341 / p 2e-76	11.2 EB05 8.3 · IC025 +2.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.3	no trial data cached
Blood glucose decreased	22	7.2 4.7–10.9ROR 7.3 · χ² 111 / p 3e-26	6.4 EB05 4.4 · IC025 +1.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 7.1 · ♀ 75% (drug 53%) · 71% consumer	no trial data cached
Renal failure acute	19	6.9 4.4–10.9ROR 7.0 · χ² 91 / p 7e-22	6.1 EB05 4.1 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 5.4	no trial data cached
Interstitial lung disease	17	5.5 3.5–8.9ROR 5.6 · χ² 59 / p 9e-15	4.9 EB05 3.2 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 4.5	no trial data cached
Glycosylated haemoglobin increased	15	9.4 5.7–15.5ROR 9.5 · χ² 104 / p 1e-24	8.0 EB05 4.9 · IC025 +2.0 3/3 methods agree	Lab value / disease marker	serious PRR 16.1	no trial data cached
Injection site haemorrhage	14	2.8 1.6–4.7ROR 2.8 · χ² 14 / p 8e-5	2.6 EB05 1.7 · IC025 +0.5	Not in label — unassessed	serious PRR 3.6	no trial data cached
Diabetes mellitus inadequate control	14	12.4 7.4–21.0ROR 12.6 · χ² 136 / p 9e-32	11.1 EB05 6.4 · IC025 +2.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 9.3	no trial data cached
End stage renal disease	13	11.1 6.5–19.1ROR 11.2 · χ² 110 / p 6e-26	9.5 EB05 5.4 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 9.0	no trial data cached
Proteinuria	12	10.0 5.7–17.6ROR 10.1 · χ² 89 / p 2e-21	8.3 EB05 4.7 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 8.3	no trial data cached
Completed suicide (death by suicide)	11	2.1 1.1–3.7ROR 2.1 · χ² 5 / p 0.013	2.0 EB05 1.2 · IC025 -0.0 PRR-only: not supported by EBGM or IC	Outcome field, not a reaction	serious PRR 1.7	no trial data cached
Renal injury	11	5.8 3.2–10.4ROR 5.8 · χ² 39 / p 2e-10	4.7 EB05 2.8 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 4.7	no trial data cached
Blood creatine phosphokinase increased	11	5.9 3.3–10.7ROR 6.0 · χ² 40 / p 1e-10	4.8 EB05 2.9 · IC025 +1.3 3/3 methods agree	Lab value / disease marker	serious PRR 4.9	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.

Lactic acidosis — n=37, PRR 18.2
Chronic kidney disease — n=41, PRR 8.4

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 Nateglinide?

In FDA FAERS, the most frequently co-reported reaction terms for Nateglinide are blood glucose increased, chronic kidney disease, lactic acidosis, hypoglycaemia, blood glucose decreased, renal failure acute. 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 Nateglinide have an FDA boxed warning?

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

Do FAERS signals prove that Nateglinide 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 af81465b-5f49-4eeb-8122-ef7fe5d90ddc, effective 20210803; matched on openfda.generic_name.exact:"NATEGLINIDE")
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, 40 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.