Drug · FAERS side-effect profile with label screen
Repaglinide side effects: what 7,416 FDA adverse event reports show
Drug class
Glinide
FDA label (Established Pharmacologic Class)
Who reports
7,416 reports · 92% serious · 708 with death outcome · 46% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Repaglinide tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitation of Use: Repaglinide 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
Repaglinide, USP is an oral blood glucose-lowering drug of the glinide class. Repaglinide, S(+)2-ethoxy-4(2((3-methyl-1-(2-(1-piperidinyl) phenyl)-butyl) amino)-2-oxoethyl) benzoic acid, is chemically 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 40 strongest signals
Labeled adverse reaction 2Labeled (related wording) 4Likely indication confounding 1Reporting / coding artifact 2Lab value / disease marker 3Not in label — unassessed 28
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.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- 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. 339 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 |
|---|---|---|---|---|---|---|
| Hypoglycaemia (low blood sugar) | 794 | 47.0 44.0–50.2ROR 52.5 · χ² 35,201 / p <1e-300 | 46.2 EB05 43.6 · IC025 +5.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 32.0 | no trial data cached |
| Lactic acidosis | 368 | 32.8 29.7–36.2ROR 34.5 · χ² 11,197 / p <1e-300 | 32.4 EB05 29.7 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 20.2 · 94% clinician | no trial data cached |
| Diabetes mellitus inadequate control | 110 | 17.7 14.7–21.3ROR 17.9 · χ² 1,703 / p <1e-300 | 17.5 EB05 14.9 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 12.6 | no trial data cached |
| Sopor | 80 | 17.0 13.7–21.2ROR 17.2 · χ² 1,184 / p 1e-259 | 16.8 EB05 14.0 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 · 92% clinician | no trial data cached |
| Hyperkalaemia (high potassium) | 198 | 16.1 14.1–18.5ROR 16.5 · χ² 2,783 / p <1e-300 | 16.0 EB05 14.2 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.2 · 94% clinician | no trial data cached |
| Hepatocellular injury | 56 | 11.2 8.6–14.5ROR 11.3 · χ² 507 / p 1e-112 | 10.8 EB05 8.5 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 · 91% clinician | no trial data cached |
| Hyperglycaemia (high blood sugar) | 139 | 10.9 9.2–12.8ROR 11.0 · χ² 1,232 / p 4e-270 | 10.7 EB05 9.3 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.5 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 558 | 10.4 9.6–11.3ROR 11.2 · χ² 4,745 / p <1e-300 | 10.3 EB05 9.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 · 94% clinician | no trial data cached |
| Hypomagnesaemia | 48 | 9.8 7.4–13.0ROR 9.9 · χ² 370 / p 9e-83 | 9.4 EB05 7.2 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 · 98% clinician | no trial data cached |
| Ischaemic stroke | 61 | 9.7 7.5–12.4ROR 9.8 · χ² 465 / p 2e-103 | 9.3 EB05 7.4 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 · 97% clinician | no trial data cached |
| Pancreatitis acute | 73 | 9.3 7.4–11.7ROR 9.4 · χ² 530 / p 2e-117 | 9.0 EB05 7.3 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.8 | no trial data cached |
| Metabolic acidosis | 100 | 9.0 7.4–10.9ROR 9.1 · χ² 698 / p 5e-154 | 8.7 EB05 7.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 · 91% clinician | no trial data cached |
| Eosinophilia | 54 | 8.8 6.7–11.4ROR 8.8 · χ² 363 / p 3e-81 | 8.3 EB05 6.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Cholestasis (bile flow blockage) | 57 | 8.5 6.5–11.0ROR 8.5 · χ² 367 / p 5e-82 | 8.1 EB05 6.4 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 · ♀ 16% (drug 46%) · 91% clinician | no trial data cached |
| Rash maculo-papular | 66 | 8.4 6.6–10.7ROR 8.5 · χ² 425 / p 1e-94 | 8.1 EB05 6.5 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 · 97% clinician | no trial data cached |
| Blood glucose fluctuation | 31 | 8.0 5.6–11.4ROR 8.0 · χ² 182 / p 8e-42 | 7.3 EB05 5.3 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious n=26 · 71% consumer | no trial data cached |
| Hypocalcaemia (low calcium) | 53 | 8.0 6.1–10.4ROR 8.0 · χ² 315 / p 9e-71 | 7.6 EB05 6.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 · 98% clinician | no trial data cached |
| Hepatic cytolysis | 34 | 7.9 5.6–11.0ROR 7.9 · χ² 197 / p 4e-45 | 7.3 EB05 5.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 · 100% clinician | no trial data cached |
| Agranulocytosis (severe loss of white cells) | 51 | 7.8 5.9–10.3ROR 7.9 · χ² 296 / p 1e-66 | 7.4 EB05 5.8 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · 96% clinician | no trial data cached |
| Drug interaction | 432 | 7.7 7.0–8.5ROR 8.1 · χ² 2,531 / p <1e-300 | 7.7 EB05 7.1 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 5.3 · 95% clinician | no trial data cached |
| Diabetic ketoacidosis | 62 | 7.3 5.7–9.4ROR 7.4 · χ² 332 / p 2e-74 | 7.0 EB05 5.6 · IC025 +2.4 3/3 methods agree | Likely indication confounding term in indications | serious PRR 4.6 · ♀ 68% (drug 46%) | no trial data cached |
| Ventricular fibrillation | 28 | 7.1 4.9–10.3ROR 7.1 · χ² 141 / p 8e-33 | 6.5 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · ♀ 0% (drug 46%) | no trial data cached |
| Toxic skin eruption | 25 | 7.0 4.7–10.4ROR 7.0 · χ² 123 / p 8e-29 | 6.3 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · 100% clinician | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 63 | 7.0 5.5–8.9ROR 7.0 · χ² 317 / p 4e-71 | 6.7 EB05 5.4 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 · 100% clinician | no trial data cached |
| Melaena (black stool) | 52 | 6.7 5.1–8.8ROR 6.7 · χ² 245 / p 2e-55 | 6.3 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Glycosylated haemoglobin increased | 55 | 6.2 4.8–8.0ROR 6.2 · χ² 234 / p 5e-53 | 5.9 EB05 4.7 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 6.8 | no trial data cached |
| Altered state of consciousness | 47 | 6.2 4.6–8.2ROR 6.2 · χ² 199 / p 2e-45 | 5.8 EB05 4.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 · 96% clinician | no trial data cached |
| Sinus bradycardia | 20 | 5.8 3.8–9.1ROR 5.9 · χ² 75 / p 2e-18 | 5.2 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 · 90% clinician | no trial data cached |
| Tubulointerstitial nephritis | 38 | 5.7 4.2–7.9ROR 5.8 · χ² 144 / p 2e-33 | 5.4 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 · 94% clinician | no trial data cached |
| Nocturia (night-time urination) | 24 | 5.6 3.8–8.4ROR 5.6 · χ² 86 / p 8e-21 | 5.1 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Hypothermia | 20 | 5.6 3.6–8.7ROR 5.6 · χ² 71 / p 2e-17 | 5.0 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Renal failure acute | 81 | 5.3 4.3–6.6ROR 5.4 · χ² 281 / p 3e-63 | 5.2 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.3 | no trial data cached |
| Gamma-glutamyltransferase increased | 41 | 5.2 3.9–7.1ROR 5.3 · χ² 136 / p 9e-32 | 4.9 EB05 3.8 · IC025 +1.8 3/3 methods agree | Lab value / disease marker | serious PRR 3.4 · ♀ 22% (drug 46%) | no trial data cached |
| Rhabdomyolysis (muscle breakdown) | 76 | 5.2 4.1–6.5ROR 5.2 · χ² 252 / p 6e-57 | 5.0 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 · 97% clinician | no trial data cached |
| Drug level increased | 30 | 5.1 3.6–7.3ROR 5.1 · χ² 96 / p 7e-23 | 4.8 EB05 3.5 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 3.5 · 97% clinician | no trial data cached |
| Encephalopathy | 44 | 5.1 3.8–6.8ROR 5.1 · χ² 140 / p 1e-32 | 4.8 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 · 91% clinician | no trial data cached |
| Septic shock | 77 | 5.0 4.0–6.3ROR 5.1 · χ² 246 / p 1e-55 | 4.9 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 · 95% clinician | no trial data cached |
| Transaminases increased | 39 | 5.0 3.6–6.8ROR 5.0 · χ² 120 / p 4e-28 | 4.7 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Cardiac failure (heart failure) | 141 | 5.0 4.2–5.9ROR 5.0 · χ² 444 / p 8e-99 | 4.9 EB05 4.2 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.1 | no trial data cached |
| Dysarthria (slurred speech) | 65 | 4.9 3.8–6.2ROR 4.9 · χ² 197 / p 4e-45 | 4.7 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 · 95% clinician | 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 |
|---|---|---|---|---|---|---|
| Hypoglycaemia (low blood sugar) | 794 | 47.0 44.0–50.2ROR 52.5 · χ² 35,201 / p <1e-300 | 46.2 EB05 43.6 · IC025 +5.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 32.0 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 558 | 10.4 9.6–11.3ROR 11.2 · χ² 4,745 / p <1e-300 | 10.3 EB05 9.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 · 94% clinician | no trial data cached |
| Drug interaction | 432 | 7.7 7.0–8.5ROR 8.1 · χ² 2,531 / p <1e-300 | 7.7 EB05 7.1 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 5.3 · 95% clinician | no trial data cached |
| Diarrhoea (diarrhea) | 385 | 1.7 1.5–1.9ROR 1.7 · χ² 112 / p 2e-26 | 1.7 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.7 | no trial data cached |
| Lactic acidosis | 368 | 32.8 29.7–36.2ROR 34.5 · χ² 11,197 / p <1e-300 | 32.4 EB05 29.7 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 20.2 · 94% clinician | no trial data cached |
| Dyspnoea (shortness of breath) | 287 | 1.4 1.3–1.6ROR 1.5 · χ² 38 / p 3e-10 | 1.4 EB05 1.3 · IC025 +0.3 | Not in label — unassessed | serious PRR 1.2 | no trial data cached |
| Asthenia (weakness) | 260 | 2.0 1.7–2.2ROR 2.0 · χ² 123 / p 9e-29 | 2.0 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | serious PRR 1.6 | no trial data cached |
| Anaemia (low red blood cells) | 248 | 3.7 3.3–4.2ROR 3.8 · χ² 485 / p 1e-107 | 3.7 EB05 3.3 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 | no trial data cached |
| Fall | 238 | 2.0 1.8–2.3ROR 2.1 · χ² 124 / p 4e-29 | 2.0 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | serious PRR 1.4 | no trial data cached |
| Blood glucose increased | 212 | 3.2 2.8–3.6ROR 3.2 · χ² 315 / p 7e-71 | 3.2 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.6 | no trial data cached |
| Hyperkalaemia (high potassium) | 198 | 16.1 14.1–18.5ROR 16.5 · χ² 2,783 / p <1e-300 | 16.0 EB05 14.2 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 10.2 · 94% clinician | no trial data cached |
| Hypotension (low blood pressure) | 182 | 2.6 2.2–3.0ROR 2.6 · χ² 175 / p 4e-40 | 2.6 EB05 2.3 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 1.9 | no trial data cached |
| Confusional state (confusion) | 181 | 3.2 2.7–3.7ROR 3.2 · χ² 267 / p 2e-60 | 3.1 EB05 2.8 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 2.5 | no trial data cached |
| Pruritus (itching) | 169 | 1.3 1.1–1.5ROR 1.3 · χ² 9 / p 0.001 | 1.3 EB05 1.1 · IC025 +0.1 | Labeled (related wording) related wording | serious PRR 1.6 | no trial data cached |
| Renal failure (kidney failure) | 165 | 3.5 3.0–4.1ROR 3.5 · χ² 292 / p 8e-66 | 3.5 EB05 3.0 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.2 | 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=368, PRR 32.8
- Sopor — n=80, PRR 17.0
- Hyperkalaemia — n=198, PRR 16.1
- Hepatocellular injury — n=56, PRR 11.2
- Acute kidney injury — n=558, PRR 10.4
- Hypomagnesaemia — n=48, PRR 9.8
- Ischaemic stroke — n=61, PRR 9.7
- Metabolic acidosis — n=100, PRR 9.0
- Eosinophilia — n=54, PRR 8.8
- Cholestasis — n=57, PRR 8.5
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 Repaglinide?
In FDA FAERS, the most frequently co-reported reaction terms for Repaglinide are hypoglycaemia, acute kidney injury, diarrhoea, lactic acidosis, dyspnoea, asthenia. 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 Repaglinide have an FDA boxed warning?
No. The FDA label retrieved for Repaglinide has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Repaglinide 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 7a93246c-9323-40c4-b590-a40dcb133c8c, effective 20230404; matched on
openfda.generic_name.exact:"REPAGLINIDE") - 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, 379 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.