Miglitol side effects: what 947 FDA adverse event reports show

Miglitol · 25 reaction terms · 404 drug–reaction co-reports · data 2026-09-14

Drug class

alpha-Glucosidase Inhibitor

FDA label (Established Pharmacologic Class)

Who reports

947 reports · 96% serious · 106 with death outcome · 39% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Miglitol tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

FDA label, Indications and Usage

What it is

DESCRIPTION Miglitol Tablets, an oral alpha-glucosidase inhibitor for use in the management of non-insulin-dependent diabetes mellitus (NIDDM). Miglitol is a desoxynojirimycin derivative, and is chemically known as 3,4,5-piperidinetriol, 1-(2-hydroxyethyl) -2-(hydroxymethyl)-, [2R-(2a,3ß,4a, 5ß)]-.

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 15 strongest signals

Labeled adverse reaction 2Likely indication confounding 1Lab value / disease marker 2Not in label — unassessed 10

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.
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.
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. 10 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
Diabetes mellitus inadequate control	25	31.3 21.3–46.1ROR 32.1 · χ² 703 / p 4e-155	30.6 EB05 21.8 · IC025 +3.6 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 22.0 · 92% clinician	no trial data cached
Hypoglycaemia (low blood sugar)	68	31.1 24.7–39.1ROR 33.4 · χ² 1,950 / p <1e-300	30.8 EB05 25.1 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 20.9	no trial data cached
Hepatic function abnormal	48	28.7 21.8–37.8ROR 30.2 · χ² 1,257 / p 1e-275	28.4 EB05 22.3 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 18.1 · 98% clinician	no trial data cached
Ileus	12	21.6 12.3–37.9ROR 21.9 · χ² 216 / p 4e-49	20.7 EB05 12.2 · IC025 +2.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 13.0	no trial data cached
Glycosylated haemoglobin increased	20	17.6 11.4–27.1ROR 17.9 · χ² 297 / p 9e-67	17.1 EB05 11.5 · IC025 +2.9 3/3 methods agree	Lab value / disease marker	serious PRR 22.7	no trial data cached
Diabetic ketoacidosis	19	17.6 11.3–27.4ROR 17.9 · χ² 281 / p 3e-63	17.1 EB05 11.3 · IC025 +2.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.5	no trial data cached
Liver disorder	34	17.0 12.2–23.7ROR 17.6 · χ² 497 / p 2e-110	16.8 EB05 12.5 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 12.0 · 91% clinician	no trial data cached
Cerebral infarction	18	16.3 10.3–25.8ROR 16.6 · χ² 244 / p 3e-55	15.7 EB05 10.1 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 9.8	no trial data cached
Disseminated intravascular coagulation	10	15.7 8.5–29.1ROR 15.8 · χ² 123 / p 6e-29	14.1 EB05 7.0 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 9.4	no trial data cached
Altered state of consciousness	15	15.4 9.3–25.5ROR 15.7 · χ² 188 / p 4e-43	14.6 EB05 8.7 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 9.3	no trial data cached
Hyperglycaemia (high blood sugar)	25	15.2 10.4–22.5ROR 15.6 · χ² 319 / p 1e-71	14.9 EB05 10.3 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 9.9 · 96% clinician	no trial data cached
Tubulointerstitial nephritis	12	14.2 8.1–24.9ROR 14.4 · χ² 134 / p 2e-31	12.8 EB05 6.9 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 8.5	no trial data cached
Gamma-glutamyltransferase increased	13	13.0 7.6–22.3ROR 13.2 · χ² 132 / p 7e-31	11.6 EB05 6.5 · IC025 +2.2 3/3 methods agree	Lab value / disease marker	serious PRR 7.5	no trial data cached
Lactic acidosis	14	9.7 5.7–16.3ROR 9.8 · χ² 100 / p 6e-24	8.2 EB05 4.9 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 5.8	no trial data cached
Interstitial lung disease	19	8.7 5.6–13.6ROR 8.9 · χ² 122 / p 1e-28	7.6 EB05 5.0 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 5.2	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)	68	31.1 24.7–39.1ROR 33.4 · χ² 1,950 / p <1e-300	30.8 EB05 25.1 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 20.9	no trial data cached
Hepatic function abnormal	48	28.7 21.8–37.8ROR 30.2 · χ² 1,257 / p 1e-275	28.4 EB05 22.3 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 18.1 · 98% clinician	no trial data cached
Liver disorder	34	17.0 12.2–23.7ROR 17.6 · χ² 497 / p 2e-110	16.8 EB05 12.5 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 12.0 · 91% clinician	no trial data cached
Hyperglycaemia (high blood sugar)	25	15.2 10.4–22.5ROR 15.6 · χ² 319 / p 1e-71	14.9 EB05 10.3 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 9.9 · 96% clinician	no trial data cached
Diabetes mellitus inadequate control	25	31.3 21.3–46.1ROR 32.1 · χ² 703 / p 4e-155	30.6 EB05 21.8 · IC025 +3.6 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 22.0 · 92% clinician	no trial data cached
Glycosylated haemoglobin increased	20	17.6 11.4–27.1ROR 17.9 · χ² 297 / p 9e-67	17.1 EB05 11.5 · IC025 +2.9 3/3 methods agree	Lab value / disease marker	serious PRR 22.7	no trial data cached
Interstitial lung disease	19	8.7 5.6–13.6ROR 8.9 · χ² 122 / p 1e-28	7.6 EB05 5.0 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 5.2	no trial data cached
Diabetic ketoacidosis	19	17.6 11.3–27.4ROR 17.9 · χ² 281 / p 3e-63	17.1 EB05 11.3 · IC025 +2.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.5	no trial data cached
Cerebral infarction	18	16.3 10.3–25.8ROR 16.6 · χ² 244 / p 3e-55	15.7 EB05 10.1 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 9.8	no trial data cached
Altered state of consciousness	15	15.4 9.3–25.5ROR 15.7 · χ² 188 / p 4e-43	14.6 EB05 8.7 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 9.3	no trial data cached
Lactic acidosis	14	9.7 5.7–16.3ROR 9.8 · χ² 100 / p 6e-24	8.2 EB05 4.9 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 5.8	no trial data cached
Gamma-glutamyltransferase increased	13	13.0 7.6–22.3ROR 13.2 · χ² 132 / p 7e-31	11.6 EB05 6.5 · IC025 +2.2 3/3 methods agree	Lab value / disease marker	serious PRR 7.5	no trial data cached
Tubulointerstitial nephritis	12	14.2 8.1–24.9ROR 14.4 · χ² 134 / p 2e-31	12.8 EB05 6.9 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 8.5	no trial data cached
Ileus	12	21.6 12.3–37.9ROR 21.9 · χ² 216 / p 4e-49	20.7 EB05 12.2 · IC025 +2.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 13.0	no trial data cached
Disseminated intravascular coagulation	10	15.7 8.5–29.1ROR 15.8 · χ² 123 / p 6e-29	14.1 EB05 7.0 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 9.4	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.

Hypoglycaemia — n=68, PRR 31.1
Hepatic function abnormal — n=48, PRR 28.7
Liver disorder — n=34, PRR 17.0
Hyperglycaemia — n=25, PRR 15.2

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 Miglitol?

In FDA FAERS, the most frequently co-reported reaction terms for Miglitol are hypoglycaemia, hepatic function abnormal, liver disorder, hyperglycaemia, diabetes mellitus inadequate control, glycosylated haemoglobin increased. 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 Miglitol have an FDA boxed warning?

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

Do FAERS signals prove that Miglitol 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 f16ecb50-e54e-43e1-8789-eaf5bc94f332, effective 20220401; matched on openfda.generic_name.exact:"MIGLITOL")
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, 25 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.