Drug · FAERS side-effect profile with label screen
Acarbose side effects: what 3,847 FDA adverse event reports show
Drug class
alpha-Glucosidase Inhibitor
FDA label (Established Pharmacologic Class)
Who reports
3,847 reports · 86% serious · 316 with death outcome · 51% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Acarbose 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 Acarbose Tablets are an oral alpha-glucosidase inhibitor for use in the management of type 2 diabetes mellitus. Acarbose is an oligosaccharide which is obtained from fermentation p.
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 1Likely indication confounding 1Lab value / disease marker 7Not in label — unassessed 31
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. 179 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 |
|---|---|---|---|---|---|---|
| Diabetes mellitus inadequate control | 102 | 31.6 26.1–38.3ROR 32.4 · χ² 2,974 / p <1e-300 | 31.2 EB05 26.5 · IC025 +4.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 24.3 | no trial data cached |
| Hypoglycaemia (low blood sugar) | 275 | 31.1 27.7–34.8ROR 33.4 · χ² 7,941 / p <1e-300 | 30.8 EB05 27.9 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 22.3 | no trial data cached |
| Lactic acidosis | 107 | 18.2 15.1–22.0ROR 18.7 · χ² 1,722 / p <1e-300 | 18.1 EB05 15.4 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 12.1 · 92% clinician | no trial data cached |
| Parkinsonism | 26 | 14.6 9.9–21.4ROR 14.7 · χ² 314 / p 1e-70 | 14.1 EB05 9.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 11.2 · ♀ 75% (drug 51%) · 100% clinician | no trial data cached |
| Cerebral infarction | 64 | 14.3 11.2–18.2ROR 14.5 · χ² 777 / p 2e-171 | 14.1 EB05 11.4 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 | no trial data cached |
| Blood glucose abnormal | 48 | 14.2 10.7–18.8ROR 14.3 · χ² 573 / p 6e-127 | 13.9 EB05 10.8 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious PRR 18.5 · 81% consumer | no trial data cached |
| Diabetic ketoacidosis | 57 | 13.0 10.0–16.8ROR 13.2 · χ² 618 / p 1e-136 | 12.8 EB05 10.1 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.7 | no trial data cached |
| Hyperkalaemia (high potassium) | 81 | 12.7 10.2–15.7ROR 12.9 · χ² 859 / p 4e-189 | 12.5 EB05 10.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 · 96% clinician | no trial data cached |
| Melaena (black stool) | 51 | 12.6 9.6–16.6ROR 12.8 · χ² 534 / p 2e-118 | 12.4 EB05 9.6 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 · 96% clinician | no trial data cached |
| Hypotonia | 23 | 12.5 8.3–18.8ROR 12.6 · χ² 232 / p 1e-52 | 11.8 EB05 7.9 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 · ♀ 100% (drug 51%) · 100% clinician | no trial data cached |
| Motor dysfunction | 22 | 11.9 7.8–18.0ROR 11.9 · χ² 208 / p 2e-47 | 11.1 EB05 7.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 · ♀ 100% (drug 51%) · 100% clinician | no trial data cached |
| Initial insomnia | 22 | 11.8 7.8–17.9ROR 11.8 · χ² 206 / p 5e-47 | 11.0 EB05 7.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=21 · ♀ 90% (drug 51%) · 95% clinician | no trial data cached |
| Muscle rigidity | 24 | 11.0 7.4–16.3ROR 11.0 · χ² 207 / p 3e-47 | 10.2 EB05 6.9 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 · ♀ 100% (drug 51%) · 100% clinician | no trial data cached |
| Hiatus hernia | 25 | 10.5 7.1–15.6ROR 10.6 · χ² 206 / p 6e-47 | 9.7 EB05 6.6 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 · ♀ 100% (drug 51%) · 91% clinician | no trial data cached |
| Blood glucose fluctuation | 21 | 10.4 6.8–16.0ROR 10.5 · χ² 169 / p 5e-39 | 9.5 EB05 6.2 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious n=17 | no trial data cached |
| Hyperglycaemia (high blood sugar) | 64 | 9.6 7.5–12.3ROR 9.8 · χ² 486 / p 6e-108 | 9.3 EB05 7.5 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Blood urea increased | 28 | 9.1 6.3–13.1ROR 9.1 · χ² 193 / p 3e-44 | 8.3 EB05 5.9 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 6.5 · ♀ 89% (drug 51%) · 93% clinician | no trial data cached |
| Renal tubular necrosis | 15 | 8.3 5.0–13.8ROR 8.4 · χ² 89 / p 2e-21 | 7.0 EB05 4.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Hypomagnesaemia | 20 | 7.9 5.1–12.2ROR 7.9 · χ² 113 / p 1e-26 | 6.9 EB05 4.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 · 95% clinician | no trial data cached |
| Hypocalcaemia (low calcium) | 27 | 7.8 5.4–11.4ROR 7.9 · χ² 153 / p 2e-35 | 7.1 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 · ♀ 78% (drug 51%) · 96% clinician | no trial data cached |
| Hyperlipidaemia | 17 | 7.7 4.8–12.4ROR 7.8 · χ² 93 / p 3e-22 | 6.6 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Renal failure acute | 57 | 7.2 5.6–9.4ROR 7.3 · χ² 300 / p 2e-67 | 6.9 EB05 5.5 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · 91% clinician | no trial data cached |
| Glycosylated haemoglobin increased | 32 | 6.9 4.9–9.8ROR 7.0 · χ² 157 / p 3e-36 | 6.4 EB05 4.7 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 7.5 | no trial data cached |
| Pancreatitis acute | 28 | 6.8 4.7–9.9ROR 6.9 · χ² 134 / p 3e-31 | 6.2 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · ♀ 74% (drug 51%) · 92% clinician | no trial data cached |
| Metabolic acidosis | 39 | 6.7 4.9–9.2ROR 6.8 · χ² 184 / p 3e-42 | 6.3 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 · 97% clinician | no trial data cached |
| Electrolyte imbalance | 14 | 6.6 3.9–11.2ROR 6.7 · χ² 62 / p 2e-15 | 5.6 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Altered state of consciousness | 25 | 6.3 4.3–9.4ROR 6.4 · χ² 107 / p 2e-25 | 5.7 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Coronary artery disease | 35 | 6.3 4.5–8.7ROR 6.3 · χ² 149 / p 1e-34 | 5.8 EB05 4.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 20 | 6.3 4.0–9.7ROR 6.3 · χ² 83 / p 4e-20 | 5.5 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 · 100% clinician | no trial data cached |
| Vitamin d deficiency | 11 | 6.2 3.4–11.1ROR 6.2 · χ² 42 / p 4e-11 | 5.0 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Cardiogenic shock | 16 | 6.1 3.8–10.0ROR 6.1 · χ² 63 / p 8e-16 | 5.3 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Sedation | 29 | 6.1 4.2–8.7ROR 6.1 · χ² 118 / p 1e-27 | 5.6 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 · ♀ 81% (drug 51%) · 100% clinician | no trial data cached |
| Blood potassium increased | 18 | 6.1 3.8–9.6ROR 6.1 · χ² 71 / p 2e-17 | 5.3 EB05 3.5 · IC025 +1.6 3/3 methods agree | Lab value / disease marker | serious PRR 5.2 | no trial data cached |
| Blood glucose increased | 206 | 5.9 5.2–6.8ROR 6.2 · χ² 848 / p 8e-187 | 5.9 EB05 5.2 · IC025 +2.3 3/3 methods agree | Lab value / disease marker | serious PRR 7.9 · 79% consumer | no trial data cached |
| Drug eruption | 19 | 5.9 3.8–9.2ROR 5.9 · χ² 72 / p 1e-17 | 5.2 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Subarachnoid haemorrhage | 11 | 5.9 3.3–10.6ROR 5.9 · χ² 40 / p 1e-10 | 4.8 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Drug-induced liver injury | 33 | 5.8 4.2–8.2ROR 5.9 · χ² 128 / p 7e-30 | 5.4 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Arteriosclerosis | 10 | 5.8 3.1–10.7ROR 5.8 · χ² 35 / p 2e-9 | 4.7 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Dysuria (painful urination) | 39 | 5.8 4.2–7.9ROR 5.8 · χ² 149 / p 1e-34 | 5.4 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 · ♀ 75% (drug 51%) | no trial data cached |
| Blood glucose decreased | 51 | 5.8 4.4–7.6ROR 5.8 · χ² 197 / p 5e-45 | 5.5 EB05 4.3 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious PRR 6.7 · 73% consumer | 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) | 275 | 31.1 27.7–34.8ROR 33.4 · χ² 7,941 / p <1e-300 | 30.8 EB05 27.9 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 22.3 | no trial data cached |
| Blood glucose increased | 206 | 5.9 5.2–6.8ROR 6.2 · χ² 848 / p 8e-187 | 5.9 EB05 5.2 · IC025 +2.3 3/3 methods agree | Lab value / disease marker | serious PRR 7.9 · 79% consumer | no trial data cached |
| Drug interaction | 145 | 5.0 4.2–5.8ROR 5.1 · χ² 461 / p 1e-102 | 4.9 EB05 4.3 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 3.7 · 96% clinician | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 141 | 5.0 4.3–5.9ROR 5.2 · χ² 457 / p 1e-101 | 5.0 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 · 91% clinician | no trial data cached |
| Lactic acidosis | 107 | 18.2 15.1–22.0ROR 18.7 · χ² 1,722 / p <1e-300 | 18.1 EB05 15.4 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 12.1 · 92% clinician | no trial data cached |
| Diabetes mellitus inadequate control | 102 | 31.6 26.1–38.3ROR 32.4 · χ² 2,974 / p <1e-300 | 31.2 EB05 26.5 · IC025 +4.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 24.3 | no trial data cached |
| Oedema peripheral (swelling of legs/feet) | 83 | 3.7 3.0–4.6ROR 3.8 · χ² 162 / p 2e-37 | 3.6 EB05 3.0 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.9 | no trial data cached |
| Hyperkalaemia (high potassium) | 81 | 12.7 10.2–15.7ROR 12.9 · χ² 859 / p 4e-189 | 12.5 EB05 10.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 · 96% clinician | no trial data cached |
| Gastrointestinal disorder | 68 | 4.2 3.3–5.3ROR 4.3 · χ² 163 / p 1e-37 | 4.1 EB05 3.3 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.7 · ♀ 80% (drug 51%) · 95% clinician | no trial data cached |
| Hyperglycaemia (high blood sugar) | 64 | 9.6 7.5–12.3ROR 9.8 · χ² 486 / p 6e-108 | 9.3 EB05 7.5 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Cerebral infarction | 64 | 14.3 11.2–18.2ROR 14.5 · χ² 777 / p 2e-171 | 14.1 EB05 11.4 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 | no trial data cached |
| Cardiac failure (heart failure) | 60 | 4.1 3.2–5.2ROR 4.1 · χ² 136 / p 8e-32 | 4.0 EB05 3.2 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 | no trial data cached |
| Chronic kidney disease | 60 | 4.3 3.3–5.5ROR 4.3 · χ² 147 / p 3e-34 | 4.1 EB05 3.3 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 | no trial data cached |
| Atrial fibrillation | 57 | 3.2 2.5–4.1ROR 3.2 · χ² 84 / p 3e-20 | 3.1 EB05 2.5 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.2 · ♀ 75% (drug 51%) | no trial data cached |
| Renal impairment | 57 | 3.7 2.9–4.8ROR 3.8 · χ² 111 / p 3e-26 | 3.6 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 | 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=275, PRR 31.1
- Lactic acidosis — n=107, PRR 18.2
- Parkinsonism — n=26, PRR 14.6
- Cerebral infarction — n=64, PRR 14.3
- Hyperkalaemia — n=81, PRR 12.7
- Melaena — n=51, PRR 12.6
- Hypotonia — n=23, PRR 12.5
- Motor dysfunction — n=22, PRR 11.9
- Initial insomnia — n=22, PRR 11.8
- Muscle rigidity — n=24, PRR 11.0
✓ A hand-written Bradford Hill causality assessment exists for this drug: Acarbose ↔ Gastrointestinal disorder.
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 Acarbose?
In FDA FAERS, the most frequently co-reported reaction terms for Acarbose are hypoglycaemia, blood glucose increased, acute kidney injury, lactic acidosis, diabetes mellitus inadequate control, oedema peripheral. 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 Acarbose have an FDA boxed warning?
No. The FDA label retrieved for Acarbose has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Acarbose 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 1ba7a072-03b0-41f2-be7a-101145bdef3a, effective 20260811; matched on
openfda.generic_name.exact:"ACARBOSE") - 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, 219 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.