Drug · FAERS side-effect profile with label screen
Alogliptin side effects: what 3,408 FDA adverse event reports show
Drug class
Not stated in label
Who reports
3,408 reports · 88% serious · 357 with death outcome · 42% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Alogliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Alogliptin tablets are a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use: Should not be used in patients with type 1 diabetes mellitus.
FDA label, Indications and Usage
What it is
Alogliptin tablets contain the active ingredient alogliptin, which is a selective, orally bioavailable inhibitor of the enzymatic activity of DPP-4.
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 8Labeled (related wording) 5Likely indication confounding 2Lab value / disease marker 2Outcome field, not a reaction 1Not in label — unassessed 22
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.
- 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. 96 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 |
|---|---|---|---|---|---|---|
| Cerebral infarction | 72 | 18.2 14.4–22.8ROR 18.5 · χ² 1,148 / p 5e-252 | 18.0 EB05 14.8 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 11.9 · 90% clinician | no trial data cached |
| Erythema multiforme | 22 | 14.5 9.6–22.1ROR 14.6 · χ² 264 / p 1e-59 | 14.0 EB05 9.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 · ♀ 67% (drug 42%) · 100% clinician | no trial data cached |
| Diabetic ketoacidosis | 52 | 13.4 10.2–17.5ROR 13.6 · χ² 582 / p 6e-129 | 13.1 EB05 10.3 · IC025 +3.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 8.8 | no trial data cached |
| Body temperature decreased | 21 | 13.0 8.5–20.0ROR 13.1 · χ² 221 / p 3e-50 | 12.3 EB05 8.0 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious PRR 9.5 | no trial data cached |
| Pancreatitis acute | 47 | 13.0 9.8–17.2ROR 13.1 · χ² 507 / p 1e-112 | 12.7 EB05 9.8 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.5 · 100% clinician | no trial data cached |
| Lactic acidosis | 49 | 9.4 7.1–12.4ROR 9.5 · χ² 360 / p 2e-80 | 9.0 EB05 7.0 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 · 91% clinician | no trial data cached |
| Interstitial lung disease | 73 | 9.3 7.4–11.7ROR 9.5 · χ² 533 / p 3e-118 | 9.0 EB05 7.3 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.2 · 94% clinician | no trial data cached |
| Drug eruption | 26 | 9.1 6.2–13.3ROR 9.1 · χ² 179 / p 4e-41 | 8.3 EB05 5.8 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 · 92% clinician | no trial data cached |
| Disseminated intravascular coagulation | 20 | 8.7 5.6–13.5ROR 8.8 · χ² 129 / p 3e-30 | 7.7 EB05 5.1 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Diabetes mellitus inadequate control | 24 | 8.3 5.6–12.4ROR 8.4 · χ² 148 / p 3e-34 | 7.5 EB05 5.2 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.4 | no trial data cached |
| Hypoglycaemia (low blood sugar) | 63 | 8.0 6.3–10.2ROR 8.1 · χ² 379 / p 1e-84 | 7.7 EB05 6.2 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.6 | no trial data cached |
| Colon cancer | 19 | 7.8 5.0–12.3ROR 7.9 · χ² 106 / p 3e-25 | 6.8 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Altered state of consciousness | 27 | 7.7 5.3–11.2ROR 7.8 · χ² 151 / p 5e-35 | 7.0 EB05 5.0 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 · 100% clinician | no trial data cached |
| Sudden death | 13 | 7.5 4.3–12.9ROR 7.5 · χ² 67 / p 2e-16 | 6.2 EB05 3.8 · IC025 +1.7 3/3 methods agree | Outcome field, not a reaction | serious PRR 4.9 | no trial data cached |
| Hepatic function abnormal | 43 | 7.1 5.3–9.6ROR 7.2 · χ² 221 / p 2e-50 | 6.7 EB05 5.2 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.1 · 95% clinician | no trial data cached |
| Glycosylated haemoglobin increased | 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 | Lab value / disease marker | serious PRR 8.0 | no trial data cached |
| Cholecystitis | 13 | 6.7 3.9–11.6ROR 6.8 · χ² 58 / p 1e-14 | 5.6 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Ileus | 13 | 6.5 3.8–11.2ROR 6.5 · χ² 55 / p 6e-14 | 5.4 EB05 3.3 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 | no trial data cached |
| Pancreatitis (pancreas inflammation) | 53 | 6.2 4.7–8.1ROR 6.2 · χ² 225 / p 5e-51 | 5.9 EB05 4.7 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 | no trial data cached |
| Circulatory collapse | 17 | 6.1 3.8–9.8ROR 6.1 · χ² 68 / p 9e-17 | 5.3 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Pancreatic carcinoma | 28 | 5.9 4.1–8.6ROR 6.0 · χ² 110 / p 5e-26 | 5.4 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Drug-induced liver injury | 29 | 5.8 4.0–8.3ROR 5.8 · χ² 110 / p 4e-26 | 5.3 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 · 93% clinician | no trial data cached |
| Hyperkalaemia (high potassium) | 32 | 5.6 4.0–8.0ROR 5.7 · χ² 118 / p 1e-27 | 5.2 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 · 97% clinician | no trial data cached |
| Hyperglycaemia (high blood sugar) | 32 | 5.4 3.8–7.7ROR 5.5 · χ² 111 / p 3e-26 | 5.0 EB05 3.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 · ♀ 63% (drug 42%) · 91% clinician | no trial data cached |
| Tuberculosis | 11 | 5.3 2.9–9.5ROR 5.3 · χ² 34 / p 3e-9 | 4.4 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Angina pectoris | 24 | 5.1 3.4–7.6ROR 5.1 · χ² 76 / p 2e-18 | 4.7 EB05 3.3 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 · ♀ 12% (drug 42%) · 92% clinician | no trial data cached |
| Acute myocardial infarction | 24 | 5.0 3.3–7.4ROR 5.0 · χ² 73 / p 8e-18 | 4.6 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Hepatic steatosis | 15 | 5.0 3.0–8.2ROR 5.0 · χ² 44 / p 2e-11 | 4.4 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Melaena (black stool) | 17 | 4.7 3.0–7.6ROR 4.8 · χ² 47 / p 4e-12 | 4.2 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Rhabdomyolysis (muscle breakdown) | 32 | 4.7 3.4–6.7ROR 4.8 · χ² 91 / p 9e-22 | 4.4 EB05 3.3 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.1 · 100% clinician | no trial data cached |
| Gastric cancer | 19 | 4.6 2.9–7.1ROR 4.6 · χ² 49 / p 1e-12 | 4.1 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 | no trial data cached |
| Diabetes mellitus | 55 | 4.4 3.4–5.7ROR 4.5 · χ² 143 / p 4e-33 | 4.3 EB05 3.4 · IC025 +1.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 3.2 | no trial data cached |
| Tubulointerstitial nephritis | 13 | 4.3 2.5–7.3ROR 4.3 · χ² 29 / p 3e-8 | 3.8 EB05 2.4 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 | no trial data cached |
| Pulmonary arterial hypertension | 10 | 4.2 2.3–7.8ROR 4.2 · χ² 21 / p 2e-6 | 3.6 EB05 2.1 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 | no trial data cached |
| Stevens-johnson syndrome (severe blistering skin reaction) | 15 | 4.1 2.5–6.9ROR 4.2 · χ² 33 / p 5e-9 | 3.7 EB05 2.4 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.7 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 102 | 4.1 3.4–5.0ROR 4.2 · χ² 240 / p 2e-54 | 4.0 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.7 | no trial data cached |
| Hypokalaemia (low potassium) | 30 | 4.0 2.8–5.7ROR 4.0 · χ² 65 / p 3e-16 | 3.8 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 · 100% clinician | no trial data cached |
| Cardiac failure (heart failure) | 52 | 4.0 3.0–5.2ROR 4.0 · χ² 114 / p 8e-27 | 3.9 EB05 3.1 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.6 | no trial data cached |
| Renal impairment | 54 | 4.0 3.0–5.2ROR 4.0 · χ² 117 / p 1e-27 | 3.9 EB05 3.1 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.7 · 92% clinician | no trial data cached |
| Pneumonia aspiration | 16 | 4.0 2.4–6.4ROR 4.0 · χ² 32 / p 6e-9 | 3.6 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 | 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 |
|---|---|---|---|---|---|---|
| Acute kidney injury (sudden kidney damage) | 102 | 4.1 3.4–5.0ROR 4.2 · χ² 240 / p 2e-54 | 4.0 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.7 | no trial data cached |
| Blood glucose increased | 84 | 2.7 2.2–3.4ROR 2.8 · χ² 91 / p 6e-22 | 2.7 EB05 2.3 · IC025 +1.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.0 | no trial data cached |
| Interstitial lung disease | 73 | 9.3 7.4–11.7ROR 9.5 · χ² 533 / p 3e-118 | 9.0 EB05 7.3 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.2 · 94% clinician | no trial data cached |
| Cerebral infarction | 72 | 18.2 14.4–22.8ROR 18.5 · χ² 1,148 / p 5e-252 | 18.0 EB05 14.8 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 11.9 · 90% clinician | no trial data cached |
| Hypoglycaemia (low blood sugar) | 63 | 8.0 6.3–10.2ROR 8.1 · χ² 379 / p 1e-84 | 7.7 EB05 6.2 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.6 | no trial data cached |
| Platelet count decreased | 55 | 3.2 2.4–4.1ROR 3.2 · χ² 80 / p 2e-19 | 3.1 EB05 2.5 · IC025 +1.2 3/3 methods agree | Lab value / disease marker | serious PRR 2.4 | no trial data cached |
| Diabetes mellitus | 55 | 4.4 3.4–5.7ROR 4.5 · χ² 143 / p 4e-33 | 4.3 EB05 3.4 · IC025 +1.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 3.2 | no trial data cached |
| Renal impairment | 54 | 4.0 3.0–5.2ROR 4.0 · χ² 117 / p 1e-27 | 3.9 EB05 3.1 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.7 · 92% clinician | no trial data cached |
| Pancreatitis (pancreas inflammation) | 53 | 6.2 4.7–8.1ROR 6.2 · χ² 225 / p 5e-51 | 5.9 EB05 4.7 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 | no trial data cached |
| Cardiac failure (heart failure) | 52 | 4.0 3.0–5.2ROR 4.0 · χ² 114 / p 8e-27 | 3.9 EB05 3.1 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.6 | no trial data cached |
| Diabetic ketoacidosis | 52 | 13.4 10.2–17.5ROR 13.6 · χ² 582 / p 6e-129 | 13.1 EB05 10.3 · IC025 +3.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 8.8 | no trial data cached |
| Lactic acidosis | 49 | 9.4 7.1–12.4ROR 9.5 · χ² 360 / p 2e-80 | 9.0 EB05 7.0 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 · 91% clinician | no trial data cached |
| Pancreatitis acute | 47 | 13.0 9.8–17.2ROR 13.1 · χ² 507 / p 1e-112 | 12.7 EB05 9.8 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.5 · 100% clinician | no trial data cached |
| Hepatic function abnormal | 43 | 7.1 5.3–9.6ROR 7.2 · χ² 221 / p 2e-50 | 6.7 EB05 5.2 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.1 · 95% clinician | no trial data cached |
| Blood creatinine increased | 39 | 3.7 2.7–5.0ROR 3.7 · χ² 73 / p 6e-18 | 3.5 EB05 2.7 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.8 · 94% clinician | 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.
- Cerebral infarction — n=72, PRR 18.2
- Erythema multiforme — n=22, PRR 14.5
- Lactic acidosis — n=49, PRR 9.4
- Drug eruption — n=26, PRR 9.1
- Disseminated intravascular coagulation — n=20, PRR 8.7
- Altered state of consciousness — n=27, PRR 7.7
- Pancreatic carcinoma — n=28, PRR 5.9
- Drug-induced liver injury — n=29, PRR 5.8
- Hyperkalaemia — n=32, PRR 5.6
- Hyperglycaemia — n=32, PRR 5.4
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 Alogliptin?
In FDA FAERS, the most frequently co-reported reaction terms for Alogliptin are acute kidney injury, blood glucose increased, interstitial lung disease, cerebral infarction, hypoglycaemia, platelet count decreased. 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 Alogliptin have an FDA boxed warning?
No. The FDA label retrieved for Alogliptin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Alogliptin 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 b25f155a-1259-47c2-aa3b-7c1356e4c7f6, effective 20250411; matched on
openfda.generic_name.exact:"ALOGLIPTIN") - 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, 136 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.