Drug · FAERS side-effect profile with label screen
Sitagliptin Phosphate side effects: what 2,672 FDA adverse event reports show
Drug class
Not stated in label
Who reports
2,672 reports · 91% serious · 233 with death outcome · 49% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Sitagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use Sitagliptin tablets should not be used in patients with type 1 diabetes. Sitagliptin has not been studied in patients with a history of pancreatitis.
FDA label, Indications and Usage
What it is
Sitagliptin tablets, USP contain sitagliptin phosphate, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Sitagliptin phosphate monohydrate is described chemically as 7-.
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) 2Likely indication confounding 5Lab value / disease marker 4Not in label — unassessed 27
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.
- 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. 69 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 | 113 | 50.4 42.0–60.4ROR 52.6 · χ² 5,390 / p <1e-300 | 49.7 EB05 42.5 · IC025 +5.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 37.2 | no trial data cached |
| Affect lability | 44 | 35.9 26.7–48.1ROR 36.5 · χ² 1,451 / p <1e-300 | 35.2 EB05 27.3 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 31.5 · ♀ 100% (drug 49%) · 95% clinician | no trial data cached |
| Motor dysfunction | 45 | 35.1 26.2–46.9ROR 35.6 · χ² 1,449 / p <1e-300 | 34.4 EB05 26.8 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 27.8 · ♀ 98% (drug 49%) · 96% clinician | no trial data cached |
| Muscle spasticity | 45 | 28.6 21.4–38.2ROR 29.0 · χ² 1,166 / p 6e-256 | 28.2 EB05 21.9 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 25.8 · ♀ 100% (drug 49%) · 93% clinician | no trial data cached |
| Skin haemorrhage | 46 | 25.1 18.8–33.4ROR 25.5 · χ² 1,037 / p 6e-228 | 24.8 EB05 19.3 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=46 · ♀ 100% (drug 49%) · 91% clinician | no trial data cached |
| Sinus congestion | 43 | 25.0 18.6–33.7ROR 25.4 · χ² 965 / p 4e-212 | 24.7 EB05 19.1 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=43 · ♀ 100% (drug 49%) · 95% clinician | no trial data cached |
| Coordination abnormal | 44 | 24.7 18.4–33.1ROR 25.0 · χ² 973 / p 8e-214 | 24.4 EB05 18.9 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 21.6 · ♀ 100% (drug 49%) · 95% clinician | no trial data cached |
| Respiratory tract congestion | 43 | 21.3 15.8–28.6ROR 21.6 · χ² 809 / p 3e-178 | 21.0 EB05 16.3 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 31.0 · ♀ 100% (drug 49%) · 95% clinician | no trial data cached |
| Hemiparesis | 46 | 21.2 15.9–28.3ROR 21.6 · χ² 865 / p 2e-190 | 21.0 EB05 16.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 14.5 · ♀ 98% (drug 49%) · 96% clinician | no trial data cached |
| Full blood count abnormal | 25 | 18.6 12.6–27.6ROR 18.8 · χ² 399 / p 4e-89 | 18.3 EB05 12.9 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious PRR 15.6 · ♀ 100% (drug 49%) | no trial data cached |
| Hypoglycaemia (low blood sugar) | 111 | 18.0 15.0–21.6ROR 18.7 · χ² 1,764 / p <1e-300 | 17.9 EB05 15.3 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.4 | no trial data cached |
| Sinus disorder | 43 | 17.0 12.7–22.9ROR 17.3 · χ² 633 / p 6e-140 | 16.9 EB05 13.0 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 23.2 · ♀ 100% (drug 49%) · 95% clinician | no trial data cached |
| Eating disorder | 44 | 16.2 12.1–21.7ROR 16.4 · χ² 611 / p 3e-135 | 16.0 EB05 12.3 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 14.3 · ♀ 100% (drug 49%) · 93% clinician | no trial data cached |
| Glycosylated haemoglobin increased | 50 | 15.6 11.9–20.5ROR 15.9 · χ² 668 / p 1e-147 | 15.4 EB05 12.1 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | serious PRR 21.0 | no trial data cached |
| Sneezing | 43 | 15.1 11.2–20.3ROR 15.3 · χ² 552 / p 2e-122 | 14.9 EB05 11.4 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 23.9 · ♀ 100% (drug 49%) · 95% clinician | no trial data cached |
| Hyperglycaemia (high blood sugar) | 66 | 14.3 11.3–18.1ROR 14.6 · χ² 802 / p 1e-176 | 14.1 EB05 11.4 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.2 | no trial data cached |
| Lactic acidosis | 57 | 14.0 10.8–18.1ROR 14.2 · χ² 673 / p 1e-148 | 13.8 EB05 10.9 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 · 95% clinician | no trial data cached |
| Aphasia (loss of speech) | 51 | 13.2 10.1–17.4ROR 13.5 · χ² 565 / p 4e-125 | 13.0 EB05 10.2 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 · ♀ 100% (drug 49%) · 92% clinician | no trial data cached |
| Angina pectoris | 46 | 12.5 9.4–16.7ROR 12.7 · χ² 477 / p 6e-106 | 12.2 EB05 9.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 · ♀ 93% (drug 49%) · 93% clinician | no trial data cached |
| Hyperkalaemia (high potassium) | 55 | 12.4 9.5–16.1ROR 12.6 · χ² 564 / p 5e-125 | 12.1 EB05 9.6 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 · 93% clinician | no trial data cached |
| Cystitis | 47 | 11.6 8.7–15.3ROR 11.7 · χ² 443 / p 1e-98 | 11.2 EB05 8.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 · ♀ 95% (drug 49%) · 94% clinician | no trial data cached |
| Diabetic ketoacidosis | 33 | 10.8 7.7–15.2ROR 10.9 · χ² 284 / p 4e-64 | 10.2 EB05 7.4 · IC025 +2.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 6.9 · ♀ 75% (drug 49%) | no trial data cached |
| Dysarthria (slurred speech) | 51 | 10.7 8.1–14.0ROR 10.8 · χ² 437 / p 3e-97 | 10.3 EB05 8.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 · ♀ 87% (drug 49%) · 90% clinician | no trial data cached |
| Hepatic cytolysis | 16 | 10.3 6.3–16.8ROR 10.3 · χ² 125 / p 3e-29 | 9.0 EB05 5.5 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Metabolic acidosis | 37 | 9.2 6.7–12.6ROR 9.3 · χ² 262 / p 4e-59 | 8.6 EB05 6.4 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 · 92% clinician | no trial data cached |
| Subdural haematoma | 15 | 8.2 5.0–13.6ROR 8.2 · χ² 88 / p 4e-21 | 6.9 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Type 2 diabetes mellitus | 35 | 8.1 5.9–11.3ROR 8.2 · χ² 212 / p 2e-48 | 7.5 EB05 5.6 · IC025 +2.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 5.3 · ♀ 94% (drug 49%) | no trial data cached |
| Inability to afford medication | 10 | 8.0 4.3–14.8ROR 8.0 · χ² 54 / p 9e-14 | 6.2 EB05 3.5 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Rhabdomyolysis (muscle breakdown) | 42 | 7.9 5.9–10.7ROR 8.0 · χ² 248 / p 4e-56 | 7.4 EB05 5.7 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 · 93% clinician | no trial data cached |
| Pancreatic carcinoma | 29 | 7.8 5.5–11.3ROR 7.9 · χ² 166 / p 2e-38 | 7.1 EB05 5.2 · IC025 +2.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 5.0 · 93% clinician | no trial data cached |
| Blood creatine phosphokinase increased | 29 | 7.8 5.4–11.2ROR 7.9 · χ² 165 / p 5e-38 | 7.1 EB05 5.1 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious PRR 5.5 · 93% clinician | no trial data cached |
| Altered state of consciousness | 21 | 7.7 5.0–11.7ROR 7.7 · χ² 115 / p 4e-27 | 6.7 EB05 4.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 · 90% clinician | no trial data cached |
| Pancreatitis acute | 21 | 7.4 4.8–11.3ROR 7.4 · χ² 110 / p 5e-26 | 6.5 EB05 4.4 · IC025 +2.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 4.7 · 100% clinician | no trial data cached |
| Bacteraemia | 10 | 6.7 3.6–12.4ROR 6.7 · χ² 43 / p 3e-11 | 5.3 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Pneumonia aspiration | 21 | 6.6 4.3–10.1ROR 6.7 · χ² 95 / p 1e-22 | 5.9 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Cholestasis (bile flow blockage) | 16 | 6.6 4.0–10.7ROR 6.6 · χ² 70 / p 3e-17 | 5.6 EB05 3.7 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Blood glucose abnormal | 15 | 6.4 3.8–10.5ROR 6.4 · χ² 63 / p 1e-15 | 5.4 EB05 3.5 · IC025 +1.6 3/3 methods agree | Lab value / disease marker | serious PRR 5.7 | no trial data cached |
| Drug eruption | 14 | 6.2 3.7–10.5ROR 6.3 · χ² 56 / p 3e-14 | 5.3 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Cataract | 47 | 6.2 4.7–8.3ROR 6.3 · χ² 201 / p 6e-46 | 5.9 EB05 4.6 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · ♀ 98% (drug 49%) | no trial data cached |
| Diabetes mellitus | 58 | 5.9 4.6–7.7ROR 6.1 · χ² 234 / p 3e-53 | 5.7 EB05 4.6 · IC025 +2.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 4.1 | 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 |
|---|---|---|---|---|---|---|
| Diabetes mellitus inadequate control | 113 | 50.4 42.0–60.4ROR 52.6 · χ² 5,390 / p <1e-300 | 49.7 EB05 42.5 · IC025 +5.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 37.2 | no trial data cached |
| Hypoglycaemia (low blood sugar) | 111 | 18.0 15.0–21.6ROR 18.7 · χ² 1,764 / p <1e-300 | 17.9 EB05 15.3 · IC025 +3.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.4 | no trial data cached |
| Blood glucose increased | 102 | 4.2 3.5–5.1ROR 4.4 · χ² 251 / p 9e-57 | 4.2 EB05 3.5 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.4 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 86 | 4.4 3.6–5.5ROR 4.5 · χ² 227 / p 2e-51 | 4.3 EB05 3.6 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.8 · 93% clinician | no trial data cached |
| Muscular weakness | 76 | 5.3 4.2–6.6ROR 5.4 · χ² 259 / p 2e-58 | 5.1 EB05 4.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 · ♀ 77% (drug 49%) | no trial data cached |
| Dysphagia (difficulty swallowing) | 66 | 5.5 4.3–6.9ROR 5.6 · χ² 238 / p 6e-54 | 5.3 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 · ♀ 85% (drug 49%) | no trial data cached |
| Hyperglycaemia (high blood sugar) | 66 | 14.3 11.3–18.1ROR 14.6 · χ² 802 / p 1e-176 | 14.1 EB05 11.4 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.2 | no trial data cached |
| Gastrointestinal disorder | 62 | 5.5 4.3–7.0ROR 5.6 · χ² 225 / p 4e-51 | 5.3 EB05 4.3 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.3 · ♀ 93% (drug 49%) · 95% clinician | no trial data cached |
| Cerebrovascular accident (stroke) | 59 | 2.7 2.1–3.5ROR 2.8 · χ² 63 / p 1e-15 | 2.7 EB05 2.2 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 1.7 · ♀ 83% (drug 49%) | no trial data cached |
| Diabetes mellitus | 58 | 5.9 4.6–7.7ROR 6.1 · χ² 234 / p 3e-53 | 5.7 EB05 4.6 · IC025 +2.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 4.1 | no trial data cached |
| Lactic acidosis | 57 | 14.0 10.8–18.1ROR 14.2 · χ² 673 / p 1e-148 | 13.8 EB05 10.9 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 · 95% clinician | no trial data cached |
| Palpitations (pounding heartbeat) | 56 | 3.8 2.9–4.9ROR 3.8 · χ² 111 / p 3e-26 | 3.7 EB05 2.9 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 · ♀ 91% (drug 49%) | no trial data cached |
| Rheumatoid arthritis | 55 | 3.8 2.9–5.0ROR 3.9 · χ² 112 / p 2e-26 | 3.7 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 · ♀ 86% (drug 49%) | no trial data cached |
| Hyperkalaemia (high potassium) | 55 | 12.4 9.5–16.1ROR 12.6 · χ² 564 / p 5e-125 | 12.1 EB05 9.6 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 · 93% clinician | no trial data cached |
| Dysarthria (slurred speech) | 51 | 10.7 8.1–14.0ROR 10.8 · χ² 437 / p 3e-97 | 10.3 EB05 8.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 · ♀ 87% (drug 49%) · 90% 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.
- Affect lability — n=44, PRR 35.9
- Motor dysfunction — n=45, PRR 35.1
- Muscle spasticity — n=45, PRR 28.6
- Skin haemorrhage — n=46, PRR 25.1
- Sinus congestion — n=43, PRR 25.0
- Coordination abnormal — n=44, PRR 24.7
- Respiratory tract congestion — n=43, PRR 21.3
- Hemiparesis — n=46, PRR 21.2
- Sinus disorder — n=43, PRR 17.0
- Eating disorder — n=44, PRR 16.2
✓ A hand-written Bradford Hill causality assessment exists for this drug: Sitagliptin (DPP-4 inhibitors) ↔ Pancreatitis.
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 Sitagliptin?
In FDA FAERS, the most frequently co-reported reaction terms for Sitagliptin are diabetes mellitus inadequate control, hypoglycaemia, blood glucose increased, acute kidney injury, muscular weakness, dysphagia. 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 Sitagliptin have an FDA boxed warning?
No. The FDA label retrieved for Sitagliptin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Sitagliptin 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 58e23b30-451c-f451-e063-6394a90a35a7, effective 20260812; matched on
openfda.generic_name.exact:"SITAGLIPTIN") - 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, 109 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.