Drug · FAERS side-effect profile with label screen
Sitagliptin and Metformin side effects: what 21,440 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Sitagliptin (Sitagliptin)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
21,440 reports · 65% serious · 2,107 with death outcome · 50% 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 (related wording) 2Likely indication confounding 13Reporting / coding artifact 1Lab value / disease marker 3Not in label — unassessed 21
What the badges mean
- 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. 1,130 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 |
|---|---|---|---|---|---|---|
| Flour sensitivity | 11 | 1,767.4 653.7–4,778.7ROR 1,768.3 · χ² 6,244 / p <1e-300 | 299.4 EB05 178.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial arm names this drug |
| Congenital great vessel anomaly | 11 | 303.0 153.9–596.5ROR 303.1 · χ² 2,294 / p <1e-300 | 165.2 EB05 98.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial arm names this drug |
| Blood lactic acid | 21 | 189.2 118.5–302.0ROR 189.4 · χ² 3,131 / p <1e-300 | 138.6 EB05 95.7 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=21 | no trial arm names this drug |
| Pneumobilia | 19 | 127.2 78.9–205.2ROR 127.3 · χ² 1,992 / p <1e-300 | 101.3 EB05 68.6 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial arm names this drug |
| Bile duct stent insertion | 38 | 109.0 78.0–152.4ROR 109.2 · χ² 3,558 / p <1e-300 | 93.6 EB05 71.2 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=38 · ♀ 29% (drug 50%) | no trial arm names this drug |
| Adenocarcinoma pancreas | 104 | 85.9 70.3–104.9ROR 86.3 · χ² 7,937 / p <1e-300 | 77.9 EB05 66.1 · IC025 +5.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=104 | no trial arm names this drug |
| Pancreatic carcinoma metastatic | 212 | 78.4 68.2–90.1ROR 79.1 · χ² 14,906 / p <1e-300 | 72.1 EB05 64.3 · IC025 +5.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=212 | no trial arm names this drug |
| Pancreaticoduodenectomy | 45 | 72.9 53.9–98.7ROR 73.1 · χ² 2,901 / p <1e-300 | 66.0 EB05 51.4 · IC025 +4.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=45 · ♀ 29% (drug 50%) | no trial arm names this drug |
| Insulin-requiring type 2 diabetes mellitus | 19 | 63.4 39.9–100.8ROR 63.4 · χ² 1,037 / p 9e-228 | 56.3 EB05 38.1 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious n=19 | no trial arm names this drug |
| Pancreatectomy | 27 | 51.6 35.1–76.0ROR 51.7 · χ² 1,225 / p 1e-268 | 47.5 EB05 34.3 · IC025 +4.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=27 · 72% consumer | no trial arm names this drug |
| Anaemia vitamin b12 deficiency | 20 | 41.6 26.6–65.0ROR 41.6 · χ² 720 / p 5e-159 | 38.5 EB05 26.3 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=19 | no trial arm names this drug |
| Anion gap abnormal | 11 | 41.4 22.7–75.7ROR 41.4 · χ² 378 / p 2e-84 | 37.4 EB05 22.3 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial arm names this drug |
| Tumour invasion | 15 | 31.6 18.9–52.9ROR 31.7 · χ² 402 / p 1e-89 | 29.6 EB05 19.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial arm names this drug |
| Hyperlipasaemia | 16 | 30.7 18.7–50.5ROR 30.7 · χ² 418 / p 4e-93 | 28.9 EB05 18.8 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial arm names this drug |
| Lung diffusion test decreased | 12 | 30.5 17.2–54.2ROR 30.5 · χ² 304 / p 2e-68 | 28.4 EB05 17.2 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial arm names this drug |
| Splenic vein thrombosis | 14 | 28.1 16.5–47.8ROR 28.1 · χ² 330 / p 5e-74 | 26.4 EB05 16.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial arm names this drug |
| Diabetic hyperosmolar coma | 12 | 27.6 15.6–49.0ROR 27.6 · χ² 274 / p 8e-62 | 25.8 EB05 15.6 · IC025 +2.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=12 | no trial arm names this drug |
| Diabetic metabolic decompensation | 37 | 26.8 19.4–37.2ROR 26.9 · χ² 870 / p 2e-191 | 25.8 EB05 19.6 · IC025 +3.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=36 · ♀ 24% (drug 50%) | no trial arm names this drug |
| Pancreatic neoplasm | 33 | 26.8 19.0–37.9ROR 26.8 · χ² 773 / p 2e-170 | 25.8 EB05 19.2 · IC025 +3.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=32 · ♀ 19% (drug 50%) | no trial arm names this drug |
| Splenectomy | 29 | 25.0 17.3–36.1ROR 25.0 · χ² 628 / p 6e-139 | 24.1 EB05 17.6 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=29 | no trial arm names this drug |
| Pancreatitis chronic | 56 | 23.8 18.3–31.1ROR 23.9 · χ² 1,173 / p 2e-257 | 23.1 EB05 18.5 · IC025 +3.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=56 | no trial arm names this drug |
| Diabetes mellitus inadequate control | 419 | 23.7 21.5–26.1ROR 24.1 · χ² 8,868 / p <1e-300 | 23.1 EB05 21.3 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 23.3 | no trial arm names this drug |
| Malignant ascites | 17 | 22.1 13.7–35.8ROR 22.2 · χ² 315 / p 8e-71 | 21.1 EB05 13.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial arm names this drug |
| Glycosylated haemoglobin abnormal | 26 | 21.9 14.9–32.4ROR 22.0 · χ² 488 / p 2e-108 | 21.2 EB05 15.1 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | serious n=13 | no trial arm names this drug |
| Radiotherapy | 39 | 20.3 14.8–27.9ROR 20.3 · χ² 683 / p 9e-151 | 19.7 EB05 15.0 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=39 | no trial arm names this drug |
| Pancreatic carcinoma | 588 | 20.2 18.6–21.9ROR 20.7 · χ² 10,495 / p <1e-300 | 19.8 EB05 18.5 · IC025 +4.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 17.6 | no trial arm names this drug |
| Adrenal adenoma | 12 | 20.0 11.3–35.5ROR 20.1 · χ² 195 / p 2e-44 | 18.8 EB05 10.8 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial arm names this drug |
| Diabetic complication | 51 | 19.8 15.0–26.2ROR 19.9 · χ² 875 / p 1e-192 | 19.3 EB05 15.2 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious n=50 · 86% consumer | no trial arm names this drug |
| Adrenal mass | 16 | 19.1 11.7–31.3ROR 19.1 · χ² 252 / p 5e-57 | 18.2 EB05 11.5 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial arm names this drug |
| Pancreatic mass | 19 | 17.8 11.3–28.1ROR 17.9 · χ² 280 / p 3e-63 | 17.1 EB05 11.2 · IC025 +2.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=17 | no trial arm names this drug |
| Lactic acidosis | 551 | 17.1 15.7–18.6ROR 17.5 · χ² 8,187 / p <1e-300 | 16.8 EB05 15.6 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 14.8 · 94% clinician | no trial arm names this drug |
| Metastases to peritoneum | 40 | 15.9 11.6–21.7ROR 15.9 · χ² 533 / p 3e-118 | 15.4 EB05 11.7 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=40 | no trial arm names this drug |
| Pancreatic cyst | 29 | 15.2 10.5–21.9ROR 15.2 · χ² 364 / p 2e-81 | 14.6 EB05 10.4 · IC025 +3.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=26 | no trial arm names this drug |
| Euglycaemic diabetic ketoacidosis | 58 | 14.4 11.1–18.7ROR 14.5 · χ² 701 / p 9e-155 | 14.1 EB05 11.2 · IC025 +3.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=58 · 100% clinician | no trial arm names this drug |
| Medication residue present | 70 | 14.3 11.3–18.1ROR 14.4 · χ² 843 / p 1e-185 | 14.0 EB05 11.4 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | serious n=11 | no trial arm names this drug |
| Anaemia of chronic disease | 13 | 14.3 8.2–24.6ROR 14.3 · χ² 145 / p 1e-33 | 12.8 EB05 7.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial arm names this drug |
| Blood glucose abnormal | 256 | 13.7 12.1–15.5ROR 13.9 · χ² 2,961 / p <1e-300 | 13.5 EB05 12.1 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious PRR 12.3 · 72% consumer | no trial arm names this drug |
| Bile duct obstruction | 26 | 13.4 9.1–19.7ROR 13.4 · χ² 282 / p 2e-63 | 12.7 EB05 8.8 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=26 | no trial arm names this drug |
| Hyperlactacidaemia | 35 | 13.1 9.4–18.3ROR 13.2 · χ² 375 / p 7e-84 | 12.6 EB05 9.3 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=35 · 100% clinician | no trial arm names this drug |
| Diabetic neuropathy | 66 | 13.1 10.3–16.7ROR 13.2 · χ² 718 / p 2e-158 | 12.8 EB05 10.3 · IC025 +3.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=63 | no trial arm names this drug |
Trial evidence (ClinicalTrials.gov)
No completed trial with posted adverse-event results was found on ClinicalTrials.gov for Sitagliptin and Metformin (searched SITAGLIPTIN).
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 |
|---|---|---|---|---|---|---|
| Blood glucose increased | 1,506 | 7.8 7.5–8.2ROR 8.4 · χ² 8,990 / p <1e-300 | 7.8 EB05 7.4 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.6 · 73% consumer | no trial arm names this drug |
| Diarrhoea (diarrhea) | 1,385 | 2.1 2.0–2.2ROR 2.2 · χ² 829 / p 1e-182 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.8 | no trial arm names this drug |
| Nausea | 1,100 | 1.4 1.3–1.4ROR 1.4 · χ² 111 / p 4e-26 | 1.4 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.4 | no trial arm names this drug |
| Drug ineffective (drug did not work) | 996 | 0.7 0.7–0.8ROR 0.7 · χ² 97 / p 3e-23 | 0.7 EB05 0.7 · IC025 -0.5 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.8 | no trial arm names this drug |
| Fatigue (tiredness) | 897 | 1.1 1.1–1.2ROR 1.1 · χ² 14 / p 1e-4 | 1.1 EB05 1.1 · IC025 +0.1 | Not in label — unassessed | serious PRR 1.2 | no trial arm names this drug |
| Acute kidney injury (sudden kidney damage) | 822 | 5.3 5.0–5.7ROR 5.5 · χ² 2,870 / p <1e-300 | 5.3 EB05 5.0 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.7 | no trial arm names this drug |
| Vomiting | 771 | 1.6 1.5–1.7ROR 1.6 · χ² 181 / p 1e-41 | 1.6 EB05 1.5 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 1.6 | no trial arm names this drug |
| Weight decreased (weight loss) | 712 | 2.5 2.3–2.7ROR 2.6 · χ² 646 / p 9e-143 | 2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.2 | no trial arm names this drug |
| Dizziness | 632 | 1.2 1.1–1.3ROR 1.2 · χ² 30 / p 2e-8 | 1.2 EB05 1.2 · IC025 +0.2 | Not in label — unassessed | serious PRR 1.2 | no trial arm names this drug |
| Pancreatitis (pancreas inflammation) | 626 | 11.7 10.8–12.6ROR 12.0 · χ² 6,055 / p <1e-300 | 11.5 EB05 10.8 · IC025 +3.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 10.4 | no trial arm names this drug |
| Dyspnoea (shortness of breath) | 618 | 1.1 1.0–1.2ROR 1.1 · χ² 3 / p 0.049 | 1.1 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 1.1 | no trial arm names this drug |
| Inappropriate schedule of drug administration | 617 | 8.4 7.8–9.1ROR 8.6 · χ² 4,009 / p <1e-300 | 8.3 EB05 7.8 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 17.9 · 77% consumer | no trial arm names this drug |
| No adverse event | 615 | 3.4 3.1–3.7ROR 3.5 · χ² 1,044 / p 2e-229 | 3.4 EB05 3.2 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 1.1 | no trial arm names this drug |
| Product dose omission issue | 599 | 2.1 1.9–2.2ROR 2.1 · χ² 329 / p 7e-74 | 2.1 EB05 1.9 · IC025 +0.9 | Reporting / coding artifact | serious PRR 1.5 · 74% consumer | no trial arm names this drug |
| Off label use (used outside approved label) | 597 | 0.7 0.6–0.7ROR 0.7 · χ² 99 / p 1e-23 | 0.7 EB05 0.6 · IC025 -0.7 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.8 | no trial arm names this drug |
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.
- Blood lactic acid — n=21, PRR 189.2
- Bile duct stent insertion — n=38, PRR 109.0
- Anaemia vitamin b12 deficiency — n=20, PRR 41.6
- Splenectomy — n=29, PRR 25.0
- Radiotherapy — n=39, PRR 20.3
- Lactic acidosis — n=551, PRR 17.1
- Metastases to peritoneum — n=40, PRR 15.9
- Bile duct obstruction — n=26, PRR 13.4
- Hyperlactacidaemia — n=35, PRR 13.1
✓ 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 and Metformin?
In FDA FAERS, the most frequently co-reported reaction terms for Sitagliptin and Metformin are blood glucose increased, diarrhoea, nausea, fatigue, acute kidney injury, vomiting. 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 and Metformin have an FDA boxed warning?
No. The FDA label retrieved for Sitagliptin and Metformin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Sitagliptin and Metformin 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, 1,170 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 - ClinicalTrials.gov API v2 (query
SITAGLIPTIN, results-bearing studies sorted by enrollment)
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.