Linagliptin side effects: what 18,129 FDA adverse event reports show

Linagliptin · Tradjenta · 1,140 reaction terms · 83,133 drug–reaction co-reports · data 2026-09-14

Drug class

Dipeptidyl Peptidase 4 Inhibitor

FDA label (Established Pharmacologic Class)

Brand names

Tradjenta

openFDA label

Who reports

18,129 reports · 70% serious · 1,687 with death outcome · 51% female

openFDA FAERS counts, all years, deduplication not applied

Used for

TRADJENTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus . TRADJENTA is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic con.

FDA label, Indications and Usage

What it is

TRADJENTA tablets for oral use contain linagliptin, an inhibitor of the DPP-4 enzyme.

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 2Likely indication confounding 1Reporting / coding artifact 1Lab value / disease marker 5Not 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.
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. 1,100 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
Cardiospasm	389	2,737.9 2,280.8–3,286.8ROR 2,798.0 · χ² 312,114 / p <1e-300	774.7 EB05 712.2 · IC025 +8.5 3/3 methods agree	Not in label — unassessed	serious n=389	no trial arm names this drug
Immunisation	255	1,680.7 1,386.4–2,037.5ROR 1,704.6 · χ² 172,350 / p <1e-300	646.7 EB05 582.8 · IC025 +8.0 3/3 methods agree	Not in label — unassessed	serious n=255	no trial arm names this drug
Palmoplantar keratoderma	383	1,331.4 1,149.7–1,541.8ROR 1,360.1 · χ² 234,285 / p <1e-300	596.3 EB05 547.9 · IC025 +8.2 3/3 methods agree	Not in label — unassessed	serious n=383	no trial arm names this drug
5-hydroxyindolacetic acid increased	20	530.3 312.1–901.3ROR 530.9 · χ² 6,855 / p <1e-300	269.2 EB05 184.0 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious n=20 · ♀ 0% (drug 51%)	no trial arm names this drug
Blood mercury abnormal	28	462.7 298.3–717.7ROR 463.4 · χ² 8,850 / p <1e-300	269.0 EB05 195.3 · IC025 +5.0 3/3 methods agree	Lab value / disease marker	serious n=28 · ♀ 0% (drug 51%)	no trial arm names this drug
Urine calcium/creatinine ratio increased	17	430.8 246.6–752.4ROR 431.2 · χ² 4,983 / p <1e-300	231.7 EB05 153.2 · IC025 +4.2 3/3 methods agree	Lab value / disease marker	serious n=17	no trial arm names this drug
Urethral caruncle	16	380.1 215.9–669.1ROR 380.4 · χ² 4,257 / p <1e-300	213.0 EB05 139.0 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious n=16	no trial arm names this drug
Cystostomy	14	380.1 207.6–695.8ROR 380.4 · χ² 3,690 / p <1e-300	205.6 EB05 130.2 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=14	no trial arm names this drug
Pulmonary valve disease	25	274.1 177.2–424.0ROR 274.5 · χ² 5,266 / p <1e-300	189.4 EB05 134.9 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=25 · ♀ 0% (drug 51%) · 100% clinician	no trial arm names this drug
Atrial tachycardia	391	263.6 236.4–294.0ROR 269.4 · χ² 82,888 / p <1e-300	212.1 EB05 195.0 · IC025 +7.2 3/3 methods agree	Not in label — unassessed	serious n=391	no trial arm names this drug
Pruritus genital	388	231.5 207.8–258.0ROR 236.5 · χ² 73,838 / p <1e-300	190.8 EB05 175.4 · IC025 +7.1 3/3 methods agree	Not in label — unassessed	serious n=385	no trial arm names this drug
Ureteric haemorrhage	11	216.2 113.5–411.9ROR 216.4 · χ² 1,804 / p <1e-300	138.7 EB05 82.7 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=11	no trial arm names this drug
Hepatojugular reflux	22	174.2 111.3–272.8ROR 174.4 · χ² 3,138 / p <1e-300	133.9 EB05 93.2 · IC025 +4.4 3/3 methods agree	Not in label — unassessed	serious n=22 · 100% clinician	no trial arm names this drug
Carotid artery occlusion	394	139.6 125.9–154.8ROR 142.7 · χ² 48,190 / p <1e-300	123.8 EB05 113.8 · IC025 +6.6 3/3 methods agree	Not in label — unassessed	serious n=394	no trial arm names this drug
Neuroglycopenia	11	130.7 70.0–243.8ROR 130.7 · χ² 1,156 / p 1e-253	97.9 EB05 58.3 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=11	no trial arm names this drug
Electrocardiogram q wave abnormal	22	121.2 78.1–188.0ROR 121.3 · χ² 2,263 / p <1e-300	100.3 EB05 69.8 · IC025 +4.3 3/3 methods agree	Lab value / disease marker	serious n=22 · 100% clinician	no trial arm names this drug
Pericardial disease	28	117.4 79.6–173.1ROR 117.6 · χ² 2,825 / p <1e-300	99.5 EB05 72.2 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious n=28 · ♀ 0% (drug 51%) · 100% clinician	no trial arm names this drug
Sleep terror	382	115.5 104.1–128.2ROR 118.0 · χ² 39,287 / p <1e-300	104.5 EB05 96.0 · IC025 +6.4 3/3 methods agree	Not in label — unassessed	serious n=381	no trial arm names this drug
Tension headache	387	114.5 103.2–127.0ROR 117.0 · χ² 39,471 / p <1e-300	103.6 EB05 95.2 · IC025 +6.4 3/3 methods agree	Not in label — unassessed	serious n=386	no trial arm names this drug
Peritoneal haematoma	10	82.6 43.5–157.0ROR 82.7 · χ² 678 / p 1e-149	67.6 EB05 39.2 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=10	no trial arm names this drug
Fibrous histiocytoma	23	80.0 52.4–122.0ROR 80.1 · χ² 1,603 / p <1e-300	70.6 EB05 49.5 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious n=23 · ♀ 0% (drug 51%)	no trial arm names this drug
Physical examination abnormal	22	74.2 48.2–114.2ROR 74.3 · χ² 1,424 / p <1e-300	65.9 EB05 45.9 · IC025 +4.1 3/3 methods agree	Reporting / coding artifact	serious n=22 · 100% clinician	no trial arm names this drug
Blood follicle stimulating hormone increased	23	71.7 47.0–109.2ROR 71.7 · χ² 1,442 / p <1e-300	64.1 EB05 45.0 · IC025 +4.1 3/3 methods agree	Lab value / disease marker	serious n=23 · ♀ 0% (drug 51%)	no trial arm names this drug
Pancreatitis haemorrhagic	26	68.2 45.9–101.2ROR 68.2 · χ² 1,561 / p <1e-300	61.6 EB05 44.2 · IC025 +4.2 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious n=26 · ♀ 100% (drug 51%) · 100% clinician	no trial arm names this drug
Subarachnoid haemorrhage	445	52.7 47.9–57.8ROR 54.0 · χ² 21,514 / p <1e-300	50.3 EB05 46.5 · IC025 +5.4 3/3 methods agree	Not in label — unassessed	serious PRR 41.3	no trial arm names this drug
Facial pain	386	52.3 47.3–57.8ROR 53.4 · χ² 18,522 / p <1e-300	49.9 EB05 45.9 · IC025 +5.4 3/3 methods agree	Not in label — unassessed	serious n=384	no trial arm names this drug
Occult blood	22	49.7 32.4–76.1ROR 49.7 · χ² 959 / p 6e-211	45.9 EB05 31.9 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious n=22 · 100% clinician	no trial arm names this drug
Insulin-like growth factor decreased	19	42.8 27.1–67.7ROR 42.9 · χ² 708 / p 3e-156	39.8 EB05 26.9 · IC025 +3.6 3/3 methods agree	Lab value / disease marker	serious n=18	no trial arm names this drug
Vasculitis	394	40.4 36.6–44.7ROR 41.3 · χ² 14,602 / p <1e-300	39.0 EB05 35.9 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious PRR 34.4	no trial arm names this drug
Pemphigoid	248	40.0 35.3–45.4ROR 40.6 · χ² 9,081 / p <1e-300	38.6 EB05 34.7 · IC025 +5.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 31.3 · 94% clinician	no trial arm names this drug
Dermatitis bullous	228	37.8 33.2–43.1ROR 38.3 · χ² 7,881 / p <1e-300	36.6 EB05 32.7 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious PRR 30.7 · 99% clinician	no trial arm names this drug
Heart failure with reduced ejection fraction	13	33.8 19.5–58.7ROR 33.9 · χ² 371 / p 5e-83	31.5 EB05 19.6 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=13	no trial arm names this drug
Anosmia (loss of smell)	387	31.7 28.7–35.0ROR 32.4 · χ² 11,168 / p <1e-300	30.8 EB05 28.3 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=386	no trial arm names this drug
Ventricular tachycardia	427	30.6 27.8–33.6ROR 31.3 · χ² 11,874 / p <1e-300	29.8 EB05 27.5 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 24.6	no trial arm names this drug
Bite	18	29.4 18.4–47.0ROR 29.5 · χ² 455 / p 3e-101	28.0 EB05 18.7 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious n=18	no trial arm names this drug
Albuminuria	13	29.0 16.7–50.2ROR 29.0 · χ² 315 / p 7e-71	27.2 EB05 16.8 · IC025 +2.9 3/3 methods agree	Labeled adverse reaction exact term	serious n=12	no trial arm names this drug
Pericarditis	393	27.9 25.3–30.8ROR 28.5 · χ² 9,936 / p <1e-300	27.2 EB05 25.1 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 22.5	no trial arm names this drug
Carotid arteriosclerosis	24	27.7 18.5–41.6ROR 27.8 · χ² 578 / p 6e-128	26.6 EB05 18.8 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious n=24 · ♀ 0% (drug 51%) · 100% clinician	no trial arm names this drug
Atrophic vulvovaginitis	16	26.0 15.8–42.6ROR 26.0 · χ² 351 / p 1e-78	24.7 EB05 16.1 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious n=16	no trial arm names this drug
Systolic dysfunction	22	24.6 16.2–37.6ROR 24.7 · χ² 466 / p 1e-103	23.7 EB05 16.5 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious n=22 · 100% clinician	no trial arm names this drug

Trial evidence (ClinicalTrials.gov)

No completed trial with posted adverse-event results was found on ClinicalTrials.gov for Linagliptin (searched LINAGLIPTIN).

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	1,376	8.5 8.0–8.9ROR 9.1 · χ² 9,069 / p <1e-300	8.4 EB05 8.0 · IC025 +3.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 9.7	no trial arm names this drug
Diarrhoea (diarrhea)	1,296	2.3 2.2–2.5ROR 2.4 · χ² 1,015 / p 6e-223	2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.6	no trial arm names this drug
Nausea	1,221	1.8 1.7–1.9ROR 1.8 · χ² 442 / p 2e-98	1.8 EB05 1.7 · IC025 +0.7	Not in label — unassessed	serious PRR 2.2	no trial arm names this drug
Fatigue (tiredness)	1,079	1.6 1.5–1.7ROR 1.6 · χ² 256 / p 6e-58	1.6 EB05 1.5 · IC025 +0.6	Not in label — unassessed	serious PRR 2.0	no trial arm names this drug
Dyspnoea (shortness of breath)	1,048	2.1 2.0–2.3ROR 2.2 · χ² 656 / p 6e-145	2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 2.2	no trial arm names this drug
Off label use (used outside approved label)	998	1.3 1.3–1.4ROR 1.3 · χ² 85 / p 2e-20	1.3 EB05 1.3 · IC025 +0.3	Reporting / coding artifact	serious PRR 1.8	no trial arm names this drug
Dizziness	983	2.3 2.2–2.4ROR 2.4 · χ² 726 / p 4e-160	2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 2.6	no trial arm names this drug
Vomiting	957	2.4 2.2–2.5ROR 2.4 · χ² 767 / p 4e-169	2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 2.6	no trial arm names this drug
Malaise (feeling unwell)	831	2.2 2.0–2.3ROR 2.2 · χ² 546 / p 6e-121	2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 2.7	no trial arm names this drug
Acute kidney injury (sudden kidney damage)	827	6.3 5.9–6.7ROR 6.6 · χ² 3,696 / p <1e-300	6.3 EB05 5.9 · IC025 +2.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 5.2 · 90% clinician	no trial arm names this drug
Headache	799	1.5 1.4–1.6ROR 1.5 · χ² 126 / p 2e-29	1.5 EB05 1.4 · IC025 +0.4	Labeled adverse reaction exact term	serious PRR 2.0	no trial arm names this drug
Arthralgia (joint pain)	770	2.2 2.0–2.3ROR 2.2 · χ² 482 / p 4e-107	2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.7	no trial arm names this drug
Pruritus (itching)	770	2.4 2.2–2.5ROR 2.4 · χ² 611 / p 3e-135	2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 3.7	no trial arm names this drug
Pyrexia (fever)	742	2.5 2.3–2.7ROR 2.5 · χ² 665 / p 8e-147	2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree	Not in label — unassessed	serious PRR 2.5	no trial arm names this drug
Pain	687	1.3 1.2–1.4ROR 1.3 · χ² 46 / p 5e-12	1.3 EB05 1.2 · IC025 +0.2	Labeled adverse reaction exact term	serious PRR 1.5	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.

Cardiospasm — n=389, PRR 2,737.9
Immunisation — n=255, PRR 1,680.7
Palmoplantar keratoderma — n=383, PRR 1,331.4
5-hydroxyindolacetic acid increased — n=20, PRR 530.3
Pulmonary valve disease — n=25, PRR 274.1
Atrial tachycardia — n=391, PRR 263.6
Pruritus genital — n=388, PRR 231.5
Hepatojugular reflux — n=22, PRR 174.2
Carotid artery occlusion — n=394, PRR 139.6
Pericardial disease — n=28, PRR 117.4

✓ A hand-written Bradford Hill causality assessment exists for this drug: Linagliptin ↔ 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 Linagliptin?

In FDA FAERS, the most frequently co-reported reaction terms for Linagliptin are blood glucose increased, diarrhoea, nausea, fatigue, dyspnoea, dizziness. 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 Linagliptin have an FDA boxed warning?

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

Do FAERS signals prove that Linagliptin 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 dfe327e8-f6ab-41e5-bdef-d520118cd83a, effective 20250827; matched on openfda.generic_name.exact:"LINAGLIPTIN")
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, 1,140 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 LINAGLIPTIN, 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.