Prescription medication · DPP-4 Inhibitor
linagliptin
Also sold as Tradjenta.
Data updated 2026-05-15
- 17,378
- FDA reportsModerately reported
- 9
- InteractionsFew interactions
- $16.77
- Brand price (NADAC)
What the data shows
linagliptin (Tradjenta) is a prescription DPP-4 Inhibitor, reported at a middle-of-the-pack volume (17,378 FDA reports), with 9 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$16.77/unit
Generic Available
Yes (2 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Information not available.
Common side effects
Runny nose or sore throat, Diarrhea
Key warnings
No specific warnings noted. Always follow your prescriber's instructions.
Side Effects (from patient reports)
Based on 17,378 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for linagliptin, by number of reports
- Blood Glucose Increased
Blood Glucose Increased
1,326 reports
- Diarrhoea
Diarrhoea
1,196 reports
- Nausea
Nausea
1,138 reports
- Fatigue
Fatigue
1,028 reports
- Dyspnoea
Dyspnoea
998 reports
- Dizziness
Dizziness
919 reports
- Vomiting
Vomiting
875 reports
- Malaise
Malaise
789 reports
- Acute Kidney Injury
Acute Kidney Injury
772 reports
- Headache
Headache
745 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for linagliptin each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where linagliptin sits
linagliptin has more FDA adverse-event reports than 52% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is linagliptin; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 17,378 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2006–2025.
Total Reports
17,378
Reports Mentioning Death
1,613
9.3% of reports — not proof of cause
Hospitalization Reports
6,542
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | BLOOD GLUCOSE INCREASED | 1,326 |
| 2 | DIARRHOEA | 1,196 |
| 3 | NAUSEA | 1,138 |
| 4 | FATIGUE | 1,028 |
| 5 | DYSPNOEA | 998 |
| 7 | DIZZINESS | 919 |
| 8 | VOMITING | 875 |
| 9 | MALAISE | 789 |
| 10 | ACUTE KIDNEY INJURY | 772 |
| 11 | HEADACHE | 745 |
| 12 | ARTHRALGIA | 723 |
| 13 | PRURITUS | 720 |
| 14 | PYREXIA | 687 |
| 16 | PAIN | 641 |
| 17 | DEHYDRATION | 601 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Known Drug Interactions
Drugs that Reduce Metformin Clearance Clinical Impact Concomitant use of drugs that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT2] / multidrug and toxin extrusion [MATE] inhibitors such as ranolazine, vandetanib, dolutegravir, and cimetidine) could increase systemic exposure to metformin and may increase the risk for lactic acidosis [see Clinical Pharmacology (12.3) ] . Alcohol Clinical Impact Alcohol is known to potentiate the effect of metformin on lactate metabolism. ( 7 ) Drugs that...
Mechanism: One drug may slow down how fast the other is removed from your body through your kidneys. This can cause a dangerous buildup of medicine and lead to a serious condition called lactic acidosis.
Drugs that Reduce Metformin Clearance Clinical Impact Concomitant use of drugs that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT2] / multidrug and toxin extrusion [MATE] inhibitors such as ranolazine, vandetanib, dolutegravir, and cimetidine) could increase systemic exposure to metformin and may increase the risk for lactic acidosis [see Clinical Pharmacology (12.3) ] .
Mechanism: Dolutegravir prevents your kidneys from removing metformin from your body. This can cause the drug to build up and increase the risk of a serious condition called lactic acidosis.
Drugs that Reduce Metformin Clearance Clinical Impact Concomitant use of drugs that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT2] / multidrug and toxin extrusion [MATE] inhibitors such as ranolazine, vandetanib, dolutegravir, and cimetidine) could increase systemic exposure to metformin and may increase the risk for lactic acidosis [see Clinical Pharmacology (12.3) ] .
Mechanism: Ranolazine stops your kidneys from getting rid of metformin properly. This can lead to a buildup of the drug, which increases the risk of a serious side effect called lactic acidosis.
Drugs that Reduce Metformin Clearance Clinical Impact Concomitant use of drugs that interfere with common renal tubular transport systems involved in the renal elimination of metformin (e.g., organic cationic transporter-2 [OCT2] / multidrug and toxin extrusion [MATE] inhibitors such as ranolazine, vandetanib, dolutegravir, and cimetidine) could increase systemic exposure to metformin and may increase the risk for lactic acidosis [see Clinical Pharmacology (12.3) ] .
Mechanism: Cimetidine makes it harder for your kidneys to filter metformin out of your system. This can cause metformin levels to rise, which may lead to a dangerous buildup of acid in your blood.
Table 2 Clinically Relevant Interactions with JENTADUETO XR Carbonic Anhydrase Inhibitors Clinical Impact Topiramate or other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide or dichlorphenamide) frequently cause a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis.
Mechanism: Topiramate can lower the level of bicarbonate in your blood, which makes your blood more acidic. This increases the risk of a serious condition called metabolic acidosis when taken with this diabetes medication.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
What are the common side effects of linagliptin?
Does linagliptin interact with other medications?
What drug class is linagliptin?
Related Medications in DPP-4 Inhibitor
Other drugs grouped near linagliptin - same-class peers and common alternatives.
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Colesevelam is a medicine that helps lower bad cholesterol (LDL-C) and control blood sugar in adults.
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Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for linagliptin: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 17,378.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 9.28%.
- bismuth subsalicylate Δ 0.01 pts · 5,567 reports · Antidiarrheal / Antacid 9.27%death share
- ketoprofen Δ 0.05 pts · 12,302 reports · Nonsteroidal Anti-Inflammatory Drug (NSAID) 9.23%death share
- ibandronate Δ 0.05 pts · 2,935 reports · Bisphosphonate 9.34%death share
- ropinirole Δ 0.05 pts · 14,664 reports · Dopamine Agonist 9.34%death share
Medication Guides
Understanding Drug Interactions
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Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for linagliptin
The FDA label for linagliptin (sold under brand names such as Tradjenta) classifies it as a prescription-only medication in the DPP-4 Inhibitor class. Regulatory labeling describes its approved uses and the patient populations studied in pre-market trials. Official labeling lists 2 commonly reported side effects, including Runny nose or sore throat, Diarrhea.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 17,378 voluntary reports. The database also lists 9 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: May 24, 2024
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages