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linagliptin

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Brand names: Tradjenta

DPP-4 Inhibitor Rx

Jentadueto XR is a drug that combines linagliptin and metformin. It helps lower blood sugar in adults with type 2 diabetes, along with diet and exercise.

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

Jentadueto XR is used to improve blood sugar control in adults with type 2 diabetes.

Common side effects

Runny nose or sore throat, Diarrhea

Key warnings

Jentadueto XR can cause a serious side effect called lactic acidosis.

How It Works

This medicine contains two drugs. Linagliptin helps your body release more insulin after you eat. Metformin helps your body use insulin better and reduces sugar production in the liver.

How to Take It

Take Jentadueto XR one time each day with a meal. Swallow the tablets whole; do not crush, split, or chew them. Your doctor will adjust your dose based on how well the medicine works for you. Make sure to have your kidney function checked before starting and while taking this medicine.

Pregnancy & Breastfeeding

Talk to your doctor if you are pregnant or plan to become pregnant. It is not known if Jentadueto XR will harm your unborn baby. Discuss the best way to control your blood sugar during pregnancy with your doctor.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time.

Storage

Store Jentadueto XR at room temperature, away from moisture.

Side Effects (from patient reports)

Based on 9,962 FDA adverse event reports.

High blood sugar
1,326
Diarrhea
1,196
Nausea
1,138
Tiredness
1,028
Difficulty breathing
998
Using the medicine for a condition it is not approved for
921
Feeling dizzy
919
Vomiting
875
Feeling unwell
789
Sudden kidney damage
772

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

Death-Related Reports

1,613

Hospitalization Reports

6,542

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 8,052 (51%)
Male 7,780 (49%)

Age Distribution

0–17 190
18–44 381
45–64 3,381
65–74 3,506
75+ 4,362

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
6 OFF LABEL USE 921
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
15 DRUG INEFFECTIVE 642

Reactions in Death Reports

DEATH 545
ACUTE KIDNEY INJURY 118
RENAL FAILURE 85
PNEUMONIA 83
DYSPNOEA 75
OFF LABEL USE 70
DIARRHOEA 61
URINARY TRACT INFECTION 60
CARDIAC ARREST 59
SEPSIS 56

Reactions in Hospitalization Reports

ACUTE KIDNEY INJURY 543
DYSPNOEA 475
DIARRHOEA 442
VOMITING 402
FATIGUE 395
OFF LABEL USE 390
FALL 385
PNEUMONIA 380
NAUSEA 379
PYREXIA 351

Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Jentadueto XR can cause a serious side effect called lactic acidosis. This is a buildup of lactic acid in your blood. Get medical help right away if you have symptoms like weakness, muscle pain, trouble breathing, stomach pain, dizziness, or a slow or irregular heartbeat. Certain conditions increase your risk, such as kidney problems, drinking a lot of alcohol, or having surgery.

Known Drug Interactions

moderate metformin

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 Reduce...

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.

What to do: Your doctor may need to monitor your kidney function and adjust your dosages. Seek medical care if you experience unusual muscle pain, trouble breathing, or extreme weakness.

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.

What to do: Your doctor may need to adjust your dose or monitor you more closely. Tell your doctor if you feel very weak, dizzy, or have trouble breathing.

moderate ranolazine

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.

What to do: Talk to your doctor about monitoring your blood levels or adjusting your dose. Seek medical help if you feel very weak, tired, or have stomach pain.

moderate cimetidine

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.

What to do: Your healthcare provider may need to adjust your dose or monitor you more frequently. Let your doctor know if you experience unusual tiredness or muscle aches.

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.

What to do: Your doctor should monitor your blood chemistry and may need to adjust your treatment if you show signs of high acid levels.

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Common Questions

Can I take Jentadueto XR if I have kidney problems?
You should not take Jentadueto XR if you have severe kidney problems. Your doctor will check your kidney function before and during treatment.
What should I do if I experience stomach upset while taking this medicine?
Take Jentadueto XR with food to help reduce stomach upset. Talk to your doctor if stomach problems continue.
Can Jentadueto XR cause low blood sugar?
Jentadueto XR can cause low blood sugar if taken with insulin or certain other diabetes medicines. Your doctor may need to lower the dose of your other medicines.
Can I drink alcohol while taking Jentadueto XR?
Avoid drinking too much alcohol while taking Jentadueto XR, as it can increase your risk of lactic acidosis.
What are the symptoms of lactic acidosis?
Symptoms include feeling very weak, tired, or uncomfortable; unusual muscle pain, trouble breathing, stomach pain with nausea and vomiting, feeling cold, dizziness, or a slow or irregular heartbeat.
Does Jentadueto XR interact with other medications?
Yes, Jentadueto XR can interact with certain medications. Tell your doctor about all the medicines you take, including prescription and over-the-counter drugs, vitamins, and herbal supplements.
What should I do if I need to have an X-ray or CT scan with contrast dye?
You may need to stop taking Jentadueto XR temporarily before having an X-ray or CT scan with contrast dye. Talk to your doctor about this.
Can Jentadueto XR cause heart problems?
Heart failure has been seen with similar medicines. Tell your doctor if you have heart problems or risk factors for heart failure.
What if I develop blisters while taking Jentadueto XR?
Tell your doctor right away if you develop blisters or skin sores, as this could be a sign of a serious skin reaction.
How often will my doctor check my vitamin B12 levels?
Your doctor may check your vitamin B12 levels every 2 to 3 years, as metformin can lower vitamin B12 levels.
What are the common side effects of linagliptin?
The most commonly reported side effects of linagliptin include Runny nose or sore throat, Diarrhea. Based on 9,962 FDA adverse event reports. Always consult your healthcare provider about potential side effects.
Does linagliptin interact with other medications?
Yes, linagliptin has 9 known drug interactions. Notable interactions include metformin, dolutegravir, ranolazine. Always inform your doctor about all medications you are taking.
What drug class is linagliptin?
linagliptin belongs to the DPP-4 Inhibitor drug class. It requires a prescription (Rx). Jentadueto XR is used to improve blood sugar control in adults with type 2 diabetes.
Is linagliptin safe during pregnancy?
Talk to your doctor if you are pregnant or plan to become pregnant. It is not known if Jentadueto XR will harm your unborn baby. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

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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. Jentadueto XR is used to improve blood sugar control in adults with type 2 diabetes. 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 9,962 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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.

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. Always consult a healthcare professional before making medication decisions.

Last updated: May 24, 2024

All federal data sources used on this page