Tradjenta & Jentadueto Side Effects
Tradjenta (linagliptin) and Jentadueto (linagliptin and metformin) can cause side effects including diarrhea and cold-like symptoms. Rare but serious side effects include joint pain, pancreatitis and skin reactions. Jentadueto has a boxed warning for lactic acidosis.
Most Recent Tradjenta & Jentadueto Side Effects Information
Gastrointestinal disorders are among the most common Tradjenta (linagliptin) and Jentadueto (linagliptin and metformin) side effects reported by the U.S. Food and Drug Administration. These account for about 25% of the adverse reactions listed in the FDA Adverse Event Reporting System, also known as FAERS.
In addition to stomach upset, GI disorders include potentially serious pancreatitis. Elevated blood glucose is another common side effect reported to the FDA for both drugs.
FDA Adverse Event Reports for Tradjenta & Jentadueto Side Effects | Tradjenta | Jentadueto |
---|---|---|
Total cases reported | 4,211 | 635 |
Serious cases (including deaths) | 1,276 | 254 |
Deaths | 201 | 17 |
Tradjenta side effects also include rash and headache. Jentadueto may cause lactic acidosis, diabetic ketoacidosis and metabolic acidosis. These are serious conditions where too much acid builds up in your blood and can result in coma or death if untreated.
FDA data indicates that both Tradjenta and Jentadueto are relatively safe, but they both have the potential to cause serious adverse reactions. For example, out of 635 reported side effects from Jentadueto, 254 (40%) were serious.
However, the reactions listed in FAERS are not verified and may not be directly related to a medication. It’s a good idea to share any concerns you have with your health care provider to determine if Tradjenta or Jentadueto should be part of your diabetes treatment.
Jentadueto Boxed Warning
Jentadueto’s label contains a black box warning for lactic acidosis. A black box warning is the most stringent type issued by the FDA. It indicates a possibility that a drug will cause serious illness or death. Jentadueto’s warning is due to the ingredient metformin, which can cause lactic acidosis.
Common Tradjenta & Jentadueto Side Effects
The most common Tradjenta side effects reported in prescribing information are runny or stuffy nose, cough and diarrhea. These are generally mild and tolerable for most patients. However, taking other medications could aggravate these symptoms and cause them to become more severe.
The Jentadueto medication guide indicates that gastrointestinal distress is the most common side effect of the medication, occurring in at least 5% of patients taking metformin. Other side effects include headache, indigestion and weakness.
- Abdominal pain
- Diarrhea
- Flatulence
- Nausea
- Vomiting
When used with other diabetes medications, linagliptin, an active ingredient in both drugs, may cause urinary tract infections, weight gain and elevated cholesterol and triglyceride levels. Speak to your doctor about monitoring for these conditions when you begin taking Tradjenta or Jentadueto.
Serious Tradjenta & Jentadueto Side Effects
Tradjenta and Jentadueto packaging materials contain warnings for pancreatitis, severe joint pain and several other potentially serious side effects. Jentadueto may also cause lactic acidosis. Both drugs are widely considered safe, and most serious side effects are rare. However, these adverse reactions can be fatal if untreated.
The FDA released a safety bulletin about the link between dipeptidyl peptidase-4 inhibitors, including linagliptin, and disabling joint pain. The agency encourages patients and medical providers to report adverse effects through the FAERS system.
- Bullous pemphigoid (an autoimmune condition causing blisters on the skin)
- Heart failure
- Hypersensitivity reactions
- Hypoglycemia
Some patients develop serious skin conditions or allergic reactions after taking linagliptin. Rashes often include raised and itchy patches of skin as well as blisters that erupt, leading to infection. Notify your doctor immediately if you develop blisters or hives, as they could be signs of a potentially life-threatening reaction to linagliptin.
When To Seek Medical Attention
Most adverse reactions to Tradjenta and Jentadueto are mild, requiring no medical intervention. However, they can become serious and even fatal. It’s a good idea to talk to your doctor if any side effects get worse or don’t go away after several days. Seek immediate medical attention if you notice signs of an allergic reaction or are having chest pain or trouble breathing.
Pancreatitis
Linagliptin is directly associated with an increased risk of pancreatitis, or inflammation of the pancreas. This small organ rests behind the stomach and plays a role in maintaining insulin and glucagon levels. Acute pancreatitis can be fatal if not treated.
“ Acute pancreatitis, including fatal pancreatitis, has been reported in patients treated with Tradjenta … Two patients treated with Tradjenta in the Carmelina trial had acute pancreatitis with a fatal outcome.”
The first symptom of pancreatitis is often abdominal pain that may spread to your back. This can be accompanied by fever, nausea and a rapid heartbeat. Notify your doctor immediately if you notice these symptoms.
While some research suggests an elevated risk of pancreatic cancer when taking DPP-4 inhibitors like Linagliptin, other studies contradict this claim. A 2018 study published in the journal Nature and data analyses from the Endocrinology and Metabolism journal has not confirmed a causal relationship. If this risk is confirmed, there is a strong potential for lawsuits seeking compensation for patients who have been injured by Tradjenta and Jentadueto.
Case Study: Linagliptin-Induced Pancreatitis
A 74-year-old Latina woman went to the emergency room because she had intense abdominal and back pain. According to a research article in the AACE Clinical Case Reports, her condition had worsened for three days. She had a history of type 2 diabetes, heart disease, and early Alzheimer’s.
Doctors diagnosed her with acute pancreatitis, which is severe inflammation of the pancreas. This was after the doctors checked for other possible causes like gallstones and alcohol. Lab tests confirmed the diagnosis — showing higher-than-normal levels of an enzyme called lipase, which is linked to pancreatitis.
The patient had been taking linagliptin for ten weeks before the symptoms started. Using a standard tool to assess drug reactions, doctors determined linagliptin as the likely cause of her pancreatitis.
The woman’s condition improved after she stopped taking linagliptin and received hospital care. She was discharged after five days and advised not to resume the medication.
Lactic Acidosis and Metabolic Disorders
Metformin, one of the active ingredients in Jentadueto, can cause lactic acidosis and other metabolic disorders. Lactic acidosis occurs when lactic acid builds to unhealthy levels in the blood.
The risk of developing this or a similar metabolic disorder is very rare. People with a history of renal impairment are at an elevated risk of developing lactic acidosis when taking Jentadueto.
According to a 2019 study released in Cureus, the cases of metformin-associated lactic acidosis, also known as MALA, are very rare. These rare cases typically occur in patients with conditions that predispose them to lactic acidosis. For many patients, the drug has many benefits. A 2022 review in the International Journal of Molecular Sciences concludes that “appropriate use of the drug, under safe conditions, induces benefits without risks.”
Early symptoms of MALA include a general feeling of malaise accompanied by gastrointestinal discomfort. You may feel more tired than normal and develop abdominal or muscle pain. Some people experience respiratory problems. While they are not severe, these symptoms may require medical attention if you are taking a medication such as Jentadueto that includes metformin.
Tradjenta & Jentadueto Alternatives
Alternative drugs are available if you decide Tradjenta or Jentadueto are not the right fit for your diabetes treatment plan. Medications from other classes may have a more favorable risk profile for your specific medical history.
Linagliptin is a DPP-4 inhibitor that helps the body produce enough insulin. Jentadueto also includes metformin, which belongs to the biguanides class of diabetes drugs. It works to lower blood glucose levels.
- Glucagon-like peptide 1 (GLP-1) agonists
- Incretin mimetics
- SGLT2 inhibitors
- Thiazolidinediones
Each of these drug classes works in a unique way to either reduce blood glucose levels or stimulate insulin production. GLP-1 agonists are a popular choice for many people with Type 2 diabetes who also want to lose weight. However, there is mixed evidence that these drugs carry a risk of severe side effects, including gallstones, pancreatitis and thyroid cancer.
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