Onglyza Side Effects

As of June 30, 2024, 58% of Onglyza side effects reported to the U.S. Food and Drug Administration were considered severe, according to the agency. Heart failure, increased blood glucose and pancreatitis were the most common Onglyza side effects reported.

These three conditions accounted for over a quarter of all side effects reported to the FDA. Heart failure accounted for 17% of all reports.

Disclaimer: Reports submitted to the FDA do not necessarily indicate that the medication caused an adverse event. It is important to consult a healthcare professional before changing your medication.

Reports have been decreasing over the years, with only 11 reports so far for 2024. Despite this, patients should still talk to their doctor about potential heart and pancreatitis risks before taking Onglyza.

“Before putting a patient on saxagliptin, I want to understand their history of these conditions and other risk factors they possess for them,” Dr. Michael O. McKinney, a doctor who practices at the medical weight loss center Healthy Outlook, told Drugwatch.

“For example, patients who have had heart failure or are known to have chronic pancreatitis are usually started on different medications.”

Respiratory tract infections, urinary tract infections and headaches were the most common saxagliptin side effects that affected 5% or more clinical trial participants.

Onglyza and Kombiglyze XR are oral medications for the treatment of Type 2 diabetes. Saxagliptin is the active ingredient in Onglyza, whereas Kombiglyze XR combines saxagliptin with metformin extended-release. Metformin is another diabetes drug.

Saxagliptin has a range of common side effects. Researchers have documented most of these effects in clinical trials and post-marketing reports.

Researchers observed these side effects in 5% or more of the clinical trial participants. The data is from five clinical trials involving 882 participants, primarily white adults aged 55, who took saxagliptin for about 21 weeks.

The more serious side effects, such as heart failure, acute pancreatitis and joint pain are detailed below.

As of June 2024, the FDA had received 748 reports of heart failure associated with Onglyza use. Its label has carried a warning about heart failure since 2016.

“When I am making prescribing decisions, I consider the advantages of glycemic control over possible harmful effects when selecting saxagliptin or other agents used to treat diabetes,” McKinney said.

A 2022 study in the Journal of the American College of Cardiology reaffirmed that saxagliptin increases the risk of hospitalization for heart failure. Another 2022 study in Biomedicines found that saxagliptin may worsen heart failure by disrupting a protective mechanism in the heart involving the protein dipeptidyl peptidase-4 (DPP4) and specific neuropeptides.

In April 2016, the FDA released a Drug Safety Communication warning about an increased risk of heart failure with saxagliptin which stated “Type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failure, particularly in patients who already have heart or kidney disease. Heart failure can result in the heart not being able to pump enough blood to meet the body’s needs. As a result, we are adding new warnings to the drug labels about this safety issue.”

The FDA found that more people taking saxagliptin or alogliptin ended up in the hospital for heart failure compared to those who took a placebo. This led to Onglyza lawsuits from individuals who allege the manufacturer failed to provide sufficient warning about the associated risks.

A review of three cardiovascular outcome studies showed a small risk of acute pancreatitis with DPP-4 inhibitors, such as Onglyza, as reported by Elsevier, a Dutch company that specializes in publishing scientific, technical and medical content.

Their online article from 2024 stated that the increased risk amounts to about 1 to 2 additional cases per 1,000 patients treated for two years. However, several other studies did not find this increased risk.

After examining the data, the FDA and European Medical Agencies declared that DPP-4 inhibitors do not significantly elevate the risk of pancreatitis or pancreatic cancer in patients with type 2 diabetes. Nonetheless, the agencies recommended continued monitoring to ensure safety.

Post-marketing reports have linked Onglyza usage to acute pancreatitis, prompting the drug’s label to recommend close monitoring for signs of this condition. One study found that 0.2% of Onglyza users developed acute pancreatitis, compared to 0.1% of those who received a placebo. Notably, most Onglyza users and all placebo-treated participants had pre-existing risk factors for pancreatitis.

According to a case report in Practical Diabetes, a 33-year-old man developed acute pancreatitis after switching from Onglyza to Kombiglyze XR. He had symptoms such as dizziness, vomiting, palpitations and breathlessness and was diagnosed with acute pancreatitis. After replacing Kombiglyze XR with insulin and metformin, staff discharged the patient who was now in stable condition.

“I look into their past medical history of pancreatic disease; also I inquire about gallstones and alcohol use,” McKinney said. “As a result, I enlighten individuals affected by this condition about its symptoms such as severe abdominal pain together with throwing up.”

DPP-4 inhibitors, including Onglyza, can lead to serious joint pain that might even require a hospital stay, according to Elsevier. The symptoms can appear anytime between 1 day and a few years after starting the treatment.

Doctors aren’t sure why this happens, but inflammation triggered by certain proteins in the body could be the cause.
Post-marketing studies found that patients experienced relief upon stopping the drug. Still, some had symptoms return when they restarted the same or a different DPP-4 inhibitor, according to the medication’s label.

If severe joint pain occurs after you start taking Onglyza, you should immediately talk to your doctor.

Editor Lindsay Donaldson contributed to this article.