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Onglyza Side Effects

Taking the diabetes drug Onglyza (saxagliptin) is associated with several minor side effects, as well as some serious, but much less common, complications.

A medicine for Type 2 diabetes patients, Onglyza (saxagliptin) can cause these common side effects: headache, diarrhea, infections in the urinary or upper respiratory tracts, as well as nausea or stomach pain.

The medication may cause changes in blood sugar. If you’re taking Onglyza, you should be familiar with the symptoms of these changes, and know what to do when they occur.

Symptoms of high blood sugar include frequent urination, fatigue, nausea, extreme hunger or thirst and blurry vision. Symptoms of low blood sugar include shaking, fast heartbeat, sweating, anxiety, dizziness, extreme hunger, weakness and irritability.

The potential side effects associated with Onglyza range from itchy skin and hives to pancreatitis or heart failure.

The following serious side effects are listed on the medication insert:
  • Skin reaction
  • Fluid retention (peripheral edema)
  • Allergic reaction (swelling of face, throat, difficulty breathing, skin rashes)
  • Disabling or severe joint pain
  • Inflammation of the pancreas (pancreatitis)
  • Heart failure

Onglyza and Pancreatitis

Research data has suggested a small, increased risk of acute pancreatitis from Onglyza and other drugs in its class. Information about pancreatitis was added to the drug’s warnings in 2011. Patients with existing risk factors should exercise caution.

The pancreas is a spongy, pear-shaped, flat gland, about 6 inches long, located in the upper left abdomen behind the stomach, where it helps convert food into fuel for the cells in the body. In addition to its proximity to the stomach, it is adjacent to the small intestine, liver, spleen and gallbladder.

It is part of the endocrine and exocrine systems, helping in digestion and in regulating blood sugar. When the stomach empties partially digested food into the intestine, the pancreas secretes enzymes through a tube known as the pancreatic duct to mix with bile from the liver to help the digestion continue. The pancreas also releases the hormones insulin and glucagon into the bloodstream to help regulate glucose from food.

Pancreatitis is a condition in which the pancreas is inflamed. This happens when pancreatic enzymes build up and start to digest the pancreas itself. In healthy individuals, the enzymes don’t become active until they reach the small intestine. With pancreatitis, the enzymes inside the inflamed pancreas attack the gland and damage the tissue.

Most patients recover completely from acute pancreatitis, which can be caused by a reaction to medication, but sometimes the condition can be life threatening.

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Pancreatitis Symptoms

Symptoms of acute pancreatitis include severe, steady pain in the upper-middle part of the abdomen, often radiating into the back, jaundice and low-grade fever. Other symptoms include nausea or vomiting, reduced blood pressure, rapid pulse, dehydration, clammy skin, unusual abdominal hardness or a mass that can be felt, abdominal bloating and tenderness, and bruising in the flanks and midsection.

Severe acute pancreatitis
In severe acute pancreatitis cases, the heart, lungs, or kidneys can fail. If bleeding happens in the pancreas, shock or death may follow.

Treatment for acute pancreatitis requires hospitalization for a few days so that the patient can receive nutritional support with feeding tubes or intravenous fluids, as well as antibiotics and medication to treat pain. In some instances, surgery may be required.

Doctors may use an endoscopic procedure to determine if the pancreatic ducts are blocked. These ducts are small tubes that carry pancreatic juices to the small intestine. If they’re blocked, the physician can use special tools through the endoscope to reopen them and potentially insert a stent.

Pancreatitis can lead to pancreatic cancer.

Pancreatic Cancer Studies

One of the most serious complications linked to Onglyza and other incretin therapies is the possibility of an increase in the risk of pancreatic cancer, a cancer that is difficult to treat because it is often not diagnosed until later stages.

In a 2013 study, researchers found pre-cancerous cells in the autopsied pancreases of people taking incretin drugs.

According to the study, one of the claims of this group of drugs is that they increase the number and size of beta cells in the pancreas — cells that are responsible for secreting insulin. In people with Type 2 diabetes, the beta cells shrink or die and lose their ability to produce insulin.

The researchers found the drugs did indeed increase the number of beta cells, but that the cells were abnormal. They also found small, benign tumors called adenomas that can become malignant.

One of the key findings was that this change only occurred in Type 2 diabetes patients who took this kind of drugs and not in people with diabetes who took other drugs.

The European Medicines Agency (EMA) reacted by saying the current evidence is not sufficient to prove a definitive link between these drugs and pancreatic cancer; however, regulators continue to monitor the situation. The FDA investigated the claims, but after the EMA released its decision, the U.S. agency took a similar position.

Onglyza and Heart Failure

Research has suggested an elevated risk of hospitalization for heart failure in patients taking Onglyza.

Heart failure is not the same thing as a heart attack. It is a common, serious, incurable condition in which the heart‘s ability to pump enough blood — containing oxygen and nutrients — to meet the body’s needs is weakened. Sometimes, the heart can’t fill with enough blood. Other times, the force with which the heart pushes blood to the rest of the body isn’t strong enough. Sometimes, both things happen.

The chambers of the heart may stretch to hold more blood, or stiffen and become thick, eventually weakening the muscle walls.

This condition can affect one or both sides of the heart; usually, it’s both sides. In cases involving the right side of the heart, the organ can’t pump enough blood to the lungs to pick up oxygen. In those cases, fluid may build up in the veins in the neck, or the feet, ankles, legs, liver or abdomen. Those involving just the left side happen when the heart can’t pump enough oxygenated blood to the rest of the body. In both instances, the patient may experience shortness of breath.

Consequently, the kidneys may cause the body to retain water and salt.

This causes blood and fluid to back up into the lungs, and fluid buildup in the feet ankles and legs, also known as edema. When this happens, you become tired and experience shortness of breath.

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Heart Failure Symptoms

The most common symptoms of heart failure are shortness of breath, fatigue and swelling in the legs, feet, ankles, legs, abdomen, and veins in the neck. The symptoms may progress, starting with fatigue from routine physical activity, such as going up stairs. As the heart gets weaker, the symptoms will worsen. Fatigue and shortness of breath may occur after dressing or walking across the room. In some cases, people have shortness of breath lying flat.

Fluid buildup may also cause weight gain, frequent urination and a cough that’s worse while lying down at night.

Although it can’t be cured, heart failure can be treated. In extreme instances, patients with heart failure may require heart transplants.

Heart failure is the leading cause of hospitalization for people ages 65 and older. About 670,000 people are diagnosed with the condition annually.

Other Serious Side Effects of Onglyza

Some Onglyza side effects can be the signs of something else happening.

Tell your doctor if you experience any of these of these symptoms, and they are severe or do not go away:
  • Sore throat
  • Headache
  • Joint pain
If you experience any of these symptoms, call your doctor immediately:
  • Rash
  • Hives
  • Skin peeling
  • Sore throat
  • Itching
  • Sudden weight gain
  • Excessive tiredness
  • Hoarseness
  • Vomiting
  • Loss of appetite
  • Difficulty breathing or swallowing
  • Shortness of breath, especially when lying down
  • Swelling of the feet, ankles, or legs
  • Swelling of the face, lips, tongue, or throat
  • Ongoing pain, that begins in the upper left or middle of the stomach but may spread to the back

Please seek the advice of a medical professional before making health care decisions.

Related Pages

Elaine Silvestrini is an award-winning journalist with 30 years of experience covering state and federal court systems. She joined Drugwatch in 2017. Her coverage for Drugwatch has been cited in the CDC’s Public Health Law News and the USA Today Network. Some of her qualifications include:

  • Centers for Disease Control and Prevention certificates in Health Literacy
  • Experience as an assistant investigator for the Federal Public Defender
  • Loyola Law School Journalist Law School Fellowship
Edited By
Medically Reviewed By
Dr. John A. Daller
Dr. John A. Daller American Board of Surgery

7 Cited Research Articles

  1. National Heart, Lung, and Blood Institute. (n.d.). What Is Heart Failure? Retrieved from:
  2. WebMD. (n.d.). Heart Disease and Congestive Heart Failure. Retrieved from:
  3. Columbia University Department of Surgery. (n.d.) The Pancreas Center. Retrieved from:
  4. Pancreatic Cancer Action Network. (n.d.). What is the Pancreas? Retrieved from:
  5. National Institute of Diabetes and Digestive and Kidney Diseases. (n.d.). What is pancreatitis? Retrieved from:
  6. (n.d.). High and Low Blood Sugar Symptoms. Retrieved from:
  7. Tucker, M.E. (2015, December 8). Small, but Detectable, Pancreatic Risk With DPP-4 Inhibitors. Retrieved from:
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