What is the incidence of pancreatitis with Ozempic (semaglutide)?

From the Guidelines

The risk of pancreatitis as a side effect of Ozempic (semaglutide) is low, and although the exact incidence is not explicitly stated in the provided evidence, it is considered a rare but potential side effect that should be monitored. Ozempic is generally considered safe for most patients, but pancreatitis remains a potential rare side effect that should be monitored. Patients should be aware of symptoms like severe abdominal pain, nausea, and vomiting, and seek immediate medical attention if these occur. The exact mechanism for pancreatitis risk with Ozempic isn't fully understood, but it's thought to be related to its effects on the pancreas as a GLP-1 receptor agonist, as mentioned in studies such as 1. This class of medications can influence pancreatic enzyme secretion and potentially lead to inflammation in rare cases. To minimize risk, patients should disclose any history of pancreatitis to their doctor before starting Ozempic, as cautioned in 1. The medication should be used cautiously in patients with a history of pancreatitis or other pancreatic disorders. Regular monitoring and adherence to prescribed dosing are important for safe use. Some key points to consider when prescribing Ozempic include:

• Monitoring for symptoms of pancreatitis, such as severe abdominal pain, nausea, and vomiting
• Using caution in patients with a history of pancreatitis or other pancreatic disorders
• Regular monitoring and adherence to prescribed dosing
• Being aware of the potential for rare but serious side effects, such as severe liver injury and acute kidney injury, as mentioned in 1 It's also important to note that the relationship between diabetes and pancreatitis is complex, and patients with diabetes may be at a higher risk of developing pancreatitis, as discussed in 1 and 1. However, the evidence does not suggest a clear causal link between Ozempic and pancreatitis, and the benefits of the medication may outweigh the risks for many patients.

From the FDA Drug Label

In glycemic control trials, acute pancreatitis was confirmed by adjudication in 7 OZEMPIC-treated patients (0.3 cases per 100 patient years) versus 3 in comparator-treated patients (0. 2 cases per 100 patient years). One case of chronic pancreatitis was confirmed in an OZEMPIC-treated patient. In a 2-year trial, acute pancreatitis was confirmed by adjudication in 8 OZEMPIC-treated patients (0.27 cases per 100 patient years) and 10 placebo-treated patients (0. 33 cases per 100 patient years), both on a background of standard of care.

The incidence of pancreatitis with Ozempic (semaglutide) is:

• Acute pancreatitis: 0.3 cases per 100 patient years in glycemic control trials and 0.27 cases per 100 patient years in a 2-year trial.
• Chronic pancreatitis: 1 case confirmed in an OZEMPIC-treated patient. 2

From the Research

Incidence of Pancreatitis with Ozempic (Semaglutide)

• The incidence of pancreatitis with Ozempic (semaglutide) is a rare but significant complication, as reported in several studies 3, 4, 5.
• A case study reported a 74-year-old male with type 2 diabetes who developed severe pancreatitis after four years of semaglutide use, with a dose increase from 0.25 to 0.5 mg weekly prior to admission 5.
• Another study found that semaglutide-induced acute pancreatitis is a rare but documented adverse effect, with limited cases reported in the literature 3.
• However, a meta-analysis of 21 eligible trials of semaglutide, including 34,721 patients, found that semaglutide therapy was not associated with an increased risk of acute pancreatitis (OR 0.7; 95% CI 0.5-1.2, I2 0%) 6.

Risk Factors and Outcomes

• The risk factors for pancreatitis with semaglutide use are not fully understood, but switching between GLP-1 agonists may increase the risk of adverse effects, especially if appropriate dose titration protocols are not followed 3.
• The outcomes of pancreatitis with semaglutide use can be severe, including distributive shock, renal failure, and death 5.
• However, most cases of drug-induced acute pancreatitis are mild in severity, and severe cases are rare 7.

Comparison of Semaglutide Regimens

• A meta-analysis found that the risk of acute pancreatitis with semaglutide use was similar across different administration regimens, including oral and subcutaneous doses 6.
• The results of the meta-analysis suggest that the use of semaglutide is not associated with an increased risk of acute pancreatitis compared to placebo, regardless of the regimen used 6.