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Link Between Ozempic and Gallbladder Disease?

By Rheingold Giuffra Ruffo Plotkin & Hellman LLP

Ozempic is a prescription drug that’s used to:

  • Manage blood sugar levels in adults with type 2 diabetes, along with lifestyle improvements in diet and exercise.
  • Lower certain risks in adults who have both heart disease and diabetes. These risks include heart attack and stroke.

Ozempic isn’t used for type 1 diabetesdiabetic ketoacidosis, or in people who have had pancreatitis. For more information, see the “What is Ozempic used for?” section below.

Ozempic comes as a liquid solution inside prefilled, disposable pens. The drug is injected under your skin.

Ozempic’s active ingredient is semaglutide. It belongs to a class of drugs called glucagon-like peptide-1 receptor agonists (GLP-1 RAs). Semaglutide comes only as the brand-name drug Ozempic. There isn’t a generic form of it available.

Reports of Serious Adverse Events

Through the end of 2021, the FDA has received more than 10,000 reports of adverse events related to the diabetes drug Ozempic. According to FAERS (FDA Adverse Reporting System), all the reported cases of cholelithiasis (gallstones) were coded as serious adverse events.

According to the Ozempic product label, cholelithiasis (gallstones) was reported in 1.5% and 0.4% of 0.5 mg and 1 mg semaglutide-treated patients, respectively, compared to 0% of patients assigned a placebo. Four acute gallbladder events led to treatment discontinuation. These included 3 events of jaundice, cholelithiasis, and hydrocholecystitis with semaglutide 0.5 mg and 1 report of bile duct stone with placebo.

The Ozempic clinical trials resulted in 90% of patients reporting cholelithiasis coded as a serious event requiring cholecystectomy (gallbladder removal).

According to Medical News, “Taking Ozempic may increase your risk of acute (short-term) gallbladder disease, which could include gallstones or redness and swelling of your gallbladder. If you show any signs of gallbladder disease, your doctor will recommend a gallbladder exam.

Healthline reports, “Ozempic has a boxed warning, or a serious warning from the Food and Drug Administration (FDA).

The FDA issued this boxed warningTrusted Source because Ozempic has been shown to cause thyroid tumors and thyroid cancer in animals. It isn’t known if Ozempic can cause thyroid tumors or medullary thyroid cancer in humans. If you have a family or personal history of medullary thyroid cancer or a rare endocrine condition called multiple endocrine neoplasia syndrome type 2, you should not take Ozempic.

Talk with your doctor if you have either of these conditions or a family history of them.

If you or a loved one have been prescribed Ozempic and have experienced any of the above-mentioned symptoms or been diagnosed with thyroid cancer, contact our Ozempic lawyers for a free initial consultation. 

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