Rybelsus: The FDA’s Approval and Novo Nordisk’s Omission

Publish Date : 07/15/2025

Rybelsus and Ozempic are two different versions of the same core drug: semaglutide. Both are made by the same company — Novo Nordisk — and both are used to help people with type 2 diabetes manage their blood sugar levels. In more recent years, they’ve also become widely used, and promoted, for weight loss.

Here’s the main difference:

• Ozempic is given as a weekly injection (a shot).
• Rybelsus is taken as a daily pill (the first of its kind in this drug class).

Both drugs belong to a category of medications called GLP-1 receptor agonists, which mimic a natural hormone in your body. This hormone helps regulate blood sugar, slows down how quickly your stomach empties, and makes you feel full longer — which is why both drugs are now being used off-label for weight loss, even though only Wegovy (another semaglutide product) is FDA-approved specifically for obesity.

Despite the convenience of a pill, Rybelsus may come with similar risks and side effects as Ozempic, including nausea, vomiting, and a condition called gastroparesis, or stomach paralysis, where food sits in the stomach too long. These effects are part of what can lead to weight loss, but they can also be serious and damaging.

In short: Rybelsus is the pill version of Ozempic. Same drug, different form. And as with Ozempic, the public is only now beginning to learn the full story behind how it works, and what it might be doing to their bodies.

Rybelsus

In September 2019, the FDA approved Rybelsus — Novo Nordisk’s oral semaglutide — for treatment of adults with type 2 diabetes. Marketed as the first once-daily GLP-1 receptor agonist in tablet form, Rybelsus was approved to improve glycemic control. Over time, its label was expanded, its restrictions lifted, and its marketing budget exploded. But there was one thing Novo Nordisk failed to include any warning regarding gastroparesis.

Despite mounting evidence that GLP-1 drugs like Rybelsus slow gastric emptying and increase the risk of ileus and intestinal obstruction, the FDA-approved label made no mention of this risk until late 2023. Throughout multiple revisions — including those prompted by the FDA — Novo Nordisk omitted a growing body of published literature and adverse event data documenting gastrointestinal damage in patients using semaglutide.

Instead, Novo Nordisk spent hundreds of millions to promote Rybelsus through television commercials, press releases, and payments to physicians. Ads made weight loss a selling point, even though Rybelsus was not approved as a weight-loss drug. The company handed out meals, funded doctor travel, and pumped out upbeat commercials downplaying serious side effects.

As case studies and clinical trials continued to show links between semaglutide and severe GI reactions — including vomiting, bowel obstruction, and surgery — Novo Nordisk pressed forward. TikTok exploded with user testimonials. FDA warnings caught up only years later. And through it all, Rybelsus prescriptions soared.

Novo Nordisk knew, or should have known, that delayed gastric emptying wasn’t just a side effect — it was the mechanism by which the drug contributed to weight loss. The company profited while patients suffered.

The question now isn’t whether they failed to warn. It’s why they didn’t.

Want to find out if you or a loved one has an Ozempic or Rybelsus claim?

Please feel free to contact an Ozempic or Rybelsus Lawsuit attorney at info@westrikeback.com or 1-877-542-4646. One of our experienced lawyers will help evaluate your claim and explain your legal rights for free. McSweeney / Langevin is providing consultations to individuals throughout the United States. Information provided by email or phone will be kept confidential.