All semaglutide labels gain a Severe Gastrointestinal Adverse Reactions warning

A new Warnings and Precautions subsection titled "Severe Gastrointestinal Adverse Reactions" was added to the U.S. prescribing information for every semaglutide product in October 2025. The change is listed under Recent Major Changes on the Ozempic injection label as section 5.7 ^[1][5], on the Wegovy label as section 5.6 ^[2][4], and on the Rybelsus and Ozempic tablets label as section 5.6 ^[3].

The wording is nearly identical across products. The Ozempic label states that "use has been associated with gastrointestinal adverse reactions, sometimes severe" and that Ozempic "is not recommended in patients with severe gastroparesis" ^[1]. The Wegovy label uses the same construction, saying Wegovy is not recommended in patients with severe gastroparesis ^[2][4], as does the label covering Rybelsus and Ozempic tablets ^[3]. Gastroparesis is a condition in which the stomach empties too slowly.

According to the Wegovy prescribing information, severe gastrointestinal adverse reactions occurred in 4.1% of adults treated with Wegovy compared with 0.9% of those on placebo ^[2]. Comparable severity percentages for Ozempic injection or for the oral semaglutide products are not included in the source label text reviewed here, so it is not yet clear from these documents how the rates differ by product or dose.

Gastrointestinal complaints were already the most commonly reported side effects on these labels. For Ozempic injection, the reactions reported in at least 5% of patients are nausea, vomiting, diarrhea, abdominal pain and constipation ^[1]. For Rybelsus and Ozempic tablets, the list is nausea, abdominal pain, diarrhea, decreased appetite, vomiting and constipation ^[3]. The Wegovy list is longer and includes nausea, diarrhea, vomiting, constipation, abdominal pain, dyspepsia, abdominal distension, eructation, flatulence, gastroenteritis and gastroesophageal reflux disease, among others ^[2].

The October 2025 change was not the only update. On the Rybelsus and Ozempic tablets label, four Warnings and Precautions sections were revised in October 2025: acute pancreatitis, acute kidney injury due to volume depletion, severe gastrointestinal adverse reactions and acute gallbladder disease ^[3]. The Wegovy label also shows an August 2025 revision to the acute kidney injury section ^[2][4], and a later removal of the "Suicidal Behavior and Ideation" section. The two Wegovy documents disagree on the timing of that removal: one lists 02/2026 ^[2], the other 01/2026 ^[4].

Why it matters for patients

This is a labeling change, not a new drug recall or a boxed warning. Semaglutide's boxed warning still concerns the risk of thyroid C-cell tumors seen in rodents ^[1][2][3]. What the new section does is give prescribers and pharmacists a specific place in the label that says GI reactions can be severe, and names one group — people with severe gastroparesis — for whom use is not recommended ^[1][2][3].

Practically, that means a conversation about stomach and bowel history is now anchored in the label itself. The labels also connect dose escalation directly to this risk: the oral semaglutide label instructs prescribers to follow the stated starting, escalation and maintenance schedule "to reduce the risk of gastrointestinal (GI) adverse reactions," cross-referencing the new section 5.6 ^[3]. Separately, all semaglutide labels note that the drug delays gastric emptying and may affect absorption of other oral medications ^[1][3].

The labels do not define, in the text reviewed, what clinical threshold counts as a "severe" GI reaction, or what counts as severe versus mild gastroparesis. Those judgments are left to clinicians.

What happens next

These labels continue to be amended. The Wegovy tablets label reviewed was revised 02/2026 ^[2]; a later Wegovy prescribing information shows a revision date of 06/2026 and adds a section 5.11, "Never Share WEGOVY FlexTouch Between Patients" ^[4]. The Ozempic injection label shows a revision date of 5/2026, with the DailyMed listing updated June 1, 2026 ^[1]. No further changes to the severe gastrointestinal adverse reactions section have been announced in these sources.