GLP-1 severe gastrointestinal adverse reactions: what the labels say

Short answer: every US label for Ozempic, Wegovy, Rybelsus, Mounjaro, Zepbound, Saxenda, Victoza and Trulicity now carries a section 5 warning titled Severe Gastrointestinal Adverse Reactions (October 2025 update). It says use is associated with gastrointestinal adverse reactions that are sometimes severe, and that the product is not recommended in patients with severe gastroparesis. Labels also note postmarketing GI adverse reactions with GLP-1 receptor agonists, including reports of ileus / intestinal obstruction on several products. Canadian monographs add matching gastroparesis, ileus and “not studied / not recommended in severe GI disease” language, plus section 8 trial discontinuation rates. Below are the trial rates, Canada vs US wording, ileus notes and what to log.

On this page: US severe GI rates · Shared label points · Canada GI / gastroparesis · Canada section 8 discontinuation · US vs Canada table · Ileus postmarketing · Signs to watch · What to log

Severe GI adverse reactions on the US labels

All eight DailyMed labels (checked November 7, 2026) include a Severe Gastrointestinal Adverse Reactions warning under Warnings and Precautions. The shared framing is: these drugs are associated with GI adverse reactions, sometimes severe; they are not recommended in severe gastroparesis; and postmarketing GI adverse reactions have been reported with GLP-1 receptor agonists. The table below summarizes the trial rates each label reports. The strengths shown are trial arms on the label, not a dosing suggestion.

MedicationSectionSevere / overall GI trial findings (US label)Gastroparesis / postmarketing note
Ozempic (semaglutide injection)5.7Severe GI AR: 0.5 mg 0.4%, 1 mg 0.8% vs placebo 0%. Overall GI: placebo 15.3%, 0.5 mg 32.7%, 1 mg 36.4%; disc. GI 3.1% / 3.8% vs 0.4%. 2 mg trial overall GI 34% vs 1 mg 30.8%.Not recommended in severe gastroparesis; postmarketing GI ARs with GLP-1 RAs
Wegovy (semaglutide)5.6Adults weight reduction severe GI: injection 4.1% vs placebo 0.9%; tablet 2% vs 0%. Overall GI injection 73% vs 47% placebo (nausea 44 vs 16, vomiting 25 vs 6, diarrhea 30 vs 16); disc. GI adults 4.3% vs 0.7%. Pediatric GI 62% vs 42%; disc. 2.3% vs 1.5%.Not recommended in severe gastroparesis
Rybelsus / Ozempic tablets5.6Severe: 7 mg 0.6%, 14 mg 2% vs placebo 0.3%. Overall GI: 14 mg 41%, 7 mg 32%, placebo 21%; disc. 8% / 4% vs 1%.Not recommended in severe gastroparesis
Mounjaro (tirzepatide)5.6Severe: 5 mg 1.3%, 10 mg 0.4%, 15 mg 1.2% vs placebo 0.9%. Overall GI 37.1% / 39.6% / 43.6% vs 20.4%; disc. 3.0% / 5.4% / 6.6% vs 0.4%.Not recommended in severe gastroparesis
Zepbound (tirzepatide)5.2Studies 1+2 severe: 5 mg 1.7%, 10 mg 2.5%, 15 mg 3.1% vs placebo 1%. Overall GI 56% all strengths vs 30%; disc. GI 1.9% / 3.3% / 4.3% vs 0.5%.Not recommended in severe gastroparesis
Saxenda (liraglutide 3 mg)5.7Severe 4.8% vs placebo 1.4%. ~68% vs 39% GI disorders; nausea 39 vs 14; disc. GI 6.2% vs 0.8%. Pediatric disc. GI 8% vs 0%.Not recommended in severe gastroparesis
Victoza (liraglutide)5.6Severe 1.2 mg 4.4%, 1.8 mg 4.2% vs placebo 1.1%. Withdrawals GI 4.3% vs 0.5%.Not recommended in severe gastroparesis
Trulicity (dulaglutide)5.6Severe 0.75 mg 2.2%, 1.5 mg 4.3% vs placebo 1.4%.Not recommended in severe gastroparesis

Overall GI adverse reactions (nausea, vomiting, diarrhea, constipation and related events) are far more common than the severe subset. Weight-management labels such as Wegovy and Zepbound report the highest overall GI rates in their trial pools. Discontinuation because of GI adverse reactions was higher than placebo on every product that reports that figure.

Shared points across the eight US labels

Canada: GI disease, gastroparesis and ileus

Canadian product monographs place gastrointestinal disease under Warnings and Precautions (often Gastrointestinal). They generally agree that severe gastroparesis is a reason not to use the drug, and several mention ileus or impaired gastric emptying.

MonographGI / gastroparesis / ileus (summary)
OzempicGLP-1 RAs may be associated with severe GI disease (ileus). Patients with gastroparesis may experience more serious or severe GI effects. Not recommended if severe gastroparesis (patient information). Post-market: delayed gastric emptying, intestinal obstruction (grouped with ileus).
WegovyLimited experience in severe gastroparesis → not recommended. GLP-1 RAs may be associated with severe GI disease (intestinal obstruction and ileus); post-market ileus / intestinal obstruction, unknown frequency.
RybelsusSame gastroparesis / ileus language as Ozempic. Not recommended if severe gastroparesis. Post-market: delayed gastric emptying, intestinal obstruction, ileus.
MounjaroNot studied in severe GI disease including severe gastroparesis → use with caution / not recommended framing in warnings; monitor and consider dose modification or discontinuation if severe GI symptoms. Post-market: ileus.
ZepboundSevere GI more frequent vs placebo in weight trials (2.7% vs 1.2% placebo in CA monograph). Not studied / not recommended in severe GI disease including severe gastroparesis. Impaired gastric emptying events reported. Post-market: ileus.
SaxendaInflammatory bowel disease and diabetic gastroparesis not studied → should not be used in this population. Patient information mentions severe stomach problems / gastroparesis.
VictozaInflammatory bowel disease and diabetic gastroparesis not studied → should not be used in this population.
TrulicitySevere Gastrointestinal Disease section: not studied in severe GI including severe gastroparesis → not recommended. Impaired gastric emptying events (including severe gastroparesis) reported; monitor and consider dose modification or discontinuation.

Notable Canada extras: Ozempic and Rybelsus explicitly link GLP-1 RAs with severe GI disease including ileus and warn that people with gastroparesis may have more serious GI effects; Mounjaro tells clinicians to monitor and consider dose modification or discontinuation if severe GI symptoms occur; Trulicity and Zepbound have a dedicated Severe Gastrointestinal Disease section saying the product was not studied in that setting and is not recommended; Zepbound’s monograph quantifies severe GI adverse reactions at 2.7% vs 1.2% placebo in weight-reduction trials.

Canada section 8: GI discontinuation rates

These figures come from section 8 (Adverse Reactions) of each Health Canada product monograph. Trial arms are listed for reference only — they are not a dosing suggestion, and you should not stop a medication based on this page.

MonographGI discontinuation / related rates (Canadian section 8)
Ozempic0.5 mg 3.9%, 1 mg 5.9% vs comparator 0.9% (placebo- and active-controlled pool). In the 2 mg trial, GI led to discontinuation in 2.7% (1 mg) and 3.3% (2 mg). Overall GI 41.7% / 42.1% vs comparator 22.0%.
WegovyAdults: permanent discontinuation for a GI adverse reaction 4.3% vs 0.7% placebo. Overall permanent AE discontinuation 6.8% vs 3.2% placebo.
Rybelsus7 mg 4.5%, 14 mg 7.9% vs placebo 0.6%. Overall GI: placebo 21.3%, 7 mg 31.8%, 14 mg 41.0%.
Mounjaro5 mg 3.0%, 10 mg 5.4%, 15 mg 6.6% vs placebo 0.4%. Overall GI 37.1% / 39.6% / 43.6% vs 20.4%. GI was the most common reason for discontinuation (4.2% in the overview).
Zepbound5 mg 1.9%, 10 mg 3.3%, 15 mg 4.3% vs placebo 0.5% (SURMOUNT-1/2 pool). Overview: GI adverse reactions led to 3.8% discontinuing tirzepatide. Overall GI ~55–56% vs ~30% placebo.
SaxendaGI adverse events led to withdrawal in 6.2% vs 0.8% placebo; severe GI AEs 4.8% vs 1.4%. Overall GI AEs 67.9% vs 39.3%. Nausea and vomiting were the most common AE leading to discontinuation.
VictozaWithdrawals due to GI adverse events 5.0% vs 0.5% comparator (mainly first 2–3 months). Overall GI events 41% on Victoza vs 17% on comparator in pooled long-term trials.
Trulicity0.75 mg 1.3%, 1.5 mg 3.5% vs placebo 0.2% in the placebo-controlled pool. Overall GI: placebo 21.3%, 0.75 mg 31.6%, 1.5 mg 41.0%. Diarrhea, nausea and vomiting were the AEs most often leading to discontinuation.

Where US and Canadian trial pools match (Mounjaro, Zepbound, Wegovy adults, Saxenda GI withdrawals), the percentages line up. Ozempic’s Canadian pool compares to an active-and-placebo comparator rather than placebo alone, so the comparator discontinuation rate (0.9%) differs from the US placebo figure (0.4%). Rybelsus and Trulicity Canadian placebo-controlled pools report slightly different absolute percentages than the US label rows above; both still show GI discontinuation well above placebo.

US vs Canada at a glance

MedicationUS severe-GI / gastroparesisCanada GI / gastroparesis / ileusGI discontinuation note
OzempicUS §5.7 Severe GI AR; not recommended in severe gastroparesisCA: severe GI disease (ileus); gastroparesis → more serious GI effects; not recommended if severe gastroparesisUS disc. GI 3.1%/3.8% vs 0.4% placebo; CA disc. GI 3.9%/5.9% vs 0.9% comparator
WegovyUS §5.6; not recommended in severe gastroparesisCA: limited experience / not recommended in severe gastroparesis; post-market ileusAdults disc. GI 4.3% vs 0.7% placebo (US and CA align)
RybelsusUS §5.6; not recommended in severe gastroparesisCA: same ileus / gastroparesis pattern as OzempicUS disc. 8%/4% (14/7 mg) vs 1%; CA disc. 7.9%/4.5% vs 0.6% placebo
MounjaroUS §5.6; not recommended in severe gastroparesisCA: not studied in severe GI incl. severe gastroparesis; monitor / consider modification or discontinuation; post-market ileusDisc. GI 3.0%/5.4%/6.6% vs 0.4% (US and CA trial pools align)
ZepboundUS §5.2; not recommended in severe gastroparesisCA: severe GI 2.7% vs 1.2% placebo in weight trials; not studied / not recommended in severe GI; post-market ileusDisc. GI 1.9%/3.3%/4.3% vs 0.5% (US and CA SURMOUNT pools align)
SaxendaUS §5.7; not recommended in severe gastroparesisCA: IBD and diabetic gastroparesis not studied → should not be used in that populationDisc. GI 6.2% vs 0.8%; severe GI AEs 4.8% vs 1.4% (US and CA align)
VictozaUS §5.6; not recommended in severe gastroparesisCA: IBD and diabetic gastroparesis not studied → should not be used in that populationUS withdrawals GI 4.3% vs 0.5%; CA withdrawals GI 5.0% vs 0.5% comparator
TrulicityUS §5.6; not recommended in severe gastroparesisCA Severe Gastrointestinal Disease: not studied / not recommended; impaired gastric emptying reportedUS severe rates 2.2%/4.3%; CA disc. GI 1.3%/3.5% vs 0.2% placebo

Ileus and intestinal obstruction: postmarketing notes

Ileus means slowed or stopped intestinal movement. Regulators list it as a postmarketing gastrointestinal finding for several GLP-1 products. The table summarizes Canadian monograph wording and the shared US class note. Frequency is usually listed as unknown because postmarketing reports are not a controlled rate.

SourceIleus / intestinal obstruction / impaired emptying wording
Ozempic (CA)Warnings: GLP-1 RAs may be associated with severe GI disease (ileus). Post-market (8.5): delayed gastric emptying, intestinal obstruction (grouped term covering intestinal obstruction, ileus, small intestinal obstruction), unknown frequency.
Wegovy (CA)Warnings: GLP-1 RAs may be associated with severe GI disease (intestinal obstruction and ileus). Post-market: intestinal obstruction and ileus, unknown frequency. Patient leaflet lists bowel obstruction / ileus.
Rybelsus (CA)Same warning and post-market grouped intestinal obstruction / ileus language as Ozempic. Ileus listed among serious adverse reactions overview.
Mounjaro (CA)Post-market gastrointestinal disorders: ileus. Patient information lists ileus (slow movement of food through intestines).
Zepbound (CA)Post-market gastrointestinal disorders: ileus. Warnings note impaired gastric emptying events including severe gastroparesis.
Trulicity (CA)Events related to impaired gastric emptying, including severe gastroparesis, have been reported; monitor and consider dose modification or discontinuation for severe GI symptoms.
Saxenda / Victoza (CA)Monographs emphasize IBD and diabetic gastroparesis were not studied and the product should not be used in that population; they do not carry the same post-market ileus grouped-term line as the semaglutide / tirzepatide monographs we checked.
US labels (class)October 2025 Severe Gastrointestinal Adverse Reactions warnings note postmarketing GI adverse reactions with GLP-1 receptor agonists; several products list ileus, intestinal obstruction or severe constipation among those reports.

Canadian patient information for Ozempic, Wegovy and Rybelsus describes intestinal obstruction including ileus as a condition where the intestine cannot push food and waste out of the body (severe constipation with stomach ache, bloating or vomiting). That is patient-facing language from the monographs, not a self-diagnosis checklist — contact a healthcare professional for severe or persistent GI symptoms.

Signs the labels tell patients to take seriously

What to log and tell your prescriber

For the other class warnings, see GLP-1 kidney and dehydration warning, GLP-1 aspiration risk under anesthesia, pancreatitis and gallbladder, heart rate and hypersensitivity, hypoglycemia and tracking side effects.

Sources

This page summarizes official product labels as general information. It is not medical advice. Do not start, stop or change any medication based on this page. Labels are updated; check the current version for your product. In an emergency call 911.

Frequently asked questions

Do Ozempic, Wegovy, Mounjaro and Zepbound cause severe stomach problems?

All eight US labels covered here carry a section 5 warning titled Severe Gastrointestinal Adverse Reactions (October 2025 label update). It says use of these drugs is associated with gastrointestinal adverse reactions, sometimes severe. Trial rates of severe GI reactions range from under 1% on lower Ozempic doses to about 4–5% on some Wegovy, Saxenda and Trulicity arms, versus lower placebo rates. Overall GI adverse reactions are much more common than the severe subset.

Can I take a GLP-1 if I have gastroparesis?

Every US label says the product is not recommended in patients with severe gastroparesis. Canadian monographs for Ozempic, Rybelsus, Wegovy, Mounjaro, Zepbound and Trulicity say the same or that experience is limited / the drug was not studied in severe gastroparesis and is not recommended. Saxenda and Victoza say inflammatory bowel disease and diabetic gastroparesis have not been studied and should not be used in that population. Ask your prescriber; Glidedose does not suggest doses or who should start.

What is ileus and why do the labels mention it?

Ileus is slowed or stopped movement of the intestines. Several US labels list ileus, intestinal obstruction or severe constipation among postmarketing gastrointestinal reports for GLP-1 receptor agonists. Canadian monographs for Ozempic, Wegovy, Rybelsus, Mounjaro and Zepbound also list ileus or intestinal obstruction under post-market GI reactions; Ozempic, Rybelsus and Wegovy warn that GLP-1 RAs may be associated with severe GI disease including ileus. Contact your healthcare professional for severe or persistent GI symptoms.

How common were severe GI reactions in the trials?

From the US labels: Ozempic severe GI 0.4% (0.5 mg) and 0.8% (1 mg) vs 0% placebo; Wegovy adults injection 4.1% vs 0.9% placebo (tablet 2% vs 0%); Rybelsus 0.6% (7 mg) and 2% (14 mg) vs 0.3% placebo; Mounjaro 1.3% / 0.4% / 1.2% on 5 / 10 / 15 mg vs 0.9% placebo; Zepbound Studies 1+2 1.7% / 2.5% / 3.1% on 5 / 10 / 15 mg vs 1% placebo; Saxenda 4.8% vs 1.4%; Victoza 4.4% (1.2 mg) and 4.2% (1.8 mg) vs 1.1%; Trulicity 2.2% (0.75 mg) and 4.3% (1.5 mg) vs 1.4%. These are trial arms reported on the labels, not a dosing suggestion.

How often did people stop because of GI side effects?

Discontinuation for GI adverse reactions was higher than placebo on every label that reports it. Examples from US labels: Ozempic 3.1% / 3.8% vs 0.4% placebo; Wegovy adults 4.3% vs 0.7%; Rybelsus 8% / 4% on 14 / 7 mg vs 1%; Mounjaro 3.0% / 5.4% / 6.6% vs 0.4%; Zepbound 1.9% / 3.3% / 4.3% vs 0.5%; Saxenda 6.2% vs 0.8% (pediatric disc. GI 8% vs 0%); Victoza withdrawals GI 4.3% vs 0.5%. Canadian section 8 figures are in the Canada table on this page (for example Rybelsus CA 4.5% / 7.9% vs 0.6% placebo; Trulicity CA 1.3% / 3.5% vs 0.2%). Logging how long nausea, vomiting, diarrhea or constipation lasted helps your prescriber decide what to do next.

Is there a Canada vs US difference on severe GI disease?

The US labels elevated Severe Gastrointestinal Adverse Reactions to its own section 5 warning in the October 2025 update and state not recommended in severe gastroparesis. Canadian monographs put similar points under Gastrointestinal warnings: Ozempic and Rybelsus note GLP-1 RAs may be associated with severe GI disease including ileus and that people with gastroparesis may have more serious GI effects; Mounjaro, Zepbound and Trulicity say not studied / not recommended in severe GI disease including severe gastroparesis; Wegovy notes limited experience and post-market ileus; Saxenda and Victoza say IBD and diabetic gastroparesis were not studied and should not be used in that population. Zepbound’s Canadian monograph also reports severe GI adverse reactions in 2.7% of tirzepatide patients vs 1.2% placebo in weight-reduction trials.

What do Canadian monographs say about stopping for GI side effects?

Section 8 (Adverse Reactions) of each Canadian product monograph reports GI discontinuation rates from the trials. Examples: Ozempic 0.5 mg 3.9% and 1 mg 5.9% vs comparator 0.9%; Wegovy adults 4.3% vs 0.7% placebo; Rybelsus 7 mg 4.5% and 14 mg 7.9% vs 0.6% placebo; Mounjaro 3.0% / 5.4% / 6.6% vs 0.4%; Zepbound 1.9% / 3.3% / 4.3% vs 0.5% (GI led to discontinuation in 3.8% overall in the overview); Saxenda GI withdrawals 6.2% vs 0.8%; Victoza GI withdrawals 5.0% vs 0.5% comparator; Trulicity 0.75 mg 1.3% and 1.5 mg 3.5% vs 0.2% placebo. These are monograph figures, not a suggestion to stop on your own.

Does every Canadian monograph list ileus?

Ozempic, Rybelsus and Wegovy warn that GLP-1 receptor agonists may be associated with severe gastrointestinal disease including ileus / intestinal obstruction, and list intestinal obstruction (grouped with ileus) under post-market adverse reactions. Mounjaro and Zepbound list ileus under post-market gastrointestinal disorders. Trulicity reports events related to impaired gastric emptying, including severe gastroparesis. Saxenda and Victoza focus on IBD and diabetic gastroparesis not having been studied rather than an ileus post-market line in the monographs we checked.

Does dose escalation reduce GI risk?

US labels describe dose escalation schedules that exist in part to reduce gastrointestinal adverse reactions. Canadian monographs likewise note that most nausea, vomiting and diarrhea reports occur during dose escalation. That is a label design note, not a suggestion to change your dose. Never change a schedule based on this page; talk to your prescriber.

What GI symptoms should I report promptly?

Labels tell patients to contact a healthcare professional for severe or persistent gastrointestinal symptoms. That includes ongoing nausea, vomiting, diarrhea, constipation, or stomach pain that will not go away. Severe vomiting or diarrhea also ties into the acute kidney injury / dehydration warning on the same labels. Canadian patient leaflets for several products also describe ileus as a condition where the intestine cannot push food and waste through (severe constipation with bloating, pain or vomiting).

What should I log in a GLP-1 tracker?

Date and time of nausea, vomiting, diarrhea, constipation or stomach pain; how strong it was; how many days it lasted; whether you could keep fluids down; and anything your care team asked you to watch. Never log a dose change suggested by an app — Glidedose is a GLP-1 tracker for dates and symptoms so you can show your prescriber.

Which US section numbers cover severe GI reactions?

Ozempic 5.7; Wegovy 5.6; Rybelsus / Ozempic tablets 5.6; Mounjaro 5.6; Zepbound 5.2; Saxenda 5.7; Victoza 5.6; Trulicity 5.6. Section numbers can change when labels are revised.

How does this connect to aspiration under anesthesia?

The same delayed gastric emptying that drives severe-GI and gastroparesis warnings also drives the pulmonary aspiration under anesthesia warning on every US label. If you have a planned procedure, see the aspiration guide and tell your surgical team you take a GLP-1. Glidedose does not suggest holds or doses.