GLP-1 Warnings and Precautions: What Each FDA Label Actually Lists

The FDA-approved prescribing information for Ozempic (semaglutide injection, revised 5/2026), Wegovy (semaglutide injection and tablets, revised 6/2026), Rybelsus and Ozempic tablets (oral semaglutide, revised 1/2026), Mounjaro (tirzepatide, revised 8/2026), Zepbound (tirzepatide, revised 8/2026) and Saxenda (liraglutide, revised 6/2026) all share the same structure at the top: a boxed warning about thyroid C-cell tumors, a contraindication for MTC and MEN 2, and a Section 5, Warnings and Precautions, that lists the same core set of risks. Each label was read on DailyMed, the National Library of Medicine's mirror of current FDA labeling, accessed 14 September 2026.

Seven subsections appear on all six labels: acute pancreatitis, acute gallbladder disease, hypoglycemia (titled with the qualifier "with concomitant use of insulin secretagogues or insulin" on the diabetes labels), acute kidney injury due to volume depletion, severe gastrointestinal adverse reactions, hypersensitivity reactions, and pulmonary aspiration during general anesthesia or deep sedation. Diabetic retinopathy complications is on five of the six — Saxenda has no such subsection — and its depth varies enormously by molecule. Ozempic, Wegovy, Mounjaro and Zepbound each carry a never-share-this-pen subsection. Heart rate increase appears only on Wegovy (5.9) and Saxenda (5.5).

This page is a transcription. It reproduces what each label says, names the section it says it in, and stops. It does not interpret the risks, rank them, or say what anyone should do about them — the labels address prescribers, and the person who prescribed your medication is the one to ask what any of it means for you. For the pharmacokinetic side of the same labels, the per-product pages such as Ozempic, Wegovy, Zepbound, Mounjaro and Saxenda quote Section 12.3 the same way.

Every one of the six labels opens with the heading WARNING: RISK OF THYROID C-CELL TUMORS, and Section 5.1 of each repeats it in full. The Ozempic, Wegovy and Rybelsus labels state that in mice and rats, semaglutide caused a dose-dependent and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure at clinically relevant plasma exposures. The Mounjaro and Zepbound labels say the same of tirzepatide in rats in a 2-year study. The Saxenda label says liraglutide causes these tumors at clinically relevant exposures in both genders of rats and mice, and adds that malignant thyroid C-cell carcinomas were detected in rats and mice (Section 5.1, each label, via DailyMed, accessed 14 September 2026).

All six then use nearly the same sentence: it is unknown whether the product causes thyroid C-cell tumors, including medullary thyroid carcinoma, in humans, as the human relevance of the rodent tumors has not been determined. The semaglutide and liraglutide labels carry one further sentence that the tirzepatide labels do not — that cases of MTC in patients treated with liraglutide have been reported in the postmarketing period, and that the data in these reports are insufficient to establish or exclude a causal relationship between MTC and GLP-1 receptor agonist use in humans.

Section 4 of every label makes MTC and MEN 2 a contraindication: a personal or family history of medullary thyroid carcinoma, or Multiple Endocrine Neoplasia syndrome type 2. Section 5.1 directs prescribers to counsel patients about the potential risk and to inform them of the symptoms of thyroid tumors, which the labels list as a mass in the neck, dysphagia, dyspnea and persistent hoarseness. The same subsection states that routine monitoring of serum calcitonin or thyroid ultrasound is of uncertain value for early detection of MTC, and that such monitoring may increase the risk of unnecessary procedures because of the low test specificity for serum calcitonin and a high background incidence of thyroid disease. That last sentence is the label's own; whether any monitoring applies to a given person is a question for the prescriber, not for this page.

The acute pancreatitis subsection is essentially the same paragraph on all six labels. It states that acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been observed in patients treated with GLP-1 receptor agonists, including the product in question. It directs the prescriber, after initiation, to observe patients carefully for signs and symptoms — which the labels describe as persistent or severe abdominal pain, sometimes radiating to the back, with or without nausea or vomiting — and states that if pancreatitis is suspected, the product should be discontinued and appropriate management initiated (Ozempic 5.2, Wegovy 5.2, Rybelsus 5.2, Mounjaro 5.2, Zepbound 5.5, Saxenda 5.2, via DailyMed, accessed 14 September 2026).

The acute gallbladder disease subsection is where the labels start to print their own numbers. The Wegovy label reports cholelithiasis in 1.6% of injection-treated adults versus 0.7% on placebo, 2.5% of tablet-treated adults versus 1% on placebo, and 3.8% of injection-treated pediatric patients aged 12 and older versus 0% on placebo, and adds that the incidence of acute gallbladder disease was greater than placebo even after accounting for the degree of weight loss (Wegovy 5.3). The Saxenda label reports cholelithiasis in 2.2% versus 0.8% and cholecystitis in 0.8% versus 0.4%, and says the majority of those patients required cholecystectomy (Saxenda 5.3). The Zepbound label reports cholelithiasis in 1.1% versus 1%, cholecystitis in 0.7% versus 0.2% and cholecystectomy in 0.2% versus none (Zepbound 5.4). The Mounjaro label reports acute gallbladder disease in 0.6% of treated adults and 0% on placebo (Mounjaro 5.8). The Ozempic label reports cholelithiasis in 1.5% and 0.4% of patients in its two dose arms and none on placebo (Ozempic 5.9). Every label ends the subsection the same way: if cholelithiasis or cholecystitis is suspected, gallbladder studies and appropriate clinical follow-up are indicated.

The acute kidney injury subsection is uniform. Each label states there have been postmarketing reports of acute kidney injury, in some cases requiring hemodialysis, and that the majority of the reported events occurred in patients who experienced gastrointestinal adverse reactions leading to dehydration, such as nausea, vomiting or diarrhea. Each directs the prescriber to monitor renal function in patients reporting reactions that could lead to volume depletion, especially during dosage initiation and escalation (Ozempic 5.6, Wegovy 5.5, Rybelsus 5.5, Mounjaro 5.5, Zepbound 5.3, Saxenda 5.6). The Wegovy label lists this subsection as revised 08/2025 and the Rybelsus label as revised 10/2025 under Recent Major Changes. The practical corollary the labels imply — that fluid intake during a rough patch matters — is covered without dosing advice in how much water to drink on a GLP-1.

Hypoglycemia is on every label, but the title tells you which product you are reading. The type 2 diabetes labels — Ozempic 5.5, Rybelsus 5.4 and Mounjaro 5.3 — title it "Hypoglycemia with Concomitant Use of Insulin Secretagogues or Insulin" and state that patients on the product together with an insulin secretagogue such as a sulfonylurea, or with insulin, may have an increased risk of hypoglycemia, including severe hypoglycemia. Each says the risk may be lowered by a reduction in the dose of the sulfonylurea or insulin — an instruction addressed to the prescriber, and one this page quotes rather than endorses. The weight-management labels — Wegovy 5.4, Zepbound 5.7 and Saxenda 5.4 — title it simply "Hypoglycemia". Wegovy and Zepbound open with the flat statement that the product lowers blood glucose and can cause hypoglycemia. The Zepbound label reports hypoglycemia in 4.2% of treated patients with type 2 diabetes versus 1.3% on placebo in Study 2, rising to 10.3% among those also taking a sulfonylurea versus 2.1% among those not, and notes that hypoglycemia has also been associated with the product in adults without type 2 diabetes. The Wegovy label states that its use in type 1 diabetes or in combination with insulin has not been evaluated (via DailyMed, accessed 14 September 2026).

Diabetic retinopathy complications is the clearest molecule-level difference in Section 5. The three semaglutide labels — Ozempic 5.3, Wegovy 5.8 and Rybelsus 5.3 — report a 2-year trial in patients with type 2 diabetes and high cardiovascular risk in which diabetic retinopathy complications occurred in 3.0% of patients on semaglutide injection versus 1.8% on placebo, with the absolute increase larger in patients with a history of retinopathy at baseline (8.2% versus 5.2%) than without (0.7% versus 0.4%). The Wegovy label adds 4% versus 2.7% from its own trial in adults with type 2 diabetes, and the Rybelsus label adds 4.2% versus 3.8% from a pooled analysis of its glycemic control trials. All three then state that rapid improvement in glucose control has been associated with a temporary worsening of diabetic retinopathy, that the effect of long-term glycemic control with semaglutide on retinopathy complications has not been studied, and that patients with a history of diabetic retinopathy should be monitored for progression. The two tirzepatide labels — Mounjaro 5.7, titled "in Patients with a History of Diabetic Retinopathy", and Zepbound 5.8 — print only the first and third of those statements — temporary worsening with rapid improvement in glucose control, and monitoring of patients with a history of retinopathy — with no trial figures; both list the subsection as updated in 2026 under Recent Major Changes.

Heart rate increase has its own subsection on just two labels. Wegovy 5.9 reports mean increases in resting heart rate of 1 to 4 beats per minute in treated adults compared with placebo, and that more treated adults than placebo patients had maximum changes of 20 bpm or more (26% versus 16%). Saxenda 5.5 reports mean increases of 2 to 3 bpm, and 4 to 9 bpm higher than placebo in a trial that monitored heart rate continuously for 24 hours. Both direct prescribers to monitor heart rate at regular intervals, both say patients should report palpitations or a racing heartbeat at rest, and both state that the product should be discontinued in patients who experience a sustained increase in resting heart rate. That decision, like every other in Section 5, sits with the prescriber.

Every label has a severe gastrointestinal adverse reactions subsection, and every one closes with the same sentence: the product is not recommended in patients with severe gastroparesis. The figures attached differ by label. Wegovy 5.6 reports severe gastrointestinal adverse reactions in 4.1% of injection-treated adults versus 0.9% on placebo, and 2% of tablet-treated adults versus 0%. Saxenda 5.7 reports 4.8% versus 1.4%. Zepbound 5.2 reports 1.7%, 2.5% and 3.1% across its three maintenance-dose arms versus 1% on placebo. Mounjaro 5.6 reports 1.3%, 0.4% and 1.2% across its three arms versus 0.9%. Ozempic 5.7 reports 0.4% and 0.8% across its two arms versus 0%. Rybelsus 5.6 reports 0.6% and 2% across its two arms versus 0.3%. Every label adds that severe gastrointestinal adverse reactions have also been reported postmarketing with GLP-1 receptor agonists, and all six list this subsection as revised in late 2025 or early 2026 under Recent Major Changes (via DailyMed, accessed 14 September 2026). The ordinary, non-severe version of these reactions is the subject of GLP-1 side effects and GLP-1 nausea tips, not of this page.

Hypersensitivity reactions is nearly uniform, with one difference in wording. Each label states that serious hypersensitivity reactions, giving anaphylaxis and angioedema as examples, have been reported with the product, and each treats a prior serious hypersensitivity reaction to the active ingredient or any excipient as a contraindication. Ozempic 5.8, Wegovy 5.7, Rybelsus 5.7 and Mounjaro 5.4 state that if a hypersensitivity reaction occurs the product should be discontinued and the reaction treated promptly per standard of care. Saxenda 5.8 and Zepbound 5.6 instead direct the patient to discontinue the product and promptly seek medical attention or advice. Each also carries the same caution: anaphylaxis and angioedema have been reported with other GLP-1 receptor agonists, and it is unknown whether a patient with such a history will be predisposed to these reactions with this product. The Zepbound label is the one that attaches a number, 0.1% of treated patients with severe hypersensitivity reactions versus none on placebo (Ozempic 5.8, Wegovy 5.7, Rybelsus 5.7, Mounjaro 5.4, Zepbound 5.6, Saxenda 5.8).

Pulmonary aspiration during general anesthesia or deep sedation is the newest shared subsection, and the wording is identical on all six labels. Each states that the product delays gastric emptying; that there have been rare postmarketing reports of pulmonary aspiration in patients receiving GLP-1 receptor agonists undergoing elective surgeries or procedures requiring general anesthesia or deep sedation who had residual gastric contents despite reported adherence to preoperative fasting recommendations; and that available data are insufficient to inform recommendations to mitigate the risk, including whether modifying preoperative fasting or temporarily discontinuing the product could reduce the incidence of retained gastric contents. Each ends by directing prescribers to instruct patients to tell healthcare providers about the medication before any planned surgery or procedure. The subsection arrived in late 2024: the Zepbound label revised 10/2024, published on FDA accessdata, lists Pulmonary Aspiration During General Anesthesia or Deep Sedation (5.10) as its only Recent Major Change, and the Ozempic label dates its own subsection 5.10 to 1/2025 (Ozempic 5.10, Wegovy 5.10, Rybelsus 5.9, Mounjaro 5.9, Zepbound 5.9, Saxenda 5.9 in the current labels).

Until early 2026 the three weight-management labels carried a subsection the diabetes labels never had. The Zepbound label revised 10/2024 (FDA accessdata) printed it as 5.9, Suicidal Behavior and Ideation: suicidal behavior and ideation have been reported in clinical trials with other weight management products; monitor patients for the emergence or worsening of depression, suicidal thoughts or behaviors, or any unusual changes in mood or behavior; discontinue in patients who experience suicidal thoughts or behaviors; avoid in patients with a history of suicidal attempts or active suicidal ideation. Wegovy and Saxenda carried equivalent text.

On 13 January 2026 the FDA published a Drug Safety Communication requesting that the holders of the Saxenda, Wegovy and Zepbound applications remove that information from their labeling. The communication describes a meta-analysis of 91 placebo-controlled trials with 107,910 patients and a retrospective cohort study of more than 2.2 million users, and states that the totality of these studies does not support a causal relationship between the use of GLP-1 receptor agonists and the occurrence of suicidal ideation and behavior. It updates the FDA's preliminary communication of 30 January 2024. The current labels reflect the change: the Wegovy label lists Suicidal Behavior and Ideation (5.10) as (Removed) 02/2026, the Saxenda label lists 5.9 as (Removed) 02/2026, and the Zepbound label lists the subsection as (Removed) with a 02/2026 date (Recent Major Changes, each label, via DailyMed, accessed 14 September 2026). The same FDA communication still advises patients to report new or worsening depression or suicidal thoughts to their healthcare provider, and names the 988 Suicide and Crisis Lifeline. A removed label warning is not a statement that mood is irrelevant; it is a statement about causation.

None of this page is actionable on its own, and it is not meant to be. What it does support is accurate record-keeping. Almost every subsection above turns on timing — abdominal pain that persists, vomiting that leads to dehydration, palpitations at rest, a change in vision after glucose control improves quickly — and timing is exactly what memory gets wrong. GLP-1 Tracker, a free iPhone app that stores what you enter on your device, is built for that narrow job: each dose with its date and injection site, weight, meals, and a dated note when something feels off, so a symptom can be placed relative to a dose or a dose change instead of reconstructed later. The symptom journal how-to covers what to record without an app at all, and preparing a summary for your doctor covers how to hand it over. If anything in Section 5 seems to describe you, the record goes to your prescriber or pharmacist; the decision about it stays with them.