GLP-1 Receptor Agonists Monitoring Bundle: The Complete Prescriber Reference

Is there one monitoring bundle for the whole class?

No. Monitoring instructions sit in each product's own label and differ by product. This page covers the Wegovy label (injection and tablets) [1] and the Foundayo (orforglipron) label [2], which share a warning list and a short set of explicit monitoring instructions.

Monitoring instructions in the labels

Blood glucose in patients with diabetes

The Wegovy label says to monitor blood glucose before starting and during treatment in patients with diabetes [1]. Foundayo gives the same instruction [2]. Both labels separately warn that insulin or an insulin secretagogue increases hypoglycemia risk, and both say to consider reducing the dose of the insulin or secretagogue at initiation [1][2]. In Foundayo Trial 2 in adults with type 2 diabetes, glucose below 54 mg/dL was reported in 2% of orforglipron-treated patients versus 0.2% on placebo, and 7% of patients taking a sulfonylurea versus 0.5% of those not taking one [2].

Kidney function when GI symptoms cause volume loss

Both labels say to monitor renal function in patients reporting adverse reactions that could lead to volume depletion, with the Foundayo label noting this matters especially during initiation and dose escalation [1][2]. In the two pooled Foundayo weight trials, acute kidney injury was reported in 0.2% of orforglipron-treated patients versus 0.05% on placebo, and hypotension in 2% versus 0.5% [2].

Heart rate

The Wegovy label instructs monitoring of heart rate at regular intervals [1]. The label reports mean resting heart rate increases of 1 to 4 bpm [1]. The Foundayo label reports 4 to 5 bpm versus 0.5 bpm on placebo [2], and tirzepatide labels report 1 to 3 bpm [3].

Eyes in patients with diabetic retinopathy

Diabetic retinopathy complications are a labeled warning for semaglutide, and the Wegovy label says patients with a history of diabetic retinopathy should be monitored [1]. In SUSTAIN 6, retinopathy complications occurred in 3% of semaglutide patients versus 1.8% on placebo [1]. The Foundayo label says the drug has not been studied in patients with diabetic retinopathy or macular edema requiring acute treatment, and that patients with a history of retinopathy should be monitored for progression [2]. Separately, EMA's safety committee concluded that NAION is a very rare side effect of semaglutide medicines, affecting up to 1 in 10,000 users [4].

Thyroid: counseling rather than calcitonin screening

The boxed warning on these products concerns medullary thyroid carcinoma, a calcitonin-secreting tumor, and both the Wegovy and Foundayo labels state that routine monitoring of serum calcitonin or thyroid ultrasound is of uncertain value for early detection and may lead to unnecessary procedures [1][2]. What the labels ask for instead is counseling about the symptoms of a thyroid tumor: a mass in the neck, difficulty swallowing, shortness of breath, or persistent hoarseness [1][2]. A personal or family history of medullary thyroid carcinoma or MEN 2 is a contraindication [1][2].

Mood and suicidal ideation

FDA reviewed a meta-analysis of 91 placebo-controlled trials (107,910 patients, 60,338 on a GLP-1 drug) and a Sentinel cohort of about 2.24 million new users, found no increased risk of suicidal behavior or ideation, and on 13 January 2026 asked manufacturers to remove that warning from the three labels that carried it: Saxenda, Wegovy and Zepbound [5]. Those labels now list the section as removed [6][1][3].

Contraindications and cautions in the Wegovy and Foundayo labels

• Personal or family history of medullary thyroid carcinoma, or MEN 2: contraindicated [1][2]
• A prior serious hypersensitivity reaction to the drug or an excipient: contraindicated [1][2]
• Pregnancy: weight loss offers no benefit in pregnancy. The Wegovy label says to discontinue when pregnancy is recognized and at least 2 months before a planned pregnancy because of the long half-life [1]; the Foundayo label says to discontinue when pregnancy is recognized [2]
• Another GLP-1 receptor agonist: the Wegovy and Foundayo labels state that concomitant use with another GLP-1 receptor agonist is not recommended [1][2]
• Severe gastroparesis: the drugs are not recommended in this setting [1][2]
• Severe hepatic impairment: Foundayo is not recommended [2]

The labels do not state that these drugs cause gastroparesis [1][2].

Dose step-up and gastrointestinal reactions

Nausea, vomiting and diarrhea were more frequent during Foundayo dose escalation and decreased over time [2].

• Wegovy injection: 0.25 mg once weekly for 4 weeks, then follow the labeled escalation, titrating every 4 weeks; the usual recommended maintenance dose is 2.4 mg weekly, and maintenance dosing depends on the indication [1]
• Wegovy tablets: 1.5 mg once daily for 30 days, then step up every 30 days to the 25 mg maintenance dose [1]
• Foundayo: 0.8 mg once daily, at least 30 days at each level (2.5, 5.5, then 9, 14.5 or 17.2 mg), maximum 17.2 mg; the label says the escalation schedule is designed to reduce GI adverse reactions [2]

The labels report these gastrointestinal adverse-reaction rates against placebo.

• Wegovy 2.4 mg injection, 68 weeks: nausea 44% versus 16%, diarrhea 30% versus 16%, vomiting 24% versus 6%, constipation 24% versus 11%; 6.8% versus 3.2% discontinued for adverse reactions [1]
• At 17.2 mg, Foundayo's reported nausea rate was 35% versus 10% with placebo, with vomiting 24% versus 4%, diarrhea 25% versus 11% and constipation 24% versus 9% [2]. Across the pooled Foundayo dose groups, 8% discontinued because of adverse reactions versus 3% on placebo, and severe gastrointestinal reactions occurred in about 3% versus 1% [2]

Rates from separate trials are not directly comparable to each other [1][2].

Other labeled risks worth tracking

• Pancreatitis: both labels say to discontinue if pancreatitis is suspected [1][2]. In the pooled Foundayo weight trials there were 6 confirmed events in 6 orforglipron-treated patients (0.14 per 100 patient-years of exposure) versus 2 events in 1 placebo patient (0.04) [2]
• Gallbladder disease: in adult weight trials, cholelithiasis was reported by 1.6% of Wegovy injection patients versus 0.7% on placebo, and cholecystitis by 0.6% versus 0.2% [1]. In the Foundayo pool, cholelithiasis was 1% versus 0.7% and acute cholecystitis 0.4% [2]
• Hypersensitivity: anaphylaxis and angioedema have been reported with these drugs [1][2]
• Pulmonary aspiration during anesthesia or deep sedation: labels instruct patients to tell healthcare providers about any planned surgery or procedure [1][2]
• Hair loss: 3% versus 1% with Wegovy 2.4 mg [1]; 5% versus 2% with Foundayo 17.2 mg, and 7% of women versus 0.9% of men [2]; 4% to 5% versus 1% with Zepbound 15 mg [3]

Oral medicines and contraception

The class delays gastric emptying, which can change absorption of oral drugs. The Wegovy label says to consider increased clinical or laboratory monitoring when these drugs are used with oral medicines that have a narrow therapeutic index or require clinical monitoring, and notes that oral semaglutide raised levothyroxine exposure by 33% [1].

Contraception advice is product-specific. Tirzepatide labels advise switching to a non-oral method or adding a barrier method for 4 weeks after starting and after each dose increase [3]. The Foundayo label advises the same for 30 days after starting and 30 days after each escalation [2]. Semaglutide labels carry no such advice, and a tablet interaction study found no clinically significant change in ethinyl estradiol or levonorgestrel [1].

The Foundayo label adds interaction instructions: avoid strong CYP3A4 inducers, cap the dose at 9 mg daily with a strong CYP3A4 inhibitor, avoid strong CYP3A4 inhibitors that also inhibit OATP1B such as ritonavir, and do not exceed simvastatin 20 mg daily because simvastatin acid exposure doubled [2].

What happens after stopping

STEP 4 took 803 adults who reached 2.4 mg weekly after a 20-week run-in and randomized them to continue semaglutide or switch to placebo for 48 weeks; the continued group lost a further 7.9% of body weight while the placebo group gained 6.9%, a difference of 14.8 percentage points [9].