What the FDA labels actually say about each approved GLP-1 drug, what changed in 2026 including Medicare coverage and a new oral medication, what the regain data shows, and the questions worth writing down before an appointment.

This is not medical advice, and we are not qualified to give any. It is a list of things that are written down in FDA labels, CMS policy documents and federal enforcement actions, assembled so that you walk into an appointment knowing what the official record says. The decision belongs to you and a clinician who knows your history.

The landscape changed substantially between late 2025 and mid 2026: a new oral drug was approved, a new oral formulation of an existing one arrived, Medicare began covering some of these medicines for weight for the first time, and the FDA asked manufacturers to remove a warning. Any article written before this year is out of date.

What is actually approved, and for what

The single most common confusion is treating these as one product. They are several, with different approved uses. What follows is drawn from current FDA labels and approval announcements.

Brand (active ingredient) Form FDA-approved indications
Ozempic (semaglutide) Injection Type 2 diabetes; reducing major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease; reducing risk of sustained eGFR decline, end-stage kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease
Rybelsus and Ozempic tablets (semaglutide) Oral Type 2 diabetes; cardiovascular risk reduction in adults with type 2 diabetes at high risk
Wegovy (semaglutide) Injection Weight reduction and long-term maintenance in adults with obesity and in adolescents 12 and older with obesity, and in adults with overweight plus at least one weight-related condition; cardiovascular risk reduction in adults with established cardiovascular disease and obesity or overweight; noncirrhotic MASH with moderate to advanced fibrosis
Wegovy tablets (semaglutide), approved December 2025 Oral Cardiovascular risk reduction; weight reduction and maintenance in adults
Mounjaro (tirzepatide) Injection Type 2 diabetes in adults and children 10 and older
Zepbound (tirzepatide) Injection Weight reduction and maintenance in adults with obesity or overweight plus a weight-related condition; moderate to severe obstructive sleep apnoea in adults with obesity
Foundayo (orforglipron), approved 1 April 2026 Oral Weight reduction and maintenance in adults with obesity or overweight plus at least one weight-related condition

Every weight indication above carries the same framing on the label: the medicine is used “in combination with a reduced-calorie diet and increased physical activity.” The NIDDK puts the same point in plainer words: “Medications don’t replace physical activity or healthy eating habits as a way to lose weight,” and they “work best when combined with a lifestyle program.”

Note also that Ozempic is not approved for weight loss. It is approved for diabetes and for cardiovascular and kidney outcomes in people with diabetes. Wegovy is the same molecule with a weight indication. Which brand appears on a prescription has real consequences for insurance coverage.

Eligibility as the FDA describes it

The thresholds studied in the trials are the ones the FDA describes. Announcing Zepbound’s approval, the agency described the population as adults with “obesity (body mass index of 30 kg/m2 or greater) or overweight (body mass index of 27 kg/m2 or greater) with at least one weight-related condition.” The original 2021 Wegovy label used the same numbers, giving hypertension, type 2 diabetes and dyslipidaemia as examples of qualifying conditions. The NIDDK page repeats the 30 and 27 thresholds.

A first question worth asking: which indication am I being prescribed under, and does my BMI and medical history fit it?

The warnings that are on every label

All of these carry a boxed warning. The Wegovy label states: “In rodents, semaglutide causes thyroid C-cell tumors at clinically relevant exposures. It is unknown whether WEGOVY causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans.” The drug “is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).” The tirzepatide labels carry equivalent language, as does the new orforglipron label.

The most common adverse reactions listed for Wegovy are “nausea, diarrhea, vomiting, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness.” Zepbound adds injection site reactions, hypersensitivity reactions, burping, hair loss and reflux.

The warnings and precautions sections run longer than most people expect: acute pancreatitis, acute gallbladder disease, hypoglycaemia when combined with insulin or a sulfonylurea, acute kidney injury from volume depletion, severe gastrointestinal reactions, hypersensitivity, diabetic retinopathy complications in people with type 2 diabetes, increased heart rate, and pulmonary aspiration during general anaesthesia or deep sedation.

That last one is newer and worth raising specifically, because it affects any surgery or procedure you may have. The Ozempic label states 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.” Its instruction is unambiguous: “Instruct patients to inform healthcare providers prior to any planned surgeries or procedures if they are taking OZEMPIC.”

One warning has come off. On 13 January 2026 the FDA requested removal of the suicidal behaviour and ideation warning from GLP-1 labels, stating that after a meta-analysis of 91 clinical trials covering 107,910 patients and a retrospective cohort of 2.2 million users, “the results did not show an increased risk for SI/B or for other relevant psychiatric adverse events,” and “the totality of these studies does not support a causal relationship.”

How much weight, and what happens if you stop

The figures come from the labels and FDA announcements. In the 68 week trial in adults without type 2 diabetes reported in the original Wegovy label, mean body weight change was minus 14.9 percent on the drug against minus 2.4 percent on placebo, with 83.5 percent losing at least 5 percent of body weight against 31.1 percent on placebo. For tirzepatide, the FDA’s approval announcement stated that patients without diabetes taking the highest dose lost “on average 18 percent of their body weight” compared with placebo, and patients with type 2 diabetes lost on average 12 percent.

Stopping is the question people ask last and should ask first. The NIDDK’s answer is short: “You probably will regain some weight after you stop taking weight management medication.” The Zepbound label documents this directly in a randomised withdrawal study: after a 36 week open-label period, participants switched to placebo gained 14.0 percent of body weight by week 88, while those who continued lost a further 5.5 percent.

That reframes the whole conversation. These are not courses of treatment with an end date. Ask what the plan is for year three and year five, and what happens if coverage lapses.

The cost and coverage picture, which changed in 2026

Medicare Part D has been barred by statute from covering drugs used for weight loss. A 2024 proposal to reinterpret that exclusion was not finalised in April 2025. Instead, CMS created a separate route.

The Medicare GLP-1 Bridge is, in CMS’s words, “a short-term demonstration run by CMS that will provide eligible Medicare Part D beneficiaries with access to certain GLP-1 drugs between July 1, 2026, and December 31, 2027,” with a 50 dollar copay, operating “outside of the Medicare Part D benefit’s coverage and payment flow.” Medicare.gov lists the covered products as Foundayo, Wegovy and Zepbound KwikPen, and sets out eligibility bands: BMI of 35 or higher; or BMI of 30 or higher with certain heart, blood pressure or kidney conditions; or BMI of 27 or higher with prediabetes or a history of heart attack, stroke or peripheral artery disease. People with type 2 diabetes, moderate to severe sleep apnoea or fatty liver disease are excluded from the demonstration, on the basis that their Part D plan may already cover the drug.

One detail worth budgeting for: that 50 dollars does not accumulate toward anything. Because the drugs are “provided outside of the Part D benefit payment flow and coverage,” CMS states that “the Part D deductible will not apply, no part of the 50 dollar copay counts towards the beneficiary’s TrOOP costs, and there is no low-income subsidy (LIS) provided for LIS beneficiaries.” Medicare.gov says the same. The spending does not move you toward your annual out-of-pocket cap, and beneficiaries who normally receive low-income help do not receive it on this pathway.

On list prices, the White House announced in November 2025 that “Ozempic and Wegovy will fall from 1,000 dollars and 1,350 dollars per month, respectively, to 350 dollars,” with Zepbound and orforglipron falling “from 1,086 dollars per month to an average of 346 dollars,” and an initial dose priced at 150 dollars per month. The fact sheet does not state effective dates. Separately, CMS published a negotiated maximum fair price under the Inflation Reduction Act for Ozempic, Rybelsus and Wegovy of 274 dollars for a 30-day supply, against a 2024 list price of 959 dollars, effective 1 January 2027.

What not to buy

The shortages that made compounded versions legal are over. The FDA declared the tirzepatide shortage resolved on 2 October 2024 and the semaglutide shortage resolved on 21 February 2025, with compounding deadlines that have long since passed. As of April 2026 the agency states that “tirzepatide and semaglutide do not currently appear on the 503B bulks list or on FDA’s drug shortage list.”

The harms the FDA documented are specific. Its 2024 alert on dosing errors reported that “patients administered five to 20 times more than the intended dose of semaglutide,” with consequences including “dehydration, acute pancreatitis and gallstones,” and some cases requiring hospitalisation. The agency also warns that unapproved salt forms “including semaglutide sodium and semaglutide acetate, are different active ingredients than are used in the approved drugs,” and cautions against products “falsely labeled for research purposes or not for human consumption.” As of 31 May 2026 the FDA had received 990 adverse event reports for compounded semaglutide and more than 730 for compounded tirzepatide.

Counterfeits of the real products are also in circulation. The FDA has issued alerts on specific counterfeit Ozempic lots, most recently in December 2025, and advises purchasing only from state-licensed pharmacies.

Telehealth advertising has drawn enforcement too. In July 2025 the FTC acted against a telemedicine firm, alleging advertised monthly prices did not include the drug, lab work or consultation fees, and that the company “published fake testimonials created by hired individuals, employees, and family members.”

The questions worth writing down

Bring these on paper. Appointments are short.

  1. Which drug and which approved indication are you prescribing under, and does my history fit it?
  2. Do I have any personal or family history of medullary thyroid carcinoma or MEN 2?
  3. What are my kidney function, gallbladder history, pancreatitis history and, if I have diabetes, my retinopathy status?
  4. I take the following medications. Which of them interact? If I take insulin or a sulfonylurea, what changes?
  5. What should I tell an anaesthetist before any procedure?
  6. If I use oral contraception, does this affect it? The Zepbound label warns that delayed gastric emptying “may reduce the efficacy of oral hormonal contraceptives” and advises a non-oral or additional barrier method for four weeks after starting and after each dose increase.
  7. What is the plan if I stop, or if my insurance stops covering it?
  8. What will this cost me, through which pharmacy, this month and next year?

If pregnancy is possible, this belongs at the top of the list rather than the bottom. The Wegovy label instructs discontinuation “when pregnancy is recognized” and at least two months before a planned pregnancy; the Zepbound label states that “weight loss offers no benefit to a pregnant patient and may cause fetal harm.”

The part that is genuinely unsettled

These medicines have produced results in trials that earlier weight-loss drugs did not approach, and the FDA has extended their approved uses to cardiovascular events, sleep apnoea, kidney outcomes and liver disease on the strength of further trials. That is a serious body of evidence and it deserves to be taken seriously.

What is not settled is what any of this looks like over a decade, in people who are not trial participants, who stop and restart as jobs and insurance change, and for whom the regain data suggests that stopping undoes the effect. Nobody has that answer yet, including the manufacturers. The honest position is that this is a long-term commitment with a strong short-term evidence base, and the person best placed to weigh that for you is someone who can see your chart.

General information, current as of September 2026, and not medical advice. Approvals, warnings, prices and coverage rules change; check the primary sources and speak to a qualified clinician about your own circumstances.

Frequently asked questions

Does Medicare cover these now?

Partly. A CMS demonstration called the Medicare GLP-1 Bridge runs from 1 July 2026 to 31 December 2027 with a 50 dollar copay for eligible Part D beneficiaries meeting set BMI and condition criteria.

Is compounded semaglutide still legal?

The shortages that permitted it ended in 2024 and 2025. The FDA has documented dosing errors of five to 20 times the intended dose and warns about unapproved salt forms.

What happens if I stop taking it?

The NIDDK states you probably will regain some weight after stopping, and trial data shows substantial regain.

What BMI qualifies?

FDA announcements describe a BMI of 30 or greater, or 27 or greater with at least one weight-related condition. Whether that fits you is a question for a clinician.

Sources

  1. Food and Drug Administration, Wegovy prescribing information
  2. Food and Drug Administration, Ozempic prescribing information
  3. Food and Drug Administration, approval of a new medication for chronic weight management
  4. Food and Drug Administration, removal of the suicidal behaviour warning from GLP-1 labelling
  5. Food and Drug Administration, concerns with unapproved GLP-1 drugs used for weight loss
  6. Food and Drug Administration, dosing errors with compounded semaglutide
  7. NIDDK, Prescription Medications to Treat Overweight and Obesity
  8. Centers for Medicare and Medicaid Services, Medicare GLP-1 Bridge
  9. Centers for Medicare and Medicaid Services, negotiated prices fact sheet
  10. Federal Trade Commission, action against a telemedicine firm over weight-loss advertising

About the author

Answerunboxed Editorial

Answerunboxed is an independent consumer guide covering money, insurance, health, home, auto, technology and careers for readers in the United States. Every article is researched from primary sources — IRS publications, CDC and NIH guidance, NAIC filings, CFPB and FTC material — and links to the sources it relies on so you can check the work yourself. We are not licensed financial advisers, insurance agents, tax professionals or physicians, and nothing published here is personalised advice for your situation.