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This page features 13 Cited Research Articles
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What Is the FDA-Approved Use of Ozempic?

Ozempic is a weekly injection that helps reduce blood sugar levels by stimulating the pancreas to produce more insulin. As of February 2025, Ozempic (semaglutide) remains FDA-approved for two uses:

  1. To improve blood sugar control in adults with type 2 diabetes, combined with diet and exercise.
  2. To reduce the risk of major cardiovascular events (such as heart attack, stroke or death) in adults with type 2 diabetes and established heart disease.

The U.S. Food and Drug Administration approved Novo Nordisk’s Ozempic in December 2017 to treat Type 2 diabetes. When combined with a healthy diet and increased exercise, it effectively lowers blood sugar levels in patients.

Patients have noted weight loss with Ozempic. While the FDA has not approved Ozempic for weight loss, doctors may sometimes prescribe it to help individuals with obesity lose weight. This is called off-label use. However, a different medication called Wegovy contains a stronger dose of semaglutide — the same active ingredient as Ozempic — and is approved for weight loss.

“We’re concerned about certain accounts from public media and social channels, including reports of off-label use of semaglutide for purely cosmetic or aesthetic weight loss…”

Off-label prescribing of drugs can be helpful when another medication is unavailable. However, it can also have unintended consequences — you should only take off-label drugs in close consultation with your health care provider. The FDA cautions that risks may outweigh the benefits of off-label use.

Ozempic Dosing Information

Ozempic uses a graduated dosing structure to allow the body to adjust to treatment. Patients start with a 0.25 mg injection once a week. After four weeks, the dose doubles to 0.5 mg.

Some patients will find this level of medication sufficient to control blood sugar levels. However, some may need additional support. The highest approved dose for Ozempic is 2.0 mg weekly.

Starting DoseMaintenance DoseAdditional SupportAdditional Support
0.25 mg0.5 mg1.0 mg2.0 mg
Once weekly for 4 weeksOnce weekly for 4 weeks or longerOnce weekly for 4 weeks or longer as needed for additional blood sugar control
Use only the Ozempic pen designed for 0.25 and 0.5 mg dosing. Use only the Ozempic pen designed for 1.0 mg dosing. Use only the Ozempic pen designed for 2.0 mg dosing.

Learning how to use an Ozempic pen involves a few basic steps. Patients must attach a clean needle, check flow levels, set the dosage and then inject the medication under the skin in the abdomen, thigh or upper arm. Patients should always follow proper sharps disposal procedures afterward.

Side Effects of Ozempic

Common Ozempic side effects are generally mild, including abdominal discomfort, nausea and constipation. Starting at a base dose and gradually increasing it can help the body adjust to semaglutide injections and minimize these effects.

Common Ozempic Side Effects
  • Abdominal pain
  • Constipation
  • Diarrhea
  • Low blood sugar
  • Nausea
  • Vomiting

Some patients have also reported loose skin after taking Ozempic. This is a common side effect of rapid weight loss.

Ozempic’s packaging also warns of more potentially severe side effects such as pancreatitis, changes in vision, kidney failure and the possibility of developing thyroid tumors. Other potential severe Ozempic side effects patients have reported include serious allergic reactions and gallbladder issues.

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Ozempic Boxed Warning and Precautions

Ozempic packaging includes a boxed warning from the FDA indicating the potential risk of thyroid cancer. Animal studies showed an increased risk of thyroid tumors, prompting the warning. Individuals with a personal or family history of certain types of thyroid cancer shouldn’t take Ozempic.

Did You Know?
Ozempic packaging contains an FDA-mandated boxed warning about the risk of thyroid tumors with information about the appearance of tumors in animal testing.
Source: Novo Nordisk

Formerly called Black Box Warnings, a boxed warning is the highest safety warning the FDA can assign to a medication. It indicates that the drug may have serious side effects or pose a unique risk.

Ozempic and Pancreatitis

Novo Nordisk includes a warning about possible pancreas inflammation in the drug’s Important Safety Information. Several clinical studies also noted pancreatitis as an Ozempic side effect.

Pancreatitis causes symptoms including fever, upset stomach, nausea and abdominal tenderness. Patients experiencing these Ozempic side effects should notify a doctor immediately.

Ozempic and Eye Health

Vision changes may occur while taking Ozempic. These include blurred vision, macular complications and worsening symptoms of diabetic retinopathy (retina damage leading to vision loss). Novo Nordisk advises patients to report any changes to their health care provider immediately.

Ozempic and Acute Kidney Injury

Acute kidney disease is a potentially severe Ozempic side effect. Monitoring kidney function can identify problems early to avoid organ damage.

Kidney failure is most likely to affect patients with preexisting kidney disorders. Novo Nordisk warns patients with kidney disease that taking Ozempic may increase dehydration and aggravate symptoms. The company recommends drinking plenty of fluids to avoid this complication.

Ozempic and Gallbladder Disease

Patient safety information discusses the potential for developing gallbladder problems while taking Ozempic and warns patients to report symptoms. A review of clinical trials for other GLP-1 medications shows an increased rate of gallbladder or biliary diseases, including cholelithiasis (gallstones). Some believe the cause may be the rapid weight loss associated with GLP-1 drugs.

Ozempic Lawsuits Filed Over Stomach Paralysis

Patients experiencing gastroparesis (stomach paralysis) after taking Ozempic have filed lawsuits. Gastroparesis occurs when stomach emptying slows to the point of nearly stopping. This rare but serious condition can cause masses called bezoars to form in the stomach, potentially leading to intestinal blockages.

Semaglutide slows digestion and stomach emptying. However, the stomach slows too much for some patients, causing problems. Early signs of gastroparesis include abdominal pain, bloating, feeling full after eating a minimal amount of food and vomiting undigested food hours after eating.

Individuals who developed gastroparesis after taking Ozempic can consult an attorney about filing a lawsuit and seeking compensation. Attorneys are currently filing Ozempic lawsuits for people who say they were injured after taking the drug.

In February 2024, a federal panel combined 55 Ozempic-related lawsuits into multidistrict litigation (MDL) in a Pennsylvania federal court. As of March 2025, there were 1,521 cases pending. The MDL includes Ozempic and other drugs in its class.

Ongoing Ozempic Shortages

A worldwide Ozempic shortage began in early 2022. The shortage was primarily due to manufacturer Novo Nordisk’s inability to meet an unexpected increase in demand. Experts attributed the surge primarily to off-label prescribing of Ozempic for weight loss rather than its approved use for Type 2 diabetes.

Despite Novo Nordisk’s attempts to increase production, shortages have continued into 2025. Government agencies like Australia’s Therapeutic Goods Administration indicate that supply will remain limited for the remainder of 2025.

Drug shortages have led many patients to seek alternative sources for Ozempic. Some pharmacies and wellness centers offer compounded versions of semaglutide, claiming they’re the same as Ozempic.

Compounded medications may have different ingredients that don’t meet the same standards as those of FDA-approved Ozempic. They may also increase the risk of adverse events or severe side effects due to improper dosing. Therefore, patients should only purchase Ozempic from credible retail pharmacies with a valid prescription from a doctor.

Ozempic Alternatives

Ozempic may not be the proper treatment for everyone with Type 2 diabetes. Your doctor will review your medical history and carefully weigh the right option for you.

Some diabetes medications are injections, while others come in pill or liquid form. Many patients need more than one medication to manage their Type 2 diabetes symptoms successfully.

Type 2 Diabetes Treatments
  • Alpha-glucosidase inhibitors: Acarbose — available under the brand names Prandase, Glucobay and Precose — slows carbohydrate digestion to prevent sudden increases in blood glucose levels after meals.
  • DPP-4 inhibitors: Drugs such as Nesina, Januvia, Onglyza and Tradjenta can help prevent high blood sugar. They’re often used in conjunction with insulin.
  • Insulin: Synthetic “human” insulin is produced using bacteria and yeast. It comes in various types, including ultra-rapid and ultra long-acting.
  • Meglitinides: Drugs such as Starlix stimulate the pancreas to produce insulin. They can be taken alone or along with other Type 2 diabetes drugs, although using meglitinides with insulin may increase hypoglycemia risks.
  • Metformin: Fortamet, Glucophage, Glumetza and Riomet are metformin drugs that decrease the amount of glucose released from the liver and help cells absorb more glucose from blood. They also increase the body’s insulin sensitivity.
  • Thiazolidinediones: Drugs such as Avandia and Actos improve the body’s capability to respond to insulin.

Multiple injectable and oral medications exist to help patients with Type 2 diabetes live healthy, active lives. Each has its own side effects, ideal patient profile and contraindications for use. Patients should discuss all options with a health care provider before making a decision.

Please seek the advice of a qualified professional before making decisions about your health or finances.
Last Modified: March 4, 2025

13 Cited Research Articles

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  1. Australian Government, Therapeutic Goods Administration. (2024, December 19). About the Ozempic (Semaglutide) Shortage 2022 - 2025. Retrieved from https://www.tga.gov.au/safety/shortages/information-about-major-medicine-shortages/about-ozempic-semaglutide-shortage-2022-2025
  2. FDA. (2024, December 18). FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss. Retrieved from https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/medications-containing-semaglutide-marketed-type-2-diabetes-or-weight-loss#
  3. U.S. Judicial Panel on Multidistrict Litigation. (2024, November 1). MDL Statistics Report - Distribution of Pending MDL Dockets by Actions Pending. Retrieved from https://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_Actions_Pending-November-1-2024_0.pdf
  4. Hazanchuk, V. (2024, July 11). Can Ozempic Affect Eye Health? Here’s What Ophthalmologists Want You to Know. Retrieved from https://www.aao.org/eye-health/news/can-ozempic-affect-eye-health-here-s-what-ophthalm#
  5. Novo Nordisk. (2024, May). Perspectives from Novo Nordisk. Retrieved from https://www.novomedlink.com/content/dam/novomedlink/semaglutide/Responsible-Use-Letter.pdf
  6. Novo Nordisk. (2024, April). The Ozempic Pen. Retrieved from https://www.ozempic.com/how-to-take/ozempic-pen.html
  7. UC Davis Health. (2023, July 19). Ozempic for Weight Loss: Does It Work, and What Do Experts Recommend? Retrieved from https://health.ucdavis.edu/blog/cultivating-health/ozempic-for-weight-loss-does-it-work-and-what-do-experts-recommend/2023/07
  8. Klein, S.R. et al. (2023, March 28). Semaglutide, Delayed Gastric Emptying, and Intraoperative Pulmonary Aspiration: A Case Report. Retrieved from https://link.springer.com/article/10.1007/s12630-023-02440-3
  9. Hale, P.M. et al. (2020, October 16). Medullary Thyroid Carcinoma Surveillance Study: A Case-Series Registry. Retrieved from https://www.liebertpub.com/doi/10.1089/thy.2019.0591
  10. FDA. (2018, February 5). Understanding Unapproved Use of Approved Drugs "Off Label." Retrieved from https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/understanding-unapproved-use-approved-drugs-label
  11. Halawi, H. et al. (2017, December). Effects of Liraglutide on Weight, Satiation, and Gastric Functions in Obesity: A Randomised, Placebo-Controlled Pilot Trial. Retrieved from https://www.thelancet.com/journals/langas/article/PIIS2468-1253(17)30285-6/abstract
  12. Novo Nordisk. (2017, December). Highlights of Prescribing Information. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209637lbl.pdf
  13. John Hopkins Medicine. (2013, February 21). Pancreatitis Doubles for Those Taking New Class of Diabetes Drugs, Scientists Say. Retrieved from https://www.sciencedaily.com/releases/2013/02/130221141104.htm