Ozempic (Semaglutide)

Ozempic (semaglutide) is a prescription drug and a Type 2 diabetes injectable medication approved by the U.S. Food and Drug Administration. It is also used to reduce the risk of major cardiovascular events in adults with Type 2 diabetes who already have cardiovascular disease. It belongs to the glucagon-like peptide 1 (GLP-1) receptor agonist class of medications.

The drug isn’t FDA-approved to treat obesity, but some doctors prescribe it for off-label uses (such as weight loss) for people without Type 2 diabetes. However, Wegovy (semaglutide) is another injectable form of semaglutide which is approved by the FDA for weight loss. Other drugs in the same class include Rybelsus (semaglutide), Saxenda (liraglutide) and Victoza (liraglutide). Mounjaro (tirzepatide) is a glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 receptor dual agonist.

People with Type 1 diabetes shouldn’t use Ozempic, and studies haven’t shown if Ozempic is safe for children under 18 (although Wegovy is approved for weight management in children and adolescents ≥ 12 years old who meet certain criteria).

Ozempic injections are once-a-week shots that work in the pancreas, liver and stomach to reduce blood sugar. According to Novo Nordisk, Ozempic is designed to respond when your blood sugar rises by working with the body’s natural processes to lower sugar levels.

When your blood sugar is high, Ozempic helps the pancreas make more insulin. It also slows the process of food leaving the stomach and prevents the liver from releasing too much glucose into the blood.

Dosages for Ozempic include 0.25 mg,0.5 mg, 1 mg or 2 mg. You may start on a 0.25 mg dose for 4 weeks prior to the 0.5 mg so that your body can get used to the medication. Doctors will adjust the dose depending on a person’s need for blood sugar control or the off-label use for weight loss.

Using Ozempic Correctly

Before you use the Ozempic Type 2 diabetes shot for the first time, your health care provider will show you how to inject it. The patient information that comes with your medication also has tips on how to use Ozempic correctly.

Inject Ozempic once a week under the skin in the thigh, upper arm or stomach. Don’t inject Ozempic into your muscle or vein. Change the spot where you inject Ozempic each week, and don’t share Ozempic injector pens with other people.

“Each patient should pay close attention to the directions the clinician gives, reread the directions listed on the medications and if they have any doubt, never hesitate to reach out to their clinician for clarification,” Antoni Adamrovich, MSN, BA, APRN, FNP-C, told Drugwatch.

Common but mild Ozempic side effects, such as nausea, stomach upset or constipation usually go away after your body gets used to the medication. If any of these persist or are bothersome, contact your health care provider right away.

Nausea, vomiting and diarrhea increased in patients taking the 1 mg dose versus the .5 mg dose of Ozempic. More patients in clinical trials who experienced gastrointestinal issues discontinued treatment versus people who took a placebo.

Some patients don’t experience many side effects at all. Paul Moss, co-owner of TB2.Health, told Drugwatch he took semaglutide as a weight loss patient and had mild side effects.

“A few weeks in, I had nausea, and then after that, I had lethargy. Those were the only two side effects I experienced,” Moss said.

Less Common Side Effects

Novo Nordisk said it received reports of less common but more serious side effects such as hypersensitivity, rash, swelling and gallbladder issues, in post-marketing reports. However, because these reports are voluntary, the drug maker can’t definitively link these adverse events directly to Ozempic.

Acute gastroparesis may cause severe vomiting, abdominal pain, problems digesting food, feelings of constant fullness and malnutrition. It can lead to hospitalization. Some patients have filed Ozempic lawsuits claiming Novo Nordisk failed to warn that Ozempic could lead to this severe side effect. One claim named both Ozempic and Mounjaro as the cause of severe gastrointestinal side effects.

Ozempic’s drug label includes several precautions and drug interaction warnings, including a boxed warning for thyroid tumors and cancer. In animal studies, researchers found semaglutide caused dose-dependent thyroid C-cell tumors and medullary thyroid carcinoma (MTC).

However, researchers don’t know if these findings are the same in humans. People at risk for MTC shouldn’t use Ozempic.

Ozempic may interact with insulin or sulfonylureas and increase the risk of hypoglycemia. Doctors may have to reduce the dosage of these drugs when starting Ozempic treatment if a patient has to take them together with Ozempic.

Because Ozempic slows the movement of food through the stomach, it may affect how well a person absorbs oral medications. In clinical trials, Ozempic didn’t affect absorption to a “clinically relevant degree,” but people who take other medications should talk to their doctor about any risks.

According to a study published in June 2023 in The Lancet, Ozempic helps a person lose about 15% of their body weight.

Although the FDA hasn’t approved Ozempic for weight loss, some doctors prescribe it for this off-label use. The FDA allows off-label prescribing at doctors’ discretion.

Off-label use of a drug can be risky. There are no clinical trials to prove the safety and efficacy of using Ozempic for weight loss. However, Novo Nordisk makes another semaglutide drug, Wegovy, that is FDA-approved for weight loss.

Wegovy and Ozempic are both semaglutide drugs, but they have slightly different dosages for their FDA indications. A person must have a body mass index of 30 or above or have a BMI of 27 along with additional obesity-related health risks to qualify for a Wegovy prescription. Doctors may use the same criteria to prescribe Ozempic for off-label use.

“The reason why these drugs work is that most people who can’t lose weight have a problem with insulin resistance. It’s not necessarily always just calories in calories out,” said Dr. Sue Decotiis, triple board-certified weight loss physician.

High demand has led to an Ozempic shortage, which may be improving very slowly. This shortage has led to challenges for patients who use it for Type 2 diabetes and weight loss, as well as other off-label uses.

In addition to high demand and manufacturing constraints, there is no generic Ozempic. In fact, in 2022, Novo Nordisk sued several generic manufacturers that applied for FDA approval to make generic Ozempic. Some patients use compounding pharmacies to legally obtain the drugs, but others have used unauthorized counterfeit versions that have flooded the market, putting themselves at risk.

Some Type 2 diabetes patients like Stephan T., who is omitting his last name for privacy reasons, lowered their dose to make their prescriptions last.

“The issue I ran into with Ozempic and Mounjaro, because they were so difficult to get, was I started going on and off the drugs, which is not healthy,” Stephan T. told Drugwatch. “It became a case of Whack-A-Mole, where I had to move my prescription to different pharmacies just to get it, and that sometimes took weeks.”

Novo Nordisk and Eli Lilly Respond to Shortages

Novo Nordisk and Eli Lilly are aware of the shortages and have come up with some strategies to respond to shortages, such as ramping up manufacturing and investing in additional manufacturing capacity. Both companies are spending billions to meet demand.

“Novo and Eli Lilly are utilizing a combination of internal and external capacity for both synthesis and fill-finish operations. Novo Recently purchased Catalant’s three fill-finish plants for $16.5 billion in February 2024. Lilly is also investing in additional manufacturing capacity — a $2.5 billion investment in a new plant in Germany and an extra $1.6 billion investment in the US plant totaling $6.4 billion within three years,” said Betty Pio, a partner in the Healthcare and Life Sciences Practice of Kearney, a global strategy and management consulting firm.

“Patients have felt the brunt of these [Ozempic and GLP-1 drug] shortages, with strict criteria for access, resorting to obtaining unofficial drugs, not using full doses on schedule to stretch out their personal supply, and just going without,” Pio said.

Unfortunately, the shortages aren’t going to end anytime soon. Shortages are expected to last into 2025, according to Pio.