Ozempic, known by its generic name semaglutide, is a prescription medication administered via a once-weekly injection. The U.S. Food and Drug Administration (FDA) has approved it for the management of type 2 diabetes in adults. It functions by helping the pancreas produce more insulin, which in turn helps to lower blood sugar levels. A notable side effect of this process is weight loss, which has led to its extensive use “off-label” for this purpose.
While not officially approved for weight management, its active ingredient, semaglutide, is available in a higher dosage under the brand name Wegovy, which is FDA-approved for weight loss. The widespread use of Ozempic for weight loss has brought attention to its associated health risks. Like any prescription drug, Ozempic carries a range of possible side effects, from common issues to more severe complications.
Common Gastrointestinal Side Effects
The most frequently reported side effects associated with Ozempic are gastrointestinal in nature. Nausea is a very common complaint among new users, alongside other digestive disturbances such as diarrhea, vomiting, constipation, and abdominal pain. These issues often arise as the body adjusts to the medication.
These effects are more pronounced when a person first begins treatment or when their prescribed dose is increased. The mechanism of the drug, which includes slowing down the process of stomach emptying, is a primary reason for these gastrointestinal responses. As food remains in the stomach longer, it can lead to feelings of fullness, discomfort, and nausea.
For many individuals, these side effects are temporary and lessen in severity over time as their body becomes accustomed to the medication. Healthcare providers often start patients on a lower dose and gradually increase it to help mitigate these initial reactions. Managing diet by eating smaller meals and avoiding high-fat foods can also help reduce the impact of these side effects.
Serious Organ-Related Complications
Beyond the more common digestive complaints, Ozempic has been linked to several more serious health complications involving internal organs. These events are less frequent but carry significant health implications that require immediate medical attention.
One of the more serious risks is pancreatitis, which is an inflammation of the pancreas. Symptoms of pancreatitis are sudden and can include severe pain in the abdomen that may radiate to the back, along with nausea and vomiting. This condition requires prompt medical evaluation.
Gallbladder problems have also been reported in patients using Ozempic. These issues can manifest as the formation of gallstones or cholecystitis, which is inflammation of the gallbladder. Symptoms to be aware of include pain in the upper right abdomen, fever, and jaundice, which is a yellowing of the skin and eyes.
Additionally, there have been reports of acute kidney injury associated with Ozempic use. In some cases, severe gastrointestinal side effects like persistent vomiting and diarrhea can lead to dehydration, which can in turn impair kidney function. Patients should stay hydrated and report any signs of decreased urination, swelling in the legs or feet, or shortness of breath to their healthcare provider.
The FDA Black Box Warning Explained
The U.S. Food and Drug Administration has assigned Ozempic its most serious type of caution, known as a “black box warning.” This warning is reserved for drugs with potentially significant and sometimes life-threatening risks.
The black box warning for Ozempic specifically addresses the risk of thyroid C-cell tumors. This concern arose from studies conducted in rodents, where semaglutide was shown to cause an increase in these types of tumors, including a rare form of thyroid cancer called medullary thyroid carcinoma (MTC). It is important to understand that these findings were in animals, and it is not yet fully understood if this risk translates to humans.
Due to this potential risk, Ozempic is contraindicated for certain individuals. People who have a personal or family history of MTC are advised against using this medication. It is also not recommended for patients with a rare condition known as Multiple Endocrine Neoplasia syndrome type 2 (MEN 2), which increases the risk of developing various tumors, including those in the thyroid gland.
Risks for Specific Patient Groups
Certain groups of patients may face a higher risk of complications when taking Ozempic, and in some cases, the medication may be entirely contraindicated. These risks extend beyond the thyroid cancer warning and relate to pre-existing health conditions that could be exacerbated by the drug’s effects.
Patients with a history of pancreatitis are advised to avoid Ozempic, as the medication has been linked to an increased risk of this condition. Similarly, individuals with a history of severe gastroparesis, a condition where the stomach cannot empty itself of food in a normal fashion, may experience a worsening of their symptoms due to Ozempic’s effect of slowing down stomach emptying.
Another specific group of concern includes patients with diabetic retinopathy, a complication of diabetes that affects the eyes. Some studies have suggested a potential for a temporary worsening of this condition, particularly in patients with a history of retinopathy who are initiating treatment with Ozempic. Close monitoring by an ophthalmologist is often recommended for these individuals.