Side Effects & Long-Term Risks for Ozempic (semaglutide)

Ozempic (semaglutide) is a prescription medication designed to improve blood sugar control in adults with type 2 diabetes. It's also approved for weight management in some countries. As a GLP-1 receptor agonist, Ozempic works by mimicking a natural hormone that regulates blood sugar and appetite.

While Ozempic has shown great results in helping many people control their diabetes and lose weight, it's important to understand that, like all medications, it can cause side effects. Some of these side effects are common and usually mild, while others are rare but potentially more serious.

Common Side Effects

Ozempic, like other GLP-1 receptor agonists, is associated with a range of side effects, primarily affecting the gastrointestinal system. The following table summarizes the frequency of common side effects based on pooled data from the SUSTAIN clinical trials for the 1.0 mg dose of Ozempic:

Key points about these side effects:

• Gastrointestinal effects are the most common, with nausea, diarrhea, and vomiting being the most frequently reported.
• Most of these side effects are mild to moderate in severity and tend to decrease over time as patients continue treatment.
• The frequency of side effects can be dose-dependent, with higher doses generally associated with a higher incidence of adverse events.

Management Strategies for Common Side Effects

To help patients better tolerate Ozempic and manage its side effects, healthcare providers often recommend the following strategies:

• Gradual dose escalation: Starting with a lower dose and gradually increasing it over time can help reduce the intensity of side effects.
• Meal modifications:
  • Eating smaller, more frequent meals
  • Avoiding high-fat or spicy foods (considering Ozempic foods to avoid)
  • Staying well-hydrated
• Timing of injection: Administering Ozempic at bedtime may help some patients sleep through the initial onset of nausea.
• Anti-emetic medications: In cases of severe nausea or vomiting, short-term use of anti-emetic drugs may be considered under medical supervision.
• Monitoring and adjusting: Regular follow-ups with healthcare providers to assess side effects and adjust treatment as necessary.

Serious Adverse Events

While less common, Ozempic has been associated with some serious adverse events that require careful consideration:

• Pancreatitis:
  • Incidence: 0.3 cases per 100 patient-years in clinical trials
  • Symptoms: Persistent severe abdominal pain, sometimes radiating to the back
  • Action: Discontinue Ozempic if pancreatitis is suspected
• Diabetic Retinopathy Complications:
  • In the SUSTAIN-6 trial, there was an increased risk of diabetic retinopathy complications (1.0% in the Ozempic group vs. 0.5% in the placebo group)
  • Risk factors: Pre-existing retinopathy, rapid improvement in glucose control
  • Recommendation: Regular eye exams, especially for patients with a history of retinopathy
• Acute Kidney Injury:
  • Associated with severe gastrointestinal adverse reactions
  • Monitor renal function in patients reporting severe GI reactions
• Hypoglycemia:
  • Increased risk when used with insulin or insulin secretagogues
  • Incidence of severe hypoglycemia: 0.8% in Ozempic-treated patients vs. 0.3% in placebo-treated patients (in combination with insulin)
• Gallbladder-related disorders:
  • Incidence: 3.1 events per 100 patient-years in Ozempic-treated patients vs. 1.4 events per 100 patient-years in placebo-treated patients
  • Includes cholelithiasis, cholecystitis, and cholangitis

Cardiovascular Safety

Cardiovascular safety is a critical consideration for diabetes medications. The SUSTAIN-6 cardiovascular outcomes trial provided important data on Ozempic's cardiovascular effects:

• Primary outcome (MACE: cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke):
  • Ozempic: 6.6%
  • Placebo: 8.9%
  • Hazard Ratio: 0.74 (95% CI: 0.58-0.95)

This data suggests that Ozempic does not increase cardiovascular risk and may offer cardiovascular benefits, though more research is needed to confirm this potential protective effect.

Thyroid Safety

There have been concerns about the potential risk of thyroid C-cell tumors with GLP-1 receptor agonists, based on findings in rodent studies. However:

• No cases of medullary thyroid carcinoma (MTC) were reported in clinical trials of Ozempic
• The relevance of rodent findings to humans is uncertain
• Ozempic is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

Safety in Special Populations

• Pregnancy and Breastfeeding:
  • Ozempic should be discontinued at least 2 months before a planned pregnancy
  • Not recommended during pregnancy or breastfeeding due to limited data
• Elderly Patients:
  • No overall differences in safety or efficacy observed between elderly and younger patients
  • Caution advised due to greater sensitivity of some older individuals
• Renal Impairment:
  • No dose adjustment needed for mild, moderate, or severe renal impairment
  • Limited experience in patients with end-stage renal disease
• Hepatic Impairment:
  • No dose adjustment needed for mild or moderate hepatic impairment
  • Limited experience in patients with severe hepatic impairment

Drug Interactions

Real-World Safety Data

After Ozempic became available to patients, researchers continued to track its safety. So far, the results from actual patient use match what we saw in the initial studies. This is good news, but doctors and researchers keep watching closely. They want to catch any rare side effects or problems that might only show up after long-term use.

• Regular follow-ups to assess efficacy and side effects
• Blood glucose monitoring, especially when used with insulin or sulfonylureas
• Annual retinal examinations, particularly in patients with existing retinopathy
• Monitoring of renal function, especially in patients with renal impairment or severe GI adverse reactions

Conclusion

Ozempic has demonstrated a generally favorable safety profile, with most side effects being gastrointestinal and typically mild to moderate. However, like all medications, it carries risks of more serious adverse events. The benefits of improved glycemic control and potential cardiovascular benefits should be weighed against these risks. Proper patient selection, education, and monitoring are so important for optimizing the safety and efficacy of Ozempic treatment.

Consider reading this article about Ozempic and Protein Shakes to learn about the importance of protein while taking Ozempic.

Writer: Carrie H. Carrie is a passionate health and nutrition writer with a strong foundation in medical and scientific research. Driven by her commitment to helping others lead healthier lives, she immerses herself in the latest scientific findings. Carrie excels at translating evidence-based knowledge into practical advice, ensuring that her readers receive accurate and valuable information on health, nutrition, and wellness. Through her writing, she aims to empower individuals to make informed decisions about their well-being.

Reviewed By: Dr. Kevin Huffman Dr. Kevin D. Huffman, D.O., is a renowned board-certified bariatric physician dedicated to the treatment of obesity. His expertise has made him a sought-after trainer for healthcare providers, and he founded American Bariatric Consultants to develop protocols and training materials trusted by medical societies, pharmaceutical companies, patients, and hospitals alike. Beyond patient care, Dr. Huffman's influence extends to preparing physicians for board certification, thereby expanding access to this crucial treatment.