Decoding the FDA: What is the new warning on Ozempic?

October 12, 2025 •

3 min read

Following multiple post-market adverse event reports, the U.S. Food and Drug Administration (FDA) has recently updated the Ozempic label with new safety warnings. The most significant recent additions concern the risks of ileus, or intestinal blockage, and pulmonary aspiration during procedures involving anesthesia. This article explains what is the new warning on Ozempic? and what it means for patient safety.

Quick Summary

The FDA has issued new warnings for Ozempic regarding ileus (intestinal blockage) and pulmonary aspiration risk during general anesthesia. These are linked to the drug's effect of slowing gastric emptying.

Key Points

New warnings: Recent FDA updates include warnings for ileus (intestinal blockage) and pulmonary aspiration risk during general anesthesia.
Ileus risk: Ozempic's effect of slowing gastric emptying can, in rare cases, cause ileus, a serious intestinal blockage.
Anesthesia risk: Patients on Ozempic must inform their medical team before surgery due to the risk of aspirating stomach contents while under anesthesia.
Long-standing warnings: The drug also carries a boxed warning regarding the risk of thyroid C-cell tumors, based on animal studies.
Serious side effects: Other serious adverse reactions include pancreatitis, diabetic retinopathy complications, and acute kidney injury.
Patient vigilance: Patients should monitor for severe symptoms like abdominal pain and persistent vomiting and communicate these with their healthcare provider.

The FDA’s New Warnings on Ozempic

Ozempic (semaglutide) is an injectable medication used to manage blood sugar in adults with type 2 diabetes and increasingly for weight loss. The FDA monitors post-market reports and updates safety information, leading to two significant updates in late 2023 and late 2024 related to serious gastrointestinal complications.

The October 2023 Warning: Ileus (Intestinal Blockage)

The FDA mandated a label update in September 2023 to include the risk of ileus. Ileus is a severe condition where intestinal contractions slow, blocking the passage of food and waste. Ozempic's mechanism of slowing gastric emptying can contribute to this risk. Symptoms include intense abdominal pain, bloating, constipation, nausea, and vomiting. Untreated ileus is a medical emergency.

The November 2024 Warning: Pulmonary Aspiration During Anesthesia

In November 2024, a warning for pulmonary aspiration during anesthesia was added for Ozempic and other GLP-1 receptor agonists. Standard fasting before surgery may be insufficient due to delayed gastric emptying caused by these drugs, increasing the risk of inhaling stomach contents into the lungs under anesthesia. This can cause lung injury or infection. Patients must inform their healthcare team about Ozempic use before any procedure requiring anesthesia.

Understanding Other Significant Ozempic Warnings

Ozempic's label includes other important safety information, including a boxed warning.

Boxed Warning for Thyroid Tumors

Animal studies showed an increased risk of thyroid C-cell tumors, including medullary thyroid carcinoma (MTC). It's unknown if this risk applies to humans. Ozempic is contraindicated in patients with a history of MTC or MEN 2.

Other Serious Adverse Reactions

Pancreatitis: A rare but serious side effect.
Diabetic Retinopathy Complications: Possible temporary worsening in patients with a history of the condition.
Acute Kidney Injury: Can result from dehydration due to gastrointestinal side effects.
Gallbladder Problems: Reported in trials and post-market use.

Comparing Ozempic Label Warnings


Warning Category	Condition	FDA Action/Date	Clinical Implication
Boxed Warning	Thyroid C-Cell Tumors (MTC)	Included on initial approval. Based on animal studies.	Most serious warning. Contraindicates use in certain patient populations.
Postmarketing Experience (Recent Update)	Ileus (Intestinal Blockage)	Label updated in September 2023, based on voluntary reports.	Serious side effect reported after approval. Requires monitoring for symptoms.
Warnings and Precautions (Class-Wide Update)	Pulmonary Aspiration (during surgery)	Label updated in November 2024 for all GLP-1s, based on postmarketing reports.	Requires informing healthcare providers before surgery due to delayed gastric emptying.
Adverse Reactions (Postmarketing Experience)	Gastroparesis (Stomach Paralysis)	Reports have led to legal action, with investigations into causation ongoing.	Reports of severe delayed gastric emptying, though not yet a formal FDA warning. Symptoms may require immediate medical attention.

What Ozempic Patients Should Do Now

Discuss Your Medical History: Review your history, especially concerning thyroid, pancreatic, or GI issues, with your doctor.
Be Vigilant for Symptoms: Watch for severe abdominal pain, persistent vomiting, or extreme constipation and contact your doctor if they occur.
Inform Surgical Teams: Always tell your medical team you are taking Ozempic before surgery or procedures requiring anesthesia.
Address GI Issues Promptly: Manage common side effects like nausea and vomiting, ensuring proper hydration. Seek medical advice for persistent symptoms.
Ensure You Have Authentic Medication: Be aware of counterfeit Ozempic; obtain medication only from licensed pharmacies.

Conclusion: Navigating Medications with Evolving Safety Information

Staying informed and communicating with healthcare providers is essential when taking medications like Ozempic with evolving safety information. The new warnings for ileus and pulmonary aspiration highlight potential risks related to the drug's action. While Ozempic provides significant benefits, understanding the full range of potential side effects is vital for safe practice. By understanding what is the new warning on Ozempic? and taking appropriate actions, patients can work with their doctors to optimize benefits and minimize risks. The FDA's ongoing monitoring and label updates demonstrate the dynamic nature of drug safety.

For more in-depth, authoritative medical information, you can consult the official FDA label for Ozempic.

Frequently Asked Questions

Ileus is a serious condition where the intestines temporarily stop contracting, causing a blockage. The warning was added after post-market reports suggested a link between Ozempic's mechanism of slowing digestion and this adverse reaction.

It means patients taking Ozempic face a higher risk of inhaling stomach contents into their lungs while under anesthesia. This is because the drug delays gastric emptying, which can counteract standard fasting procedures. You must inform your medical team about your Ozempic use before any procedure requiring anesthesia.

While animal studies showed an increased risk of thyroid tumors, it is currently unknown whether Ozempic causes thyroid cancer in humans. Due to this uncertainty, the FDA requires a boxed warning, and the drug is contraindicated for individuals with a personal or family history of medullary thyroid carcinoma or MEN 2.

You should not stop taking Ozempic without consulting your doctor. The risk of these severe side effects is rare, and the benefits of the medication often outweigh them. Your healthcare provider can help you weigh your personal risks and monitor for symptoms.

The drug's mechanism and associated risks, including the delayed gastric emptying, are the same regardless of the condition being treated. The FDA warnings apply to all users of Ozempic.

Ileus refers to a temporary lack of muscular contractions in the intestines leading to a blockage. Gastroparesis, or stomach paralysis, is a chronic condition where stomach muscle contractions are slowed or stopped, delaying the emptying of food. Both are serious gastrointestinal issues reported with Ozempic use.

You should discuss any gastrointestinal symptoms with your doctor, especially if they are severe or persistent. Staying well-hydrated is important to prevent kidney problems secondary to nausea, vomiting, or diarrhea. Eating a bland diet and avoiding sugary or greasy foods can also help manage mild symptoms.