Welcome to the FDA Side Effects Update. This series is designed to keep you informed about the latest safety advisories and newly documented side effects of your medications.
How to Read This Report
This report is prepared using the most recent information posted in the SrLC database. It highlights recent safety labeling changes. It includes only newly reported side effects and safety information; additional side effects and warnings will appear on the drug label. Not all recent changes to the SrLC database or the label may be listed here. For all changes and the complete list of warnings and side effects, please click on the drug label link.
Each of the items (approval and update dates, drug names, etc.) contained in this report are obtained from the SrLC. The side effects and medication descriptions are simplified and made clearer, if needed. Sometimes, additional sources, like a medical dictionary, may be used to translate technical medical phrases. Other sources (company news, FDA press releases, etc.) may be used to learn about some label changes.
Side Effect Update for All GLP-1 Receptor Agonists
The FDA is now requiring safety information about the serious risk of pulmonary aspiration during procedures requiring sedation, such as surgery, to be included on drug labels for all Glucagon-like peptide-1 (GLP-1) receptor agonists.
Pulmonary aspiration happens when food or stomach contents are inhaled into your lungs during procedures that use anesthesia or deep sedation.
GLP-1 drugs like Ozempic, Wegovy and Mounjaro delay gastric emptying, increasing the risk for pulmonary aspiration.
While requiring the new warning, the FDA makes no recommendations on how to reduce the risk. Instead, the label instructs patients taking these drugs to notify healthcare providers before any planned surgeries or procedures.
An earlier Clinical Practice Guidance joint statement made in October 2024 by multiple medical societies (American Society of Anesthesiologists (ASA), American Gastroenterological Association, American Society for Metabolic and Bariatric Surgery, International Society of Perioperative Care of Patients with Obesity, and the Society of American Gastrointestinal and Endoscopic Surgeons) states that most patients should continue taking their GLP-1 drugs before elective surgery.
The following drugs received safety label updates on November 1, 2024, with the new warning about the risk of pulmonary aspiration. Additionally, Mounjaro, Trulicity, and Zepbound include the rarely reported side effect of dysgeusia, or an altered sense of taste. Mounjaro and Zepbound also include rare reports of dysethesia (altered sense of touch) among clinical trial participants.
All treatments for type 2 diabetes listed below are to be used along with diet and exercise. With the exception of Rybelsus, which is taken orally once a day, all other medications are subcutaneous injections (a shot directed at fatty tissue just under the skin) and, unless otherwise specified, are administered weekly.
Byetta (active ingredient: exenatide synthetic); Bydureon (active ingredient: exenatide synthetic); Bydureon BCISE extended-release (active ingredient: exenatide synthetic)
Initial FDA Approval: 2005 for Byetta and Bydureon; extended release version approved in 2017
Side Effect Update Date: November 1, 2024
Medication Description: Treats type 2 diabetes
Updated Side Effects/Safety Information: Warns about the serious risk of pulmonary aspiration during general anesthesia or deep sedation.
Essential Extras: The original version of Bydureon has been discontinued, but Bydureon BCISE (extended release) remains available.
Byetta is administered twice daily.
FDA Safety Announcements:
Bydureon Extended Release Safety Label Change and Revised Label
Byetta FDA Safety Label Change and Byetta Revised Drug Label
Bydureon FDA Safety Label Change and Revised Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Mounjaro (active ingredient: tirzepatide)
Initial FDA Approval: 2022
Side Effect Update Date: November 1, 2024
Medication Description: Treats type 2 diabetes
Updated Side Effects/Safety Information: Warns about the serious risk of pulmonary aspiration during general anesthesia or deep sedation.
Label also updated with clinical trials reports of dysesthesia (unpleasant or altered sense of touch), reported by 0.4% of patients treated with Mounjaro (all strengths). No events were reported by patients receiving placebo.
An addition to the Gastrointestinal Adverse Reaction section notes that a small number of patients have reported the experience of dysgeusia (altered sense of taste).
Essential Extras: The rare side effect of dysesthesia, or altered sense of touch, has also been added to the clinical trials adverse effects for GLP-1 weight loss drug Zepbound. Based on the number of FDA Adverse Events reports received for this unusual side effect, the FDA is monitoring all the GLP-1 drugs for possible regulatory action related to the side effect.
FDA Safety Announcement: Mounjaro FDA Safety Label Change and Revised Drug Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Ozempic (active ingredient: semaglutide)
Initial FDA Approval: 2017
Side Effect Update Date: November 1, 2024
Medication Description: This medication treats type 2 diabetes and is also used to reduce the risk of major adverse cardiovascular events in patients with type 2 diabetes and established cardiovascular disease.
Updated Side Effects/Safety Information: Warns about the serious risk of pulmonary aspiration during general anesthesia or deep sedation.
FDA Safety Announcement: Ozempic FDA Safety Label Change and Revised Drug Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Rybelsus (active ingredient: semaglutide) pills
Initial FDA Approval: 2019 (injectable semaglutide approved in 2017)
Side Effect Update Date: November 1, 2024
Medication Description: Treats type 2 diabetes
Updated Side Effects/Safety Information: Warns about the serious risk of pulmonary aspiration during general anesthesia or deep sedation.
FDA Safety Announcement: Rybelsus FDA Safety Label Change and Revised Drug Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Saxenda (active ingredient: liraglutide)
Initial FDA Approval: 2014 (liraglutide approved in 2010)
Side Effect Update Date: November 1, 2024
Medication Description: For chronic weight management.
Updated Side Effects/Safety Information: Warns about the serious risk of pulmonary aspiration during general anesthesia or deep sedation.
Essential Extras: This medication is administered once daily.
FDA Safety Announcement: Saxenda FDA Safety Label Change and Revised Drug Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Soliqua 100/33 (active ingredients: insulin glargine and lixisenatide)
Initial FDA Approval: 2016
Side Effect Update Date: November 1, 2024
Medication Description: Treats type 2 diabetes
Updated Side Effects/Safety Information: Warns about the serious risk of pulmonary aspiration during general anesthesia or deep sedation.
Essential Extras: This medication is administered once daily.
FDA Safety Announcement: Soliqua FDA Safety Label Change and Revised Drug Label
Trulicity (active ingredient: dulaglutide)
Initial FDA Approval: 2014
Side Effect Update Date: November 1, 2024
Medication Description: Treats type 2 diabetes
Updated Side Effects/Safety Information: Warns about the serious risk of pulmonary aspiration during general anesthesia or deep sedation.
The Warnings and Precautions section now notes clinical trial results regarding the severe gastrointestinal effects among patients receiving Trulicity vs. placebo. The Patient Medication Guide was updated to warn of the risk of severe stomach problems.
The postmarketing experience section now includes reports of dysgeusia (altered sense of taste).
FDA Safety Announcement: Trulicity FDA Safety Label Change and Revised Drug Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Victoza (active ingredient:liraglutide)
Initial FDA Approval: 2010
Side Effect Update Date: November 1, 2024
Medication Description: Treats type 2 diabetes.
Updated Side Effects/Safety Information: Warns about the serious risk of pulmonary aspiration during general anesthesia or deep sedation.
FDA Safety Announcement: Victoza FDA Safety Label Change and Revised Drug Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Wegovy (active ingredient: semaglutide)
Initial FDA Approval: 2021 (semaglutide approved in 2017)
Side Effect Update Date: November 1, 2024
Medication Description: Taken to help with weight loss. Also taken to reduce the risk of major adverse cardiovascular events in patients with established cardiovascular disease and either obesity or overweight.
Updated Side Effects/Safety Information: Warns about the serious risk of pulmonary aspiration during general anesthesia or deep sedation.
FDA Safety Announcement: Wegovy FDA Safety Label Change and Revised Drug Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Xultophy 100/3.6 (active ingredients: insulin degludec and liraglutide)
Initial FDA Approval: 2016
Side Effect Update Date: November 1, 2024
Medication Description: Treats type 2 diabetes
Updated Side Effects/Safety Information: Warns about the serious risk of pulmonary aspiration during general anesthesia or deep sedation.
Essential Extras: This medication is administered once daily.
FDA Safety Announcement: Xultophy FDA Safety Label Change and Revised Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Zepbound (active ingredient: tirzepatide)
Initial FDA Approval: 2022
Side Effect Update Date: October 18, 2024
Medication Description: Weekly injectable GLP-1 drug for weight loss.
Updated Side Effects/Safety Information: Warns about the serious risk of pulmonary aspiration during general anesthesia or deep sedation.
The clinical trials section of the label have had extensive changes, which include the addition of reported side effects of dysgeusia (altered sense of taste) and dysethesia (unpleasant or altered sense of touch), which were experienced by a small number of patients.
Essential Extras: The rare side effect of dysesthesia, or altered sense of touch, has also been added to the clinical trials adverse effects for GLP-1 weight loss drug Mounjaro. Based on the number of FDA Adverse Events reports received for this unusual side effect, the FDA is monitoring all the GLP-1 drugs for possible regulatory action related to the side effect.
FDA Safety Announcement: Zepbound FDA Safety Label Change and Revised Drug Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
