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. In this installment, we’re highlighting safety updates concerning these drugs: Byetta, Bydureon BCISE, Mounjaro, Saxenda, Soliqua 100/33, Trulicity, Victoza, and Xultophy 100/3.6.
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 GLP-1 Receptor Agonists
The FDA is requiring that Glucagon-like peptide-1 (GLP-1) drug labels include updated warnings about the risk of serious kidney injury associated with the drugs’ gastrointestinal effects. Side effects like diarrhea, nausea, and vomiting may cause severe dehydration or “volume depletion,” leading to kidney injury. Some reported cases of kidney injury have required hemodialysis treatment.
Healthcare providers are advised to monitor renal (kidney) function in patients reporting adverse reactions that could lead to severe dehydration, especially when the drug is first started and doses are escalated. Signs of potential kidney injury include persistent (or extended) nausea, vomiting, and diarrhea.
The FDA also required changes to the labels to achieve a more uniform presentation of side effects and risk information for all of the drugs in the GLP-1 category, including adding or changing subsections for “Acute Pancreatitis” and “Severe Gastrointestinal Adverse Reactions” and revising the “Patient Counseling” section and “Medication Guide.” Some of the labels were also updated with post-marketing reports of hair loss (alopecia) and the neurological symptom of “altered sense of touch,” or dysethesia. Read the revised labels for all changes and additions.
The following safety label changes were made in response to an FDA letter (like this notification letter for Mounjaro) informing drug sponsors of the required warning updates. Ozempic, Rybelsus, Wegovy, and Zepbound were not included in the most recent updates because their labels already included the required safety information. Each treatment listed below is administered by subcutaneous injection (a shot directed at fatty tissue just under the skin) and, unless otherwise specified, is administered weekly.
Byetta (active ingredient: exenatide synthetic) subcutaneous injection; Bydureon BCISE extended-release subcutaneous injection (active ingredient: exenatide synthetic)
Initial FDA Approval: 2005 for Byetta and Bydureon; extended release version approved in 2017
Side Effect Update Date: May 28, 2025
Medication Description: Treats type 2 diabetes
Updated Side Effects/Safety Information: A new warning about the risk of serious kidney injury caused by dehydration due to gastrointestinal adverse effects like diarrhea and vomiting. Signs of potential kidney injury include persistent (or extended) nausea, vomiting, and diarrhea.
The postmarketing experience section now includes reports of dysesthesia (altered sense of touch).
Essential Extras: The original version of Bydureon has been discontinued, but Bydureon BCISE (extended release) remains available and is administered weekly. 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
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Mounjaro (active ingredient: tirzepatide) subcutaneous injection
Initial FDA Approval: 2022
Side Effect Update Date: May 28, 2025
Medication Description: Treats type 2 diabetes
Updated Side Effects/Safety Information: A new warning about the risk of serious kidney injury caused by dehydration due to gastrointestinal adverse effects like diarrhea and vomiting. Signs of potential kidney injury include persistent (or extended) nausea, vomiting, and diarrhea.
The postmarketing experience section now includes reports of alopecia (hair loss).
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.
Saxenda (active ingredient: liraglutide) subcutaneous injection
Initial FDA Approval: 2014 (liraglutide approved in 2010)
Side Effect Update Date: May 28, 2025
Medication Description: For chronic weight management
Updated Side Effects/Safety Information: A new warning section on “Severe Gastrointestinal Adverse Reactions.” An additional warning about the risk of serious kidney injury caused by dehydration due to gastrointestinal adverse effects like diarrhea and vomiting. Signs of potential kidney injury include persistent (or extended) nausea, vomiting, and diarrhea.
The postmarketing experience section now includes reports of alopecia (hair loss) and dysesthesia (altered sense of touch).
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) subcutaneous injection
Initial FDA Approval: 2016
Side Effect Update Date: May 28, 2025
Medication Description: Treats type 2 diabetes
Updated Side Effects/Safety Information: A new warning section on “Severe Gastrointestinal Adverse Reactions.” An additional new warning about the risk of serious kidney injury caused by dehydration due to gastrointestinal adverse effects like diarrhea and vomiting. Signs of potential kidney injury include persistent (or extended) nausea, vomiting, and diarrhea.
The postmarketing experience section now includes reports of alopecia (hair loss) and dysesthesia (altered sense of touch).
Essential Extras: This medication is administered once daily.
FDA Safety Announcement: Soliqua FDA Safety Label Change and Revised Drug Label
Trulicity (active ingredient: dulaglutide) subcutaneous injection
Initial FDA Approval: 2014
Side Effect Update Date: May 28, 2025
Medication Description: Treats type 2 diabetes
Updated Side Effects/Safety Information: A new warning about the risk of serious kidney injury caused by dehydration due to gastrointestinal adverse effects like diarrhea and vomiting. Signs of potential kidney injury include persistent (or extended) nausea, vomiting, and diarrhea.
Clinical trial results concerning pancreas-related adverse effects have also been added
The postmarketing experience section now includes reports of alopecia (hair loss) and dysesthesia (altered sense of touch).
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) subcutaneous injection
Initial FDA Approval: 2010
Side Effect Update Date: May 28, 2025
Medication Description: Treats type 2 diabetes
Updated Side Effects/Safety Information: A new warning section on “Severe Gastrointestinal Adverse Reactions.” An additional new warning about the risk of serious kidney injury caused by dehydration due to gastrointestinal adverse effects like diarrhea and vomiting. Signs of potential kidney injury include persistent (or extended) nausea, vomiting, and diarrhea.
Clinical trial results concerning pancreas-related adverse effects have also been added
The postmarketing experience section now includes reports of alopecia (hair loss) and dysesthesia (altered sense of touch).
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.
Xultophy 100/3.6 (active ingredients: insulin degludec and liraglutide) subcutaneous injection
Initial FDA Approval: 2016
Side Effect Update Date: May 28, 2025
Medication Description: Treats type 2 diabetes
Updated Side Effects/Safety Information: A new warning section on “Severe Gastrointestinal Adverse Reactions.” An additional new warning about the risk of serious kidney injury caused by dehydration due to gastrointestinal adverse effects like diarrhea and vomiting. Signs of potential kidney injury include persistent (or extended) nausea, vomiting, and diarrhea.
Clinical trial results concerning pancreas-related adverse effects have also been added.
The postmarketing experience section now includes reports of alopecia (hair loss) and dysesthesia (altered sense of touch).
Essential Extras: This medication is administered once daily.FDA Safety Announcement: Xultophy FDA Safety Label Change and Revised Label
