Evidence summary
What the cited records say
The cited DailyMed label identifies Tirzepatide and contains the product's official indications and warnings. This profile links to the label without restating it as medical guidance.↗
Cited context
Related records
Organizations named in cited records
- U.S. National Library of Medicine↗
Dated source history
Updates connected to this profile
Safety
FDA details concerns with unapproved GLP-1 products↗
FDA's public page describes agency concerns and actions involving unapproved versions of semaglutide and tirzepatide, with adverse-event information dated May 31, 2026.↗
Regulatory
FDA proposes excluding three GLP-1 ingredients from the 503B bulks list↗
FDA proposed excluding semaglutide, tirzepatide, and liraglutide from the list of bulk substances that 503B outsourcing facilities may use for compounding.↗
Regulatory
FDA warning letter names retatrutide and tirzepatide products↗
FDA issued a warning letter to Gram Peptides that describes the agency's findings about products marketed with retatrutide and tirzepatide.↗
Safety
FDA requests removal of a warning from certain GLP-1 drug labels↗
FDA asked manufacturers to remove suicidal behavior and ideation warning language from certain semaglutide, tirzepatide, and liraglutide labels.↗