Pramlintide U.S. label context · version 1
This page preserves this version's wording and source pins. Open the current profile →
What does the U.S. product label say?
Symlin · Read September 15, 2026 · Preserved label summary 1
Which population and use does the label cover?
The cited label describes adjunctive use with mealtime insulin in type 1 or type 2 diabetes when desired glucose control has not been achieved despite optimal insulin therapy. Pediatric safety and effectiveness have not been established. Label: 1, 8.4 ↗
Which safety limits matter?
The boxed warning concerns severe hypoglycemia when used with insulin, particularly in type 1 diabetes. Contraindications include hypoglycemia unawareness, confirmed gastroparesis and serious hypersensitivity. A study reporting no overall increase in severe events does not cancel the label warning. Label: 1, 4, 5, 8.4, boxed warning ↗
Label edition and source pins
U.S. product labeling hosted by the National Library of Medicine. This account concerns this product and label edition; other formulations and jurisdictions require their own records.
SYMLINPEN (pramlintide acetate) injection · SPL version 18 · published 2024-08-20
Label ZIP SHA-256: 41e40e12d2e7bbf400a8bcd1a8032e423aa305f795982acb1264301692a93a15. Extracted XML SHA-256: e223f4cb25daee6d6785fc4e0d427c65dbbe94d27da19f34b5fafb7ba6a1842a.