Abaloparatide 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?
Tymlos · Read September 15, 2026 · Preserved label summary 1
Which population and use does the label cover?
The cited label covers postmenopausal women with osteoporosis at high fracture risk or failure or intolerance of other available osteoporosis therapies. For men in the corresponding osteoporosis population, its indication is to increase bone density; that wording differs from the fracture-reduction account for women. Label: 1 ↗
Which safety limits matter?
The label contraindicates severe hypersensitivity, including reported anaphylaxis and angioedema. Warnings also address osteosarcoma risk, orthostatic hypotension, high blood calcium and urinary calcium or stones. The rodent osteosarcoma finding does not establish that Tymlos causes osteosarcoma in humans. Label: 4, 5 ↗
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.
TYMLOS (abaloparatide) injection, solution · SPL version 19 · published 2026-08-17
Label ZIP SHA-256: 0972d261dcba3ae48d54920e976a32e45e2f7b9f8c2f3458dd827ca900db9c44. Extracted XML SHA-256: 4ac5a2ba440d0e916a9741978deee40d0ba4d42f291d6e40d1d113dae70b533f.