Is Abaloparatide safe?
Phase 3 safety plus label warnings
The most common side effects in trials were hypercalciuria (extra calcium in urine), dizziness, nausea, headache, palpitations, fatigue, upper belly pain and vertigo. Orthostatic hypotension is a drop in blood pressure on standing. It can happen within hours of a dose. So the label says to give the first shots where the patient can sit or lie down. 6
Rats on abaloparatide got osteosarcoma, a bone cancer, and the risk rose with the dose. The label first had a boxed warning about this. The FDA removed it in late 2021 after reviewing post-marketing data from this drug and the related parathyroid hormone class. The risk now sits in the warnings section. The label still advises against the drug for people at higher baseline risk of osteosarcoma. These include people with Paget's disease of bone or past skeletal radiation. 6
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More on Abaloparatide
Citations
- StatPearls: Abaloparatide ncbi.nlm.nih.gov
- PMC review: PTH1 receptor pharmacology of abaloparatide pmc.ncbi.nlm.nih.gov
- StatPearls: Physiology, bone remodeling ncbi.nlm.nih.gov
- NIAMS: Bone mineral density tests, what the numbers mean niams.nih.gov
- Miller 2016, JAMA: ACTIVE trial of abaloparatide vs placebo in postmenopausal osteoporosis jamanetwork.com
- FDA: Tymlos (abaloparatide) prescribing information, 2024 accessdata.fda.gov
- Radius Health: Tymlos product site tymlos.com
- Biochemical Pharmacology 2019: abaloparatide, a first-in-class PTHrP analog sciencedirect.com
Reference information only, not medical advice. Drawn from the Abaloparatide article, fact-checked against the cited sources. No dosing anywhere on this site.