Teriparatide (Forteo, Forsteo)
Teriparatide; recombinant human parathyroid hormone (1-34); rhPTH(1-34); PTH 1-34. Synonyms: LY333334, hPTH(1-34). Molecular formula: C181H291N55O51S2, MW 4117.8 Da.
Approved status applies to specific products, routes, and indications, not every use context discussed online.
An FDA-approved daily injection (Forteo) for people with severe osteoporosis that actually builds new bone rather than just slowing bone loss. In the main clinical trial, it cut spine fracture risk by 65% and other fracture risk by 53% compared to placebo.
Safety Summary
In the two principal osteoporosis trials (N=1382), the overall safety profile was favorable with 7% discontinuation due to adverse events in the teriparatide group vs 6% in placebo. All-cause mortality was 1% in both groups. Serious adverse events occurred in 16% (teriparatide) vs 19% (placebo). The most clinically significant adverse effects are: (1) Transient hypercalcemia occurring 4-6 hours post-dose (11% women, 6% men had at least one episode; returns to baseline by 16-24 hours; consecutive confirmed elevations in only 3% of women and 1% of men; serum calcium peaked at ~4.25 h post-dose and remained below 11 mg/dL in >99% of women per visit) -- FDA label Section 6.1; PMC2978887; (2) Orthostatic hypotension occurring mainly with initial doses, typically within 4 hours, resolving within minutes to hours -- FDA label Section 5.4; (3) The rodent osteosarcoma signal that prompted a 2-year lifetime treatment duration limit, though a 15-year post-marketing surveillance study and two large US claims-based surveillance studies (379,283 and 153,316 users) found 3 and 0 osteosarcoma cases respectively, suggesting similar risk to general population (PMC8037129; FDA label Section 6.2). The boxed warning was revised (narrowed) in 2020. In the glucocorticoid-induced osteoporosis trial (n=428), nausea was more common (14% vs 7% active control). Post-marketing pharmacovigilance (FAERS analysis) confirmed the known safety profile with nausea and GI disorders as the most commonly reported events.3389/fphar.2024.1391356 via). Immunogenicity: antibodies to teriparatide detected in ~3% of women; no impact on efficacy or safety reported (FDA label). No CYP-mediated drug interactions. Real-world reports from patient forums confirm transient nausea, bone/joint pain, dizziness, and fatigue as the most common complaints (; Mayo Clinic Connect; HealthUnlocked via).
Clinical check-in
If real-world use or exposure is being considered, review potential interactions, contraindications, and monitoring needs with a licensed clinician rather than relying on summary copy alone.
Sources: [1-16]