Teriparatide (Forteo): Uses, Dosage and Side Effects
Teriparatide (Forteo): the FDA-approved osteoporosis peptide - label dosing, boxed-warning history, and the 2020 removal explained.
The short version
Teriparatide (Forteo and generics) is an FDA-approved peptide, injected daily, that builds new bone in people at high fracture risk. Its pivotal trial showed fewer new fractures and higher bone density. It once carried a boxed warning over bone cancer (osteosarcoma) in rats. FDA removed that warning in November 2020 after real-world human data found no increased risk, but kept a narrower caution.
- FDA-approved for osteoporosis at high fracture risk: postmenopausal women, men, and steroid-induced osteoporosis.
- The pivotal trial found fewer new spine and non-spine fractures than placebo.
- FDA removed its rat-based osteosarcoma boxed warning in November 2020 after human data found no increased risk.
- The label still advises against more than 2 years of lifetime use unless fracture risk stays high.
Teriparatide at a glance
- What it is
- Recombinant human parathyroid hormone (1-34), a peptide
- Main use
- FDA-approved to treat osteoporosis in postmenopausal women and men at high fracture risk, and glucocorticoid-induced osteoporosis in men and women at high fracture risk, by stimulating new bone formation.
- Generic name
- teriparatide
- Brand names
- Forteo (Eli Lilly) and Bonsity (Alvogen) Label
- Molecular formula
- C181H291N55O51S2 (4118 g/mol) Structure
- Evidence
- Strong human evidence
- US status
- FDA-approved · prescription only
- Australia
- TGA-registered · prescription only
- Half-life
- About 1 hour, per the FDA label.
- Dose
- Set by the FDA label Dosing page
Dosing: the FDA label schedule.
Consistent findings across large trials or meta-analyses. FDA approval rests on a randomised, placebo-controlled pivotal trial in postmenopausal women with prior vertebral fracture, which found reduced new fractures and increased bone mineral density.
What is teriparatide?
Teriparatide is the active 1-34 fragment of human parathyroid hormone (PTH), made by recombinant DNA technology. It is approved under the brand Forteo and as generic teriparatide.
US legal status - FDA-approved · prescription only
FDA-approved as Forteo since 2002, with generic teriparatide also approved. Requires a prescription.
AU legal status - TGA-registered · prescription only
Schedule 4 of the Poisons Standard - prescription only - and on the ARTG.
Regulators reach their own conclusions on their own timelines. Where these two disagree, the difference is the point - not an error.
Teriparatide structure
How teriparatide works
Timing decides what PTH does to bone. Constantly high PTH, as in disease, breaks bone down. A once-daily injection instead builds bone, because short bursts favour the bone-forming cells (osteoblasts) over bone breakdown.
Teriparatide benefits: what the research shows
The pivotal Fracture Prevention Trial Neer 2001 - Neer RM, Arnaud CD, Zanchetta JR et al. Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Engl J Med. 2001;344(19):1434-41., in the references below was randomised and placebo-controlled, in postmenopausal women who already had a spinal fracture. Teriparatide reduced new vertebral and nonvertebral fractures and raised bone mineral density compared with placebo. That trial is the evidence behind FDA approval.
It is approved for three groups, all at high fracture risk:
- postmenopausal women with osteoporosis
- men with primary or hypogonadal osteoporosis
- men and women with glucocorticoid-induced osteoporosis
Teriparatide dosage
The approved dose is 20 mcg once a day, injected under the skin from a prefilled pen. Full schedule and duration guidance: teriparatide dosage.
Teriparatide side effects
The label lists these common side effects:
- nausea
- leg cramps
- dizziness
- a brief drop in blood pressure on standing (orthostatic hypotension) shortly after a dose, so the label advises taking the first few doses where you can sit or lie down
Full detail: teriparatide side effects.
Is teriparatide legal?
US legal status - FDA-approved · prescription only
An FDA-approved prescription medicine. It has been through clinical trials for its approved use, and legally requires a prescription from a licensed clinician.
AU legal status - TGA-registered · prescription only
Registered on the Australian Register of Therapeutic Goods, and prescription-only under the Poisons Standard. The TGA has evaluated it for quality, safety and efficacy in its approved use. It needs a prescription from an Australian-registered prescriber, and cannot lawfully be advertised to the public.
Regulators reach their own conclusions on their own timelines. Where these two disagree, the difference is the point - not an error.
It is FDA-approved and needs a prescriber in both the US and Australia. It is not sold over the counter. An unlabelled “research” vial sold outside the approved supply chain is not the same product.
Related reading
- Teriparatide dosage: the FDA label schedule
- Abaloparatide (Tymlos): the other approved PTH-pathway peptide
- US peptide regulation tracker
How Teriparatide compares
Bone health. Doses for unapproved compounds are common practice, not trial-established. All bone health peptides →
| Compound | Main use | Evidence | Usual dose | US status |
|---|---|---|---|---|
| Teriparatide | FDA-approved to treat osteoporosis in postmenopausal women and men at high fracture risk, and glucocorticoid-induced osteoporosis in men and women at high fracture risk, by stimulating new bone formation. | Strong human evidence | FDA label | FDA-approved · prescription only |
| Abaloparatide | FDA-approved to treat osteoporosis in postmenopausal women at high fracture risk, and to increase bone density in men with osteoporosis at high fracture risk, by stimulating new bone formation. | Strong human evidence | FDA label | FDA-approved · prescription only |
Where to get Teriparatide legally
Teriparatide is an FDA-approved prescription medicine, so the legal route is a licensed prescriber, in person or by telehealth, and a licensed pharmacy.
How telehealth prescribing works, what it costs and what to check: telehealth peptide prescribing.
Common questions
What is the usual teriparatide dose?
The FDA-approved dose is 20 mcg once a day, injected under the skin from a prefilled pen. See the dosing page for the full schedule.
What are the side effects of teriparatide?
The label lists nausea, leg cramps and dizziness as common. Blood pressure can drop briefly on standing (orthostatic hypotension) shortly after a dose. The label also keeps a warnings-section caution about osteosarcoma. Full detail is on the dosing page.
Did teriparatide cause cancer in its trials?
Not in humans. The original boxed warning came from rats that developed osteosarcoma on high, prolonged doses. Two real-world studies linking pharmacy claims to state cancer registries found no increase in human users. FDA removed the boxed warning in November 2020 but kept a narrower caution, because long-term human use is less fully studied.
What is teriparatide used for?
Its FDA label covers osteoporosis at high fracture risk in three groups: postmenopausal women, men with primary or hypogonadal osteoporosis, and men and women with osteoporosis from long-term glucocorticoid (steroid) use. In postmenopausal women the label says it reduces vertebral and nonvertebral fractures. It builds new bone rather than only slowing bone loss.
Is teriparatide the same as Prolia?
No. Teriparatide (Forteo) is a fragment of parathyroid hormone, injected daily, that stimulates new bone. Prolia is denosumab, an antibody that binds RANKL to block the cells that break bone down (osteoclasts), given as 60 mg every 6 months. Both treat osteoporosis, but from opposite sides of bone turnover.
Does teriparatide affect your teeth?
The label does not establish a dental effect. Its trial table lists tooth disorder in 2.0% of teriparatide patients versus 1.3% on placebo, without saying the drug caused it. I found no osteonecrosis-of-the-jaw warning in the Forteo label, unlike the Prolia (denosumab) label. Raise dental questions with your prescriber and dentist.
What is the brand name of teriparatide?
Teriparatide is sold under the brand names Forteo and Bonsity. Forteo is approved for osteoporosis in postmenopausal women at high risk of fracture, increasing bone mass in men with primary or hypogonadal osteoporosis at high risk of fracture, and glucocorticoid-induced osteoporosis in men and women at high risk of fracture. Bonsity is approved for osteoporosis in postmenopausal women at high risk of fracture, increasing bone mass in men with primary or hypogonadal osteoporosis at high risk of fracture, and glucocorticoid-induced osteoporosis in men and women at high risk of fracture.
What is the generic name for Forteo?
The generic name for Forteo is teriparatide. Forteo is Eli Lilly's brand, approved for osteoporosis in postmenopausal women at high risk of fracture, increasing bone mass in men with primary or hypogonadal osteoporosis at high risk of fracture, and glucocorticoid-induced osteoporosis in men and women at high risk of fracture.
What is the generic name for Bonsity?
The generic name for Bonsity is teriparatide. Bonsity is Alvogen's brand, approved for osteoporosis in postmenopausal women at high risk of fracture, increasing bone mass in men with primary or hypogonadal osteoporosis at high risk of fracture, and glucocorticoid-induced osteoporosis in men and women at high risk of fracture.
Is Forteo the same as teriparatide?
Yes. Forteo is a brand of teriparatide, made by Eli Lilly: the active ingredient is teriparatide. It comes as a once-daily subcutaneous injection (prefilled pen, 28 daily doses), dosed at 20 mcg once daily. Compounded or research-vial teriparatide is not Forteo and has not been through its FDA review.
Is Bonsity the same as teriparatide?
Yes. Bonsity is a brand of teriparatide, made by Alvogen: the active ingredient is teriparatide. It comes as a once-daily subcutaneous injection (prefilled pen), dosed at 20 mcg once daily. Compounded or research-vial teriparatide is not Bonsity and has not been through its FDA review.
Is Forteo the same as Bonsity?
Forteo and Bonsity contain the same active ingredient, teriparatide. They are approved for different uses and doses: Forteo for osteoporosis in postmenopausal women at high risk of fracture, increasing bone mass in men with primary or hypogonadal osteoporosis at high risk of fracture, and glucocorticoid-induced osteoporosis in men and women at high risk of fracture (20 mcg once daily); Bonsity for osteoporosis in postmenopausal women at high risk of fracture, increasing bone mass in men with primary or hypogonadal osteoporosis at high risk of fracture, and glucocorticoid-induced osteoporosis in men and women at high risk of fracture (20 mcg once daily).
References (5 sources)
Bibliographic detail is fetched from PubMed, not written by me - so a citation here cannot drift from the paper it names. Study design comes from PubMed's own tags rather than my judgement.
- 1.Neer RM, Arnaud CD, Zanchetta JR et al. Effect of parathyroid hormone (1-34) on fractures and bone mineral density in postmenopausal women with osteoporosis. N Engl J Med. 2001;344(19):1434-41.Randomised trialPMID 11346808
- 2.Krege JH, Gilsenan AW, Komacko JL et al. Teriparatide and Osteosarcoma Risk: History, Science, Elimination of Boxed Warning, and Other Label Updates. JBMR Plus. 2022;6(9):e10665.ReviewPMID 36111201full text
- 3.FORTEO (teriparatide) injection - full prescribing information, current label including post-2020 osteosarcoma language and dosing.- DailyMed, US National Library of Medicinelabel
- 4.PROLIA (denosumab) injection - prescribing information: human IgG2 monoclonal antibody that binds RANKL, 60 mg subcutaneously once every 6 months, and its osteonecrosis-of-the-jaw warning.- DailyMed, US National Library of Medicinelabel
- 5.BONSITY (teriparatide) injection - prescribing information- DailyMed, National Library of Medicinelabel