Is teriparatide FDA-approved, and what does the research show?

What is teriparatide?

Teriparatide is a laboratory-made version of part of parathyroid hormone ¹. That hormone is the body's main regulator of calcium and phosphate in bone and kidney ¹. Human parathyroid hormone is a chain of 84 amino acids ¹. Teriparatide matches the first 34, the region that carries the hormone's biological activity ¹. FDA's label calls it a parathyroid hormone analog, written PTH 1-34 ¹.

It is made in bacteria engineered to produce it ¹. The full hormone, PTH 1-84, is a different molecule ¹, covered on its own page. Abaloparatide, sold as Tymlos, is a different molecule with its own FDA approval ⁵, covered on its own page. Eli Lilly sells teriparatide in the United States as Forteo ². Other companies now sell it under its own name and as Bonsity ⁶.

Is teriparatide FDA-approved?

Yes. Teriparatide is approved by FDA as the prescription medicine Forteo, a bone drug for people with osteoporosis at high risk of fracture ¹, ². FDA's Drugs@FDA record shows Eli Lilly's new drug application, NDA 021318, approved on November 26, 2002, with marketing status "Prescription" ². The approval letter of that day covered the first two of the label's three uses ³. The third, osteoporosis from sustained glucocorticoid treatment, came with a supplement approved July 22, 2009 ², ⁷.

The current label, revised August 2026 and held in FDA's own files, lists three indications ¹, ⁸. The first is "the treatment of postmenopausal women with osteoporosis at high risk for fracture," which the label defines as "having a history of osteoporotic fracture or multiple risk factors for fracture," "or who have failed or are intolerant to other available osteoporosis therapy" ¹. The second is "to increase bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy" ¹.

Primary osteoporosis is bone loss with no other disease behind it, and hypogonadal osteoporosis is bone loss that comes with low sex-hormone levels. The third is "the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy ... at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy" ¹. Glucocorticoids are steroid medicines such as prednisone ¹.

Teriparatide is not a wellness, weight or performance peptide ¹. No indication on the label concerns healthy bone, muscle, aging or body composition ¹. The Medication Guide calls Forteo "a prescription medicine," so a licensed clinician's prescription is the only route to it ¹.

The label's header dates the initial U.S. approval of teriparatide to 1987 ¹. Drugs@FDA also lists a discontinued teriparatide acetate injectable, Parathar, under an earlier application number, whose approval date the record does not give ⁶. FDA withdrew approval of Parathar (NDA 019498) effective September 22, 1999, after its holder told the agency the product was "no longer marketed" ⁹.

Forteo is no longer the only teriparatide product. Drugs@FDA lists six later teriparatide applications approved between October 2019 and October 2026 ⁶. Two hold their own new drug applications and four hold abbreviated applications, the route for generic copies ⁶. All six are listed as prescription products in the record, whose data are dated November 6, 2026 ⁶.

See the FDA status of every peptide, updated weekly.

How does teriparatide work?

Teriparatide acts on the same cell-surface receptors as the body's own parathyroid hormone ¹. The label says it binds them "with the same affinity" and has "the same physiological actions on bone and kidney" ¹.

The pattern of exposure decides what it does to bone ¹. In the label's daily pattern of use, it "stimulates new bone formation ... by preferential stimulation of osteoblastic activity over osteoclastic activity" ¹. That is, it favors the cells that build bone over the cells that remove it. A continuous excess of the body's own hormone, as in hyperparathyroidism, "may be detrimental to the skeleton because bone resorption may be stimulated more than bone formation" ¹.

In people, the label describes the effect as an increase in skeletal mass, in markers of bone formation and resorption, and in bone strength ¹. The peptide clears quickly: its half-life, the time for half of it to leave the blood, is about an hour ¹. Blood calcium rises for a few hours after each dose and returns to baseline by 16 to 24 hours ¹. The label draws this account from human trials and monkey studies ¹.

What does the research show?

FDA's approval, the top of the evidence scale, rests on randomized trials in people with osteoporosis: two against placebo and, for the glucocorticoid use, one against another bone drug ⁴, ¹. Placebo-controlled means one group received an inactive injection for comparison. The pivotal trial was published in May 2001 ⁴.

It randomized 1,637 postmenopausal women with osteoporosis to one of two teriparatide dose levels or placebo, injected daily ⁴. The trial enrolled women with prior vertebral fractures, fractures of the spine ⁴. On the baseline X-ray the label counts 90 percent with at least one, so the result belongs to women with established disease ¹. Observation ran a median of 21 months by the paper's count, and treatment a median of 19 months by the label's ⁴, ¹.

Studied in people against placebo: bone mineral density, the mineral content of bone measured by a scan and called bone density below, rose at both dose levels ⁴. Spine density rose 9 and 13 percentage points more than placebo, and density at the femoral neck, the top of the thigh bone, 3 and 6 points more ⁴. The higher dose raised bone density more but did not reduce fractures more, and it was more likely to cause side effects ⁴.

The label reports the arm FDA approved ¹. In it, 541 women took the approved dose, and 444 of them were in the fracture analysis ¹. One or more new vertebral fractures occurred in 5.0 percent of that arm against 14.3 percent on placebo ¹. That is an absolute reduction of 9.3 percentage points and a relative reduction of 65 percent ¹.

The 95 percent confidence interval, the range the true effect most likely falls in, was 45 to 78 percent ¹. Any nonvertebral fracture, a break anywhere but the spine, fell from 5.5 percent to 2.6 percent, a relative reduction of 53 percent ¹. Lumbar spine density rose 9.7 percent from baseline against 1.1 percent on placebo, and 96 percent of the treated women gained spine density ¹.

Studied in men: a double-blind, placebo-controlled trial, in which neither patients nor doctors knew who had the drug, enrolled 437 men with primary or hypogonadal osteoporosis ¹. Its primary endpoint, the main result it was designed to measure, was lumbar spine bone density ¹. Treatment ran a median of 10 months ¹. In the 151 men on the approved dose, spine density rose 5.9 percent from baseline against 0.5 percent in the 147 on placebo ¹.

The men's trial measured bone density, not fractures ¹. The label's wording for men is "to increase bone mass" ¹.

Studied in glucocorticoid users: a randomized, double-blind trial enrolled 428 men and women aged 22 to 89 with osteoporosis who were taking glucocorticoids ¹. Each had taken prednisone or an equivalent steroid for three months or more, at or above the label's threshold ¹. The trial compared teriparatide with a daily oral bisphosphonate, a bone drug of a different class, over 18 months ¹. In the 214 on teriparatide, spine density rose 7.2 percent, total hip density 3.6 percent and femoral neck density 3.7 percent from baseline ¹. The label does not present the comparator's results, citing the difference in mechanism and doubt about whether density predicts fracture across the two classes ¹.

What has not been studied is set out in the label itself ¹. It records no studies in people with liver impairment or on dialysis, no established safety or effectiveness in children, and no human data in pregnancy ¹. It also notes limited data on the risk of osteosarcoma, a rare bone cancer, beyond two years of use ¹.

What are the side effects?

The label's safety analysis covers 1,382 patients from two placebo-controlled trials in women and men, 691 on the approved dose and 691 on placebo ¹. The trials ran a median of 19 months in women and 11 months in men ¹. Deaths from any cause were 1 percent in each group ¹. Serious adverse events were 16 percent on teriparatide against 19 percent on placebo, and early withdrawal for adverse events 7 percent against 6 percent ¹.

The label names joint pain, pain and nausea as the most common adverse reactions ¹. In its table, joint pain was reported by 10.1 percent against 8.4 on placebo, and nausea by 8.5 against 6.7 ¹. Dizziness was reported by 8.0 percent against 5.4, leg cramps by 2.6 against 1.3, and fainting by 2.6 against 1.4 ¹.

The transient calcium rise was counted in the trials: at least one episode of transient high calcium occurred in 11 percent of women and 6 percent of men on teriparatide ¹. On placebo it occurred in 2 percent of women and none of the men ¹. In short studies of healthy volunteers, 5 percent had a brief fall in blood pressure on standing, typically within the first several doses ¹.

In the 18-month glucocorticoid trial, serious adverse events were 21 percent on teriparatide against 18 percent on the bisphosphonate, and nausea 14 percent against 7 ¹. Antibodies that reacted with teriparatide appeared in 3 percent of the women given the approved dose in the pivotal trial ¹. The label reports no hypersensitivity reactions among them and no apparent effect on calcium or bone density ¹.

Osteosarcoma is one of the label's warnings, in its section 5.2 ¹. In rats given teriparatide daily for two years, the label reports "a marked dose-related increase in the incidence of osteosarcoma" ¹. Tumors were seen at all three doses in that study, and the incidence reached 40 to 50 percent in the high-dose groups ¹. No bone tumors were found in a long-term monkey study ¹.

In people, the label says: "Osteosarcoma has been reported in patients treated with FORTEO in the post marketing setting; however, an increased risk of osteosarcoma has not been observed in observational studies in humans" ¹. Observational studies follow patients in ordinary care rather than assigning a treatment. Two such studies of U.S. insurance records found three and zero osteosarcoma cases among 379,283 and 153,316 Forteo users ¹. The label says the results "suggest a similar risk" to comparators but reads them with caution because of the data's limits ¹.

The label no longer carries a boxed warning. FDA approved a supplement on November 16, 2020, that provided for "Removal of the Boxed Warning regarding osteosarcoma" ¹⁰, ². The warning now stands in the label's section 5.2 ¹. It says to avoid Forteo in five groups of patients who "are at increased baseline risk of osteosarcoma" ¹.

They are open epiphyses, meaning still-growing bones in children and young adults, and metabolic bone diseases other than osteoporosis, including Paget's disease ¹. They also include bone metastases, cancer that has spread to bone, or a history of bone cancers; prior radiation therapy involving the skeleton; and hereditary disorders predisposing to osteosarcoma ¹. The label adds that there are "limited data assessing the risk of osteosarcoma beyond 2 years of FORTEO use" ¹.

The label rules out Forteo "in patients with a history of severe hypersensitivity to teriparatide or any of the inactive ingredients of FORTEO" ¹. It notes that such reactions "have included anaphylaxis and angioedema," severe allergic reactions and swelling beneath the skin ¹. Its other warnings begin with high blood calcium, with the instruction to avoid it "in patients known to have an underlying hypercalcemic disorder, such as primary hyperparathyroidism" ¹.

They go on to calciphylaxis, calcium deposits that block small blood vessels in the skin, and worsening skin calcification reported after marketing ¹. Then come kidney stones, where it "has not been studied in patients with active urolithiasis," and a brief drop in blood pressure on first doses ¹. They end with digoxin, a heart drug, because the calcium rise "may predispose patients to digitalis toxicity" ¹.

Post-marketing reports add anaphylaxis, angioedema, hives, blood calcium above 13 mg/dL, muscle spasms of the leg or back, and injection-site pain, swelling and bruising ¹. For pregnancy the label has no human data and says to "Consider discontinuing FORTEO when pregnancy is recognized" ¹. For breastfeeding it says, "Avoid FORTEO use in women who are breastfeeding" ¹.

In sport

Teriparatide is not named on WADA's 2026 Prohibited List, and neither is parathyroid hormone ¹¹. WADA, the World Anti-Doping Agency, lists peptide hormones in section S2.2 ¹¹. That section names testosterone-stimulating peptides, corticotrophins, growth hormone with its analogs and fragments, and growth hormone releasing factors ¹¹.

What JumpstartMD offers

JumpstartMD does not prescribe teriparatide. Our peptide library covers it so you have the facts on its FDA status and the evidence, current as of November 10, 2026.

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Compounded medications are not FDA-approved, and FDA does not review their safety, effectiveness, or quality before they are marketed. A licensed clinician decides after an evaluation whether a peptide is appropriate for you, and not every patient will qualify.