FDA label
What is Forteo used for?
Forteo contains teriparatide. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “FORTEO is indicated: For the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined herein 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. In postmenopausal women with osteoporosis, FORTEO reduces the risk of vertebral and nonvertebral fractures; To i...”
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Forteo, injection, solution
Indications and Usage, quoted from the label by Eli Lilly and Company (NDA021318). Cross-references to other label sections are left out.
FORTEO is indicated:
- For the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined herein 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. In postmenopausal women with osteoporosis, FORTEO reduces the risk of vertebral and nonvertebral fractures.
- 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.
- For the treatment of men and women with osteoporosis associated with sustained systemic glucocorticoid therapy (daily dosage equivalent to 5 mg or greater of prednisone) at high risk for fracture or who have failed or are intolerant to other available osteoporosis therapy.
Source: DailyMed label, set id aae667c5-381f-4f92-93df-2ed6158d07b0, version 44, effective August 3, 2026. NDC 0002-8400, one of 2 listings for this product.
Questions
What is Forteo used for?
The FDA label says: “FORTEO is indicated: For the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined herein 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. In postmenopausal women with osteoporosis, FORTEO reduces the risk of vertebral and nonvertebral fractures; To i...”
What drug class is Forteo?
FDA lists teriparatide in the Parathyroid Hormone Analog established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Forteo
- Is Forteo a controlled substance?Federal schedule
- Generic for ForteoFDA Orange Book
- What is Teriparatide used for?FDA label uses
- Is Teriparatide a controlled substance?Federal schedule
- Generic for BonsityFDA Orange Book
- Parathyroid Hormone Analogs listFDA drug class
- Forteo Medicare Part D coverageBy plan and state
- NDC 0002-8400Forteo NDC record
- NDC 0002-9678Forteo NDC record