FDA-filed SPL labeling · retrieved through openFDA

Teriparatide Injection

Teriparatide injection is a synthetic parathyroid hormone analog used to treat osteoporosis and build bone mass in postmenopausal women, men, and people on long-term steroid therapy who are at high risk for fractures.

Brand names BonsityForteoParatharYorvipath
Drug class Parathyroid Hormone Analog
Rx Form 1 Route Subcutaneous
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 8 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

At a glance
Linked label effectiveJun 16, 2025
Clinical labels in scope 8
AvailabilityRx
Earliest approval/marketing year 2002
FDA-listed product records 22
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 21, 2026
Teriparatide Injection at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Teriparatide injection is a once-daily injectable treatment that actively builds new bone, making it a meaningful option for postmenopausal women, men, and people on long-term steroids who face a high risk of fractures. Lifetime use is generally capped at 2 years, and your doctor will monitor your calcium levels and overall response. It's important to discuss your full medical history — especially any bone conditions, cancer history, or other medications — before starting.

📖 Teriparatide Injection: Patient Information Guide

A plain-language walkthrough of Teriparatide Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.

🎯What it's used for

Teriparatide injection is a synthetic parathyroid hormone analog approved for the following conditions:

  • Treatment of postmenopausal women with osteoporosis who are at high risk for fracture — including those who have already had an osteoporotic fracture, have multiple risk factors, or have not responded to or cannot tolerate other osteoporosis treatments; reduces risk of spinal and non-spinal fractures
  • Increasing bone mass in men with primary or hypogonadal osteoporosis (osteoporosis linked to low testosterone or other primary causes) who are at high risk for fracture or have failed other therapies
  • Treatment of men and women with glucocorticoid-induced osteoporosis — bone loss caused by taking systemic steroid medications (equivalent to 5 mg or more of prednisone per day) — who are at high risk for fracture or have failed other therapies
⚙️How it works

Teriparatide is a lab-made copy of the first 34 amino acids of parathyroid hormone (PTH) — the body's natural regulator of calcium and bone metabolism. When injected once daily, it binds to the same receptors as natural PTH and preferentially activates bone-building cells (osteoblasts) over bone-dissolving cells (osteoclasts). This shifts the balance toward new bone formation, increasing bone mass, improving bone structure, and strengthening the skeleton over time.

This is different from most osteoporosis drugs, which mainly slow bone breakdown. Teriparatide actually stimulates bone growth — making it an anabolic (bone-building) treatment rather than just a bone-preserving one.

💊How it's taken

Teriparatide injection is given as a once-daily subcutaneous (under-the-skin) shot into the thigh or abdomen using a prefilled pen device. It can be taken with or without food. The pen should be discarded 28 days after first use.

  • Administer the first several doses in a place where you can sit or lie down quickly, in case of dizziness
  • Your prescriber will likely recommend supplemental calcium and vitamin D if your diet doesn't provide enough
  • Lifetime use is generally limited to 2 years — your doctor will advise if continued use is appropriate for your specific fracture risk
🤒Side effects — in detail

The most commonly reported side effects include:

  • Joint pain (arthralgia)
  • Nausea
  • Dizziness
  • Headache
  • Weakness or fatigue
  • Leg cramps
  • Constipation, diarrhea, or upset stomach
  • Injection site reactions — pain, swelling, or bruising at the injection site

More serious reactions — including severe allergic reactions (anaphylaxis), signs of high blood calcium (unusual weakness, confusion, irregular heartbeat), bone pain or swelling that could signal a rare bone tumor, and painful skin changes (calciphylaxis) — require immediate medical attention.

⚠️Warnings & precautions
  • Rare bone tumor risk (osteosarcoma): Teriparatide caused bone tumors in animal studies, and rare cases have been reported in people. Avoid use in children, people with Paget's disease of bone, those with a history of bone cancer or radiation to the skeleton, and anyone with hereditary conditions linked to osteosarcoma. Lifetime use is generally capped at 2 years.
  • High blood calcium (hypercalcemia): Teriparatide can temporarily raise calcium levels after each dose. Avoid in people who already have high calcium disorders. If you take digoxin, this is especially important to monitor.
  • Skin calcification and calciphylaxis: Serious reports of painful skin and tissue calcification have been reported. Stop teriparatide immediately if this develops, especially in patients with autoimmune disease, kidney failure, or those taking warfarin or steroids.
  • Kidney stones (urolithiasis): Use with caution if you have a history of active or recent kidney stones, as teriparatide may make this worse.
  • Dizziness after injection (orthostatic hypotension): Some people feel lightheaded shortly after their dose, especially early in treatment. Sit or lie down for the first few doses.
  • Allergic reactions: Anaphylaxis, angioedema (severe swelling), and hives have been reported. Stop teriparatide and seek emergency care if these occur.
🔀What it interacts with

There is one key drug interaction to be aware of with teriparatide injection:

  • Digoxin (a heart medication): Teriparatide can temporarily raise blood calcium levels, and high calcium increases the sensitivity of the heart to digoxin — raising the risk of digoxin toxicity (signs include irregular heartbeat, nausea, and visual changes). Tell your doctor if you take digoxin so they can monitor you closely.

This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.

📋Before taking it
  • Severe allergy to teriparatide or Forteo ingredients: Forteo is contraindicated if you have had a severe allergic reaction (anaphylaxis or angioedema) to teriparatide or any inactive ingredient in Forteo
  • Children and teenagers: Safety and effectiveness have not been established in pediatric patients, and they are at higher baseline risk of osteosarcoma due to open growth plates — avoid use
  • Bone cancer history or radiation to the skeleton: Avoid teriparatide if you have or have had bone metastases, skeletal malignancies, or prior external beam or implant radiation to the skeleton
  • Paget's disease of bone or other metabolic bone diseases: Avoid use — these conditions already raise osteosarcoma risk
  • High blood calcium (hypercalcemia): Avoid teriparatide if you have an underlying condition causing high calcium, such as primary hyperparathyroidism
  • Kidney stones: Use carefully if you have active or recent kidney stones — teriparatide may worsen this condition
  • Pregnancy: No adequate human data exist; consider stopping teriparatide when pregnancy is recognized
  • Breastfeeding: It is not known if teriparatide passes into breast milk — breastfeeding is not recommended during treatment
  • Kidney impairment: No pharmacokinetic differences were found in patients with moderate impairment, but use in severe renal impairment has limited data — discuss with your doctor
  • Older adults: No significant differences in safety or effectiveness were observed in patients 65 and older compared to younger adults
🚑If you take too much

Accidental overdose has been reported — in some cases, the entire contents of the pen (far more than the recommended dose) were injected at once. Reported effects included nausea, weakness, lethargy, and low blood pressure; high calcium levels may also occur with a delay.

There is no specific antidote. If overdose is suspected, stop teriparatide, seek medical attention, and expect monitoring of calcium and phosphorus levels along with supportive care such as fluids.

📡Pharmacodynamics — effects in the body

After each dose, teriparatide causes a temporary rise in blood calcium that peaks about 4–6 hours after injection and returns to baseline within 16–24 hours — so the effect is transient, not sustained. It also mildly increases urinary calcium excretion and briefly lowers blood phosphorus levels.

With daily use over time, these transient effects translate into measurable increases in bone mass, improved bone architecture, and greater bone strength — reflecting the drug's anabolic (bone-building) action on the skeleton.

🔬Pharmacokinetics — how your body processes it

Teriparatide is absorbed quickly after a subcutaneous injection, reaching peak blood levels in about 30 minutes and clearing to undetectable levels within 3 hours — giving it a very short half-life of roughly 45–50 minutes. Absorption is nearly complete, with about 95% bioavailability after injection.

The drug is cleared from the body through both the liver and other tissues at a rapid rate, consistent with enzyme-based breakdown similar to natural parathyroid hormone, followed by excretion through the kidneys. No significant differences in how the body handles the drug were seen across age groups.

📦How to store it

Store teriparatide injection, USP under refrigeration at 2°C to 8°C (36°F to 46°F) at all times except when administering the product. refrigerator; deliver the dose immediately following removal from the refrigerator. Do not freeze.

📄 Written from Teriparatide Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →

1

Nutrient depletion considerations

Teriparatide Injection has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

See the full Teriparatide Injection nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

🩺 Pharmacist Counseling Corner

Quick, plain-English answers to the questions patients ask most about Teriparatide Injection — the kind of thing our pharmacy team would talk through with you at the counter.

What exactly is teriparatide and how is it different from other osteoporosis medications?
Most osteoporosis drugs work by slowing down the cells that break bone down. Teriparatide works the opposite way — it actually stimulates your body to build new bone. It's a lab-made version of parathyroid hormone, which your body naturally uses to regulate bone and calcium. This makes it one of the few true bone-building treatments available, which is why it's often used when other options haven't worked well enough or when fracture risk is especially high.
How do I give myself the injection and are there things I need to know before I start?
You'll use a prefilled pen device to inject it just under the skin — into your thigh or abdomen — once a day. Your pharmacist or nurse will walk you through the first time. For the first few doses, make sure you're somewhere you can sit or lie down quickly, because some people feel lightheaded shortly after the injection. Also, always check the liquid before you inject — it should be clear and colorless. Toss the pen 28 days after you first use it, even if there's medicine left.
What side effects should I expect, and which ones mean I should call the doctor right away?
The most common things people notice are joint pain, nausea, dizziness, and sometimes leg cramps or headache — these are generally manageable. What you want to call your doctor about right away: feeling unusually weak, confused, or having a very fast or irregular heartbeat (which can be a sign of high calcium), new or unusual bone pain or swelling, painful skin sores, or kidney stone symptoms like severe back or side pain. And if you ever have a serious allergic reaction — throat swelling, trouble breathing, hives — get emergency help immediately.
I heard there's a concern about bone cancer with this drug. Should I be worried?
This comes up, and it's a fair question. In animal studies, very high doses did cause a type of bone tumor called osteosarcoma. In human observational studies so far, the risk doesn't appear to be elevated above the general population, but it's something doctors take seriously. That's part of why the treatment is generally limited to 2 years over your lifetime, and why it's avoided in people who already have a higher baseline risk — like children, people with Paget's disease of bone, or anyone who's had radiation to the skeleton. If you don't have those risk factors, your doctor has weighed this and determined the benefit outweighs the risk for you.
How long will I need to take teriparatide, and what happens when I stop?
Treatment is generally not continued beyond 2 years total over your lifetime, and only if you still have a high fracture risk. Your doctor will assess this with you. After stopping, it's common to transition to another osteoporosis medication to help maintain the bone gains you've made — your prescriber will guide that next step. Don't stop on your own without talking to your doctor first.
Can I take this if I'm pregnant or breastfeeding?
Teriparatide hasn't been studied in pregnant women, so there's no solid safety data. The guidance is to consider stopping it as soon as you know you're pregnant. Breastfeeding is also not recommended while using this medication, because it's unknown whether the drug passes into breast milk. If you're pregnant, planning to become pregnant, or breastfeeding, have that conversation with your doctor right away so you can figure out the safest path forward.
Is Teriparatide Injection available over the counter?
Teriparatide Injection is dispensed by prescription according to its FDA labeling, so it isn't sold over the counter. Your prescriber and pharmacist will determine if it's appropriate for you.
When was Teriparatide Injection first available?
Teriparatide Injection has been available in the United States since at least 2002, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Teriparatide Injection?
Teriparatide Injection is supplied by 10 manufacturers listed in the FDA NDC Directory, including Eli Lilly and Company, Alvogen, Inc., Apotex Corp..

💬 Answers drafted from Teriparatide Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →

🧰 Keep exploring

💊 How Teriparatide Injection comes

Teriparatide Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Injection

By injection · Under the skin
Brands Bonsity Forteo
How this form is used
What it may be used for
  • Treatment of postmenopausal women with osteoporosis at high risk for fracture, or who have failed or cannot tolerate other osteoporosis therapies
  • Increasing bone mass in men with primary or hypogonadal osteoporosis at high risk for fracture
  • Treatment of men and women with osteoporosis caused by long-term systemic glucocorticoid (steroid) use at high risk for fracture
Important instructions
  • Administer as a subcutaneous (under-the-skin) injection into the thigh or abdominal region once daily
  • For the first few doses, administer in a setting where the patient can sit or lie down in case of dizziness or lightheadedness
  • Inspect the solution before each use — do not use if it appears cloudy, colored, or contains particles; the solution should be clear and colorless
  • Discard the prefilled pen delivery device 28 days after first use
Available strengths 3 strengths
22 FDA-listed product records

📊 Teriparatide Injection across the U.S. market

How Teriparatide Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1
Dose forms
10
Manufacturers
3
Brand names
22
FDA-listed product records
2002
First marketed
Eli Lilly and Company27%
Alvogen, Inc.14%
Apotex Corp.14%
Prasco Laboratories14%
Teva Pharmaceuticals USA, Inc.9%
Alvogen Inc.5%
Other makers18%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

📈 How widely Teriparatide Injection is used

A general measure of how commonly Teriparatide Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Teriparatide Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

14,225
Medicaid prescriptions filled (Q1–Q4 2025)
$71.1M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Teriparatide Injection prescribed? Of the 1,596 medications we measure, Teriparatide Injection ranks #864 by Medicaid prescriptions — more than 46% of them.

Where Teriparatide Injection ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Teriparatide Injection product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 28 actuation / 0.02 mg/actuation pen injector is the most-dispensed Teriparatide Injection product — about 90% of these Medicaid prescriptions.

28 ACTUAT teriparatide 0.02 MG/ACTUAT Pen Injector Most dispensed

12,873 Medicaid prescriptions (Q1–Q4 2025) 90% of Teriparatide Injection prescriptions shown $41.6M gross reimbursement (before rebates) ≈ $3,234 per prescription (gross)

Summed across the 8 of 10 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1435115

0.98 ML teriparatide 0.3 MG/ML Pen Injector

1,195 Medicaid prescriptions (Q1–Q4 2025) 8% of Teriparatide Injection prescriptions shown $26.1M gross reimbursement (before rebates) ≈ $21,844 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2693645

1.4 ML teriparatide 0.3 MG/ML Pen Injector

145 Medicaid prescriptions (Q1–Q4 2025) 1% of Teriparatide Injection prescriptions shown $3.1M gross reimbursement (before rebates) ≈ $21,589 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2693647

0.56 ML teriparatide 0.3 MG/ML Pen Injector

12 Medicaid prescriptions (Q1–Q4 2025) <1% of Teriparatide Injection prescriptions shown $263,255 gross reimbursement (before rebates) ≈ $21,938 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2693637

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Teriparatide Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 11 of 19 listed Teriparatide Injection NDCs with Medicaid activity.

🔍 Compare Teriparatide Injection products

A representative set of FDA-listed product records for Teriparatide Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category Details
💊Injection
250 mcg/mL Subcutaneous Alvogen, Inc. × 3 listings NDA View NDC →
250 mcg/mL Subcutaneous Alvogen Inc. NDA View NDC →
250 mcg/mL Subcutaneous Amphastar Pharmaceuticals, Inc. ANDA View NDC →
250 mcg/mL Subcutaneous Apotex Corp. × 3 listings ANDA View NDC →
250 mcg/mL Subcutaneous BluePoint Laboratories ANDA View NDC →
0.98 g/0.98 g Boehringer Ingelheim RCV GmbH & Co KG BULK INGREDIENT View NDC →
TERIPARATIDE 1 U/U Cytovance Biologics, Inc. DRUG FOR FURTHER PROCESSING View NDC →
250 mcg/mL Subcutaneous Eli Lilly and Company × 6 listings NDA View NDC →
250 mcg/mL Subcutaneous Prasco Laboratories × 3 listings NDA AUTHORIZED GENERIC View NDC →
250 mcg/mL Subcutaneous Teva Pharmaceuticals USA, Inc. × 2 listings ANDA View NDC →

Showing 22 of 22 products — FDA National Drug Code Directory. See every product, package size and price: browse all 22 Teriparatide Injection NDCs →

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Teriparatide Injection RxCUI 32915 1 dose form · 4 strengths

Look up RxCUI 32915 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

🏷️ Sold under these brand names

Bonsity Forteo Parathar Yorvipath

🏭 Manufacturers & labelers

Eli Lilly and Company 6 Alvogen, Inc. 3 Apotex Corp. 3 Prasco Laboratories 3 Teva Pharmaceuticals USA, Inc. 2 Alvogen Inc. 1 Amphastar Pharmaceuticals, Inc. 1 BluePoint Laboratories 1 Boehringer Ingelheim RCV GmbH & Co KG 1 Cytovance Biologics, Inc. 1

RxNorm drug class

Teriparatide Injection belongs to the Parathyroid Hormone Analog class.

Pharmacologic class Parathyroid Hormone Analog
Drug family (ATC) Parathyroid hormones and analogues

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

🔬 Where this comes from

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Jun 16, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Teriparatide Injection.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Teriparatide Injection after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
8
NDC products indexed
22
Distinct labelers/manufacturers represented
10
Linked representative label
Prasco Laboratories
Linked label effective
Jun 16, 2025
Composite sections available
24
Linked SPL Set ID
ab322675-4769-45b0-b146-14fbaa3135d0
Linked SPL Document ID
0bc59709-3046-4364-b275-14464c1e9f8f
Open the linked representative label on DailyMed ↗

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 8 FDA-filed SPL label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.

Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Prasco Laboratories is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.

This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.