pharmacopeia
GET
/api/v1/drug/teriparatide

Mechanism of action

Sourced from openFDA

Endogenous 84-amino acid parathyroid hormone (PTH) is the primary regulator of calcium and phosphate metabolism in bone and kidney. Physiological actions of PTH include regulation of bone metabolism, renal tubular reabsorption of calcium and phosphate, and intestinal calcium absorption.

Hormone Receptor

Indications

Sourced from openFDA
  • Teriparatide injection 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, teriparatide injection reduces the risk of vertebral and nonvertebral fractures.ICD-10: M81.0

Contraindications

Sourced from openFDA
  • Teriparatide injection is contraindicated in patients with hypersensitivity to teriparatide or to any of its excipients. Hypersensitivity reactions have included angioedema and anaphylaxis [see Adverse Reactions ( 6.2 )] .contraindicated

Dosage & administration

Sourced from openFDA

Recommended dosage is 20 mcg subcutaneously once a day ( 2.1 ) Consider supplemental calcium and Vitamin D based on individual patient needs ( 2.1 ) Administer as a subcutaneous injection into the thigh or abdominal region ( 2.2 ) Administer initially under circumstances in which the patient can sit or lie down if symptoms of orthostatic hypotension occur ( 2.2 ) Use of teriparatide for more than 2 years during a patient's lifetime should only be considered if a patient remains at or has returned to having a high risk for fracture ( 2.3 ) 2.1 Recommended Dosage The recommended dosage is 20 mcg given subcutaneously once a day. Instruct patients to take supplemental calcium and vitamin D if daily dietary intake is inadequate. 2.2 Administration Instructions Administer teriparatide injection as a subcutaneous injection into the thigh or abdominal region. Teriparatide injection is not approved for intravenous or intramuscular use. Teriparatide injection should be administered initially under circumstances in which the patient can sit or lie down if symptoms of orthostatic hypotension occur [see Warnings and Precautions ( 5.4 )] . Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration (teriparatide injection is a clear and colorless liquid). Do not use if solid particles appear or if the solution is cloudy or colored.

Warnings & precautions

Sourced from openFDA

Osteosarcoma : Avoid use in patients with increased risk of osteosarcoma including patients with open epiphyses, metabolic bone diseases including Paget's disease, bone metastases or history of skeletal malignancies, prior external beam or implant radiation therapy involving the skeleton, and hereditary disorders predisposing to osteosarcoma. ( 5.1 ) Hypercalcemia and Cutaneous Calcification : Avoid in patients known to have an underlying hypercalcemic disorder. Discontinue in patients developing worsening of previously stable cutaneous calcification. ( 5.2 ) Risk of Urolithiasis : Consider the risk/benefit in patients with active or recent urolithiasis because of risk of exacerbation ( 5.3 ) Orthostatic Hypotension : Transient orthostatic hypotension may occur with initial doses of teriparatide injection ( 5.4 ) 5.1 Osteosarcoma An increase in the incidence of osteosarcoma (a malignant bone tumor) was observed in male and female rats treated with teriparatide. Osteosarcoma has been reported in patients treated with teriparatide in the post marketing setting; however, an increased risk of osteosarcoma has not been observed in observational studies in humans. There are limited data assessing the risk of osteosarcoma beyond 2 years of teriparatide use [see Dosage and Administration ( 2.3 ), Adverse Reactions ( 6.2 ), Nonclinical Toxicology ( 13.1 )] .

Adverse reactions

Sourced from openFDA

Most common adverse reactions (>10%) include: arthralgia, pain, and nausea ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alvogen, Inc. at 1-866-770-3024 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Men with Primary or Hypogonadal Osteoporosis and Postmenopausal Women with Osteoporosis The safety of teriparatide in the treatment of osteoporosis in men and postmenopausal women was assessed in two randomized, double-blind, placebo-controlled trials of 1382 patients (21% men, 79% women) aged 28 to 86 years (mean 67 years) [see Clinical Studies ( 14.1 , 14.2 )] . The median durations of the trials were 11 months for men and 19 months for women, with 691 patients exposed to teriparatide and 691 patients to placebo. All patients received 1000 mg of calcium plus at least 400 IU of vitamin D supplementation per day. The incidence of all-cause mortality was 1% in the teriparatide group and 1% in the placebo group. The incidence of serious adverse events was 16% in the teriparatide group and 19% in the placebo group. Early discontinuation due to adverse events occurred in 7% in the teriparatide group and 6% in the placebo group. Table 1 lists adverse events from these two trials that occurred in ≥2% of teriparatide-treated and more frequently than placebo-treated patients.

Use in specific populations

Sourced from openFDA

Pregnancy: Consider discontinuing when pregnancy is recognized ( 8.1 ) Lactation: Breastfeeding is not recommended ( 8.2 ) Pediatric Use: Safety and effectiveness not established. Avoid use due to increased baseline risk of osteosarcoma ( 5.1 , 8.4 ) 8.1 Pregnancy Risk Summary There are no available data on teriparatide injection use in pregnant women to evaluate for drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Consider discontinuing teriparatide injection when pregnancy is recognized. In animal reproduction studies, teriparatide increased skeletal deviations and variations in mouse offspring at subcutaneous doses equivalent to more than 60 times the recommended 20 mcg human daily dose (based on body surface area, mcg/m 2 ), and produced mild growth retardation and reduced motor activity in rat offspring at subcutaneous doses equivalent to more than 120 times the human dose (see Data) . The background risk of major birth defects and miscarriage for the indicated population is unknown. The background risk in the US general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies.

Pharmacokinetics

Sourced from openFDA
Metabolism
The pharmacokinetic parameters of teriparatide following single subcutaneous administration of teriparatide injection in patients with osteoporosis are shown in Table 2. Table 2.

Overdosage

Sourced from openFDA

In postmarketing spontaneous reports, there have been cases of medication errors in which the entire contents (up to 800 mcg) (40 times the recommended dose) of the teriparatide prefilled delivery device (pen) have been administered as a single dose. Transient events reported have included nausea, weakness/lethargy and hypotension. No fatalities associated with overdose have been reported. Additional signs, symptoms, and complications of teriparatide overdosage may include a delayed hypercalcemic effect, vomiting, dizziness, and headache. Overdose Management - There is no specific antidote for a teriparatide overdosage. Treatment of suspected overdosage should include discontinuation of teriparatide injection, monitoring of serum calcium and phosphorus, and implementation of appropriate supportive measures, such as hydration.

Approval history

Sourced from openFDA
  • Nov 26, 2002NDANDA021318Lilly
  • Oct 4, 2019NDANDA211939Alvogen
  • Nov 16, 2023ANDAANDA208569Teva Pharms Usa
  • Nov 16, 2023ANDAANDA211097Apotex
  • Dec 12, 2025ANDAANDA213641Amphastar Pharms Inc

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
111,637 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Nausea8,9838.0%
  2. 2Arthralgia8,6717.8%
  3. 3Pain In Extremity8,3507.5%
  4. 4Dizziness8,2867.4%
  5. 5Fall7,8927.1%
  6. 6Pain7,5346.7%
  7. 7Fatigue7,1806.4%
  8. 8Back Pain5,9195.3%
  9. 9Muscle Spasms5,7385.1%
  10. 10Malaise5,6665.1%
  11. 11Headache5,4754.9%
  12. 12Asthenia5,4364.9%
  13. 13Injection Site Erythema5,0524.5%
  14. 14Injection Site Pain4,8154.3%
  15. 15Injection Site Bruising4,7684.3%

Literature

View JSON

Recent PubMed references pinned to Teriparatide as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

View JSON

The 10 most recently updated of 182 ClinicalTrials.gov registrations naming Teriparatide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Teriparatide work?
Endogenous 84-amino acid parathyroid hormone (PTH) is the primary regulator of calcium and phosphate metabolism in bone and kidney. Physiological actions of PTH include regulation of bone metabolism, renal tubular reabsorption of calcium and phosphate, and intestinal calcium absorption.
What is Teriparatide used for?
According to FDA labeling, Teriparatide carries indications including: Teriparatide injection 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, teriparatide injection reduces the risk of vertebral and nonvertebral fractures.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Teriparatide?
Teriparatide is classified as Parathyroid hormones and analogues, Parathyroid Hormone Analog, Hormone Receptor Agonists, Bone Formation Stimulation, Decreased Renal Ca++ Excretion, Decreased Renal PO4-- Excretion, Increased PTH Secretion, Stimulation Small Intestine Fluid/Electrolyte Absorption.
What are the brand names for Teriparatide?
Teriparatide is marketed under brand names including Bonsity, Forteo, Yorvipath.
What are the contraindications for Teriparatide?
Teriparatide labeling lists contraindications including: Teriparatide injection is contraindicated in patients with hypersensitivity to teriparatide or to any of its excipients. Hypersensitivity reactions have included angioedema and anaphylaxis [see Adverse Reactions ( 6.2 )] .. Always consult the full prescribing information and a clinician.
Note. Data for teriparatide is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

Search pharmacopeia

Search drugs, classes, and ingredients