Approved

Calcitonin: Approved Uses, Mechanism, and Side Effects

Drafted by an automated content engine from FDA, PubChem, ClinicalTrials.gov, NIH DSLD, and Open Beauty Facts data.

Molecular formulaC151H226N40O45S3
Molecular weight3417.9 g/mol
Registered trials457
PubChem CID118984394
Drug classCalcitonin [EPC]
Brand namesCALCITONIN SALMON

Mechanism of Action

12.1 Mechanism of Action Calcitonin salmon is a calcitonin receptor agonist. Calcitonin salmon acts primarily on bone, but direct renal effects and actions on the gastrointestinal tract are also recognized. Calcitonin salmon appears to have actions essentially identical to calcitonins of mammalian origin, but its potency per mg is greater and it has a longer duration of action. The actions of calcitonin on bone and its role in normal human bone physiology are still not completely elucidated, alt

Source: FDA label

Key takeaways

  • Calcitonin salmon is FDA approved for Paget's disease of bone, hypercalcemia, and postmenopausal osteoporosis when other treatments are not suitable.
  • It works by acting on calcitonin receptors, with effects mainly on bone but also on the kidneys and gastrointestinal tract.
  • More than 450 clinical trials in the registry have studied calcitonin or used it as a comparator or diagnostic marker.
  • The most frequently reported adverse events include nausea, falls, and musculoskeletal pain.
  • Prescribers are advised to periodically reassess continued use given a possible link between calcitonin salmon and malignancy.

What calcitonin is

Calcitonin salmon is a synthetic version of the calcitonin hormone, marketed under the brand name Calcitonin Salmon. As a calcitonin receptor agonist, it mimics the activity of naturally occurring calcitonin but with greater potency per milligram and a longer duration of action than mammalian forms. Its primary site of action is bone, though it also produces direct effects on the kidneys and gastrointestinal tract. The compound corresponds to PubChem CID 118984394.

What calcitonin is approved for

Calcitonin salmon injection is indicated for symptomatic Paget's disease of bone in patients with moderate to severe, multi-bone involvement when alternative treatments are not suitable. It is also approved for treating hypercalcemia and for postmenopausal osteoporosis, again when other therapies are not appropriate options. Notably, the label states that fracture reduction efficacy has not been demonstrated in the osteoporosis indication. Because of a possible association between calcitonin salmon and malignancy, prescribing information calls for periodic re-evaluation of the need for continued therapy.

What the evidence shows

The clinical trials registry lists 457 studies connected to calcitonin. Sampled trials illustrate the breadth of this footprint beyond the approved indications: one completed study examined pharmacologic treatment options for congenital nephrogenic diabetes insipidus, while another completed trial evaluated a respiratory multiplex PCR and procalcitonin testing strategy to reduce antibiotic use in severe COVID-19 pneumonia.

Reported side effects

Adverse event reports (not measures of incidence or proof of causation) most commonly describe gastrointestinal and musculoskeletal complaints. Nausea leads the list at 253 reports, followed closely by reports of the drug being ineffective (248) and falls (217). Pain-related terms are also prominent, including general pain (212), arthralgia (187), and back pain (173), alongside dizziness (180) and headache (175).

FAQ

What is calcitonin used for?
Calcitonin salmon is approved to treat symptomatic Paget's disease of bone, hypercalcemia, and postmenopausal osteoporosis when other treatments are not suitable. It is not shown to reduce fracture risk in osteoporosis. Its use in osteoporosis and Paget's disease is generally reserved for patients who cannot use alternative therapies.
How does calcitonin work in the body?
Calcitonin salmon acts as a calcitonin receptor agonist, with its main effects occurring in bone tissue. It also has direct actions on the kidneys and gastrointestinal tract. Compared to mammalian calcitonins, it is more potent per milligram and lasts longer in the body.
What are the most common side effects reported with calcitonin?
The most frequently reported adverse events include nausea, falls, and various forms of pain such as arthralgia and back pain. Dizziness and headache are also commonly reported. These figures reflect adverse event reports, not confirmed incidence rates or causation.
Is there a warning about long-term calcitonin use?
Yes. Due to a possible association between calcitonin salmon and malignancy, prescribing information recommends that clinicians periodically reassess whether continued therapy is still needed. This is a labeled limitation of use rather than a boxed warning.
How much research exists on calcitonin?
More than 450 clinical trials in the registry involve calcitonin, spanning its approved uses and other research applications. Examples include studies on nephrogenic diabetes insipidus treatment and the use of procalcitonin testing to guide antibiotic decisions in COVID-19 pneumonia.
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Sources: DailyMed label ClinicalTrials.gov FAERS PubChem

Updated 2026-08-03