Calcitonin: Medicine Overview
Calcitonin salmon is an approved injectable and nasal medicine for bone and calcium conditions; this page covers US labels, the EU restriction on osteoporosis use and the cancer-risk signal.
Content last updated . This page has not been medically reviewed.
Quick overview
Calcitonin acts on bone, according to the labels. The medicine form most often discussed is calcitonin salmon, a synthetic version modeled on the salmon form. This page compares what the US labels and the European Medicines Agency (EMA) say. It is education only and gives no dosing or advice about starting or stopping treatment.Evidence label used here: approved medicine, with a regulatory split: the same drug family is treated differently in the US and EU for osteoporosis.
Molecule and products
- Active ingredient: calcitonin salmon, described in the Miacalcin injection label as a synthetic calcitonin receptor agonist. [1]
- Brand and forms: Miacalcin injection (Mylan) for subcutaneous or intramuscular use, with initial US approval listed as 1975; and generic calcitonin salmon nasal spray labels. [1][2]
- Source: the label says calcitonin salmon acts essentially like mammalian calcitonins but with greater potency per milligram and longer action. [1]
What the label says it does
The label says calcitonin acts mainly on bone, with direct kidney effects and actions on the gut also recognized, and that calcitonin receptors have been found on osteoclasts and osteoblasts. It adds that its role in normal human bone physiology is not fully understood. [1] Single injections cause a transient drop in bone breakdown; with prolonged use the decrease in resorption is smaller but persistent. [1]Monitoring and professional care
The label calls for adequate calcium and vitamin D intake and monitoring for low calcium, and for the need for continued therapy to be reassessed. [1] See Bone and Mineral Regulation Peptide Medicines and Teriparatide and Abaloparatide for other bone peptide medicines, and Osteoporosis and Bone Health for general information.Off-label and investigational questions
Oral calcitonin was investigational in some of the trials the regulators reviewed, and the EMA note refers to studies of an unlicensed oral medicine. [3] Proper evidence not found for any other use in the labels and EMA page read. Calcitonin is not interchangeable with parathyroid-hormone analogues.Frequently asked questions
Is calcitonin the same as the hormone my body makes?
Calcitonin salmon is a synthetic hormone modeled on the salmon form, not the human molecule, and the label says it is more potent per milligram than mammalian calcitonins. [1]
Is calcitonin approved for osteoporosis?
In the US, the labels list postmenopausal osteoporosis when other treatments are not suitable. In the EU, the EMA's committee concluded in 2012 that it should no longer be used for osteoporosis. [1][3]
Why did Europe restrict it?
The EMA's committee found a small increase in cancers with long-term use and limited fracture benefit. [3]
Does the nasal spray still exist?
A US calcitonin nasal spray label was read for this page. The EMA recommended that the nasal spray no longer be used in the EU. [2][3]
Should I change treatment?
This page cannot advise that. Please talk with your prescriber, and see the hub Approved, Investigational and Unapproved Peptides.
More details: evidence, limits and cautions
The details behind this page: cautions, limits of the evidence and where sources disagree. Open any note to read it.
Approved uses by jurisdiction
| Jurisdiction and product | Indications in the source |
|---|---|
| United States, Miacalcin injection | Symptomatic Paget's disease of bone when alternatives are not suitable; hypercalcemia; postmenopausal osteoporosis when alternatives are not suitable, with the note that fracture-reduction efficacy has not been demonstrated. [1] |
| United States, calcitonin salmon nasal spray | Postmenopausal osteoporosis in women more than 5 years past menopause when alternatives are not suitable; fracture-reduction efficacy has not been demonstrated; not shown to increase bone density in early postmenopausal women. [2] |
| European Union (EMA review, 2012-2013) | Only the injection or infusion remains, for Paget's disease in people who cannot be treated otherwise, prevention of acute bone loss after sudden immobilization, and hypercalcemia caused by cancer. Osteoporosis use and the nasal spray are no longer supported. [3] |
Laws and approvals change. The EMA review was completed on 19 July 2012 and the European Commission decided on 13 February 2013, so check current national labels for today's status. Other countries were not verified.
The cancer-risk signal
- US label. A meta-analysis of 21 randomized trials (10,883 people, 6 months to 5 years) of calcitonin salmon, mostly nasal or investigational oral forms, found malignancies in 4.1% of treated people versus 2.9% on placebo. The label says an increased risk cannot be excluded with long-term injected use and that the need for continued therapy should be re-evaluated periodically. [1]
- EU review. The EMA's committee found a higher proportion of patients treated for long periods may develop cancers of various types than those on placebo. The increase varied from 0.7% in oral-formulation studies to 2.4% in nasal-formulation studies. It concluded benefits did not outweigh risks for osteoporosis, and recommended the shortest possible treatment at the smallest effective dose for remaining uses. [3]
A small increased risk in group data does not tell any one person their own risk.
Other major safety information
References
- MIACALCIN (calcitonin salmon) injection, prescribing information (DailyMed label version dated 2024-09-15). Read 2026-10-22.
- Calcitonin Salmon nasal spray (Apotex), prescribing information (DailyMed label version dated 2026-09-10). Read 2026-10-22.
- EMA, Calcitonin: referral (review of calcitonin-containing medicines, 2012-2013). Read 2026-10-22.