FDA-filed SPL labeling · retrieved through openFDA

Calcitonin Salmon Injection

Calcitonin salmon injection is a synthetic hormone used to treat Paget's disease of bone, high blood calcium (hypercalcemia), and postmenopausal osteoporosis when other treatments are not suitable.

Brand names Miacalcin InjectionCalcimar InjectionMiacalcin
Drug class ⓘ Calcitonin
Rx Form 1 Routes Intramuscular, Subcutaneous · Intramuscular; 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 12 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 effectiveSep 15, 2024
Clinical labels in scope ⓘ12
AvailabilityRx
Earliest approval/marketing year ⓘ1978
FDA-listed product records ⓘ19
Boxed warningNone found in compared labels
How we combine label and product data →
✓No current FDA shortage listed · checked Sep 22, 2026
Other forms & routes:
Nasal
⭐ Calcitonin Salmon Injection at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Calcitonin salmon injection (Miacalcin) is a hormone-based treatment for Paget's disease of bone, high blood calcium emergencies, and postmenopausal osteoporosis when other therapies aren't an option. It is generally well tolerated, but serious allergic reactions are possible and there is a signal for increased cancer risk with long-term use that your doctor will monitor. Follow your prescriber's instructions closely, keep up with calcium and vitamin D intake as directed, and report any unusual symptoms promptly.
How we write & review this content — our editorial policy →

📖 Calcitonin Salmon Injection: Patient Information Guide

A plain-language walkthrough of Calcitonin Salmon 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▾

Calcitonin salmon injection is approved for three distinct conditions, and it is generally reserved for patients who cannot use or have not responded to other therapies.

  • Paget's disease of bone: Miacalcin injection treats symptomatic, moderate-to-severe Paget's disease — a disorder where abnormal bone breakdown and rebuilding causes bone pain and deformity. It is not recommended for people without symptoms.
  • Hypercalcemia (high blood calcium): Miacalcin injection is used in urgent situations to rapidly lower dangerously high calcium levels, often as part of a broader treatment plan that may include IV fluids and other medications.
  • Postmenopausal osteoporosis: Miacalcin injection is used in women more than 5 years past menopause when other osteoporosis treatments are not suitable. Clinical evidence shows it increases total body calcium, but fracture reduction has not been demonstrated with this injection.

Because of a possible association with increased cancer risk over time, the ongoing need for calcitonin salmon should be reassessed regularly by your prescriber.

⚙️How it works▾

Calcitonin salmon is a synthetic version of calcitonin — a hormone that naturally helps control calcium levels and bone turnover. It works by activating calcitonin receptors found on osteoclasts (the cells that break down bone) and osteoblasts (the cells that build bone). By slowing down osteoclast activity, it reduces the rate at which bone is broken down and calcium is released into the bloodstream. It also acts on the kidneys to increase the amount of calcium, phosphate, and sodium excreted in urine, which helps lower elevated blood calcium levels.

Calcitonin salmon is more potent per milligram than naturally occurring mammalian calcitonin and has a longer duration of action. The body's response to a single injection tends to be more pronounced at first; with long-term use, the effect on bone resorption is smaller but persistent.

💊How it's taken▾

Miacalcin injection is given by subcutaneous (under-the-skin) or intramuscular (into-the-muscle) injection. For Paget's disease and postmenopausal osteoporosis, it is typically injected once daily. For hypercalcemia, it is started every 12 hours, with the frequency potentially increased to every 6 hours if there is no sufficient response over several days.

  • If the injection volume is larger than 2 mL, intramuscular injection is preferred and should be given at multiple sites.
  • For osteoporosis treatment, adequate daily calcium and vitamin D are recommended alongside the injection.
  • Always follow your prescriber's exact schedule — do not adjust your dose or timing on your own.
🤒Side effects — in detail▾

The most common side effects with Miacalcin injection include:

  • Nausea, with or without vomiting — most common when starting treatment and often improves over time
  • Redness or inflammation at the injection site
  • Flushing of the face or hands
  • Skin rash or itching, particularly around the earlobes
  • Nighttime urination, abdominal pain, poor appetite, feverish sensation, eye pain, foot swelling, or a salty taste

Serious reactions to watch for include signs of a severe allergic reaction (trouble breathing, throat or tongue swelling), muscle cramps or twitching from low blood calcium, and any new or unexplained lumps or changes that could suggest cancer — contact your doctor or seek emergency care immediately if these occur.

⚠️Warnings & precautions▾
  • Serious allergic reactions: Anaphylaxis (a life-threatening allergic reaction), including fatal cases, has been reported. Emergency support should be available whenever this injection is administered. If you have a suspected allergy to calcitonin salmon, a skin test should be done before starting.
  • Possible increased cancer risk: A review of clinical trial data found a higher rate of malignancies in calcitonin-salmon-treated patients compared to placebo. A direct cause has not been proven, but the need for ongoing treatment should be reviewed regularly by your doctor.
  • Low blood calcium (hypocalcemia): This can cause muscle cramps, twitching, and seizures. Pre-existing low calcium must be corrected before starting treatment, and calcium/vitamin D intake should be adequate throughout.
  • Antibody formation: About half of patients with Paget's disease who were tested developed antibodies to calcitonin salmon after several months of use. If the medication stops working over time, this may be the reason — tell your doctor.
  • Urine changes: Abnormal particles in the urine have been reported during use; periodic urine monitoring may be recommended.
🔀What it interacts with▾

Formal drug interaction studies have not been conducted with calcitonin salmon injection, but one important interaction has been identified:

  • Lithium: Calcitonin salmon can increase how much lithium is excreted in the urine, which may lower lithium blood levels. If you take lithium (used for bipolar disorder or other conditions), your dose may need to be adjusted — let your prescriber and pharmacist know.

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▾
  • Allergy to calcitonin salmon: Do not use this medication if you are allergic to calcitonin salmon or any of its ingredients — serious and potentially fatal reactions have occurred.
  • Low blood calcium: Hypocalcemia must be fully corrected before starting treatment. Vitamin D deficiency and other mineral disorders should also be treated first.
  • Pregnancy: There are no adequate human studies. Animal data showed decreased fetal birth weights at higher doses. Discuss the risks carefully with your doctor before using during pregnancy.
  • Breastfeeding: It is unknown whether calcitonin salmon passes into human milk. Animal studies showed it inhibits milk production in rats. Discuss the decision with your doctor.
  • Children: Safety and effectiveness have not been established in pediatric patients.
  • Older adults: Clinical studies did not include enough older patients to draw firm conclusions. Caution is advised, generally starting at the lower end of the dosing range, due to the higher likelihood of other health conditions or multiple medications.
🚑If you take too much▾

Taking too much calcitonin salmon injection may cause low blood calcium (hypocalcemia), which can lead to tetany — involuntary muscle cramps and spasms. Nausea and vomiting have also been reported with high single doses. If overdose is suspected, calcium given by injection (intravenously) may be needed to treat low calcium, so provisions for that should be available.

📡Pharmacodynamics — effects in the body▾

Calcitonin salmon works primarily on bone by inhibiting osteoclasts — the cells that break down bone. A single injection produces a marked but temporary slowdown in bone resorption; with continued use, a smaller but sustained reduction in bone breakdown persists. In the kidneys, injectable calcitonin salmon increases the excretion of calcium, phosphate, and sodium in the urine by reducing how much the kidneys reabsorb. In the gastrointestinal tract, short-term use of the injectable form has been shown to temporarily reduce the volume and acidity of stomach secretions and the output of pancreatic enzymes, though whether this continues with long-term use has not been fully studied.

🔬Pharmacokinetics — how your body processes it▾

When given by injection, calcitonin salmon is well absorbed — about 66% with intramuscular injection and about 71% with subcutaneous injection. After a subcutaneous dose, peak blood levels are reached in roughly 23 minutes. The medication is cleared from the body relatively quickly, with a half-life of about 58–64 minutes depending on the injection route. The volume of distribution — a measure of how widely the drug spreads through the body — is relatively small, suggesting it does not extensively accumulate in tissues.

📦How to store it▾

Store in a refrigerator between 2° to 8°C (36° to 46°F). Protect from freezing.

📄 Written from Calcitonin Salmon 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 →

🩺 Pharmacist Counseling Corner

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

What exactly is Miacalcin injection used for? ▾
Miacalcin injection is used for three main conditions: Paget's disease of bone (a disorder where bones break down and rebuild abnormally), a dangerous spike in blood calcium called hypercalcemia, and postmenopausal osteoporosis in women who are at least 5 years past menopause. In all cases, it's typically used when other treatments haven't worked or aren't an option for you. It does increase total bone calcium for osteoporosis, but it hasn't been proven to reduce fractures, so your doctor will weigh that when deciding if it's right for you.
How do I give myself this injection, and does it matter where I inject it? ▾
You'll inject Miacalcin either just under the skin (subcutaneous) or into the muscle (intramuscular) — your prescriber will tell you which is right for your situation. If the dose volume is larger than 2 mL, intramuscular injection at more than one site is preferred. Always inspect the vial first — the solution should be clear and colorless with no particles. Use sterile technique every time and dispose of your needles safely. Your pharmacist or nurse can walk you through the exact steps if you haven't done injections before.
What side effects should I expect, and which ones mean I need to call my doctor? ▾
The most common side effects are nausea — especially when you first start — and redness or irritation at the injection site; these affect roughly 1 in 10 people. Some people also notice flushing of the face or hands. These tend to ease up as your body adjusts. You should call your doctor right away if you have muscle cramps, twitching, or seizures (signs of low blood calcium), or if the medication seems to stop working after it was helping before. And get emergency help immediately for any trouble breathing, throat or tongue swelling, or signs of a severe allergic reaction — these are rare but serious.
I heard there's something about a cancer risk with this drug. Should I be worried? ▾
This is a fair question and worth understanding clearly. A large review of clinical trial data found that patients who used calcitonin salmon had a slightly higher rate of cancers compared to patients who didn't — about 4% versus 3%. A direct cause-and-effect link has not been proven, and most of those studies used the nasal spray form. That said, the risk can't be ruled out with the injection either. Your doctor takes this seriously, which is why they'll regularly reassess whether you still need to stay on this medication. If you have concerns, bring them up at your next visit — it's always the right question to ask.
Do I need to take calcium or vitamin D along with this injection? ▾
Yes, if you're using Miacalcin injection for postmenopausal osteoporosis or Paget's disease. Getting enough calcium and vitamin D is important because calcitonin salmon can affect your body's calcium balance. The label specifically recommends at least 1,000 mg of elemental calcium and at least 400 International Units of vitamin D daily for osteoporosis treatment. Ask your pharmacist about the best way to get those through diet or supplements, and make sure your doctor knows what you're taking.
Can I use this injection if I'm pregnant or breastfeeding? ▾
There's no solid human data on calcitonin salmon use during pregnancy, and animal studies did show lower fetal birth weights at higher doses. If you're pregnant or thinking about becoming pregnant, talk to your doctor before using this medication so you can weigh the risks together. For breastfeeding, it's unknown whether calcitonin salmon passes into human milk, and animal studies suggested it can reduce milk production. Your doctor will help you decide what's safest for you and your baby.
Is Calcitonin Salmon Injection available over the counter? ▾
Calcitonin Salmon 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 Calcitonin Salmon Injection first available? ▾
Calcitonin Salmon Injection has been available in the United States since at least 1978, based on FDA approval history (Drugs@FDA) and product marketing records.
Who makes Calcitonin Salmon Injection? ▾
Calcitonin Salmon Injection is supplied by 13 manufacturers listed in the FDA NDC Directory, including Mylan Institutional LLC, Fresenius Kabi USA, LLC, Amneal Pharmaceuticals LLC.

💬 Answers drafted from Calcitonin Salmon 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

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💊 How Calcitonin Salmon Injection comes

Calcitonin Salmon 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

Into a muscle · Under the skin
Brands Miacalcin
How this form is used
What it may be used for
  • Miacalcin injection treats symptomatic Paget's disease of bone in moderate to severe cases when other treatments are not suitable
  • Miacalcin injection is used for urgent reduction of high blood calcium (hypercalcemia), used alongside other treatments
  • Miacalcin injection treats postmenopausal osteoporosis in women more than 5 years past menopause when other treatments are not suitable — note that fracture reduction has not been proven
Important instructions
  • Miacalcin injection is given subcutaneously (under the skin) or intramuscularly (into the muscle); if the volume exceeds 2 mL, intramuscular injection at multiple sites is preferred
  • Miacalcin injection should be inspected before use — only use if the solution is clear, colorless, and free of particles; do not use if the vial is damaged
  • Use sterile injection technique and dispose of needles properly after each use
  • When using Miacalcin injection for osteoporosis or Paget's disease, ensure adequate daily calcium and vitamin D intake as directed by your prescriber
Available strengths 3 strengths
200 [IU]/mL 200 [USP'U]/mL 400 [USP'U]/2 mL
19 FDA-listed product records ⓘ

📊 Calcitonin Salmon Injection across the U.S. market

How Calcitonin Salmon 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 ⓘ
13
Manufacturers
2
Brand names
19
FDA-listed product records ⓘ
1978
First marketed ⓘ
Mylan Institutional LLC32%
Fresenius Kabi USA, LLC11%
Amneal Pharmaceuticals LLC5%
Cipla USA Inc.5%
Dr. Reddy's Laboratories, Inc.5%
Hikma Pharmaceuticals USA Inc.5%
Other makers37%

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

📈 How widely Calcitonin Salmon Injection is used

A general measure of how commonly Calcitonin Salmon 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 Calcitonin Salmon 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.

31
Medicaid prescriptions filled (Q1–Q4 2025)
$4,273 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Calcitonin Salmon Injection prescribed? Of the 1,596 medications we measure, Calcitonin Salmon Injection ranks #1,561 by Medicaid prescriptions — more than 2% of them.

Where Calcitonin Salmon Injection ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #1,561 of 1,596
#1,556 Mecasermin Injection 35 Rx #1,557 Hepatitis B Vaccine 33 Rx #1,558 Retifanlimab-dlwr Inje... 33 Rx #1,559 Chloramphenicol Inject... 32 Rx #1,560 Loncastuximab Tesirine... 32 Rx #1,561 Calcitonin Salmon Inje... 31 Rx #1,562 Emapalumab-lzsg Inject... 29 Rx #1,563 Safinamide 26 Rx #1,564 Dalteparin Injection 26 Rx #1,565 Verteporfin Injection 25 Rx #1,566 Esomeprazole Injection 25 Rx

Utilization by Calcitonin Salmon 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.

salmon calcitonin 200 UNT/ML Injectable Solution

31 Medicaid prescriptions (Q1–Q4 2025) 100% of Calcitonin Salmon Injection prescriptions shown $4,273 gross reimbursement (before rebates) ≈ $138 per prescription (gross)

Summed across the 1 of 12 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 308866

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 Calcitonin Salmon 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 1 of 12 listed Calcitonin Salmon Injection NDCs with Medicaid activity.

🔍 Compare Calcitonin Salmon Injection products

A representative set of FDA-listed product records for Calcitonin Salmon 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.)

Showing 19 of 19 products — FDA National Drug Code Directory. See every product, package size and price: browse all 19 Calcitonin Salmon 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) Calcitonin Salmon Injection RxCUI 36118 2 dose forms · 4 strengths
  1. Dose form (SCDF) Injectable Solution RxCUI 371188 In current FDA listings
    Clinical drug / strength (SCD) 50 UNT/ML RxCUI 248087 100 UNT/ML RxCUI 248088 200 UNT/ML RxCUI 308866
  2. Dose form (SCDF) Nasal Spray RxCUI 374899 No current FDA listing
    Clinical drug / strength (SCD) 200 UNT/ACTUAT RxCUI 313919

Look up RxCUI 36118 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

Miacalcin Injection Calcimar Injection Miacalcin

🏭 Manufacturers & labelers

Mylan Institutional LLC 6 Fresenius Kabi USA, LLC 2 Amneal Pharmaceuticals LLC 1 Cipla USA Inc. 1 Dr. Reddy's Laboratories, Inc. 1 Hikma Pharmaceuticals USA Inc. 1 Hikma Pharmaceuticals USA Inc.(dba Leucadia Pharmaceuticals) 1 Leucadia Pharmaceuticals 1 Par Health USA, LLC 1 Par Pharmaceutical, Inc. 1 Sagent Pharmaceuticals 1 Zydus Lifesciences Limited 1 Zydus Pharmaceuticals USA Inc. 1

RxNorm drug class

Calcitonin Salmon Injection belongs to the Calcitonin class.

Pharmacologic class Calcitonin
Drug family (ATC) Calcitonin preparations

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 Sep 15, 2024
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Calcitonin Salmon 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 Calcitonin Salmon Injection after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
12
NDC products indexed
19
Distinct labelers/manufacturers represented
13
Linked representative label ⓘ
Mylan Institutional LLC
Linked label effective
Sep 15, 2024
Composite sections available
23
Linked SPL Set ID
26caf31f-7f7c-48a8-a1ac-35d2ceefda2b
Linked SPL Document ID
58cc8f82-89b9-4c9f-afb1-86250118bf0f
Open the linked representative label on DailyMed ↗
NDC package records associated with this linked SPL 1

How we combine label and product data

HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 12 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. Mylan Institutional LLC 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.