FDA-filed SPL labeling · retrieved through openFDA

Calcitonin Salmon Nasal Spray

Calcitonin salmon nasal spray is a hormone-based medication used to treat postmenopausal osteoporosis in women who cannot use other osteoporosis therapies.

Brand names ForticalMiacalcin Nasal SprayMiacalcin
Drug class Calcitonin
Rx Form 1 Route Nasal
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 2 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 29, 2026
Clinical labels in scope 2
AvailabilityRx
Earliest approval/marketing year 1978
FDA-listed product records 7
Boxed warningNone found in compared labels
How we combine label and product data →
No current FDA shortage listed · checked Sep 21, 2026
Calcitonin Salmon Nasal Spray at a glance The quick version — the full detail is in the Patient Information Guide below.
💊
HelloPharmacist Editorial Team Bottom Line
Calcitonin Salmon Nasal Spray is a second-line option for postmenopausal osteoporosis — used when other treatments aren't suitable — that helps slow bone breakdown but has not been proven to reduce fracture risk. A possible small increase in cancer risk with long-term use means your doctor should regularly review whether continuing it makes sense for you. Take it with adequate calcium and vitamin D, alternate nostrils daily, and report any nasal problems or signs of allergic reaction to your doctor promptly.

📖 Calcitonin Salmon Nasal Spray: Patient Information Guide

A plain-language walkthrough of Calcitonin Salmon Nasal Spray — 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 nasal spray has one FDA-approved use:

  • Postmenopausal osteoporosis: CALCITONIN SALMON nasal spray is approved for women who are more than 5 years past menopause and for whom other osteoporosis treatments are not suitable (for example, women who cannot tolerate or who are unwilling to use other therapies). It is considered a second-line option.
  • It has not been shown to reduce fractures.
  • It has not been shown to increase spinal bone density in women in the early years after menopause.
  • Because of a possible link to increased cancer risk, the need for continued therapy should be reviewed regularly by your doctor.
⚙️How it works

Calcitonin salmon is a synthetic version of calcitonin, a hormone that acts primarily on bone. It binds to calcitonin receptors on osteoclasts (the cells that break down bone), reducing their activity and slowing the rate of bone loss. It has a greater potency and longer duration of action than natural mammalian calcitonins. It also has some effects on the kidneys and gastrointestinal tract, though these are not central to its use in osteoporosis.

💊How it's taken

Calcitonin Salmon Nasal Spray is taken as one spray into one nostril once a day, alternating nostrils daily. Before the very first use, let the bottle reach room temperature and prime the pump until a full spray is released — you do not need to re-prime it before any dose after that. Always hold your head upright when using the spray.

  • Take it alongside adequate calcium (at least 1000 mg elemental calcium daily) and vitamin D (at least 400 International Units daily) as your doctor advises.
  • Unopened bottles should be stored in the refrigerator; bring to room temperature before first use.
  • Always follow your prescriber's specific instructions and the directions on the label.
🤒Side effects — in detail

The most common side effects with calcitonin salmon nasal spray affect the nose and include:

  • Rhinitis (nasal irritation, runny nose)
  • Nosebleeds (epistaxis)
  • Nasal symptoms: crusting, dryness, soreness, itching, redness
  • Back pain
  • Joint pain (arthralgia)
  • Headache
  • Sinusitis
  • Influenza-like symptoms, rash, nausea, dizziness

Serious reactions to watch for include severe allergic reactions (trouble breathing, throat swelling, anaphylaxis), signs of low blood calcium (muscle cramps, twitching, seizures), and severe nasal ulcers — all of which require prompt medical attention.

⚠️Warnings & precautions
  • Possible increased cancer risk: A review of 21 clinical trials found a higher rate of malignancies in patients treated with calcitonin salmon compared with placebo. A direct cause has not been confirmed, but your doctor should regularly reassess whether you should continue this medication.
  • Severe allergic reactions: Anaphylaxis and anaphylactic shock have been reported — get emergency help immediately if you have trouble breathing or throat swelling.
  • Low blood calcium (hypocalcemia): Can cause muscle cramps, twitching, and seizures. Low calcium must be corrected before starting this medication.
  • Nasal damage: Nasal ulcers and other nasal changes can develop. Periodic nasal exams are recommended; the medication should be stopped if severe ulceration occurs.
  • Antibody formation: About 69% of patients in one study developed antibodies to calcitonin salmon over 2 years. This can cause the medication to stop working over time.
🔀What it interacts with

Few formal drug interaction studies have been done with calcitonin salmon nasal spray, but one important interaction is known:

  • Lithium: Calcitonin salmon may speed up the removal of lithium through the kidneys, lowering lithium levels in your blood. If you take lithium, your doctor may need to adjust your dose.

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: Do not use if you have had a serious allergic reaction to calcitonin salmon or any component of the spray.
  • Low blood calcium (hypocalcemia): This must be fully treated before you start this medication.
  • Mineral or vitamin deficiencies: Conditions like vitamin D deficiency should be treated before or during use.
  • Older adults: Nasal side effects (irritation, nosebleeds) are more common in people over 65, especially those over 75.
  • Children: Safety and effectiveness have not been established in pediatric patients.
  • Pregnancy: Not indicated for use during pregnancy. Animal studies showed reduced fetal birth weights at high doses.
  • Breastfeeding: Not indicated during breastfeeding; calcitonin has been shown to inhibit milk production in animals.
  • Lithium users: Tell your doctor, as your lithium dose may need monitoring or adjustment.
🚑If you take too much

Taking too much calcitonin salmon nasal spray could cause dangerously low blood calcium (hypocalcemia), which may lead to muscle cramping or tetany (severe, painful muscle contractions). If an overdose is suspected, calcium should be available for treatment. Studies have examined single doses and short courses at higher-than-recommended amounts without serious adverse effects, but any suspected overdose should be treated as a medical situation.

📡Pharmacodynamics — effects in the body

Calcitonin salmon slows the breakdown of bone by reducing the number and activity of osteoclasts (bone-dissolving cells), leading to a persistent decrease in the rate of bone resorption with ongoing use. It also causes a mild reduction in blood calcium levels, keeping them within the normal range in healthy adults. In people with more rapid bone turnover, blood calcium reductions can be more pronounced. Doses above a certain threshold do not produce additional biological response.

🔬Pharmacokinetics — how your body processes it

When sprayed into the nose, calcitonin salmon is absorbed quickly through the nasal lining, reaching peak blood levels in about 13 minutes. Its bioavailability by the nasal route is only about 3–5% compared to an injected dose, meaning most of the drug does not reach the bloodstream. The drug is cleared from the body rapidly, with a half-life (the time it takes for half the drug to leave the body) of around 18 minutes, and it does not accumulate with repeated daily use.

📦How to store it

Store unopened bottle in refrigerator between 2°C to 8°C (36°F to 46°F). Protect from freezing. Store bottle in use at room temperature between 20°C to 25°C (68°F to 77°F) in an upright position, for up to 30 days (2 mL fill) or 35 days (3.

📄 Written from Calcitonin Salmon Nasal Spray’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 Nasal Spray — the kind of thing our pharmacy team would talk through with you at the counter.

Why is my doctor prescribing this instead of other osteoporosis medications?
Calcitonin salmon nasal spray is generally considered a second-choice option for postmenopausal osteoporosis. It's typically recommended when other osteoporosis treatments — like bisphosphonates — aren't a good fit for you, whether because of side effects, interactions, or personal preference. Your doctor has decided that, for your situation, the benefits outweigh the risks.
How do I use the nasal spray correctly?
Before you use it for the very first time, take the bottle out of the refrigerator and let it reach room temperature. Then prime the pump by pressing the side arms down repeatedly until a full spray comes out. After that, you don't need to prime it again. Each day, spray one puff into one nostril — and alternate nostrils every day. Keep your head upright when you spray. That's it — just one spray, once a day.
What side effects should I expect, and which ones should I call about right away?
The most common issues are nasal — things like a runny nose, nosebleeds, dryness, or irritation inside the nose. Back pain, joint pain, and headache are also reported. Those are worth mentioning at your next appointment but aren't emergencies. However, if you have trouble breathing, swelling of your throat or tongue, severe muscle cramps or twitching, or a very bad nosebleed, get help right away — these are signs of a serious reaction.
I heard there might be a cancer risk. Should I be worried?
It's a fair concern. A review of 21 clinical trials found a slightly higher rate of cancers in people who used calcitonin salmon compared to those who took a placebo — about 4% versus 3%. Researchers haven't confirmed a direct cause-and-effect relationship, and the absolute difference is small. Because of this uncertainty, your doctor should regularly check in with you to make sure continuing the medication still makes sense for your situation. Don't stop it on your own — talk to your prescriber.
Do I need to take calcium and vitamin D too?
Yes, and this is important. Calcitonin salmon nasal spray works best when your calcium and vitamin D levels are adequate. Your doctor will likely recommend at least 1000 mg of elemental calcium and at least 400 International Units of vitamin D per day. If your calcium is low before you start, that needs to be corrected first — low calcium can cause muscle cramps, twitching, or even seizures.
What happens if the spray stops working over time?
Some people develop antibodies — proteins that their immune system makes against the medication — which can reduce how well it works. In one study, about 69% of patients had measurable antibodies after two years of use. If you feel like the medication has stopped helping, let your doctor know. They'll review whether it's still the right treatment for you or whether a different approach makes more sense.
Is Calcitonin Salmon Nasal Spray available over the counter?
Calcitonin Salmon Nasal Spray 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 Nasal Spray first available?
Calcitonin Salmon Nasal Spray 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 Nasal Spray?
Calcitonin Salmon Nasal Spray is supplied by 5 manufacturers listed in the FDA NDC Directory, including Apotex Corp., Bryant Ranch Prepack, Endo USA, Inc..

💬 Answers drafted from Calcitonin Salmon Nasal Spray’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 Calcitonin Salmon Nasal Spray comes

Calcitonin Salmon Nasal Spray 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.

Nasal spray

In the nose
How this form is used
What it may be used for
  • CALCITONIN SALMON nasal spray is used to treat postmenopausal osteoporosis in women more than 5 years past menopause when alternative treatments are not suitable
  • CALCITONIN SALMON nasal spray has not been shown to reduce fracture risk or to increase spinal bone density in early postmenopausal women
Important instructions
  • CALCITONIN SALMON nasal spray is used as one spray into one nostril once daily, alternating nostrils each day
  • Before the very first use, allow CALCITONIN SALMON nasal spray to reach room temperature, then prime the pump until a full spray is released — do not re-prime before subsequent daily doses
  • Hold your head upright when administering CALCITONIN SALMON nasal spray
  • Use CALCITONIN SALMON nasal spray alongside adequate calcium (at least 1000 mg elemental calcium per day) and vitamin D (at least 400 International Units per day) as directed
Available strengths 2 strengths
7 FDA-listed product records

📊 Calcitonin Salmon Nasal Spray across the U.S. market

How Calcitonin Salmon Nasal Spray 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
5
Manufacturers
1
Brand names
7
FDA-listed product records
1978
First marketed
Apotex Corp.43%
Bryant Ranch Prepack14%
Endo USA, Inc.14%
Par Health USA, LLC14%
Par Pharmaceutical, Inc.14%

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 Nasal Spray is used

A general measure of how commonly Calcitonin Salmon Nasal Spray 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 Nasal Spray 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.

5,954
Medicaid prescriptions filled (Q1–Q4 2025)
$351,256 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Calcitonin Salmon Nasal Spray prescribed? Of the 1,596 medications we measure, Calcitonin Salmon Nasal Spray ranks #1,020 by Medicaid prescriptions — more than 36% of them.

Where Calcitonin Salmon Nasal Spray ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5

Utilization by Calcitonin Salmon Nasal Spray 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/ACTUAT Nasal Spray

5,954 Medicaid prescriptions (Q1–Q4 2025) 100% of Calcitonin Salmon Nasal Spray prescriptions shown $351,256 gross reimbursement (before rebates) ≈ $59 per prescription (gross)

Summed across the 2 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 313919

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 Nasal Spray, 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 2 of 4 listed Calcitonin Salmon Nasal Spray NDCs with Medicaid activity.

🔍 Compare Calcitonin Salmon Nasal Spray products

A representative set of FDA-listed product records for Calcitonin Salmon Nasal Spray — 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
💊Nasal spray
200 [IU] Nasal Apotex Corp. × 3 listings ANDA View NDC →
200 [IU] Nasal Bryant Ranch Prepack ANDA View NDC →
200 [IU]/0.09 mL Nasal Endo USA, Inc. ANDA View NDC →
200 [IU]/0.09 mL Nasal Par Health USA, LLC ANDA View NDC →
200 [IU]/0.09 mL Nasal Par Pharmaceutical, Inc. ANDA View NDC →

Showing 7 of 7 products — FDA National Drug Code Directory. See every product, package size and price: browse all 7 Calcitonin Salmon Nasal Spray 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 Nasal Spray RxCUI 36118 2 dose forms · 4 strengths
  1. Dose form (SCDF) Injectable Solution RxCUI 371188 No current FDA listing
    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 In current FDA listings
    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

Fortical Miacalcin Nasal Spray Miacalcin

🏭 Manufacturers & labelers

Apotex Corp. 3 Bryant Ranch Prepack 1 Endo USA, Inc. 1 Par Health USA, LLC 1 Par Pharmaceutical, Inc. 1

RxNorm drug class

Calcitonin Salmon Nasal Spray 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 Jun 29, 2026
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Calcitonin Salmon Nasal Spray.
📈
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 Nasal Spray after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
2
NDC products indexed
7
Distinct labelers/manufacturers represented
5
Linked representative label
Par Pharmaceutical, Inc.
Linked label effective
Jun 29, 2026
Composite sections available
22
Linked SPL Set ID
a6eaedb3-5c96-4859-be43-a48c9c818bc7
Linked SPL Document ID
0f4b56a3-ce50-41b6-985a-270bf416ffef
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 2 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. Par Pharmaceutical, Inc. 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.