Short answer: The Miacalcin injection label lists nausea with or without vomiting (about 10%, mostly at the start), injection site inflammation (about 10%) and flushing of the face or hands (about 2% to 5%) as the most common side effects, from open-label trials without placebo. It has no boxed warning; its warnings cover serious allergic reactions, low calcium, a possible higher cancer risk and antibodies.
What Miacalcin is approved for: Miacalcin injection is a calcitonin approved for symptomatic Paget's disease of bone when other treatments are not suitable; for early treatment of hypercalcemic emergencies, with other agents; and for postmenopausal osteoporosis in women more than 5 years past menopause when other treatments are not suitable (sections 1.1 to 1.3). The label says fracture reduction has not been shown, and continued use is re-evaluated periodically because of a possible link with cancer (section 1.4).
Source
MIACALCIN (calcitonin salmon) injection, for subcutaneous or intramuscular use, prescribing information. Mylan Institutional (Viatris). DailyMed, version published June 19, 2026. DailyMed setid 89cd4f46-b88a-4c10-b25c-47352280dc4e
No. The current Miacalcin label has no boxed warning.
These are the label's own numbers from the Adverse Reactions section. Where the label compares with placebo (a dummy treatment), both columns are shown, so you can see how much more often a reaction happened on Miacalcin.
| Adverse reaction | Rate on the label | Note |
|---|---|---|
| Nausea with or without vomiting | About 10% | Most evident when treatment is first started; tends to decrease or disappear with continued use |
| Local inflammatory reactions at the injection site | About 10% | Subcutaneous or intramuscular injection sites |
| Flushing of face or hands | About 2% to 5% | |
| Skin rashes and itching of the ear lobes | Reported, no rate given | |
| Nighttime urination, feverish sensation, eye pain, poor appetite, abdominal pain, swelling of the feet, salty taste | Reported, no rate given |
The safety of calcitonin salmon injection was studied in open-label trials lasting several months to two years. The label gives approximate rates and no placebo comparison.
| Patients | Malignancies | Risk Difference (%) | 95% Confidence Interval (%) |
|---|---|---|---|
| All (nasal spray + oral) | All | 1.0 | (0.3, 1.6) |
| All (nasal spray + oral) | Excluding basal cell carcinoma | 0.5 | (-0.1, 1.2) |
| All (nasal spray only) | All | 1.4 | (0.3, 2.6) |
| All (nasal spray only) | Excluding basal cell carcinoma | 0.8 | (-0.2, 1.8) |
From a meta-analysis of 21 randomized trials of nasal spray or investigational oral calcitonin salmon (10,883 patients, 6 months to 5 years); the injection was not studied in it. Risk difference is the gap in the percentage of patients with any cancer.
In the cancer meta-analysis, malignancies occurred in 4.1% on calcitonin salmon (254 of 6,151) vs 2.9% on placebo (137 of 4,732); in the 18 nasal-spray trials, 4.5% vs 2.3%. The result was heavily influenced by one large 5-year trial.
Antibodies to calcitonin salmon were found after 2 to 18 months in about half of the Paget's disease patients tested; people with high levels usually lose response to treatment.
In two 2-year osteoporosis studies (34 on calcitonin, 35 controls), there were 6 vs 5 new spine fractures in year one and 7 vs 7 in year two. The label says there is no evidence Miacalcin lowers fracture risk.
Reported after approval: fatal anaphylaxis, hives, low calcium with cramps, twitching or seizures, flu-like symptoms, fatigue, swelling, joint and muscle pain, high blood pressure, diarrhea, frequent urination, dizziness, headache, tingling, tremor and vision changes.
The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.
Serious allergic reactions. Bronchospasm, swelling of the tongue or throat, anaphylactic shock and death from anaphylaxis have been reported. Medical support is kept available when it is given, and skin testing with a dilute solution may be considered in people with suspected allergy.
Low blood calcium. Low calcium with tetany (muscle cramps, twitching) and seizures has been reported. Low calcium and vitamin D deficiency are corrected before starting, and calcium is watched in people at risk during the first doses.
Possible cancer risk. A meta-analysis of nasal and oral calcitonin trials found more cancers on calcitonin (4.1% vs 2.9%). A higher risk cannot be excluded for the injection, so benefits are weighed against possible risks and the need for continued use is reviewed periodically (section 1.4).
Antibodies and loss of response. Antibodies to calcitonin salmon can form and are considered when someone who first responded later stops responding.
Urine sediment changes. Urine casts were seen in young volunteers on bed rest given the injection, with no other sign of kidney problems; they cleared after stopping. Periodic urine checks may be considered.
Lithium. Calcitonin salmon may lower lithium levels by increasing its clearance in urine, and the lithium dose may need adjusting.
From the Patient Counseling Information (section 17) that comes with Miacalcin:
Dose Track has a side-effect log. Each entry records the symptom, a severity (none, mild, moderate, severe or life-threatening), the date and an optional note, and can be tied to a specific dose or logged on its own. The history screen shows what you logged over time, which makes it easier to tell your prescriber when a reaction started and whether it is easing. The app records what you enter; it does not judge whether a symptom is serious. For anything on the label's call-your-doctor list, call your doctor.
This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.