What the label lists and what reports show
Calcitonin salmon side effects
Calcitonin salmon's FDA label: “Most common adverse reactions are nausea with or without vomiting (10%), injection site inflammation (10%), and flushing of the face or hands (2% to 5%) ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at …” FAERS holds 3,109 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (254 reports).
- Generic listed
Check it at the source: the calcitonin salmon FDA label on DailyMed (effective September 15, 2024, Mylan Institutional LLC); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of Calcitonin Salmon (synthetic origin) Nasal Spray?Calcitonin Salmon (synthetic origin) Nasal Spray may cause serious side effects, including: allergic reactions Some people have had an allergic reaction when using calcitonin salmon nasal spray. Some reactions may be serious and can be life threatening. Call your healthcare provider or go to the nearest hospital emergency room right away if you have any of these symptoms of an allergic reaction. trouble breathing swelling of your face, throat or tongue fast heartbeat chest pain feel dizzy or faint If you might be allergic to calcitonin salmon, your healthcare provider should do a skin test before you use Calcitonin Salmon (synthetic origin) Nasal Spray. low calcium levels in your blood (hypocalcemia) Calcitonin Salmon (synthetic origin) Nasal Spray may lower the calcium levels in your blood. […]
Source: FDA drug label (Calcitonin Salmon), Apotex Corp., effective September 10, 2026 (SPL set c82eb602-12e1-692b-d660-f8d5b5736b54), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions are nausea with or without vomiting (10%), injection site inflammation (10%), and flushing of the face or hands (2% to 5%) ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Table 1: Risk Difference for Malignancies in Calcitonin Salmon-Treated Patients Compared with Placebo-Treated Patients
| Malignancies | Risk Difference The overall adjusted risk difference is the difference between the… | 95% Confidence Interval The corresponding 95% confidence interval for the overall… |
|---|---|---|
| All | 1.0 | (0.3, 1.6) |
| Excluding basal cell carcinoma | 0.5 | (-0.1, 1.2) |
| All | 1.4 | (0.3, 2.6) |
| Excluding basal cell carcinoma | 0.8 | (-0.2, 1.8) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious adverse reactions are discussed in greater detail in other sections of the label: • Hypersensitivity Reactions, including anaphylaxis [see Warnings and Precautions (5.1) ] • Hypocalcemia [see Warnings and Precautions (5.2) ] • Malignancy [see Warnings and Precautions (5.3) ] Most common adverse reactions are nausea with or without vomiting (10%), injection site inflammation (10%), and flushing of the face or hands (2% to 5%) ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Mylan at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of calcitonin salmon injection was assessed in open-label trials several months to two years in duration. The most common adverse reactions are discussed below. Nausea Nausea with or without vomiting has been noted in about 10% of patients treated with calcitonin salmon. It is most evident when treatment is first initiated and tends to decrease or disappear with continued administration. …
Source: FDA drug label, Mylan Institutional LLC, effective September 15, 2024 (SPL set 26caf31f-7f7c-48a8-a1ac-35d2ceefda2b), via openFDA; the full label on DailyMed
What do FAERS reports show?
3,109 reports list calcitonin salmon among the medicines taken, each a report of something that happened, not proof the medicine caused it; 278 are coded as a death and 997 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 22 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Calcitonin salmon: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions