Drug · FAERS side-effect profile with label screen
Calcitonin Salmon side effects: what 3,108 FDA adverse event reports show
Drug class
Calcitonin
FDA label (Established Pharmacologic Class)
Who reports
3,108 reports · 71% serious · 278 with death outcome · 85% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Calcitonin-salmon synthetic injection is a calcitonin, indicated for the following conditions: • Treatment of symptomatic Paget’s disease of bone when alternative treatments are not suitable ( 1.1 ) • Treatment of hypercalcemia ( 1.2 ) • Treatment of postmenopausal osteoporosis when alternative treatments are not suitable.
FDA label, Indications and Usage
What it is
Calcitonin, USP is a polypeptide hormone secreted by the parafollicular cells of the thyroid gland in mammals and by the ultimobranchial gland of birds and fish. Calcitonin-salmon Injection, U.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Likely indication confounding 14Reporting / coding artifact 2Lab value / disease marker 1Not in label — unassessed 23
What the badges mean
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 301 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Hypercalcaemia | 45 | 24.7 18.5–33.0ROR 25.1 · χ² 997 / p 5e-219 | 24.4 EB05 19.0 · IC025 +3.8 3/3 methods agree | Likely indication confounding term in indications | serious PRR 21.4 · 91% clinician | no trial data cached |
| Body height decreased | 39 | 24.4 17.9–33.4ROR 24.7 · χ² 850 / p 4e-187 | 24.1 EB05 18.4 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=31 | no trial data cached |
| Spinal fracture | 64 | 21.7 17.0–27.7ROR 22.2 · χ² 1,242 / p 3e-272 | 21.5 EB05 17.5 · IC025 +3.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 17.1 · 75% consumer | no trial data cached |
| Intervertebral disc degeneration | 29 | 21.1 14.7–30.3ROR 21.3 · χ² 533 / p 2e-118 | 20.8 EB05 15.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 19.5 | no trial data cached |
| Osteopenia | 47 | 20.8 15.7–27.7ROR 21.1 · χ² 866 / p 1e-190 | 20.6 EB05 16.1 · IC025 +3.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 18.2 | no trial data cached |
| Rib fracture | 53 | 17.5 13.4–22.8ROR 17.7 · χ² 805 / p 2e-177 | 17.3 EB05 13.7 · IC025 +3.5 3/3 methods agree | Likely indication confounding term in indications | serious PRR 15.1 | no trial data cached |
| Hyperlipidaemia | 28 | 15.8 10.9–22.8ROR 15.9 · χ² 373 / p 2e-83 | 15.5 EB05 11.0 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 13.6 | no trial data cached |
| Atelectasis | 21 | 14.6 9.6–22.4ROR 14.7 · χ² 253 / p 3e-57 | 14.1 EB05 9.3 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 12.0 | no trial data cached |
| Osteoporosis | 88 | 14.4 11.8–17.8ROR 14.8 · χ² 1,088 / p 8e-239 | 14.3 EB05 12.0 · IC025 +3.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 12.9 | no trial data cached |
| Product odour abnormal | 22 | 14.3 9.4–21.7ROR 14.4 · χ² 259 / p 1e-58 | 13.8 EB05 9.2 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Bone disorder | 37 | 13.6 9.9–18.8ROR 13.8 · χ² 419 / p 2e-93 | 13.3 EB05 9.9 · IC025 +3.0 3/3 methods agree | Likely indication confounding term in indications | serious PRR 12.3 | no trial data cached |
| Hiatus hernia | 26 | 13.5 9.2–19.9ROR 13.7 · χ² 289 / p 4e-65 | 13.0 EB05 9.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 12.0 | no trial data cached |
| Femur fracture | 62 | 13.5 10.5–17.3ROR 13.8 · χ² 705 / p 2e-155 | 13.3 EB05 10.7 · IC025 +3.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 11.0 | no trial data cached |
| Hip fracture | 63 | 13.3 10.4–16.9ROR 13.5 · χ² 702 / p 6e-155 | 13.1 EB05 10.5 · IC025 +3.2 3/3 methods agree | Likely indication confounding term in indications | serious PRR 10.9 | no trial data cached |
| Fracture | 36 | 12.8 9.3–17.8ROR 13.0 · χ² 381 / p 3e-85 | 12.5 EB05 9.2 · IC025 +2.9 3/3 methods agree | Likely indication confounding term in indications | serious PRR 11.4 | no trial data cached |
| Foot fracture | 36 | 12.8 9.2–17.7ROR 12.9 · χ² 379 / p 9e-85 | 12.4 EB05 9.2 · IC025 +2.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 11.6 | no trial data cached |
| Bone density decreased | 59 | 12.6 9.8–16.2ROR 12.8 · χ² 618 / p 1e-136 | 12.4 EB05 9.8 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious PRR 8.8 | no trial data cached |
| Pharmaceutical product complaint | 47 | 12.1 9.1–16.0ROR 12.2 · χ² 465 / p 2e-103 | 11.7 EB05 9.0 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 14.4 | no trial data cached |
| Bursitis | 21 | 11.8 7.7–18.0ROR 11.8 · χ² 196 / p 8e-45 | 10.9 EB05 7.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 10.7 | no trial data cached |
| Hypercholesterolaemia | 16 | 11.3 6.9–18.4ROR 11.4 · χ² 140 / p 1e-32 | 10.1 EB05 6.1 · IC025 +2.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 9.7 | no trial data cached |
| Osteoarthritis | 68 | 10.8 8.5–13.7ROR 11.0 · χ² 596 / p 5e-132 | 10.6 EB05 8.5 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.7 | no trial data cached |
| Wrist fracture | 19 | 10.7 6.8–16.8ROR 10.8 · χ² 157 / p 2e-36 | 9.6 EB05 6.2 · IC025 +2.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 10.2 | no trial data cached |
| Emphysema | 16 | 10.7 6.5–17.4ROR 10.7 · χ² 131 / p 1e-30 | 9.4 EB05 5.7 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 | no trial data cached |
| Mitral valve incompetence | 17 | 10.1 6.3–16.3ROR 10.2 · χ² 131 / p 1e-30 | 8.9 EB05 5.6 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 | no trial data cached |
| Product packaging quantity issue | 16 | 9.9 6.1–16.1ROR 9.9 · χ² 119 / p 5e-28 | 8.6 EB05 5.3 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Oral candidiasis (oral thrush) | 18 | 9.3 5.9–14.8ROR 9.4 · χ² 126 / p 2e-29 | 8.2 EB05 5.2 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 | no trial data cached |
| Coronary artery disease | 42 | 9.3 6.9–12.6ROR 9.4 · χ² 303 / p 4e-68 | 8.8 EB05 6.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 | no trial data cached |
| Osteomyelitis | 24 | 9.0 6.0–13.3ROR 9.0 · χ² 162 / p 2e-37 | 8.1 EB05 5.6 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Foot deformity | 14 | 8.5 5.0–14.4ROR 8.6 · χ² 85 / p 1e-20 | 7.1 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 | no trial data cached |
| Tenderness | 13 | 8.4 4.9–14.5ROR 8.4 · χ² 78 / p 6e-19 | 6.9 EB05 4.2 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Osteonecrosis of jaw (jawbone death) | 31 | 8.4 5.9–11.9ROR 8.5 · χ² 195 / p 1e-44 | 7.7 EB05 5.6 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Rotator cuff syndrome | 16 | 8.4 5.1–13.7ROR 8.4 · χ² 97 / p 4e-23 | 7.1 EB05 4.5 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Cardiomegaly | 15 | 8.2 4.9–13.5ROR 8.2 · χ² 87 / p 5e-21 | 6.9 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Dental caries | 13 | 7.9 4.6–13.7ROR 8.0 · χ² 72 / p 1e-17 | 6.5 EB05 4.0 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 | no trial data cached |
| Blood calcium decreased | 13 | 7.8 4.5–13.4ROR 7.8 · χ² 70 / p 3e-17 | 6.4 EB05 3.9 · IC025 +1.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 7.3 | no trial data cached |
| Multiple fractures | 19 | 7.7 4.9–12.1ROR 7.8 · χ² 105 / p 7e-25 | 6.7 EB05 4.5 · IC025 +2.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 6.3 | no trial data cached |
| Electrolyte imbalance | 13 | 7.6 4.4–13.1ROR 7.7 · χ² 68 / p 7e-17 | 6.3 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Increased tendency to bruise | 10 | 7.3 3.9–13.6ROR 7.3 · χ² 48 / p 2e-12 | 5.7 EB05 3.3 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Pulmonary mass | 16 | 7.3 4.5–11.8ROR 7.3 · χ² 80 / p 2e-19 | 6.2 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Arteriosclerosis | 10 | 7.2 3.9–13.3ROR 7.2 · χ² 47 / p 4e-12 | 5.6 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Fall | 219 | 4.4 3.9–5.1ROR 4.7 · χ² 591 / p 9e-131 | 4.4 EB05 3.9 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Arthralgia (joint pain) | 188 | 3.1 2.7–3.5ROR 3.2 · χ² 264 / p 1e-59 | 3.0 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 | no trial data cached |
| Back pain | 173 | 5.0 4.3–5.8ROR 5.3 · χ² 559 / p 6e-124 | 5.0 EB05 4.4 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Pain in extremity | 146 | 3.3 2.8–3.9ROR 3.5 · χ² 240 / p 2e-54 | 3.3 EB05 2.9 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Feeling abnormal | 93 | 2.6 2.1–3.2ROR 2.7 · χ² 92 / p 5e-22 | 2.6 EB05 2.2 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 | no trial data cached |
| Urinary tract infection (bladder infection) | 89 | 3.5 2.9–4.3ROR 3.6 · χ² 160 / p 5e-37 | 3.5 EB05 2.9 · IC025 +1.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 3.4 | no trial data cached |
| Osteoporosis | 88 | 14.4 11.8–17.8ROR 14.8 · χ² 1,088 / p 8e-239 | 14.3 EB05 12.0 · IC025 +3.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 12.9 | no trial data cached |
| Oedema peripheral (swelling of legs/feet) | 83 | 4.6 3.7–5.7ROR 4.7 · χ² 230 / p 3e-52 | 4.5 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.1 | no trial data cached |
| Myalgia (muscle pain) | 79 | 3.1 2.5–3.9ROR 3.2 · χ² 114 / p 7e-27 | 3.1 EB05 2.6 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 | no trial data cached |
| Gastrooesophageal reflux disease (acid reflux) | 75 | 6.3 5.0–7.9ROR 6.4 · χ² 331 / p 3e-74 | 6.1 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Blood pressure increased | 72 | 3.2 2.5–4.0ROR 3.2 · χ² 106 / p 4e-25 | 3.1 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.7 | no trial data cached |
| Cerebrovascular accident (stroke) | 68 | 2.7 2.1–3.4ROR 2.7 · χ² 72 / p 1e-17 | 2.7 EB05 2.2 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.2 | no trial data cached |
| Osteoarthritis | 68 | 10.8 8.5–13.7ROR 11.0 · χ² 596 / p 5e-132 | 10.6 EB05 8.5 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.7 | no trial data cached |
| Spinal fracture | 64 | 21.7 17.0–27.7ROR 22.2 · χ² 1,242 / p 3e-272 | 21.5 EB05 17.5 · IC025 +3.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 17.1 · 75% consumer | no trial data cached |
| Hip fracture | 63 | 13.3 10.4–16.9ROR 13.5 · χ² 702 / p 6e-155 | 13.1 EB05 10.5 · IC025 +3.2 3/3 methods agree | Likely indication confounding term in indications | serious PRR 10.9 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Body height decreased — n=39, PRR 24.4
- Intervertebral disc degeneration — n=29, PRR 21.1
- Hyperlipidaemia — n=28, PRR 15.8
- Atelectasis — n=21, PRR 14.6
- Hiatus hernia — n=26, PRR 13.5
- Pharmaceutical product complaint — n=47, PRR 12.1
- Bursitis — n=21, PRR 11.8
- Osteoarthritis — n=68, PRR 10.8
- Coronary artery disease — n=42, PRR 9.3
- Osteomyelitis — n=24, PRR 9.0
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Calcitonin Salmon?
In FDA FAERS, the most frequently co-reported reaction terms for Calcitonin Salmon are fall, arthralgia, back pain, pain in extremity, feeling abnormal, urinary tract infection. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Calcitonin Salmon have an FDA boxed warning?
No. The FDA label retrieved for Calcitonin Salmon has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Calcitonin Salmon causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 26f19d56-44fd-dc7a-46e8-afaaaba5734f, effective 20250917; matched on
openfda.generic_name.exact:"CALCITONIN SALMON") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 341 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.