Calcium side effects: what 147,677 FDA adverse event reports show

Calcium · Ag-X · 1,188 reaction terms · 773,623 drug–reaction co-reports · data 2026-09-14

Drug class

Calcium

FDA label (Established Pharmacologic Class)

Brand names

Ag-X

openFDA label

Who reports

147,677 reports · 61% serious · 10,254 with death outcome · 78% female

openFDA FAERS counts, all years, deduplication not applied

Used for

SECTION take two capsules once, two times a day

FDA label, Indications and Usage

What it is

Calcium atom is an alkaline earth metal atom. It has a role as a macronutrient.

PubChem CID 5460341 (ChEBI)

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

Lab value / disease marker 11No label text to screen 29

What the badges mean

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.
No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.

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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,148 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Deep vein thrombosis postoperative	647	69.8 63.5–76.7ROR 70.1 · calibrated p 2e-6 ✓	46.8 EB05 43.8 · IC025 +5.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=647 · ♀ 100% (drug 78%) · 100% clinician	no trial arm names this drug
Lupus vulgaris	385	67.8 60.0–76.6ROR 68.0 · calibrated p 2e-6 ✓	45.8 EB05 42.1 · IC025 +5.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=385 · ♀ 100% (drug 78%) · 100% clinician	no trial arm names this drug
C-reactive protein	264	58.1 50.3–67.1ROR 58.2 · calibrated p 6e-6 ✓	41.2 EB05 37.2 · IC025 +5.1 3/3 methods agree	Lab value / disease marker	serious n=264 · ♀ 100% (drug 78%) · 100% clinician	no trial arm names this drug
Anti-cyclic citrullinated peptide antibody	179	51.9 43.7–61.6ROR 51.9 · calibrated p 1e-5 ✓	37.9 EB05 33.5 · IC025 +4.9 3/3 methods agree	Lab value / disease marker	serious n=179 · ♀ 100% (drug 78%) · 100% clinician	no trial arm names this drug
Swollen joint count increased	748	44.6 41.1–48.5ROR 44.9 · calibrated p 3e-5 ✓	34.0 EB05 32.0 · IC025 +4.9 3/3 methods agree	Lab value / disease marker	serious n=746 · ♀ 100% (drug 78%) · 100% clinician	no trial arm names this drug
Adjustment disorder with depressed mood	451	40.8 36.7–45.3ROR 40.9 · calibrated p 5e-5 ✓	31.7 EB05 29.3 · IC025 +4.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=449 · ♀ 100% (drug 78%) · 100% clinician	no trial arm names this drug
Blood pressure diastolic abnormal	574	40.7 37.1–44.6ROR 40.8 · calibrated p 5e-5 ✓	31.7 EB05 29.5 · IC025 +4.8 3/3 methods agree	Lab value / disease marker	serious n=547 · 91% clinician	no trial arm names this drug
Blood pressure systolic abnormal	542	39.3 35.8–43.3ROR 39.5 · calibrated p 6e-5 ✓	30.9 EB05 28.7 · IC025 +4.8 3/3 methods agree	Lab value / disease marker	serious n=524 · 90% clinician	no trial arm names this drug
Recalled product	373	38.6 34.4–43.3ROR 38.7 · calibrated p 7e-5 ✓	30.4 EB05 27.9 · IC025 +4.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=360	no trial arm names this drug
Rheumatic fever	919	37.7 35.0–40.5ROR 37.9 · calibrated p 7e-5 ✓	29.8 EB05 28.3 · IC025 +4.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=919 · ♀ 100% (drug 78%) · 94% clinician	no trial arm names this drug
Dislocation of vertebra	443	35.1 31.7–39.0ROR 35.2 · calibrated p 1e-4 ✓	28.2 EB05 26.1 · IC025 +4.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=442 · ♀ 100% (drug 78%) · 100% clinician	no trial arm names this drug
X-ray abnormal	315	30.3 26.8–34.2ROR 30.3 · calibrated p 3e-4 ✓	25.0 EB05 22.8 · IC025 +4.4 3/3 methods agree	Lab value / disease marker	serious n=315 · ♀ 100% (drug 78%) · 100% clinician	no trial arm names this drug
Retinitis	282	28.7 25.3–32.6ROR 28.8 · calibrated p 3e-4 ✓	23.9 EB05 21.7 · IC025 +4.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=282 · ♀ 100% (drug 78%) · 100% clinician	no trial arm names this drug
Facet joint syndrome	503	26.8 24.4–29.5ROR 26.9 · calibrated p 5e-4 ✓	22.6 EB05 21.0 · IC025 +4.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=502 · ♀ 100% (drug 78%) · 100% clinician	no trial arm names this drug
Rheumatoid factor positive	860	24.7 23.0–26.6ROR 24.9 · calibrated p 7e-4 ✓	21.1 EB05 20.0 · IC025 +4.3 3/3 methods agree	Lab value / disease marker	serious n=860 · ♀ 100% (drug 78%) · 94% clinician	no trial arm names this drug
Duodenal ulcer perforation	1,049	23.5 22.1–25.1ROR 23.7 · calibrated p 9e-4 ✓	20.3 EB05 19.3 · IC025 +4.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 19.0 · ♀ 100% (drug 78%) · 95% clinician	no trial arm names this drug
Anti-cyclic citrullinated peptide antibody positive	961	22.1 20.6–23.6ROR 22.2 · calibrated p 0.001 ✓	19.2 EB05 18.2 · IC025 +4.1 3/3 methods agree	Lab value / disease marker	serious PRR 18.0 · ♀ 100% (drug 78%) · 95% clinician	no trial arm names this drug
Nasal oedema	237	21.5 18.8–24.7ROR 21.5 · calibrated p 0.001 ✓	18.7 EB05 16.8 · IC025 +4.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=225 · ♀ 100% (drug 78%) · 100% clinician	no trial arm names this drug
Seronegative arthritis	141	20.3 17.0–24.2ROR 20.3 · calibrated p 0.002 ✓	17.8 EB05 15.4 · IC025 +3.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=140 · ♀ 100% (drug 78%) · 100% clinician	no trial arm names this drug
Bone erosion	417	18.8 17.0–20.9ROR 18.9 · calibrated p 0.003 ✓	16.7 EB05 15.4 · IC025 +3.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=416 · ♀ 100% (drug 78%)	no trial arm names this drug
Peripheral venous disease	462	18.5 16.8–20.3ROR 18.5 · calibrated p 0.003 ✓	16.4 EB05 15.2 · IC025 +3.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=457 · ♀ 100% (drug 78%) · 100% clinician	no trial arm names this drug
Pemphigus	1,406	18.0 17.0–19.0ROR 18.2 · calibrated p 0.003 ✓	16.0 EB05 15.4 · IC025 +3.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 15.1 · ♀ 100% (drug 78%) · 93% clinician	no trial arm names this drug
Helicobacter infection	1,112	17.3 16.2–18.4ROR 17.4 · calibrated p 0.004 ✓	15.5 EB05 14.7 · IC025 +3.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 15.2 · ♀ 100% (drug 78%) · 93% clinician	no trial arm names this drug
Muscle injury	844	16.2 15.1–17.4ROR 16.3 · calibrated p 0.005 ✓	14.6 EB05 13.8 · IC025 +3.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 14.6 · ♀ 100% (drug 78%) · 93% clinician	no trial arm names this drug
Hand deformity	1,308	15.7 14.8–16.6ROR 15.8 · calibrated p 0.006 ✓	14.2 EB05 13.5 · IC025 +3.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 14.3 · ♀ 100% (drug 78%) · 91% clinician	no trial arm names this drug
Sleep disorder due to general medical condition, insomnia type	635	15.4 14.2–16.8ROR 15.5 · calibrated p 0.006 ✓	14.0 EB05 13.1 · IC025 +3.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=615 · ♀ 100% (drug 78%)	no trial arm names this drug
Blood calcium increased	845	15.0 14.0–16.1ROR 15.1 · calibrated p 0.007 ✓	13.7 EB05 12.9 · IC025 +3.6 3/3 methods agree	Lab value / disease marker	serious n=370 · 72% consumer	no trial arm names this drug
C-reactive protein abnormal	595	14.4 13.3–15.7ROR 14.5 · calibrated p 0.008 ✓	13.2 EB05 12.3 · IC025 +3.6 3/3 methods agree	Lab value / disease marker	serious n=591 · ♀ 100% (drug 78%) · 100% clinician	no trial arm names this drug
Porphyria acute	118	13.2 10.9–15.9ROR 13.2 · calibrated p 0.012 ✓	12.0 EB05 10.3 · IC025 +3.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=118 · ♀ 100% (drug 78%) · 100% clinician	no trial arm names this drug
Folliculitis	882	13.2 12.3–14.1ROR 13.2 · calibrated p 0.012 ✓	12.1 EB05 11.4 · IC025 +3.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 13.2 · ♀ 100% (drug 78%) · 94% clinician	no trial arm names this drug
Obstructive sleep apnoea syndrome	112	12.3 10.1–14.9ROR 12.3 · calibrated p 0.016 ✓	11.3 EB05 9.6 · IC025 +3.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=110 · ♀ 0% (drug 78%) · 100% clinician	no trial arm names this drug
Blood calcium abnormal	129	11.9 10.0–14.3ROR 11.9 · calibrated p 0.018 ✓	10.9 EB05 9.4 · IC025 +3.1 3/3 methods agree	Lab value / disease marker	serious n=94	no trial arm names this drug
Synovitis	1,357	11.5 10.9–12.1ROR 11.6 · calibrated p 0.019 ✓	10.7 EB05 10.2 · IC025 +3.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 10.4 · ♀ 100% (drug 78%) · 91% clinician	no trial arm names this drug
Breast cancer stage iii	483	11.4 10.4–12.6ROR 11.5 · calibrated p 0.020 ✓	10.6 EB05 9.8 · IC025 +3.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=483 · ♀ 100% (drug 78%) · 100% clinician	no trial arm names this drug
Autoimmune disorder	713	11.4 10.5–12.3ROR 11.4 · calibrated p 0.020 ✓	10.5 EB05 9.9 · IC025 +3.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 10.4 · ♀ 100% (drug 78%)	no trial arm names this drug
Drug tolerance decreased	207	11.3 9.8–13.0ROR 11.3 · calibrated p 0.022 ✓	10.4 EB05 9.3 · IC025 +3.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=200 · ♀ 100% (drug 78%) · 100% clinician	no trial arm names this drug
Lip dry	661	11.2 10.4–12.2ROR 11.3 · calibrated p 0.021 ✓	10.4 EB05 9.8 · IC025 +3.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=612 · ♀ 100% (drug 78%)	no trial arm names this drug
Exostosis	664	11.1 10.2–12.0ROR 11.1 · calibrated p 0.022 ✓	10.3 EB05 9.7 · IC025 +3.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 10.8	no trial arm names this drug
Kyphosis	129	11.1 9.2–13.2ROR 11.1 · calibrated p 0.024 ✓	10.2 EB05 8.8 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=120	no trial arm names this drug
Sciatica	1,133	10.9 10.2–11.5ROR 10.9 · calibrated p 0.024 ✓	10.1 EB05 9.6 · IC025 +3.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 11.7	no trial arm names this drug

Clinical concept groups

MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.

Concept	Reports	PRR 95% CI	Reading
Fall / fracture	7,692	2.92.8–3.0	signal
Tendon disorder	669	2.52.3–2.7	signal
Osteonecrosis	949	2.42.2–2.5	signal
Serious infection	12,032	2.22.2–2.3	signal
Interstitial lung disease	1,366	2.01.9–2.1	raised
Anaemia	4,211	2.01.9–2.1	raised
Opportunistic infection	1,776	1.91.8–1.9	raised
Depression	3,546	1.81.7–1.9	raised
Liver injury	3,750	1.81.7–1.8	raised
Arrhythmia / qt	2,399	1.81.7–1.8	raised
Venous thromboembolism	2,403	1.61.5–1.6	raised
Hyponatraemia	837	1.51.4–1.6	raised
Hyperglycaemia / diabetes	3,538	1.51.4–1.5	raised
Gi bleeding	1,820	1.41.4–1.5	raised
Kidney injury	4,099	1.31.2–1.3	raised
Pancreatitis	713	1.31.2–1.4	raised

Trial evidence (ClinicalTrials.gov)

ClinicalTrials.gov returned results-bearing trials mentioning Calcium only as a background or rescue medication (NCT00529373, NCT00239681); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.

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
Fatigue (tiredness)	14,552	2.7 2.6–2.7ROR 2.9 · calibrated p 0.668	2.7 EB05 2.6 · IC025 +1.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	age-adj. PRR 2.4 · serious PRR 3.1	no trial arm names this drug
Off label use (used outside approved label)	12,470	2.1 2.0–2.1ROR 2.2 · calibrated p 0.975	2.0 EB05 2.0 · IC025 +1.0 3/3 methods agree	Reporting / coding artifact	age-adj. PRR 2.0 · serious PRR 2.4	no trial arm names this drug
Nausea	10,970	2.0 2.0–2.0ROR 2.1 · calibrated p 0.980	2.0 EB05 1.9 · IC025 +0.9	No label text to screen label has no adverse-reaction text	age-adj. PRR 1.9 · serious PRR 2.3	no trial arm names this drug
Drug ineffective (drug did not work)	10,694	1.2 1.1–1.2ROR 1.2 · calibrated p 0.417	1.2 EB05 1.1 · IC025 +0.2	Reporting / coding artifact	age-adj. PRR 1.4 · serious PRR 1.9	no trial arm names this drug
Pain	10,403	2.4 2.4–2.5ROR 2.5 · calibrated p 0.799	2.4 EB05 2.4 · IC025 +1.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	age-adj. PRR 2.7 · serious PRR 2.7	no trial arm names this drug
Diarrhoea (diarrhea)	10,274	2.3 2.2–2.3ROR 2.4 · calibrated p 0.864	2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	age-adj. PRR 2.0 · serious PRR 2.5	no trial arm names this drug
Arthralgia (joint pain)	9,922	3.5 3.4–3.5ROR 3.6 · calibrated p 0.452	3.4 EB05 3.3 · IC025 +1.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	age-adj. PRR 3.3 · serious PRR 4.2	no trial arm names this drug
Headache	9,315	2.1 2.1–2.2ROR 2.2 · calibrated p 0.949	2.1 EB05 2.1 · IC025 +1.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	age-adj. PRR 2.1 · serious PRR 2.6	no trial arm names this drug
Dyspnoea (shortness of breath)	7,979	2.0 2.0–2.1ROR 2.1 · calibrated p 0.984	2.0 EB05 2.0 · IC025 +1.0	No label text to screen label has no adverse-reaction text	age-adj. PRR 1.8 · serious PRR 2.1	no trial arm names this drug
Dizziness	7,948	2.3 2.2–2.3ROR 2.4 · calibrated p 0.875	2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	age-adj. PRR 2.0 · serious PRR 2.5	no trial arm names this drug
Asthenia (weakness)	7,162	2.7 2.7–2.8ROR 2.8 · calibrated p 0.686	2.7 EB05 2.7 · IC025 +1.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	age-adj. PRR 2.3 · serious PRR 2.7	no trial arm names this drug
Pain in extremity	7,029	3.4 3.4–3.5ROR 3.6 · calibrated p 0.470	3.4 EB05 3.3 · IC025 +1.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	age-adj. PRR 3.2 · serious PRR 3.8	no trial arm names this drug
Fall	6,671	2.9 2.8–3.0ROR 3.0 · calibrated p 0.634	2.8 EB05 2.8 · IC025 +1.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	age-adj. PRR 2.2 · serious PRR 2.8	no trial arm names this drug
Vomiting	6,638	2.0 2.0–2.1ROR 2.1 · calibrated p 0.983	2.0 EB05 2.0 · IC025 +1.0	No label text to screen label has no adverse-reaction text	age-adj. PRR 2.0 · serious PRR 2.3	no trial arm names this drug
Malaise (feeling unwell)	6,354	2.1 2.0–2.1ROR 2.1 · calibrated p 0.994	2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	age-adj. PRR 2.0 · serious PRR 2.5	no trial arm names this drug

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

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 Calcium?

In FDA FAERS, the most frequently co-reported reaction terms for Calcium are fatigue, nausea, pain, diarrhoea, arthralgia, headache. 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 Calcium have an FDA boxed warning?

No. The FDA label retrieved for Calcium has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Calcium 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 bdee5e24-645b-7fa0-e053-2995a90a7d25, effective 20240220; matched on openfda.generic_name.exact:"CALCIUM")
PubChem CID 5460341 description (ChEBI)
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, field patient.drug.openfda.generic_name.exact, 1,188 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
ClinicalTrials.gov API v2 (query CALCIUM, results-bearing studies sorted by enrollment)

Page generated 2026-10-14. 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.