Drug · FAERS side-effect profile with label screen
Calcium Chloride side effects: what 3,021 FDA adverse event reports show
Drug class
Form of calcium
FDA label, Indications wording
Who reports
3,021 reports · 90% serious · 702 with death outcome · 59% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Calcium chloride injection is indicated for the treatment of adult and pediatric patients with acute symptomatic hypocalcemia. Limitations of Use The safety and effectiveness of calcium chloride injection for long-term use has not been established. Calcium chloride injection is a form of calcium indicated for the treatment of adult and pediatric and patients with acute symptomatic hypocalcemia.
FDA label, Indications and Usage
What it is
10% calcium chloride injection, USP is a sterile, nonpyrogenic, hypertonic solution for single administration only.
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 1Reporting / coding artifact 4Lab value / disease marker 1Not in label — unassessed 34
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. 300 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 |
|---|---|---|---|---|---|---|
| Pemphigus | 218 | 123.8 108.8–140.9ROR 133.4 · χ² 25,986 / p <1e-300 | 120.4 EB05 107.6 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious PRR 77.9 · ♀ 100% (drug 59%) · 99% clinician | no trial data cached |
| Helicobacter infection | 119 | 81.9 68.6–97.8ROR 85.3 · χ² 9,326 / p <1e-300 | 80.0 EB05 68.6 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 54.6 · ♀ 100% (drug 59%) · 98% clinician | no trial data cached |
| Pericarditis | 179 | 75.3 65.3–86.9ROR 80.0 · χ² 12,923 / p <1e-300 | 74.0 EB05 65.3 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 48.0 · ♀ 100% (drug 59%) · 98% clinician | no trial data cached |
| Folliculitis | 101 | 68.5 56.5–83.1ROR 70.8 · χ² 6,588 / p <1e-300 | 67.0 EB05 56.7 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 50.9 · ♀ 100% (drug 59%) · 96% clinician | no trial data cached |
| Hand deformity | 123 | 65.8 55.3–78.4ROR 68.6 · χ² 7,720 / p <1e-300 | 64.6 EB05 55.6 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 45.3 · ♀ 100% (drug 59%) · 99% clinician | no trial data cached |
| Multi-organ failure | 133 | 53.0 44.9–62.6ROR 55.4 · χ² 6,687 / p <1e-300 | 52.2 EB05 45.2 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 33.6 | no trial data cached |
| Liver injury | 178 | 51.4 44.6–59.4ROR 54.6 · χ² 8,700 / p <1e-300 | 50.8 EB05 44.8 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 33.6 · ♀ 100% (drug 59%) · 99% clinician | no trial data cached |
| Prescribed overdose | 138 | 49.8 42.3–58.7ROR 52.2 · χ² 6,513 / p <1e-300 | 49.2 EB05 42.7 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 53.9 · ♀ 100% (drug 59%) · 97% clinician | no trial data cached |
| Autoimmune disorder | 67 | 48.9 38.6–62.0ROR 50.0 · χ² 3,076 / p <1e-300 | 47.9 EB05 39.1 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 33.2 · ♀ 100% (drug 59%) · 99% clinician | no trial data cached |
| Pulmonary fibrosis | 133 | 48.6 41.1–57.4ROR 50.8 · χ² 6,118 / p <1e-300 | 48.0 EB05 41.5 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 31.2 · ♀ 90% (drug 59%) · 94% clinician | no trial data cached |
| Synovitis | 124 | 48.0 40.4–57.1ROR 50.0 · χ² 5,625 / p <1e-300 | 47.3 EB05 40.8 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 31.9 · ♀ 100% (drug 59%) · 98% clinician | no trial data cached |
| Fear | 184 | 47.4 41.2–54.6ROR 50.4 · χ² 8,269 / p <1e-300 | 46.9 EB05 41.5 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 40.9 · ♀ 39% (drug 59%) | no trial data cached |
| Irritable bowel syndrome | 137 | 44.8 38.0–52.8ROR 46.8 · χ² 5,787 / p <1e-300 | 44.2 EB05 38.4 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 35.8 · ♀ 100% (drug 59%) · 97% clinician | no trial data cached |
| Lower limb fracture | 120 | 43.9 36.8–52.3ROR 45.6 · χ² 4,957 / p <1e-300 | 43.3 EB05 37.2 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 30.6 · ♀ 100% (drug 59%) · 94% clinician | no trial data cached |
| Injury | 407 | 40.2 36.7–44.0ROR 46.3 · χ² 15,477 / p <1e-300 | 39.9 EB05 36.7 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 31.6 | no trial data cached |
| Type 2 diabetes mellitus | 191 | 39.5 34.4–45.3ROR 42.1 · χ² 7,092 / p <1e-300 | 39.1 EB05 34.7 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 26.4 · ♀ 100% (drug 59%) · 97% clinician | no trial data cached |
| Renal injury | 168 | 39.0 33.7–45.2ROR 41.3 · χ² 6,164 / p <1e-300 | 38.7 EB05 34.0 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 24.8 · ♀ 37% (drug 59%) | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 83 | 38.4 31.0–47.5ROR 39.5 · χ² 2,971 / p <1e-300 | 37.9 EB05 31.5 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 24.4 · ♀ 38% (drug 59%) | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 116 | 36.2 30.3–43.3ROR 37.6 · χ² 3,917 / p <1e-300 | 35.8 EB05 30.7 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 33.0 · ♀ 100% (drug 59%) · 98% clinician | no trial data cached |
| Anhedonia | 128 | 33.7 28.4–39.9ROR 35.1 · χ² 4,013 / p <1e-300 | 33.4 EB05 28.8 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 23.7 · ♀ 38% (drug 59%) | no trial data cached |
| Sciatica | 75 | 33.0 26.3–41.2ROR 33.8 · χ² 2,283 / p <1e-300 | 32.6 EB05 26.8 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 28.2 · ♀ 100% (drug 59%) · 93% clinician | no trial data cached |
| Psoriatic arthropathy | 180 | 31.2 27.1–36.0ROR 33.1 · χ² 5,216 / p <1e-300 | 31.0 EB05 27.3 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 25.0 · ♀ 97% (drug 59%) · 98% clinician | no trial data cached |
| Fibromyalgia | 107 | 30.7 25.5–37.0ROR 31.8 · χ² 3,035 / p <1e-300 | 30.4 EB05 25.9 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 25.7 · ♀ 100% (drug 59%) · 97% clinician | no trial data cached |
| Prescribed underdose | 86 | 30.0 24.4–37.0ROR 30.9 · χ² 2,377 / p <1e-300 | 29.7 EB05 24.8 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 32.7 · ♀ 100% (drug 59%) · 97% clinician | no trial data cached |
| Wound infection | 44 | 28.2 21.0–37.8ROR 28.6 · χ² 1,123 / p 2e-246 | 27.8 EB05 21.6 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 19.2 · ♀ 100% (drug 59%) · 93% clinician | no trial data cached |
| Contraindicated product administered | 119 | 27.5 23.0–32.8ROR 28.6 · χ² 3,002 / p <1e-300 | 27.3 EB05 23.4 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious PRR 21.4 · ♀ 99% (drug 59%) · 98% clinician | no trial data cached |
| Oedema | 213 | 27.4 24.1–31.2ROR 29.4 · χ² 5,385 / p <1e-300 | 27.2 EB05 24.3 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 21.9 · ♀ 97% (drug 59%) · 98% clinician | no trial data cached |
| Hypercholesterolaemia | 37 | 26.9 19.5–37.1ROR 27.3 · χ² 895 / p 6e-197 | 26.5 EB05 20.1 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 18.2 · ♀ 91% (drug 59%) | no trial data cached |
| Cardiogenic shock | 50 | 24.4 18.5–32.1ROR 24.8 · χ² 1,095 / p 2e-240 | 24.1 EB05 19.0 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 15.2 | no trial data cached |
| Systemic lupus erythematosus | 117 | 23.0 19.3–27.5ROR 23.9 · χ² 2,439 / p <1e-300 | 22.9 EB05 19.6 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 15.0 · ♀ 96% (drug 59%) · 97% clinician | no trial data cached |
| Joint range of motion decreased | 42 | 21.9 16.2–29.5ROR 22.2 · χ² 814 / p 3e-179 | 21.6 EB05 16.6 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 17.7 · ♀ 100% (drug 59%) · 93% clinician | no trial data cached |
| Lower respiratory tract infection | 142 | 21.8 18.6–25.6ROR 22.8 · χ² 2,796 / p <1e-300 | 21.7 EB05 18.9 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 14.7 · ♀ 91% (drug 59%) · 97% clinician | no trial data cached |
| Impaired healing | 102 | 21.6 17.9–26.2ROR 22.3 · χ² 1,982 / p <1e-300 | 21.5 EB05 18.2 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 16.6 · ♀ 100% (drug 59%) · 95% clinician | no trial data cached |
| Blood calcium decreased | 35 | 21.6 15.5–30.0ROR 21.8 · χ² 665 / p 6e-147 | 21.3 EB05 16.0 · IC025 +3.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 16.7 · ♀ 91% (drug 59%) | no trial data cached |
| Bursitis | 37 | 21.3 15.5–29.4ROR 21.6 · χ² 695 / p 2e-153 | 21.1 EB05 15.9 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 16.0 · ♀ 100% (drug 59%) · 100% clinician | no trial data cached |
| Wound | 85 | 21.3 17.2–26.2ROR 21.9 · χ² 1,619 / p <1e-300 | 21.1 EB05 17.6 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 16.1 · ♀ 100% (drug 59%) · 98% clinician | no trial data cached |
| Incorrect route of product administration | 51 | 21.1 16.1–27.7ROR 21.5 · χ² 955 / p 5e-210 | 20.9 EB05 16.5 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 26.9 · 90% clinician | no trial data cached |
| Blood cholesterol increased | 136 | 20.3 17.2–23.9ROR 21.2 · χ² 2,473 / p <1e-300 | 20.2 EB05 17.5 · IC025 +4.0 3/3 methods agree | Lab value / disease marker | serious PRR 19.6 · ♀ 89% (drug 59%) · 95% clinician | no trial data cached |
| Sleep disorder | 199 | 19.8 17.3–22.6ROR 21.1 · χ² 3,533 / p <1e-300 | 19.7 EB05 17.5 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 20.8 · ♀ 90% (drug 59%) · 97% clinician | no trial data cached |
| Therapy non-responder | 122 | 19.0 16.0–22.7ROR 19.8 · χ² 2,066 / p <1e-300 | 18.9 EB05 16.3 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 19.8 · ♀ 94% (drug 59%) · 97% clinician | 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 |
|---|---|---|---|---|---|---|
| Pain | 427 | 4.8 4.4–5.3ROR 5.4 · χ² 1,326 / p 1e-290 | 4.8 EB05 4.4 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
| Injury | 407 | 40.2 36.7–44.0ROR 46.3 · χ² 15,477 / p <1e-300 | 39.9 EB05 36.7 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 31.6 | no trial data cached |
| Anxiety | 291 | 7.1 6.4–7.9ROR 7.7 · χ² 1,534 / p <1e-300 | 7.0 EB05 6.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Renal failure (kidney failure) | 273 | 14.2 12.7–15.9ROR 15.5 · χ² 3,348 / p <1e-300 | 14.1 EB05 12.8 · IC025 +3.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.1 | no trial data cached |
| Pyrexia (fever) | 268 | 5.4 4.8–6.0ROR 5.8 · χ² 965 / p 3e-212 | 5.3 EB05 4.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 · ♀ 81% (drug 59%) · 93% clinician | no trial data cached |
| Hypotension (low blood pressure) | 244 | 8.5 7.5–9.5ROR 9.1 · χ² 1,612 / p <1e-300 | 8.4 EB05 7.5 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.3 · 90% clinician | no trial data cached |
| Pemphigus | 218 | 123.8 108.8–140.9ROR 133.4 · χ² 25,986 / p <1e-300 | 120.4 EB05 107.6 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious PRR 77.9 · ♀ 100% (drug 59%) · 99% clinician | no trial data cached |
| Pneumonia (lung infection) | 217 | 4.7 4.1–5.3ROR 4.9 · χ² 630 / p 3e-139 | 4.6 EB05 4.1 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.1 · 92% clinician | no trial data cached |
| Condition aggravated | 217 | 5.0 4.4–5.7ROR 5.3 · χ² 698 / p 5e-154 | 4.9 EB05 4.4 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 4.8 · 92% clinician | no trial data cached |
| Joint swelling | 214 | 12.3 10.8–14.0ROR 13.2 · χ² 2,229 / p <1e-300 | 12.3 EB05 10.9 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 13.4 · ♀ 99% (drug 59%) · 95% clinician | no trial data cached |
| Oedema | 213 | 27.4 24.1–31.2ROR 29.4 · χ² 5,385 / p <1e-300 | 27.2 EB05 24.3 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 21.9 · ♀ 97% (drug 59%) · 98% clinician | no trial data cached |
| Unevaluable event | 205 | 18.8 16.5–21.5ROR 20.1 · χ² 3,450 / p <1e-300 | 18.8 EB05 16.7 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 21.1 · ♀ 37% (drug 59%) | no trial data cached |
| Pain in extremity | 203 | 4.8 4.2–5.5ROR 5.0 · χ² 610 / p 5e-135 | 4.7 EB05 4.2 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 · ♀ 90% (drug 59%) | no trial data cached |
| Sleep disorder | 199 | 19.8 17.3–22.6ROR 21.1 · χ² 3,533 / p <1e-300 | 19.7 EB05 17.5 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 20.8 · ♀ 90% (drug 59%) · 97% clinician | no trial data cached |
| Urticaria (hives) | 198 | 8.3 7.2–9.5ROR 8.8 · χ² 1,266 / p 2e-277 | 8.1 EB05 7.2 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 · ♀ 82% (drug 59%) · 97% clinician | 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.
- Pemphigus — n=218, PRR 123.8
- Helicobacter infection — n=119, PRR 81.9
- Pericarditis — n=179, PRR 75.3
- Folliculitis — n=101, PRR 68.5
- Hand deformity — n=123, PRR 65.8
- Multi-organ failure — n=133, PRR 53.0
- Liver injury — n=178, PRR 51.4
- Prescribed overdose — n=138, PRR 49.8
- Autoimmune disorder — n=67, PRR 48.9
- Pulmonary fibrosis — n=133, PRR 48.6
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 Chloride?
In FDA FAERS, the most frequently co-reported reaction terms for Calcium Chloride are pain, injury, anxiety, renal failure, pyrexia, hypotension. 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 Chloride have an FDA boxed warning?
No. The FDA label retrieved for Calcium Chloride has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Calcium Chloride 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 5b0bd762-4c87-597e-e063-6394a90a8303, effective 20260909; matched on
openfda.generic_name.exact:"CALCIUM CHLORIDE") - 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, 340 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.