Drug · FAERS side-effect profile with label screen
Magnesium Chloride side effects: what 1,723 FDA adverse event reports show
Drug class
Not stated in label
Who reports
1,723 reports · 76% serious · 265 with death outcome · 62% female
openFDA FAERS counts, all years, deduplication not applied
Used for
As an electrolyte replenisher in magnesium deficiencies.
FDA label, Indications and Usage
What it is
DESCRIPTION Magnesium Chloride Injection is a sterile solution of Magnesium Chloride Hexahydrate in Water for Injection q.s.
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
Reporting / coding artifact 3Lab value / disease marker 2No label text to screen 35
What the badges mean
- 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.
- 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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 90 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 |
|---|---|---|---|---|---|---|
| Hypercholesterolaemia | 44 | 56.2 41.9–75.3ROR 57.6 · χ² 2,320 / p <1e-300 | 54.7 EB05 42.4 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 45.0 · ♀ 97% (drug 62%) · 98% clinician | no trial data cached |
| Helicobacter infection | 39 | 46.7 34.2–63.7ROR 47.8 · χ² 1,693 / p <1e-300 | 45.6 EB05 34.8 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 37.2 · ♀ 100% (drug 62%) · 100% clinician | no trial data cached |
| Pemphigus | 46 | 45.2 33.9–60.1ROR 46.4 · χ² 1,936 / p <1e-300 | 44.2 EB05 34.5 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 34.2 · ♀ 100% (drug 62%) · 98% clinician | no trial data cached |
| Folliculitis | 38 | 44.9 32.8–61.5ROR 45.9 · χ² 1,582 / p <1e-300 | 43.8 EB05 33.3 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 39.8 · ♀ 100% (drug 62%) · 95% clinician | no trial data cached |
| Joint range of motion decreased | 47 | 42.9 32.4–56.9ROR 44.1 · χ² 1,877 / p <1e-300 | 42.1 EB05 32.9 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 40.4 · ♀ 95% (drug 62%) | no trial data cached |
| Back injury | 36 | 40.6 29.3–56.1ROR 41.4 · χ² 1,346 / p 5e-295 | 39.7 EB05 29.9 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 40.5 · ♀ 97% (drug 62%) | no trial data cached |
| Hand deformity | 43 | 40.1 29.8–53.9ROR 41.1 · χ² 1,596 / p <1e-300 | 39.3 EB05 30.4 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.9 · ♀ 100% (drug 62%) · 98% clinician | no trial data cached |
| Bursitis | 38 | 38.4 28.0–52.6ROR 39.3 · χ² 1,344 / p 1e-294 | 37.6 EB05 28.6 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 34.1 · ♀ 97% (drug 62%) · 95% clinician | no trial data cached |
| Synovitis | 56 | 37.9 29.2–49.0ROR 39.1 · χ² 1,968 / p <1e-300 | 37.3 EB05 29.8 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 29.4 · ♀ 98% (drug 62%) · 96% clinician | no trial data cached |
| Pericarditis | 49 | 35.9 27.2–47.3ROR 36.9 · χ² 1,622 / p <1e-300 | 35.3 EB05 27.8 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 27.3 · ♀ 100% (drug 62%) · 96% clinician | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 60 | 32.7 25.5–42.0ROR 33.9 · χ² 1,811 / p <1e-300 | 32.3 EB05 26.0 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 35.8 · ♀ 100% (drug 62%) · 95% clinician | no trial data cached |
| Taste disorder | 53 | 32.2 24.7–42.1ROR 33.2 · χ² 1,571 / p <1e-300 | 31.8 EB05 25.3 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 47.1 · ♀ 87% (drug 62%) | no trial data cached |
| Irritable bowel syndrome | 54 | 30.8 23.7–40.1ROR 31.8 · χ² 1,526 / p <1e-300 | 30.4 EB05 24.2 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 29.0 · ♀ 100% (drug 62%) · 91% clinician | no trial data cached |
| Red blood cell sedimentation rate increased | 26 | 28.6 19.5–41.9ROR 29.0 · χ² 663 / p 1e-146 | 28.0 EB05 20.1 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious PRR 24.5 · ♀ 100% (drug 62%) · 96% clinician | no trial data cached |
| Wound infection | 24 | 26.9 18.1–40.1ROR 27.3 · χ² 572 / p 9e-127 | 26.4 EB05 18.6 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 21.8 · ♀ 91% (drug 62%) · 100% clinician | no trial data cached |
| Obesity | 33 | 25.2 18.0–35.3ROR 25.7 · χ² 742 / p 1e-163 | 24.8 EB05 18.5 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.1 · ♀ 97% (drug 62%) · 97% clinician | no trial data cached |
| Liver injury | 43 | 21.7 16.1–29.1ROR 22.2 · χ² 826 / p 5e-182 | 21.4 EB05 16.6 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.0 · ♀ 90% (drug 62%) · 91% clinician | no trial data cached |
| Wound | 47 | 20.6 15.5–27.3ROR 21.1 · χ² 856 / p 2e-188 | 20.4 EB05 15.9 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.5 · ♀ 100% (drug 62%) · 91% clinician | no trial data cached |
| Impaired healing | 52 | 19.3 14.8–25.2ROR 19.9 · χ² 883 / p 2e-194 | 19.1 EB05 15.1 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 17.6 · ♀ 100% (drug 62%) · 90% clinician | no trial data cached |
| Laryngitis | 16 | 17.9 11.0–29.2ROR 18.1 · χ² 239 / p 3e-54 | 17.3 EB05 10.9 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=15 | no trial data cached |
| Night sweats | 46 | 17.4 13.1–23.1ROR 17.8 · χ² 695 / p 2e-153 | 17.2 EB05 13.4 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 21.6 · ♀ 98% (drug 62%) | no trial data cached |
| Contraindicated product administered | 42 | 17.0 12.6–22.9ROR 17.4 · χ² 615 / p 5e-136 | 16.8 EB05 12.9 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 15.6 · ♀ 97% (drug 62%) | no trial data cached |
| Type 2 diabetes mellitus | 46 | 16.6 12.5–22.1ROR 17.0 · χ² 658 / p 2e-145 | 16.4 EB05 12.7 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.9 · ♀ 95% (drug 62%) · 91% clinician | no trial data cached |
| Psoriatic arthropathy | 54 | 16.4 12.6–21.3ROR 16.8 · χ² 763 / p 2e-168 | 16.2 EB05 12.8 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.6 · ♀ 100% (drug 62%) · 96% clinician | no trial data cached |
| C-reactive protein increased | 47 | 15.7 11.9–20.9ROR 16.2 · χ² 634 / p 3e-140 | 15.6 EB05 12.1 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | serious PRR 12.4 · ♀ 98% (drug 62%) · 94% clinician | no trial data cached |
| Autoimmune disorder | 12 | 15.3 8.7–26.8ROR 15.4 · χ² 146 / p 7e-34 | 14.0 EB05 7.6 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.3 | no trial data cached |
| Systemic lupus erythematosus | 44 | 15.1 11.3–20.3ROR 15.5 · χ² 567 / p 1e-125 | 14.9 EB05 11.5 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.8 · ♀ 100% (drug 62%) · 100% clinician | no trial data cached |
| Fibromyalgia | 29 | 14.5 10.1–20.9ROR 14.8 · χ² 352 / p 7e-79 | 14.2 EB05 10.1 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.0 · ♀ 100% (drug 62%) | no trial data cached |
| Eructation (belching) | 22 | 14.1 9.3–21.3ROR 14.3 · χ² 254 / p 1e-57 | 13.5 EB05 9.0 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=21 | no trial data cached |
| Hypomagnesaemia | 16 | 14.0 8.6–22.9ROR 14.2 · χ² 181 / p 2e-41 | 13.1 EB05 7.9 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.3 | no trial data cached |
| Frequent bowel movements | 30 | 13.6 9.5–19.4ROR 13.8 · χ² 337 / p 1e-75 | 13.2 EB05 9.4 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.8 · ♀ 89% (drug 62%) · 90% clinician | no trial data cached |
| Osteoarthritis | 47 | 13.5 10.2–17.9ROR 13.8 · χ² 531 / p 1e-117 | 13.2 EB05 10.2 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.4 · ♀ 100% (drug 62%) · 93% clinician | no trial data cached |
| Infusion related reaction (reaction during infusion) | 72 | 13.3 10.6–16.6ROR 13.8 · χ² 806 / p 1e-177 | 13.1 EB05 10.7 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.5 · ♀ 95% (drug 62%) · 96% clinician | no trial data cached |
| Epilepsy | 32 | 12.8 9.1–18.0ROR 13.0 · χ² 335 / p 3e-75 | 12.3 EB05 8.9 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.7 · ♀ 96% (drug 62%) · 97% clinician | no trial data cached |
| Liver function test increased | 22 | 12.6 8.3–19.0ROR 12.7 · χ² 223 / p 1e-50 | 11.8 EB05 7.8 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.8 · 91% clinician | no trial data cached |
| Musculoskeletal pain | 53 | 12.2 9.4–15.9ROR 12.6 · χ² 535 / p 9e-119 | 12.0 EB05 9.4 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.2 · ♀ 96% (drug 62%) · 96% clinician | no trial data cached |
| Lung disorder | 49 | 12.2 9.2–16.1ROR 12.5 · χ² 493 / p 2e-109 | 11.9 EB05 9.2 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.2 · ♀ 98% (drug 62%) · 92% clinician | no trial data cached |
| Mucosal inflammation | 25 | 11.7 7.9–17.2ROR 11.8 · χ² 234 / p 5e-53 | 11.0 EB05 7.5 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.0 · 92% clinician | no trial data cached |
| Sciatica | 15 | 11.5 7.0–19.1ROR 11.6 · χ² 134 / p 3e-31 | 10.2 EB05 6.0 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.9 | no trial data cached |
| Maternal exposure during pregnancy | 81 | 11.2 9.0–13.8ROR 11.7 · χ² 743 / p 7e-164 | 11.0 EB05 9.0 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 10.8 · ♀ 100% (drug 62%) · 95% 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 |
|---|---|---|---|---|---|---|
| Muscle spasms | 85 | 5.6 4.6–6.9ROR 5.9 · χ² 322 / p 3e-72 | 5.5 EB05 4.6 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.6 · ♀ 89% (drug 62%) | no trial data cached |
| Maternal exposure during pregnancy | 81 | 11.2 9.0–13.8ROR 11.7 · χ² 743 / p 7e-164 | 11.0 EB05 9.0 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 10.8 · ♀ 100% (drug 62%) · 95% clinician | no trial data cached |
| Memory impairment | 72 | 6.4 5.1–8.0ROR 6.6 · χ² 322 / p 2e-72 | 6.1 EB05 5.0 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.0 · ♀ 94% (drug 62%) | no trial data cached |
| Infusion related reaction (reaction during infusion) | 72 | 13.3 10.6–16.6ROR 13.8 · χ² 806 / p 1e-177 | 13.1 EB05 10.7 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.5 · ♀ 95% (drug 62%) · 96% clinician | no trial data cached |
| Dyspepsia (indigestion) | 63 | 7.8 6.1–10.0ROR 8.1 · χ² 369 / p 1e-82 | 7.5 EB05 6.0 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.4 | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 60 | 32.7 25.5–42.0ROR 33.9 · χ² 1,811 / p <1e-300 | 32.3 EB05 26.0 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 35.8 · ♀ 100% (drug 62%) · 95% clinician | no trial data cached |
| Joint swelling | 59 | 6.0 4.6–7.7ROR 6.1 · χ² 240 / p 2e-54 | 5.7 EB05 4.6 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.3 · ♀ 89% (drug 62%) | no trial data cached |
| Rheumatoid arthritis | 56 | 6.0 4.7–7.8ROR 6.2 · χ² 231 / p 2e-52 | 5.8 EB05 4.6 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.6 · ♀ 96% (drug 62%) · 91% clinician | no trial data cached |
| Synovitis | 56 | 37.9 29.2–49.0ROR 39.1 · χ² 1,968 / p <1e-300 | 37.3 EB05 29.8 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 29.4 · ♀ 98% (drug 62%) · 96% clinician | no trial data cached |
| Migraine | 55 | 7.1 5.4–9.2ROR 7.3 · χ² 281 / p 2e-63 | 6.7 EB05 5.3 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.5 · ♀ 96% (drug 62%) | no trial data cached |
| Swelling | 55 | 7.2 5.5–9.3ROR 7.4 · χ² 287 / p 1e-64 | 6.8 EB05 5.4 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.5 · ♀ 94% (drug 62%) | no trial data cached |
| Psoriatic arthropathy | 54 | 16.4 12.6–21.3ROR 16.8 · χ² 763 / p 2e-168 | 16.2 EB05 12.8 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.6 · ♀ 100% (drug 62%) · 96% clinician | no trial data cached |
| Irritable bowel syndrome | 54 | 30.8 23.7–40.1ROR 31.8 · χ² 1,526 / p <1e-300 | 30.4 EB05 24.2 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 29.0 · ♀ 100% (drug 62%) · 91% clinician | no trial data cached |
| Hepatic enzyme increased | 53 | 9.5 7.3–12.4ROR 9.8 · χ² 395 / p 3e-88 | 9.1 EB05 7.1 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious PRR 10.2 · ♀ 100% (drug 62%) · 92% clinician | no trial data cached |
| Musculoskeletal pain | 53 | 12.2 9.4–15.9ROR 12.6 · χ² 535 / p 9e-119 | 12.0 EB05 9.4 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.2 · ♀ 96% (drug 62%) · 96% clinician | no trial data cached |
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 Magnesium Chloride?
In FDA FAERS, the most frequently co-reported reaction terms for Magnesium Chloride are muscle spasms, memory impairment, infusion related reaction, dyspepsia, glossodynia, joint swelling. 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 Magnesium Chloride have an FDA boxed warning?
No. The FDA label retrieved for Magnesium Chloride has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Magnesium 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 2105d1c1-54ef-4d1a-a63c-b1619e8b50db, effective 20211015; matched on
openfda.generic_name.exact:"MAGNESIUM CHLORIDE" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - 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, 130 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.