Drug · FAERS side-effect profile with label screen
Magnesium Carbonate side effects: what 1,167 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Magnesium Carbonate (Humco Dewees Carminative)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
1,167 reports · 83% serious · 281 with death outcome · 65% female
openFDA FAERS counts, all years, deduplication not applied
Used for
For the temporary relief of upset stomach or sour stomach, and acid indigestion.
FDA label, Indications and Usage
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 2Lab value / disease marker 2No label text to screen 36
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. 124 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 |
|---|---|---|---|---|---|---|
| Vaginal discharge | 92 | 166.1 136.4–202.3ROR 180.2 · χ² 14,800 / p <1e-300 | 159.2 EB05 133.7 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=92 · ♀ 100% (drug 65%) | no trial data cached |
| Macular degeneration | 98 | 149.0 123.2–180.2ROR 162.5 · χ² 14,147 / p <1e-300 | 143.7 EB05 121.3 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 110.8 · ♀ 100% (drug 65%) | no trial data cached |
| Oral candidiasis (oral thrush) | 93 | 129.4 106.4–157.3ROR 140.5 · χ² 11,639 / p <1e-300 | 125.2 EB05 105.2 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 125.0 · ♀ 100% (drug 65%) | no trial data cached |
| Paraesthesia oral | 95 | 119.6 98.5–145.1ROR 130.1 · χ² 10,984 / p <1e-300 | 116.0 EB05 97.7 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 147.4 · ♀ 100% (drug 65%) | no trial data cached |
| Hypercholesterolaemia | 60 | 113.4 88.5–145.2ROR 119.5 · χ² 6,533 / p <1e-300 | 108.8 EB05 87.6 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 83.2 · 95% clinician | no trial data cached |
| Appendicitis | 58 | 112.8 87.7–145.1ROR 118.7 · χ² 6,279 / p <1e-300 | 108.2 EB05 86.8 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 79.0 · ♀ 0% (drug 65%) · 98% clinician | no trial data cached |
| Ventricular fibrillation | 59 | 95.7 74.6–122.8ROR 100.7 · χ² 5,407 / p <1e-300 | 92.4 EB05 74.3 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 66.2 · ♀ 0% (drug 65%) · 97% clinician | no trial data cached |
| Incorrect route of product administration | 81 | 87.0 70.5–107.4ROR 93.4 · χ² 6,774 / p <1e-300 | 84.9 EB05 70.5 · IC025 +5.5 3/3 methods agree | Reporting / coding artifact | serious PRR 120.2 · ♀ 23% (drug 65%) · 95% clinician | no trial data cached |
| Wound infection | 51 | 84.7 64.7–110.8ROR 88.5 · χ² 4,117 / p <1e-300 | 81.8 EB05 64.6 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 62.8 · ♀ 98% (drug 65%) · 96% clinician | no trial data cached |
| Helicobacter infection | 41 | 72.5 53.7–98.1ROR 75.1 · χ² 2,812 / p <1e-300 | 70.0 EB05 53.8 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 53.1 · ♀ 100% (drug 65%) · 93% clinician | no trial data cached |
| Folliculitis | 39 | 68.1 50.0–92.8ROR 70.4 · χ² 2,503 / p <1e-300 | 65.7 EB05 50.2 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 55.4 · ♀ 100% (drug 65%) · 92% clinician | no trial data cached |
| Synovitis | 68 | 67.9 53.9–85.6ROR 72.1 · χ² 4,406 / p <1e-300 | 66.5 EB05 54.2 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 49.3 · ♀ 100% (drug 65%) · 96% clinician | no trial data cached |
| Hyperlipidaemia | 45 | 67.7 50.8–90.2ROR 70.4 · χ² 2,882 / p <1e-300 | 65.7 EB05 51.1 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 51.6 · ♀ 2% (drug 65%) · 96% clinician | no trial data cached |
| Frequent bowel movements | 100 | 67.0 55.6–80.9ROR 73.2 · χ² 6,423 / p <1e-300 | 66.0 EB05 55.8 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 71.6 · ♀ 97% (drug 65%) | no trial data cached |
| Pemphigus | 46 | 66.7 50.2–88.6ROR 69.4 · χ² 2,903 / p <1e-300 | 64.8 EB05 50.5 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 46.3 · ♀ 100% (drug 65%) · 96% clinician | no trial data cached |
| Joint range of motion decreased | 49 | 66.1 50.2–87.0ROR 69.0 · χ² 3,068 / p <1e-300 | 64.3 EB05 50.5 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 58.3 · ♀ 100% (drug 65%) · 92% clinician | no trial data cached |
| Cardiogenic shock | 52 | 65.7 50.4–85.8ROR 68.7 · χ² 3,240 / p <1e-300 | 64.0 EB05 50.7 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 45.4 · ♀ 0% (drug 65%) · 98% clinician | no trial data cached |
| Bacterial infection | 66 | 64.1 50.7–81.0ROR 67.9 · χ² 4,024 / p <1e-300 | 62.7 EB05 51.0 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 51.2 · ♀ 0% (drug 65%) · 97% clinician | no trial data cached |
| Hand deformity | 43 | 59.2 44.2–79.5ROR 61.5 · χ² 2,398 / p <1e-300 | 57.6 EB05 44.6 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 44.6 · ♀ 100% (drug 65%) · 93% clinician | no trial data cached |
| Taste disorder | 64 | 57.6 45.3–73.1ROR 60.8 · χ² 3,493 / p <1e-300 | 56.5 EB05 45.8 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 80.1 · ♀ 100% (drug 65%) · 92% clinician | no trial data cached |
| Neuralgia | 74 | 55.0 44.1–68.6ROR 58.6 · χ² 3,861 / p <1e-300 | 54.1 EB05 44.5 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 55.8 · ♀ 8% (drug 65%) · 96% clinician | no trial data cached |
| Blood test abnormal | 42 | 53.9 40.0–72.6ROR 55.9 · χ² 2,123 / p <1e-300 | 52.5 EB05 40.5 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | serious PRR 55.8 · ♀ 8% (drug 65%) · 95% clinician | no trial data cached |
| Aspiration | 32 | 53.2 37.8–74.9ROR 54.7 · χ² 1,584 / p <1e-300 | 51.5 EB05 38.2 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 37.9 · ♀ 7% (drug 65%) · 100% clinician | no trial data cached |
| Pericarditis | 49 | 53.0 40.3–69.7ROR 55.3 · χ² 2,442 / p <1e-300 | 51.8 EB05 40.7 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 37.0 · ♀ 100% (drug 65%) · 96% clinician | no trial data cached |
| Ulcer | 46 | 52.0 39.2–69.1ROR 54.1 · χ² 2,246 / p <1e-300 | 50.8 EB05 39.7 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 45.5 · ♀ 5% (drug 65%) · 98% clinician | no trial data cached |
| Procedural pain | 78 | 50.8 41.0–63.0ROR 54.4 · χ² 3,754 / p <1e-300 | 50.1 EB05 41.4 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 60.7 · ♀ 100% (drug 65%) | no trial data cached |
| Sciatica | 43 | 48.8 36.4–65.5ROR 50.7 · χ² 1,964 / p <1e-300 | 47.7 EB05 36.9 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 45.5 · ♀ 90% (drug 65%) · 95% clinician | no trial data cached |
| Colitis | 102 | 48.8 40.5–58.7ROR 53.4 · χ² 4,722 / p <1e-300 | 48.2 EB05 40.9 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 36.4 · ♀ 97% (drug 65%) | no trial data cached |
| Gout | 48 | 48.1 36.5–63.5ROR 50.2 · χ² 2,164 / p <1e-300 | 47.2 EB05 37.0 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 50.4 · ♀ 0% (drug 65%) · 98% clinician | no trial data cached |
| End stage renal disease | 49 | 47.9 36.4–63.1ROR 50.0 · χ² 2,201 / p <1e-300 | 47.0 EB05 36.9 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 33.2 · ♀ 0% (drug 65%) · 98% clinician | no trial data cached |
| Full blood count abnormal | 28 | 47.8 33.2–69.0ROR 49.0 · χ² 1,235 / p 8e-271 | 46.3 EB05 33.6 · IC025 +4.1 3/3 methods agree | Lab value / disease marker | serious PRR 44.0 · ♀ 0% (drug 65%) · 100% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 74 | 47.8 38.3–59.6ROR 50.9 · χ² 3,338 / p <1e-300 | 47.1 EB05 38.8 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 33.1 · ♀ 0% (drug 65%) · 99% clinician | no trial data cached |
| Micturition urgency | 29 | 46.1 32.1–66.0ROR 47.2 · χ² 1,232 / p 4e-270 | 44.7 EB05 32.6 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 51.0 · ♀ 8% (drug 65%) · 93% clinician | no trial data cached |
| Bursitis | 30 | 44.8 31.4–63.8ROR 45.9 · χ² 1,238 / p 1e-271 | 43.5 EB05 32.0 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 36.5 · ♀ 100% (drug 65%) | no trial data cached |
| Epilepsy | 74 | 43.7 35.0–54.5ROR 46.6 · χ² 3,040 / p <1e-300 | 43.1 EB05 35.5 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 30.4 · ♀ 100% (drug 65%) · 92% clinician | no trial data cached |
| Rectal haemorrhage | 102 | 42.6 35.4–51.3ROR 46.6 · χ² 4,101 / p <1e-300 | 42.2 EB05 35.8 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 31.6 · ♀ 97% (drug 65%) · 90% clinician | no trial data cached |
| Colitis ulcerative | 102 | 41.2 34.2–49.6ROR 45.0 · χ² 3,958 / p <1e-300 | 40.8 EB05 34.6 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 30.7 · ♀ 96% (drug 65%) | no trial data cached |
| Prescribed overdose | 43 | 40.0 29.8–53.7ROR 41.5 · χ² 1,595 / 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 45.1 · ♀ 100% (drug 65%) · 93% clinician | no trial data cached |
| Lower limb fracture | 40 | 37.7 27.8–51.2ROR 39.0 · χ² 1,391 / p <1e-300 | 37.0 EB05 28.4 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 27.3 · ♀ 100% (drug 65%) · 95% clinician | no trial data cached |
| Blood cholesterol increased | 95 | 36.7 30.2–44.5ROR 39.8 · χ² 3,261 / p <1e-300 | 36.4 EB05 30.6 · IC025 +4.6 3/3 methods agree | Lab value / disease marker | serious PRR 38.6 · ♀ 41% (drug 65%) · 96% 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 |
|---|---|---|---|---|---|---|
| Abdominal pain | 187 | 14.5 12.7–16.5ROR 17.0 · χ² 2,354 / p <1e-300 | 14.4 EB05 12.8 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.3 · 91% clinician | no trial data cached |
| Anaemia (low red blood cells) | 186 | 17.5 15.4–20.0ROR 20.7 · χ² 2,906 / p <1e-300 | 17.5 EB05 15.5 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.4 | no trial data cached |
| Constipation | 167 | 13.9 12.1–16.0ROR 16.0 · χ² 2,002 / p <1e-300 | 13.8 EB05 12.1 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.5 | no trial data cached |
| Drug intolerance | 156 | 29.2 25.2–33.8ROR 33.5 · χ² 4,228 / p <1e-300 | 29.0 EB05 25.4 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | serious PRR 32.8 · 94% clinician | no trial data cached |
| Swelling | 139 | 26.8 22.9–31.3ROR 30.3 · χ² 3,434 / p <1e-300 | 26.7 EB05 23.1 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 29.7 · 93% clinician | no trial data cached |
| Infusion related reaction (reaction during infusion) | 133 | 36.2 30.9–42.5ROR 40.8 · χ² 4,529 / p <1e-300 | 36.0 EB05 31.2 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 31.7 · ♀ 99% (drug 65%) | no trial data cached |
| Drug hypersensitivity | 124 | 11.5 9.7–13.6ROR 12.7 · χ² 1,186 / p 3e-260 | 11.4 EB05 9.7 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 21.7 · 94% clinician | no trial data cached |
| General physical health deterioration | 124 | 19.4 16.4–22.9ROR 21.6 · χ² 2,157 / p <1e-300 | 19.3 EB05 16.6 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 15.8 · ♀ 35% (drug 65%) · 97% clinician | no trial data cached |
| Therapeutic product effect incomplete | 122 | 31.1 26.2–36.7ROR 34.6 · χ² 3,524 / p <1e-300 | 30.9 EB05 26.5 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | serious PRR 40.5 · ♀ 100% (drug 65%) · 90% clinician | no trial data cached |
| Sleep disorder | 118 | 30.4 25.6–36.0ROR 33.7 · χ² 3,325 / p <1e-300 | 30.2 EB05 25.9 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 33.6 · 97% clinician | no trial data cached |
| Product use in unapproved indication | 113 | 8.3 7.0–9.9ROR 9.1 · χ² 728 / p 1e-160 | 8.1 EB05 6.9 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 12.6 · 95% clinician | no trial data cached |
| Somnolence (drowsiness) | 113 | 10.1 8.5–12.0ROR 11.1 · χ² 926 / p 9e-204 | 9.9 EB05 8.5 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.7 · ♀ 23% (drug 65%) | no trial data cached |
| Dyspepsia (indigestion) | 110 | 20.2 16.9–24.1ROR 22.2 · χ² 1,992 / p <1e-300 | 20.1 EB05 17.1 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.6 · ♀ 98% (drug 65%) | no trial data cached |
| Dry mouth | 105 | 23.3 19.4–28.0ROR 25.5 · χ² 2,227 / p <1e-300 | 23.2 EB05 19.7 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 31.5 · 94% clinician | no trial data cached |
| Erythema (skin redness) | 104 | 9.1 7.6–10.9ROR 9.9 · χ² 749 / p 3e-165 | 8.9 EB05 7.5 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.4 · ♀ 97% (drug 65%) | 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 Carbonate?
In FDA FAERS, the most frequently co-reported reaction terms for Carbonate are abdominal pain, anaemia, constipation, swelling, infusion related reaction, drug hypersensitivity. 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 Carbonate have an FDA boxed warning?
No. The FDA label retrieved for Carbonate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Carbonate 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 163bceeb-ca74-413e-88b9-5c7bc9bbeb0d, effective 20231215; matched on
openfda.generic_name.exact:"MAGNESIUM CARBONATE") - 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, 164 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.