Drug · FAERS side-effect profile with label screen
Carbonate and Hydroxide side effects: what 2,943 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Calcium Carbonate, Magnesium Hydroxide (Supreme Antacid)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
2,943 reports · 91% serious · 273 with death outcome · 58% female
openFDA FAERS counts, all years, deduplication not applied
Used for
relieves heartburn sour stomach acid indigestion upset stomache due to these symptoms
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 1Lab value / disease marker 1No label text to screen 38
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. 61 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 |
|---|---|---|---|---|---|---|
| End stage renal disease | 576 | 230.1 213.5–247.9ROR 285.8 · χ² 127,088 / p <1e-300 | 221.2 EB05 206.4 · IC025 +7.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 140.4 · 74% consumer | no trial data cached |
| Chronic kidney disease | 1,897 | 180.8 175.9–185.9ROR 507.0 · χ² 331,799 / p <1e-300 | 176.0 EB05 169.5 · IC025 +7.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 113.0 | no trial data cached |
| Renal injury | 430 | 103.5 94.8–113.1ROR 121.1 · χ² 42,993 / p <1e-300 | 101.6 EB05 93.8 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 64.5 | no trial data cached |
| Multiple fractures | 161 | 69.9 60.1–81.3ROR 73.9 · χ² 10,765 / p <1e-300 | 68.7 EB05 60.2 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 40.7 | no trial data cached |
| Tubulointerstitial nephritis | 175 | 67.2 58.2–77.6ROR 71.4 · χ² 11,248 / p <1e-300 | 66.1 EB05 58.3 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 42.1 | no trial data cached |
| Vitamin d deficiency | 87 | 64.2 52.1–79.0ROR 66.1 · χ² 5,300 / p <1e-300 | 62.8 EB05 52.4 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 45.1 · ♀ 82% (drug 58%) | no trial data cached |
| Renal failure (kidney failure) | 1,019 | 54.7 52.0–57.5ROR 83.1 · χ² 53,581 / p <1e-300 | 54.2 EB05 51.5 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 34.5 | no trial data cached |
| Bone disorder | 137 | 53.5 45.4–63.1ROR 56.1 · χ² 6,961 / p <1e-300 | 52.7 EB05 45.7 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 39.0 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 1,087 | 51.2 48.8–53.7ROR 80.6 · χ² 53,469 / p <1e-300 | 50.8 EB05 48.3 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.1 | no trial data cached |
| Osteoporosis | 283 | 49.3 44.1–55.1ROR 54.4 · χ² 13,275 / p <1e-300 | 48.8 EB05 44.2 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.8 | no trial data cached |
| Nephropathy | 56 | 42.8 33.0–55.5ROR 43.6 · χ² 2,230 / p <1e-300 | 42.0 EB05 33.5 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 28.6 | no trial data cached |
| Intervertebral disc degeneration | 50 | 38.5 29.2–50.7ROR 39.1 · χ² 1,779 / p <1e-300 | 37.8 EB05 29.8 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 27.1 | no trial data cached |
| Renal tubular necrosis | 52 | 37.9 28.9–49.6ROR 38.5 · χ² 1,821 / p <1e-300 | 37.2 EB05 29.5 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 23.9 | no trial data cached |
| Gastrooesophageal reflux disease (acid reflux) | 382 | 34.1 31.0–37.5ROR 39.0 · χ² 12,228 / p <1e-300 | 33.9 EB05 31.1 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.8 · 73% consumer | no trial data cached |
| Osteopenia | 67 | 31.4 24.8–39.8ROR 32.1 · χ² 1,936 / p <1e-300 | 31.0 EB05 25.3 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 21.2 · ♀ 81% (drug 58%) | no trial data cached |
| Foot fracture | 70 | 26.3 20.9–33.2ROR 26.9 · χ² 1,675 / p <1e-300 | 26.1 EB05 21.3 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.6 · ♀ 84% (drug 58%) | no trial data cached |
| Ankle fracture | 52 | 24.0 18.3–31.4ROR 24.4 · χ² 1,119 / p 1e-245 | 23.7 EB05 18.8 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.1 · ♀ 83% (drug 58%) | no trial data cached |
| Wrist fracture | 34 | 20.3 14.5–28.3ROR 20.5 · χ² 602 / p 3e-133 | 20.0 EB05 14.9 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.0 · ♀ 91% (drug 58%) | no trial data cached |
| Arthritis | 174 | 15.8 13.6–18.2ROR 16.7 · χ² 2,396 / p <1e-300 | 15.7 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 | no trial data cached |
| Osteoarthritis | 82 | 13.8 11.1–17.1ROR 14.1 · χ² 959 / p 7e-211 | 13.6 EB05 11.3 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.4 | no trial data cached |
| Bipolar disorder | 21 | 13.7 8.9–21.0ROR 13.8 · χ² 234 / p 4e-53 | 13.0 EB05 8.5 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.9 · ♀ 100% (drug 58%) | no trial data cached |
| Back disorder | 31 | 13.6 9.5–19.2ROR 13.7 · χ² 348 / p 7e-78 | 13.1 EB05 9.5 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.9 | no trial data cached |
| Carpal tunnel syndrome | 25 | 12.7 8.6–18.8ROR 12.8 · χ² 258 / p 3e-58 | 12.1 EB05 8.3 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.9 · ♀ 92% (drug 58%) | no trial data cached |
| Intervertebral disc protrusion | 39 | 12.7 9.3–17.3ROR 12.9 · χ² 408 / p 4e-91 | 12.3 EB05 9.2 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.9 | no trial data cached |
| Back injury | 19 | 12.5 8.0–19.6ROR 12.6 · χ² 190 / p 2e-43 | 11.6 EB05 7.4 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.4 | no trial data cached |
| Lower limb fracture | 33 | 12.3 8.8–17.3ROR 12.5 · χ² 332 / p 2e-74 | 11.9 EB05 8.6 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.8 · ♀ 88% (drug 58%) | no trial data cached |
| Spinal disorder | 16 | 12.0 7.4–19.6ROR 12.1 · χ² 151 / p 6e-35 | 10.9 EB05 6.5 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.8 | no trial data cached |
| Upper limb fracture | 33 | 11.8 8.4–16.5ROR 11.9 · χ² 314 / p 1e-70 | 11.3 EB05 8.2 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.5 | no trial data cached |
| Ligament sprain | 16 | 11.6 7.1–18.9ROR 11.6 · χ² 144 / p 2e-33 | 10.4 EB05 6.3 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=14 | no trial data cached |
| Gallbladder disorder | 27 | 10.8 7.4–15.7ROR 10.8 · χ² 229 / p 5e-52 | 10.0 EB05 7.0 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.2 · ♀ 89% (drug 58%) | no trial data cached |
| Bone density decreased | 47 | 10.6 8.0–14.1ROR 10.7 · χ² 398 / p 6e-89 | 10.2 EB05 7.8 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious PRR 8.0 | no trial data cached |
| Rib fracture | 30 | 10.4 7.3–14.9ROR 10.5 · χ² 246 / p 9e-56 | 9.8 EB05 6.9 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.2 | no trial data cached |
| Product odour abnormal | 15 | 10.3 6.2–17.1ROR 10.4 · χ² 117 / p 2e-27 | 8.9 EB05 5.4 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious n=10 | no trial data cached |
| Joint dislocation | 14 | 9.5 5.6–16.0ROR 9.5 · χ² 98 / p 2e-23 | 8.0 EB05 4.8 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.7 | no trial data cached |
| Glaucoma | 24 | 8.9 6.0–13.2ROR 8.9 · χ² 160 / p 5e-37 | 8.0 EB05 5.5 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.8 | no trial data cached |
| Dyspepsia (indigestion) | 117 | 8.5 7.1–10.2ROR 8.8 · χ² 770 / p 8e-170 | 8.3 EB05 7.1 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.3 · 83% consumer | no trial data cached |
| Spinal fracture | 22 | 7.9 5.2–11.9ROR 7.9 · χ² 125 / p 2e-29 | 7.0 EB05 4.8 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.2 | no trial data cached |
| Joint injury | 23 | 7.7 5.1–11.5ROR 7.7 · χ² 127 / p 1e-29 | 6.8 EB05 4.7 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.7 | no trial data cached |
| Angina pectoris | 30 | 7.4 5.2–10.6ROR 7.5 · χ² 160 / p 5e-37 | 6.8 EB05 4.9 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.7 | no trial data cached |
| Chronic obstructive pulmonary disease | 51 | 7.0 5.3–9.2ROR 7.1 · χ² 255 / p 8e-58 | 6.6 EB05 5.2 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.0 | 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 |
|---|---|---|---|---|---|---|
| Chronic kidney disease | 1,897 | 180.8 175.9–185.9ROR 507.0 · χ² 331,799 / p <1e-300 | 176.0 EB05 169.5 · IC025 +7.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 113.0 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 1,087 | 51.2 48.8–53.7ROR 80.6 · χ² 53,469 / p <1e-300 | 50.8 EB05 48.3 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.1 | no trial data cached |
| Renal failure (kidney failure) | 1,019 | 54.7 52.0–57.5ROR 83.1 · χ² 53,581 / p <1e-300 | 54.2 EB05 51.5 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 34.5 | no trial data cached |
| End stage renal disease | 576 | 230.1 213.5–247.9ROR 285.8 · χ² 127,088 / p <1e-300 | 221.2 EB05 206.4 · IC025 +7.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 140.4 · 74% consumer | no trial data cached |
| Renal injury | 430 | 103.5 94.8–113.1ROR 121.1 · χ² 42,993 / p <1e-300 | 101.6 EB05 93.8 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 64.5 | no trial data cached |
| Gastrooesophageal reflux disease (acid reflux) | 382 | 34.1 31.0–37.5ROR 39.0 · χ² 12,228 / p <1e-300 | 33.9 EB05 31.1 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.8 · 73% consumer | no trial data cached |
| Osteoporosis | 283 | 49.3 44.1–55.1ROR 54.4 · χ² 13,275 / p <1e-300 | 48.8 EB05 44.2 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.8 | no trial data cached |
| Depression | 218 | 6.8 6.0–7.7ROR 7.3 · χ² 1,084 / p 5e-238 | 6.7 EB05 6.0 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.7 | no trial data cached |
| Tubulointerstitial nephritis | 175 | 67.2 58.2–77.6ROR 71.4 · χ² 11,248 / p <1e-300 | 66.1 EB05 58.3 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 42.1 | no trial data cached |
| Arthritis | 174 | 15.8 13.6–18.2ROR 16.7 · χ² 2,396 / p <1e-300 | 15.7 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 | no trial data cached |
| Multiple fractures | 161 | 69.9 60.1–81.3ROR 73.9 · χ² 10,765 / p <1e-300 | 68.7 EB05 60.2 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 40.7 | no trial data cached |
| Bone disorder | 137 | 53.5 45.4–63.1ROR 56.1 · χ² 6,961 / p <1e-300 | 52.7 EB05 45.7 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 39.0 | no trial data cached |
| Dyspepsia (indigestion) | 117 | 8.5 7.1–10.2ROR 8.8 · χ² 770 / p 8e-170 | 8.3 EB05 7.1 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.3 · 83% consumer | no trial data cached |
| Vitamin d deficiency | 87 | 64.2 52.1–79.0ROR 66.1 · χ² 5,300 / p <1e-300 | 62.8 EB05 52.4 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 45.1 · ♀ 82% (drug 58%) | no trial data cached |
| Osteoarthritis | 82 | 13.8 11.1–17.1ROR 14.1 · χ² 959 / p 7e-211 | 13.6 EB05 11.3 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.4 | 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 and Hydroxide?
In FDA FAERS, the most frequently co-reported reaction terms for Carbonate and Hydroxide are chronic kidney disease, acute kidney injury, renal failure, end stage renal disease, renal injury, gastrooesophageal reflux disease. 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 and Hydroxide have an FDA boxed warning?
No. The FDA label retrieved for Carbonate and Hydroxide has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Carbonate and Hydroxide 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 5e946ed2-819e-fb40-e053-2991aa0a6f77, effective 20231101; matched on
openfda.generic_name.exact:"CALCIUM CARBONATE, MAGNESIUM HYDROXIDE") - 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, 101 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.