Drug · FAERS side-effect profile with label screen
Carbonate side effects: what 66,750 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Calcium Carbonate (Tums Chewy Bites Orange And Cream Es)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
66,750 reports · 80% serious · 9,270 with death outcome · 67% female
openFDA FAERS counts, all years, deduplication not applied
Used for
relieves • heartburn • acid indigestion • sour stomach • upset stomach associated with these symptoms
FDA label, Indications and Usage
What it is
Carbonate is a carbon oxoanion. It is a conjugate base of a hydrogencarbonate.
PubChem CID 19660 (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
Reporting / coding artifact 2Lab value / disease marker 8No label text to screen 30
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. 1,186 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 |
|---|---|---|---|---|---|---|
| Milk-alkali syndrome | 368 | 742.9 615.4–896.9ROR 747.0 · χ² 79,856 / p <1e-300 | 216.4 EB05 198.5 · IC025 +7.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=366 · 95% clinician | no trial arm names this drug |
| Fractional exhaled nitric oxide increased | 99 | 424.7 313.5–575.3ROR 425.3 · χ² 17,442 / p <1e-300 | 173.4 EB05 146.6 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=99 · ♀ 0% (drug 67%) | no trial arm names this drug |
| Vaginal flatulence | 168 | 387.3 308.6–485.9ROR 388.2 · χ² 28,547 / p <1e-300 | 169.1 EB05 148.7 · IC025 +6.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=168 · ♀ 100% (drug 67%) | no trial arm names this drug |
| Lupus vulgaris | 579 | 300.1 267.7–336.3ROR 302.7 · χ² 87,394 / p <1e-300 | 151.9 EB05 141.8 · IC025 +6.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=579 · ♀ 100% (drug 67%) · 96% clinician | no trial arm names this drug |
| Anti-cyclic citrullinated peptide antibody | 310 | 274.4 235.5–319.7ROR 275.6 · χ² 44,572 / p <1e-300 | 144.5 EB05 131.5 · IC025 +6.7 3/3 methods agree | Lab value / disease marker | serious n=310 · ♀ 100% (drug 67%) · 95% clinician | no trial arm names this drug |
| Deep vein thrombosis postoperative | 905 | 271.1 248.1–296.4ROR 274.8 · χ² 129,578 / p <1e-300 | 144.4 EB05 136.7 · IC025 +7.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=905 · ♀ 100% (drug 67%) · 96% clinician | no trial arm names this drug |
| Grip strength | 106 | 266.2 205.3–345.1ROR 266.6 · χ² 14,899 / p <1e-300 | 139.9 EB05 118.9 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=106 · ♀ 100% (drug 67%) · 100% clinician | no trial arm names this drug |
| Pulmonary vasculitis | 220 | 225.0 189.2–267.7ROR 225.8 · χ² 28,256 / p <1e-300 | 129.2 EB05 115.5 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=220 · ♀ 0% (drug 67%) | no trial arm names this drug |
| C-reactive protein | 372 | 219.3 192.0–250.4ROR 220.5 · χ² 47,146 / p <1e-300 | 127.8 EB05 117.3 · IC025 +6.6 3/3 methods agree | Lab value / disease marker | serious n=372 · ♀ 100% (drug 67%) · 100% clinician | no trial arm names this drug |
| Swollen joint count increased | 1,247 | 210.2 195.7–225.8ROR 214.2 · χ² 154,415 / p <1e-300 | 125.3 EB05 119.5 · IC025 +6.8 3/3 methods agree | Lab value / disease marker | serious n=1,247 · ♀ 100% (drug 67%) · 97% clinician | no trial arm names this drug |
| Rheumatic fever | 1,664 | 194.1 182.6–206.3ROR 199.0 · χ² 196,228 / p <1e-300 | 119.4 EB05 114.7 · IC025 +6.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=1,663 · ♀ 100% (drug 67%) · 96% clinician | no trial arm names this drug |
| Adjustment disorder with depressed mood | 754 | 188.4 172.2–206.2ROR 190.6 · χ² 87,201 / p <1e-300 | 117.1 EB05 110.2 · IC025 +6.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=753 · ♀ 100% (drug 67%) · 97% clinician | no trial arm names this drug |
| Facet joint syndrome | 1,167 | 185.3 172.4–199.2ROR 188.6 · χ² 133,624 / p <1e-300 | 116.0 EB05 110.5 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=1,167 · ♀ 100% (drug 67%) · 97% clinician | no trial arm names this drug |
| Total lung capacity increased | 100 | 181.7 141.9–232.6ROR 182.0 · χ² 11,201 / p <1e-300 | 112.4 EB05 95.1 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=100 · ♀ 100% (drug 67%) · 100% clinician | no trial arm names this drug |
| Swollen joint count | 87 | 172.3 132.5–223.9ROR 172.5 · χ² 9,400 / p <1e-300 | 108.4 EB05 90.6 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=87 · ♀ 100% (drug 67%) · 100% clinician | no trial arm names this drug |
| Total lung capacity abnormal | 132 | 167.1 135.2–206.5ROR 167.4 · χ² 14,035 / p <1e-300 | 107.1 EB05 92.7 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=132 · ♀ 0% (drug 67%) | no trial arm names this drug |
| Subcutaneous drug absorption impaired | 187 | 164.6 137.8–196.5ROR 165.0 · χ² 19,727 / p <1e-300 | 106.6 EB05 94.3 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=187 · ♀ 100% (drug 67%) · 100% clinician | no trial arm names this drug |
| Sleep disorder therapy | 62 | 157.0 115.6–213.1ROR 157.1 · χ² 6,268 / p <1e-300 | 101.2 EB05 81.8 · IC025 +5.4 3/3 methods agree | Reporting / coding artifact | serious n=62 · ♀ 0% (drug 67%) · 100% clinician | no trial arm names this drug |
| Neurologic neglect syndrome | 183 | 152.8 128.0–182.3ROR 153.2 · χ² 18,360 / p <1e-300 | 101.5 EB05 89.7 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=183 · ♀ 100% (drug 67%) · 100% clinician | no trial arm names this drug |
| Dislocation of vertebra | 724 | 151.9 139.0–166.0ROR 153.6 · χ² 72,668 / p <1e-300 | 101.9 EB05 95.8 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=723 · ♀ 100% (drug 67%) · 96% clinician | no trial arm names this drug |
| X-ray abnormal | 540 | 136.5 123.4–151.0ROR 137.6 · χ² 50,282 / p <1e-300 | 94.7 EB05 88.1 · IC025 +6.3 3/3 methods agree | Lab value / disease marker | serious n=540 · ♀ 100% (drug 67%) · 97% clinician | no trial arm names this drug |
| Retinitis | 443 | 113.6 101.9–126.6ROR 114.3 · χ² 36,058 / p <1e-300 | 83.0 EB05 76.7 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=443 · ♀ 100% (drug 67%) · 95% clinician | no trial arm names this drug |
| Spirometry abnormal | 154 | 111.7 92.9–134.2ROR 111.9 · χ² 12,324 / p <1e-300 | 81.5 EB05 71.2 · IC025 +5.8 3/3 methods agree | Lab value / disease marker | serious n=154 · ♀ 0% (drug 67%) | no trial arm names this drug |
| Duodenal ulcer perforation | 1,852 | 106.1 100.7–111.7ROR 109.0 · χ² 143,437 / p <1e-300 | 79.1 EB05 76.2 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 57.2 · ♀ 100% (drug 67%) · 96% clinician | no trial arm names this drug |
| Capillaritis | 66 | 102.4 77.6–135.3ROR 102.5 · χ² 4,903 / p <1e-300 | 75.6 EB05 61.5 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=66 · ♀ 0% (drug 67%) · 100% clinician | no trial arm names this drug |
| Rheumatoid factor positive | 1,406 | 101.3 95.4–107.5ROR 103.4 · χ² 105,064 / p <1e-300 | 76.4 EB05 73.1 · IC025 +6.1 3/3 methods agree | Lab value / disease marker | serious n=1,406 · ♀ 100% (drug 67%) · 97% clinician | no trial arm names this drug |
| Mite allergy | 151 | 97.4 81.1–116.9ROR 97.6 · χ² 10,878 / p <1e-300 | 73.6 EB05 64.3 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=151 · ♀ 0% (drug 67%) | no trial arm names this drug |
| Chronic kidney disease-mineral and bone disorder | 246 | 93.1 80.8–107.4ROR 93.5 · χ² 17,155 / p <1e-300 | 71.4 EB05 64.2 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=246 | no trial arm names this drug |
| Carotid artery thrombosis | 184 | 86.2 73.3–101.5ROR 86.5 · χ² 12,053 / p <1e-300 | 67.2 EB05 59.4 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=184 · ♀ 100% (drug 67%) · 100% clinician | no trial arm names this drug |
| Antineutrophil cytoplasmic antibody positive | 151 | 82.1 68.6–98.2ROR 82.3 · χ² 9,494 / p <1e-300 | 64.6 EB05 56.4 · IC025 +5.5 3/3 methods agree | Lab value / disease marker | serious n=151 · ♀ 0% (drug 67%) | no trial arm names this drug |
| Peripheral venous disease | 823 | 81.5 75.5–88.0ROR 82.5 · χ² 51,725 / p <1e-300 | 64.6 EB05 61.0 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=821 · ♀ 100% (drug 67%) · 96% clinician | no trial arm names this drug |
| Anti-cyclic citrullinated peptide antibody positive | 1,461 | 81.3 76.7–86.0ROR 83.0 · χ² 91,655 / p <1e-300 | 64.5 EB05 61.8 · IC025 +5.9 3/3 methods agree | Lab value / disease marker | serious PRR 46.8 · ♀ 100% (drug 67%) · 96% clinician | no trial arm names this drug |
| Asthma-chronic obstructive pulmonary disease overlap syndrome | 102 | 76.5 61.6–95.0ROR 76.6 · χ² 6,029 / p <1e-300 | 60.8 EB05 51.5 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=102 · ♀ 100% (drug 67%) · 100% clinician | no trial arm names this drug |
| Hypocholesterolaemia | 59 | 74.4 56.0–98.8ROR 74.4 · χ² 3,383 / p <1e-300 | 59.1 EB05 47.5 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=59 · ♀ 100% (drug 67%) · 100% clinician | no trial arm names this drug |
| Hyperparathyroidism secondary | 481 | 73.6 66.7–81.3ROR 74.2 · χ² 27,770 / p <1e-300 | 59.5 EB05 55.2 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=480 · 100% clinician | no trial arm names this drug |
| Helicobacter infection | 1,901 | 72.0 68.5–75.6ROR 74.0 · χ² 107,869 / p <1e-300 | 58.5 EB05 56.3 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 44.7 · ♀ 100% (drug 67%) · 96% clinician | no trial arm names this drug |
| Analgesic therapy | 57 | 71.6 53.7–95.5ROR 71.6 · χ² 3,163 / p <1e-300 | 57.2 EB05 45.8 · IC025 +4.8 3/3 methods agree | Reporting / coding artifact | serious n=57 · ♀ 0% (drug 67%) · 100% clinician | no trial arm names this drug |
| Mycotic allergy | 156 | 71.3 59.9–84.8ROR 71.4 · χ² 8,726 / p <1e-300 | 57.7 EB05 50.5 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=153 · ♀ 0% (drug 67%) | no trial arm names this drug |
| Seronegative arthritis | 207 | 71.0 61.0–82.5ROR 71.2 · χ² 11,555 / p <1e-300 | 57.6 EB05 51.3 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=207 · ♀ 100% (drug 67%) · 100% clinician | no trial arm names this drug |
| Nephrogenic anaemia | 832 | 68.0 63.1–73.2ROR 68.8 · χ² 44,942 / p <1e-300 | 55.8 EB05 52.7 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=832 | no trial arm names this drug |
Trial evidence (ClinicalTrials.gov)
ClinicalTrials.gov returned results-bearing trials mentioning Carbonate only as a background or rescue medication (NCT00529373, NCT00153816); 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) | 6,489 | 2.6 2.6–2.7ROR 2.8 · χ² 6,788 / p <1e-300 | 2.6 EB05 2.6 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.9 | no trial arm names this drug |
| Nausea | 5,944 | 2.4 2.3–2.4ROR 2.5 · χ² 4,885 / p <1e-300 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.7 | no trial arm names this drug |
| Off label use (used outside approved label) | 5,213 | 1.9 1.8–1.9ROR 2.0 · χ² 2,271 / p <1e-300 | 1.9 EB05 1.8 · IC025 +0.9 | Reporting / coding artifact | serious PRR 2.3 | no trial arm names this drug |
| Diarrhoea (diarrhea) | 5,200 | 2.6 2.5–2.6ROR 2.7 · χ² 5,018 / p <1e-300 | 2.5 EB05 2.5 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.5 | no trial arm names this drug |
| Pain | 5,132 | 2.6 2.6–2.7ROR 2.8 · χ² 5,308 / p <1e-300 | 2.6 EB05 2.6 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.7 | no trial arm names this drug |
| Drug ineffective (drug did not work) | 5,005 | 1.2 1.2–1.2ROR 1.2 · χ² 168 / p 9e-39 | 1.2 EB05 1.2 · IC025 +0.2 | Reporting / coding artifact | serious PRR 2.0 | no trial arm names this drug |
| Chronic kidney disease | 4,969 | 21.7 21.1–22.3ROR 23.4 · χ² 92,069 / p <1e-300 | 20.4 EB05 19.9 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.9 | no trial arm names this drug |
| Dyspnoea (shortness of breath) | 4,937 | 2.8 2.7–2.8ROR 2.9 · χ² 5,628 / p <1e-300 | 2.7 EB05 2.7 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.5 | no trial arm names this drug |
| Vomiting | 4,720 | 3.2 3.1–3.3ROR 3.3 · χ² 7,155 / p <1e-300 | 3.2 EB05 3.1 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.1 | no trial arm names this drug |
| Headache | 4,407 | 2.2 2.2–2.3ROR 2.3 · χ² 3,019 / p <1e-300 | 2.2 EB05 2.2 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.8 | no trial arm names this drug |
| Pneumonia (lung infection) | 4,002 | 3.9 3.8–4.0ROR 4.1 · χ² 8,745 / p <1e-300 | 3.9 EB05 3.8 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.9 | no trial arm names this drug |
| Arthralgia (joint pain) | 3,895 | 3.0 2.9–3.1ROR 3.1 · χ² 5,143 / p <1e-300 | 3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.5 | no trial arm names this drug |
| Malaise (feeling unwell) | 3,798 | 2.7 2.6–2.8ROR 2.8 · χ² 4,209 / p <1e-300 | 2.7 EB05 2.6 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.0 | no trial arm names this drug |
| Acute kidney injury (sudden kidney damage) | 3,746 | 7.9 7.7–8.1ROR 8.3 · χ² 22,150 / p <1e-300 | 7.7 EB05 7.5 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.6 | no trial arm names this drug |
| Pyrexia (fever) | 3,603 | 3.3 3.2–3.4ROR 3.4 · χ² 5,783 / p <1e-300 | 3.3 EB05 3.2 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.8 | 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 Carbonate?
In FDA FAERS, the most frequently co-reported reaction terms for Carbonate are fatigue, nausea, diarrhoea, pain, chronic kidney disease, dyspnoea. 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 036ef1ed-32ef-46b8-8817-b3f63a014280, effective 20250214; matched on
openfda.generic_name.exact:"CALCIUM CARBONATE") - PubChem CID 19660 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, fieldpatient.drug.openfda.generic_name.exact, 1,226 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
CARBONATE, results-bearing studies sorted by enrollment)
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.