Drug · FAERS side-effect profile with label screen
Carbonate and Simethicone side effects: what 5,372 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Calcium Carbonate, Simethicone (Premier Value Maximum Strength Assorted Fruit)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
5,372 reports · 71% serious · 467 with death outcome · 68% female
openFDA FAERS counts, all years, deduplication not applied
Used for
relieves: ▪ acid indigestion ▪ heartburn ▪ sour stomach ▪ upset stomach due to these symptoms ▪ bloating and pressure commonly referred to as gas
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 1No label text to screen 39
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.
- 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. 511 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 | 320 | 68.9 61.9–76.7ROR 73.2 · χ² 20,996 / p <1e-300 | 67.5 EB05 61.5 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 55.0 | no trial data cached |
| Chronic kidney disease | 1,128 | 58.2 55.3–61.4ROR 73.4 · χ² 62,674 / p <1e-300 | 57.3 EB05 54.6 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 47.4 | no trial data cached |
| Renal injury | 243 | 31.8 28.1–36.0ROR 33.3 · χ² 7,172 / p <1e-300 | 31.5 EB05 28.3 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.7 | no trial data cached |
| Multiple fractures | 128 | 30.3 25.6–36.0ROR 31.1 · χ² 3,577 / p <1e-300 | 30.0 EB05 25.9 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 23.2 | no trial data cached |
| Vitamin d deficiency | 70 | 28.2 22.3–35.6ROR 28.6 · χ² 1,797 / p <1e-300 | 27.8 EB05 22.8 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.9 | no trial data cached |
| Bone disorder | 102 | 21.8 17.9–26.4ROR 22.2 · χ² 1,990 / p <1e-300 | 21.6 EB05 18.3 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.8 | no trial data cached |
| Tubulointerstitial nephritis | 101 | 21.1 17.4–25.7ROR 21.5 · χ² 1,908 / p <1e-300 | 21.0 EB05 17.7 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.2 | no trial data cached |
| Osteoporosis | 220 | 20.9 18.4–23.8ROR 21.8 · χ² 4,142 / p <1e-300 | 20.8 EB05 18.6 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.9 | no trial data cached |
| Intervertebral disc degeneration | 45 | 18.9 14.1–25.4ROR 19.1 · χ² 743 / p 5e-164 | 18.7 EB05 14.5 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.2 | no trial data cached |
| Gastrooesophageal reflux disease (acid reflux) | 357 | 17.4 15.8–19.3ROR 18.6 · χ² 5,510 / p <1e-300 | 17.3 EB05 15.9 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.2 · 74% consumer | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 599 | 15.4 14.3–16.6ROR 17.2 · χ² 8,073 / p <1e-300 | 15.3 EB05 14.3 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.5 | no trial data cached |
| Renal failure (kidney failure) | 524 | 15.3 14.1–16.6ROR 16.9 · χ² 7,021 / p <1e-300 | 15.3 EB05 14.2 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.5 | no trial data cached |
| Flatulence (gas) | 218 | 15.1 13.2–17.2ROR 15.7 · χ² 2,847 / p <1e-300 | 15.0 EB05 13.4 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.6 · 76% consumer | no trial data cached |
| Osteopenia | 58 | 14.9 11.5–19.2ROR 15.0 · χ² 735 / p 5e-162 | 14.7 EB05 11.7 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.2 | no trial data cached |
| Nephropathy | 35 | 14.6 10.5–20.3ROR 14.7 · χ² 428 / p 2e-95 | 14.3 EB05 10.6 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.6 | no trial data cached |
| Renal tubular necrosis | 31 | 12.3 8.7–17.5ROR 12.4 · χ² 311 / p 8e-70 | 11.8 EB05 8.5 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.1 | no trial data cached |
| Foot fracture | 57 | 11.7 9.0–15.2ROR 11.8 · χ² 547 / p 3e-121 | 11.4 EB05 9.0 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.7 | no trial data cached |
| Wrist fracture | 33 | 10.8 7.7–15.1ROR 10.8 · χ² 282 / p 2e-63 | 10.2 EB05 7.4 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.9 | no trial data cached |
| Ankle fracture | 39 | 9.8 7.2–13.4ROR 9.9 · χ² 300 / p 2e-67 | 9.3 EB05 6.9 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.3 | no trial data cached |
| Eructation (belching) | 46 | 9.5 7.1–12.6ROR 9.5 · χ² 339 / p 6e-76 | 9.0 EB05 6.9 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=20 · 87% consumer | no trial data cached |
| Hiatus hernia | 31 | 9.3 6.6–13.3ROR 9.4 · χ² 222 / p 2e-50 | 8.6 EB05 6.2 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.8 | no trial data cached |
| Atelectasis | 22 | 8.9 5.8–13.5ROR 8.9 · χ² 145 / p 9e-34 | 7.9 EB05 5.3 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.3 | no trial data cached |
| Back disorder | 36 | 8.6 6.2–11.9ROR 8.7 · χ² 234 / p 3e-53 | 8.0 EB05 6.0 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.8 | no trial data cached |
| Intervertebral disc protrusion | 45 | 8.0 6.0–10.7ROR 8.1 · χ² 269 / p 9e-61 | 7.5 EB05 5.8 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.9 | no trial data cached |
| Arthritis | 160 | 7.9 6.8–9.2ROR 8.1 · χ² 964 / p 6e-212 | 7.8 EB05 6.8 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.8 · 77% consumer | no trial data cached |
| Malnutrition | 22 | 7.7 5.1–11.7ROR 7.8 · χ² 122 / p 1e-28 | 6.9 EB05 4.7 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.5 | no trial data cached |
| Osteoarthritis | 82 | 7.5 6.1–9.3ROR 7.6 · χ² 459 / p 5e-102 | 7.3 EB05 6.0 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.8 · 81% consumer | no trial data cached |
| Irritable bowel syndrome | 41 | 7.5 5.5–10.2ROR 7.5 · χ² 224 / p 6e-51 | 7.0 EB05 5.3 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.7 · 74% consumer | no trial data cached |
| Lower limb fracture | 36 | 7.4 5.3–10.2ROR 7.4 · χ² 191 / p 8e-44 | 6.8 EB05 5.1 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.2 | no trial data cached |
| Dyspepsia (indigestion) | 180 | 7.2 6.2–8.3ROR 7.4 · χ² 951 / p 3e-209 | 7.0 EB05 6.2 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.4 · 83% consumer | no trial data cached |
| Abdominal distension (bloating) | 188 | 7.1 6.1–8.1ROR 7.3 · χ² 975 / p 2e-214 | 6.9 EB05 6.1 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.2 | no trial data cached |
| Gallbladder disorder | 32 | 7.0 4.9–9.9ROR 7.0 · χ² 158 / p 2e-36 | 6.4 EB05 4.7 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.8 | no trial data cached |
| Ligament sprain | 17 | 6.7 4.2–10.8ROR 6.7 · χ² 77 / p 8e-19 | 5.8 EB05 3.8 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=16 | no trial data cached |
| Back injury | 18 | 6.5 4.1–10.3ROR 6.5 · χ² 78 / p 5e-19 | 5.6 EB05 3.8 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.0 | no trial data cached |
| Gastrointestinal pain | 18 | 6.4 4.0–10.2ROR 6.4 · χ² 77 / p 9e-19 | 5.6 EB05 3.7 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.4 | no trial data cached |
| Carpal tunnel syndrome | 23 | 6.4 4.3–9.6ROR 6.4 · χ² 99 / p 1e-23 | 5.7 EB05 4.0 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.9 · ♀ 91% (drug 68%) | no trial data cached |
| Joint injury | 35 | 6.4 4.6–8.9ROR 6.4 · χ² 154 / p 1e-35 | 5.9 EB05 4.4 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.0 | no trial data cached |
| Gastritis | 43 | 6.4 4.7–8.6ROR 6.4 · χ² 190 / p 2e-43 | 6.0 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 | no trial data cached |
| Impaired gastric emptying | 20 | 6.1 4.0–9.5ROR 6.1 · χ² 81 / p 1e-19 | 5.4 EB05 3.7 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.6 | no trial data cached |
| Economic problem | 24 | 6.1 4.1–9.1ROR 6.1 · χ² 97 / p 4e-23 | 5.5 EB05 3.9 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 5.4 · ♀ 46% (drug 68%) | 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 | 1,128 | 58.2 55.3–61.4ROR 73.4 · χ² 62,674 / p <1e-300 | 57.3 EB05 54.6 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 47.4 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 599 | 15.4 14.3–16.6ROR 17.2 · χ² 8,073 / p <1e-300 | 15.3 EB05 14.3 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.5 | no trial data cached |
| Renal failure (kidney failure) | 524 | 15.3 14.1–16.6ROR 16.9 · χ² 7,021 / p <1e-300 | 15.3 EB05 14.2 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.5 | no trial data cached |
| Nausea | 475 | 2.3 2.2–2.6ROR 2.5 · χ² 380 / p 5e-85 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.3 | no trial data cached |
| Diarrhoea (diarrhea) | 447 | 2.7 2.5–3.0ROR 2.9 · χ² 496 / p 4e-110 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.4 | no trial data cached |
| Fatigue (tiredness) | 424 | 2.1 1.9–2.3ROR 2.2 · χ² 262 / p 3e-59 | 2.1 EB05 2.0 · IC025 +0.9 | No label text to screen label has no adverse-reaction text | serious PRR 2.2 | no trial data cached |
| Gastrooesophageal reflux disease (acid reflux) | 357 | 17.4 15.8–19.3ROR 18.6 · χ² 5,510 / p <1e-300 | 17.3 EB05 15.9 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.2 · 74% consumer | no trial data cached |
| End stage renal disease | 320 | 68.9 61.9–76.7ROR 73.2 · χ² 20,996 / p <1e-300 | 67.5 EB05 61.5 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 55.0 | no trial data cached |
| Pain | 281 | 1.8 1.6–2.0ROR 1.8 · χ² 98 / p 2e-23 | 1.8 EB05 1.6 · IC025 +0.6 | No label text to screen label has no adverse-reaction text | serious PRR 1.7 | no trial data cached |
| Vomiting | 260 | 2.2 1.9–2.4ROR 2.2 · χ² 165 / p 5e-38 | 2.2 EB05 1.9 · IC025 +0.9 | No label text to screen label has no adverse-reaction text | serious PRR 2.0 | no trial data cached |
| Renal injury | 243 | 31.8 28.1–36.0ROR 33.3 · χ² 7,172 / p <1e-300 | 31.5 EB05 28.3 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.7 | no trial data cached |
| Depression | 228 | 3.9 3.4–4.4ROR 4.0 · χ² 492 / p 2e-109 | 3.9 EB05 3.5 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.9 | no trial data cached |
| Constipation | 221 | 4.0 3.5–4.5ROR 4.1 · χ² 496 / p 4e-110 | 4.0 EB05 3.5 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.7 | no trial data cached |
| Osteoporosis | 220 | 20.9 18.4–23.8ROR 21.8 · χ² 4,142 / p <1e-300 | 20.8 EB05 18.6 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.9 | no trial data cached |
| Fall | 219 | 2.6 2.3–2.9ROR 2.6 · χ² 212 / p 3e-48 | 2.6 EB05 2.3 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.3 | 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 Simethicone?
In FDA FAERS, the most frequently co-reported reaction terms for Carbonate and Simethicone are chronic kidney disease, acute kidney injury, renal failure, nausea, diarrhoea, fatigue. 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 Simethicone have an FDA boxed warning?
No. The FDA label retrieved for Carbonate and Simethicone has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Carbonate and Simethicone 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 e25bf9ca-415b-4a3e-a502-59074308da54, effective 20241025; matched on
openfda.generic_name.exact:"CALCIUM CARBONATE, SIMETHICONE") - 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, 551 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.