Drug · FAERS side-effect profile with label screen
Aluminum Hydroxide and Carbonate side effects: what 6,763 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Aluminum Hydroxide (Aluminum Hydroxide)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
6,763 reports · 88% serious · 608 with death outcome · 61% female
openFDA FAERS counts, all years, deduplication not applied
Used for
relieves heartburn acid indigestion sour stomach
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 1Outcome field, not a reaction 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.
- Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
- 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. 542 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 | 117 | 19.8 16.5–23.7ROR 20.1 · χ² 2,059 / p <1e-300 | 19.6 EB05 16.8 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.8 | no trial data cached |
| Tubulointerstitial nephritis | 115 | 19.1 16.0–23.0ROR 19.5 · χ² 1,949 / p <1e-300 | 19.0 EB05 16.2 · 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 |
| Chronic kidney disease | 457 | 18.6 17.0–20.3ROR 19.9 · χ² 7,569 / p <1e-300 | 18.5 EB05 17.1 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.3 | no trial data cached |
| Hepatocellular injury | 80 | 17.5 14.1–21.8ROR 17.7 · χ² 1,225 / p 1e-268 | 17.4 EB05 14.4 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.4 · 96% clinician | no trial data cached |
| Subarachnoid haemorrhage | 47 | 14.3 10.8–19.1ROR 14.4 · χ² 567 / p 1e-125 | 14.1 EB05 10.9 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.3 | no trial data cached |
| Vasculitis | 52 | 13.9 10.6–18.2ROR 14.0 · χ² 606 / p 3e-134 | 13.6 EB05 10.7 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.7 | no trial data cached |
| Impaired quality of life | 63 | 13.6 10.7–17.4ROR 13.7 · χ² 722 / p 3e-159 | 13.4 EB05 10.8 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.2 · ♀ 33% (drug 61%) | no trial data cached |
| Inappropriate antidiuretic hormone secretion | 41 | 12.5 9.2–17.0ROR 12.6 · χ² 422 / p 4e-94 | 12.2 EB05 9.2 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.2 · 100% clinician | no trial data cached |
| Hiatus hernia | 50 | 12.0 9.1–15.8ROR 12.1 · χ² 491 / p 4e-109 | 11.7 EB05 9.1 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.3 | no trial data cached |
| Renal injury | 114 | 11.8 9.8–14.2ROR 12.0 · χ² 1,115 / p 1e-244 | 11.7 EB05 9.9 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.7 | no trial data cached |
| Oesophagitis | 41 | 11.7 8.6–15.8ROR 11.7 · χ² 388 / p 1e-86 | 11.2 EB05 8.5 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.4 | no trial data cached |
| Sudden death | 38 | 11.1 8.0–15.2ROR 11.1 · χ² 336 / p 2e-75 | 10.6 EB05 7.8 · IC025 +2.7 3/3 methods agree | Outcome field, not a reaction | serious PRR 7.2 · ♀ 31% (drug 61%) · 100% clinician | no trial data cached |
| Anosmia (loss of smell) | 49 | 10.5 7.9–13.9ROR 10.6 · χ² 411 / p 1e-91 | 10.1 EB05 7.8 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=49 | no trial data cached |
| Pericarditis | 55 | 10.3 7.9–13.4ROR 10.3 · χ² 449 / p 5e-100 | 9.9 EB05 7.8 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.7 | no trial data cached |
| Ventricular tachycardia | 53 | 9.9 7.6–13.0ROR 10.0 · χ² 416 / p 8e-93 | 9.5 EB05 7.5 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.5 | no trial data cached |
| Muscle twitching | 73 | 9.8 7.8–12.3ROR 9.9 · χ² 568 / p 7e-126 | 9.5 EB05 7.8 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.0 | no trial data cached |
| Hepatic cytolysis | 38 | 9.7 7.0–13.3ROR 9.7 · χ² 286 / p 2e-64 | 9.1 EB05 6.8 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.3 · 100% clinician | no trial data cached |
| Gastrooesophageal reflux disease (acid reflux) | 249 | 9.7 8.5–10.9ROR 10.0 · χ² 1,924 / p <1e-300 | 9.5 EB05 8.6 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.5 | no trial data cached |
| Impaired work ability | 63 | 9.1 7.1–11.7ROR 9.2 · χ² 447 / p 2e-99 | 8.8 EB05 7.0 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.5 · ♀ 38% (drug 61%) | no trial data cached |
| Hyponatraemia (low sodium) | 165 | 9.1 7.8–10.6ROR 9.3 · χ² 1,185 / p 6e-260 | 9.0 EB05 7.9 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.1 · 93% clinician | no trial data cached |
| Frequent bowel movements | 78 | 9.0 7.2–11.2ROR 9.1 · χ² 546 / p 4e-121 | 8.7 EB05 7.2 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.7 | no trial data cached |
| Swollen tongue | 87 | 8.6 7.0–10.7ROR 8.7 · χ² 580 / p 2e-128 | 8.4 EB05 7.0 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.6 | no trial data cached |
| Tinnitus (ringing in the ears) | 128 | 8.6 7.3–10.3ROR 8.8 · χ² 857 / p 1e-188 | 8.5 EB05 7.3 · 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 |
| Cholestasis (bile flow blockage) | 53 | 8.6 6.6–11.3ROR 8.7 · χ² 349 / p 4e-78 | 8.2 EB05 6.4 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.7 · ♀ 38% (drug 61%) · 92% clinician | no trial data cached |
| Vitamin d deficiency | 27 | 8.6 5.9–12.5ROR 8.6 · χ² 174 / p 6e-40 | 7.8 EB05 5.5 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.3 · ♀ 89% (drug 61%) | no trial data cached |
| Gastritis | 70 | 8.3 6.6–10.4ROR 8.3 · χ² 440 / p 6e-98 | 8.0 EB05 6.5 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.8 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 399 | 8.1 7.4–9.0ROR 8.6 · χ² 2,503 / p <1e-300 | 8.1 EB05 7.4 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.3 | no trial data cached |
| Accidental overdose | 87 | 7.4 6.0–9.1ROR 7.5 · χ² 474 / p 2e-105 | 7.2 EB05 6.0 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 7.9 | no trial data cached |
| Rash maculo-papular | 52 | 7.3 5.6–9.6ROR 7.3 · χ² 276 / p 4e-62 | 6.9 EB05 5.4 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.3 · 94% clinician | no trial data cached |
| Nightmare | 78 | 7.0 5.6–8.7ROR 7.0 · χ² 393 / p 1e-87 | 6.7 EB05 5.5 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.5 | no trial data cached |
| Multiple fractures | 37 | 6.9 5.0–9.6ROR 7.0 · χ² 182 / p 1e-41 | 6.4 EB05 4.9 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.4 | no trial data cached |
| Toxic skin eruption | 22 | 6.8 4.5–10.3ROR 6.8 · χ² 102 / p 3e-24 | 6.0 EB05 4.2 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.4 · 100% clinician | no trial data cached |
| Nephropathy | 20 | 6.6 4.3–10.3ROR 6.6 · χ² 90 / p 1e-21 | 5.8 EB05 4.0 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.6 | no trial data cached |
| Eosinophilia | 37 | 6.6 4.8–9.1ROR 6.6 · χ² 169 / p 6e-39 | 6.1 EB05 4.6 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.5 · 92% clinician | no trial data cached |
| Rectal haemorrhage | 91 | 6.6 5.3–8.0ROR 6.6 · χ² 423 / p 3e-94 | 6.4 EB05 5.3 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.6 · ♀ 40% (drug 61%) | no trial data cached |
| Lip swelling | 70 | 6.5 5.2–8.3ROR 6.6 · χ² 323 / p 2e-72 | 6.3 EB05 5.1 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.8 | no trial data cached |
| Haematemesis (vomiting blood) | 53 | 6.5 4.9–8.5ROR 6.5 · χ² 240 / p 2e-54 | 6.1 EB05 4.9 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.2 | no trial data cached |
| Diplopia (double vision) | 54 | 6.5 4.9–8.4ROR 6.5 · χ² 243 / p 4e-55 | 6.1 EB05 4.9 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.8 | no trial data cached |
| Osteoporosis | 83 | 6.3 5.1–7.8ROR 6.3 · χ² 361 / p 7e-81 | 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 4.4 | no trial data cached |
| Systemic lupus erythematosus | 70 | 6.1 4.9–7.8ROR 6.2 · χ² 296 / p 1e-66 | 5.9 EB05 4.8 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.1 | 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 | 457 | 18.6 17.0–20.3ROR 19.9 · χ² 7,569 / p <1e-300 | 18.5 EB05 17.1 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.3 | no trial data cached |
| Diarrhoea (diarrhea) | 419 | 2.0 1.8–2.2ROR 2.1 · χ² 221 / p 2e-50 | 2.0 EB05 1.9 · IC025 +0.9 | No label text to screen label has no adverse-reaction text | serious PRR 2.1 | no trial data cached |
| Nausea | 406 | 1.6 1.5–1.8ROR 1.6 · χ² 93 / p 3e-22 | 1.6 EB05 1.5 · IC025 +0.5 | No label text to screen label has no adverse-reaction text | serious PRR 1.7 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 399 | 8.1 7.4–9.0ROR 8.6 · χ² 2,503 / p <1e-300 | 8.1 EB05 7.4 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.3 | no trial data cached |
| Vomiting | 398 | 2.6 2.4–2.9ROR 2.7 · χ² 410 / p 2e-91 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.4 | no trial data cached |
| Dyspnoea (shortness of breath) | 383 | 2.1 1.9–2.3ROR 2.2 · χ² 225 / p 3e-51 | 2.1 EB05 1.9 · IC025 +0.9 | No label text to screen label has no adverse-reaction text | serious PRR 1.8 | no trial data cached |
| Fatigue (tiredness) | 373 | 1.5 1.3–1.6ROR 1.5 · χ² 62 / p 2e-15 | 1.5 EB05 1.4 · IC025 +0.4 | No label text to screen label has no adverse-reaction text | serious PRR 1.5 | no trial data cached |
| Headache | 361 | 1.8 1.6–2.0ROR 1.8 · χ² 128 / p 5e-30 | 1.8 EB05 1.6 · IC025 +0.7 | No label text to screen label has no adverse-reaction text | serious PRR 2.1 | no trial data cached |
| Pain | 300 | 1.5 1.4–1.7ROR 1.5 · χ² 53 / p 2e-13 | 1.5 EB05 1.4 · IC025 +0.4 | No label text to screen label has no adverse-reaction text | serious PRR 1.4 | no trial data cached |
| Malaise (feeling unwell) | 296 | 2.1 1.9–2.3ROR 2.1 · χ² 170 / p 3e-39 | 2.1 EB05 1.9 · IC025 +0.9 | No label text to screen label has no adverse-reaction text | serious PRR 2.1 | no trial data cached |
| Pyrexia (fever) | 273 | 2.4 2.2–2.7ROR 2.5 · χ² 235 / p 2e-53 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.0 | no trial data cached |
| Abdominal pain upper | 266 | 4.0 3.6–4.5ROR 4.1 · χ² 605 / p 7e-134 | 4.0 EB05 3.6 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.2 | no trial data cached |
| Renal failure (kidney failure) | 263 | 6.1 5.4–6.9ROR 6.3 · χ² 1,122 / p 2e-246 | 6.0 EB05 5.4 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.0 | no trial data cached |
| Gastrooesophageal reflux disease (acid reflux) | 249 | 9.7 8.5–10.9ROR 10.0 · χ² 1,924 / p <1e-300 | 9.5 EB05 8.6 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.5 | no trial data cached |
| Dizziness | 243 | 1.5 1.3–1.7ROR 1.5 · χ² 43 / p 3e-11 | 1.5 EB05 1.4 · IC025 +0.4 | No label text to screen label has no adverse-reaction text | serious PRR 1.5 | 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 Aluminum Hydroxide and Carbonate?
In FDA FAERS, the most frequently co-reported reaction terms for Aluminum Hydroxide and Carbonate are chronic kidney disease, diarrhoea, nausea, acute kidney injury, vomiting, 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 Aluminum Hydroxide and Carbonate have an FDA boxed warning?
No. The FDA label retrieved for Aluminum Hydroxide and Carbonate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Aluminum Hydroxide and 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 27c574a5-1fe0-4973-9a31-9beb4fc6ec46, effective 20251211; matched on
openfda.generic_name.exact:"ALUMINUM 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, 582 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.