Drug · FAERS side-effect profile with label screen
Aluminum Hydroxide side effects: what 740 FDA adverse event reports show
Drug class
Not stated in label
Who reports
740 reports · 97% serious · 210 with death outcome · 60% 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 4Lab value / disease marker 1No label text to screen 35
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. 48 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 |
|---|---|---|---|---|---|---|
| Drug level increased | 160 | 276.4 240.7–317.3ROR 352.3 · χ² 43,233 / p <1e-300 | 265.0 EB05 232.3 · IC025 +6.9 3/3 methods agree | Reporting / coding artifact | serious PRR 180.6 · ♀ 100% (drug 60%) · 94% clinician | no trial data cached |
| Appendicitis | 53 | 162.5 125.3–210.8ROR 174.9 · χ² 8,301 / p <1e-300 | 152.8 EB05 121.2 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 97.6 · ♀ 0% (drug 60%) · 98% clinician | no trial data cached |
| Ventricular fibrillation | 54 | 138.0 106.7–178.6ROR 148.8 · χ² 7,179 / p <1e-300 | 131.1 EB05 104.3 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 82.0 · ♀ 0% (drug 60%) · 98% clinician | no trial data cached |
| Electrocardiogram qt prolonged | 169 | 133.7 117.1–152.7ROR 172.9 · χ² 22,055 / p <1e-300 | 131.1 EB05 115.3 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 80.6 · ♀ 100% (drug 60%) · 93% clinician | no trial data cached |
| Cardiogenic shock | 52 | 103.6 79.7–134.8ROR 111.4 · χ² 5,167 / p <1e-300 | 99.6 EB05 78.9 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 61.4 · ♀ 0% (drug 60%) · 98% clinician | no trial data cached |
| Bacterial infection | 54 | 82.6 63.9–106.9ROR 89.0 · χ² 4,264 / p <1e-300 | 80.1 EB05 63.7 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 56.7 · ♀ 2% (drug 60%) · 98% clinician | no trial data cached |
| Incorrect route of product administration | 47 | 79.5 60.2–104.8ROR 84.8 · χ² 3,556 / p <1e-300 | 76.9 EB05 60.1 · IC025 +5.0 3/3 methods agree | Reporting / coding artifact | serious PRR 94.3 · ♀ 2% (drug 60%) · 100% clinician | no trial data cached |
| Neuralgia | 54 | 63.2 48.9–81.8ROR 68.1 · χ² 3,242 / p <1e-300 | 61.8 EB05 49.1 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 55.8 · ♀ 0% (drug 60%) · 98% clinician | no trial data cached |
| Nephropathy | 20 | 60.5 39.3–93.3ROR 62.2 · χ² 1,110 / p 1e-243 | 57.3 EB05 39.1 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 38.3 · ♀ 95% (drug 60%) · 90% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 59 | 60.0 47.0–76.7ROR 65.1 · χ² 3,364 / p <1e-300 | 58.8 EB05 47.3 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 35.7 · ♀ 0% (drug 60%) · 98% clinician | no trial data cached |
| Ascites | 57 | 55.0 42.9–70.6ROR 59.5 · χ² 2,967 / p <1e-300 | 54.0 EB05 43.2 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 33.2 · ♀ 4% (drug 60%) · 96% clinician | no trial data cached |
| Hyperlipidaemia | 23 | 54.5 36.4–81.5ROR 56.2 · χ² 1,153 / p 5e-253 | 52.2 EB05 36.6 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 35.7 · ♀ 0% (drug 60%) · 96% clinician | no trial data cached |
| Ulcer | 28 | 49.9 34.7–71.8ROR 51.8 · χ² 1,291 / p 4e-283 | 48.3 EB05 35.0 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 37.4 · ♀ 0% (drug 60%) | no trial data cached |
| Body height decreased | 18 | 47.3 29.9–74.6ROR 48.4 · χ² 768 / p 2e-169 | 45.1 EB05 30.2 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=18 | no trial data cached |
| Foot deformity | 18 | 46.0 29.2–72.7ROR 47.2 · χ² 748 / p 6e-165 | 44.0 EB05 29.4 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 31.8 | no trial data cached |
| Joint range of motion decreased | 20 | 42.5 27.5–65.4ROR 43.6 · χ² 768 / p 2e-169 | 40.9 EB05 27.9 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.2 · ♀ 100% (drug 60%) · 95% clinician | no trial data cached |
| End stage renal disease | 26 | 40.1 27.4–58.4ROR 41.5 · χ² 951 / p 4e-209 | 38.9 EB05 27.9 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 23.8 · ♀ 0% (drug 60%) · 96% clinician | no trial data cached |
| Gout | 25 | 39.5 26.9–58.1ROR 40.8 · χ² 899 / p 8e-198 | 38.4 EB05 27.3 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 35.5 · ♀ 0% (drug 60%) · 100% clinician | no trial data cached |
| Blood test abnormal | 18 | 36.4 23.0–57.4ROR 37.3 · χ² 584 / p 3e-129 | 35.1 EB05 23.5 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 33.1 | no trial data cached |
| Sciatica | 19 | 34.0 21.8–53.0ROR 34.9 · χ² 575 / p 2e-127 | 32.9 EB05 22.3 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 27.2 | no trial data cached |
| Blood cholesterol increased | 52 | 31.6 24.3–41.1ROR 33.9 · χ² 1,513 / p <1e-300 | 31.3 EB05 24.8 · IC025 +4.2 3/3 methods agree | Lab value / disease marker | serious PRR 28.6 · ♀ 4% (drug 60%) · 96% clinician | no trial data cached |
| Hepatic steatosis | 20 | 30.5 19.8–47.0ROR 31.3 · χ² 541 / p 5e-120 | 29.7 EB05 20.3 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.7 · ♀ 95% (drug 60%) | no trial data cached |
| Drug interaction | 170 | 30.4 26.6–34.7ROR 39.2 · χ² 4,834 / p <1e-300 | 30.3 EB05 26.6 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious PRR 20.3 · ♀ 98% (drug 60%) · 93% clinician | no trial data cached |
| Electrolyte imbalance | 12 | 29.6 16.9–51.9ROR 30.1 · χ² 303 / p 3e-68 | 28.3 EB05 17.2 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.3 | no trial data cached |
| Aspiration | 11 | 28.8 16.0–51.8ROR 29.2 · χ² 268 / p 2e-60 | 27.5 EB05 16.2 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.6 | no trial data cached |
| Synovitis | 18 | 28.3 17.9–44.7ROR 29.0 · χ² 447 / p 2e-99 | 27.5 EB05 18.4 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.6 | no trial data cached |
| Diabetes mellitus | 75 | 27.8 22.4–34.4ROR 30.8 · χ² 1,915 / p <1e-300 | 27.6 EB05 22.7 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.0 · ♀ 28% (drug 60%) · 96% clinician | no trial data cached |
| Hyponatraemia (low sodium) | 55 | 27.8 21.5–35.8ROR 29.9 · χ² 1,394 / p <1e-300 | 27.5 EB05 21.9 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.9 · ♀ 6% (drug 60%) · 96% clinician | no trial data cached |
| Chronic obstructive pulmonary disease | 51 | 27.7 21.3–36.2ROR 29.7 · χ² 1,290 / p 8e-283 | 27.5 EB05 21.7 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.3 · ♀ 12% (drug 60%) · 98% clinician | no trial data cached |
| Stress | 69 | 27.2 21.7–34.1ROR 29.9 · χ² 1,720 / p <1e-300 | 27.0 EB05 22.1 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.9 · ♀ 2% (drug 60%) · 97% clinician | no trial data cached |
| Skin infection | 10 | 25.4 13.7–47.0ROR 25.7 · χ² 211 / p 5e-48 | 24.1 EB05 13.6 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.9 | no trial data cached |
| Impaired quality of life | 12 | 23.6 13.5–41.5ROR 24.0 · χ² 238 / p 5e-54 | 22.7 EB05 13.6 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.9 | no trial data cached |
| Tubulointerstitial nephritis | 15 | 22.7 13.8–37.5ROR 23.2 · χ² 290 / p 3e-65 | 22.0 EB05 14.0 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.6 | no trial data cached |
| Limb injury | 21 | 22.0 14.4–33.5ROR 22.6 · χ² 400 / p 3e-89 | 21.6 EB05 14.8 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.9 · ♀ 90% (drug 60%) · 95% clinician | no trial data cached |
| Pulmonary embolism (lung blood clot) | 71 | 21.1 16.9–26.3ROR 23.2 · χ² 1,344 / p 2e-294 | 21.0 EB05 17.2 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.6 · ♀ 3% (drug 60%) · 99% clinician | no trial data cached |
| Thrombosis | 60 | 21.1 16.5–26.9ROR 22.9 · χ² 1,132 / p 2e-248 | 20.9 EB05 16.9 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.0 · ♀ 2% (drug 60%) · 95% clinician | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 11 | 20.7 11.5–37.2ROR 21.0 · χ² 187 / p 8e-43 | 19.7 EB05 11.1 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.3 | no trial data cached |
| Joint stiffness | 19 | 20.5 13.2–32.0ROR 21.0 · χ² 334 / p 7e-75 | 20.1 EB05 13.4 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.2 | no trial data cached |
| Cholelithiasis | 23 | 19.9 13.3–29.7ROR 20.5 · χ² 394 / p 5e-88 | 19.5 EB05 13.6 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.5 · ♀ 87% (drug 60%) | no trial data cached |
| Sleep disorder | 46 | 18.6 14.1–24.7ROR 19.8 · χ² 752 / p 6e-166 | 18.5 EB05 14.4 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.9 · ♀ 5% (drug 60%) · 93% 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 |
|---|---|---|---|---|---|---|
| Drug interaction | 170 | 30.4 26.6–34.7ROR 39.2 · χ² 4,834 / p <1e-300 | 30.3 EB05 26.6 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious PRR 20.3 · ♀ 98% (drug 60%) · 93% clinician | no trial data cached |
| Electrocardiogram qt prolonged | 169 | 133.7 117.1–152.7ROR 172.9 · χ² 22,055 / p <1e-300 | 131.1 EB05 115.3 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 80.6 · ♀ 100% (drug 60%) · 93% clinician | no trial data cached |
| Drug level increased | 160 | 276.4 240.7–317.3ROR 352.3 · χ² 43,233 / p <1e-300 | 265.0 EB05 232.3 · IC025 +6.9 3/3 methods agree | Reporting / coding artifact | serious PRR 180.6 · ♀ 100% (drug 60%) · 94% clinician | no trial data cached |
| Product use issue | 91 | 13.8 11.4–16.7ROR 15.6 · χ² 1,077 / p 2e-236 | 13.7 EB05 11.5 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 18.2 · ♀ 100% (drug 60%) · 94% clinician | no trial data cached |
| Diabetes mellitus | 75 | 27.8 22.4–34.4ROR 30.8 · χ² 1,915 / p <1e-300 | 27.6 EB05 22.7 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.0 · ♀ 28% (drug 60%) · 96% clinician | no trial data cached |
| Pulmonary embolism (lung blood clot) | 71 | 21.1 16.9–26.3ROR 23.2 · χ² 1,344 / p 2e-294 | 21.0 EB05 17.2 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.6 · ♀ 3% (drug 60%) · 99% clinician | no trial data cached |
| General physical health deterioration | 70 | 17.3 13.8–21.6ROR 19.0 · χ² 1,062 / p 3e-233 | 17.2 EB05 14.0 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 11.9 · ♀ 13% (drug 60%) · 97% clinician | no trial data cached |
| Sepsis (blood infection) | 69 | 17.5 14.0–21.9ROR 19.2 · χ² 1,064 / p 1e-233 | 17.4 EB05 14.2 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.5 · ♀ 16% (drug 60%) · 96% clinician | no trial data cached |
| Stress | 69 | 27.2 21.7–34.1ROR 29.9 · χ² 1,720 / p <1e-300 | 27.0 EB05 22.1 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.9 · ♀ 2% (drug 60%) · 97% clinician | no trial data cached |
| Abdominal distension (bloating) | 60 | 16.4 12.8–20.9ROR 17.7 · χ² 854 / p 5e-188 | 16.2 EB05 13.0 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.2 · ♀ 6% (drug 60%) · 92% clinician | no trial data cached |
| Thrombosis | 60 | 21.1 16.5–26.9ROR 22.9 · χ² 1,132 / p 2e-248 | 20.9 EB05 16.9 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.0 · ♀ 2% (drug 60%) · 95% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 59 | 60.0 47.0–76.7ROR 65.1 · χ² 3,364 / p <1e-300 | 58.8 EB05 47.3 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 35.7 · ♀ 0% (drug 60%) · 98% clinician | no trial data cached |
| Swelling | 57 | 17.3 13.5–22.2ROR 18.7 · χ² 863 / p 6e-190 | 17.2 EB05 13.7 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.7 · ♀ 2% (drug 60%) · 98% clinician | no trial data cached |
| Ascites | 57 | 55.0 42.9–70.6ROR 59.5 · χ² 2,967 / p <1e-300 | 54.0 EB05 43.2 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 33.2 · ♀ 4% (drug 60%) · 96% clinician | no trial data cached |
| Intentional product misuse | 56 | 18.3 14.2–23.5ROR 19.7 · χ² 901 / p 3e-198 | 18.2 EB05 14.5 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 24.7 · ♀ 0% (drug 60%) · 98% clinician | 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?
In FDA FAERS, the most frequently co-reported reaction terms for Aluminum Hydroxide are electrocardiogram qt prolonged, diabetes mellitus, pulmonary embolism, sepsis, stress, abdominal distension. 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 have an FDA boxed warning?
No. The FDA label retrieved for Aluminum Hydroxide has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Aluminum 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 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, 88 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.