Drug · FAERS side-effect profile with label screen
Hydroxide side effects: what 13,393 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Magnesium Hydroxide (Milk Of Magnesia Cherry)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
13,393 reports · 79% serious · 2,054 with death outcome · 62% female
openFDA FAERS counts, all years, deduplication not applied
Used for
relieves occasional constipation (irregularity) generally produces bowel movement in 1/2 to 6 hours
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 6Lab value / disease marker 4No 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. 1,125 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 |
|---|---|---|---|---|---|---|
| Vaginal flatulence | 93 | 686.8 538.3–876.4ROR 691.6 · χ² 43,602 / p <1e-300 | 433.1 EB05 364.1 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=93 · ♀ 100% (drug 62%) · 92% clinician | no trial arm names this drug |
| Sedation complication | 519 | 411.0 373.6–452.1ROR 427.5 · χ² 167,333 / p <1e-300 | 320.9 EB05 298.4 · IC025 +7.8 3/3 methods agree | Reporting / coding artifact | serious n=519 · ♀ 100% (drug 62%) | no trial arm names this drug |
| Creatinine renal clearance decreased | 518 | 231.1 211.1–253.1ROR 240.4 · χ² 103,056 / p <1e-300 | 199.7 EB05 185.7 · IC025 +7.3 3/3 methods agree | Lab value / disease marker | serious n=517 · ♀ 100% (drug 62%) | no trial arm names this drug |
| Sleep disorder therapy | 22 | 209.6 134.3–327.1ROR 209.9 · χ² 3,840 / p <1e-300 | 159.4 EB05 110.9 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | serious n=22 · 100% clinician | no trial arm names this drug |
| Appendicolith | 38 | 174.0 124.5–243.3ROR 174.5 · χ² 5,721 / p <1e-300 | 145.2 EB05 110.4 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=38 · ♀ 0% (drug 62%) · 100% clinician | no trial arm names this drug |
| Multiple drug therapy | 68 | 169.0 131.7–217.0ROR 169.9 · χ² 10,086 / p <1e-300 | 146.2 EB05 119.3 · IC025 +5.8 3/3 methods agree | Reporting / coding artifact | serious n=68 · ♀ 100% (drug 62%) | no trial arm names this drug |
| Analgesic therapy | 23 | 126.8 82.9–193.9ROR 127.0 · χ² 2,537 / p <1e-300 | 107.0 EB05 75.1 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious n=23 · 100% clinician | no trial arm names this drug |
| Drug therapy | 23 | 121.2 79.3–185.2ROR 121.4 · χ² 2,431 / p <1e-300 | 103.0 EB05 72.3 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious n=23 · 100% clinician | no trial arm names this drug |
| Creatinine renal clearance increased | 54 | 121.1 91.9–159.7ROR 121.6 · χ² 5,855 / p <1e-300 | 108.2 EB05 86.1 · IC025 +5.3 3/3 methods agree | Lab value / disease marker | serious n=54 · ♀ 100% (drug 62%) · 93% clinician | no trial arm names this drug |
| Female genital tract fistula | 96 | 92.4 75.3–113.5ROR 93.1 · χ² 8,107 / p <1e-300 | 85.8 EB05 72.4 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=96 · ♀ 100% (drug 62%) · 93% clinician | no trial arm names this drug |
| Blood calcium decreased | 557 | 81.3 74.8–88.4ROR 84.8 · χ² 41,899 / p <1e-300 | 77.1 EB05 71.8 · IC025 +6.0 3/3 methods agree | Lab value / disease marker | serious PRR 70.6 · ♀ 97% (drug 62%) | no trial arm names this drug |
| Hypermagnesaemia | 29 | 74.1 51.1–107.5ROR 74.3 · χ² 1,927 / p <1e-300 | 67.7 EB05 49.5 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=29 · 100% clinician | no trial arm names this drug |
| Radiculopathy | 107 | 66.2 54.6–80.2ROR 66.7 · χ² 6,524 / p <1e-300 | 62.8 EB05 53.4 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=107 · ♀ 95% (drug 62%) | no trial arm names this drug |
| Orthostatic hypotension (dizziness on standing) | 641 | 59.7 55.2–64.4ROR 62.6 · χ² 35,573 / p <1e-300 | 57.4 EB05 53.8 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 47.8 · ♀ 97% (drug 62%) | no trial arm names this drug |
| Proctitis | 96 | 55.5 45.3–67.9ROR 55.8 · χ² 4,903 / p <1e-300 | 53.0 EB05 44.7 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=96 · ♀ 100% (drug 62%) · 92% clinician | no trial arm names this drug |
| Calcium deficiency | 41 | 50.8 37.3–69.3ROR 51.0 · χ² 1,891 / p <1e-300 | 48.2 EB05 37.0 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=39 | no trial arm names this drug |
| Nephrogenic anaemia | 147 | 50.8 43.1–59.8ROR 51.3 · χ² 6,900 / p <1e-300 | 48.9 EB05 42.6 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=147 | no trial arm names this drug |
| Chronic kidney disease-mineral and bone disorder | 30 | 44.9 31.2–64.5ROR 45.0 · χ² 1,208 / p 5e-265 | 42.5 EB05 31.2 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=30 | no trial arm names this drug |
| Subcutaneous drug absorption impaired | 15 | 44.3 26.5–73.9ROR 44.3 · χ² 575 / p 2e-127 | 41.0 EB05 26.4 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=15 | no trial arm names this drug |
| Chronic sinusitis | 101 | 43.3 35.6–52.8ROR 43.7 · χ² 4,023 / p <1e-300 | 41.9 EB05 35.5 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=101 · ♀ 100% (drug 62%) · 92% clinician | no trial arm names this drug |
| Rebound acid hypersecretion | 80 | 41.9 33.6–52.3ROR 42.1 · χ² 3,070 / p <1e-300 | 40.5 EB05 33.5 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=80 | no trial arm names this drug |
| Sedation | 590 | 36.2 33.4–39.2ROR 37.8 · χ² 19,736 / p <1e-300 | 35.4 EB05 33.0 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 35.8 · ♀ 98% (drug 62%) | no trial arm names this drug |
| Hyperparathyroidism secondary | 57 | 36.0 27.7–46.8ROR 36.2 · χ² 1,863 / p <1e-300 | 34.9 EB05 27.9 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=57 | no trial arm names this drug |
| Facet joint syndrome | 64 | 32.4 25.3–41.5ROR 32.6 · χ² 1,878 / p <1e-300 | 31.5 EB05 25.5 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=64 · ♀ 100% (drug 62%) · 92% clinician | no trial arm names this drug |
| Primary sequestrum | 17 | 29.5 18.3–47.7ROR 29.6 · χ² 432 / p 3e-96 | 28.2 EB05 18.6 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=17 | no trial arm names this drug |
| Hyperphosphataemia | 39 | 29.3 21.4–40.2ROR 29.4 · χ² 1,019 / p 5e-224 | 28.4 EB05 21.7 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=39 · ♀ 0% (drug 62%) · 100% clinician | no trial arm names this drug |
| Infusion site reaction | 53 | 29.0 22.1–38.1ROR 29.2 · χ² 1,382 / p <1e-300 | 28.3 EB05 22.4 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=53 · ♀ 100% (drug 62%) · 100% clinician | no trial arm names this drug |
| Vertebral foraminal stenosis | 15 | 28.9 17.3–48.2ROR 28.9 · χ² 370 / p 1e-82 | 27.5 EB05 17.6 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=14 | no trial arm names this drug |
| End stage renal disease | 314 | 27.1 24.3–30.3ROR 27.8 · χ² 7,747 / p <1e-300 | 26.6 EB05 24.3 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.5 | no trial arm names this drug |
| Peripheral venous disease | 65 | 25.9 20.3–33.0ROR 26.0 · χ² 1,505 / p <1e-300 | 25.3 EB05 20.5 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=65 · ♀ 100% (drug 62%) · 100% clinician | no trial arm names this drug |
| Chronic hepatitis | 13 | 25.6 14.8–44.2ROR 25.6 · χ² 278 / p 1e-62 | 24.3 EB05 15.0 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=13 | no trial arm names this drug |
| Blood phosphorus increased | 43 | 25.1 18.6–33.9ROR 25.2 · χ² 955 / p 7e-210 | 24.5 EB05 18.9 · IC025 +3.8 3/3 methods agree | Lab value / disease marker | serious n=42 · ♀ 0% (drug 62%) · 100% clinician | no trial arm names this drug |
| Hypoparathyroidism | 12 | 24.9 14.1–44.1ROR 24.9 · χ² 248 / p 3e-56 | 23.6 EB05 14.2 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | no trial arm names this drug |
| Renal function test abnormal | 70 | 24.2 19.1–30.6ROR 24.3 · χ² 1,511 / p <1e-300 | 23.7 EB05 19.4 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious n=68 · ♀ 100% (drug 62%) | no trial arm names this drug |
| Cognitive disorder | 687 | 23.4 21.8–25.2ROR 24.7 · χ² 14,554 / p <1e-300 | 23.1 EB05 21.7 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 23.4 · ♀ 94% (drug 62%) | no trial arm names this drug |
| Depressed level of consciousness | 562 | 22.6 20.8–24.5ROR 23.5 · χ² 11,431 / p <1e-300 | 22.3 EB05 20.8 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.7 · ♀ 96% (drug 62%) | no trial arm names this drug |
| Osteosclerosis | 21 | 21.1 13.7–32.4ROR 21.1 · χ² 377 / p 3e-84 | 20.4 EB05 14.0 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=21 · 70% consumer | no trial arm names this drug |
| Chronic kidney disease | 1,010 | 20.9 19.7–22.2ROR 22.5 · χ² 18,919 / p <1e-300 | 20.6 EB05 19.6 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.4 | no trial arm names this drug |
| Deep vein thrombosis postoperative | 24 | 19.4 13.0–29.0ROR 19.4 · χ² 395 / p 3e-88 | 18.8 EB05 13.2 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=24 · 100% clinician | no trial arm names this drug |
| Onychomadesis | 50 | 19.1 14.4–25.2ROR 19.1 · χ² 827 / p 3e-182 | 18.7 EB05 14.7 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=50 · ♀ 100% (drug 62%) · 100% clinician | no trial arm names this drug |
Trial evidence (ClinicalTrials.gov)
ClinicalTrials.gov returned results-bearing trials mentioning Hydroxide only as a background or rescue medication (NCT00223080, NCT02117934); 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 |
|---|---|---|---|---|---|---|
| Constipation | 1,635 | 11.9 11.4–12.5ROR 13.4 · χ² 16,370 / p <1e-300 | 11.8 EB05 11.3 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.8 | no trial arm names this drug |
| Pain | 1,229 | 3.1 3.0–3.3ROR 3.3 · χ² 1,830 / p <1e-300 | 3.1 EB05 3.0 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.4 · ♀ 83% (drug 62%) | no trial arm names this drug |
| Fall | 1,171 | 5.5 5.2–5.8ROR 6.0 · χ² 4,394 / p <1e-300 | 5.5 EB05 5.2 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.7 · ♀ 82% (drug 62%) | no trial arm names this drug |
| Nausea | 1,071 | 2.1 2.0–2.3ROR 2.2 · χ² 662 / p 3e-146 | 2.1 EB05 2.0 · IC025 +1.0 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 |
| Chronic kidney disease | 1,010 | 20.9 19.7–22.2ROR 22.5 · χ² 18,919 / p <1e-300 | 20.6 EB05 19.6 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.4 | no trial arm names this drug |
| Drug ineffective (drug did not work) | 977 | 1.2 1.1–1.2ROR 1.2 · χ² 23 / p 7e-7 | 1.2 EB05 1.1 · IC025 +0.1 | Reporting / coding artifact | serious PRR 1.2 | no trial arm names this drug |
| Diarrhoea (diarrhea) | 908 | 2.2 2.1–2.4ROR 2.3 · χ² 619 / p 5e-137 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 1.9 | no trial arm names this drug |
| Hypotension (low blood pressure) | 886 | 7.0 6.5–7.4ROR 7.4 · χ² 4,530 / p <1e-300 | 6.9 EB05 6.5 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.8 · ♀ 82% (drug 62%) | no trial arm names this drug |
| Fatigue (tiredness) | 835 | 1.7 1.6–1.8ROR 1.7 · χ² 239 / p 3e-54 | 1.7 EB05 1.6 · IC025 +0.6 | No label text to screen label has no adverse-reaction text | serious PRR 1.8 | no trial arm names this drug |
| Off label use (used outside approved label) | 772 | 1.4 1.3–1.5ROR 1.4 · χ² 89 / p 2e-21 | 1.4 EB05 1.3 · IC025 +0.4 | Reporting / coding artifact | serious PRR 1.5 | no trial arm names this drug |
| Acute kidney injury (sudden kidney damage) | 740 | 7.6 7.1–8.2ROR 8.0 · χ² 4,272 / p <1e-300 | 7.6 EB05 7.1 · IC025 +2.8 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 |
| Dyspnoea (shortness of breath) | 736 | 2.0 1.9–2.2ROR 2.1 · χ² 398 / p 6e-89 | 2.0 EB05 1.9 · IC025 +0.9 | No label text to screen label has no adverse-reaction text | serious PRR 1.9 | no trial arm names this drug |
| Balance disorder | 719 | 13.1 12.2–14.1ROR 13.8 · χ² 7,988 / p <1e-300 | 13.0 EB05 12.2 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.8 · ♀ 91% (drug 62%) | no trial arm names this drug |
| Death | 702 | 1.3 1.2–1.4ROR 1.3 · χ² 43 / p 2e-11 | 1.3 EB05 1.2 · IC025 +0.2 | Outcome field, not a reaction | serious PRR 0.9 | no trial arm names this drug |
| Vomiting | 692 | 2.3 2.2–2.5ROR 2.4 · χ² 525 / p 2e-116 | 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 2.2 | 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 Hydroxide?
In FDA FAERS, the most frequently co-reported reaction terms for Hydroxide are constipation, pain, fall, nausea, chronic kidney disease, diarrhoea. 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 Hydroxide have an FDA boxed warning?
No. The FDA label retrieved for Hydroxide has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that 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 12361478-d178-4950-9458-4e2e56565599, effective 20231106; matched on
openfda.generic_name.exact:"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, 1,165 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
HYDROXIDE, 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.