Drug · FAERS side-effect profile with label screen
Magnesium Citrate Oral Solution side effects: what 5,978 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Magnesium Citrate
openFDA label
Who reports
5,978 reports · 71% serious · 1,018 with death outcome · 72% female
openFDA FAERS counts, all years, deduplication not applied
Used for
■ For relief of occasional constipation (irregularity). ■ Generally produces bowel movement in ½ 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 4Lab value / disease marker 3No label text to screen 33
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. 644 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 |
|---|---|---|---|---|---|---|
| Folliculitis | 329 | 115.3 103.6–128.3ROR 122.0 · χ² 35,983 / p <1e-300 | 110.9 EB05 101.2 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 105.5 · ♀ 99% (drug 72%) | not reported in cached trials |
| Pemphigus | 385 | 112.0 101.5–123.6ROR 119.6 · χ² 40,943 / p <1e-300 | 108.0 EB05 99.2 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 88.1 · ♀ 100% (drug 72%) · 92% clinician | not reported in cached trials |
| Hypercholesterolaemia | 274 | 103.3 91.9–116.2ROR 108.2 · χ² 26,873 / p <1e-300 | 99.7 EB05 90.2 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 86.0 · ♀ 100% (drug 72%) | not reported in cached trials |
| Helicobacter infection | 285 | 100.8 89.8–113.1ROR 105.8 · χ² 27,276 / p <1e-300 | 97.3 EB05 88.2 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 83.8 · ♀ 99% (drug 72%) | not reported in cached trials |
| Bursitis | 313 | 93.3 83.7–104.1ROR 98.4 · χ² 27,766 / p <1e-300 | 90.4 EB05 82.3 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 86.6 · ♀ 99% (drug 72%) | not reported in cached trials |
| Joint range of motion decreased | 314 | 84.3 75.6–94.0ROR 88.9 · χ² 25,167 / p <1e-300 | 81.9 EB05 74.6 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 84.4 · ♀ 100% (drug 72%) | not reported in cached trials |
| Pericarditis | 389 | 83.8 76.0–92.3ROR 89.5 · χ² 31,000 / p <1e-300 | 81.5 EB05 74.9 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 66.8 · ♀ 100% (drug 72%) · 92% clinician | not reported in cached trials |
| Wound infection | 235 | 77.4 68.2–87.9ROR 80.6 · χ² 17,278 / p <1e-300 | 75.3 EB05 67.6 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 65.8 · ♀ 100% (drug 72%) | not reported in cached trials |
| Synovitis | 377 | 74.8 67.7–82.5ROR 79.7 · χ² 26,807 / p <1e-300 | 72.9 EB05 67.0 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 62.1 · ♀ 100% (drug 72%) · 92% clinician | not reported in cached trials |
| Hand deformity | 272 | 74.4 66.2–83.7ROR 77.9 · χ² 19,221 / p <1e-300 | 72.5 EB05 65.5 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 64.1 · ♀ 100% (drug 72%) | not reported in cached trials |
| Back injury | 223 | 73.7 64.7–83.9ROR 76.5 · χ² 15,594 / p <1e-300 | 71.7 EB05 64.2 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 77.0 · ♀ 98% (drug 72%) | not reported in cached trials |
| Taste disorder | 332 | 59.0 53.1–65.6ROR 62.4 · χ² 18,584 / p <1e-300 | 57.9 EB05 52.8 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 92.7 · ♀ 97% (drug 72%) | not reported in cached trials |
| Irritable bowel syndrome | 331 | 55.1 49.6–61.3ROR 58.3 · χ² 17,283 / p <1e-300 | 54.1 EB05 49.4 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 55.1 · ♀ 98% (drug 72%) | not reported in cached trials |
| Obesity | 239 | 53.3 47.0–60.4ROR 55.5 · χ² 12,033 / p <1e-300 | 52.3 EB05 47.0 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 49.1 · ♀ 98% (drug 72%) | not reported in cached trials |
| Glossodynia (burning tongue/mouth pain) | 330 | 52.5 47.2–58.4ROR 55.5 · χ² 16,388 / p <1e-300 | 51.6 EB05 47.1 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 60.6 · ♀ 100% (drug 72%) | not reported in cached trials |
| Coeliac disease | 141 | 51.1 43.3–60.2ROR 52.3 · χ² 6,774 / p <1e-300 | 50.0 EB05 43.5 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 49.7 · ♀ 100% (drug 72%) | not reported in cached trials |
| Fibromyalgia | 347 | 50.8 45.8–56.3ROR 53.9 · χ² 16,662 / p <1e-300 | 49.9 EB05 45.7 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 52.7 · ♀ 100% (drug 72%) | not reported in cached trials |
| Wound | 396 | 50.6 46.0–55.7ROR 54.1 · χ² 18,964 / p <1e-300 | 49.8 EB05 45.8 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 48.1 · ♀ 99% (drug 72%) | not reported in cached trials |
| Contraindicated product administered | 375 | 44.1 40.0–48.7ROR 47.0 · χ² 15,581 / p <1e-300 | 43.5 EB05 39.9 · IC025 +5.2 3/3 methods agree | Reporting / coding artifact | serious PRR 43.8 · ♀ 100% (drug 72%) · 90% clinician | not reported in cached trials |
| Liver injury | 296 | 43.4 38.8–48.6ROR 45.6 · χ² 12,088 / p <1e-300 | 42.8 EB05 38.8 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 36.0 · ♀ 99% (drug 72%) · 91% clinician | not reported in cached trials |
| Epilepsy | 329 | 38.2 34.4–42.4ROR 40.4 · χ² 11,765 / p <1e-300 | 37.7 EB05 34.4 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 30.8 · ♀ 100% (drug 72%) | not reported in cached trials |
| Type 2 diabetes mellitus | 363 | 38.1 34.4–42.1ROR 40.5 · χ² 12,945 / p <1e-300 | 37.6 EB05 34.5 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 32.0 · ♀ 99% (drug 72%) · 91% clinician | not reported in cached trials |
| Systemic lupus erythematosus | 354 | 35.4 32.0–39.2ROR 37.6 · χ² 11,706 / p <1e-300 | 35.0 EB05 32.1 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 29.1 · ♀ 100% (drug 72%) · 91% clinician | not reported in cached trials |
| Impaired healing | 327 | 35.2 31.7–39.2ROR 37.2 · χ² 10,753 / p <1e-300 | 34.8 EB05 31.8 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious PRR 34.1 · ♀ 99% (drug 72%) | not reported in cached trials |
| C-reactive protein increased | 360 | 35.0 31.7–38.7ROR 37.2 · χ² 11,769 / p <1e-300 | 34.6 EB05 31.7 · IC025 +4.9 3/3 methods agree | Lab value / disease marker | serious PRR 29.2 · ♀ 100% (drug 72%) · 96% clinician | not reported in cached trials |
| Psoriatic arthropathy | 396 | 34.8 31.7–38.3ROR 37.2 · χ² 12,879 / p <1e-300 | 34.5 EB05 31.7 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 35.2 · ♀ 100% (drug 72%) · 92% clinician | not reported in cached trials |
| Liver function test increased | 210 | 34.8 30.5–39.8ROR 36.1 · χ² 6,808 / p <1e-300 | 34.4 EB05 30.7 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 43.2 · ♀ 98% (drug 72%) | not reported in cached trials |
| Night sweats | 317 | 34.8 31.3–38.8ROR 36.7 · χ² 10,298 / p <1e-300 | 34.4 EB05 31.4 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 46.8 · ♀ 97% (drug 72%) | not reported in cached trials |
| Adverse reaction | 128 | 34.1 28.7–40.5ROR 34.9 · χ² 4,046 / p <1e-300 | 33.7 EB05 29.0 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious n=128 · ♀ 99% (drug 72%) | not reported in cached trials |
| Red blood cell sedimentation rate increased | 103 | 32.8 27.1–39.8ROR 33.4 · χ² 3,120 / p <1e-300 | 32.4 EB05 27.5 · IC025 +4.5 3/3 methods agree | Lab value / disease marker | serious PRR 29.9 · ♀ 100% (drug 72%) · 95% clinician | not reported in cached trials |
| Autoimmune disorder | 83 | 30.6 24.7–38.0ROR 31.1 · χ² 2,331 / p <1e-300 | 30.2 EB05 25.1 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 26.3 · ♀ 100% (drug 72%) · 90% clinician | not reported in cached trials |
| Therapeutic product effect decreased | 364 | 29.0 26.2–32.0ROR 30.8 · χ² 9,743 / p <1e-300 | 28.7 EB05 26.3 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious PRR 45.4 · ♀ 99% (drug 72%) | not reported in cached trials |
| Blood cholesterol increased | 377 | 28.6 25.9–31.5ROR 30.4 · χ² 9,937 / p <1e-300 | 28.3 EB05 26.0 · IC025 +4.6 3/3 methods agree | Lab value / disease marker | serious PRR 33.9 · ♀ 100% (drug 72%) | not reported in cached trials |
| Gait inability | 259 | 27.6 24.5–31.1ROR 28.8 · χ² 6,579 / p <1e-300 | 27.4 EB05 24.7 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 27.3 · ♀ 98% (drug 72%) | not reported in cached trials |
| Laryngitis | 81 | 26.3 21.2–32.7ROR 26.7 · χ² 1,935 / p <1e-300 | 26.0 EB05 21.6 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=81 · ♀ 100% (drug 72%) · 93% clinician | not reported in cached trials |
| Prescribed overdose | 138 | 25.2 21.3–29.7ROR 25.7 · χ² 3,158 / p <1e-300 | 24.9 EB05 21.6 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 33.5 · ♀ 98% (drug 72%) · 96% clinician | not reported in cached trials |
| Osteoarthritis | 296 | 24.6 22.0–27.5ROR 25.8 · χ² 6,641 / p <1e-300 | 24.4 EB05 22.1 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.0 · ♀ 98% (drug 72%) | not reported in cached trials |
| Lower respiratory tract infection | 280 | 21.8 19.4–24.4ROR 22.8 · χ² 5,509 / p <1e-300 | 21.6 EB05 19.6 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.4 · ♀ 98% (drug 72%) | not reported in cached trials |
| Infusion related reaction (reaction during infusion) | 408 | 21.8 19.8–23.9ROR 23.3 · χ² 8,042 / p <1e-300 | 21.6 EB05 19.9 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 21.8 · ♀ 98% (drug 72%) | not reported in cached trials |
| Inflammation | 313 | 21.5 19.3–24.0ROR 22.6 · χ² 6,073 / p <1e-300 | 21.3 EB05 19.4 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.7 · ♀ 98% (drug 72%) | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Magnesium Citrate Oral Solution as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (0 of 40 signal terms matched).
- NCT03017235 — A Study Comparing the Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution With PREPOPI (N=917, PHASE3; 20 AE terms posted; arms: NaP/MC Oral Solution; PREPOPIK®)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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) | 820 | 3.7 3.5–3.9ROR 4.1 · χ² 1,675 / p <1e-300 | 3.7 EB05 3.5 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.4 | not reported in cached trials |
| Nausea | 814 | 3.6 3.4–3.9ROR 4.0 · χ² 1,599 / p <1e-300 | 3.6 EB05 3.4 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.6 | not reported in cached trials |
| Off label use (used outside approved label) | 764 | 3.1 2.9–3.3ROR 3.4 · χ² 1,122 / p 3e-246 | 3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 4.0 | not reported in cached trials |
| Drug ineffective (drug did not work) | 758 | 2.0 1.9–2.2ROR 2.2 · χ² 414 / p 2e-92 | 2.0 EB05 1.9 · IC025 +0.9 | Reporting / coding artifact | serious PRR 3.7 | not reported in cached trials |
| Pain | 754 | 4.3 4.0–4.6ROR 4.8 · χ² 1,961 / p <1e-300 | 4.3 EB05 4.0 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.0 | not reported in cached trials |
| Diarrhoea (diarrhea) | 731 | 4.0 3.7–4.3ROR 4.4 · χ² 1,682 / p <1e-300 | 4.0 EB05 3.7 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.5 | not reported in cached trials |
| Headache | 671 | 3.8 3.5–4.0ROR 4.1 · χ² 1,396 / p <1e-300 | 3.7 EB05 3.5 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.2 · ♀ 92% (drug 72%) | not reported in cached trials |
| Asthenia (weakness) | 579 | 5.4 5.0–5.8ROR 5.9 · χ² 2,108 / p <1e-300 | 5.4 EB05 5.0 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.7 | not reported in cached trials |
| Dizziness | 575 | 4.1 3.7–4.4ROR 4.4 · χ² 1,349 / p 1e-295 | 4.0 EB05 3.8 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.1 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 569 | 3.5 3.3–3.8ROR 3.8 · χ² 1,056 / p 6e-232 | 3.5 EB05 3.3 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.7 | not reported in cached trials |
| Rash | 560 | 4.5 4.2–4.9ROR 4.9 · χ² 1,568 / p <1e-300 | 4.5 EB05 4.2 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.4 · ♀ 93% (drug 72%) | not reported in cached trials |
| Arthralgia (joint pain) | 553 | 4.7 4.3–5.1ROR 5.1 · χ² 1,628 / p <1e-300 | 4.7 EB05 4.3 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.2 | not reported in cached trials |
| Vomiting | 525 | 3.9 3.6–4.3ROR 4.2 · χ² 1,168 / p 3e-256 | 3.9 EB05 3.6 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.3 | not reported in cached trials |
| Abdominal pain upper | 490 | 8.4 7.7–9.1ROR 9.0 · χ² 3,200 / p <1e-300 | 8.3 EB05 7.7 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.5 · ♀ 92% (drug 72%) | not reported in cached trials |
| Gastrooesophageal reflux disease (acid reflux) | 476 | 20.9 19.2–22.8ROR 22.6 · χ² 8,991 / p <1e-300 | 20.8 EB05 19.3 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.9 · ♀ 97% (drug 72%) | not reported in cached trials |
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.
✓ A hand-written Bradford Hill causality assessment exists for this drug: Minoxidil (oral) ↔ Pericardial effusion.
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 Magnesium Citrate Oral Solution?
In FDA FAERS, the most frequently co-reported reaction terms for Magnesium Citrate Oral Solution are fatigue, nausea, pain, diarrhoea, headache, asthenia. 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 Magnesium Citrate Oral Solution have an FDA boxed warning?
No. The FDA label retrieved for Magnesium Citrate Oral Solution has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Magnesium Citrate Oral Solution 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 4019fbd0-fcf9-77a6-e063-6294a90a5ae7, effective 20250930; matched on
openfda.generic_name.exact:"MAGNESIUM CITRATE ORAL SOLUTION") - 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, 684 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
MAGNESIUM CITRATE ORAL SOLUTION, 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.