Drug · FAERS side-effect profile with label screen
Sodium Citrate side effects: what 1,233 FDA adverse event reports show
Drug class
Not stated in label
Who reports
1,233 reports · 91% serious · 424 with death outcome · 51% female
openFDA FAERS counts, all years, deduplication not applied
Used for
For the relief of heartburn, sour stomach, acid indigestion, and upset stomach and accompanying nausea associated with overindulgence in food and drink.
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 3No label text to screen 31
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. 54 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 |
|---|---|---|---|---|---|---|
| Appendicitis | 230 | 431.5 383.4–485.8ROR 530.3 · χ² 95,942 / p <1e-300 | 406.5 EB05 364.3 · IC025 +7.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 271.2 · ♀ 3% (drug 51%) · 96% clinician | no trial data cached |
| Ventricular fibrillation | 214 | 333.2 294.6–376.9ROR 403.0 · χ² 69,209 / p <1e-300 | 317.5 EB05 283.3 · IC025 +7.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 208.0 · ♀ 3% (drug 51%) · 96% clinician | no trial data cached |
| Cardiogenic shock | 226 | 273.7 243.0–308.3ROR 334.9 · χ² 60,191 / p <1e-300 | 263.3 EB05 235.7 · IC025 +7.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 171.0 · ♀ 3% (drug 51%) · 96% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 231 | 142.0 126.3–159.6ROR 174.5 · χ² 31,963 / p <1e-300 | 139.2 EB05 124.7 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 89.4 · ♀ 3% (drug 51%) · 96% clinician | no trial data cached |
| Ascites | 231 | 134.6 119.8–151.3ROR 165.4 · χ² 30,300 / p <1e-300 | 132.1 EB05 118.4 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 86.1 · ♀ 3% (drug 51%) · 96% clinician | no trial data cached |
| Incorrect route of product administration | 125 | 127.4 107.9–150.6ROR 141.7 · χ² 15,450 / p <1e-300 | 124.1 EB05 106.9 · IC025 +6.1 3/3 methods agree | Reporting / coding artifact | serious PRR 160.6 · ♀ 5% (drug 51%) · 98% clinician | no trial data cached |
| Bacterial infection | 118 | 108.7 91.5–129.2ROR 120.1 · χ² 12,419 / p <1e-300 | 106.2 EB05 91.1 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 78.6 · ♀ 7% (drug 51%) · 95% clinician | no trial data cached |
| Hyperlipidaemia | 66 | 94.2 74.4–119.1ROR 99.4 · χ² 5,960 / p <1e-300 | 91.2 EB05 74.2 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 65.5 · ♀ 14% (drug 51%) · 97% clinician | no trial data cached |
| Neuralgia | 116 | 81.7 68.7–97.2ROR 90.1 · χ² 9,135 / p <1e-300 | 80.3 EB05 68.8 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 76.7 · ♀ 5% (drug 51%) · 97% clinician | no trial data cached |
| Hyponatraemia (low sodium) | 252 | 76.6 68.6–85.5ROR 96.0 · χ² 18,689 / p <1e-300 | 75.8 EB05 68.3 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 49.5 · ♀ 2% (drug 51%) · 92% clinician | no trial data cached |
| Ulcer | 66 | 70.7 55.9–89.5ROR 74.7 · χ² 4,453 / p <1e-300 | 69.1 EB05 56.2 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 56.5 · ♀ 8% (drug 51%) · 95% clinician | no trial data cached |
| End stage renal disease | 75 | 69.5 55.8–86.6ROR 74.0 · χ² 4,981 / p <1e-300 | 68.1 EB05 56.1 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 44.0 · ♀ 10% (drug 51%) · 95% clinician | no trial data cached |
| Gout | 65 | 61.7 48.7–78.3ROR 65.1 · χ² 3,813 / p <1e-300 | 60.5 EB05 49.1 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 59.1 · ♀ 9% (drug 51%) · 98% clinician | no trial data cached |
| Caesarean section | 40 | 58.0 42.8–78.8ROR 59.9 · χ² 2,179 / p <1e-300 | 56.4 EB05 43.2 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 34.0 · 100% clinician | no trial data cached |
| Stress | 228 | 54.1 48.1–60.8ROR 66.1 · χ² 11,828 / p <1e-300 | 53.7 EB05 48.1 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 56.8 · ♀ 3% (drug 51%) · 96% clinician | no trial data cached |
| Blood test abnormal | 43 | 52.2 38.9–70.1ROR 54.1 · χ² 2,105 / p <1e-300 | 51.0 EB05 39.4 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | serious PRR 50.7 · ♀ 13% (drug 51%) · 95% clinician | no trial data cached |
| Blood calcium decreased | 33 | 49.9 35.6–69.9ROR 51.2 · χ² 1,529 / p <1e-300 | 48.4 EB05 36.1 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious PRR 39.5 · ♀ 97% (drug 51%) | no trial data cached |
| Blood cholesterol increased | 128 | 46.8 39.7–55.2ROR 52.1 · χ² 5,688 / p <1e-300 | 46.4 EB05 40.0 · IC025 +5.0 3/3 methods agree | Lab value / disease marker | serious PRR 45.0 · ♀ 6% (drug 51%) · 97% clinician | no trial data cached |
| Abdominal distension (bloating) | 240 | 39.3 35.1–44.1ROR 48.6 · χ² 8,954 / p <1e-300 | 39.1 EB05 35.2 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 43.8 · ♀ 4% (drug 51%) · 95% clinician | no trial data cached |
| Chronic obstructive pulmonary disease | 120 | 39.2 33.1–46.5ROR 43.4 · χ² 4,433 / p <1e-300 | 38.9 EB05 33.4 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 29.0 · ♀ 6% (drug 51%) · 97% clinician | no trial data cached |
| Aspiration | 24 | 37.8 25.4–56.1ROR 38.5 · χ² 821 / p 8e-181 | 36.7 EB05 25.9 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 24.6 · ♀ 5% (drug 51%) · 100% clinician | no trial data cached |
| Sepsis (blood infection) | 241 | 36.8 32.9–41.2ROR 45.5 · χ² 8,385 / p <1e-300 | 36.6 EB05 32.9 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 23.5 · ♀ 5% (drug 51%) · 95% clinician | no trial data cached |
| General physical health deterioration | 245 | 36.3 32.5–40.7ROR 45.1 · χ² 8,414 / p <1e-300 | 36.2 EB05 32.5 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious PRR 27.0 · ♀ 7% (drug 51%) · 95% clinician | no trial data cached |
| Drug exposure during pregnancy | 73 | 36.1 28.9–45.1ROR 38.3 · χ² 2,452 / p <1e-300 | 35.7 EB05 29.3 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | serious PRR 22.6 · ♀ 84% (drug 51%) · 98% clinician | no trial data cached |
| Hypercholesterolaemia | 18 | 32.0 20.3–50.7ROR 32.5 · χ² 510 / p 3e-113 | 31.0 EB05 20.8 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 21.6 | no trial data cached |
| Status epilepticus | 21 | 31.6 20.7–48.3ROR 32.1 · χ² 592 / p 6e-131 | 30.8 EB05 21.2 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 20.1 · ♀ 90% (drug 51%) | no trial data cached |
| Micturition urgency | 21 | 31.6 20.6–48.2ROR 32.1 · χ² 590 / p 1e-130 | 30.7 EB05 21.2 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 31.5 · 95% clinician | no trial data cached |
| Dry mouth | 147 | 30.9 26.6–36.0ROR 35.0 · χ² 4,235 / p <1e-300 | 30.8 EB05 26.8 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 38.7 · ♀ 5% (drug 51%) · 96% clinician | no trial data cached |
| Full blood count abnormal | 19 | 30.7 19.6–48.0ROR 31.2 · χ² 516 / p 2e-114 | 29.8 EB05 20.2 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious PRR 25.9 | no trial data cached |
| Premature baby | 52 | 29.3 22.5–38.3ROR 30.6 · χ² 1,395 / p <1e-300 | 29.0 EB05 23.0 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 18.2 · 100% clinician | no trial data cached |
| Diabetes mellitus | 127 | 28.2 24.0–33.3ROR 31.4 · χ² 3,318 / p <1e-300 | 28.1 EB05 24.2 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.5 · ♀ 11% (drug 51%) · 95% clinician | no trial data cached |
| Encephalopathy | 39 | 27.1 19.9–36.9ROR 28.0 · χ² 955 / p 6e-210 | 26.8 EB05 20.4 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.8 · ♀ 97% (drug 51%) | no trial data cached |
| Thrombosis | 128 | 27.0 22.9–31.8ROR 30.0 · χ² 3,189 / p <1e-300 | 26.9 EB05 23.2 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.8 · ♀ 12% (drug 51%) · 96% clinician | no trial data cached |
| Sleep disorder | 111 | 27.0 22.6–32.3ROR 29.6 · χ² 2,760 / p <1e-300 | 26.9 EB05 22.9 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 28.3 · ♀ 7% (drug 51%) · 95% clinician | no trial data cached |
| Liver function test increased | 32 | 25.6 18.1–36.0ROR 26.2 · χ² 730 / p 4e-161 | 25.2 EB05 18.7 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.3 · 91% clinician | no trial data cached |
| Sputum discoloured | 14 | 25.2 15.0–42.5ROR 25.5 · χ² 302 / p 8e-68 | 24.4 EB05 15.3 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 21.0 | no trial data cached |
| Intentional product misuse | 117 | 22.9 19.3–27.3ROR 25.2 · χ² 2,440 / p <1e-300 | 22.8 EB05 19.6 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious PRR 32.8 · ♀ 7% (drug 51%) · 95% clinician | no trial data cached |
| Swelling | 121 | 22.1 18.6–26.1ROR 24.4 · χ² 2,420 / p <1e-300 | 22.0 EB05 18.9 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.5 · ♀ 8% (drug 51%) · 95% clinician | no trial data cached |
| Exposure during pregnancy | 79 | 21.6 17.5–26.8ROR 23.0 · χ² 1,537 / p <1e-300 | 21.5 EB05 17.8 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 19.1 · ♀ 100% (drug 51%) | no trial data cached |
| Obstructive airways disorder | 14 | 21.4 12.7–36.0ROR 21.6 · χ² 251 / p 6e-57 | 20.6 EB05 12.8 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.1 | 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 |
|---|---|---|---|---|---|---|
| Vomiting | 270 | 9.8 8.8–10.9ROR 12.3 · χ² 2,172 / p <1e-300 | 9.7 EB05 8.8 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.2 · ♀ 16% (drug 51%) · 93% clinician | no trial data cached |
| Hyponatraemia (low sodium) | 252 | 76.6 68.6–85.5ROR 96.0 · χ² 18,689 / p <1e-300 | 75.8 EB05 68.3 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 49.5 · ♀ 2% (drug 51%) · 92% clinician | no trial data cached |
| General physical health deterioration | 245 | 36.3 32.5–40.7ROR 45.1 · χ² 8,414 / p <1e-300 | 36.2 EB05 32.5 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious PRR 27.0 · ♀ 7% (drug 51%) · 95% clinician | no trial data cached |
| Abdominal pain | 241 | 17.6 15.8–19.8ROR 21.7 · χ² 3,806 / p <1e-300 | 17.6 EB05 15.8 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.9 · ♀ 10% (drug 51%) · 95% clinician | no trial data cached |
| Sepsis (blood infection) | 241 | 36.8 32.9–41.2ROR 45.5 · χ² 8,385 / p <1e-300 | 36.6 EB05 32.9 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 23.5 · ♀ 5% (drug 51%) · 95% clinician | no trial data cached |
| Abdominal distension (bloating) | 240 | 39.3 35.1–44.1ROR 48.6 · χ² 8,954 / p <1e-300 | 39.1 EB05 35.2 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 43.8 · ♀ 4% (drug 51%) · 95% clinician | no trial data cached |
| Constipation | 234 | 18.4 16.4–20.7ROR 22.5 · χ² 3,871 / p <1e-300 | 18.4 EB05 16.5 · IC025 +3.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 21.0 · ♀ 8% (drug 51%) · 95% clinician | no trial data cached |
| Ascites | 231 | 134.6 119.8–151.3ROR 165.4 · χ² 30,300 / p <1e-300 | 132.1 EB05 118.4 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 86.1 · ♀ 3% (drug 51%) · 96% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 231 | 142.0 126.3–159.6ROR 174.5 · χ² 31,963 / p <1e-300 | 139.2 EB05 124.7 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 89.4 · ♀ 3% (drug 51%) · 96% clinician | no trial data cached |
| Appendicitis | 230 | 431.5 383.4–485.8ROR 530.3 · χ² 95,942 / p <1e-300 | 406.5 EB05 364.3 · IC025 +7.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 271.2 · ♀ 3% (drug 51%) · 96% clinician | no trial data cached |
| Stress | 228 | 54.1 48.1–60.8ROR 66.1 · χ² 11,828 / p <1e-300 | 53.7 EB05 48.1 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 56.8 · ♀ 3% (drug 51%) · 96% clinician | no trial data cached |
| Cardiogenic shock | 226 | 273.7 243.0–308.3ROR 334.9 · χ² 60,191 / p <1e-300 | 263.3 EB05 235.7 · IC025 +7.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 171.0 · ♀ 3% (drug 51%) · 96% clinician | no trial data cached |
| Ventricular fibrillation | 214 | 333.2 294.6–376.9ROR 403.0 · χ² 69,209 / p <1e-300 | 317.5 EB05 283.3 · IC025 +7.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 208.0 · ♀ 3% (drug 51%) · 96% clinician | no trial data cached |
| Condition aggravated | 174 | 9.8 8.5–11.3ROR 11.3 · χ² 1,386 / p <1e-300 | 9.7 EB05 8.5 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 9.5 · ♀ 14% (drug 51%) · 94% clinician | no trial data cached |
| Somnolence (drowsiness) | 164 | 13.9 12.0–16.0ROR 15.9 · χ² 1,965 / p <1e-300 | 13.8 EB05 12.1 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.0 · ♀ 9% (drug 51%) · 93% 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 Sodium Citrate?
In FDA FAERS, the most frequently co-reported reaction terms for Sodium Citrate are vomiting, hyponatraemia, abdominal pain, sepsis, abdominal distension, constipation. 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 Sodium Citrate have an FDA boxed warning?
No. The FDA label retrieved for Sodium Citrate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Sodium Citrate 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 25c9825d-a4e8-4671-e063-6294a90ab46d, effective 20250624; matched on
openfda.generic_name.exact:"SODIUM CITRATE") - 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, 94 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.