Drug · FAERS side-effect profile with label screen
Trisodium side effects: what 6,860 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Trisodium Citrate Dihydrate (Sodium Citrate W/V Anticoagulant)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
6,860 reports · 3% serious · 101 with death outcome · 70% female
openFDA FAERS counts, all years, deduplication not applied
Used for
SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP is intended for use only for the anticoagulation of whole blood as part of automated apheresis procedures. [See Dosage and Administration (2) .] SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP is intended for use only for the anticoagulation of whole blood as part of automated apheresis procedures. ( 1 )
FDA label, Indications and Usage
What it is
SODIUM CITRATE 4% W/V ANTICOAGULANT SOLUTION USP is designed to be metered by an apheresis device in apheresis procedures, to prevent platelet activation and coagulation as blood moves throughout the extracorporeal unit (tubing set) in an apheresis procedure.
FDA label, Description section
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
Labeled adverse reaction 1Reporting / coding artifact 1Not in label — unassessed 38
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- 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.
- 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.
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. 41 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 |
|---|---|---|---|---|---|---|
| Pallor | 2,657 | 330.2 319.7–341.0ROR 538.3 · χ² 786,697 / p <1e-300 | 297.1 EB05 287.7 · IC025 +8.1 3/3 methods agree | Not in label — unassessed | serious PRR 136.8 · 100% clinician | no trial data cached |
| Thirst | 1,340 | 248.6 236.4–261.4ROR 308.7 · χ² 305,289 / p <1e-300 | 229.0 EB05 218.9 · IC025 +7.6 3/3 methods agree | Not in label — unassessed | serious PRR 56.0 · 100% clinician | no trial data cached |
| Feeling hot | 2,896 | 151.4 147.1–155.9ROR 261.3 · χ² 413,107 / p <1e-300 | 144.1 EB05 139.7 · IC025 +7.1 3/3 methods agree | Not in label — unassessed | serious PRR 82.0 · 100% clinician | no trial data cached |
| Paraesthesia (tingling/numbness) | 5,693 | 114.5 113.1–115.9ROR 668.2 · χ² 621,617 / p <1e-300 | 110.3 EB05 107.9 · IC025 +6.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 39.6 · 100% clinician | no trial data cached |
| Hyperhidrosis (excessive sweating) | 2,310 | 55.7 53.9–57.7ROR 83.5 · χ² 122,647 / p <1e-300 | 54.7 EB05 52.9 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 34.1 · 100% clinician | no trial data cached |
| Injection site haematoma | 242 | 51.3 45.3–58.1ROR 53.2 · χ² 11,698 / p <1e-300 | 50.3 EB05 45.2 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=1 · 100% clinician | no trial data cached |
| Restlessness | 573 | 48.5 44.9–52.5ROR 52.9 · χ² 26,257 / p <1e-300 | 47.7 EB05 44.5 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 23.3 · 100% clinician | no trial data cached |
| Dysgeusia (altered taste) | 1,165 | 48.4 45.9–51.1ROR 58.1 · χ² 53,403 / p <1e-300 | 47.6 EB05 45.4 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 28.3 · 100% clinician | no trial data cached |
| Paraesthesia oral | 158 | 34.0 29.1–39.7ROR 34.7 · χ² 4,970 / p <1e-300 | 33.5 EB05 29.3 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 87.1 · 100% clinician | no trial data cached |
| Vision blurred (blurred vision) | 1,190 | 26.9 25.5–28.3ROR 32.3 · χ² 29,528 / p <1e-300 | 26.6 EB05 25.4 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 · 100% clinician | no trial data cached |
| Hypoaesthesia oral | 123 | 25.2 21.1–30.0ROR 25.6 · χ² 2,808 / p <1e-300 | 24.9 EB05 21.4 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 72.1 · 100% clinician | no trial data cached |
| Dyspepsia (indigestion) | 711 | 22.3 20.8–23.9ROR 24.8 · χ² 14,412 / p <1e-300 | 22.1 EB05 20.8 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 2.2 · 100% clinician | no trial data cached |
| Chills | 756 | 19.8 18.5–21.2ROR 22.1 · χ² 13,466 / p <1e-300 | 19.7 EB05 18.5 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 · 100% clinician | no trial data cached |
| Appendicitis | 57 | 18.9 14.5–24.4ROR 19.0 · χ² 940 / p 8e-207 | 18.6 EB05 14.9 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 335.1 · ♀ 0% (drug 70%) · 95% clinician | no trial data cached |
| Dizziness | 2,967 | 18.3 17.8–18.8ROR 31.5 · χ² 49,452 / p <1e-300 | 18.2 EB05 17.7 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 · 100% clinician | no trial data cached |
| Cold sweat | 95 | 16.5 13.5–20.2ROR 16.8 · χ² 1,365 / p 4e-299 | 16.4 EB05 13.8 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 101.2 · 100% clinician | no trial data cached |
| Peripheral coldness | 72 | 16.0 12.7–20.2ROR 16.2 · χ² 996 / p 6e-219 | 15.9 EB05 13.0 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 65.3 · 100% clinician | no trial data cached |
| Ventricular fibrillation | 50 | 13.8 10.4–18.2ROR 13.9 · χ² 578 / p 6e-128 | 13.5 EB05 10.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 242.3 · ♀ 0% (drug 70%) · 94% clinician | no trial data cached |
| Neck pain | 226 | 12.4 10.9–14.1ROR 12.8 · χ² 2,352 / p <1e-300 | 12.3 EB05 11.0 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 · 100% clinician | no trial data cached |
| Nausea | 3,051 | 11.9 11.6–12.2ROR 20.6 · χ² 31,403 / p <1e-300 | 11.8 EB05 11.5 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 15.5 · 100% clinician | no trial data cached |
| Cardiogenic shock | 55 | 11.8 9.1–15.4ROR 11.9 · χ² 532 / p 4e-118 | 11.5 EB05 9.1 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 207.5 · ♀ 0% (drug 70%) · 95% clinician | no trial data cached |
| Asthenia (weakness) | 1,370 | 11.2 10.7–11.7ROR 13.7 · χ² 12,865 / p <1e-300 | 11.1 EB05 10.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 · 100% clinician | no trial data cached |
| Hypoaesthesia (numbness) | 531 | 10.9 10.0–11.8ROR 11.7 · χ² 4,764 / p <1e-300 | 10.8 EB05 10.0 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 36.0 · 100% clinician | no trial data cached |
| Tachypnoea | 48 | 10.9 8.2–14.4ROR 10.9 · χ² 419 / p 2e-93 | 10.5 EB05 8.1 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 114.6 · ♀ 43% (drug 70%) · 100% clinician | no trial data cached |
| Movement disorder | 109 | 10.4 8.6–12.5ROR 10.5 · χ² 911 / p 3e-200 | 10.2 EB05 8.6 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 29.9 · 100% clinician | no trial data cached |
| Muscle spasms | 516 | 8.6 7.9–9.4ROR 9.2 · χ² 3,486 / p <1e-300 | 8.6 EB05 7.9 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 27.9 · 100% clinician | no trial data cached |
| Ascites | 75 | 7.8 6.2–9.8ROR 7.9 · χ² 438 / p 1e-97 | 7.5 EB05 6.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 139.3 · ♀ 0% (drug 70%) · 96% clinician | no trial data cached |
| Incorrect route of product administration | 42 | 7.7 5.7–10.4ROR 7.7 · χ² 236 / p 1e-53 | 7.2 EB05 5.5 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 243.5 · ♀ 14% (drug 70%) · 95% clinician | no trial data cached |
| Muscle twitching | 53 | 7.0 5.4–9.2ROR 7.1 · χ² 267 / p 2e-60 | 6.7 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 47.3 · 100% clinician | no trial data cached |
| Palpitations (pounding heartbeat) | 251 | 6.6 5.8–7.4ROR 6.8 · χ² 1,184 / p 1e-259 | 6.5 EB05 5.8 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 0.7 · 100% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 58 | 6.4 4.9–8.2ROR 6.4 · χ² 257 / p 4e-58 | 6.1 EB05 4.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 111.9 · ♀ 2% (drug 70%) · 93% clinician | no trial data cached |
| Abdominal pain | 473 | 6.2 5.7–6.8ROR 6.6 · χ² 2,090 / p <1e-300 | 6.2 EB05 5.7 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 22.2 · 99% clinician | no trial data cached |
| Bacterial infection | 37 | 6.1 4.4–8.4ROR 6.1 · χ² 153 / p 2e-35 | 5.7 EB05 4.3 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 124.0 · ♀ 0% (drug 70%) · 95% clinician | no trial data cached |
| Atelectasis | 18 | 5.7 3.6–9.0ROR 5.7 · χ² 65 / p 4e-16 | 5.0 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 101.1 | no trial data cached |
| Confusional state (confusion) | 295 | 5.6 5.0–6.2ROR 5.8 · χ² 1,110 / p 9e-244 | 5.5 EB05 5.0 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 · 100% clinician | no trial data cached |
| Brain injury | 18 | 5.5 3.5–8.7ROR 5.5 · χ² 62 / p 2e-15 | 4.9 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 98.0 | no trial data cached |
| Motor dysfunction | 18 | 5.4 3.4–8.6ROR 5.5 · χ² 61 / p 3e-15 | 4.8 EB05 3.2 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 120.7 | no trial data cached |
| Neuralgia | 37 | 4.7 3.4–6.4ROR 4.7 · χ² 103 / p 2e-24 | 4.4 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 122.1 · ♀ 0% (drug 70%) · 95% clinician | no trial data cached |
| Muscle tightness | 24 | 4.5 3.0–6.8ROR 4.6 · χ² 63 / p 1e-15 | 4.2 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 · 100% clinician | no trial data cached |
| Muscle atrophy | 18 | 4.4 2.8–7.0ROR 4.4 · χ² 44 / p 2e-11 | 4.0 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 99.5 | 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 |
|---|---|---|---|---|---|---|
| Paraesthesia (tingling/numbness) | 5,693 | 114.5 113.1–115.9ROR 668.2 · χ² 621,617 / p <1e-300 | 110.3 EB05 107.9 · IC025 +6.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 39.6 · 100% clinician | no trial data cached |
| Nausea | 3,051 | 11.9 11.6–12.2ROR 20.6 · χ² 31,403 / p <1e-300 | 11.8 EB05 11.5 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 15.5 · 100% clinician | no trial data cached |
| Dizziness | 2,967 | 18.3 17.8–18.8ROR 31.5 · χ² 49,452 / p <1e-300 | 18.2 EB05 17.7 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 · 100% clinician | no trial data cached |
| Feeling hot | 2,896 | 151.4 147.1–155.9ROR 261.3 · χ² 413,107 / p <1e-300 | 144.1 EB05 139.7 · IC025 +7.1 3/3 methods agree | Not in label — unassessed | serious PRR 82.0 · 100% clinician | no trial data cached |
| Pallor | 2,657 | 330.2 319.7–341.0ROR 538.3 · χ² 786,697 / p <1e-300 | 297.1 EB05 287.7 · IC025 +8.1 3/3 methods agree | Not in label — unassessed | serious PRR 136.8 · 100% clinician | no trial data cached |
| Hyperhidrosis (excessive sweating) | 2,310 | 55.7 53.9–57.7ROR 83.5 · χ² 122,647 / p <1e-300 | 54.7 EB05 52.9 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 34.1 · 100% clinician | no trial data cached |
| Asthenia (weakness) | 1,370 | 11.2 10.7–11.7ROR 13.7 · χ² 12,865 / p <1e-300 | 11.1 EB05 10.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 · 100% clinician | no trial data cached |
| Thirst | 1,340 | 248.6 236.4–261.4ROR 308.7 · χ² 305,289 / p <1e-300 | 229.0 EB05 218.9 · IC025 +7.6 3/3 methods agree | Not in label — unassessed | serious PRR 56.0 · 100% clinician | no trial data cached |
| Vision blurred (blurred vision) | 1,190 | 26.9 25.5–28.3ROR 32.3 · χ² 29,528 / p <1e-300 | 26.6 EB05 25.4 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 · 100% clinician | no trial data cached |
| Dysgeusia (altered taste) | 1,165 | 48.4 45.9–51.1ROR 58.1 · χ² 53,403 / p <1e-300 | 47.6 EB05 45.4 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 28.3 · 100% clinician | no trial data cached |
| Chills | 756 | 19.8 18.5–21.2ROR 22.1 · χ² 13,466 / p <1e-300 | 19.7 EB05 18.5 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.0 · 100% clinician | no trial data cached |
| Dyspepsia (indigestion) | 711 | 22.3 20.8–23.9ROR 24.8 · χ² 14,412 / p <1e-300 | 22.1 EB05 20.8 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 2.2 · 100% clinician | no trial data cached |
| Restlessness | 573 | 48.5 44.9–52.5ROR 52.9 · χ² 26,257 / p <1e-300 | 47.7 EB05 44.5 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 23.3 · 100% clinician | no trial data cached |
| Hypoaesthesia (numbness) | 531 | 10.9 10.0–11.8ROR 11.7 · χ² 4,764 / p <1e-300 | 10.8 EB05 10.0 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 36.0 · 100% clinician | no trial data cached |
| Muscle spasms | 516 | 8.6 7.9–9.4ROR 9.2 · χ² 3,486 / p <1e-300 | 8.6 EB05 7.9 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 27.9 · 100% clinician | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Pallor — n=2,657, PRR 330.2
- Thirst — n=1,340, PRR 248.6
- Feeling hot — n=2,896, PRR 151.4
- Hyperhidrosis — n=2,310, PRR 55.7
- Injection site haematoma — n=242, PRR 51.3
- Restlessness — n=573, PRR 48.5
- Dysgeusia — n=1,165, PRR 48.4
- Paraesthesia oral — n=158, PRR 34.0
- Vision blurred — n=1,190, PRR 26.9
- Hypoaesthesia oral — n=123, PRR 25.2
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 Trisodium?
In FDA FAERS, the most frequently co-reported reaction terms for Trisodium are paraesthesia, nausea, dizziness, feeling hot, pallor, hyperhidrosis. 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 Trisodium have an FDA boxed warning?
No. The FDA label retrieved for Trisodium has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Trisodium 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 c9d0e9c8-379f-4895-b272-329efab575c4, effective 20250124; matched on
openfda.generic_name.exact:"TRISODIUM CITRATE DIHYDRATE") - 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, 81 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.