Drug · FAERS side-effect profile with label screen
Potassium Citrate side effects: what 5,448 FDA adverse event reports show
Drug class
Citrate salt of potassium
FDA label, Indications wording
Who reports
5,448 reports · 60% serious · 316 with death outcome · 52% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Potassium citrate is a citrate salt of potassium indicated for the management of: Renal tubular acidosis (RTA) with calcium stones ( 1.1 ) Hypocitraturic calcium oxalate nephrolithiasis of any etiology ( 1.2 ) Uric acid lithiasis with or without calciu.
FDA label, Indications and Usage
What it is
Potassium citrate is a citrate salt of potassium.
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 (related wording) 3Likely indication confounding 3Reporting / coding artifact 2Lab value / disease marker 3Not in label — unassessed 29
What the badges mean
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- 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.
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. 380 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 |
|---|---|---|---|---|---|---|
| Nephrolithiasis (kidney stones) | 275 | 23.3 20.7–26.1ROR 24.4 · χ² 5,813 / p <1e-300 | 23.1 EB05 20.9 · IC025 +4.3 3/3 methods agree | Likely indication confounding term in indications | serious PRR 22.0 | no trial data cached |
| Multiple fractures | 39 | 9.1 6.6–12.4ROR 9.1 · χ² 272 / p 3e-61 | 8.5 EB05 6.4 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 · ♀ 95% (drug 52%) | no trial data cached |
| Flank pain | 22 | 9.1 6.0–13.8ROR 9.1 · χ² 150 / p 1e-34 | 8.1 EB05 5.5 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 · 80% consumer | no trial data cached |
| Blood potassium decreased | 55 | 7.0 5.4–9.2ROR 7.1 · χ² 279 / p 6e-63 | 6.7 EB05 5.3 · IC025 +2.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 6.5 | no trial data cached |
| Product use complaint | 27 | 6.7 4.6–9.8ROR 6.7 · χ² 125 / p 2e-29 | 6.1 EB05 4.4 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious n=18 · 85% consumer | no trial data cached |
| Urosepsis | 15 | 6.3 3.8–10.4ROR 6.3 · χ² 61 / p 3e-15 | 5.3 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Kidney infection | 30 | 5.9 4.1–8.4ROR 5.9 · χ² 117 / p 2e-27 | 5.4 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 · ♀ 75% (drug 52%) · 70% consumer | no trial data cached |
| Chronic kidney disease | 117 | 5.9 4.9–7.0ROR 6.0 · χ² 470 / p 2e-104 | 5.7 EB05 4.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Dysuria (painful urination) | 55 | 5.7 4.4–7.5ROR 5.8 · χ² 211 / p 4e-48 | 5.5 EB05 4.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Proteinuria | 26 | 5.3 3.6–7.8ROR 5.3 · χ² 87 / p 7e-21 | 4.9 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 2.0 · ♀ 73% (drug 52%) · 83% consumer | no trial data cached |
| Eructation (belching) | 26 | 5.3 3.6–7.7ROR 5.3 · χ² 86 / p 1e-20 | 4.8 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious n=21 · ♀ 23% (drug 52%) | no trial data cached |
| Splenomegaly | 16 | 5.3 3.2–8.6ROR 5.3 · χ² 51 / p 5e-13 | 4.6 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Taste disorder | 27 | 5.2 3.6–7.6ROR 5.2 · χ² 87 / p 5e-21 | 4.8 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 · ♀ 100% (drug 52%) · 85% consumer | no trial data cached |
| Seasonal allergy | 19 | 5.2 3.3–8.1ROR 5.2 · χ² 60 / p 5e-15 | 4.6 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Renal pain | 14 | 5.1 3.0–8.6ROR 5.1 · χ² 42 / p 4e-11 | 4.4 EB05 2.8 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.1 | no trial data cached |
| Nerve compression | 12 | 5.0 2.8–8.8ROR 5.0 · χ² 35 / p 2e-9 | 4.3 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Nocturia (night-time urination) | 15 | 4.8 2.9–7.9ROR 4.8 · χ² 41 / p 8e-11 | 4.2 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Glomerular filtration rate decreased | 15 | 4.8 2.9–7.9ROR 4.8 · χ² 41 / p 8e-11 | 4.2 EB05 2.7 · IC025 +1.2 3/3 methods agree | Lab value / disease marker | serious PRR 4.5 | no trial data cached |
| Blood potassium increased | 20 | 4.7 3.1–7.4ROR 4.8 · χ² 55 / p 5e-14 | 4.3 EB05 3.0 · IC025 +1.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 4.8 · 70% consumer | no trial data cached |
| Sleep apnoea syndrome | 23 | 4.6 3.1–7.0ROR 4.6 · χ² 62 / p 2e-15 | 4.3 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Prostatic specific antigen increased | 16 | 4.4 2.7–7.3ROR 4.5 · χ² 39 / p 2e-10 | 4.0 EB05 2.6 · IC025 +1.2 3/3 methods agree | Lab value / disease marker | serious PRR 5.7 | no trial data cached |
| Electrolyte imbalance | 13 | 4.3 2.5–7.5ROR 4.4 · χ² 30 / p 2e-8 | 3.8 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Hypokalaemia (low potassium) | 51 | 4.3 3.3–5.6ROR 4.3 · χ² 125 / p 3e-29 | 4.1 EB05 3.3 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Clostridium difficile infection | 24 | 4.3 2.9–6.4ROR 4.3 · χ² 57 / p 3e-14 | 4.0 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Increased tendency to bruise | 10 | 4.2 2.2–7.8ROR 4.2 · χ² 21 / p 2e-6 | 3.6 EB05 2.1 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious n=5 | no trial data cached |
| Squamous cell carcinoma | 10 | 4.1 2.2–7.6ROR 4.1 · χ² 20 / p 3e-6 | 3.5 EB05 2.1 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Urinary incontinence | 31 | 4.0 2.8–5.7ROR 4.0 · χ² 68 / p 1e-16 | 3.8 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 · ♀ 83% (drug 52%) | no trial data cached |
| Pharyngitis | 13 | 4.0 2.3–6.9ROR 4.0 · χ² 26 / p 1e-7 | 3.6 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Incontinence | 11 | 4.0 2.2–7.2ROR 4.0 · χ² 22 / p 2e-6 | 3.5 EB05 2.1 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| End stage renal disease | 19 | 4.0 2.5–6.2ROR 4.0 · χ² 39 / p 2e-10 | 3.7 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Impaired gastric emptying | 13 | 3.9 2.3–6.8ROR 3.9 · χ² 25 / p 2e-7 | 3.5 EB05 2.2 · IC025 +0.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.3 | no trial data cached |
| Hypocalcaemia (low calcium) | 19 | 3.9 2.5–6.1ROR 3.9 · χ² 38 / p 4e-10 | 3.6 EB05 2.4 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Cystitis | 32 | 3.9 2.7–5.4ROR 3.9 · χ² 65 / p 4e-16 | 3.7 EB05 2.7 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Neck pain | 56 | 3.9 3.0–5.0ROR 3.9 · χ² 116 / p 3e-27 | 3.7 EB05 3.0 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Hypercalcaemia | 12 | 3.7 2.1–6.6ROR 3.8 · χ² 21 / p 2e-6 | 3.3 EB05 2.1 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 | no trial data cached |
| Neutrophil count increased | 10 | 3.7 2.0–7.0ROR 3.7 · χ² 17 / p 1e-5 | 3.3 EB05 1.9 · IC025 +0.6 | Lab value / disease marker | serious PRR 3.6 | no trial data cached |
| Micturition urgency | 11 | 3.7 2.1–6.7ROR 3.7 · χ² 19 / p 5e-6 | 3.3 EB05 2.0 · IC025 +0.7 | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Product physical issue | 19 | 3.7 2.3–5.7ROR 3.7 · χ² 34 / p 2e-9 | 3.4 EB05 2.3 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious n=6 | no trial data cached |
| Infusion site pain | 12 | 3.6 2.1–6.4ROR 3.6 · χ² 20 / p 4e-6 | 3.2 EB05 2.0 · IC025 +0.7 3/3 methods agree | Labeled (related wording) related wording | serious n=11 | no trial data cached |
| Aspiration | 10 | 3.6 1.9–6.6ROR 3.6 · χ² 16 / p 3e-5 | 3.1 EB05 1.9 · IC025 +0.6 | Not in label — unassessed | serious PRR 3.2 | 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 |
|---|---|---|---|---|---|---|
| Diarrhoea (diarrhea) | 333 | 2.0 1.8–2.2ROR 2.1 · χ² 169 / p 8e-39 | 2.0 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.7 | no trial data cached |
| Pain | 306 | 1.9 1.7–2.1ROR 2.0 · χ² 136 / p 8e-32 | 1.9 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 2.1 | no trial data cached |
| Nephrolithiasis (kidney stones) | 275 | 23.3 20.7–26.1ROR 24.4 · χ² 5,813 / p <1e-300 | 23.1 EB05 20.9 · IC025 +4.3 3/3 methods agree | Likely indication confounding term in indications | serious PRR 22.0 | no trial data cached |
| Dizziness | 241 | 1.9 1.6–2.1ROR 1.9 · χ² 98 / p 3e-23 | 1.9 EB05 1.7 · IC025 +0.7 | Not in label — unassessed | serious PRR 2.0 | no trial data cached |
| Fall | 202 | 2.3 2.0–2.7ROR 2.4 · χ² 156 / p 5e-36 | 2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.4 | no trial data cached |
| Urinary tract infection (bladder infection) | 144 | 3.3 2.8–3.8ROR 3.3 · χ² 225 / p 4e-51 | 3.2 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.4 | no trial data cached |
| Decreased appetite (loss of appetite) | 125 | 2.1 1.7–2.5ROR 2.1 · χ² 69 / p 4e-17 | 2.1 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | serious PRR 2.0 | no trial data cached |
| Anaemia (low red blood cells) | 123 | 2.5 2.1–3.0ROR 2.5 · χ² 108 / p 1e-25 | 2.5 EB05 2.1 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.5 | no trial data cached |
| Gait disturbance | 120 | 2.4 2.0–2.9ROR 2.4 · χ² 98 / p 2e-23 | 2.4 EB05 2.1 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 | no trial data cached |
| Chronic kidney disease | 117 | 5.9 4.9–7.0ROR 6.0 · χ² 470 / p 2e-104 | 5.7 EB05 4.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Back pain | 114 | 1.9 1.6–2.3ROR 1.9 · χ² 47 / p 3e-12 | 1.9 EB05 1.6 · IC025 +0.6 | Not in label — unassessed | serious PRR 2.0 | no trial data cached |
| Product dose omission issue | 108 | 1.5 1.2–1.8ROR 1.5 · χ² 15 / p 4e-5 | 1.5 EB05 1.2 · IC025 +0.2 | Reporting / coding artifact | serious PRR 2.7 | no trial data cached |
| Feeling abnormal | 106 | 1.7 1.4–2.0ROR 1.7 · χ² 30 / p 2e-8 | 1.7 EB05 1.4 · IC025 +0.4 | Not in label — unassessed | serious PRR 2.2 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 106 | 2.7 2.2–3.2ROR 2.7 · χ² 110 / p 4e-26 | 2.7 EB05 2.3 · IC025 +1.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.5 | no trial data cached |
| Dehydration | 106 | 3.1 2.5–3.7ROR 3.1 · χ² 146 / p 8e-34 | 3.0 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.1 | 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.
- Multiple fractures — n=39, PRR 9.1
- Flank pain — n=22, PRR 9.1
- Kidney infection — n=30, PRR 5.9
- Chronic kidney disease — n=117, PRR 5.9
- Dysuria — n=55, PRR 5.7
- Proteinuria — n=26, PRR 5.3
- Eructation — n=26, PRR 5.3
- Taste disorder — n=27, PRR 5.2
- Sleep apnoea syndrome — n=23, PRR 4.6
- Hypokalaemia — n=51, PRR 4.3
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 Potassium Citrate?
In FDA FAERS, the most frequently co-reported reaction terms for Potassium Citrate are diarrhoea, pain, nephrolithiasis, dizziness, fall, urinary tract infection. 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 Potassium Citrate have an FDA boxed warning?
No. The FDA label retrieved for Potassium Citrate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Potassium 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 2215dc1d-0b5a-469e-9b51-4d7480a51078, effective 20250714; matched on
openfda.generic_name.exact:"POTASSIUM 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, 420 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.