potassium citrate Side Effects
Also known as: Urocit-K
Analysis of 5,207 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
5,207
Death-Related
298
5.7% of reports
Hospitalizations
1,643
31.6% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 298 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 122 |
| OFF LABEL USE | 19 |
| PNEUMONIA | 15 |
| ANAEMIA | 14 |
| STEVENS-JOHNSON SYNDROME | 13 |
| FATIGUE | 12 |
| ORAL DISORDER | 12 |
| RESPIRATORY FAILURE | 12 |
| THROMBOCYTOPENIA | 12 |
| BLISTER | 11 |
| CONJUNCTIVITIS | 11 |
| LIP EROSION | 11 |
| NIKOLSKY^S SIGN | 11 |
| OCULAR HYPERAEMIA | 11 |
| PRURITUS | 11 |
| PURPURA | 11 |
| SWOLLEN TONGUE | 11 |
| ABDOMINAL PAIN | 10 |
| DRUG INEFFECTIVE | 10 |
| DIARRHOEA | 9 |
Reactions in Hospitalization Reports
Top reactions in 1,643 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| FALL | 138 |
| NEPHROLITHIASIS | 130 |
| PNEUMONIA | 130 |
| PAIN | 122 |
| DYSPNOEA | 112 |
| NAUSEA | 103 |
| FATIGUE | 91 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 89 |
| DIARRHOEA | 88 |
| ANAEMIA | 87 |
| DIZZINESS | 82 |
| DEHYDRATION | 81 |
| OFF LABEL USE | 81 |
| URINARY TRACT INFECTION | 78 |
| PYREXIA | 75 |
| ABDOMINAL PAIN | 74 |
| ACUTE KIDNEY INJURY | 70 |
| CONDITION AGGRAVATED | 70 |
| VOMITING | 69 |
| ASTHENIA | 67 |
Nearby — Related Medications
What the FAERS Data Reveals About potassium citrate Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 5,207 voluntary reports linked to potassium citrate and its brand equivalents (Urocit-K), spanning 2004 through 2025. Of those, 298 (5.7%) listed death as an outcome and 1,643 (31.6%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 51% were female and 49% male; age distribution skews toward 45-64, with 1,160 reports in that bracket. The single most reported reaction is drug ineffective with 425 submissions, followed by fatigue and nausea.
FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.
Read our methodology — how this data is sourced, computed, and verified.