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Drug side effects

potassium citrate Side Effects

The reactions most often reported to the FDA for potassium citrate (also sold as Urocit-K), with demographics, serious outcomes, and reporting trends.

Data updated 2026-05-15

5,207
FAERS reports

Data from the FDA Adverse Event Reporting System (FAERS), 2004 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.

The most commonly reported side effects of potassium citrate come from 5,207 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.

This page analyzes 5,207 reports to the FDA Adverse Event Reporting System (FAERS) for potassium citrate (Urocit-K): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.

Total Reports

5,207

Reports Mentioning Death

298

5.7% of reports — not proof the medicine caused the death

Hospitalizations

1,643

31.6% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

FATIGUE
346
NAUSEA
320
DIARRHOEA
310
PAIN
300
NEPHROLITHIASIS
270
DIZZINESS
228
DYSPNOEA
220
HEADACHE
202
FALL
198
VOMITING
174
PNEUMONIA
152
ASTHENIA
149
ARTHRALGIA
142
PYREXIA
140
URINARY TRACT INFECTION
139
CONDITION AGGRAVATED
138
PRURITUS
136
RASH
135

Who Reports Side Effects

Gender Distribution

Female 2,452 (51%)
Male 2,347 (49%)
Unknown 7

Age Distribution

0-17 161 (5%)
18-44 502 (14%)
45-64 1,160 (33%)
65-74 987 (28%)
75+ 708 (20%)

Reporting Trend by Year

2004 2025

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
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
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
URINARY TRACT INFECTION 78
PYREXIA 75
ABDOMINAL PAIN 74
ACUTE KIDNEY INJURY 70
CONDITION AGGRAVATED 70
VOMITING 69
ASTHENIA 67

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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 fatigue with 346 submissions, followed by nausea and diarrhoea.

How to read these numbers

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.

Drugs With a Similar FAERS Report Volume

Other medications with a total FDA adverse-event report count closest to potassium citrate's 5,207.