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What the label lists and what reports show

Potassium citrate side effects

Potassium citrate's FDA label lists its adverse reactions in its own words. FAERS holds 5,453 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (368 reports).

  • Generic listed

Check it at the source: the potassium citrate FDA label on DailyMed (effective December 2, 2021, Mission Pharmacal Company); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Some patients may develop minor gastrointestinal complaints during Urocit-K therapy, such as abdominal discomfort, vomiting, diarrhea, loose bowel movements or nausea. These symptoms are due to the irritation of the gastrointestinal tract, and may be alleviated by taking the dose with meals or snacks, or by reducing the dosage. Patients may find intact matrices in their feces. Some patients may develop minor gastrointestinal complaints such as abdominal discomfort, vomiting, diarrhea, loose bowel movements or nausea. These may be alleviated by taking the dose with meals or snacks or by reducing the dosage (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Mission Pharmacal Company at 1-800-298-1087 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Source: FDA drug label, Mission Pharmacal Company, effective December 2, 2021 (SPL set 72cdea1b-2240-41db-987d-86d5c6aaa978), via openFDA; the full label on DailyMed

What do FAERS reports show?

5,453 reports list potassium citrate among the medicines taken, each a report of something that happened, not proof the medicine caused it; 316 are coded as a death and 1,706 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 3 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Potassium citrate: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions