Sodium citrate: adverse event reports filed with FDA

624

reports as suspect product

0% of all reports · about 29 a year

44

reports, 12 months to June 2026

37 in the 12 months before

95.2%

marked serious by the reporter

55.7% across the class

55.3%

record death among outcomes, as reported

345 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Sodium citrate reports recording the termmedian drug in anti-coagulant

1. Abdominal distensiona bloated abdomen35.9%224
2. Hyponatraemialow blood sodium35.6%222
3. General physical health deteriorationgeneral decline in health35.4%221
4. Ascitesfluid in the abdomen35.1%219
5. Appendicitis34.9%218
6. Multiple organ dysfunction syndromeseveral organs failing34.9%218
7. Vomitingbeing sick34.9%218
8. Appendicolith34.8%217
9. Nauseafeeling sick34.6%216
10. Off label useused for a purpose or in a way not on the label34.5%215
11. Sepsisa severe body-wide response to infection34.5%215
12. Stressstress34.5%215
13. Abdominal painstomach or belly pain34.3%214
14. Cardiogenic shockshock from the heart failing to pump34.3%214
15. Constipationconstipation34%212
16. Ventricular fibrillationa chaotic rhythm from the lower heart chambers32.7%204
17. Condition aggravatedthe condition being treated got worse24.4%152
18. Blood phosphorus increased23.1%144
19. Somnolencedrowsiness22.8%142
20. Dry mouthdry mouth21.8%136
21. Incorrect route of product administrationthe product was given by the wrong route19.7%123
22. Anaemialow red blood cells19.6%122
23. Myasthenia gravis19.4%121
24. Blood cholesterol increasedraised cholesterol19.1%119
25. Blood uric acid increasedraised uric acid18.3%114
26. Thrombosis18.3%114
27. Chronic obstructive pulmonary diseaseCOPD, a long-term lung disease17.9%112
28. Diabetes mellitusdiabetes17.9%112
29. Drug hypersensitivityan allergic-type reaction to a medicine17.6%110
30. Intentional product misusedeliberate use not as intended17.6%110

Top 30 of 286 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 10 drugs in the anti-coagulant class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 28,971 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 16.3% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 624 reports.

Drugs most often listed in the same reports

Other products listed in reports where Sodium citrate is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the anti-coagulant class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Sodium citrate as a suspect or interacting product; reports listing it only as a concomitant medication (581) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.