Post-marketing safety associated with sodium zirconium cyclosilicate: a pharmacovigilance study based on the FDA reporting system

Sodium zirconium cyclosilicate (SZC) is a novel oral therapy for hyperkalemia with limited adverse reactions documented on its label. Accordingly, the objective of this study was to investigate real-world adverse events (AEs) associated with SZC using the FDA Adverse Event Reporting System (FAERS). Relevant data regarding SZC were extracted from FAERS, and signal detection was conducted using four distinct algorithms. The Weibull shape parameter characterized the AE onset time. Kaplan-Meier analysis was used to evaluate the cumulative incidence of AEs associated with SZC. Among 8,846,085 case reports recorded in the FAERS database, 1,160 SZC-related AEs were identified. Beyond AEs, such as hypokalemia, edema, constipation, and ileus, listed on the SZC label, 26 additional positive risk signals were not stated, including X-ray gastrointestinal tract abnormal, cardiac failure, and aspiration pneumonia. The median onset time of SZC-related AEs was 42 days. Furthermore, AEs differed between male and female patients. This study confirmed SZC label safety warnings and identified new AEs, offering insights for clinical monitoring of SZC. We studied a medicine called Sodium Zirconium Cyclosilicate (SZC). It helps lower high potassium levels in the blood, which is a common problem for people with diabetes, heart failure, or kidney disease. Even though many people use SZC, we don’t know much about its side effects. Sometimes, medicines have side effects that we only discover after lots of people have taken them. To find out more about SZC, we used a big database from the U.S. Food and Drug Administration (FDA) that collects reports of side effects. We used special methods to check for any hidden side effects. We found that SZC can cause some side effects that we already knew about, like low potassium, swelling, constipation, and bowel problems. But we also found some new ones, like unusual X-ray results in the gut, heart problems, and a type of lung infection called aspiration pneumonia. We also discovered that side effects usually started around 42 days after people began taking SZC. There were also differences in the side effects between men and women. Our study helps bring attention to side effects that might have been missed before. Knowing more about these side effects can help doctors and patients use SZC more safely. This way, we can make sure the medicine helps more than it hurts.