Assessment of Riociguat-related adverse events: a disproportionality analysis utilizing the FDA adverse event reporting system database

Riociguat is a novel soluble guanylate cyclase stimulator approved for the treatment of pulmonary arterial hypertension (PAH). Despite its widespread use, there has been a lack of large-scale studies assessing the adverse events (AEs) associated with this medication. This study aimed to evaluate the AEs related to Riociguat by analyzing data from the FDA Adverse Event Reporting System (FAERS) from Q4 2013 to Q1 2024. A total of 12,149 AE reports were analyzed using four different disproportionality signal detection methodologies to identify significant AEs associated with Riociguat. The analysis revealed 117 preferred terms (PTs) with significant disproportionality signals across all four methods. Among these, common AEs included ‘headache,’ ‘dizziness,’ ‘hypotension,’ ‘nausea,’ ‘fall,’ and ‘loss of consciousness.’ Notably, several unexpected AEs, such as ‘fatigue,’ ‘malaise,’ ‘asthenia,’ ‘feeling abnormal,’ and ‘pain in extremity,’ were identified, which were not highlighted in the product’s package insert. Additionally, gender-specific differences were observed in certain adverse events. This study offers insights into Riociguat’s side effects. Clinicians should monitor patients closely for unexpected symptoms like limb pain and fatigue, paying particular attention to male patients, as some AEs occur more frequently in this group. Riociguat is used to treat PAH and chronic thromboembolic pulmonary hypertension (CTEPH), with its indications expanding. This study analyzed 12,149 reports from the FAERS between 2013 and 2024. Common side effects like headache, dizziness, and syncope were identified, along with unexpected ones such as fatigue, malaise, and limb pain. Notably, some side effects were observed differently in males and females. These findings suggest that doctors should closely monitor patients using Riociguat to minimize risks and ensure the safe use of the drug.