Background/Objectives: Vedolizumab is a gut-selective anti-integrin monoclonal antibody approved for the treatment of inflammatory bowel disease (IBD). While clinical trials have demonstrated a favorable safety profile, real-world studies are essential for identifying rare adverse events (AEs) and evaluating post-marketing safety. This study assessed vedolizumab’s safety in a real-world cohort and supported the detection of potential safety signals. Methods: A retrospective chart review was conducted on adult IBD patients treated with vedolizumab at a tertiary center in the Republic of Serbia between October 2021 and August 2022. Data included demographics, AEs, and newly reported extraintestinal manifestations (EIMs). Exposure-adjusted incidence rates were calculated per 100 patient-years (PYs). Disproportionality analysis using the FDA Adverse Event Reporting System (FAERS) was performed to identify safety signals, employing reporting odds ratios (RORs) and proportional reporting ratios (PRRs) for AEs also observed in the cohort. Prior IBD therapies and reasons for discontinuation were evaluated. Results: A total of 107 patients (42.1% Crohn’s disease, 57.9% ulcerative colitis) were included, with a median vedolizumab exposure of 605 days. There were 92 AEs (56.51/100 PYs), most frequently infections (23.95/100 PYs), gastrointestinal disorders (4.30/100 PYs), and skin disorders (4.30/100 PYs). The most frequently reported preferred terms (PTs) included COVID-19, COVID-19 pneumonia, nephrolithiasis, and nasopharyngitis. Arthralgia (12.90/100 PYs) was the most frequent newly reported EIM. No discontinuations due to vedolizumab AEs occurred. FAERS analysis revealed potential signals for events not listed in prescribing information but observed in the cohort: nephrolithiasis, abdominal pain, diarrhea, malaise, cholangitis, gastrointestinal infection, blood pressure decreased, weight decreased, female genital tract fistula, respiratory symptom, and appendicectomy. Most patients had received three prior therapies, often stopping one due to AEs. Conclusions: Vedolizumab demonstrated a favorable safety profile in the IBD cohort. However, FAERS-identified signals, such as nephrolithiasis, gastrointestinal infections, and decreased blood pressure, warrant further investigation in larger, more diverse populations.

Background/Objectives: The safety profile of adalimumab in inflammatory bowel disease (IBD) has been established in clinical trials, but post-marketing surveillance remains important for detecting rare and late-onset adverse events (AEs). This study aimed to evaluate long-term safety and temporal dynamics of AEs in an IBD cohort treated with adalimumab, and to identify potential safety signals using the FDA Adverse Event Reporting System (FAERS). Methods: This retrospective single-center study included patients with IBD treated with adalimumab. Demographic, clinical, and treatment-related data, including AEs and newly identified extraintestinal manifestations (EIMs), were collected. Time-to-event (TTE) analyses were used to assess AEs temporal patterns and covariates associated with onset. FAERS disproportionality analysis was performed for cohort-identified AEs and EIMs. Results: A total of 217 patients with 591.29 patient-years (PYs) of exposure (up to 9.62 years) were included. AE incidence was 106.6/100 PY. Time to first AE was described using the Kaplan–Meier method, and additionally the Weibull distribution, with an estimated median time of 11.4 months (95% CI: 9.7–13.5). The most frequent AEs were infections (32.30/100 PY), hepatic events (9.98/100 PY), and cutaneous manifestations (8.46/100 PY), characterized by TTE analysis. Serious outcomes, including malignancies and demyelinating events, were rare. Several unlisted MedDRA preferred terms, including infectious, cutaneous, vascular, proliferative, and musculoskeletal events, emerged as FAERS signals. Conclusions: This study provides long-term real-world evidence supporting the established safety profile of adalimumab in IBD. First AEs occurred throughout treatment exposure with lower hazard over time. Isolated FAERS signals, including vascular occlusive events, may warrant further investigation and continued pharmacovigilance.