**Background:** Adverse drug events (ADEs) are a major cause of patient harm and healthcare burden globally. Antimicrobial-related ADEs constitute a significant proportion of drug-related adverse reactions. In Jordan, prior research focused on healthcare professionals' knowledge and attitudes toward pharmacovigilance, but no study had described the trends and characteristics of antimicrobial-related ADEs using the national pharmacovigilance database. This study aimed to assess antimicrobial-related ADE reporting in Jordan from 2003 to 2022, including trends, seriousness, types of ADEs, antimicrobial groups involved, and the relationship with the WHO AWaRe antibiotic classification.
**Methods:** This was a cross-sectional study of Individual Case Safety Reports (ICSRs) submitted to the Jordan Food and Drug Administration (JFDA) pharmacovigilance center. Data were extracted from the VigiBase database using ATC codes for systemic antibacterials (J01), systemic antimycotics (J02), systemic antivirals (J05), systemic antifungals (D01B), antibiotics (A07AA), and aminoquinolines (P01BA). Reports from 2003 to 2022 were included. Extracted data included age, gender, reporter qualification, seriousness, actions taken, and MedDRA system organ class (SOC) for each ADE. Frequencies and percentages were used to describe categorical variables. The most consumed antibiotics in Jordan (2020) and their AWaRe categories were obtained from a previously published study.
**Key Results:** A total of 279 ICSRs were analyzed, reporting 539 ADEs. The number of ICSRs increased markedly after 2019, with the highest numbers in 2022 (96 cases) and 2019 (65 cases). Most patients were aged 18–64 years (43.37%), and females (48.75%) outnumbered males (35.84%). Physicians (36.92%) and pharmacists (30.10%) were the most common reporters. Serious ADEs occurred in 43.01% of patients, with 20.79% causing or prolonging hospitalization, 4.66% resulting in death, and 3.58% being life-threatening. The most common actions taken were drug withdrawal (41.94%) and no dose change (5.73%). The most frequently reported ADEs were skin and subcutaneous tissue disorders (19.48%), general disorders and administration site conditions (16.33%), gastrointestinal disorders (12.8%), and nervous system disorders (7.98%). Among specific ADEs, rash (10.76%), edema (5.19%), drug ineffectiveness (5.19%), vomiting (4.27%), and urticaria (4.08%) were most common. Tetracyclines accounted for the highest number of ADEs (n=101), followed by fluoroquinolones (n=54), third-generation cephalosporins (n=48), and carbapenems (n=42). Tetracyclines were associated with most cases of edema (15/28), urticaria (17/22), and allergy/hypersensitivity (8/22). Antivirals were linked to renal/urinary disorders (13/30) and blood/lymphatic disorders (8/27). Among the top ten consumed antibiotics in Jordan (2020), ciprofloxacin (Watch group) had the highest number of ADEs (n=26), followed by cefuroxime (Watch, n=24) and amoxicillin/clavulanic acid (Access, n=22). Watch group antibiotics accounted for 77.6% of ADEs among the top ten, compared to 22.4% for Access group antibiotics. No ADEs were reported for doxycycline or clindamycin (both Access).
**Clinical Implications:** This study provides the first nationwide description of antimicrobial-related ADEs in Jordan. The increase in reporting after 2019 suggests that regulatory actions by the JFDA, including updated pharmacovigilance guidelines, electronic reporting tools, and awareness campaigns, have improved ADE reporting. However, the overall number of reports remains low, indicating underreporting. The higher proportion of ADEs associated with Watch group antibiotics underscores the need for antimicrobial stewardship programs to monitor and rationalize the use of these agents. The findings highlight specific antimicrobial–ADE associations (e.g., tetracyclines with skin reactions, antivirals with renal disorders) that can guide clinicians in risk assessment and patient monitoring. Limitations include missing data on age, gender, and reporter qualifications, as well as the inability to confirm causality for deaths. Future efforts should focus on improving report quality, encouraging reporting among healthcare professionals, and integrating pharmacovigilance with antimicrobial stewardship to enhance patient safety.