Post-Marketing Reporting Patterns of Ceftazidime–Avibactam and Ceftolozane–Tazobactam: Analysis of Adverse Event Reports from EudraVigilance
5 affiliations
- 1Department of Chemical, Biological, Pharmaceutical and Environmental Sciences, , 98166 Messina, Italy;
- 2Department of Clinical and Experimental Medicine, , 98125 Messina, Italy; (F.M.S.); (N.I.); (E.I.); (V.A.)
- 3Department of Biomedical Sciences, , 09042 Monserrato, Italy;
- 4Department of Medicine, Surgery and Pharmacy, School of Specialization in Hospital Pharmacy, , 07100 Sassari, Italy
- 5Department of Biomedical and Dental Sciences and Morphological and Functional Imaging, , 98125 Messina, Italy;
Abstract
Background/Objectives: Ceftazidime/avibactam (CA) and ceftolozane/tazobactam (CT) are WHO Reserve-group antibiotics increasingly used for multidrug-resistant Gram-negative infections. Comparative post-marketing pharmacovigilance data remain limited. Methods: A retrospective pharmacovigilance study was conducted using Individual Case Safety Reports (ICSRs) retrieved from the EudraVigilance database. Reports listing CA or CT as suspected drugs were included. Comparative reporting analyses were performed using reporting odds ratios (RORs) with 95% confidence intervals (CIs) at System Organ Class (SOC) and Preferred Term (PT) levels. Results: A total of 1414 ICSRs were identified (CA: 967; CT: 447). Serious reports were more frequent for CA than CT (91.0% vs. 78.7%), whereas fatal outcomes were proportionally higher for CT (21.0% vs. 12.8%). At the SOC level, CA showed higher reporting for hepatobiliary disorders (ROR 2.00; 95% CI 1.20–3.35), investigations (ROR 2.67; 95% CI 1.92–3.71), nervous system disorders (ROR 1.51; 95% CI 1.07–2.15), and psychiatric disorders (ROR 3.25; 95% CI 1.37–7.72). At the PT level, CA showed higher reporting for encephalopathy (ROR 4.25; 95% CI 1.28–14.09), blood creatinine increased (ROR 7.37; 95% CI 1.76–30.93), platelet count decreased (ROR 26.9; 95% CI 3.71–195.0), and diarrhoea (ROR 2.83; 95% CI 1.09–7.34). Death was less frequently reported for CA relative to CT (ROR 0.17; 95% CI 0.10–0.29). Conclusions: This EudraVigilance-based analysis identified distinct reporting patterns for CA and CT. CA showed higher reporting for neurological, hepatobiliary, and laboratory-related events, whereas CT reports more frequently involved infection-related contexts. These findings support continued post-marketing surveillance, while clinical monitoring should follow established clinical guidance and product information.
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BibTeX
@article{gianguzzo2026postmarketing,
title = {{Post-Marketing Reporting Patterns of Ceftazidime–Avibactam and Ceftolozane–Tazobactam: Analysis of Adverse Event Reports from EudraVigilance}},
author = {Viviana Maria Gianguzzo and Michelangelo Rottura and Federica Maria Sacco and Giuseppina Sanna and Matthew Gavino Donadu and Natasha Irrera and Egidio Imbalzano and Giovanni Pallio and Vincenzo Arcoraci},
journal = {Antibiotics (Basel, Switzerland)},
year = {2026},
month = oct,
doi = {10.3390/antibiotics15100982},
url = {https://europepmc.org/article/PMC/PMC13700556},
note = {CC BY},
}
RIS
TY - JOUR
TI - Post-Marketing Reporting Patterns of Ceftazidime–Avibactam and Ceftolozane–Tazobactam: Analysis of Adverse Event Reports from EudraVigilance
AU - Viviana Maria Gianguzzo
AU - Michelangelo Rottura
AU - Federica Maria Sacco
AU - Giuseppina Sanna
AU - Matthew Gavino Donadu
AU - Natasha Irrera
AU - Egidio Imbalzano
AU - Giovanni Pallio
AU - Vincenzo Arcoraci
PY - 2026
DA - 2026/10/01
JO - Antibiotics (Basel, Switzerland)
DO - 10.3390/antibiotics15100982
UR - https://europepmc.org/article/PMC/PMC13700556
AB - Background/Objectives: Ceftazidime/avibactam (CA) and ceftolozane/tazobactam (CT) are WHO Reserve-group antibiotics increasingly used for multidrug-resistant Gram-negative infections. Comparative post-marketing pharmacovigilance data remain limited. Methods: A retrospective pharmacovigilance study was conducted using Individual Case Safety Reports (ICSRs) retrieved from the EudraVigilance database. Reports listing CA or CT as suspected drugs were included. Comparative reporting analyses were performed using reporting odds ratios (RORs) with 95% confidence intervals (CIs) at System Organ Class (SOC) and Preferred Term (PT) levels. Results: A total of 1414 ICSRs were identified (CA: 967; CT: 447). Serious reports were more frequent for CA than CT (91.0% vs. 78.7%), whereas fatal outcomes were proportionally higher for CT (21.0% vs. 12.8%). At the SOC level, CA showed higher reporting for hepatobiliary disorders (ROR 2.00; 95% CI 1.20–3.35), investigations (ROR 2.67; 95% CI 1.92–3.71), nervous system disorders (ROR 1.51; 95% CI 1.07–2.15), and psychiatric disorders (ROR 3.25; 95% CI 1.37–7.72). At the PT level, CA showed higher reporting for encephalopathy (ROR 4.25; 95% CI 1.28–14.09), blood creatinine increased (ROR 7.37; 95% CI 1.76–30.93), platelet count decreased (ROR 26.9; 95% CI 3.71–195.0), and diarrhoea (ROR 2.83; 95% CI 1.09–7.34). Death was less frequently reported for CA relative to CT (ROR 0.17; 95% CI 0.10–0.29). Conclusions: This EudraVigilance-based analysis identified distinct reporting patterns for CA and CT. CA showed higher reporting for neurological, hepatobiliary, and laboratory-related events, whereas CT reports more frequently involved infection-related contexts. These findings support continued post-marketing surveillance, while clinical monitoring should follow established clinical guidance and product information.
SN - 2079-6382
ER -