Incidence and Risk Factors of Hypersensitivity Reactions to Intravenous Ceftriaxone in Iraqi Hospitals: Nationwide Prospective Study

Ban Abdulameer Al-Shimran; Haydar Adnan Fawzi; Alaa Fadhel Hassan; Manal Mohammed Younus

doi:10.54133/ajms.v10i2.2694

Authors

Ban Abdulameer Al-Shimran Iraqi Pharmacovigilance Center, Ministry of Health, Baghdad, Iraq https://orcid.org/0000-0002-9565-794X
Haydar Adnan Fawzi Department of Pharmacy, Al-Mustafa University College, Baghdad, Iraq https://orcid.org/0000-0001-9970-0119
Alaa Fadhel Hassan Al-Mahmoudiya General Hospital, Al-Mahmoudiya, Iraq https://orcid.org/0000-0002-0732-7079
Manal Mohammed Younus Iraqi Pharmacovigilance Center, Ministry of Health, Baghdad, Iraq https://orcid.org/0000-0001-9475-5700

DOI:

https://doi.org/10.54133/ajms.v10i2.2694

Keywords:

Adverse drug reactions, Ceftriaxone hypersensitivity, Pharmacovigilance in Iraq , Prospective cohort study , Risk factors

Abstract

Background: Ceftriaxone is a widely used cephalosporin in Iraqi hospitals. Despite its broad-spectrum safety profile, hypersensitivity reactions are underreported and poorly characterized in the local setting. Objective: To estimate the incidence of intravenous ceftriaxone-associated hypersensitivity reactions among hospitalized Iraqi patients and identify predictors of risk. Methods: A nationwide, prospective cohort study was conducted from April to July 2024 across ten public hospitals selected for high ceftriaxone use and geographic representation. Inpatients receiving ceftriaxone infusions were actively monitored until discharged. Standardized forms captured demographics, medical history, ceftriaxone dosing, co-medications, and infusion details. Reactions within 12 hours were graded according to the Ring and Messmer scale. Data were audited monthly. Incidence was calculated for predictors of allergic reactions. Results: Of 5,732 patients, 50 experienced hypersensitivities (0.87%; 95% CI 0.65–1.15). Most reactions were mild (Grade I, 70%), followed by Grade II (24%) and Grade III (6%). Rates varied regionally (0–7.3%). Univariate analysis identified prior allergies (OR=3.29), budesonide use (OR=3.04), and fewer ceftriaxone doses (OR 0.80) as risk factors for increased risk. In multivariate models, budesonide use (OR=3.39, p=0.022) and the number of doses (OR=0.78 per additional dose, p=0.036) remained significant. Conclusions: Ceftriaxone-related hypersensitivity in Iraqi public hospitals occurs at a low incidence similar to global reports. Key predictors include underlying atopy (indicated by recent budesonide use) and fewer administered doses. Hypersensitivity reactions mostly occur early in the treatment course. Therefore, active pharmacovigilance and increased clinical monitoring are important during the first few doses of ceftriaxone.

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