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cefazolin dibenzylamine (Daren)

✓ Approved

Pfizer, Inc. · Small Molecule · Small Molecule

What is cefazolin dibenzylamine?

cefazolin dibenzylamine is a small molecule developed by Pfizer, Inc.. It is approved for therapeutic indications via injectable (others) or intramuscular (im) injection.

Drug Profile

Brand NamesDaren
CompanyPfizer, Inc.
Drug ClassSmall Molecule
RouteInjectable (Others), Intramuscular (IM) Injection
StatusApproved
Sources: ClinicalTrials.gov, Pfizer, Inc.

Therapeutic Indications

cefazolin dibenzylamine is developed for 2 unique indications across 1 therapeutic area.

Therapeutic AreaConditionPhase
Infections and infestationsUrinary tract infection✓ Approved
Infections and infestationsRespiratory tract infection✓ Approved

Related Research Articles

PubMedBritish journal of anaesthesia2026-08-28

Carbon footprint of anaesthesia pharmaceuticals and disposable products during Caesarean delivery: a single-centre prospective observational study.

Kouwenberg Lisanne H J A LHJA, Demir Melisa M, van Bodegraven Lisa L, Colenbrander Elisabeth C A ECA et al.

The healthcare sector, particularly surgical care, is a major contributor to greenhouse gas emissions. This study aimed to investigate the carbon footprint of anaesthesia during Caesarean delivery, considering the impact of disposable products and pharmaceuticals, to identify environmental hotspots. A prospective observational study was conducted in a Dutch tertiary hospital, based on 50 Caesarean deliveries between July and October 2025. The carbon footprint of anaesthesia pharmaceuticals and disposable products was calculated using estimated kilograms of carbon dioxide equivalents (kg CO2-eq) from life-cycle assessment data and for pharmaceuticals using active pharmaceutical ingredients from life-cycle inventory data. The mean carbon footprint of anaesthesia pharmaceuticals and disposable products was 5.6 kg CO2-eq per Caesarean delivery. Disposables accounted for 80% (4.5 kg CO2-eq) of the total footprint. The prepackaged neuraxial tray, syringes, and warming blanket were the largest contributors, and ∼4% of the impact stemmed from unused disposable products. Pharmaceuticals contributed 1.1 kg CO2-eq, with i.v. fluids, cefazolin, and i.v. paracetamol being the highest. Disposable products were the main contributor to the carbon footprint of anaesthesia during Caesarean delivery. Addressing unnecessary use of disposable products is an achievable goal for reducing emissions. In addition, minimising wasted pharmaceuticals or unused disposable products is important, given that they significantly amplify the carbon footprint without providing clinical benefit.

PMID 42665486
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PubMedAntibiotics (Basel, Switzerland)2026-08-27

Cefazolin Versus Flucloxacillin for Methicillin-Susceptible Staphylococcus aureus Bone and Joint Infections: A Retrospective Single-Center Comparative Study of Effectiveness and Renal Safety of Intravenous Monotherapy.

Werneburg Felix F, Beschauner Juliane J, Werneburg Laura Isabell LI, Zeh Alexander A et al.

Background/Objectives: In methicillin-susceptible Staphylococcus aureus (MSSA) bacteremia, randomized evidence indicates comparable efficacy of cefazolin and antistaphylococcal penicillins with less nephrotoxicity; whether this extends to bone and joint infection (BJI) is unknown. We compared both agents in MSSA BJI. Methods: We retrospectively analyzed all adults at a single center with culture-confirmed, monomicrobial MSSA BJI treated with inpatient intravenous cefazolin or flucloxacillin monotherapy (January 2022-January 2025)-a selected population excluding rifampicin-based combination therapy, outpatient parenteral therapy, polymicrobial infection, and concurrent bacteremia/endocarditis. Endpoints, a priori exploratory, comprised effectiveness (mortality; clinical success) and renal safety (peri-treatment acute kidney injury [AKI]); the AKI comparison was additionally adjusted for confounders. Results: Among 110 patients (64 cefazolin, 46 flucloxacillin), baseline characteristics were comparable except for more frequent nephrotoxic co-medication with cefazolin (56.2% vs. 26.1%; p = 0.002). No statistically significant differences in effectiveness were detected: 30-day clinical success was 89.1% versus 80.4% (ARD 8.6 percentage points, 95% CI -4.7 to +23.3) and one-year clinical success 79.7% versus 65.2% (ARD 14.5, 95% CI -2.2 to +31.0); these imprecise estimates are compatible with effects ranging from no difference to a clinically relevant benefit of cefazolin. Peri-treatment AKI occurred in 19.0% versus 30.4% (ARD 11.4, 95% CI -4.7 to +27.7; adjusted odds ratio 2.27, 95% CI 0.87-5.91); the difference was confined to stage 1. Conclusions: In this selected inpatient monotherapy cohort, cefazolin was associated with numerically fewer AKI events, without statistically significant differences in any comparison. These exploratory findings support cefazolin as a rational targeted option for MSSA BJI, pending prospective confirmation.

PMID 42650723
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PubMedMicroorganisms2026-08-27

Retrospective Study on Antimicrobial Susceptibility of Staphylococcus hyicus Strains Isolated in Northern Italy Between 2022 and 2025.

Cordioli Benedetta B, Prosperi Alice A, Torreggiani Camilla C, Chiapponi Chiara C et al.

Sudden outbreaks of exudative epidermitis (EE) are managed with antibiotics. This retrospective observational study evaluated the antimicrobial susceptibility of Staphylococcus (S.) hyicus strains isolated in Northern Italy between January 2022 and April 2025. Isolates were recovered from clinical cases submitted to IZSLER diagnostic laboratories. To ensure data independence, only one isolate per pig farm or strains from the same farm isolated at least 6 months apart were included in the final analysis. Strains resulted from bacteriological examinations on skin swabs (65) and synovial fluid (1) of pigs with EE. Antimicrobial susceptibility was assessed by determining the MIC of 16 antimicrobials in broth microdilution. MIC50 and MIC90 values were determined, and strains were classified as wild-type (WT) or non-WT according to EUCAST ECOFFs. Each antimicrobial showed different sub-populations with reduced susceptibility. MIC50 and MIC90 values were identical or differed by one dilution for most antimicrobials. The highest ratios of non-WT strains were penicillin (97%), tetracycline (91%), and clindamycin (90%). Conversely, non-WT strains ranged between 3 and 6% for oxacillin, cefazolin, ceftiofur, and rifampin.

PMID 42655078
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PubMedHealth science reports2026-08-27

A Disproportionality Analysis of β-lactam Antibiotic Related Blood and Lymphatic System Disorders Based on the FDA Adverse Event Reporting System Database.

Liu Jing J, Zhang Min M, Tang Zongwei Z, Wang Xiaoxiao X et al.

β-lactam antibiotics stand as the most profoundly impactful classes of antibacterial agents worldwide. Their widespread application has raised safety concerns over adverse events (AEs), such as blood and lymphatic system disorders (BLSDs). This study systematically evaluated and compared BLSDs associated with β-lactam antibiotics based on real-world data. We reviewed the FDA Adverse Event Reporting System (FAERS) database from 2004Q1 to 2025Q1. To explore the associations between 30 FDA-approved β-lactam antibiotics and BLSDs, 4 disproportionality analysis algorithms were utilized, including reporting odds ratio, proportional reporting ratio, bayesian confidence propagation neural network, and multi-item gamma poisson shrinker. Our analytical framework included subgroup analysis and sensitivity analysis, with the Weibull distribution applied to model the pattern of BLSDs over time. The total number of reported BLSDs was 7872, accounting for 6.93% of all AEs related to β-lactam antibiotics. Notably, piperacillin/tazobactam, ceftriaxone, meropenem, cefazolin, cefepime, ceftazidime, ampicillin, oxacillin, cefotetan, and piperacillin produced strong signals of disproportionate reporting for BLSDs. Pyrexia, rash, and acute kidney injury emerged as the most frequently reported concurrent AEs. At the designated medical event level, several β-lactam antibiotics were found to be associated with agranulocytosis, hemolytic anemia, immune thrombocytopenia, pancytopenia, and other hematological AEs. With respect to the time-to-onset patterns, ceftriaxone, meropenem, and ceftazidime were classified as early failure modes, whereas cefepime, cefotetan, oxacillin, and piperacillin were categorized as wearout failure modes. This study revealed a notable association between β-lactam antibiotics and BLSDs, underscoring the importance of blood tests in clinical practice when β-lactam antibiotics are prescribed.

PMID 42656770
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PubMedClinical pharmacokinetics2026-08-26

Pharmacokinetics and Target Attainment of Antimicrobial Drugs Throughout Pregnancy. Part II: Cephalosporins.

Elzinga Femke A FA, Ferrier Kaylee R M KRM, Mulder Fabian F, van der Veen Eline H EH et al.

Understanding the pharmacokinetics (PK) of antibiotics in pregnant women is essential for safe and effective treatment. This review is part of a series that evaluates the PK, exposure, and target attainment of antibiotics during pregnancy. Part II focuses on cephalosporins and investigates if evidence-based dosing regimens are developed. A systematic literature search was conducted using PubMed on 24 July 2025. Articles containing PK data on pregnant women treated with any of the 35 selected cephalosporins were classified as relevant. Extracted PK and target attainment parameters included volume of distribution (Vd), clearance (CL), drug concentrations, area under the curve, elimination half-life (t1/2), probability of target attainment, and proposed dosing regimens. Of 219 articles identified, 44 met the inclusion criteria, covering 14 out of 35 cephalosporins. During second (T2) and third (T3) trimesters of pregnancy, Vd (9.2-18.4%) and CL (30.8-100%) were higher compared with nonpregnant, first trimester, or postpartum women. Consequently, reduced target attainment was reported in T2 and T3 pregnant women. Evidence-based dosing regimens were proposed for pregnant women receiving cefazolin, cefuroxime, cefoxitin, ceftazidime, cephradine, cefatrizine, and ceftizoxime. During pregnancy, an increase in Vd and CL was observed, indicating a potential need for higher or additional dosages, or shorter dosing intervals to achieve target attainment. However, evidence-based dosing adjustments were identified for only seven cephalosporins. These findings highlight significant gaps in knowledge and underscore the need for further research to characterize PK profiles and establish dosing recommendations for the remaining cephalosporins in pregnant women.

PMID 42645651
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PubMedInternational journal of obstetric anesthesia2026-08-24

Cefazolin administration prior to caesarean delivery and breastmilk microbiome: a nested cohort within a randomised clinical trial.

Eley Victoria V, Martin Elizabeth E, Amoako Akwasi A, Hartel Gunter G et al.

Consistent with guidelines, anaesthetists administer pre-incision cefazolin to patients having caesarean delivery in Australia. These antibiotics may impact the breastmilk microbiome. We hypothesised that the breastmilk microbiome of mothers administered cefazolin would differ from those administered placebo. In this nested cohort within a randomised clinical trial, samples were collected from adult females having caesarean delivery. Patients received cefazolin 2 g in 100 mL normal saline (cefazolin group) or 100 mL normal saline (placebo group) prior to skin incision. Breastmilk samples were collected by participants on post-operative day 14 and 30 and immediately frozen. Microbial composition of samples was assessed via long-read 16S rRNA sequencing. From the cefazolin group, there were 12 samples (day 14) and 13 (day 30). From the placebo group, there were 11 (day 14) and 9 (day 30). Full-length 16S rRNA sequencing yielded sufficient reads to characterise the breastmilk microbiota at both time points. Cefazolin exposure was associated with alterations in the composition, including increased abundances of the aerobic species Roseateles spp. and Cutibacterium acnes and a predominance of Gram-negative taxa. These shifts suggest suppression of Gram-positive commensals. The resulting microbial communities appeared relatively static and enriched with less-characterised, environmentally associated genera, indicating that cefazolin may potentially disrupt normal breastmilk microbial maturation by creating niches preferentially occupied by antibiotic-tolerant taxa. In this small, restricted sample, cefazolin exposure prior to delivery exerted modest effects on the breastmilk microbiome. The clinical implications require further evaluation in a larger, diverse population.

PMID 42636549
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