ArticleClinical and translational science2026
Consciousness Disturbances Reported With Clindamycin Versus Cefazolin in Surgical Patients: A Global Pharmacovigilance Analysis Using VigiBase.
Article in Clinical and translational science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Clindamycin is a common β-lactam substitute for surgical prophylaxis. Whether peri-operative disturbances in consciousness are disproportionately reported with clindamycin in global pharmacovigilance data remains unclear. Using WHO VigiBase (up to January 27, 2025), we performed a de-duplicated case/non-case disproportionality analysis of Individual Case Safety Reports (ICSRs) co-reporting ≥ 1 anesthetic or sedative. Cases were defined by the MedDRA HLT "Disturbances in consciousness NEC." We estimated RORs and aRORs for clindamycin versus cefazolin and other peri-operative comparators (metronidazole, vancomycin, ampicillin), adjusting for age group, sex, and co-reported medications. K-modes clustering characterized co-reporting patterns among clindamycin reports. Sensitivity analyses excluded sepsis-related terms/vasopressors and applied a narrower outcome definition excluding syncope/presyncope. Of 3623 clindamycin ICSRs, 159 (4.4%) included a consciousness-disturbance term. Versus cefazolin, clindamycin generated a disproportionality signal (ROR 2.59, 95% CI 2.07-3.24; aROR 2.23, 95% CI 1.70-2.91), with similar estimates after excluding sepsis/vasopressors (aROR 2.21, 95% CI 1.64-2.98) and syncope/presyncope (aROR 2.11, 95% CI 1.60-2.79). Clustering suggested co-reporting patterns consistent with lidocaine-enriched older-age reports, sedative/anesthetic-enriched younger-age reports, and opioid-enriched reports with high-acuity markers. In VigiBase, disproportionality analyses identified a reporting signal for disturbances in consciousness with clindamycin relative to cefazolin in surgical settings. Because spontaneous reports lack exposure denominators and are susceptible to residual confounding, these findings are hypothesis-generating and do not estimate incidence or comparative risk. Evaluation in data sources with denominators and prospective clinical characterization is warranted.
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