Relationship Between Trimethoprim‐Sulfamethoxazole‐Induced Hepatotoxicity and Cytochrome Protein 450 2C9 Using Food and Drug Administration Adverse Event Reporting System Database.

Background: Trimethoprim‐sulfamethoxazole (TMP‐SMX) is the second most frequently implicated drug for liver injury. A previous study reported that its onset may be due to the activation of cytochrome protein 450 (CYP) 2C9. However, few studies have measured the expression levels of CYP2C9 in clinica...

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Publicado en:Journal of Clinical Pharmacy & Therapeutics Vol. 2026; pp. 1 - 8
Autores principales: Kato, Hideo, Shiraishi, Chihiro, Hagihara, Mao, Mikamo, Hiroshige, Iwamoto, Takuya, Imran, Ali
Formato: research tables/charts Journal Article
Publicado: Wiley-Blackwell 3/3/2026
Acceso en línea:Ver este registro en EBSCOhost
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      dt: 3/3/2026
      vid: 2026
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      pub: Wiley-Blackwell
      place: Malden, Massachusetts
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        10.1155/jcpt/8891620
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        atl: Relationship Between Trimethoprim‐Sulfamethoxazole‐Induced Hepatotoxicity and Cytochrome Protein 450 2C9 Using Food and Drug Administration Adverse Event Reporting System Database.
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        au:
          Kato, Hideo
          Shiraishi, Chihiro
          Hagihara, Mao
          Mikamo, Hiroshige
          Iwamoto, Takuya
          Imran, Ali
        affil: Department of Pharmacy,, Mie University Hospital,, Tsu, Mie, Japan, mie-u.ac.jp
      sug:
        subj:
          Hepatotoxicity
          Trimethoprim-Sulfamethoxazole Combination Adverse Effects
          Cytochrome P-450 Enzyme System
          Adverse Drug Event
          United States Food and Drug Administration
          Voluntary Reporting
          Human
          Female
          Male
          Pharmacovigilance
          Hypothesis
          Drug Interactions
          Fluconazole
          Metronidazole
          Voriconazole
          Relative Risk
          Data Analysis Software
          Descriptive Statistics
          Confidence Intervals
          Odds Ratio
          Statistical Significance
          Female
          Male
      ab: Background: Trimethoprim‐sulfamethoxazole (TMP‐SMX) is the second most frequently implicated drug for liver injury. A previous study reported that its onset may be due to the activation of cytochrome protein 450 (CYP) 2C9. However, few studies have measured the expression levels of CYP2C9 in clinical settings; thus, the association between TMP‐SMX–induced liver injury and CYP2C9 has not yet been revealed. This study investigated the reporting frequency of liver injury associated with TMP‐SMX alone and in combination with a CYP2C9 inducer or inhibitor. Methods: Disproportionality analyses using the Food and Drug Administration adverse event reporting system database were performed to compare the reporting frequency (reporting odds ratio [ROR]; 95% confidence interval [CI]) of drug‐induced liver injuries. The reference group consisted of patients administered TMP‐SMX alone. Rifampicin was used as the CYP inducer, and fluconazole, metronidazole, and voriconazole as the inhibitors. Drug–drug interaction (DDI) signals were calculated based on the Ω shrinkage measure. Results: The reporting frequency of liver injury increased when used in combination with rifampicin (ROR = 16.90, 95% CI = 13.50–21.15). The concomitant use of inhibitors did not increase the reporting frequency of liver injury (fluconazole, ROR = 0.675, 95% CI = 0.583–0.782; metronidazole, ROR = 0.672, 95% CI = 0.585–0.772; voriconazole, ROR = 1.435, 95% CI = 1.237–1.665). TMP‐SMX plus rifampicin only demonstrated DDI signals of liver injury in the Ω shrinkage measure (Ω = 2.878, 95% CI = 2.607–3.148). Conclusions: The present study provides insight into the reporting patterns of TMP‐SMX–associated liver injury with the concomitant use of CYP inducers and inhibitors and suggests a potential safety signal involving increased CYP2C9 activity. These findings should be interpreted with caution because disproportionality analyses cannot establish causality, and further clinical and mechanistic studies are warranted.
      pubtype: Academic Journal
      doctype:
        research
        tables/charts
        Journal Article
      ougenre: Article
    language: English
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