title: Hypersensitivity reactions associated with fidaxomicin use.
abstract: We report hypersensitivity reactions associated with fidaxomicin, an antibacterial drug approved for the treatment of Clostridium difficile-associated diarrhea. These reactions are viewed as significant because of severity and unexpected because fidaxomicin is minimally absorbed. The fidaxomicin labeling was revised to include information about the possibility of hypersensitivity reactions.
authors.affiliation: Division of Anti-Infective Products, Food and Drug Administration, Silver Spring, Maryland.
authors.forename: Dmitri E
authors.initials: DE
authors.lastname: Iarikov
authors.forename: John
authors.initials: J
authors.lastname: Alexander
authors.forename: Sumathi
authors.initials: S
authors.lastname: Nambiar
mesh_terms: D000328:Adult; D000368:Aged; D000617:Aminoglycosides / Q000009:adverse effects* / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000009:adverse effects* / Q000627:therapeutic use; D016360:Clostridioides difficile / Q000302:isolation & purification; D003015:Clostridium Infections / Q000188:drug therapy / Q000382:microbiology; D003967:Diarrhea / Q000188:drug therapy / Q000382:microbiology; D004342:Drug Hypersensitivity; D005260:Female; D000077732:Fidaxomicin; D006801:Humans; D008297:Male; D008875:Middle Aged
chemical_list: D000617:Aminoglycosides; D000900:Anti-Bacterial Agents; D000077732:Fidaxomicin
keywords: adverse reactions; fidaxomicin; hypersensitivity