Safety profile of aztreonam in clinical trials.
The clinical safety of aztreonam in the treatment of suspected aerobic gram-negative infections was assessed in 346 patients who received single doses and in 2,388 patients who received multiple doses. Of those administered multiple doses, 163 (6.8%) experienced 172 adverse clinical effects. The most common were local reactions at the injection site, rash, diarrhea, and nausea and/or vomiting. Among aztreonam and control groups, three-fold increases in serum aspartate aminotransferase (SGOT) and serum alanine aminotransferase (SGPT) values occurred at comparably low frequencies; the mean values of SGOT and SGPT were slightly higher in patients administered aztreonam than in those given cefamandole. Treatment with aztreonam was discontinued in 51 (2.1%) of 2,388 patients because of adverse clinical effects or abnormal laboratory test values. Suprainfections (infections due to new pathogens occurring at the original site of infection during treatment with the study drug that were treated with another antibiotic) were reported in 2%-6% of aztreonam-treated patients, a frequency similar to that observed in control groups. Aztreonam is well tolerated and has a safety profile similar to that of other beta-lactam antibiotics.
D000410:Alanine Transaminase / Q000097:blood; D001219:Aspartate Aminotransferases / Q000097:blood; D001398:Aztreonam / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D001424:Bacterial Infections / Q000097:blood / Q000188:drug therapy*; D056486:Chemical and Drug Induced Liver Injury / Q000209:etiology; D002986:Clinical Trials as Topic; D003092:Colitis / Q000139:chemically induced; D003967:Diarrhea / Q000139:chemically induced; D003875:Drug Eruptions / Q000209:etiology; D006090:Gram-Negative Bacteria; D006470:Hemorrhage / Q000139:chemically induced; D006801:Humans; D007565:Jaundice / Q000139:chemically induced; D007668:Kidney / Q000187:drug effects; D012449:Safety
D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase; D001398:Aztreonam