USP Quality Review

No. 70, Issued November 1999

Gentamicin: Reactions

During July and August 1999, the USP Practitioners' Reporting NetworkSM received five reports, involving eight patients, describing adverse reactions to gentamicin sulfate injection. Four patients received an ESI Lederle gentamicin product and four patients an American Pharmaceutical Partners, Inc., gentamicin product. All reports involved pyrogen-like reactions. Patients were described as suffering from signs and symptoms that included dyspnea, blood pressure elevation, tachycardia, shaking, chills, tremors, fever, rash, aches, and malaise. In five patients, the reported dosages were specified as either a once-daily-dosing regimen or a loading dose administration.