Zyvox

Zyvox Adverse Reactions

linezolid

Manufacturer:

Pfizer
The information highlighted (if any) are the most recent updates for this brand.
Full Prescribing Info
Adverse Reactions
The safety of Zyvox formulations was evaluated in 2046 patients enrolled in 7 phase 3 comparator-controlled clinical trials, who were treated for up to 28 days. In these studies, 85% of the adverse events reported with Zyvox were described as mild to moderate in intensity. Table 11 shows the incidence of adverse events reported in at least 2% of patients in these trials. The most common adverse events in patients treated with Zyvox were diarrhea (incidence across studies: 2.8-11%), headache (incidence across studies: 0.5-11.3%) and nausea (incidence across studies: 3.4-9.6%). (See Table 11.)


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Other adverse events reported in phase 2 and 3 studies included oral moniliasis, vaginal moniliasis, hypertension, dyspepsia, localized abdominal pain, pruritus and tongue discoloration. Table 12 shows the incidence of drug-related adverse events reported in at least 1% of patients in these trials by dose of Zyvox. (See Table 12.)


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Laboratory Changes: Zyvox has been associated with thrombocytopenia when used in doses up to and including 600 mg every 12 hrs for up to 28 days. In phase 3 comparator-controlled trials, the percentage of patients who developed a substantially low platelet count (defined as <75% of lower limit of normal and/or baseline) was 2.4% (range among studies: 0.3-10%) with Zyvox and 1.5% (range among studies: 0.4-7%) with a comparator. Thrombocytopenia associated with the use of Zyvox appears to be dependent on duration of therapy, (generally >2 weeks of treatment). The platelet counts for most patients returned to the normal range/baseline during the follow-up period. No related clinical adverse events were identified in phase 3 clinical trials in patients developing thrombocytopenia. Bleeding events were identified in thrombocytopenic patients in a compassionate use program for Zyvox; the role of linezolid in these events cannot be determined (see Warnings).
Changes seen in other laboratory parameters, without regard to drug relationship, revealed no substantial differences between Zyvox and the comparators. These changes were generally not clinically significant, did not lead to discontinuation of therapy, and were reversible. The incidence of patients with at least one substantially abnormal hematologic or serum chemistry value is presented in Tables 13 and 14. (See Tables 13 and 14.)


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