The incidences of treatment emergent adverse events were similar in ceftaroline and comparator groups (45.7% vs 46.7%, respectively). The most common adverse reactions occurring in ≥ 3% of patients treated with ceftaroline were diarrhoea, headache, nausea, and pruritus, and were generally mild or moderate in severity.
The following adverse reactions have been identified during clinical trials with ZINFORO. Adverse reactions are classified according to frequency and System Organ Class. Frequency categories for the adverse events are defined according to the following conventions: Very common (≥ 1/10), Common (≥ 1/100, < 1/10), Uncommon (≥ 1/1000, < 1/100), Rare (≥ 1/10000, < 1/1000). (See Table 4.)
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Description of selected adverse reactions: Rash: Rash was observed at a common frequency in the pooled Phase III studies in cSSTI with administration of ZINFORO every 12 hours (600 mg administered over 60 minutes every 12 hours) and the COVERS study in cSSTI with administration every 8 hours (600 mg administered over 120 minutes every 8 hours). However, the frequency of rash in the subgroup of Asian patients receiving ZINFORO every 8 hours (COVERS) was very common (18.5%).