Zavicefta Adverse Reactions

In seven Phase 2 and Phase 3 clinical trials, 2024 adults were treated with Ceftazidime (as pentahydrate)/Avibactam (as sodium) (Zavicefta). The most common adverse drug reactions occurring in ≥5% of patients treated with Ceftazidime (as pentahydrate)/Avibactam (as sodium) (Zavicefta) were Coombs direct test positive, nausea, and diarrhea. These were usually mild or moderate in intensity. No clinically significant differences were observed in the safety profile across indications.
The following adverse drug reactions have been reported with ceftazidime alone and/or identified during all Phase 2 and Phase 3 clinical trials with Ceftazidime (as pentahydrate)/Avibactam (as sodium) (Zavicefta) (N = 2024). Adverse reactions are classified according to frequency and System Organ Class. Frequency categories are derived from adverse reactions and/or potentially clinically significant laboratory abnormalities, and are defined according to the following conventions: Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1,000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (<1/10,000); Unknown (cannot be estimated from the available data). (See Table 18.)

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Pediatric population: The safety assessment in children is based on the safety data from 1 trial in which 61 pediatric patients aged from 3 years to less than 18 years with cIAI received Ceftazidime (as pentahydrate)/Avibactam (as sodium) (Zavicefta) and 67 patients with cUTI (aged from 3 months to less than 18 years) received Ceftazidime (as pentahydrate)/Avibactam (as sodium). Overall, the safety profile in these 128 pediatric patients was similar to that observed in the adult population with cIAI and cUTI.