Tygacil Adverse Reactions

Expected frequency of adverse reactions is presented in CIOMS frequency categories: Very Common: ≥10%; Common: ≥1% and <10%; Uncommon: ≥0.1% and <1%; Rare: ≥0.01% and <0.1%; Very Rare: <0.01%; Frequency not known: cannot be estimated from the available data.
For patients who received tigecycline, the following adverse reactions were reported: See Table 16.

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In a pooled analysis of all 13 Phase 3 and 4 trials that included a comparator, death occurred in 4.0% (150/3788) of subjects receiving tigecycline and 3.0% (110/3646) of subjects receiving comparator drugs. In a pooled analysis of these trials, the risk difference of all-cause mortality was 0.9% (95% CI 0.1, 1.8) between tigecycline and comparator-treated subjects. In a pooled analysis of these trials, based on a random effects model by trial weight, an adjusted risk difference of all-cause mortality was 0.6% (95% CI 0.1, 1.2) between tigecycline-treated and comparator-treated subjects. No significant differences were observed between tigecycline and comparators within each infection type (see Table 17). The cause of the imbalance has not been established. Generally, deaths were the result of worsening infection, or complications of infection or underlying co-morbidities. (See Table 17.)

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The most common treatment-emergent adverse reactions in subjects treated with tigecycline were nausea 29.9% (19.3% mild; 9.2% moderate; 1.4% severe) and vomiting 19.9% (12.1% mild; 6.8% moderate; 1.1% severe). In general, nausea or vomiting occurred early (Days 1-2).
Discontinuation from tigecycline was most frequently associated with nausea (1.6%) and vomiting (1.3%).
Pediatric population: Very limited safety data were available from two PK studies (see Pharmacology: Pharmacokinetics under Actions). No new or unexpected safety concerns were observed with tigecycline in these studies.
In an open-label, single ascending dose PK study, the safety of tigecycline was investigated in 25 children aged 8 to 16 years who recently recovered from infections. The adverse reaction profile of tigecycline in these 25 subjects was generally consistent with that in adults.
The safety of tigecycline was also investigated in an open-label, ascending multi-dose PK study in 58 children aged 8 to 11 years with cSSSI (n=15), cIAI (n=24) or community acquired pneumonia (n=19). The adverse reaction profile of tigecycline in these 58 subjects was generally consistent with that in adults, with the exception of nausea (48.3%), vomiting (46.6%) and elevated lipase in serum (6.9%) which were seen at greater frequencies in children than in adults.