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%) and very rare (<0.01%).
For patients who received tigecycline, the following adverse reactions were reported: Blood and Lymphatic System Disorders: Common: Prolonged activated partial thromboplastin time (aPTT), prolonged prothrombin time (PT). Uncommon: Increased international normalized ratio (INR).
Immune System Disorders: Undetermined Frequency: Anaphylaxis/anaphylactoid reactions.
Metabolism and Nutrition Disorders: Common: Bilirubinemia, increased blood urea nitrogen (BUN), hypoproteinemia, hypoglycemia.
Nervous System Disorders: Common: Dizziness.
Cardiac Disorders: Common: Phlebitis. Uncommon: Thrombophlebitis.
Respiratory, Thoracic and Mediastinal Disorders: Common: Pneumonia.
Gastrointestinal Disorders: Very Common: Nausea, vomiting, diarrhea. Common: Anorexia, abdominal pain, dyspepsia. Uncommon: Acute pancreatitis.
Hepatobiliary Disorders: Common: Elevated aspartate aminotransferase (AST) and alanine aminotransferase (ALT) in serum (AST and ALT abnormalities in tigecycline-treated patients were reported more frequently in the post-therapy period than in those in comparator-treated patients, which occurred more often on therapy). Uncommon: Jaundice. Undetermined Frequency: Hepatic cholestasis.
Skin and Subcutaneous Tissue Disorders: Common: Pruritus, rash. Undetermined Frequency: Severe skin reactions including Stevens-Johnson syndrome.
General Disorders and Administration Site Conditions: Common: Headache, abnormal healing. Uncommon: Injection site inflammation, pain, reaction, edema and phlebitis.
Investigations: Common: Elevated serum amylase.
In a pooled analysis of all 13 phase 3 and 4 trials that included a comparator, death occurred in 4% (150/3788) of patients receiving tigecycline and 3% (110/3646) of patients 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 patients. 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- and comparator-treated patients. No significant differences were observed between tigecycline and comparators within each infection type (see Table 13). 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.

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The most common treatment-emergent adverse reactions in patients treated with tigecycline were nausea 26.4% (16.9% mild; 8.1% moderate; 1.3% severe) and vomiting 18.1% (11% mild; 6.1% moderate; 1% severe). In general, nausea or vomiting occurred early (days 1-2).
Discontinuation from tigecycline was most frequently associated with nausea (1.1%) and vomiting (1.1%).