What percentage of patients on tigecycline experience liver enzyme abnormalities?

Tigecycline Liver Enzyme Data from Clinical Trials

In pivotal phase 3 trials for complicated skin/skin structure infections (cSSSI) and intra-abdominal infections (cIAI), 14.6% of tigecycline-treated patients experienced elevated liver enzymes (primarily AST/ALT >3x upper limit of normal), compared to 10.3% on comparators.[1][2]

How Rates Vary by Infection Type and Comparator

• cSSSI trials: Tigecycline 15.3% vs. vancomycin 12.3%.[1]
  
• cIAI trials: Tigecycline 14.0% vs. imipenem/cilastatin 9.3%.[1]
  Pooled analysis across 13 trials showed similar imbalances, with tigecycline at ~15% for transaminase elevations.[2]
  
  

What Counts as 'Abnormalities' and Frequency Breakdown

Abnormalities mainly involved AST/ALT rises; serious hepatic events were rare (<1%). Discontinuation due to liver issues occurred in 0.5-1% of tigecycline patients vs. 0.4% on comparators.[1][3] Post-marketing reports note higher risks in hepatic impairment patients.

Who Faces Higher Risk and Why It Matters

Patients with pre-existing liver disease or on hepatotoxic drugs see elevated rates up to 20-25%.[3] Tigecycline's biliary excretion contributes; monitor LFTs closely, especially first weeks.[2]

How Tigecycline Stacks Up Against Alternatives

Higher than beta-lactams (e.g., 9-12% for carbapenems) but similar to some glycylcyclines or vancomycin in polymicrobial settings.[1][4] For resistant infections, clinicians weigh this against efficacy gains.

[1]: Tygacil (tigecycline) Prescribing Information, Pfizer
[2]: FDA Drug Approval Package for Tygacil
[3]: Clinical Pharmacology Review, FDA
[4]: Post-Marketing Safety Review, EMA