How often do nausea and vomiting occur with tigecycline?

Nausea and Vomiting Rates in Tigecycline Clinical Trials

Tigecycline, an antibiotic used for complicated infections, commonly causes gastrointestinal side effects. In pivotal phase 3 trials, nausea occurred in 26-30% of patients overall, with vomiting in 18-20%. These rates were higher than comparators like vancomycin or imipenem (nausea 14-15%, vomiting 8-11%). Most events were mild to moderate and happened early, often on day 1.[1][2]

How Rates Differ by Indication and Dose

• Skin/skin structure infections: Nausea 23%, vomiting 15%.
  
• Intra-abdominal infections: Nausea 27%, vomiting 19%.
  
• Pneumonia: Nausea 29%, vomiting 20%.
  
  Intravenous doses of 100 mg loading followed by 50 mg every 12 hours drove these rates; oral formulations aren't available. Discontinuation due to nausea was 2-4%, vomiting 1-2%.[1][2]
  
  

Factors Raising Nausea/Vomiting Risk

Higher incidence in females (32% nausea vs. 25% males) and elderly patients. Rates doubled in ventilator-associated pneumonia trials (nausea ~40%). Infusion over 30-60 minutes and antiemetics like ondansetron reduce severity.[1][3]

Management and Patient Experiences

Guidelines recommend premedication with antiemetics and slower infusions. Patients report symptoms peak within 24-48 hours and resolve post-treatment, but 5-10% experience severe cases needing intervention. No long-term GI risks noted.[2][3]

Comparison to Other Antibiotics

Tigecycline's GI effects exceed carbapenems (nausea <15%) and linezolid (10-15%), but it's similar to some tetracyclines. This profile limits outpatient use.[1]

[1]: Tigecycline Prescribing Information (FDA)
[2]: ClinicalTrials.gov summaries for TYGACIL trials (NCT00079217, NCT00091819)
[3]: DrugPatentWatch.com - Tigecycline side effect profile