Common Side Effects and Their Frequencies
Tigecycline, an antibiotic for complicated infections, has side effects reported in clinical trials and post-marketing data. Nausea occurs in 26% of patients, vomiting in 18%, and diarrhea in 13%. These are the most frequent, often leading to discontinuation in 1-4% of cases.[1][2]
Serious Side Effects Frequencies
Serious risks include increased mortality (4% tigecycline vs. 3% comparators in trials), superinfections (7%), and pancreatitis (less than 1%). Hypersensitivity reactions appear in under 1%, while acute pancreatitis and hepatic failure are rare (0.1-1%).[1][3]
How Frequencies Were Determined
Data come from phase 3 trials involving over 3,700 patients, where adverse events were tracked versus comparators. Post-approval surveillance shows higher rates for some events like Clostridium difficile diarrhea (exact frequency unknown but monitored).[2][4]
Side Effects by Patient Group
In ventilator-associated pneumonia trials, nausea hit 23% and vomiting 16%. Elderly patients see similar rates, but renal impairment may elevate risks without adjusted dosing. Pediatric data is limited, with nausea at 40% in small studies.[1][3]
Factors Influencing Side Effect Rates
Higher doses increase GI effects (e.g., 100mg loading dose). Duration beyond 14 days raises superinfection risk. No major sex differences, but obesity correlates with lower efficacy and possibly more adverse events.[2][4]
Managing and Reporting Side Effects
Monitor for GI symptoms early; antiemetics help. Discontinue if pancreatitis suspected. Report to FDA via MedWatch for real-world frequency updates.[3]
[1]: Tigecycline Prescribing Information (Pfizer)
[2]: Drugs.com - Tigecycline Side Effects
[3]: FDA Label - Tygacil
[4]: RxList - Tigecycline