Common Side Effects of Tigecycline Injection
Tigecycline, an IV antibiotic for complicated infections, commonly causes nausea (26%), vomiting (18%), diarrhea (13%), and elevated liver enzymes. These occur in clinical trials and post-marketing reports.[1][2]
What Counts as Rare Side Effects?
Rare side effects, defined as those in <1% of patients or from spontaneous reports, include:
- Anaphylaxis or hypersensitivity reactions like rash, urticaria, or angioedema.
- Thrombocytopenia (low platelets).
- Pancreatitis.
- Severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis.
- Hepatic failure or jaundice.
- Increased INR or prothrombin time, risking bleeding.
These appear in FDA labeling and EMEA summaries, often with unknown frequency due to voluntary reporting.[1][3]
How Often Do They Happen and in Whom?
Incidence is low; for example, anaphylaxis occurred in 0.6% of trial patients. Risk factors include prior allergies, renal/hepatic impairment, or concurrent drugs like warfarin. Post-approval surveillance flags higher risks in elderly or critically ill patients.[2][4]
Why Do These Rare Effects Occur?
Tigecycline inhibits bacterial protein synthesis but can trigger immune responses (hypersensitivity) or affect human cells (e.g., liver toxicity via mitochondrial interference). Case reports link pancreatitis to high doses.[3][5]
What Should Patients Watch For?
Seek immediate care for symptoms like difficulty breathing, severe abdominal pain, unexplained bruising, yellowing skin, or blistering rash. Discontinue if suspected.[1]
Reporting and Monitoring
The FDA's FAERS database logs hundreds of tigecycline-related rare events since 2005 approval. Clinicians monitor labs (liver, platelets) during 7-14 day courses.[4]
Sources
[1]: FDA Tigecycline Label
[2]: Tygacil Prescribing Information
[3]: EMA Tigecycline Summary
[4]: FDA Adverse Event Reporting System
[5]: PubMed Case Reports on Tigecycline