What are the common side effects of tigecycline?

Common Side Effects of Tigecycline

Gastrointestinal side effects are the most common adverse reactions associated with tigecycline, particularly nausea (26%) and vomiting (18%), which typically occur during the first 1-2 days of therapy. 1

Gastrointestinal Effects

• Nausea (26% overall: 17% mild, 8% moderate, 1% severe) 1
• Vomiting (18% overall: 11% mild, 6% moderate, 1% severe) 1
• Diarrhea (12%) 1
• Abdominal pain (6%) 1
• Dyspepsia (2%) 1
• Anorexia (<2%) 1

Dermatological Effects

• Pruritus (itching) (<2%) 2, 1
• Rash (3%) 2, 1
• Photosensitivity (tetracycline-class effect) 1

Hematological Effects

• Prolonged activated partial thromboplastin time (aPTT) 2, 1
• Prolonged prothrombin time (PT) 2, 1
• Increased international normalized ratio (INR) 1
• Thrombocytopenia 1
• Anemia (5%) 1

Hepatic Effects

• Elevated liver function tests 2, 1
• Jaundice (<2%) 1

Metabolic Effects

• Hypoglycemia 2, 1
• Hypoproteinemia 2, 1
• Elevated amylase 2, 1
• Elevated blood urea nitrogen 2, 1
• Hypocalcemia 1

Neurological Effects

• Dizziness (3%) 2, 1
• Headache (6%) 2, 1
• Pseudotumor cerebri (tetracycline-class effect) 1

Vascular Effects

• Phlebitis (3%) 2, 1
• Thrombophlebitis (<2%) 1

Injection Site Reactions

• Inflammation, pain, edema, phlebitis (<2%) 1

Serious Adverse Effects to Monitor

• Increased risk of mortality compared to other antibiotics (observed in clinical studies) 2, 1
• Sepsis/septic shock (2% vs 1% with comparators) 2, 1
• Acute pancreatitis (post-marketing reports) 1, 3, 4
• Severe skin reactions including Stevens-Johnson Syndrome 1
• Clostridium difficile-associated diarrhea 1

Special Considerations

Monitoring Requirements

• Monitor coagulation parameters (PT, aPTT) if administered with warfarin 1
• Monitor for signs of pancreatitis (abdominal pain, nausea, vomiting with elevated amylase/lipase) 3, 4
• Monitor liver function tests 2, 1
• Monitor for hypoglycemia, especially in diabetic patients 1

Contraindications and Cautions

• Hypersensitivity to tigecycline or tetracyclines 2
• Pregnancy (Category D) - may cause fetal harm 1
• Children under 8 years (risk of teeth discoloration) 2, 1
• Severe hepatic impairment (Child-Pugh class C) - requires dose reduction 1
• Caution in patients with intestinal perforation (avoid monotherapy) 1

Management of Common Side Effects

• For nausea and vomiting, consider antiemetics and slower infusion rate 2
• Some studies have used lower doses (50 mg/day instead of 50 mg twice daily) to improve tolerance 2
• Discontinuation due to adverse effects occurs in approximately 7% of patients, most commonly due to nausea (1%) and vomiting (1%) 1

Tigecycline is generally administered as a 100 mg loading dose followed by 50 mg twice daily intravenously for 5-14 days, with dose adjustments required for severe hepatic impairment 2, 1.