What are the side effects of Ertapenem?

Ertapenem Side Effects

Ertapenem commonly causes diarrhea, nausea, headache, and infused vein complications, with most adverse reactions being mild to moderate in intensity. 1, 2

Common Side Effects

Based on the FDA drug label and clinical studies, the most frequently reported adverse effects include:

• Gastrointestinal effects:

  • Diarrhea (5-6%)
  • Nausea (2.5-3.4%)
  • Vomiting

• Infusion-related reactions:

  • Infused vein complications (3.2-4.5%)
  • Phlebitis and/or thrombophlebitis
  • Infusion site pain (especially in pediatric patients)

• Neurological effects:

  • Headache
  • Dizziness

• Other common effects:

  • Elevated liver enzymes (alanine aminotransferase elevations in 8.3-8.8% of patients)
  • Vaginitis in females 2

Serious Adverse Effects

Though less common, ertapenem can cause several serious adverse reactions:

• Hypersensitivity reactions:

  • Anaphylactic reactions 1
  • Allergic reactions to β-lactams

• Neurological complications:

  • Seizures and other central nervous system adverse experiences 1
  • Peripheral neuropathy, particularly in patients with renal impairment 3, 4

• Gastrointestinal complications:

  • Clostridioides difficile-associated diarrhea (ranging from mild diarrhea to fatal colitis) 1

• Drug interactions:

  • Reduced serum concentration of valproic acid when co-administered, potentially increasing risk of breakthrough seizures 1

Special Considerations for Specific Populations

Patients with Renal Impairment

• Dose adjustment is necessary if creatinine clearance is ≤30 mL/min/1.73 m² 1
• Patients with advanced renal failure (Stage 5 CKD) may experience prolonged neurotoxicity even with recommended reduced doses 3, 4
• Reported neurotoxicity symptoms include:
  • Hallucinations
  • Asterixis
  • Myoclonic jerks
  • Cognitive impairment 4

Elderly Patients

• No overall differences in safety have been observed between elderly (≥65 years and ≥75 years) and younger patients 1, 2

Pediatric Patients

• Most common adverse reactions in pediatric patients include:
  • Diarrhea
  • Vomiting
  • Infusion site pain 1

Administration Precautions

• Do not mix or co-infuse ertapenem with other medications
• Do not use diluents containing dextrose (α-D-glucose)
• Should be infused over 30 minutes
• When administered intramuscularly, caution should be taken to avoid inadvertent injection into a blood vessel 1

Monitoring Recommendations

• Monitor for signs of hypersensitivity reactions, especially in patients with known allergies to β-lactams
• Monitor for neurological symptoms, particularly in patients with renal impairment
• Evaluate if diarrhea occurs, as it could indicate Clostridioides difficile-associated colitis
• Monitor liver function tests, especially in patients with pre-existing hepatic disease

Contraindications

• Known hypersensitivity to product components or anaphylactic reactions to β-lactams
• When administered intramuscularly, ertapenem is contraindicated in patients with known hypersensitivity to local anesthetics of the amide type (due to the use of lidocaine HCl as a diluent) 1

Ertapenem is generally well-tolerated with a safety profile comparable to other commonly used antibiotics such as piperacillin-tazobactam and ceftriaxone 2, but careful monitoring is essential, particularly in patients with renal impairment.