What are the potential side effects of Ertapenem in adults with a history of infections or underlying medical conditions?

Ertapenem Side Effects

Ertapenem is generally well-tolerated with most adverse events being mild to moderate in severity, with the most common side effects being diarrhea (≥5%), nausea (≥5%), headache (≥5%), and infused vein complications (≥5%) in adults. 1

Common Adverse Effects in Adults

The FDA-approved labeling identifies the following adverse reactions occurring in ≥5% of patients:

• Diarrhea - most frequently reported 1, 2
• Nausea 1, 2
• Headache 1, 2
• Infused vein complications (phlebitis/thrombophlebitis at injection site) 1, 2
• Vaginitis in females 2
• Vomiting 2

Pediatric Adverse Effects

In pediatric patients, the adverse reaction profile is comparable to adults, with diarrhea (≥5%), vomiting (≥5%), and infusion site pain (≥5%) being the most common. 1

Laboratory Abnormalities

Ertapenem is associated with increased laboratory adverse events compared to other antimicrobial regimens, though none have been reported as serious. 3

• A meta-analysis of complicated intra-abdominal infections found significantly more laboratory adverse events with ertapenem versus comparators (OR: 1.73,95% CI: 1.14-2.61) 3
• These laboratory abnormalities did not translate into serious clinical consequences 3

Tolerability Profile

The overall tolerability of ertapenem is excellent, with withdrawal rates due to adverse events comparable to other recommended antimicrobial regimens. 3, 4

• Meta-analysis showed no significant difference in clinical adverse events between ertapenem and comparators (OR: 0.86,95% CI: 0.61-1.20) 3
• Most adverse events are mild to moderate in severity 2, 4

Critical Considerations for Special Populations

For patients with underlying medical conditions or history of infections, ertapenem demonstrates an excellent safety profile with no specific contraindications beyond standard carbapenem precautions. 2, 4

• The once-daily dosing schedule (1 gram IV) reduces infusion-related complications compared to multiple-daily-dose regimens 5, 6
• The drug is particularly valuable for polymicrobial infections where both Enterobacteriaceae and anaerobic bacteria are involved 2

Important Caveats

Broad use of ertapenem may hasten the appearance of carbapenem-resistant Enterobacteriaceae, Pseudomonas, and Acinetobacter species, which is a significant antimicrobial stewardship concern. 7

• Reserve ertapenem for appropriate indications rather than routine use in mild-to-moderate infections where narrower-spectrum agents would suffice 7
• The drug lacks activity against Pseudomonas aeruginosa, Acinetobacter species, methicillin-resistant staphylococci, and enterococci 6