Rocephin (Ceftriaxone) Safety in Pregnancy
Rocephin (ceftriaxone) is safe to use during pregnancy and belongs to the cephalosporin class, which is considered one of the safest antibiotic classes for pregnant women. 1, 2
Evidence-Based Safety Profile
FDA Classification and Animal Studies
- Ceftriaxone is FDA Pregnancy Category B, meaning reproductive studies in mice and rats at doses up to 20 times the usual human dose showed no evidence of embryotoxicity, fetotoxicity, or teratogenicity. 3, 4
- Primate studies at approximately 3 times the human dose demonstrated no embryotoxicity or teratogenicity. 3, 4
- No impairment of fertility was observed in rats given intravenous ceftriaxone at daily doses up to 586 mg/kg/day (approximately 20 times the recommended clinical dose). 3, 4
Guideline Recommendations
- Expert panels explicitly recommend penicillins and cephalosporins as the safest antibiotic classes during pregnancy and should be used when endoscopic evidence of purulence is present in acute rhinosinusitis or acute exacerbations of chronic rhinosinusitis. 1
- The European Respiratory Society guidelines confirm that cephalosporins, including ceftriaxone, are among the safest options for bacterial infections during pregnancy. 2
Clinical Considerations
When to Use Ceftriaxone
- Ceftriaxone can be given for acute bacterial rhinosinusitis or acute exacerbations when endoscopic evidence of purulence is present. 1
- The medication is appropriate for treating bacterial infections throughout pregnancy, though the FDA label notes that "this drug should be used during pregnancy only if clearly needed" since adequate and well-controlled studies in pregnant women are lacking. 3, 4
Important Caveats
- Avoid ceftriaxone in hyperbilirubinemic neonates, especially premature infants, as it can displace bilirubin from serum albumin. 3, 4
- Low concentrations of ceftriaxone are excreted in human milk, so caution should be exercised when administering to nursing women. 3, 4
Antibiotics to Avoid During Pregnancy
In contrast to the safety of cephalosporins, the following antibiotics should not be used during pregnancy as they put the fetus at risk: