From the FDA Drug Label
Pregnancy Teratogenic Effects Teratogenic Effects Pregnancy Category B: Reproductive studies have been performed in mice and rats at doses up to 20 times the usual human dose and have no evidence of embryotoxicity, fetotoxicity or teratogenicity. In primates, no embryotoxicity or teratogenicity was demonstrated at a dose approximately 3 times the human dose There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed
Key Points:
- The FDA drug label categorizes ceftriaxone as Pregnancy Category B.
- Reproductive studies in animals have shown no evidence of embryotoxicity, fetotoxicity, or teratogenicity.
- However, there are no adequate and well-controlled studies in pregnant women.
- The drug should be used during pregnancy only if clearly needed.
It is safe to give a pregnant patient ceftriaxone for a UTI if clearly needed, as the benefits outweigh the risks, but caution and careful consideration should be exercised due to the lack of adequate and well-controlled studies in pregnant women 1 1.
From the Research
Rocephin (ceftriaxone) is generally considered safe for treating urinary tract infections (UTIs) in pregnant patients, as supported by the most recent evidence from 2, which reviewed international guidelines for UTI treatment during pregnancy. The typical dose for UTIs is 1-2 grams IV or IM once daily for 7-14 days, depending on the severity of the infection. Key points to consider when treating UTIs in pregnant patients include:
- Ceftriaxone is particularly useful for complicated UTIs or when oral antibiotics are not appropriate.
- For uncomplicated UTIs in pregnancy, oral options like nitrofurantoin, cephalexin, or amoxicillin-clavulanate are often preferred first-line treatments when the organism is susceptible, as noted in 3.
- Treatment should always be guided by urine culture and sensitivity results when available, and completing the full course of antibiotics is crucial even if symptoms improve quickly.
- Ensuring adequate hydration during treatment is also important, and any pregnant patient with a UTI should be monitored closely as untreated or inadequately treated UTIs can lead to pyelonephritis, which increases risks of preterm labor and low birth weight. Additionally, a recent study 4 found that amoxicillin-clavulanate may be a useful alternative therapy for the treatment of ceftriaxone non-susceptible Enterobacterales UTIs, providing another option for treatment in certain cases.