Is Fosfomycin Safe in Pregnancy
Status
cautionReason
Limited pregnancy data. Official labels say use only if clearly needed and provider review is needed.
Drug Information
Safe Amount
Dosage must be determined by your provider based on individual risk/benefit.
Effects
- Pregnancy
- Human data are limited. Official labeling says use during pregnancy only if clearly needed.
- Mother
- Used to treat bacterial infections, including UTIs. Side effects may still occur.
- Baby
- Placental transfer occurs. Animal data did not show malformations, but human data are limited.
Trimester Notes
- 1st Trimester
- A large study found no increased risk of major congenital anomalies with first-trimester exposure, but official data remain limited.
- 2nd Trimester
- No trimester-specific official warning was found in the cited sources; provider review is still needed.
- 3rd Trimester
- No trimester-specific official dosing or warning was found in the cited sources.
Risk-Benefit Note
Treating a confirmed urinary infection in pregnancy can be important for mother and baby. The decision should balance infection risks against limited fetal safety data.
Conditions & Warnings
- Consult OB/GYN or prescriber
- Prescription drug: do not start, stop, or continue without provider review
- Use only if clearly needed per official labeling
Alternatives
- Nitrofurantoin if appropriate for the infection and gestational age
- Cephalexin or other beta-lactam options if appropriate
- Consult your OB/GYN or prescriber for culture-guided treatment
References
- FDA label for Monurol (fosfomycin tromethamine)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/050717s009lbl.pdf - FDA label for Contepo (fosfomycin)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/212271s000lbl.pdf