fosfomycin

What the FDA Data Shows for fosfomycin

The FDA label for fosfomycin (sold under brand names such as Monurol) classifies it as a prescription-only medication in the Phosphonic Acid Antibiotic class. This medicine treats uncomplicated urinary tract infections (UTIs) in women. Official labeling lists 5 commonly reported side effects, including Diarrhea, Vaginal inflammation (vaginitis), Nausea.

Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. Voluntary reports accumulate over the lifetime of a drug and reflect wide-ranging clinical use. The database also lists 2 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated minor severity. NADAC pricing from CMS shows a generic unit cost of $41.92.

Report counts do not establish causation — a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice — always consult a licensed healthcare provider before starting, stopping, or changing any medication.