Two medicines, side by side
Fosfomycin vs levofloxacin
Fosfomycin and levofloxacin are both labeled for urinary tract infections. Drugs@FDA records approvals of fosfomycin since 1996 and of levofloxacin since 1996. Pharmacies paid $26.22 per unit (Fosfomycin 3 g sachet) and $0.259 per levofloxacin 750 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. Only the levofloxacin label carries a boxed warning.
Check it at the source: the fosfomycin FDA label on DailyMed (effective April 9, 2026); the levofloxacin FDA label on DailyMed (effective July 10, 2024).
Highlights of the fosfomycin record
Fosfomycin (Monurol) · label of April 9, 2026
Used for
From the label: indicationsFosfomycin tromethamine granules for oral solution is indicated only for the treatment of uncomplicated urinary tract infections (acute cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis. Fosfomycin tromethamine granules for oral solution is not indicated for the treatment of pyelonephritis or perinephric abscess. […]
On the market
- Earliest approval on file
- December 19, 1996
- Generic labelers
- 10 labelers
- Pharmacy cost
- $26.22 per unit
Supply and safety
- Shortage
- No current entry
- Recalls
- 2
Highlights of the levofloxacin record
Levofloxacin (Levaquin) · label of July 10, 2024
SERIOUS ADVERSE REACTIONS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CENTRAL NERVOUS SYSTEM EFFECTS AND EXACERBATION OF MYASTHENIA GRAVIS See full prescribing information for complete boxed warning.
Used for
From the label: indicationsLevofloxacin is a fluoroquinolone antibacterial indicated in adults (18 years of age and older) with infections caused by designated, susceptible bacteria and in pediatric patients where indicated ( 1 , 12.4 ). […]
On the market
- Earliest approval on file
- December 20, 1996
- Generic labelers
- 44 labelers
- Pharmacy cost
- $0.259 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 13
Source: FDA drug labels via openFDA (Fosfomycin label of April 9, 2026, Levofloxacin label of July 10, 2024); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do fosfomycin and levofloxacin differ on the record?
Only the levofloxacin label carries a boxed warning.
Generics: fosfomycin since 2020; levofloxacin since 2010 (Drugs@FDA).
| Fosfomycin | Levofloxacin | |
|---|---|---|
| Labeled for | Urinary tract infections | Bacterial infections, Urinary tract infections |
| Pharmacologic class | n/a | Fluoroquinolone Antibacterial |
| How it works (label) | n/a | Levofloxacin is a member of the fluoroquinolone class of antibacterial agents [see Microbiology ( 12.4 )]. |
| Half-life (label) | n/a | The mean terminal plasma elimination half-life of levofloxacin ranges from approximately 6 to 8 hours following single or multiple doses of levofloxacin given orally or intravenously. |
| Earliest approval on file (Drugs@FDA) | December 19, 1996 | December 20, 1996 |
| First generic approved | October 6, 2020 | December 20, 2010 |
| Generic labelers (NDC) | 10 labelers | 44 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $26.22 per unit (Fosfomycin 3 g sachet) | $0.259 per tablet (Levofloxacin 750 mg tablet) |
| 12-month price change | -29% | -11% |
| Boxed warning | No | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 2 | 13 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 598 | 59,954 |
| DEA schedule | none | none |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
What next?
- Alternatives to fosfomycin
- every medicine labeled for the same conditions