Fosfomycin for Male UTI
Fosfomycin is NOT recommended for routine use in men with UTIs due to limited efficacy data in this population, according to European Urology guidelines 1.
Guideline Recommendations for Men
The European Urology guidelines explicitly state that fosfomycin should not be used for routine treatment of UTIs in men due to insufficient clinical efficacy data in this population 1.
The FDA label restricts fosfomycin indication to uncomplicated urinary tract infections (acute cystitis) in women only, with no approval for use in men 2.
All major guidelines (American Urological Association, European Association of Urology, American College of Physicians) recommend fosfomycin as first-line therapy specifically for uncomplicated cystitis in women, not men 1.
Pharmacokinetic Considerations in Men
While fosfomycin does distribute to the prostate and seminal vesicles after oral administration 2, this tissue penetration has not translated into proven clinical efficacy in controlled trials for male UTIs 1.
The single 3-gram dose provides therapeutic urinary concentrations for 24-48 hours 1, but this duration may be insufficient for male UTIs, which often involve prostatic tissue requiring longer treatment courses.
Limited Evidence in Special Circumstances
One small observational study (16 male patients, 21 UTI episodes) showed potential benefit of oral fosfomycin-trometamol for multidrug-resistant Enterobacterales in men, using modified dosing regimens 3:
This study used off-label, extended dosing regimens far exceeding the FDA-approved single-dose regimen, and the high relapse rate (58% in prostatitis) demonstrates suboptimal efficacy 3.
Clinical Pitfalls and Caveats
Do not use the standard single 3-gram dose for male UTIs - this regimen is only validated for uncomplicated cystitis in women 1, 2.
Male UTIs are often complicated by prostatic involvement, requiring longer antibiotic courses that penetrate prostatic tissue effectively 1.
Fosfomycin should never be used for pyelonephritis or complicated UTIs in either sex due to insufficient efficacy data 1, 2.
Recommended Alternatives for Male UTIs
For sexually active adult males with UTI, consider fluoroquinolones or trimethoprim-sulfamethoxazole as first-line agents, assuming local resistance patterns are favorable 1.
For multidrug-resistant organisms in men, carbapenems remain the standard of care rather than oral fosfomycin 3.
If fosfomycin is considered for MDR organisms in men when other options are exhausted, it should only be used with infectious disease consultation and extended dosing regimens (not the single-dose regimen), recognizing this is off-label use with limited supporting evidence 3.