Last reviewed 2026-04-20 · How we verify

Monurol (FOSFOMYCIN)

Monurol (FOSFOMYCIN) is a small molecule antibiotic developed by ZAMBON SPA and currently owned by Zambon Spa. It is used to treat urinary tract infections caused by Enterococcus and Escherichia coli. Monurol was FDA approved in 1996 and is now off-patent, with multiple generic manufacturers available. It has a half-life of 1.9 hours and bioavailability of 31%. As an off-patent medication, Monurol is widely available in the market.

At a glance

Approved indications

• Enterococcus Urinary Tract Infection
• Escherichia coli urinary tract infection
• Urinary tract infectious disease

Common side effects

• anorexia
• constipation
• dry mouth
• dysuria
• ear disorder
• fever
• flatulence
• flu syndrome
• hematuria
• infection
• insomnia
• lymphadenopathy

Key clinical trials

• FOsfomycin for Male Urinary Tract Infection (PHASE3)
• Therapeutic Options for CRAB (PHASE4)
• Preoperative Prophylactic Fosfomycin Trometamol Versus 5-day Levofloxacin in Prevention of Postpercutaneous Nephrolithotomy Infectious Complications and Sepsis. (NA)
• Safety and Efficacy of a Weekly Oral Cyclic Antibiotic Programme in the Prevention of Urinary Tract Infection on Neurological Bladder (PHASE4)
• Pivmecillinam as Oral Step-Down Treatment for Escherichia Coli Febrile Urinary Tract Infection Versus Standard of Care (PHASE4)
• NextGen - Clinical Implication of Next Generation Sequencing (PHASE4)
• PK/PD Relationship of CAZ/AVI and FOS in the Treatment of Patients With Infections Due to CRE
• A Combination Therapy With Ceftazidime and Fosfomycin Will be Compared to Ceftazidime Alone in Hospitalized Adult Patients With Suspected Severe Gram-negative Bacterial Infections (PHASE3)

Primary sources

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