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Oral nitrofurantoin monohydrate/macrocrystals
Nitrofurantoin inhibits bacterial DNA and RNA synthesis by interfering with bacterial enzyme systems, making it bactericidal against susceptible urinary tract pathogens.
Nitrofurantoin inhibits bacterial DNA and RNA synthesis by interfering with bacterial enzyme systems, making it bactericidal against susceptible urinary tract pathogens. Used for Urinary tract infection prophylaxis in women and children, Acute uncomplicated urinary tract infection.
At a glance
| Generic name | Oral nitrofurantoin monohydrate/macrocrystals |
|---|---|
| Sponsor | NICHD Global Network for Women's and Children's Health |
| Drug class | Nitrofuran antibiotic |
| Target | Bacterial DNA and RNA synthesis; bacterial nitroreductase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Nitrofurantoin is a prodrug that is activated by bacterial nitroreductase enzymes to form reactive intermediates that damage bacterial DNA and inhibit key metabolic enzymes. It is particularly effective against gram-negative and some gram-positive bacteria commonly causing urinary tract infections. The drug concentrates in urine, achieving high local concentrations at the site of infection.
Approved indications
- Urinary tract infection prophylaxis in women and children
- Acute uncomplicated urinary tract infection
Common side effects
- Nausea
- Headache
- Diarrhea
- Peripheral neuropathy (with chronic use)
- Pulmonary toxicity (rare)
- Hepatotoxicity (rare)
Key clinical trials
- Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries (PHASE3)
- Microbiome-Modulating Prophylaxis RCT: Antibiotic vs Gynoflor in Postmenopausal Women With Recurrent Cystitis (PHASE4)
- Comparative Study to Evaluate Efficacy and Safety of Gepotidacin to Nitrofurantoin in Treatment of Uncomplicated Urinary Tract Infection (UTI) (PHASE3)
- A Study to Evaluate Efficacy and Safety of Gepotidacin in the Treatment of Uncomplicated Urinary Tract Infection (UTI) (PHASE3)
- EXtended Use of FOsfomycin for the Treatment of CYstitis in Primary Care (PHASE3)
- Antibiotic Bladder Instillations vs. Oral Suppression for the Treatment of Recurrent Urinary Tract Infections (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
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