{"id":"oral-nitrofurantoin-monohydrate-macrocrystals","safety":{"commonSideEffects":[{"rate":"5-10","effect":"Nausea"},{"rate":"1-3","effect":"Headache"},{"rate":"1-3","effect":"Diarrhea"},{"rate":"0.1-0.5","effect":"Peripheral neuropathy (with chronic use)"},{"rate":null,"effect":"Pulmonary toxicity (rare)"},{"rate":null,"effect":"Hepatotoxicity (rare)"}]},"_chembl":{"chemblId":"CHEMBL572","moleculeType":"Small molecule","molecularWeight":"238.16"},"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"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.","oneSentence":"Nitrofurantoin inhibits bacterial DNA and RNA synthesis by interfering with bacterial enzyme systems, making it bactericidal against susceptible urinary tract pathogens.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T01:24:47.872Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Urinary tract infection prophylaxis in women and children"},{"name":"Acute uncomplicated urinary tract infection"}]},"trialDetails":[{"nctId":"NCT06723392","phase":"PHASE3","title":"Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries","status":"RECRUITING","sponsor":"NICHD Global Network for Women's and Children's Health","startDate":"2025-12-08","conditions":"Preterm Birth, Small for Gestational Age (SGA), Stillbirth","enrollment":1134},{"nctId":"NCT07186465","phase":"PHASE4","title":"Microbiome-Modulating Prophylaxis RCT: Antibiotic vs Gynoflor in Postmenopausal Women With Recurrent Cystitis","status":"RECRUITING","sponsor":"Mahidol University","startDate":"2025-09-11","conditions":"Cystitis, Recurrent, Urinary Tract Infections","enrollment":100},{"nctId":"NCT04187144","phase":"PHASE3","title":"Comparative Study to Evaluate Efficacy and Safety of Gepotidacin to Nitrofurantoin in Treatment of Uncomplicated Urinary Tract Infection (UTI)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2020-04-23","conditions":"Urinary Tract Infections","enrollment":1606},{"nctId":"NCT04020341","phase":"PHASE3","title":"A Study to Evaluate Efficacy and Safety of Gepotidacin in the Treatment of Uncomplicated Urinary Tract Infection (UTI)","status":"COMPLETED","sponsor":"GlaxoSmithKline","startDate":"2019-10-17","conditions":"Urinary Tract Infections","enrollment":1531},{"nctId":"NCT05254808","phase":"PHASE3","title":"EXtended Use of FOsfomycin for the Treatment of CYstitis in Primary Care","status":"TERMINATED","sponsor":"MJM Bonten","startDate":"2021-09-06","conditions":"Urinary Tract Infections","enrollment":13},{"nctId":"NCT04285320","phase":"PHASE4","title":"Antibiotic Bladder Instillations vs. Oral Suppression for the Treatment of Recurrent Urinary Tract Infections","status":"UNKNOWN","sponsor":"Atlantic Health System","startDate":"2021-03","conditions":"Recurrent Urinary Tract Infection","enrollment":100}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":1,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"phase_3","status":"active","brandName":"Oral nitrofurantoin monohydrate/macrocrystals","genericName":"Oral nitrofurantoin monohydrate/macrocrystals","companyName":"NICHD Global Network for Women's and Children's Health","companyId":"nichd-global-network-for-women-s-and-children-s-health","modality":"Small molecule","firstApprovalDate":"","aiSummary":"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.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}