Nitrofurantoin

Overview

Nitrofurantoin is a nitrofuran antibiotic used to treat uncomplicated urinary tract infections. Nitrofurantoin is converted by bacterial nitroreductases to electrophilic intermediates which inhibit the citric acid cycle as well as synthesis of DNA, RNA, and protein. This drug is more resistant to the development of bacterial resistance because it acts on many targets at once. Nitrofurantoin is a second line treatment to trimethoprim/sulfamethoxazole. Nitrofurantoin was granted FDA approval on 6 February 1953.

Indication

Nitrofurantoin is indicated to treat acute uncomplicated urinary tract infections.

Associated Conditions

Acute Cystitis
Urinary Tract Infection

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
An Open Clinical Trial of the Safety and Efficacy of the Drug Fluorothiazinone, 300 Mg Tablets with the Participation of Adult Patients with Chronic Bacterial Cystitis"	2025/02/07	NCT06815549	Phase 3	Not yet recruiting	Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation
Asymptomatic Bacteriuria in Pregnancy in Low- and Middle-IncomE Countries	2024/12/09	NCT06723392	Phase 3	Not yet recruiting	NICHD Global Network for Women's and Children's Health
Clinical Trial Testing Whether Targeted Antibiotic Prophylaxis Can Reduce Infections After Cystectomy Compared to Empiric Prophylaxis	2024/11/29	NCT06709196	Phase 4	Recruiting	Rigshospitalet, Denmark
COMPARISON OF NITROFURANTOIN WITH FOSFOMYCIN in TREATING CYSTITIS IN WOMEN	2024/07/24	NCT06518291	Phase 4	Not yet recruiting	Shalamar Institute of Health Sciences
Bladder Botox UTI Antibiotic Prophylaxis	2024/04/29	NCT06387329	Phase 4	Recruiting	Walter Reed National Military Medical Center
Intravesical Gentamicin to Prevent Recurrent UTI	2024/03/27	NCT06332781	Phase 4	Recruiting	Women and Infants Hospital of Rhode Island
Gag Therapy for Recurrent Urinary Tract Infection Assessing Comparability to International Nitrofurantoin Gold Standard Study	2022/12/15	NCT05652374	Phase 4	Recruiting	Radboud University Medical Center
A Study to Investigate the Efficacy and Safety With Gepotidacin in Japanese Female Participants With Uncomplicated Urinary Tract Infection (Acute Cystitis)	2022/11/30	NCT05630833	Phase 3	Completed	GlaxoSmithKline
The Effectiveness of Single Antibiotic Paste Nitrofurantoin Versus Double Antibiotic Paste	2022/10/31	NCT05600023	Phase 4	Completed	Altamash Institute of Dental Medicine
Use of Prophylactic Antibiotics Prior to OnabotulinumtoxinA	2022/08/29	NCT05519072	Phase 4	Recruiting	Atlantic Health System

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Nitrofurantoin Monohydrate/ Macrocrystalline	A-S Medication Solutions	50090-0866	ORAL	25 mg in 1 1	6/20/2012
Nitrofurantoin Monohydrate/ Macrocrystalline	A-S Medication Solutions	50090-0866	ORAL	75 mg in 1 1	6/20/2012
nitrofurantoin macrocrystals	Lifestar Pharma LLC	70756-410	ORAL	25 mg in 1 1	3/24/2023
NITROFURANTOIN MACROCRYSTALS	DIRECT RX	61919-458	ORAL	100 mg in 1 1	1/12/2023
Nitrofurantoin Monohydrate/ Macrocrystalline	REMEDYREPACK INC.	70518-0265	ORAL	25 mg in 1 1	1/4/2024
Nitrofurantoin Monohydrate/ Macrocrystalline	REMEDYREPACK INC.	70518-0265	ORAL	75 mg in 1 1	1/4/2024
Nitrofurantoin monohydrate/macrocrystals (monohydrate/macrocrystals)	NuCare Pharmaceuticals,Inc.	68071-4535	ORAL	25 mg in 1 1	3/15/2021
Nitrofurantoin monohydrate/macrocrystals (monohydrate/macrocrystals)	NuCare Pharmaceuticals,Inc.	68071-4535	ORAL	75 mg in 1 1	3/15/2021
Nitrofurantion	NuCare Pharmaceuticals,Inc.	68071-2647	ORAL	100 mg in 1 1	2/24/2022
Nitrofurantoin (monohydrate/macrocrystals)	Teva Pharmaceuticals USA, Inc.	0480-3470	ORAL	25 mg in 1 1	12/18/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
AA PHARMA NITROFURANTOIN TABLET 50 mg	APOTEX INC	SIN00439P	TABLET	50 mg	4/27/1988
AA PHARMA NITROFURANTOIN TABLET 100 mg	APOTEX INC	SIN00290P	TABLET	100 mg	4/21/1988

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
UROSINA CAP	N/A	EUROPHARM LABORATOIRES COMPANY LIMITED	N/A	N/A	12/28/2002

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
NITROFURANTOIN MLABS nitrofurantoin 50 mg capsule bottle pack	299382	Micro Labs Pty Ltd	Medicine	A	12/21/2018
NITROFURANTOIN MLABS nitrofurantoin 100 mg capsule bottle pack	299387	Micro Labs Pty Ltd	Medicine	A	12/21/2018
MACRODANTIN 100mg Capsule	60065	Pfizer Australia Pty Ltd	Medicine	A	5/29/1997
URODANTIN nitrofurantoin 100 mg capsule bottle pack	299381	Micro Labs Pty Ltd	Medicine	A	12/21/2018
NITRODANTIN nitrofurantoin 100 mg capsule bottle pack	299386	Micro Labs Pty Ltd	Medicine	A	12/21/2018
URODANTIN nitrofurantoin 50 mg capsule bottle pack	299384	Micro Labs Pty Ltd	Medicine	A	12/21/2018
Nitrofurantoin BNM nitrofurantoin 100 mg hard capsule blister pack	346712	Boucher & Muir Pty Ltd	Medicine	A	10/8/2021
NITRODANTIN nitrofurantoin 50 mg capsule bottle pack	299380	Micro Labs Pty Ltd	Medicine	A	12/21/2018
MACRODANTIN 50mg capsules	60064	Pfizer Australia Pty Ltd	Medicine	A	5/29/1997
NITROFURANTOIN EM nitrofurantoin 100 mg capsule blister	319274	Emcure Pharmaceuticals Pty Ltd	Medicine	A	10/22/2020

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
MACRODANTIN CAP 25MG	norwich eaton canada inc.	00452491	Capsule - Oral	25 MG / CAP	12/31/1979
MACRODANTIN CAP 50MG	norwich eaton canada inc.	00452505	Capsule - Oral	50 MG / CAP	12/31/1979
JAMP NITROFURANTOIN	Jamp Pharma Corporation	02495511	Capsule - Oral	100 MG	4/2/2025
NEPHRONEX TAB 50MG	laboratoires cortunon inc.	00082783	Tablet - Oral	50 MG / TAB	4/19/1985
NU-NITROFURANTOIN TABLETS	nu-pharm inc	02239231	Tablet - Oral	50 MG / TAB	N/A
MACRODANTIN (100 MG)	procter & gamble pharmaceuticals canada inc	01997645	Capsule - Oral	100 MG	12/31/1993
JAMP NITROFURANTOIN BID	Jamp Pharma Corporation	02544954	Capsule - Oral	100 MG	2/18/2025
NITROFURANTOINE 100 TAB 100MG	PRO DOC LIMITEE	00563765	Tablet - Oral	100 MG / TAB	12/31/1982
NOVO-FURAN TAB 50MG	novopharm limited	00021563	Tablet - Oral	50 MG	12/31/1967
TEVA-NITROFURANTOIN	teva canada limited	02231016	Capsule - Oral	100 MG	4/30/1997

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
FURANTOINA 50 mg COMPRIMIDOS	Laboratorios Ern S.A.	22974	COMPRIMIDO	Medicamento Sujeto A Prescripción Médica	Commercialized
FURANTOINA 10 mg/ml SUSPENSION ORAL	Laboratorios Ern S.A.	34388	SUSPENSIÓN ORAL	Medicamento Sujeto A Prescripción Médica	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

Related News

Uncomplicated UTIs Impose Significant Economic Burden on Healthcare Systems

4 months ago

• Uncomplicated urinary tract infections (uUTIs) lead to substantially higher healthcare costs, with patients incurring over £1200 in annual healthcare expenses compared to £460 for matched controls. • Treatment failure in uUTIs creates economic burden through additional healthcare visits, repeated diagnostic tests, and rescue medications, while potentially leading to serious complications like pyelonephritis and sepsis. • A large-scale study of 120,519 female patients in England found that 0.2% required hospitalization during their uUTI episode, with key risk factors including older age and prior hospital admissions.

FDA Approves Blujepa: First Novel Oral Antibiotic for UTIs in Over Two Decades

5 months ago

• The FDA has approved gepotidacin (Blujepa), the first new class of oral antibiotics for urinary tract infections in nearly 30 years, addressing growing concerns about antimicrobial resistance. • Developed by GSK with partial funding from US government agencies, Blujepa works by interfering with bacterial enzymes needed for replication, potentially reducing the likelihood of resistance development. • Clinical trials involving over 3,000 females demonstrated Blujepa's efficacy comparable to or better than nitrofurantoin, with availability expected in the second half of 2025.

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