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Drug ReportsNitrofurantoin macrocrystalline
Nitrofurantoin
Furadantin, Ivadantin, Macrobid, Macrocrystalline, Macrodantin, Nitrofurantoin, Nitrofurantoin Nitrofurantoin (nitrofurantoin) is a small molecule pharmaceutical. Nitrofurantoin was first approved as Furadantin on 1982-01-01. It is used to treat bacterial infections, escherichia coli infections, klebsiella infections, staphylococcal infections, and urinary tract infections in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
urogenital diseasesD000091642
Trade Name
FDA
EMA
No data
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name
Status
Last Update
furadantinNew Drug Application2024-03-28
macrobidNew Drug Application2024-12-30
macrodantinNew Drug Application2023-06-01
nitrofurantion macrocrystalsNew Drug Application2018-06-05
nitrofurantoinANDA2025-01-23
nitrofurantoin (macrocrystals)ANDA2024-10-15
nitrofurantoin (monohydrate/macrocrystals)ANDA2025-01-15
nitrofurantoin macrocrystalsANDA2025-02-05
nitrofurantoin monoNew Drug Application2022-10-09
nitrofurantoin monohydrate macrocrystallineNew Drug Application2020-12-14
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Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
J: Antiinfectives for systemic use
— J01: Antibacterials for systemic use
— J01X: Other antibacterials in atc
— J01XE: Nitrofuran derivatives, antibacterials for systemic use
— J01XE01: Nitrofurantoin
— J01XE51: Nitrofurantoin, combinations
HCPCS
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Clinical
Clinical Trials
75 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Urinary tract infectionsD014552EFO_0003103N39.024421839
InfectionsD007239EFO_0000544—21515831
Communicable diseasesD003141——11512322
CystitisD003556EFO_1000025N30—336—12
BacteriuriaD001437—R82.71——1135
NephrolithiasisD053040—N20.0——1214
Kidney calculiD007669EFO_0004253N20——1214
RecurrenceD012008—————4—4
Overactive urinary bladderD053201EFO_1000781N32.81———3—3
Urinary bladder neoplasmsD001749—C671——2—3
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Kidney diseasesD007674EFO_0003086N08111——2
Asymptomatic diseasesD058070————1—12
Chronic renal insufficiencyD051436—N18——1——1
Congenital abnormalitiesD000013EFO_0003915Q89.9——1——1
Premature birthD047928EFO_0003917O60——1——1
StillbirthD050497—P95——1——1
Escherichia coli infectionsD004927EFO_1001318B96.20——1——1
Klebsiella pneumoniaeD007711NCBITaxon_573B96.1——1——1
Enterococcus faecalisD013293NCBITaxon_1351———1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
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Kidney transplantationD016030——11———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———3———14
OsteomyelitisD010019EFO_0003102M861————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
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SepsisD018805EFO_0001420A41.9————22
Wounds and injuriesD014947—T14.8————11
Chemical and drug induced liver injuryD056486EFO_0004228—————11
Asymptomatic infectionsD058345——————11
HypospadiasD007021EFO_0004209Q54————11
UrolithiasisD052878—N20-N23————11
HematuriaD006417—R31————11
Menstruation disturbancesD008599—N91.5————11
MetaplasiaD008679——————11
ConizationD019092——————11
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameNitrofurantoin
INNnitrofurantoin
Description
Nitrofurantoin is an imidazolidine-2,4-dione that is hydantoin substituted at position 1 by a [(5-nitro-2-furyl)methylene]amino group. An antibiotic that damages bacterial DNA. It has a role as a hepatotoxic agent, an antiinfective agent and an antibacterial drug. It is an organonitrogen heterocyclic antibiotic, an organooxygen heterocyclic antibiotic, a nitrofuran antibiotic and an imidazolidine-2,4-dione. It is functionally related to a semicarbazide.
Classification
Small molecule
Drug classantiepileptics (hydantoin derivatives)
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Structure (InChI/SMILES or Protein Sequence)
O=C1CN(/N=C/c2ccc([N+](=O)[O-])o2)C(=O)N1
Identifiers
PDB—
CAS-ID67-20-9
RxCUI—
ChEMBL IDCHEMBL572
ChEBI ID71415
PubChem CID6604200
DrugBankDB00698
UNII ID927AH8112L (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
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Nitrofurantoin – RVL Pharmaceuticals
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Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 13,599 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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8,371 adverse events reported
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