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Nitrofurantoin
Furadantin, Ivadantin, Macrobid, Macrodantin (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
Furadantin, Macrodantin (generic drugs available since 1993-01-28, discontinued: Furalan, Ivadantin)
Combinations
Macrobid (generic drugs available since 1993-01-28)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Nitrofurantoin
Tradename
Company
Number
Date
Products
FURADANTINCasper PharmaN-009175 RX1982-01-01
1 products, RLD, RS
Show 1 discontinued
Nitrofurantoin
+
Nitrofurantoin
+
macrocrystalline
Tradename
Company
Number
Date
Products
MACROBIDAlmatica PharmaN-020064 RX1991-12-24
1 products, RLD, RS
Nitrofurantoin sodium
Tradename
Company
Number
Date
Products
IVADANTINProcter And GambleN-012402 DISCN1982-01-01
1 products
Hide discontinued
Nitrofurantoin
+
macrocrystalline
Tradename
Company
Number
Date
Products
MACRODANTINAlmatica PharmaN-016620 RX1982-01-01
3 products, RLD
Labels
FDA
EMA
Brand Name
Status
Last Update
furadantinNew Drug Application2021-01-04
macrobidNew Drug Application2020-12-31
macrodantinNew Drug Application2020-06-01
nitrofurantoin macrocrystalsNew Drug Application2023-05-16
nitrofurantoin monohydrate/ macrocrystallineNew Drug Application2023-06-05
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
bacterial infections—D001424A49
escherichia coli infectionsEFO_1001318D004927B96.20
klebsiella infectionsEFO_1001353D007710—
staphylococcal infections—D013203A49.01
urinary tract infectionsEFO_0003103D014552N39.0
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
No data
Clinical
Clinical Trials
40 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_0003103N39.012412423
CystitisD003556EFO_1000025N30—1—2—3
NephrolithiasisD053040N20.0———112
Pelvic organ prolapseD056887EFO_0004710———112
PulpitisD011671EFO_1001139K04.0———2—2
Urinary bladder neoplasmsD001749C67———1—1
Kidney calculiD007669EFO_0004253N20.0———1—1
Stress urinary incontinenceD014550HP_0010992———1—1
Postoperative painD010149G89.18———1—1
Prostatic hyperplasiaD011470EFO_0000284N40———1—1
Show 2 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Chronic renal insufficiencyD051436N18——1——1
Vesico-ureteral refluxD014718EFO_0007536N13.7——1——1
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—3———14
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SepsisD018805A41.9————11
Urinary incontinenceD014549HP_0000020R32————11
Asymptomatic diseasesD058070————11
HematuriaD006417HP_0000790R31————11
Pregnancy complicationsD011248————11
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)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
O=C1CN(/N=C/c2ccc([N+](=O)[O-])o2)C(=O)N1
Identifiers
PDB—
CAS-ID67-20-9
RxCUI7454
ChEMBL IDCHEMBL572
ChEBI ID71415
PubChem CID6604200
DrugBankDB00698
UNII ID927AH8112L (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Nitrofurantoin - RVL Pharmaceuticals
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 11,275 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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606 adverse events reported
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