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Drug ReportsNitrofurantoin
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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Drug
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Variants
Financial
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Safety
Events Timeline
5D
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YTD
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
urogenital diseasesD000091642
Trade Name
FDA
EMA
Furadantin, Macrodantin, Nitrofurantoin (discontinued: Furadantin, Furalan, Ivadantin, Nitrofurantoin, Nitrofurantoin macrocrystalline)
Combinations
Macrobid, Nitrofurantoin (monohydrate/macrocrystals) (discontinued: Nitrofurantoin (monohydrate/macrocrystals))
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Nitrofurantoin
+
Nitrofurantoin
+
macrocrystalline
Tradename
Company
Number
Date
Products
MACROBIDAlmatica PharmaN-020064 RX1991-12-24
1 products, RLD, RS
Nitrofurantoin
Tradename
Company
Number
Date
Products
FURADANTINCasper PharmaN-009175 RX1982-01-01
2 products, RLD
Show 1 discontinued
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
macrobidNew Drug Application2025-11-21
macrodantinNew Drug Application2025-10-14
nitrofurantion macrocrystalsNew Drug Application2018-06-05
nitrofurantoinNDA authorized generic2025-11-11
nitrofurantoin (macrocrystals)ANDA2024-10-15
nitrofurantoin (monohydrate/macrocrystals)ANDA2025-12-16
nitrofurantoin macrocrystalsANDA2025-12-18
nitrofurantoin monoNew Drug Application2022-10-09
nitrofurantoin monohydrate macrocrystallineNew Drug Application2025-07-09
nitrofurantoin monohydrate/ macrocrystallineNew Drug Application2025-10-16
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Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
urinary tract infectionsEFO_0003103D014552N39.0
bacterial infections—D001424A49
escherichia coli infectionsEFO_1001318D004927B96.20
staphylococcal infections—D013203A49.01
klebsiella infectionsEFO_1001353D007710—
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
83 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MalnutritionD044342EFO_0008572E40-E46————11
Healthy volunteers/patients———————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)Loading
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
$
€
£
â‚£
Nitrofurantoin – RVL Pharmaceuticals
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Estimated US medical usage
Nitrofurantoin
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 14,935 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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8,905 adverse events reported
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