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 |
|---|---|
| infections | D007239 |
| urogenital diseases | D000091642 |
Trade Name
FDA
EMA
Furadantin, Macrodantin, Nitrofurantoin (discontinued: Furadantin, Furalan, Ivadantin, Nitrofurantoin, Nitrofurantoin macrocrystalline)
CombinationsMacrobid, 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
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Nitrofurantoin
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macrocrystalline
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| MACROBID | Almatica Pharma | N-020064 RX | 1991-12-24 | 1 products, RLD, RS |
Nitrofurantoin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| FURADANTIN | Casper Pharma | N-009175 RX | 1982-01-01 | 2 products, RLD |
Show 1 discontinued
Nitrofurantoin sodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| IVADANTIN | Procter And Gamble | N-012402 DISCN | 1982-01-01 | 1 products |
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Nitrofurantoin
+
macrocrystalline
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| MACRODANTIN | Almatica Pharma | N-016620 RX | 1982-01-01 | 3 products, RLD |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| furadantin | New Drug Application | 2024-03-28 |
| macrobid | New Drug Application | 2025-03-17 |
| macrodantin | New Drug Application | 2023-06-01 |
| nitrofurantion macrocrystals | New Drug Application | 2018-06-05 |
| nitrofurantoin | ANDA | 2025-03-26 |
| nitrofurantoin (macrocrystals) | ANDA | 2024-10-15 |
| nitrofurantoin (monohydrate/macrocrystals) | ANDA | 2025-03-26 |
| nitrofurantoin macrocrystals | ANDA | 2025-02-05 |
| nitrofurantoin mono | New Drug Application | 2022-10-09 |
| nitrofurantoin monohydrate macrocrystalline | New Drug Application | 2020-12-14 |
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Agency Specific
FDA
EMA
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Patent Expiration
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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 infections | D014552 | EFO_0003103 | N39.0 | 2 | 4 | 4 | 21 | 8 | 39 |
| Infections | D007239 | EFO_0000544 | — | 2 | 1 | 5 | 15 | 8 | 31 |
| Communicable diseases | D003141 | — | — | 1 | 1 | 5 | 12 | 3 | 22 |
| Cystitis | D003556 | EFO_1000025 | N30 | — | 3 | 3 | 6 | — | 12 |
| Bacteriuria | D001437 | — | R82.71 | — | — | 1 | 1 | 3 | 5 |
| Nephrolithiasis | D053040 | — | N20.0 | — | — | 1 | 2 | 1 | 4 |
| Kidney calculi | D007669 | EFO_0004253 | N20 | — | — | 1 | 2 | 1 | 4 |
| Recurrence | D012008 | — | — | — | — | — | 4 | — | 4 |
| Overactive urinary bladder | D053201 | EFO_1000781 | N32.81 | — | — | — | 3 | — | 3 |
| Urinary bladder neoplasms | D001749 | — | C67 | 1 | — | — | 2 | — | 3 |
Show 21 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Kidney diseases | D007674 | EFO_0003086 | N08 | 1 | 1 | 1 | — | — | 2 |
| Asymptomatic diseases | D058070 | — | — | — | — | 1 | — | 1 | 2 |
| Chronic renal insufficiency | D051436 | — | N18 | — | — | 1 | — | — | 1 |
| Congenital abnormalities | D000013 | EFO_0003915 | Q89.9 | — | — | 1 | — | — | 1 |
| Premature birth | D047928 | EFO_0003917 | O60 | — | — | 1 | — | — | 1 |
| Stillbirth | D050497 | — | P95 | — | — | 1 | — | — | 1 |
| Escherichia coli infections | D004927 | EFO_1001318 | B96.20 | — | — | 1 | — | — | 1 |
| Klebsiella pneumoniae | D007711 | NCBITaxon_573 | B96.1 | — | — | 1 | — | — | 1 |
| Enterococcus faecalis | D013293 | NCBITaxon_1351 | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Kidney transplantation | D016030 | — | — | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 3 | — | — | — | 1 | 4 |
| Osteomyelitis | D010019 | EFO_0003102 | M86 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sepsis | D018805 | EFO_0001420 | A41.9 | — | — | — | — | 2 | 2 |
| Wounds and injuries | D014947 | — | T14.8 | — | — | — | — | 1 | 1 |
| Chemical and drug induced liver injury | D056486 | EFO_0004228 | — | — | — | — | — | 1 | 1 |
| Asymptomatic infections | D058345 | — | — | — | — | — | — | 1 | 1 |
| Hypospadias | D007021 | EFO_0004209 | Q54 | — | — | — | — | 1 | 1 |
| Urolithiasis | D052878 | — | N20-N23 | — | — | — | — | 1 | 1 |
| Hematuria | D006417 | — | R31 | — | — | — | — | 1 | 1 |
| Menstruation disturbances | D008599 | — | N91.5 | — | — | — | — | 1 | 1 |
| Metaplasia | D008679 | — | — | — | — | — | — | 1 | 1 |
| Conization | D019092 | — | — | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Nitrofurantoin |
| INN | nitrofurantoin |
| 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 class | antiepileptics (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-ID | 67-20-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL572 |
| ChEBI ID | 71415 |
| PubChem CID | 6604200 |
| DrugBank | DB00698 |
| UNII ID | 927AH8112L (ChemIDplus, GSRS) |
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Nitrofurantoin – RVL Pharmaceuticals
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Estimated US medical usage
Nitrofurantoin
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Trends
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Safety
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Adverse Events
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8,511 adverse events reported
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