pharmacopeia
GET
/api/v1/drug/nitrofurantoin
2D structure
1-[(E)-(5-nitrofuran-2-yl)methylideneamino]imidazolidine-2,4-dione
SMILES C1C(=O)NC(=O)N1/N=C/C2=CC=C(O2)[N+](=O)[O-]
InChIKey NXFQHRVNIOXGAQ-YCRREMRBSA-N

Mechanism of action

Sourced from openFDA

Nitrofurantoin is an antibacterial drug [ see Microbiology (12.4)] .

Enzyme

Indications

Sourced from openFDA
  • & USAGE Nitrofurantoin is indicated in adults and pediatric patients 1 month of age and older for the treatment of urinary tract infections due to susceptible strains of Escherichia coli , Enterococcus species, Staphylococcus aureus , Klebsiella species and Enterobacter species. Limitations of Use Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses [see Warnings and Precautions (5.7)].ICD-10: N39.0

Contraindications

Sourced from openFDA
  • Nitrofurantoin is contraindicated in: patients with known hypersensitivity to nitrofurantoin [see Warnings and Precautions (5.1)]. patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with nitrofurantoin [see Warnings and Precautions (5.3)].contraindicated

Dosage & administration

Sourced from openFDA

DOSAGE & ADMINISTRATION Adult Patients: 50 mg to 100 mg four times a day -the lower dosage level is recommended for uncomplicated urinary tract infections. (2.2) Pediatric Patients: 5 mg/kg to 7 mg/kg of body weight per 24 hours, given in four divided doses (contraindicated under one month of age). (2.3) 2.1 Recommended Dosage and Administration in Adult Patients The recommended dosage is 50 mg to 100 mg of nitrofurantoin four times a day. For long-term suppressive therapy in adults, a reduction of dosage to 50 mg to 100 mg at bedtime may be adequate . The benefits of long-term suppressive therapy should be balanced against the increased potential for systemic toxicity and for the development of antibacterial resistance [see Warnings and Precautions (5.2, 5.4, 5.6)]. Administer nitrofurantoin with food to improve drug absorption [see Clinical Pharmacology (12.3)] and, in some patients, tolerance. 2.2 Recommended Dosage and Administration in Pediatric Patients (1 month of age and older) The recommended dosage of nitrofurantoin is 5 mg/kg to 7 mg/kg of body weight per 24 hours, given in four divided doses in pediatric patients aged 1 month and older. Administer nitrofurantoin with food to improve drug absorption [ s ee Clinical Pharmacology (12.3)] and, in some patients, tolerance. Table 1 lists individual dosage volumes for nitrofurantoin oral suspension (25 mg/5 mL) based on body weight for pediatric patients.

Warnings & precautions

Sourced from openFDA

Hypersensitivity Reactions: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving nitrofurantoin. If signs and symptoms of a hypersensitivity reaction occurs, immediately discontinue nitrofurantoin. (5.1) Pulmonary Reactions: Discontinue if sign and symptoms of pulmonary reactions occur and take appropriate measures. (5.2) Hepatotoxicity: Discontinue if signs/symptoms of hepatitis occur. Monitor liver function tests. (5.3) Neuropathy: Peripheral neuropathy has occurred. (5.4) Hemolytic Anemia: Discontinue if sign and symptoms of hemolysis occur. (5.5) Clostridioides difficile -associated diarrhea: Evaluate patients if diarrhea occurs. (5.6) 5.1 Hypersensitivity Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving nitrofurantoin [see Adverse Reactions (6)]. If signs and symptoms of a hypersensitivity reaction occurs, immediately discontinue nitrofurantoin and initiate appropriate medications and/or supportive care. Nitrofurantoin is contraindicated in patients with known hypersensitivity to nitrofurantoin. 5.2 Pulmonary Reactions Acute, subacute, or chronic pulmonary reactions have been reported in patients treated with nitrofurantoin. If these reactions occur, discontinue nitrofurantoin and take appropriate measures. Reports have cited pulmonary reactions as a contributing cause of death. Chronic pulmonary reactions (diffuse interstitial pneumonitis or pulmonary fibrosis, or both) can develop insidiously.

Adverse reactions

Sourced from openFDA

The following clinically significant adverse reactions are discussed in more detail in other sections of the labeling: Hypersensitivity Reactions [see Warnings and Precautions (5.1)] Pulmonary Reactions [see Warnings and Precautions (5.2)] Hepatotoxicity [see Warnings and Precautions (5.3)] Neuropathy [see Warnings and Precautions (5.4)] Hemolytic anemia [see Warnings and Precautions (5.5)] Clostridioides difficile -associated Diarrhea [see Warnings and Precautions (5.6)] Persistence or Reappearance of Bacteriuria [see Warnings and Precautions (5.7)] The following adverse reactions associated with the use of nitrofurantoin formulations, including nitrofurantoin oral suspension, were identified in clinical studies or post-marketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Respiratory : chronic, subacute, or acute pulmonary hypersensitivity reactions have occurred. Chronic pulmonary reactions have occurred generally in patients who have received continuous treatment for six months or longer. Malaise, dyspnea on exertion, cough, and altered pulmonary function are common manifestations which can occur insidiously. Radiologic and histologic findings of diffuse interstitial pneumonitis or fibrosis, or both, are also common manifestations of the chronic pulmonary reaction. Fever is prominent.

Use in specific populations

Sourced from openFDA

Lactation: Breastfeeding is not recommended in infants under one month of age or with glucose-6-phosphate dehydrogenase (G6PD) deficiency. (8.2) Pediatric Use: Nitrofurantoin is contraindicated in pediatric patients under one month of age. (8.4) 8.1 Pregnancy Risk Summary Nitrofurantoin is contraindicated in pregnant women at term (38 weeks to 42 weeks gestation), during labor and delivery, or when the onset of labor is imminent because of the possibility of hemolytic anemia in the infant (see Clinical Considerations). Published epidemiological studies, including cohort studies and case control studies, have reported inconsistent findings related to nitrofurantoin use during the first trimester and risk of major birth defects. These studies cannot definitively establish the presence or absence of risk due to several methodological limitations. The limited number of epidemiological studies available have not identified drug-associated risks of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In animal reproduction studies, no fetotoxicity was observed when nitrofurantoin was administered orally to pregnant rats and rabbits, during organogenesis, at up to 6 times the recommended human dose (see Data ). The background risk of major birth defects and miscarriage for the indicated population is unknown.

Pharmacokinetics

Sourced from openFDA
Metabolism
Absorption Orally administered nitrofurantoin is readily absorbed. Blood concentrations at therapeutic dosage are usually low.

Overdosage

Sourced from openFDA

Incidents of acute overdosage of nitrofurantoin have resulted in symptoms such as vomiting. Induction of emesis is recommended. There is no specific antidote, but a high fluid intake should be maintained to promote urinary excretion of the drug. Nitrofurantoin is dialyzable.

Approval history

Sourced from openFDA
  • Dec 23, 1953NDANDA009175Casper Pharma Llc
  • Jun 5, 1970NDANDA016620Almatica
  • Dec 24, 1991NDANDA020064Almatica
  • Jan 28, 1993ANDAANDA073652Impax Labs Inc
  • Jan 28, 1993ANDAANDA073671Impax Labs Inc
  • Jul 9, 1997ANDAANDA074967Aurobindo Pharma Usa
  • Aug 18, 2004ANDAANDA077025Aurobindo Pharma Usa
  • Apr 5, 2005ANDAANDA077066Sandoz

FDA shortages

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Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Nitrofurantoin, Oral Suspension, 25 mg/5 mL (NDC 69238-2512-9)To be discontinued
    Sponsor: Amneal Pharmaceuticals
    Updated

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
24,593 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Urinary Tract Infection2,45110.0%
  2. 2Nausea1,9768.0%
  3. 3Fatigue1,9688.0%
  4. 4Headache1,7877.3%
  5. 5Pain1,6146.6%
  6. 6Dyspnoea1,5246.2%
  7. 7Diarrhoea1,3985.7%
  8. 8Dizziness1,2795.2%
  9. 9Drug Hypersensitivity1,2485.1%
  10. 10Drug Ineffective1,2455.1%
  11. 11Vomiting1,2455.1%
  12. 12Rash1,2375.0%
  13. 13Pyrexia1,1984.9%
  14. 14Malaise1,1954.9%
  15. 15Off Label Use1,1074.5%

Literature

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Recent PubMed references pinned to Nitrofurantoin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 86 ClinicalTrials.gov registrations naming Nitrofurantoin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Nitrofurantoin. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

  • G6PDCPIC AClinPGx 3FDA label: Actionable PGx
    G6PD

Frequently asked questions

How does Nitrofurantoin work?
Nitrofurantoin is an antibacterial drug [ see Microbiology (12.4)] .
What is Nitrofurantoin used for?
According to FDA labeling, Nitrofurantoin carries indications including: & USAGE Nitrofurantoin is indicated in adults and pediatric patients 1 month of age and older for the treatment of urinary tract infections due to susceptible strains of Escherichia coli , Enterococcus species, Staphylococcus aureus , Klebsiella species and Enterobacter species. Limitations of Use Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses [see Warnings and Precautions (5.7)].. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Nitrofurantoin?
Nitrofurantoin is classified as Nitrofuran derivatives, Nitrofuran Antibacterial, Cellular Structure Molecule Interactions, Enzyme Inhibitors, Decreased Cell Wall Synthesis & Repair, Decreased DNA Replication, Decreased Metabolic Rate, Decreased Protein Synthesis.
What are the brand names for Nitrofurantoin?
Nitrofurantoin is marketed under brand names including Furadantin, Macrobid, Macrodantin.
What are the contraindications for Nitrofurantoin?
Nitrofurantoin labeling lists contraindications including: Nitrofurantoin is contraindicated in: patients with known hypersensitivity to nitrofurantoin [see Warnings and Precautions (5.1)]. patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with nitrofurantoin [see Warnings and Precautions (5.3)].. Always consult the full prescribing information and a clinician.
Note. Data for nitrofurantoin is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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