{
 "query": "nitrofurantoin",
 "ingredient": "nitrofurantoin",
 "slug": "nitrofurantoin",
 "rxcui": "7454",
 "brands": [
  "Furadantin"
 ],
 "names": [
  "nitrofurantoin"
 ],
 "classes": [
  {
   "id": "J01XE",
   "name": "Nitrofuran derivatives"
  }
 ],
 "alternatives": [],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 106
  },
  "boxed_warning": "",
  "indications_and_usage": "INDICATIONS AND USAGE Nitrofurantoin Macrocrystals is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus , and certain susceptible strains of Klebsiella and Enterobacter species. Nitrofurantoin is not indicated for the treatment of pyelonephritis or perinephric abscesses. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nitrofurantoin Macrocrystals and other antibacterial drugs, Nitrofurantoin Macrocrystals should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Nitrofurantoins lack the broader tissue distribution of other therapeutic agents approved for urinary tract infections. Consequently, many patients who are treated with Nitrofurantoin Macrocrystals are predisposed to persistence or reappearance of bacteriu...",
  "contraindications": "CONTRAINDICATIONS Anuria, oliguria, or significant impairment of renal function (creatinine clearance under 60 mL per minute or clinically significant elevated serum creatinine) are contraindications. Treatment of this type of patient carries an increased risk of toxicity because of impaired excretion of the drug. Because of the possibility of hemolytic anemia due to immature erythrocyte enzyme systems (glutathione instability), the drug is contraindicated in pregnant patients at term (38-42 weeks\u2019 gestation), during labor and delivery, or when the onset of labor is imminent. For the same reason, the drug is contraindicated in neonates under one month of age. Nitrofurantoin Macrocrystals is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with nitrofurantoin. Nitrofurantoin Macrocrystals is also contraindicated in those patients with known hypersensitivity to nitrofurantoin.",
  "warnings_and_cautions": "",
  "warnings": "WARNINGS Pulmonary reactions: ACUTE, SUBACUTE, OR CHRONIC PULMONARY REACTIONS HAVE BEEN OBSERVED IN PATIENTS TREATED WITH NITROFURANTOIN. IF THESE REACTIONS OCCUR, NITROFURANTOIN MACROCRYSTALS SHOULD BE DISCONTINUED AND APPROPRIATE MEASURES TAKEN. 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. THESE REACTIONS OCCUR RARELY AND GENERALLY IN PATIENTS RECEIVING THERAPY FOR SIX MONTHS OR LONGER. CLOSE MONITORING OF THE PULMONARY CONDITION OF PATIENTS RECEIVING LONG-TERM THERAPY IS WARRANTED AND REQUIRES THAT THE BENEFITS OF THERAPY BE WEIGHED AGAINST POTENTIAL RISKS (SEE RESPIRATORY REACTIONS). Hepatotoxicity: Hepatic reactions, including hepatitis, cholestatic jaundice, chronic active hepatitis, and hepatic necrosis, occur rarely. Fatalities have been reported. The onset of chronic active hepatitis may be insidious, and patients should be monitored periodically for changes in biochemical tests that would indicate liver injury. If hepatitis occurs, the drug should be withdrawn immediately and appropriate measures should be taken. Neuropathy: Pe...",
  "adverse_reactions": "ADVERSE REACTIONS Respiratory: CHRONIC, SUBACUTE, OR ACUTE PULMONARY HYPERSENSITIVITY REACTIONS MAY OCCUR. CHRONIC PULMONARY REACTIONS OCCUR 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 RARELY PROMINENT. THE SEVERITY OF CHRONIC PULMONARY REACTIONS AND THEIR DEGREE OF RESOLUTION APPEAR TO BE RELATED TO THE DURATION OF THERAPY AFTER THE FIRST CLINICAL SIGNS APPEAR. PULMONARY FUNCTION MAY BE IMPAIRED PERMANENTLY , EVEN AFTER CESSATION OF THERAPY. THE RISK IS GREATER WHEN CHRONIC PULMONARY REACTIONS ARE NOT RECOGNIZED EARLY. In subacute pulmonary reactions, fever and eosinophilia occur less often than in the acute form. Upon cessation of therapy, recovery may require several months. If the symptoms are not recognized as being drug-related and nitrofurantoin therapy is not stopped, the symptoms may become more severe. Acute pulmonary reactions are commonly man...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Information for Patients Patients should be advised to take Nitrofurantoin Macrocrystals with food to further enhance tolerance and improve drug absorption. Patients should be instructed to complete the full course of therapy; however, they should be advised to contact their physician if any unusual symptoms occur during therapy. Many patients who cannot tolerate microcrystalline nitrofurantoin are able to take Nitrofurantoin Macrocrystals without nausea. Patients should be advised not to use antacid preparations containing magnesium trisilicate while taking Nitrofurantoin Macrocrystals. Patients should be counseled that antibacterial drugs including Nitrofurantoin Macrocrystals should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When Nitrofurantoin Macrocrystals is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria wil...",
  "spl_medguide": "",
  "clinical_studies": "",
  "brand_name": "Nitrofurantion Macrocrystals",
  "manufacturer": "Proficient Rx LP",
  "application_number": "NDA016620",
  "pharm_class_epc": [
   "Nitrofuran Antibacterial [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20230728",
  "set_id": "29b72c21-ab85-41de-b025-f139e6e13ccc",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 17952,
  "serious": 13913,
  "death": 1172,
  "hospitalization": 6041,
  "primary_suspect": 17916,
  "top_reactions": [
   [
    "Urinary Tract Infection",
    1548
   ],
   [
    "Fatigue",
    1424
   ],
   [
    "Nausea",
    1259
   ],
   [
    "Headache",
    1192
   ],
   [
    "Diarrhoea",
    999
   ],
   [
    "Dyspnoea",
    983
   ],
   [
    "Rash",
    953
   ],
   [
    "Pain",
    918
   ],
   [
    "Malaise",
    899
   ],
   [
    "Drug Ineffective",
    855
   ],
   [
    "Dizziness",
    844
   ],
   [
    "Pyrexia",
    844
   ],
   [
    "Off Label Use",
    841
   ],
   [
    "Vomiting",
    828
   ],
   [
    "Fall",
    690
   ]
  ],
  "by_year": {
   "2019": 2070,
   "2020": 1865,
   "2021": 1675,
   "2022": 1399,
   "2023": 1357,
   "2024": 1252,
   "2025": 1285,
   "2026": 608
  },
  "by_year_primary": {
   "2019": 2067,
   "2020": 1864,
   "2021": 1671,
   "2022": 1393,
   "2023": 1344,
   "2024": 1248,
   "2025": 1282,
   "2026": 607
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [
  {
   "class": "Class II",
   "date": "20181221",
   "reason": "Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.",
   "firm": "LUPIN SOMERSET",
   "status": "Terminated"
  },
  {
   "class": "Class II",
   "date": "20180628",
   "reason": "Subpotent Drug and Failed Content Uniformity.",
   "firm": "LUPIN SOMERSET",
   "status": "Terminated"
  }
 ],
 "recall_total": 2,
 "drugsfda": {
  "applications": 20,
  "nda": 2,
  "anda": 13,
  "first_approval": "19530206",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 25,
  "labeling_recent": 1,
  "sponsors": [
   "ACTAVIS MID ATLANTIC",
   "AMNEAL PHARMS",
   "ANNORA PHARMA",
   "AUROBINDO PHARMA",
   "BIOCON PHARMA",
   "CASPER PHARMA LLC",
   "CHARTWELL MOLECULAR",
   "ELKINS SINN"
  ],
  "unapproved": false,
  "first_approval_fmt": "02/06/1953"
 },
 "trials": {
  "total": 89,
  "completed": 44,
  "terminated": 10,
  "with_results": 19,
  "industry": 17,
  "phase3": 11,
  "results_share": 0.4318181818181818,
  "terminated_share": 0.11235955056179775
 },
 "pubmed": {
  "rct": 50,
  "meta": 11,
  "recent_rct": 5,
  "cochrane": []
 },
 "payments": {
  "year": "2024",
  "usd": 0.0,
  "records": 0,
  "by_name": [],
  "names_checked": [
   "nitrofurantoin",
   "Furadantin"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 2564,
  "beneficiaries": 1149,
  "spend": 6114728.92,
  "by_brand": [
   {
    "brand": "Nitrofurantoin",
    "claims": 2564,
    "per_claim": 2384.8396724,
    "is_generic": true
   }
  ],
  "per_claim": 2384.8396723868955
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": true,
  "status": "AddedToEml",
  "name": "nitrofurantoin",
  "matched": "nitrofurantoin",
  "stewardship": [
   "KeyAccessGroup",
   "AccessGroup"
  ]
 },
 "exposure": null,
 "scores": {
  "safety": {
   "score": 100,
   "letter": "A",
   "why": [
    "Death share in reports is near or below the FAERS average (0.7x)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 43,
   "letter": "F",
   "why": [
    "50 randomized trials and 11 systematic reviews/meta-analyses indexed in PubMed",
    "On the WHO Model List of Essential Medicines (shown for context; no score effect)",
    "No Cochrane review found (-5)",
    "Only 43% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 97,
   "letter": "A",
   "why": [
    "Recalls since 2016: 0 Class I, 2 Class II, 0 Class III across 13 generic makers (-3)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 100,
   "letter": "A",
   "why": [
    "Pharma paid doctors $0 tied to this drug last year: negligible",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 70,
   "letter": "C",
   "why": [
    "Generic versions approved (13 applications)",
    "No same-class alternatives found: little leverage to switch (-30)"
   ],
   "weight": 0.1
  }
 },
 "total": 82,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are urinary tract infection, fatigue, nausea, headache. How would we recognize and handle those?",
  "What result are we expecting, by when, and what is the plan if it does not happen?",
  "If 100 people like me took this drug, how many would actually get better because of it, and how many would be harmed by it? (Doctors call these the number needed to treat and the number needed to harm.)"
 ]
}