{
 "query": "rifaximin",
 "ingredient": "rifaximin",
 "slug": "rifaximin",
 "rxcui": "35619",
 "brands": [
  "XIFAXAN"
 ],
 "names": [
  "rifaximin"
 ],
 "classes": [
  {
   "id": "A07AA",
   "name": "Antibiotics"
  }
 ],
 "alternatives": [
  "amphotericin b",
  "colistin",
  "fidaxomicin",
  "kanamycin",
  "natamycin",
  "neomycin",
  "nystatin",
  "paromomycin",
  "polymyxin b",
  "rifamycin sv",
  "streptomycin",
  "vancomycin"
 ],
 "label": {
  "route_mode": "ORAL",
  "route_counts": {
   "ORAL": 3
  },
  "boxed_warning": "",
  "indications_and_usage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of XIFAXAN and other antibacterial drugs, XIFAXAN when used to treat infection 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. XIFAXAN is a rifamycin antibacterial indicated for: \u2022 Treatment of travelers\u2019 diarrhea (TD) caused by noninvasive strains of Escherichia coli in adult and pediatric patients 12 years of age and older. ( 1.1 ) \u2022 Reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults. ( 1.2 ) \u2022 Treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults. ( 1.3 ) Limitations of Use TD: Should not use in patients with diarrhea complicated by fever or blood in the stool or diarrhea due to pathogens other than Escherichia coli. ( 1.1, 5.1 ) 1.1 Travelers\u2019 Diarrhea XIFAXAN is indicated for the treatment of travelers\u2019 diarrhea (TD) ca...",
  "contraindications": "is contraindicated in patients with a hypersensitivity to rifaximin, any of the rifamycin antimicrobial agents, or any of the components in XIFAXAN. Hypersensitivity reactions have included exfoliative dermatitis, angioneurotic edema, and anaphylaxis [see Adverse Reactions ( 6.2 )] . History of hypersensitivity to rifaximin, rifamycin antimicrobial agents, or any of the components of XIFAXAN. ( 4) )",
  "warnings_and_cautions": "\u2022 Travelers\u2019 Diarrhea Not Caused by E. coli : XIFAXAN was not effective in diarrhea complicated by fever and/or blood in the stool or diarrhea due to pathogens other than E. coli . If diarrhea symptoms get worse or persist for more than 24 to 48 hours, discontinue XIFAXAN and consider alternative antibiotics. ( 5.1 ) \u2022 Clostridium difficile -Associated Diarrhea: Evaluate if diarrhea occurs after therapy or does not improve or worsens during therapy. ( 5.2 ) \u2022 Hepatic Impairment: Use with caution in patients with severe (Child-Pugh Class C) hepatic impairment. ( 5.4 , 8.7 ) \u2022 Concomitant P-glycoprotein (P-gp) inhibitors (e.g., cyclosporine): Caution should be exercised when concomitant use of XIFAXAN and a P-glycoprotein inhibitor is needed. ( 5.5, 7.1 ) 5.1 Travelers\u2019 Diarrhea Not Caused by Escherichia coli XIFAXAN was not found to be effective in patients with diarrhea complicated by fever and/or blood in the stool or diarrhea due to pathogens other than Escherichia coli. Discontinue XIFAXAN if diarrhea symptoms get worse or persist more than 24 to 48 hours and alternative antibiotic therapy should be considered. XIFAXAN is not effective in cases of travelers\u2019 diarrhea due to Camp...",
  "warnings": "",
  "adverse_reactions": "The following clinically significant adverse reactions are described elsewhere in labeling: \u2022 Clostridium difficile -associated diarrhea [see Warnings and Precautions ( 5.2 )] Most common adverse reactions: \u2022 TD (\u22652%): Headache ( 6.1 ) \u2022 HE (\u226510%): Peripheral edema, nausea, constipation, dizziness, fatigue, urinary tract infection, insomnia, anemia, pruritus, and ascites ( 6.1 ) \u2022 IBS-D (\u22652%): ALT increased, nausea ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Travelers\u2019 Diarrhea The safety of XIFAXAN 200 mg taken three times a day was evaluated in patients with travelers\u2019 diarrhea consisting of 320 patients in two placebo-controlled clinical trials with 95% of patients receiving three or four days of treatment with XIFAXAN. The population studied had a mean age of 31.3 (18-79) years of which ap...",
  "drug_abuse_and_dependence": "",
  "controlled_substance": "",
  "recent_major_changes": "",
  "information_for_patients": "Persistent Diarrhea For those patients being treated for travelers\u2019 diarrhea, discontinue XIFAXAN if diarrhea persists more than 24-48 hours or worsens. Advise the patient to seek medical care for fever and/or blood in the stool [see Warnings and Precautions ( 5.1 )]. Clostridium difficile- Associated Diarrhea Clostridium difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including XIFAXAN, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibiotics alters the normal flora of the colon which may lead to C. difficile . Patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If diarrhea occurs after therapy or does not improve or worsens during therapy, advise patients to contact a physician as soon as possible [see Warnings and Precautions ( 5.2 )]. Administration with Food Inform patients that XIFAXAN may be taken with or without food. Antibacterial Resistance Counsel patients that antibacterial drugs including XIFAXAN should only be used to treat bacterial infections. They do not trea...",
  "spl_medguide": "",
  "clinical_studies": "14.1 Travelers\u2019 Diarrhea The efficacy of XIFAXAN given as 200 mg orally taken three times a day for 3 days was evaluated in 2 randomized, multi\u2011center, double-blind, placebo-controlled studies in adult subjects with travelers\u2019 diarrhea. One study was conducted at clinical sites in Mexico, Guatemala, and Kenya (Study 1). The other study was conducted in Mexico, Guatemala, Peru, and India (Study 2). Stool specimens were collected before treatment and 1 to 3 days following the end of treatment to identify enteric pathogens. The predominant pathogen in both studies was Escherichia coli . The clinical efficacy of XIFAXAN was assessed by the time to return to normal, formed stools, and resolution of symptoms. The primary efficacy endpoint was time to last unformed stool (TLUS) which was defined as the time to the last unformed stool passed, after which clinical cure was declared. Table 5 displays the median TLUS and the number of patients who achieved clinical cure for the intent to treat (ITT) population of Study 1. The duration of diarrhea was significantly shorter in patients treated with XIFAXAN than in the placebo group. More patients treated with XIFAXAN were classified as clinical...",
  "brand_name": "XIFAXAN",
  "manufacturer": "Cardinal Health 107, LLC",
  "application_number": "NDA021361",
  "pharm_class_epc": [
   "Rifamycin Antibacterial [EPC]"
  ],
  "route": [
   "ORAL"
  ],
  "effective_time": "20250827",
  "set_id": "7afafa63-3236-4212-9589-045db6b01c0b",
  "has_boxed_warning": false,
  "controlled": false,
  "mentions_rems": false
 },
 "faers": {
  "total": 20812,
  "serious": 16510,
  "death": 6183,
  "hospitalization": 8272,
  "primary_suspect": 20764,
  "top_reactions": [
   [
    "Death",
    4181
   ],
   [
    "Hospitalisation",
    1868
   ],
   [
    "Diarrhoea",
    1215
   ],
   [
    "Off Label Use",
    1188
   ],
   [
    "Therapy Interrupted",
    1120
   ],
   [
    "Ammonia Increased",
    842
   ],
   [
    "Hepatic Encephalopathy",
    824
   ],
   [
    "Nausea",
    806
   ],
   [
    "Fatigue",
    778
   ],
   [
    "Confusional State",
    744
   ],
   [
    "Drug Ineffective",
    719
   ],
   [
    "Insurance Issue",
    712
   ],
   [
    "Inability To Afford Medication",
    704
   ],
   [
    "Hepatic Cirrhosis",
    682
   ],
   [
    "Condition Aggravated",
    639
   ]
  ],
  "by_year": {
   "2019": 2024,
   "2020": 2086,
   "2021": 2018,
   "2022": 1770,
   "2023": 2021,
   "2024": 1635,
   "2025": 1327,
   "2026": 897
  },
  "by_year_primary": {
   "2019": 2023,
   "2020": 2084,
   "2021": 2017,
   "2022": 1759,
   "2023": 2008,
   "2024": 1633,
   "2025": 1314,
   "2026": 894
  }
 },
 "faers_base": {
  "total": 20692304,
  "serious_share": 0.5742697381596559,
  "death_share": 0.09102355155810585
 },
 "recalls": [],
 "recall_total": 0,
 "drugsfda": {
  "applications": 10,
  "nda": 2,
  "anda": 1,
  "first_approval": "20040525",
  "rems": false,
  "rems_last": "",
  "labeling_supplements": 8,
  "labeling_recent": 2,
  "sponsors": [
   "ACTAVIS LABS FL INC",
   "ALKEM LABORATORIES LIMITED",
   "CIPLA LTD",
   "MYLAN PHARMACEUTICALS INC",
   "NORWICH",
   "NORWICH PHARMACEUTICALS INC",
   "SALIX PHARMS",
   "SANDOZ INC"
  ],
  "unapproved": false,
  "first_approval_fmt": "05/25/2004"
 },
 "trials": {
  "total": 231,
  "completed": 99,
  "terminated": 42,
  "with_results": 45,
  "industry": 66,
  "phase3": 56,
  "results_share": 0.45454545454545453,
  "terminated_share": 0.18181818181818182
 },
 "pubmed": {
  "rct": 148,
  "meta": 33,
  "recent_rct": 38,
  "cochrane": [
   {
    "pmid": "37467180",
    "title": "Rifaximin for prevention and treatment of hepatic encephalopathy in people with cirrhosis",
    "year": "2023"
   }
  ]
 },
 "payments": {
  "year": "2024",
  "usd": 3092033.9,
  "records": 115823,
  "by_name": [
   [
    "XIFAXAN",
    3092033.9
   ]
  ],
  "names_checked": [
   "rifaximin",
   "XIFAXAN"
  ],
  "source": "bulk-index"
 },
 "partd": {
  "year": "2024",
  "claims": 416690,
  "beneficiaries": 104805,
  "spend": 1158111408.6,
  "by_brand": [
   {
    "brand": "Xifaxan",
    "claims": 416690,
    "per_claim": 2779.3117391,
    "is_generic": false
   }
  ],
  "per_claim": 2779.3117391826054
 },
 "mdl": [],
 "dsc": [],
 "settlements": [],
 "prescrire": null,
 "eml": {
  "listed": false,
  "status": null,
  "name": "rifaximin",
  "matched": "rifaximin",
  "stewardship": [
   "WatchGroup"
  ]
 },
 "exposure": {
  "years": [
   "2024",
   "2025",
   "2026"
  ],
  "reports_recent": 3841,
  "fills": 416690,
  "per_million": 9217.883798507284,
  "ratio": 3.329018081996193,
  "median": 2768.949753790441
 },
 "scores": {
  "safety": {
   "score": 73,
   "letter": "C",
   "why": [
    "9,218 FDA reports naming it as the suspect drug per million Medicare fills, 3.3x the median drug on this site (-10)",
    "Death appears in 3.3x the share of reports seen across all of FAERS (-12)",
    "Off-label use is among the five most-reported items: widely used beyond its approved evidence (-5)"
   ],
   "weight": 0.35
  },
  "evidence": {
   "score": 63,
   "letter": "C",
   "why": [
    "148 randomized trials and 33 systematic reviews/meta-analyses indexed in PubMed",
    "1 independent Cochrane review(s) exist",
    "Only 45% of completed registered trials posted results (-8)"
   ],
   "weight": 0.25
  },
  "regulatory": {
   "score": 96,
   "letter": "A",
   "why": [
    "No recalls on record since 2016",
    "2 label changes approved since 2021 (-4)"
   ],
   "weight": 0.15
  },
  "conflict": {
   "score": 70,
   "letter": "C",
   "why": [
    "Pharma paid doctors $3,092,034 tied to this drug last year (-30)",
    "Not named in any pending federal MDL"
   ],
   "weight": 0.15
  },
  "options": {
   "score": 100,
   "letter": "A",
   "why": [
    "Generic versions approved (1 applications)",
    "12 same-class alternatives exist"
   ],
   "weight": 0.1
  }
 },
 "total": 76,
 "grade": "B",
 "questions": [
  "The most-reported problems in FDA's adverse event data are death, hospitalisation, diarrhoea. How would we recognize and handle those?",
  "Off-label use is among the most-reported items for this drug. Is my use on-label, and if not, what evidence supports it?",
  "Why this one over amphotericin b, colistin, fidaxomicin? What would make you pick one of those instead?",
  "The manufacturer pays physicians heavily to promote this drug. Have you received anything from them?",
  "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.)"
 ]
}