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Drug ReportsRifaximin
Rifaximin
Xifaxan (rifaximin) is a small molecule pharmaceutical. Rifaximin was first approved as Xifaxan on 2004-05-25. It is used to treat bacterial infections, diarrhea, and irritable bowel syndrome in the USA.
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Events Timeline
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3M
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YTD
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2Y
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FDA approval date
EMA approval date
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Study first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
digestive system diseasesD004066
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Xifaxan
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Rifaximin
Tradename
Company
Number
Date
Products
XIFAXANSalix PharmaceuticalsN-021361 RX2004-05-25
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
xifaxanNew Drug Application2025-08-27
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Rifaximin, Xifaxan, Salix Pharms
86425732029-10-02U-1481
89693982029-10-02U-1481
79281152029-07-24U-1121
88290172029-07-24U-1562
89462522029-07-24U-1481
94211952029-07-24U-1481
96298282029-07-24U-1994
103148282029-07-24U-1481
103353972029-07-24U-2579
107096942029-07-24U-2579
83095692029-07-18U-1707, U-1708
104563842029-02-26U-2643, U-2644
107656672029-02-26U-2643, U-2644
115649122029-02-26U-3511, U-3512
117795712029-02-26U-3706
81931962027-09-02DS, DPU-1707, U-1708
85189492026-02-27DP
87419042026-02-27DPU-1526, U-1707, U-1708
92719682026-02-27DP
107037632026-02-27U-1708, U-2847, U-2848
79065422025-06-01DS, DP
79152752025-02-23U-1707, U-1708
70456202024-06-19DS, DP
76121992024-06-19DS, DP
79022062024-06-19DS, DP
81586442024-06-19DP
81587812024-06-19DP
88354522024-06-19DS, DP
88532312024-06-19DP
ATC Codes
A: Alimentary tract and metabolism drugs
A07: Antidiarrheals, intestinal antiinflammatory/antiinfective agents
A07A: Intestinal antiinfectives
A07AA: Antibiotics, intestinal
A07AA11: Rifaximin
D: Dermatologicals
D06: Antibiotics and chemotherapeutics for dermatological use
D06A: Antibiotics for topical use
D06AX: Other antibiotics for topical use in atc
D06AX11: Rifaximin
HCPCS
No data
Clinical
Clinical Trials
213 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hepatic encephalopathyD006501K72.913510111240
Liver cirrhosisD008103EFO_0001422K74.01012101239
FibrosisD005355110771029
DiarrheaD003967R19.714116525
Irritable bowel syndromeD043183EFO_0000555K582856623
Brain diseasesD001927G93.401224312
Liver diseasesD008107EFO_0001421K70-K77426
AscitesD001201R18415
InflammationD007249MP_000184514115
Hepatic insufficiencyD04855055
Show 22 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SyndromeD0135771224
ObesityD009765EFO_0001073E66.91113
RosaceaD012393L7133
AdenocarcinomaD0002301112
Intestinal pseudo-obstructionD007418EFO_1000988K56.0112
NeoplasmsD009369C80212
Alzheimer diseaseD000544EFO_0000249F03122
Sickle cell anemiaD000755EFO_0000697D5722
Heart failureD006333EFO_0003144I50112
Breast neoplasmsD001943EFO_0003869C5011
Show 16 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Diabetes mellitusD003920EFO_0000400E08-E1311
Chronic kidney failureD007676EFO_0003884N18.611
PharmacokineticsD01059911
Persian gulf syndromeD018923EFO_000743011
Bone marrow transplantationD01602611
ConstipationD003248K59.011
DyskinesiasD020820G2411
Waldenstrom macroglobulinemiaD008258C88.011
ParaproteinemiasD010265D47.211
Communicable diseasesD00314111
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Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Colonic neoplasmsD003110C1822
Fatty liverD005234EFO_000393422
Gastrointestinal diseasesD00576722
Gastrointestinal hemorrhageD006471K92.222
Esophageal and gastric varicesD004932EFO_0009545I8522
FeverD005334R50.911
HyperthermiaD00008446211
Ulcerative colitisD003093EFO_0000729K5111
ColitisD003092EFO_0003872K52.911
UlcerD014456MPATH_57911
Show 23 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameRifaximin
INNrifaximin
Description
Rifaximin is a semisynthetic member of the class of rifamycins and non-systemic gastrointestinal site-specific broad spectrum antibiotic. Used in the treatment of traveller's diarrhoea, hepatic encephalopathy and irritable bowel syndrome. It has a role as a gastrointestinal drug, an orphan drug and an antimicrobial agent. It is a member of rifamycins, an acetate ester, a lactam, an organic heterohexacyclic compound, a macrocycle, a semisynthetic derivative and a cyclic ketal.
Classification
Small molecule
Drug classantibiotics (rifamycin derivatives)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CO[C@H]1/C=C/O[C@@]2(C)Oc3c(C)c(O)c4c(O)c(c5c(nc6cc(C)ccn65)c4c3C2=O)NC(=O)/C(C)=C\C=C\[C@H](C)[C@H](O)[C@@H](C)[C@@H](O)[C@@H](C)[C@H](OC(C)=O)[C@@H]1C
Identifiers
PDB
CAS-ID80621-81-4
RxCUI
ChEMBL IDCHEMBL1617
ChEBI ID75246
PubChem CID6436173
DrugBankDB01220
UNII IDL36O5T016N (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
£
No data
Estimated US medical usage
Rifaximin
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 7,626 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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14,367 adverse events reported
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