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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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Rifaximin, 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 |
|---|---|---|---|---|
| XIFAXAN | Salix Pharmaceuticals | N-021361 RX | 2004-05-25 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| xifaxan | New Drug Application | 2025-08-27 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| irritable bowel syndrome | EFO_0000555 | D043183 | K58 |
| diarrhea | — | D003967 | R19.7 |
| bacterial infections | — | D001424 | A49 |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Rifaximin, Xifaxan, Salix Pharms | |||
| 8642573 | 2029-10-02 | U-1481 | |
| 8969398 | 2029-10-02 | U-1481 | |
| 7928115 | 2029-07-24 | U-1121 | |
| 8829017 | 2029-07-24 | U-1562 | |
| 8946252 | 2029-07-24 | U-1481 | |
| 9421195 | 2029-07-24 | U-1481 | |
| 9629828 | 2029-07-24 | U-1994 | |
| 10314828 | 2029-07-24 | U-1481 | |
| 10335397 | 2029-07-24 | U-2579 | |
| 10709694 | 2029-07-24 | U-2579 | |
| 8309569 | 2029-07-18 | U-1707, U-1708 | |
| 10456384 | 2029-02-26 | U-2643, U-2644 | |
| 10765667 | 2029-02-26 | U-2643, U-2644 | |
| 11564912 | 2029-02-26 | U-3511, U-3512 | |
| 11779571 | 2029-02-26 | U-3706 | |
| 8193196 | 2027-09-02 | DS, DP | U-1707, U-1708 |
| 8518949 | 2026-02-27 | DP | |
| 8741904 | 2026-02-27 | DP | U-1526, U-1707, U-1708 |
| 9271968 | 2026-02-27 | DP | |
| 10703763 | 2026-02-27 | U-1708, U-2847, U-2848 | |
| 7906542 | 2025-06-01 | DS, DP | |
| 7915275 | 2025-02-23 | U-1707, U-1708 | |
| 7045620 | 2024-06-19 | DS, DP | |
| 7612199 | 2024-06-19 | DS, DP | |
| 7902206 | 2024-06-19 | DS, DP | |
| 8158644 | 2024-06-19 | DP | |
| 8158781 | 2024-06-19 | DP | |
| 8835452 | 2024-06-19 | DS, DP | |
| 8853231 | 2024-06-19 | DP | |
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
229 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 encephalopathy | D006501 | — | K72.91 | 4 | 6 | 10 | 11 | 12 | 42 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 11 | 12 | 11 | 12 | 41 |
| Fibrosis | D005355 | — | — | 1 | 11 | 7 | 7 | 9 | 29 |
| Diarrhea | D003967 | — | R19.7 | 1 | 3 | 11 | 7 | 5 | 25 |
| Irritable bowel syndrome | D043183 | EFO_0000555 | K58 | 2 | 8 | 6 | 6 | 7 | 25 |
| Brain diseases | D001927 | — | G93.40 | — | 1 | 1 | 4 | 3 | 9 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | — | — | — | 4 | 2 | 6 |
| Ascites | D001201 | — | R18 | — | — | 4 | 1 | — | 5 |
| Inflammation | D007249 | MP_0001845 | — | 1 | 4 | 1 | 1 | — | 5 |
| Hepatic insufficiency | D048550 | — | — | — | — | — | 5 | — | 5 |
Show 27 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Crohn disease | D003424 | EFO_0000384 | K50 | 1 | 7 | 4 | — | — | 11 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | 3 | 4 | 2 | — | — | 6 |
| Abdominal pain | D015746 | EFO_0003766 | R10.9 | — | 1 | 3 | — | 2 | 5 |
| Recurrence | D012008 | — | — | — | 1 | 2 | — | 1 | 4 |
| Inflammatory bowel diseases | D015212 | EFO_0003767 | — | — | 3 | 2 | — | — | 3 |
| Dyspepsia | D004415 | EFO_0008533 | K30 | — | 2 | 1 | — | 1 | 3 |
| Digestive system diseases | D004066 | EFO_0000405 | K92.9 | — | 1 | 1 | — | 2 | 3 |
| Rectal neoplasms | D012004 | — | — | 1 | 1 | 1 | — | 1 | 3 |
| Fecal microbiota transplantation | D000069467 | — | — | 1 | 1 | 1 | — | 1 | 3 |
| Dysentery | D004403 | EFO_1001869 | — | — | 1 | 1 | — | 1 | 2 |
Show 15 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Obesity | D009765 | EFO_0001073 | E66.9 | 1 | 1 | — | — | 1 | 3 |
| Rosacea | D012393 | — | L71 | — | 3 | — | — | — | 3 |
| Syndrome | D013577 | — | — | 1 | 1 | — | — | 2 | 3 |
| Adenocarcinoma | D000230 | — | — | 1 | 1 | — | — | 1 | 2 |
| Intestinal pseudo-obstruction | D007418 | EFO_1000988 | K56.0 | — | 1 | — | — | 1 | 2 |
| Neoplasms | D009369 | — | C80 | 2 | 1 | — | — | — | 2 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | 1 | 2 | — | — | — | 2 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | — | 2 | — | — | — | 2 |
| Heart failure | D006333 | EFO_0003144 | I50 | — | 1 | — | — | 1 | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | — | — | — | 1 |
Show 17 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 1 | — | — | — | — | 1 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | 1 | — | — | — | — | 1 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
| Persian gulf syndrome | D018923 | EFO_0007430 | — | 1 | — | — | — | — | 1 |
| Bone marrow transplantation | D016026 | — | — | 1 | — | — | — | — | 1 |
| Dyskinesias | D020820 | — | G24 | 1 | — | — | — | — | 1 |
| Waldenstrom macroglobulinemia | D008258 | — | C88.0 | 1 | — | — | — | — | 1 |
| Paraproteinemias | D010265 | — | D47.2 | 1 | — | — | — | — | 1 |
| Communicable diseases | D003141 | — | — | 1 | — | — | — | — | 1 |
| Sclerosing cholangitis | D015209 | EFO_0004268 | K83.01 | 1 | — | — | — | — | 1 |
Show 2 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colonic neoplasms | D003110 | — | C18 | — | — | — | — | 2 | 2 |
| Fatty liver | D005234 | EFO_0003934 | — | — | — | — | — | 2 | 2 |
| Colorectal neoplasms | D015179 | — | — | — | — | — | — | 2 | 2 |
| Gastrointestinal diseases | D005767 | — | — | — | — | — | — | 2 | 2 |
| Gastrointestinal hemorrhage | D006471 | — | K92.2 | — | — | — | — | 2 | 2 |
| Esophageal and gastric varices | D004932 | EFO_0009545 | I85 | — | — | — | — | 2 | 2 |
| Fever | D005334 | — | R50.9 | — | — | — | — | 1 | 1 |
| Hyperthermia | D000084462 | — | — | — | — | — | — | 1 | 1 |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | — | — | — | — | 1 | 1 |
| Colitis | D003092 | EFO_0003872 | K52.9 | — | — | — | — | 1 | 1 |
Show 22 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Rifaximin |
| INN | rifaximin |
| 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 class | antibiotics (rifamycin derivatives) |
| Image (chem structure or protein) |  |
| 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-ID | 80621-81-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1617 |
| ChEBI ID | 75246 |
| PubChem CID | 6436173 |
| DrugBank | DB01220 |
| UNII ID | L36O5T016N (ChemIDplus, GSRS) |
Target
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Variants
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Estimated US medical usage
Rifaximin
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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15,348 adverse events reported
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