rifaximin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
antibiotics, rifamycin derivatives	2379	80621-81-4

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: rifaximine rifaximin xifaxan refaximin	Rifaximin is a semi-synthetic derivative of rifampin and acts by binding to the beta-subunit of bacterial DNA-dependent RNA polymerase blocking one of the steps in transcription. This results in inhibition of bacterial protein synthesis and consequently inhibits the growth of bacteria. Molecular weight: 785.89 Formula: C43H51N3O11 CLOGP: 7.19 LIPINSKI: 3 HAC: 14 HDO: 5 TPSA: 198.38 ALOGS: -5.03 ROTB: 3 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

rifaximine
rifaximin
xifaxan
refaximin

Rifaximin is a semi-synthetic derivative of rifampin and acts by binding to the beta-subunit of bacterial DNA-dependent RNA polymerase blocking one of the steps in transcription. This results in inhibition of bacterial protein synthesis and consequently inhibits the growth of bacteria.

Molecular weight: 785.89
Formula: C43H51N3O11
CLOGP: 7.19
LIPINSKI: 3
HAC: 14
HDO: 5
TPSA: 198.38
ALOGS: -5.03
ROTB: 3

Status: ONP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

Dose	Unit	Route
0.60	g	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	4	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.00 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	0.04 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	10.91 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	1 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

Date	Agency	Company	Orphan
May 25, 2004	FDA	SALIX PHARMS

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Death	564.27	16.78	456	9055	373925	63105586
Inability to afford medication	360.31	16.78	81	9430	2266	63477245
Hepatic encephalopathy	360.03	16.78	112	9399	11170	63468341
Hospitalisation	253.61	16.78	158	9353	84923	63394588
Ammonia increased	248.96	16.78	69	9442	4587	63474924
Hepatic cirrhosis	151.54	16.78	74	9437	24660	63454851
Ascites	134.86	16.78	81	9430	40647	63438864
Insurance issue	123.47	16.78	43	9468	6078	63473433
Therapy interrupted	116.46	16.78	68	9443	32387	63447124
Hepatic failure	115.67	16.78	70	9441	35586	63443925
Chronic hepatic failure	110.58	16.78	24	9487	567	63478944
Varices oesophageal	99.28	16.78	31	9480	3117	63476394
Portal hypertension	51.68	16.78	20	9491	3799	63475712
Abdominal distension	48.08	16.78	62	9449	86553	63392958
Blood bilirubin increased	46.52	16.78	41	9470	37099	63442412
Liver transplant	45.83	16.78	16	9495	2275	63477236
Encephalopathy	39.37	16.78	38	9473	38582	63440929
Therapy cessation	38.90	16.78	34	9477	30423	63449088
Confusional state	38.41	16.78	99	9412	236281	63243230
Hospice care	37.67	16.78	20	9491	7912	63471599
Hepatic infarction	35.97	16.78	10	9501	670	63478841
Gastrointestinal bacterial overgrowth	33.40	16.78	10	9501	872	63478639
Abdominal pain	33.25	16.78	108	9403	293348	63186163
Diarrhoea	28.10	16.78	193	9318	715173	62764338
Acute hepatic failure	26.55	16.78	22	9489	18305	63461206
Treatment noncompliance	26.02	16.78	30	9481	37295	63442216
Cirrhosis alcoholic	24.69	16.78	6	9505	236	63479275
Paracentesis	24.22	16.78	8	9503	962	63478549
Amoebic colitis	23.42	16.78	3	9508	0	63479511
Liver disorder	23.09	16.78	34	9477	53653	63425858
Arthropathy	22.53	16.78	4	9507	234788	63244723
Ammonia abnormal	22.18	16.78	5	9506	141	63479370
Portal hypertensive gastropathy	21.66	16.78	7	9504	785	63478726
Complications of transplanted liver	21.63	16.78	6	9505	399	63479112
Gastric varices	20.69	16.78	5	9506	192	63479319
Maternal exposure during pregnancy	20.57	16.78	4	9507	220058	63259453
Alopecia	19.98	16.78	13	9498	337523	63141988
Rheumatoid arthritis	19.23	16.78	7	9504	253812	63225699
Hepatorenal syndrome	18.85	16.78	8	9503	1924	63477587
Haematemesis	18.81	16.78	23	9488	30389	63449122
Autoimmune pancytopenia	18.21	16.78	4	9507	100	63479411
Aplasia	18.16	16.78	10	9501	4249	63475262
Drug intolerance	18.11	16.78	12	9499	308649	63170862
Herpes simplex viraemia	18.04	16.78	5	9506	331	63479180
Acute generalised exanthematous pustulosis	17.50	16.78	14	9497	11085	63468426
Glossodynia	17.26	16.78	3	9508	178873	63300638
Mental status changes	16.91	16.78	25	9486	39574	63439937

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Hepatic encephalopathy	528.58	17.29	183	9016	14502	34933230
Inability to afford medication	406.75	17.29	91	9108	1379	34946353
Death	386.98	17.29	495	8704	397554	34550178
Hospitalisation	271.61	17.29	175	9024	56727	34891005
Ammonia increased	210.83	17.29	68	9131	4301	34943431
Insurance issue	181.95	17.29	51	9148	1988	34945744
Hepatic cirrhosis	159.88	17.29	82	9117	17232	34930500
Ascites	157.57	17.29	116	9083	46455	34901277
Hepatic failure	142.19	17.29	97	9102	34434	34913298
Therapy interrupted	115.34	17.29	61	9138	13636	34934096
Hepatocellular carcinoma	64.77	17.29	34	9165	7475	34940257
Encephalopathy	63.21	17.29	61	9138	35258	34912474
Chronic hepatic failure	55.78	17.29	15	9184	499	34947233
Hepatorenal syndrome	51.10	17.29	21	9178	2645	34945087
Liver transplant	48.71	17.29	20	9179	2514	34945218
Megacolon	47.87	17.29	18	9181	1792	34945940
Liver disorder	44.56	17.29	49	9150	32948	34914784
Abdominal distension	42.72	17.29	64	9135	58428	34889304
Hospice care	42.27	17.29	25	9174	6915	34940817
Oesophageal varices haemorrhage	41.38	17.29	19	9180	3127	34944605
Confusional state	41.11	17.29	106	9093	144054	34803678
Portal hypertensive gastropathy	39.61	17.29	12	9187	615	34947117
Sopor	36.02	17.29	28	9171	12108	34935624
Hepatitis C	34.33	17.29	25	9174	9805	34937927
Cirrhosis alcoholic	32.18	17.29	11	9188	831	34946901
Asterixis	31.66	17.29	12	9187	1221	34946511
Clostridium test positive	31.31	17.29	16	9183	3326	34944406
Hyperammonaemia	31.29	17.29	20	9179	6347	34941385
Poverty of speech	30.93	17.29	8	9191	228	34947504
Abdominal pain	29.22	17.29	102	9097	163516	34784216
Diarrhoea	28.85	17.29	188	9011	389724	34558008
Portal shunt procedure	28.59	17.29	5	9194	18	34947714
Portal hypertension	28.38	17.29	16	9183	4046	34943686
Ureaplasma infection	27.35	17.29	8	9191	363	34947369
Peritonitis bacterial	27.10	17.29	18	9181	6092	34941640
Varices oesophageal	26.80	17.29	15	9184	3740	34943992
Abdominal cavity drainage	26.46	17.29	8	9191	407	34947325
Jaundice	26.34	17.29	37	9162	31845	34915887
Paracentesis	26.00	17.29	8	9191	432	34947300
Symptom recurrence	25.55	17.29	9	9190	744	34946988
Pseudomembranous colitis	25.10	17.29	13	9186	2778	34944954
Functional gastrointestinal disorder	24.80	17.29	12	9187	2219	34945513
Mental status changes	24.06	17.29	39	9160	38044	34909688
Portal vein thrombosis	24.00	17.29	14	9185	3774	34943958
Ammonia abnormal	22.56	17.29	5	9194	72	34947660
Product supply issue	22.56	17.29	8	9191	674	34947058
Disease complication	22.49	17.29	12	9187	2724	34945008
Enterococcus test positive	22.48	17.29	9	9190	1060	34946672
Microscopic enteritis	21.73	17.29	3	9196	0	34947732
Hepatic lesion	21.63	17.29	13	9186	3699	34944033
Febrile neutropenia	21.19	17.29	5	9194	136844	34810888
Therapy cessation	20.84	17.29	24	9175	16949	34930783
Sprue-like enteropathy	20.78	17.29	7	9192	506	34947226
Skin necrosis	20.69	17.29	15	9184	5838	34941894
Multiple organ dysfunction syndrome	20.45	17.29	55	9144	76511	34871221
Biopsy liver	20.41	17.29	6	9193	277	34947455
Neurological symptom	20.20	17.29	13	9186	4172	34943560
Factor V inhibition	17.90	17.29	5	9194	192	34947540
Myocardial infarction	17.64	17.29	5	9194	121080	34826652
Rectal haemorrhage	17.46	17.29	35	9164	40214	34907518
Blood bilirubin increased	17.45	17.29	34	9165	38262	34909470

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Death	754.25	15.35	737	15579	565777	79162295
Hepatic encephalopathy	753.38	15.35	254	16062	23912	79704160
Inability to afford medication	682.28	15.35	149	16167	2624	79725448
Hospitalisation	375.84	15.35	236	16080	94000	79634072
Ammonia increased	368.45	15.35	112	16204	7523	79720549
Insurance issue	280.45	15.35	85	16231	5648	79722424
Ascites	263.45	15.35	174	16142	75388	79652684
Hepatic cirrhosis	223.29	15.35	119	16197	34787	79693285
Therapy interrupted	220.86	15.35	114	16202	31227	79696845
Hepatic failure	196.58	15.35	134	16182	61078	79666994
Chronic hepatic failure	109.43	15.35	28	16288	991	79727081
Varices oesophageal	97.21	15.35	39	16277	5952	79722120
Hepatocellular carcinoma	84.93	15.35	40	16276	8981	79719091
Encephalopathy	83.54	15.35	85	16231	67312	79660760
Abdominal distension	74.03	15.35	106	16210	119544	79608528
Liver transplant	72.48	15.35	29	16287	4394	79723678
Portal hypertension	71.51	15.35	33	16283	7075	79720997
Confusional state	69.67	15.35	181	16135	317816	79410256
Hepatorenal syndrome	66.66	15.35	27	16289	4222	79723850
Portal hypertensive gastropathy	56.65	15.35	18	16298	1396	79726676
Blood bilirubin increased	55.33	15.35	68	16248	66164	79661908
Hospice care	51.74	15.35	30	16286	10294	79717778
Abdominal pain	47.47	15.35	181	16135	389388	79338684
Megacolon	47.35	15.35	20	16296	3475	79724597
Paracentesis	45.26	15.35	15	16301	1330	79726742
Cirrhosis alcoholic	44.58	15.35	14	16302	1045	79727027
Asterixis	41.77	15.35	17	16299	2690	79725382
Diarrhoea	41.73	15.35	315	16001	880174	78847898
Sopor	41.55	15.35	42	16274	32968	79695104
Multiple organ dysfunction syndrome	40.22	15.35	81	16235	120165	79607907
Jaundice	38.59	15.35	51	16265	53298	79674774
Peritonitis bacterial	38.13	15.35	24	16292	9543	79718529
Mental status changes	38.02	15.35	57	16259	66902	79661170
Hepatitis C	37.98	15.35	26	16290	11899	79716173
Oesophageal varices haemorrhage	37.48	15.35	18	16298	4218	79723854
Liver disorder	36.03	15.35	58	16258	72359	79655713
Gastrointestinal bacterial overgrowth	32.63	15.35	10	16306	688	79727384
Portal vein thrombosis	32.06	15.35	18	16298	5809	79722263
Abdominal cavity drainage	30.93	15.35	10	16306	820	79727252
Clostridium test positive	30.35	15.35	18	16298	6436	79721636
Hyperammonaemia	30.25	15.35	22	16294	11071	79717001
Hypervolaemia	29.63	15.35	40	16276	42650	79685422
Portal shunt procedure	29.24	15.35	5	16311	21	79728051
Febrile neutropenia	28.93	15.35	6	16310	230993	79497079
Rheumatoid arthritis	26.98	15.35	5	16311	208465	79519607
Rectal haemorrhage	26.22	15.35	52	16264	76248	79651824
Hepatic infarction	26.04	15.35	9	16307	906	79727166
Arthropathy	25.80	15.35	3	16313	177108	79550964
Poverty of speech	25.62	15.35	8	16308	586	79727486
Musculoskeletal stiffness	25.40	15.35	3	16313	175005	79553067
Hyperbilirubinaemia	25.18	15.35	28	16288	24490	79703582
Ureaplasma infection	24.83	15.35	9	16307	1041	79727031
Hepatic lesion	24.14	15.35	16	16300	6943	79721129
Portal shunt	23.88	15.35	5	16311	71	79728001
Functional gastrointestinal disorder	23.68	15.35	14	16302	4976	79723096
Musculoskeletal toxicity	23.68	15.35	6	16310	204	79727868
Renal failure	23.29	15.35	92	16224	200876	79527196
Anaemia	23.13	15.35	163	16153	444852	79283220
Therapy cessation	22.79	15.35	33	16283	37529	79690543
Pseudomembranous colitis	22.72	15.35	14	16302	5360	79722712
Drug intolerance	22.57	15.35	13	16303	264106	79463966
Microscopic enteritis	22.48	15.35	3	16313	0	79728072
Haematemesis	22.18	15.35	39	16277	52225	79675847
Treatment noncompliance	22.18	15.35	39	16277	52229	79675843
Disease complication	21.23	15.35	13	16303	4924	79723148
Completed suicide	21.14	15.35	12	16304	245755	79482317
Joint swelling	20.94	15.35	17	16299	288629	79439443
Condition aggravated	20.72	15.35	174	16142	500950	79227122
Splenomegaly	20.11	15.35	23	16293	20731	79707341
Gastric varices	19.98	15.35	7	16309	734	79727338
Nasopharyngitis	19.63	15.35	14	16302	253867	79474205
Alpha 1 foetoprotein increased	19.39	15.35	7	16309	801	79727271
Ammonia abnormal	19.12	15.35	5	16311	193	79727879
Clostridium difficile colitis	19.06	15.35	28	16288	32255	79695817
Therapeutic product effect decreased	19.04	15.35	5	16311	163858	79564214
Product supply issue	19.03	15.35	9	16307	2039	79726033
Alopecia	18.91	15.35	12	16304	231343	79496729
Drug hypersensitivity	18.86	15.35	20	16296	298896	79429176
Enterococcus test positive	18.79	15.35	9	16307	2095	79725977
Hepatic cancer	18.24	15.35	16	16300	10513	79717559
Acute kidney injury	18.21	15.35	174	16142	519230	79208842
Non-alcoholic steatohepatitis	18.14	15.35	9	16307	2263	79725809
Acute hepatic failure	17.61	15.35	26	16290	30087	79697985
Hepatic mass	17.49	15.35	9	16307	2442	79725630
Biopsy liver	17.19	15.35	6	16310	622	79727450
Toxicity to various agents	17.17	15.35	38	16278	421502	79306570
Neurological symptom	16.54	15.35	14	16302	8769	79719303
Arthralgia	16.36	15.35	61	16255	571742	79156330
Sinusitis	16.17	15.35	10	16306	195491	79532581
External ear neoplasm malignant	16.13	15.35	3	16313	22	79728050
Sprue-like enteropathy	16.07	15.35	7	16309	1311	79726761
Factor V inhibition	15.88	15.35	5	16311	376	79727696
Rash	15.72	15.35	63	16253	578295	79149777
Hypoglycaemia	15.59	15.35	51	16265	101543	79626529

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	A07AA11	ALIMENTARY TRACT AND METABOLISM ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS INTESTINAL ANTIINFECTIVES Antibiotics
ATC	D06AX11	DERMATOLOGICALS ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE ANTIBIOTICS FOR TOPICAL USE Other antibiotics for topical use
FDA CS	M0019113	Rifamycins
FDA EPC	N0000175500	Rifamycin Antibacterial
MeSH PA	D000900	Anti-Bacterial Agents
MeSH PA	D000890	Anti-Infective Agents
MeSH PA	D005765	Gastrointestinal Agents
CHEBI has role	CHEBI:33281	antibiotics
CHEBI has role	CHEBI:55324	gastrointestinal drugs
CHEBI has role	CHEBI:71031	orphan drugs

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Hepatic encephalopathy	indication	13920009	DOID:13413
Irritable bowel syndrome with diarrhea	indication	197125005
Diarrhea due to E. Coli	indication
Traveler's diarrhea	off-label use	11840006
Hemorrhagic diarrhea	contraindication	95545007
Fever	contraindication	386661006
Pseudomembranous enterocolitis	contraindication	397683000

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	3.02	acidic
pKa2	7.28	acidic
pKa3	11.32	acidic
pKa4	12.55	acidic
pKa5	2.08	Basic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
550MG	XIFAXAN	SALIX PHARMS	N021361	March 24, 2010	RX	TABLET	ORAL	7915275	Feb. 23, 2025	TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS.
550MG	XIFAXAN	SALIX PHARMS	N021361	March 24, 2010	RX	TABLET	ORAL	7915275	Feb. 23, 2025	TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS AND SYMPTOMS THEREOF.
200MG	XIFAXAN	SALIX PHARMS	N021361	May 25, 2004	RX	TABLET	ORAL	10703763	Feb. 27, 2026	REDUCTION IN RISK OF OVERT HEPATIC ENCEPHALOPATHY (HE) RECURRENCE IN ADULTS
200MG	XIFAXAN	SALIX PHARMS	N021361	May 25, 2004	RX	TABLET	ORAL	10703763	Feb. 27, 2026	TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS.
200MG	XIFAXAN	SALIX PHARMS	N021361	May 25, 2004	RX	TABLET	ORAL	10703763	Feb. 27, 2026	TREATMENT OF TRAVELERS DIARRHEA (TD) CAUSED BY NONINVASIVE STRAINS OF ESCHERIA COLI IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
200MG	XIFAXAN	SALIX PHARMS	N021361	May 25, 2004	RX	TABLET	ORAL	8741904	Feb. 27, 2026	THE TREATMENT OF PATIENTS WITH TRAVELERS DIARRHEA (TD) OR THE REDUCTION IN RISK OF OVERT HEPATIC ENCEPHALOPATHY (HE) RECURRENCE
550MG	XIFAXAN	SALIX PHARMS	N021361	March 24, 2010	RX	TABLET	ORAL	10703763	Feb. 27, 2026	REDUCTION IN RISK OF OVERT HEPATIC ENCEPHALOPATHY (HE) RECURRENCE IN ADULTS
550MG	XIFAXAN	SALIX PHARMS	N021361	March 24, 2010	RX	TABLET	ORAL	10703763	Feb. 27, 2026	TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS.
550MG	XIFAXAN	SALIX PHARMS	N021361	March 24, 2010	RX	TABLET	ORAL	10703763	Feb. 27, 2026	TREATMENT OF TRAVELERS DIARRHEA (TD) CAUSED BY NONINVASIVE STRAINS OF ESCHERIA COLI IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
550MG	XIFAXAN	SALIX PHARMS	N021361	March 24, 2010	RX	TABLET	ORAL	8741904	Feb. 27, 2026	THE TREATMENT OF PATIENTS WITH TRAVELERS DIARRHEA (TD) OR THE REDUCTION IN RISK OF OVERT HEPATIC ENCEPHALOPATHY (HE) RECURRENCE
550MG	XIFAXAN	SALIX PHARMS	N021361	March 24, 2010	RX	TABLET	ORAL	8741904	Feb. 27, 2026	TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS.
550MG	XIFAXAN	SALIX PHARMS	N021361	March 24, 2010	RX	TABLET	ORAL	8741904	Feb. 27, 2026	TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS AND SYMPTOMS THEREOF.
550MG	XIFAXAN	SALIX PHARMS	N021361	March 24, 2010	RX	TABLET	ORAL	8193196	Sept. 2, 2027	TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS.
550MG	XIFAXAN	SALIX PHARMS	N021361	March 24, 2010	RX	TABLET	ORAL	8193196	Sept. 2, 2027	TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS AND SYMPTOMS THEREOF.
550MG	XIFAXAN	SALIX PHARMS	N021361	March 24, 2010	RX	TABLET	ORAL	10456384	Feb. 26, 2029	TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS 65 YEARS OF AGE OR OLDER
550MG	XIFAXAN	SALIX PHARMS	N021361	March 24, 2010	RX	TABLET	ORAL	10456384	Feb. 26, 2029	TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS 65 YEARS OF AGE OR OLDER AND SYMPTOMS THEREOF
550MG	XIFAXAN	SALIX PHARMS	N021361	March 24, 2010	RX	TABLET	ORAL	10765667	Feb. 26, 2029	TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS 65 YEARS OF AGE OR OLDER
550MG	XIFAXAN	SALIX PHARMS	N021361	March 24, 2010	RX	TABLET	ORAL	10765667	Feb. 26, 2029	TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS 65 YEARS OF AGE OR OLDER AND SYMPTOMS THEREOF
550MG	XIFAXAN	SALIX PHARMS	N021361	March 24, 2010	RX	TABLET	ORAL	11564912	Feb. 26, 2029	TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULT FEMALE SUBJECTS
550MG	XIFAXAN	SALIX PHARMS	N021361	March 24, 2010	RX	TABLET	ORAL	11564912	Feb. 26, 2029	TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULT FEMALE SUBJECTS AND SYMPTOMS THEREOF
550MG	XIFAXAN	SALIX PHARMS	N021361	March 24, 2010	RX	TABLET	ORAL	8309569	July 18, 2029	TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS.
550MG	XIFAXAN	SALIX PHARMS	N021361	March 24, 2010	RX	TABLET	ORAL	8309569	July 18, 2029	TREATMENT OF IRRITABLE BOWEL SYNDROME WITH DIARRHEA (IBS-D) IN ADULTS AND SYMPTOMS THEREOF.
200MG	XIFAXAN	SALIX PHARMS	N021361	May 25, 2004	RX	TABLET	ORAL	7928115	July 24, 2029	METHOD OF TREATING TRAVELERS DIARRHEA
550MG	XIFAXAN	SALIX PHARMS	N021361	March 24, 2010	RX	TABLET	ORAL	10314828	July 24, 2029	REDUCTION IN RISK OF OVERT HEPATIC ENCEPHALOPATHY (HE) RECURRENCE
550MG	XIFAXAN	SALIX PHARMS	N021361	March 24, 2010	RX	TABLET	ORAL	10335397	July 24, 2029	REDUCTION IN A SUBJECTS RISK OF EXPERIENCING A BREAKTHROUGH OVERT HEPATIC ENCEPHALOPATHY (HE) EPISODE
550MG	XIFAXAN	SALIX PHARMS	N021361	March 24, 2010	RX	TABLET	ORAL	10709694	July 24, 2029	REDUCTION IN A SUBJECTS RISK OF EXPERIENCING A BREAKTHROUGH OVERT HEPATIC ENCEPHALOPATHY (HE) EPISODE
550MG	XIFAXAN	SALIX PHARMS	N021361	March 24, 2010	RX	TABLET	ORAL	8829017	July 24, 2029	TREATMENT OF PATIENTS WITH HEPATIC ENCEPHALOPATHY (HE)
550MG	XIFAXAN	SALIX PHARMS	N021361	March 24, 2010	RX	TABLET	ORAL	8946252	July 24, 2029	REDUCTION IN RISK OF OVERT HEPATIC ENCEPHALOPATHY (HE) RECURRENCE
550MG	XIFAXAN	SALIX PHARMS	N021361	March 24, 2010	RX	TABLET	ORAL	9421195	July 24, 2029	REDUCTION IN RISK OF OVERT HEPATIC ENCEPHALOPATHY (HE) RECURRENCE
550MG	XIFAXAN	SALIX PHARMS	N021361	March 24, 2010	RX	TABLET	ORAL	9629828	July 24, 2029	REDUCTION IN RISK OF OVERT HEPATIC ENCEPHALOPATHY (HE) IN ADULTS
550MG	XIFAXAN	SALIX PHARMS	N021361	March 24, 2010	RX	TABLET	ORAL	8642573	Oct. 2, 2029	REDUCTION IN RISK OF OVERT HEPATIC ENCEPHALOPATHY (HE) RECURRENCE
550MG	XIFAXAN	SALIX PHARMS	N021361	March 24, 2010	RX	TABLET	ORAL	8969398	Oct. 2, 2029	REDUCTION IN RISK OF OVERT HEPATIC ENCEPHALOPATHY (HE) RECURRENCE

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Nuclear receptor subfamily 1 group I member 2	Nuclear hormone receptor	O75469	NR1I2_HUMAN		EC50	5.66		CHEMBL
Bacterial DNA-directed RNA polymerase	Enzyme		RPOA_ECOLI RPOZ_ECOLI RPOC_ECOLI RPOB_ECOLI	INHIBITOR				CHEMBL	CHEMBL

External reference:

ID	Source
4021474	VUID
N0000148858	NUI
D02554	KEGG_DRUG
4021474	VANDF
C0073374	UMLSCUI
CHEBI:75246	CHEBI
RXM	PDB_CHEM_ID
CHEMBL1617	ChEMBL_ID
D000078262	MESH_DESCRIPTOR_UI
DB01220	DRUGBANK_ID
12012	IUPHAR_LIGAND_ID
5244	INN_ID
L36O5T016N	UNII
6436173	PUBCHEM_CID
35619	RXNORM
18641	MMSL
54029	MMSL
d05294	MMSL
007765	NDDF
412553001	SNOMEDCT_US
412554007	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
XIFAXAN	HUMAN PRESCRIPTION DRUG LABEL	1	50090-2445	TABLET	200 mg	ORAL	NDA	24 sections
XIFAXAN	HUMAN PRESCRIPTION DRUG LABEL	1	50090-2445	TABLET	200 mg	ORAL	NDA	24 sections
XIFAXAN	HUMAN PRESCRIPTION DRUG LABEL	1	54868-5972	TABLET	200 mg	ORAL	NDA	26 sections
XIFAXAN	HUMAN PRESCRIPTION DRUG LABEL	1	54868-6154	TABLET	550 mg	ORAL	NDA	26 sections
XIFAXAN	HUMAN PRESCRIPTION DRUG LABEL	1	55154-6777	TABLET	550 mg	ORAL	NDA	24 sections
XIFAXAN	HUMAN PRESCRIPTION DRUG LABEL	1	55154-6777	TABLET	550 mg	ORAL	NDA	24 sections
XIFAXAN	HUMAN PRESCRIPTION DRUG LABEL	1	65649-301	TABLET	200 mg	ORAL	NDA	24 sections
XIFAXAN	HUMAN PRESCRIPTION DRUG LABEL	1	65649-301	TABLET	200 mg	ORAL	NDA	24 sections
XIFAXAN	HUMAN PRESCRIPTION DRUG LABEL	1	65649-303	TABLET	550 mg	ORAL	NDA	24 sections
XIFAXAN	HUMAN PRESCRIPTION DRUG LABEL	1	65649-303	TABLET	550 mg	ORAL	NDA	24 sections
XIFAXAN	HUMAN PRESCRIPTION DRUG LABEL	1	68151-4980	TABLET	200 mg	ORAL	NDA	26 sections
XIFAXAN	HUMAN PRESCRIPTION DRUG LABEL	1	68258-1107	TABLET	200 mg	ORAL	NDA	26 sections
XIFAXAN	HUMAN PRESCRIPTION DRUG LABEL	1	69189-0309	TABLET	200 mg	ORAL	NDA	26 sections