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

Stem definition	Drug id	CAS RN
antivirals	2373	36791-04-5

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: ribavirin ribamide ribamidil ribavarin tribavirin	A nucleoside antimetabolite antiviral agent that blocks nucleic acid synthesis and is used against both RNA and DNA viruses. Molecular weight: 244.21 Formula: C8H12N4O5 CLOGP: -2.57 LIPINSKI: 0 HAC: 9 HDO: 4 TPSA: 143.72 ALOGS: -0.87 ROTB: 3 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

ribavirin
ribamide
ribamidil
ribavarin
tribavirin

A nucleoside antimetabolite antiviral agent that blocks nucleic acid synthesis and is used against both RNA and DNA viruses.

Molecular weight: 244.21
Formula: C8H12N4O5
CLOGP: -2.57
LIPINSKI: 0
HAC: 9
HDO: 4
TPSA: 143.72
ALOGS: -0.87
ROTB: 3

Status: OFP

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

Drug dosage:

Dose	Unit	Route
6	g	Inhal.solution
1	g	O

ADMET properties:

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Property	Value	Reference
BA (Bioavailability)	60 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
CL (Clearance)	5.20 mL/min/kg	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	45 hours	Lombardo F, Berellini G, Obach RS
MRTD (Maximum Recommended Therapeutic Daily Dose)	35.10 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
EoM (Fraction excreted unchanged in urine)	17 %	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	142 mg/mL	Benet LZ, Broccatelli F, Oprea TI
Vd (Volume of distribution)	14 L/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	1 %	Lombardo F, Berellini G, Obach RS
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI

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Approvals:

Date	Agency	Company	Orphan
Dec. 31, 1985	FDA	VALEANT PHARM INTL
Nov. 21, 2001	PMDA	Schering-Plough

FDA Adverse Event Reporting System (Female)

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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
Anaemia	3602.22	13.80	2695	61277	290735	63134315
Haemoglobin decreased	1076.30	13.80	1002	62970	144483	63280567
White blood cell count decreased	940.88	13.80	912	63060	138192	63286858
Hepatitis C	831.98	13.80	279	63693	4995	63420055
Platelet count decreased	793.60	13.80	766	63206	115356	63309694
Hepatocellular carcinoma	744.29	13.80	209	63763	1985	63423065
Neutrophil count decreased	461.94	13.80	412	63560	55994	63369056
Jaundice	378.08	13.80	279	63693	28972	63396078
Blood bilirubin increased	360.33	13.80	299	63673	36841	63388209
Ascites	358.45	13.80	310	63662	40418	63384632

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FDA Adverse Event Reporting System (Male)

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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
Anaemia	2514.21	12.42	2946	81831	230389	34641765
Hepatitis C	1870.42	12.42	752	84025	9078	34863076
Hepatocellular carcinoma	1842.45	12.42	691	84086	6818	34865336
Rash	989.00	12.42	1859	82918	220893	34651261
White blood cell count decreased	742.90	12.42	1030	83747	94415	34777739
Fatigue	713.07	12.42	2238	82539	368415	34503739
Hepatic cirrhosis	701.02	12.42	467	84310	16847	34855307
Haemoglobin decreased	676.48	12.42	1118	83659	119654	34752500
Influenza like illness	583.05	12.42	505	84272	27129	34845025
Pruritus	517.16	12.42	1093	83684	140888	34731266

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FDA Adverse Event Reporting System (Geriatric)

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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
Anaemia	5224.38	11.53	4707	114892	440308	79184481
Hepatocellular carcinoma	2484.00	11.53	801	118798	8220	79616569
Hepatitis C	2476.11	11.53	856	118743	11069	79613720
Haemoglobin decreased	1496.22	11.53	1751	117848	220368	79404421
White blood cell count decreased	1424.86	11.53	1577	118022	186711	79438078
Platelet count decreased	1117.13	11.53	1416	118183	193248	79431541
Hepatic cirrhosis	854.02	11.53	574	119025	34332	79590457
Ascites	847.58	11.53	784	118815	74778	79550011
Rash	813.02	11.53	2294	117305	576064	79048725
Neutrophil count decreased	782.93	11.53	829	118770	93130	79531659

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FDA Adverse Event Reporting System (Pediatric)

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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
Exposure via body fluid	61.94	36.84	10	47	3	89732

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Pharmacologic Action:

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Source	Code	Description
ATC	J05AP01	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HCV infections
CHEBI has role	CHEBI:22587	antiviral agents
CHEBI has role	CHEBI:35221	antimetabolite
CHEBI has role	CHEBI:35441	antiinfective agents
CHEBI has role	CHEBI:59897	reverse transcriptase inhibitors
CHEBI has role	CHEBI:149553	anticoronaviral drug
FDA EPC	N0000175466	Nucleoside Analog Antiviral
FDA EXT	N0000175459	Nucleoside Analog
MeSH PA	D000890	Anti-Infective Agents
MeSH PA	D000963	Antimetabolites

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

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Disease	Relation	SNOMED_ID	DOID
Respiratory syncytial virus infection	indication	55735004	DOID:1273
Chronic hepatitis C	indication	128302006
Compensated cirrhosis	indication	371139006
Lassa fever	off-label use	19065005	DOID:9537
Influenza due to Influenza virus, type B	off-label use	24662006
Congo-Crimean hemorrhagic fever	off-label use	43489008	DOID:12287
Hemorrhagic nephroso-nephritis	off-label use	102455002
Coronavirus infection	off-label use	186747009
Rift valley fever	off-label use	402917003	DOID:1328
Influenza due to Influenza A virus	off-label use	442438000

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

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Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	11.65	acidic
pKa2	12.27	acidic
pKa3	13.44	acidic
pKa4	0.35	Basic

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Orange Book patent data (new drug applications)

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Orange Book exclusivity data (new drug applications)

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Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Inosine-5'-monophosphate dehydrogenase 1	Enzyme	P20839	IMDH1_HUMAN	INHIBITOR	IC50	6	IUPHAR	CHEMBL
Ectonucleotide pyrophosphatase/phosphodiesterase family member 1	Enzyme	P22413	ENPP1_HUMAN				WOMBAT-PK
Cytosolic purine 5'-nucleotidase	Enzyme	P49902	5NTC_HUMAN				WOMBAT-PK
Inosine-5'-monophosphate dehydrogenase 2	Enzyme	P12268	IMDH2_HUMAN	INHIBITOR	IC50	6	IUPHAR
DNA topoisomerase 1	Enzyme	P11387	TOP1_HUMAN		IC50	4.18	CHEMBL
Adenosine receptor A1	GPCR	P30542	AA1R_HUMAN		Ki	5.13	CHEMBL
Adenosine kinase	Kinase	P55263	ADK_HUMAN				WOMBAT-PK
NS5B protein	Enzyme		Q8JXU8_9HEPC	INHIBITOR			CHEMBL	CHEMBL
NS5	Unclassified		A0A143MHK7_ZIKV		EC50	4.68	CHEMBL
Adenosine receptor A1	GPCR		AA1R_MOUSE		Ki	5.35	CHEMBL

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External reference:

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ID	Source
RBV	PDB_CHEM_ID
003018	NDDF
35063004	SNOMEDCT_US
3543	INN_ID
37542	PUBCHEM_CID
387188005	SNOMEDCT_US
4019299	VUID
4019299	VANDF
43465	MMSL
49717AWG6K	UNII

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
REBETOL	HUMAN PRESCRIPTION DRUG LABEL	1	0085-1194	CAPSULE	200 mg	ORAL	NDA	31 sections
REBETOL	HUMAN PRESCRIPTION DRUG LABEL	1	0085-1194	CAPSULE	200 mg	ORAL	NDA	31 sections
REBETOL	HUMAN PRESCRIPTION DRUG LABEL	1	0085-1318	LIQUID	40 mg	ORAL	NDA	31 sections
REBETOL	HUMAN PRESCRIPTION DRUG LABEL	1	0085-1318	LIQUID	40 mg	ORAL	NDA	31 sections
REBETOL	HUMAN PRESCRIPTION DRUG LABEL	1	0085-1351	CAPSULE	200 mg	ORAL	NDA	31 sections
REBETOL	HUMAN PRESCRIPTION DRUG LABEL	1	0085-1351	CAPSULE	200 mg	ORAL	NDA	31 sections
REBETOL	HUMAN PRESCRIPTION DRUG LABEL	1	0085-1385	CAPSULE	200 mg	ORAL	NDA	31 sections
REBETOL	HUMAN PRESCRIPTION DRUG LABEL	1	0085-1385	CAPSULE	200 mg	ORAL	NDA	31 sections
Ribavirin	HUMAN PRESCRIPTION DRUG LABEL	1	42494-423	POWDER, FOR SOLUTION	6 g	RESPIRATORY (INHALATION)	NDA	23 sections
Ribavirin	HUMAN PRESCRIPTION DRUG LABEL	1	53808-0781	CAPSULE	200 mg	ORAL	ANDA	21 sections

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