ribavirin 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: -2.85 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:

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

Approvals:

Date	Agency	Company	Orphan
Dec. 31, 1985	FDA	VALEANT PHARM INTL

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
Anaemia	3153.10	12.52	2669	61024	253110	46369259
Hepatitis C	1508.33	12.52	492	63201	5826	46616543
Haemoglobin decreased	926.01	12.52	1004	62689	127945	46494424
White blood cell count decreased	873.09	12.52	912	62781	111319	46511050
Platelet count decreased	696.79	12.52	767	62926	99257	46523112
Hepatocellular carcinoma	569.43	12.52	194	63499	2645	46619724
Neutrophil count decreased	441.41	12.52	409	63284	43017	46579352
Rash	429.53	12.52	1259	62434	355253	46267116
Hepatic cirrhosis	327.84	12.52	226	63467	15506	46606863
Decreased appetite	324.80	12.52	775	62918	193061	46429308
Blood bilirubin increased	303.70	12.52	299	63394	33885	46588484
Jaundice	297.50	12.52	274	63419	28571	46593798
Ascites	292.07	12.52	302	63391	36282	46586087
Fatigue	288.48	12.52	1606	62087	607091	46015278
Anal pruritus	282.12	12.52	81	63612	598	46621771
Hyperbilirubinaemia	280.98	12.52	176	63517	10262	46612107
Hepatic encephalopathy	272.75	12.52	171	63522	9986	46612383
Dysgeusia	263.34	12.52	300	63393	40191	46582178
Influenza like illness	258.15	12.52	354	63339	57216	46565153
Pruritus	248.23	12.52	810	62883	241542	46380827
Anorectal discomfort	245.79	12.52	98	63595	2123	46620246
Hepatic failure	229.94	12.52	255	63438	33161	46589208
Rheumatoid arthritis	226.69	12.52	30	63663	240185	46382184
Viral load increased	225.92	12.52	81	63612	1294	46621075
Haemolytic anaemia	223.16	12.52	149	63544	9693	46612676
Drug hypersensitivity	221.81	12.52	34	63659	243791	46378578
Leukopenia	221.49	12.52	361	63332	67982	46554387
Depression	217.60	12.52	615	63078	169489	46452880
Retinopathy	216.17	12.52	92	63601	2364	46620005
Asthenia	211.17	12.52	911	62782	310164	46312205
Nausea	200.38	12.52	1608	62085	685846	45936523
Red blood cell count decreased	194.19	12.52	231	63462	32392	46589977
Insomnia	190.47	12.52	575	63118	164349	46458020
Toxicity to various agents	170.31	12.52	40	63653	211726	46410643
Completed suicide	168.93	12.52	7	63686	145913	46476456
Pancytopenia	157.32	12.52	354	63339	84704	46537665
Hyperuricaemia	156.56	12.52	91	63602	4626	46617743
Thrombocytopenia	139.18	12.52	434	63259	126147	46496222
Proctalgia	124.38	12.52	79	63614	4717	46617652
Hepatitis C RNULL positive	124.16	12.52	28	63665	62	46622307
Pyrexia	118.89	12.52	848	62845	347954	46274415
Vomiting	117.23	12.52	1033	62660	451761	46170608
Joint swelling	115.75	12.52	41	63652	166032	46456337
Hepatitis C RNULL increased	114.11	12.52	29	63664	125	46622244
Death	108.51	12.52	182	63511	335366	46287003
Dry skin	102.06	12.52	193	63500	40823	46581546
Hepatitis E	101.11	12.52	44	63649	1195	46621174
Fall	100.51	12.52	185	63508	328912	46293457
Vogt-Koyanagi-Harada disease	98.14	12.52	25	63668	109	46622260
Autoimmune hepatitis	93.96	12.52	81	63612	7733	46614636
Cryoglobulinaemia	93.06	12.52	30	63663	340	46622029
Hepatitis B reactivation	92.67	12.52	44	63649	1470	46620899
Off label use	91.02	12.52	244	63449	379597	46242772
Peripheral swelling	89.90	12.52	52	63641	158019	46464350
Contraindicated product administered	88.74	12.52	5	63688	79942	46542427
Neutropenia	87.43	12.52	407	63286	142797	46479572
Chills	87.40	12.52	309	63384	95723	46526646
Hyperthyroidism	86.84	12.52	93	63600	11618	46610751
Weight decreased	86.36	12.52	537	63156	210312	46412057
Drug intolerance	84.15	12.52	48	63645	147001	46475368
Therapeutic product effect decreased	83.62	12.52	8	63685	82593	46539776
Product use issue	81.93	12.52	15	63678	94629	46527740
Hepatic cancer	80.27	12.52	51	63642	3046	46619323
Oesophageal varices haemorrhage	79.34	12.52	37	63656	1186	46621183
Irritability	76.75	12.52	140	63553	28806	46593563
Malignant neoplasm progression	75.48	12.52	3	63690	64923	46557446
Condition aggravated	75.41	12.52	137	63556	244915	46377454
Retinal exudates	73.48	12.52	30	63663	692	46621677
Porphyria non-acute	71.39	12.52	24	63669	313	46622056
Portal vein thrombosis	69.92	12.52	43	63650	2424	46619945
Alopecia	67.29	12.52	415	63278	161999	46460370
Cutaneous sarcoidosis	66.79	12.52	23	63670	324	46622045
Haemorrhoids	64.60	12.52	102	63591	18675	46603694
Genotype drug resistance test positive	63.41	12.52	25	63668	525	46621844
Hypersensitivity	61.07	12.52	69	63624	150252	46472117
Arthropathy	60.55	12.52	20	63673	84680	46537689
Nasopharyngitis	60.08	12.52	73	63620	153925	46468444
Product use in unapproved indication	59.99	12.52	24	63669	90249	46532120
Disease progression	59.49	12.52	25	63668	91275	46531094
Retinal haemorrhage	59.49	12.52	51	63642	4832	46617537
Sarcoidosis	59.05	12.52	52	63641	5107	46617262
Therapeutic product effect incomplete	58.47	12.52	17	63676	78136	46544233
Oxygen saturation decreased	57.67	12.52	12	63681	69152	46553217
Blood uric acid increased	57.64	12.52	47	63646	4154	46618215
Infection	55.71	12.52	60	63633	133532	46488837
Pain	55.59	12.52	402	63291	476546	46145823
Varices oesophageal	55.20	12.52	39	63654	2780	46619589
Intentional overdose	54.70	12.52	11	63682	64933	46557436
Injection site pain	54.43	12.52	40	63653	107112	46515257
Osteoarthritis	51.22	12.52	11	63682	62014	46560355
Drug eruption	50.14	12.52	98	63595	21231	46601138
Hypertension	49.31	12.52	123	63570	196233	46426136
Headache	49.10	12.52	920	62773	477432	46144937
Autoimmune thyroiditis	49.06	12.52	37	63656	2918	46619451
Virologic failure	48.73	12.52	32	63661	2023	46620346
Renal impairment	48.02	12.52	215	63478	74157	46548212
Febrile neutropenia	47.19	12.52	36	63657	94591	46527778
Drug abuse	47.05	12.52	14	63679	63394	46558975
Erythema multiforme	46.98	12.52	62	63631	9642	46612727
Pain in extremity	46.73	12.52	188	63505	258492	46363877
Hypotension	46.59	12.52	162	63531	232427	46389942
Wound	46.51	12.52	3	63690	42799	46579570
Transfusion	45.68	12.52	72	63621	13159	46609210
Exposure via body fluid	45.12	12.52	19	63674	475	46621894
Musculoskeletal stiffness	44.30	12.52	41	63652	97952	46524417
Sinusitis	44.07	12.52	68	63625	129700	46492669
Flushing	43.21	12.52	17	63676	64597	46557772
Systemic lupus erythematosus	42.21	12.52	18	63675	65162	46557207
Anger	41.62	12.52	65	63628	11787	46610582
Depressive symptom	41.61	12.52	33	63660	2803	46619566
Hypothyroidism	41.58	12.52	115	63578	31223	46591146
Basedow's disease	41.16	12.52	16	63677	323	46622046
Cardiac failure congestive	40.75	12.52	39	63654	91711	46530658
Arthralgia	39.70	12.52	313	63380	364290	46258079
Hepatic cancer recurrent	39	12.52	10	63683	45	46622324
Liver transplant rejection	38.93	12.52	24	63669	1359	46621010
Plasma cell myeloma	38.59	12.52	7	63686	44471	46577898
Cardiac arrest	38.35	12.52	40	63653	90359	46532010
Rash pruritic	38.25	12.52	140	63553	44075	46578294
Dry mouth	37.89	12.52	162	63531	54764	46567605
Blood pressure increased	37.85	12.52	72	63621	126594	46495775
Exposure via direct contact	37.79	12.52	12	63681	129	46622240
Malaise	37.77	12.52	648	63045	330584	46291785
Pulmonary embolism	37.73	12.52	56	63637	108529	46513840
Intentional product misuse	37.62	12.52	9	63684	47119	46575250
Exposure via father	37.15	12.52	15	63678	336	46622033
Toxic skin eruption	36.82	12.52	63	63630	12324	46610045
Drug ineffective	36.49	12.52	679	63014	677159	45945210
Dehydration	35.98	12.52	354	63339	159186	46463183
Hepatic fibrosis	35.91	12.52	31	63662	2964	46619405
Drug reaction with eosinophilia and systemic symptoms	35.86	12.52	105	63588	29443	46592926
Hospitalisation	35.79	12.52	21	63672	63364	46559005
Hepatorenal syndrome	35.37	12.52	25	63668	1783	46620586
Blood cholesterol increased	35.36	12.52	6	63687	40007	46582362
Electrocardiogram QT prolonged	35.16	12.52	13	63680	51312	46571057
Tongue pigmentation	35.08	12.52	8	63685	19	46622350
Type 1 diabetes mellitus	34.65	12.52	30	63663	2880	46619489
Urticaria	34.37	12.52	68	63625	117824	46504545
Mobility decreased	34.32	12.52	20	63673	60574	46561795
Osteoporosis	33.94	12.52	7	63686	40601	46581768
Exposure via partner	33.18	12.52	11	63682	137	46622232
Psoriatic arthropathy	33.17	12.52	5	63688	36374	46585995
Liver transplant	33.07	12.52	27	63666	2390	46619979
Angiotensin converting enzyme increased	32.81	12.52	9	63684	55	46622314
Yellow skin	32.41	12.52	25	63668	2039	46620330
Coronary artery disease	32.29	12.52	4	63689	33748	46588621
Injury	32.16	12.52	10	63683	44017	46578352
Therapy non-responder	32.04	12.52	126	63567	41026	46581343
Arthritis	31.91	12.52	35	63658	77281	46545088
Nasal congestion	31.61	12.52	13	63680	48100	46574269
Chronic hepatitis C	31.07	12.52	11	63682	169	46622200
C-reactive protein increased	30.89	12.52	21	63672	58569	46563800
Deep vein thrombosis	30.89	12.52	38	63655	79735	46542634
Blood pressure fluctuation	30.67	12.52	3	63690	30445	46591924
Gait disturbance	30.55	12.52	99	63594	145164	46477205
Neuropathy peripheral	30.49	12.52	48	63645	90845	46531524
Intentional product use issue	30.49	12.52	17	63676	52763	46569606
Bilirubin conjugated increased	30.49	12.52	27	63666	2671	46619698
Thyroiditis	30.43	12.52	22	63671	1626	46620743
Child-Pugh-Turcotte score increased	29.58	12.52	8	63685	46	46622323
Loss of personal independence in daily activities	29.48	12.52	21	63672	57162	46565207
Anaphylactic reaction	29.42	12.52	18	63675	53094	46569275
Ammonia increased	29.39	12.52	33	63660	4344	46618025
Aplastic anaemia	29.07	12.52	42	63651	7111	46615258
Thirst	28.98	12.52	53	63640	10923	46611446
Anorectal disorder	28.83	12.52	20	63673	1384	46620985
Psoriasis	27.83	12.52	40	63653	78564	46543805
Maternal exposure during pregnancy	27.50	12.52	62	63631	102487	46519882
Pregnancy of partner	27.21	12.52	7	63686	32	46622337
Hepatitis C virus test positive	27.21	12.52	10	63683	172	46622197
Weight increased	26.92	12.52	124	63569	164349	46458020
Paternal drugs affecting foetus	26.57	12.52	8	63685	71	46622298
Cerebrovascular accident	26.35	12.52	62	63631	100977	46521392
Blood count abnormal	26.13	12.52	68	63625	17810	46604559
Swelling	26.07	12.52	85	63608	124426	46497943
Hepatic enzyme increased	25.75	12.52	45	63648	81742	46540627
Wheezing	25.74	12.52	21	63672	53365	46569004
Disease recurrence	25.72	12.52	69	63624	18402	46603967
Impaired healing	25.69	12.52	9	63684	36734	46585635
Viral mutation identified	25.54	12.52	21	63672	1878	46620491
Chest discomfort	25.51	12.52	53	63640	90216	46532153
Encephalopathy	25.47	12.52	102	63591	33487	46588882
Chronic kidney disease	25.34	12.52	12	63681	40859	46581510
Complications of transplanted liver	25.19	12.52	12	63681	404	46621965
Face oedema	25.12	12.52	70	63623	19083	46603286
Glomerulonephritis	24.58	12.52	19	63674	1554	46620815
Myocardial infarction	24.52	12.52	61	63632	97467	46524902
Liver transplant failure	24.38	12.52	6	63687	22	46622347
Myalgia	24.35	12.52	266	63427	122822	46499547
Pain in jaw	24.20	12.52	11	63682	38361	46584008
Fluid overload	24.19	12.52	4	63689	27181	46595188
Hypersplenism	24.16	12.52	10	63683	239	46622130
Hepatitis C virus test	24.06	12.52	5	63688	6	46622363
Disturbance in attention	24.05	12.52	96	63597	31464	46590905
Maternal exposure before pregnancy	23.84	12.52	30	63663	4451	46617918
Haemolysis	23.78	12.52	35	63658	6024	46616345
Ocular icterus	23.69	12.52	27	63666	3613	46618756
Urate nephropathy	23.28	12.52	8	63685	112	46622257
Rash papular	23.04	12.52	53	63640	12845	46609524
Injection site rash	22.96	12.52	60	63633	15753	46606616
Serotonin syndrome	22.85	12.52	3	63690	24217	46598152
Erythema nodosum	22.82	12.52	27	63666	3759	46618610
Intentional self-injury	22.79	12.52	3	63690	24163	46598206
Muscular weakness	22.66	12.52	58	63635	91786	46530583
Respiratory arrest	22.44	12.52	9	63684	33807	46588562
Splenomegaly	22.14	12.52	44	63649	9644	46612725
Surgery	22.01	12.52	6	63687	28779	46593590
Pancreas transplant rejection	21.80	12.52	8	63685	137	46622232
Bronchitis	21.74	12.52	73	63620	105906	46516463
Extradural abscess	21.35	12.52	13	63680	720	46621649
Paraesthesia	20.75	12.52	86	63607	117351	46505018
Emotional distress	20.66	12.52	8	63685	30699	46591670
Peritonitis bacterial	20.63	12.52	40	63653	8613	46613756
Injection site swelling	20.54	12.52	15	63678	40312	46582057
Pneumonia	20.44	12.52	376	63317	375944	46246425
Sleep apnoea syndrome	20.36	12.52	3	63690	22198	46600171
Blood pressure systolic increased	20.21	12.52	7	63686	28780	46593589
Subarachnoid haemorrhage	20.11	12.52	46	63647	11107	46611262
Pneumonia aspiration	20.03	12.52	9	63684	31596	46590773
Mood swings	19.96	12.52	58	63635	16194	46606175
Clostridium difficile infection	19.63	12.52	5	63688	25098	46597271
Memory impairment	19.61	12.52	176	63517	77161	46545208
Constipation	19.57	12.52	148	63545	173949	46448420
Aplasia pure red cell	19.49	12.52	27	63666	4398	46617971
Multiple sclerosis	19.27	12.52	5	63688	24786	46597583
Oral mucosal blistering	18.97	12.52	28	63665	4832	46617537
Alcoholism	18.94	12.52	19	63674	2199	46620170
Cardio-respiratory arrest	18.79	12.52	33	63660	59836	46562533
Feeling cold	18.44	12.52	62	63631	18709	46603660
Lymphocyte count decreased	18.35	12.52	6	63687	25583	46596786
Breast cancer	18.34	12.52	21	63672	45497	46576872
Upper respiratory tract infection	18.22	12.52	37	63656	63519	46558850
Herpes zoster	18.22	12.52	41	63652	67831	46554538
Atrial fibrillation	18.21	12.52	76	63617	103514	46518855
Inflammation	18.09	12.52	24	63669	48757	46573612
Hepatic hydrothorax	18.03	12.52	5	63688	32	46622337
Ocular sarcoidosis	18.03	12.52	5	63688	32	46622337
Skin disorder	18.00	12.52	69	63624	22194	46600175
Anaphylactic shock	18	12.52	3	63690	20271	46602098
Hepatorenal failure	17.97	12.52	11	63682	615	46621754
Hemiparesis	17.75	12.52	3	63690	20066	46602303
Hypoxia	17.74	12.52	27	63666	51811	46570558
Product prescribing error	17.72	12.52	3	63690	20044	46602325
Device issue	17.64	12.52	3	63690	19977	46602392
Lower respiratory tract infection	17.62	12.52	30	63663	55059	46567310
Viral load decreased	17.52	12.52	5	63688	36	46622333
Crying	17.49	12.52	66	63627	21075	46601294
Haematocrit decreased	17.36	12.52	94	63599	34963	46587406
Abdominal discomfort	17.23	12.52	128	63565	151037	46471332
Overdose	17.21	12.52	76	63617	101903	46520466
Rhinorrhoea	17.12	12.52	24	63669	47641	46574728
Hypoglycaemia	17.02	12.52	30	63663	54319	46568050
Liver function test increased	17.00	12.52	5	63688	22821	46599548
Hepatitis B	16.97	12.52	23	63670	3670	46618699
Hepatopulmonary syndrome	16.87	12.52	4	63689	12	46622357
Mucosal inflammation	16.80	12.52	17	63676	38959	46583410
Hepatitis virus-associated nephropathy	16.80	12.52	3	63690	0	46622369
Miscarriage of partner	16.80	12.52	3	63690	0	46622369
Hashitoxicosis	16.80	12.52	3	63690	0	46622369
Retinal detachment	16.57	12.52	27	63666	5073	46617296
Alanine aminotransferase increased	16.51	12.52	189	63504	88262	46534107
Gastric varices haemorrhage	16.50	12.52	6	63687	100	46622269
Respiratory failure	16.40	12.52	70	63623	94746	46527623
Eczema	16.31	12.52	63	63630	20337	46602032
Anti-erythropoietin antibody positive	16.26	12.52	9	63684	416	46621953
Asthma	16.19	12.52	67	63626	91475	46530894
Rheumatoid factor positive	16.15	12.52	4	63689	20457	46601912
Premature delivery	16.14	12.52	5	63688	22064	46600305
Emotional disorder	16.12	12.52	45	63648	12279	46610090
Femur fracture	16.10	12.52	16	63677	36981	46585388
Immune thrombocytopenia	15.99	12.52	35	63658	8206	46614163
Blood disorder	15.91	12.52	28	63665	5599	46616770
Dermatitis	15.83	12.52	49	63644	14159	46608210
Somnolence	15.78	12.52	137	63556	156384	46465985
Drug withdrawal syndrome	15.56	12.52	9	63684	27375	46594994
Retinal disorder	15.29	12.52	14	63679	1447	46620922
Adverse drug reaction	15.28	12.52	23	63670	44339	46578030
Injection site eczema	15.25	12.52	4	63689	20	46622349
Limb discomfort	15.21	12.52	6	63687	22770	46599599
Suicidal ideation	15.16	12.52	130	63563	56252	46566117
Chromaturia	15.10	12.52	50	63643	14969	46607400
Coma	15.05	12.52	36	63657	58313	46564056
Hair texture abnormal	15.00	12.52	19	63674	2837	46619532
Thrombosis	14.94	12.52	34	63659	56035	46566334
VIIIth nerve lesion	14.79	12.52	4	63689	23	46622346
Congenital tongue anomaly	14.72	12.52	3	63690	3	46622366
Hepatitis C RNULL decreased	14.72	12.52	3	63690	3	46622366
Blood bilirubin abnormal	14.67	12.52	10	63683	673	46621696
Metastases to bone	14.63	12.52	3	63690	17473	46604896
Mental disorder	14.59	12.52	65	63628	22360	46600009
Musculoskeletal pain	14.58	12.52	48	63645	70080	46552289
Neoplasm malignant	14.41	12.52	7	63686	23492	46598877
Throat irritation	14.39	12.52	11	63682	28890	46593479
Bleeding varicose vein	14.34	12.52	7	63686	249	46622120
Guillain-Barre syndrome	14.23	12.52	20	63673	3302	46619067
Blood bilirubin unconjugated increased	14.22	12.52	8	63685	382	46621987
Influenza	14.18	12.52	68	63625	89202	46533167
Paranoia	14.16	12.52	39	63654	10558	46611811
Rhinocerebral mucormycosis	14.14	12.52	6	63687	153	46622216
Unresponsive to stimuli	13.90	12.52	14	63679	32160	46590209
Osteonecrosis	13.87	12.52	9	63684	25735	46596634
Bone disorder	13.84	12.52	5	63688	20028	46602341
Overgrowth fungal	13.77	12.52	5	63688	83	46622286
Hepatocellular injury	13.75	12.52	12	63681	29510	46592859
Stomatitis	13.68	12.52	148	63545	68149	46554220
Bursitis	13.63	12.52	5	63688	19837	46602532
Cerebral arteriovenous malformation haemorrhagic	13.51	12.52	3	63690	6	46622363
Bronchopulmonary disease	13.51	12.52	3	63690	6	46622363
Oral lichen planus	13.51	12.52	8	63685	421	46621948
Acute respiratory failure	13.39	12.52	12	63681	29126	46593243
Bradycardia	13.36	12.52	46	63647	66252	46556117
Metastases to liver	13.34	12.52	5	63688	19580	46602789
Infection reactivation	13.28	12.52	10	63683	787	46621582
Localised infection	13.27	12.52	8	63685	23793	46598576
Facial paralysis	13.22	12.52	44	63649	13206	46609163
Alopecia universalis	13.19	12.52	5	63688	94	46622275
Pulmonary hypertension	13.05	12.52	18	63675	35975	46586394
Angioedema	12.98	12.52	21	63672	39321	46583048
Non-neutralising antibodies positive	12.91	12.52	3	63690	8	46622361
Aspartate aminotransferase increased	12.86	12.52	164	63529	78536	46543833
Gingival bleeding	12.84	12.52	40	63653	11599	46610770
Hypophagia	12.81	12.52	76	63617	29230	46593139
Joint stiffness	12.65	12.52	11	63682	27097	46595272
Rib fracture	12.65	12.52	5	63688	18949	46603420
Gastroenteritis rotavirus	12.64	12.52	5	63688	106	46622263
Hepatitis cholestatic	12.55	12.52	28	63665	6649	46615720
Hepatic neoplasm	12.55	12.52	14	63679	1830	46620539
Myelodysplastic syndrome	12.54	12.52	3	63690	15708	46606661
Bronchospasm	12.53	12.52	3	63690	15704	46606665

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
Hepatitis C	3246.40	11.71	1264	82591	11941	29856682
Anaemia	2378.94	11.71	2905	80950	205087	29663536
Hepatocellular carcinoma	1500.55	11.71	666	83189	8944	29859679
Rash	995.26	11.71	1858	81997	190031	29678592
White blood cell count decreased	732.28	11.71	1031	82824	82916	29785707
Fatigue	681.75	11.71	2202	81653	318471	29550152
Hepatic cirrhosis	666.62	11.71	464	83391	15535	29853088
Haemoglobin decreased	603.32	11.71	1116	82739	112982	29755641
Influenza like illness	542.01	11.71	499	83356	25106	29843517
Pruritus	525.80	11.71	1075	82780	117129	29751494
Ascites	515.53	11.71	567	83288	35354	29833269
Treatment failure	507.41	11.71	553	83302	34126	29834497
Platelet count decreased	427.26	11.71	927	82928	105202	29763421
Insomnia	421.95	11.71	855	83000	92481	29776142
Hepatic encephalopathy	391.96	11.71	322	83533	13870	29854753
Blood bilirubin increased	370.40	11.71	484	83371	36152	29832471
Anorectal discomfort	362.81	11.71	150	83705	1667	29866956
Depression	355.88	11.71	783	83072	89654	29778969
Genotype drug resistance test positive	343.98	11.71	139	83716	1450	29867173
Retinopathy	338.38	11.71	147	83708	1863	29866760
Anal pruritus	313.71	11.71	94	83761	351	29868272
Death	311.51	11.71	326	83529	356957	29511666
Neutrophil count decreased	301.30	11.71	474	83381	41980	29826643
Dysgeusia	300.76	11.71	359	83496	24442	29844181
Toxicity to various agents	286.16	11.71	72	83783	177111	29691512
Irritability	285.02	11.71	337	83518	22713	29845910
Hepatic failure	273.93	11.71	403	83452	33640	29834983
Hepatic cancer	272.80	11.71	190	83665	6358	29862265
Hyperbilirubinaemia	249.04	11.71	271	83584	16671	29851952
Liver transplant	240.13	11.71	129	83726	2673	29865950
Hyperuricaemia	232.33	11.71	181	83674	7213	29861410
Jaundice	223.92	11.71	358	83497	32128	29836495
Oesophageal varices haemorrhage	219.04	11.71	125	83730	2926	29865697
Headache	209.49	11.71	1036	82819	181270	29687353
Decreased appetite	203.84	11.71	895	82960	149015	29719608
Viral load increased	199.73	11.71	115	83740	2739	29865884
Hypotension	182.21	11.71	176	83679	200389	29668234
Nausea	181.31	11.71	1434	82421	295523	29573100
Febrile neutropenia	174.70	11.71	42	83813	106651	29761972
Malignant neoplasm progression	172.05	11.71	7	83848	72280	29796343
Leukopenia	171.54	11.71	441	83414	55718	29812905
Drug abuse	158.79	11.71	21	83834	82051	29786572
Retinal exudates	149.37	11.71	61	83794	655	29867968
Proctalgia	148.25	11.71	112	83743	4260	29864363
Completed suicide	148.23	11.71	47	83808	99445	29769178
Hepatitis C RNULL positive	146.38	11.71	45	83810	187	29868436
Fall	143.70	11.71	179	83676	181693	29686930
Dry skin	136.60	11.71	234	83621	22220	29846403
Hepatitis C RNULL increased	132.37	11.71	47	83808	331	29868292
Cardiac failure congestive	127.28	11.71	39	83816	84368	29784255
Plasma cell myeloma	124.50	11.71	6	83849	53456	29815167
Drug ineffective	123.95	11.71	1475	82380	338912	29529711
Virologic failure	123.87	11.71	89	83766	3130	29865493
Hepatitis E	120.21	11.71	68	83787	1564	29867059
Haemorrhoids	118.85	11.71	158	83697	11983	29856640
Haemolytic anaemia	118.16	11.71	143	83712	9867	29858756
Acute kidney injury	115.96	11.71	387	83468	273455	29595168
Disease progression	114.98	11.71	40	83815	79834	29788789
Viral mutation identified	106.57	11.71	75	83780	2551	29866072
Varices oesophageal	106.12	11.71	84	83771	3425	29865198
Red blood cell count decreased	103.36	11.71	228	83627	26093	29842530
Porphyria non-acute	103.09	11.71	42	83813	448	29868175
Drug hypersensitivity	102.67	11.71	32	83823	68487	29800136
Mood swings	101.74	11.71	116	83739	7510	29861113
Cryoglobulinaemia	101.24	11.71	37	83818	286	29868337
Infusion related reaction	99.74	11.71	3	83852	40561	29828062
Product use in unapproved indication	94.48	11.71	44	83811	73649	29794974
Rash pruritic	93.73	11.71	200	83655	22372	29846251
Hepatic cancer recurrent	93.16	11.71	36	83819	330	29868293
Pneumonia	89.68	11.71	559	83296	333747	29534876
Pancytopenia	89.40	11.71	472	83383	84580	29784043
Myocardial infarction	88.68	11.71	134	83721	125491	29743132
Retinal haemorrhage	86.11	11.71	85	83770	4658	29863965
Chronic hepatitis C	85.57	11.71	37	83818	463	29868160
Weight decreased	84.69	11.71	716	83139	150205	29718418
Depressed mood	83.91	11.71	162	83693	16867	29851756
Oxygen saturation decreased	81.90	11.71	12	83843	43428	29825195
Drug eruption	80.64	11.71	162	83693	17364	29851259
Vogt-Koyanagi-Harada disease	79.98	11.71	22	83833	55	29868568
Injection site rash	78.76	11.71	71	83784	3468	29865155
Atrial fibrillation	78.57	11.71	113	83742	108011	29760612
Blood pressure increased	73.83	11.71	56	83799	71872	29796751
Coronary artery disease	73.07	11.71	24	83831	49688	29818935
Thrombocytopenia	72.58	11.71	642	83213	136402	29732221
Cardiac arrest	71.52	11.71	93	83762	92757	29775866
Hepatic hydrothorax	71.44	11.71	18	83837	27	29868596
Portal hypertension	71.41	11.71	70	83785	3803	29864820
Asthenia	71.22	11.71	938	82917	220352	29648271
Erythema multiforme	70.71	11.71	99	83756	7886	29860737
Hepatorenal syndrome	69.34	11.71	57	83798	2454	29866169
Blood uric acid increased	67.77	11.71	84	83771	5939	29862684
Electrocardiogram QT prolonged	67.31	11.71	10	83845	35825	29832798
Rheumatoid arthritis	65.84	11.71	17	83838	41180	29827443
Portal vein thrombosis	64.60	11.71	63	83792	3401	29865222
Renal impairment	64.47	11.71	430	83425	83754	29784869
Hyperkalaemia	64.47	11.71	54	83801	65956	29802667
Mucosal inflammation	63.48	11.71	6	83849	30488	29838135
Hypertension	63.31	11.71	155	83700	121199	29747424
Intentional overdose	62.79	11.71	19	83836	41462	29827161
Hepatitis C virus test positive	62.79	11.71	29	83826	428	29868195
Hospitalisation	62.37	11.71	23	83832	44296	29824327
Cardio-respiratory arrest	62.23	11.71	42	83813	57264	29811359
Intentional product misuse	62.15	11.71	11	83844	34656	29833967
Injection site erythema	61.41	11.71	126	83729	13708	29854915
Foetal exposure during pregnancy	61.30	11.71	14	83841	36857	29831766
Hepatitis B reactivation	60.66	11.71	56	83799	2821	29865802
Tachycardia	59.77	11.71	71	83784	73668	29794955
Therapy non-responder	59.75	11.71	200	83655	29253	29839370
Bradycardia	58.76	11.71	58	83797	65468	29803155
Anger	56.27	11.71	107	83748	11013	29857610
Off label use	55.33	11.71	440	83415	248850	29619773
Respiratory failure	55.31	11.71	125	83730	100517	29768106
General physical health deterioration	54.23	11.71	125	83730	99819	29768804
Therapeutic product effect incomplete	53.99	11.71	14	83841	33820	29834803
Peripheral swelling	53.68	11.71	55	83800	61019	29807604
Flushing	53.65	11.71	9	83846	29483	29839140
Peritonitis bacterial	53.33	11.71	106	83749	11272	29857351
Suicidal ideation	51.46	11.71	219	83636	35895	29832728
Weight increased	50.82	11.71	82	83773	74831	29793792
Liver transplant rejection	50.70	11.71	45	83810	2153	29866470
Cerebrovascular accident	48.92	11.71	100	83755	83377	29785246
Hypoxia	48.15	11.71	38	83817	47816	29820807
Pneumonia aspiration	47.72	11.71	23	83832	37757	29830866
Dry mouth	47.08	11.71	156	83699	22694	29845929
Hepatitis C RNULL	46.14	11.71	12	83843	22	29868601
Hepatic pain	45.67	11.71	34	83821	1264	29867359
C-reactive protein increased	44.39	11.71	34	83821	43439	29825184
Neuropathy peripheral	44.27	11.71	81	83774	70394	29798229
Asthma	44.22	11.71	23	83832	36151	29832472
Anaphylactic reaction	43.85	11.71	12	83843	27970	29840653
Pregnancy of partner	43.81	11.71	20	83835	287	29868336
Chronic obstructive pulmonary disease	43.49	11.71	39	83816	46087	29822536
Alopecia	42.80	11.71	135	83720	19140	29849483
Cardiac failure	41.57	11.71	109	83746	83309	29785314
Pulmonary embolism	41.35	11.71	99	83756	78036	29790587
Gastric varices haemorrhage	40.74	11.71	18	83837	238	29868385
Bleeding varicose vein	40.62	11.71	19	83836	289	29868334
Osteonecrosis of jaw	40.57	11.71	3	83852	18615	29850008
Angioedema	40.37	11.71	23	83832	34361	29834262
Neutropenia	40.04	11.71	542	83313	127998	29740625
Prostate cancer	40.01	11.71	9	83846	23948	29844675
Hypersensitivity	39.67	11.71	56	83799	53972	29814651
Focal segmental glomerulosclerosis	39.37	11.71	36	83819	1791	29866832
Hypoglycaemia	39.29	11.71	51	83804	50930	29817693
Intentional product use issue	39.16	11.71	27	83828	36413	29832210
Blood bilirubin unconjugated increased	38.53	11.71	24	83831	662	29867961
Cardiac disorder	37.28	11.71	34	83821	39859	29828764
Malaise	37.10	11.71	665	83190	166297	29702326
Yellow skin	37.05	11.71	37	83818	2056	29866567
Condition aggravated	36.53	11.71	231	83624	137635	29730988
Wrong technique in product usage process	36.35	11.71	21	83834	31134	29837489
Therapeutic product effect decreased	36.26	11.71	18	83837	29058	29839565
Skin disorder	36.26	11.71	92	83763	11516	29857107
Gastrointestinal haemorrhage	35.79	11.71	117	83738	83329	29785294
Hyponatraemia	35.67	11.71	85	83770	67117	29801506
Blood pressure fluctuation	34.99	11.71	4	83851	17499	29851124
Abortion spontaneous	34.47	11.71	11	83844	53	29868570
Neuroleptic malignant syndrome	34.47	11.71	3	83852	16292	29852331
Contraindicated product administered	34.29	11.71	4	83851	17227	29851396
Hepatic fibrosis	34.13	11.71	46	83809	3534	29865089
Encephalopathy	33.96	11.71	179	83676	32026	29836597
Facial paralysis	33.91	11.71	81	83774	9762	29858861
Respiratory arrest	33.74	11.71	20	83835	29238	29839385
COVID-19	33.55	11.71	5	83850	17873	29850750
Viral load	33.38	11.71	12	83843	88	29868535
Basedow's disease	33.20	11.71	11	83844	61	29868562
Disturbance in attention	32.92	11.71	136	83719	21993	29846630
Rhabdomyolysis	32.50	11.71	82	83773	63498	29805125
Haematuria	32.39	11.71	47	83808	44787	29823836
Hepatitis C virus test	32.33	11.71	11	83844	67	29868556
Arthropathy	32.27	11.71	9	83846	20718	29847905
Pain in extremity	32.20	11.71	179	83676	110042	29758581
Joint swelling	32.19	11.71	51	83804	46895	29821728
Sedation	32.09	11.71	4	83851	16369	29852254
Alopecia universalis	31.89	11.71	10	83845	45	29868578
Pulmonary oedema	31.86	11.71	46	83809	43929	29824694
Muscular weakness	31.83	11.71	83	83772	63562	29805061
Hepatitis C RNULL fluctuation	31.68	11.71	7	83848	3	29868620
International normalised ratio increased	31.67	11.71	53	83802	47686	29820937
Pneumocystis jirovecii pneumonia	31.64	11.71	5	83850	17115	29851508
Mental disorder	31.53	11.71	96	83759	13353	29855270
Acute myocardial infarction	31.36	11.71	63	83792	52876	29815747
Affect lability	31.19	11.71	43	83812	3375	29865248
Drug reaction with eosinophilia and systemic symptoms	31.19	11.71	160	83695	28328	29840295
Haemolysis	31.08	11.71	65	83790	7166	29861457
Sarcoidosis	30.60	11.71	38	83817	2691	29865932
Clostridium difficile infection	30.59	11.71	4	83851	15779	29852844
Wheezing	30.57	11.71	25	83830	30913	29837710
Biliary colic	30.28	11.71	24	83831	980	29867643
Transfusion	29.69	11.71	65	83790	7396	29861227
Child-Pugh-Turcotte score increased	29.66	11.71	10	83845	59	29868564
Blood pressure decreased	29.65	11.71	54	83801	47021	29821602
Vomiting	29.59	11.71	815	83040	219003	29649620
Optic ischaemic neuropathy	29.41	11.71	32	83823	1966	29866657
Myalgia	29.31	11.71	336	83519	76331	29792292
Injection site reaction	29.26	11.71	81	83774	10679	29857944
Device related infection	29.22	11.71	6	83849	17009	29851614
Eczema	29.09	11.71	93	83762	13276	29855347
Cardiogenic shock	28.84	11.71	6	83849	16855	29851768
Mood altered	28.54	11.71	68	83787	8182	29860441
Constipation	28.47	11.71	192	83663	112714	29755909
Injection site ulcer	28.12	11.71	14	83841	246	29868377
Sepsis	28.12	11.71	268	83587	146127	29722496
Glomerulonephritis membranoproliferative	27.82	11.71	16	83839	380	29868243
Heart rate decreased	27.72	11.71	12	83843	20982	29847641
Acute myeloid leukaemia	27.69	11.71	8	83847	17998	29850625
Injection site pruritus	27.30	11.71	53	83802	5539	29863084
Blood cholesterol increased	27.11	11.71	7	83848	16963	29851660
Hypocalcaemia	27.01	11.71	13	83842	21363	29847260
Anorectal disorder	26.96	11.71	22	83833	937	29867686
Basal cell carcinoma	26.91	11.71	6	83849	16062	29852561
Orthostatic hypotension	26.80	11.71	17	83838	23962	29844661
Pyrexia	26.75	11.71	1042	82813	293447	29575176
Acute on chronic liver failure	26.62	11.71	11	83844	122	29868501
Seizure	26.58	11.71	164	83691	98311	29770312
Product prescribing error	26.55	11.71	7	83848	16726	29851897
Metabolic acidosis	26.35	11.71	40	83815	37421	29831202
Exposure via body fluid	26.33	11.71	10	83845	87	29868536
Urinary retention	26.33	11.71	32	83823	32885	29835738
Retinal detachment	25.98	11.71	49	83806	5011	29863612
Ocular icterus	25.67	11.71	37	83818	3027	29865596
Homicidal ideation	25.57	11.71	33	83822	2430	29866193
Chills	25.43	11.71	312	83543	72026	29796597
Ventricular tachycardia	25.21	11.71	18	83837	23844	29844779
Psychotic disorder	25.07	11.71	123	83732	21392	29847231
Sleep apnoea syndrome	25.00	11.71	8	83847	16849	29851774
Bilirubin conjugated increased	24.54	11.71	38	83817	3313	29865310
Therapeutic embolisation	24.51	11.71	14	83841	328	29868295
Psoriatic arthropathy	24.25	11.71	7	83848	15754	29852869
Ammonia increased	24.22	11.71	43	83812	4198	29864425
Somnolence	24.16	11.71	165	83690	96598	29772025
Depressed level of consciousness	23.93	11.71	44	83811	38178	29830445
Chronic hepatitis	23.85	11.71	17	83838	590	29868033
Pregnancy	23.85	11.71	12	83843	216	29868407
Musculoskeletal stiffness	23.64	11.71	40	83815	35841	29832782
Nasopharyngitis	23.54	11.71	85	83770	58764	29809859
Fluid overload	23.53	11.71	12	83843	19080	29849543
Renal disorder	23.45	11.71	129	83726	23455	29845168
Disease recurrence	23.45	11.71	90	83765	14071	29854552
Respiratory distress	23.39	11.71	35	83820	32937	29835686
Mobility decreased	23.31	11.71	23	83832	25976	29842647
Complications of transplanted liver	23.22	11.71	12	83843	229	29868394
Coma hepatic	23.18	11.71	15	83840	443	29868180
Herpes zoster	23.02	11.71	30	83825	29913	29838710
Genital herpes simplex	22.92	11.71	10	83845	128	29868495
Pleural effusion	22.88	11.71	118	83737	73948	29794675
Overdose	22.47	11.71	141	83714	84196	29784427
Exposure via direct contact	22.41	11.71	7	83848	31	29868592
Mitral valve incompetence	22.04	11.71	5	83850	13229	29855394
Osteoarthritis	21.93	11.71	12	83843	18337	29850286
Poisoning	21.78	11.71	3	83852	11379	29857244
Type 1 diabetes mellitus	21.76	11.71	38	83817	3661	29864962
Acute stress disorder	21.75	11.71	10	83845	146	29868477
Heart rate irregular	21.73	11.71	4	83851	12255	29856368
Testicular germ cell tumour mixed	21.56	11.71	7	83848	36	29868587
Product use issue	21.51	11.71	62	83793	45954	29822669
Myelodysplastic syndrome	21.42	11.71	13	83842	18765	29849858
Alpha 1 foetoprotein increased	21.37	11.71	17	83838	698	29867925
Haemophilic arthropathy	21.33	11.71	10	83845	153	29868470
Thrombosis	21.16	11.71	55	83800	42176	29826447
Ejection fraction decreased	21.13	11.71	8	83847	15167	29853456
Ventricular fibrillation	21.05	11.71	8	83847	15130	29853493
Hepatic neoplasm	21.03	11.71	26	83829	1833	29866790
Autoimmune hepatitis	21.00	11.71	37	83818	3590	29865033
Emotional disorder	20.98	11.71	45	83810	5049	29863574
Acute respiratory failure	20.81	11.71	25	83830	25825	29842798
Upper respiratory tract infection	20.64	11.71	28	83827	27448	29841175
Deafness congenital	20.53	11.71	7	83848	43	29868580
Circulatory collapse	20.39	11.71	16	83839	20198	29848425
Angina pectoris	20.29	11.71	32	83823	29486	29839137
Anticoagulation drug level below therapeutic	20.28	11.71	16	83839	649	29867974
Ammonia abnormal	20.18	11.71	8	83847	79	29868544
Diverticulitis	20.00	11.71	12	83843	17433	29851190
Hyperlipidaemia	19.93	11.71	7	83848	13900	29854723
Urticaria	19.83	11.71	82	83773	54524	29814099
Premature baby	19.83	11.71	11	83844	16680	29851943
Normal newborn	19.82	11.71	10	83845	181	29868442
Toxic epidermal necrolysis	19.66	11.71	13	83842	17927	29850696
Labelled drug-drug interaction medication error	19.65	11.71	3	83852	10535	29858088
Porphyria	19.63	11.71	7	83848	50	29868573
Tubulointerstitial nephritis	19.56	11.71	13	83842	17878	29850745
Memory impairment	19.53	11.71	174	83681	37000	29831623
Fat intolerance	19.52	11.71	4	83851	0	29868623
Emotional distress	19.30	11.71	10	83845	15755	29852868
Facial paresis	19.06	11.71	31	83824	2819	29865804
Liver transplant failure	19.02	11.71	8	83847	93	29868530
Photophobia	19.01	11.71	47	83808	5789	29862834
Sudden visual loss	18.94	11.71	5	83850	10	29868613
Hip fracture	18.94	11.71	4	83851	11120	29857503
Ischaemic stroke	18.94	11.71	11	83844	16264	29852359
Squamous cell carcinoma	18.93	11.71	3	83852	10247	29858376
Palmar-plantar erythrodysaesthesia syndrome	18.85	11.71	9	83846	14861	29853762
Dyskinesia	18.79	11.71	20	83835	21814	29846809
Osteonecrosis	18.64	11.71	11	83844	16124	29852499
Sinusitis	18.63	11.71	41	83814	33304	29835319
Hydrocholecystis	18.62	11.71	10	83845	207	29868416
Sopor	18.61	11.71	4	83851	10987	29857636
Coma	18.54	11.71	55	83800	40394	29828229
Anaphylactic shock	18.47	11.71	8	83847	13985	29854638
Parosmia	18.47	11.71	21	83834	1355	29867268
Drug interaction	18.40	11.71	422	83433	199146	29669477
Diabetic hyperglycaemic coma	18.30	11.71	6	83849	32	29868591
Neurotoxicity	18.27	11.71	7	83848	13175	29855448
Lethargy	18.27	11.71	180	83675	39339	29829284
Asterixis	18.25	11.71	20	83835	1239	29867384
Hepatic lesion	18.17	11.71	32	83823	3104	29865519
Cutaneous sarcoidosis	17.83	11.71	8	83847	110	29868513
Unresponsive to stimuli	17.82	11.71	29	83826	26390	29842233
Synovitis	17.76	11.71	3	83852	9780	29858843
Gastric varices	17.75	11.71	12	83843	382	29868241
Mitochondrial toxicity	17.71	11.71	28	83827	2486	29866137
Chronic kidney disease	17.67	11.71	51	83804	37787	29830836
Oral lichen planus	17.59	11.71	9	83846	168	29868455
Feeling cold	17.46	11.71	62	83793	9337	29859286
Interstitial lung disease	17.43	11.71	98	83757	60099	29808524
Toxic skin eruption	17.42	11.71	69	83786	10946	29857677
Bronchitis	17.36	11.71	54	83801	39071	29829552
Bacterascites	17.29	11.71	4	83851	3	29868620
Thought blocking	17.09	11.71	8	83847	122	29868501
Optic neuropathy	16.97	11.71	22	83833	1627	29866996
Blood iron increased	16.81	11.71	16	83839	838	29867785
Pityriasis	16.76	11.71	4	83851	4	29868619
Chest discomfort	16.69	11.71	68	83787	45412	29823211
Liver disorder	16.59	11.71	141	83714	29581	29839042
Paraesthesia	16.52	11.71	87	83768	54240	29814383
Photosensitivity reaction	16.37	11.71	62	83793	9632	29858991
Injection site pain	16.34	11.71	38	83817	30272	29838351
Papilloedema	16.26	11.71	26	83829	2330	29866293
Alpha 1 foetoprotein abnormal	16.22	11.71	5	83850	21	29868602
Portal hypertensive gastropathy	16.21	11.71	13	83842	540	29868083
Intestinal obstruction	16.09	11.71	18	83837	19194	29849429
Dysphagia	16.04	11.71	93	83762	56605	29812018
Blood disorder	16.04	11.71	30	83825	3049	29865574
Neutropenic sepsis	15.91	11.71	6	83849	11403	29857220
Peritonitis	15.84	11.71	22	83833	21353	29847270
Thirst	15.72	11.71	49	83806	6900	29861723
Mouth ulceration	15.62	11.71	65	83790	10544	29858079
Haemorrhoidal haemorrhage	15.55	11.71	30	83825	3120	29865503
Alanine aminotransferase increased	15.46	11.71	293	83562	73983	29794640
Injection site necrosis	15.30	11.71	11	83844	387	29868236
Bronchospasm	15.17	11.71	5	83850	10333	29858290
Oesophageal variceal ligation	15.16	11.71	6	83849	59	29868564
Fundoscopy abnormal	15.15	11.71	4	83851	8	29868615
Status epilepticus	15.15	11.71	6	83849	11066	29857557
Pneumonitis	15.14	11.71	34	83821	27420	29841203
Feeling abnormal	15.12	11.71	233	83622	56523	29812100
Productive cough	15.01	11.71	39	83816	29914	29838709
Liver function test abnormal	14.98	11.71	41	83814	30909	29837714
Sudden hearing loss	14.94	11.71	15	83840	839	29867784
Tachypnoea	14.87	11.71	12	83843	14940	29853683
Injection site dermatitis	14.84	11.71	4	83851	9	29868614
White blood cell count increased	14.76	11.71	59	83796	39614	29829009
Hallucination, visual	14.74	11.71	14	83841	16099	29852524
Gait disturbance	14.72	11.71	136	83719	74641	29793982
Viral load undetectable	14.64	11.71	3	83852	0	29868623
Hepatocellular injury	14.49	11.71	31	83824	25440	29843183
Haematemesis	14.47	11.71	124	83731	26079	29842544
Ventricular extrasystoles	14.46	11.71	7	83848	11467	29857156
Exposure during pregnancy	14.45	11.71	4	83851	9257	29859366
Nephritic syndrome	14.40	11.71	6	83849	68	29868555
Extrapyramidal disorder	14.30	11.71	6	83849	10687	29857936
Therapy responder	14.22	11.71	8	83847	182	29868441
Infective spondylitis	14.22	11.71	8	83847	182	29868441
Hepatic amoebiasis	14.17	11.71	6	83849	71	29868552
Retinal vein thrombosis	14.11	11.71	10	83845	344	29868279
Infection	14.10	11.71	145	83710	77929	29790694
Remission not achieved	14.10	11.71	6	83849	72	29868551
Cholelithiasis	14.09	11.71	101	83754	20124	29848499
Myopathy	14.06	11.71	6	83849	10580	29858043
Blood creatine phosphokinase increased	14.02	11.71	69	83786	43779	29824844
Unevaluable event	14.01	11.71	44	83811	31741	29836882
Depressive symptom	13.98	11.71	20	83835	1625	29866998
Blood pressure systolic increased	13.97	11.71	13	83842	15097	29853526
Limb discomfort	13.96	11.71	4	83851	9046	29859577
Impaired work ability	13.90	11.71	41	83814	5602	29863021
Ear injury	13.87	11.71	5	83850	37	29868586
Nasal congestion	13.86	11.71	19	83836	18547	29850076
Hypokalaemia	13.84	11.71	83	83772	50109	29818514
Pseudomonas infection	13.82	11.71	6	83849	10476	29858147
Product quality issue	13.80	11.71	95	83760	18679	29849944
Adrenal insufficiency	13.78	11.71	6	83849	10457	29858166
Generalised tonic-clonic seizure	13.62	11.71	21	83834	19530	29849093
Injury	13.61	11.71	25	83830	21706	29846917
Respiratory tract infection	13.57	11.71	14	83841	15492	29853131
Lung disorder	13.56	11.71	44	83811	31425	29837198
Atrial flutter	13.54	11.71	12	83843	14269	29854354
Delirium	13.54	11.71	63	83792	40568	29828055
Neoplasm malignant	13.54	11.71	18	83837	17796	29850827
Failure to thrive	13.50	11.71	3	83852	8051	29860572
Drug level increased	13.49	11.71	19	83836	18335	29850288
Fungal infection	13.42	11.71	11	83844	13589	29855034
Hypomagnesaemia	13.42	11.71	16	83839	16582	29852041
Neutralising antibodies positive	13.40	11.71	6	83849	82	29868541
Borderline personality disorder	13.36	11.71	10	83845	375	29868248
Cytomegalovirus infection	13.32	11.71	29	83826	23645	29844978
Nephrotic syndrome	13.29	11.71	46	83809	6839	29861784
Skin cancer	13.27	11.71	3	83852	7958	29860665
Mental status changes	13.26	11.71	56	83799	37023	29831600
Gallbladder cancer	13.23	11.71	8	83847	209	29868414
Urinary tract infection	13.22	11.71	137	83718	73522	29795101
Post procedural haemorrhage	13.15	11.71	3	83852	7907	29860716
Drug withdrawal syndrome	13.12	11.71	22	83833	19787	29848836
Left ventricular dysfunction	13.11	11.71	4	83851	8687	29859936
Clostridium difficile colitis	13.01	11.71	10	83845	12758	29855865
Urinary incontinence	12.99	11.71	17	83838	16923	29851700
Tongue ulceration	12.96	11.71	16	83839	1126	29867497
Decubitus ulcer	12.86	11.71	3	83852	7785	29860838
Incorrect route of product administration	12.67	11.71	8	83847	11307	29857316
Myocardial ischaemia	12.65	11.71	18	83837	17299	29851324
Anti-erythropoietin antibody positive	12.62	11.71	14	83841	879	29867744
Cyanosis	12.61	11.71	9	83846	11926	29856697
Mesenteric vein thrombosis	12.59	11.71	11	83844	515	29868108
Transaminases decreased	12.57	11.71	3	83852	3	29868620
Oral herpes	12.57	11.71	34	83821	4421	29864202
Hypercatabolism	12.57	11.71	3	83852	3	29868620
Delusional disorder, erotomanic type	12.57	11.71	3	83852	3	29868620
Blood count	12.57	11.71	3	83852	3	29868620
Bacterial pericarditis	12.57	11.71	3	83852	3	29868620
Aphasia	12.50	11.71	22	83833	19417	29849206
Arteriosclerosis coronary artery	12.38	11.71	8	83847	11168	29857455
Small intestinal obstruction	12.34	11.71	12	83843	13647	29854976
Genital herpes	12.24	11.71	11	83844	535	29868088
Pemphigoid	12.23	11.71	3	83852	7525	29861098
Hepatitis chronic active	12.22	11.71	5	83850	54	29868569
Hypernatraemia	12.12	11.71	3	83852	7481	29861142
Oedema due to hepatic disease	12.10	11.71	4	83851	22	29868601
Hydronephrosis	12.07	11.71	5	83850	8978	29859645
Deafness neurosensory	12.07	11.71	23	83832	2370	29866253
Shock	12.05	11.71	29	83826	22830	29845793
Bronchopulmonary aspergillosis	12.04	11.71	10	83845	12274	29856349
Impetigo	12.04	11.71	13	83842	792	29867831
Osteomyelitis	12.03	11.71	14	83841	14667	29853956
Hot flush	12.03	11.71	14	83841	14666	29853957
Granulocyte count decreased	12.01	11.71	12	83843	667	29867956
Body temperature decreased	12.00	11.71	6	83849	9649	29858974
Glossodynia	11.95	11.71	28	83827	3333	29865290
Lymphocyte count decreased	11.87	11.71	22	83833	19033	29849590
Muscle rigidity	11.85	11.71	7	83848	10254	29858369
Skin burning sensation	11.85	11.71	30	83825	3750	29864873
Procalcitonin	11.81	11.71	4	83851	24	29868599
Aspergillus infection	11.75	11.71	7	83848	10207	29858416

Pharmacologic Action:

Source	Code	Description
ATC	J05AP01	ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HCV infections
FDA EXT	N0000175459	Nucleoside Analog
FDA EPC	N0000175466	Nucleoside Analog Antiviral
MeSH PA	D000890	Anti-Infective Agents
MeSH PA	D000963	Antimetabolites
MeSH PA	D000998	Antiviral Agents
MeSH PA	D009676	Noxae
CHEBI has role	CHEBI:22587	antiviral agents
CHEBI has role	CHEBI:35221	antimetabolite
CHEBI has role	CHEBI:35441	anti-infective drugs
CHEBI has role	CHEBI:59897	rna-dependent dna polymerase inhibitors
CHEBI has role	CHEBI:149553	anti-coronaviral agents

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Respiratory syncytial virus infection	indication	55735004	DOID:1273
Chronic hepatitis C	indication	128302006
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
Chronic obstructive lung disease	contraindication	13645005	DOID:3083
Cirrhosis of liver	contraindication	19943007	DOID:5082
Myocardial infarction	contraindication	22298006	DOID:5844
Constitutional aplastic anemia	contraindication	28975000	DOID:1342
Sarcoidosis	contraindication	31541009	DOID:11335
Thalassemia	contraindication	40108008	DOID:10241
Periodontitis	contraindication	41565005	DOID:824
Coronary arteriosclerosis	contraindication	53741008	DOID:3393
Hemolytic anemia	contraindication	61261009	DOID:583
Interstitial pneumonia	contraindication	64667001
Pancreatitis	contraindication	75694006	DOID:4989
Pancytopenia	contraindication	127034005	DOID:12450
Hb SS disease	contraindication	127040003	DOID:10923
Asthma	contraindication	195967001	DOID:2841
Impaired renal function disorder	contraindication	197663003
Anemia	contraindication	271737000	DOID:2355
Pregnancy, function	contraindication	289908002
Bone marrow depression	contraindication	307762000
Autoimmune hepatitis	contraindication	408335007
Breastfeeding (mother)	contraindication	413712001
Myocardial ischemia	contraindication	414795007	DOID:3393
Pulmonary Infiltrates	contraindication

Acid dissociation constants calculated using MoKa v3.0.0

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

Orange Book patent data (new drug applications)

None

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
Inosine-5'-monophosphate dehydrogenase 1	Enzyme	P20839	IMDH1_HUMAN	INHIBITOR	IC50	6		IUPHAR	CHEMBL
DNA topoisomerase 1	Enzyme	P11387	TOP1_HUMAN		IC50	4.18		CHEMBL
Cytosolic purine 5'-nucleotidase	Enzyme	P49902	5NTC_HUMAN					WOMBAT-PK
Ectonucleotide pyrophosphatase/phosphodiesterase family member 1	Enzyme	P22413	ENPP1_HUMAN					WOMBAT-PK
Adenosine kinase	Kinase	P55263	ADK_HUMAN					WOMBAT-PK
Inosine-5'-monophosphate dehydrogenase 2	Enzyme	P12268	IMDH2_HUMAN	INHIBITOR	IC50	6		IUPHAR
NS5B protein	Enzyme		Q8JXU8_9HEPC	INHIBITOR				CHEMBL	CHEMBL

External reference:

ID	Source
4019299	VUID
N0000147496	NUI
D00423	KEGG_DRUG
4019299	VANDF
C0702024	UMLSCUI
CHEBI:63580	CHEBI
RBV	PDB_CHEM_ID
CHEMBL1643	ChEMBL_ID
D012254	MESH_DESCRIPTOR_UI
DB00811	DRUGBANK_ID
6842	IUPHAR_LIGAND_ID
3543	INN_ID
49717AWG6K	UNII
5064	PUBCHEM_CID
9344	RXNORM
43465	MMSL
5421	MMSL
d00085	MMSL
003018	NDDF
35063004	SNOMEDCT_US
387188005	SNOMEDCT_US

Pharmaceutical products:

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	0085-1318	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	0085-1385	CAPSULE	200 mg	ORAL	NDA	31 sections
Virazole	HUMAN PRESCRIPTION DRUG LABEL	1	0187-0007	POWDER, FOR SOLUTION	6 g	RESPIRATORY (INHALATION)	NDA	21 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
Ribavirin	HUMAN PRESCRIPTION DRUG LABEL	1	53808-0782	TABLET, FILM COATED	200 mg	ORAL	ANDA	16 sections
Ribavirin	HUMAN PRESCRIPTION DRUG LABEL	1	63629-2149	POWDER, FOR SOLUTION	6 g	RESPIRATORY (INHALATION)	NDA	22 sections
Ribavirin	HUMAN PRESCRIPTION DRUG LABEL	1	65841-046	TABLET, FILM COATED	200 mg	ORAL	ANDA	1 sections
Ribavirin	HUMAN PRESCRIPTION DRUG LABEL	1	65841-129	TABLET, FILM COATED	600 mg	ORAL	ANDA	1 sections
Ribavirin	HUMAN PRESCRIPTION DRUG LABEL	1	65841-260	CAPSULE	200 mg	ORAL	ANDA	1 sections
Ribavirin	HUMAN PRESCRIPTION DRUG LABEL	1	65841-603	TABLET, FILM COATED	400 mg	ORAL	ANDA	1 sections
Ribavirin	HUMAN PRESCRIPTION DRUG LABEL	1	65841-632	TABLET, FILM COATED	500 mg	ORAL	ANDA	1 sections
Ribavirin	Human Prescription Drug Label	1	65862-207	TABLET, FILM COATED	200 mg	ORAL	ANDA	28 sections
Ribavirin	Human Prescription Drug Label	1	65862-290	CAPSULE	200 mg	ORAL	ANDA	28 sections
Ribavirin	HUMAN PRESCRIPTION DRUG LABEL	1	68382-046	TABLET, FILM COATED	200 mg	ORAL	ANDA	29 sections
Ribavirin	HUMAN PRESCRIPTION DRUG LABEL	1	68382-127	TABLET, FILM COATED	400 mg	ORAL	ANDA	29 sections
Ribavirin	HUMAN PRESCRIPTION DRUG LABEL	1	68382-128	TABLET, FILM COATED	500 mg	ORAL	ANDA	29 sections
Ribavirin	HUMAN PRESCRIPTION DRUG LABEL	1	68382-129	TABLET, FILM COATED	600 mg	ORAL	ANDA	29 sections
Ribavirin	HUMAN PRESCRIPTION DRUG LABEL	1	68382-260	CAPSULE	200 mg	ORAL	ANDA	28 sections
RIBAVIRIN	HUMAN PRESCRIPTION DRUG LABEL	1	68382-395	POWDER, FOR SOLUTION	6 g	RESPIRATORY (INHALATION)	ANDA	19 sections
RIBAVIRIN	HUMAN PRESCRIPTION DRUG LABEL	1	68475-003	POWDER, FOR SOLUTION	6 g	RESPIRATORY (INHALATION)	ANDA	19 sections
Ribavirin	HUMAN PRESCRIPTION DRUG LABEL	1	68682-019	POWDER, FOR SOLUTION	6 g	RESPIRATORY (INHALATION)	NDA	21 sections