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

Stem definitionDrug idCAS RN
antivirals 2373 36791-04-5

Description:

MoleculeDescription

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:

DoseUnitRoute
6 g Inhal.solution
1 g O

ADMET properties:

PropertyValueReference
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 ┬ÁM/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:

DateAgencyCompanyOrphan
Dec. 31, 1985 FDA VALEANT PHARM INTL

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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:

SourceCodeDescription
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)

DiseaseRelationSNOMED_IDDOID
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 levelDissociation constantType (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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Inosine-5'-monophosphate dehydrogenase 1 Enzyme INHIBITOR IC50 6 IUPHAR CHEMBL
DNA topoisomerase 1 Enzyme IC50 4.18 CHEMBL
Cytosolic purine 5'-nucleotidase Enzyme WOMBAT-PK
Ectonucleotide pyrophosphatase/phosphodiesterase family member 1 Enzyme WOMBAT-PK
Adenosine kinase Kinase WOMBAT-PK
Inosine-5'-monophosphate dehydrogenase 2 Enzyme INHIBITOR IC50 6 IUPHAR
NS5B protein Enzyme INHIBITOR CHEMBL CHEMBL

External reference:

IDSource
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:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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