ribavirin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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: -2.57
  • LIPINSKI: 0
  • HAC: 9
  • HDO: 4
  • TPSA: 143.72
  • ALOGS: -0.87
  • ROTB: 3
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

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 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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 -1.424 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 23.714 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 1.321 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 1.026 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 86.850 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 92.900 % High 1
herg hERG pIC50 3.432 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 0.728 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 3.258 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 75.680 % High 1
kinase-safety-class ACVR2B,AXL,BRAF,CAMK2D,CDK5,CDK9,DYRK1B,EIF2AK3,ERBB2,GRK2,ITK,MAP2K6,MAP3K21,MAPK7,NTRK1,NTRK2,PDK1,PDK2,PRKDC,TEK 20
kinase-selectivity-class MAP2K6,PDK1 2
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 0.624 High 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 4.592 High 1
mh-clint Mouse hepatocyte intrinsic clearance 0.294 High 1
mppb Mouse plasma protein binding (% unbound) 92.060 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 2.742 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 0 High 1
pppb Pig plasma protein binding (% unbound) 94.800 % High 1
rat-kpuu-brain Rat brain Kpuu 0.013 % High 1
rh-clint Rat hepatocyte intrinsic clearance 1.660 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 96.880 % High 1
rppb Rat plasma protein binding (% unbound) 89.640 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 877.001 uM High 1

Approvals:

DateAgencyCompanyOrphan
Nov. 21, 2001 PMDA Schering-Plough
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 3551.88 16.08 2296 49063 350506 90226582
Haemoglobin decreased 1002.81 16.08 788 50571 161168 90415920
Hepatitis C 966.42 16.08 278 51081 5382 90571706
Hepatocellular carcinoma 857.75 16.08 212 51147 2216 90574872
Platelet count decreased 786.65 16.08 638 50721 136331 90440757
White blood cell count decreased 750.67 16.08 676 50683 166433 90410655
Jaundice 465.83 16.08 267 51092 32250 90544838
Blood bilirubin increased 442.99 16.08 287 51072 43183 90533905
Ascites 437.55 16.08 295 51064 47445 90529643
Hepatic failure 391.83 16.08 257 51102 39471 90537617
Hyperbilirubinaemia 390.94 16.08 180 51179 13756 90563332
Neutrophil count decreased 363.94 16.08 311 51048 71221 90505867
Hepatic encephalopathy 346.50 16.08 165 51194 13607 90563481
Haemolytic anaemia 337.26 16.08 154 51205 11543 90565545
Rash 318.69 16.08 1081 50278 795019 89782069
Anal pruritus 304.39 16.08 77 51282 890 90576198
Nausea 297.25 16.08 1327 50032 1108989 89468099
Leukopenia 268.91 16.08 308 51051 100402 90476686
Anorectal discomfort 260.11 16.08 88 51271 2946 90574142
Fatigue 258.30 16.08 1310 50049 1152713 89424375
Pancytopenia 228.32 16.08 310 51049 119953 90457135
Viral load increased 211.14 16.08 64 51295 1492 90575596
Thrombocytopenia 205.19 16.08 399 50960 208326 90368762
Asthenia 194.78 16.08 704 50655 533047 90044041
Influenza like illness 192.66 16.08 233 51126 80378 90496710
Pruritus 185.63 16.08 700 50659 540825 90036263
Dysgeusia 179.24 16.08 183 51176 52377 90524711
Hepatic cirrhosis 178.21 16.08 199 51160 63054 90514034
Decreased appetite 177.68 16.08 542 50817 375998 90201090
Drug hypersensitivity 174.84 16.08 27 51332 463582 90113506
Red blood cell count decreased 173.94 16.08 170 51189 46181 90530907
Joint swelling 169.21 16.08 39 51320 503261 90073827
Systemic lupus erythematosus 159.39 16.08 12 51347 361884 90215204
Depression 159.22 16.08 451 50908 300150 90276938
Retinopathy 156.30 16.08 63 51296 3471 90573617
Contraindicated product administered 155.27 16.08 6 51353 320133 90256955
Arthropathy 153.50 16.08 15 51344 366227 90210861
Neutropenia 149.16 16.08 367 50992 224537 90352551
Hepatitis C RNA positive 148.41 16.08 27 51332 45 90577043
Drug intolerance 140.21 16.08 40 51319 447551 90129537
Insomnia 131.82 16.08 452 50907 333022 90244066
Vomiting 131.72 16.08 829 50530 787464 89789624
Proctalgia 130.02 16.08 72 51287 8126 90568962
Therapeutic product effect decreased 128.73 16.08 7 51352 277564 90299524
Rheumatoid arthritis 128.15 16.08 25 51334 362589 90214499
Product use issue 122.53 16.08 20 51339 329899 90247189
Hepatitis C RNA increased 122.21 16.08 26 51333 128 90576960
Hyperuricaemia 114.83 16.08 62 51297 6657 90570431
Condition aggravated 112.79 16.08 103 51256 595442 89981646
Cryoglobulinaemia 108.55 16.08 33 51326 777 90576311
Psoriatic arthropathy 108.28 16.08 5 51354 228330 90348758
Hypersensitivity 106.30 16.08 63 51296 454614 90122474
Pyrexia 106.08 16.08 688 50671 659797 89917291
Impaired healing 105.28 16.08 7 51352 234192 90342896
Peripheral swelling 104.20 16.08 52 51307 413054 90164034
Blood cholesterol increased 104.00 16.08 3 51356 208009 90369079
Helicobacter infection 101.33 16.08 7 51352 226843 90350245
Pericarditis 101.14 16.08 16 51343 270135 90306953
Oesophageal varices haemorrhage 99.91 16.08 36 51323 1456 90575632
Off label use 99.85 16.08 308 51051 1101944 89475144
Nasopharyngitis 98.59 16.08 54 51305 407050 90170038
Hepatic enzyme increased 97.82 16.08 41 51318 360695 90216393
Autoimmune hepatitis 97.24 16.08 65 51294 10286 90566802
Irritable bowel syndrome 96.90 16.08 5 51354 207443 90369645
Musculoskeletal stiffness 95.61 16.08 25 51334 296507 90280581
Product use in unapproved indication 91.50 16.08 38 51321 336198 90240890
Glossodynia 91.46 16.08 34 51325 321745 90255343
Mobility decreased 91.30 16.08 16 51343 250718 90326370
Pain 90.46 16.08 278 51081 996063 89581025
Chills 90.20 16.08 218 51141 131763 90445325
Irritability 89.95 16.08 106 51253 35556 90541532
Genotype drug resistance test positive 89.95 16.08 25 51334 424 90576664
Virologic failure 89.32 16.08 37 51322 2187 90574901
Haemorrhoids 89.25 16.08 92 51267 26610 90550478
Hepatitis B reactivation 89.05 16.08 44 51315 3930 90573158
Type 2 diabetes mellitus 88.69 16.08 7 51352 203237 90373851
Injury 88.40 16.08 6 51353 197343 90379745
Dehydration 86.96 16.08 275 51084 194172 90382916
Portal vein thrombosis 86.32 16.08 40 51319 3098 90573990
Infection 86.26 16.08 49 51310 362045 90215043
Porphyria non-acute 84.94 16.08 22 51337 281 90576807
Wheezing 82.84 16.08 17 51342 238063 90339025
Swelling 82.24 16.08 70 51289 418988 90158100
Toxicity to various agents 80.82 16.08 31 51328 287815 90289273
Hepatic cancer 80.52 16.08 44 51315 4837 90572251
Retinal exudates 79.13 16.08 25 51334 671 90576417
COVID-19 79.07 16.08 4 51355 168839 90408249
Osteoarthritis 76.96 16.08 10 51349 195720 90381368
Sinusitis 76.73 16.08 50 51309 343038 90234050
Discomfort 76.26 16.08 30 51329 274305 90302783
Fibromyalgia 75.45 16.08 13 51346 206256 90370832
Dry skin 74.10 16.08 158 51201 87915 90489173
Vogt-Koyanagi-Harada disease 73.62 16.08 21 51338 393 90576695
Liver injury 71.36 16.08 7 51352 170560 90406528
Renal impairment 70.81 16.08 173 51186 105248 90471840
Varices oesophageal 70.58 16.08 37 51322 3742 90573346
Intentional product use issue 68.54 16.08 19 51340 216873 90360215
Gastrointestinal disorder 68.23 16.08 30 51329 256657 90320431
Abdominal discomfort 67.36 16.08 104 51255 477224 90099864
Lower respiratory tract infection 67.10 16.08 29 51330 250630 90326458
Cutaneous sarcoidosis 66.86 16.08 20 51339 445 90576643
Renal failure 66.73 16.08 194 51165 130813 90446275
Hypertension 65.22 16.08 99 51260 457433 90119655
Bursitis 62.02 16.08 3 51356 131651 90445437
Maternal exposure during pregnancy 61.51 16.08 68 51291 359995 90217093
C-reactive protein increased 60.96 16.08 14 51345 181375 90395713
Drug reaction with eosinophilia and systemic symptoms 60.45 16.08 96 51263 42662 90534426
Urticaria 60.40 16.08 53 51306 312681 90264407
Peritonitis bacterial 59.77 16.08 37 51322 5134 90571954
Hyperthyroidism 59.23 16.08 62 51297 18248 90558840
Weight increased 59.00 16.08 91 51268 417836 90159252
Completed suicide 58.02 16.08 7 51352 145051 90432037
Therapeutic product effect incomplete 57.62 16.08 19 51340 193877 90383211
Liver transplant 55.95 16.08 27 51332 2290 90574798
Inflammation 55.77 16.08 16 51343 178576 90398512
Ill-defined disorder 53.41 16.08 19 51340 184872 90392216
Viral mutation identified 50.12 16.08 24 51335 2001 90575087
Rash pruritic 50.06 16.08 130 51229 82084 90495004
Hepatorenal syndrome 49.87 16.08 24 51335 2024 90575064
Arthralgia 49.54 16.08 250 51109 778272 89798816
Sarcoidosis 49.38 16.08 44 51315 10629 90566459
Retinal haemorrhage 48.93 16.08 34 51325 5730 90571358
Alanine aminotransferase increased 48.92 16.08 163 51196 118175 90458913
Exposure via direct contact 48.74 16.08 12 51347 123 90576965
Encephalopathy 48.25 16.08 91 51268 46353 90530735
Exposure via father 48.02 16.08 14 51345 284 90576804
Weight decreased 46.43 16.08 371 50988 379539 90197549
Obesity 45.00 16.08 4 51355 105503 90471585
Liver transplant rejection 44.36 16.08 21 51338 1707 90575381
Exposure via partner 44.23 16.08 11 51348 118 90576970
Yellow skin 43.76 16.08 24 51335 2657 90574431
Ammonia increased 43.71 16.08 30 51329 4956 90572132
Autoimmune thyroiditis 43.66 16.08 32 51327 5861 90571227
Child-Pugh-Turcotte score increased 43.37 16.08 8 51351 15 90577073
Headache 43.15 16.08 707 50652 862039 89715049
Bilirubin conjugated increased 42.92 16.08 25 51334 3105 90573983
Aspartate aminotransferase increased 42.73 16.08 142 51217 102795 90474293
Myalgia 41.62 16.08 203 51156 174922 90402166
Loss of personal independence in daily activities 41.02 16.08 13 51346 136092 90440996
Tongue pigmentation 40.99 16.08 8 51351 23 90577065
Sciatica 40.27 16.08 5 51354 101377 90475711
Toxic skin eruption 39.96 16.08 47 51312 15727 90561361
Arthritis 39.29 16.08 23 51336 167292 90409796
Haemolysis 39.20 16.08 35 51324 8475 90568613
Lung disorder 39.05 16.08 18 51341 149865 90427223
Hepatitis cholestatic 39.02 16.08 35 51324 8526 90568562
Anorectal disorder 38.26 16.08 20 51339 2011 90575077
Face oedema 38.10 16.08 56 51303 23262 90553826
Aplasia pure red cell 38.02 16.08 28 51331 5166 90571922
Injection site pain 37.87 16.08 26 51333 173673 90403415
Exposure via body fluid 37.86 16.08 14 51345 610 90576478
Lethargy 37.57 16.08 99 51260 63040 90514048
Ocular icterus 37.40 16.08 25 51334 3955 90573133
Wound infection 36.17 16.08 8 51351 106394 90470694
Syncope 36.10 16.08 160 51199 132503 90444585
Aplastic anaemia 36.07 16.08 41 51318 13228 90563860
Basedow's disease 35.56 16.08 11 51348 275 90576813
Anger 34.95 16.08 41 51318 13679 90563409
Mood swings 34.23 16.08 50 51309 20652 90556436
Hypoaesthesia 34.15 16.08 80 51279 314130 90262958
Hepatic fibrosis 33.98 16.08 24 51335 4151 90572937
Hepatitis E 33.78 16.08 18 51341 1881 90575207
Fall 33.34 16.08 150 51209 481660 90095428
Osteoporosis 33.33 16.08 7 51352 96524 90480564
Malaise 32.95 16.08 490 50869 585496 89991592
Haematocrit decreased 32.84 16.08 73 51286 41759 90535329
Overgrowth fungal 32.75 16.08 9 51350 146 90576942
Blister 32.73 16.08 59 51300 254939 90322149
Hypothyroidism 32.32 16.08 84 51275 53043 90524045
Epistaxis 32.32 16.08 114 51245 85011 90492077
Disease progression 32.12 16.08 25 51334 156590 90420498
Asthma 32.01 16.08 55 51304 242105 90334983
Intentional product misuse 31.98 16.08 6 51353 89598 90487490
Liver function test increased 31.79 16.08 5 51354 84850 90492238
Angiotensin converting enzyme increased 31.74 16.08 8 51351 91 90576997
Live birth 31.18 16.08 4 51355 79103 90497985
Hepatic cancer recurrent 31.18 16.08 9 51350 176 90576912
Oxygen saturation decreased 31.11 16.08 11 51348 107472 90469616
Rash papular 30.57 16.08 47 51312 20308 90556780
Splenomegaly 30.26 16.08 37 51322 12887 90564201
Muscular weakness 30.09 16.08 44 51315 206622 90370466
Lip dry 29.79 16.08 10 51349 100945 90476143
Contusion 29.73 16.08 61 51298 251155 90325933
Hypersplenism 28.78 16.08 10 51349 363 90576725
Erythema multiforme 28.58 16.08 35 51324 12211 90564877
Intentional overdose 28.21 16.08 9 51350 93825 90483263
Urate nephropathy 28.08 16.08 8 51351 149 90576939
Abortion induced 27.78 16.08 34 51325 11854 90565234
Pancreas transplant rejection 27.41 16.08 8 51351 163 90576925
Liver transplant failure 27.20 16.08 6 51353 36 90577052
Disturbance in attention 27.15 16.08 73 51286 47036 90530052
Oral mucosal blistering 27.10 16.08 26 51333 6898 90570190
Pregnancy of partner 27.06 16.08 6 51353 37 90577051
Chromaturia 27.00 16.08 43 51316 19144 90557944
Depressive symptom 26.89 16.08 23 51336 5262 90571826
Hospitalisation 26.84 16.08 20 51339 128080 90449008
Sepsis 26.70 16.08 184 51175 179630 90397458
Pain in extremity 26.18 16.08 149 51210 450380 90126708
Hepatorenal failure 25.99 16.08 11 51348 686 90576402
Inappropriate schedule of product administration 25.92 16.08 28 51331 149905 90427183
Transfusion 25.73 16.08 40 51319 17448 90559640
Hepatitis C virus test positive 25.45 16.08 7 51352 114 90576974
Gait disturbance 25.45 16.08 70 51289 260426 90316662
Pathogen resistance 25.40 16.08 27 51332 8088 90569000
Erythema nodosum 25.30 16.08 23 51336 5701 90571387
Disorientation 25.06 16.08 68 51291 44046 90533042
Extradural abscess 25.02 16.08 13 51346 1291 90575797
Dermatitis 24.91 16.08 45 51314 22175 90554913
Anti-erythropoietin antibody positive 24.67 16.08 9 51350 377 90576711
Emotional disorder 24.48 16.08 36 51323 14961 90562127
Blood creatinine increased 24.41 16.08 118 51241 101268 90475820
Glomerulonephritis 24.38 16.08 16 51343 2454 90574634
Alcoholism 23.69 16.08 14 51345 1786 90575302
Blood potassium decreased 23.63 16.08 70 51289 47657 90529431
General physical health deterioration 23.10 16.08 113 51246 355002 90222086
Thyroiditis 23.07 16.08 18 51341 3619 90573469
Red blood cell sedimentation rate increased 22.98 16.08 9 51350 82586 90494502
Drug ineffective 22.89 16.08 604 50755 1383694 89193394
Blood pressure systolic increased 22.87 16.08 3 51356 58342 90518746
Paranoia 22.55 16.08 32 51327 12876 90564212
Musculoskeletal pain 22.53 16.08 39 51320 171212 90405876
Gait inability 22.50 16.08 30 51329 146426 90430662
Road traffic accident 22.29 16.08 17 51342 107609 90469479
Facial paralysis 22.12 16.08 35 51324 15499 90561589
Hypophagia 22.04 16.08 57 51302 35880 90541208
Nasal congestion 21.75 16.08 10 51349 83404 90493684
Suicidal ideation 21.56 16.08 91 51268 73764 90503324
Depressed mood 21.48 16.08 70 51289 50152 90526936
Blood albumin decreased 21.41 16.08 36 51323 16767 90560321
Full blood count abnormal 21.38 16.08 57 51302 36540 90540548
Guillain-Barre syndrome 21.31 16.08 19 51340 4593 90572495
Drug abuse 21.28 16.08 10 51349 82337 90494751
Rhinocerebral mucormycosis 21.25 16.08 10 51349 802 90576286
Night sweats 21.21 16.08 25 51334 128741 90448347
Injection site rash 21.05 16.08 44 51315 24129 90552959
Type 1 diabetes mellitus 20.61 16.08 19 51340 4793 90572295
Complications of transplanted liver 20.53 16.08 8 51351 403 90576685
Blood bilirubin unconjugated increased 20.41 16.08 8 51351 409 90576679
Paraesthesia 20.41 16.08 73 51286 250253 90326835
Autoimmune disorder 20.32 16.08 9 51350 76735 90500353
Septic shock 20.30 16.08 98 51261 84062 90493026
Paternal drugs affecting foetus 20.24 16.08 5 51354 52 90577036
Abortion spontaneous 20.18 16.08 72 51287 53984 90523104
Hepatic hydrothorax 20.16 16.08 5 51354 53 90577035
Blood pressure fluctuation 19.83 16.08 3 51356 52410 90524678
Hepatitis B 19.66 16.08 18 51341 4501 90572587
Colitis ulcerative 19.55 16.08 5 51354 60261 90516827
Drug eruption 19.54 16.08 54 51305 35353 90541735
Vision blurred 19.52 16.08 118 51241 110175 90466913
Sleep disorder 19.50 16.08 53 51306 197977 90379111
Oral candidiasis 19.49 16.08 54 51305 35401 90541687
Miscarriage of partner 19.43 16.08 3 51356 0 90577088
Cerebral arteriovenous malformation haemorrhagic 19.43 16.08 3 51356 0 90577088
Hepatitis virus-associated nephropathy 19.43 16.08 3 51356 0 90577088
Joint stiffness 19.37 16.08 10 51349 78032 90499056
VIIIth nerve lesion 19.28 16.08 4 51355 17 90577071
Gingival bleeding 19.08 16.08 32 51327 14871 90562217
Portal hypertension 19.06 16.08 18 51341 4683 90572405
Multiple organ dysfunction syndrome 19.02 16.08 83 51276 68253 90508835
Adverse drug reaction 18.86 16.08 23 51336 116678 90460410
Gastric varices haemorrhage 18.82 16.08 6 51353 166 90576922
Pulmonary fibrosis 18.66 16.08 20 51339 107483 90469605
Therapy responder 18.46 16.08 7 51352 327 90576761
Excessive dynamic airway collapse 18.43 16.08 4 51355 22 90577066
Disease recurrence 18.43 16.08 55 51304 37598 90539490
Epilepsy 18.32 16.08 12 51347 82194 90494894
Flushing 18.30 16.08 14 51345 88477 90488611
Crying 18.19 16.08 43 51316 25602 90551486
Hypertrichosis 18.16 16.08 11 51348 1468 90575620
Glomerulonephritis membranoproliferative 18.13 16.08 7 51352 344 90576744
Retinal disorder 17.90 16.08 12 51347 1907 90575181
Bleeding varicose vein 17.75 16.08 7 51352 364 90576724
Ocular sarcoidosis 17.71 16.08 5 51354 90 90576998
Cholecystitis acute 17.45 16.08 24 51335 9380 90567708
Febrile neutropenia 17.44 16.08 40 51319 158309 90418779
Psoriasis 17.37 16.08 36 51323 147718 90429370
Vertigo 17.35 16.08 82 51277 69729 90507359
Maternal exposure before pregnancy 16.99 16.08 26 51333 11187 90565901
Congenital tongue anomaly 16.89 16.08 3 51356 4 90577084
Retinal detachment 16.74 16.08 20 51339 6802 90570286
Prothrombin time prolonged 16.74 16.08 24 51335 9748 90567340
Hepatic function abnormal 16.72 16.08 61 51298 46227 90530861
Mental disorder 16.57 16.08 48 51311 32270 90544818
Visual acuity reduced 16.33 16.08 39 51320 23371 90553717
Cheilitis 16.28 16.08 17 51342 4990 90572098
Oral pain 16.24 16.08 48 51311 32635 90544453
Acute hepatic failure 16.19 16.08 38 51321 22523 90554565
Frequent bowel movements 16.18 16.08 6 51353 56929 90520159
Hepatitis C virus test 16.14 16.08 3 51356 6 90577082
Oedema due to hepatic disease 16.14 16.08 3 51356 6 90577082

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
Anaemia 2280.48 13.59 2535 67494 277743 42273563
Hepatitis C 2107.22 13.59 745 69284 9388 42541918
Hepatocellular carcinoma 2066.79 13.59 696 69333 7498 42543808
Rash 875.01 13.59 1599 68430 275355 42275951
Hepatic cirrhosis 713.11 13.59 429 69600 19273 42532033
Fatigue 692.76 13.59 1912 68117 433729 42117577
Haemoglobin decreased 581.46 13.59 888 69141 131583 42419723
Treatment failure 562.60 13.59 600 69429 62024 42489282
White blood cell count decreased 557.94 13.59 791 69238 109605 42441701
Ascites 491.37 13.59 533 69496 56145 42495161
Blood bilirubin increased 482.28 13.59 461 69568 41791 42509515
Genotype drug resistance test positive 462.70 13.59 141 69888 1063 42550243
Insomnia 447.36 13.59 741 69288 117512 42433794
Hepatic encephalopathy 440.15 13.59 296 69733 16146 42535160
Pruritus 429.90 13.59 953 69076 187818 42363488
Influenza like illness 426.58 13.59 380 69649 31460 42519846
Platelet count decreased 389.41 13.59 763 69266 137818 42413488
Anorectal discomfort 372.31 13.59 140 69889 2115 42549191
Hepatic failure 359.61 13.59 375 69654 37725 42513581
Depression 357.22 13.59 649 69380 110714 42440592
Anal pruritus 334.14 13.59 87 69942 335 42550971
Hyperbilirubinaemia 320.37 13.59 268 69761 20367 42530939
Jaundice 302.56 13.59 327 69702 34262 42517044
Hepatic cancer 274.39 13.59 172 69857 8308 42542998
Liver transplant 274.05 13.59 118 69911 2573 42548733
Retinopathy 252.10 13.59 106 69923 2175 42549131
Irritability 244.36 13.59 265 69764 27863 42523443
Oesophageal varices haemorrhage 240.98 13.59 118 69911 3489 42547817
Virologic failure 229.59 13.59 118 69911 3876 42547430
Headache 205.34 13.59 857 69172 238512 42312794
Toxicity to various agents 205.18 13.59 61 69968 229075 42322231
Nausea 203.24 13.59 1227 68802 395572 42155734
Viral load increased 203.08 13.59 99 69930 2898 42548408
Neutrophil count decreased 196.01 13.59 364 69665 63051 42488255
Leukopenia 187.46 13.59 393 69636 74353 42476953
Febrile neutropenia 178.35 13.59 43 69986 185660 42365646
Death 175.64 13.59 317 69712 470868 42080438
Off label use 171.02 13.59 513 69516 637822 41913484
Hepatitis C RNA positive 158.17 13.59 40 69989 133 42551173
Dysgeusia 157.72 13.59 235 69794 33954 42517352
Hepatitis C RNA increased 153.28 13.59 44 69985 262 42551044
Malignant neoplasm progression 151.98 13.59 6 70023 108394 42442912
Haemolytic anaemia 141.40 13.59 134 69895 11993 42539313
Decreased appetite 137.09 13.59 654 69375 192483 42358823
Product use in unapproved indication 135.35 13.59 67 69962 184389 42366917
Retinal exudates 134.67 13.59 51 69978 786 42550520
Peritonitis bacterial 133.28 13.59 102 69927 6813 42544493
Disease progression 125.31 13.59 40 69989 143616 42407690
Proctalgia 124.52 13.59 99 69930 6994 42544312
Haemorrhoids 124.47 13.59 147 69882 16950 42534356
Viral mutation identified 124.22 13.59 74 69955 3257 42548049
Porphyria non-acute 120.64 13.59 41 69988 453 42550853
Hypotension 119.26 13.59 149 69880 257482 42293824
Varices oesophageal 117.75 13.59 79 69950 4286 42547020
Drug hypersensitivity 112.65 13.59 15 70014 99374 42451932
Fall 108.14 13.59 136 69893 234384 42316922
Drug abuse 105.05 13.59 22 70007 104749 42446557
Thrombocytopenia 103.05 13.59 598 69431 189681 42361625
Pancytopenia 102.54 13.59 424 69605 117319 42433987
Cryoglobulinaemia 100.61 13.59 37 69992 523 42550783
Depressed mood 99.72 13.59 155 69874 23229 42528077
Hyperuricaemia 96.52 13.59 97 69932 9327 42541979
Hepatic cancer recurrent 95.54 13.59 31 69998 293 42551013
Mood swings 92.52 13.59 92 69937 8734 42542572
Asthenia 88.01 13.59 773 69256 280020 42271286
Condition aggravated 84.35 13.59 190 69839 260564 42290742
Hepatorenal syndrome 82.67 13.59 54 69975 2800 42548506
Hepatic hydrothorax 80.59 13.59 18 70011 28 42551278
Rash pruritic 77.62 13.59 171 69858 33432 42517874
Therapeutic product effect incomplete 77.35 13.59 12 70017 70927 42480379
Haemolysis 75.75 13.59 86 69943 9503 42541803
Hepatitis B reactivation 74.22 13.59 61 69968 4517 42546789
Completed suicide 73.83 13.59 33 69996 96432 42454874
Oxygen saturation decreased 72.72 13.59 10 70019 64677 42486629
Portal vein thrombosis 72.47 13.59 60 69969 4489 42546817
Portal hypertension 69.80 13.59 60 69969 4727 42546579
Dry skin 67.98 13.59 204 69825 48134 42503172
Renal impairment 67.29 13.59 358 69671 109870 42441436
Blood pressure increased 64.77 13.59 44 69985 101884 42449422
Hepatitis C virus test positive 64.43 13.59 23 70006 297 42551009
Hospitalisation 64.23 13.59 21 70008 74309 42476997
Intentional product misuse 64.12 13.59 12 70017 61888 42489418
Mucosal inflammation 62.23 13.59 5 70024 49369 42501937
Acute kidney injury 62.21 13.59 352 69677 366985 42184321
Cardiac failure congestive 61.36 13.59 32 69997 85570 42465736
Red blood cell count decreased 60.87 13.59 153 69876 32562 42518744
General physical health deterioration 60.42 13.59 97 69932 151149 42400157
Drug ineffective 60.25 13.59 1405 68624 628792 41922514
Anger 59.31 13.59 89 69940 12929 42538377
Liver transplant rejection 54.97 13.59 40 69989 2473 42548833
Focal segmental glomerulosclerosis 54.48 13.59 40 69989 2508 42548798
Vogt-Koyanagi-Harada disease 54.39 13.59 18 70011 182 42551124
Encephalopathy 53.06 13.59 169 69860 41164 42510142
Suicidal ideation 52.18 13.59 186 69843 47975 42503331
Plasma cell myeloma 51.97 13.59 8 70021 47570 42503736
Hypertension 51.45 13.59 125 69904 167079 42384227
Asthma 51.43 13.59 19 70010 62295 42489011
Retinal haemorrhage 51.19 13.59 55 69974 5715 42545591
Hepatitis C RNA 49.42 13.59 12 70017 32 42551274
Pulmonary embolism 49.39 13.59 75 69954 119537 42431769
Gastric varices haemorrhage 48.34 13.59 18 70011 264 42551042
Weight increased 48.26 13.59 64 69965 107919 42443387
C-reactive protein increased 48.22 13.59 22 70007 63538 42487768
Injection site rash 48.15 13.59 53 69976 5659 42545647
Weight decreased 47.30 13.59 536 69493 207412 42343894
Blood bilirubin unconjugated increased 47.21 13.59 23 70006 672 42550634
Bleeding varicose vein 47.01 13.59 19 70010 351 42550955
Yellow skin 45.97 13.59 35 69994 2319 42548987
Hypoxia 45.85 13.59 29 70000 69757 42481549
Atrial fibrillation 45.64 13.59 101 69928 139492 42411814
Prostate cancer 45.50 13.59 9 70020 44634 42506672
Intentional overdose 45.41 13.59 14 70015 51442 42499864
Tachycardia 45.08 13.59 60 69969 101027 42450279
Lethargy 44.87 13.59 174 69855 46716 42504590
Injection site pain 43.85 13.59 20 70009 57778 42493528
Inappropriate schedule of product administration 42.69 13.59 57 69972 95845 42455461
Child-Pugh-Turcotte score increased 42.23 13.59 10 70019 23 42551283
Viral load 41.31 13.59 12 70017 75 42551231
Cardiogenic shock 41.28 13.59 5 70024 35635 42515671
Pregnancy of partner 40.79 13.59 18 70011 417 42550889
Electrocardiogram QT prolonged 40.62 13.59 14 70015 47931 42503375
Heart rate decreased 40.23 13.59 6 70023 36526 42514780
Hyperkalaemia 39.85 13.59 44 69985 80414 42470892
Ocular icterus 39.49 13.59 36 69993 3065 42548241
Anaphylactic reaction 38.86 13.59 11 70018 42732 42508574
Coronary artery disease 38.61 13.59 20 70009 53700 42497606
Wheezing 38.48 13.59 21 70008 54760 42496546
Intentional product use issue 38.15 13.59 37 69992 71796 42479510
Foetal exposure during pregnancy 38.08 13.59 15 70014 47296 42504010
Peripheral swelling 37.84 13.59 56 69973 90214 42461092
Cardiac failure 37.71 13.59 74 69955 106782 42444524
Facial paralysis 37.37 13.59 71 69958 12492 42538814
Pneumonia aspiration 36.95 13.59 18 70011 50060 42501246
Erythema multiforme 36.89 13.59 62 69967 9915 42541391
Flushing 36.63 13.59 8 70021 37020 42514286
Drug reaction with eosinophilia and systemic symptoms 36.15 13.59 151 69878 41924 42509382
Biliary colic 36.12 13.59 23 70006 1141 42550165
Bilirubin conjugated increased 36.10 13.59 37 69992 3640 42547666
Sedation 35.98 13.59 4 70025 30471 42520835
Vomiting 35.65 13.59 671 69358 289052 42262254
Glomerulonephritis membranoproliferative 34.39 13.59 17 70012 513 42550793
Chronic hepatitis C 34.12 13.59 17 70012 522 42550784
Chronic obstructive pulmonary disease 34.11 13.59 32 69997 63082 42488224
Acute on chronic liver failure 33.71 13.59 11 70018 106 42551200
Cardiac arrest 33.39 13.59 82 69947 109238 42442068
Alanine aminotransferase increased 33.29 13.59 254 69775 88152 42463154
Affect lability 33.19 13.59 37 69992 4007 42547299
Hepatic cytolysis 33.05 13.59 3 70026 26841 42524465
Bradycardia 33.01 13.59 56 69973 85428 42465878
Blood cholesterol increased 32.90 13.59 3 70026 26738 42524568
Hepatic fibrosis 32.37 13.59 40 69989 4832 42546474
Therapy non-responder 32.31 13.59 173 69856 53186 42498120
Pneumonia 31.91 13.59 495 69534 421654 42129652
Neutropenia 31.86 13.59 482 69547 198949 42352357
Hepatic pain 31.71 13.59 24 70005 1576 42549730
Cardio-respiratory arrest 31.37 13.59 30 69999 58606 42492700
Hypersensitivity 31.21 13.59 44 69985 72326 42478980
Respiratory failure 31.19 13.59 107 69922 128025 42423281
Neuropathy peripheral 30.63 13.59 77 69952 101776 42449530
Blood pressure fluctuation 30.61 13.59 4 70025 26904 42524402
Disturbance in attention 30.36 13.59 113 69916 29753 42521553
Somnolence 30.33 13.59 124 69905 140981 42410325
Hyponatraemia 30.29 13.59 77 69952 101385 42449921
Drug eruption 30.20 13.59 95 69934 22980 42528326
Hepatitis C RNA fluctuation 30.05 13.59 6 70023 3 42551303
Mood altered 29.96 13.59 59 69970 10659 42540647
Cholelithiasis 29.54 13.59 95 69934 23251 42528055
Alpha 1 foetoprotein increased 29.02 13.59 17 70012 725 42550581
Wrong technique in product usage process 29.00 13.59 17 70012 42618 42508688
Ventricular fibrillation 28.82 13.59 7 70022 30116 42521190
Acute stress disorder 28.72 13.59 11 70018 175 42551131
Genital herpes simplex 28.60 13.59 10 70019 121 42551185
Pain in extremity 28.37 13.59 139 69890 150465 42400841
Contraindicated product administered 28.17 13.59 4 70025 25268 42526038
Myalgia 28.17 13.59 261 69768 95819 42455487
Pneumocystis jirovecii pneumonia 28.04 13.59 4 70025 25177 42526129
Hepatitis E 28.02 13.59 30 69999 3104 42548202
Psoriatic arthropathy 27.72 13.59 4 70025 24963 42526343
Depressed level of consciousness 27.51 13.59 23 70006 47947 42503359
Therapeutic product effect decreased 27.50 13.59 15 70014 39135 42512171
Ammonia increased 27.40 13.59 36 69993 4623 42546683
Anorectal disorder 27.39 13.59 20 70009 1243 42550063
Rheumatoid arthritis 27.37 13.59 18 70011 42422 42508884
Testicular germ cell tumour mixed 27.29 13.59 7 70022 25 42551281
Haematemesis 27.22 13.59 110 69919 30089 42521217
Facial paresis 27.12 13.59 30 69999 3220 42548086
Musculoskeletal stiffness 27.08 13.59 33 69996 57732 42493574
Hepatic neoplasm 27.05 13.59 25 70004 2166 42549140
Alopecia universalis 26.35 13.59 10 70019 155 42551151
Therapeutic embolisation 26.13 13.59 12 70017 306 42551000
Angioedema 26.09 13.59 19 70010 42458 42508848
Muscular weakness 25.99 13.59 62 69967 83436 42467870
Joint swelling 25.86 13.59 45 69984 67977 42483329
Cerebrovascular accident 25.82 13.59 78 69951 97082 42454224
Blood pressure systolic increased 25.79 13.59 7 70022 27961 42523345
Homicidal ideation 25.43 13.59 27 70002 2767 42548539
Drug ineffective for unapproved indication 25.42 13.59 23 70006 46140 42505166
Mental disorder 25.25 13.59 76 69953 17953 42533353
Haemophilic arthropathy 25.24 13.59 11 70018 247 42551059
Psychotic disorder 25.23 13.59 105 69924 29103 42522203
Coma hepatic 25.20 13.59 13 70016 430 42550876
Exposure via direct contact 25.08 13.59 7 70022 37 42551269
Hyperlipidaemia 24.96 13.59 3 70026 21513 42529793
Pregnancy 24.84 13.59 11 70018 257 42551049
Basedow's disease 24.78 13.59 7 70022 39 42551267
Incorrect route of product administration 24.55 13.59 5 70024 24300 42527006
Pulmonary oedema 24.37 13.59 31 69998 53241 42498065
Skin disorder 24.27 13.59 72 69957 16872 42534434
Cardiac disorder 23.96 13.59 27 70002 48905 42502401
Lung disorder 23.95 13.59 26 70003 47897 42503409
Optic ischaemic neuropathy 23.83 13.59 26 70003 2749 42548557
Blood pressure decreased 23.65 13.59 37 69992 58295 42493011
Genital herpes 23.50 13.59 15 70014 747 42550559
Retinal detachment 23.39 13.59 40 69989 6485 42544821
Ammonia abnormal 23.33 13.59 8 70021 91 42551215
Upper respiratory tract infection 23.24 13.59 21 70008 42152 42509154
Product prescribing error 23.22 13.59 7 70022 26105 42525201
Myocardial infarction 23.03 13.59 115 69914 123894 42427412
Constipation 23.01 13.59 164 69865 162127 42389179
Malaise 22.91 13.59 482 69547 211674 42339632
Loss of personal independence in daily activities 22.78 13.59 29 70000 49787 42501519
Hepatitis C virus test 22.49 13.59 7 70022 57 42551249
Liver transplant failure 22.02 13.59 8 70021 109 42551197
Anticoagulation drug level below therapeutic 21.69 13.59 16 70013 1010 42550296
Neurotoxicity 21.66 13.59 6 70023 23645 42527661
Myelosuppression 21.29 13.59 21 70008 40440 42510866
Troponin increased 21.29 13.59 3 70026 19059 42532247
Haematuria 21.28 13.59 39 69990 57760 42493546
Osteonecrosis of jaw 21.27 13.59 3 70026 19046 42532260
Thrombosis 21.22 13.59 51 69978 68460 42482846
Photosensitivity reaction 21.15 13.59 57 69972 12645 42538661
Stress 20.99 13.59 25 70004 44187 42507119
Hepatic lesion 20.86 13.59 31 69998 4463 42546843
Pyrexia 20.70 13.59 817 69212 393225 42158081
Hypocalcaemia 20.56 13.59 12 70017 30161 42521145
Abortion spontaneous 20.55 13.59 11 70018 393 42550913
Nasopharyngitis 20.53 13.59 70 69959 83926 42467380
Diabetic hyperglycaemic coma 20.45 13.59 6 70023 39 42551267
Myelodysplastic syndrome 20.40 13.59 6 70023 22739 42528567
Alpha 1 foetoprotein abnormal 20.16 13.59 5 70024 15 42551291
Metabolic acidosis 19.99 13.59 34 69995 51824 42499482
Thought blocking 19.98 13.59 8 70021 144 42551162
Arthropathy 19.85 13.59 12 70017 29585 42521721
Syncope 19.81 13.59 250 69779 99156 42452150
Hypoglycaemia 19.79 13.59 43 69986 59811 42491495
Rhabdomyolysis 19.76 13.59 64 69965 77955 42473351
Bronchiectasis 19.74 13.59 3 70026 18016 42533290
Anaphylactic shock 19.69 13.59 7 70022 23510 42527796
Orthostatic hypotension 19.67 13.59 13 70016 30557 42520749
Tubulointerstitial nephritis 19.52 13.59 14 70015 31534 42519772
Fat intolerance 19.42 13.59 4 70025 3 42551303
Bacterascites 19.42 13.59 4 70025 3 42551303
Ventricular tachycardia 19.17 13.59 13 70016 30147 42521159
Toxic epidermal necrolysis 19.16 13.59 10 70019 26740 42524566
Infection in an immunocompromised host 19.08 13.59 15 70014 1042 42550264
Adrenal insufficiency 18.90 13.59 4 70025 18920 42532386
Device related infection 18.84 13.59 5 70024 20274 42531032
Normal newborn 18.64 13.59 10 70019 359 42550947
Liver disorder 18.48 13.59 120 69909 39524 42511782
Inflammation 18.48 13.59 17 70012 33830 42517476
Mitochondrial toxicity 18.23 13.59 22 70007 2593 42548713
Pleural effusion 18.10 13.59 90 69939 97076 42454230
Exposure via body fluid 18.02 13.59 7 70022 116 42551190
Sarcoidosis 17.96 13.59 26 70003 3656 42547650
Productive cough 17.93 13.59 36 69993 51531 42499775
Urticaria 17.88 13.59 62 69967 73974 42477332
Sudden visual loss 17.83 13.59 5 70024 27 42551279
Ejection fraction decreased 17.78 13.59 7 70022 22080 42529226
Portal hypertensive gastropathy 17.78 13.59 13 70016 810 42550496
Asterixis 17.56 13.59 16 70013 1361 42549945
Respiratory distress 17.46 13.59 26 70003 41794 42509512
Gastric varices 17.45 13.59 12 70017 678 42550628
Acute respiratory failure 17.38 13.59 23 70006 38835 42512471
Retinal vein thrombosis 17.34 13.59 10 70019 414 42550892
COVID-19 pneumonia 17.15 13.59 7 70022 21606 42529700
Diverticulitis 17.08 13.59 8 70021 22765 42528541
Drug intolerance 17.06 13.59 71 69958 80353 42470953
Borderline personality disorder 17.02 13.59 10 70019 429 42550877
Sepsis 17.01 13.59 228 69801 199106 42352200
Anti-erythropoietin antibody positive 16.97 13.59 13 70016 869 42550437
Oral herpes 16.97 13.59 38 69991 7506 42543800
Nightmare 16.97 13.59 10 70019 25002 42526304
Clostridium difficile infection 16.94 13.59 8 70021 22651 42528655
Urinary retention 16.90 13.59 27 70002 42187 42509119
Heart rate irregular 16.85 13.59 3 70026 16047 42535259
Haemorrhoidal haemorrhage 16.80 13.59 27 70002 4161 42547145
Arthritis 16.75 13.59 27 70002 42038 42509268
Emotional disorder 16.74 13.59 34 69995 6280 42545026
Hepatitis chronic active 16.57 13.59 6 70023 81 42551225
Coma 16.47 13.59 40 69989 53514 42497792
Alopecia 16.43 13.59 93 69936 29183 42522123
Acute myeloid leukaemia 16.42 13.59 8 70021 22248 42529058
Hypophosphataemia 16.27 13.59 7 70022 20938 42530368
Viral load undetectable 16.24 13.59 3 70026 0 42551306
Labelled drug-drug interaction medication error 16.17 13.59 3 70026 15579 42535727
Synovitis 16.15 13.59 3 70026 15564 42535742
Cutaneous sarcoidosis 16.07 13.59 7 70022 157 42551149
Ear injury 16.04 13.59 5 70024 41 42551265
Aplasia pure red cell 16.01 13.59 36 69993 7130 42544176
Nasal congestion 15.89 13.59 15 70014 29486 42521820
Respiratory arrest 15.84 13.59 14 70015 28410 42522896
Dry mouth 15.80 13.59 116 69913 39763 42511543
Skin irritation 15.77 13.59 37 69992 7537 42543769
Sleep apnoea syndrome 15.59 13.59 8 70021 21600 42529706
Accidental exposure to product 15.55 13.59 7 70022 20386 42530920
Mouth ulceration 15.53 13.59 57 69972 14906 42536400
Gallbladder cancer 15.25 13.59 8 70021 274 42551032
Oesophageal variceal ligation 15.25 13.59 6 70023 103 42551203
Tongue ulceration 15.20 13.59 15 70014 1410 42549896
Lymphocyte count decreased 15.14 13.59 14 70015 27795 42523511
Photophobia 15.12 13.59 38 69991 8081 42543225
Therapy responder 15.08 13.59 7 70022 183 42551123
Deafness congenital 15.04 13.59 6 70023 107 42551199
Mobility decreased 14.69 13.59 22 70007 35284 42516022
Neutropenic sepsis 14.69 13.59 4 70025 15942 42535364
Fungal infection 14.68 13.59 7 70022 19715 42531591
Pneumonitis 14.61 13.59 29 70000 41689 42509617
Oral lichen planus 14.54 13.59 7 70022 199 42551107
Feeling abnormal 14.54 13.59 177 69852 69609 42481697
Aspergillus infection 14.53 13.59 4 70025 15833 42535473
Body temperature decreased 14.49 13.59 3 70026 14410 42536896
Chemical burn of skin 14.36 13.59 4 70025 21 42551285
Product use issue 14.34 13.59 71 69958 76680 42474626
Dysphagia 14.33 13.59 66 69963 72653 42478653
Neutralising antibodies positive 14.32 13.59 6 70023 122 42551184
Blood uric acid increased 14.30 13.59 57 69972 15490 42535816
Chronic hepatitis 14.26 13.59 11 70018 743 42550563
Tachypnoea 14.22 13.59 9 70020 21653 42529653
Fibrosis 14.21 13.59 21 70008 3009 42548297
Basal cell carcinoma 14.18 13.59 10 70019 22723 42528583
Transaminases decreased 14.16 13.59 3 70026 3 42551303
Delusional disorder, erotomanic type 14.16 13.59 3 70026 3 42551303
Back pain 14.04 13.59 157 69872 141619 42409687
Suspected transmission of an infectious agent via product 13.99 13.59 12 70017 942 42550364
Injection site erythema 13.98 13.59 68 69961 20127 42531179
Hepatic amoebiasis 13.98 13.59 5 70024 65 42551241
Gene mutation identification test positive 13.87 13.59 7 70022 221 42551085
Pulmonary tuberculosis 13.85 13.59 29 70000 5472 42545834
Seizure 13.79 13.59 129 69900 120432 42430874
Hypomagnesaemia 13.64 13.59 16 70013 28472 42522834
Therapy partial responder 13.59 13.59 8 70021 20013 42531293

FDA Adverse Event Reporting System (Geriatric)

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 5044.09 12.97 4043 95002 543043 109947211
Hepatitis C 2848.83 12.97 852 98193 11721 110478533
Hepatocellular carcinoma 2833.56 12.97 804 98241 9076 110481178
Haemoglobin decreased 1349.83 12.97 1371 97674 247356 110242898
White blood cell count decreased 1133.68 12.97 1203 97842 228187 110262067
Platelet count decreased 1079.79 12.97 1175 97870 229268 110260986
Ascites 972.00 12.97 744 98301 92064 110398190
Blood bilirubin increased 886.71 12.97 650 98395 75322 110414932
Hyperbilirubinaemia 750.94 12.97 419 98626 30252 110460002
Hepatic encephalopathy 741.26 12.97 404 98641 27852 110462402
Jaundice 737.14 12.97 527 98518 58709 110431545
Fatigue 730.83 12.97 2563 96482 1213395 109276859
Hepatic failure 701.87 12.97 543 98502 68196 110422058
Rash 699.69 12.97 1955 97090 819009 109671245
Hepatic cirrhosis 672.64 12.97 526 98519 67100 110423154
Neutrophil count decreased 585.39 12.97 628 98417 120313 110369941
Insomnia 470.41 12.97 1013 98032 359577 110130677
Leukopenia 463.04 12.97 617 98428 148174 110342080
Genotype drug resistance test positive 460.28 12.97 127 98918 1279 110488975
Anal pruritus 446.51 12.97 117 98928 950 110489304
Influenza like illness 438.12 12.97 465 98580 87947 110402307
Pruritus 435.36 12.97 1324 97721 580236 109910018
Anorectal discomfort 394.57 12.97 146 98899 3980 110486274
Haemolytic anaemia 388.48 12.97 239 98806 20681 110469573
Retinopathy 388.11 12.97 147 98898 4282 110485972
Oesophageal varices haemorrhage 372.37 12.97 147 98898 4798 110485456
Depression 362.64 12.97 846 98199 316489 110173765
Hepatic cancer 362.18 12.97 184 98861 10972 110479282
Thrombocytopenia 334.92 12.97 870 98175 348015 110142239
Pancytopenia 330.01 12.97 637 98408 208976 110281278
Infusion related reaction 324.75 12.97 3 99042 381159 110109095
Irritability 317.49 12.97 295 98750 47514 110442740
Nausea 316.28 12.97 2036 97009 1233654 109256600
Drug hypersensitivity 304.49 12.97 28 99017 454062 110036192
Viral load increased 298.80 12.97 113 98932 3277 110486977
Virologic failure 293.52 12.97 124 98921 4828 110485426
Liver transplant 289.07 12.97 120 98925 4469 110485785
Decreased appetite 287.66 12.97 1008 98037 474838 110015416
Hepatitis C RNA positive 280.81 12.97 61 98984 191 110490063
Hyperuricaemia 234.70 12.97 152 98893 14379 110475875
Joint swelling 221.99 12.97 61 98984 442784 110047470
Synovitis 221.30 12.97 5 99040 274087 110216167
Dysgeusia 220.25 12.97 292 98753 69693 110420561
Toxicity to various agents 218.09 12.97 79 98966 480476 110009778
Renal impairment 208.01 12.97 496 98549 187949 110302305
Hepatitis C RNA increased 207.31 12.97 53 98992 386 110489868
Arthropathy 205.99 12.97 13 99032 287509 110202745
Asthenia 204.31 12.97 1181 97864 687818 109802436
Proctalgia 200.61 12.97 133 98912 13089 110477165
Varices oesophageal 197.05 12.97 106 98939 7109 110483145
COVID-19 195.80 12.97 5 99040 245055 110245199
Peritonitis bacterial 194.68 12.97 120 98925 10413 110479841
Contraindicated product administered 191.38 12.97 7 99038 248260 110241994
Porphyria non-acute 187.47 12.97 55 98990 702 110489552
Cryoglobulinaemia 186.63 12.97 62 98983 1217 110489037
Off label use 182.77 12.97 710 98335 1499475 108990779
Hepatitis B reactivation 177.01 12.97 100 98945 7384 110482870
Condition aggravated 173.89 12.97 243 98802 734593 109755661
Hypersensitivity 172.40 12.97 73 98972 403925 110086329
Retinal exudates 170.57 12.97 58 98987 1226 110489028
Viral mutation identified 170.54 12.97 82 98963 4337 110485917
Portal vein thrombosis 168.81 12.97 95 98950 6963 110483291
Rheumatoid arthritis 166.46 12.97 33 99012 299580 110190674
Haemorrhoids 164.98 12.97 181 98864 35491 110454763
Systemic lupus erythematosus 164.33 12.97 18 99027 254320 110235934
Wound 163.82 12.97 12 99033 234425 110255829
Product use in unapproved indication 162.34 12.97 100 98945 447277 110042977
Neutropenia 157.69 12.97 709 98336 373911 110116343
Drug intolerance 155.82 12.97 85 98960 406427 110083827
Peripheral swelling 149.81 12.97 88 98957 403946 110086308
Musculoskeletal stiffness 148.93 12.97 34 99011 279788 110210466
Therapeutic product effect decreased 148.79 12.97 21 99024 244295 110245959
Blood cholesterol increased 146.74 12.97 4 99041 184781 110305473
Psoriatic arthropathy 143.63 12.97 8 99037 196753 110293501
Treatment failure 143.43 12.97 559 98486 276675 110213579
Hepatic cancer recurrent 141.45 12.97 37 99008 298 110489956
Red blood cell count decreased 139.24 12.97 228 98817 65695 110424559
Wheezing 137.87 12.97 30 99015 255200 110235054
Pain 136.12 12.97 422 98623 954533 109535721
Hepatorenal syndrome 135.31 12.97 71 98974 4526 110485728
Helicobacter infection 133.98 12.97 7 99038 181870 110308384
Dry skin 133.76 12.97 297 98748 107356 110382898
Duodenal ulcer perforation 133.60 12.97 6 99039 177694 110312560
Malignant neoplasm progression 127.71 12.97 7 99038 174560 110315694
Headache 124.89 12.97 1272 97773 881105 109609149
Fall 124.17 12.97 219 98826 603263 109886991
Vogt-Koyanagi-Harada disease 123.39 12.97 38 99007 578 110489676
Nasopharyngitis 122.36 12.97 104 98941 394257 110095997
Weight increased 120.32 12.97 119 98926 419525 110070729
Completed suicide 118.38 12.97 35 99010 242346 110247908
Mobility decreased 118.32 12.97 33 99012 237389 110252865
Therapeutic product effect incomplete 117.48 12.97 28 99017 223777 110266477
Maternal exposure during pregnancy 117.06 12.97 41 99004 254842 110235412
Fibromyalgia 113.21 12.97 11 99034 170898 110319356
Folliculitis 113.16 12.97 10 99035 167643 110322611
Irritable bowel syndrome 113.03 12.97 9 99036 164206 110326048
Liver transplant rejection 111.04 12.97 59 98986 3859 110486395
Osteoarthritis 110.48 12.97 16 99029 182607 110307647
Febrile neutropenia 109.14 12.97 75 98970 316692 110173562
C-reactive protein increased 109.13 12.97 30 99015 217889 110272365
Injury 108.48 12.97 15 99030 177250 110313004
Swelling 105.95 12.97 95 98950 350946 110139308
Hypertension 105.89 12.97 184 98861 509900 109980354
Retinal haemorrhage 105.57 12.97 79 98966 9422 110480832
Depressed mood 103.22 12.97 191 98854 60618 110429636
C-reactive protein abnormal 102.25 12.97 3 99042 129692 110360562
Product use issue 101.91 12.97 78 98967 311617 110178637
Sinusitis 101.21 12.97 71 98974 296617 110193637
Intentional product use issue 100.66 12.97 48 98997 247858 110242396
Rheumatoid factor positive 100.43 12.97 4 99041 131636 110358618
Encephalopathy 98.86 12.97 222 98823 80833 110409421
Hepatic hydrothorax 96.70 12.97 22 99023 90 110490164
Pericarditis 95.98 12.97 38 99007 219076 110271178
Lethargy 94.34 12.97 238 98807 93338 110396916
Urticaria 94.18 12.97 88 98957 318769 110171485
Portal hypertension 94.15 12.97 71 98974 8566 110481688
Glossodynia 93.22 12.97 41 99004 221963 110268291
Hepatic enzyme increased 93.10 12.97 90 98955 320802 110169452
Alanine aminotransferase increased 92.90 12.97 368 98677 183405 110306849
Mood swings 92.30 12.97 108 98937 22704 110467550
Pyrexia 92.11 12.97 1217 97828 897048 109593206
Impaired healing 89.70 12.97 32 99013 196685 110293569
Drug abuse 89.62 12.97 24 99021 177387 110312867
Yellow skin 89.49 12.97 52 98993 4050 110486204
Disease progression 89.20 12.97 54 98991 243980 110246274
Asthma 87.89 12.97 58 98987 250233 110240021
Haemolysis 87.76 12.97 88 98957 15551 110474703
Inflammation 87.15 12.97 32 99013 193206 110297048
Oxygen saturation decreased 85.67 12.97 18 99027 156964 110333290
Bursitis 81.87 12.97 10 99035 129908 110360346
Ill-defined disorder 81.57 12.97 20 99025 156833 110333421
Type 2 diabetes mellitus 80.52 12.97 29 99016 177203 110313051
Joint range of motion decreased 80.26 12.97 8 99037 121824 110368430
Discomfort 79.18 12.97 47 98998 214660 110275594
Cutaneous sarcoidosis 76.84 12.97 26 99019 541 110489713
Child-Pugh-Turcotte score increased 76.58 12.97 16 99029 39 110490215
Bilirubin conjugated increased 76.49 12.97 55 98990 6169 110484085
Infection 74.80 12.97 131 98914 362069 110128185
Injection site pain 74.47 12.97 33 99012 177889 110312365
Lung disorder 74.41 12.97 34 99011 180013 110310241
Ocular icterus 73.27 12.97 53 98992 6000 110484254
Intentional product misuse 73.02 12.97 15 99030 132889 110357365
Erythema multiforme 72.55 12.97 92 98953 21005 110469249
Gastrointestinal disorder 71.16 12.97 67 98978 241885 110248369
Vomiting 70.62 12.97 1176 97869 909499 109580755
Anger 70.35 12.97 86 98959 18921 110471333
Autoimmune hepatitis 69.98 12.97 76 98969 14728 110475526
Hypotension 69.23 12.97 239 98806 523610 109966644
Lower respiratory tract infection 68.41 12.97 70 98975 243036 110247218
Liver injury 67.67 12.97 25 99020 150388 110339866
Glomerulonephritis membranoproliferative 66.57 12.97 26 99019 824 110489430
Rash pruritic 66.28 12.97 216 98829 97853 110392401
Prescribed overdose 65.68 12.97 3 99042 87578 110402676
Facial paralysis 65.57 12.97 94 98951 24120 110466134
Chills 64.44 12.97 339 98706 190241 110300013
Arthritis 64.20 12.97 35 99010 167551 110322703
Gastric varices haemorrhage 64.09 12.97 22 99023 479 110489775
Focal segmental glomerulosclerosis 63.61 12.97 42 99003 4103 110486151
Intentional overdose 63.11 12.97 20 99025 132481 110357773
Myalgia 62.89 12.97 377 98668 222004 110268250
Obesity 59.82 12.97 14 99031 113337 110376917
Basedow's disease 59.36 12.97 17 99028 198 110490056
Hypoaesthesia 59.27 12.97 120 98925 314103 110176151
Haematemesis 59.21 12.97 150 98895 58958 110431296
Suicidal ideation 59.13 12.97 202 98843 93735 110396519
Death 59.13 12.97 375 98670 698494 109791760
General physical health deterioration 58.94 12.97 190 98855 425105 110065149
Ammonia increased 58.83 12.97 53 98992 8197 110482057
Pain in extremity 57.97 12.97 232 98813 486886 110003368
Aspartate aminotransferase increased 57.90 12.97 290 98755 159646 110330608
Renal failure 57.75 12.97 374 98671 226200 110264054
Hospitalisation 57.20 12.97 28 99017 142465 110347789
Psychotic disorder 57.13 12.97 135 98910 50802 110439452
Hepatitis C virus test positive 55.86 12.97 19 99026 402 110489852
Aplasia pure red cell 55.79 12.97 55 98990 9523 110480731
Blood pressure increased 55.57 12.97 91 98954 258282 110231972
Loss of personal independence in daily activities 55.08 12.97 33 99012 149987 110340267
Wound infection 54.86 12.97 10 99035 96455 110393799
Drug eruption 54.62 12.97 137 98908 53522 110436732
Weight decreased 54.58 12.97 650 98395 467407 110022847
Muscular weakness 53.92 12.97 87 98958 248381 110241873
Hepatitis E 53.88 12.97 39 99006 4420 110485834
Syncope 53.26 12.97 337 98708 202199 110288055
Inappropriate schedule of product administration 52.49 12.97 63 98982 203574 110286680
Osteoporosis 51.86 12.97 8 99037 87144 110403110
Disturbance in attention 51.69 12.97 147 98898 61848 110428406
Lip dry 51.57 12.97 13 99032 100070 110390184
Abdominal discomfort 51.12 12.97 181 98864 393677 110096577
Blood pressure systolic increased 50.81 12.97 7 99038 82984 110407270
Hypercholesterolaemia 50.42 12.97 10 99035 90827 110399427
Sedation 50.32 12.97 3 99042 69680 110420574
Liver transplant failure 50.29 12.97 14 99031 146 110490108
Live birth 50.15 12.97 3 99042 69481 110420773
Chronic hepatitis C 49.85 12.97 20 99025 681 110489573
Hepatitis C RNA 49.81 12.97 11 99034 38 110490216
Flushing 49.54 12.97 16 99029 104720 110385534
Splenomegaly 49.39 12.97 83 98962 24415 110465839
Blood bilirubin unconjugated increased 48.89 12.97 23 99022 1158 110489096
Contusion 48.51 12.97 84 98961 233277 110256977
Hepatic fibrosis 48.25 12.97 47 98998 8019 110482235
Anaphylactic reaction 48.14 12.97 21 99024 114279 110375975
Arthralgia 46.98 12.97 459 98586 779173 109711081
Gait disturbance 46.91 12.97 113 98932 278095 110212159
Blood pressure fluctuation 46.55 12.97 6 99039 74818 110415436
Exposure during pregnancy 46.19 12.97 49 98996 167375 110322879
Drug reaction with eosinophilia and systemic symptoms 45.23 12.97 169 98876 81926 110408328
Hepatic neoplasm 44.86 12.97 33 99012 3834 110486420
Lower limb fracture 44.64 12.97 7 99038 75341 110414913
Paraesthesia 44.53 12.97 115 98930 276406 110213848
Injection site rash 42.84 12.97 76 98969 23343 110466911
Optic ischaemic neuropathy 42.80 12.97 33 99012 4114 110486140
Sciatica 42.16 12.97 15 99030 92384 110397870
Cardiac failure congestive 41.87 12.97 44 99001 150956 110339298
Musculoskeletal pain 41.69 12.97 62 98983 182961 110307293
Alopecia universalis 41.67 12.97 15 99030 377 110489877
Upper respiratory tract infection 41.46 12.97 34 99011 131294 110358960
Serotonin syndrome 41.38 12.97 3 99042 59150 110431104
Electrocardiogram QT prolonged 41.37 12.97 23 99022 108937 110381317
Autoimmune thyroiditis 41.34 12.97 39 99006 6395 110483859
Hepatitis C virus test 40.78 12.97 10 99035 60 110490194
Toxic skin eruption 40.05 12.97 81 98964 27434 110462820
Anorectal disorder 40.04 12.97 27 99018 2732 110487522
Mucosal inflammation 39.96 12.97 18 99027 96123 110394131
Night sweats 39.50 12.97 37 99008 133946 110356308
Sarcoidosis 38.81 12.97 52 98993 12527 110477727
Hip arthroplasty 38.56 12.97 3 99042 55810 110434444
Nasal congestion 38.41 12.97 20 99025 98262 110391992
Nail disorder 37.65 12.97 4 99041 57931 110432323
Hepatitis cholestatic 37.41 12.97 61 98984 17505 110472749
Dermatitis 37.06 12.97 79 98966 27758 110462496
Retinal detachment 35.96 12.97 47 98998 11053 110479201
Therapeutic embolisation 35.72 12.97 15 99030 575 110489679
Incorrect route of product administration 35.66 12.97 7 99038 64054 110426200
Pulmonary embolism 35.45 12.97 88 98957 214386 110275868
Angiotensin converting enzyme increased 34.92 12.97 11 99034 181 110490073
Vision blurred 34.72 12.97 216 98829 128806 110361448
Chromaturia 34.21 12.97 79 98966 29281 110460973
Heart rate decreased 33.61 12.97 16 99029 82740 110407514
Nephrotic syndrome 33.57 12.97 51 98994 13780 110476474
Blister 33.29 12.97 99 98946 227277 110262977
Tongue pigmentation 33.22 12.97 8 99037 44 110490210
Blood creatinine increased 32.92 12.97 278 98767 182611 110307643
Alcoholism 32.91 12.97 27 99018 3680 110486574
Hepatic cytolysis 32.87 12.97 5 99040 55048 110435206
Transaminases increased 32.86 12.97 128 98917 63262 110426992
Drug interaction 32.62 12.97 629 98416 499554 109990700
Gait inability 32.24 12.97 45 99000 136331 110353923
Photosensitivity reaction 32.21 12.97 71 98974 25518 110464736
Testicular germ cell tumour mixed 32.20 12.97 7 99038 22 110490232
Skin disorder 32.18 12.97 98 98947 42815 110447439
Type 1 diabetes mellitus 31.98 12.97 40 99005 9007 110481247
Blood albumin decreased 31.78 12.97 74 98971 27578 110462676
Liver function test increased 31.77 12.97 20 99025 88528 110401726
Drug ineffective for unapproved indication 30.78 12.97 28 99017 102810 110387444
Exostosis 30.31 12.97 3 99042 45953 110444301
Emotional disorder 30.28 12.97 53 98992 16107 110474147
Alpha 1 foetoprotein increased 30.24 12.97 15 99030 849 110489405
Hyperthyroidism 30.08 12.97 75 98970 29186 110461068
Mood altered 30.01 12.97 62 98983 21313 110468941
Gastric varices 30.00 12.97 15 99030 864 110489390
Viral load 29.90 12.97 8 99037 71 110490183
Biliary colic 29.80 12.97 28 99017 4569 110485685
Acute stress disorder 29.66 12.97 13 99032 554 110489700
Anti-erythropoietin antibody positive 29.57 12.97 14 99031 715 110489539
Pulmonary fibrosis 29.12 12.97 29 99016 102013 110388241
Glomerulonephritis 29.12 12.97 28 99017 4702 110485552
Stomatitis 28.87 12.97 134 98911 270108 110220146
Pulmonary tuberculosis 28.53 12.97 38 99007 9101 110481153
Portal hypertensive gastropathy 28.47 12.97 19 99026 1889 110488365
Overgrowth fungal 28.35 12.97 9 99036 152 110490102
Aplastic anaemia 27.88 12.97 65 98980 24243 110466011
Myelosuppression 27.87 12.97 26 99019 94314 110395940
Neck pain 27.76 12.97 42 99003 123088 110367166
Hepatitis C RNA fluctuation 27.75 12.97 5 99040 3 110490251
Hypoxia 27.47 12.97 46 98999 129469 110360785
Plasma cell myeloma 27.40 12.97 11 99034 62925 110427329
Homicidal ideation 27.25 12.97 24 99021 3603 110486651
Paranoia 26.95 12.97 61 98984 22313 110467941
Pathogen resistance 26.89 12.97 53 98992 17619 110472635
Adverse drug reaction 26.83 12.97 33 99012 105526 110384728
Cardiogenic shock 26.69 12.97 9 99036 57329 110432925
Acute on chronic liver failure 26.11 12.97 11 99034 425 110489829
Erythema nodosum 26.09 12.97 31 99014 6622 110483632
Taste disorder 26.01 12.97 13 99032 65374 110424880
Asterixis 25.96 12.97 22 99023 3136 110487118
Hypersplenism 25.93 12.97 13 99032 753 110489501
Haemorrhoidal haemorrhage 25.80 12.97 34 99011 8059 110482195
Sudden hearing loss 25.51 12.97 19 99026 2250 110488004
Urate nephropathy 25.36 12.97 9 99036 217 110490037
Anticoagulation drug level below therapeutic 25.24 12.97 17 99028 1717 110488537
Cholelithiasis 25.09 12.97 118 98927 63304 110426950
Sudden visual loss 24.97 12.97 7 99038 75 110490179
Complications of transplanted liver 24.41 12.97 11 99034 501 110489753
Neuropathy peripheral 24.17 12.97 81 98964 179196 110311058
Renal disorder 24.11 12.97 98 98947 49381 110440873
Hepatitis virus-associated nephropathy 24.08 12.97 4 99041 0 110490254
Genital herpes simplex 24.01 12.97 11 99034 521 110489733
Adjustment disorder with depressed mood 24.00 12.97 5 99040 43878 110446376
Neutralising antibodies positive 23.94 12.97 10 99035 378 110489876
Throat irritation 23.91 12.97 9 99036 53543 110436711
Bleeding varicose vein 23.84 12.97 12 99033 701 110489553
Thought blocking 23.83 12.97 9 99036 260 110489994
Red blood cell sedimentation rate increased 23.82 12.97 21 99024 78281 110411973
Hepatic pain 23.80 12.97 25 99020 4665 110485589
Malaise 23.78 12.97 778 98267 671041 109819213
Pancreatitis acute 23.74 12.97 112 98933 60162 110430092
Skin irritation 23.70 12.97 48 98997 16271 110473983
Visual acuity reduced 23.68 12.97 73 98972 32100 110458154
Adverse event 23.68 12.97 38 99007 108771 110381483
Oral lichen planus 23.59 12.97 13 99032 914 110489340
Genital herpes 23.56 12.97 19 99026 2528 110487726
Injection site swelling 23.52 12.97 13 99032 61777 110428477
Coronary artery disease 23.33 12.97 18 99027 71672 110418582
Pneumocystis jirovecii pneumonia 23.10 12.97 5 99040 42730 110447524
Hepatic lesion 23.04 12.97 33 99012 8460 110481794
Alpha 1 foetoprotein abnormal 22.76 12.97 6 99039 50 110490204
Haematocrit decreased 22.59 12.97 118 98927 65999 110424255
Pregnancy of partner 22.53 12.97 9 99036 303 110489951
Rash papular 22.51 12.97 65 98980 27574 110462680
Amaurosis fugax 22.47 12.97 18 99027 2372 110487882
Anaphylactic shock 22.46 12.97 9 99036 51537 110438717
Photophobia 22.35 12.97 62 98983 25709 110464545
Product prescribing error 22.30 12.97 9 99036 51322 110438932
Diverticulitis 22.27 12.97 10 99035 53512 110436742
Pneumonia aspiration 22.15 12.97 24 99021 81209 110409045
Muscle spasticity 22.05 12.97 3 99042 35912 110454342
Blood uric acid increased 21.94 12.97 55 98990 21474 110468780
Dehydration 21.92 12.97 362 98683 279149 110211105
Frequent bowel movements 21.89 12.97 19 99026 71371 110418883
Autoimmune disorder 21.87 12.97 16 99029 65467 110424787
Oedema due to hepatic disease 21.87 12.97 5 99040 21 110490233
Angioedema 21.82 12.97 34 99011 98466 110391788
Coma hepatic 21.78 12.97 13 99032 1064 110489190
Oral mucosal blistering 21.77 12.97 31 99014 7903 110482351
Procedural pain 21.77 12.97 3 99042 35562 110454692
Joint stiffness 21.73 12.97 17 99028 67226 110423028
Mental disorder 21.48 12.97 80 98965 38711 110451543
Immune thrombocytopenia 21.40 12.97 56 98989 22438 110467816
Faeces discoloured 21.35 12.97 73 98972 33875 110456379
Accidental exposure to product 21.35 12.97 9 99036 49999 110440255
Rhinorrhoea 21.28 12.97 37 99008 102629 110387625
Basal cell carcinoma 21.26 12.97 7 99038 45263 110444991
Face oedema 21.08 12.97 72 98973 33397 110456857
Remission not achieved 21.01 12.97 10 99035 517 110489737
Injection site dermatitis 21.00 12.97 5 99040 26 110490228
Skin lesion 20.38 12.97 96 98949 51535 110438719
Migraine 20.22 12.97 82 98963 171570 110318684
Depressed level of consciousness 20.21 12.97 44 99001 112234 110378020
Colitis 20.21 12.97 38 99007 102285 110387969
Immunodeficiency 20.09 12.97 5 99040 38833 110451421
Transplant failure 20.05 12.97 25 99020 5610 110484644
Stress 20.04 12.97 40 99005 105308 110384946
Chest discomfort 19.89 12.97 84 98961 173764 110316490
Orthostatic hypotension 19.87 12.97 18 99027 66231 110424023
Chronic hepatic failure 19.80 12.97 13 99032 1258 110488996
Blood bilirubin abnormal 19.70 12.97 15 99030 1835 110488419
Lupus-like syndrome 19.70 12.97 6 99039 40786 110449468
Hepatic function abnormal 19.52 12.97 142 98903 89153 110401101
Gingival bleeding 19.50 12.97 50 98995 19789 110470465
Back injury 19.50 12.97 9 99036 47390 110442864
Hepatic mass 19.46 12.97 18 99027 2880 110487374
Sleep apnoea syndrome 19.44 12.97 6 99039 40441 110449813
Affect lability 19.40 12.97 48 98997 18589 110471665
Therapy responder 19.32 12.97 9 99036 443 110489811
Transplant rejection 19.27 12.97 57 98988 24510 110465744
Infection in an immunocompromised host 19.16 12.97 15 99030 1912 110488342
Bacterascites 19.07 12.97 4 99041 10 110490244
Hepatorenal failure 19.00 12.97 13 99032 1347 110488907
Delirium 18.90 12.97 60 98985 134965 110355289
Respiratory depression 18.89 12.97 3 99042 31998 110458256
Optic neuropathy 18.75 12.97 22 99023 4636 110485618
Device issue 18.75 12.97 4 99041 34531 110455723
Device related infection 18.75 12.97 6 99039 39513 110450741
Ammonia abnormal 18.64 12.97 8 99037 324 110489930
Tinnitus 18.63 12.97 105 98940 60435 110429819
Respiratory arrest 18.51 12.97 15 99030 58284 110431970
Extradural abscess 18.45 12.97 15 99030 2019 110488235
Hepatopulmonary syndrome 18.44 12.97 7 99038 205 110490049
Clostridium difficile infection 18.39 12.97 12 99033 52117 110438137
Sopor 18.34 12.97 5 99040 36541 110453713
Surgery 18.33 12.97 7 99038 41276 110448978
Ocular sarcoidosis 18.10 12.97 6 99039 117 110490137
Chronic hepatitis 18.07 12.97 14 99031 1758 110488496
Model for end stage liver disease score 18.06 12.97 3 99042 0 110490254
Transfusion 18.02 12.97 57 98988 25415 110464839
Retinal vein occlusion 17.95 12.97 20 99025 3987 110486267
Hair disorder 17.95 12.97 12 99033 1197 110489057
Muscle spasms 17.88 12.97 161 98884 277996 110212258
Chronic obstructive pulmonary disease 17.86 12.97 45 99000 109113 110381141
Mitochondrial toxicity 17.73 12.97 18 99027 3227 110487027
Pancreas transplant rejection 17.68 12.97 8 99037 368 110489886
Cheilitis 17.66 12.97 25 99020 6340 110483914
Acute respiratory failure 17.62 12.97 25 99020 75235 110415019
Cerebrovascular accident 17.56 12.97 93 98952 181191 110309063
Respiratory disorder 17.43 12.97 23 99022 71359 110418895
Cardiac arrest 17.40 12.97 104 98941 196649 110293605
Hepatitis B 17.33 12.97 31 99014 9581 110480673
Hip fracture 17.29 12.97 5 99040 35146 110455108
Pityriasis 17.27 12.97 4 99041 18 110490236
Psoriasis 17.05 12.97 66 98979 139927 110350327
Facial paresis 16.95 12.97 24 99021 6089 110484165
Hydrocholecystis 16.95 12.97 9 99036 588 110489666
VIIIth nerve lesion 16.93 12.97 4 99041 20 110490234
Body temperature decreased 16.84 12.97 6 99039 36929 110453325
Labelled drug-drug interaction medication error 16.74 12.97 3 99042 29299 110460955
Abnormal dreams 16.70 12.97 36 99009 12744 110477510
Lymphocyte count decreased 16.64 12.97 16 99029 57227 110433027
Portopulmonary hypertension 16.63 12.97 6 99039 152 110490102
Poisoning 16.58 12.97 3 99042 29102 110461152
Palmar-plantar erythrodysaesthesia syndrome 16.55 12.97 8 99037 41017 110449237
Lymph node tuberculosis 16.49 12.97 11 99034 1093 110489161
Pain in jaw 16.46 12.97 13 99032 51164 110439090
Tachycardia 16.46 12.97 127 98918 226518 110263736
Movement disorder 16.45 12.97 6 99039 36398 110453856
Limb discomfort 16.43 12.97 8 99037 40846 110449408
Therapeutic response decreased 16.40 12.97 39 99006 96460 110393794
Therapy non-responder 16.37 12.97 214 98831 157093 110333161
Suspected transmission of an infectious agent via product 16.36 12.97 12 99033 1388 110488866
Serum ferritin increased 16.21 12.97 34 99011 11813 110478441
Blood pressure diastolic decreased 16.07 12.97 6 99039 35879 110454375
Exposure via direct contact 16.06 12.97 5 99040 79 110490175
Deafness unilateral 16.00 12.97 20 99025 4499 110485755
Oesophageal variceal ligation 15.96 12.97 6 99039 171 110490083
Exposure via partner 15.91 12.97 4 99041 27 110490227
Wrong technique in product usage process 15.91 12.97 34 99011 87314 110402940
Viraemia 15.90 12.97 19 99026 4083 110486171
Intervertebral discitis 15.88 12.97 25 99020 6965 110483289
Gene mutation identification test positive 15.87 12.97 7 99038 303 110489951
Epilepsy 15.87 12.97 42 99003 100167 110390087
Procalcitonin 15.78 12.97 4 99041 28 110490226
Myoclonus 15.67 12.97 5 99040 32993 110457261
Haematotoxicity 15.67 12.97 48 98997 21034 110469220
Bulimia nervosa 15.66 12.97 7 99038 313 110489941
Haemorrhoids thrombosed 15.61 12.97 7 99038 315 110489939
Overdose 15.61 12.97 134 98911 233660 110256594
Hypoalbuminaemia 15.42 12.97 59 98986 28915 110461339
COVID-19 pneumonia 15.36 12.97 7 99038 37136 110453118
Excessive dynamic airway collapse 15.10 12.97 4 99041 34 110490220
Retinal vein thrombosis 15.07 12.97 9 99036 737 110489517
Sleep disorder 15.05 12.97 110 98935 198534 110291720
Granulomatous liver disease 15.04 12.97 12 99033 1572 110488682
Colitis ulcerative 15.04 12.97 29 99016 77334 110412920
Joint dislocation 14.84 12.97 6 99039 34184 110456070
Haemophilic arthropathy 14.77 12.97 6 99039 211 110490043
Congenital uterine anomaly 14.77 12.97 3 99042 6 110490248
Deafness 14.72 12.97 55 98990 26654 110463600
Laryngitis 14.64 12.97 10 99035 42401 110447853
Fat intolerance 14.61 12.97 4 99041 39 110490215
Hepatic amoebiasis 14.56 12.97 5 99040 109 110490145
Neurotoxicity 14.51 12.97 10 99035 42197 110448057
Paraesthesia oral 14.47 12.97 6 99039 33665 110456589
Cerebral arteriovenous malformation haemorrhagic 14.45 12.97 3 99042 7 110490247
Hyperlipidaemia 14.45 12.97 7 99038 35841 110454413
Blood disorder 14.42 12.97 29 99016 9781 110480473
Bone marrow failure 14.42 12.97 95 98950 57753 110432501
Gallbladder cancer 14.40 12.97 8 99037 572 110489682
Lung abscess 14.37 12.97 20 99025 4992 110485262
Throat tightness 14.34 12.97 6 99039 33483 110456771
Generalised oedema 14.32 12.97 60 98985 30644 110459610
Peritoneal tuberculosis 14.27 12.97 8 99037 582 110489672
Epistaxis 14.26 12.97 179 98866 130193 110360061
Prostate cancer 14.21 12.97 8 99037 37633 110452621
Tendonitis 14.21 12.97 3 99042 26080 110464174
Limb injury 14.20 12.97 8 99037 37628 110452626
Prurigo 14.14 12.97 11 99034 1389 110488865
International normalised ratio decreased 14.13 12.97 26 99019 8210 110482044
Myelodysplastic syndrome 14.10 12.97 8 99037 37476 110452778
Sinus congestion 13.80 12.97 5 99040 30454 110459800
Hepatitis C antibody positive 13.79 12.97 6 99039 251 110490003
Anaemia macrocytic 13.74 12.97 24 99021 7279 110482975
Depressive symptom 13.74 12.97 26 99019 8388 110481866
Incorrect product administration duration 13.71 12.97 45 99000 20453 110469801
Deafness neurosensory 13.62 12.97 28 99017 9591 110480663
Somnolence 13.61 12.97 186 98859 297263 110192991
Cataract 13.61 12.97 32 99013 79453 110410801
CD4 lymphocytes decreased 13.59 12.97 15 99030 2959 110487295
Portal vein flow decreased 13.57 12.97 4 99041 52 110490202
Disorientation 13.55 12.97 109 98936 70562 110419692
Retinitis 13.51 12.97 6 99039 32321 110457933
Bronchitis 13.36 12.97 84 98961 156948 110333306
Medication error 13.26 12.97 49 98996 105317 110384937
Cortisol free urine decreased 13.24 12.97 3 99042 12 110490242
Hyperalbuminaemia 13.23 12.97 4 99041 57 110490197
Alcohol abuse 13.15 12.97 19 99026 4910 110485344
Influenza 13.12 12.97 93 98952 169008 110321246
Acute hepatic failure 13.10 12.97 66 98979 36402 110453852
Oral tuberculosis 13.05 12.97 3 99042 13 110490241
Osteonecrosis 12.98 12.97 7 99038 33734 110456520

FDA Adverse Event Reporting System (Pediatric)

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
Maternal drugs affecting foetus 10.58 10.41 3 3 842 113105

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
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:35221 antimetabolite
CHEBI has role CHEBI:35441 antiinfective agent
CHEBI has role CHEBI:35469 antidepressant
CHEBI has role CHEBI:35526 hypoglycemic agent
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:59897 EC 2.7.7.49 (RNA-directed DNA polymerase) inhibitor
CHEBI has role CHEBI:62868 hepatoprotective agent
CHEBI has role CHEBI:64946 anti-HIV agent
CHEBI has role CHEBI:64951 anti-HBV agent
CHEBI has role CHEBI:149553 anticoronaviral agent
CHEBI has role CHEBI:233423 antifibrotic agent

Related Drugs by ATC class:

J05AP Antivirals for treatment of HCV infections 18 drugs
asunaprevirbeclabuvirboceprevirdaclatasvirdasabuvirelbasvirglecaprevirgrazoprevirledipasvirombitasvirparitaprevirpibrentasvir show all 18 →

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

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




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

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
Ectonucleotide pyrophosphatase/phosphodiesterase family member 1 Enzyme WOMBAT-PK
Cytosolic purine 5'-nucleotidase Enzyme WOMBAT-PK
Inosine-5'-monophosphate dehydrogenase 2 Enzyme INHIBITOR IC50 6 IUPHAR
DNA topoisomerase 1 Enzyme IC50 4.18 CHEMBL
Eukaryotic translation initiation factor 4E Nuclear other Kd 5.08 CHEMBL
Adenosine receptor A1 GPCR Ki 5.13 CHEMBL
Adenosine kinase Kinase WOMBAT-PK
NS5B protein Enzyme INHIBITOR CHEMBL CHEMBL
NS5 Enzyme EC50 4.68 CHEMBL
Adenosine receptor A1 GPCR Ki 5.35 CHEMBL

External reference:

IDSource
4019299 VUID
N0000147496 NUI
D00423 KEGG_DRUG
4019299 VANDF
C0035525 UMLSCUI
CHEBI:63580 CHEBI
RBV PDB_CHEM_ID
CHEMBL1643 ChEMBL_ID
DB00811 DRUGBANK_ID
D012254 MESH_DESCRIPTOR_UI
37542 PUBCHEM_CID
6842 IUPHAR_LIGAND_ID
3543 INN_ID
49717AWG6K UNII
9344 RXNORM
43465 MMSL
5421 MMSL
d00085 MMSL
003018 NDDF
35063004 SNOMEDCT_US
387188005 SNOMEDCT_US
49717AWG6K INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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 65862-207 TABLET, FILM COATED 200 mg ORAL ANDA 27 sections
Ribavirin Human Prescription Drug Label 1 65862-290 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
Ribavirin HUMAN PRESCRIPTION DRUG LABEL 1 72162-1331 POWDER, FOR SOLUTION 6 g RESPIRATORY (INHALATION) NDA 22 sections