valaciclovir ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
antivirals bicyclic heterocycle compounds 2798 124832-27-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • valacyclovir
  • valaciclovir
  • valcivir
  • valacyclovir hydrochloride
  • valacyclovir HCl
A prodrug of acyclovir that is used in the treatment of HERPES ZOSTER and HERPES SIMPLEX VIRUS INFECTION of the skin and mucous membranes, including GENITAL HERPES.
  • Molecular weight: 324.34
  • Formula: C13H20N6O4
  • CLOGP: -1.22
  • LIPINSKI: 0
  • HAC: 10
  • HDO: 3
  • TPSA: 146.85
  • ALOGS: -1.97
  • ROTB: 8

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
3 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 174 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 154.16 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
fu (Fraction unbound in plasma) 1 % Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K

Approvals:

DateAgencyCompanyOrphan
June 23, 1995 FDA GLAXOSMITHKLINE

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
Plasma cell myeloma 352.15 10.02 318 78426 35587 63374691
Acute kidney injury 327.63 10.02 887 77857 262528 63147750
Altered state of consciousness 305.29 10.02 252 78492 24978 63385300
Febrile neutropenia 296.58 10.02 529 78215 117920 63292358
Contraindicated product administered 224.17 10.02 11 78733 217637 63192641
Cytokine release syndrome 218.51 10.02 164 78580 14150 63396128
Neurotoxicity 216.67 10.02 175 78569 16815 63393463
Pemphigus 212.20 10.02 3 78741 183723 63226555
Encephalopathy 207.95 10.02 248 78496 38372 63371906
Toxic encephalopathy 200.14 10.02 116 78628 6463 63403815
Synovitis 193.91 10.02 9 78735 186909 63223369
Drug ineffective 184.39 10.02 673 78071 1044092 62366186
Hand deformity 182.45 10.02 3 78741 159454 63250824
Hepatocellular injury 172.99 10.02 191 78553 27190 63383088
Neutropenia 172.64 10.02 543 78201 174462 63235816
Glossodynia 169.45 10.02 14 78730 178862 63231416
Drug reaction with eosinophilia and systemic symptoms 165.48 10.02 207 78537 33629 63376649
Systemic lupus erythematosus 158.44 10.02 33 78711 208885 63201393
Dyslalia 150.53 10.02 45 78699 432 63409846
Toxic skin eruption 146.12 10.02 124 78620 12761 63397517
Dysarthria 144.97 10.02 219 78525 42492 63367786
Treatment failure 139.93 10.02 37 78707 199006 63211272
Agranulocytosis 129.72 10.02 158 78586 24976 63385302
Drug intolerance 127.58 10.02 117 78627 308544 63101734
Wound 123.32 10.02 26 78718 163237 63247041
Arthropathy 123.17 10.02 69 78675 234723 63175555
Blood urea increased 118.92 10.02 155 78589 26224 63384054
Joint swelling 116.59 10.02 141 78603 327525 63082753
Rash maculo-papular 116.07 10.02 169 78575 31727 63378551
Therapeutic product effect decreased 111.49 10.02 50 78694 193137 63217141
Swelling 108.40 10.02 109 78635 275269 63135009
Thrombocytopenia 107.40 10.02 421 78323 150736 63259542
Drug hypersensitivity 107.05 10.02 137 78607 310550 63099728
Pancytopenia 106.95 10.02 313 78431 96620 63313658
Herpes zoster 106.50 10.02 282 78462 82180 63328098
Rheumatoid arthritis 100.42 10.02 100 78644 253719 63156559
Helicobacter infection 97.72 10.02 4 78740 92781 63317497
Alopecia 97.65 10.02 168 78576 337368 63072910
Febrile bone marrow aplasia 94.55 10.02 76 78668 7249 63403029
Oral herpes 91.76 10.02 136 78608 25938 63384340
Completed suicide 90.02 10.02 34 78710 145639 63264639
Herpes simplex 88.50 10.02 77 78667 8194 63402084
Pericarditis 87.74 10.02 27 78717 131552 63278726
Abdominal discomfort 87.17 10.02 166 78578 320719 63089559
Pyrexia 79.47 10.02 912 77832 469566 62940712
Neuropathy peripheral 79.42 10.02 315 78429 113352 63296926
White blood cell count decreased 78.29 10.02 361 78383 138743 63271535
Vocal cord dysfunction 76.35 10.02 28 78716 529 63409749
Rheumatoid factor positive 76.17 10.02 8 78736 84398 63325880
Blood creatinine increased 72.64 10.02 257 78487 87587 63322691
Intentional overdose 72.46 10.02 5 78739 74147 63336131
Discomfort 72.02 10.02 61 78683 167313 63242965
Maternal exposure during pregnancy 71.72 10.02 101 78643 219961 63190317
Hepatic cytolysis 70.17 10.02 91 78653 15316 63394962
Nervous system disorder 69.09 10.02 100 78644 18666 63391612
Muscle injury 68.20 10.02 3 78741 65342 63344936
Diffuse large B-cell lymphoma refractory 66.92 10.02 32 78712 1198 63409080
Laryngitis fungal 64.85 10.02 18 78726 129 63410149
Herpes virus infection 64.08 10.02 54 78690 5502 63404776
Acute generalised exanthematous pustulosis 62.57 10.02 73 78671 11026 63399252
Tumour lysis syndrome 62.53 10.02 66 78678 8924 63401354
Eosinophilia 62.53 10.02 106 78638 22650 63387628
Platelet count decreased 62.13 10.02 297 78447 115825 63294453
Immune effector cell-associated neurotoxicity syndrome 61.02 10.02 37 78707 2240 63408038
Product use issue 59.03 10.02 115 78629 220405 63189873
Drug abuse 58.02 10.02 10 78734 72508 63337770
Hepatic enzyme increased 56.36 10.02 103 78641 202225 63208053
Pain 55.43 10.02 620 78124 740008 62670270
Rectal prolapse 55.15 10.02 33 78711 1950 63408328
Mobility decreased 54.81 10.02 42 78702 121117 63289161
Folliculitis 53.48 10.02 11 78733 70306 63339972
Septic shock 52.57 10.02 192 78552 66437 63343841
Injection site inflammation 52.01 10.02 41 78703 3802 63406476
Impaired healing 51.08 10.02 32 78712 102510 63307768
Cholestasis 50.10 10.02 112 78632 29322 63380956
Depressed level of consciousness 49.92 10.02 180 78564 61898 63348380
Lymphopenia 49.87 10.02 85 78659 18242 63392036
Laryngeal stenosis 49.55 10.02 25 78719 1053 63409225
Musculoskeletal stiffness 48.77 10.02 97 78647 184521 63225757
Ophthalmic herpes simplex 48.18 10.02 19 78725 441 63409837
Dermatitis exfoliative generalised 48.07 10.02 39 78705 3768 63406510
Hallucination, visual 47.95 10.02 86 78658 19212 63391066
Encephalitis cytomegalovirus 47.87 10.02 20 78724 541 63409737
Diarrhoea 47.80 10.02 1192 77552 714174 62696104
Acute myeloid leukaemia 47.28 10.02 80 78664 17067 63393211
Product tampering 46.37 10.02 18 78726 400 63409878
Cryopyrin associated periodic syndrome 45.32 10.02 17 78727 343 63409935
Aplasia 44.26 10.02 39 78705 4220 63406058
Renal disorder 42.78 10.02 113 78631 32861 63377417
Hypersensitivity 42.77 10.02 202 78542 292483 63117795
Arthralgia 40.93 10.02 481 78263 569229 62841049
Cytomegalovirus infection 39.39 10.02 83 78661 20869 63389409
Adulterated product 39.22 10.02 14 78730 244 63410034
Graft versus host disease 38.99 10.02 45 78699 6718 63403560
Lower respiratory tract infection 38.97 10.02 65 78679 132242 63278036
Bronchopulmonary aspergillosis 37.76 10.02 50 78694 8585 63401693
COVID-19 37.76 10.02 255 78489 112848 63297430
Therapeutic product effect incomplete 37.23 10.02 61 78683 124995 63285283
Claustrophobia 36.52 10.02 20 78724 998 63409280
COVID-19 pneumonia 36.18 10.02 64 78680 14145 63396133
Human herpesvirus 6 encephalitis 36.03 10.02 13 78731 234 63410044
Irritable bowel syndrome 35.47 10.02 30 78714 82382 63327896
Post herpetic neuralgia 35.36 10.02 26 78718 2173 63408105
Infusion related reaction 34.38 10.02 172 78572 245349 63164929
Neurological symptom 34.22 10.02 39 78705 5744 63404534
Renal impairment 33.67 10.02 206 78538 88149 63322129
Skin lesion 33.66 10.02 99 78645 30622 63379656
Bladder prolapse 33.56 10.02 25 78719 2131 63408147
C-reactive protein abnormal 33.45 10.02 8 78736 46088 63364190
Suicide attempt 33.22 10.02 17 78727 60901 63349377
Somatic symptom disorder 33.06 10.02 27 78717 2633 63407645
Toxicity to various agents 33.04 10.02 176 78568 247074 63163204
Myoclonus 32.35 10.02 65 78679 15803 63394475
Drug interaction 31.80 10.02 161 78583 228970 63181308
Hip arthroplasty 31.34 10.02 10 78734 47636 63362642
Psoriatic arthropathy 30.79 10.02 41 78703 91479 63318799
Full blood count decreased 30.58 10.02 86 78658 25938 63384340
Toxic erythema of chemotherapy 30.36 10.02 10 78734 135 63410143
Genital herpes simplex 30.02 10.02 12 78732 289 63409989
Escherichia bacteraemia 29.70 10.02 30 78714 3853 63406425
Neutrophil count decreased 29.23 10.02 143 78601 56263 63354015
Fungal endocarditis 28.87 10.02 11 78733 232 63410046
Renal tubular disorder 28.75 10.02 25 78719 2657 63407621
Urine output decreased 28.67 10.02 51 78693 11319 63398959
Plasma cell myeloma recurrent 28.65 10.02 27 78717 3186 63407092
Delirium 28.27 10.02 131 78613 50410 63359868
Bacterial sepsis 27.42 10.02 29 78715 3929 63406349
Posterior reversible encephalopathy syndrome 27.30 10.02 64 78680 17281 63392997
Hyperthermia 26.96 10.02 44 78700 9112 63401166
Cerebellar stroke 26.84 10.02 11 78733 283 63409995
Cytopenia 26.68 10.02 50 78694 11551 63398727
Mixed liver injury 26.45 10.02 31 78713 4704 63405574
Pathogen resistance 26.38 10.02 36 78708 6362 63403916
Sepsis 26.24 10.02 298 78446 152825 63257453
Cytomegalovirus chorioretinitis 26.16 10.02 20 78724 1773 63408505
Laboratory test abnormal 26.00 10.02 83 78661 26829 63383449
Red blood cell sedimentation rate increased 25.95 10.02 11 78733 43971 63366307
Psychiatric symptom 25.60 10.02 32 78712 5191 63405087
Type 2 diabetes mellitus 25.40 10.02 25 78719 63843 63346435
Serotonin syndrome 25.16 10.02 3 78741 28679 63381599
Disorientation 24.89 10.02 106 78638 39346 63370932
Gastrointestinal disorder 24.59 10.02 82 78662 131157 63279121
Hypophagia 24.58 10.02 90 78654 31169 63379109
Fibromyalgia 24.14 10.02 39 78705 80381 63329897
Pneumonia 24.13 10.02 739 78005 456028 62954250
Deep vein thrombosis 23.94 10.02 182 78562 83618 63326660
Mucormycosis 23.47 10.02 23 78721 2848 63407430
Infective aneurysm 23.35 10.02 11 78733 398 63409880
Restlessness 23.33 10.02 85 78659 29368 63380910
Pulse abnormal 23.28 10.02 21 78723 2343 63407935
Loss of personal independence in daily activities 23.28 10.02 54 78690 97236 63313042
Cerebral ventricle dilatation 23.24 10.02 15 78729 1014 63409264
Knee arthroplasty 23.00 10.02 20 78724 54186 63356092
Lymphocyte count decreased 22.86 10.02 86 78658 30171 63380107
Congenital herpes simplex infection 22.78 10.02 4 78740 0 63410278
Eye infection bacterial 22.66 10.02 9 78735 213 63410065
Hallucination 22.28 10.02 130 78614 54687 63355591
Bicytopenia 22.24 10.02 21 78723 2484 63407794
Genital herpes 22.23 10.02 18 78726 1734 63408544
Foreign body in reproductive tract 22.04 10.02 13 78731 748 63409530
Neuropsychiatric syndrome 21.99 10.02 6 78738 40 63410238
Hepatitis acute 21.84 10.02 40 78704 9080 63401198
Blood uric acid increased 21.83 10.02 30 78714 5337 63404941
Intentional self-injury 21.78 10.02 3 78741 25684 63384594
Plasmacytoma 21.72 10.02 21 78723 2558 63407720
Ophthalmic herpes zoster 21.58 10.02 19 78725 2054 63408224
Metabolic encephalopathy 21.45 10.02 31 78713 5778 63404500
Peripheral swelling 21.23 10.02 219 78525 265723 63144555
Blister 21.11 10.02 86 78658 129728 63280550
Acute pulmonary oedema 21.10 10.02 37 78707 8121 63402157
Biopsy skin abnormal 21.02 10.02 7 78737 98 63410180
Vitamin D decreased 20.93 10.02 42 78702 10200 63400078
Decreased appetite 20.92 10.02 432 78312 250620 63159658
Sedation 20.91 10.02 11 78733 38798 63371480
Epstein-Barr virus associated lymphoma 20.89 10.02 11 78733 507 63409771
Bacterial vaginosis 20.85 10.02 16 78728 1426 63408852
Spina bifida 20.59 10.02 13 78731 846 63409432
Speech disorder 20.33 10.02 102 78642 40527 63369751
Mucosal excoriation 20.01 10.02 4 78740 4 63410274
Anaphylactic reaction 19.89 10.02 32 78712 66068 63344210
Terminal ileitis 19.68 10.02 12 78732 734 63409544
Chronic lymphocytic leukaemia 19.63 10.02 20 78724 2594 63407684
Blood immunoglobulin E increased 19.53 10.02 24 78720 3825 63406453
Feeling abnormal 19.53 10.02 275 78469 148117 63262161
Cryptosporidiosis infection 19.52 10.02 9 78735 310 63409968
Vitiligo 19.19 10.02 15 78729 1374 63408904
Pneumocystis jirovecii pneumonia 19.00 10.02 55 78689 16859 63393419
Osteoarthritis 18.96 10.02 58 78686 95285 63314993
Epstein-Barr virus infection 18.89 10.02 35 78709 8015 63402263
Pseudolymphoma 18.89 10.02 11 78733 618 63409660
Gamma-glutamyltransferase increased 18.88 10.02 88 78656 33943 63376335
Squamous cell carcinoma of skin 18.78 10.02 30 78714 6102 63404176
Meningoencephalitis herpetic 18.62 10.02 14 78730 1210 63409068
Campylobacter colitis 18.50 10.02 5 78739 32 63410246
Bone marrow necrosis 18.15 10.02 6 78738 82 63410196
Macular degeneration 18.15 10.02 4 78740 24372 63385906
Vision blurred 18.11 10.02 184 78560 91740 63318538
Intracranial pressure increased 18.01 10.02 27 78717 5200 63405078
Sopor 17.85 10.02 3 78741 22161 63388117
Dermatitis atopic 17.68 10.02 38 78706 9686 63400592
Liver injury 17.56 10.02 30 78714 60490 63349788
Fear of disease 17.55 10.02 14 78730 1320 63408958
International normalised ratio increased 17.52 10.02 19 78725 46406 63363872
Aspergillus infection 17.52 10.02 34 78710 8059 63402219
Blood cholesterol increased 17.44 10.02 59 78685 93973 63316305
Bacteraemia 17.21 10.02 54 78690 17294 63392984
Emotional distress 17.20 10.02 83 78661 32466 63377812
Dermo-hypodermitis 17.18 10.02 8 78736 282 63409996
Ectropion 17.12 10.02 7 78737 179 63410099
Partial seizures 17.10 10.02 28 78716 5814 63404464
Congenital pyelocaliectasis 17.08 10.02 3 78741 0 63410278
Blood lactate dehydrogenase increased 16.88 10.02 65 78679 23051 63387227
Mycetoma mycotic 16.78 10.02 4 78740 14 63410264
Tractional retinal detachment 16.72 10.02 5 78739 48 63410230
Confusional state 16.60 10.02 397 78347 235983 63174295
Meningitis 16.59 10.02 31 78713 7146 63403132
Lichenification 16.47 10.02 9 78735 447 63409831
Drug monitoring procedure not performed 16.45 10.02 10 78734 608 63409670
Infective chondritis 16.36 10.02 4 78740 16 63410262
Contusion 16.26 10.02 114 78630 149930 63260348
Cell death 16.17 10.02 18 78726 2583 63407695
Portal vein cavernous transformation 16.14 10.02 6 78738 118 63410160
Pseudomyopia 16.11 10.02 5 78739 55 63410223
Streptococcal bacteraemia 15.97 10.02 15 78729 1762 63408516
Renal failure 15.87 10.02 219 78525 117433 63292845
Hypoglycaemic seizure 15.83 10.02 9 78735 483 63409795
Musculoskeletal pain 15.72 10.02 60 78684 92217 63318061
Mycobacterial peritonitis 15.72 10.02 5 78739 60 63410218
Chronic papillomatous dermatitis 15.64 10.02 5 78739 61 63410217
Rhabdomyolysis 15.49 10.02 19 78725 43932 63366346
Metastases to liver 15.48 10.02 5 78739 23634 63386644
Seasonal allergy 15.37 10.02 59 78685 20891 63389387
Laryngeal inflammation 15.31 10.02 6 78738 137 63410141
Dyspnoea 15.24 10.02 668 78076 660645 62749633
Soliloquy 15.21 10.02 7 78737 240 63410038
Thermal burn 15.09 10.02 27 78717 6019 63404259
Citrobacter sepsis 15.01 10.02 3 78741 3 63410275
Imperception 15.01 10.02 3 78741 3 63410275
Central nervous system necrosis 14.99 10.02 6 78738 145 63410133
Cholecystitis chronic 14.98 10.02 37 78707 10324 63399954
Joint range of motion decreased 14.96 10.02 11 78733 32417 63377861
Bradycardia 14.95 10.02 44 78700 73183 63337095
Neurosis 14.66 10.02 7 78737 261 63410017
Hepatitis E 14.56 10.02 13 78731 1431 63408847
Ischaemic stroke 14.37 10.02 52 78692 17905 63392373
Inappropriate antidiuretic hormone secretion 14.31 10.02 47 78697 15415 63394863
Pneumocystis jirovecii infection 14.26 10.02 13 78731 1471 63408807
Escherichia pyelonephritis 14.25 10.02 8 78736 419 63409859
Human ehrlichiosis 14.23 10.02 6 78738 166 63410112
Acute febrile neutrophilic dermatosis 14.22 10.02 18 78726 2956 63407322
Venoocclusive disease 14.12 10.02 15 78729 2043 63408235
Obesity 14.03 10.02 10 78734 29942 63380336
Eye infection toxoplasmal 14.03 10.02 7 78737 288 63409990
Mucosal inflammation 14.01 10.02 103 78641 46825 63363453
Cardiac arrest 14.01 10.02 63 78681 92482 63317796
Condition aggravated 13.94 10.02 386 78358 401831 63008447
CSF cell count increased 13.81 10.02 4 78740 34 63410244
Constipation 13.79 10.02 371 78373 224572 63185706
Herpes ophthalmic 13.63 10.02 12 78732 1297 63408981
Bone marrow failure 13.59 10.02 72 78672 29218 63381060
Embedded device 13.46 10.02 19 78725 3464 63406814
Leukaemia recurrent 13.40 10.02 12 78732 1326 63408952
Pain in extremity 13.39 10.02 311 78433 331175 63079103
Therapeutic response decreased 13.27 10.02 36 78708 61489 63348789
Limbic encephalitis 13.26 10.02 7 78737 324 63409954
Dermatitis exfoliative 13.14 10.02 24 78720 5435 63404843
Hypercholesterolaemia 13.13 10.02 5 78739 21329 63388949
Pharyngeal inflammation 13.13 10.02 9 78735 673 63409605
Meningocele 12.93 10.02 3 78741 9 63410269
Psychiatric decompensation 12.93 10.02 12 78732 1389 63408889
Rhegmatogenous retinal detachment 12.89 10.02 5 78739 111 63410167
Metastases to bone 12.82 10.02 5 78739 21014 63389264
Cardiac failure congestive 12.78 10.02 65 78679 92368 63317910
Pyelitis 12.77 10.02 6 78738 216 63410062
Rash pustular 12.72 10.02 28 78716 7254 63403024
Tri-iodothyronine free increased 12.66 10.02 6 78738 220 63410058
Hepatitis cholestatic 12.64 10.02 27 78717 6851 63403427
Scab 12.61 10.02 29 78715 7734 63402544
Subacute combined cord degeneration 12.56 10.02 6 78738 224 63410054
Chills 12.55 10.02 204 78540 113174 63297104
Coronary artery disease 12.50 10.02 13 78731 32364 63377914
Cytomegalovirus test positive 12.47 10.02 17 78727 3001 63407277
Muscle spasms 12.44 10.02 267 78477 155883 63254395
Aminoaciduria 12.33 10.02 5 78739 125 63410153
Incoherent 12.31 10.02 21 78723 4509 63405769
Antiviral drug level above therapeutic 12.27 10.02 3 78741 12 63410266
Tumour flare 12.22 10.02 7 78737 381 63409897
Neuralgia 12.21 10.02 64 78680 25862 63384416
Adverse event 12.12 10.02 43 78701 67516 63342762
Kussmaul respiration 12.00 10.02 6 78738 248 63410030
Thrombosis 11.99 10.02 128 78616 64627 63345651
Sciatica 11.93 10.02 15 78729 34309 63375969
Hepatic cirrhosis 11.93 10.02 8 78736 24726 63385552
Hypertension 11.85 10.02 260 78484 279043 63131235
Gastrointestinal haemorrhage 11.84 10.02 56 78688 81120 63329158
Angina bullosa haemorrhagica 11.84 10.02 5 78739 139 63410139
Macrocytosis 11.82 10.02 15 78729 2470 63407808
Nephropathy toxic 11.80 10.02 32 78712 9447 63400831
Cardiomyopathy acute 11.80 10.02 6 78738 257 63410021
Prescribed overdose 11.79 10.02 15 78729 34138 63376140
Death 11.78 10.02 364 78380 374017 63036261
Drug resistance 11.78 10.02 58 78686 22875 63387403
Acute respiratory distress syndrome 11.72 10.02 59 78685 23475 63386803
Autoimmune nephritis 11.68 10.02 7 78737 415 63409863
Progressive multifocal leukoencephalopathy 11.63 10.02 39 78705 12932 63397346
Conjunctivitis viral 11.61 10.02 6 78738 266 63410012
Rash vesicular 11.57 10.02 20 78724 4338 63405940
Graft versus host disease in gastrointestinal tract 11.54 10.02 17 78727 3224 63407054
Hypouricaemia 11.49 10.02 5 78739 150 63410128
Anal infection 11.46 10.02 4 78740 65 63410213
Nausea 11.42 10.02 1218 77526 853253 62557025
Pancreatitis acute 11.41 10.02 65 78679 27101 63383177
Haemophagocytic lymphohistiocytosis 11.40 10.02 34 78710 10593 63399685
Pseudomonas infection 11.21 10.02 35 78709 11178 63399100
Lymphocyte morphology abnormal 11.18 10.02 7 78737 449 63409829
Hepatitis 11.13 10.02 86 78658 39702 63370576
Visual acuity reduced 11.07 10.02 55 78689 21771 63388507
Grip strength decreased 11.03 10.02 7 78737 22280 63387998
Cerebral thrombosis 11.03 10.02 12 78732 1679 63408599
Nystagmus 10.96 10.02 24 78720 6196 63404082
Monocyte percentage increased 10.92 10.02 10 78734 1138 63409140
Blood pressure systolic abnormal 10.91 10.02 39 78705 13347 63396931
Hemianopia homonymous 10.86 10.02 8 78736 670 63409608
Thrombotic thrombocytopenic purpura 10.71 10.02 18 78726 3818 63406460
Cerebral venous thrombosis 10.64 10.02 13 78731 2061 63408217
Incorrect route of product administration 10.62 10.02 11 78733 27441 63382837
Oliguria 10.61 10.02 30 78714 9071 63401207
Thrombotic microangiopathy 10.59 10.02 33 78711 10528 63399750
Chronic obstructive pulmonary disease 10.52 10.02 41 78703 62645 63347633
Product dose omission issue 10.50 10.02 372 78372 233941 63176337
Engraftment syndrome 10.49 10.02 7 78737 501 63409777
Disease progression 10.46 10.02 212 78532 122546 63287732
Middle insomnia 10.45 10.02 37 78707 12606 63397672
Herpes simplex viraemia 10.42 10.02 6 78738 330 63409948
Erythema multiforme 10.41 10.02 32 78712 10137 63400141
Poriomania 10.34 10.02 4 78740 88 63410190
Muscular weakness 10.32 10.02 211 78533 122142 63288136
Mucosal erosion 10.31 10.02 11 78733 1505 63408773
Coordination abnormal 10.28 10.02 39 78705 13734 63396544
Hypoglycaemia 10.26 10.02 39 78705 60026 63350252
Acute lymphocytic leukaemia 10.14 10.02 14 78730 2502 63407776
Nephritis 10.14 10.02 14 78730 2502 63407776
Vitamin B12 decreased 10.13 10.02 17 78727 3603 63406675
Limb injury 10.08 10.02 60 78684 25417 63384861
Brain injury 10.03 10.02 25 78719 7018 63403260

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
Febrile neutropenia 421.05 11.29 791 57723 136058 34762359
Plasma cell myeloma 316.93 11.29 371 58143 41666 34856751
Cytokine release syndrome 292.19 11.29 268 58246 22609 34875808
Neurotoxicity 235.86 11.29 214 58300 17796 34880621
Neutropenia 220.90 11.29 669 57845 156109 34742308
Thrombocytopenia 175.19 11.29 617 57897 155630 34742787
Pyrexia 162.38 11.29 1031 57483 331982 34566435
Agranulocytosis 156.19 11.29 196 58318 23625 34874792
Acute generalised exanthematous pustulosis 153.62 11.29 111 58403 6665 34891752
Encephalopathy 152.86 11.29 238 58276 35081 34863336
Completed suicide 138.68 11.29 6 58508 98162 34800255
Drug reaction with eosinophilia and systemic symptoms 138.06 11.29 219 58295 32793 34865624
Febrile bone marrow aplasia 130.55 11.29 109 58405 8100 34890317
Rash maculo-papular 129.11 11.29 196 58318 28255 34870162
Drug abuse 125.23 11.29 11 58503 99085 34799332
Acute kidney injury 116.42 11.29 890 57624 304098 34594319
Toxic skin eruption 116.28 11.29 118 58396 11267 34887150
Pancytopenia 112.74 11.29 383 58131 94774 34803643
Toxic encephalopathy 109.98 11.29 82 58432 5167 34893250
Toxicity to various agents 105.45 11.29 108 58406 200254 34698163
Hepatocellular injury 103.59 11.29 155 58359 22056 34876361
Dermatitis exfoliative generalised 89.25 11.29 63 58451 3644 34894773
Dyslalia 89.04 11.29 34 58480 526 34897891
Neuropathy peripheral 87.30 11.29 322 58192 82941 34815476
Nervous system disorder 80.31 11.29 110 58404 14433 34883984
Altered state of consciousness 78.51 11.29 139 58375 22754 34875663
Drug ineffective 78.50 11.29 447 58067 456304 34442113
Hepatic cytolysis 77.58 11.29 108 58406 14388 34884029
Pneumonia 76.43 11.29 934 57580 361693 34536724
Dysarthria 75.93 11.29 175 58339 34607 34863810
Herpes zoster 73.92 11.29 172 58342 34227 34864190
White blood cell count decreased 70.86 11.29 332 58182 95113 34803304
Bronchopulmonary aspergillosis 67.92 11.29 102 58412 14557 34883860
Squamous cell carcinoma of skin 65.74 11.29 86 58428 10795 34887622
Microsporidia infection 65.00 11.29 29 58485 677 34897740
Tumour lysis syndrome 64.28 11.29 108 58406 16951 34881466
Cytopenia 63.96 11.29 92 58422 12631 34885786
Cholestasis 61.49 11.29 138 58376 26810 34871607
Chronic lymphocytic leukaemia 58.76 11.29 52 58462 4180 34894237
COVID-19 56.98 11.29 269 58245 77281 34821136
Cerebral toxoplasmosis 55.30 11.29 35 58479 1686 34896731
Drug interaction 53.00 11.29 197 58317 225749 34672668
Ophthalmic herpes simplex 52.34 11.29 20 58494 310 34898107
Intentional overdose 47.44 11.29 8 58506 43666 34854751
Acute myeloid leukaemia 46.75 11.29 98 58416 18172 34880245
Dyspnoea 45.86 11.29 407 58107 376375 34522042
Lymphopenia 45.80 11.29 91 58423 16244 34882173
Pathogen resistance 45.38 11.29 67 58447 9415 34889002
Platelet count decreased 44.10 11.29 347 58167 119370 34779047
Intentional product misuse 44.07 11.29 11 58503 45600 34852817
Aplasia 44.04 11.29 46 58468 4542 34893875
Face oedema 43.51 11.29 73 58441 11443 34886974
Suicide attempt 42.86 11.29 7 58507 39109 34859308
Hypoglycaemia 42.65 11.29 19 58495 54621 34843796
Pseudomonas infection 40.93 11.29 74 58440 12308 34886109
Demodicidosis 40.91 11.29 15 58499 206 34898211
Graft versus host disease 39.93 11.29 67 58447 10502 34887915
Lung disorder 39.57 11.29 138 58376 34558 34863859
Hyperleukocytosis 39.11 11.29 30 58484 1972 34896445
Nephritis allergic 36.63 11.29 17 58497 436 34897981
Immune effector cell-associated neurotoxicity syndrome 35.23 11.29 37 58477 3676 34894741
Inappropriate schedule of product administration 34.52 11.29 32 58482 62264 34836153
Septic shock 33.84 11.29 221 58293 71613 34826804
Diffuse large B-cell lymphoma 33.73 11.29 51 58463 7319 34891098
Graft versus host disease in gastrointestinal tract 33.70 11.29 36 58478 3647 34894770
Squamous cell carcinoma 33.47 11.29 65 58449 11410 34887007
Eosinophilia 33.17 11.29 108 58406 26114 34872303
Hyperuricaemia 33.10 11.29 53 58461 7990 34890427
Depression 31.98 11.29 72 58442 97026 34801391
Parainfluenzae virus infection 31.98 11.29 31 58483 2799 34895618
Genital herpes 31.19 11.29 17 58497 618 34897799
Neutrophil count decreased 30.99 11.29 168 58346 50936 34847481
Bradycardia 30.92 11.29 49 58465 75369 34823048
Rhinovirus infection 30.79 11.29 37 58477 4262 34894155
Thrombotic microangiopathy 30.74 11.29 60 58454 10570 34887847
Herpes simplex 30.61 11.29 42 58472 5517 34892900
Confusional state 30.46 11.29 372 58142 143788 34754629
International normalised ratio increased 30.37 11.29 21 58493 47306 34851111
Congenital herpes simplex infection 30.14 11.29 8 58506 33 34898384
Encephalitis 30.02 11.29 48 58466 7229 34891188
Purpura 29.57 11.29 58 58456 10253 34888164
Pulmonary sarcoidosis 29.40 11.29 16 58498 580 34897837
Pain 28.51 11.29 213 58301 204462 34693955
Rhabdomyolysis 28.21 11.29 44 58470 68119 34830298
Hypogammaglobulinaemia 27.83 11.29 48 58466 7692 34890725
Mucosal inflammation 27.63 11.29 133 58381 38489 34859928
Myocardial infarction 27.41 11.29 107 58407 120978 34777439
Wrong technique in product usage process 27.32 11.29 13 58501 35973 34862444
Death 27.23 11.29 486 58028 397563 34500854
Drug hypersensitivity 27.10 11.29 59 58455 80470 34817947
Respiratory tract infection bacterial 26.97 11.29 23 58491 1759 34896658
Differentiation syndrome 26.90 11.29 21 58493 1417 34897000
Escherichia sepsis 26.60 11.29 36 58478 4668 34893749
Conjunctival irritation 26.27 11.29 9 58505 100 34898317
Bronchopneumopathy 25.97 11.29 14 58500 498 34897919
Eosinophilic colitis 25.95 11.29 11 58503 226 34898191
Anxiety 25.74 11.29 83 58431 99345 34799072
Delirium 25.59 11.29 143 58371 43848 34854569
Respiratory tract infection viral 25.53 11.29 26 58488 2491 34895926
COVID-19 pneumonia 25.28 11.29 74 58440 16893 34881524
Drug dependence 25.08 11.29 5 58509 24212 34874205
Lymphocytosis 25.02 11.29 26 58488 2551 34895866
Escherichia bacteraemia 24.76 11.29 29 58485 3251 34895166
Respiratory tract infection 24.76 11.29 81 58433 19631 34878786
Blood pressure increased 24.62 11.29 71 58443 88031 34810386
Hypercalcaemia 24.54 11.29 69 58445 15399 34883018
Rash 24.36 11.29 515 57999 222237 34676180
Infective exacerbation of chronic obstructive airways disease 24.23 11.29 22 58492 1829 34896588
Injection site pain 24.12 11.29 18 58496 38987 34859430
Cardiac arrest 23.71 11.29 82 58432 96077 34802340
Drug resistance 23.64 11.29 96 58418 25831 34872586
Musculoskeletal stiffness 23.55 11.29 26 58488 46654 34851763
Plasma cell myeloma recurrent 23.49 11.29 33 58481 4432 34893985
Drug withdrawal syndrome 23.00 11.29 3 58511 19831 34878586
Stress 22.98 11.29 11 58503 30336 34868081
Aggression 22.81 11.29 19 58495 38945 34859472
Hyperhidrosis 22.65 11.29 59 58455 75633 34822784
Pericarditis 22.60 11.29 56 58458 11589 34886828
Ichthyosis 22.29 11.29 8 58506 103 34898314
Pneumocystis jirovecii pneumonia 22.12 11.29 78 58436 19632 34878785
Vaccination failure 22.01 11.29 17 58497 1129 34897288
Hallucination 21.60 11.29 154 58360 51344 34847073
Infection 21.58 11.29 240 58274 90675 34807742
Psychiatric symptom 21.58 11.29 28 58486 3485 34894932
Tumour flare 21.55 11.29 15 58499 848 34897569
Respiratory arrest 21.49 11.29 10 58504 28033 34870384
Angina pectoris 21.37 11.29 13 58501 31350 34867067
Aplastic anaemia 21.32 11.29 49 58465 9667 34888750
Bacteraemia 21.25 11.29 77 58437 19640 34878777
Malignant neoplasm progression 21.09 11.29 76 58438 87970 34810447
Botryomycosis 21.04 11.29 6 58508 34 34898383
Varicella zoster virus infection 20.82 11.29 20 58494 1786 34896631
Chest pain 20.58 11.29 126 58388 126636 34771781
Basal cell carcinoma 20.54 11.29 76 58438 19582 34878835
Pneumonia fungal 20.44 11.29 40 58474 7060 34891357
Malignant neoplasm of unknown primary site 20.28 11.29 11 58503 396 34898021
Influenza 19.96 11.29 147 58367 49519 34848898
Full blood count decreased 19.80 11.29 71 58443 18017 34880400
Aspergillus infection 19.77 11.29 55 58459 12199 34886218
Blood creatinine abnormal 19.51 11.29 22 58492 2368 34896049
Blood creatine phosphokinase increased 19.49 11.29 28 58486 44829 34853588
Atrial fibrillation 19.37 11.29 300 58214 122093 34776324
Blood lactate dehydrogenase increased 19.30 11.29 83 58431 22907 34875510
Haematochezia 19.29 11.29 30 58484 46504 34851913
Monoclonal immunoglobulin present 19.23 11.29 15 58499 1011 34897406
Coronary artery disease 19.22 11.29 32 58482 48273 34850144
Nocardiosis 19.02 11.29 28 58486 3923 34894494
Streptococcal bacteraemia 18.98 11.29 20 58494 1995 34896422
Hallucination, visual 18.77 11.29 69 58445 17722 34880695
Therapeutic product effect incomplete 18.73 11.29 35 58479 50506 34847911
Hyperthermia 18.60 11.29 49 58465 10528 34887889
Human herpesvirus 6 encephalitis 18.57 11.29 10 58504 355 34898062
Pseudomonal bacteraemia 18.53 11.29 17 58497 1432 34896985
Polymyositis 18.49 11.29 17 58497 1436 34896981
Hepatitis cholestatic 18.46 11.29 41 58473 7906 34890511
Genital erythema 18.44 11.29 9 58505 259 34898158
Laryngeal cancer metastatic 18.17 11.29 6 58508 59 34898358
Bacterial sepsis 18.15 11.29 32 58482 5218 34893199
Citrobacter infection 17.91 11.29 11 58503 502 34897915
Morganella infection 17.74 11.29 11 58503 511 34897906
Bacillus bacteraemia 17.65 11.29 6 58508 65 34898352
Respiratory depression 17.58 11.29 3 58511 16242 34882175
Logorrhoea 17.57 11.29 21 58493 2405 34896012
Acute HIV infection 17.57 11.29 6 58508 66 34898351
Melaena 17.52 11.29 20 58494 35360 34863057
Haemorrhoids thrombosed 17.50 11.29 8 58506 198 34898219
JC virus infection 17.47 11.29 20 58494 2188 34896229
Escherichia infection 17.45 11.29 41 58473 8204 34890213
Glomerulosclerosis 17.42 11.29 13 58501 820 34897597
SARS-CoV-2 sepsis 17.41 11.29 7 58507 125 34898292
Myelodysplastic syndrome 17.41 11.29 71 58443 19137 34879280
Herpes zoster reactivation 17.39 11.29 9 58505 294 34898123
Positive end-expiratory pressure 17.20 11.29 4 58510 8 34898409
Facial paralysis 17.14 11.29 48 58466 10686 34887731
Pulmonary sepsis 17.05 11.29 20 58494 2245 34896172
Toxic neuropathy 17.04 11.29 11 58503 548 34897869
Lymphocytic infiltration 16.86 11.29 12 58502 703 34897714
Pneumonia haemophilus 16.76 11.29 10 58504 433 34897984
Hyperbilirubinaemia 16.67 11.29 64 58450 16779 34881638
Brief psychotic disorder with marked stressors 16.62 11.29 8 58506 223 34898194
Graft versus host disease in lung 16.61 11.29 11 58503 573 34897844
Ophthalmic herpes zoster 16.42 11.29 13 58501 895 34897522
Lymphocyte count decreased 16.25 11.29 78 58436 22544 34875873
Pneumonia pneumococcal 16.24 11.29 19 58495 2127 34896290
Mantle cell lymphoma recurrent 16.16 11.29 12 58502 751 34897666
Dyscalculia 16.13 11.29 6 58508 86 34898331
Incorrect disposal of product 16.10 11.29 9 58505 344 34898073
Acute myocardial infarction 15.97 11.29 42 58472 53677 34844740
Wheezing 15.94 11.29 28 58486 41374 34857043
Colitis 15.89 11.29 113 58401 37637 34860780
CSF cell count increased 15.84 11.29 5 58509 42 34898375
Viral mutation identified 15.79 11.29 22 58492 2932 34895485
Blood glucose increased 15.70 11.29 58 58456 66660 34831757
Loss of consciousness 15.69 11.29 78 58436 82589 34815828
Labelled drug-drug interaction medication error 15.65 11.29 3 58511 14936 34883481
Sleep disorder 15.60 11.29 18 58496 31670 34866747
Fluid imbalance 15.58 11.29 8 58506 257 34898160
Arthralgia 15.58 11.29 196 58318 169845 34728572
Myositis 15.52 11.29 50 58464 12020 34886397
Stomatitis 15.49 11.29 123 58391 42391 34856026
Myoclonus 15.44 11.29 57 58457 14668 34883749
Hypercapnic coma 15.43 11.29 7 58507 170 34898247
Disseminated cryptococcosis 15.32 11.29 15 58499 1371 34897046
Cytomegalovirus infection 15.22 11.29 85 58429 26050 34872367
Dermatitis exfoliative 15.14 11.29 34 58480 6605 34891812
Aeromonas infection 15.06 11.29 8 58506 276 34898141
Pityriasis rubra pilaris 15.04 11.29 6 58508 105 34898312
Parvovirus B19 infection 14.95 11.29 12 58502 843 34897574
Disorientation 14.95 11.29 101 58413 33087 34865330
Hemiparesis 14.87 11.29 4 58510 15774 34882643
Abdominal pain 14.83 11.29 189 58325 163429 34734988
Hypocalcaemia 14.82 11.29 80 58434 24209 34874208
Lactic acidosis 14.81 11.29 22 58492 34750 34863667
Mixed liver injury 14.77 11.29 21 58493 2852 34895565
Folliculitis 14.72 11.29 27 58487 4539 34893878
Metabolic acidosis 14.69 11.29 32 58482 43648 34854769
Bronchial haemorrhage 14.68 11.29 11 58503 698 34897719
Mutism 14.47 11.29 12 58502 883 34897534
Haematemesis 14.46 11.29 15 58499 27696 34870721
Sepsis 14.45 11.29 373 58141 166188 34732229
Fall 14.36 11.29 246 58268 202639 34695778
Flushing 14.31 11.29 20 58494 32400 34866017
Periorbital cellulitis 14.28 11.29 8 58506 307 34898110
Haemophagocytic lymphohistiocytosis 14.27 11.29 51 58463 12922 34885495
Complications of transplanted heart 14.26 11.29 8 58506 308 34898109
Blood osmolarity abnormal 14.11 11.29 3 58511 3 34898414
Haemolytic anaemia 14.01 11.29 44 58470 10435 34887982
Cerebrovascular accident 13.91 11.29 84 58430 84727 34813690
Donor leukocyte infusion 13.83 11.29 4 58510 24 34898393
Bladder cancer 13.77 11.29 5 58509 16273 34882144
Klebsiella sepsis 13.72 11.29 17 58497 2020 34896397
Renal disorder 13.62 11.29 81 58433 25399 34873018
Amyotrophy 13.43 11.29 9 58505 478 34897939
Plasmacytoma 13.41 11.29 23 58491 3668 34894749
CSF volume increased 13.31 11.29 4 58510 28 34898389
Urinary tract infection pseudomonal 13.30 11.29 12 58502 989 34897428
Venous thrombosis 13.27 11.29 22 58492 3413 34895004
Pneumonia viral 13.18 11.29 21 58493 3153 34895264
Product quality issue 13.17 11.29 6 58508 17029 34881388
Diarrhoea 13.12 11.29 787 57727 389125 34509292
Cerebellar syndrome 13.09 11.29 18 58496 2370 34896047
Pain in extremity 13.06 11.29 142 58372 126371 34772046
Enterococcal sepsis 12.98 11.29 15 58499 1657 34896760
Macular fibrosis 12.97 11.29 8 58506 368 34898049
Diabetic ketoacidosis 12.96 11.29 7 58507 18025 34880392
Tender joint count decreased 12.85 11.29 6 58508 156 34898261
Swollen joint count decreased 12.85 11.29 6 58508 156 34898261
Oesophagitis 12.81 11.29 50 58464 13211 34885206
Retinal detachment 12.73 11.29 28 58486 5363 34893054
Jugular vein thrombosis 12.67 11.29 15 58499 1700 34896717
Aphasia 12.64 11.29 70 58444 21384 34877033
Serotonin syndrome 12.58 11.29 9 58505 19924 34878493
Neutropenic sepsis 12.57 11.29 51 58463 13716 34884701
Acute lymphocytic leukaemia 12.52 11.29 20 58494 3009 34895408
Bone hypertrophy 12.48 11.29 6 58508 167 34898250
Aplasia pure red cell 12.44 11.29 30 58484 6102 34892315
Mixed dementia 12.44 11.29 7 58507 271 34898146
Gastrointestinal haemorrhage 12.33 11.29 92 58422 88385 34810032
Injury 12.21 11.29 10 58504 20677 34877740
Renal ischaemia 12.17 11.29 9 58505 560 34897857
Dermatitis bullous 12.10 11.29 32 58482 6890 34891527
Medication error 12.08 11.29 15 58499 25550 34872867
Pulmonary congestion 12.04 11.29 4 58510 13761 34884656
Renal tubular disorder 11.98 11.29 25 58489 4618 34893799
Bone marrow failure 11.98 11.29 87 58427 29166 34869251
Lymphocytic lymphoma 11.96 11.29 4 58510 41 34898376
Cardiac dysfunction 11.88 11.29 17 58497 2321 34896096
Cardiac failure congestive 11.88 11.29 86 58428 83184 34815233
Incorrect route of product administration 11.84 11.29 5 58509 14840 34883577
Mantle cell lymphoma 11.83 11.29 13 58501 1359 34897058
Chest discomfort 11.81 11.29 49 58465 54481 34843936
Heart rate increased 11.77 11.29 39 58475 46304 34852113
Wrong strength 11.74 11.29 5 58509 104 34898313
Klebsiella bacteraemia 11.71 11.29 13 58501 1375 34897042
Suicidal ideation 11.68 11.29 32 58482 40356 34858061
Out of specification test results 11.63 11.29 4 58510 45 34898372
Sopor 11.58 11.29 3 58511 12133 34886284
Peripheral sensory neuropathy 11.56 11.29 31 58483 6729 34891688
Peripheral T-cell lymphoma unspecified recurrent 11.55 11.29 4 58510 46 34898371
Headache 11.53 11.29 252 58262 200383 34698034
Depressed level of consciousness 11.52 11.29 116 58398 42725 34855692
Vomiting 11.52 11.29 321 58193 247300 34651117
Swollen tongue 11.52 11.29 5 58509 14600 34883817
Oral mucosal erythema 11.47 11.29 8 58506 454 34897963
Arthritis 11.36 11.29 22 58492 31324 34867093
Ventricular fibrillation 11.34 11.29 13 58501 22941 34875476

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
Febrile neutropenia 719.00 9.87 1210 109750 229789 79403639
Plasma cell myeloma 493.50 9.87 481 110479 52778 79580650
Cytokine release syndrome 483.79 9.87 401 110559 35597 79597831
Neurotoxicity 472.28 9.87 379 110581 32139 79601289
Acute kidney injury 387.42 9.87 1587 109373 517817 79115611
Neutropenia 353.14 9.87 1038 109922 286672 79346756
Drug reaction with eosinophilia and systemic symptoms 296.74 9.87 405 110555 63839 79569589
Agranulocytosis 294.66 9.87 338 110622 44692 79588736
Encephalopathy 289.07 9.87 410 110550 66987 79566441
Thrombocytopenia 288.89 9.87 918 110042 264341 79369087
Toxic encephalopathy 282.38 9.87 184 110776 11256 79622172
Toxic skin eruption 268.03 9.87 233 110727 22060 79611368
Hepatocellular injury 256.94 9.87 324 110636 47269 79586159
Rash maculo-papular 250.66 9.87 348 110612 55730 79577698
Pyrexia 244.55 9.87 1697 109263 677012 78956416
Altered state of consciousness 221.88 9.87 289 110671 43533 79589895
Completed suicide 220.90 9.87 38 110922 245729 79387699
Pancytopenia 201.10 9.87 596 110364 165149 79468279
Febrile bone marrow aplasia 198.07 9.87 156 110804 12864 79620564
Acute generalised exanthematous pustulosis 190.79 9.87 172 110788 17082 79616346
Drug abuse 185.39 9.87 10 110950 162681 79470747
Dyslalia 181.85 9.87 65 110895 1007 79632421
Drug ineffective 176.15 9.87 841 110119 1080072 78553356
Dysarthria 163.57 9.87 318 110642 67304 79566124
Hepatic cytolysis 158.03 9.87 192 110768 26959 79606469
Synovitis 152.74 9.87 16 110944 150718 79482710
Contraindicated product administered 149.13 9.87 21 110939 157517 79475911
Drug hypersensitivity 129.38 9.87 135 110825 298781 79334647
Nervous system disorder 124.99 9.87 170 110790 26686 79606742
Dermatitis exfoliative generalised 121.58 9.87 92 110868 7149 79626279
Pemphigus 120.47 9.87 4 110956 99578 79533850
Toxicity to various agents 118.80 9.87 256 110704 421284 79212144
Drug intolerance 118.03 9.87 116 110844 264003 79369425
Tumour lysis syndrome 116.70 9.87 155 110805 23784 79609644
Cholestasis 115.14 9.87 236 110724 51873 79581555
Herpes zoster 114.01 9.87 336 110624 92747 79540681
Joint swelling 111.26 9.87 143 110817 288503 79344925
Intentional overdose 107.97 9.87 11 110949 105949 79527479
Eosinophilia 104.51 9.87 209 110751 45136 79588292
Lymphopenia 104.05 9.87 167 110793 30390 79603038
Bronchopulmonary aspergillosis 103.56 9.87 141 110819 22153 79611275
Systemic lupus erythematosus 99.86 9.87 23 110937 121126 79512302
Septic shock 99.64 9.87 386 110574 122415 79511013
Arthropathy 97.66 9.87 63 110897 177048 79456380
Therapeutic product effect decreased 96.36 9.87 54 110906 163809 79469619
Ophthalmic herpes simplex 93.47 9.87 36 110924 694 79632734
Swelling 92.46 9.87 99 110861 216612 79416816
Pneumonia 92.30 9.87 1358 109602 658888 78974540
Herpes simplex 90.90 9.87 98 110862 12089 79621339
Glossodynia 90.56 9.87 17 110943 103320 79530108
Immune effector cell-associated neurotoxicity syndrome 88.80 9.87 70 110890 5778 79627650
Wound 86.42 9.87 27 110933 116152 79517276
COVID-19 85.12 9.87 439 110521 157235 79476193
Aplasia 84.57 9.87 77 110883 7743 79625685
Platelet count decreased 83.21 9.87 509 110451 194155 79439273
Acute myeloid leukaemia 83.05 9.87 152 110808 30733 79602695
Pathogen resistance 81.15 9.87 100 110860 14242 79619186
Neuropathy peripheral 80.89 9.87 400 110560 140905 79492523
Squamous cell carcinoma of skin 79.65 9.87 98 110862 13935 79619493
Drug interaction 78.22 9.87 305 110655 414878 79218550
Oral herpes 77.49 9.87 138 110822 27316 79606112
Anti-cyclic citrullinated peptide antibody positive 76.55 9.87 12 110948 83131 79550297
Rheumatoid arthritis 75.52 9.87 108 110852 208362 79425066
Helicobacter infection 74.33 9.87 6 110954 69698 79563730
White blood cell count decreased 73.44 9.87 481 110479 187807 79445621
Alopecia 73.30 9.87 131 110829 231224 79402204
Cytopenia 70.22 9.87 112 110848 20271 79613157
Pain 70.19 9.87 634 110326 703168 78930260
Duodenal ulcer perforation 69.77 9.87 6 110954 66205 79567223
Vocal cord dysfunction 67.05 9.87 27 110933 588 79632840
Chronic lymphocytic leukaemia 66.99 9.87 55 110905 4811 79628617
COVID-19 pneumonia 66.51 9.87 133 110827 28716 79604712
Treatment failure 64.07 9.87 86 110874 170400 79463028
Microsporidia infection 61.42 9.87 29 110931 937 79632491
Hallucination, visual 60.57 9.87 138 110822 32591 79600837
Suicide attempt 60.38 9.87 20 110940 82912 79550516
Musculoskeletal stiffness 60.14 9.87 94 110866 174914 79458514
Hallucination 59.61 9.87 257 110703 85488 79547940
Pseudomonas infection 58.90 9.87 105 110855 20798 79612630
Laryngitis fungal 58.46 9.87 17 110943 129 79633299
Abdominal discomfort 58.26 9.87 168 110792 250559 79382869
Blood urea increased 57.71 9.87 174 110786 48616 79584812
Rheumatoid factor positive 56.55 9.87 8 110952 59831 79573597
Arthralgia 56.54 9.87 516 110444 571287 79062141
Confusional state 55.80 9.87 682 110278 317315 79316113
Graft versus host disease 55.14 9.87 85 110875 14941 79618487
Blood creatinine increased 51.54 9.87 381 110579 154676 79478752
Human herpesvirus 6 encephalitis 51.40 9.87 23 110937 655 79632773
Escherichia bacteraemia 51.12 9.87 54 110906 6508 79626920
Bacterial sepsis 51.02 9.87 60 110900 8138 79625290
Encephalitis cytomegalovirus 50.90 9.87 27 110933 1123 79632305
Graft versus host disease in gastrointestinal tract 50.75 9.87 53 110907 6303 79627125
Discomfort 50.70 9.87 60 110900 125557 79507871
Mobility decreased 49.69 9.87 58 110902 122117 79511311
Neutrophil count decreased 49.56 9.87 260 110700 93699 79539729
Myoclonus 49.39 9.87 115 110845 27545 79605883
Maternal exposure during pregnancy 48.19 9.87 72 110888 136466 79496962
Depressed level of consciousness 47.95 9.87 263 110697 96389 79537039
Laryngeal stenosis 46.62 9.87 25 110935 1063 79632365
Rectal prolapse 46.46 9.87 32 110928 2146 79631282
Pneumocystis jirovecii pneumonia 46.31 9.87 124 110836 32384 79601044
Herpes virus infection 46.23 9.87 53 110907 6996 79626432
Face oedema 45.95 9.87 113 110847 28023 79605405
Sepsis 44.74 9.87 572 110388 268856 79364572
Thrombotic microangiopathy 44.13 9.87 91 110869 20078 79613350
Hypoglycaemia 43.76 9.87 46 110914 101548 79531880
Hypersensitivity 43.56 9.87 202 110758 262037 79371391
Impaired healing 43.31 9.87 35 110925 87620 79545808
Demodicidosis 42.72 9.87 15 110945 220 79633208
Therapeutic product effect incomplete 42.37 9.87 83 110877 141562 79491866
Hyperuricaemia 42.25 9.87 66 110894 11733 79621695
Cryopyrin associated periodic syndrome 41.73 9.87 17 110943 382 79633046
Renal disorder 41.45 9.87 141 110819 41964 79591464
Hyperthermia 41.39 9.87 83 110877 17954 79615474
Drug resistance 41.24 9.87 141 110819 42072 79591356
Bacteraemia 40.65 9.87 119 110841 32705 79600723
Product tampering 40.57 9.87 17 110943 411 79633017
International normalised ratio increased 40.41 9.87 35 110925 84686 79548742
Cytomegalovirus infection 40.41 9.87 141 110819 42503 79590925
Mixed liver injury 39.94 9.87 51 110909 7527 79625901
Renal tubular disorder 39.59 9.87 47 110913 6439 79626989
Hyperleukocytosis 39.11 9.87 31 110929 2579 79630849
Dyspnoea 38.49 9.87 904 110056 856121 78777307
Mucosal inflammation 38.39 9.87 207 110753 75373 79558055
Bradycardia 38.36 9.87 82 110878 135475 79497953
Delirium 37.85 9.87 224 110736 84403 79549025
Bladder prolapse 37.49 9.87 24 110936 1423 79632005
Aspergillus infection 36.80 9.87 82 110878 19079 79614349
Rhinovirus infection 36.48 9.87 50 110910 7903 79625525
Pain in extremity 36.39 9.87 328 110632 364210 79269218
Irritable bowel syndrome 35.87 9.87 21 110939 62220 79571208
Adulterated product 35.87 9.87 14 110946 280 79633148
Red blood cell sedimentation rate increased 35.39 9.87 10 110950 45932 79587496
Escherichia sepsis 35.33 9.87 51 110909 8457 79624971
Plasma cell myeloma recurrent 35.18 9.87 39 110921 4962 79628466
Tumour flare 35.13 9.87 21 110939 1102 79632326
Drug dependence 35.09 9.87 7 110953 40762 79592666
Fibromyalgia 33.95 9.87 24 110936 64316 79569112
Osteoarthritis 33.85 9.87 43 110917 87266 79546162
Squamous cell carcinoma 33.61 9.87 70 110890 15552 79617876
Hepatitis cholestatic 33.30 9.87 65 110895 13787 79619641
Disorientation 33.29 9.87 174 110786 62602 79570826
Injection site inflammation 33.27 9.87 34 110926 3942 79629486
Streptococcal bacteraemia 32.31 9.87 32 110928 3574 79629854
Cardiac arrest 31.98 9.87 127 110833 171969 79461459
Psychiatric symptom 31.92 9.87 44 110916 6991 79626437
Nephritis allergic 31.92 9.87 17 110943 713 79632715
Peripheral swelling 31.75 9.87 232 110728 269385 79364043
Intentional self-injury 31.43 9.87 4 110956 32415 79601013
Hypogammaglobulinaemia 31.41 9.87 61 110899 12890 79620538
Rhabdomyolysis 31.21 9.87 60 110900 103071 79530357
Cerebral toxoplasmosis 31.06 9.87 26 110934 2336 79631092
Renal failure 30.98 9.87 421 110539 200547 79432881
Serotonin syndrome 30.83 9.87 12 110948 45015 79588413
Blood lactate dehydrogenase increased 30.83 9.87 122 110838 39048 79594380
Death 30.52 9.87 580 110380 565934 79067494
Encephalitis 30.44 9.87 65 110895 14695 79618733
Obesity 30.30 9.87 6 110954 35119 79598309
Ophthalmic herpes zoster 30.15 9.87 27 110933 2657 79630771
Wrong technique in product usage process 30.11 9.87 35 110925 73840 79559588
Dermatitis exfoliative 30.00 9.87 54 110906 10775 79622653
Genital herpes 29.62 9.87 24 110936 2060 79631368
Blood glucose increased 28.96 9.87 74 110886 114901 79518527
Hepatic enzyme increased 28.94 9.87 143 110817 182467 79450961
Musculoskeletal pain 28.89 9.87 62 110898 102292 79531136
Neurological symptom 28.54 9.87 47 110913 8736 79624692
Aplastic anaemia 28.28 9.87 71 110889 17834 79615594
Speech disorder 28.25 9.87 150 110810 54295 79579133
Sopor 27.73 9.87 6 110954 33004 79600424
Respiratory tract infection bacterial 27.60 9.87 23 110937 2054 79631374
Contusion 27.50 9.87 110 110850 148666 79484762
Deep vein thrombosis 27.44 9.87 273 110687 120646 79512782
Hip arthroplasty 27.14 9.87 8 110952 35748 79597680
C-reactive protein abnormal 26.92 9.87 17 110943 48350 79585078
Colitis 26.58 9.87 184 110776 73123 79560305
Sedation 26.55 9.87 20 110940 51875 79581553
Purpura 26.33 9.87 73 110887 19454 79613974
Acute pulmonary oedema 26.33 9.87 60 110900 14170 79619258
Fall 26.32 9.87 499 110461 487130 79146298
Conjunctival irritation 25.95 9.87 9 110951 127 79633301
Eosinophilic colitis 25.91 9.87 13 110947 481 79632947
Genital herpes simplex 25.91 9.87 12 110948 371 79633057
CSF cell count increased 25.88 9.87 9 110951 128 79633300
Skin lesion 25.75 9.87 121 110839 41723 79591705
Psoriatic arthropathy 25.74 9.87 43 110917 77956 79555472
Lung disorder 25.65 9.87 196 110764 80361 79553067
Diffuse large B-cell lymphoma 25.63 9.87 54 110906 12095 79621333
Vaccination failure 25.63 9.87 21 110939 1832 79631596
Claustrophobia 25.55 9.87 18 110942 1252 79632176
Product use issue 25.44 9.87 179 110781 209643 79423785
Lymphocyte count decreased 25.02 9.87 131 110829 47158 79586270
Pneumonia fungal 25.02 9.87 51 110909 11159 79622269
Haemophagocytic lymphohistiocytosis 24.99 9.87 77 110883 21760 79611668
Parainfluenzae virus infection 24.98 9.87 35 110925 5647 79627781
Atrial fibrillation 24.79 9.87 400 110560 197486 79435942
Metastases to liver 24.08 9.87 5 110955 28309 79605119
Toxic erythema of chemotherapy 23.74 9.87 10 110950 245 79633183
Differentiation syndrome 23.74 9.87 23 110937 2501 79630927
Somatic symptom disorder 23.64 9.87 23 110937 2514 79630914
Varicella zoster virus infection 23.58 9.87 30 110930 4411 79629017
Acute febrile neutrophilic dermatosis 23.54 9.87 28 110932 3844 79629584
Pseudomonal bacteraemia 23.36 9.87 25 110935 3057 79630371
Hepatitis acute 22.86 9.87 60 110900 15482 79617946
Folliculitis 22.82 9.87 26 110934 55354 79578074
Gastrointestinal disorder 22.81 9.87 90 110870 122115 79511313
Bronchopneumopathy 22.67 9.87 14 110946 779 79632649
Respiratory arrest 22.67 9.87 28 110932 57522 79575906
Blood cholesterol increased 22.57 9.87 52 110908 83668 79549760
Bicytopenia 22.39 9.87 30 110930 4640 79628788
Myocardial infarction 22.36 9.87 157 110803 183972 79449456
Mucosal excoriation 22.32 9.87 4 110956 0 79633428
Foreign body in reproductive tract 22.17 9.87 13 110947 658 79632770
Restlessness 22.04 9.87 125 110835 46367 79587061
Pulmonary sarcoidosis 22.03 9.87 17 110943 1360 79632068
Viral mutation identified 21.99 9.87 27 110933 3831 79629597
Eye infection toxoplasmal 21.75 9.87 12 110948 540 79632888
Cerebellar stroke 21.61 9.87 12 110948 547 79632881
Epstein-Barr virus infection 21.56 9.87 56 110904 14360 79619068
Hyperbilirubinaemia 21.46 9.87 79 110881 24439 79608989
Genital erythema 21.44 9.87 10 110950 314 79633114
Diarrhoea 21.27 9.87 1459 109501 879030 78754398
Myelodysplastic syndrome 21.18 9.87 91 110869 30210 79603218
Drug withdrawal syndrome 21.04 9.87 11 110949 34707 79598721
Joint range of motion decreased 20.99 9.87 10 110950 33272 79600156
Ichthyosis 20.73 9.87 8 110952 155 79633273
Pancreatitis acute 20.71 9.87 129 110831 49475 79583953
Malignant neoplasm of unknown primary site 20.68 9.87 13 110947 747 79632681
Haemorrhoids thrombosed 20.52 9.87 9 110951 244 79633184
Knee arthroplasty 20.46 9.87 18 110942 43230 79590198
Blister 20.43 9.87 91 110869 119385 79514043
Anaphylactic reaction 20.25 9.87 55 110905 83688 79549740
Eye infection bacterial 20.21 9.87 10 110950 359 79633069
Renal impairment 20.15 9.87 320 110640 157463 79475965
Infective exacerbation of chronic obstructive airways disease 20.09 9.87 22 110938 2762 79630666
Lower respiratory tract infection 20.01 9.87 102 110858 129118 79504310
Arthritis 19.95 9.87 87 110873 114793 79518635
Coronary artery disease 19.89 9.87 38 110922 65436 79567992
Respiratory tract infection viral 19.87 9.87 27 110933 4232 79629196
Serum sickness 19.84 9.87 25 110935 3641 79629787
Bone marrow failure 19.55 9.87 130 110830 50977 79582451
Lactic acidosis 19.54 9.87 43 110917 70316 79563112
Acute lymphocytic leukaemia 19.50 9.87 29 110931 4940 79628488
Loss of personal independence in daily activities 19.49 9.87 75 110885 102505 79530923
Mucormycosis 19.46 9.87 39 110921 8430 79624998
Post herpetic neuralgia 19.41 9.87 21 110939 2600 79630828
Metastases to bone 19.41 9.87 5 110955 24422 79609006
Pneumonia influenzal 19.32 9.87 22 110938 2882 79630546
Type 2 diabetes mellitus 19.31 9.87 31 110929 57091 79576337
Pericarditis 19.30 9.87 77 110883 104159 79529269
Lymphocytosis 19.29 9.87 28 110932 4665 79628763
Nocardiosis 19.28 9.87 31 110929 5648 79627780
Cell death 19.27 9.87 28 110932 4671 79628757
Posterior reversible encephalopathy syndrome 19.20 9.87 80 110880 26201 79607227
Acute lymphocytic leukaemia recurrent 19.15 9.87 28 110932 4696 79628732
Venoocclusive liver disease 18.93 9.87 47 110913 11724 79621704
Weight increased 18.84 9.87 272 110688 277114 79356314
Acute HIV infection 18.74 9.87 6 110954 65 79633363
Cerebellar syndrome 18.72 9.87 30 110930 5450 79627978
Haematochezia 18.71 9.87 61 110899 87584 79545844
Antiviral drug level above therapeutic 18.57 9.87 6 110954 67 79633361
Graft versus host disease in lung 18.52 9.87 13 110947 899 79632529
SARS-CoV-2 sepsis 18.46 9.87 7 110953 129 79633299
Incorrect route of product administration 18.46 9.87 13 110947 34916 79598512
Terminal ileitis 18.45 9.87 13 110947 904 79632524
Enteritis 18.18 9.87 53 110907 14530 79618898
Axonal neuropathy 17.98 9.87 18 110942 2036 79631392
Fungal endocarditis 17.96 9.87 11 110949 603 79632825
Depression 17.90 9.87 204 110756 216586 79416842
Pulmonary fibrosis 17.86 9.87 21 110939 44091 79589337
Hypercholesterolaemia 17.84 9.87 5 110955 23090 79610338
Intentional product misuse 17.81 9.87 70 110890 95095 79538333
Facial paralysis 17.70 9.87 67 110893 21005 79612423
Campylobacter colitis 17.67 9.87 5 110955 34 79633394
Injection site pain 17.64 9.87 107 110853 129731 79503697
Bacterial vaginosis 17.36 9.87 14 110946 1194 79632234
Extrapyramidal disorder 17.35 9.87 5 110955 22674 79610754
Klebsiella sepsis 17.32 9.87 22 110938 3230 79630198
Torsade de pointes 17.30 9.87 3 110957 19309 79614119
Hepatic cirrhosis 17.16 9.87 14 110946 34892 79598536
Blood creatine phosphokinase increased 17.06 9.87 42 110918 66048 79567380
Dry mouth 16.95 9.87 64 110896 87955 79545473
Meningoencephalitis herpetic 16.63 9.87 17 110943 1972 79631456
Pulse abnormal 16.63 9.87 22 110938 3362 79630066
Angina pectoris 16.63 9.87 29 110931 51703 79581725
Herpes ophthalmic 16.61 9.87 15 110945 1492 79631936
Hypertension 16.54 9.87 343 110617 330649 79302779
Fear of disease 16.53 9.87 14 110946 1278 79632150
Neutropenic colitis 16.51 9.87 29 110931 5678 79627750
Labelled drug-drug interaction medication error 16.40 9.87 9 110951 27641 79605787
Peripheral T-cell lymphoma unspecified recurrent 16.35 9.87 5 110955 46 79633382
Ischaemic stroke 16.32 9.87 90 110870 33041 79600387
Tender joint count decreased 16.23 9.87 7 110953 182 79633246
Swollen joint count decreased 16.16 9.87 7 110953 184 79633244
Glomerulosclerosis 16.12 9.87 13 110947 1109 79632319
Full blood count decreased 16.10 9.87 77 110883 26742 79606686
Dermatitis bullous 16.09 9.87 50 110910 14195 79619233
Morganella infection 16.06 9.87 13 110947 1114 79632314
Cytomegalovirus chorioretinitis 16.01 9.87 28 110932 5462 79627966
Laryngeal cancer metastatic 15.97 9.87 5 110955 50 79633378
Muscle rigidity 15.93 9.87 4 110956 19878 79613550
Disseminated cryptococcosis 15.93 9.87 16 110944 1818 79631610
Device malfunction 15.91 9.87 5 110955 21443 79611985
Biopsy skin abnormal 15.89 9.87 7 110953 192 79633236
Brief psychotic disorder with marked stressors 15.82 9.87 8 110952 301 79633127
Jugular vein thrombosis 15.72 9.87 25 110935 4513 79628915
Urine output decreased 15.72 9.87 58 110902 17964 79615464
Pityriasis rubra pilaris 15.66 9.87 6 110954 114 79633314
Condition aggravated 15.48 9.87 556 110404 500568 79132860
Neuropsychiatric syndrome 15.47 9.87 6 110954 118 79633310
Amyotrophy 15.37 9.87 10 110950 610 79632818
Haemolytic anaemia 15.25 9.87 57 110903 17763 79615665
Botryomycosis 15.23 9.87 5 110955 59 79633369
Cyanosis 15.23 9.87 8 110952 25174 79608254
Portal vein cavernous transformation 15.19 9.87 6 110954 124 79633304
Poriomania 15.15 9.87 7 110953 215 79633213
Cardiac failure congestive 15.13 9.87 126 110834 142276 79491152
Logorrhoea 15.05 9.87 24 110936 4341 79629087
Rash morbilliform 14.95 9.87 29 110931 6121 79627307
Lichenification 14.91 9.87 11 110949 822 79632606
Plasmacytoma 14.90 9.87 24 110936 4379 79629049
Nephropathy toxic 14.80 9.87 62 110898 20357 79613071
Erythema multiforme 14.72 9.87 56 110904 17595 79615833
Melaena 14.71 9.87 40 110920 60850 79572578
Neuralgia 14.68 9.87 88 110872 33296 79600132
Gastrointestinal haemorrhage 14.67 9.87 133 110827 147586 79485842
Imperception 14.66 9.87 3 110957 3 79633425
Blood immunoglobulin E increased 14.63 9.87 28 110932 5854 79627574
Mycobacterial peritonitis 14.58 9.87 5 110955 68 79633360
Pneumocystis jirovecii infection 14.51 9.87 19 110941 2875 79630553
Acute respiratory distress syndrome 14.46 9.87 108 110852 43959 79589469
Complications of transplanted heart 14.46 9.87 8 110952 362 79633066
Haematemesis 14.46 9.87 32 110928 52232 79581196
Limbic encephalitis 14.43 9.87 11 110949 864 79632564
Rash vesicular 14.42 9.87 28 110932 5917 79627511
Cytomegalovirus test positive 14.41 9.87 28 110932 5919 79627509
Peripheral T-cell lymphoma unspecified 14.39 9.87 10 110950 680 79632748
Aeromonas infection 14.34 9.87 8 110952 368 79633060
Bacillus bacteraemia 14.25 9.87 6 110954 147 79633281
Venoocclusive disease 14.23 9.87 24 110936 4549 79628879
Thrombotic thrombocytopenic purpura 14.22 9.87 29 110931 6347 79627081
Gastrooesophageal reflux disease 14.11 9.87 86 110874 104160 79529268
Actinic keratosis 14.10 9.87 28 110932 6014 79627414
Escherichia infection 14.08 9.87 56 110904 17961 79615467
Cerebrovascular accident 14.07 9.87 143 110817 155149 79478279
Vitiligo 14.07 9.87 16 110944 2093 79631335
Flushing 14.05 9.87 69 110891 88199 79545229
Aphasia 13.93 9.87 112 110848 46620 79586808
Klebsiella bacteraemia 13.92 9.87 19 110941 2991 79630437
Poisoning 13.90 9.87 9 110951 25263 79608165
Enterococcal sepsis 13.82 9.87 18 110942 2708 79630720
Platelet count increased 13.72 9.87 7 110953 22399 79611029
Respiratory depression 13.68 9.87 11 110949 27619 79605809
Infective chondritis 13.68 9.87 4 110956 31 79633397
Pseudomonal sepsis 13.68 9.87 28 110932 6146 79627282
Drug ineffective for unapproved indication 13.67 9.87 32 110928 51206 79582222
Metastatic squamous cell carcinoma 13.63 9.87 9 110951 563 79632865
Pulmonary sepsis 13.62 9.87 21 110939 3691 79629737
Crystalluria 13.62 9.87 11 110949 940 79632488
Respiratory syncytial virus infection 13.53 9.87 36 110924 9366 79624062
Citrobacter infection 13.43 9.87 11 110949 959 79632469
Mixed dementia 13.36 9.87 7 110953 284 79633144
Toxic neuropathy 13.33 9.87 11 110949 969 79632459
Pseudolymphoma 13.29 9.87 12 110948 1193 79632235
Incorrect disposal of product 13.28 9.87 11 110949 974 79632454
Tractional retinal detachment 13.25 9.87 5 110955 91 79633337
Neurosis 13.22 9.87 8 110952 429 79632999
CSF volume increased 13.16 9.87 4 110956 36 79633392
Depressed mood 13.16 9.87 30 110930 48450 79584978
Gamma-glutamyltransferase increased 13.15 9.87 125 110835 54555 79578873
Meningitis 13.09 9.87 36 110924 9546 79623882
Respiratory tract infection 13.08 9.87 114 110846 48575 79584853
Fracture 13.07 9.87 7 110953 21794 79611634
Infective aneurysm 13.06 9.87 11 110949 997 79632431
Hyperphosphataemia 13.05 9.87 28 110932 6348 79627080
Rash pustular 13.05 9.87 40 110920 11271 79622157
Wrong strength 13.03 9.87 6 110954 183 79633245
Autoimmune haemolytic anaemia 12.99 9.87 33 110927 8347 79625081
Necrotising retinitis 12.96 9.87 12 110948 1233 79632195
Lymphocytic lymphoma 12.90 9.87 5 110955 98 79633330
Rash erythematous 12.89 9.87 130 110830 57639 79575789
Generalised tonic-clonic seizure 12.89 9.87 26 110934 43884 79589544
Rhegmatogenous retinal detachment 12.82 9.87 6 110954 190 79633238
Alpha haemolytic streptococcal infection 12.62 9.87 16 110944 2344 79631084
Pseudomyopia 12.59 9.87 5 110955 105 79633323
Pneumonia klebsiella 12.49 9.87 24 110936 5030 79628398
Embedded device 12.49 9.87 19 110941 3300 79630128
Lymphocytic infiltration 12.49 9.87 13 110947 1540 79631888
Varicella virus test positive 12.43 9.87 6 110954 204 79633224
Malignant neoplasm progression 12.42 9.87 125 110835 135865 79497563
Laryngeal inflammation 12.40 9.87 6 110954 205 79633223
Acute myocardial infarction 12.39 9.87 60 110900 76976 79556452
Exostosis 12.38 9.87 4 110956 16854 79616574
Benign neoplasm of skin 12.37 9.87 5 110955 110 79633318
Body temperature decreased 12.28 9.87 16 110944 32129 79601299
Soliloquy 12.22 9.87 9 110951 671 79632757
T-cell prolymphocytic leukaemia 12.20 9.87 4 110956 47 79633381
Dyscalculia 12.16 9.87 5 110955 115 79633313
Metabolic encephalopathy 12.14 9.87 34 110926 9113 79624315
Inappropriate schedule of product administration 12.13 9.87 123 110837 133505 79499923
Pneumonia viral 12.11 9.87 34 110926 9124 79624304
Adverse event 12.11 9.87 43 110917 60171 79573257
Bladder cancer 12.11 9.87 6 110954 19520 79613908
Right ventricular failure 12.09 9.87 9 110951 23488 79609940
Parkinsonism 12.07 9.87 4 110956 16580 79616848
Leukaemia recurrent 12.07 9.87 17 110943 2757 79630671
Campylobacter gastroenteritis 12.02 9.87 12 110948 1353 79632075
Decreased appetite 11.99 9.87 587 110373 341831 79291597
Pulmonary congestion 11.97 9.87 12 110948 27088 79606340
Glossoptosis 11.88 9.87 6 110954 225 79633203
Malaise 11.83 9.87 559 110401 489310 79144118
Persecutory delusion 11.76 9.87 23 110937 4886 79628542
Grip strength decreased 11.74 9.87 8 110952 21861 79611567
Periorbital cellulitis 11.70 9.87 10 110950 925 79632503
Bursitis 11.60 9.87 20 110940 35824 79597604
Peripheral nerve palsy 11.56 9.87 4 110956 56 79633372
Progressive multifocal leukoencephalopathy 11.55 9.87 58 110902 20542 79612886
Cryptosporidiosis infection 11.51 9.87 9 110951 734 79632694
Gingival erosion 11.49 9.87 5 110955 133 79633295
Herpes zoster meningoencephalitis 11.32 9.87 9 110951 752 79632676
Cytomegalovirus colitis 11.28 9.87 22 110938 4663 79628765
Gait inability 11.24 9.87 43 110917 58874 79574554
Parvovirus B19 infection 11.21 9.87 12 110948 1468 79631960
Conjunctivitis viral 11.15 9.87 6 110954 257 79633171
Tri-iodothyronine free increased 11.08 9.87 6 110954 260 79633168
Dermo-hypodermitis 11.04 9.87 9 110951 779 79632649
Transient ischaemic attack 11.02 9.87 37 110923 52658 79580770
Drug monitoring procedure not performed 11.02 9.87 10 110950 1001 79632427
Disability 11.02 9.87 5 110955 17115 79616313
Melanaemia 11.01 9.87 4 110956 65 79633363
Venous thrombosis 11.01 9.87 28 110932 7088 79626340
SAPHO syndrome 10.95 9.87 7 110953 414 79633014
Retinal detachment 10.95 9.87 33 110927 9214 79624214
Cerebral thrombosis 10.94 9.87 15 110945 2372 79631056
Urinary tract infection pseudomonal 10.93 9.87 13 110947 1785 79631643
Hypotension 10.92 9.87 501 110459 439816 79193612
Hypercapnic coma 10.91 9.87 7 110953 417 79633011
Thermal burn 10.90 9.87 28 110932 7132 79626296
Polymyositis 10.90 9.87 17 110943 3019 79630409
Blood creatinine abnormal 10.85 9.87 22 110938 4795 79628633
Ectropion 10.85 9.87 7 110953 421 79633007
Tongue disorder 10.84 9.87 3 110957 13972 79619456
Chronic obstructive pulmonary disease 10.78 9.87 72 110888 85347 79548081
Schizophrenia 10.76 9.87 4 110956 15436 79617992
Herpes simplex meningoencephalitis 10.74 9.87 4 110956 70 79633358
Medication error 10.73 9.87 54 110906 68588 79564840
Arteriosclerosis 10.72 9.87 6 110954 18221 79615207
Cerebral venous thrombosis 10.70 9.87 16 110944 2737 79630691
Hypoglycaemic seizure 10.69 9.87 9 110951 815 79632613
Device related infection 10.67 9.87 83 110877 34211 79599217
Metastases to lung 10.65 9.87 6 110954 18157 79615271
Bone marrow necrosis 10.64 9.87 6 110954 282 79633146
Incoherent 10.61 9.87 29 110931 7663 79625765
Peripheral sensory neuropathy 10.58 9.87 41 110919 12992 79620436
Skin necrosis 10.57 9.87 6 110954 18081 79615347
Hypophagia 10.56 9.87 103 110857 45264 79588164
Central nervous system necrosis 10.54 9.87 6 110954 287 79633141
Abdominal pain 10.53 9.87 439 110521 389130 79244298
General physical health deterioration 10.50 9.87 297 110663 274941 79358487
Pulmonary embolism 10.50 9.87 313 110647 171341 79462087
Tuberculosis 10.49 9.87 4 110956 15194 79618234
Meningitis enteroviral 10.44 9.87 4 110956 76 79633352
Monoclonal immunoglobulin present 10.42 9.87 10 110950 1075 79632353
Inflammation 10.39 9.87 82 110878 93671 79539757
Epstein-Barr virus associated lymphoma 10.39 9.87 10 110950 1079 79632349
Anuria 10.36 9.87 57 110903 20906 79612522
Hepatic encephalopathy 10.34 9.87 11 110949 24155 79609273
General physical condition abnormal 10.34 9.87 26 110934 6537 79626891
Herpes zoster oticus 10.30 9.87 7 110953 459 79632969
Basal cell carcinoma 10.30 9.87 88 110872 37287 79596141
Leukopenia 10.24 9.87 223 110737 116290 79517138
Ventricular fibrillation 10.17 9.87 18 110942 31908 79601520
Abnormal behaviour 10.17 9.87 86 110874 36335 79597093
Influenza 10.13 9.87 244 110716 129362 79504066
Therapy non-responder 10.11 9.87 81 110879 92224 79541204
Asthma 10.05 9.87 130 110830 134965 79498463
Mantle cell lymphoma 10.05 9.87 11 110949 1380 79632048
Cardiomyopathy acute 10.00 9.87 6 110954 317 79633111
Vitamin D decreased 9.95 9.87 33 110927 9692 79623736
Injection site swelling 9.92 9.87 33 110927 47099 79586329
Fluoride increased 9.90 9.87 4 110956 88 79633340
Erythema annulare 9.89 9.87 5 110955 188 79633240

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC J05AB11 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Nucleosides and nucleotides excl. reverse transcriptase inhibitors
FDA MoA N0000020060 DNA Polymerase Inhibitors
FDA EXT N0000175459 Nucleoside Analog
FDA EPC N0000175468 Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000998 Antiviral Agents
FDA EPC N0000180187 Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor
FDA EPC N0000180188 Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor

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

DiseaseRelationSNOMED_IDDOID
Herpes labialis indication 1475003
Herpes zoster indication 4740000 DOID:8536
Genital herpes simplex indication 33839006 DOID:8704
Varicella indication 38907003 DOID:8659
Recurrent genital herpes simplex indication 402894005
Suppression of Recurrent Herpes Simplex Infection in HIV indication
Suppression of Recurrent Herpes Simplex Infection indication
Prevention of Cytomegalovirus Disease off-label use
Prevention of Herpes Zoster in Immunocompromised Patient off-label use
Dehydration contraindication 34095006
Thrombotic thrombocytopenic purpura contraindication 78129009 DOID:10772
Hemolytic uremic syndrome contraindication 111407006 DOID:12554
Impaired renal function disorder contraindication 197663003




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.97 acidic
pKa2 7.83 Basic
pKa3 3.83 Basic
pKa4 2.12 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
DNA polymerase catalytic subunit Enzyme INHIBITOR WOMBAT-PK CHEMBL

External reference:

IDSource
4024006 VUID
N0000022011 NUI
D08664 KEGG_DRUG
124832-26-4 SECONDARY_CAS_RN
4020944 VANDF
4024006 VANDF
C0249458 UMLSCUI
CHEBI:9919 CHEBI
TXC PDB_CHEM_ID
CHEMBL1349 ChEMBL_ID
CHEMBL1201110 ChEMBL_ID
DB00577 DRUGBANK_ID
4824 IUPHAR_LIGAND_ID
135398742 PUBCHEM_CID
236081 RXNORM
169290 MMSL
41695 MMSL
5660 MMSL
d03838 MMSL
005049 NDDF
005050 NDDF
324820003 SNOMEDCT_US
412325002 SNOMEDCT_US
96098007 SNOMEDCT_US
D000077483 MESH_DESCRIPTOR_UI
7106 INN_ID
MZ1IW7Q79D UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
VALTREX HUMAN PRESCRIPTION DRUG LABEL 1 0173-0565 TABLET, FILM COATED 1 g ORAL NDA 25 sections
VALTREX HUMAN PRESCRIPTION DRUG LABEL 1 0173-0565 TABLET, FILM COATED 1 g ORAL NDA 25 sections
VALTREX HUMAN PRESCRIPTION DRUG LABEL 1 0173-0565 TABLET, FILM COATED 1 g ORAL NDA 25 sections
VALTREX HUMAN PRESCRIPTION DRUG LABEL 1 0173-0565 TABLET, FILM COATED 1 g ORAL NDA 25 sections
VALTREX HUMAN PRESCRIPTION DRUG LABEL 1 0173-0933 TABLET, FILM COATED 500 mg ORAL NDA 25 sections
VALTREX HUMAN PRESCRIPTION DRUG LABEL 1 0173-0933 TABLET, FILM COATED 500 mg ORAL NDA 25 sections
VALTREX HUMAN PRESCRIPTION DRUG LABEL 1 0173-0933 TABLET, FILM COATED 500 mg ORAL NDA 25 sections
VALTREX HUMAN PRESCRIPTION DRUG LABEL 1 0173-0933 TABLET, FILM COATED 500 mg ORAL NDA 25 sections
Valacyclovir Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0378-4275 TABLET, FILM COATED 500 mg ORAL ANDA 27 sections
Valacyclovir Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0378-4275 TABLET, FILM COATED 500 mg ORAL ANDA 27 sections
Valacyclovir Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0378-4276 TABLET, FILM COATED 1 g ORAL ANDA 27 sections
Valacyclovir Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0378-4276 TABLET, FILM COATED 1 g ORAL ANDA 27 sections
Valacyclovir Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0781-5208 TABLET 500 mg ORAL ANDA 25 sections
Valacyclovir Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0781-5209 TABLET 1 g ORAL ANDA 25 sections
Valacyclovir Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6565 TABLET, FILM COATED 500 mg ORAL ANDA 25 sections
Valacyclovir Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6565 TABLET, FILM COATED 500 mg ORAL ANDA 25 sections
valacyclovir hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10544-937 TABLET, FILM COATED 1 g ORAL ANDA 23 sections
Valacyclovir Hydrochloride Human Prescription Drug Label 1 16714-697 TABLET, FILM COATED 1 g ORAL ANDA 25 sections
Valacyclovir Hydrochloride Human Prescription Drug Label 1 16714-697 TABLET, FILM COATED 1 g ORAL ANDA 25 sections
Valacyclovir Hydrochloride Human Prescription Drug Label 1 16714-697 TABLET, FILM COATED 1 g ORAL ANDA 25 sections
Valacyclovir Hydrochloride Human Prescription Drug Label 1 16714-698 TABLET, FILM COATED 500 mg ORAL ANDA 25 sections
Valacyclovir Hydrochloride Human Prescription Drug Label 1 16714-698 TABLET, FILM COATED 500 mg ORAL ANDA 25 sections
Valacyclovir Hydrochloride Human Prescription Drug Label 1 16714-698 TABLET, FILM COATED 500 mg ORAL ANDA 25 sections
Valacyclovir Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 21695-832 TABLET, FILM COATED 500 mg ORAL ANDA 27 sections
Valacyclovir Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 21695-965 TABLET, FILM COATED 1 g ORAL ANDA 27 sections
Valacyclovir HUMAN PRESCRIPTION DRUG LABEL 1 31722-704 TABLET, FILM COATED 500 mg ORAL ANDA 24 sections
Valacyclovir HUMAN PRESCRIPTION DRUG LABEL 1 31722-705 TABLET, FILM COATED 1 g ORAL ANDA 24 sections
Valacyclovir Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 43063-730 TABLET, FILM COATED 500 mg ORAL ANDA 25 sections
Valacyclovir Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 43063-730 TABLET, FILM COATED 500 mg ORAL ANDA 25 sections
Valacyclovir Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 43063-730 TABLET, FILM COATED 500 mg ORAL ANDA 25 sections