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

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
Altered state of consciousness 309.52 9.98 246 66670 21664 50516544
Plasma cell myeloma 287.42 9.98 275 66641 31047 50507161
Acute kidney injury 272.23 9.98 788 66128 227270 50310938
Febrile neutropenia 211.04 9.98 425 66491 97242 50440966
Encephalopathy 203.85 9.98 237 66679 33474 50504734
Neurotoxicity 188.10 9.98 156 66760 14584 50523624
Toxic encephalopathy 179.75 9.98 104 66812 5411 50532797
Drug ineffective 176.79 9.98 530 66386 818803 49719405
Contraindicated product administered 170.30 9.98 6 66910 148952 50389256
Hepatocellular injury 157.83 9.98 183 66733 25764 50512444
Dyslalia 146.54 9.98 44 66872 400 50537808
Dysarthria 141.86 9.98 209 66707 37194 50501014
Cytokine release syndrome 137.25 9.98 104 66812 8530 50529678
Drug reaction with eosinophilia and systemic symptoms 133.45 9.98 176 66740 28248 50509960
Synovitis 131.82 9.98 8 66908 123857 50414351
Toxic skin eruption 125.02 9.98 110 66806 11141 50527067
Blood urea increased 121.64 9.98 153 66763 23432 50514776
Neutropenia 115.96 9.98 444 66472 147521 50390687
Glossodynia 110.44 9.98 12 66904 115557 50422651
Treatment failure 103.66 9.98 27 66889 137610 50400598
Systemic lupus erythematosus 99.59 9.98 31 66885 140591 50397617
Joint swelling 92.53 9.98 113 66803 245173 50293035
Herpes zoster 91.37 9.98 252 66664 70534 50467674
Drug hypersensitivity 91.19 9.98 119 66797 250891 50287317
Agranulocytosis 90.46 9.98 126 66790 21295 50516913
Rheumatoid arthritis 87.85 9.98 83 66833 202467 50335741
Drug intolerance 86.86 9.98 97 66819 219007 50319201
Completed suicide 84.96 9.98 34 66882 131855 50406353
Pancytopenia 83.71 9.98 273 66643 83757 50454451
Wound 83.07 9.98 19 66897 105775 50432433
Rash maculo-papular 83.02 9.98 136 66780 26505 50511703
Blood creatinine increased 79.10 9.98 251 66665 75909 50462299
Pyrexia 76.92 9.98 804 66112 379399 50158809
Arthropathy 75.40 9.98 59 66857 157847 50380361
Neuropathy peripheral 74.63 9.98 289 66627 96468 50441740
Herpes simplex 73.58 9.98 67 66849 7095 50531113
White blood cell count decreased 73.07 9.98 327 66589 116395 50421813
Nervous system disorder 72.37 9.98 98 66818 16125 50522083
Therapeutic product effect decreased 71.30 9.98 46 66870 136004 50402204
Thrombocytopenia 70.62 9.98 345 66571 127328 50410880
Swelling 70.11 9.98 98 66818 200774 50337434
Alopecia 67.64 9.98 139 66777 244908 50293300
Febrile bone marrow aplasia 66.73 9.98 60 66856 6251 50531957
Intentional overdose 66.58 9.98 4 66912 62500 50475708
Oral herpes 64.84 9.98 106 66810 20619 50517589
Laryngitis fungal 63.71 9.98 18 66898 129 50538079
Abdominal discomfort 61.74 9.98 134 66782 231507 50306701
Acute generalised exanthematous pustulosis 61.09 9.98 67 66849 8871 50529337
Maternal exposure during pregnancy 58.74 9.98 75 66841 159703 50378505
Platelet count decreased 55.55 9.98 272 66644 100454 50437754
Herpes virus infection 54.78 9.98 48 66868 4833 50533375
Depressed level of consciousness 54.64 9.98 172 66744 51781 50486427
Diarrhoea 53.19 9.98 1081 65835 587395 49950813
Tumour lysis syndrome 53.11 9.98 57 66859 7364 50530844
Drug abuse 52.84 9.98 8 66908 59838 50478370
Dermatitis exfoliative generalised 52.68 9.98 39 66877 3087 50535121
Rectal prolapse 51.78 9.98 31 66885 1718 50536490
Helicobacter infection 50.55 9.98 4 66912 49698 50488510
Discomfort 48.62 9.98 43 66873 108337 50429871
Injection site inflammation 47.42 9.98 37 66879 3168 50535040
Encephalitis cytomegalovirus 47.30 9.98 20 66896 522 50537686
Diffuse large B-cell lymphoma refractory 45.88 9.98 24 66892 1022 50537186
Pericarditis 44.90 9.98 24 66892 78665 50459543
Renal disorder 44.87 9.98 107 66809 27398 50510810
Pain 43.32 9.98 524 66392 578379 49959829
Aplasia 41.80 9.98 37 66879 3776 50534432
Rheumatoid factor positive 41.08 9.98 8 66908 49851 50488357
Cytomegalovirus infection 40.93 9.98 80 66836 17882 50520326
Bronchopulmonary aspergillosis 40.33 9.98 50 66866 7542 50530666
Hallucination, visual 37.96 9.98 74 66842 16508 50521700
Delirium 37.93 9.98 124 66792 38068 50500140
Arthralgia 37.55 9.98 385 66531 438317 50099891
Vocal cord dysfunction 37.07 9.98 15 66901 349 50537859
Ophthalmic herpes simplex 36.76 9.98 15 66901 357 50537851
Acute myeloid leukaemia 36.63 9.98 69 66847 15005 50523203
Septic shock 36.36 9.98 161 66755 57014 50481194
Eosinophilia 35.35 9.98 77 66839 18575 50519633
Cholestasis 35.33 9.98 93 66823 25308 50512900
Toxicity to various agents 35.11 9.98 153 66763 212346 50325862
Graft versus host disease 35.01 9.98 42 66874 6124 50532084
Product use issue 34.62 9.98 93 66823 149382 50388826
Immune effector cell-associated neurotoxicity syndrome 33.06 9.98 20 66896 1130 50537078
Full blood count decreased 32.29 9.98 83 66833 22263 50515945
Therapeutic product effect incomplete 31.54 9.98 45 66871 91470 50446738
Hypersensitivity 31.39 9.98 162 66754 214999 50323209
Lymphopenia 31.34 9.98 66 66850 15555 50522653
Myoclonus 31.22 9.98 63 66853 14407 50523801
Renal impairment 30.70 9.98 188 66728 75473 50462735
Toxic erythema of chemotherapy 30.29 9.98 10 66906 127 50538081
Impaired healing 29.74 9.98 29 66887 69757 50468451
Musculoskeletal stiffness 29.70 9.98 80 66836 128401 50409807
Plasma cell myeloma recurrent 29.55 9.98 26 66890 2632 50535576
Urine output decreased 29.53 9.98 51 66865 10370 50527838
Cerebellar stroke 29.30 9.98 11 66905 208 50538000
Suicide attempt 29.18 9.98 16 66900 51716 50486492
Bladder prolapse 29.08 9.98 22 66894 1799 50536409
Fungal endocarditis 28.96 9.98 11 66905 215 50537993
Mobility decreased 28.87 9.98 38 66878 79910 50458298
Human herpesvirus 6 encephalitis 28.83 9.98 10 66906 149 50538059
Hepatic enzyme increased 28.51 9.98 90 66826 137290 50400918
Blood uric acid increased 28.41 9.98 30 66886 3804 50534404
Laboratory test abnormal 28.32 9.98 81 66835 23127 50515081
Post herpetic neuralgia 27.99 9.98 22 66894 1904 50536304
Lower respiratory tract infection 27.95 9.98 52 66864 95149 50443059
Renal tubular disorder 27.42 9.98 24 66892 2413 50535795
Folliculitis 27.12 9.98 9 66907 39216 50498992
Drug interaction 26.53 9.98 155 66761 199466 50338742
Bacterial sepsis 26.30 9.98 28 66888 3584 50534624
Psychiatric symptom 25.74 9.98 31 66885 4539 50533669
Deep vein thrombosis 25.36 9.98 175 66741 73129 50465079
Restlessness 25.23 9.98 82 66834 25091 50513117
Cytopenia 24.94 9.98 43 66873 8732 50529476
Decreased appetite 23.60 9.98 385 66531 200538 50337670
Eye infection bacterial 23.46 9.98 8 66908 113 50538095
Disorientation 23.38 9.98 101 66815 35383 50502825
Genital herpes simplex 23.19 9.98 9 66907 187 50538021
Infective aneurysm 22.94 9.98 11 66905 388 50537820
Hallucination 22.90 9.98 122 66794 46535 50491673
Serotonin syndrome 22.52 9.98 3 66913 24710 50513498
Congenital herpes simplex infection 22.52 9.98 4 66912 0 50538208
Spina bifida 22.33 9.98 13 66903 684 50537524
Mixed liver injury 22.09 9.98 25 66891 3426 50534782
Neuropsychiatric syndrome 21.61 9.98 6 66910 40 50538168
Mucormycosis 21.26 9.98 21 66895 2462 50535746
Cerebral ventricle dilatation 21.19 9.98 14 66902 923 50537285
Terminal ileitis 21.19 9.98 12 66904 599 50537609
Dyspnoea 21.18 9.98 557 66359 547051 49991157
Neutrophil count decreased 21.01 9.98 118 66798 45908 50492300
Biopsy skin abnormal 20.99 9.98 7 66909 92 50538116
Bradycardia 20.92 9.98 33 66883 64393 50473815
Pneumonia 20.86 9.98 651 66265 377750 50160458
Loss of personal independence in daily activities 20.79 9.98 38 66878 70012 50468196
Infusion related reaction 20.78 9.98 135 66781 169422 50368786
Laryngeal stenosis 20.72 9.98 13 66903 784 50537424
Skin lesion 20.71 9.98 80 66836 26647 50511561
Intentional self-injury 20.60 9.98 3 66913 23109 50515099
Sepsis 20.46 9.98 267 66649 132658 50405550
Pathogen resistance 20.43 9.98 31 66885 5658 50532550
Anaphylactic reaction 20.23 9.98 25 66891 54030 50484178
Plasmacytoma 20.10 9.98 20 66896 2365 50535843
Cryptosporidiosis infection 19.79 9.98 9 66907 281 50537927
Mucosal excoriation 19.75 9.98 4 66912 4 50538204
Squamous cell carcinoma of skin 19.71 9.98 29 66887 5149 50533059
Pneumocystis jirovecii pneumonia 19.69 9.98 53 66863 14610 50523598
Ophthalmic herpes zoster 19.67 9.98 17 66899 1680 50536528
Bicytopenia 19.67 9.98 18 66898 1918 50536290
Gastrointestinal disorder 19.51 9.98 62 66854 94394 50443814
Chronic lymphocytic leukaemia 18.63 9.98 19 66897 2314 50535894
Vitamin D decreased 18.62 9.98 37 66879 8369 50529839
Vitiligo 18.56 9.98 14 66902 1140 50537068
Metabolic encephalopathy 18.52 9.98 28 66888 5093 50533115
Genital herpes 18.43 9.98 16 66900 1591 50536617
Epstein-Barr virus associated lymphoma 18.42 9.98 10 66906 459 50537749
International normalised ratio increased 18.31 9.98 18 66898 43134 50495074
Lymphocyte count decreased 18.19 9.98 76 66840 26231 50511977
Campylobacter colitis 18.18 9.98 5 66911 32 50538176
Speech disorder 18.17 9.98 94 66822 35454 50502754
Irritable bowel syndrome 18.01 9.98 25 66891 51416 50486792
Ectropion 17.83 9.98 7 66909 150 50538058
Bacterial vaginosis 17.75 9.98 13 66903 1012 50537196
Cell death 17.61 9.98 18 66898 2197 50536011
Confusional state 17.48 9.98 344 66572 185584 50352624
Cytomegalovirus chorioretinitis 17.27 9.98 15 66901 1492 50536716
Meningoencephalitis herpetic 17.23 9.98 13 66903 1059 50537149
Posterior reversible encephalopathy syndrome 17.16 9.98 51 66865 14877 50523331
Congenital pyelocaliectasis 16.89 9.98 3 66913 0 50538208
Mycetoma mycotic 16.75 9.98 4 66912 13 50538195
C-reactive protein abnormal 16.58 9.98 8 66908 27801 50510407
Tractional retinal detachment 16.50 9.98 5 66911 47 50538161
Soliloquy 16.47 9.98 7 66909 185 50538023
Knee arthroplasty 16.33 9.98 14 66902 35832 50502376
Hip arthroplasty 16.32 9.98 10 66906 30419 50507789
Pseudolymphoma 16.29 9.98 10 66906 580 50537628
Infective chondritis 16.10 9.98 4 66912 16 50538192
Hyperthermia 16.00 9.98 33 66883 7663 50530545
Chronic papillomatous dermatitis 15.96 9.98 5 66911 53 50538155
Product tampering 15.87 9.98 7 66909 203 50538005
Pseudomyopia 15.80 9.98 5 66911 55 50538153
Hypoglycaemic seizure 15.77 9.98 9 66907 456 50537752
Epstein-Barr virus infection 15.74 9.98 31 66885 6966 50531242
Rhabdomyolysis 15.74 9.98 17 66899 39010 50499198
Escherichia bacteraemia 15.72 9.98 20 66896 3096 50535112
Drug monitoring procedure not performed 15.52 9.98 9 66907 470 50537738
Mycobacterial peritonitis 15.40 9.98 5 66911 60 50538148
Hepatitis 15.27 9.98 82 66834 31371 50506837
Dermo-hypodermitis 15.26 9.98 7 66909 223 50537985
Laryngeal inflammation 15.18 9.98 6 66910 131 50538077
Sedation 15.15 9.98 11 66905 30599 50507609
Central nervous system necrosis 15.10 9.98 6 66910 133 50538075
Neurological symptom 15.10 9.98 24 66892 4558 50533650
Death 15.02 9.98 322 66594 325057 50213151
Metastases to liver 15.01 9.98 4 66912 20100 50518108
Acute pulmonary oedema 14.92 9.98 31 66885 7236 50530972
Citrobacter sepsis 14.81 9.98 3 66913 3 50538205
Neurosis 14.78 9.98 7 66909 240 50537968
Accidental exposure to product 14.74 9.98 6 66910 23051 50515157
Bone marrow necrosis 14.70 9.98 5 66911 70 50538138
Cardiac arrest 14.55 9.98 59 66857 83592 50454616
Nausea 14.38 9.98 1100 65816 704298 49833910
Cardiac failure congestive 14.38 9.98 60 66856 84322 50453886
Venoocclusive disease 14.34 9.98 15 66901 1881 50536327
Thermal burn 14.12 9.98 24 66892 4817 50533391
Hepatitis acute 14.11 9.98 32 66884 7929 50530279
Cholecystitis chronic 14.06 9.98 36 66880 9633 50528575
Red blood cell sedimentation rate increased 14.01 9.98 11 66905 29405 50508803
Human ehrlichiosis 14.00 9.98 6 66910 162 50538046
Disseminated varicella zoster virus infection 13.98 9.98 5 66911 82 50538126
Eye infection toxoplasmal 13.95 9.98 7 66909 273 50537935
Rhegmatogenous retinal detachment 13.92 9.98 5 66911 83 50538125
Aspergillus infection 13.89 9.98 29 66887 6792 50531416
Lichenification 13.83 9.98 8 66908 416 50537792
Pain in extremity 13.79 9.98 266 66650 272599 50265609
Blood pressure systolic abnormal 13.68 9.98 31 66885 7675 50530533
Hepatitis E 13.62 9.98 12 66904 1217 50536991
Meningocele 13.60 9.98 3 66913 6 50538202
Antiviral drug level above therapeutic 13.60 9.98 3 66913 6 50538202
Pyelitis 13.54 9.98 6 66910 176 50538032
Pharyngeal inflammation 13.49 9.98 9 66907 603 50537605
Leukaemia recurrent 13.41 9.98 12 66904 1242 50536966
Psychiatric decompensation 13.38 9.98 12 66904 1246 50536962
Coronary artery disease 13.08 9.98 12 66904 29714 50508494
Dermatitis exfoliative 13.07 9.98 24 66892 5118 50533090
Cardiomyopathy acute 12.97 9.98 6 66910 195 50538013
Peripheral swelling 12.92 9.98 193 66723 205743 50332465
Autoimmune nephritis 12.90 9.98 7 66909 321 50537887
Therapeutic response decreased 12.82 9.98 27 66889 47204 50491004
Foreign body in reproductive tract 12.77 9.98 8 66908 481 50537727
Graft versus host disease in gastrointestinal tract 12.71 9.98 17 66899 2764 50535444
Tri-iodothyronine free increased 12.69 9.98 6 66910 205 50538003
Thrombosis 12.62 9.98 121 66795 55712 50482496
Hepatitis cholestatic 12.45 9.98 26 66890 6091 50532117
Embedded device 12.44 9.98 17 66899 2820 50535388
Rash vesicular 12.37 9.98 19 66897 3504 50534704
Blood lactate dehydrogenase increased 12.36 9.98 55 66861 19507 50518701
Tandem gait test abnormal 12.28 9.98 3 66913 11 50538197
Gamma-glutamyltransferase increased 12.25 9.98 74 66842 29549 50508659
Subacute combined cord degeneration 12.22 9.98 6 66910 223 50537985
Kussmaul respiration 12.10 9.98 6 66910 228 50537980
Bone marrow failure 12.07 9.98 70 66846 27554 50510654
Asthma 12.05 9.98 69 66847 89268 50448940
Aminoaciduria 12.02 9.98 5 66911 125 50538083
COVID-19 12.01 9.98 104 66812 46558 50491650
Renal failure 12.01 9.98 203 66713 106430 50431778
Neuralgia 12.01 9.98 59 66857 21804 50516404
COVID-19 pneumonia 11.94 9.98 31 66885 8364 50529844
Streptococcal bacteraemia 11.87 9.98 12 66904 1446 50536762
Acute febrile neutrophilic dermatosis 11.84 9.98 16 66900 2626 50535582
Wrong technique in product usage process 11.77 9.98 36 66880 55474 50482734
Nystagmus 11.75 9.98 24 66892 5537 50532671
Feeling abnormal 11.72 9.98 232 66684 125260 50412948
Constipation 11.70 9.98 325 66591 185383 50352825
Anal infection 11.70 9.98 4 66912 57 50538151
Escherichia pyelonephritis 11.61 9.98 7 66909 393 50537815
Inappropriate antidiuretic hormone secretion 11.57 9.98 41 66875 13102 50525106
Angina bullosa haemorrhagica 11.53 9.98 5 66911 139 50538069
Rash pustular 11.43 9.98 26 66890 6455 50531753
Hypouricaemia 11.40 9.98 5 66911 143 50538065
Hemianopia homonymous 11.37 9.98 8 66908 585 50537623
Gastrointestinal haemorrhage 11.36 9.98 54 66862 73267 50464941
Pneumocystis jirovecii infection 11.32 9.98 11 66905 1264 50536944
Lymphocyte morphology abnormal 11.29 9.98 7 66909 413 50537795
Tumour flare 11.25 9.98 6 66910 266 50537942
Progressive multifocal leukoencephalopathy 11.19 9.98 37 66879 11420 50526788
Cerebral thrombosis 11.14 9.98 12 66904 1556 50536652
Incoherent 11.08 9.98 20 66896 4210 50533998
Coordination abnormal 11.05 9.98 37 66879 11497 50526711
Metastases to bone 11.00 9.98 5 66911 17990 50520218
Visual acuity reduced 10.81 9.98 54 66862 20085 50518123
Thrombotic thrombocytopenic purpura 10.76 9.98 18 66898 3567 50534641
Cytomegalovirus colitis 10.73 9.98 13 66903 1914 50536294
Acute lymphocytic leukaemia 10.70 9.98 14 66902 2227 50535981
Malignant neoplasm progression 10.66 9.98 50 66866 68074 50470134
CSF cell count increased 10.56 9.98 3 66913 22 50538186
Condition aggravated 10.45 9.98 306 66610 296752 50241456
Oliguria 10.34 9.98 29 66887 8187 50530021
Myocardial infarction 10.34 9.98 72 66844 88955 50449253
Disseminated cytomegaloviral infection 10.26 9.98 5 66911 183 50538025
Cholestatic liver injury 10.24 9.98 13 66903 2008 50536200
Partial seizures with secondary generalisation 10.23 9.98 6 66910 320 50537888
Acute myopia 10.14 9.98 4 66912 87 50538121
Erythema annulare 10.09 9.98 4 66912 88 50538120
Vision blurred 10.09 9.98 153 66763 78494 50459714
Engraftment syndrome 10.06 9.98 6 66910 330 50537878
Asterixis 10.06 9.98 10 66906 1181 50537027
Product substitution issue 10.03 9.98 41 66875 14016 50524192
Unevaluable event 10.01 9.98 99 66817 45967 50492241

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 317.95 11.09 633 49747 111607 29412540
Plasma cell myeloma 249.89 11.09 312 50068 36803 29487344
Cytokine release syndrome 195.48 11.09 169 50211 12950 29511197
Pyrexia 147.65 11.09 914 49466 286708 29237439
Neutropenia 143.17 11.09 521 49859 131190 29392957
Encephalopathy 141.11 11.09 216 50164 30827 29493320
Neurotoxicity 139.09 11.09 147 50233 14466 29509681
Acute generalised exanthematous pustulosis 128.64 11.09 93 50287 5490 29518657
Completed suicide 128.49 11.09 6 50374 90240 29433907
Thrombocytopenia 124.92 11.09 507 49873 134316 29389831
Drug reaction with eosinophilia and systemic symptoms 120.55 11.09 190 50190 27802 29496345
Febrile bone marrow aplasia 120.36 11.09 100 50280 7251 29516896
Agranulocytosis 110.51 11.09 154 50226 20186 29503961
Toxic encephalopathy 108.94 11.09 78 50302 4534 29519613
Drug abuse 108.47 11.09 7 50373 79876 29444271
Hepatocellular injury 102.47 11.09 152 50228 21091 29503056
Toxicity to various agents 101.57 11.09 88 50292 173573 29350574
Rash maculo-papular 96.56 11.09 159 50221 24130 29500017
Pancytopenia 93.62 11.09 333 50047 82835 29441312
Toxic skin eruption 90.80 11.09 97 50283 9660 29514487
Dyslalia 89.06 11.09 33 50347 459 29523688
Altered state of consciousness 88.39 11.09 137 50243 19752 29504395
Acute kidney injury 87.96 11.09 760 49620 264507 29259640
Neuropathy peripheral 82.16 11.09 287 50093 70740 29453407
Dermatitis exfoliative generalised 77.46 11.09 53 50327 2863 29521284
Nervous system disorder 74.95 11.09 100 50280 12574 29511573
Drug ineffective 71.17 11.09 348 50032 362822 29161325
Microsporidia infection 70.83 11.09 29 50351 534 29523613
Dysarthria 70.59 11.09 160 50220 30751 29493396
Pneumonia 69.93 11.09 842 49538 319330 29204817
Bronchopulmonary aspergillosis 69.35 11.09 95 50285 12249 29511898
Herpes zoster 69.13 11.09 156 50224 29896 29494251
Drug interaction 63.11 11.09 153 50227 197232 29326915
White blood cell count decreased 62.18 11.09 294 50086 83068 29441079
Cytopenia 58.61 11.09 78 50302 9781 29514366
Tumour lysis syndrome 56.67 11.09 92 50288 13792 29510355
Squamous cell carcinoma of skin 56.32 11.09 75 50305 9411 29514736
Ophthalmic herpes simplex 52.44 11.09 19 50361 247 29523900
Cerebral toxoplasmosis 50.58 11.09 31 50349 1385 29522762
Chronic lymphocytic leukaemia 50.48 11.09 45 50335 3588 29520559
Pathogen resistance 49.46 11.09 65 50315 8051 29516096
Demodicidosis 47.36 11.09 15 50365 125 29524022
Face oedema 45.91 11.09 71 50309 10212 29513935
Cholestasis 41.38 11.09 110 50270 23352 29500795
Intentional overdose 40.83 11.09 8 50372 38520 29485627
Acute myeloid leukaemia 39.39 11.09 87 50293 16426 29507721
Suicide attempt 38.51 11.09 6 50374 34104 29490043
Graft versus host disease 38.21 11.09 63 50317 9565 29514582
Nephritis allergic 38.01 11.09 17 50363 392 29523755
Dyspnoea 37.95 11.09 365 50015 326367 29197780
Aplasia 37.10 11.09 40 50340 4023 29520124
Hypoglycaemia 37.03 11.09 18 50362 48328 29475819
Pseudomonas infection 36.50 11.09 66 50314 10786 29513361
Platelet count decreased 36.12 11.09 303 50077 104369 29419778
Graft versus host disease in gastrointestinal tract 35.01 11.09 35 50345 3223 29520924
Lung disorder 33.61 11.09 121 50259 30241 29493906
Intentional product misuse 31.31 11.09 10 50370 34651 29489496
Septic shock 31.31 11.09 198 50182 62362 29461785
Pulmonary sarcoidosis 30.99 11.09 16 50364 511 29523636
Genital herpes 30.05 11.09 16 50364 545 29523602
Congenital herpes simplex infection 30.00 11.09 8 50372 33 29524114
Parainfluenzae virus infection 29.56 11.09 27 50353 2222 29521925
International normalised ratio increased 29.03 11.09 20 50360 44352 29479795
Differentiation syndrome 29.02 11.09 20 50360 1093 29523054
Bradycardia 28.73 11.09 42 50338 65587 29458560
Lymphopenia 28.63 11.09 68 50312 13465 29510682
Eosinophilia 28.63 11.09 93 50287 22068 29502079
Thrombotic microangiopathy 28.19 11.09 52 50328 8629 29515518
Squamous cell carcinoma 27.91 11.09 57 50323 10194 29513953
Inappropriate schedule of product administration 27.84 11.09 21 50359 44451 29479696
Drug hypersensitivity 26.90 11.09 47 50333 68359 29455788
Encephalitis 26.77 11.09 43 50337 6387 29517760
Confusional state 26.72 11.09 334 50046 127543 29396604
Pericarditis 26.62 11.09 51 50329 8706 29515441
Rhinovirus infection 26.50 11.09 30 50350 3186 29520961
Depression 26.36 11.09 67 50313 85080 29439067
Conjunctival irritation 26.12 11.09 9 50371 100 29524047
Infective exacerbation of chronic obstructive airways disease 26.08 11.09 22 50358 1628 29522519
Delirium 25.81 11.09 134 50246 39263 29484884
Drug resistance 25.70 11.09 88 50292 21452 29502695
Rhabdomyolysis 25.57 11.09 40 50340 60768 29463379
Myocardial infarction 25.54 11.09 99 50281 110197 29413950
Mucosal inflammation 25.42 11.09 114 50266 31481 29492666
Wrong technique in product usage process 25.15 11.09 11 50369 31417 29492730
Herpes simplex 25.03 11.09 36 50344 4854 29519293
Plasma cell myeloma recurrent 24.81 11.09 31 50349 3652 29520495
Tumour flare 24.75 11.09 14 50366 538 29523609
Death 23.84 11.09 425 49955 341659 29182488
Human herpesvirus 6 encephalitis 23.66 11.09 10 50370 200 29523947
Eosinophilic colitis 23.66 11.09 10 50370 200 29523947
Psychiatric symptom 23.39 11.09 28 50352 3156 29520991
Full blood count decreased 23.32 11.09 70 50310 15922 29508225
Neutrophil count decreased 23.11 11.09 140 50240 43427 29480720
Escherichia sepsis 23.10 11.09 31 50349 3918 29520229
Nocardiosis 22.86 11.09 28 50352 3232 29520915
Ichthyosis 22.66 11.09 8 50372 96 29524051
Injection site pain 22.06 11.09 14 50366 32432 29491715
Hallucination 22.04 11.09 141 50239 44571 29479576
Hepatitis cholestatic 22.02 11.09 41 50339 6852 29517295
Aggression 21.97 11.09 17 50363 35524 29488623
Angina pectoris 21.89 11.09 10 50370 27840 29496307
Genital erythema 21.82 11.09 9 50371 169 29523978
Malignant neoplasm progression 21.43 11.09 60 50320 73799 29450348
Immune effector cell-associated neurotoxicity syndrome 21.42 11.09 19 50361 1505 29522642
Rash 21.25 11.09 447 49933 189372 29334775
Botryomycosis 20.94 11.09 6 50374 34 29524113
Drug dependence 20.92 11.09 5 50375 20976 29503171
Hyperuricaemia 20.79 11.09 40 50340 6849 29517298
Respiratory arrest 20.74 11.09 9 50371 25824 29498323
Drug withdrawal syndrome 20.67 11.09 3 50377 17981 29506166
Malignant neoplasm of unknown primary site 20.46 11.09 11 50369 382 29523765
Hyperleukocytosis 20.27 11.09 19 50361 1616 29522531
Purpura 20.19 11.09 47 50333 9185 29514962
Anxiety 20.15 11.09 76 50304 85289 29438858
Varicella zoster virus infection 20.03 11.09 18 50362 1450 29522697
Influenza 19.99 11.09 131 50249 41750 29482397
Atrial fibrillation 19.98 11.09 271 50109 105375 29418772
Hypogammaglobulinaemia 19.96 11.09 36 50344 5871 29518276
JC virus infection 19.69 11.09 20 50360 1877 29522270
Cardiac arrest 19.69 11.09 77 50303 85514 29438633
Diffuse large B-cell lymphoma 19.63 11.09 37 50343 6239 29517908
Polymyositis 19.55 11.09 17 50363 1311 29522836
Infection 19.38 11.09 208 50172 76543 29447604
Myositis 18.93 11.09 49 50331 10234 29513913
Glomerulosclerosis 18.92 11.09 13 50367 707 29523440
COVID-19 18.64 11.09 115 50265 35899 29488248
Morganella infection 18.60 11.09 11 50369 460 29523687
Blood pressure increased 18.55 11.09 64 50316 73739 29450408
Lymphocytic infiltration 18.49 11.09 12 50368 593 29523554
Viral mutation identified 18.47 11.09 22 50358 2466 29521681
Hyperhidrosis 18.30 11.09 53 50327 64487 29459660
Logorrhoea 18.27 11.09 21 50359 2267 29521880
Laryngeal cancer metastatic 18.07 11.09 6 50374 59 29524088
Aspergillus infection 18.04 11.09 49 50331 10532 29513615
Stress 18.04 11.09 7 50373 21483 29502664
Pityriasis rubra pilaris 17.98 11.09 6 50374 60 29524087
Bacillus bacteraemia 17.80 11.09 6 50374 62 29524085
Haemorrhoids thrombosed 17.79 11.09 8 50372 187 29523960
Brief psychotic disorder with marked stressors 17.71 11.09 8 50372 189 29523958
Hallucination, visual 17.61 11.09 61 50319 14954 29509193
Dyscalculia 17.50 11.09 5 50375 28 29524119
Acute HIV infection 17.46 11.09 6 50374 66 29524081
SARS-CoV-2 sepsis 17.40 11.09 7 50373 123 29524024
Anti-cyclic citrullinated peptide antibody positive 17.34 11.09 13 50367 811 29523336
Incorrect disposal of product 17.27 11.09 9 50371 293 29523854
Bronchopneumopathy 17.27 11.09 10 50370 402 29523745
Disseminated cryptococcosis 17.18 11.09 15 50365 1163 29522984
Positive end-expiratory pressure 17.13 11.09 4 50376 8 29524139
Hypercalcaemia 16.89 11.09 54 50326 12705 29511442
Blood creatinine abnormal 16.80 11.09 19 50361 2015 29522132
CSF cell count increased 16.80 11.09 5 50375 33 29524114
Pain 16.79 11.09 199 50181 171233 29352914
Mutism 16.64 11.09 12 50368 705 29523442
Citrobacter infection 16.62 11.09 10 50370 432 29523715
Escherichia infection 16.54 11.09 36 50344 6728 29517419
Hyperthermia 16.41 11.09 44 50336 9386 29514761
Renal disorder 16.31 11.09 79 50301 22516 29501631
Sepsis 16.27 11.09 337 50043 142345 29381802
Periorbital cellulitis 16.23 11.09 8 50372 231 29523916
Fluid imbalance 16.14 11.09 8 50372 234 29523913
Depressed level of consciousness 16.10 11.09 113 50267 36829 29487318
Escherichia bacteraemia 16.05 11.09 22 50358 2836 29521311
Coronary artery disease 15.92 11.09 32 50348 44158 29479989
Blood creatine phosphokinase increased 15.90 11.09 28 50352 40616 29483531
Acute myocardial infarction 15.86 11.09 37 50343 48401 29475746
Haematochezia 15.85 11.09 24 50356 36959 29487188
Lymphocyte count decreased 15.85 11.09 70 50310 19201 29504946
Pneumonia pneumococcal 15.76 11.09 17 50363 1710 29522437
Aeromonas infection 15.68 11.09 8 50372 249 29523898
Myelodysplastic syndrome 15.68 11.09 66 50314 17728 29506419
Complications of transplanted heart 15.54 11.09 8 50372 254 29523893
Hypercapnic coma 15.47 11.09 7 50373 166 29523981
Graft versus host disease in lung 15.47 11.09 10 50370 491 29523656
Therapeutic product effect incomplete 15.45 11.09 27 50353 39278 29484869
Haemolytic anaemia 15.44 11.09 43 50337 9376 29514771
Herpes zoster reactivation 15.31 11.09 8 50372 262 29523885
Cerebellar syndrome 15.27 11.09 18 50362 1996 29522151
Basal cell carcinoma 15.12 11.09 63 50317 16847 29507300
Bacterial sepsis 15.05 11.09 28 50352 4675 29519472
Bronchial haemorrhage 14.88 11.09 11 50369 672 29523475
Folliculitis 14.78 11.09 25 50355 3875 29520272
Venous thrombosis 14.77 11.09 22 50358 3060 29521087
Chest pain 14.72 11.09 121 50259 111852 29412295
Hepatic cytolysis 14.58 11.09 39 50341 8308 29515839
Adverse drug reaction 14.57 11.09 80 50300 23940 29500207
Musculoskeletal stiffness 14.48 11.09 26 50354 37432 29486715
Gastrointestinal haemorrhage 14.45 11.09 78 50302 79455 29444692
Amyotrophy 14.41 11.09 9 50371 416 29523731
Angioedema 14.38 11.09 20 50360 31895 29492252
Dermatitis exfoliative 14.37 11.09 33 50347 6392 29517755
Monoclonal immunoglobulin present 14.26 11.09 12 50368 885 29523262
Serotonin syndrome 14.21 11.09 6 50374 17506 29506641
Enterococcal sepsis 14.09 11.09 15 50365 1487 29522660
Blood osmolarity abnormal 14.06 11.09 3 50377 3 29524144
Respiratory depression 13.93 11.09 3 50377 13520 29510627
Retinal detachment 13.89 11.09 27 50353 4659 29519488
Cytomegalovirus infection 13.87 11.09 77 50303 23138 29501009
Ophthalmic herpes zoster 13.83 11.09 11 50369 749 29523398
Loss of consciousness 13.80 11.09 72 50308 73984 29450163
Metabolic acidosis 13.80 11.09 27 50353 37635 29486512
Donor leukocyte infusion 13.77 11.09 4 50376 24 29524123
Product quality issue 13.64 11.09 5 50375 15890 29508257
Hospitalisation 13.60 11.09 37 50343 45951 29478196
Oesophagitis 13.60 11.09 48 50332 11875 29512272
Melaena 13.59 11.09 20 50360 31156 29492991
Pneumonia haemophilus 13.56 11.09 8 50372 333 29523814
Benign neoplasm of skin 13.46 11.09 5 50375 70 29524077
Chronic kidney disease 13.44 11.09 26 50354 36390 29487757
Hemiparesis 13.40 11.09 4 50376 14482 29509665
CSF volume increased 13.24 11.09 4 50376 28 29524119
Pulmonary sepsis 12.98 11.09 16 50364 1858 29522289
Feeding disorder 12.97 11.09 30 50350 5837 29518310
Fall 12.97 11.09 218 50162 176960 29347187
Arthralgia 12.93 11.09 164 50216 139453 29384694
Acute lymphocytic leukaemia 12.93 11.09 19 50361 2612 29521535
Wheezing 12.91 11.09 23 50357 33217 29490930
Macular fibrosis 12.90 11.09 8 50372 365 29523782
Renal tubular disorder 12.81 11.09 25 50355 4327 29519820
Disorientation 12.70 11.09 90 50290 29425 29494722
Pulmonary hypertension 12.69 11.09 8 50372 18600 29505547
Gastric varices 12.61 11.09 8 50372 380 29523767
Haematemesis 12.59 11.09 14 50366 24612 29499535
Cerebrovascular accident 12.59 11.09 78 50302 76833 29447314
Lymphocytosis 12.54 11.09 16 50364 1924 29522223
Renal ischaemia 12.49 11.09 9 50371 528 29523619
Streptococcal bacteraemia 12.49 11.09 15 50365 1696 29522451
Oral mucosal erythema 12.46 11.09 8 50372 388 29523759
T-cell prolymphocytic leukaemia 12.36 11.09 4 50376 36 29524111
Mixed dementia 12.35 11.09 7 50373 270 29523877
Pneumocystis jirovecii pneumonia 12.35 11.09 59 50321 16720 29507427
Sleep disorder 12.32 11.09 14 50366 24372 29499775
Contraindicated product administered 12.26 11.09 8 50372 18258 29505889
Flushing 12.25 11.09 19 50361 28973 29495174
Respiratory tract infection 12.23 11.09 56 50324 15595 29508552
Pneumonia fungal 12.19 11.09 29 50351 5748 29518399
Serum sickness 12.12 11.09 15 50365 1750 29522397
Hyperbilirubinaemia 12.09 11.09 54 50326 14880 29509267
Facial paralysis 12.07 11.09 40 50340 9589 29514558
Retinitis 12.05 11.09 7 50373 283 29523864
Stomatitis 12.02 11.09 106 50274 37007 29487140
Lymphocytic lymphoma 11.98 11.09 4 50376 40 29524107
Wrong strength 11.97 11.09 5 50375 97 29524050
Injury 11.91 11.09 9 50371 19037 29505110
Abdominal pain 11.80 11.09 161 50219 135196 29388951
Haemophagocytic lymphohistiocytosis 11.74 11.09 42 50338 10462 29513685
Aphasia 11.68 11.09 64 50316 19134 29505013
Blood lactate dehydrogenase increased 11.67 11.09 64 50316 19145 29505002
Colitis 11.58 11.09 92 50288 31156 29492991
Peripheral T-cell lymphoma unspecified recurrent 11.48 11.09 4 50376 46 29524101
General physical health deterioration 11.41 11.09 116 50264 102741 29421406
Blood creatinine increased 11.39 11.09 206 50174 84896 29439251
Plasmacytoma 11.38 11.09 20 50360 3195 29520952
Herpes zoster oticus 11.35 11.09 5 50375 111 29524036
Neurocryptococcosis 11.32 11.09 3 50377 12 29524135
Laboratory test abnormal 11.32 11.09 61 50319 18124 29506023
Hypereosinophilic syndrome 11.30 11.09 6 50374 203 29523944
Rash erythematous 11.25 11.09 69 50311 21493 29502654
Blood glucose increased 11.19 11.09 57 50323 58927 29465220

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 513.93 9.86 952 92698 186705 64218377
Plasma cell myeloma 382.80 9.86 400 93250 45675 64359407
Neurotoxicity 334.13 9.86 294 93356 27110 64377972
Acute kidney injury 302.47 9.86 1371 92279 447869 63957213
Cytokine release syndrome 298.03 9.86 245 93405 20584 64384498
Encephalopathy 270.14 9.86 378 93272 58441 64346641
Toxic encephalopathy 265.81 9.86 170 93480 9645 64395437
Drug reaction with eosinophilia and systemic symptoms 245.37 9.86 346 93304 53871 64351211
Hepatocellular injury 241.73 9.86 313 93337 44922 64360160
Altered state of consciousness 234.09 9.86 282 93368 37620 64367462
Pyrexia 230.92 9.86 1492 92158 557152 63847930
Neutropenia 218.48 9.86 804 92846 238820 64166262
Toxic skin eruption 217.46 9.86 198 93452 19086 64385996
Completed suicide 206.63 9.86 38 93612 224376 64180706
Agranulocytosis 201.87 9.86 263 93387 37966 64367116
Thrombocytopenia 196.53 9.86 742 92908 223059 64182023
Rash maculo-papular 180.83 9.86 278 93372 46748 64358334
Dyslalia 176.93 9.86 63 93587 922 64404160
Drug ineffective 166.34 9.86 644 93006 839603 63565479
Acute generalised exanthematous pustulosis 165.70 9.86 148 93502 13910 64391172
Febrile bone marrow aplasia 162.27 9.86 133 93517 11122 64393960
Pancytopenia 162.12 9.86 517 93133 142792 64262290
Dysarthria 156.71 9.86 297 93353 59109 64345973
Drug abuse 155.83 9.86 9 93641 132365 64272717
Nervous system disorder 123.73 9.86 160 93490 22918 64382164
Toxicity to various agents 120.24 9.86 215 93435 363298 64041784
Dermatitis exfoliative generalised 111.62 9.86 82 93568 5834 64399248
Synovitis 110.03 9.86 9 93641 99081 64306001
Bronchopulmonary aspergillosis 109.72 9.86 137 93513 18948 64386134
Contraindicated product administered 108.87 9.86 14 93636 107815 64297267
Drug hypersensitivity 108.62 9.86 111 93539 237704 64167378
Herpes zoster 104.80 9.86 302 93348 78885 64326197
Tumour lysis syndrome 96.83 9.86 130 93520 19310 64385772
Intentional overdose 92.46 9.86 11 93639 89933 64315149
Ophthalmic herpes simplex 88.68 9.86 33 93617 551 64404531
Joint swelling 85.94 9.86 112 93538 215270 64189812
Drug interaction 85.18 9.86 257 93393 361826 64043256
Pathogen resistance 81.82 9.86 96 93554 12447 64392635
Septic shock 79.82 9.86 334 93316 105103 64299979
Pneumonia 77.76 9.86 1191 92459 558385 63846697
Cholestasis 77.52 9.86 189 93461 44683 64360399
Neuropathy peripheral 75.88 9.86 355 93295 117170 64287912
Herpes simplex 74.38 9.86 84 93566 10452 64394630
Aplasia 73.73 9.86 69 93581 6884 64398198
Drug intolerance 72.70 9.86 100 93550 187892 64217190
Eosinophilia 71.87 9.86 166 93484 37910 64367172
Squamous cell carcinoma of skin 69.46 9.86 86 93564 11790 64393292
Cytopenia 67.39 9.86 97 93553 15374 64389708
Microsporidia infection 66.00 9.86 29 93621 756 64404326
Lymphopenia 64.83 9.86 126 93524 25531 64379551
Acute myeloid leukaemia 64.74 9.86 131 93519 27332 64377750
Platelet count decreased 64.03 9.86 440 93210 167271 64237811
Chronic lymphocytic leukaemia 62.21 9.86 51 93599 4264 64400818
Therapeutic product effect decreased 62.12 9.86 46 93604 115305 64289777
Blood urea increased 60.94 9.86 171 93479 43982 64361100
Hallucination 59.37 9.86 236 93414 72552 64332530
Laryngitis fungal 58.45 9.86 17 93633 123 64404959
White blood cell count decreased 58.42 9.86 411 93239 157426 64247656
Swelling 58.23 9.86 89 93561 160129 64244953
Systemic lupus erythematosus 58.16 9.86 20 93630 77592 64327490
Rheumatoid arthritis 57.12 9.86 94 93556 164200 64240882
Depressed level of consciousness 57.03 9.86 252 93398 81184 64323898
Arthropathy 56.86 9.86 55 93595 120912 64284170
Blood creatinine increased 56.50 9.86 364 93286 135418 64269664
Oral herpes 55.01 9.86 108 93542 22044 64383038
Suicide attempt 53.72 9.86 18 93632 70989 64334093
Wound 53.47 9.86 22 93628 76455 64328627
Graft versus host disease in gastrointestinal tract 52.54 9.86 52 93598 5560 64399522
Graft versus host disease 52.15 9.86 81 93569 13732 64391350
Confusional state 52.06 9.86 594 93056 260550 64144532
Glossodynia 51.45 9.86 15 93635 64681 64340401
Immune effector cell-associated neurotoxicity syndrome 51.30 9.86 37 93613 2558 64402524
Human herpesvirus 6 encephalitis 50.14 9.86 20 93630 406 64404676
Hallucination, visual 48.88 9.86 118 93532 27716 64377366
Demodicidosis 48.31 9.86 15 93635 139 64404943
Encephalitis cytomegalovirus 47.49 9.86 25 93625 980 64404102
Pain 47.35 9.86 545 93105 552966 63852116
Rectal prolapse 46.98 9.86 30 93620 1696 64403386
Face oedema 46.77 9.86 108 93542 24653 64380429
Arthralgia 46.70 9.86 414 93236 441846 63963236
Renal disorder 45.92 9.86 134 93516 35231 64369851
Alopecia 45.38 9.86 109 93541 165581 64239501
Delirium 45.36 9.86 210 93440 68984 64336098
Bacterial sepsis 45.23 9.86 55 93595 7402 64397680
Bradycardia 44.57 9.86 64 93586 118155 64286927
Pseudomonas infection 42.98 9.86 86 93564 17797 64387285
Dyspnoea 41.73 9.86 764 92886 717910 63687172
Abdominal discomfort 40.27 9.86 133 93517 182189 64222893
International normalised ratio increased 39.57 9.86 34 93616 79133 64325949
Herpes virus infection 39.42 9.86 47 93603 6197 64398885
Renal tubular disorder 39.34 9.86 46 93604 5941 64399141
Sepsis 38.95 9.86 508 93142 229833 64175249
Hypoglycaemia 38.72 9.86 44 93606 89848 64315234
Treatment failure 38.61 9.86 69 93581 116747 64288335
Anti-cyclic citrullinated peptide antibody positive 38.49 9.86 12 93638 49550 64355532
Cytomegalovirus infection 38.23 9.86 130 93520 37069 64368013
Drug resistance 37.24 9.86 124 93526 34978 64370104
Myoclonus 36.35 9.86 99 93551 25019 64380063
Helicobacter infection 36.34 9.86 6 93644 38356 64366726
Pneumocystis jirovecii pneumonia 36.16 9.86 105 93545 27529 64377553
Hepatitis cholestatic 36.11 9.86 64 93586 12091 64392991
Tumour flare 35.55 9.86 19 93631 768 64404314
Plasma cell myeloma recurrent 35.00 9.86 36 93614 4029 64401053
Psychiatric symptom 34.42 9.86 44 93606 6229 64398853
Injection site inflammation 34.22 9.86 32 93618 3189 64401893
Bladder prolapse 33.99 9.86 21 93629 1120 64403962
Duodenal ulcer perforation 33.75 9.86 5 93645 34620 64370462
Maternal exposure during pregnancy 33.18 9.86 55 93595 95829 64309253
Nephritis allergic 33.14 9.86 17 93633 631 64404451
Neutrophil count decreased 32.74 9.86 208 93442 76988 64328094
Pain in extremity 32.71 9.86 282 93368 302803 64102279
Wrong technique in product usage process 32.35 9.86 28 93622 64946 64340136
Musculoskeletal stiffness 32.20 9.86 83 93567 123123 64281959
Deep vein thrombosis 32.20 9.86 262 93388 104920 64300162
Rhinovirus infection 31.93 9.86 42 93608 6114 64398968
Death 31.89 9.86 501 93149 482204 63922878
Serotonin syndrome 31.43 9.86 9 93641 39273 64365809
Discomfort 31.26 9.86 43 93607 80835 64324247
Lung disorder 31.18 9.86 172 93478 60528 64344554
Thrombotic microangiopathy 30.75 9.86 72 93578 16583 64388499
Hyperuricaemia 30.71 9.86 54 93596 10137 64394945
Rhabdomyolysis 30.47 9.86 54 93596 91672 64313410
Aspergillus infection 30.45 9.86 71 93579 16308 64388774
Vocal cord dysfunction 30.32 9.86 14 93636 411 64404671
Hypersensitivity 30 9.86 165 93485 196287 64208795
Therapeutic product effect incomplete 30.00 9.86 66 93584 103416 64301666
Disorientation 29.89 9.86 160 93490 55668 64349414
Encephalitis 29.66 9.86 60 93590 12511 64392571
Cardiac arrest 29.02 9.86 120 93530 153944 64251138
Squamous cell carcinoma 29.00 9.86 63 93587 13806 64391276
Mobility decreased 29.00 9.86 50 93600 85790 64319292
Dermatitis exfoliative 28.83 9.86 53 93597 10299 64394783
Intentional self-injury 28.76 9.86 4 93646 29040 64376042
Mucosal inflammation 28.65 9.86 172 93478 62412 64342670
Hyperthermia 28.47 9.86 67 93583 15483 64389599
Escherichia bacteraemia 28.24 9.86 37 93613 5366 64399716
Rheumatoid factor positive 27.96 9.86 8 93642 34930 64370152
Drug dependence 27.85 9.86 7 93643 33305 64371777
Restlessness 27.75 9.86 123 93527 39662 64365420
Ophthalmic herpes zoster 27.75 9.86 24 93626 2160 64402922
Sopor 27.31 9.86 5 93645 29656 64375426
Cerebral toxoplasmosis 27.21 9.86 22 93628 1804 64403278
Escherichia sepsis 27.02 9.86 42 93608 7123 64397959
Speech disorder 26.73 9.86 140 93510 48301 64356781
Genital herpes 26.49 9.86 22 93628 1873 64403209
Conjunctival irritation 25.57 9.86 9 93641 127 64404955
Fall 25.41 9.86 439 93211 416387 63988695
Differentiation syndrome 24.95 9.86 22 93628 2032 64403050
Eosinophilic colitis 24.84 9.86 12 93638 391 64404691
Mixed liver injury 24.80 9.86 35 93615 5446 64399636
Genital erythema 24.54 9.86 10 93640 215 64404867
Pulmonary sarcoidosis 24.38 9.86 17 93633 1114 64403968
Toxic erythema of chemotherapy 24.24 9.86 10 93640 222 64404860
Viral mutation identified 24.17 9.86 27 93623 3319 64401763
Hepatic cytolysis 24.07 9.86 59 93591 13990 64391092
CSF cell count increased 23.69 9.86 8 93642 99 64404983
Impaired healing 23.52 9.86 32 93618 60441 64344641
Cerebellar stroke 23.51 9.86 12 93638 441 64404641
Myocardial infarction 23.32 9.86 143 93507 165678 64239404
Haemophagocytic lymphohistiocytosis 23.12 9.86 67 93583 17542 64387540
Hypogammaglobulinaemia 22.94 9.86 48 93602 10251 64394831
Renal failure 22.93 9.86 381 93269 181307 64223775
Respiratory arrest 22.74 9.86 26 93624 52959 64352123
Blood glucose increased 22.72 9.86 70 93580 98003 64307079
Eye infection toxoplasmal 22.69 9.86 12 93638 475 64404607
Varicella zoster virus infection 22.49 9.86 28 93622 3860 64401222
Nocardiosis 22.41 9.86 31 93619 4736 64400346
Mucosal excoriation 22.15 9.86 4 93646 0 64405082
Blood lactate dehydrogenase increased 22.12 9.86 101 93549 32977 64372105
Ichthyosis 21.99 9.86 8 93642 125 64404957
Peripheral swelling 21.92 9.86 196 93454 208957 64196125
Red blood cell sedimentation rate increased 21.80 9.86 9 93641 31226 64373856
Serum sickness 21.79 9.86 25 93625 3164 64401918
Infective exacerbation of chronic obstructive airways disease 21.74 9.86 22 93628 2416 64402666
Haemorrhoids thrombosed 21.57 9.86 9 93641 206 64404876
Cell death 21.56 9.86 28 93622 4026 64401056
Genital herpes simplex 21.43 9.86 10 93640 301 64404781
Malignant neoplasm of unknown primary site 21.41 9.86 13 93637 672 64404410
Lymphocyte count decreased 21.35 9.86 116 93534 40583 64364499
Hyperleukocytosis 21.16 9.86 20 93630 2020 64403062
Eye infection bacterial 21.13 9.86 9 93641 217 64404865
Intentional product misuse 21.04 9.86 46 93604 72249 64332833
Streptococcal bacteraemia 20.88 9.86 24 93626 3043 64402039
COVID-19 20.87 9.86 164 93486 64976 64340106
Injection site pain 20.83 9.86 87 93563 111321 64293761
Anaphylactic reaction 20.55 9.86 43 93607 68621 64336461
Renal impairment 20.43 9.86 292 93358 134725 64270357
Osteoarthritis 20.39 9.86 38 93612 63298 64341784
Atrial fibrillation 20.22 9.86 355 93295 170734 64234348
Metastases to liver 20.07 9.86 5 93645 23936 64381146
Angioedema 19.99 9.86 37 93613 61784 64343298
Acute lymphocytic leukaemia 19.91 9.86 28 93622 4343 64400739
Epstein-Barr virus infection 19.88 9.86 51 93599 12437 64392645
Cerebellar syndrome 19.76 9.86 30 93620 4986 64400096
Terminal ileitis 19.63 9.86 12 93638 628 64404454
Parainfluenzae virus infection 19.58 9.86 29 93621 4714 64400368
Fungal endocarditis 19.54 9.86 11 93639 493 64404589
Laryngeal stenosis 19.46 9.86 13 93637 794 64404288
Bacteraemia 19.38 9.86 84 93566 26827 64378255
Venoocclusive liver disease 19.26 9.86 44 93606 9971 64395111
Pancreatitis acute 19.12 9.86 117 93533 42738 64362344
Acute pulmonary oedema 19.05 9.86 51 93599 12758 64392324
Full blood count decreased 19.03 9.86 74 93576 22508 64382574
Musculoskeletal pain 18.84 9.86 58 93592 81236 64323846
Drug withdrawal syndrome 18.84 9.86 11 93639 31280 64373802
Acute HIV infection 18.83 9.86 6 93644 61 64405021
Coronary artery disease 18.81 9.86 37 93613 60396 64344686
SARS-CoV-2 sepsis 18.33 9.86 7 93643 126 64404956
Diffuse large B-cell lymphoma 18.27 9.86 44 93606 10317 64394765
Sedation 18.17 9.86 20 93630 41442 64363640
Pityriasis rubra pilaris 17.93 9.86 6 93644 72 64405010
Enteritis 17.88 9.86 48 93602 12029 64393053
Skin lesion 17.82 9.86 102 93548 36380 64368702
C-reactive protein abnormal 17.79 9.86 10 93640 29037 64376045
Irritable bowel syndrome 17.54 9.86 17 93633 37352 64367730
Purpura 17.48 9.86 60 93590 17186 64387896
Campylobacter colitis 17.46 9.86 5 93645 34 64405048
Angina pectoris 17.39 9.86 24 93626 45057 64360025
Glomerulosclerosis 17.36 9.86 13 93637 952 64404130
Post herpetic neuralgia 17.34 9.86 19 93631 2286 64402796
Product use issue 17.32 9.86 139 93511 151576 64253506
Mucormycosis 17.28 9.86 35 93615 7306 64397776
Urine output decreased 17.26 9.86 58 93592 16434 64388648
Contusion 17.23 9.86 96 93554 113869 64291213
Graft versus host disease in lung 17.13 9.86 12 93638 792 64404290
Myelodysplastic syndrome 16.83 9.86 82 93568 27497 64377585
Colitis 16.80 9.86 144 93506 58530 64346552
Hyperbilirubinaemia 16.68 9.86 68 93582 21137 64383945
Gastrointestinal haemorrhage 16.63 9.86 118 93532 132194 64272888
Diarrhoea 16.55 9.86 1240 92410 721464 63683618
Brief psychotic disorder with marked stressors 16.49 9.86 8 93642 263 64404819
Rash morbilliform 16.48 9.86 28 93622 5113 64399969
Haemolytic anaemia 16.40 9.86 56 93594 15997 64389085
Decreased appetite 16.35 9.86 529 93121 280760 64124322
Acute febrile neutrophilic dermatosis 16.18 9.86 22 93628 3307 64401775
Peripheral T-cell lymphoma unspecified recurrent 16.14 9.86 5 93645 46 64405036
Rash vesicular 16.09 9.86 27 93623 4883 64400199
Acute myocardial infarction 15.98 9.86 50 93600 69668 64335414
Muscle rigidity 15.97 9.86 3 93647 17470 64387612
Venoocclusive disease 15.93 9.86 24 93626 3961 64401121
Rash erythematous 15.89 9.86 123 93527 48510 64356572
Biopsy skin abnormal 15.81 9.86 7 93643 186 64404896
Metastases to bone 15.77 9.86 5 93645 20430 64384652
Laryngeal cancer metastatic 15.77 9.86 5 93645 50 64405032
Cerebrovascular accident 15.73 9.86 126 93524 137457 64267625
Cardiac failure congestive 15.67 9.86 118 93532 130462 64274620
Haematochezia 15.64 9.86 47 93603 66326 64338756
Logorrhoea 15.60 9.86 24 93626 4035 64401047
Gastrointestinal disorder 15.59 9.86 72 93578 89637 64315445
Disseminated cryptococcosis 15.57 9.86 15 93635 1552 64403530
Bacillus bacteraemia 15.56 9.86 6 93644 111 64404971
Amyotrophy 15.42 9.86 10 93640 581 64404501
Bronchopneumopathy 15.38 9.86 10 93640 583 64404499
Complications of transplanted heart 15.30 9.86 8 93642 309 64404773
Neuropsychiatric syndrome 15.22 9.86 6 93644 118 64404964
Peripheral T-cell lymphoma unspecified 15.02 9.86 10 93640 607 64404475
Botryomycosis 15.02 9.86 5 93645 59 64405023
Malignant neoplasm progression 15.01 9.86 99 93551 112772 64292310
Dermatitis bullous 15.00 9.86 45 93605 12009 64393073
Product tampering 14.90 9.86 7 93643 214 64404868
Lactic acidosis 14.82 9.86 43 93607 61367 64343715
Aphasia 14.81 9.86 106 93544 40800 64364282
Aeromonas infection 14.76 9.86 8 93642 333 64404749
Extrapyramidal disorder 14.71 9.86 5 93645 19547 64385535
Neuralgia 14.67 9.86 76 93574 26108 64378974
Pseudomyopia 14.65 9.86 5 93645 64 64405018
Mycobacterial peritonitis 14.51 9.86 5 93645 66 64405016
Enterococcal sepsis 14.49 9.86 18 93632 2476 64402606
Body temperature decreased 14.39 9.86 10 93640 25918 64379164
Labelled drug-drug interaction medication error 14.39 9.86 7 93643 22055 64383027
Incorrect disposal of product 14.38 9.86 11 93639 832 64404250
Pneumonia influenzal 14.33 9.86 18 93632 2504 64402578
Rhegmatogenous retinal detachment 14.31 9.86 6 93644 139 64404943
Obesity 14.23 9.86 6 93644 20556 64384526
Knee arthroplasty 14.23 9.86 11 93639 26988 64378094
Device malfunction 14.18 9.86 4 93646 17629 64387453
Neurological symptom 14.15 9.86 31 93619 6833 64398249
Blood creatine phosphokinase increased 14.13 9.86 41 93609 58517 64346565
Swollen tongue 14.10 9.86 18 93632 34936 64370146
Meningoencephalitis herpetic 14.10 9.86 15 93635 1746 64403336
Vitiligo 14.05 9.86 15 93635 1753 64403329
Bacterial vaginosis 13.95 9.86 11 93639 870 64404212
Pneumonia fungal 13.87 9.86 36 93614 8841 64396241
Actinic keratosis 13.83 9.86 26 93624 5139 64399943
Aplastic anaemia 13.73 9.86 48 93602 13872 64391210
Neurosis 13.71 9.86 8 93642 384 64404698
Erythema multiforme 13.68 9.86 52 93598 15649 64389433
Campylobacter gastroenteritis 13.65 9.86 12 93638 1104 64403978
Haematemesis 13.59 9.86 30 93620 46969 64358113
Hip arthroplasty 13.59 9.86 7 93643 21344 64383738
Accidental exposure to product 13.57 9.86 11 93639 26353 64378729
Infective chondritis 13.51 9.86 4 93646 31 64405051
Wrong strength 13.46 9.86 6 93644 162 64404920
Cytomegalovirus colitis 13.41 9.86 22 93628 3906 64401176
Bone marrow failure 13.37 9.86 117 93533 47835 64357247
Rash pustular 13.35 9.86 38 93612 9847 64395235
Tractional retinal detachment 13.35 9.86 5 93645 85 64404997
Lymphocytosis 13.24 9.86 21 93629 3623 64401459
Periorbital cellulitis 13.19 9.86 10 93640 746 64404336
Depression 13.18 9.86 187 93463 183104 64221978
Flushing 13.15 9.86 64 93586 78584 64326498
Blood pressure increased 13.14 9.86 174 93476 172378 64232704
Lymphocytic infiltration 13.12 9.86 13 93637 1391 64403691
Mixed dementia 13.10 9.86 7 93643 283 64404799
Varicella virus test positive 13.06 9.86 6 93644 174 64404908
Cyanosis 13.04 9.86 8 93642 22147 64382935
Soliloquy 13.02 9.86 9 93641 581 64404501
CSF volume increased 12.99 9.86 4 93646 36 64405046
Sleep disorder 12.86 9.86 44 93606 59665 64345417
Nephropathy toxic 12.86 9.86 55 93595 17459 64387623
Citrobacter infection 12.81 9.86 10 93640 779 64404303
Generalised tonic-clonic seizure 12.75 9.86 24 93626 39833 64365249
Iron deficiency anaemia 12.75 9.86 8 93642 21881 64383201
Condition aggravated 12.74 9.86 428 93222 371998 64033084
Lymphocytic lymphoma 12.70 9.86 5 93645 98 64404984
Cytomegalovirus test positive 12.67 9.86 25 93625 5119 64399963
Glossoptosis 12.63 9.86 6 93644 188 64404894
Benign neoplasm of skin 12.60 9.86 5 93645 100 64404982
Laryngeal inflammation 12.55 9.86 6 93644 191 64404891
T-cell prolymphocytic leukaemia 12.52 9.86 4 93646 41 64405041
Foreign body in reproductive tract 12.52 9.86 8 93642 453 64404629
Product administration error 12.49 9.86 13 93637 27630 64377452
Pseudolymphoma 12.46 9.86 11 93639 1018 64404064
Progressive multifocal leukoencephalopathy 12.44 9.86 56 93594 18176 64386906
Leukaemia recurrent 12.39 9.86 17 93633 2577 64402505
Poriomania 12.38 9.86 6 93644 197 64404885
Plasmacytoma 12.31 9.86 21 93629 3849 64401233
Thrombotic thrombocytopenic purpura 12.30 9.86 27 93623 5957 64399125
Injection site swelling 12.29 9.86 26 93624 41327 64363755
Cryptosporidiosis infection 12.28 9.86 9 93641 638 64404444
Venous thrombosis 12.23 9.86 28 93622 6353 64398729
Escherichia infection 12.21 9.86 49 93601 15119 64389963
Klebsiella bacteraemia 12.19 9.86 16 93634 2324 64402758
Wheezing 12.11 9.86 68 93582 80511 64324571
Pneumocystis jirovecii infection 12.08 9.86 16 93634 2345 64402737
Lower respiratory tract infection 12.07 9.86 84 93566 94530 64310552
Peripheral nerve palsy 12.03 9.86 4 93646 47 64405035
Limbic encephalitis 11.98 9.86 9 93641 662 64404420
Asthma 11.93 9.86 85 93565 95140 64309942
Arthritis 11.92 9.86 72 93578 83742 64321340
Fibromyalgia 11.89 9.86 21 93629 35710 64369372
Infective aneurysm 11.87 9.86 10 93640 868 64404214
Melaena 11.85 9.86 39 93611 53509 64351573
Hypotension 11.85 9.86 443 93207 380531 64024551
Polymyositis 11.81 9.86 17 93633 2693 64402389
Respiratory depression 11.79 9.86 10 93640 23433 64381649
Acute lymphocytic leukaemia recurrent 11.70 9.86 21 93629 4005 64401077
Pneumonia klebsiella 11.66 9.86 21 93629 4016 64401066
Ectropion 11.65 9.86 7 93643 355 64404727
Gingival erosion 11.65 9.86 5 93645 123 64404959
Incorrect route of product administration 11.64 9.86 10 93640 23288 64381794
Lichenification 11.62 9.86 9 93641 693 64404389
Embedded device 11.61 9.86 17 93633 2735 64402347
Loss of personal independence in daily activities 11.52 9.86 60 93590 72394 64332688
Gastric varices 11.50 9.86 8 93642 522 64404560
Cerebral thrombosis 11.49 9.86 15 93635 2167 64402915
Hypercholesterolaemia 11.45 9.86 4 93646 15369 64389713
Poisoning 11.42 9.86 9 93641 21870 64383212
Tri-iodothyronine free increased 11.40 9.86 6 93644 235 64404847
Dyscalculia 11.39 9.86 4 93646 56 64405026
Cardiomyopathy acute 11.38 9.86 6 93644 236 64404846
Autoimmune haemolytic anaemia 11.37 9.86 29 93621 7047 64398035
Transient ischaemic attack 11.36 9.86 30 93620 44152 64360930
Dermo-hypodermitis 11.35 9.86 8 93642 533 64404549
Blood pressure systolic abnormal 11.34 9.86 36 93614 9906 64395176
Weight increased 11.32 9.86 230 93420 213118 64191964
Facial paralysis 11.29 9.86 56 93594 18910 64386172
Erythema annulare 11.29 9.86 5 93645 133 64404949
Depressed mood 11.20 9.86 27 93623 40985 64364097
Hypercapnic coma 11.14 9.86 7 93643 385 64404697
Posterior reversible encephalopathy syndrome 11.10 9.86 64 93586 22882 64382200
Neurocryptococcosis 11.10 9.86 3 93647 16 64405066
Injection site erythema 11.05 9.86 59 93591 70741 64334341
Pulmonary congestion 11.05 9.86 11 93639 23869 64381213
Hepatic enzyme increased 11.03 9.86 128 93522 129815 64275267
Right ventricular failure 11.00 9.86 9 93641 21462 64383620
Metabolic encephalopathy 10.99 9.86 31 93619 7994 64397088
Hypoglycaemic seizure 10.91 9.86 9 93641 759 64404323
Herpes simplex meningoencephalitis 10.91 9.86 4 93646 64 64405018
Drug level increased 10.90 9.86 86 93564 34110 64370972
Melanaemia 10.85 9.86 4 93646 65 64405017
Klebsiella sepsis 10.73 9.86 16 93634 2616 64402466
Fracture 10.73 9.86 7 93643 18748 64386334
Morganella infection 10.70 9.86 10 93640 996 64404086
Platelet count increased 10.66 9.86 7 93643 18689 64386393
Meningitis enteroviral 10.63 9.86 4 93646 69 64405013
Anuria 10.59 9.86 55 93595 18909 64386173
Gastrooesophageal reflux disease 10.52 9.86 74 93576 83069 64322013
Fluid imbalance 10.48 9.86 7 93643 427 64404655
Central nervous system necrosis 10.48 9.86 6 93644 278 64404804
Arteriosclerosis 10.41 9.86 5 93645 15872 64389210
Cardio-respiratory arrest 10.39 9.86 92 93558 98301 64306781
Pyelitis 10.38 9.86 6 93644 283 64404799
Drug monitoring procedure not performed 10.38 9.86 9 93641 813 64404269
Thermal burn 10.33 9.86 25 93625 5881 64399201
Incoherent 10.24 9.86 28 93622 7090 64397992
Myositis 10.21 9.86 49 93601 16328 64388754
Pulmonary sepsis 10.19 9.86 17 93633 3058 64402024
Hepatic cirrhosis 10.14 9.86 14 93636 26284 64378798
Gingival ulceration 10.12 9.86 9 93641 841 64404241
Pneumonia aspiration 10.04 9.86 48 93602 59223 64345859
Medication error 9.98 9.86 38 93612 49928 64355154
Psoriatic arthropathy 9.94 9.86 31 93619 43250 64361832
Adenocarcinoma of colon 9.93 9.86 22 93628 4886 64400196
Cytomegalovirus chorioretinitis 9.92 9.86 22 93628 4890 64400192

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
MZ1IW7Q79D UNII
135398742 PUBCHEM_CID
236081 RXNORM
169290 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

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 0173-0933 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 0378-4276 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 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 16714-698 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 HUMAN PRESCRIPTION DRUG LABEL 1 43063-771 TABLET, FILM COATED 1 g ORAL ANDA 24 sections
Valacyclovir HUMAN PRESCRIPTION DRUG LABEL 1 43063-771 TABLET, FILM COATED 1 g ORAL ANDA 24 sections
Valacyclovir hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 43063-778 TABLET 500 mg ORAL ANDA 27 sections
Valacyclovir hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 43063-778 TABLET 500 mg ORAL ANDA 27 sections
Valacyclovir Human Prescription Drug Label 1 43353-883 TABLET, FILM COATED 500 mg ORAL ANDA 26 sections
Valacyclovir Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 49483-690 TABLET 500 mg ORAL ANDA 26 sections
Valacyclovir Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 49483-691 TABLET 1 g ORAL ANDA 26 sections
Valacyclovir hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 50090-1735 TABLET 500 mg ORAL ANDA 26 sections
Valacyclovir Hydrochloride Human Prescription Drug Label 1 50090-2223 TABLET, FILM COATED 1 g ORAL ANDA 27 sections
Valacyclovir Hydrochloride Human Prescription Drug Label 1 50090-2223 TABLET, FILM COATED 1 g ORAL ANDA 27 sections
Valacyclovir Hydrochloride Human Prescription Drug Label 1 50090-2223 TABLET, FILM COATED 1 g ORAL ANDA 27 sections
Valacyclovir Hydrochloride Human Prescription Drug Label 1 50090-2224 TABLET, FILM COATED 500 mg ORAL ANDA 27 sections