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

Stem definitionDrug idCAS RN
antivirals bicyclic heterocycle compounds 85 59277-89-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • zovirax
  • acyclovir
  • aciclovir
  • acyclovir sodium
Acyclovir is a synthetic purine nucleoside analogue with in vitro and in vivo inhibitory activity against herpes simplex virus types 1 (HSV-1), 2 (HSV-2), and varicella-zoster virus (VZV). The inhibitory activity of acyclovir is highly selective due to its affinity for the enzyme thymidine kinase (TK) encoded by HSV and VZV. This viral enzyme converts acyclovir into acyclovir monophosphate, a nucleotide analogue. The monophosphate is further converted into diphosphate by cellular guanylate kinase and into triphosphate by a number of cellular enzymes. In vitro, acyclovir triphosphate stops replication of herpes viral DNA.
  • Molecular weight: 225.21
  • Formula: C8H11N5O3
  • CLOGP: -2.42
  • LIPINSKI: 0
  • HAC: 8
  • HDO: 3
  • TPSA: 114.76
  • ALOGS: -1.42
  • ROTB: 4

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
4 g O
4 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 4 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 2.50 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 75 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 59.06 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 22.50 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.71 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 4.70 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.85 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 2.50 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
March 29, 1982 FDA VALEANT BERMUDA

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 935.56 10.27 838 121202 43640 46520382
Febrile neutropenia 600.85 10.27 967 121073 93660 46470362
White blood cell count decreased 529.14 10.27 1006 121034 111225 46452797
Rheumatoid arthritis 476.47 10.27 41 121999 240174 46323848
Neuropathy peripheral 378.87 10.27 774 121266 90119 46473903
Platelet count decreased 365.19 10.27 807 121233 99217 46464805
Lymphocyte count decreased 364.92 10.27 390 121650 25199 46538823
Full blood count decreased 324.64 10.27 343 121697 21868 46542154
Drug ineffective 321.52 10.27 823 121217 677015 45887007
Urine abnormality 314.56 10.27 191 121849 5403 46558619
Neutropenia 289.19 10.27 927 121113 142277 46421745
Completed suicide 283.46 10.27 27 122013 145893 46418129
Neutrophil count decreased 261.97 10.27 434 121606 42992 46521030
Pyrexia 245.70 10.27 1655 120385 347147 46216875
Pneumonia 240.14 10.27 1743 120297 374577 46189445
Thrombocytopenia 236.29 10.27 798 121242 125783 46438239
Laboratory test abnormal 223.46 10.27 287 121753 22560 46541462
Urinary sediment present 215.45 10.27 102 121938 1718 46562304
Urine leukocyte esterase positive 214.17 10.27 113 121927 2422 46561600
Crystal urine present 191.44 10.27 84 121956 1175 46562847
Cytomegalovirus infection 183.87 10.27 232 121808 17912 46546110
Cytokine release syndrome 179.84 10.27 141 121899 6082 46557940
Neurotoxicity 179.72 10.27 200 121840 13517 46550505
Red blood cells urine positive 178.15 10.27 101 121939 2506 46561516
Contraindicated product administered 175.05 10.27 8 122032 79939 46484083
White blood cells urine positive 166.29 10.27 114 121926 3986 46560036
Graft versus host disease 162.32 10.27 136 121904 6452 46557570
Drug hypersensitivity 159.72 10.27 244 121796 243581 46320441
Toxicity to various agents 154.59 10.27 196 121844 211570 46352452
Arthralgia 151.07 10.27 471 121569 364132 46199890
Drug abuse 139.94 10.27 6 122034 63402 46500620
Blood urine present 130.77 10.27 161 121879 12121 46551901
Pancytopenia 129.48 10.27 502 121538 84556 46479466
Injection site pain 129.40 10.27 59 121981 107093 46456929
Lymphocyte percentage decreased 128.68 10.27 83 121957 2616 46561406
Sepsis 126.17 10.27 694 121346 135320 46428702
Neutrophil percentage increased 124.10 10.27 81 121959 2606 46561416
Diarrhoea 123.44 10.27 2099 119941 557503 46006519
Urine analysis abnormal 121.21 10.27 95 121945 4095 46559927
Acute graft versus host disease in skin 118.78 10.27 82 121958 2900 46561122
Thrombosis 118.47 10.27 369 121671 55700 46508322
Encephalitis viral 116.40 10.27 65 121975 1565 46562457
Intentional overdose 116.08 10.27 16 122024 64928 46499094
Treatment failure 115.96 10.27 49 121991 93038 46470984
Pain 111.06 10.27 761 121279 476187 46087835
Herpes zoster 107.73 10.27 406 121634 67466 46496556
Acute graft versus host disease 107.24 10.27 87 121953 3943 46560079
Condition aggravated 106.03 10.27 310 121730 244742 46319280
Therapeutic product effect decreased 103.66 10.27 43 121997 82558 46481464
Bacterial test 101.03 10.27 54 121986 1189 46562833
Pemphigus 100.85 10.27 4 122036 45270 46518752
Constipation 99.60 10.27 787 121253 173310 46390712
Neutropenic sepsis 99.42 10.27 141 121899 12183 46551839
Plasma cell myeloma recurrent 90.76 10.27 64 121976 2343 46561679
Mucosal inflammation 89.35 10.27 264 121776 38712 46525310
Rash 89.04 10.27 1366 120674 355146 46208876
Urine ketone body present 87.91 10.27 60 121980 2082 46561940
Psoriasis 84.91 10.27 50 121990 78554 46485468
Cytomegalovirus viraemia 83.56 10.27 79 121961 4399 46559623
Maternal exposure during pregnancy 83.30 10.27 87 121953 102462 46461560
Bacterial test positive 82.59 10.27 78 121962 4338 46559684
Herpes simplex 80.65 10.27 97 121943 7126 46556896
Meningoencephalitis herpetic 79.75 10.27 44 121996 1034 46562988
Pre-engraftment immune reaction 79.45 10.27 28 122012 208 46563814
Culture urine positive 79.43 10.27 68 121972 3323 46560699
Acute myeloid leukaemia recurrent 79.34 10.27 48 121992 1348 46562674
Overdose 76.83 10.27 92 121948 101887 46462135
Lymphopenia 76.74 10.27 141 121899 15152 46548870
Therapeutic product effect incomplete 75.91 10.27 56 121984 78097 46485925
Haemoglobin urine present 74.79 10.27 36 122004 630 46563392
Systemic lupus erythematosus 73.95 10.27 39 122001 65141 46498881
Cytopenia 71.91 10.27 95 121945 7673 46556349
Adverse drug reaction 71.73 10.27 267 121773 44095 46519927
Acute graft versus host disease in intestine 70.80 10.27 48 121992 1647 46562375
Crystalluria 70.34 10.27 30 122010 390 46563632
Nephropathy toxic 68.76 10.27 91 121949 7363 46556659
Pathogen resistance 68.68 10.27 82 121958 5978 46558044
Specific gravity urine decreased 68.67 10.27 30 122010 415 46563607
Acute myeloid leukaemia 67.55 10.27 136 121904 15642 46548380
Epstein-Barr virus infection 67.54 10.27 86 121954 6698 46557324
Encephalitis cytomegalovirus 67.19 10.27 31 122009 491 46563531
Suicide attempt 66.89 10.27 30 122010 55006 46509016
Multiple organ dysfunction syndrome 65.87 10.27 289 121751 51421 46512601
Ageusia 65.60 10.27 112 121928 11360 46552662
Joint swelling 65.46 10.27 219 121821 165854 46398168
Bronchopulmonary aspergillosis 65.30 10.27 89 121951 7407 46556615
Cytomegalovirus test positive 62.91 10.27 55 121985 2765 46561257
Red blood cell count decreased 61.91 10.27 207 121833 32416 46531606
Drug intolerance 61.38 10.27 189 121851 146860 46417162
Intentional product misuse 59.98 10.27 24 122016 47104 46516918
Injection site reaction 59.87 10.27 25 122015 47824 46516198
Myocardial infarction 59.60 10.27 102 121938 97426 46466596
Drug interaction 59.31 10.27 301 121739 202793 46361229
Light chain analysis increased 58.53 10.27 36 122004 1042 46562980
Chronic graft versus host disease 58.50 10.27 52 121988 2673 46561349
Multiple allergies 57.50 10.27 83 121957 7288 46556734
Post transplant lymphoproliferative disorder 57.12 10.27 60 121980 3796 46560226
Inappropriate schedule of product administration 56.42 10.27 52 121988 64961 46499061
Encephalopathy 55.84 10.27 204 121836 33385 46530637
Monocyte percentage increased 54.53 10.27 34 122006 1009 46563013
Wrong technique in product usage process 54.14 10.27 38 122002 54384 46509638
Injection site erythema 54.10 10.27 69 121971 74358 46489664
Fatigue 53.96 10.27 2020 120020 606677 45957345
Dilatation intrahepatic duct acquired 53.58 10.27 30 122010 726 46563296
Pneumonia fungal 53.36 10.27 60 121980 4100 46559922
Engraftment syndrome 53.23 10.27 22 122018 263 46563759
Acute kidney injury 53.20 10.27 889 121151 234966 46329056
Stem cell transplant 53.16 10.27 41 121999 1725 46562297
Smooth muscle cell neoplasm 53.03 10.27 27 122013 536 46563486
Suicidal ideation 52.71 10.27 42 121998 56340 46507682
Plasmacytoma 52.65 10.27 47 121993 2430 46561592
Blood potassium decreased 51.76 10.27 217 121823 37846 46526176
Swelling 51.26 10.27 161 121879 124350 46439672
Psoriatic arthropathy 50.61 10.27 16 122024 36363 46527659
Immune effector cell-associated neurotoxicity syndrome 50.44 10.27 28 122012 666 46563356
Rhabdomyolysis 49.14 10.27 24 122016 41885 46522137
Red cell distribution width increased 49.13 10.27 79 121961 7625 46556397
Nitrite urine present 48.98 10.27 28 122012 706 46563316
Human herpesvirus 6 infection 47.38 10.27 44 121996 2395 46561627
Injection site bruising 47.26 10.27 17 122023 35619 46528403
Encephalitis 46.99 10.27 76 121964 7372 46556650
Knee arthroplasty 46.92 10.27 4 122036 23661 46540361
Off label use 46.49 10.27 706 121334 379135 46184887
Aspergillus infection 45.79 10.27 72 121968 6818 46557204
Venoocclusive liver disease 45.69 10.27 56 121984 4195 46559827
Intentional self-injury 45.50 10.27 5 122035 24161 46539861
Hypoglycaemia 45.38 10.27 45 121995 54304 46509718
Varicella zoster virus infection 44.99 10.27 42 121998 2301 46561721
Muscle spasms 44.94 10.27 506 121534 122607 46441415
Blood creatinine increased 44.49 10.27 347 121693 76056 46487966
Urinary casts 44.49 10.27 23 122017 472 46563550
Factor XIII deficiency 44.39 10.27 14 122026 70 46563952
Cystitis haemorrhagic 43.53 10.27 50 121990 3497 46560525
Anaphylactic reaction 43.18 10.27 45 121995 53067 46510955
Pain in extremity 43.15 10.27 450 121590 258230 46305792
Injection site swelling 43.05 10.27 26 122014 40301 46523721
Glossodynia 42.81 10.27 32 122008 44341 46519681
Graft versus host disease in skin 42.73 10.27 41 121999 2326 46561696
Respiratory syncytial virus infection 41.50 10.27 57 121983 4778 46559244
Injection site pruritus 40.53 10.27 27 122013 39716 46524306
Herpes virus infection 40.49 10.27 56 121984 4726 46559296
Thyroxine free increased 40.24 10.27 25 122015 737 46563285
Wound 39.86 10.27 32 122008 42770 46521252
Mean cell haemoglobin decreased 39.07 10.27 43 121997 2869 46561153
Disseminated mucormycosis 38.93 10.27 14 122026 111 46563911
Graft versus host disease in gastrointestinal tract 38.35 10.27 40 122000 2510 46561512
Deep vein thrombosis 38.32 10.27 347 121693 79426 46484596
CSF protein increased 38.27 10.27 21 122019 488 46563534
Haemoglobin decreased 37.98 10.27 509 121531 128440 46435582
Tumour lysis syndrome 37.93 10.27 68 121972 7168 46556854
Sopor 37.59 10.27 4 122036 19824 46544198
Urine leukocyte esterase 37.29 10.27 14 122026 127 46563895
Influenza 37.28 10.27 377 121663 88893 46475129
Blood thyroid stimulating hormone increased 37.18 10.27 60 121980 5809 46558213
Seasonal allergy 37.15 10.27 97 121943 13237 46550785
Unevaluable event 36.50 10.27 226 121814 45949 46518073
C-reactive protein abnormal 36.25 10.27 6 122034 21264 46542758
Thrombotic microangiopathy 36.04 10.27 72 121968 8234 46555788
Breast cancer 35.41 10.27 40 122000 45478 46518544
Leukocyturia 35.27 10.27 25 122015 923 46563099
Bacterial sepsis 35.16 10.27 45 121995 3522 46560500
Product use issue 35.11 10.27 128 121912 94516 46469506
Pulmonary arterial hypertension 35.01 10.27 12 122028 25916 46538106
Protein urine present 34.63 10.27 54 121986 5077 46558945
Alopecia 34.29 10.27 266 121774 162148 46401874
Septic shock 34.29 10.27 264 121776 57629 46506393
Acute graft versus host disease in liver 33.80 10.27 21 122019 619 46563403
Venoocclusive disease 33.65 10.27 33 122007 1923 46562099
Ophthalmic herpes simplex 33.40 10.27 16 122024 277 46563745
Osteoarthritis 33.38 10.27 70 121970 61955 46502067
Blood thyroid stimulating hormone decreased 32.71 10.27 46 121994 3943 46560079
Engraft failure 32.70 10.27 17 122023 353 46563669
Pleocytosis 32.54 10.27 19 122021 499 46563523
Loss of personal independence in daily activities 32.08 10.27 63 121977 57120 46506902
Clostridium difficile colitis 31.95 10.27 114 121926 18439 46545583
Rash pruritic 31.62 10.27 211 121829 44004 46520018
Blood pressure systolic increased 31.52 10.27 18 122022 28769 46535253
Dyspnoea 31.35 10.27 1069 120971 514479 46049543
Disseminated varicella zoster virus infection 31.35 10.27 21 122019 706 46563316
Abdominal discomfort 31.25 10.27 249 121791 150916 46413106
Microtia 31.14 10.27 16 122024 324 46563698
Arthritis 31.09 10.27 101 121939 77215 46486807
Renal disorder 30.88 10.27 145 121895 26541 46537481
Depression 30.80 10.27 290 121750 169814 46394208
Infusion related reaction 30.65 10.27 148 121892 101060 46462962
Taste disorder 30.51 10.27 55 121985 5823 46558199
Musculoskeletal stiffness 30.44 10.27 142 121898 97851 46466171
Congenital nail disorder 30.40 10.27 11 122029 89 46563933
Musculoskeletal pain 30.05 10.27 89 121951 70039 46493983
Asthma 30.02 10.27 130 121910 91412 46472610
Enterococcal infection 29.64 10.27 60 121980 6927 46557095
Lactic acidosis 29.56 10.27 27 122013 33882 46530140
Epstein-Barr virus associated lymphoproliferative disorder 29.35 10.27 27 122013 1452 46562570
Therapeutic response decreased 29.32 10.27 42 121998 43103 46520919
Graft versus host disease in liver 29.30 10.27 17 122023 441 46563581
Discomfort 29.25 10.27 48 121992 46622 46517400
Haematocrit decreased 29.23 10.27 174 121866 34883 46529139
Monocyte count decreased 29.04 10.27 29 122011 1728 46562294
Staphylococcal sepsis 28.82 10.27 62 121978 7470 46556552
Specific gravity urine increased 28.75 10.27 13 122027 196 46563826
Drug withdrawal syndrome 28.75 10.27 18 122022 27366 46536656
Toxoplasmosis 28.74 10.27 26 122014 1368 46562654
Cells in urine 28.63 10.27 12 122028 149 46563873
Fall 28.56 10.27 649 121391 328448 46235574
Adenovirus infection 28.37 10.27 36 122004 2794 46561228
Metastases to liver 28.35 10.27 8 122032 19577 46544445
Plasma cell leukaemia 28.10 10.27 24 122016 1169 46562853
Red blood cells urine 27.41 10.27 16 122024 420 46563602
CD4 lymphocytes decreased 27.40 10.27 27 122013 1583 46562439
Hypersensitivity 27.33 10.27 256 121784 150065 46413957
Antiviral drug level above therapeutic 27.27 10.27 6 122034 3 46564019
Encephalitis autoimmune 27.27 10.27 23 122017 1101 46562921
Injection site haemorrhage 27.25 10.27 10 122030 20699 46543323
Full blood count increased 27.20 10.27 21 122019 885 46563137
Skin exfoliation 27.16 10.27 163 121877 32775 46531247
Differentiation syndrome 27.10 10.27 21 122019 890 46563132
Red blood cell sedimentation rate increased 27.00 10.27 13 122027 22876 46541146
Hip arthroplasty 26.97 10.27 7 122033 18105 46545917
International normalised ratio increased 26.86 10.27 51 121989 46832 46517190
Arthropathy 26.74 10.27 122 121918 84578 46479444
Mobility decreased 26.61 10.27 76 121964 60518 46503504
Acute lymphocytic leukaemia recurrent 26.50 10.27 30 122010 2065 46561957
Underdose 26.50 10.27 9 122031 19549 46544473
Stomatitis 26.41 10.27 284 121756 68013 46496009
Accidental exposure to product 26.39 10.27 11 122029 21070 46542952
Abortion spontaneous 26.33 10.27 46 121994 43600 46520422
Abdominal wall infection 26.32 10.27 10 122030 94 46563928
Fryns syndrome 26.12 10.27 9 122031 62 46563960
Bacteraemia 26.04 10.27 89 121951 14090 46549932
Tooth disorder 25.79 10.27 125 121915 23178 46540844
Haemophagocytic lymphohistiocytosis 25.65 10.27 63 121977 8279 46555743
Cardio-respiratory arrest 25.63 10.27 76 121964 59793 46504229
Infusion site pain 25.62 10.27 71 121969 10036 46553986
Drug dependence 25.54 10.27 10 122030 19891 46544131
Device expulsion 25.13 10.27 21 122019 27521 46536501
Hospitalisation 24.66 10.27 84 121956 63301 46500721
Respiratory failure 24.58 10.27 366 121674 94450 46469572
Osteoporosis 24.31 10.27 43 121997 40565 46523457
Tri-iodothyronine free decreased 24.28 10.27 12 122028 223 46563799
Obesity 24.23 10.27 4 122036 14202 46549820
Metabolic acidosis 24.19 10.27 40 122000 38740 46525282
Sedation 24.13 10.27 15 122025 22895 46541127
Cardiac arrest 24.12 10.27 138 121902 90261 46473761
Herpes simplex encephalitis 24.09 10.27 13 122027 292 46563730
Antinuclear antibody negative 24.04 10.27 12 122028 228 46563794
Target skin lesion 23.94 10.27 9 122031 82 46563940
Fibromyalgia 23.32 10.27 37 122003 36426 46527596
Herpes zoster cutaneous disseminated 23.31 10.27 10 122030 132 46563890
Blood test abnormal 23.27 10.27 66 121974 9454 46554568
Band sensation 23.12 10.27 17 122023 665 46563357
Blood brain barrier defect 23.11 10.27 9 122031 91 46563931
Herpes zoster meningoencephalitis 23.00 10.27 12 122028 251 46563771
CSF measles antibody positive 22.99 10.27 8 122032 57 46563965
Renal failure 22.98 10.27 421 121619 113173 46450849
Gastrointestinal haemorrhage 22.93 10.27 114 121926 77259 46486763
Escherichia bacteraemia 22.88 10.27 32 122008 2729 46561293
Cytokine storm 22.75 10.27 12 122028 257 46563765
Surgery 22.71 10.27 25 122015 28760 46535262
Congenital diaphragmatic hernia 22.67 10.27 11 122029 196 46563826
No adverse event 22.59 10.27 34 122006 34197 46529825
Cataract 22.54 10.27 199 121841 45216 46518806
Band neutrophil percentage increased 22.52 10.27 11 122029 199 46563823
Premature delivery 22.49 10.27 15 122025 22054 46541968
Hyperbilirubinaemia 22.31 10.27 69 121971 10369 46553653
Hypogammaglobulinaemia 22.24 10.27 46 121994 5392 46558630
Oxygen saturation decreased 22.20 10.27 99 121941 69065 46494957
Rubella antibody positive 22.19 10.27 8 122032 64 46563958
Primary myelofibrosis 22.19 10.27 8 122032 64 46563958
Red blood cell count increased 22.15 10.27 29 122011 2321 46561701
Myelocyte count increased 22.11 10.27 13 122027 346 46563676
Dry skin 22.08 10.27 183 121857 40833 46523189
Herpes simplex reactivation 22.08 10.27 13 122027 347 46563675
Exposure during pregnancy 22.00 10.27 179 121861 108033 46455989
Anti-thyroid antibody positive 21.99 10.27 14 122026 431 46563591
Coronary artery disease 21.82 10.27 34 122006 33718 46530304
Lymph node palpable 21.82 10.27 9 122031 107 46563915
Injury 21.79 10.27 52 121988 43975 46520047
Mean cell haemoglobin concentration increased 21.77 10.27 14 122026 439 46563583
Myelocyte percentage increased 21.47 10.27 10 122030 162 46563860
Serotonin syndrome 21.45 10.27 19 122021 24201 46539821
Oral herpes 21.45 10.27 104 121936 19286 46544736
Dysgeusia 21.44 10.27 180 121860 40311 46523711
Incorrect route of product administration 21.41 10.27 8 122032 16375 46547647
Klebsiella test positive 21.35 10.27 19 122021 978 46563044
Mean cell volume decreased 21.30 10.27 29 122011 2411 46561611
Toxic neuropathy 21.24 10.27 13 122027 373 46563649
Coombs positive haemolytic anaemia 21.11 10.27 13 122027 377 46563645
Product quality issue 21.11 10.27 38 122002 35610 46528412
Foot deformity 21.07 10.27 7 122033 15418 46548604
Immune thrombocytopenia 20.99 10.27 58 121982 8183 46555839
Type 2 diabetes mellitus 20.95 10.27 13 122027 19862 46544160
Acute generalised exanthematous pustulosis 20.87 10.27 63 121977 9342 46554680
Thyroxine free decreased 20.74 10.27 14 122026 477 46563545
Flushing 20.66 10.27 259 121781 64355 46499667
Skin discolouration 20.46 10.27 151 121889 32529 46531493
Anaphylactic shock 20.37 10.27 14 122026 20260 46543762
Injection site mass 20.24 10.27 7 122033 15033 46548989
Ear swelling 20.23 10.27 19 122021 1049 46562973
Tri-iodothyronine free increased 20.23 10.27 10 122030 186 46563836
Injection site rash 20.20 10.27 8 122032 15805 46548217
Urine oxalate increased 19.94 10.27 10 122030 192 46563830
Human chorionic gonadotropin increased 19.81 10.27 20 122020 1207 46562815
Pneumonia influenzal 19.76 10.27 22 122018 1487 46562535
Pneumonia cytomegaloviral 19.75 10.27 25 122015 1935 46562087
Chest pain 19.74 10.27 333 121707 175991 46388031
Craniofacial deformity 19.55 10.27 8 122032 93 46563929
Abdominal wall wound 19.52 10.27 7 122033 55 46563967
Blood pressure fluctuation 19.37 10.27 31 122009 30417 46533605
Herpes simplex pneumonia 19.28 10.27 5 122035 10 46564012
Red cell distribution width decreased 19.15 10.27 17 122023 872 46563150
Haemorrhagic disorder 19.15 10.27 16 122024 756 46563266
Dyslalia 19.12 10.27 14 122026 544 46563478
Diabetes mellitus 19.03 10.27 67 121973 49998 46514024
Pulmonary thrombosis 18.76 10.27 52 121988 7350 46556672
Rash maculo-papular 18.72 10.27 131 121909 27743 46536279
Creatinine urine decreased 18.67 10.27 9 122031 158 46563864
Antineutrophil cytoplasmic antibody positive 18.60 10.27 13 122027 469 46563553
Pseudomonas infection 18.58 10.27 62 121978 9696 46554326
Herpes simplex meningoencephalitis 18.55 10.27 6 122034 33 46563989
Jarisch-Herxheimer reaction 18.44 10.27 11 122029 301 46563721
Autoimmune thyroiditis 18.43 10.27 30 122010 2925 46561097
Device malfunction 18.39 10.27 6 122034 13368 46550654
Staphylococcal bacteraemia 18.34 10.27 40 122000 4864 46559158
Angina pectoris 18.25 10.27 26 122014 26749 46537273
Insomnia 18.19 10.27 562 121478 164362 46399660
Focal myositis 18.12 10.27 6 122034 36 46563986
Electrocardiogram QT prolonged 18.00 10.27 71 121969 51254 46512768
Cytomegalovirus hepatitis 17.99 10.27 11 122029 315 46563707
Pregnancy 17.87 10.27 27 122013 27110 46536912
Hypoglossal nerve paralysis 17.86 10.27 5 122035 15 46564007
Small intestine adenocarcinoma 17.86 10.27 5 122035 15 46564007
Renal impairment 17.70 10.27 283 121757 74089 46489933
Drug resistance 17.68 10.27 91 121949 17277 46546745
Chronic obstructive pulmonary disease 17.60 10.27 84 121956 57549 46506473
Band neutrophil count increased 17.50 10.27 11 122029 331 46563691
Monoclonal immunoglobulin present 17.48 10.27 15 122025 735 46563287
Toxic encephalopathy 17.48 10.27 40 122000 5022 46559000
Hordeolum 17.48 10.27 25 122015 2176 46561846
Myeloblast percentage decreased 17.45 10.27 6 122034 41 46563981
Treatment noncompliance 17.33 10.27 32 122008 29699 46534323
Injection site urticaria 17.12 10.27 5 122035 11962 46552060
Monocyte percentage decreased 17.10 10.27 8 122032 131 46563891
Tonsillar haemorrhage 17.09 10.27 9 122031 192 46563830
Congenital herpes simplex infection 17.04 10.27 4 122036 4 46564018
Gastritis fungal 16.91 10.27 7 122033 84 46563938
Clostridium difficile infection 16.87 10.27 118 121922 24985 46539037
Haemorrhage intracranial 16.87 10.27 72 121968 12652 46551370
Respiratory arrest 16.69 10.27 40 122000 33776 46530246
Thyroid stimulating immunoglobulin 16.53 10.27 6 122034 49 46563973
Pulmonary hypoplasia 16.46 10.27 10 122030 283 46563739
Monocyte count increased 16.38 10.27 39 122001 5025 46558997
Sensitisation 16.37 10.27 14 122026 683 46563339
Metastases to bone 16.35 10.27 13 122027 17463 46546559
Herpes ophthalmic 16.29 10.27 16 122024 934 46563088
Pseudomonal sepsis 16.29 10.27 23 122017 1979 46562043
Eczema herpeticum 16.28 10.27 7 122033 93 46563929
Impaired healing 16.19 10.27 46 121994 36697 46527325
Thunderclap headache 16.12 10.27 8 122032 150 46563872
Delayed engraftment 16.12 10.27 6 122034 53 46563969
Meningitis listeria 16.03 10.27 11 122029 385 46563637
Caesarean section 15.98 10.27 12 122028 16591 46547431
Injection site warmth 15.97 10.27 8 122032 13764 46550258
Organic brain syndrome 15.61 10.27 8 122032 161 46563861
Herpes simplex viraemia 15.61 10.27 8 122032 161 46563861
Blood pressure increased 15.58 10.27 235 121805 126431 46437591
Glomerulonephritis chronic 15.52 10.27 8 122032 163 46563859
Intentional product use issue 15.50 10.27 78 121962 52702 46511320
Hepatic enzyme increased 15.41 10.27 138 121902 81649 46482373
Pneumonia parainfluenzae viral 15.38 10.27 6 122034 61 46563961
Hepatitis fulminant 15.37 10.27 30 122010 3372 46560650
Bone erosion 15.36 10.27 3 122037 9440 46554582
Hypoaesthesia 15.28 10.27 413 121627 118456 46445566
Listeriosis 15.23 10.27 17 122023 1152 46562870
Post herpetic neuralgia 15.18 10.27 22 122018 1938 46562084
Blood creatine phosphokinase increased 15.15 10.27 31 122009 27693 46536329
Thyroid stimulating immunoglobulin increased 15.11 10.27 7 122033 112 46563910
Joint stiffness 15.08 10.27 30 122010 27078 46536944
Device issue 15.06 10.27 18 122022 19962 46544060
Right ventricular failure 15.02 10.27 12 122028 16081 46547941
Disseminated intravascular coagulation 15.00 10.27 93 121947 18912 46545110
CSF test abnormal 14.96 10.27 10 122030 335 46563687
Medication error 14.91 10.27 37 122003 30874 46533148
Hyperuricaemia 14.91 10.27 36 122004 4681 46559341
Helicobacter infection 14.89 10.27 6 122034 11730 46552292
Hypertension 14.87 10.27 395 121645 195961 46368061
Anxiety 14.86 10.27 362 121678 181595 46382427
Basophil percentage decreased 14.85 10.27 3 122037 0 46564022
Blood pressure decreased 14.85 10.27 88 121952 57071 46506951
Blastomycosis 14.84 10.27 9 122031 254 46563768
Leukaemia 14.82 10.27 29 122011 3266 46560756
Mean cell haemoglobin concentration decreased 14.79 10.27 25 122015 2515 46561507
Systemic candida 14.77 10.27 26 122014 2701 46561321
Magnetic resonance imaging abnormal 14.71 10.27 26 122014 2710 46561312
Migraine 14.62 10.27 115 121925 69911 46494111
Blood thyroid stimulating hormone abnormal 14.61 10.27 13 122027 669 46563353
Bacterial infection 14.50 10.27 82 121958 16134 46547888
Varicella 14.47 10.27 20 122020 1686 46562336
Meningitis 14.47 10.27 42 121998 6094 46557928
Metastases to lung 14.36 10.27 5 122035 10691 46553331
Bilirubin urine present 14.35 10.27 6 122034 74 46563948
Hepatic cirrhosis 14.35 10.27 12 122028 15720 46548302
Geotrichum infection 14.30 10.27 11 122029 461 46563561
Pneumonia bacterial 14.26 10.27 45 121995 6834 46557188
Amyloidosis 14.21 10.27 16 122024 1095 46562927
Diabetic ketoacidosis 14.16 10.27 16 122024 18194 46545828
Tendonitis 14.15 10.27 10 122030 14267 46549755
Aplastic anaemia 14.11 10.27 46 121994 7107 46556915
Infusion site scar 14.05 10.27 8 122032 200 46563822
Blood pressure diastolic decreased 14.03 10.27 10 122030 14201 46549821
Avulsion fracture 14.03 10.27 9 122031 281 46563741
Acute disseminated encephalomyelitis 13.98 10.27 8 122032 202 46563820
Premature labour 13.98 10.27 6 122034 11293 46552729
Myalgia 13.91 10.27 232 121808 122856 46441166
Blood creatinine decreased 13.91 10.27 35 122005 4669 46559353
Cardiac failure congestive 13.91 10.27 163 121877 91587 46472435
Body height decreased 13.88 10.27 56 121984 9596 46554426
Hyponatraemia 13.87 10.27 184 121856 101148 46462874
Herpes zoster infection neurological 13.86 10.27 6 122034 81 46563941
Tumour flare 13.83 10.27 9 122031 288 46563734
Eye swelling 13.81 10.27 95 121945 20008 46544014
Leukopenia 13.71 10.27 253 121787 68090 46495932
Sepsis syndrome 13.53 10.27 14 122026 870 46563152
Refractoriness to platelet transfusion 13.45 10.27 5 122035 44 46563978
Diabetes mellitus inadequate control 13.44 10.27 9 122031 13205 46550817
Varicella virus test positive 13.36 10.27 6 122034 89 46563933
Arteritis infective 13.35 10.27 5 122035 45 46563977
Blood loss anaemia 13.34 10.27 3 122037 8554 46555468
Culture stool positive 13.32 10.27 9 122031 307 46563715
Monoclonal immunoglobulin increased 13.30 10.27 6 122034 90 46563932
Gait disturbance 13.27 10.27 284 121756 144979 46419043
Inflammation 13.26 10.27 74 121966 48707 46515315
Joint range of motion decreased 13.23 10.27 12 122028 15112 46548910
Lung infiltration 13.22 10.27 72 121968 13971 46550051
Oesophageal atresia 13.21 10.27 11 122029 517 46563505
Tracheo-oesophageal fistula 13.20 10.27 11 122029 518 46563504
Posterior reversible encephalopathy syndrome 13.17 10.27 76 121964 15065 46548957
Brain oedema 13.14 10.27 66 121974 12412 46551610
Acquired macroglossia 13.06 10.27 6 122034 94 46563928
Depressed mood 13.06 10.27 44 121996 33275 46530747
Housebound 13.06 10.27 8 122032 230 46563792
Infusion site discomfort 12.92 10.27 12 122028 653 46563369
Pericarditis 12.87 10.27 27 122013 23900 46540122
Bone marrow transplant 12.85 10.27 12 122028 658 46563364
Immune system disorder 12.81 10.27 48 121992 7947 46556075
Melaena 12.81 10.27 34 122006 27738 46536284
Muscle rigidity 12.79 10.27 5 122035 9956 46554066
Congenital syphilis 12.78 10.27 3 122037 3 46564019
Atrial fibrillation 12.77 10.27 358 121682 103232 46460790
Ulcer 12.76 10.27 16 122024 17376 46546646
Lung neoplasm malignant 12.72 10.27 13 122027 15476 46548546
Blood bilirubin increased 12.68 10.27 141 121899 34043 46529979
Gastroenteritis salmonella 12.66 10.27 10 122030 436 46563586
Pneumonia pseudomonal 12.62 10.27 21 122019 2085 46561937
Extravasation 12.56 10.27 21 122019 2094 46561928
Ovarian cyst 12.54 10.27 11 122029 14076 46549946
Immunosuppressant drug level increased 12.54 10.27 27 122013 3255 46560767
Ear pruritus 12.52 10.27 21 122019 2099 46561923
Obstructive airways disorder 12.52 10.27 10 122030 13402 46550620
Body temperature decreased 12.51 10.27 10 122030 13399 46550623
Interstitial lung disease 12.50 10.27 86 121954 53863 46510159
Blood glucose increased 12.50 10.27 124 121916 71889 46492133
Femur fracture 12.46 10.27 52 121988 36945 46527077
Obliterative bronchiolitis 12.43 10.27 19 122021 1756 46562266
Eosinophil count increased 12.42 10.27 47 121993 7819 46556203
Dystonia 12.38 10.27 7 122033 11250 46552772
Model for end stage liver disease score increased 12.37 10.27 4 122036 22 46564000
Nodal arrhythmia 12.35 10.27 16 122024 1267 46562755
Allogenic stem cell transplantation 12.32 10.27 3 122037 4 46564018
COVID-19 12.30 10.27 87 121953 18488 46545534
Hiatus hernia 12.25 10.27 18 122022 18284 46545738
Blast cell count increased 12.24 10.27 9 122031 352 46563670
Device breakage 12.22 10.27 5 122035 9687 46554335
Factor XIII Inhibition 12.22 10.27 4 122036 23 46563999
Pneumonia aspiration 12.21 10.27 42 121998 31563 46532459
Periorbital swelling 12.21 10.27 16 122024 1282 46562740
Neuropsychiatric syndrome 12.15 10.27 5 122035 59 46563963
Mantle cell lymphoma 12.14 10.27 11 122029 580 46563442
Ejection fraction 12.12 10.27 11 122029 581 46563441
Duodenal stenosis 12.12 10.27 11 122029 581 46563441
Cytomegalovirus infection reactivation 12.11 10.27 17 122023 1455 46562567
Procedural pain 12.08 10.27 10 122030 13169 46550853
Corneal lesion 12.08 10.27 4 122036 24 46563998
Human herpesvirus 6 encephalitis 12.02 10.27 6 122034 114 46563908
Idiopathic pneumonia syndrome 12.00 10.27 9 122031 363 46563659
Acute lymphocytic leukaemia 11.98 10.27 24 122016 2749 46561273
Malignant sweat gland neoplasm 11.94 10.27 4 122036 25 46563997
Genital rash 11.94 10.27 10 122030 474 46563548
Lipaemic index score 11.93 10.27 5 122035 62 46563960
Cerebral artery stenosis 11.85 10.27 9 122031 370 46563652
Retinal depigmentation 11.81 10.27 8 122032 274 46563748
Sinus disorder 11.81 10.27 79 121961 16484 46547538
Salmonella test positive 11.81 10.27 4 122036 26 46563996
Porphyria acute 11.79 10.27 9 122031 373 46563649
Lupus-like syndrome 11.74 10.27 3 122037 7841 46556181
Fear 11.74 10.27 15 122025 16157 46547865
Mycobacterium kansasii infection 11.70 10.27 6 122034 121 46563901
Anti-thyroid antibody 11.57 10.27 3 122037 6 46564016
Varicella zoster pneumonia 11.55 10.27 4 122036 28 46563994
Capillary leak syndrome 11.48 10.27 19 122021 1878 46562144
Dyskinesia 11.47 10.27 38 122002 28887 46535135
Abdominal pain 11.47 10.27 488 121552 229543 46334479
Campylobacter gastroenteritis 11.46 10.27 9 122031 389 46563633
Injection site phlebitis 11.40 10.27 6 122034 128 46563894
Rash papular 11.39 10.27 65 121975 12833 46551189
Pulmonary fibrosis 11.38 10.27 22 122018 20070 46543952
Haemodialysis 11.34 10.27 51 121989 9166 46554856
Acute myocardial infarction 11.29 10.27 44 121996 31880 46532142
Palpitations 11.28 10.27 178 121862 95081 46468941
Feeling hot 11.26 10.27 150 121890 37778 46526244
Oesophageal irritation 11.19 10.27 6 122034 133 46563889
Dust allergy 11.18 10.27 10 122030 518 46563504
Streptococcal infection 11.13 10.27 33 122007 4845 46559177
Vision blurred 11.13 10.27 280 121760 79428 46484594
Transplant failure 11.09 10.27 15 122025 1239 46562783
Nephrectomy 11.07 10.27 10 122030 525 46563497
Septic embolus 11.05 10.27 12 122028 789 46563233
pH urine increased 11.04 10.27 7 122033 214 46563808
Genital lesion 11.02 10.27 5 122035 76 46563946
Premature baby 11.00 10.27 19 122021 18093 46545929
Post procedural complication 10.99 10.27 15 122025 15714 46548308
Wheezing 10.99 10.27 88 121952 53298 46510724
Staphylococcus test positive 10.95 10.27 27 122013 3557 46560465
Eosinophil percentage decreased 10.91 10.27 6 122034 140 46563882
Labelled drug-drug interaction medication error 10.91 10.27 5 122035 9056 46554966
Congenital tricuspid valve incompetence 10.90 10.27 5 122035 78 46563944
Emphysema 10.90 10.27 5 122035 9049 46554973
Peripheral sensory neuropathy 10.88 10.27 40 122000 6563 46557459
Joint dislocation 10.87 10.27 8 122032 11178 46552844
Coagulation test abnormal 10.87 10.27 11 122029 666 46563356
Pneumonia respiratory syncytial viral 10.87 10.27 11 122029 666 46563356
Body temperature increased 10.85 10.27 106 121934 24755 46539267
Sinoatrial block 10.84 10.27 12 122028 806 46563216
Refractory anaemia with an excess of blasts 10.76 10.27 9 122031 426 46563596
Renal tubular necrosis 10.70 10.27 56 121984 10703 46553319
Phyllodes tumour 10.68 10.27 4 122036 36 46563986
Nystagmus 10.66 10.27 36 122004 5663 46558359
Basophil count increased 10.65 10.27 12 122028 822 46563200
Pneumococcal sepsis 10.62 10.27 10 122030 554 46563468
Partial seizures 10.60 10.27 33 122007 4977 46559045
Haemorrhage 10.59 10.27 92 121948 54777 46509245
Hepatitis B antibody positive 10.59 10.27 4 122036 37 46563985
Urobilinogen urine increased 10.58 10.27 6 122034 149 46563873
Infusion site extravasation 10.55 10.27 34 122006 5222 46558800
Somnolence 10.54 10.27 320 121720 156201 46407821
Iron deficiency anaemia 10.50 10.27 18 122022 17188 46546834
Non-Hodgkin's lymphoma recurrent 10.48 10.27 3 122037 10 46564012
Pneumonia necrotising 10.47 10.27 8 122032 332 46563690
Injection site induration 10.47 10.27 4 122036 8075 46555947
Pneumocystis jirovecii pneumonia 10.44 10.27 72 121968 15176 46548846
Cerebellar haemangioma 10.40 10.27 4 122036 39 46563983
BK virus infection 10.38 10.27 23 122017 2826 46561196
Incorrect dose administered 10.36 10.27 73 121967 45477 46518545
Eosinophil percentage increased 10.31 10.27 12 122028 851 46563171
Klebsiella bacteraemia 10.30 10.27 14 122026 1162 46562860
Pre-eclampsia 10.29 10.27 4 122036 7990 46556032

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
Plasma cell myeloma 851.82 10.47 1015 108988 52447 29790028
Febrile neutropenia 505.58 10.47 1171 108832 105522 29736953
Pneumonia 416.52 10.47 2361 107642 331945 29510530
White blood cell count decreased 374.08 10.47 900 109103 83047 29759428
Neuropathy peripheral 360.66 10.47 798 109205 69677 29772798
Platelet count decreased 335.57 10.47 1002 109001 105127 29737348
Pyrexia 280.26 10.47 1943 108060 292546 29549929
Completed suicide 276.57 10.47 24 109979 99468 29743007
Drug abuse 276.32 10.47 5 109998 82067 29760408
Full blood count decreased 264.07 10.47 307 109696 15410 29827065
Neurotoxicity 240.96 10.47 269 109734 12913 29829562
Neutropenia 234.64 10.47 1014 108989 127526 29714949
Thrombosis 221.26 10.47 483 109520 41748 29800727
Cytokine release syndrome 219.18 10.47 224 109779 9709 29832766
Toxicity to various agents 212.17 10.47 203 109800 176980 29665495
Graft versus host disease 192.18 10.47 211 109792 9939 29832536
Neutrophil count decreased 191.85 10.47 458 109545 41996 29800479
Adverse drug reaction 190.79 10.47 321 109682 22824 29819651
Acute graft versus host disease in skin 175.29 10.47 140 109863 4376 29838099
Laboratory test abnormal 167.07 10.47 259 109744 17183 29825292
Cytomegalovirus infection 164.95 10.47 305 109698 23369 29819106
Drug interaction 151.87 10.47 316 109687 199252 29643223
Acute graft versus host disease 143.67 10.47 140 109863 5724 29836751
Pancytopenia 131.21 10.47 639 109364 84413 29758062
Rash 125.29 10.47 1163 108840 190726 29651749
Meningoencephalitis herpetic 110.53 10.47 55 109948 723 29841752
Chronic graft versus host disease 107.83 10.47 102 109901 4017 29838458
Influenza 107.17 10.47 377 109626 43021 29799454
Acute graft versus host disease in intestine 105.14 10.47 80 109923 2325 29840150
Herpes zoster 104.26 10.47 293 109710 29650 29812825
Intentional product misuse 103.06 10.47 6 109997 34661 29807814
Rheumatoid arthritis 101.72 10.47 15 109988 41182 29801293
Thrombocytopenia 93.56 10.47 839 109164 136205 29706270
Cytomegalovirus viraemia 93.02 10.47 110 109893 5619 29836856
Bronchopulmonary aspergillosis 92.85 10.47 164 109839 12120 29830355
Myocardial infarction 92.01 10.47 203 109800 125422 29717053
Cystitis haemorrhagic 91.45 10.47 100 109903 4687 29837788
Sepsis 91.28 10.47 879 109124 145516 29696959
Encephalitis 90.62 10.47 115 109888 6321 29836154
Intentional overdose 89.81 10.47 21 109982 41460 29801015
Overdose 89.19 10.47 107 109896 84230 29758245
Psoriasis 89.14 10.47 23 109980 42483 29799992
Deep vein thrombosis 84.40 10.47 442 109561 60059 29782416
Fatigue 83.43 10.47 1645 108358 319028 29523447
Herpes simplex 83.11 10.47 92 109911 4372 29838103
Suicide attempt 78.61 10.47 19 109984 36678 29805797
Hypoglycaemia 78.17 10.47 45 109958 50936 29791539
Plasma cell myeloma recurrent 75.31 10.47 77 109926 3337 29839138
Tooth disorder 72.74 10.47 125 109878 9036 29833439
International normalised ratio increased 69.20 10.47 45 109958 47694 29794781
Encephalitis viral 66.30 10.47 46 109957 1154 29841321
Infection 62.20 10.47 495 109508 77579 29764896
Acute myeloid leukaemia recurrent 62.13 10.47 49 109954 1503 29840972
Mucosal inflammation 61.24 10.47 248 109755 30246 29812229
Suicidal ideation 61.13 10.47 28 109975 36086 29806389
Chronic lymphocytic leukaemia 60.94 10.47 80 109923 4548 29837927
Cardio-respiratory arrest 60.25 10.47 73 109930 57233 29785242
Adenovirus infection 58.10 10.47 75 109928 4193 29838282
Wrong technique in product usage process 57.86 10.47 21 109982 31134 29811341
Acute graft versus host disease in liver 57.67 10.47 43 109960 1211 29841264
Immune effector cell-associated neurotoxicity syndrome 57.37 10.47 37 109966 819 29841656
Injection site pain 57.02 10.47 20 109983 30290 29812185
Neutropenic sepsis 56.88 10.47 128 109875 11281 29831194
Drug dependence 56.83 10.47 6 109997 21289 29821186
Plasmacytoma 55.42 10.47 65 109938 3291 29839184
Lymphocyte count decreased 53.61 10.47 173 109830 18882 29823593
Body height decreased 53.01 10.47 67 109936 3667 29838808
Varicella zoster virus infection 52.85 10.47 41 109962 1227 29841248
Tumour lysis syndrome 52.83 10.47 134 109869 12751 29829724
Cytomegalovirus test positive 52.70 10.47 66 109937 3579 29838896
Rhabdomyolysis 52.26 10.47 96 109907 63484 29778991
Herpes simplex oesophagitis 52.13 10.47 20 109983 132 29842343
Inappropriate schedule of product administration 51.65 10.47 42 109961 39686 29802789
Diarrhoea 50.72 10.47 1594 108409 332509 29509966
Hyperkalaemia 50.50 10.47 104 109899 65906 29776569
Bradycardia 50.33 10.47 103 109900 65423 29777052
Acute myeloid leukaemia 50.22 10.47 163 109840 17843 29824632
Acute myocardial infarction 49.98 10.47 73 109930 52866 29789609
Toxic encephalopathy 49.18 10.47 72 109931 4537 29837938
Arthralgia 49.01 10.47 295 109708 135496 29706979
Pneumonia fungal 48.60 10.47 79 109924 5454 29837021
Drug ineffective 47.91 10.47 922 109081 339465 29503010
Seasonal allergy 47.49 10.47 72 109931 4681 29837794
Light chain analysis increased 46.96 10.47 35 109968 985 29841490
Cardiac arrest 46.75 10.47 179 109824 92671 29749804
Epstein-Barr virus infection 46.18 10.47 86 109917 6620 29835855
Dyspnoea 45.61 10.47 907 109096 332388 29510087
Gastrointestinal haemorrhage 45.23 10.47 156 109847 83290 29759185
Respiratory arrest 44.59 10.47 26 109977 29232 29813243
Renal disorder 44.36 10.47 188 109815 23396 29819079
Nephropathy toxic 43.99 10.47 111 109892 10528 29831947
Angioedema 43.89 10.47 37 109966 34347 29808128
Venoocclusive liver disease 43.30 10.47 83 109920 6530 29835945
Depression 42.59 10.47 179 109824 90258 29752217
Anxiety 42.25 10.47 178 109825 89693 29752782
Ageusia 41.92 10.47 98 109905 8855 29833620
Red blood cell count decreased 41.40 10.47 199 109804 26122 29816353
Asthma 41.38 10.47 43 109960 36131 29806344
Pneumonia cytomegaloviral 41.02 10.47 51 109952 2745 29839730
Necrotising retinitis 40.55 10.47 28 109975 697 29841778
Full blood count increased 39.60 10.47 29 109974 794 29841681
Septic shock 39.57 10.47 382 109621 63225 29779250
Interstitial lung disease 39.47 10.47 103 109900 60094 29782381
Blood pressure increased 38.61 10.47 135 109868 71793 29770682
Pulmonary thrombosis 38.37 10.47 77 109926 6266 29836209
Psoriatic arthropathy 38.30 10.47 6 109997 15755 29826720
Herpes virus infection 38.28 10.47 47 109956 2497 29839978
Blood bilirubin increased 38.26 10.47 248 109755 36388 29806087
Blood creatine phosphokinase increased 38.02 10.47 64 109939 43784 29798691
Thrombotic microangiopathy 37.89 10.47 92 109911 8518 29833957
Constipation 37.62 10.47 603 109400 112303 29730172
Human herpesvirus 6 infection 37.57 10.47 41 109962 1917 29840558
Crystal urine present 37.13 10.47 19 109984 266 29842209
Contraindicated product administered 36.74 10.47 9 109994 17222 29825253
Coronary artery disease 36.61 10.47 80 109923 49632 29792843
Engraft failure 36.47 10.47 22 109981 431 29842044
Stem cell transplant 36.40 10.47 42 109961 2089 29840386
Parainfluenzae virus infection 36.22 10.47 41 109962 1997 29840478
Therapeutic product effect incomplete 35.66 10.47 43 109960 33791 29808684
Intentional self-injury 35.63 10.47 4 109999 13528 29828947
Electrocardiogram QT prolonged 35.23 10.47 48 109955 35787 29806688
Fusarium infection 35.06 10.47 30 109973 1034 29841441
Engraftment syndrome 34.86 10.47 27 109976 806 29841669
Pneumonia viral 34.82 10.47 46 109957 2631 29839844
Condition aggravated 34.77 10.47 331 109672 137535 29704940
Aggression 34.73 10.47 51 109952 36856 29805619
Multiple allergies 34.55 10.47 41 109962 2102 29840373
Muscle spasms 34.43 10.47 377 109626 64461 29778014
Drug withdrawal syndrome 34.08 10.47 15 109988 19794 29822681
Post transplant lymphoproliferative disorder 34.01 10.47 66 109937 5240 29837235
Blood count abnormal 33.87 10.47 107 109896 11545 29830930
Lactic acidosis 33.61 10.47 39 109964 31174 29811301
Protein total increased 33.10 10.47 40 109963 2090 29840385
Graft versus host disease in skin 32.91 10.47 50 109953 3257 29839218
Squamous cell carcinoma of skin 32.62 10.47 90 109913 9005 29833470
Chest pain 32.45 10.47 276 109727 117351 29725124
Taste disorder 32.33 10.47 51 109952 3432 29839043
Hospitalisation 32.08 10.47 72 109931 44247 29798228
Neuroleptic malignant syndrome 31.96 10.47 10 109993 16285 29826190
Bacterial infection 31.49 10.47 110 109893 12500 29829975
Respiratory depression 31.32 10.47 3 110000 11500 29830975
Organic brain syndrome 30.68 10.47 12 109991 84 29842391
Off label use 30.63 10.47 690 109313 248600 29593875
Encephalopathy 30.62 10.47 213 109790 31992 29810483
Sedation 30.46 10.47 11 109992 16362 29826113
Enterococcal infection 30.11 10.47 82 109921 8142 29834333
Cardiac failure congestive 30.09 10.47 184 109819 84223 29758252
Loss of consciousness 29.90 10.47 170 109833 79205 29763270
Venoocclusive disease 29.89 10.47 42 109961 2548 29839927
Unevaluable event 29.50 10.47 209 109794 31576 29810899
Hepatic cirrhosis 29.34 10.47 11 109992 15988 29826487
Fungal infection 29.22 10.47 113 109890 13487 29828988
Acute lymphocytic leukaemia recurrent 28.94 10.47 42 109961 2625 29839850
Cytopenia 28.92 10.47 81 109922 8175 29834300
Multiple organ dysfunction syndrome 28.74 10.47 358 109645 63129 29779346
Injury 28.21 10.47 23 109980 21708 29820767
Product quality issue 28.16 10.47 17 109986 18757 29823718
Neutrophil Pelger-Huet anomaly present 27.93 10.47 15 109988 233 29842242
Pain in extremity 27.62 10.47 265 109738 109956 29732519
Rectal haemorrhage 27.60 10.47 54 109949 34885 29807590
Rash pruritic 27.48 10.47 159 109844 22413 29820062
Urine abnormality 27.42 10.47 31 109972 1508 29840967
Lymphocyte percentage decreased 27.37 10.47 36 109967 2050 29840425
Drug resistance 27.30 10.47 146 109857 19987 29822488
Herpes ophthalmic 27.23 10.47 18 109985 416 29842059
Graft versus host disease in gastrointestinal tract 27.20 10.47 44 109959 3025 29839450
Headache 27.03 10.47 489 109514 181817 29660658
Aspartate aminotransferase 26.99 10.47 12 109991 120 29842355
Bacteraemia 26.94 10.47 121 109882 15439 29827036
Oral herpes 26.85 10.47 54 109949 4401 29838074
Polyomavirus viraemia 26.83 10.47 19 109984 493 29841982
Crystalluria 26.77 10.47 17 109986 366 29842109
Pre-engraftment immune reaction 26.76 10.47 11 109992 89 29842386
Treatment noncompliance 26.71 10.47 32 109971 25221 29817254
Pseudomonal sepsis 26.58 10.47 43 109960 2957 29839518
Spinal fracture 26.45 10.47 69 109934 6679 29835796
Colitis ulcerative 26.34 10.47 10 109993 14424 29828051
Somnolence 26.25 10.47 228 109775 96535 29745940
Mucormycosis 26.14 10.47 59 109944 5209 29837266
Enterococcal bacteraemia 26.04 10.47 29 109974 1387 29841088
Immune system disorder 25.96 10.47 52 109951 4225 29838250
Hyperbilirubinaemia 25.85 10.47 127 109876 16815 29825660
Haemophagocytic lymphohistiocytosis 25.84 10.47 87 109916 9704 29832771
Viral haemorrhagic cystitis 25.80 10.47 23 109980 838 29841637
Foetal exposure during pregnancy 25.79 10.47 61 109942 36810 29805665
Vomiting 25.70 10.47 613 109390 219205 29623270
Labelled drug-drug interaction medication error 25.63 10.47 4 109999 10534 29831941
Emotional distress 25.49 10.47 13 109990 15752 29826723
Metabolic acidosis 25.40 10.47 63 109940 37398 29805077
Leukaemia recurrent 25.39 10.47 30 109973 1531 29840944
Wheezing 25.15 10.47 47 109956 30891 29811584
Blood pressure systolic increased 25.13 10.47 12 109991 15098 29827377
Ophthalmic herpes simplex 24.96 10.47 14 109989 238 29842237
Abdominal pain 24.73 10.47 350 109653 135304 29707171
Cardiogenic shock 24.28 10.47 16 109987 16845 29825630
Blood test abnormal 24.27 10.47 59 109944 5466 29837009
Toxic epidermal necrolysis 24.25 10.47 130 109873 17810 29824665
Neutrophil percentage increased 24.20 10.47 32 109971 1832 29840643
Strongyloidiasis 24.10 10.47 36 109967 2310 29840165
Herpes zoster meningitis 24.01 10.47 7 109996 16 29842459
Clostridium difficile infection 23.86 10.47 118 109885 15665 29826810
Urine leukocyte esterase positive 23.70 10.47 15 109988 321 29842154
Arteriosclerosis coronary artery 23.51 10.47 6 109997 11170 29831305
Blood pressure fluctuation 23.38 10.47 18 109985 17485 29824990
Stress 23.20 10.47 24 109979 20211 29822264
COVID-19 23.12 10.47 128 109875 17750 29824725
Herpes simplex meningoencephalitis 23.05 10.47 5 109998 0 29842475
Schizophrenia 23.02 10.47 3 110000 9045 29833430
Monoclonal immunoglobulin present 22.84 10.47 22 109981 886 29841589
Peritonitis 22.70 10.47 27 109976 21348 29821127
Urine analysis abnormal 22.62 10.47 31 109972 1837 29840638
Muscle rigidity 22.59 10.47 5 109998 10256 29832219
Atrial fibrillation 22.57 10.47 538 109465 107586 29734889
Mantle cell lymphoma 22.43 10.47 28 109975 1513 29840962
Immunodeficiency 22.33 10.47 49 109954 4245 29838230
Lower respiratory tract infection fungal 22.25 10.47 18 109985 573 29841902
Glycosylated haemoglobin increased 22.20 10.47 4 109999 9487 29832988
Haematochezia 22.09 10.47 59 109944 34163 29808312
Haematotoxicity 22.07 10.47 61 109942 6109 29836366
Tooth deposit 21.90 10.47 10 109993 107 29842368
Oroantral fistula 21.72 10.47 13 109990 251 29842224
Hiccups 21.60 10.47 80 109923 9354 29833121
Pulmonary arterial hypertension 21.58 10.47 4 109999 9297 29833178
Drug hypersensitivity 21.57 10.47 155 109848 68364 29774111
Angina pectoris 21.32 10.47 48 109955 29470 29813005
Dry eye 21.24 10.47 62 109941 6406 29836069
Therapeutic product effect decreased 21.23 10.47 47 109956 29029 29813446
Underdose 21.19 10.47 9 109994 12132 29830343
Anti-platelet antibody positive 21.18 10.47 13 109990 263 29842212
Congenital herpes simplex infection 21.09 10.47 8 109995 51 29842424
Stevens-Johnson syndrome 20.94 10.47 123 109880 17433 29825042
Melaena 20.88 10.47 56 109947 32381 29810094
Cerebrovascular accident 20.77 10.47 201 109802 83276 29759199
Osteoarthritis 20.77 10.47 22 109981 18327 29824148
General physical health deterioration 20.72 10.47 251 109752 99693 29742782
Fibrous histiocytoma 20.68 10.47 10 109993 123 29842352
Fear 20.60 10.47 7 109996 10818 29831657
Cyanosis 20.59 10.47 9 109994 11926 29830549
Peritonitis bacterial 20.57 10.47 8 109995 11370 29831105
Hepatocellular carcinoma 20.53 10.47 5 109998 9605 29832870
Enterococcal sepsis 20.48 10.47 27 109976 1541 29840934
Staphylococcal bacteraemia 20.46 10.47 63 109940 6705 29835770
Lactose intolerance 20.25 10.47 20 109983 831 29841644
Myalgia 20.19 10.47 182 109821 76485 29765990
Herpes simplex encephalitis 20.19 10.47 13 109990 287 29842188
Treatment failure 20.04 10.47 63 109940 34616 29807859
Fungaemia 19.79 10.47 32 109971 2199 29840276
Product dose omission issue 19.75 10.47 458 109545 91173 29751302
Hepatic encephalopathy 19.73 10.47 14 109989 14178 29828297
Pneumonia respiratory syncytial viral 19.43 10.47 17 109986 604 29841871
Monocyte percentage increased 19.31 10.47 20 109983 880 29841595
Cystitis viral 19.25 10.47 15 109988 452 29842023
Diffuse large B-cell lymphoma 19.23 10.47 68 109935 7773 29834702
Synovitis 19.19 10.47 6 109997 9777 29832698
Streptococcal bacteraemia 19.15 10.47 27 109976 1643 29840832
Specific gravity urine increased 19.11 10.47 9 109994 104 29842371
Herpes zoster meningoencephalitis 19.08 10.47 12 109991 254 29842221
Phlebitis infective 19.05 10.47 10 109993 148 29842327
Epstein-Barr viraemia 19.02 10.47 20 109983 896 29841579
Mobility decreased 19.00 10.47 42 109961 25957 29816518
Poisoning 18.99 10.47 9 109994 11373 29831102
Malignant neoplasm progression 18.86 10.47 172 109831 72115 29770360
Plasma cell leukaemia 18.85 10.47 20 109983 905 29841570
Metastases to bone 18.81 10.47 6 109997 9652 29832823
Incorrect route of product administration 18.79 10.47 9 109994 11306 29831169
Depressed mood 18.63 10.47 21 109982 17008 29825467
Cytomegalovirus infection reactivation 18.60 10.47 27 109976 1688 29840787
Immunodeficiency common variable 18.53 10.47 10 109993 157 29842318
Diabetes mellitus inadequate control 18.53 10.47 12 109991 12750 29829725
Coma 18.45 10.47 81 109922 40368 29802107
Chest discomfort 18.45 10.47 95 109908 45385 29797090
Anaphylactic reaction 18.24 10.47 48 109955 27934 29814541
Bone lesion 18.20 10.47 34 109969 2623 29839852
Salivary hypersecretion 18.11 10.47 3 110000 7563 29834912
Bone marrow transplant 18.10 10.47 20 109983 948 29841527
Accessory spleen 18.04 10.47 10 109993 166 29842309
Haematopoietic stem cell mobilisation 17.88 10.47 10 109993 169 29842306
Achromobacter infection 17.66 10.47 7 109996 51 29842424
CNS ventriculitis 17.61 10.47 11 109992 230 29842245
Clostridium difficile colitis 17.58 10.47 93 109910 12675 29829800
Poikiloderma 17.57 10.47 10 109993 175 29842300
Mucosal disorder 17.48 10.47 25 109978 1542 29840933
Genital herpes simplex 17.40 10.47 9 109994 129 29842346
Pathogen resistance 17.36 10.47 69 109934 8341 29834134
Candida infection 17.28 10.47 106 109897 15256 29827219
Viral infection 17.22 10.47 105 109898 15080 29827395
Hordeolum 17.20 10.47 17 109986 707 29841768
Sleep apnoea syndrome 17.15 10.47 22 109981 16835 29825640
Blood lactate dehydrogenase increased 17.14 10.47 132 109871 20469 29822006
Blood glucose increased 17.12 10.47 144 109859 61386 29781089
Body temperature decreased 17.11 10.47 7 109996 9648 29832827
Paranoia 17.08 10.47 8 109995 10180 29832295
Corneal deposits 17.03 10.47 10 109993 186 29842289
Peripheral swelling 17.00 10.47 317 109686 60757 29781718
Gastroenteritis adenovirus 16.94 10.47 8 109995 93 29842382
Device issue 16.83 10.47 4 109999 7812 29834663
Product substitution issue 16.64 10.47 8 109995 10027 29832448
Meningitis cryptococcal 16.57 10.47 28 109975 1996 29840479
Protein total abnormal 16.44 10.47 12 109991 327 29842148
Blood potassium decreased 16.31 10.47 111 109892 16551 29825924
Basal cell carcinoma 16.30 10.47 108 109895 15960 29826515
Congenital pneumonia 16.29 10.47 8 109995 102 29842373
Hypertension 16.27 10.47 331 109672 121023 29721452
Duodenal ulcer 16.25 10.47 8 109995 9893 29832582
Disseminated varicella zoster virus infection 16.15 10.47 19 109984 965 29841510
Diabetic ketoacidosis 16.13 10.47 21 109982 15965 29826510
Escherichia bacteraemia 16.10 10.47 34 109969 2868 29839607
Pancreatitis 16.08 10.47 74 109929 36416 29806059
Product use issue 16.03 10.47 101 109902 45915 29796560
Intentional product use issue 16 10.47 74 109929 36366 29806109
Cardiac failure 15.98 10.47 213 109790 83205 29759270
Hypogammaglobulinaemia 15.98 10.47 49 109954 5203 29837272
Cerebral infarction 15.88 10.47 47 109956 26326 29816149
Nasopharyngitis 15.88 10.47 304 109699 58545 29783930
Graft versus host disease in liver 15.87 10.47 19 109984 983 29841492
Transplant failure 15.87 10.47 31 109972 2473 29840002
Staphylococcal sepsis 15.83 10.47 73 109930 9418 29833057
Escherichia sepsis 15.82 10.47 41 109962 3953 29838522
Type 2 diabetes mellitus 15.79 10.47 16 109987 13606 29828869
Withdrawal syndrome 15.76 10.47 11 109992 11239 29831236
Dystonia 15.76 10.47 8 109995 9719 29832756
Pulmonary embolism 15.75 10.47 387 109616 77748 29764727
Anaphylactic shock 15.59 10.47 17 109986 13976 29828499
Haematemesis 15.56 10.47 47 109956 26156 29816319
Cytomegalovirus chorioretinitis 15.55 10.47 36 109967 3232 29839243
White blood cell count abnormal 15.52 10.47 32 109971 2654 29839821
Obesity 15.49 10.47 6 109997 8549 29833926
Syncope 15.47 10.47 219 109784 84684 29757791
Hallucination 15.43 10.47 111 109892 48948 29793527
Coronary artery stenosis 15.39 10.47 7 109996 9063 29833412
Campylobacter gastroenteritis 15.37 10.47 17 109986 807 29841668
Atrial septal defect 15.30 10.47 3 110000 6698 29835777
Surgery 15.27 10.47 12 109991 11539 29830936
Genital herpes 15.21 10.47 14 109989 532 29841943
Abnormal behaviour 15.19 10.47 46 109957 25577 29816898
Chronic obstructive pulmonary disease 15.18 10.47 103 109900 46023 29796452
Therapy cessation 15.15 10.47 20 109983 15117 29827358
Pain 15.13 10.47 501 109502 172140 29670335
Injection site haemorrhage 15.09 10.47 5 109998 7850 29834625
Klebsiella bacteraemia 15.06 10.47 19 109984 1038 29841437
Pancreatic carcinoma 15.03 10.47 5 109998 7832 29834643
Hyperhidrosis 14.86 10.47 166 109837 66924 29775551
Angina unstable 14.80 10.47 14 109989 12296 29830179
Back disorder 14.72 10.47 52 109951 5942 29836533
Pneumonia influenzal 14.70 10.47 21 109982 1294 29841181
Hypouricaemia 14.69 10.47 10 109993 243 29842232
CSF protein increased 14.59 10.47 16 109987 752 29841723
Blood pressure decreased 14.57 10.47 107 109896 46968 29795507
Pulmonary hypertension 14.54 10.47 30 109973 19006 29823469
Musculoskeletal stiffness 14.52 10.47 75 109928 35806 29806669
Oxygen saturation decreased 14.29 10.47 97 109906 43343 29799132
Lymphopenia 14.29 10.47 90 109913 13073 29829402
Bone pain 14.24 10.47 119 109884 18907 29823568
White blood cells urine positive 14.20 10.47 19 109984 1100 29841375
Lung neoplasm malignant 14.14 10.47 21 109982 15111 29827364
Gastric ulcer 14.12 10.47 21 109982 15100 29827375
Bacterial sepsis 14.10 10.47 45 109958 4881 29837594
Hyperpyrexia 14.08 10.47 30 109973 2547 29839928
Antiviral drug level above therapeutic 14.05 10.47 6 109997 54 29842421
Chronic lymphocytic leukaemia transformation 14.00 10.47 9 109994 198 29842277
Chills 13.90 10.47 356 109647 71982 29770493
Alanine aminotransferase 13.87 10.47 5 109998 27 29842448
Fungal abscess central nervous system 13.86 10.47 6 109997 56 29842419
CSF lactate increased 13.83 10.47 3 110000 0 29842475
Skin exfoliation 13.83 10.47 138 109865 23034 29819441
Follicular mucinosis 13.72 10.47 5 109998 28 29842447
Atrioventricular block complete 13.69 10.47 7 109996 8470 29834005
Palpitations 13.68 10.47 70 109933 33503 29808972
Light chain disease 13.62 10.47 7 109996 99 29842376
Agitation 13.53 10.47 130 109873 53943 29788532
Therapeutic response unexpected 13.44 10.47 8 109995 8895 29833580
Erectile dysfunction 13.43 10.47 29 109974 18073 29824402
Arteriosclerosis 13.41 10.47 12 109991 10821 29831654
Ventricular tachycardia 13.33 10.47 44 109959 23818 29818657
Atrial flutter 13.30 10.47 94 109909 14187 29828288
CSF cell count increased 13.30 10.47 5 109998 31 29842444
Vitamin B complex deficiency 13.29 10.47 8 109995 156 29842319
Hyperlipidaemia 13.29 10.47 19 109984 13888 29828587
Pancreatitis acute 13.26 10.47 49 109954 25646 29816829
Thoracic vertebral fracture 13.25 10.47 21 109982 1419 29841056
Loss of personal independence in daily activities 13.24 10.47 38 109965 21497 29820978
Psychotic disorder 13.21 10.47 38 109965 21477 29820998
Ventricular fibrillation 13.21 10.47 22 109981 15116 29827359
Miosis 13.20 10.47 6 109997 7770 29834705
Obliterative bronchiolitis 13.20 10.47 19 109984 1179 29841296
Herpes zoster reactivation 13.16 10.47 5 109998 32 29842443
Postural tremor 13.16 10.47 10 109993 290 29842185
Nightmare 13.09 10.47 15 109988 12061 29830414
Sleep disorder 13.09 10.47 46 109957 24433 29818042
Eczema herpeticum 13.08 10.47 7 109996 108 29842367
Pathological fracture 13.03 10.47 39 109964 4087 29838388
Amyloidosis 12.98 10.47 26 109977 2113 29840362
Band neutrophil percentage increased 12.96 10.47 7 109996 110 29842365
Epstein-Barr virus associated lymphoproliferative disorder 12.96 10.47 23 109980 1705 29840770
Musculoskeletal pain 12.90 10.47 64 109939 30876 29811599
Peptic ulcer haemorrhage 12.89 10.47 12 109991 463 29842012
Idiopathic pneumonia syndrome 12.86 10.47 9 109994 229 29842246
Metastases to liver 12.82 10.47 15 109988 11950 29830525
Reticulocytosis 12.78 10.47 10 109993 303 29842172
Blood loss anaemia 12.77 10.47 6 109997 7621 29834854
Accidental exposure to product 12.76 10.47 11 109992 10104 29832371
Adenomatous polyposis coli 12.73 10.47 8 109995 169 29842306
Meningitis aseptic 12.65 10.47 27 109976 2295 29840180
Acanthamoeba infection 12.63 10.47 12 109991 475 29842000
Neutrophil morphology abnormal 12.61 10.47 6 109997 71 29842404
Glomerulosclerosis 12.60 10.47 14 109989 668 29841807
Sinusitis 12.59 10.47 182 109821 33163 29809312
Blood triglycerides increased 12.57 10.47 20 109983 13997 29828478
Obstructive airways disorder 12.51 10.47 9 109994 9050 29833425
Vitamin D decreased 12.49 10.47 29 109974 2608 29839867
Asterixis 12.48 10.47 19 109984 1240 29841235
Neutrophil percentage decreased 12.47 10.47 11 109992 395 29842080
Haematuria 12.43 10.47 105 109898 44729 29797746
Central nervous system lesion 12.42 10.47 43 109960 4863 29837612
Product storage error 12.40 10.47 4 109999 6387 29836088
Capillaritis 12.38 10.47 7 109996 121 29842354
Pallor 12.33 10.47 38 109965 21011 29821464
pH urine increased 12.32 10.47 6 109997 75 29842400
Hepatosplenomegaly neonatal 12.32 10.47 5 109998 39 29842436
Diaphragmatic injury 12.32 10.47 5 109998 39 29842436
Varicella virus test positive 12.25 10.47 6 109997 76 29842399
Aspergillus test positive 12.24 10.47 11 109992 405 29842070
Dyslalia 12.20 10.47 12 109991 496 29841979
Accidental overdose 12.18 10.47 31 109972 18244 29824231
Bradycardia foetal 12.18 10.47 9 109994 250 29842225
Neuralgic amyotrophy 12.17 10.47 8 109995 183 29842292
Mastitis 12.17 10.47 8 109995 183 29842292
Pulmonary fibrosis 12.17 10.47 25 109978 15865 29826610
Haematoma 12.15 10.47 46 109957 23907 29818568
Ischaemic stroke 12.13 10.47 26 109977 16249 29826226
Ischaemic cardiomyopathy 12.11 10.47 4 109999 6293 29836182
Eosinophil percentage increased 12.06 10.47 12 109991 503 29841972
Metastases to lung 12.05 10.47 7 109996 7888 29834587
Hepatic vein occlusion 12.03 10.47 7 109996 128 29842347
Hypophosphataemia 12.01 10.47 61 109942 8184 29834291
Anhedonia 11.97 10.47 8 109995 8361 29834114
Fall 11.95 10.47 546 109457 181326 29661149
Impaired work ability 11.93 10.47 3 110000 5640 29836835
Gynaecomastia 11.92 10.47 8 109995 8343 29834132
Bronchitis 11.91 10.47 206 109797 38919 29803556
Knee arthroplasty 11.89 10.47 3 110000 5627 29836848
Malaise 11.84 10.47 497 109506 166465 29676010
Myocardial ischaemia 11.83 10.47 29 109974 17288 29825187
Red blood cell sedimentation rate increased 11.82 10.47 6 109997 7289 29835186
Polyarteritis nodosa 11.81 10.47 9 109994 262 29842213
HIV associated nephropathy 11.81 10.47 9 109994 262 29842213
Lumbar puncture abnormal 11.76 10.47 3 110000 3 29842472
Porocarcinoma 11.76 10.47 3 110000 3 29842472
Pneumocystis jirovecii pneumonia 11.73 10.47 105 109898 17015 29825460
Adenoviral haemorrhagic cystitis 11.71 10.47 11 109992 429 29842046
BK virus infection 11.71 10.47 39 109964 4325 29838150
Hepatitis C 11.70 10.47 19 109984 13186 29829289
Swollen tongue 11.67 10.47 19 109984 13173 29829302
Nervous system disorder 11.58 10.47 85 109918 12984 29829491
Device occlusion 11.57 10.47 4 109999 6116 29836359
Disturbance in attention 11.55 10.47 42 109961 22087 29820388
Mania 11.50 10.47 10 109993 9144 29833331
Red blood cells urine positive 11.46 10.47 21 109982 1596 29840879
Product prescribing error 11.45 10.47 28 109975 16705 29825770
Renal failure 11.39 10.47 581 109422 128385 29714090
Gastric disorder 11.39 10.47 72 109931 10471 29832004
Road traffic accident 11.34 10.47 29 109974 17042 29825433
Monoclonal immunoglobulin increased 11.34 10.47 5 109998 49 29842426
Illness 11.23 10.47 32 109971 3262 29839213
Post procedural complication 11.23 10.47 16 109987 11710 29830765
Flushing 11.18 10.47 63 109940 29429 29813046
Gastrointestinal candidiasis 11.18 10.47 7 109996 147 29842328
White blood cell disorder 11.16 10.47 18 109985 1234 29841241
Viral upper respiratory tract infection 11.13 10.47 28 109975 2650 29839825
Coombs direct test positive 11.08 10.47 9 109994 288 29842187
Pleocytosis 11.06 10.47 11 109992 461 29842014
Post herpetic neuralgia 11.04 10.47 16 109987 999 29841476
Embolism 11.02 10.47 53 109950 6956 29835519
Acute generalised exanthematous pustulosis 10.99 10.47 48 109955 6050 29836425
Respiratory tract infection viral 10.94 10.47 17 109986 1129 29841346
Gait disturbance 10.92 10.47 201 109802 74576 29767899
Rash papulosquamous 10.91 10.47 5 109998 54 29842421
Prostatic specific antigen increased 10.89 10.47 17 109986 11987 29830488
Central venous pressure increased 10.89 10.47 4 109999 23 29842452
C-reactive protein increased 10.86 10.47 222 109781 43251 29799224
Dermatitis allergic 10.84 10.47 46 109957 5726 29836749
Extravasation 10.83 10.47 22 109981 1806 29840669
Hip fracture 10.82 10.47 74 109929 11050 29831425
Macular fibrosis 10.76 10.47 10 109993 385 29842090
Corneal graft rejection 10.75 10.47 4 109999 24 29842451
Upper gastrointestinal haemorrhage 10.73 10.47 43 109960 21985 29820490
Band neutrophil count increased 10.71 10.47 8 109995 226 29842249
Dizziness 10.71 10.47 596 109407 194313 29648162
Bacterial test 10.66 10.47 7 109996 160 29842315
Faeces discoloured 10.63 10.47 22 109981 13924 29828551
Alternaria infection 10.57 10.47 9 109994 308 29842167
Aspergillus infection 10.57 10.47 69 109934 10145 29832330
Injection site swelling 10.54 10.47 10 109993 8770 29833705
Middle insomnia 10.53 10.47 4 109999 5769 29836706
Pulpitis dental 10.52 10.47 10 109993 396 29842079
Systemic infection 10.49 10.47 13 109990 697 29841778
Listeria sepsis 10.47 10.47 7 109996 165 29842310

Pharmacologic Action:

SourceCodeDescription
ATC D06BB03 DERMATOLOGICALS
ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
CHEMOTHERAPEUTICS FOR TOPICAL USE
Antivirals
ATC D06BB53 DERMATOLOGICALS
ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
CHEMOTHERAPEUTICS FOR TOPICAL USE
Antivirals
ATC J05AB01 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Nucleosides and nucleotides excl. reverse transcriptase inhibitors
ATC S01AD03 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFECTIVES
Antivirals
FDA MoA N0000020060 DNULL Polymerase Inhibitors
FDA EXT N0000175459 Nucleoside Analog
FDA EPC N0000175468 Herpesvirus Nucleoside Analog DNULL Polymerase Inhibitor
CHEBI has role CHEBI:35221 antimetabolite
CHEBI has role CHEBI:36044 anti-virus drug
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000998 Antiviral Agents
FDA EPC N0000180187 Herpes Simplex Virus Nucleoside Analog DNULL Polymerase Inhibitor
FDA EPC N0000180188 Herpes Zoster Virus Nucleoside Analog DNULL Polymerase Inhibitor

Drug Use (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
Herpes simplex indication 88594005 DOID:8566
Herpes simplex infection of skin indication 240475000
Recurrent herpes simplex labialis indication 402892009
Recurrent genital herpes simplex indication 402894005
Encephalitis due to Herpesvirus indication 428638009
Recurrent Mucocutaneous Herpes Simplex indication
Suppression of Recurrent Herpes Simplex Infection indication
Herpes zoster ophthalmicus off-label use 87513003
Granulomatosis Infantiseptica off-label use
Herpes Zoster Hepatitis off-label use
Neonatal Herpes Meningoencephalitis off-label use
Disseminated Herpes Simplex Neonatal Infection off-label use
Herpes Simplex Hepatitis off-label use
Prevention of Herpes Zoster in Immunocompromised Patient off-label use
Urinary tract obstruction contraindication 7163005 DOID:5200
Hypercholesterolemia contraindication 13644009
Myocardial infarction contraindication 22298006 DOID:5844
Dehydration contraindication 34095006
Hypertensive disorder contraindication 38341003 DOID:10763
Diabetes mellitus contraindication 73211009 DOID:9351
Thrombotic thrombocytopenic purpura contraindication 78129009 DOID:10772
Hyperglycemia contraindication 80394007 DOID:4195
Kidney disease contraindication 90708001 DOID:557
Hemolytic uremic syndrome contraindication 111407006 DOID:12554
Impaired renal function disorder contraindication 197663003
Cerebrovascular accident contraindication 230690007
Telangiectasia disorder contraindication 247479008
Pregnancy, function contraindication 289908002
Osteopenia contraindication 312894000
Adrenal cortical hypofunction contraindication 386584007 DOID:10493
Cardiovascular event risk contraindication 395112001
Atrophoderma contraindication 399979006
Peripheral vascular disease contraindication 400047006
Breastfeeding (mother) contraindication 413712001
Obesity contraindication 414916001 DOID:9970
Smokes tobacco daily contraindication 449868002
Vertebral Metastases contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.97 acidic
pKa2 13.01 acidic
pKa3 3.83 Basic
pKa4 2.12 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
3% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** AVACLYR FERA PHARMS LLC N202408 March 29, 2019 DISCN OINTMENT OPHTHALMIC March 29, 2026 INDICATED FOR THE TREATMENT OF ACUTE HERPETIC KERATITIS (DENDRITIC ULCERS) IN PATIENTS WITH HERPES SIMPLEX (HSV-1 AND HSV-2) VIRUS

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
DNA polymerase catalytic subunit Enzyme WOMBAT-PK
Thymidine kinase Kinase WOMBAT-PK
Thymidine kinase Kinase WOMBAT-PK
Thymidine kinase Kinase WOMBAT-PK
Purine nucleoside phosphorylase Unclassified Kd 4.90 CHEMBL

External reference:

IDSource
X4HES1O11F UNII
4018781 VUID
N0000147084 NUI
D00222 KEGG_DRUG
69657-51-8 SECONDARY_CAS_RN
C0001367 UMLSCUI
CHEBI:2453 CHEBI
AC2 PDB_CHEM_ID
CHEMBL184 ChEMBL_ID
CHEMBL1200380 ChEMBL_ID
135398513 PUBCHEM_CID
DB00787 DRUGBANK_ID
D000212 MESH_DESCRIPTOR_UI
4435 INN_ID
4829 IUPHAR_LIGAND_ID
152535 RXNORM
14023 MMSL
1579 MMSL
4132 MMSL
4133 MMSL
981 MMSL
d00001 MMSL
003016 NDDF
003017 NDDF
372729009 SNOMEDCT_US
41193000 SNOMEDCT_US
72387009 SNOMEDCT_US
4018781 VANDF
4018782 VANDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Acyclovir HUMAN PRESCRIPTION DRUG LABEL 1 0093-3630 CREAM 50 mg TOPICAL NDA authorized generic 26 sections
Acyclovir HUMAN PRESCRIPTION DRUG LABEL 1 0143-9657 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 500 mg INTRAVENOUS ANDA 23 sections
Acyclovir HUMAN PRESCRIPTION DRUG LABEL 1 0143-9658 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 1 g INTRAVENOUS ANDA 23 sections
acyclovir HUMAN PRESCRIPTION DRUG LABEL 1 0168-0825 OINTMENT 50 mg TOPICAL ANDA 22 sections
Zovirax HUMAN PRESCRIPTION DRUG LABEL 1 0187-0993 OINTMENT 50 mg TOPICAL NDA 21 sections
Zovirax HUMAN PRESCRIPTION DRUG LABEL 1 0187-0994 CREAM 50 mg TOPICAL NDA 26 sections
Xerese HUMAN PRESCRIPTION DRUG LABEL 2 0187-5104 CREAM 50 mg TOPICAL NDA 26 sections
Acyclovir HUMAN PRESCRIPTION DRUG LABEL 1 0378-8700 OINTMENT 50 mg TOPICAL ANDA 20 sections
Acyclovir HUMAN PRESCRIPTION DRUG LABEL 1 0378-8712 SUSPENSION 200 mg ORAL NDA authorized generic 20 sections
Zovirax HUMAN PRESCRIPTION DRUG LABEL 1 0378-9735 SUSPENSION 200 mg ORAL NDA 20 sections
acyclovir HUMAN PRESCRIPTION DRUG LABEL 1 0440-7033 TABLET 800 mg ORAL ANDA 22 sections
Acyclovir HUMAN PRESCRIPTION DRUG LABEL 1 0472-0082 SUSPENSION 200 mg ORAL ANDA 19 sections
Acyclovir HUMAN PRESCRIPTION DRUG LABEL 1 0591-1159 OINTMENT 50 mg TOPICAL NDA authorized generic 22 sections
Acyclovir HUMAN PRESCRIPTION DRUG LABEL 1 0713-0630 OINTMENT 50 mg TOPICAL ANDA 19 sections
ACYCLOVIR HUMAN PRESCRIPTION DRUG LABEL 1 0904-5789 CAPSULE 200 mg ORAL ANDA 21 sections
acyclovir HUMAN PRESCRIPTION DRUG LABEL 1 0904-5790 TABLET 400 mg ORAL ANDA 22 sections
Acyclovir HUMAN PRESCRIPTION DRUG LABEL 1 10544-039 TABLET 400 mg ORAL ANDA 20 sections
Acyclovir HUMAN PRESCRIPTION DRUG LABEL 1 10544-089 CAPSULE 200 mg ORAL ANDA 20 sections
Acyclovir HUMAN PRESCRIPTION DRUG LABEL 1 10544-101 CAPSULE 200 mg ORAL ANDA 22 sections
Acyclovir HUMAN PRESCRIPTION DRUG LABEL 1 10544-102 TABLET 400 mg ORAL ANDA 22 sections
Acyclovir HUMAN PRESCRIPTION DRUG LABEL 1 10544-103 TABLET 800 mg ORAL ANDA 22 sections
Acyclovir HUMAN PRESCRIPTION DRUG LABEL 1 12634-520 TABLET 400 mg ORAL ANDA 22 sections
acyclovir HUMAN PRESCRIPTION DRUG LABEL 1 12634-697 TABLET 800 mg ORAL ANDA 22 sections
acyclovir HUMAN PRESCRIPTION DRUG LABEL 1 13668-515 OINTMENT 50 mg TOPICAL ANDA 16 sections
ACYCLOVIR HUMAN PRESCRIPTION DRUG LABEL 1 16590-003 TABLET 800 mg ORAL ANDA 18 sections
ACYCLOVIR HUMAN PRESCRIPTION DRUG LABEL 1 16590-370 TABLET 400 mg ORAL ANDA 18 sections
Acyclovir HUMAN PRESCRIPTION DRUG LABEL 1 16714-668 OINTMENT 50 mg TOPICAL ANDA 12 sections
acyclovir HUMAN PRESCRIPTION DRUG LABEL 1 16714-885 OINTMENT 50 mg TOPICAL ANDA 19 sections
Acyclovir HUMAN PRESCRIPTION DRUG LABEL 1 17856-0083 SUSPENSION 200 mg ORAL ANDA 19 sections
Acyclovir HUMAN PRESCRIPTION DRUG LABEL 1 21695-009 CAPSULE 200 mg ORAL ANDA 18 sections