lamivudine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
uridine derivatives used as antiviral agents and as antineoplastics 1539 134678-17-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • lamivudine
  • virolam
  • zeffix
A reverse transcriptase inhibitor and ZALCITABINE analog in which a sulfur atom replaces the 3' carbon of the pentose ring. It is used to treat HIV disease.
  • Molecular weight: 229.25
  • Formula: C8H11N3O3S
  • CLOGP: -1.46
  • LIPINSKI: 0
  • HAC: 6
  • HDO: 2
  • TPSA: 88.15
  • ALOGS: -1.92
  • ROTB: 2
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.30 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 70 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 67 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 21.81 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 86 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 1.30 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 4.80 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.94 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 9.10 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Aug. 8, 1996 EMA VIIV HLTHCARE
Nov. 17, 1995 FDA VIIV HLTHCARE
Jan. 14, 2020 PMDA ViiV Healthcare K.K.

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
Exposure during pregnancy 2120.41 16.30 1113 26071 135229 56129654
Abortion spontaneous 1311.70 16.30 563 26621 43190 56221693
Virologic failure 1281.34 16.30 268 26916 1458 56263425
Viral mutation identified 1242.77 16.30 261 26923 1453 56263430
Drug resistance 1091.50 16.30 400 26784 20142 56244741
Stillbirth 1067.66 16.30 296 26888 5918 56258965
Pathogen resistance 850.60 16.30 246 26938 5754 56259129
Foetal exposure during pregnancy 806.29 16.30 371 26813 33452 56231431
Immune reconstitution inflammatory syndrome 797.06 16.30 231 26953 5443 56259440
Abortion induced 684.24 16.30 233 26951 9412 56255471
Premature baby 421.08 16.30 199 26985 19006 56245877
Pregnancy 360.91 16.30 215 26969 32818 56232065
Blood HIV RNA increased 346.18 16.30 76 27108 536 56264347
Maternal exposure during pregnancy 298.18 16.30 410 26774 189143 56075740
Live birth 296.60 16.30 158 27026 19447 56245436
Caesarean section 290.38 16.30 146 27038 15945 56248938
Fanconi syndrome acquired 274.99 16.30 69 27115 916 56263967
Hepatitis B reactivation 267.73 16.30 82 27102 2342 56262541
Foetal death 261.53 16.30 112 27072 8475 56256408
Lipodystrophy acquired 239.15 16.30 66 27118 1291 56263592
Hepatotoxicity 214.95 16.30 152 27032 31001 56233882
Hepatitis B 204.93 16.30 74 27110 3550 56261333
Blood bilirubin increased 192.25 16.30 146 27038 33208 56231675
Treatment noncompliance 190.69 16.30 144 27040 32479 56232404
Maternal drugs affecting foetus 187.30 16.30 76 27108 5017 56259866
CD4 lymphocytes decreased 179.84 16.30 53 27131 1322 56263561
Hypomania 179.76 16.30 73 27111 4829 56260054
HIV infection 178.97 16.30 42 27142 412 56264471
Jaundice cholestatic 171.40 16.30 73 27111 5446 56259437
Premature rupture of membranes 164.64 16.30 68 27116 4697 56260186
Premature labour 158.12 16.30 88 27096 11794 56253089
Rheumatoid arthritis 152.22 16.30 8 27176 382596 55882287
Pain 138.97 16.30 74 27110 663110 55601773
Schizophrenia 134.92 16.30 76 27108 10423 56254460
Anaemia 133.99 16.30 355 26829 267156 55997727
Drug ineffective 130.51 16.30 152 27032 918837 55346046
Pre-eclampsia 130.01 16.30 69 27115 8417 56256466
Foetal growth restriction 126.81 16.30 64 27120 7035 56257848
Mitochondrial toxicity 126.71 16.30 31 27153 368 56264515
Acquired gene mutation 123.98 16.30 36 27148 851 56264032
Fatigue 121.18 16.30 122 27062 788430 55476453
Viral load increased 119.92 16.30 38 27146 1216 56263667
Human immunodeficiency virus transmission 117.34 16.30 21 27163 39 56264844
Fanconi syndrome 114.96 16.30 37 27147 1246 56263637
Hepatitis B DNA increased 112.45 16.30 25 27159 188 56264695
Joint swelling 112.31 16.30 7 27177 289793 55975090
Trisomy 21 107.54 16.30 27 27157 359 56264524
Lactic acidosis 102.97 16.30 105 27079 35241 56229642
Nephropathy toxic 99.59 16.30 58 27126 8469 56256414
Premature delivery 98.79 16.30 91 27093 26969 56237914
Fall 97.82 16.30 26 27158 357484 55907399
Lipoatrophy 97.71 16.30 24 27160 290 56264593
Psychotic disorder 97.42 16.30 85 27099 23473 56241410
Osteomalacia 95.51 16.30 28 27156 685 56264198
Hyperbilirubinaemia 94.79 16.30 60 27124 10175 56254708
Hypophosphataemia 92.67 16.30 58 27126 9644 56255239
Genotype drug resistance test positive 88.79 16.30 23 27161 349 56264534
Polydactyly 87.87 16.30 22 27162 289 56264594
Portal hypertension 87.83 16.30 40 27144 3501 56261382
Normal newborn 87.74 16.30 51 27133 7419 56257464
Infusion related reaction 87.53 16.30 3 27181 208928 56055955
Peripheral swelling 87.07 16.30 7 27177 234719 56030164
Glycosuria 86.73 16.30 29 27155 1103 56263780
Proteinuria 86.27 16.30 70 27114 17500 56247383
Nasopharyngitis 83.62 16.30 6 27178 220953 56043930
Mitochondrial cytopathy 83.56 16.30 20 27164 215 56264668
Renal tubular dysfunction 82.76 16.30 22 27162 371 56264512
Abdominal discomfort 82.07 16.30 17 27167 277257 55987626
Ventricular septal defect 81.89 16.30 40 27144 4098 56260785
Off label use 80.77 16.30 90 27094 556090 55708793
Placental disorder 79.64 16.30 29 27155 1424 56263459
Congenital umbilical hernia 77.86 16.30 20 27164 293 56264590
Birth mark 77.28 16.30 17 27167 121 56264762
Alopecia 77.15 16.30 23 27161 293435 55971448
Amniotic cavity infection 76.92 16.30 27 27157 1191 56263692
Ectopic kidney 76.47 16.30 15 27169 55 56264828
Hyperlactacidaemia 76.30 16.30 33 27151 2555 56262328
Systemic lupus erythematosus 73.99 16.30 3 27181 180075 56084808
Alpha 1 foetoprotein abnormal 72.56 16.30 14 27170 46 56264837
Alanine aminotransferase increased 71.69 16.30 147 27037 93515 56171368
Product dose omission issue 70.91 16.30 8 27176 204745 56060138
Hepatomegaly 70.83 16.30 52 27132 11223 56253660
Premature separation of placenta 70.72 16.30 28 27156 1732 56263151
CSF HIV escape syndrome 70.12 16.30 15 27169 92 56264791
Jaundice 68.66 16.30 75 27109 27219 56237664
Blood lactic acid increased 67.53 16.30 40 27144 6024 56258859
Small for dates baby 66.51 16.30 33 27151 3497 56261386
Aspartate aminotransferase increased 66.01 16.30 132 27052 82470 56182413
Rash maculo-papular 65.13 16.30 75 27109 28832 56236051
Fat tissue increased 64.50 16.30 20 27164 595 56264288
Retinoblastoma 62.77 16.30 14 27170 107 56264776
Oligohydramnios 62.76 16.30 38 27146 5956 56258927
Cholelithiasis 62.73 16.30 86 27098 39378 56225505
Congenital anomaly 62.60 16.30 25 27159 1582 56263301
Ectopic pregnancy 62.41 16.30 28 27156 2366 56262517
Pulmonary tuberculosis 61.87 16.30 34 27150 4442 56260441
Hepatic failure 60.98 16.30 78 27106 33408 56231475
Sinusitis 60.78 16.30 11 27173 197570 56067313
Arthralgia 59.68 16.30 94 27090 501575 55763308
Ergot poisoning 59.66 16.30 13 27171 88 56264795
Drug intolerance 59.08 16.30 27 27157 264791 56000092
Renal tubular disorder 58.06 16.30 27 27157 2479 56262404
Swelling 57.41 16.30 22 27162 239749 56025134
Atrial septal defect 57.41 16.30 37 27147 6469 56258414
Stevens-Johnson syndrome 56.52 16.30 62 27122 22601 56242282
Drug interaction 56.15 16.30 225 26959 209530 56055353
Placental insufficiency 56.14 16.30 22 27162 1324 56263559
Immune reconstitution inflammatory syndrome associated tuberculosis 55.80 16.30 16 27168 361 56264522
Lymphadenopathy 54.87 16.30 76 27108 35132 56229751
Meningitis cryptococcal 54.20 16.30 21 27163 1226 56263657
Hypertriglyceridaemia 53.61 16.30 34 27150 5782 56259101
Foetal distress syndrome 53.51 16.30 21 27163 1269 56263614
Discomfort 53.18 16.30 4 27180 141757 56123126
Umbilical cord abnormality 52.08 16.30 17 27167 599 56264284
Malaria 49.72 16.30 13 27171 205 56264678
Completed suicide 49.57 16.30 4 27180 133829 56131054
Constipation 49.22 16.30 18 27166 201925 56062958
Pain in extremity 47.76 16.30 44 27140 297387 55967496
Hepatitis 47.18 16.30 71 27113 35370 56229513
Therapeutic product effect decreased 46.88 16.30 12 27172 169440 56095443
Anaemia macrocytic 46.87 16.30 25 27159 3078 56261805
Cleft lip and palate 46.51 16.30 14 27170 376 56264507
Tuberculosis 46.00 16.30 40 27144 10989 56253894
Ultrasound antenatal screen abnormal 45.72 16.30 11 27173 121 56264762
Hepatic cytolysis 44.37 16.30 39 27145 10867 56254016
Meningomyelocele 44.13 16.30 15 27169 600 56264283
Arnold-Chiari malformation 43.69 16.30 15 27169 619 56264264
Dyspnoea 43.65 16.30 144 27040 592433 55672450
Cushing's syndrome 43.36 16.30 15 27169 633 56264250
Ultrasound scan abnormal 42.62 16.30 12 27172 253 56264630
Mitochondrial DNA deletion 42.12 16.30 7 27177 6 56264877
Low birth weight baby 41.89 16.30 30 27154 6228 56258655
Necrotising colitis 41.73 16.30 14 27170 538 56264345
Pericarditis 41.05 16.30 3 27181 108920 56155963
Ocular icterus 41.02 16.30 24 27160 3532 56261351
Blood bilirubin unconjugated increased 40.38 16.30 12 27172 308 56264575
Hydrops foetalis 39.64 16.30 13 27171 465 56264418
Drug hypersensitivity 39.31 16.30 45 27139 275160 55989723
Macrocephaly 39.24 16.30 9 27175 79 56264804
Patent ductus arteriosus 38.69 16.30 24 27160 3927 56260956
Rickets 38.45 16.30 8 27176 42 56264841
Headache 37.69 16.30 141 27043 558903 55705980
Neonatal disorder 37.57 16.30 13 27171 549 56264334
Cleft palate 37.25 16.30 15 27169 970 56263913
Contusion 35.70 16.30 9 27175 128421 56136462
Tuberculoma of central nervous system 35.64 16.30 11 27173 322 56264561
Gestational diabetes 35.16 16.30 30 27154 8034 56256849
Pregnancy on contraceptive 35.07 16.30 15 27169 1130 56263753
Gene mutation 34.78 16.30 16 27168 1433 56263450
Product use issue 34.24 16.30 24 27160 186017 56078866
Hypouricaemia 34.24 16.30 9 27175 145 56264738
CD4 lymphocytes increased 34.18 16.30 9 27175 146 56264737
Metabolic acidosis 33.93 16.30 66 27118 40388 56224495
Multiple-drug resistance 33.59 16.30 22 27162 3952 56260931
Weight increased 33.40 16.30 37 27147 229666 56035217
Isosporiasis 33.00 16.30 7 27177 41 56264842
Hepatitis A 32.78 16.30 11 27173 423 56264460
Neutropenia 32.62 16.30 157 27027 158010 56106873
AIDS cholangiopathy 32.31 16.30 6 27178 15 56264868
Neural tube defect 31.91 16.30 9 27175 191 56264692
Placental infarction 31.73 16.30 10 27174 314 56264569
Cardiac murmur 31.61 16.30 33 27151 11368 56253515
Atrial fibrillation 31.51 16.30 7 27177 108890 56155993
Cardiac malposition 31.44 16.30 7 27177 53 56264830
Benign hydatidiform mole 31.41 16.30 8 27176 113 56264770
Hydrocephalus 31.31 16.30 23 27161 4966 56259917
Back pain 30.50 16.30 42 27142 237128 56027755
HIV-associated neurocognitive disorder 30.31 16.30 8 27176 131 56264752
Renal tubular acidosis 30.31 16.30 15 27169 1580 56263303
Influenza 29.94 16.30 5 27179 95256 56169627
Hepatosplenomegaly 29.60 16.30 17 27167 2416 56262467
Spina bifida 29.51 16.30 12 27172 796 56264087
Infection 29.38 16.30 32 27152 200174 56064709
Asthma 29.29 16.30 9 27175 112761 56152122
Pruritus 29.13 16.30 69 27115 316554 55948329
Neutropenia neonatal 29.10 16.30 7 27177 77 56264806
Gamma-glutamyltransferase increased 29.00 16.30 53 27131 30952 56233931
Chronic disease 28.85 16.30 7 27177 80 56264803
Twin pregnancy 28.84 16.30 13 27171 1110 56263773
Lymphadenitis 28.84 16.30 18 27166 2977 56261906
Psoriasis 28.83 16.30 5 27179 92687 56172196
Bilirubin conjugated increased 28.72 16.30 17 27167 2556 56262327
Drug reaction with eosinophilia and systemic symptoms 28.59 16.30 52 27132 30252 56234631
Dyslipidaemia 28.45 16.30 24 27160 6329 56258554
Ballismus 28.31 16.30 7 27177 87 56264796
Postpartum haemorrhage 28.22 16.30 15 27169 1834 56263049
Prenatal screening test abnormal 28.04 16.30 5 27179 9 56264874
Isoimmune haemolytic disease 28.02 16.30 6 27178 37 56264846
Gestational hypertension 27.80 16.30 16 27168 2283 56262600
Blister 27.73 16.30 9 27175 108878 56156005
Hydromyelia 27.69 16.30 5 27179 10 56264873
Feeling abnormal 27.68 16.30 15 27169 133587 56131296
Ascites 27.61 16.30 58 27126 37486 56227397
Musculoskeletal stiffness 27.57 16.30 21 27163 155986 56108897
Double outlet right ventricle 27.49 16.30 6 27178 41 56264842
Infertility 27.10 16.30 11 27173 726 56264157
Anembryonic gestation 26.71 16.30 10 27174 531 56264352
Foetal growth abnormality 26.55 16.30 6 27178 49 56264834
Bicuspid pulmonary valve 26.55 16.30 4 27180 0 56264883
Hepatitis B surface antigen positive 26.44 16.30 6 27178 50 56264833
Vomiting 26.34 16.30 361 26823 497867 55767016
Lymph node tuberculosis 26.28 16.30 11 27173 785 56264098
Funisitis 26.01 16.30 5 27179 16 56264867
Cerebral toxoplasmosis 25.89 16.30 11 27173 815 56264068
Diarrhoea 25.64 16.30 192 26992 638315 55626568
Cholestatic liver injury 25.45 16.30 15 27169 2237 56262646
Transaminases increased 25.43 16.30 48 27136 28722 56236161
Malignant neoplasm progression 25.14 16.30 3 27181 73584 56191299
Lower respiratory tract infection 25.11 16.30 12 27172 114782 56150101
Blood pressure increased 25.07 16.30 20 27164 145156 56119727
Retinal toxicity 24.99 16.30 12 27172 1184 56263699
Micrognathia 24.95 16.30 8 27176 266 56264617
Muscle spasms 24.90 16.30 18 27166 137353 56127530
Ovarian failure 24.90 16.30 12 27172 1193 56263690
Eyelid oedema 24.83 16.30 27 27157 9741 56255142
Renal failure 24.46 16.30 112 27072 110388 56154495
Neonatal aspiration 24.45 16.30 7 27177 157 56264726
Fat redistribution 24.31 16.30 4 27180 3 56264880
Acquired aminoaciduria 24.31 16.30 4 27180 3 56264880
Abortion missed 24.29 16.30 13 27171 1611 56263272
Kaposi's sarcoma 24.29 16.30 7 27177 161 56264722
Migraine 24.28 16.30 6 27178 86791 56178092
Foetal anaemia 24.24 16.30 6 27178 75 56264808
Hypophosphataemic osteomalacia 24.12 16.30 7 27177 165 56264718
Hyperphosphaturia 24.07 16.30 5 27179 26 56264857
Alpha 1 foetoprotein increased 24.04 16.30 7 27177 167 56264716
Fallot's tetralogy 23.95 16.30 6 27178 79 56264804
Hepatic displacement 23.91 16.30 5 27179 27 56264856
Hepatic enzyme increased 23.87 16.30 153 27031 171231 56093652
Cytomegalovirus chorioretinitis 23.75 16.30 13 27171 1685 56263198
Anaemia neonatal 23.35 16.30 8 27176 328 56264555
Hepatitis B DNA assay positive 23.33 16.30 5 27179 31 56264852
Death neonatal 23.24 16.30 10 27174 764 56264119
Haemorrhage in pregnancy 23.20 16.30 13 27171 1763 56263120
Necrotising enterocolitis neonatal 23.19 16.30 7 27177 190 56264693
Lipase increased 23.14 16.30 25 27159 8954 56255929
Cachexia 22.81 16.30 19 27165 4923 56259960
Neonatal respiratory distress syndrome 22.68 16.30 15 27169 2739 56262144
Diastasis recti abdominis 22.56 16.30 5 27179 37 56264846
AIDS related complication 22.50 16.30 4 27180 7 56264876
Blood creatine phosphokinase MB increased 22.23 16.30 11 27173 1158 56263725
Respiratory distress 22.22 16.30 48 27136 31619 56233264
Type III hyperlipidaemia 22.15 16.30 4 27180 8 56264875
Anxiety 22.13 16.30 37 27147 193135 56071748
Cholestasis of pregnancy 22.13 16.30 11 27173 1170 56263713
Dizziness 22.08 16.30 100 27084 376040 55888843
Loss of personal independence in daily activities 22.04 16.30 6 27178 81363 56183520
Breech delivery 22.00 16.30 5 27179 42 56264841
Lipohypertrophy 21.87 16.30 9 27175 615 56264268
Blood creatine phosphokinase increased 21.51 16.30 44 27140 27908 56236975
Aminoaciduria 21.42 16.30 6 27178 124 56264759
Dyschezia 21.39 16.30 13 27171 2050 56262833
COVID-19 21.36 16.30 5 27179 75053 56189830
Fontanelle bulging 21.26 16.30 4 27180 11 56264872
Antiviral drug level below therapeutic 21.13 16.30 5 27179 51 56264832
Placenta praevia 20.98 16.30 10 27174 970 56263913
Pallor 20.98 16.30 40 27144 24109 56240774
Malaise 20.88 16.30 99 27085 367761 55897122
Gastroschisis 20.86 16.30 7 27177 269 56264614
Urinary tract infection 20.86 16.30 54 27130 240459 56024424
Pubertal failure 20.76 16.30 4 27180 13 56264870
Pleocytosis 20.62 16.30 9 27175 712 56264171
Bovine tuberculosis 20.62 16.30 5 27179 57 56264826
Developmental delay 20.57 16.30 11 27173 1361 56263522
Breast neoplasm 20.54 16.30 11 27173 1365 56263518
Myopathy toxic 20.53 16.30 8 27176 474 56264409
CSF protein increased 20.52 16.30 8 27176 475 56264408
Ventricular hypoplasia 20.42 16.30 6 27178 148 56264735
Therapeutic product effect incomplete 20.41 16.30 13 27171 106018 56158865
Congenital hydrocephalus 20.34 16.30 6 27178 150 56264733
Spinal cord injury 20.29 16.30 9 27175 740 56264143
Carnitine deficiency 20.19 16.30 6 27178 154 56264729
Osteoporosis 20.05 16.30 63 27121 51989 56212894
Vertical infection transmission 19.91 16.30 3 27181 0 56264883
Pharyngotonsillitis 19.87 16.30 6 27178 163 56264720
Social avoidant behaviour 19.85 16.30 14 27170 2838 56262045
Osteoarthritis 19.81 16.30 7 27177 80289 56184594
Renal glycosuria 19.74 16.30 4 27180 18 56264865
Ebstein's anomaly 19.74 16.30 4 27180 18 56264865
Amenorrhoea 19.70 16.30 23 27161 8963 56255920
Influenza like illness 19.61 16.30 3 27181 60985 56203898
Varices oesophageal 19.57 16.30 14 27170 2902 56261981
Portal vein thrombosis 19.48 16.30 13 27171 2410 56262473
Meningitis tuberculous 19.37 16.30 8 27176 552 56264331
Eclampsia 19.33 16.30 7 27177 338 56264545
Insomnia 19.10 16.30 40 27144 191820 56073063
Congenital intestinal malformation 19.07 16.30 4 27180 22 56264861
Pulmonary artery atresia 19.07 16.30 4 27180 22 56264861
Thyroid tuberculosis 19.07 16.30 4 27180 22 56264861
Hypotension 18.97 16.30 60 27124 250448 56014435
Diaphragmatic aplasia 18.92 16.30 4 27180 23 56264860
Acquired immunodeficiency syndrome 18.88 16.30 5 27179 83 56264800
Disseminated Bacillus Calmette-Guerin infection 18.77 16.30 4 27180 24 56264859
Aqueductal stenosis 18.77 16.30 4 27180 24 56264859
Hemiataxia 18.77 16.30 4 27180 24 56264859
Blood alkaline phosphatase increased 18.70 16.30 51 27133 38894 56225989
Placental necrosis 18.50 16.30 4 27180 26 56264857
Blood cholesterol increased 18.48 16.30 6 27178 72573 56192310
Lactate pyruvate ratio increased 18.45 16.30 5 27179 91 56264792
Myelopathy 18.43 16.30 13 27171 2635 56262248
Pyrexia 18.39 16.30 294 26890 418479 55846404
HELLP syndrome 18.38 16.30 9 27175 927 56263956
Acute stress disorder 18.26 16.30 6 27178 216 56264667
Secondary hypogonadism 18.01 16.30 5 27179 100 56264783
Delayed puberty 17.87 16.30 5 27179 103 56264780
Cervix operation 17.83 16.30 3 27181 3 56264880
Oxygen saturation decreased 17.70 16.30 8 27176 79059 56185824
Nasal congestion 17.62 16.30 3 27181 56367 56208516
Death 17.59 16.30 95 27089 341331 55923552
Mycobacterium avium complex infection 17.49 16.30 13 27171 2856 56262027
Cryptococcosis 17.43 16.30 9 27175 1037 56263846
Cervical dysplasia 17.37 16.30 13 27171 2888 56261995
Cleft lip 17.19 16.30 5 27179 119 56264764
Developmental coordination disorder 17.16 16.30 4 27180 38 56264845
Persistent left superior vena cava 17.16 16.30 4 27180 38 56264845
Hepatitis C 17.00 16.30 17 27167 5569 56259314
Genital prolapse 16.97 16.30 4 27180 40 56264843
Musculoskeletal pain 16.97 16.30 9 27175 81143 56183740
Fibromyalgia 16.90 16.30 4 27180 59599 56205284
Intentional product use issue 16.89 16.30 14 27170 99719 56165164
Acute fatty liver of pregnancy 16.71 16.30 4 27180 43 56264840
Intentional overdose 16.70 16.30 6 27178 68111 56196772
Anaphylactic reaction 16.65 16.30 4 27180 58991 56205892
Infected vasculitis 16.62 16.30 3 27181 6 56264877
Carbon dioxide combining power abnormal 16.62 16.30 3 27181 6 56264877
Glycocholic acid increased 16.62 16.30 3 27181 6 56264877
Growth hormone-producing pituitary tumour 16.62 16.30 3 27181 6 56264877
Threatened labour 16.60 16.30 8 27176 795 56264088
Oropharyngeal pain 16.50 16.30 10 27174 83778 56181105
Bronchitis 16.41 16.30 18 27166 112293 56152590
Foetal heart rate abnormal 16.35 16.30 7 27177 528 56264355

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
Viral mutation identified 1819.51 12.46 481 46250 2288 31648325
Virologic failure 1544.39 12.46 435 46296 2730 31647883
Immune reconstitution inflammatory syndrome 1520.48 12.46 538 46193 7640 31642973
Pathogen resistance 1357.90 12.46 503 46228 8198 31642415
Drug resistance 967.68 12.46 535 46196 22918 31627695
Lipodystrophy acquired 822.94 12.46 270 46461 2994 31647619
Foetal exposure during pregnancy 733.45 12.46 552 46179 40324 31610289
Hepatitis B 728.14 12.46 286 46445 5495 31645118
Drug interaction 667.56 12.46 1139 45592 207404 31443209
Depression 654.39 12.46 735 45996 90080 31560533
Exposure during pregnancy 563.12 12.46 268 46463 8330 31642283
Mitochondrial toxicity 491.97 12.46 173 46558 2400 31648213
Hepatitis B reactivation 366.85 12.46 152 46579 3366 31647247
Hepatitis B DNA increased 361.40 12.46 95 46636 438 31650175
Osteomalacia 355.41 12.46 105 46626 795 31649818
Acquired gene mutation 315.82 12.46 105 46626 1215 31649398
Eyelid ptosis 314.84 12.46 156 46575 5299 31645314
Fanconi syndrome acquired 283.15 12.46 106 46625 1774 31648839
Viral load increased 270.97 12.46 107 46624 2082 31648531
Blood HIV RNA increased 249.45 12.46 85 46646 1066 31649547
Progressive external ophthalmoplegia 229.81 12.46 84 46647 1310 31649303
Lipoatrophy 210.12 12.46 61 46670 431 31650182
Pinealoblastoma 205.14 12.46 49 46682 138 31650475
Premature baby 192.74 12.46 181 46550 17885 31632728
Hypertriglyceridaemia 192.12 12.46 128 46603 7670 31642943
Diplopia 186.92 12.46 160 46571 14002 31636611
Hypophosphataemia 186.59 12.46 130 46601 8384 31642229
Hepatic failure 177.93 12.46 230 46501 32472 31618141
HIV infection 172.28 12.46 71 46660 1549 31649064
Fanconi syndrome 163.81 12.46 69 46662 1593 31649020
Multiple-drug resistance 162.30 12.46 94 46637 4386 31646227
Genotype drug resistance test 155.62 12.46 33 46698 41 31650572
CD4 lymphocytes decreased 153.29 12.46 66 46665 1611 31649002
Renal tubular disorder 153.08 12.46 90 46641 4320 31646293
Kaposi's sarcoma 152.29 12.46 55 46676 827 31649786
Hepatic fibrosis 147.60 12.46 84 46647 3790 31646823
Polydactyly 143.01 12.46 57 46674 1137 31649476
Off label use 139.82 12.46 185 46546 347089 31303524
Gene mutation 133.36 12.46 54 46677 1124 31649489
Trisomy 21 131.02 12.46 44 46687 526 31650087
Loss of personal independence in daily activities 129.55 12.46 183 46548 28105 31622508
Osteoporosis 119.61 12.46 114 46617 11469 31639144
Alanine aminotransferase increased 118.40 12.46 307 46424 74349 31576264
Meningitis cryptococcal 115.26 12.46 60 46671 2263 31648350
Treatment failure 114.23 12.46 211 46520 40581 31610032
Portal hypertension 113.70 12.46 70 46661 3655 31646958
Retinal toxicity 109.90 12.46 36 46695 396 31650217
HIV-associated neurocognitive disorder 105.98 12.46 33 46698 304 31650309
Maternal drugs affecting foetus 105.73 12.46 68 46663 3835 31646778
Treatment noncompliance 101.47 12.46 155 46576 25529 31625084
Product dose omission issue 99.04 12.46 18 46713 105568 31545045
Fall 97.41 12.46 79 46652 186010 31464603
Blood lactic acid increased 94.92 12.46 76 46655 6054 31644559
Volvulus 94.80 12.46 43 46688 1192 31649421
Blood phosphorus decreased 93.67 12.46 57 46674 2914 31647699
Mycobacterium avium complex infection 93.48 12.46 53 46678 2373 31648240
Hyperlactacidaemia 92.50 12.46 55 46676 2695 31647918
Osteonecrosis 92.18 12.46 108 46623 13776 31636837
Nephropathy toxic 92.01 12.46 98 46633 11255 31639358
Completed suicide 91.66 12.46 13 46718 91501 31559112
CSF HIV escape syndrome 89.63 12.46 26 46705 183 31650430
Hepatic cirrhosis 89.55 12.46 113 46618 15561 31635052
Acquired immunodeficiency syndrome 89.22 12.46 32 46699 471 31650142
Jaundice 89.00 12.46 160 46571 30127 31620486
Cytomegalovirus chorioretinitis 88.62 12.46 58 46673 3370 31647243
Pneumonia 88.35 12.46 231 46500 335081 31315532
Mitochondrial cytopathy 84.25 12.46 24 46707 157 31650456
Renal tubular dysfunction 83.45 12.46 29 46702 387 31650226
Drug abuse 82.20 12.46 15 46716 87743 31562870
Hyperlipidaemia 81.82 12.46 99 46632 13061 31637552
Death 80.79 12.46 268 46463 360301 31290312
Dyspnoea 80.64 12.46 250 46481 343229 31307384
Peripheral swelling 80.17 12.46 5 46726 67860 31582753
Hypouricaemia 79.83 12.46 25 46706 235 31650378
Aspartate aminotransferase increased 79.71 12.46 238 46493 62481 31588132
Hepatitis C 76.14 12.46 86 46645 10544 31640069
Hypotension 76.14 12.46 115 46616 204503 31446110
Drug-induced liver injury 75.82 12.46 132 46599 24231 31626382
Neonatal disorder 74.58 12.46 32 46699 774 31649839
Varices oesophageal 72.81 12.46 51 46680 3315 31647298
Progressive multifocal leukoencephalopathy 71.97 12.46 78 46653 9135 31641478
Ophthalmoplegia 71.86 12.46 40 46691 1728 31648885
Psychiatric decompensation 70.35 12.46 41 46690 1935 31648678
Proteinuria 70.23 12.46 104 46627 16659 31633954
Fatigue 69.76 12.46 257 46474 334949 31315664
Hepatitis 69.25 12.46 120 46611 21946 31628667
Caesarean section 68.47 12.46 40 46691 1896 31648717
Lymphadenopathy 67.98 12.46 131 46600 25990 31624623
Dyslipidaemia 67.94 12.46 64 46667 6342 31644271
Pulmonary tuberculosis 67.86 12.46 56 46675 4655 31645958
Dandy-Walker syndrome 67.77 12.46 21 46710 190 31650423
Hepatomegaly 66.26 12.46 76 46655 9474 31641139
Pain 65.63 12.46 109 46622 186650 31463963
Anaemia macrocytic 65.21 12.46 45 46686 2855 31647758
Renal impairment 65.12 12.46 276 46455 86073 31564540
Lactic acidosis 64.16 12.46 144 46587 31793 31618820
Blood alkaline phosphatase increased 63.93 12.46 137 46594 29316 31621297
Glycosuria 62.43 12.46 32 46699 1168 31649445
Constipation 61.92 12.46 55 46676 123936 31526677
Hepatic function abnormal 61.70 12.46 166 46565 41056 31609557
Malignant neoplasm progression 61.33 12.46 20 46711 78978 31571635
Hyperbilirubinaemia 60.71 12.46 94 46637 15656 31634957
Congenital umbilical hernia 60.65 12.46 21 46710 277 31650336
Blood pressure increased 60.36 12.46 21 46710 79612 31571001
Oesophageal candidiasis 59.85 12.46 49 46682 4028 31646585
Birth mark 59.29 12.46 18 46713 151 31650462
Congenital anomaly 59.21 12.46 32 46699 1303 31649310
Urine phosphorus increased 58.20 12.46 14 46717 41 31650572
Tuberculosis 57.23 12.46 66 46665 8275 31642338
Blood bilirubin increased 56.15 12.46 145 46586 34991 31615622
Atrial fibrillation 53.83 12.46 53 46678 113730 31536883
Lipohypertrophy 51.54 12.46 18 46713 244 31650369
Pregnancy 51.34 12.46 18 46713 247 31650366
Hepatosplenomegaly 50.89 12.46 44 46687 3899 31646714
Blood triglycerides increased 50.30 12.46 79 46652 13318 31637295
Atrioventricular septal defect 50.19 12.46 17 46714 209 31650404
Calculus urinary 49.74 12.46 28 46703 1236 31649377
Talipes 49.60 12.46 32 46699 1814 31648799
Inappropriate schedule of product administration 49.08 12.46 8 46723 50815 31599798
Human immunodeficiency virus transmission 48.35 12.46 11 46720 23 31650590
Depressive symptom 48.00 12.46 33 46698 2081 31648532
Genotype drug resistance test positive 47.75 12.46 26 46705 1075 31649538
CD4 lymphocytes increased 46.49 12.46 16 46715 207 31650406
Plasma cell myeloma 46.24 12.46 13 46718 56518 31594095
Nasopharyngitis 45.70 12.46 18 46713 63227 31587386
Nodular regenerative hyperplasia 45.55 12.46 24 46707 928 31649685
Congenital central nervous system anomaly 45.53 12.46 20 46711 513 31650100
Infusion related reaction 45.44 12.46 8 46723 48047 31602566
Hepatocellular carcinoma 45.12 12.46 60 46671 8696 31641917
Pyelocaliectasis 44.78 12.46 25 46706 1086 31649527
Gamma-glutamyltransferase increased 44.63 12.46 115 46616 27710 31622903
Cachexia 44.40 12.46 52 46679 6627 31643986
Hepatic cancer 44.32 12.46 56 46675 7719 31642894
Facial wasting 44.20 12.46 14 46717 137 31650476
Hepatitis B virus test 44.17 12.46 8 46723 0 31650613
Hepatic encephalopathy 43.74 12.46 75 46656 13596 31637017
Oesophageal varices haemorrhage 43.30 12.46 35 46696 2825 31647788
Multiple fractures 43.04 12.46 26 46705 1311 31649302
Cryptococcosis 42.76 12.46 32 46699 2306 31648307
Optic nerve neoplasm 42.44 12.46 10 46721 26 31650587
Opportunistic infection 42.30 12.46 27 46704 1502 31649111
Splenomegaly 42.13 12.46 74 46657 13675 31636938
Anaemia neonatal 42.07 12.46 16 46715 280 31650333
Immune reconstitution inflammatory syndrome associated tuberculosis 41.70 12.46 18 46713 442 31650171
Congenital neoplasm 41.39 12.46 10 46721 30 31650583
Blood bilirubin unconjugated increased 41.25 12.46 19 46712 546 31650067
Oral candidiasis 41.14 12.46 65 46666 11012 31639601
Joint swelling 40.63 12.46 14 46717 53417 31597196
Basedow's disease 40.62 12.46 11 46720 58 31650555
Depression suicidal 40.57 12.46 27 46704 1613 31649000
Cryptorchism 40.42 12.46 29 46702 1958 31648655
Brain stem stroke 39.84 12.46 15 46716 255 31650358
Pneumocystis jirovecii pneumonia 39.72 12.46 85 46646 18166 31632447
Small for dates baby 39.69 12.46 37 46694 3618 31646995
Bone density decreased 39.19 12.46 27 46704 1708 31648905
Cerebral toxoplasmosis 39.11 12.46 26 46705 1551 31649062
Urine calcium increased 38.98 12.46 10 46721 41 31650572
Nephrolithiasis 38.80 12.46 108 46623 27231 31623382
Confusional state 37.97 12.46 88 46643 133246 31517367
Cardiac failure congestive 37.50 12.46 37 46694 79350 31571263
Aminoaciduria 37.48 12.46 12 46719 122 31650491
Life expectancy shortened 37.20 12.46 10 46721 51 31650562
Osteopenia 36.94 12.46 39 46692 4432 31646181
Mycobacterium avium complex immune restoration disease 36.77 12.46 9 46722 29 31650584
Tearfulness 36.64 12.46 27 46704 1900 31648713
Acute hepatitis C 36.37 12.46 11 46720 91 31650522
Wheezing 36.27 12.46 5 46726 35981 31614632
Mitochondrial myopathy 36.20 12.46 13 46718 192 31650421
Cardio-respiratory arrest 35.31 12.46 16 46715 51710 31598903
Hepatotoxicity 34.84 12.46 83 46648 19043 31631570
Macrocephaly 34.60 12.46 16 46715 464 31650149
White matter lesion 34.52 12.46 18 46713 681 31649932
Intentional product misuse 34.43 12.46 7 46724 37944 31612669
Liver disorder 34.23 12.46 109 46622 29598 31621015
Prostate cancer 33.98 12.46 7 46724 37594 31613019
Ascites 33.96 12.46 135 46596 40878 31609735
Renal tubular acidosis 33.94 12.46 27 46704 2130 31648483
Viraemia 33.78 12.46 21 46710 1115 31649498
Blood phosphorus abnormal 33.66 12.46 11 46720 120 31650493
Mycobacterial infection 33.01 12.46 27 46704 2216 31648397
Osteoporotic fracture 32.82 12.46 20 46711 1025 31649588
Death neonatal 32.77 12.46 14 46717 335 31650278
Psychomotor skills impaired 32.70 12.46 31 46700 3096 31647517
Febrile neutropenia 32.66 12.46 83 46648 121766 31528847
Psoriasis 32.60 12.46 14 46717 46705 31603908
Disease progression 32.46 12.46 52 46679 90412 31560201
Blood pyruvic acid increased 32.45 12.46 7 46724 10 31650603
Dizziness 31.98 12.46 168 46563 198979 31451634
Hydrocele 31.58 12.46 25 46706 1958 31648655
Oesophageal atresia 31.58 12.46 15 46716 463 31650150
Toxicity to various agents 31.49 12.46 149 46582 181338 31469275
Feeling abnormal 31.28 12.46 23 46708 56979 31593634
Congenital hydronephrosis 31.24 12.46 17 46714 702 31649911
Rhabdomyosarcoma 31.19 12.46 9 46722 62 31650551
Cerebrovascular accident 31.13 12.46 43 46688 79441 31571172
Cushing's syndrome 30.90 12.46 14 46717 387 31650226
Flushing 30.81 12.46 4 46727 30124 31620489
Chronic obstructive pulmonary disease 30.79 12.46 14 46717 45152 31605461
Thrombosis 30.77 12.46 14 46717 45137 31605476
Transaminases increased 30.53 12.46 92 46639 24249 31626364
Therapeutic product effect decreased 30.48 12.46 5 46726 31617 31618996
Somnolence 30.47 12.46 63 46668 99382 31551231
Epistaxis 30.35 12.46 21 46710 53686 31596927
Neurodevelopmental disorder 30.25 12.46 14 46717 407 31650206
Stevens-Johnson syndrome 30.15 12.46 74 46657 17298 31633315
HIV lipodystrophy 29.76 12.46 7 46724 18 31650595
Anaemia 29.50 12.46 460 46271 213062 31437551
Hepatitis cholestatic 29.44 12.46 44 46687 7102 31643511
Cardiac arrest 29.39 12.46 54 46677 89008 31561605
Drug ineffective 29.05 12.46 410 46321 395163 31255450
HIV viraemia 28.96 12.46 8 46723 46 31650567
Hypersplenism 28.70 12.46 13 46718 359 31650254
HIV test positive 28.67 12.46 10 46721 135 31650478
Lactate pyruvate ratio increased 28.50 12.46 6 46725 7 31650606
Speech disorder developmental 28.34 12.46 24 46707 2067 31648546
Injection site pain 28.25 12.46 8 46723 34626 31615987
Vanishing bile duct syndrome 27.86 12.46 15 46716 606 31650007
Muscle spasms 27.73 12.46 36 46695 68282 31582331
Mitochondrial DNA depletion 27.61 12.46 5 46726 0 31650613
Tremor 27.35 12.46 44 46687 76376 31574237
Product use issue 27.32 12.46 26 46705 56733 31593880
HIV associated nephropathy 27.13 12.46 12 46719 313 31650300
Cardiac disorder 26.97 12.46 12 46719 39202 31611411
Meningomyelocele 26.89 12.46 10 46721 164 31650449
Bone metabolism disorder 26.81 12.46 11 46720 237 31650376
Astrocytoma, low grade 26.58 12.46 8 46723 65 31650548
Retroviral rebound syndrome 26.55 12.46 6 46725 12 31650601
Fat tissue increased 26.28 12.46 12 46719 338 31650275
Stress 26.26 12.46 3 46728 24938 31625675
Contusion 26.26 12.46 8 46723 33020 31617593
Low set ears 26.21 12.46 13 46718 442 31650171
Hepatitis A 26.18 12.46 13 46718 443 31650170
Tubulointerstitial nephritis 26.18 12.46 73 46658 18423 31632190
Viral load decreased 26.16 12.46 7 46724 35 31650578
Syncope 26.06 12.46 54 46677 85128 31565485
Bone pain 26.05 12.46 75 46656 19276 31631337
Neurosyphilis 25.99 12.46 7 46724 36 31650577
Prenatal screening test abnormal 25.92 12.46 6 46725 14 31650599
Cardiac failure 25.87 12.46 55 46676 85898 31564715
Hypophosphataemic osteomalacia 25.84 12.46 9 46722 121 31650492
Lymph node tuberculosis 25.81 12.46 13 46718 457 31650156
Hypospadias 25.42 12.46 27 46704 3089 31647524
COVID-19 25.37 12.46 26 46705 54795 31595818
Hepatitis B surface antigen positive 25.06 12.46 9 46722 133 31650480
Beta 2 microglobulin urine increased 24.93 12.46 8 46723 82 31650531
Product use in unapproved indication 24.71 12.46 70 46661 99101 31551512
HIV wasting syndrome 24.67 12.46 8 46723 85 31650528
Blood uric acid increased 24.52 12.46 38 46693 6332 31644281
Incorrect dose administered 24.49 12.46 11 46720 35741 31614872
Cellulitis 24.30 12.46 21 46710 47997 31602616
Urinary tract infection 24.14 12.46 48 46683 76821 31573792
Limb deformity 24.13 12.46 13 46718 526 31650087
Granulomatous rosacea 24.01 12.46 9 46722 151 31650462
Congenital cytomegalovirus infection 23.51 12.46 6 46725 24 31650589
Histoplasmosis disseminated 23.47 12.46 17 46714 1165 31649448
Secondary syphilis 23.46 12.46 7 46724 55 31650558
Blood triglycerides abnormal 23.26 12.46 10 46721 243 31650370
Pyrexia 23.26 12.46 599 46132 303241 31347372
Neonatal asphyxia 23.23 12.46 11 46720 337 31650276
Anogenital warts 23.15 12.46 13 46718 571 31650042
Spider naevus 23.12 12.46 6 46725 26 31650587
Haematochezia 22.62 12.46 16 46715 40448 31610165
Genital herpes 22.61 12.46 13 46718 598 31650015
Tuberculoid leprosy 22.53 12.46 7 46724 64 31650549
Atypical mycobacterial infection 22.43 12.46 14 46717 749 31649864
Chest discomfort 22.18 12.46 24 46707 49345 31601268
Intracranial pressure increased 22.14 12.46 27 46704 3588 31647025
Trimethylaminuria 22.13 12.46 5 46726 10 31650603
Hyperhidrosis 22.10 12.46 41 46690 67352 31583261
Withdrawal hepatitis 22.08 12.46 4 46727 0 31650613
Toxoplasmosis 22.06 12.46 17 46714 1280 31649333
Angioedema 22.02 12.46 11 46720 33607 31617006
Amoebiasis 21.97 12.46 7 46724 70 31650543
Hepatic cytolysis 21.95 12.46 49 46682 10774 31639839
Anal cancer 21.91 12.46 11 46720 384 31650229
Hepatitis D 21.79 12.46 6 46725 34 31650579
Influenza 21.69 12.46 20 46711 44305 31606308
Live birth 21.68 12.46 9 46722 200 31650413
Unevaluable event 21.59 12.46 9 46722 30566 31620047
Pruritus 21.55 12.46 103 46628 125064 31525549
Cardiac murmur 21.50 12.46 37 46694 6725 31643888
Meningitis tuberculous 21.42 12.46 13 46718 661 31649952
Blood creatinine increased 21.41 12.46 213 46518 88865 31561748
Antimitochondrial antibody positive 21.37 12.46 6 46725 37 31650576
Blood glucose increased 21.08 12.46 36 46695 61047 31589566
Foetal growth restriction 20.99 12.46 27 46704 3788 31646825
Umbilical cord abnormality 20.96 12.46 6 46725 40 31650573
Parotid gland enlargement 20.92 12.46 10 46721 313 31650300
Oxygen saturation decreased 20.85 12.46 25 46706 49090 31601523
Night blindness 20.81 12.46 9 46722 222 31650391
Blood creatine phosphokinase increased 20.73 12.46 119 46612 41855 31608758
Urticaria 20.68 12.46 33 46698 57484 31593129
Pre-eclampsia 20.59 12.46 6 46725 43 31650570
Hypercholesterolaemia 20.55 12.46 40 46691 7990 31642623
Strongyloidiasis 20.52 12.46 22 46709 2544 31648069
Urine phosphorus decreased 20.35 12.46 6 46725 45 31650568
Weight increased 20.33 12.46 59 46672 82888 31567725
Bradycardia 20.33 12.46 45 46686 69282 31581331
Visual field defect 20.30 12.46 28 46703 4200 31646413
Chest pain 20.27 12.46 96 46635 116861 31533752
Pulmonary embolism 20.06 12.46 58 46673 81588 31569025
Bacterial pyelonephritis 20.06 12.46 9 46722 243 31650370
Primary syphilis 20.00 12.46 5 46726 18 31650595
Asthma 19.95 12.46 20 46711 42591 31608022
Macrocytosis 19.82 12.46 14 46717 922 31649691
AIDS related complication 19.79 12.46 5 46726 19 31650594
Normal newborn 19.78 12.46 8 46723 166 31650447
Diaphragmatic hernia 19.69 12.46 9 46722 254 31650359
Oropharyngeal pain 19.59 12.46 11 46720 31472 31619141
Interstitial lung disease 19.57 12.46 38 46693 61365 31589248
Agitation 19.55 12.46 31 46700 54138 31596475
Taeniasis 19.49 12.46 6 46725 53 31650560
Pancreatitis 19.39 12.46 104 46627 35667 31614946
Exomphalos 19.39 12.46 8 46723 175 31650438
Perinatal HIV infection 19.32 12.46 4 46727 4 31650609
Maternal condition affecting foetus 19.32 12.46 4 46727 4 31650609
Neuromyopathy 19.23 12.46 14 46717 967 31649646
Liver transplant rejection 19.22 12.46 19 46712 1997 31648616
Optic atrophy 19.12 12.46 13 46718 805 31649808
Pilonidal cyst congenital 19.03 12.46 5 46726 23 31650590
Lower respiratory tract infection 18.86 12.46 9 46722 28228 31622385
Drug dependence 18.82 12.46 5 46726 22574 31628039
Oropharyngeal candidiasis 18.73 12.46 12 46719 672 31649941
Malaria 18.66 12.46 8 46723 193 31650420
Developmental hip dysplasia 18.65 12.46 9 46722 288 31650325
Gastrointestinal haemorrhage 18.61 12.46 61 46670 82488 31568125
Cataract 18.51 12.46 6 46725 23801 31626812
Cryoglobulinaemia 18.44 12.46 10 46721 410 31650203
Borderline leprosy 18.43 12.46 4 46727 6 31650607
Nervous system disorder 18.43 12.46 52 46679 13211 31637402
Hepatitis C virus test 18.40 12.46 6 46725 65 31650548
Bronchitis 18.32 12.46 18 46713 38699 31611914
Back pain 18.27 12.46 91 46640 109322 31541291
Rectal haemorrhage 18.22 12.46 16 46715 36288 31614325
Asymptomatic viral hepatitis 18.21 12.46 5 46726 28 31650585
International normalised ratio increased 18.17 12.46 24 46707 45199 31605414
Hepatitis B DNA assay positive 18.15 12.46 6 46725 68 31650545
Abdominal discomfort 18.15 12.46 30 46701 51537 31599076
Gynaecomastia 18.06 12.46 41 46690 9113 31641500
Sickle cell disease 17.87 12.46 7 46724 133 31650480
Blood pressure decreased 17.85 12.46 27 46704 48064 31602549
Diverticulitis 17.85 12.46 3 46728 18642 31631971
Chordee 17.84 12.46 6 46725 72 31650541
Cerebral ventricle dilatation 17.84 12.46 13 46718 899 31649714
Neonatal pneumothorax 17.70 12.46 4 46727 8 31650605
Loss of anatomical alignment after fracture reduction 17.70 12.46 4 46727 8 31650605
Subchondral insufficiency fracture 17.70 12.46 4 46727 8 31650605
Crystal urine 17.69 12.46 6 46725 74 31650539
Delirium 17.67 12.46 21 46710 41400 31609213
Blood uric acid decreased 17.59 12.46 9 46722 327 31650286
Hydrops foetalis 17.55 12.46 10 46721 452 31650161
Hyperphosphatasaemia 17.51 12.46 5 46726 33 31650580
Meconium ileus 17.51 12.46 5 46726 33 31650580
Hospitalisation 17.51 12.46 29 46702 49778 31600835
Infection 17.48 12.46 62 46669 81869 31568744
White blood cell count increased 17.47 12.46 19 46712 38981 31611632
Anaphylactic reaction 17.44 12.46 11 46720 29542 31621071
Renal atrophy 17.41 12.46 14 46717 1121 31649492
Persistent foetal circulation 17.37 12.46 9 46722 336 31650277
Bulbar palsy 17.33 12.46 8 46723 231 31650382
Haematoma 17.21 12.46 7 46724 24132 31626481
Hepatic enzyme increased 17.21 12.46 101 46630 35807 31614806
Pneumonia aspiration 17.20 12.46 19 46712 38707 31611906
Acquired aminoaciduria 17.09 12.46 4 46727 10 31650603
Erosive duodenitis 17.04 12.46 15 46716 1361 31649252
ADAMTS13 activity decreased 16.94 12.46 6 46725 85 31650528
Lymphocytic infiltration 16.91 12.46 11 46720 632 31649981
Melaena 16.86 12.46 14 46717 32640 31617973
Fracture malunion 16.81 12.46 4 46727 11 31650602
Cardiogenic shock 16.81 12.46 6 46725 22402 31628211
Creutzfeldt-Jakob disease 16.79 12.46 5 46726 39 31650574
Glucose urine present 16.60 12.46 13 46718 1002 31649611
Polyneuropathy chronic 16.57 12.46 5 46726 41 31650572
Gonadal dysgenesis 16.56 12.46 3 46728 0 31650613
Atypical mycobacterial lymphadenitis 16.56 12.46 3 46728 0 31650613
Meconium stain 16.56 12.46 3 46728 0 31650613
Alpha 1 foetoprotein increased 16.49 12.46 11 46720 660 31649953
Femoral neck fracture 16.47 12.46 21 46710 2919 31647694
Sepsis 16.44 12.46 144 46587 151785 31498828
Optic nerve cupping 16.36 12.46 5 46726 43 31650570
Chronic hepatitis B 16.36 12.46 5 46726 43 31650570
Liver transplant 16.35 12.46 19 46712 2400 31648213
Hyperkalaemia 16.34 12.46 45 46686 64306 31586307
Heart rate increased 16.33 12.46 22 46709 41088 31609525
Neutrophil count decreased 16.32 12.46 27 46704 46367 31604246
Endocardial fibroelastosis 16.32 12.46 4 46727 13 31650600
Encephalitis 16.30 12.46 33 46698 6782 31643831
Dyspnoea exertional 16.24 12.46 20 46711 38817 31611796
Acute on chronic liver failure 16.10 12.46 6 46725 99 31650514
Clostridium difficile infection 16.06 12.46 3 46728 17276 31633337
Rhinorrhoea 15.89 12.46 7 46724 23005 31627608
Protrusion tongue 15.81 12.46 7 46724 183 31650430
Bone marrow oedema 15.79 12.46 10 46721 549 31650064
Hepatitis B e antigen positive 15.78 12.46 5 46726 49 31650564
Erythema 15.75 12.46 63 46668 80342 31570271
Dysmorphism 15.75 12.46 21 46710 3051 31647562
Coccidioidomycosis 15.74 12.46 11 46720 712 31649901
Anal cancer stage 0 15.67 12.46 4 46727 16 31650597
Dehydration 15.65 12.46 107 46624 119004 31531609
Colitis ulcerative 15.64 12.46 4 46727 18525 31632088
Distributive shock 15.63 12.46 13 46718 1092 31649521
Hepatitis viral 15.62 12.46 10 46721 559 31650054
C-reactive protein increased 15.59 12.46 30 46701 48620 31601993
Urinary retention 15.59 12.46 16 46715 33709 31616904
Transient ischaemic attack 15.56 12.46 8 46723 24048 31626565
Arthropathy 15.56 12.46 8 46723 24043 31626570
Musculoskeletal stiffness 15.54 12.46 23 46708 41302 31609311
Psoriatic arthropathy 15.48 12.46 5 46726 19878 31630735
Anaemia megaloblastic 15.47 12.46 7 46724 193 31650420
Optic neuropathy 15.45 12.46 16 46715 1777 31648836
Ear malformation 15.38 12.46 8 46723 301 31650312
Micrognathia 15.33 12.46 8 46723 303 31650310
Malabsorption 15.31 12.46 17 46714 2044 31648569
Non-Hodgkin's lymphoma 15.31 12.46 15 46716 1560 31649053
Cytokine release syndrome 15.24 12.46 3 46728 16639 31633974
Sinusitis 15.23 12.46 19 46712 36677 31613936
Wrong technique in product usage process 15.21 12.46 16 46715 33327 31617286
Basal cell carcinoma 15.20 12.46 4 46727 18175 31632438
Respiratory arrest 15.18 12.46 10 46721 26247 31624366
Glomerulonephritis proliferative 15.17 12.46 7 46724 202 31650411
Renal glycosuria 15.12 12.46 4 46727 19 31650594
Full blood count decreased 15.10 12.46 3 46728 16537 31634076
Portal fibrosis 15.09 12.46 8 46723 313 31650300
Anxiety 15.03 12.46 76 46655 90957 31559656
Blood pressure systolic increased 14.97 12.46 5 46726 19465 31631148
Amylase increased 14.95 12.46 28 46703 5434 31645179
Optic disc haemorrhage 14.95 12.46 5 46726 59 31650554
Full blood count abnormal 14.85 12.46 3 46728 16344 31634269
Sickle cell anaemia 14.83 12.46 7 46724 213 31650400
Adrenogenital syndrome 14.79 12.46 5 46726 61 31650552
Anogenital dysplasia 14.77 12.46 6 46725 126 31650487
Ultrasound antenatal screen 14.72 12.46 6 46725 127 31650486
Intentional overdose 14.64 12.46 24 46707 41365 31609248
Musculoskeletal toxicity 14.59 12.46 6 46725 130 31650483
Liver tenderness 14.59 12.46 6 46725 130 31650483
Product quality issue 14.55 12.46 3 46728 16108 31634505
Osteocalcin increased 14.49 12.46 3 46728 3 31650610
Tracheal fistula repair 14.49 12.46 3 46728 3 31650610
Hepatitis B DNA decreased 14.49 12.46 3 46728 3 31650610
Disseminated tuberculosis 14.41 12.46 17 46714 2182 31648431
Nasal congestion 14.39 12.46 6 46725 20375 31630238
Overdose 14.37 12.46 70 46661 84594 31566019
Congenital tuberculosis 14.34 12.46 4 46727 24 31650589
Psychotic disorder 14.32 12.46 68 46663 22225 31628388
Hyperphosphaturia 14.30 12.46 5 46726 68 31650545
Drug intolerance 14.27 12.46 35 46696 51998 31598615
Headache 14.25 12.46 188 46543 183464 31467149
Creatinine renal clearance abnormal 14.25 12.46 7 46724 233 31650380
Erythema elevatum diutinum 14.20 12.46 4 46727 25 31650588
Red blood cell schistocytes present 14.19 12.46 7 46724 235 31650378
Hypoglycaemia 14.18 12.46 34 46697 50912 31599701
Scleral discolouration 14.06 12.46 7 46724 240 31650373
Disseminated mycobacterium avium complex infection 14.04 12.46 5 46726 72 31650541
Late developer 14.03 12.46 3 46728 4 31650609
Osteodystrophy 14.03 12.46 3 46728 4 31650609
Retroviral infection 14.03 12.46 3 46728 4 31650609
Sleep apnoea syndrome 13.95 12.46 5 46726 18620 31631993
Pancytopenia 13.94 12.46 193 46538 87123 31563490
Mobility decreased 13.91 12.46 12 46719 27457 31623156
Myopia 13.90 12.46 12 46719 1061 31649552
Hepatic steatosis 13.87 12.46 54 46677 16185 31634428
Neuropsychiatric symptoms 13.87 12.46 9 46722 515 31650098
Neck deformity 13.79 12.46 5 46726 76 31650537
Aggression 13.78 12.46 21 46710 37270 31613343
Portal hypertensive gastropathy 13.67 12.46 9 46722 528 31650085
Nephropathy 13.66 12.46 27 46704 5452 31645161
Developmental delay 13.65 12.46 18 46713 2587 31648026
Fluid retention 13.61 12.46 10 46721 24792 31625821
Goitre 13.60 12.46 14 46717 1545 31649068
Memory impairment 13.59 12.46 22 46709 38108 31612505
Retinoblastoma 13.57 12.46 4 46727 30 31650583
Diarrhoea 13.57 12.46 406 46325 352003 31298610
Glucose tolerance impaired 13.56 12.46 19 46712 2893 31647720
Product prescribing error 13.52 12.46 6 46725 19636 31630977
Ultrasound antenatal screen abnormal 13.50 12.46 5 46726 81 31650532
Spermatozoa progressive motility abnormal 13.45 12.46 4 46727 31 31650582
Lymphangiectasia 13.45 12.46 4 46727 31 31650582
Gout 13.41 12.46 5 46726 18169 31632444
Syphilis 13.30 12.46 8 46723 400 31650213
Vision blurred 13.30 12.46 26 46705 41889 31608724
Oedema peripheral 13.30 12.46 101 46630 109738 31540875
Congenital pigmentation disorder 13.28 12.46 3 46728 6 31650607
Benign hepatic neoplasm 13.28 12.46 3 46728 6 31650607
Molluscum contagiosum 13.25 12.46 7 46724 272 31650341
Graft infection 13.25 12.46 8 46723 403 31650210
Tracheal stenosis 13.14 12.46 6 46725 169 31650444
Hyponatraemia 13.12 12.46 60 46671 73739 31576874
Intestinal obstruction 13.12 12.46 7 46724 20603 31630010
Pain in extremity 13.07 12.46 109 46622 116094 31534519
Subacute sclerosing panencephalitis 13.03 12.46 4 46727 35 31650578
Ocular icterus 13.03 12.46 18 46713 2705 31647908
Congenital hydrocephalus 13.02 12.46 5 46726 90 31650523
Birth trauma 12.96 12.46 3 46728 7 31650606
Ergot poisoning 12.93 12.46 4 46727 36 31650577
Stomatitis 12.92 12.46 24 46707 39414 31611199
Orthostatic hypotension 12.88 12.46 10 46721 24109 31626504
Plasmablastic lymphoma 12.78 12.46 7 46724 293 31650320
Skin candida 12.73 12.46 8 46723 433 31650180
Tracheo-oesophageal fistula 12.70 12.46 8 46723 435 31650178
Atrial flutter 12.69 12.46 3 46728 14652 31635961
Congenital anaemia 12.68 12.46 3 46728 8 31650605
Congenital hearing disorder 12.67 12.46 5 46726 97 31650516
Pneumonitis 12.59 12.46 16 46715 30636 31619977
Toxic optic neuropathy 12.58 12.46 10 46721 788 31649825
Drug withdrawal syndrome 12.48 12.46 6 46725 18744 31631869

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
Immune reconstitution inflammatory syndrome 2328.42 12.50 721 57811 12269 70857643
Viral mutation identified 2250.84 12.50 536 57996 3086 70866826
Virologic failure 2187.51 12.50 530 58002 3320 70866592
Drug resistance 1695.03 12.50 760 57772 37430 70832482
Pathogen resistance 1688.10 12.50 568 57964 12711 70857201
Exposure during pregnancy 1098.71 12.50 758 57774 86959 70782953
Lipodystrophy acquired 1068.16 12.50 306 58226 3910 70866002
Abortion spontaneous 986.54 12.50 467 58065 26012 70843900
Hepatitis B 917.18 12.50 318 58214 7796 70862116
Stillbirth 826.12 12.50 245 58287 3560 70866352
Blood HIV RNA increased 742.81 12.50 188 58344 1438 70868474
Mitochondrial toxicity 673.93 12.50 197 58335 2713 70867199
Hepatitis B reactivation 648.42 12.50 221 58311 5134 70864778
Drug interaction 588.85 12.50 1094 57438 380347 70489565
Abortion induced 558.33 12.50 209 58323 6416 70863496
Fanconi syndrome acquired 493.63 12.50 150 58382 2377 70867535
Acquired gene mutation 476.88 12.50 140 58392 1958 70867954
Hepatitis B DNA increased 466.55 12.50 110 58422 600 70869312
Osteomalacia 421.77 12.50 117 58415 1317 70868595
Foetal exposure during pregnancy 348.06 12.50 142 58390 5503 70864409
Eyelid ptosis 312.42 12.50 157 58375 9945 70859967
Depression 303.76 12.50 569 57963 198405 70671507
Viral load increased 299.69 12.50 104 58428 2552 70867360
Progressive external ophthalmoplegia 281.33 12.50 85 58447 1319 70868593
Hepatic failure 269.78 12.50 283 58249 57342 70812570
Hypophosphataemia 264.55 12.50 166 58366 16160 70853752
CD4 lymphocytes decreased 253.92 12.50 91 58441 2460 70867452
Lipoatrophy 252.50 12.50 66 58466 581 70869331
Fanconi syndrome 244.75 12.50 90 58442 2623 70867289
Treatment noncompliance 225.65 12.50 233 58299 46341 70823571
Blood bilirubin increased 219.77 12.50 259 58273 59642 70810270
Nephropathy toxic 212.65 12.50 152 58380 18362 70851550
Pregnancy 212.54 12.50 168 58364 23613 70846299
Rheumatoid arthritis 206.03 12.50 8 58524 291797 70578115
CSF HIV escape syndrome 198.15 12.50 48 58484 299 70869613
Live birth 190.95 12.50 127 58405 13652 70856260
Portal hypertension 189.36 12.50 97 58435 6395 70863517
HIV infection 189.36 12.50 63 58469 1354 70868558
Meningitis cryptococcal 189.17 12.50 79 58453 3249 70866663
Multiple-drug resistance 180.75 12.50 98 58434 7257 70862655
Hepatotoxicity 177.84 12.50 200 58332 43786 70826126
Pain 177.77 12.50 155 58377 628661 70241251
Renal tubular disorder 174.48 12.50 90 58442 6020 70863892
Caesarean section 170.62 12.50 111 58421 11496 70858416
Diplopia 170.23 12.50 159 58373 27988 70841924
Hepatic fibrosis 169.48 12.50 89 58443 6178 70863734
Alanine aminotransferase increased 164.76 12.50 371 58161 147109 70722803
Kaposi's sarcoma 160.49 12.50 48 58484 718 70869194
Hypertriglyceridaemia 159.19 12.50 107 58425 11704 70858208
Peripheral swelling 155.80 12.50 10 58522 236553 70633359
Jaundice 152.10 12.50 197 58335 49911 70820001
Joint swelling 149.62 12.50 17 58515 253194 70616718
Proteinuria 147.77 12.50 150 58382 29224 70840688
Pulmonary tuberculosis 145.57 12.50 87 58445 7758 70862154
Fall 145.22 12.50 94 58438 444002 70425910
Maternal exposure during pregnancy 143.40 12.50 303 58229 115042 70754870
Completed suicide 140.01 12.50 13 58519 227122 70642790
Mitochondrial cytopathy 138.60 12.50 37 58495 356 70869556
Hypomania 135.71 12.50 76 58456 5996 70863916
Genotype drug resistance test positive 135.58 12.50 47 58485 1149 70868763
Maternal drugs affecting foetus 135.34 12.50 51 58481 1593 70868319
Lymphadenopathy 134.51 12.50 183 58349 48608 70821304
Foetal death 133.78 12.50 76 58456 6163 70863749
Retinal toxicity 133.56 12.50 48 58484 1308 70868604
Glycosuria 132.61 12.50 54 58478 2081 70867831
Off label use 132.05 12.50 259 58273 742801 70127111
Hyperbilirubinaemia 127.91 12.50 123 58409 22445 70847467
Infusion related reaction 125.30 12.50 10 58522 197524 70672388
Lactic acidosis 124.97 12.50 206 58326 64818 70805094
Hepatitis C 124.25 12.50 95 58437 12712 70857200
Renal tubular dysfunction 123.38 12.50 39 58493 708 70869204
Fatigue 123.11 12.50 316 58216 824003 70045909
Aspartate aminotransferase increased 122.79 12.50 302 58230 126676 70743236
Nasopharyngitis 119.28 12.50 20 58512 222186 70647726
Tuberculosis 116.00 12.50 97 58435 14751 70855161
HIV-associated neurocognitive disorder 114.87 12.50 31 58501 312 70869600
Hyperlactacidaemia 114.76 12.50 64 58468 5008 70864904
Product dose omission issue 113.62 12.50 21 58511 217447 70652465
Mycobacterium avium complex infection 113.17 12.50 60 58472 4246 70865666
Jaundice cholestatic 111.47 12.50 78 58454 9106 70860806
Psychotic disorder 110.94 12.50 146 58386 37555 70832357
Gene mutation 109.16 12.50 48 58484 2243 70867669
Hepatomegaly 106.12 12.50 99 58433 17393 70852519
Dyslipidaemia 104.23 12.50 77 58455 9783 70860129
Arthropathy 102.90 12.50 5 58527 150052 70719860
Immune reconstitution inflammatory syndrome associated tuberculosis 99.46 12.50 34 58498 796 70869116
Hepatic cirrhosis 98.25 12.50 124 58408 30607 70839305
Anaemia 96.67 12.50 616 57916 402807 70467105
Premature rupture of membranes 95.95 12.50 52 58480 3846 70866066
Hypouricaemia 95.13 12.50 28 58504 395 70869517
Osteonecrosis 93.76 12.50 118 58414 29042 70840870
Synovitis 93.02 12.50 3 58529 129225 70740687
Pinealoblastoma 90.39 12.50 19 58513 54 70869858
Hepatic function abnormal 89.58 12.50 183 58349 67813 70802099
Dyspnoea 88.07 12.50 333 58199 769727 70100185
Premature labour 88.01 12.50 64 58468 7936 70861976
Drug-induced liver injury 87.30 12.50 162 58370 55951 70813961
Urine phosphorus increased 86.63 12.50 19 58513 70 70869842
Renal impairment 86.10 12.50 288 58244 143649 70726263
Constipation 84.36 12.50 52 58480 252386 70617526
Abdominal discomfort 83.95 12.50 36 58496 214622 70655290
Stevens-Johnson syndrome 83.21 12.50 124 58408 35783 70834129
Blood alkaline phosphatase increased 82.47 12.50 162 58370 58359 70811553
Acquired immunodeficiency syndrome 81.78 12.50 23 58509 273 70869639
Hepatitis 81.16 12.50 147 58385 49833 70820079
Pre-eclampsia 80.86 12.50 56 58476 6429 70863483
Osteoporosis 79.62 12.50 144 58388 48763 70821149
Sinusitis 78.96 12.50 21 58511 169174 70700738
Fat tissue increased 78.57 12.50 29 58503 854 70869058
Gamma-glutamyltransferase increased 77.18 12.50 145 58387 50540 70819372
Hepatocellular carcinoma 76.27 12.50 65 58467 10143 70859769
Blood lactic acid increased 75.13 12.50 67 58465 11106 70858806
Blood phosphorus decreased 74.72 12.50 52 58480 6017 70863895
Injection site pain 74.43 12.50 6 58526 117613 70752299
Schizophrenia 74.25 12.50 80 58452 16688 70853224
Psychiatric decompensation 73.95 12.50 40 58492 2947 70866965
Blood bilirubin unconjugated increased 73.63 12.50 28 58504 897 70869015
Ophthalmoplegia 73.34 12.50 39 58493 2776 70867136
Therapeutic product effect decreased 72.17 12.50 15 58517 143003 70726909
Cytomegalovirus chorioretinitis 71.40 12.50 48 58484 5250 70864662
Premature baby 71.34 12.50 41 58491 3398 70866514
Systemic lupus erythematosus 71.15 12.50 3 58529 101899 70768013
Hepatosplenomegaly 70.78 12.50 49 58483 5621 70864291
Drug intolerance 70.65 12.50 50 58482 225637 70644275
Alopecia 68.96 12.50 39 58493 198451 70671461
Ergot poisoning 67.73 12.50 17 58515 125 70869787
Blood pressure increased 67.00 12.50 36 58496 188481 70681431
Retinoblastoma 66.70 12.50 16 58516 95 70869817
Varices oesophageal 65.72 12.50 46 58486 5371 70864541
Progressive multifocal leukoencephalopathy 65.37 12.50 80 58452 19134 70850778
Drug ineffective 65.03 12.50 482 58050 939270 69930642
Pneumocystis jirovecii pneumonia 62.82 12.50 99 58433 29983 70839929
Wound 62.57 12.50 5 58527 98727 70771185
Cachexia 61.92 12.50 57 58475 9843 70860069
Loss of personal independence in daily activities 61.90 12.50 182 58350 84728 70785184
Normal newborn 61.69 12.50 47 58485 6253 70863659
Contusion 61.45 12.50 15 58517 128021 70741891
Swelling 61.37 12.50 40 58492 188499 70681413
Hepatic encephalopathy 61.00 12.50 83 58449 22035 70847877
Hypotension 60.12 12.50 155 58377 404226 70465686
Cryptococcosis 59.57 12.50 36 58496 3274 70866638
Hyperlipidaemia 59.04 12.50 85 58447 23778 70846134
Splenomegaly 58.50 12.50 75 58457 18795 70851117
Cholelithiasis 58.35 12.50 124 58408 47216 70822696
Calculus urinary 58.32 12.50 30 58502 1994 70867918
Ascites 58.32 12.50 154 58378 67393 70802519
Lipohypertrophy 58.00 12.50 23 58509 826 70869086
Blood triglycerides increased 57.61 12.50 76 58456 19588 70850324
Arthralgia 56.54 12.50 219 58313 503171 70366741
Drug abuse 55.51 12.50 26 58506 147230 70722682
Cushing's syndrome 55.48 12.50 23 58509 928 70868984
Amniotic cavity infection 55.46 12.50 22 58510 791 70869121
Feeling abnormal 55.41 12.50 24 58508 142295 70727617
Hepatic cytolysis 54.41 12.50 73 58459 19119 70850793
Transaminases increased 54.34 12.50 120 58412 46898 70823014
Hepatitis A 54.19 12.50 22 58510 841 70869071
Facial wasting 54.08 12.50 13 58519 78 70869834
Lymph node tuberculosis 54.01 12.50 23 58509 993 70868919
Renal tubular acidosis 53.76 12.50 34 58498 3352 70866560
Arthritis 52.14 12.50 9 58523 97971 70771941
Cerebral toxoplasmosis 51.90 12.50 28 58504 2052 70867860
Product use issue 51.06 12.50 44 58488 179893 70690019
Hypophosphataemic osteomalacia 50.59 12.50 16 58516 291 70869621
Nephrolithiasis 50.49 12.50 117 58415 47206 70822706
Mitochondrial DNA deletion 50.31 12.50 9 58523 6 70869906
Oligohydramnios 50.11 12.50 32 58500 3208 70866704
Hepatitis B surface antigen positive 49.95 12.50 14 58518 164 70869748
Blood creatinine increased 49.94 12.50 242 58290 142759 70727153
Weight increased 48.67 12.50 78 58454 242253 70627659
Premature delivery 48.53 12.50 73 58459 21231 70848681
Alpha 1 foetoprotein abnormal 48.31 12.50 11 58521 50 70869862
Psoriasis 48.28 12.50 11 58521 98422 70771490
Injection site erythema 48.21 12.50 3 58529 72921 70796991
Urinary tract infection 48.17 12.50 82 58450 248687 70621225
Oesophageal varices haemorrhage 47.79 12.50 33 58499 3770 70866142
Renal failure 47.19 12.50 292 58240 188778 70681134
Ectopic pregnancy 46.82 12.50 24 58508 1584 70868328
Pyrexia 46.69 12.50 731 57801 606221 70263691
Malignant neoplasm progression 46.65 12.50 21 58511 121718 70748194
Aminoaciduria 45.99 12.50 14 58518 223 70869689
Death 45.80 12.50 241 58291 509820 70360092
Oesophageal candidiasis 45.64 12.50 45 58487 8462 70861450
Rickets 45.62 12.50 11 58521 67 70869845
Pancreatitis 45.35 12.50 134 58398 62534 70807378
Basedow's disease 44.82 12.50 14 58518 244 70869668
HIV viraemia 44.81 12.50 11 58521 73 70869839
Headache 44.78 12.50 288 58244 580117 70289795
Premature separation of placenta 44.61 12.50 21 58511 1151 70868761
Meningitis tuberculous 44.18 12.50 21 58511 1176 70868736
Tuberculoma of central nervous system 43.92 12.50 17 58515 572 70869340
Impaired healing 43.87 12.50 5 58527 74369 70795543
Inappropriate schedule of product administration 43.71 12.50 17 58515 107538 70762374
Placental disorder 43.55 12.50 19 58513 871 70869041
Pain in extremity 43.37 12.50 133 58399 327949 70541963
Placental insufficiency 43.27 12.50 20 58512 1051 70868861
CD4 lymphocytes increased 43.11 12.50 14 58518 278 70869634
Asthma 43.00 12.50 23 58509 120770 70749142
Influenza 42.96 12.50 20 58512 113680 70756232
Pruritus 42.95 12.50 144 58388 345416 70524496
Nodular regenerative hyperplasia 42.64 12.50 21 58511 1272 70868640
Granulomatous rosacea 42.54 12.50 13 58519 210 70869702
Rash maculo-papular 42.38 12.50 114 58418 50431 70819481
Ocular icterus 42.31 12.50 35 58497 5242 70864670
Atrial fibrillation 42.28 12.50 54 58478 184294 70685618
Stomatitis 42.17 12.50 27 58505 128484 70741428
Psoriatic arthropathy 41.83 12.50 3 58529 64768 70805144
Umbilical cord abnormality 41.81 12.50 12 58520 154 70869758
Acquired aminoaciduria 40.73 12.50 8 58524 14 70869898
Hepatitis cholestatic 40.35 12.50 51 58481 12599 70857313
Lower respiratory tract infection 40.29 12.50 21 58511 111892 70758020
Oxygen saturation decreased 40.24 12.50 23 58509 116406 70753506
Hepatitis B virus test 40.21 12.50 7 58525 3 70869909
Wheezing 39.75 12.50 14 58518 94156 70775756
Mycobacterium avium complex immune restoration disease 39.39 12.50 8 58524 18 70869894
Toxicity to various agents 39.28 12.50 172 58360 382000 70487912
Malaria 39.07 12.50 14 58518 378 70869534
Hepatic cancer 39.06 12.50 44 58488 9639 70860273
Anaemia macrocytic 38.87 12.50 33 58499 5122 70864790
Drug hypersensitivity 38.65 12.50 101 58431 262358 70607554
Depression suicidal 38.53 12.50 26 58506 2861 70867051
Pancytopenia 38.09 12.50 234 58298 150873 70719039
White matter lesion 38.03 12.50 22 58510 1846 70868066
Oropharyngeal pain 37.87 12.50 16 58516 96294 70773618
Optic nerve neoplasm 37.74 12.50 8 58524 24 70869888
HIV associated nephropathy 37.61 12.50 13 58519 315 70869597
HIV test positive 37.48 12.50 10 58522 96 70869816
Urine calcium increased 37.48 12.50 10 58522 96 70869816
Opportunistic infection 37.37 12.50 25 58507 2711 70867201
Heart rate decreased 37.00 12.50 4 58528 62011 70807901
Intentional product misuse 36.89 12.50 10 58522 79585 70790327
Depressive symptom 36.69 12.50 32 58500 5149 70864763
Withdrawal hepatitis 36.60 12.50 6 58526 0 70869912
Mitochondrial DNA depletion 36.60 12.50 6 58526 0 70869912
Brain stem stroke 36.42 12.50 15 58517 595 70869317
Malaise 36.40 12.50 209 58323 432723 70437189
Musculoskeletal stiffness 36.31 12.50 41 58491 147719 70722193
Psychomotor skills impaired 35.57 12.50 29 58503 4255 70865657
Tearfulness 35.54 12.50 31 58501 4989 70864923
Mitochondrial myopathy 35.18 12.50 12 58520 279 70869633
Nasal congestion 35.01 12.50 6 58526 65666 70804246
Viraemia 34.59 12.50 23 58509 2469 70867443
Disseminated tuberculosis 34.56 12.50 28 58504 4072 70865840
Hepatitis B DNA assay positive 34.45 12.50 9 58523 79 70869833
Muscle spasms 34.42 12.50 46 58486 154000 70715912
Dizziness 34.40 12.50 233 58299 463908 70406004
Acute hepatitis C 34.18 12.50 11 58521 212 70869700
Oral candidiasis 33.85 12.50 68 58464 24884 70845028
Back pain 33.67 12.50 113 58419 271039 70598873
Pericarditis 33.42 12.50 14 58518 84691 70785221
Blister 33.14 12.50 21 58511 100505 70769407
Hyperphosphaturia 32.96 12.50 9 58523 95 70869817
Gynaecomastia 32.78 12.50 34 58498 6789 70863123
Strongyloidiasis 32.60 12.50 26 58506 3697 70866215
Bone metabolism disorder 32.39 12.50 13 58519 482 70869430
Blood pressure fluctuation 32.33 12.50 5 58527 59007 70810905
Mycobacterial infection 31.92 12.50 25 58507 3463 70866449
Anaphylactic reaction 31.89 12.50 11 58521 74963 70794949
Bronchitis 31.66 12.50 30 58502 117213 70752699
Blood phosphorus abnormal 31.38 12.50 11 58521 278 70869634
Toxoplasmosis 31.28 12.50 22 58510 2588 70867324
Pregnancy on contraceptive 31.20 12.50 15 58517 862 70869050
Infection 31.11 12.50 81 58451 210704 70659208
Renal glycosuria 31.08 12.50 7 58525 30 70869882
Bilirubin conjugated increased 30.80 12.50 29 58503 5152 70864760
Neutropenia neonatal 30.71 12.50 7 58525 32 70869880
Stress 30.64 12.50 9 58523 67957 70801955
Retroviral rebound syndrome 30.37 12.50 6 58526 11 70869901
Vanishing bile duct syndrome 30.34 12.50 17 58515 1342 70868570
Hypercholesterolaemia 30.31 12.50 54 58478 18063 70851849
Diabetes mellitus 29.86 12.50 128 58404 71696 70798216
Helicobacter infection 29.86 12.50 5 58527 55651 70814261
Benign hydatidiform mole 29.60 12.50 8 58524 81 70869831
Rhinorrhoea 29.54 12.50 9 58523 66362 70803550
Night blindness 29.26 12.50 12 58520 471 70869441
Confusional state 29.19 12.50 128 58404 284270 70585642
AIDS cholangiopathy 29.10 12.50 6 58526 15 70869897
HIV lipodystrophy 29.10 12.50 6 58526 15 70869897
Hyperphosphatasaemia 29.00 12.50 8 58524 88 70869824
Cerebrovascular accident 28.95 12.50 46 58486 143424 70726488
Somnolence 28.75 12.50 87 58445 215519 70654393
Chronic kidney disease 28.69 12.50 113 58419 60944 70808968
Discomfort 28.45 12.50 27 58505 105409 70764503
Migraine 28.40 12.50 12 58520 72226 70797686
Spina bifida 28.29 12.50 8 58524 97 70869815
Liver disorder 28.17 12.50 113 58419 61455 70808457
Cardio-respiratory arrest 28.09 12.50 25 58507 100652 70769260
Liver transplant 27.53 12.50 25 58507 4241 70865671
Tuberculoid leprosy 27.37 12.50 8 58524 110 70869802
Secondary syphilis 27.15 12.50 7 58525 58 70869854
Bone density decreased 27.11 12.50 40 58492 11434 70858478
Amoebiasis 27.10 12.50 8 58524 114 70869798
Blood triglycerides abnormal 27.08 12.50 11 58521 421 70869491
Hepatic steatosis 27.08 12.50 75 58457 33738 70836174
Congenital anomaly 26.98 12.50 10 58522 298 70869614
Metabolic acidosis 26.79 12.50 127 58405 74219 70795693
HIV wasting syndrome 26.64 12.50 7 58525 63 70869849
Respiratory arrest 26.50 12.50 6 58526 53927 70815985
Fibromyalgia 26.36 12.50 4 58528 47870 70822042
Diarrhoea 26.26 12.50 472 58060 782869 70087043
Encephalitis 26.03 12.50 43 58489 13542 70856370
Flushing 25.96 12.50 18 58514 82154 70787758
Beta 2 microglobulin urine increased 25.80 12.50 8 58524 136 70869776
Anogenital warts 25.73 12.50 13 58519 832 70869080
Intentional overdose 25.64 12.50 26 58506 98409 70771503
Erythema 25.56 12.50 82 58450 199481 70670431
COVID-19 25.27 12.50 30 58502 105727 70764185
Atypical mycobacterial lymphadenitis 25.02 12.50 5 58527 10 70869902
Placental infarction 25.02 12.50 8 58524 151 70869761
Cardiac failure congestive 24.98 12.50 46 58486 135411 70734501
Hospitalisation 24.89 12.50 19 58513 82549 70787363
Herpes simplex 24.89 12.50 38 58494 11194 70858718
Epistaxis 24.64 12.50 29 58503 102598 70767314
Glucose urine present 24.55 12.50 16 58516 1661 70868251
Thrombosis 24.51 12.50 16 58516 75389 70794523
Genital herpes 24.42 12.50 17 58515 1968 70867944
Tremor 24.36 12.50 58 58474 155566 70714346
Lymphocytic infiltration 24.11 12.50 15 58517 1437 70868475
Nervous system disorder 23.91 12.50 58 58474 24088 70845824
Liver transplant rejection 23.85 12.50 20 58512 3052 70866860
Borderline leprosy 23.84 12.50 5 58527 14 70869898
Dermatitis exfoliative 23.81 12.50 36 58496 10515 70859397
Rhabdomyosarcoma 23.78 12.50 8 58524 178 70869734
Urine phosphorus decreased 23.46 12.50 6 58526 48 70869864
Syncope 23.45 12.50 65 58467 165644 70704268
Hepatitis fulminant 23.36 12.50 28 58504 6553 70863359
Chronic disease 23.32 12.50 7 58525 106 70869806
Central nervous system lesion 23.30 12.50 39 58493 12414 70857498
Blood uric acid increased 23.29 12.50 33 58499 9096 70860816
Unevaluable event 23.27 12.50 7 58525 52056 70817856
Primary syphilis 23.11 12.50 5 58527 17 70869895
Taeniasis 22.93 12.50 6 58526 53 70869859
Treatment failure 22.93 12.50 200 58332 143942 70725970
Molluscum contagiosum 22.78 12.50 10 58522 465 70869447
Anxiety 22.70 12.50 99 58433 220231 70649681
Blood bicarbonate decreased 22.62 12.50 24 58508 4917 70864995
Foetal growth restriction 22.59 12.50 16 58516 1903 70868009
Parotid gland enlargement 22.44 12.50 12 58520 864 70869048
Intracranial pressure increased 22.43 12.50 29 58503 7327 70862585
Blood creatine phosphokinase increased 22.32 12.50 105 58427 61158 70808754
Tubulointerstitial nephritis 22.30 12.50 69 58463 33007 70836905
Cholestatic liver injury 22.27 12.50 22 58510 4146 70865766
Osteoporotic fracture 22.15 12.50 21 58511 3763 70866149
Gastroschisis 22.09 12.50 5 58527 22 70869890
Burning sensation 22.07 12.50 8 58524 52862 70817050
Hepatic enzyme increased 22.02 12.50 212 58320 156778 70713134
Viral load decreased 21.91 12.50 5 58527 23 70869889
Hepatitis E 21.91 12.50 18 58514 2670 70867242
Haematochezia 21.80 12.50 17 58515 73064 70796848
Hyponatraemia 21.77 12.50 64 58468 160023 70709889
Hydrops foetalis 21.69 12.50 8 58524 235 70869677
Chronic hepatitis B 21.69 12.50 9 58523 364 70869548
Urticaria 21.58 12.50 66 58466 162983 70706929
Hot flush 21.57 12.50 7 58525 49577 70820335
Anaemia neonatal 21.57 12.50 5 58527 25 70869887
Bradycardia 21.51 12.50 44 58488 124571 70745341
Placenta praevia 21.50 12.50 11 58521 723 70869189
Erosive duodenitis 21.46 12.50 15 58517 1747 70868165
Fluid retention 21.22 12.50 13 58519 63372 70806540
Nephropathy 21.19 12.50 31 58501 8794 70861118
Anembryonic gestation 21.19 12.50 9 58523 386 70869526
Bulbar palsy 21.10 12.50 8 58524 254 70869658
Injury 21.00 12.50 14 58518 65231 70804681
Breech delivery 20.94 12.50 5 58527 29 70869883
Cardiac arrest 20.94 12.50 65 58467 159769 70710143
Chronic obstructive pulmonary disease 20.80 12.50 20 58512 77621 70792291
Haematoma 20.77 12.50 7 58525 48411 70821501
Swollen tongue 20.61 12.50 3 58529 37043 70832869
Ileal ulcer 20.61 12.50 12 58520 1019 70868893
Non-Hodgkin's lymphoma 20.59 12.50 14 58518 1560 70868352
Hepatitis D 20.49 12.50 6 58526 83 70869829
Cough 20.43 12.50 171 58361 325206 70544706
Gestational diabetes 20.43 12.50 25 58507 5976 70863936
Memory impairment 20.35 12.50 28 58504 92613 70777299
Isosporiasis 20.12 12.50 7 58525 173 70869739
Small for dates baby 20.08 12.50 9 58523 440 70869472
Cryoglobulinaemia 20.07 12.50 11 58521 832 70869080
Type III hyperlipidaemia 20.02 12.50 4 58528 8 70869904
Loss of anatomical alignment after fracture reduction 20.02 12.50 4 58528 8 70869904
Diverticulitis 19.80 12.50 5 58527 41729 70828183
Cystitis 19.77 12.50 7 58525 46934 70822978
Chest pain 19.66 12.50 124 58408 251136 70618776
Antimitochondrial antibody positive 19.63 12.50 6 58526 97 70869815
Histoplasmosis disseminated 19.31 12.50 15 58517 2053 70867859
Incorrect dose administered 19.30 12.50 16 58516 66703 70803209
Hypoglycaemia 19.28 12.50 30 58502 94334 70775578
Neck pain 19.26 12.50 16 58516 66641 70803271
Ballismus 19.20 12.50 7 58525 199 70869713
Neuromyopathy 19.09 12.50 13 58519 1452 70868460
Abortion missed 18.92 12.50 12 58520 1189 70868723
Congenital intestinal malformation 18.87 12.50 4 58528 12 70869900
Lymphadenitis 18.85 12.50 20 58512 4097 70865815
Osteoarthritis 18.84 12.50 20 58512 74127 70795785
Cellulitis 18.77 12.50 33 58499 98895 70771017
Postpartum haemorrhage 18.72 12.50 13 58519 1498 70868414
Central nervous system immune reconstitution inflammatory response 18.65 12.50 5 58527 49 70869863
Fat redistribution 18.63 12.50 6 58526 116 70869796
Hepatitis viral 18.58 12.50 11 58521 963 70868949
Hepatitis B surface antibody positive 18.47 12.50 7 58525 222 70869690
Optic nerve cupping 18.47 12.50 5 58527 51 70869861
Retroviral infection 18.40 12.50 4 58528 14 70869898
Lip swelling 18.40 12.50 3 58529 34051 70835861
Bacterial pyelonephritis 18.32 12.50 9 58523 542 70869370
Plasma cell myeloma 18.31 12.50 20 58512 73181 70796731
Oropharyngeal candidiasis 18.31 12.50 13 58519 1552 70868360
Vertical infection transmission 18.30 12.50 3 58529 0 70869912
Prenatal screening test abnormal 18.30 12.50 3 58529 0 70869912
AIDS related complex 18.30 12.50 3 58529 0 70869912
Alpha 1 foetoprotein increased 18.26 12.50 10 58522 755 70869157
Portal hypertensive gastropathy 18.25 12.50 12 58520 1264 70868648
Orthostatic hypotension 18.19 12.50 10 58522 51733 70818179
Chest discomfort 18.19 12.50 48 58484 124333 70745579
Erythema elevatum diutinum 18.18 12.50 4 58528 15 70869897
Ultrasound scan abnormal 18.18 12.50 7 58525 232 70869680
Pubertal failure 18.18 12.50 4 58528 15 70869897
Blood lactate dehydrogenase increased 18.13 12.50 67 58465 35060 70834852
Balance disorder 18.08 12.50 29 58503 90099 70779813
CD4 lymphocytes 17.98 12.50 4 58528 16 70869896
AIDS related complication 17.96 12.50 5 58527 57 70869855
Pneumonia aspiration 17.94 12.50 15 58517 62274 70807638
Visual field defect 17.93 12.50 28 58504 8410 70861502
Pneumonia 17.86 12.50 366 58166 595866 70274046
Brain oedema 17.83 12.50 51 58481 23367 70846545
Amylase increased 17.82 12.50 31 58501 10177 70859735
Foetal growth abnormality 17.78 12.50 4 58528 17 70869895
Clostridium difficile infection 17.75 12.50 5 58527 38811 70831101
Localised infection 17.74 12.50 3 58529 33155 70836757
Trisomy 21 17.73 12.50 5 58527 60 70869852
Therapeutic product effect incomplete 17.73 12.50 46 58486 119836 70750076
Red blood cell sedimentation rate increased 17.63 12.50 5 58527 38637 70831275
Astrocytoma, low grade 17.61 12.50 6 58526 139 70869773
Post inflammatory pigmentation change 17.51 12.50 8 58524 409 70869503
Disseminated Bacillus Calmette-Guerin infection 17.41 12.50 7 58525 261 70869651
Paraparesis 17.28 12.50 18 58514 3611 70866301
Renal atrophy 17.23 12.50 13 58519 1704 70868208
Paraesthesia 17.14 12.50 62 58470 145475 70724437
Anal cancer stage 0 17.09 12.50 4 58528 21 70869891
Meningomyelocele 17.09 12.50 4 58528 21 70869891
Plasmodium falciparum infection 17.09 12.50 5 58527 69 70869843
Bone pain 17.00 12.50 85 58447 50737 70819175
Disease progression 16.99 12.50 69 58463 156603 70713309
Product use in unapproved indication 16.95 12.50 101 58431 207377 70662535
Albuminuria 16.79 12.50 9 58523 651 70869261
Illness 16.73 12.50 3 58529 31788 70838124
Drug dependence 16.71 12.50 5 58527 37316 70832596
Red blood cells urine 16.70 12.50 9 58523 658 70869254
Dry skin 16.69 12.50 13 58519 55918 70813994
Gestational hypertension 16.69 12.50 13 58519 1787 70868125
ADAMTS13 activity decreased 16.68 12.50 6 58526 164 70869748
Vomiting 16.67 12.50 622 57910 592489 70277423
Hypersplenism 16.65 12.50 8 58524 459 70869453
Benign hepatic neoplasm 16.58 12.50 5 58527 77 70869835
Neurosyphilis 16.50 12.50 4 58528 25 70869887
Dehydration 16.48 12.50 114 58418 226028 70643884
Blood uric acid decreased 16.48 12.50 11 58521 1189 70868723
Cleft lip and palate 16.37 12.50 6 58526 173 70869739
Ultrasound antenatal screen abnormal 16.29 12.50 5 58527 82 70869830
Blood pressure systolic increased 16.23 12.50 14 58518 57245 70812667
Kwashiorkor 16.23 12.50 3 58529 3 70869909
Cervix operation 16.23 12.50 3 58529 3 70869909
Funisitis 16.23 12.50 3 58529 3 70869909
Hepatitis B DNA decreased 16.23 12.50 3 58529 3 70869909
Hyperhidrosis 16.20 12.50 55 58477 131531 70738381
Influenza like illness 16.18 12.50 18 58514 65313 70804599
Portal vein thrombosis 16.13 12.50 21 58511 5341 70864571
Product prescribing error 16.08 12.50 6 58526 38946 70830966
Hydrocephalus 16.04 12.50 26 58506 8059 70861853
Drug reaction with eosinophilia and systemic symptoms 15.99 12.50 92 58440 57921 70811991
Breast cancer 15.95 12.50 4 58528 33545 70836367
Eclampsia 15.87 12.50 6 58526 189 70869723
Musculoskeletal toxicity 15.87 12.50 6 58526 189 70869723
Insomnia 15.77 12.50 110 58422 217696 70652216
Viral hepatitis carrier 15.75 12.50 4 58528 31 70869881
Spermatozoa progressive motility abnormal 15.75 12.50 4 58528 31 70869881
Choroiditis 15.67 12.50 11 58521 1290 70868622
Mobility decreased 15.63 12.50 39 58493 102960 70766952
Rectal haemorrhage 15.38 12.50 19 58513 65812 70804100
Acute hepatic failure 15.32 12.50 54 58478 27618 70842294
Eyelid oedema 15.29 12.50 33 58499 12694 70857218
International normalised ratio increased 15.25 12.50 27 58505 80699 70789213
Heart rate irregular 15.24 12.50 3 58529 29740 70840172
Blood pressure decreased 15.22 12.50 33 58499 91482 70778430
Limb discomfort 15.22 12.50 3 58529 29702 70840210
Anogenital dysplasia 15.18 12.50 5 58527 104 70869808
Cardiac failure 15.08 12.50 64 58468 143477 70726435
Ovarian failure 15.04 12.50 8 58524 570 70869342
Acute fatty liver of pregnancy 15.03 12.50 4 58528 38 70869874
Dyspnoea exertional 15.02 12.50 26 58506 78404 70791508
Visual impairment 15.01 12.50 27 58505 80223 70789689
Infected vasculitis 15.01 12.50 3 58529 6 70869906
Carbon dioxide combining power abnormal 15.01 12.50 3 58529 6 70869906
Hyperbilirubinaemia neonatal 15.01 12.50 3 58529 6 70869906
Hydromyelia 15.01 12.50 3 58529 6 70869906
Glycocholic acid increased 15.01 12.50 3 58529 6 70869906
Glomerulonephritis proliferative 14.97 12.50 7 58525 378 70869534
Developmental delay 14.92 12.50 10 58522 1088 70868824
Hyperphosphataemia 14.86 12.50 18 58514 4258 70865654
Portal fibrosis 14.83 12.50 8 58524 586 70869326
Plasmablastic lymphoma 14.78 12.50 8 58524 590 70869322
Hepatic necrosis 14.76 12.50 26 58506 8620 70861292
Musculoskeletal pain 14.67 12.50 33 58499 90294 70779618
Upper respiratory tract infection 14.54 12.50 27 58505 79247 70790665
Crystal urine 14.51 12.50 5 58527 120 70869792
Lipase increased 14.43 12.50 36 58496 15210 70854702
Osteocalcin increased 14.41 12.50 3 58529 8 70869904
Atypical mycobacterial infection 14.40 12.50 11 58521 1469 70868443
Renal tubular necrosis 14.40 12.50 47 58485 23124 70846788
Colitis ulcerative 14.39 12.50 5 58527 33918 70835994
Myopia 14.34 12.50 12 58520 1825 70868087
Antiviral drug level below therapeutic 14.34 12.50 4 58528 46 70869866
Portal vein occlusion 14.34 12.50 4 58528 46 70869866
CSF protein increased 14.33 12.50 10 58522 1162 70868750
Acute stress disorder 14.29 12.50 7 58525 419 70869493
Basal cell carcinoma 14.23 12.50 5 58527 33693 70836219
Distributive shock 14.22 12.50 13 58519 2224 70867688
Secondary adrenocortical insufficiency 14.19 12.50 14 58518 2633 70867279
Antiviral drug level above therapeutic 14.18 12.50 4 58528 48 70869864
Graft infection 14.16 12.50 8 58524 642 70869270
Necrotising enterocolitis neonatal 14.15 12.50 3 58529 9 70869903
Acute lymphocytic leukaemia 14.08 12.50 20 58512 5525 70864387
Pathological fracture 14.07 12.50 27 58505 9556 70860356
Carnitine deficiency 14.03 12.50 6 58526 262 70869650
Blood creatine phosphokinase MB increased 13.97 12.50 14 58518 2683 70867229
Hypoalbuminaemia 13.93 12.50 41 58491 19081 70850831
Acute hepatitis B 13.93 12.50 7 58525 443 70869469
Cholestasis 13.91 12.50 77 58455 47795 70822117
Wrong technique in product usage process 13.88 12.50 22 58510 68676 70801236
Dry mouth 13.82 12.50 23 58509 70434 70799478
Pharyngotonsillitis 13.81 12.50 6 58526 272 70869640
Multiple fractures 13.76 12.50 22 58510 6743 70863169
Ear pain 13.70 12.50 3 58529 27596 70842316
Osteodystrophy 13.69 12.50 3 58529 11 70869901
Ill-defined disorder 13.65 12.50 15 58517 54726 70815186
Subacute sclerosing panencephalitis 13.62 12.50 4 58528 56 70869856
Genital ulceration 13.61 12.50 8 58524 691 70869221
Cervical dysplasia 13.58 12.50 12 58520 1964 70867948
Optic neuropathy 13.57 12.50 15 58517 3218 70866694
Pneumonitis 13.57 12.50 15 58517 54582 70815330
Acute on chronic liver failure 13.51 12.50 6 58526 287 70869625
Hypervolaemia 13.49 12.50 8 58524 39698 70830214
Colour vision tests abnormal 13.48 12.50 3 58529 12 70869900
Cytomegalovirus oesophagitis 13.48 12.50 8 58524 704 70869208
Cerebellar syndrome 13.48 12.50 19 58513 5212 70864700
Pleocytosis 13.47 12.50 10 58522 1279 70868633
Burkitt's lymphoma 13.46 12.50 5 58527 150 70869762
Prurigo 13.45 12.50 10 58522 1283 70868629
Anaphylactic shock 13.42 12.50 5 58527 32485 70837427
Gastrointestinal haemorrhage 13.39 12.50 63 58469 137345 70732567
Macrocephaly 13.36 12.50 4 58528 60 70869852
Emotional distress 13.35 12.50 7 58525 37181 70832731
Heart rate increased 13.32 12.50 44 58488 106104 70763808
Colitis 13.31 12.50 20 58512 63794 70806118
Spermatozoa progressive motility decreased 13.30 12.50 4 58528 61 70869851
Disseminated intravascular coagulation 13.29 12.50 59 58473 33539 70836373
Dry eye 13.28 12.50 5 58527 32277 70837635
Bovine tuberculosis 13.27 12.50 5 58527 156 70869756
Trimethylaminuria 13.18 12.50 5 58527 159 70869753
Acute HIV infection 13.18 12.50 4 58528 63 70869849
Subchondral insufficiency fracture 13.18 12.50 4 58528 63 70869849
Hyperintensity in brain deep nuclei 13.07 12.50 4 58528 65 70869847
Melanaemia 13.07 12.50 4 58528 65 70869847
Spinal cord injury 13.05 12.50 9 58523 1026 70868886
Cystostomy 13.01 12.50 4 58528 66 70869846
Abdominal pain upper 12.94 12.50 100 58432 193502 70676410
Congenital diaphragmatic hernia 12.94 12.50 3 58529 15 70869897
Hepatitis D RNA positive 12.94 12.50 3 58529 15 70869897
Agitation 12.93 12.50 37 58495 93338 70776574
Herpes virus infection 12.83 12.50 21 58511 6563 70863349
Vaccination failure 12.78 12.50 10 58522 1383 70868529
Syphilis 12.76 12.50 7 58525 530 70869382
Interstitial lung disease 12.72 12.50 44 58488 104641 70765271
Hypertension 12.70 12.50 170 58362 295863 70574049
Hyperuricaemia 12.68 12.50 28 58504 10938 70858974
Multiple organ dysfunction syndrome 12.58 12.50 141 58391 108374 70761538
Neuroleptic malignant syndrome 12.56 12.50 3 58529 26004 70843908
Bone marrow oedema 12.52 12.50 10 58522 1425 70868487
Therapeutic response decreased 12.50 12.50 18 58514 58435 70811477

FDA Adverse Event Reporting System (Pediatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Neutropenia 37.65 36.60 22 638 195 88937

Pharmacologic Action:

SourceCodeDescription
ATC J05AF05 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Nucleoside and nucleotide reverse transcriptase inhibitors
ATC J05AR01 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HIV infections, combinations
ATC J05AR02 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HIV infections, combinations
ATC J05AR04 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HIV infections, combinations
ATC J05AR05 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HIV infections, combinations
ATC J05AR07 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HIV infections, combinations
ATC J05AR11 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HIV infections, combinations
ATC J05AR12 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HIV infections, combinations
ATC J05AR13 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HIV infections, combinations
ATC J05AR16 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HIV infections, combinations
ATC J05AR24 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HIV infections, combinations
ATC J05AR25 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HIV infections, combinations
ATC J05AR27 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HIV infections, combinations
FDA MoA N0000009947 Nucleoside Reverse Transcriptase Inhibitors
FDA EPC N0000175462 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
FDA EPC N0000175656 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor
CHEBI has role CHEBI:36044 antiviral drugs
CHEBI has role CHEBI:50266 Prodrugs
CHEBI has role CHEBI:50904 alergeno
CHEBI has role CHEBI:53756 reverse transcriptase inhibitors
CHEBI has role CHEBI:64951 anti-HBV agents
MeSH PA D019380 Anti-HIV Agents
MeSH PA D000890 Anti-Infective Agents
MeSH PA D044966 Anti-Retroviral Agents
MeSH PA D000998 Antiviral Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D019384 Nucleic Acid Synthesis Inhibitors
MeSH PA D018894 Reverse Transcriptase Inhibitors

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

DiseaseRelationSNOMED_IDDOID
Chronic type B viral hepatitis indication 61977001
Human immunodeficiency virus infection indication 86406008 DOID:526
Prevention of Hepatitis B Reactivation in Immunocompromised Patients off-label use
Prevention of HIV Infection after Exposure off-label use
Toxic amblyopia contraindication 965003
Myositis contraindication 26889001 DOID:633
Hepatic failure contraindication 59927004
Pancreatitis contraindication 75694006 DOID:4989
Large liver contraindication 80515008
Kidney disease contraindication 90708001 DOID:557
Lactic acidosis contraindication 91273001 DOID:3650
Disorder of muscle contraindication 129565002 DOID:423
Steatosis of liver contraindication 197321007
Acute pancreatitis contraindication 197456007 DOID:2913
Chronic pancreatitis contraindication 235494005
Disease of liver contraindication 235856003 DOID:409
Anemia contraindication 271737000 DOID:2355
Hypertriglyceridemia contraindication 302870006
Neutropenic disorder contraindication 303011007 DOID:1227
Bone marrow depression contraindication 307762000
Breastfeeding (mother) contraindication 413712001
Obesity contraindication 414916001 DOID:9970
Drug Resistance to Anti-retroviral Therapy contraindication
HLA-B 5701 Positive Status contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 12.95 acidic
pKa2 4.18 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
150MG;EQ 300MG BASE DUTREBIS MERCK SHARP DOHME N206510 Feb. 6, 2015 DISCN TABLET ORAL 7217713 Oct. 21, 2022 TREATMENT OF HIV-1 INFECTION
150MG;EQ 300MG BASE DUTREBIS MERCK SHARP DOHME N206510 Feb. 6, 2015 DISCN TABLET ORAL 7435734 Oct. 21, 2022 TREATMENT OF HIV-1 INFECTION
150MG;EQ 300MG BASE DUTREBIS MERCK SHARP DOHME N206510 Feb. 6, 2015 DISCN TABLET ORAL 7754731 March 11, 2029 TREATMENT OF HIV-1 INFECTION
EQ 50MG BASE;300MG DOVATO VIIV HLTHCARE N211994 April 8, 2019 RX TABLET ORAL 11234985 Jan. 24, 2031 TREATMENT OF HIV INFECTION
100MG;300MG;300MG DELSTRIGO MSD MERCK CO N210807 Aug. 30, 2018 RX TABLET ORAL 8486975 Oct. 7, 2031 FOR THE TREATMENT OF HIV-1 INFECTION IN ADULT PATIENTS WITH NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY
100MG;300MG;300MG DELSTRIGO MSD MERCK CO N210807 Aug. 30, 2018 RX TABLET ORAL 8486975 Oct. 7, 2031 TREATMENT OF HIV-1 INFECTION IN ADULT PATIENTS AS A REPLACEMENT THERAPY IN VIROLOGICALLY SUPPRESSED ADULTS WITH NO HISTORY OF TREATMENT FAILURE AND NO KNOWN SUBSTITUTIONS ASSOCIATED WITH RESISTANCE TO THE INDIVIDUAL COMPONENTS OF DELSTRIGO
100MG;300MG;300MG DELSTRIGO MSD MERCK CO N210807 Aug. 30, 2018 RX TABLET ORAL 8486975 Oct. 7, 2031 TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS WEIGHING AT LEAST 35KG WITH NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR TO REPLACE THE CURRENT ANTIRETROVIRAL REGIMEN IN THOSE WHO ARE VIROLOGICALLY SUPPRESSED

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 50MG BASE;300MG DOVATO VIIV HLTHCARE N211994 April 8, 2019 RX TABLET ORAL April 8, 2022 NEW COMBINATION
100MG;300MG;300MG DELSTRIGO MSD MERCK CO N210807 Aug. 30, 2018 RX TABLET ORAL Sept. 19, 2022 EXPANDED INDICATION FOR PTS WHO ARE VIROLOGICALLY SUPPRESSED (HIV-1 RNA LESS THAN 50 COPIES/ML) ON A STABLE ARV REGIMEN WITH NO HX OF TX FAILURE AND NO KNOWN SUBSTITUTIONS ASSOCIATED W RESISTANCE TO DORAVIRINE, LAMIVUDINE OR TENOFOVIR DISOPROXIL FUMARATE
EQ 50MG BASE;300MG DOVATO VIIV HLTHCARE N211994 April 8, 2019 RX TABLET ORAL Aug. 6, 2023 TO REPLACE THE CURRENT ANTIRETROVIRAL REGIMEN IN THOSE WHO ARE VIROLOGICALLY SUPRESSED (HIV-1 RNA LESS THAN 50 COPIES PER ML) ON A STABLE ANTIRETROVIRAL REGIMEN WITH NO HISTORY OF TREATMENT FAILURE
100MG;300MG;300MG DELSTRIGO MSD MERCK CO N210807 Aug. 30, 2018 RX TABLET ORAL Aug. 30, 2023 NEW CHEMICAL ENTITY
100MG;300MG;300MG DELSTRIGO MSD MERCK CO N210807 Aug. 30, 2018 RX TABLET ORAL Jan. 27, 2025 NEW PATIENT POPULATION

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Deoxycytidine kinase Kinase WOMBAT-PK
Protein P Polyprotein INHIBITOR CHEMBL CHEMBL
Reverse transcriptase/RNaseH Enzyme INHIBITOR EC50 7.38 CHEMBL CHEMBL
Capsid protein Unclassified EC50 6.43 CHEMBL

External reference:

IDSource
4020938 VUID
N0000148418 NUI
D00353 KEGG_DRUG
4020938 VANDF
C0209738 UMLSCUI
CHEBI:63577 CHEBI
3TC PDB_CHEM_ID
CHEMBL141 ChEMBL_ID
DB00709 DRUGBANK_ID
D019259 MESH_DESCRIPTOR_UI
60825 PUBCHEM_CID
6908 INN_ID
2T8Q726O95 UNII
68244 RXNORM
186277 MMSL
4956 MMSL
d03858 MMSL
005079 NDDF
108698001 SNOMEDCT_US
386897000 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
DELSTRIGO HUMAN PRESCRIPTION DRUG LABEL 3 0006-5007 TABLET, FILM COATED 300 mg ORAL NDA 32 sections
DELSTRIGO HUMAN PRESCRIPTION DRUG LABEL 3 0006-5007 TABLET, FILM COATED 300 mg ORAL NDA 32 sections
EPIVIRHBV HUMAN PRESCRIPTION DRUG LABEL 1 0173-0662 TABLET, FILM COATED 100 mg ORAL NDA 26 sections
EPIVIRHBV HUMAN PRESCRIPTION DRUG LABEL 1 0173-0663 SOLUTION 5 mg ORAL NDA 26 sections
LAMIVUDINE HUMAN PRESCRIPTION DRUG LABEL 1 0904-6583 TABLET, FILM COATED 150 mg ORAL ANDA 27 sections
Lamivudine HUMAN PRESCRIPTION DRUG LABEL 1 10135-605 SOLUTION 10 mg ORAL ANDA 25 sections
Combivir HUMAN PRESCRIPTION DRUG LABEL 2 16590-061 TABLET, FILM COATED 150 mg ORAL NDA 16 sections
EPIVIR HUMAN PRESCRIPTION DRUG LABEL 1 21695-367 TABLET, FILM COATED 150 mg ORAL NDA 26 sections
COMBIVIR HUMAN PRESCRIPTION DRUG LABEL 2 21695-846 TABLET, FILM COATED 150 mg ORAL NDA 26 sections
Lamivudine and Zidovudine HUMAN PRESCRIPTION DRUG LABEL 2 21695-996 TABLET, FILM COATED 150 mg ORAL ANDA 26 sections
lamivudine Human Prescription Drug Label 1 31722-001 TABLET, FILM COATED 100 mg ORAL ANDA 25 sections
LAMIVUDINE and ZIDOVUDINE Human Prescription Drug Label 2 31722-506 TABLET, FILM COATED 150 mg ORAL ANDA 25 sections
LAMIVUDINE and ZIDOVUDINE Human Prescription Drug Label 2 31722-506 TABLET, FILM COATED 150 mg ORAL ANDA 25 sections
Lamivudine and Zidovudine HUMAN PRESCRIPTION DRUG LABEL 2 31722-739 TABLET, FILM COATED 150 mg ORAL ANDA 24 sections
Lamivudine Human Prescription Drug Label 1 31722-752 TABLET, FILM COATED 100 mg ORAL ANDA 28 sections
Lamivudine Human Prescription Drug Label 1 31722-753 TABLET, FILM COATED 150 mg ORAL ANDA 25 sections
Lamivudine Human Prescription Drug Label 1 31722-754 TABLET, FILM COATED 300 mg ORAL ANDA 25 sections
Lamivudine Human Prescription Drug Label 1 33342-001 TABLET, FILM COATED 150 mg ORAL ANDA 26 sections
Lamivudine Human Prescription Drug Label 1 33342-002 TABLET, FILM COATED 300 mg ORAL ANDA 26 sections
Lamivudine and Zidovudine Human Prescription Drug Label 2 33342-003 TABLET 150 mg ORAL ANDA 25 sections
Lamivudine and Zidovudine Human Prescription Drug Label 2 33342-003 TABLET 150 mg ORAL ANDA 25 sections
Abacavir and Lamivudine Human Prescription Drug Label 2 35573-402 TABLET, FILM COATED 300 mg ORAL ANDA 29 sections
Abacavir and Lamivudine Human Prescription Drug Label 2 35573-430 TABLET, FILM COATED 300 mg ORAL ANDA 27 sections
Abacavir and Lamivudine Human Prescription Drug Label 2 35573-430 TABLET, FILM COATED 300 mg ORAL ANDA 27 sections
Abacavir and Lamivudine HUMAN PRESCRIPTION DRUG LABEL 2 42291-115 TABLET, FILM COATED 300 mg ORAL ANDA 28 sections
Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Human Prescription Drug Label 3 42385-928 TABLET, FILM COATED 300 mg ORAL ANDA 30 sections
Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Human Prescription Drug Label 3 42385-929 TABLET, FILM COATED 300 mg ORAL ANDA 30 sections
Abacavir and Lamivudine Human Prescription Drug Label 2 42385-962 TABLET, FILM COATED 300 mg ORAL ANDA 28 sections
LAMIVUDINE and ZIDOVUDINE HUMAN PRESCRIPTION DRUG LABEL 2 43063-900 TABLET, FILM COATED 150 mg ORAL ANDA 25 sections
LAMIVUDINE and ZIDOVUDINE HUMAN PRESCRIPTION DRUG LABEL 2 43063-900 TABLET, FILM COATED 150 mg ORAL ANDA 25 sections