lamivudine 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 ┬ÁM/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

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 2743.51 15.53 1372 30350 106840 46547500
Abortion spontaneous 1607.30 15.53 718 31004 42928 46611412
Virologic failure 1351.53 15.53 307 31415 1748 46652592
Foetal exposure during pregnancy 1320.34 15.53 564 31158 30183 46624157
Viral mutation identified 1266.70 15.53 287 31435 1612 46652728
Stillbirth 1143.48 15.53 340 31382 6151 46648189
Drug resistance 1119.86 15.53 427 31295 16941 46637399
Pathogen resistance 822.96 15.53 260 31462 5800 46648540
Abortion induced 788.18 15.53 287 31435 9973 46644367
Immune reconstitution inflammatory syndrome 778.96 15.53 246 31476 5479 46648861
Maternal exposure during pregnancy 770.31 15.53 602 31120 101947 46552393
Live birth 566.43 15.53 226 31496 10104 46644236
Premature baby 519.05 15.53 251 31471 17861 46636479
Pregnancy 466.05 15.53 267 31455 26870 46627470
Foetal death 406.54 15.53 170 31552 8573 46645767
Caesarean section 404.25 15.53 206 31516 16397 46637943
Lipodystrophy acquired 391.80 15.53 107 31615 1398 46652942
Blood HIV RNULL increased 337.23 15.53 81 31641 606 46653734
Fanconi syndrome acquired 248.08 15.53 68 31654 901 46653439
Congenital umbilical hernia 243.11 15.53 58 31664 420 46653920
Foetal growth restriction 228.09 15.53 104 31618 6463 46647877
Premature rupture of membranes 219.07 15.53 90 31632 4333 46650007
Premature delivery 217.67 15.53 153 31569 21916 46632424
Premature labour 206.84 15.53 116 31606 11183 46643157
Hepatitis B reactivation 193.21 15.53 62 31660 1452 46652888
Hepatotoxicity 187.43 15.53 147 31575 24862 46629478
HIV infection 186.68 15.53 49 31673 544 46653796
Maternal drugs affecting foetus 174.83 15.53 82 31640 5436 46648904
Hepatitis B 165.58 15.53 70 31652 3623 46650717
CD4 lymphocytes decreased 161.60 15.53 55 31667 1555 46652785
Treatment noncompliance 159.27 15.53 144 31578 29587 46624753
Viral load increased 157.98 15.53 52 31670 1323 46653017
Normal newborn 153.41 15.53 77 31645 5924 46648416
Mitochondrial toxicity 145.28 15.53 36 31686 311 46654029
Fall 135.98 15.53 29 31693 329068 46325272
Pre-eclampsia 135.34 15.53 78 31644 7916 46646424
Pain 131.70 15.53 81 31641 476867 46177473
Rheumatoid arthritis 128.52 15.53 9 31713 240206 46414134
Drug ineffective 127.59 15.53 165 31557 677673 45976667
Birth mark 126.50 15.53 30 31692 211 46654129
Acquired gene mutation 124.80 15.53 36 31686 580 46653760
Hyperbilirubinaemia 121.02 15.53 80 31642 10358 46643982
Blood bilirubin increased 120.76 15.53 132 31590 34052 46620288
Trisomy 21 115.74 15.53 31 31691 374 46653966
Hypomania 114.21 15.53 57 31665 4331 46650009
Jaundice cholestatic 109.70 15.53 58 31664 4971 46649369
Fatigue 108.53 15.53 154 31568 608543 46045797
Mitochondrial cytopathy 104.61 15.53 27 31695 279 46654061
Hepatitis B DNULL increased 103.83 15.53 25 31697 189 46654151
Genotype drug resistance test positive 101.95 15.53 30 31692 520 46653820
Fanconi syndrome 101.09 15.53 34 31688 926 46653414
Human immunodeficiency virus transmission 101.00 15.53 21 31701 72 46654268
Anaemia 96.52 15.53 386 31336 255393 46398947
Ectopic pregnancy 93.15 15.53 42 31680 2540 46651800
Lipoatrophy 91.84 15.53 25 31697 322 46654018
Polydactyly 89.92 15.53 25 31697 350 46653990
Hyperlactacidaemia 86.22 15.53 38 31684 2177 46652163
Schizophrenia 85.83 15.53 60 31662 8508 46645832
Osteomalacia 84.22 15.53 27 31695 630 46653710
Oligohydramnios 83.75 15.53 50 31672 5415 46648925
Ventricular septal defect 83.69 15.53 45 31677 3989 46650351
Atrial septal defect 81.93 15.53 52 31670 6280 46648060
Hypophosphataemia 81.87 15.53 55 31667 7312 46647028
Placental disorder 81.27 15.53 32 31690 1377 46652963
Congenital anomaly 77.88 15.53 32 31690 1540 46652800
Congenital naevus 77.72 15.53 20 31702 204 46654136
Lactic acidosis 77.40 15.53 105 31617 33804 46620536
Off label use 76.95 15.53 87 31635 379754 46274586
Joint swelling 76.40 15.53 11 31711 166062 46488278
Peripheral swelling 76.24 15.53 9 31713 158062 46496278
Jaundice 76.22 15.53 96 31626 28749 46625591
Nasopharyngitis 76.22 15.53 8 31714 153990 46500350
Portal hypertension 75.49 15.53 40 31682 3443 46650897
Premature separation of placenta 74.96 15.53 32 31690 1696 46652644
Renal tubular disorder 73.08 15.53 35 31687 2430 46651910
Proteinuria 72.98 15.53 72 31650 16481 46637859
Acoustic stimulation tests abnormal 72.64 15.53 17 31705 112 46654228
Ectopic kidney 72.61 15.53 16 31706 77 46654263
Pain in extremity 72.50 15.53 43 31679 258637 46395703
Amniotic cavity infection 72.35 15.53 28 31694 1150 46653190
Drug interaction 72.16 15.53 301 31421 202793 46451547
Nephropathy toxic 71.88 15.53 51 31671 7403 46646937
Low birth weight baby 71.24 15.53 45 31677 5389 46648951
Glycosuria 71.14 15.53 27 31695 1051 46653289
Alpha 1 foetoprotein abnormal 70.53 15.53 15 31707 59 46654281
Twin pregnancy 68.74 15.53 27 31695 1154 46653186
Supernumerary nipple 67.60 15.53 15 31707 75 46654265
Renal tubular dysfunction 67.12 15.53 19 31703 285 46654055
Malaria 66.69 15.53 18 31704 224 46654116
Low set ears 63.53 15.53 18 31704 271 46654069
Congenital skin dimples 63.49 15.53 16 31706 149 46654191
Fat tissue increased 62.68 15.53 21 31701 565 46653775
Blood lactic acid increased 62.30 15.53 42 31680 5615 46648725
Placental insufficiency 62.24 15.53 26 31696 1305 46653035
Gestational diabetes 61.90 15.53 46 31676 7173 46647167
Patent ductus arteriosus 60.92 15.53 36 31686 3826 46650514
Foetal distress syndrome 60.36 15.53 25 31697 1228 46653112
Small for dates baby 60.26 15.53 35 31687 3602 46650738
Completed suicide 59.85 15.53 13 31709 145907 46508433
Constipation 59.43 15.53 22 31700 174075 46480265
Psychotic disorder 59.31 15.53 75 31647 22546 46631794
Arthralgia 59.21 15.53 98 31624 364505 46289835
Hypertriglyceridaemia 57.26 15.53 40 31682 5664 46648676
Retinoblastoma 56.69 15.53 14 31708 119 46654221
Infusion related reaction 56.44 15.53 3 31719 101205 46553135
Neural tube defect 55.70 15.53 15 31707 185 46654155
Dyspnoea 54.34 15.53 175 31547 515373 46138967
Ergot poisoning 53.69 15.53 15 31707 214 46654126
Product dose omission issue 53.13 15.53 24 31698 168496 46485844
Pulmonary tuberculosis 51.80 15.53 35 31687 4696 46649644
Multiple-drug resistance 51.50 15.53 28 31694 2537 46651803
Meningitis cryptococcal 51.40 15.53 22 31700 1173 46653167
Rash maculo-papular 51.40 15.53 78 31644 27796 46626544
Hepatic enzyme increased 50.73 15.53 146 31576 81641 46572699
Hepatitis 49.57 15.53 83 31639 32132 46622208
Drug hypersensitivity 49.12 15.53 56 31666 243769 46410571
Sinusitis 48.50 15.53 14 31708 129754 46524586
Alopecia 46.88 15.53 26 31696 162388 46491952
Cleft lip and palate 46.83 15.53 15 31707 349 46653991
Umbilical cord abnormality 46.78 15.53 17 31705 585 46653755
Ultrasound antenatal screen abnormal 45.73 15.53 12 31710 133 46654207
Anaemia macrocytic 45.20 15.53 26 31696 2627 46651713
Atrial fibrillation 45.05 15.53 8 31714 103582 46550758
Alanine aminotransferase increased 44.70 15.53 147 31575 88304 46566036
Hepatomegaly 44.21 15.53 46 31676 11207 46643133
Stevens-Johnson syndrome 44.10 15.53 66 31656 23231 46631109
Feeling abnormal 44.04 15.53 15 31707 125045 46529295
Influenza 43.23 15.53 5 31717 89265 46565075
Pregnancy on contraceptive 43.11 15.53 19 31703 1088 46653252
Urinary tract infection 42.84 15.53 52 31670 220214 46434126
Cholestasis of pregnancy 42.84 15.53 19 31703 1105 46653235
Hepatic failure 42.26 15.53 79 31643 33337 46621003
Tuberculosis 42.21 15.53 43 31679 10222 46644118
Ultrasound scan abnormal 41.88 15.53 13 31709 272 46654068
Arthritis 40.98 15.53 3 31719 77313 46577027
Aspartate aminotransferase increased 40.85 15.53 132 31590 78568 46575772
Diarrhoea 40.82 15.53 219 31503 559383 46094957
Back pain 40.41 15.53 50 31672 209989 46444351
Ocular icterus 40.02 15.53 27 31695 3613 46650727
HIV-associated neurocognitive disorder 39.90 15.53 11 31711 149 46654191
Mitochondrial DNULL deletion 39.74 15.53 7 31715 6 46654334
Abdominal discomfort 39.73 15.53 27 31695 151138 46503202
Polyhydramnios 37.87 15.53 21 31701 1978 46652362
Contusion 37.52 15.53 7 31715 87480 46566860
Gene mutation 37.16 15.53 17 31705 1063 46653277
Benign hydatidiform mole 37.16 15.53 10 31712 123 46654217
Therapeutic product effect decreased 36.75 15.53 6 31716 82595 46571745
Cerebral toxoplasmosis 36.72 15.53 15 31707 711 46653629
Gastroschisis 36.68 15.53 11 31711 204 46654136
Placenta praevia 36.66 15.53 16 31706 895 46653445
Psoriasis 36.60 15.53 5 31717 78599 46575741
Cleft palate 36.56 15.53 16 31706 901 46653439
Anxiety 36.40 15.53 42 31680 181915 46472425
Dyslipidaemia 36.04 15.53 30 31692 5510 46648830
Musculoskeletal stiffness 35.83 15.53 11 31711 97982 46556358
Death neonatal 35.77 15.53 11 31711 223 46654117
Cushing's syndrome 35.66 15.53 15 31707 766 46653574
Blood pressure increased 35.51 15.53 21 31701 126645 46527695
Neutropenia neonatal 35.32 15.53 9 31713 88 46654252
Hypouricaemia 35.02 15.53 10 31712 155 46654185
Dizziness 34.09 15.53 118 31604 340296 46314044
Microcephaly 34.06 15.53 14 31708 674 46653666
Blood bilirubin unconjugated increased 34.02 15.53 12 31710 378 46653962
Immune reconstitution inflammatory syndrome associated tuberculosis 33.99 15.53 12 31710 379 46653961
Drug reaction with eosinophilia and systemic symptoms 33.85 15.53 67 31655 29481 46624859
Lymphadenopathy 33.73 15.53 72 31650 33416 46620924
Malignant neoplasm progression 33.08 15.53 3 31719 64923 46589417
Contraindicated product administered 33.01 15.53 7 31715 79940 46574400
Infection 32.33 15.53 26 31696 133566 46520774
Muscle spasms 32.33 15.53 22 31700 123091 46531249
Drug-induced liver injury 32.10 15.53 60 31662 25308 46629032
CSF HIV escape syndrome 32.06 15.53 7 31715 32 46654308
Bronchitis 31.99 15.53 16 31706 105963 46548377
AIDS related complication 31.89 15.53 7 31715 33 46654307
Malaise 31.71 15.53 117 31605 331115 46323225
Swelling 31.71 15.53 23 31699 124488 46529852
Hepatocellular injury 31.51 15.53 65 31657 29457 46624883
Skull malformation 31.39 15.53 11 31711 340 46654000
Hydrops foetalis 31.29 15.53 11 31711 343 46653997
Neonatal disorder 31.28 15.53 13 31709 644 46653696
Portal vein thrombosis 31.27 15.53 20 31702 2447 46651893
Meningomyelocele 31.21 15.53 12 31710 484 46653856
CD4 lymphocytes increased 30.80 15.53 9 31713 152 46654188
Gamma-glutamyltransferase increased 30.55 15.53 67 31655 31673 46622667
Drug intolerance 30.43 15.53 33 31689 147016 46507324
Renal failure 30.35 15.53 155 31567 113439 46540901
AIDS cholangiopathy 30.26 15.53 6 31716 15 46654325
Hepatitis A 30.12 15.53 11 31711 384 46653956
Therapeutic product effect incomplete 29.99 15.53 8 31714 78145 46576195
Ichthyosis 29.93 15.53 7 31715 46 46654294
Isosporiasis 29.80 15.53 7 31715 47 46654293
Hepatic necrosis 29.72 15.53 27 31695 5574 46648766
Transaminases increased 29.49 15.53 61 31661 27700 46626640
Hepatosplenomegaly 29.22 15.53 19 31703 2391 46651949
Anembryonic gestation 29.21 15.53 12 31710 577 46653763
Congenital hydrocephalus 29.11 15.53 8 31714 107 46654233
Left ventricular dilatation 28.91 15.53 10 31712 297 46654043
Cardiac malposition 28.83 15.53 7 31715 55 46654285
Gestational hypertension 28.63 15.53 18 31704 2137 46652203
Placental infarction 28.63 15.53 10 31712 306 46654034
Abortion missed 28.38 15.53 16 31706 1556 46652784
Arnold-Chiari malformation 28.37 15.53 11 31711 454 46653886
Acute hepatic failure 28.28 15.53 42 31680 14679 46639661
Headache 28.16 15.53 200 31522 478152 46176188
Hyperhidrosis 27.69 15.53 13 31709 89295 46565045
Thrombosis 27.49 15.53 3 31719 56066 46598274
Somnolence 27.31 15.53 40 31682 156481 46497859
Talipes 27.26 15.53 15 31707 1392 46652948
Migraine 27.19 15.53 7 31715 70019 46584321
Cervix operation 27.10 15.53 5 31717 7 46654333
Developmental delay 26.82 15.53 14 31708 1168 46653172
Liver transplant 26.74 15.53 18 31704 2399 46651941
Toxicity to various agents 26.55 15.53 66 31656 211700 46442640
Alpha 1 foetoprotein increased 26.35 15.53 8 31714 155 46654185
Necrotising colitis 26.31 15.53 11 31711 553 46653787
Ballismus 26.24 15.53 7 31715 83 46654257
Intentional overdose 26.18 15.53 6 31716 64938 46589402
Lymph node tuberculosis 25.94 15.53 12 31710 770 46653570
Cholelithiasis 25.87 15.53 71 31651 38610 46615730
Wheezing 25.81 15.53 3 31719 53383 46600957
Renal tubular acidosis 25.61 15.53 15 31707 1568 46652772
Cellulitis 25.49 15.53 8 31714 70280 46584060
Tuberculoma of central nervous system 25.21 15.53 9 31713 294 46654046
Bicuspid pulmonary valve 25.18 15.53 4 31718 0 46654340
Infertility 24.94 15.53 11 31711 631 46653709
Spina bifida 24.59 15.53 11 31711 653 46653687
Ovarian failure 24.53 15.53 13 31709 1119 46653221
Double outlet right ventricle 24.51 15.53 6 31716 49 46654291
Asthma 24.51 15.53 16 31706 91526 46562814
Breech delivery 24.40 15.53 6 31716 50 46654290
Ascites 24.32 15.53 67 31655 36517 46617823
Flushing 24.07 15.53 7 31715 64607 46589733
Prenatal screening test abnormal 23.86 15.53 5 31717 18 46654322
Funisitis 23.86 15.53 5 31717 18 46654322
Postpartum haemorrhage 23.85 15.53 15 31707 1782 46652558
Hepatitis B surface antigen positive 23.70 15.53 6 31716 57 46654283
Hyperphosphaturia 23.65 15.53 5 31717 19 46654321
Plagiocephaly 23.42 15.53 6 31716 60 46654280
Cervical dysplasia 23.42 15.53 18 31704 2951 46651389
Hepatitis C 23.35 15.53 25 31697 6293 46648047
Anaphylactic reaction 23.31 15.53 4 31718 53108 46601232
Lymphadenitis 23.23 15.53 17 31705 2588 46651752
Hypophosphataemic osteomalacia 23.19 15.53 7 31715 133 46654207
Cerebral ventricle dilatation 23.10 15.53 12 31710 991 46653349
Anaemia neonatal 23.08 15.53 8 31714 239 46654101
Neonatal aspiration 22.85 15.53 7 31715 140 46654200
Osteoarthritis 22.60 15.53 7 31715 62018 46592322
Nasal congestion 22.54 15.53 3 31719 48110 46606230
Retinal toxicity 22.34 15.53 12 31710 1061 46653279
Hepatitis B surface antibody positive 22.13 15.53 6 31716 76 46654264
Myopathy toxic 22.10 15.53 8 31714 272 46654068
Hepatic displacement 22.06 15.53 5 31717 28 46654312
Hepatitis B DNULL assay positive 22.06 15.53 5 31717 28 46654312
Kaposi's sarcoma 21.69 15.53 7 31715 167 46654173
Loss of consciousness 21.61 15.53 25 31697 108213 46546127
Cardiac arrest 21.36 15.53 18 31704 90381 46563959
Death 21.35 15.53 137 31585 335411 46318929
Delivery 21.25 15.53 10 31712 667 46653673
Uterine dilation and curettage 21.21 15.53 11 31711 906 46653434
Fallot's tetralogy 21.20 15.53 6 31716 90 46654250
Cerebral calcification 21.19 15.53 7 31715 180 46654160
Spinocerebellar disorder 21.10 15.53 5 31717 35 46654305
Cytomegalovirus chorioretinitis 21.06 15.53 13 31709 1494 46652846
Viral load decreased 20.98 15.53 5 31717 36 46654304
Metabolic acidosis 20.98 15.53 66 31656 38714 46615626
Chlamydial infection 20.80 15.53 8 31714 323 46654017
Dysmorphism 20.62 15.53 14 31708 1893 46652447
Neck pain 20.59 15.53 6 31716 55300 46599040
Pulmonary valve stenosis 20.57 15.53 8 31714 333 46654007
Foetal heart rate disorder 20.55 15.53 6 31716 101 46654239
Pleocytosis 20.53 15.53 9 31713 509 46653831
Complication of pregnancy 20.51 15.53 9 31713 510 46653830
Renal colic 20.49 15.53 12 31710 1254 46653086
Injection site reaction 20.14 15.53 4 31718 47845 46606495
Haemorrhage in pregnancy 20.14 15.53 13 31709 1615 46652725
Chest discomfort 20.10 15.53 19 31703 90250 46564090
Mental disability 20.07 15.53 6 31716 110 46654230
Oxygen saturation decreased 20.04 15.53 11 31711 69153 46585187
Diastasis recti abdominis 19.99 15.53 5 31717 45 46654295
Congenital central nervous system anomaly 19.98 15.53 8 31714 360 46653980
Spinal cord injury 19.88 15.53 9 31713 549 46653791
Hypotension 19.79 15.53 86 31636 232503 46421837
Cleft lip 19.78 15.53 6 31716 116 46654224
Disseminated Bacillus Calmette-Guerin infection 19.64 15.53 4 31718 12 46654328
Genital prolapse 19.61 15.53 5 31717 49 46654291
Hepatic encephalopathy 19.54 15.53 29 31693 10128 46644212
Fat redistribution 19.40 15.53 4 31718 13 46654327
Pubertal failure 19.40 15.53 4 31718 13 46654327
Hydrocephalus 19.27 15.53 20 31702 4857 46649483
Ultrasound uterus abnormal 19.26 15.53 5 31717 53 46654287
White blood cell count decreased 19.26 15.53 29 31693 112202 46542138
Gait disturbance 19.20 15.53 44 31678 145219 46509121
Neonatal respiratory distress syndrome 19.20 15.53 15 31707 2518 46651822
Acute fatty liver of pregnancy 19.17 15.53 4 31718 14 46654326
Chest pain 19.07 15.53 59 31663 176265 46478075
Cough 19.07 15.53 86 31636 230163 46424177
Lactate pyruvate ratio increased 19.01 15.53 5 31717 56 46654284
Dehydration 19 15.53 51 31671 159489 46494851
Carnitine deficiency 18.96 15.53 6 31716 134 46654206
Maxillonasal dysplasia 18.96 15.53 4 31718 15 46654325
Vertical infection transmission 18.89 15.53 3 31719 0 46654340
Dermatitis allergic 18.76 15.53 32 31690 12571 46641769
Bovine tuberculosis 18.69 15.53 5 31717 60 46654280
Lipase increased 18.66 15.53 26 31696 8577 46645763
Nodular regenerative hyperplasia 18.63 15.53 7 31715 265 46654075
Hypoxia 18.62 15.53 6 31716 51832 46602508
Retroplacental haematoma 18.48 15.53 6 31716 146 46654194
Foetal malformation 18.44 15.53 6 31716 147 46654193
Influenza like illness 18.44 15.53 8 31714 57562 46596778
Cerebrovascular accident 18.43 15.53 25 31697 101014 46553326
Cushingoid 18.39 15.53 22 31700 6244 46648096
Ebstein's anomaly 18.37 15.53 4 31718 18 46654322
Cardiac murmur 18.37 15.53 30 31692 11374 46642966
Bilirubin conjugated increased 18.37 15.53 15 31707 2683 46651657
Ventricular hypoplasia 18.32 15.53 6 31716 150 46654190
Osteoporosis 18.31 15.53 65 31657 40543 46613797
HELLP syndrome 18.29 15.53 10 31712 916 46653424
Loss of personal independence in daily activities 18.23 15.53 8 31714 57175 46597165
Blood pressure decreased 18.21 15.53 8 31714 57151 46597189
Placental necrosis 18.03 15.53 4 31718 20 46654320
Neutropenia 17.95 15.53 162 31560 143042 46511298
Blood creatine phosphokinase MB increased 17.94 15.53 11 31711 1250 46653090
Primary hypothyroidism 17.79 15.53 5 31717 73 46654267
Cachexia 17.75 15.53 19 31703 4780 46649560
Intentional product misuse 17.75 15.53 5 31717 47123 46607217
Thyroid tuberculosis 17.71 15.53 4 31718 22 46654318
Congenital retinoblastoma 17.71 15.53 4 31718 22 46654318
Hot flush 17.58 15.53 4 31718 43513 46610827
Diaphragmatic aplasia 17.56 15.53 4 31718 23 46654317
Pruritus 17.49 15.53 95 31627 242257 46412083
Discomfort 17.49 15.53 5 31717 46665 46607675
CSF protein increased 17.48 15.53 8 31714 501 46653839
Pharyngotonsillitis 17.42 15.53 6 31716 176 46654164
Aqueductal stenosis 17.41 15.53 4 31718 24 46654316
Hemiataxia 17.41 15.53 4 31718 24 46654316
Eclampsia 17.29 15.53 7 31715 324 46654016
Lipohypertrophy 17.11 15.53 9 31713 763 46653577
Dry mouth 17.01 15.53 8 31714 54918 46599422
Anencephaly 16.98 15.53 6 31716 190 46654150
Chronic obstructive pulmonary disease 16.94 15.53 9 31713 57624 46596716
Toxoplasmosis 16.92 15.53 11 31711 1383 46652957
Aminoaciduria 16.83 15.53 6 31716 195 46654145
Acquired aminoaciduria 16.81 15.53 3 31719 3 46654337
Brain malformation 16.76 15.53 4 31718 29 46654311
Eosinophilia 16.74 15.53 39 31683 19178 46635162
Product use issue 16.68 15.53 24 31698 94620 46559720
Pulmonary artery atresia 16.64 15.53 4 31718 30 46654310
Hepatitis acute 16.59 15.53 24 31698 8190 46646150
Pain in jaw 16.59 15.53 3 31719 38369 46615971
Threatened labour 16.59 15.53 9 31713 812 46653528
Musculoskeletal pain 16.52 15.53 14 31708 70114 46584226
Fluid retention 16.49 15.53 7 31715 51039 46603301
Weight increased 16.43 15.53 57 31665 164416 46489924
Acute stress disorder 16.38 15.53 6 31716 211 46654129
Memory impairment 16.38 15.53 17 31705 77320 46577020
Pyrexia 16.38 15.53 330 31392 348472 46305868
Acquired immunodeficiency syndrome 16.32 15.53 5 31717 100 46654240
Prolonged pregnancy 16.32 15.53 5 31717 100 46654240
Secondary hypogonadism 16.32 15.53 5 31717 100 46654240
Congenital eye disorder 16.30 15.53 4 31718 33 46654307
Developmental coordination disorder 16.30 15.53 4 31718 33 46654307
Cryptococcosis 16.27 15.53 9 31713 843 46653497
Plasma cell myeloma 16.24 15.53 5 31717 44473 46609867
Gastrooesophageal reflux disease 16.14 15.53 16 31706 74328 46580012
Visual impairment 16.10 15.53 13 31709 66676 46587664
Ureteric dilatation 16.09 15.53 4 31718 35 46654305
Respiratory distress 16.06 15.53 53 31669 31863 46622477
Hepatic cirrhosis 16.04 15.53 34 31688 15698 46638642
Pulmonary artery stenosis congenital 15.94 15.53 6 31716 228 46654112
Product size issue 15.93 15.53 7 31715 398 46653942
Micrognathia 15.89 15.53 6 31716 230 46654110
Sepsis neonatal 15.86 15.53 7 31715 402 46653938
Treatment failure 15.86 15.53 113 31609 92974 46561366
Delayed puberty 15.79 15.53 5 31717 112 46654228
Varices oesophageal 15.77 15.53 14 31708 2805 46651535
Breast disorder 15.76 15.53 12 31710 1939 46652401
Blood creatine phosphokinase increased 15.75 15.53 48 31674 27676 46626664
Fibrinolysis 15.62 15.53 4 31718 40 46654300
Congenital pyelocaliectasis 15.59 15.53 3 31719 6 46654334
Lenticulostriatal vasculopathy 15.59 15.53 3 31719 6 46654334
Ectopic ureter 15.59 15.53 3 31719 6 46654334
Carbon dioxide combining power abnormal 15.59 15.53 3 31719 6 46654334
Growth hormone-producing pituitary tumour 15.59 15.53 3 31719 6 46654334
Infected vasculitis 15.59 15.53 3 31719 6 46654334
Glycocholic acid increased 15.59 15.53 3 31719 6 46654334

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 1546.86 11.73 434 51900 2192 29897952
Immune reconstitution inflammatory syndrome 1524.99 11.73 580 51754 8521 29891623
Virologic failure 1498.80 11.73 443 51891 2776 29897368
Foetal exposure during pregnancy 1295.09 11.73 804 51530 36067 29864077
Pathogen resistance 1055.12 11.73 435 51899 7975 29892169
Lipodystrophy acquired 893.19 11.73 306 52028 3254 29896890
Drug resistance 875.02 11.73 504 51830 19629 29880515
Hepatitis B 586.14 11.73 261 52073 5811 29894333
Exposure during pregnancy 509.56 11.73 271 52063 8990 29891154
Mitochondrial toxicity 423.47 11.73 161 52173 2353 29897791
Hepatitis B DNULL increased 332.60 11.73 92 52242 435 29899709
Osteomalacia 303.65 11.73 97 52237 811 29899333
Acquired gene mutation 303.65 11.73 103 52231 1058 29899086
Fanconi syndrome acquired 295.18 11.73 118 52216 1985 29898159
Drug interaction 290.76 11.73 885 51449 198683 29701461
Hepatitis B reactivation 288.30 11.73 127 52207 2750 29897394
Blood HIV RNULL increased 283.64 11.73 103 52231 1313 29898831
Viral load increased 266.80 11.73 120 52214 2734 29897410
Premature baby 266.30 11.73 226 52108 16465 29883679
Eyelid ptosis 244.26 11.73 137 52197 5051 29895093
Congenital umbilical hernia 231.17 11.73 65 52269 330 29899814
Progressive external ophthalmoplegia 220.15 11.73 83 52251 1183 29898961
Hypertriglyceridaemia 206.74 11.73 145 52189 7953 29892191
Depression 190.42 11.73 460 51874 89977 29810167
Pinealoblastoma 189.18 11.73 47 52287 131 29900013
Lipoatrophy 180.16 11.73 59 52275 538 29899606
Polydactyly 175.76 11.73 70 52264 1165 29898979
HIV infection 171.55 11.73 75 52259 1593 29898551
Renal tubular disorder 164.79 11.73 105 52229 4901 29895243
Hypophosphataemia 163.95 11.73 127 52207 8118 29892026
Fanconi syndrome 157.58 11.73 72 52262 1703 29898441
Genotype drug resistance test 150.03 11.73 33 52301 41 29900103
Nephropathy toxic 149.40 11.73 134 52200 10505 29889639
Osteoporosis 147.17 11.73 133 52201 10530 29889614
Diplopia 143.24 11.73 147 52187 13625 29886519
Meningitis cryptococcal 142.56 11.73 70 52264 1954 29898190
Kaposi's sarcoma 138.45 11.73 56 52278 972 29899172
Dandy-Walker syndrome 130.54 11.73 33 52301 101 29900043
Birth mark 130.28 11.73 37 52297 196 29899948
Hepatic fibrosis 130.20 11.73 80 52254 3500 29896644
CD4 lymphocytes decreased 129.32 11.73 66 52268 2004 29898140
Fall 126.59 11.73 81 52253 181791 29718353
Treatment failure 123.23 11.73 219 52115 34460 29865684
Maternal drugs affecting foetus 122.02 11.73 82 52252 4191 29895953
Hepatic failure 120.98 11.73 215 52119 33828 29866316
Death 120.90 11.73 280 52054 357003 29543141
Hypotension 115.88 11.73 108 52226 200457 29699687
Retinal toxicity 114.65 11.73 38 52296 361 29899783
Pneumonia 111.45 11.73 264 52070 334042 29566102
Trisomy 21 108.79 11.73 38 52296 429 29899715
HIV-associated neurocognitive disorder 104.11 11.73 34 52300 307 29899837
Alanine aminotransferase increased 102.57 11.73 324 52010 73952 29826192
Mycobacterium avium complex infection 102.22 11.73 62 52272 2649 29897495
Hepatic cirrhosis 96.33 11.73 129 52205 15870 29884274
Off label use 96.25 11.73 181 52153 249109 29651035
Drug-induced liver injury 95.17 11.73 149 52185 21125 29879019
Completed suicide 94.91 11.73 28 52306 99464 29800680
Hyperbilirubinaemia 90.58 11.73 129 52205 16813 29883331
Osteonecrosis 89.44 11.73 125 52209 16010 29884134
Portal hypertension 88.85 11.73 65 52269 3808 29896336
Gene mutation 87.97 11.73 38 52296 783 29899361
Proteinuria 87.90 11.73 124 52210 16021 29884123
Renal tubular dysfunction 87.50 11.73 31 52303 366 29899778
Hepatitis C 86.52 11.73 111 52223 13094 29887050
Jaundice 85.81 11.73 181 52153 32305 29867839
Cytomegalovirus chorioretinitis 84.52 11.73 59 52275 3209 29896935
Blood lactic acid increased 82.97 11.73 74 52260 5756 29894388
Drug abuse 82.20 11.73 21 52313 82051 29818093
Hyperlipidaemia 80.48 11.73 110 52224 13797 29886347
Blood phosphorus decreased 79.69 11.73 55 52279 2937 29897207
Nephrolithiasis 79.66 11.73 150 52184 24660 29875484
Neonatal disorder 77.31 11.73 36 52298 890 29899254
Dyspnoea 76.97 11.73 311 52023 332984 29567160
Mitochondrial cytopathy 76.37 11.73 24 52310 189 29899955
Renal impairment 76.11 11.73 320 52014 83864 29816280
Anaemia macrocytic 75.19 11.73 50 52284 2510 29897634
Aspartate aminotransferase increased 69.37 11.73 256 52078 63166 29836978
Treatment noncompliance 69.37 11.73 143 52191 25110 29875034
Multiple-drug resistance 68.92 11.73 50 52284 2891 29897253
Congenital anomaly 67.95 11.73 37 52297 1285 29898859
Malignant neoplasm progression 67.73 11.73 21 52313 72266 29827878
Atrial fibrillation 66.22 11.73 55 52279 108069 29792075
Acquired immunodeficiency syndrome 65.80 11.73 27 52307 487 29899657
Hepatosplenomegaly 64.98 11.73 53 52281 3648 29896496
Hyperlactacidaemia 64.96 11.73 46 52288 2560 29897584
Hepatitis 64.25 11.73 129 52205 22227 29877917
Pulmonary tuberculosis 63.92 11.73 59 52275 4798 29895346
Cardiac arrest 62.27 11.73 43 52291 92807 29807337
Blood pressure increased 62.04 11.73 24 52310 71904 29828240
Hepatomegaly 61.99 11.73 82 52252 9965 29890179
Congenital central nervous system anomaly 61.11 11.73 24 52310 384 29899760
Volvulus 61 11.73 34 52300 1237 29898907
Progressive multifocal leukoencephalopathy 60.99 11.73 77 52257 8936 29891208
Hypouricaemia 60.52 11.73 21 52313 232 29899912
Peripheral swelling 60.43 11.73 16 52318 61058 29839086
Immune reconstitution inflammatory syndrome associated tuberculosis 60.16 11.73 24 52310 401 29899743
Lymphadenopathy 59.98 11.73 132 52202 24244 29875900
Anal cancer 59.36 11.73 24 52310 416 29899728
Dyslipidaemia 59.30 11.73 61 52273 5666 29894478
Blood bilirubin increased 58.22 11.73 168 52166 36468 29863676
Tuberculosis 57.85 11.73 71 52263 8006 29892138
Cryptorchism 57.25 11.73 36 52298 1641 29898503
Lactic acidosis 56.39 11.73 150 52184 31063 29869081
Urine phosphorus increased 56.09 11.73 14 52320 40 29900104
Cardiac failure congestive 55.40 11.73 40 52294 84367 29815777
Hepatotoxicity 54.91 11.73 107 52227 18038 29882106
Pregnancy 54.83 11.73 19 52315 209 29899935
Talipes 54.79 11.73 35 52299 1640 29898504
Caesarean section 53.91 11.73 38 52296 2099 29898045
Pain 53.66 11.73 141 52193 172500 29727644
Blood alkaline phosphatase increased 53.56 11.73 148 52186 31339 29868805
Oesophageal candidiasis 53.20 11.73 50 52284 4160 29895984
Fatigue 52.96 11.73 336 51998 320337 29579807
Plasma cell myeloma 52.90 11.73 14 52320 53448 29846696
Varices oesophageal 52.85 11.73 46 52288 3463 29896681
Small for dates baby 52.28 11.73 44 52290 3164 29896980
Glycosuria 52.06 11.73 31 52303 1280 29898864
Constipation 51.85 11.73 73 52261 112833 29787311
Lipohypertrophy 51.74 11.73 20 52314 306 29899838
Pneumocystis jirovecii pneumonia 50.65 11.73 100 52234 17020 29883124
Blood triglycerides increased 50.37 11.73 89 52245 13928 29886216
Ophthalmoplegia 49.62 11.73 30 52304 1274 29898870
Death neonatal 49.45 11.73 20 52314 347 29899797
Cryptococcosis 47.69 11.73 33 52301 1769 29898375
Osteoporotic fracture 47.61 11.73 27 52307 1016 29899128
CD4 lymphocytes increased 47.39 11.73 18 52316 262 29899882
Cachexia 45.56 11.73 57 52277 6554 29893590
Infusion related reaction 45.46 11.73 8 52326 40556 29859588
Calculus urinary 45.19 11.73 28 52306 1243 29898901
CSF HIV escape syndrome 44.92 11.73 14 52320 107 29900037
Cardio-respiratory arrest 44.85 11.73 22 52312 57284 29842860
Facial wasting 44.57 11.73 15 52319 150 29899994
Opportunistic infection 44.53 11.73 28 52306 1276 29898868
Oesophageal atresia 44.52 11.73 20 52314 454 29899690
Confusional state 44.30 11.73 107 52227 134727 29765417
Inappropriate schedule of product administration 44.17 11.73 8 52326 39720 29860424
Hepatic function abnormal 43.91 11.73 167 52167 41778 29858366
Drug ineffective 43.62 11.73 383 51951 340004 29560140
Splenomegaly 42.64 11.73 81 52253 13399 29886745
Syphilis 41.93 11.73 18 52316 365 29899779
Chronic obstructive pulmonary disease 40.41 11.73 15 52319 46111 29854033
Hepatitis B virus test 40.27 11.73 8 52326 3 29900141
Pyelocaliectasis 40.26 11.73 24 52310 993 29899151
Nasopharyngitis 39.77 11.73 27 52307 58822 29841322
Transaminases increased 39.63 11.73 110 52224 23347 29876797
Skull malformation 39.36 11.73 17 52317 350 29899794
Meningomyelocele 39.36 11.73 13 52321 122 29900022
Bone density decreased 38.89 11.73 29 52305 1749 29898395
Multiple fractures 38.69 11.73 26 52308 1328 29898816
Extraocular muscle paresis 38.65 11.73 18 52316 445 29899699
Tubulointerstitial nephritis 38.61 11.73 92 52242 17799 29882345
Foetal growth restriction 38.60 11.73 39 52295 3546 29896598
Joint swelling 38.31 11.73 17 52317 46929 29853215
Human immunodeficiency virus transmission 38.31 11.73 9 52325 18 29900126
Basedow's disease 38.31 11.73 11 52323 61 29900083
Thrombosis 38.25 11.73 13 52321 42218 29857926
Syncope 37.87 11.73 56 52278 84847 29815297
Ascites 37.58 11.73 143 52191 35778 29864366
Product dose omission issue 37.51 11.73 64 52270 91567 29808577
Disease progression 37.29 11.73 51 52283 79823 29820321
Anogenital warts 36.90 11.73 18 52316 495 29899649
Anaemia neonatal 36.03 11.73 15 52319 281 29899863
Optic nerve neoplasm 35.74 11.73 9 52325 27 29900117
Mycobacterium avium complex immune restoration disease 35.69 11.73 10 52324 50 29900094
Contusion 35.42 11.73 6 52328 31274 29868870
Gamma-glutamyltransferase increased 35.07 11.73 122 52212 29228 29870916
Low birth weight baby 35.05 11.73 48 52286 6028 29894116
Genotype drug resistance test positive 34.94 11.73 26 52308 1563 29898581
Congenital hydronephrosis 34.94 11.73 19 52315 658 29899486
Febrile neutropenia 34.76 11.73 85 52249 106608 29793536
Blood bilirubin unconjugated increased 34.70 11.73 19 52315 667 29899477
Cerebral ventricle dilatation 34.57 11.73 20 52314 782 29899362
Neonatal asphyxia 34.50 11.73 15 52319 314 29899830
Oesophageal varices haemorrhage 34.34 11.73 34 52300 3017 29897127
Toxicity to various agents 33.79 11.73 177 52157 177006 29723138
Psoriasis 33.74 11.73 16 52318 42490 29857654
Congenital skin dimples 33.47 11.73 12 52322 147 29899997
Hydrocele 33.24 11.73 28 52306 2016 29898128
Therapeutic product effect incomplete 33.20 11.73 9 52325 33825 29866319
Hepatic encephalopathy 32.83 11.73 75 52259 14117 29886027
Flushing 32.65 11.73 6 52328 29486 29870658
Amniotic band syndrome 32.55 11.73 8 52326 21 29900123
Hypospadias 32.29 11.73 31 52303 2648 29897496
Acute hepatitis C 32.21 11.73 12 52322 165 29899979
Viraemia 32.17 11.73 22 52312 1157 29898987
Lymph node tuberculosis 32.08 11.73 16 52318 462 29899682
Oral candidiasis 31.94 11.73 64 52270 11007 29889137
Congenital neoplasm 31.76 11.73 8 52326 24 29900120
Urine calcium increased 31.28 11.73 8 52326 26 29900118
Epistaxis 31.13 11.73 28 52306 52953 29847191
Hepatitis cholestatic 30.92 11.73 52 52282 7820 29892324
Hepatic cancer 30.86 11.73 47 52287 6501 29893643
Wheezing 30.79 11.73 8 52326 30930 29869214
Urinary tract infection 30.55 11.73 51 52283 73608 29826536
Nodular regenerative hyperplasia 30.39 11.73 18 52316 736 29899408
White matter lesion 30.31 11.73 17 52317 626 29899518
Blood phosphorus abnormal 30.23 11.73 11 52323 141 29900003
Ventricular septal defect 30.22 11.73 34 52300 3495 29896649
Periarthritis 30.02 11.73 20 52314 1007 29899137
Congenital naevus 29.99 11.73 8 52326 32 29900112
Cerebral toxoplasmosis 29.97 11.73 23 52311 1449 29898695
Hyperkalaemia 29.96 11.73 43 52291 65967 29834177
Speech disorder developmental 29.82 11.73 21 52313 1158 29898986
Hypercholesterolaemia 29.62 11.73 50 52284 7542 29892602
Dysmorphism 29.49 11.73 26 52308 1991 29898153
Neurodevelopmental disorder 29.41 11.73 11 52323 153 29899991
Intentional product misuse 29.17 11.73 12 52322 34655 29865489
Exomphalos 29.03 11.73 11 52323 159 29899985
Mitochondrial myopathy 28.78 11.73 11 52323 163 29899981
Osteopenia 28.77 11.73 38 52296 4610 29895534
Tremor 28.72 11.73 55 52279 75308 29824836
Malaria 28.62 11.73 12 52322 229 29899915
Blood pyruvic acid increased 28.58 11.73 7 52327 18 29900126
HIV lipodystrophy 28.58 11.73 7 52327 18 29900126
Vision blurred 28.50 11.73 19 52315 41797 29858347
Adrenogenital syndrome 28.30 11.73 9 52325 74 29900070
Prenatal screening test abnormal 28.05 11.73 7 52327 20 29900124
Therapeutic product effect decreased 28.03 11.73 8 52326 29068 29871076
Dehydration 27.91 11.73 116 52218 123423 29776721
Liver disorder 27.60 11.73 114 52220 29608 29870536
Cerebrovascular accident 27.58 11.73 66 52268 83411 29816733
Macrocephaly 27.46 11.73 13 52321 334 29899810
Diabetes mellitus 27.41 11.73 145 52189 41720 29858424
Astrocytoma, low grade 27.33 11.73 8 52326 48 29900096
Viral load decreased 27.19 11.73 8 52326 49 29900095
Blood creatinine increased 27.04 11.73 261 52073 91114 29809030
Mitochondrial DNULL depletion 26.76 11.73 5 52329 0 29900144
Diaphragmatic hernia 26.69 11.73 12 52322 273 29899871
Cardiac murmur 26.65 11.73 45 52289 6789 29893355
Influenza 26.63 11.73 22 52312 43376 29856768
Umbilical cord abnormality 26.53 11.73 8 52326 54 29900090
Hepatitis A 26.39 11.73 14 52320 461 29899683
Injection site pain 26.31 11.73 10 52324 30300 29869844
Lactate pyruvate ratio increased 26.24 11.73 6 52328 10 29900134
Developmental delay 26.23 11.73 25 52309 2116 29898028
Alpha 1 foetoprotein increased 26.05 11.73 16 52318 699 29899445
Encephalitis 25.93 11.73 43 52291 6393 29893751
Congenital syphilis 25.88 11.73 6 52328 11 29900133
Feeling abnormal 25.73 11.73 37 52297 56719 29843425
Bradycardia 25.69 11.73 47 52287 65479 29834665
Rhabdomyosarcoma 25.68 11.73 8 52326 61 29900083
Product use in unapproved indication 25.36 11.73 57 52277 73636 29826508
Hypophosphataemic osteomalacia 25.34 11.73 9 52325 107 29900037
Unevaluable event 25.17 11.73 12 52322 31773 29868371
Low set ears 24.96 11.73 13 52321 412 29899732
International normalised ratio increased 24.88 11.73 28 52306 47711 29852433
Mycobacterial infection 24.79 11.73 22 52312 1699 29898445
Hepatitis B surface antigen positive 24.48 11.73 9 52325 119 29900025
Delirium 24.44 11.73 21 52313 40610 29859534
Amoebiasis 24.35 11.73 7 52327 39 29900105
Normal newborn 24.34 11.73 10 52324 181 29899963
Aminoaciduria 24.28 11.73 9 52325 122 29900022
Renal colic 24.24 11.73 22 52312 1750 29898394
Taeniasis 24.23 11.73 8 52326 75 29900069
Fat tissue increased 24.11 11.73 12 52322 345 29899799
Cushing's syndrome 23.94 11.73 13 52321 449 29899695
Developmental hip dysplasia 23.88 11.73 11 52323 265 29899879
Pyrexia 23.84 11.73 678 51656 293811 29606333
Cerebellar hypoplasia 23.82 11.73 6 52328 18 29900126
Anaemia 23.45 11.73 501 51833 207491 29692653
Atrial septal defect 23.37 11.73 42 52292 6659 29893485
Limb deformity 23.30 11.73 13 52321 474 29899670
Dizziness 23.27 11.73 223 52111 194686 29705458
Parotid gland enlargement 23.11 11.73 11 52323 286 29899858
Neurosyphilis 22.99 11.73 7 52327 49 29900095
Angioedema 22.93 11.73 16 52318 34368 29865776
Primary syphilis 22.91 11.73 6 52328 22 29900122
Tuberculoid leprosy 22.87 11.73 7 52327 50 29900094
Renal hypoplasia 22.85 11.73 8 52326 91 29900053
Sepsis 22.74 11.73 156 52178 146239 29753905
Cellulitis 22.72 11.73 29 52305 46755 29853389
Bronchitis 22.60 11.73 21 52313 39104 29861040
HIV viraemia 22.54 11.73 8 52326 95 29900049
Gastrointestinal haemorrhage 22.35 11.73 73 52261 83373 29816771
Intracranial pressure increased 22.32 11.73 29 52305 3461 29896683
Congenital cytomegalovirus infection 22.30 11.73 6 52328 25 29900119
Cryoglobulinaemia 22.24 11.73 11 52323 312 29899832
Pneumonia aspiration 22.15 11.73 20 52314 37760 29862384
Incorrect dose administered 22.13 11.73 14 52320 31672 29868472
Beta 2 microglobulin urine increased 22.09 11.73 8 52326 101 29900043
White blood cell count increased 22.09 11.73 22 52312 39651 29860493
Blood pressure decreased 22.02 11.73 30 52304 47045 29853099
Hyperplasia adrenal 21.99 11.73 5 52329 8 29900136
Congenital anaemia 21.99 11.73 5 52329 8 29900136
Vanishing bile duct syndrome 21.95 11.73 14 52320 654 29899490
Myelosuppression 21.93 11.73 43 52291 7279 29892865
Stevens-Johnson syndrome 21.86 11.73 74 52260 17482 29882662
Anxiety 21.81 11.73 82 52252 89789 29810355
Hypermetabolism 21.75 11.73 9 52325 166 29899978
Respiratory arrest 21.74 11.73 12 52322 29246 29870898
Histoplasmosis disseminated 21.71 11.73 16 52318 948 29899196
Cardiac failure 21.64 11.73 74 52260 83344 29816800
Meningitis tuberculous 21.50 11.73 13 52321 552 29899592
HIV test positive 21.45 11.73 10 52324 248 29899896
Withdrawal hepatitis 21.41 11.73 4 52330 0 29900144
Anogenital dysplasia 21.31 11.73 9 52325 175 29899969
Sickle cell disease 21.15 11.73 8 52326 115 29900029
Lymphoma 20.71 11.73 51 52283 10070 29890074
Hyperhidrosis 20.64 11.73 55 52279 67035 29833109
Diverticulitis 20.53 11.73 3 52331 17442 29882702
Intentional product use issue 20.53 11.73 20 52314 36420 29863724
Hypoglycaemia 20.49 11.73 36 52298 50945 29849199
Hepatitis viral 20.47 11.73 12 52322 481 29899663
Infection 20.43 11.73 69 52265 78005 29822139
Live birth 20.42 11.73 9 52325 195 29899949
Stomatitis 20.38 11.73 21 52313 37258 29862886
Night blindness 20.37 11.73 9 52325 196 29899948
Spider naevus 20.36 11.73 6 52328 37 29900107
Chronic hepatitis C 20.32 11.73 12 52322 488 29899656
Gynaecomastia 20.28 11.73 45 52289 8306 29891838
Wrong technique in product usage process 20.12 11.73 15 52319 31140 29869004
Bone pain 20.10 11.73 76 52258 18950 29881194
Muscle spasms 20.06 11.73 53 52281 64785 29835359
Anaphylactic reaction 20.05 11.73 12 52322 27970 29872174
Glucose urine present 19.99 11.73 15 52319 913 29899231
Venolymphatic malformation 19.83 11.73 6 52328 41 29900103
Pulmonary embolism 19.80 11.73 70 52264 78065 29822079
Overdose 19.78 11.73 78 52256 84259 29815885
Patent ductus arteriosus 19.75 11.73 26 52308 3143 29897001
Atypical mycobacterial infection 19.69 11.73 14 52320 784 29899360
Chordee 19.65 11.73 7 52327 84 29900060
Antimitochondrial antibody positive 19.58 11.73 6 52328 43 29900101
Hepatitis D 19.46 11.73 6 52328 44 29900100
Neuromyopathy 19.38 11.73 15 52319 957 29899187
Urine phosphorus decreased 19.35 11.73 6 52328 45 29900099
Cataract 19.29 11.73 7 52327 21828 29878316
Agitation 19.28 11.73 41 52293 54032 29846112
Melaena 19.22 11.73 17 52317 32420 29867724
Renal failure 19.09 11.73 324 52010 128642 29771502
Lymphadenitis 19.05 11.73 19 52315 1701 29898443
HIV peripheral neuropathy 19.01 11.73 6 52328 48 29900096
Hepatic steatosis 18.99 11.73 63 52271 14730 29885414
Chest pain 18.93 11.73 124 52210 117503 29782641
Heart rate increased 18.80 11.73 24 52310 38697 29861447
Blood creatine phosphokinase increased 18.70 11.73 136 52198 43712 29856432
Maternal condition affecting foetus 18.64 11.73 4 52330 4 29900140
Late developer 18.64 11.73 4 52330 4 29900140
Urinary retention 18.62 11.73 18 52316 32899 29867245
Liver transplant rejection 18.52 11.73 21 52313 2177 29897967
Blood pressure fluctuation 18.45 11.73 4 52330 17499 29882645
Cranial nerve palsies multiple 18.39 11.73 6 52328 54 29900090
Renal glycosuria 18.36 11.73 5 52329 22 29900122
Macrocytosis 18.23 11.73 14 52320 883 29899261
Hepatocellular carcinoma 18.18 11.73 47 52287 9563 29890581
Oropharyngeal candidiasis 18.17 11.73 13 52321 735 29899409
Renal tubular acidosis 18.13 11.73 19 52315 1803 29898341
Hepatic enzyme decreased 18.10 11.73 6 52328 57 29900087
Granulomatous rosacea 18.08 11.73 8 52326 175 29899969
Cushingoid 18.03 11.73 22 52312 2465 29897679
HIV wasting syndrome 18.00 11.73 7 52327 109 29900035
Hemivertebra 18.00 11.73 7 52327 109 29900035
Portal vein thrombosis 17.96 11.73 26 52308 3438 29896706
Clostridium difficile infection 17.93 11.73 3 52331 15780 29884364
Bacterial pyelonephritis 17.92 11.73 9 52325 264 29899880
Full blood count decreased 17.83 11.73 3 52331 15714 29884430
Stillbirth 17.79 11.73 8 52326 182 29899962
Blood glucose increased 17.77 11.73 52 52282 61478 29838666
Neuropsychiatric symptoms 17.76 11.73 11 52323 488 29899656
Glucose urine 17.75 11.73 4 52330 6 29900138
Borderline leprosy 17.75 11.73 4 52330 6 29900138
AIDS related complication 17.68 11.73 5 52329 26 29900118
Blood uric acid increased 17.59 11.73 35 52299 5988 29894156
Prostate cancer 17.55 11.73 10 52324 23947 29876197
Haematoma 17.55 11.73 10 52324 23943 29876201
Hyperphosphatasaemia 17.52 11.73 5 52329 27 29900117
Urticaria 17.38 11.73 44 52290 54562 29845582
Birth trauma 17.37 11.73 4 52330 7 29900137
Asymptomatic viral hepatitis 17.37 11.73 5 52329 28 29900116
Renal atrophy 17.33 11.73 14 52320 950 29899194
Interstitial lung disease 17.29 11.73 51 52283 60146 29839998
Pilonidal cyst congenital 17.22 11.73 5 52329 29 29900115
Product use issue 17.16 11.73 34 52300 45982 29854162
Hepatitis B DNULL assay positive 17.08 11.73 6 52328 69 29900075
Musculoskeletal toxicity 17.08 11.73 6 52328 69 29900075
Neonatal pneumothorax 17.03 11.73 4 52330 8 29900136
Stress 17.03 11.73 7 52327 20228 29879916
Retroviral infection 17.03 11.73 4 52330 8 29900136
Genital herpes 16.85 11.73 11 52323 535 29899609
Hepatitis C virus test 16.85 11.73 6 52328 72 29900072
Hallucination 16.83 11.73 38 52296 49021 29851123
Pulmonary oedema 16.82 11.73 32 52302 43943 29856201
Foetal cystic hygroma 16.71 11.73 4 52330 9 29900135
Meconium ileus 16.67 11.73 5 52329 33 29900111
Chest discomfort 16.62 11.73 34 52300 45446 29854698
Rectal haemorrhage 16.61 11.73 22 52312 34917 29865227
Femoral neck fracture 16.61 11.73 23 52311 2919 29897225
Blood uric acid decreased 16.54 11.73 9 52325 312 29899832
Acquired aminoaciduria 16.41 11.73 4 52330 10 29900134
Toxoplasmosis 16.37 11.73 14 52320 1029 29899115
Bone tuberculosis 16.36 11.73 9 52325 319 29899825
Crystal urine 16.34 11.73 6 52328 79 29900065
Basal cell carcinoma 16.29 11.73 4 52330 16064 29884080
Arthropathy 16.14 11.73 8 52326 20719 29879425
Back pain 16.08 11.73 109 52225 102487 29797657
Ergot poisoning 16.07 11.73 6 52328 83 29900061
Arthrotoxicity 16.05 11.73 3 52331 0 29900144
Retroviral rebound syndrome 16.05 11.73 3 52331 0 29900144
Cell death 16.04 11.73 20 52314 2291 29897853
Lymphocytic infiltration 16.04 11.73 11 52323 581 29899563
Asthma 15.98 11.73 24 52310 36150 29863994
Congenital hand malformation 15.90 11.73 10 52324 456 29899688
Erythema elevatum diutinum 15.88 11.73 4 52330 12 29900132
Haematochezia 15.81 11.73 22 52312 34200 29865944
Polyneuropathy chronic 15.73 11.73 5 52329 41 29900103
Endocardial fibroelastosis 15.64 11.73 4 52330 13 29900131
Foetal death 15.64 11.73 8 52326 244 29899900
Pneumonitis 15.54 11.73 15 52319 27439 29872705
Optic atrophy 15.52 11.73 12 52322 764 29899380
Pancreatitis 15.45 11.73 113 52221 36377 29863767
Ear malformation 15.40 11.73 8 52326 252 29899892
Pleural effusion 15.23 11.73 72 52262 73994 29826150
Secondary syphilis 15.23 11.73 5 52329 46 29900098
ADAMTS13 activity decreased 15.22 11.73 6 52328 97 29900047
Bone marrow oedema 15.20 11.73 10 52324 493 29899651
Tracheal stenosis 15.15 11.73 7 52327 170 29899974
Malabsorption 15.10 11.73 18 52316 1969 29898175
HIV associated nephropathy 15.09 11.73 8 52326 263 29899881
Haemophilia 15.00 11.73 4 52330 16 29900128
Anal cancer stage 0 15.00 11.73 4 52330 16 29900128
Skin candida 14.96 11.73 10 52324 506 29899638
Mobility decreased 14.96 11.73 14 52320 25985 29874159
Persistent foetal circulation 14.95 11.73 9 52325 379 29899765
Foetal distress syndrome 14.94 11.73 13 52321 978 29899166
Injection site erythema 14.92 11.73 3 52331 13831 29886313
Congenital hydrocephalus 14.89 11.73 6 52328 103 29900041
Hyperuricaemia 14.86 11.73 37 52297 7357 29892787
Sinusitis 14.85 11.73 22 52312 33323 29866821
Retinal deposits 14.80 11.73 4 52330 17 29900127
Biliary colic 14.79 11.73 13 52321 991 29899153
Disseminated cryptococcosis 14.74 11.73 13 52321 996 29899148
Musculoskeletal stiffness 14.72 11.73 25 52309 35856 29864288
Micrognathia 14.71 11.73 8 52326 277 29899867
Renal aplasia 14.70 11.73 11 52323 667 29899477
Lower respiratory tract infection 14.66 11.73 15 52319 26699 29873445
Blood lactate dehydrogenase increased 14.63 11.73 73 52261 20528 29879616
Viral hepatitis carrier 14.62 11.73 4 52330 18 29900126
Congenital foot malformation 14.60 11.73 7 52327 185 29899959
Hepatitis B e antigen positive 14.60 11.73 5 52329 53 29900091
Herpes virus infection 14.53 11.73 20 52314 2524 29897620
Portal hypertensive gastropathy 14.34 11.73 10 52324 543 29899601
Anaemia megaloblastic 14.33 11.73 7 52327 193 29899951
CD4 lymphocytes abnormal 14.29 11.73 6 52328 115 29900029
Optic nerve cupping 14.27 11.73 5 52329 57 29900087
Pulmonary sequestration 14.27 11.73 5 52329 57 29900087
Platelet count decreased 14.14 11.73 118 52216 106011 29794133
Intestinal obstruction 14.10 11.73 8 52326 19204 29880940
Drug dependence 14.08 11.73 10 52324 21285 29878859
Gastroschisis 14.05 11.73 6 52328 120 29900024
Hypersplenism 14.01 11.73 8 52326 305 29899839
Osteocalcin increased 13.98 11.73 3 52331 3 29900141
Tracheal fistula repair 13.98 11.73 3 52331 3 29900141
Gonadal dysgenesis 13.98 11.73 3 52331 3 29900141
Hepatitis B DNULL decreased 13.98 11.73 3 52331 3 29900141
Meconium stain 13.98 11.73 3 52331 3 29900141
Oedema peripheral 13.95 11.73 118 52216 105714 29794430
Sleep apnoea syndrome 13.91 11.73 6 52328 16851 29883293
COVID-19 13.77 11.73 7 52327 17871 29882273
Glomerulonephritis proliferative 13.64 11.73 7 52327 215 29899929
Renal disorder 13.64 11.73 79 52255 23505 29876639
Unmasking of previously unidentified disease 13.63 11.73 10 52324 588 29899556
Cough 13.62 11.73 147 52187 125495 29774649
Ultrasound antenatal screen abnormal 13.61 11.73 5 52329 66 29900078
Limb malformation 13.60 11.73 8 52326 323 29899821
Sickle cell anaemia 13.55 11.73 7 52327 218 29899926
Hyperphosphaturia 13.54 11.73 5 52329 67 29900077
Non-Hodgkin's lymphoma 13.53 11.73 16 52318 1735 29898409
Osteodystrophy 13.52 11.73 3 52331 4 29900140
Umbilical cord vascular disorder 13.52 11.73 3 52331 4 29900140
Atypical mycobacterial lymphadenitis 13.52 11.73 3 52331 4 29900140
Congenital abdominal hernia 13.39 11.73 4 52330 26 29900118
Neutrophil count increased 13.39 11.73 5 52329 15318 29884826
Rhinorrhoea 13.39 11.73 10 52324 20744 29879400
Injury 13.35 11.73 11 52323 21720 29878424
Osteonecrosis of jaw 13.31 11.73 8 52326 18610 29881534
Bone scan abnormal 13.28 11.73 5 52329 71 29900073
Nasal congestion 13.25 11.73 8 52326 18558 29881586
Creatinine renal clearance abnormal 13.24 11.73 7 52327 229 29899915
Hepatic enzyme increased 13.21 11.73 102 52232 33392 29866752
Protrusion tongue 13.21 11.73 7 52327 230 29899914
Liver tenderness 13.20 11.73 6 52328 140 29900004
Aplasia cutis congenita 13.20 11.73 6 52328 140 29900004
Neck deformity 13.15 11.73 5 52329 73 29900071
Neurocryptococcosis 13.12 11.73 3 52331 5 29900139
Loss of consciousness 13.11 11.73 83 52251 79292 29820852
Oxygen saturation decreased 13.06 11.73 36 52298 43404 29856740
Papillary thyroid cancer 13.03 11.73 10 52324 630 29899514
Attention deficit hyperactivity disorder 13.01 11.73 16 52318 1808 29898336
Gastrointestinal disorder 13 11.73 89 52245 28048 29872096
Deep vein thrombosis 12.92 11.73 58 52276 60443 29839701
Contraindicated product administered 12.90 11.73 7 52327 17224 29882920
Microcephaly 12.86 11.73 10 52324 642 29899502
Spine malformation 12.86 11.73 6 52328 149 29899995
Cerebellar syndrome 12.79 11.73 17 52317 2075 29898069
Subacute sclerosing panencephalitis 12.78 11.73 4 52330 31 29900113
Congenital pigmentation disorder 12.77 11.73 3 52331 6 29900138
Palmar-plantar erythrodysaesthesia syndrome 12.75 11.73 5 52329 14865 29885279
Scleral discolouration 12.73 11.73 7 52327 248 29899896
Somnolence 12.70 11.73 108 52226 96655 29803489
Pancytopenia 12.69 11.73 214 52120 84838 29815306
Drug level decreased 12.68 11.73 30 52304 5775 29894369
Congenital tuberculosis 12.67 11.73 4 52330 32 29900112
Haemophilic arthropathy 12.57 11.73 6 52328 157 29899987
Dyspnoea exertional 12.51 11.73 27 52307 35403 29864741
Urinary incontinence 12.51 11.73 7 52327 16933 29883211
Respiratory failure 12.47 11.73 114 52220 100528 29799616
Twin pregnancy 12.46 11.73 3 52331 7 29900137
Cardiogenic shock 12.41 11.73 7 52327 16854 29883290
Bone metabolism disorder 12.40 11.73 7 52327 261 29899883
Psoriatic arthropathy 12.40 11.73 6 52328 15755 29884389
Pain in jaw 12.37 11.73 3 52331 12153 29887991
Loss of personal independence in daily activities 12.36 11.73 72 52262 21463 29878681
Newborn persistent pulmonary hypertension 12.35 11.73 5 52329 87 29900057
Thalassaemia alpha 12.26 11.73 4 52330 36 29900108
Drug withdrawal syndrome 12.20 11.73 10 52324 19799 29880345
Hydronephrosis 12.20 11.73 39 52295 8944 29891200
Product quality issue 12.17 11.73 9 52325 18765 29881379
Neutrophil count decreased 12.17 11.73 36 52298 42418 29857726
Molluscum contagiosum 12.12 11.73 7 52327 273 29899871
Portal fibrosis 12.07 11.73 8 52326 399 29899745
Spermatozoa progressive motility abnormal 12.07 11.73 4 52330 38 29900106
Graft infection 12.06 11.73 8 52326 400 29899744
Haematocrit decreased 12.04 11.73 22 52312 30677 29869467
Seborrhoeic dermatitis 12.01 11.73 13 52321 1280 29898864
Reversible ischaemic neurological deficit 11.98 11.73 4 52330 39 29900105
Viral load 11.95 11.73 5 52329 95 29900049
Foetal monitoring abnormal 11.91 11.73 3 52331 9 29900135
Retinal telangiectasia 11.91 11.73 3 52331 9 29900135
Hereditary optic atrophy 11.91 11.73 3 52331 9 29900135
Congenital nystagmus 11.91 11.73 3 52331 9 29900135
Tracheal deviation 11.91 11.73 3 52331 9 29900135
Transient tachypnoea of the newborn 11.85 11.73 6 52328 179 29899965
Nephropathy 11.84 11.73 28 52306 5388 29894756
Erythema 11.78 11.73 83 52251 77368 29822776

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 EXT N0000175459 Nucleoside Analog
FDA EPC N0000175462 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
FDA EPC N0000175656 Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor
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
CHEBI has role CHEBI:36044 anti-virus drug
CHEBI has role CHEBI:50266 prodrugs
CHEBI has role CHEBI:50904 allergene
CHEBI has role CHEBI:53756 reverse transcriptase inhibitor
CHEBI has role CHEBI:59897 rna-dependent dna polymerase inhibitors
CHEBI has role CHEBI:64951 anti-hepatitis b virus agents

Drug Use (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

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)

None

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 COMBINULLTION
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 RNULL 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 RNULL 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

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Deoxycytidine kinase Kinase WOMBAT-PK
Reverse transcriptase/RNaseH Enzyme INHIBITOR EC50 7.38 CHEMBL CHEMBL
Protein P Polyprotein INHIBITOR CHEMBL 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
D019259 MESH_DESCRIPTOR_UI
DB00709 DRUGBANK_ID
6908 INN_ID
2T8Q726O95 UNII
60825 PUBCHEM_CID
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 31 sections
Abacavir and Lamivudine HUMAN PRESCRIPTION DRUG LABEL 2 0093-5382 TABLET, FILM COATED 300 mg ORAL ANDA 28 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 31722-739 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
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 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
LAMIVUDINE and ZIDOVUDINE HUMAN PRESCRIPTION DRUG LABEL 2 43063-900 TABLET, FILM COATED 150 mg ORAL ANDA 25 sections
SYMFI LO HUMAN PRESCRIPTION DRUG LABEL 3 49502-425 TABLET, FILM COATED 300 mg ORAL NDA 32 sections
CIMDUO HUMAN PRESCRIPTION DRUG LABEL 2 49502-450 TABLET, FILM COATED 300 mg ORAL NDA 29 sections
SYMFI HUMAN PRESCRIPTION DRUG LABEL 3 49502-475 TABLET, FILM COATED 300 mg ORAL NDA 31 sections
COMBIVIR HUMAN PRESCRIPTION DRUG LABEL 2 49702-202 TABLET, FILM COATED 150 mg ORAL NDA 25 sections
EPIVIR HUMAN PRESCRIPTION DRUG LABEL 1 49702-203 TABLET, FILM COATED 150 mg ORAL NDA 25 sections