zidovudine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
uridine derivatives used as antiviral agents and as antineoplastics 2861 30516-87-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • zidovudine
  • azidothymidine
  • azitidin
  • AZT
A dideoxynucleoside compound in which the 3'-hydroxy group on the sugar moiety has been replaced by an azido group. This modification prevents the formation of phosphodiester linkages which are needed for the completion of nucleic acid chains. The compound is a potent inhibitor of HIV replication, acting as a chain-terminator of viral DNA during reverse transcription. It improves immunologic function, partially reverses the HIV-induced neurological dysfunction, and improves certain other clinical abnormalities associated with AIDS. Its principal toxic effect is dose-dependent suppression of bone marrow, resulting in anemia and leukopenia.
  • Molecular weight: 267.25
  • Formula: C10H13N5O4
  • CLOGP: 0.04
  • LIPINSKI: 0
  • HAC: 9
  • HDO: 2
  • TPSA: 108.30
  • ALOGS: -1.21
  • ROTB: 3
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.60 g O
0.60 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 20.10 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 2.80 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 37.42 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 63 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 1.80 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 25 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.80 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 1.30 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 -0.033 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 3.048 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 8.356 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 1.862 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 88.560 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 89.440 % High 1
herg hERG pIC50 3.811 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 0.966 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 3.162 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 85.960 % High 1
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 2.223 High 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 2.612 High 1
mh-clint Mouse hepatocyte intrinsic clearance 0.910 High 1
mppb Mouse plasma protein binding (% unbound) 87.520 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 4.046 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 0 Moderate 0.72
pppb Pig plasma protein binding (% unbound) 88.890 % High 1
rat-kpuu-brain Rat brain Kpuu 0.244 % High 1
rh-clint Rat hepatocyte intrinsic clearance 1.285 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 96.340 % High 1
rppb Rat plasma protein binding (% unbound) 87.040 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 961.612 uM High 1

Approvals:

DateAgencyCompanyOrphan
March 19, 1987 FDA VIIV HLTHCARE
March 18, 1998 EMA ViiV Healthcare BV

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 2127.86 26.33 954 14448 237456 90375589
Foetal exposure during pregnancy 1526.80 26.33 476 14926 42499 90570546
Stillbirth 922.90 26.33 221 15181 7222 90605823
Abortion spontaneous 871.61 26.33 332 15070 53724 90559321
Premature baby 844.25 26.33 267 15135 24810 90588235
Virologic failure 554.83 26.33 117 15285 2107 90610938
Viral mutation identified 554.11 26.33 115 15287 1910 90611135
Caesarean section 475.98 26.33 161 15241 18416 90594629
Drug resistance 461.47 26.33 179 15223 30270 90582775
Abortion induced 430.66 26.33 134 15268 11754 90601291
Pathogen resistance 395.50 26.33 115 15287 8000 90605045
Immune reconstitution inflammatory syndrome 375.68 26.33 107 15295 6912 90606133
Pregnancy 342.20 26.33 180 15222 61867 90551178
Premature rupture of membranes 330.47 26.33 92 15310 5466 90607579
Maternal drugs affecting foetus 328.03 26.33 90 15312 5065 90607980
Maternal exposure during pregnancy 274.44 26.33 321 15081 359742 90253303
Premature labour 254.70 26.33 93 15309 13283 90599762
Lipodystrophy acquired 251.19 26.33 57 15345 1457 90611588
Anaemia 236.80 26.33 295 15107 352507 90260538
Treatment noncompliance 197.62 26.33 118 15284 51609 90561436
Foetal growth restriction 192.72 26.33 69 15333 9311 90603734
Foetal death 179.84 26.33 82 15320 20641 90592404
Live birth 165.34 26.33 124 15278 78983 90534062
Pre-eclampsia 163.85 26.33 64 15338 10984 90602061
Premature delivery 152.13 26.33 90 15312 38672 90574373
Patent ductus arteriosus 142.60 26.33 46 15356 4523 90608522
Amniotic cavity infection 130.13 26.33 33 15369 1363 90611682
Sudden infant death syndrome 127.27 26.33 25 15377 309 90612736
Atrial septal defect 126.71 26.33 49 15353 8185 90604860
Blood HIV RNA increased 125.83 26.33 29 15373 795 90612250
Trisomy 21 125.19 26.33 26 15376 432 90612613
Human immunodeficiency virus transmission 124.09 26.33 19 15383 41 90613004
Ventricular septal defect 123.35 26.33 43 15359 5364 90607681
Hydrops foetalis 123.18 26.33 27 15375 586 90612459
Meningomyelocele 121.94 26.33 27 15375 615 90612430
Polydactyly 121.86 26.33 24 15378 301 90612744
Hypertriglyceridaemia 118.04 26.33 46 15356 7843 90605202
Umbilical cord abnormality 114.88 26.33 26 15376 656 90612389
CD4 lymphocytes decreased 112.41 26.33 30 15372 1517 90611528
Neonatal disorder 107.51 26.33 24 15378 568 90612477
Foetal distress syndrome 95.75 26.33 27 15375 1678 90611367
Congenital anomaly 94.92 26.33 37 15365 6310 90606735
Hepatomegaly 94.84 26.33 46 15356 13280 90599765
Portal hypertension 94.36 26.33 34 15368 4667 90608378
Neural tube defect 94.24 26.33 18 15384 190 90612855
Blood lactic acid increased 93.10 26.33 40 15362 8738 90604307
Small for dates baby 92.27 26.33 34 15368 4973 90608072
Neonatal respiratory distress syndrome 91.81 26.33 30 15372 3071 90609974
Alpha 1 foetoprotein abnormal 88.90 26.33 14 15388 39 90613006
Pain 88.04 26.33 30 15372 996311 89616734
Meconium stain 87.55 26.33 17 15385 197 90612848
Low birth weight baby 86.99 26.33 39 15363 9428 90603617
Gestational diabetes 85.93 26.33 40 15362 10542 90602503
Anal atresia 85.88 26.33 19 15383 431 90612614
Genitalia external ambiguous 85.49 26.33 16 15386 150 90612895
Acquired gene mutation 84.45 26.33 23 15379 1256 90611789
Congenital heart valve disorder 82.62 26.33 14 15388 69 90612976
Lipoatrophy 80.47 26.33 17 15385 308 90612737
Bladder agenesis 79.82 26.33 15 15387 144 90612901
Placental disorder 79.20 26.33 23 15379 1588 90611457
Congenital genital malformation 78.56 26.33 15 15387 158 90612887
Congenital pulmonary valve disorder 77.79 26.33 13 15389 58 90612987
Alanine aminotransferase increased 77.51 26.33 98 15304 118240 90494805
Aspartate aminotransferase increased 76.73 26.33 91 15311 102846 90510199
Exomphalos 76.18 26.33 18 15384 551 90612494
Off label use 75.98 26.33 47 15355 1102205 89510840
Cardiac murmur 75.98 26.33 44 15358 18150 90594895
Gastrointestinal malformation 75.52 26.33 15 15387 197 90612848
Drug ineffective 75.36 26.33 75 15327 1384223 89228822
Neutropenia neonatal 74.71 26.33 13 15389 77 90612968
Premature separation of placenta 74.60 26.33 24 15378 2338 90610707
Anaemia macrocytic 73.17 26.33 28 15374 4544 90608501
Cloacal exstrophy 72.93 26.33 14 15388 152 90612893
Viral load increased 71.15 26.33 21 15381 1535 90611510
Mitochondrial toxicity 68.40 26.33 17 15385 646 90612399
Anaemia neonatal 66.99 26.33 15 15387 360 90612685
CSF HIV escape syndrome 65.71 26.33 12 15390 97 90612948
Necrotising colitis 65.32 26.33 19 15383 1319 90611726
Abdominal discomfort 65.28 26.33 4 15398 477324 90135721
Tethered cord syndrome 64.95 26.33 14 15388 280 90612765
Caudal regression syndrome 64.41 26.33 13 15389 186 90612859
Spina bifida 63.63 26.33 17 15385 863 90612182
Meningitis cryptococcal 63.57 26.33 20 15382 1813 90611232
Malaria 63.53 26.33 13 15389 200 90612845
Fatigue 63.31 26.33 62 15340 1153961 89459084
Ultrasound antenatal screen abnormal 62.88 26.33 12 15390 126 90612919
Gastrointestinal disorder congenital 61.88 26.33 12 15390 138 90612907
Arthralgia 61.18 26.33 28 15374 778494 89834551
Neonatal respiratory arrest 59.59 26.33 10 15392 46 90612999
Normal newborn 56.41 26.33 40 15362 23322 90589723
Necrotising enterocolitis neonatal 55.96 26.33 12 15390 234 90612811
Mitochondrial cytopathy 55.77 26.33 12 15390 238 90612807
Fall 55.45 26.33 8 15394 481802 90131243
Cleft lip and palate 51.81 26.33 14 15388 742 90612303
Hyperbilirubinaemia 51.12 26.33 31 15371 13905 90599140
Hyperlactacidaemia 51.06 26.33 21 15381 4115 90608930
Astrocytoma malignant 50.36 26.33 8 15394 24 90613021
Enlarged clitoris 49.68 26.33 10 15392 141 90612904
Rheumatoid arthritis 49.67 26.33 3 15399 362611 90250434
Pulmonary valve sclerosis 48.98 26.33 8 15394 30 90613015
Developmental delay 48.53 26.33 16 15386 1684 90611361
Ventricular hypertrophy 48.00 26.33 19 15383 3372 90609673
Arnold-Chiari malformation 47.82 26.33 13 15389 705 90612340
Hepatic cytolysis 46.49 26.33 40 15362 30876 90582169
Swelling 45.86 26.33 8 15394 419050 90193995
Sepsis neonatal 45.07 26.33 12 15390 601 90612444
Twin pregnancy 44.93 26.33 14 15388 1229 90611816
Coarctation of the aorta 44.86 26.33 12 15390 612 90612433
Acute lymphocytic leukaemia 43.99 26.33 17 15385 2831 90610214
Genotype drug resistance test positive 43.76 26.33 11 15391 438 90612607
Ultrasound scan abnormal 43.21 26.33 10 15392 279 90612766
Rickets 42.94 26.33 8 15394 73 90612972
Condition aggravated 42.87 26.33 24 15378 595521 90017524
Neutropenia 42.56 26.33 108 15294 224796 90388249
Large for dates baby 42.18 26.33 11 15391 508 90612537
Alopecia 41.73 26.33 16 15386 495055 90117990
Complication of delivery 41.57 26.33 9 15393 184 90612861
Macrocephaly 40.64 26.33 9 15393 205 90612840
Rash maculo-papular 40.51 26.33 42 15360 40891 90572154
Fanconi syndrome acquired 40.46 26.33 13 15389 1261 90611784
Isoimmune haemolytic disease 40.44 26.33 7 15395 40 90613005
Congenital ectopic bladder 40.28 26.33 8 15394 105 90612940
Ultrasound antenatal screen 40.15 26.33 9 15393 217 90612828
Cleft palate 40.04 26.33 13 15389 1303 90611742
Anencephaly 40.03 26.33 10 15392 388 90612657
Hepatotoxicity 40.01 26.33 44 15358 45798 90567247
Hydromyelia 39.49 26.33 6 15396 12 90613033
Adrenogenital syndrome 39.47 26.33 7 15395 47 90612998
Plagiocephaly 39.10 26.33 8 15394 123 90612922
Jaundice 38.91 26.33 37 15365 32480 90580565
AIDS cholangiopathy 38.57 26.33 6 15396 15 90613030
Neonatal aspiration 38.23 26.33 8 15394 138 90612907
Placenta praevia 37.87 26.33 12 15390 1113 90611932
Trisomy 18 37.86 26.33 8 15394 145 90612900
Congenital anomaly in offspring 37.55 26.33 8 15394 151 90612894
Hydrocephalus 37.33 26.33 19 15383 6075 90606970
Pruritus 37.29 26.33 23 15379 541502 90071543
Pain in extremity 37.24 26.33 15 15387 450514 90162531
Haemorrhage in pregnancy 37.19 26.33 14 15388 2171 90610874
Oligohydramnios 37.11 26.33 20 15382 7181 90605864
Respiratory distress 36.83 26.33 39 15363 38907 90574138
Single umbilical artery 36.63 26.33 9 15393 326 90612719
Musculoskeletal stiffness 36.33 26.33 4 15398 296528 90316517
Stevens-Johnson syndrome 36.25 26.33 34 15368 29342 90583703
Arthropathy 35.93 26.33 9 15393 366233 90246812
Ergot poisoning 35.52 26.33 7 15395 88 90612957
HIV antibody positive 34.94 26.33 5 15397 5 90613040
Pericarditis 34.79 26.33 3 15399 270148 90342897
Neonatal hepatomegaly 34.03 26.33 5 15397 7 90613038
Hyperandrogenism 33.83 26.33 7 15395 114 90612931
Infection 33.45 26.33 10 15392 362084 90250961
Heart disease congenital 33.37 26.33 12 15390 1637 90611408
Product dose omission issue 33.17 26.33 5 15397 291682 90321363
HIV test positive 33.02 26.33 6 15396 47 90612998
Cardiac malposition 32.91 26.33 6 15396 48 90612997
Product use issue 32.57 26.33 8 15394 329911 90283134
Hypoaesthesia 32.25 26.33 7 15395 314203 90298842
Micrognathia 32.21 26.33 8 15394 303 90612742
Pallor 31.93 26.33 34 15368 34131 90578914
Ectopic pregnancy 31.85 26.33 14 15388 3227 90609818
Congenital genital malformation female 31.71 26.33 6 15396 60 90612985
Microcephaly 31.54 26.33 11 15391 1373 90611672
Foetal heart rate abnormal 31.30 26.33 10 15392 952 90612093
Weight increased 31.28 26.33 16 15386 417911 90195134
Fallot's tetralogy 31.02 26.33 6 15396 68 90612977
Hepatic displacement 31.00 26.33 5 15397 17 90613028
Hypotonia 30.95 26.33 21 15381 11405 90601640
Induced labour 30.84 26.33 10 15392 998 90612047
Chlamydial infection 30.83 26.33 8 15394 362 90612683
Alpha 1 foetoprotein increased 30.76 26.33 7 15395 181 90612864
Stomatitis 30.57 26.33 5 15397 274693 90338352
Dyspnoea 29.89 26.33 66 15336 880889 89732156
Placental insufficiency 29.49 26.33 11 15391 1664 90611381
Drug intolerance 29.45 26.33 20 15382 447571 90165474
Foetal cardiac disorder 29.45 26.33 5 15397 25 90613020
Exposure via breast milk 29.41 26.33 12 15390 2303 90610742
Pulmonary tuberculosis 29.40 26.33 15 15387 4819 90608226
Gestational hypertension 29.36 26.33 13 15389 3049 90609996
Drug hypersensitivity 28.83 26.33 22 15380 463587 90149458
Metabolic acidosis 28.61 26.33 41 15361 55635 90557410
Product use in unapproved indication 28.09 26.33 11 15391 336225 90276820
Anxiety 27.81 26.33 9 15393 309763 90303282
Diastasis recti abdominis 27.77 26.33 5 15397 37 90613008
Vaginal haemorrhage 27.26 26.33 30 15372 31241 90581804
Foetal anaemia 27.12 26.33 6 15396 136 90612909
Anembryonic gestation 27.11 26.33 8 15394 584 90612461
Varices oesophageal 26.75 26.33 13 15389 3766 90609279

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
Foetal exposure during pregnancy 1224.26 16.51 534 18302 46777 42555722
Exposure during pregnancy 983.51 16.51 292 18544 8256 42594243
Lipodystrophy acquired 967.03 16.51 238 18598 3212 42599287
Virologic failure 650.43 16.51 179 18657 3815 42598684
Viral mutation identified 649.11 16.51 172 18664 3159 42599340
Mitochondrial toxicity 640.60 16.51 162 18674 2453 42600046
Pathogen resistance 571.11 16.51 208 18628 11242 42591257
Eyelid ptosis 486.89 16.51 161 18675 6500 42595999
Immune reconstitution inflammatory syndrome 486.30 16.51 179 18657 9964 42592535
Premature baby 408.73 16.51 201 18635 22952 42579547
Progressive external ophthalmoplegia 328.67 16.51 84 18752 1327 42601172
Diplopia 279.06 16.51 149 18687 20167 42582332
Pinealoblastoma 276.83 16.51 51 18785 136 42602363
Drug resistance 228.28 16.51 158 18678 34090 42568409
Lipoatrophy 221.65 16.51 49 18787 396 42602103
Maternal drugs affecting foetus 184.79 16.51 68 18768 3771 42598728
Blood lactic acid increased 166.64 16.51 78 18758 7961 42594538
Caesarean section 162.23 16.51 53 18783 2053 42600446
Volvulus 148.38 16.51 49 18787 1964 42600535
Hypertriglyceridaemia 146.70 16.51 77 18759 10049 42592450
Anaemia 140.90 16.51 352 18484 279926 42322573
Neonatal disorder 125.91 16.51 35 18801 772 42601727
Hepatic fibrosis 125.45 16.51 55 18781 4817 42597682
Ophthalmoplegia 109.69 16.51 40 18796 2160 42600339
HIV-associated neurocognitive disorder 107.56 16.51 26 18810 322 42602177
Hyperlactacidaemia 106.70 16.51 48 18788 4468 42598031
Blood HIV RNA increased 106.42 16.51 36 18800 1555 42600944
Off label use 106.25 16.51 77 18759 638258 41964241
CSF HIV escape syndrome 104.12 16.51 23 18813 185 42602314
Anaemia macrocytic 97.62 16.51 42 18794 3513 42598986
Congenital anomaly 91.90 16.51 32 18804 1509 42600990
Polydactyly 90.79 16.51 30 18806 1204 42601295
CD4 lymphocytes decreased 88.67 16.51 33 18803 1888 42600611
Trisomy 18 88.35 16.51 27 18809 838 42601661
Pregnancy 87.87 16.51 21 18815 247 42602252
Trisomy 21 85.13 16.51 24 18812 558 42601941
Osteonecrosis 82.42 16.51 63 18773 15802 42586697
Cleft lip and palate 82.20 16.51 26 18810 906 42601593
Hydrops foetalis 78.80 16.51 25 18811 880 42601619
Human immunodeficiency virus transmission 78.68 16.51 15 18821 51 42602448
Aspartate aminotransferase increased 78.31 16.51 130 18706 77033 42525466
Anaemia neonatal 74.17 16.51 20 18816 392 42602107
Treatment noncompliance 73.64 16.51 87 18749 37585 42564914
Cryptorchism 72.76 16.51 29 18807 1998 42600501
Ultrasound antenatal screen 72.37 16.51 21 18815 543 42601956
Alanine aminotransferase increased 70.46 16.51 134 18702 88272 42514227
Hypospadias 68.97 16.51 33 18803 3534 42598965
Small for dates baby 67.73 16.51 37 18799 5226 42597273
Multiple-drug resistance 66.38 16.51 41 18795 7281 42595218
Product use in unapproved indication 62.72 16.51 5 18831 184451 42418048
Low birth weight baby 61.76 16.51 44 18792 9911 42592588
Foetal distress syndrome 60.75 16.51 22 18814 1164 42601335
Drug ineffective 60.74 16.51 117 18719 630080 41972419
Portal hypertension 57.07 16.51 32 18804 4755 42597744
Chordee 56.83 16.51 12 18824 76 42602423
Ventricular septal defect 56.81 16.51 31 18805 4368 42598131
Drug-induced liver injury 56.72 16.51 77 18759 38196 42564303
Hyperlipidaemia 56.45 16.51 58 18778 21458 42581041
Fall 56.11 16.51 17 18819 234503 42367996
Dyslipidaemia 54.71 16.51 40 18796 9378 42593121
Optic nerve neoplasm 54.45 16.51 10 18826 26 42602473
Congenital neoplasm 53.40 16.51 10 18826 30 42602469
Hydrocele 53.32 16.51 25 18811 2558 42599941
Kaposi's sarcoma 53.21 16.51 18 18818 777 42601722
Product dose omission issue 52.98 16.51 4 18832 154361 42448138
Viral load increased 52.74 16.51 26 18810 2971 42599528
Acquired immunodeficiency syndrome 52.49 16.51 16 18820 492 42602007
Blood antidiuretic hormone increased 50.59 16.51 10 18826 43 42602456
Pain 49.78 16.51 23 18813 244825 42357674
Atrial septal defect 49.12 16.51 35 18801 7884 42594615
Patent ductus arteriosus 49.10 16.51 26 18810 3450 42599049
Mitochondrial myopathy 46.73 16.51 12 18824 193 42602306
Death 45.70 16.51 87 18749 471098 42131401
Congenital hydronephrosis 45.42 16.51 16 18820 781 42601718
Congenital naevus 45.02 16.51 8 18828 16 42602483
Nodular regenerative hyperplasia 44.72 16.51 17 18819 1031 42601468
Lymphadenopathy 43.30 16.51 63 18773 33302 42569197
Rhabdomyosarcoma 43.04 16.51 9 18827 54 42602445
Splenomegaly 43.00 16.51 45 18791 17002 42585497
HIV infection 42.27 16.51 18 18818 1467 42601032
Cytomegalovirus chorioretinitis 42.26 16.51 26 18810 4585 42597914
Lipohypertrophy 42.08 16.51 12 18824 291 42602208
Osteoporotic fracture 41.97 16.51 18 18818 1493 42601006
Meningomyelocele 40.63 16.51 11 18825 219 42602280
Cardiac murmur 40.13 16.51 38 18798 12737 42589762
Pneumonia 39.99 16.51 79 18757 422070 42180429
Blood pyruvic acid increased 39.39 16.51 7 18829 14 42602485
Blood creatine phosphokinase increased 39.38 16.51 74 18762 48264 42554235
Abortion spontaneous 38.68 16.51 12 18824 392 42602107
Limb deformity 38.32 16.51 13 18823 566 42601933
Gastroschisis 38.26 16.51 10 18826 173 42602326
Mycobacterium avium complex infection 38.17 16.51 21 18815 3006 42599493
Hypertonia 37.87 16.51 25 18811 4976 42597523
Atrial fibrillation 37.43 16.51 8 18828 139585 42462914
Gamma-glutamyltransferase increased 37.37 16.51 58 18778 32439 42570060
Congenital cytomegalovirus infection 37.14 16.51 7 18829 22 42602477
Hepatomegaly 36.91 16.51 35 18801 11750 42590749
Malignant neoplasm progression 36.65 16.51 3 18833 108397 42494102
Oesophageal candidiasis 35.17 16.51 25 18811 5610 42596889
White matter lesion 34.85 16.51 14 18822 984 42601515
Acquired gene mutation 34.81 16.51 16 18820 1564 42600935
Strabismus 34.41 16.51 18 18818 2330 42600169
Blood pressure increased 33.97 16.51 3 18833 101925 42500574
Neonatal hyponatraemia 33.96 16.51 8 18828 88 42602411
Pulmonary tuberculosis 33.40 16.51 24 18812 5477 42597022
Jaundice 33.35 16.51 57 18779 34532 42567967
Blood triglycerides increased 33.20 16.51 38 18798 15858 42586641
Astrocytoma, low grade 33.02 16.51 8 18828 100 42602399
Neutropenia neonatal 32.46 16.51 13 18823 907 42601592
COVID-19 32.43 16.51 6 18830 115942 42486557
Blood bilirubin increased 32.34 16.51 63 18773 42189 42560310
Hypotension 32.16 16.51 40 18796 257591 42344908
Speech disorder developmental 32.02 16.51 17 18819 2268 42600231
Foetal growth restriction 31.96 16.51 23 18813 5260 42597239
Constipation 31.80 16.51 16 18820 162275 42440224
Facial wasting 31.61 16.51 8 18828 121 42602378
Congenital mitral valve incompetence 30.79 16.51 8 18828 135 42602364
Dyspnoea 30.13 16.51 98 18738 442523 42159976
Macrocytosis 30.02 16.51 13 18823 1104 42601395
Congenital anaemia 29.69 16.51 5 18831 6 42602493
Developmental delay 29.30 16.51 18 18818 3164 42599335
Genotype drug resistance test positive 29.08 16.51 13 18823 1191 42601308
Enophthalmos 28.85 16.51 5 18831 8 42602491
Hepatic function abnormal 28.09 16.51 67 18769 51500 42550999
Fatigue 27.91 16.51 99 18737 435542 42166957
Ear malformation 27.68 16.51 9 18827 343 42602156
Retroperitoneal disorder 27.65 16.51 6 18830 44 42602455
Exomphalos 27.49 16.51 8 18828 209 42602290
Death neonatal 27.43 16.51 9 18827 353 42602146
Cystitis noninfective 27.35 16.51 10 18826 544 42601955
Post streptococcal glomerulonephritis 27.29 16.51 7 18829 112 42602387
Cerebrovascular accident 27.23 16.51 5 18831 97155 42505344
Hepatitis B 27.09 16.51 23 18813 6688 42595811
Dysphagia 27.01 16.51 82 18754 72637 42529862
Prenatal screening test abnormal 26.96 16.51 5 18831 14 42602485
Talipes 26.79 16.51 15 18821 2221 42600278
Transaminases increased 26.35 16.51 50 18786 32835 42569664
Live birth 26.31 16.51 8 18828 244 42602255
Hepatitis C virus test 26.17 16.51 6 18830 58 42602441
Oral candidiasis 26.06 16.51 32 18804 14373 42588126
Tuberculoid leprosy 25.55 16.51 6 18830 65 42602434
Cachexia 25.25 16.51 24 18812 8080 42594419
Febrile neutropenia 25.13 16.51 27 18809 185676 42416823
Sickle cell anaemia 25.12 16.51 8 18828 285 42602214
Late developer 24.66 16.51 4 18832 3 42602496
Anogenital warts 24.60 16.51 10 18826 725 42601774
HIV wasting syndrome 24.55 16.51 6 18830 78 42602421
Congenital hydrocephalus 24.46 16.51 7 18829 172 42602327
Sudden infant death syndrome 24.43 16.51 8 18828 312 42602187
Ultrasound antenatal screen abnormal 24.27 16.51 6 18830 82 42602417
Immune recovery uveitis 24.21 16.51 6 18830 83 42602416
Maternal condition affecting foetus 24.13 16.51 4 18832 4 42602495
Perinatal HIV infection 24.13 16.51 4 18832 4 42602495
Heart disease congenital 23.87 16.51 12 18824 1430 42601069
Treatment failure 23.62 16.51 71 18765 62553 42539946
Thalassaemia alpha 23.37 16.51 5 18831 34 42602465
Renal aneurysm 23.36 16.51 7 18829 203 42602296
Lactate pyruvate ratio increased 23.24 16.51 4 18832 6 42602493
Birth trauma 23.24 16.51 4 18832 6 42602493
Acute lymphocytic leukaemia 23.22 16.51 16 18820 3415 42599084
Progressive multifocal leukoencephalopathy 23.12 16.51 27 18809 11509 42590990
Malaria 23.10 16.51 7 18829 211 42602288
Hepatosplenomegaly 23.09 16.51 18 18818 4642 42597857
Nervous system disorder 23.08 16.51 33 18803 17162 42585337
Floppy eyelid syndrome 23 16.51 5 18831 37 42602462
Leukopenia 22.97 16.51 79 18757 74667 42527832
Genitalia external ambiguous 22.44 16.51 7 18829 233 42602266
Blood triglycerides decreased 22.09 16.51 6 18830 121 42602378
Meningitis tuberculous 21.91 16.51 9 18827 670 42601829
Cryptococcosis 21.80 16.51 15 18821 3196 42599303
Disease progression 21.62 16.51 19 18817 143637 42458862
Polyneuropathy chronic 21.48 16.51 5 18831 52 42602447
Lagophthalmos 21.47 16.51 6 18830 135 42602364
ADAMTS13 activity decreased 21.02 16.51 6 18830 146 42602353
Blood alkaline phosphatase increased 20.89 16.51 46 18790 33551 42568948
Meconium peritonitis 20.89 16.51 4 18832 14 42602485
Pancytopenia 20.82 16.51 105 18731 117638 42484861
Congenital abdominal hernia 20.67 16.51 4 18832 15 42602484
CD4 lymphocytes increased 20.61 16.51 6 18830 157 42602342
Heart transplant rejection 20.33 16.51 11 18825 1523 42600976
Cleft lip 20.29 16.51 7 18829 321 42602178
Congenital retinoblastoma 20.18 16.51 3 18833 0 42602499
Vision abnormal neonatal 20.18 16.51 3 18833 0 42602499
Neonatal intestinal obstruction 20.18 16.51 3 18833 0 42602499
Abdominal hernia 20.10 16.51 14 18822 3041 42599458
Hepatitis 20.03 16.51 40 18796 27260 42575239
Sickle cell disease 19.89 16.51 6 18830 178 42602321
Hyperbilirubinaemia 19.88 16.51 34 18802 20601 42581898
Pneumocystis jirovecii pneumonia 19.82 16.51 38 18798 25143 42577356
Cardiac arrest 19.63 16.51 12 18824 109308 42493191
Congenital aortic anomaly 19.61 16.51 5 18831 78 42602421
Blood insulin increased 19.48 16.51 7 18829 362 42602137
Portal vein thrombosis 19.20 16.51 16 18820 4533 42597966
Meningitis cryptococcal 19.19 16.51 14 18822 3269 42599230
Pruritus 18.97 16.51 34 18802 188737 42413762
Lactic acidosis 18.68 16.51 53 18783 45208 42557291
Hypotonia 18.65 16.51 22 18814 9477 42593022
Subacute sclerosing panencephalitis 18.59 16.51 4 18832 28 42602471
Somnolence 18.55 16.51 21 18815 141084 42461415
Herpes zoster 18.52 16.51 48 18788 38829 42563670
Nasopharyngitis 18.47 16.51 7 18829 83989 42518510
Congenital central nervous system anomaly 18.28 16.51 8 18828 697 42601802
Drug interaction 18.17 16.51 189 18647 266810 42335689
Completed suicide 18.16 16.51 10 18826 96455 42506044
Drug abuse 18.13 16.51 12 18824 104759 42497740
CSF virus identified 17.81 16.51 4 18832 35 42602464
Abnormal dreams 17.65 16.51 20 18816 8251 42594248
Twin pregnancy 17.63 16.51 3 18833 4 42602495
Neck deformity 17.62 16.51 5 18831 119 42602380
Atrophy 17.34 16.51 9 18827 1146 42601353
Portal venous gas 17.29 16.51 7 18829 502 42601997
Retinal toxicity 17.06 16.51 7 18829 520 42601979
Lymph node tuberculosis 17.06 16.51 7 18829 520 42601979
Gastroenteritis 17.04 16.51 28 18808 16421 42586078
Torsade de pointes 17.03 16.51 20 18816 8574 42593925
Reticulocytosis 17.01 16.51 6 18830 294 42602205
Trisomy 15 16.88 16.51 3 18833 6 42602493
Lipase increased 16.78 16.51 22 18814 10544 42591955
Exophthalmos 16.77 16.51 8 18828 850 42601649
Feeling abnormal 16.76 16.51 5 18831 69781 42532718
Back pain 16.65 16.51 23 18813 141753 42460746
Adrenogenital syndrome 16.59 16.51 4 18832 49 42602450
Subacute combined cord degeneration 16.52 16.51 5 18831 150 42602349

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
Virologic failure 1212.13 18.09 265 22412 4687 110561935
Lipodystrophy acquired 1202.07 18.09 259 22418 4265 110562357
Exposure during pregnancy 1160.87 18.09 601 22076 166823 110399799
Viral mutation identified 1062.15 18.09 233 22444 4186 110562436
Pathogen resistance 920.80 18.09 275 22402 17397 110549225
Immune reconstitution inflammatory syndrome 917.49 18.09 269 22408 15957 110550665
Abortion spontaneous 827.50 18.09 298 22379 33984 110532638
Stillbirth 817.97 18.09 187 22490 4077 110562545
Mitochondrial toxicity 768.09 18.09 169 22508 3076 110563546
Foetal exposure during pregnancy 655.60 18.09 175 22502 7330 110559292
Drug resistance 616.01 18.09 277 22400 56097 110510525
Eyelid ptosis 494.46 18.09 160 22517 13167 110553455
Abortion induced 409.70 18.09 123 22554 7896 110558726
Progressive external ophthalmoplegia 397.95 18.09 85 22592 1335 110565287
Blood HIV RNA increased 319.77 18.09 77 22600 2111 110564511
Caesarean section 306.62 18.09 113 22564 13704 110552918
Diplopia 285.16 18.09 149 22528 41745 110524877
Lipoatrophy 277.81 18.09 55 22622 579 110566043
Anaemia 277.28 18.09 441 22236 546645 110019977
Treatment noncompliance 222.73 18.09 155 22522 72835 110493787
Premature rupture of membranes 210.65 18.09 65 22612 4572 110562050
Pregnancy 208.24 18.09 130 22547 50937 110515685
Maternal drugs affecting foetus 186.22 18.09 47 22630 1570 110565052
Portal hypertension 185.59 18.09 69 22608 8568 110558054
CSF HIV escape syndrome 181.05 18.09 35 22642 322 110566300
Maternal exposure during pregnancy 171.27 18.09 235 22442 254648 110311974
CD4 lymphocytes decreased 162.22 18.09 48 22629 2926 110563696
Premature labour 146.26 18.09 59 22618 9113 110557509
HIV-associated neurocognitive disorder 140.70 18.09 29 22648 379 110566243
Hepatic fibrosis 139.45 18.09 55 22622 8011 110558611
Premature baby 139.08 18.09 48 22629 4807 110561815
Pinealoblastoma 131.20 18.09 21 22656 52 110566570
Acquired gene mutation 126.76 18.09 39 22638 2715 110563907
Pre-eclampsia 122.12 18.09 51 22626 8599 110558023
Live birth 121.16 18.09 106 22571 69378 110497244
Ophthalmoplegia 117.02 18.09 39 22638 3511 110563111
Hydrops foetalis 116.77 18.09 28 22649 753 110565869
Alanine aminotransferase increased 116.70 18.09 165 22512 183608 110383014
Ultrasound antenatal screen 114.33 18.09 27 22650 679 110565943
Aspartate aminotransferase increased 114.21 18.09 152 22525 159784 110406838
Cleft lip and palate 108.18 18.09 26 22651 706 110565916
Premature delivery 107.56 18.09 71 22606 30561 110536061
Trisomy 18 101.88 18.09 24 22653 597 110566025
Foetal death 97.65 18.09 53 22624 15992 110550630
Hypertriglyceridaemia 94.55 18.09 52 22625 16102 110550520
Pain 92.83 18.09 40 22637 954915 109611707
Dyslipidaemia 89.63 18.09 50 22627 15915 110550707
Viral load increased 83.66 18.09 30 22647 3360 110563262
Lymphadenopathy 83.50 18.09 83 22594 63752 110502870
Genotype drug resistance test positive 78.02 18.09 23 22654 1383 110565239
Off label use 77.36 18.09 118 22559 1500067 109066555
Osteonecrosis 74.43 18.09 59 22618 33682 110532940
Meningitis cryptococcal 73.75 18.09 30 22647 4732 110561890
Hepatomegaly 73.64 18.09 49 22628 21365 110545257
Pulmonary tuberculosis 72.30 18.09 36 22641 9103 110557519
Joint swelling 71.47 18.09 5 22672 442840 110123782
Peripheral swelling 70.04 18.09 3 22674 404031 110162591
Hyperlactacidaemia 69.60 18.09 34 22643 8252 110558370
Amniotic cavity infection 69.10 18.09 19 22658 888 110565734
Nasopharyngitis 68.12 18.09 3 22674 394358 110172264
Multiple-drug resistance 67.69 18.09 39 22638 13196 110553426
Alpha 1 foetoprotein abnormal 64.53 18.09 11 22666 45 110566577
Mycobacterium avium complex infection 64.46 18.09 29 22648 5848 110560774
Fall 63.98 18.09 22 22655 603460 109963162
Jaundice 61.34 18.09 68 22609 59168 110507454
Blood lactic acid increased 61.25 18.09 39 22638 15782 110550840
Kaposi's sarcoma 59.52 18.09 16 22661 686 110565936
HIV viraemia 55.80 18.09 11 22666 113 110566509
Acute lymphocytic leukaemia 55.56 18.09 26 22651 5739 110560883
Hepatic cytolysis 54.95 18.09 62 22615 54991 110511631
Splenomegaly 54.38 18.09 43 22634 24455 110542167
Pancytopenia 53.73 18.09 127 22550 209486 110357136
Facial wasting 53.66 18.09 10 22667 74 110566548
Cytomegalovirus chorioretinitis 53.22 18.09 27 22650 7101 110559521
Drug-induced liver injury 52.68 18.09 91 22586 119976 110446646
Rickets 52.12 18.09 10 22667 88 110566534
Malaria 52.10 18.09 13 22664 414 110566208
Product use in unapproved indication 51.55 18.09 14 22663 447363 110119259
Premature separation of placenta 50.66 18.09 17 22660 1563 110565059
Abdominal discomfort 49.98 18.09 10 22667 393848 110172774
Gestational diabetes 49.44 18.09 26 22651 7363 110559259
Acquired immunodeficiency syndrome 49.24 18.09 12 22665 346 110566276
Blood triglycerides increased 48.87 18.09 40 22637 23886 110542736
Optic nerve neoplasm 48.86 18.09 8 22669 24 110566598
Tuberculosis 47.84 18.09 35 22642 17739 110548883
Cachexia 47.73 18.09 31 22646 12974 110553648
Stevens-Johnson syndrome 47.12 18.09 53 22624 46848 110519774
Mitochondrial myopathy 46.41 18.09 12 22665 442 110566180
Gamma-glutamyltransferase increased 46.40 18.09 60 22617 61249 110505373
Nodular regenerative hyperplasia 46.23 18.09 16 22661 1615 110565007
Placental disorder 45.05 18.09 14 22663 1007 110565615
White matter lesion 44.88 18.09 18 22659 2736 110563886
Rheumatoid arthritis 43.97 18.09 5 22672 299608 110267014
Hyperlipidaemia 43.92 18.09 45 22632 35803 110530819
Product dose omission issue 43.36 18.09 7 22670 321775 110244847
Drug interaction 43.31 18.09 210 22467 499973 110066649
Leukopenia 42.37 18.09 94 22583 148697 110417925
Arthralgia 42.28 18.09 59 22618 779573 109787049
Blood antidiuretic hormone increased 41.84 18.09 8 22669 69 110566553
Synovitis 41.69 18.09 4 22673 274088 110292534
Proteinuria 41.53 18.09 46 22631 39972 110526650
Normal newborn 41.38 18.09 35 22642 21861 110544761
Sinusitis 41.01 18.09 6 22671 296682 110269940
Drug ineffective 41.00 18.09 167 22510 1520373 109046249
Wheezing 40.81 18.09 3 22674 255227 110311395
Astrocytoma malignant 39.91 18.09 7 22670 35 110566587
Fanconi syndrome acquired 39.86 18.09 17 22660 3017 110563605
Placenta praevia 39.75 18.09 12 22665 783 110565839
Blood bilirubin increased 39.26 18.09 62 22615 75910 110490712
Pneumocystis jirovecii pneumonia 39.07 18.09 46 22631 42689 110523933
COVID-19 38.85 18.09 3 22674 245057 110321565
Transaminases increased 38.83 18.09 56 22621 63334 110503288
Mitochondrial cytopathy 38.24 18.09 10 22667 385 110566237
Meningitis tuberculous 38.02 18.09 13 22664 1265 110565357
Twin pregnancy 37.55 18.09 12 22665 946 110565676
AIDS cholangiopathy 37.44 18.09 6 22671 15 110566607
Arthropathy 37.10 18.09 7 22670 287515 110279107
Lipohypertrophy 36.97 18.09 12 22665 994 110565628
Swelling 36.81 18.09 13 22664 351028 110215594
Wound 36.80 18.09 3 22674 234434 110332188
Pyrexia 36.46 18.09 311 22366 897954 109668668
Oesophageal candidiasis 36.33 18.09 25 22652 11509 110555113
Constipation 36.25 18.09 14 22663 357772 110208850
Brain oedema 36.23 18.09 38 22639 31060 110535562
Varices oesophageal 36.20 18.09 21 22656 7194 110559428
Stomatitis 36.13 18.09 6 22671 270236 110296386
Anaemia macrocytic 35.96 18.09 21 22656 7282 110559340
Hepatotoxicity 35.93 18.09 54 22623 63346 110503276
Musculoskeletal stiffness 35.71 18.09 7 22670 279815 110286807
Hepatic function abnormal 35.71 18.09 65 22612 89230 110477392
Fatigue 34.99 18.09 130 22547 1215828 109350794
Rhabdomyosarcoma 34.68 18.09 8 22669 181 110566441
Retinoblastoma 34.43 18.09 7 22670 85 110566537
Blood alkaline phosphatase increased 34.08 18.09 56 22621 70879 110495743
HIV infection 33.93 18.09 12 22665 1291 110565331
Umbilical cord abnormality 33.92 18.09 8 22669 200 110566422
Pericarditis 33.85 18.09 3 22674 219111 110347511
Neutropenia neonatal 33.58 18.09 6 22671 34 110566588
Pruritus 33.55 18.09 42 22635 581518 109985104
Rash maculo-papular 33.53 18.09 57 22620 74165 110492457
Osteoporotic fracture 33.50 18.09 18 22659 5319 110561303
Tuberculoid leprosy 32.76 18.09 7 22670 110 110566512
Immune reconstitution inflammatory syndrome associated tuberculosis 32.45 18.09 11 22666 1043 110565579
Post streptococcal glomerulonephritis 32.41 18.09 7 22670 116 110566506
Retroperitoneal disorder 32.24 18.09 6 22671 44 110566578
Amylase increased 32.22 18.09 24 22653 12495 110554127
Hepatitis C 32.13 18.09 24 22653 12549 110554073
Fat tissue increased 31.91 18.09 11 22666 1097 110565525
Progressive multifocal leukoencephalopathy 31.79 18.09 32 22645 24924 110541698
Ergot poisoning 31.66 18.09 7 22670 130 110566492
Strabismus 31.32 18.09 15 22662 3484 110563138
Gynaecomastia 30.91 18.09 21 22656 9469 110557153
Ectopic pregnancy 30.61 18.09 13 22664 2284 110564338
Cryptococcosis 30.14 18.09 16 22661 4615 110562007
Congenital retinoblastoma 29.97 18.09 4 22673 0 110566622
Dysphagia 29.96 18.09 84 22593 153516 110413106
Therapeutic product effect incomplete 29.85 18.09 5 22672 223800 110342822
Induced labour 29.82 18.09 10 22667 917 110565705
Portal hypertensive gastropathy 29.47 18.09 12 22665 1896 110564726
Oligohydramnios 29.44 18.09 15 22662 3979 110562643
Hepatitis 29.21 18.09 60 22617 89994 110476628
Hepatosplenomegaly 29.16 18.09 18 22659 6901 110559721
Ultrasound antenatal screen abnormal 29.07 18.09 6 22671 79 110566543
Torsade de pointes 28.83 18.09 29 22648 22571 110544051
Hyperbilirubinaemia 28.01 18.09 33 22644 30638 110535984
Anogenital warts 27.83 18.09 10 22667 1126 110565496
Nephropathy toxic 27.51 18.09 31 22646 27447 110539175
HIV infection CDC category C 27.33 18.09 5 22672 33 110566589
Anaemia neonatal 27.33 18.09 5 22672 33 110566589
Lower respiratory tract infection 27.25 18.09 8 22669 243098 110323524
Alopecia 27.18 18.09 21 22656 364732 110201890
Completed suicide 27.13 18.09 8 22669 242373 110324249
Floppy eyelid syndrome 26.83 18.09 5 22672 37 110566585
Infection 26.81 18.09 21 22656 362179 110204443
Atrial fibrillation 26.78 18.09 7 22670 229635 110336987
Ileal ulcer 26.61 18.09 11 22666 1806 110564816
Astrocytoma, low grade 26.57 18.09 6 22671 123 110566499
Inappropriate schedule of product administration 26.18 18.09 5 22672 203632 110362990
Renal aneurysm 26.16 18.09 7 22670 295 110566327
Discomfort 26.10 18.09 6 22671 214701 110351921
Hepatitis B 26.03 18.09 19 22658 9593 110557029
Speech disorder developmental 25.99 18.09 9 22668 910 110565712
Glycosuria 25.77 18.09 12 22665 2618 110564004
Lipase increased 25.75 18.09 25 22652 18647 110547975
Immune recovery uveitis 25.67 18.09 6 22671 144 110566478
Dry mouth 25.51 18.09 5 22672 199943 110366679
Nervous system disorder 25.50 18.09 32 22645 31689 110534933
Asthma 25.01 18.09 10 22667 250281 110316341
Antiviral drug level below therapeutic 24.97 18.09 5 22672 56 110566566
Foetal distress syndrome 24.93 18.09 8 22669 639 110565983
Chlamydial infection 24.87 18.09 8 22669 644 110565978
Congenital anomaly 24.81 18.09 9 22668 1042 110565580
Macrocephaly 24.73 18.09 5 22672 59 110566563
Vaginal haemorrhage 24.61 18.09 28 22649 25046 110541576
Lymph node tuberculosis 24.37 18.09 9 22668 1095 110565527
Pneumonia 24.34 18.09 95 22582 876619 109690003
Condition aggravated 24.19 18.09 74 22603 734762 109831860
Retinal toxicity 24.15 18.09 10 22667 1649 110564973
Folliculitis 24.08 18.09 3 22674 167650 110398972
Enophthalmos 23.81 18.09 5 22672 72 110566550
Drug intolerance 23.80 18.09 29 22648 406483 110160139
Oral candidiasis 23.78 18.09 37 22640 44723 110521899
Cerebral toxoplasmosis 23.74 18.09 12 22665 3130 110563492
Insulin resistance 23.72 18.09 10 22667 1724 110564898
HIV wasting syndrome 23.68 18.09 5 22672 74 110566548
Anembryonic gestation 23.65 18.09 7 22670 427 110566195
Congestive cardiomyopathy 23.39 18.09 21 22656 14198 110552424
Hypotension 23.35 18.09 45 22632 523804 110042818
Product use issue 23.15 18.09 18 22659 311677 110254945
Dyspnoea 23.08 18.09 133 22544 1106739 109459883
Neonatal disorder 22.49 18.09 4 22673 22 110566600
Meningomyelocele 22.49 18.09 4 22673 22 110566600
Human immunodeficiency virus transmission 22.48 18.09 3 22674 0 110566622
Foetal cardiac disorder 22.34 18.09 4 22673 23 110566599
Portal venous gas 22.24 18.09 7 22670 525 110566097
Oxygen saturation decreased 22.09 18.09 3 22674 156979 110409643
Liver transplant 22.08 18.09 13 22664 4576 110562046
Feeling abnormal 22.06 18.09 5 22672 180706 110385916
Encephalitis 21.90 18.09 23 22654 18816 110547806
Acute stress disorder 21.80 18.09 7 22670 560 110566062
Arthritis 21.78 18.09 4 22673 167582 110399040
Injury 21.45 18.09 5 22672 177260 110389362
Gestational hypertension 21.29 18.09 10 22667 2224 110564398
Ocular icterus 21.17 18.09 14 22663 6039 110560583
Drug hypersensitivity 21.12 18.09 38 22639 454052 110112570
Amniotic fluid volume decreased 21.12 18.09 6 22671 316 110566306
ADAMTS13 activity decreased 21.00 18.09 6 22671 323 110566299
Breech delivery 20.97 18.09 4 22673 34 110566588
Anxiety 20.86 18.09 24 22653 345054 110221568
Calculus urinary 20.83 18.09 11 22666 3141 110563481
Sudden infant death syndrome 20.65 18.09 6 22671 343 110566279
Blood creatine phosphokinase increased 20.60 18.09 46 22631 73031 110493591
CSF virus identified 20.57 18.09 4 22673 38 110566584
HIV associated nephropathy 20.43 18.09 6 22671 356 110566266
Hepatitis A 20.40 18.09 8 22669 1147 110565475
Blood pressure increased 20.38 18.09 14 22663 258359 110308263
Atrophy 20.36 18.09 10 22667 2454 110564168
Hepatic encephalopathy 20.36 18.09 27 22650 28229 110538393
Febrile neutropenia 20.29 18.09 21 22656 316746 110249876
CD4 lymphocytes increased 20.20 18.09 6 22671 370 110566252
Ventricular septal defect 20.17 18.09 7 22670 712 110565910
Gene mutation 19.96 18.09 11 22666 3418 110563204
Bovine tuberculosis 19.84 18.09 5 22672 166 110566456
Blister 19.77 18.09 11 22666 227365 110339257
Opportunistic infection 19.62 18.09 11 22666 3532 110563090
Placental insufficiency 19.52 18.09 8 22669 1286 110565336
Patent ductus arteriosus 19.34 18.09 5 22672 184 110566438
Bone marrow failure 19.30 18.09 39 22638 57809 110508813
Hydromyelia 19.18 18.09 3 22674 6 110566616
Hyperbilirubinaemia neonatal 19.18 18.09 3 22674 6 110566616
Lymphocytic infiltration 19.10 18.09 9 22668 2016 110564606
Lipomatosis 18.97 18.09 6 22671 457 110566165
Psoriasis 18.95 18.09 3 22674 139990 110426632
Musculoskeletal pain 18.80 18.09 7 22670 183016 110383606
Lymphoedema 18.75 18.09 19 22658 14910 110551712
Erythropenia 18.68 18.09 6 22671 481 110566141
Toxic epidermal necrolysis 18.63 18.09 38 22639 56689 110509933
Migraine 18.60 18.09 6 22671 171646 110394976
Non-Hodgkin's lymphoma 18.59 18.09 8 22669 1451 110565171
Developmental delay 18.56 18.09 8 22669 1457 110565165
Hepatitis C virus test 18.54 18.09 4 22673 66 110566556
Acute HIV infection 18.48 18.09 4 22673 67 110566555
Mesenteric artery thrombosis 18.25 18.09 7 22670 946 110565676
Abortion missed 18.19 18.09 8 22669 1529 110565093
Ultrasound scan abnormal 18.18 18.09 5 22672 234 110566388
Amylase abnormal 18.16 18.09 4 22673 73 110566549
Exophthalmos 18.11 18.09 9 22668 2264 110564358

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
Blood lactic acid increased 59.06 31.79 27 1030 100 112796
Hypertriglyceridaemia 45.87 31.79 18 1039 40 112856
Neutropenia 43.91 31.79 33 1024 358 112538
Pregnancy 42.11 31.79 15 1042 22 112874
Aspartate aminotransferase increased 41.27 31.79 17 1040 45 112851
Blood creatine phosphokinase increased 39.11 31.79 14 1043 21 112875
Anaemia macrocytic 35.65 31.79 12 1045 13 112883
Platelet count increased 35.19 31.79 12 1045 14 112882
Volvulus 34.52 31.79 18 1039 94 112802

Pharmacologic Action:

SourceCodeDescription
ATC J05AF01 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 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
FDA MoA N0000009947 Nucleoside Reverse Transcriptase Inhibitors
FDA EPC N0000175462 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000963 Antimetabolites
MeSH PA D000998 Antiviral Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D018894 Reverse Transcriptase Inhibitors
MeSH PA D019380 Anti-HIV Agents
MeSH PA D019384 Nucleic Acid Synthesis Inhibitors
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:33231 antitubercular agent
CHEBI has role CHEBI:35221 antimetabolite
CHEBI has role CHEBI:35441 antiinfective agent
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35718 antifungal agent
CHEBI has role CHEBI:36044 antiviral drug
CHEBI has role CHEBI:53756 HIV-1 reverse transcriptase inhibitor
CHEBI has role CHEBI:64946 anti-HIV agent

Related Drugs by ATC class:

J05AF Nucleoside and nucleotide reverse transcriptase inhibitors 12 drugs
abacaviradefovir dipivoxilclevudinedidanosineemtricitabineentecavirlamivudinestavudinetelbivudinetenofovir alafenamidetenofovir disoproxilzalcitabine
J05AR Antivirals for treatment of HIV infections, combinations 19 drugs
abacaviratazanavirbictegravircobicistatdarunavirdolutegravirdoravirineefavirenzelvitegraviremtricitabinelamivudinelopinavir show all 19 →

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

DiseaseRelationSNOMED_IDDOID
Human immunodeficiency virus infection indication 86406008 DOID:526
Prevention of Maternal-Fetal Transmission of HIV indication
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
HLA-B 5701 Positive Status contraindication
Drug Resistance to Anti-retroviral Therapy contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.17 acidic
pKa2 13.72 acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
5-hydroxytryptamine receptor 2A GPCR IC50 5.51 WOMBAT-PK
Thymidine kinase, cytosolic Kinase Ki 5.54 CHEMBL
Thymidylate kinase Kinase Ki 4.55 WOMBAT-PK
Sigma non-opioid intracellular receptor 1 Membrane receptor Ki 4 WOMBAT-PK
Reverse transcriptase/RNaseH Enzyme INHIBITOR IC50 8.52 CHEMBL CHEMBL
Pol polyprotein Enzyme IC50 8.22 CHEMBL
Gag-Pro-Pol polyprotein Polyprotein EC50 8.31 WOMBAT-PK
Reverse transcriptase/RNaseH Enzyme IC50 6.11 WOMBAT-PK
Reverse transcriptase Enzyme IC50 4.74 CHEMBL
Thymidylate kinase Kinase Ki 4.55 CHEMBL
Thymidine kinase Kinase IC50 4.90 CHEMBL
Reverse transcriptase protein Enzyme IC50 5.44 CHEMBL

External reference:

IDSource
4019502 VUID
N0000147622 NUI
D00413 KEGG_DRUG
4019502 VANDF
C0043474 UMLSCUI
CHEBI:10110 CHEBI
AZZ PDB_CHEM_ID
CHEMBL129 ChEMBL_ID
DB00495 DRUGBANK_ID
D015215 MESH_DESCRIPTOR_UI
35370 PUBCHEM_CID
4825 IUPHAR_LIGAND_ID
6118 INN_ID
4B9XT59T7S UNII
11413 RXNORM
5703 MMSL
71929 MMSL
d00034 MMSL
003019 NDDF
27479000 SNOMEDCT_US
387151007 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Combivir HUMAN PRESCRIPTION DRUG LABEL 2 16590-061 TABLET, FILM COATED 300 mg ORAL NDA 16 sections
Zidovudine HUMAN PRESCRIPTION DRUG LABEL 1 21695-369 TABLET, FILM COATED 300 mg ORAL ANDA 27 sections
COMBIVIR HUMAN PRESCRIPTION DRUG LABEL 2 21695-846 TABLET, FILM COATED 300 mg ORAL NDA 26 sections
Lamivudine and Zidovudine HUMAN PRESCRIPTION DRUG LABEL 2 21695-996 TABLET, FILM COATED 300 mg ORAL ANDA 26 sections
LAMIVUDINE and ZIDOVUDINE HUMAN PRESCRIPTION DRUG LABEL 2 31722-506 TABLET, FILM COATED 300 mg ORAL ANDA 24 sections
Zidovudine HUMAN PRESCRIPTION DRUG LABEL 1 31722-509 TABLET 300 mg ORAL ANDA 27 sections
Lamivudine and Zidovudine HUMAN PRESCRIPTION DRUG LABEL 2 31722-739 TABLET, FILM COATED 300 mg ORAL ANDA 24 sections
Lamivudine and Zidovudine Human Prescription Drug Label 2 33342-003 TABLET 300 mg ORAL ANDA 25 sections
LAMIVUDINE and ZIDOVUDINE HUMAN PRESCRIPTION DRUG LABEL 2 43063-900 TABLET, FILM COATED 300 mg ORAL ANDA 24 sections
LAMIVUDINE and ZIDOVUDINE HUMAN PRESCRIPTION DRUG LABEL 2 43063-900 TABLET, FILM COATED 300 mg ORAL ANDA 24 sections
COMBIVIR HUMAN PRESCRIPTION DRUG LABEL 2 49702-202 TABLET, FILM COATED 300 mg ORAL NDA 25 sections
RETROVIR HUMAN PRESCRIPTION DRUG LABEL 1 49702-211 CAPSULE 100 mg ORAL NDA 25 sections
RETROVIR HUMAN PRESCRIPTION DRUG LABEL 1 49702-212 SOLUTION 10 mg ORAL NDA 25 sections
RETROVIR HUMAN PRESCRIPTION DRUG LABEL 1 49702-213 INJECTION, SOLUTION 10 mg INTRAVENOUS NDA 25 sections
COMBIVIR HUMAN PRESCRIPTION DRUG LABEL 2 52959-546 TABLET, FILM COATED 300 mg ORAL NDA 26 sections
zidovudine HUMAN PRESCRIPTION DRUG LABEL 1 53104-0105 SYRUP 50 mg ORAL ANDA 27 sections
Zidovudine HUMAN PRESCRIPTION DRUG LABEL 1 53808-0812 TABLET, FILM COATED 300 mg ORAL ANDA 27 sections
Zidovudine HUMAN PRESCRIPTION DRUG LABEL 1 53808-0878 TABLET, FILM COATED 300 mg ORAL ANDA 27 sections
COMBIVIR HUMAN PRESCRIPTION DRUG LABEL 2 53808-0895 TABLET, FILM COATED 300 mg ORAL NDA 25 sections
TRIZIVIR HUMAN PRESCRIPTION DRUG LABEL 3 53808-0990 TABLET, FILM COATED 300 mg ORAL NDA 28 sections
Lamivudine and Zidovudine HUMAN PRESCRIPTION DRUG LABEL 2 54741-102 TABLET, FILM COATED 300 mg ORAL ANDA 26 sections
Lamivudine Zidovudine HUMAN PRESCRIPTION DRUG LABEL 2 61919-061 TABLET 300 mg ORAL ANDA 17 sections
Zidovudine Human Prescription Drug Label 1 65862-024 TABLET, FILM COATED 300 mg ORAL ANDA 25 sections
Lamivudine and Zidovudine Human Prescription Drug Label 2 65862-036 TABLET, FILM COATED 300 mg ORAL ANDA 24 sections
Zidovudine Human Prescription Drug Label 1 65862-048 SYRUP 10 mg ORAL ANDA 25 sections
Zidovudine Human Prescription Drug Label 1 65862-107 CAPSULE 100 mg ORAL ANDA 25 sections
Zidovudine HUMAN PRESCRIPTION DRUG LABEL 1 67046-1613 TABLET 300 mg ORAL ANDA 26 sections
ABACAVIR, LAMIVUDINE AND ZIDOVUDINE HUMAN PRESCRIPTION DRUG LABEL 3 68180-286 TABLET 300 mg ORAL ANDA 28 sections
LAMIVUDINE and ZIDOVUDINE HUMAN PRESCRIPTION DRUG LABEL 2 71335-0639 TABLET, FILM COATED 300 mg ORAL ANDA 25 sections
Lamivudine and Zidovudine HUMAN PRESCRIPTION DRUG LABEL 2 71335-1916 TABLET 300 mg ORAL ANDA 25 sections