zidovudine ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | 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A dideoxynucleoside compound in which the 3'-hydroxy group on the sugar moiety has been replaced by an azido group.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) 25 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 2.80 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 37.42 ยตM/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

Approvals:

DateAgencyCompanyOrphan
March 19, 1987 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 2237.51 23.55 965 14478 135377 56141247
Foetal exposure during pregnancy 1351.53 23.55 460 14983 33363 56243261
Stillbirth 872.04 23.55 224 15219 5990 56270634
Premature baby 808.36 23.55 272 15171 18933 56257691
Abortion spontaneous 752.32 23.55 322 15121 43431 56233193
Viral mutation identified 496.38 23.55 111 15332 1603 56275021
Virologic failure 479.26 23.55 108 15335 1618 56275006
Abortion induced 422.84 23.55 141 15302 9504 56267120
Drug resistance 419.08 23.55 171 15272 20371 56256253
Caesarean section 405.30 23.55 156 15287 15935 56260689
Pregnancy 377.03 23.55 183 15260 32850 56243774
Immune reconstitution inflammatory syndrome 356.06 23.55 109 15334 5565 56271059
Pathogen resistance 329.17 23.55 104 15339 5896 56270728
Premature rupture of membranes 300.93 23.55 92 15351 4673 56271951
Maternal drugs affecting foetus 299.10 23.55 93 15350 5000 56271624
Live birth 267.79 23.55 123 15320 19482 56257142
Maternal exposure during pregnancy 257.06 23.55 287 15156 189266 56087358
Foetal death 255.15 23.55 94 15349 8493 56268131
Premature labour 225.52 23.55 94 15349 11788 56264836
Lipodystrophy acquired 210.26 23.55 53 15390 1304 56275320
Foetal growth restriction 186.43 23.55 71 15372 7028 56269596
Anaemia 179.27 23.55 287 15156 267224 56009400
Pre-eclampsia 163.93 23.55 68 15375 8418 56268206
Treatment noncompliance 148.16 23.55 99 15344 32524 56244100
HIV infection 145.72 23.55 32 15411 422 56276202
Premature delivery 139.71 23.55 89 15354 26971 56249653
Congenital anomaly 136.31 23.55 39 15404 1568 56275056
Patent ductus arteriosus 131.32 23.55 47 15396 3904 56272720
Blood HIV RNA increased 125.77 23.55 30 15413 582 56276042
Sudden infant death syndrome 124.31 23.55 25 15418 208 56276416
Amniotic cavity infection 118.93 23.55 33 15410 1185 56275439
Polydactyly 117.11 23.55 25 15418 286 56276338
Atrial septal defect 115.17 23.55 49 15394 6457 56270167
Human immunodeficiency virus transmission 115.00 23.55 19 15424 41 56276583
Hypertriglyceridaemia 113.66 23.55 47 15396 5769 56270855
Trisomy 21 111.73 23.55 25 15418 361 56276263
Ventricular septal defect 110.85 23.55 42 15401 4096 56272528
Drug ineffective 108.65 23.55 59 15384 918930 55357694
Meningomyelocele 105.17 23.55 26 15417 589 56276035
Neonatal disorder 102.39 23.55 25 15418 537 56276087
CD4 lymphocytes decreased 101.69 23.55 30 15413 1345 56275279
Umbilical cord abnormality 100.11 23.55 25 15418 591 56276033
Foetal distress syndrome 99.16 23.55 29 15414 1261 56275363
Pain 96.82 23.55 31 15412 663153 55613471
Alpha 1 foetoprotein abnormal 94.10 23.55 16 15427 44 56276580
Rheumatoid arthritis 91.64 23.55 3 15440 382601 55894023
Hydrops foetalis 90.84 23.55 22 15421 456 56276168
Blood lactic acid increased 88.91 23.55 40 15403 6024 56270600
Small for dates baby 87.99 23.55 34 15409 3496 56273128
Low birth weight baby 87.70 23.55 40 15403 6218 56270406
Fatigue 82.80 23.55 58 15385 788494 55488130
Acquired gene mutation 81.88 23.55 23 15420 864 56275760
Neonatal respiratory distress syndrome 81.23 23.55 30 15413 2724 56273900
Normal newborn 80.95 23.55 40 15403 7430 56269194
Neural tube defect 80.58 23.55 17 15426 183 56276441
Gestational diabetes 78.05 23.55 40 15403 8024 56268600
Off label use 77.61 23.55 28 15415 556152 55720472
Congenital heart valve disorder 76.62 23.55 14 15429 65 56276559
Congenital pulmonary valve disorder 75.12 23.55 13 15430 41 56276583
Meconium stain 75.03 23.55 16 15427 182 56276442
Placental disorder 74.76 23.55 24 15419 1429 56275195
Anal atresia 74.33 23.55 18 15425 373 56276251
Anaemia macrocytic 74.20 23.55 29 15414 3074 56273550
Hepatomegaly 73.32 23.55 43 15400 11232 56265392
Necrotising colitis 72.97 23.55 19 15424 533 56276091
Lipoatrophy 72.94 23.55 17 15426 297 56276327
Genitalia external ambiguous 72.28 23.55 15 15428 148 56276476
Fall 67.84 23.55 9 15434 357501 55919123
Cardiac murmur 67.68 23.55 41 15402 11360 56265264
Bladder agenesis 67.11 23.55 14 15429 142 56276482
Premature separation of placenta 66.36 23.55 23 15420 1737 56274887
Viral load increased 65.70 23.55 21 15422 1233 56275391
Arthralgia 63.85 23.55 29 15414 501640 55774984
Portal hypertension 63.76 23.55 27 15416 3514 56273110
Exomphalos 63.38 23.55 17 15426 536 56276088
Congenital genital malformation 61.78 23.55 13 15430 138 56276486
Anaemia neonatal 61.48 23.55 15 15428 321 56276303
Cloacal exstrophy 60.79 23.55 13 15430 150 56276474
Abdominal discomfort 60.45 23.55 4 15439 277270 55999354
CSF HIV escape syndrome 60.19 23.55 12 15431 95 56276529
Gastrointestinal malformation 59.15 23.55 13 15430 172 56276452
Mitochondrial toxicity 58.92 23.55 15 15428 384 56276240
Ultrasound antenatal screen abnormal 57.68 23.55 12 15431 120 56276504
Malaria 57.03 23.55 13 15430 205 56276419
Spina bifida 57.01 23.55 17 15426 791 56275833
Neutropenia neonatal 56.88 23.55 11 15432 73 56276551
Tethered cord syndrome 56.06 23.55 13 15430 222 56276402
Mitochondrial cytopathy 56.06 23.55 13 15430 222 56276402
Neonatal respiratory arrest 54.98 23.55 10 15433 45 56276579
Caudal regression syndrome 54.38 23.55 12 15431 162 56276462
Gastrointestinal disorder congenital 51.27 23.55 11 15432 129 56276495
Hyperlactacidaemia 50.85 23.55 21 15422 2567 56274057
Meningitis cryptococcal 49.75 23.55 17 15426 1230 56275394
Necrotising enterocolitis neonatal 47.53 23.55 11 15432 186 56276438
Twin pregnancy 47.52 23.55 16 15427 1107 56275517
Hyperbilirubinaemia 46.28 23.55 31 15412 10204 56266420
Pulmonary valve sclerosis 45.37 23.55 8 15435 29 56276595
Hepatotoxicity 45.17 23.55 49 15394 31104 56245520
Enlarged clitoris 44.59 23.55 10 15433 146 56276478
Developmental delay 44.38 23.55 16 15427 1356 56275268
Macrocephaly 44.32 23.55 9 15434 79 56276545
Anencephaly 43.77 23.55 11 15432 267 56276357
Astrocytoma malignant 43.46 23.55 8 15435 39 56276585
Arnold-Chiari malformation 43.26 23.55 13 15430 621 56276003
Sepsis neonatal 43.08 23.55 12 15431 437 56276187
Rickets 42.96 23.55 8 15435 42 56276582
Congenital ectopic bladder 42.56 23.55 9 15434 98 56276526
Product dose omission issue 41.69 23.55 4 15439 204749 56071875
Genotype drug resistance test positive 40.59 23.55 11 15432 361 56276263
Coarctation of the aorta 40.18 23.55 12 15431 561 56276063
Alanine aminotransferase increased 40.12 23.55 83 15360 93579 56183045
Ventricular hypertrophy 40.09 23.55 19 15424 3219 56273405
Aspartate aminotransferase increased 39.94 23.55 77 15366 82525 56194099
Hepatic cytolysis 39.88 23.55 29 15414 10877 56265747
Pain in extremity 39.67 23.55 16 15427 297415 55979209
HIV antibody positive 39.57 23.55 6 15437 5 56276619
Ultrasound scan abnormal 39.32 23.55 10 15433 255 56276369
Condition aggravated 39.26 23.55 23 15420 344875 55931749
Swelling 38.98 23.55 9 15434 239762 56036862
Alopecia 38.79 23.55 16 15427 293442 55983182
Neonatal aspiration 38.73 23.55 9 15434 155 56276469
Complication of delivery 38.31 23.55 9 15434 163 56276461
Large for dates baby 37.84 23.55 11 15432 468 56276156
Isoimmune haemolytic disease 37.71 23.55 7 15436 36 56276588
Rash maculo-papular 37.66 23.55 43 15400 28864 56247760
Cleft palate 37.63 23.55 13 15430 972 56275652
Fanconi syndrome acquired 37.63 23.55 13 15430 972 56275652
Adrenogenital syndrome 36.80 23.55 7 15436 42 56276582
Oligohydramnios 36.72 23.55 22 15421 5972 56270652
AIDS cholangiopathy 35.70 23.55 6 15437 15 56276609
Single umbilical artery 34.68 23.55 9 15434 249 56276375
Placenta praevia 33.86 23.55 12 15431 968 56275656
Congenital anomaly in offspring 33.74 23.55 8 15435 151 56276473
Acute lymphocytic leukaemia 33.67 23.55 16 15427 2728 56273896
Haemorrhage in pregnancy 33.51 23.55 14 15429 1762 56274862
Congenital genital malformation female 33.36 23.55 6 15437 25 56276599
Neutropenia 33.10 23.55 107 15336 158060 56118564
HIV test positive 32.81 23.55 6 15437 28 56276596
Foetal heart rate abnormal 32.37 23.55 10 15433 525 56276099
Hydrocephalus 32.36 23.55 19 15424 4970 56271654
Hepatitis 32.19 23.55 44 15399 35397 56241227
Pruritus 32.12 23.55 24 15419 316599 55960025
Urinary tract infection 31.96 23.55 13 15430 240500 56036124
Microcephaly 31.82 23.55 11 15432 824 56275800
Ergot poisoning 31.75 23.55 7 15436 94 56276530
Arthropathy 31.60 23.55 8 15435 200267 56076357
Dyspnoea 31.38 23.55 73 15370 592504 55684120
Jaundice 31.24 23.55 38 15405 27256 56249368
Drug intolerance 31.06 23.55 17 15426 264801 56011823
Cleft lip and palate 31 23.55 9 15434 381 56276243
Hyperandrogenism 30.97 23.55 7 15436 106 56276518
Pneumonia 30.78 23.55 40 15403 407058 55869566
Hydromyelia 30.52 23.55 5 15438 10 56276614
Gestational hypertension 30.04 23.55 14 15429 2285 56274339
Stevens-Johnson syndrome 30.01 23.55 34 15409 22629 56253995
Neonatal hepatomegaly 29.89 23.55 5 15438 12 56276612
Respiratory distress 29.80 23.55 40 15403 31627 56244997
Infection 29.71 23.55 9 15434 200197 56076427
Ectopic pregnancy 29.50 23.55 14 15429 2380 56274244
Micrognathia 29.42 23.55 8 15435 266 56276358
Cardiac malposition 29.41 23.55 6 15437 54 56276570
Chlamydial infection 28.47 23.55 8 15435 301 56276323
Product use issue 28.27 23.55 8 15435 186033 56090591
Anxiety 28.10 23.55 9 15434 193163 56083461
Weight increased 28.03 23.55 14 15429 229689 56046935
Alpha 1 foetoprotein increased 27.97 23.55 7 15436 167 56276457
Foetal anaemia 27.61 23.55 6 15437 75 56276549
Foetal cardiac disorder 27.58 23.55 5 15438 22 56276602
Heart disease congenital 27.51 23.55 11 15432 1237 56275387
Fallot's tetralogy 27.33 23.55 6 15437 79 56276545
Hypotonia 27.11 23.55 21 15422 8656 56267968
Musculoskeletal stiffness 27.11 23.55 5 15438 156002 56120622
Induced labour 27.06 23.55 10 15433 909 56275715
Hepatic displacement 26.73 23.55 5 15438 27 56276597
Placental insufficiency 26.71 23.55 11 15432 1335 56275289
Pallor 26.63 23.55 33 15410 24116 56252508
Diastasis recti abdominis 25.38 23.55 5 15438 37 56276587
Constipation 25.11 23.55 12 15431 201931 56074693
Glycosuria 25.03 23.55 10 15433 1122 56275502
Polyhydramnios 24.94 23.55 12 15431 2103 56274521
Bronchopulmonary dysplasia 24.52 23.55 7 15436 279 56276345
Proteinuria 24.36 23.55 27 15416 17543 56259081
Anembryonic gestation 24.05 23.55 8 15435 533 56276091
Antiviral drug level below therapeutic 23.94 23.55 5 15438 51 56276573
Pulmonary tuberculosis 23.78 23.55 15 15428 4461 56272163
Lymphadenitis 23.73 23.55 13 15430 2982 56273642

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 1138.51 16.01 530 18179 40346 31638289
Exposure during pregnancy 914.90 16.01 296 18413 8302 31670333
Lipodystrophy acquired 797.13 16.01 214 18495 3050 31675585
Mitochondrial toxicity 610.77 16.01 165 18544 2408 31676227
Viral mutation identified 598.77 16.01 165 18544 2604 31676031
Virologic failure 567.98 16.01 163 18546 3002 31675633
Pathogen resistance 509.36 16.01 192 18517 8509 31670126
Immune reconstitution inflammatory syndrome 458.95 16.01 175 18534 8003 31670632
Eyelid ptosis 433.85 16.01 151 18558 5304 31673331
Premature baby 397.93 16.01 200 18509 17866 31660769
Diplopia 294.89 16.01 151 18558 14011 31664624
Progressive external ophthalmoplegia 291.74 16.01 81 18628 1313 31677322
Pinealoblastoma 262.10 16.01 51 18658 136 31678499
Drug resistance 238.66 16.01 157 18552 23296 31655339
Lipoatrophy 207.78 16.01 50 18659 442 31678193
Maternal drugs affecting foetus 174.83 16.01 71 18638 3832 31674803
Blood lactic acid increased 153.09 16.01 74 18635 6056 31672579
HIV infection 152.83 16.01 51 18658 1569 31677066
Hypertriglyceridaemia 144.67 16.01 77 18632 7721 31670914
Volvulus 133.10 16.01 43 18666 1192 31677443
Caesarean section 128.89 16.01 47 18662 1889 31676746
Anaemia 123.69 16.01 339 18370 213183 31465452
Neonatal disorder 120.26 16.01 36 18673 770 31677865
Hyperlactacidaemia 119.65 16.01 49 18660 2701 31675934
Hepatic fibrosis 115.95 16.01 53 18656 3821 31674814
CSF HIV escape syndrome 107.93 16.01 25 18684 184 31678451
Blood HIV RNA increased 107.64 16.01 36 18673 1115 31677520
HIV-associated neurocognitive disorder 100.92 16.01 26 18683 311 31678324
Ophthalmoplegia 99.69 16.01 38 18671 1730 31676905
Anaemia macrocytic 94.16 16.01 42 18667 2858 31675777
Congenital anomaly 87.34 16.01 32 18677 1303 31677332
CD4 lymphocytes decreased 87.26 16.01 34 18675 1643 31676992
Off label use 83.67 16.01 51 18658 347223 31331412
Pregnancy 82.06 16.01 21 18688 244 31678391
Small for dates baby 81.93 16.01 41 18668 3614 31675021
Polydactyly 79.53 16.01 29 18680 1165 31677470
Trisomy 21 78.77 16.01 24 18685 546 31678089
Osteonecrosis 75.82 16.01 64 18645 13820 31664815
Anaemia neonatal 74.99 16.01 20 18689 276 31678359
Acquired immunodeficiency syndrome 68.75 16.01 21 18688 482 31678153
Hyperlipidaemia 68.47 16.01 59 18650 13101 31665534
Low birth weight baby 66.81 16.01 45 18664 6925 31671710
Multiple-drug resistance 65.96 16.01 38 18671 4442 31674193
Hypospadias 64.14 16.01 33 18676 3083 31675552
Drug-induced liver injury 61.70 16.01 74 18635 24289 31654346
Human immunodeficiency virus transmission 58.40 16.01 11 18698 23 31678612
Kaposi's sarcoma 57.18 16.01 21 18688 861 31677774
Treatment noncompliance 56.99 16.01 73 18636 25611 31653024
Ventricular septal defect 56.30 16.01 32 18677 3645 31674990
Fall 55.99 16.01 20 18689 186069 31492566
Dyslipidaemia 55.82 16.01 39 18670 6367 31672268
Cryptorchism 55.76 16.01 26 18683 1961 31676674
Chordee 54.81 16.01 12 18697 66 31678569
Cardiac murmur 53.92 16.01 39 18670 6723 31671912
Viral load increased 53.36 16.01 26 18683 2163 31676472
Hydrocele 52.72 16.01 25 18684 1958 31676677
Optic nerve neoplasm 51.56 16.01 10 18699 26 31678609
Congenital neoplasm 50.51 16.01 10 18699 30 31678605
Drug ineffective 50.03 16.01 99 18610 395474 31283161
Aspartate aminotransferase increased 49.16 16.01 112 18597 62607 31616028
Portal hypertension 48.02 16.01 29 18680 3696 31674939
Product dose omission issue 47.43 16.01 4 18705 105582 31573053
Blood antidiuretic hormone increased 47.16 16.01 10 18699 46 31678589
Pain 46.87 16.01 26 18683 186733 31491902
Patent ductus arteriosus 46.78 16.01 27 18682 3166 31675469
Foetal distress syndrome 46.70 16.01 19 18690 1029 31677606
Atrial septal defect 46.43 16.01 36 18673 6891 31671744
Pneumonia 45.82 16.01 80 18629 335232 31343403
Splenomegaly 43.71 16.01 47 18662 13702 31664933
Osteoporotic fracture 43.35 16.01 18 18691 1027 31677608
Mitochondrial myopathy 43.29 16.01 12 18697 193 31678442
Congenital naevus 42.71 16.01 8 18701 16 31678619
Death 42.39 16.01 94 18615 360475 31318160
Nodular regenerative hyperplasia 41.53 16.01 17 18692 935 31677700
Alanine aminotransferase increased 41.46 16.01 117 18592 74539 31604096
Lipohypertrophy 40.38 16.01 12 18697 250 31678385
Atrial fibrillation 40.16 16.01 9 18700 113774 31564861
Lymphadenopathy 39.76 16.01 62 18647 26059 31652576
Rhabdomyosarcoma 39.37 16.01 9 18700 62 31678573
Hypotension 39.02 16.01 38 18671 204580 31474055
Product use in unapproved indication 38.94 16.01 6 18703 99165 31579470
Congenital hydronephrosis 38.91 16.01 15 18694 704 31677931
Blood pyruvic acid increased 38.85 16.01 7 18702 10 31678625
Hepatomegaly 38.28 16.01 37 18672 9513 31669122
Blood creatine phosphokinase increased 37.46 16.01 79 18630 41895 31636740
Foetal growth restriction 37.45 16.01 25 18684 3790 31674845
Mycobacterium avium complex infection 36.84 16.01 21 18688 2405 31676230
Hypertonia 36.55 16.01 25 18684 3943 31674692
Trisomy 18 36.14 16.01 12 18697 363 31678272
Oesophageal candidiasis 35.94 16.01 25 18684 4052 31674583
Meningomyelocele 35.89 16.01 10 18699 164 31678471
White matter lesion 35.76 16.01 14 18695 685 31677950
Limb deformity 35.56 16.01 13 18696 526 31678109
Malignant neoplasm progression 35.45 16.01 3 18706 78995 31599640
Febrile neutropenia 35.10 16.01 14 18695 121835 31556800
Congenital cytomegalovirus infection 34.88 16.01 7 18702 23 31678612
Jaundice 34.29 16.01 63 18646 30224 31648411
Astrocytoma, low grade 33.84 16.01 8 18701 65 31678570
Neonatal hyponatraemia 33.21 16.01 8 18701 71 31678564
Blood pressure increased 33.20 16.01 4 18705 79629 31599006
Constipation 32.95 16.01 16 18693 123975 31554660
Pulmonary tuberculosis 32.70 16.01 25 18684 4686 31673949
Neutropenia neonatal 32.60 16.01 13 18696 668 31677967
Macrocytosis 31.81 16.01 14 18695 922 31677713
Gamma-glutamyltransferase increased 31.65 16.01 58 18651 27767 31650868
Speech disorder developmental 31.48 16.01 18 18691 2073 31676562
Post streptococcal glomerulonephritis 31.31 16.01 7 18702 43 31678592
Dyspnoea 30.94 16.01 102 18607 343377 31335258
Talipes 30.80 16.01 17 18692 1829 31676806
Cytomegalovirus chorioretinitis 30.17 16.01 21 18688 3407 31675228
Congenital mitral valve incompetence 30.09 16.01 8 18701 109 31678526
Live birth 29.73 16.01 9 18700 200 31678435
Blood triglycerides increased 29.58 16.01 38 18671 13359 31665276
Cleft lip and palate 29.58 16.01 11 18698 467 31678168
Congenital anaemia 28.24 16.01 5 18704 6 31678629
Facial wasting 28.07 16.01 8 18701 143 31678492
Developmental delay 27.83 16.01 18 18691 2587 31676048
Acquired gene mutation 27.23 16.01 14 18695 1306 31677329
Completed suicide 27.20 16.01 10 18699 91504 31587131
Congenital hydrocephalus 26.85 16.01 7 18702 88 31678547
Mitochondrial cytopathy 26.64 16.01 8 18701 173 31678462
Genotype drug resistance test positive 26.60 16.01 13 18696 1088 31677547
Exomphalos 26.55 16.01 8 18701 175 31678460
Hydrops foetalis 26.30 16.01 10 18699 452 31678183
Ear malformation 26.27 16.01 9 18700 300 31678335
Sudden infant death syndrome 25.97 16.01 8 18701 189 31678446
Gastroschisis 25.58 16.01 7 18702 107 31678528
Transaminases increased 25.52 16.01 49 18660 24292 31654343
Enophthalmos 25.51 16.01 5 18704 14 31678621
Drug abuse 25.40 16.01 10 18699 87748 31590887
Prenatal screening test abnormal 25.26 16.01 5 18704 15 31678620
Death neonatal 25.20 16.01 9 18700 340 31678295
Cachexia 25.13 16.01 25 18684 6654 31671981
Sickle cell anaemia 25.10 16.01 8 18701 212 31678423
Pancytopenia 25.03 16.01 110 18599 87206 31591429
CD4 lymphocytes increased 24.99 16.01 8 18701 215 31678420
Lactic acidosis 24.96 16.01 57 18652 31880 31646755
Cerebrovascular accident 24.80 16.01 8 18701 79476 31599159
Meningitis cryptococcal 24.69 16.01 16 18693 2307 31676328
Strabismus 24.65 16.01 14 18695 1592 31677043
Pneumocystis jirovecii pneumonia 24.60 16.01 41 18668 18210 31660425
Hepatitis B 24.31 16.01 23 18686 5758 31672877
Heart disease congenital 24.23 16.01 13 18696 1322 31677313
Fatigue 24.08 16.01 109 18600 335097 31343538
Anogenital warts 24.02 16.01 10 18699 574 31678061
Hepatitis C virus test 23.83 16.01 6 18703 65 31678570
Tuberculoid leprosy 23.83 16.01 6 18703 65 31678570
Late developer 23.51 16.01 4 18705 3 31678632
Hyperbilirubinaemia 23.43 16.01 37 18672 15713 31662922
Retinal toxicity 23.33 16.01 9 18700 423 31678212
Hepatic function abnormal 23.25 16.01 65 18644 41157 31637478
Maternal condition affecting foetus 22.97 16.01 4 18705 4 31678631
Perinatal HIV infection 22.97 16.01 4 18705 4 31678631
Cardiac arrest 22.89 16.01 12 18697 89050 31589585
Treatment failure 22.69 16.01 64 18645 40728 31637907
Ultrasound antenatal screen abnormal 22.69 16.01 6 18703 80 31678555
Normal newborn 22.66 16.01 7 18702 167 31678468
Dysphagia 22.45 16.01 80 18629 57596 31621039
ADAMTS13 activity decreased 22.35 16.01 6 18703 85 31678550
Oral candidiasis 22.26 16.01 30 18679 11047 31667588
COVID-19 22.25 16.01 3 18706 54818 31623817
HIV wasting syndrome 22.22 16.01 6 18703 87 31678548
Birth trauma 22.08 16.01 4 18705 6 31678629
Lagophthalmos 21.79 16.01 6 18703 94 31678541
Progressive multifocal leukoencephalopathy 21.72 16.01 27 18682 9186 31669449
Malaria 21.66 16.01 7 18702 194 31678441
Hepatosplenomegaly 21.16 16.01 18 18691 3925 31674710
Genitalia external ambiguous 21.14 16.01 7 18702 210 31678425
Polyneuropathy chronic 21.11 16.01 5 18704 41 31678594
Lactate pyruvate ratio increased 21.03 16.01 4 18705 9 31678626
Nervous system disorder 20.90 16.01 32 18677 13231 31665404
Leukopenia 20.65 16.01 78 18631 57750 31620885
Maternal exposure during pregnancy 20.49 16.01 19 18690 4637 31673998
Hepatitis 20.22 16.01 42 18667 22024 31656611
Ultrasound antenatal screen 20.10 16.01 6 18703 127 31678508
Heart transplant rejection 19.98 16.01 11 18698 1178 31677457
Lymphocytic infiltration 19.88 16.01 9 18700 634 31678001
Cryptococcosis 19.82 16.01 14 18695 2324 31676311
Sickle cell disease 19.79 16.01 6 18703 134 31678501
Meconium peritonitis 19.74 16.01 4 18705 14 31678621
Hypercholesterolaemia 19.68 16.01 24 18685 8006 31670629
Meningitis tuberculous 19.47 16.01 9 18700 665 31677970
Vision abnormal neonatal 19.31 16.01 3 18706 0 31678635
Congenital retinoblastoma 19.31 16.01 3 18706 0 31678635
Neonatal intestinal obstruction 19.31 16.01 3 18706 0 31678635
Neutropenia 19.11 16.01 145 18564 140219 31538416
Tuberculosis 18.95 16.01 24 18685 8317 31670318
Back pain 18.94 16.01 22 18687 109391 31569244
Congenital abdominal hernia 18.93 16.01 4 18705 18 31678617
Acute lymphocytic leukaemia 18.80 16.01 16 18693 3490 31675145
Abnormal dreams 18.66 16.01 22 18687 7086 31671549
Hypotonia 18.60 16.01 22 18687 7111 31671524
Abdominal hernia 18.50 16.01 14 18695 2584 31676051
Cleft lip 18.35 16.01 7 18702 319 31678316
Neck deformity 18.30 16.01 5 18704 76 31678559
Congenital central nervous system anomaly 18.20 16.01 8 18701 525 31678110
Neonatal asphyxia 17.91 16.01 7 18702 341 31678294
Thalassaemia alpha 17.83 16.01 4 18705 25 31678610
Congenital aortic anomaly 17.83 16.01 5 18704 84 31678551
Blood insulin increased 17.70 16.01 7 18702 352 31678283
Anaemia megaloblastic 17.69 16.01 6 18703 194 31678441
Blood bilirubin increased 17.50 16.01 53 18656 35083 31643552
Congenital hearing disorder 17.16 16.01 5 18704 97 31678538
Vanishing bile duct syndrome 17.03 16.01 8 18701 613 31678022
Nasopharyngitis 17.03 16.01 8 18701 63237 31615398
Disease progression 16.97 16.01 17 18692 90447 31588188
Osteoma 16.97 16.01 4 18705 32 31678603
CSF virus identified 16.97 16.01 4 18705 32 31678603
Total lung capacity decreased 16.96 16.01 8 18701 619 31678016
Hydronephrosis 16.78 16.01 24 18685 9337 31669298
Twin pregnancy 16.77 16.01 3 18706 4 31678631
Subacute sclerosing panencephalitis 16.65 16.01 4 18705 35 31678600
Acute kidney injury 16.64 16.01 97 18612 279617 31399018
Red blood cell schistocytes present 16.57 16.01 6 18703 236 31678399
Scleral discolouration 16.45 16.01 6 18703 241 31678394
Lipase increased 16.34 16.01 23 18686 8820 31669815
Immune reconstitution inflammatory syndrome associated tuberculosis 16.02 16.01 7 18702 453 31678182
Trisomy 15 16.02 16.01 3 18706 6 31678629

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
Exposure during pregnancy 1296.47 16.59 606 21890 87111 70818837
Virologic failure 1003.50 16.59 235 22261 3615 70902333
Lipodystrophy acquired 982.28 16.59 235 22261 3981 70901967
Viral mutation identified 933.04 16.59 219 22277 3403 70902545
Immune reconstitution inflammatory syndrome 844.07 16.59 265 22231 12725 70893223
Stillbirth 773.22 16.59 190 22306 3615 70902333
Pathogen resistance 764.20 16.59 247 22249 13032 70892916
Mitochondrial toxicity 718.28 16.59 170 22326 2740 70903208
Abortion spontaneous 715.46 16.59 281 22215 26198 70879750
Drug resistance 584.84 16.59 271 22225 37919 70868029
Foetal exposure during pregnancy 552.20 16.59 158 22338 5487 70900461
Eyelid ptosis 430.62 16.59 150 22346 9952 70895996
Abortion induced 404.59 16.59 129 22367 6496 70899452
Progressive external ophthalmoplegia 346.28 16.59 82 22414 1322 70904626
Blood HIV RNA increased 314.13 16.59 78 22418 1548 70904400
Diplopia 288.27 16.59 152 22344 27995 70877953
Lipoatrophy 252.78 16.59 55 22441 592 70905356
Pregnancy 247.98 16.59 130 22366 23651 70882297
Live birth 239.79 16.59 107 22389 13672 70892276
Caesarean section 234.08 16.59 100 22396 11507 70894441
Anaemia 221.22 16.59 430 22066 402993 70502955
Premature rupture of membranes 193.87 16.59 65 22431 3833 70902115
Maternal exposure during pregnancy 182.07 16.59 203 22293 115142 70790806
Treatment noncompliance 169.98 16.59 131 22365 46443 70859505
Maternal drugs affecting foetus 169.65 16.59 48 22448 1596 70904352
CSF HIV escape syndrome 166.81 16.59 35 22461 312 70905636
HIV infection 162.78 16.59 45 22451 1372 70904576
Foetal death 157.08 16.59 63 22433 6176 70899772
CD4 lymphocytes decreased 152.94 16.59 49 22447 2502 70903446
Premature labour 135.58 16.59 61 22435 7939 70898009
Premature baby 134.79 16.59 48 22448 3391 70902557
Pre-eclampsia 127.86 16.59 55 22441 6430 70899518
Hepatic fibrosis 126.36 16.59 54 22442 6213 70899735
Pinealoblastoma 122.05 16.59 21 22475 52 70905896
Portal hypertension 121.26 16.59 53 22443 6439 70899509
Acquired gene mutation 112.37 16.59 37 22459 2061 70903887
HIV-associated neurocognitive disorder 105.64 16.59 24 22472 319 70905629
Ophthalmoplegia 101.72 16.59 37 22459 2778 70903170
Premature delivery 100.50 16.59 70 22426 21234 70884714
Pain 92.56 16.59 42 22454 628774 70277174
Hypertriglyceridaemia 91.23 16.59 53 22443 11758 70894190
Meningitis cryptococcal 78.25 16.59 32 22464 3296 70902652
Dyslipidaemia 78.16 16.59 45 22451 9815 70896133
Viral load increased 78.04 16.59 30 22466 2626 70903322
Hyperlactacidaemia 77.53 16.59 36 22460 5036 70900912
Rheumatoid arthritis 73.13 16.59 5 22491 291800 70614148
Off label use 73.10 16.59 77 22419 742983 70162965
Fall 72.93 16.59 25 22471 444071 70461877
Lymphadenopathy 71.99 16.59 83 22413 48708 70857240
Genotype drug resistance test positive 71.80 16.59 23 22473 1173 70904775
Alpha 1 foetoprotein abnormal 71.66 16.59 13 22483 48 70905900
Hepatomegaly 67.73 16.59 51 22445 17441 70888507
Drug-induced liver injury 67.38 16.59 86 22410 56027 70849921
Normal newborn 67.23 16.59 35 22461 6265 70899683
Osteonecrosis 67.19 16.59 63 22433 29097 70876851
Pulmonary tuberculosis 65.39 16.59 37 22459 7808 70898140
Kaposi's sarcoma 64.08 16.59 19 22477 747 70905201
Amniotic cavity infection 62.96 16.59 19 22477 794 70905154
Peripheral swelling 62.49 16.59 3 22493 236560 70669388
Multiple-drug resistance 62.15 16.59 35 22461 7320 70898628
Alanine aminotransferase increased 61.55 16.59 141 22355 147339 70758609
Aspartate aminotransferase increased 60.46 16.59 128 22368 126850 70779098
Drug ineffective 59.16 16.59 132 22364 939620 69966328
Joint swelling 58.87 16.59 6 22490 253205 70652743
Jaundice 57.34 16.59 75 22421 50033 70855915
Acquired immunodeficiency syndrome 56.17 16.59 14 22482 282 70905666
Nasopharyngitis 55.10 16.59 4 22492 222202 70683746
Mycobacterium avium complex infection 54.95 16.59 27 22469 4279 70901669
Hepatic cytolysis 51.14 16.59 45 22451 19147 70886801
Rickets 50.05 16.59 10 22486 68 70905880
Splenomegaly 49.80 16.59 44 22452 18826 70887122
Blood lactic acid increased 48.72 16.59 35 22461 11138 70894810
Facial wasting 48.51 16.59 10 22486 81 70905867
Product dose omission issue 48.41 16.59 6 22490 217462 70688486
Premature separation of placenta 48.37 16.59 17 22479 1155 70904793
Malaria 47.58 16.59 13 22483 379 70905569
Hepatotoxicity 47.50 16.59 64 22432 43922 70862026
Completed suicide 46.55 16.59 8 22488 227127 70678821
Mitochondrial myopathy 46.51 16.59 12 22484 279 70905669
Tuberculosis 46.08 16.59 38 22458 14810 70891138
Acute lymphocytic leukaemia 45.80 16.59 26 22470 5519 70900429
Optic nerve neoplasm 45.37 16.59 8 22488 24 70905924
Proteinuria 45.06 16.59 51 22445 29323 70876625
Pancytopenia 44.83 16.59 127 22369 150980 70754968
Hyperlipidaemia 44.62 16.59 46 22450 23817 70882131
White matter lesion 44.05 16.59 18 22478 1850 70904098
Gestational diabetes 43.89 16.59 26 22470 5975 70899973
Nodular regenerative hyperplasia 43.04 16.59 16 22480 1277 70904671
Mitochondrial cytopathy 42.93 16.59 12 22484 381 70905567
Anaemia macrocytic 42.12 16.59 24 22472 5131 70900817
Constipation 41.75 16.59 14 22482 252424 70653524
Arthralgia 41.16 16.59 60 22436 503330 70402618
Placental disorder 40.94 16.59 14 22482 876 70905072
Cachexia 40.87 16.59 30 22466 9870 70896078
Gamma-glutamyltransferase increased 40.55 16.59 64 22432 50621 70855327
Stevens-Johnson syndrome 39.93 16.59 53 22443 35854 70870094
Fatigue 39.61 16.59 132 22364 824187 70081761
Placenta praevia 39.53 16.59 13 22483 721 70905227
Abdominal discomfort 38.98 16.59 10 22486 214648 70691300
Blood triglycerides increased 38.75 16.59 39 22457 19625 70886323
Hepatitis 38.46 16.59 62 22434 49918 70856030
Blood antidiuretic hormone increased 37.96 16.59 8 22488 73 70905875
Twin pregnancy 37.64 16.59 13 22483 838 70905110
Pyrexia 37.58 16.59 324 22172 606628 70299320
Cytomegalovirus chorioretinitis 36.28 16.59 22 22474 5276 70900672
Leukopenia 36.03 16.59 94 22402 106466 70799482
Pneumocystis jirovecii pneumonia 35.93 16.59 46 22450 30036 70875912
Fanconi syndrome acquired 35.73 16.59 17 22479 2510 70903438
Rash maculo-papular 35.26 16.59 60 22436 50485 70855463
Hypotension 35.24 16.59 46 22450 404335 70501613
Astrocytoma malignant 34.86 16.59 7 22489 49 70905899
AIDS cholangiopathy 34.83 16.59 6 22490 15 70905933
Atrial fibrillation 34.61 16.59 8 22488 184340 70721608
Post streptococcal glomerulonephritis 34.61 16.59 7 22489 51 70905897
Sinusitis 34.57 16.59 6 22490 169189 70736759
Lipohypertrophy 33.84 16.59 12 22484 837 70905111
Product use in unapproved indication 33.45 16.59 12 22484 207466 70698482
Oesophageal candidiasis 33.37 16.59 25 22471 8482 70897466
Meningitis tuberculous 33.32 16.59 13 22483 1184 70904764
Umbilical cord abnormality 32.24 16.59 8 22488 158 70905790
Osteoporotic fracture 31.95 16.59 18 22478 3766 70902182
Congenital anomaly 31.81 16.59 9 22487 299 70905649
Pneumonia 31.76 16.59 91 22405 596141 70309807
Oligohydramnios 31.74 16.59 17 22479 3223 70902725
Transaminases increased 31.73 16.59 55 22441 46963 70858985
Rhabdomyosarcoma 31.34 16.59 8 22488 178 70905770
Neutropenia neonatal 31.12 16.59 6 22490 33 70905915
Blood bilirubin increased 30.37 16.59 62 22434 59839 70846109
Immune reconstitution inflammatory syndrome associated tuberculosis 30.32 16.59 11 22485 819 70905129
Retinoblastoma 30.08 16.59 7 22489 104 70905844
Fat tissue increased 29.66 16.59 11 22485 872 70905076
Tuberculoid leprosy 29.66 16.59 7 22489 111 70905837
Ectopic pregnancy 29.61 16.59 13 22483 1595 70904353
Amylase increased 29.35 16.59 25 22471 10183 70895765
Hydrops foetalis 29.22 16.59 8 22488 235 70905713
Arthropathy 29.21 16.59 6 22490 150051 70755897
Glycosuria 29.09 16.59 14 22482 2121 70903827
Gynaecomastia 28.90 16.59 21 22475 6802 70899146
Cryptococcosis 28.64 16.59 16 22480 3294 70902654
Retinal toxicity 28.38 16.59 12 22484 1344 70904604
Ergot poisoning 28.37 16.59 7 22489 135 70905813
Hepatic function abnormal 28.32 16.59 65 22431 67931 70838017
Brain oedema 28.27 16.59 36 22460 23382 70882566
Foetal distress syndrome 28.09 16.59 9 22487 459 70905489
Drug interaction 28.09 16.59 212 22284 381229 70524719
Ileal ulcer 28.00 16.59 11 22485 1020 70904928
Hyperbilirubinaemia 27.73 16.59 35 22461 22533 70883415
Synovitis 27.71 16.59 4 22492 129224 70776724
Febrile neutropenia 26.48 16.59 16 22480 204302 70701646
Nephropathy toxic 26.46 16.59 31 22465 18483 70887465
Anogenital warts 26.46 16.59 10 22486 835 70905113
Oxygen saturation decreased 26.42 16.59 3 22493 116426 70789522
Induced labour 26.41 16.59 10 22486 840 70905108
Anaemia neonatal 26.33 16.59 5 22491 25 70905923
Ultrasound antenatal screen abnormal 26.32 16.59 6 22490 81 70905867
Dyspnoea 26.01 16.59 141 22355 769919 70136029
Varices oesophageal 26.01 16.59 18 22478 5399 70900549
Congenital retinoblastoma 25.99 16.59 4 22492 3 70905945
Influenza 25.63 16.59 3 22493 113697 70792251
Malignant neoplasm progression 25.57 16.59 4 22492 121735 70784213
Swelling 25.52 16.59 14 22482 188525 70717423
Speech disorder developmental 25.43 16.59 9 22487 624 70905324
Hepatosplenomegaly 25.27 16.59 18 22478 5652 70900296
Feeling abnormal 25.12 16.59 7 22489 142312 70763636
Blood alkaline phosphatase increased 24.43 16.59 56 22440 58465 70847483
Death 24.20 16.59 82 22414 509979 70395969
Blood pressure increased 24.09 16.59 15 22481 188502 70717446
Antiviral drug level below therapeutic 23.78 16.59 5 22491 45 70905903
Chlamydial infection 23.77 16.59 8 22488 477 70905471
Pruritus 23.75 16.59 46 22450 345514 70560434
Torsade de pointes 23.70 16.59 29 22467 18087 70887861
Hepatitis B 23.59 16.59 20 22476 8094 70897854
Cerebral toxoplasmosis 23.47 16.59 12 22484 2068 70903880
CD4 lymphocytes increased 23.37 16.59 7 22489 285 70905663
COVID-19 23.32 16.59 3 22493 105754 70800194
Stomatitis 23.29 16.59 6 22490 128505 70777443
Astrocytoma, low grade 23.27 16.59 6 22490 139 70905809
Musculoskeletal stiffness 23.05 16.59 9 22487 147751 70758197
Condition aggravated 22.93 16.59 65 22431 427570 70478378
Therapeutic product effect incomplete 22.90 16.59 5 22491 119877 70786071
Insulin resistance 22.80 16.59 10 22486 1224 70904724
Infection 22.77 16.59 20 22476 210765 70695183
Dysphagia 22.66 16.59 83 22413 112751 70793197
Lipase increased 22.58 16.59 26 22470 15220 70890728
Macrocephaly 22.55 16.59 5 22491 59 70905889
Portal hypertensive gastropathy 22.48 16.59 10 22486 1266 70904682
Progressive multifocal leukoencephalopathy 22.35 16.59 29 22467 19185 70886763
ADAMTS13 activity decreased 22.33 16.59 6 22490 164 70905784
Congestive cardiomyopathy 22.13 16.59 22 22474 10904 70895044
Gestational hypertension 22.12 16.59 11 22485 1789 70904159
HIV wasting syndrome 22.11 16.59 5 22491 65 70905883
Hypercholesterolaemia 22.10 16.59 28 22468 18089 70887859
Cleft lip and palate 22.02 16.59 6 22490 173 70905775
Enophthalmos 21.44 16.59 5 22491 75 70905873
Wound 21.30 16.59 3 22493 98729 70807219
Anembryonic gestation 21.29 16.59 7 22489 388 70905560
Neonatal disorder 21.24 16.59 4 22492 19 70905929
Foetal cardiac disorder 21.24 16.59 4 22492 19 70905929
Sudden infant death syndrome 21.22 16.59 6 22490 199 70905749
Vaginal haemorrhage 21.04 16.59 29 22467 20323 70885625
Calculus urinary 20.90 16.59 11 22485 2013 70903935
Acute stress disorder 20.77 16.59 7 22489 419 70905529
Opportunistic infection 20.39 16.59 12 22484 2724 70903224
Alopecia 20.06 16.59 20 22476 198470 70707478
Nervous system disorder 20.02 16.59 31 22465 24115 70881833
Wheezing 19.99 16.59 3 22493 94167 70811781
Patent ductus arteriosus 19.91 16.59 5 22491 104 70905844
Encephalitis 19.84 16.59 23 22473 13562 70892386
Ventricular septal defect 19.80 16.59 7 22489 484 70905464
Foetal heart rate abnormal 19.63 16.59 6 22490 262 70905686
Inappropriate schedule of product administration 19.53 16.59 5 22491 107550 70798398
Amniotic fluid volume decreased 19.41 16.59 6 22490 272 70905676
Hepatitis A 19.28 16.59 8 22488 855 70905093
Erythema 19.17 16.59 21 22475 199542 70706406
Urinary tract infection 18.99 16.59 31 22465 248738 70657210
Arthritis 18.89 16.59 4 22492 97976 70807972
CSF virus identified 18.83 16.59 4 22492 38 70905910
Vanishing bile duct syndrome 18.78 16.59 9 22487 1350 70904598
Back pain 18.71 16.59 36 22460 271116 70634832
Cushing's syndrome 18.53 16.59 8 22488 943 70905005
Delivery 18.51 16.59 7 22489 586 70905362
HIV associated nephropathy 18.43 16.59 6 22490 322 70905626
Oropharyngeal pain 18.43 16.59 4 22492 96306 70809642
Atrophy 18.38 16.59 10 22486 1956 70903992
Product use issue 18.33 16.59 18 22478 179919 70726029
Hepatic cirrhosis 18.24 16.59 34 22462 30697 70875251
Pain in extremity 18.22 16.59 49 22447 328033 70577915
Anxiety 18.22 16.59 26 22470 220304 70685644
Lymphocytic infiltration 18.22 16.59 9 22487 1443 70904505
Epistaxis 18.20 16.59 5 22491 102622 70803326
Herpes simplex 18.07 16.59 20 22476 11212 70894736
Lymph node tuberculosis 18.02 16.59 8 22488 1008 70904940
Bovine tuberculosis 17.97 16.59 5 22491 156 70905792
Pancreatitis 17.91 16.59 52 22444 62616 70843332
Fanconi syndrome 17.89 16.59 11 22485 2702 70903246
Hydromyelia 17.88 16.59 3 22493 6 70905942
Hyperbilirubinaemia neonatal 17.88 16.59 3 22493 6 70905942
Liver transplant 17.77 16.59 13 22483 4253 70901695
Amylase abnormal 17.69 16.59 4 22492 52 70905896
Placental insufficiency 17.61 16.59 8 22488 1063 70904885
Cerebrovascular accident 17.53 16.59 12 22484 143458 70762490
Non-Hodgkin's lymphoma 17.53 16.59 9 22487 1565 70904383
Hyponatraemia 17.51 16.59 15 22481 160072 70745876
Developmental delay 17.42 16.59 8 22488 1090 70904858
Ocular icterus 17.41 16.59 14 22482 5263 70900685
Subacute sclerosing panencephalitis 17.41 16.59 4 22492 56 70905892
Lipomatosis 17.31 16.59 6 22490 391 70905557
Pericarditis 17.30 16.59 3 22493 84702 70821246
Cellulitis 17.21 16.59 5 22491 98923 70807025
Discomfort 17.15 16.59 6 22490 105430 70800518
Erythropenia 17.11 16.59 6 22490 405 70905543
Trisomy 21 17.09 16.59 4 22492 61 70905887
Psoriasis 17.08 16.59 5 22491 98428 70807520
Necrotising enterocolitis neonatal 17.01 16.59 3 22493 9 70905939
Acute HIV infection 16.97 16.59 4 22492 63 70905885
Lagophthalmos 16.97 16.59 6 22490 415 70905533
Gene mutation 16.95 16.59 10 22486 2281 70903667
Hepatic necrosis 16.76 16.59 17 22479 8629 70897319
Abortion missed 16.74 16.59 8 22488 1193 70904755
Strabismus 16.66 16.59 10 22486 2354 70903594

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 56.43 33.21 27 1001 87 88677
Neutropenia 55.30 33.21 33 995 184 88580
Aspartate aminotransferase increased 38.47 33.21 18 1010 54 88710
Hypertriglyceridaemia 38.24 33.21 18 1010 55 88709
Pregnancy 37.90 33.21 15 1013 25 88739
Blood creatine phosphokinase increased 33.77 33.21 14 1014 28 88736

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
CHEBI has role CHEBI:35221 antimetabolite
CHEBI has role CHEBI:36044 antiviral drugs
CHEBI has role CHEBI:53756 reverse transcriptase inhibitors
CHEBI has role CHEBI:36047 antibacterial drugs
CHEBI has role CHEBI:50696 PBP3 inhibitor
CHEBI has role CHEBI:88188 allergenic drug
MeSH PA D019380 Anti-HIV Agents
MeSH PA D000890 Anti-Infective Agents
MeSH PA D044966 Anti-Retroviral Agents
MeSH PA D000963 Antimetabolites
MeSH PA D000998 Antiviral Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D009676 Noxae
MeSH PA D019384 Nucleic Acid Synthesis Inhibitors
MeSH PA D018894 Reverse Transcriptase Inhibitors

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

DiseaseRelationSNOMED_IDDOID
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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 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 Unclassified 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 25 sections
LAMIVUDINE and ZIDOVUDINE Human Prescription Drug Label 2 31722-506 TABLET, FILM COATED 300 mg ORAL ANDA 25 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 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 25 sections
LAMIVUDINE and ZIDOVUDINE HUMAN PRESCRIPTION DRUG LABEL 2 43063-900 TABLET, FILM COATED 300 mg ORAL ANDA 25 sections
COMBIVIR HUMAN PRESCRIPTION DRUG LABEL 2 49702-202 TABLET, FILM COATED 300 mg ORAL NDA 25 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 49702-211 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 49702-212 SOLUTION 10 mg ORAL NDA 25 sections
RETROVIR HUMAN PRESCRIPTION DRUG LABEL 1 49702-213 INJECTION, SOLUTION 10 mg INTRAVENOUS NDA 25 sections
RETROVIR HUMAN PRESCRIPTION DRUG LABEL 1 49702-213 INJECTION, SOLUTION 10 mg INTRAVENOUS NDA 25 sections
TRIZIVIR HUMAN PRESCRIPTION DRUG LABEL 3 49702-217 TABLET, FILM COATED 300 mg ORAL NDA 26 sections
TRIZIVIR HUMAN PRESCRIPTION DRUG LABEL 3 49702-217 TABLET, FILM COATED 300 mg ORAL NDA 26 sections
LAMIVUDINE and ZIDOVUDINE HUMAN PRESCRIPTION DRUG LABEL 2 50268-456 TABLET, FILM COATED 300 mg ORAL ANDA 25 sections
Zidovudine Human Prescription Drug Label 1 52343-044 CAPSULE 100 mg ORAL ANDA 25 sections
Zidovudine Human Prescription Drug Label 1 52343-045 TABLET, FILM COATED 300 mg ORAL ANDA 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 53104-0100 CAPSULE 100 mg ORAL ANDA 25 sections
Zidovudine HUMAN PRESCRIPTION DRUG LABEL 1 53104-0101 TABLET, FILM COATED 300 mg ORAL ANDA 21 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