lamivudine 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 1539 134678-17-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

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

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.30 g O

ADMET properties:

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

Approvals:

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

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Exposure during pregnancy 2114.40 15.83 1095 25269 119920 50458840
Abortion spontaneous 1276.25 15.83 557 25807 41215 50537545
Virologic failure 1218.05 15.83 256 26108 1308 50577452
Viral mutation identified 1201.94 15.83 255 26109 1374 50577386
Drug resistance 1063.02 15.83 392 25972 18597 50560163
Stillbirth 1017.12 15.83 287 26077 5665 50573095
Pathogen resistance 814.23 15.83 239 26125 5450 50573310
Immune reconstitution inflammatory syndrome 781.83 15.83 230 26134 5286 50573474
Foetal exposure during pregnancy 745.20 15.83 337 26027 27022 50551738
Abortion induced 658.71 15.83 229 26135 9115 50569645
Premature baby 376.36 15.83 186 26178 18151 50560609
Pregnancy 367.84 15.83 215 26149 29362 50549398
Blood HIV RNA increased 348.66 15.83 76 26288 473 50578287
Live birth 294.42 15.83 152 26212 16256 50562504
Maternal exposure during pregnancy 274.31 15.83 375 25989 159403 50419357
Caesarean section 266.63 15.83 140 26224 15499 50563261
Fanconi syndrome acquired 264.34 15.83 67 26297 856 50577904
Foetal death 245.58 15.83 108 26256 8072 50570688
Lipodystrophy acquired 235.55 15.83 66 26298 1263 50577497
Hepatitis B reactivation 231.08 15.83 72 26292 2015 50576745
Hepatotoxicity 215.95 15.83 149 26215 27077 50551683
Maternal drugs affecting foetus 181.96 15.83 76 26288 5001 50573759
Blood bilirubin increased 179.01 15.83 142 26222 31896 50546864
CD4 lymphocytes decreased 177.26 15.83 53 26311 1286 50577474
Treatment noncompliance 173.54 15.83 136 26228 30014 50548746
Hypomania 170.11 15.83 70 26294 4435 50574325
Jaundice cholestatic 161.59 15.83 70 26294 5041 50573719
Premature rupture of membranes 158.91 15.83 67 26297 4513 50574247
Premature labour 154.75 15.83 88 26276 11388 50567372
Schizophrenia 145.67 15.83 73 26291 7324 50571436
Anaemia 128.97 15.83 354 26010 252102 50326658
Pre-eclampsia 128.56 15.83 69 26295 7975 50570785
Drug ineffective 127.92 15.83 144 26220 819189 49759571
Mitochondrial toxicity 127.72 15.83 31 26333 327 50578433
Pain 126.03 15.83 73 26291 578830 49999930
Acquired gene mutation 123.60 15.83 36 26328 795 50577965
Viral load increased 119.90 15.83 38 26326 1125 50577635
Hepatitis B 117.90 15.83 50 26314 3416 50575344
Hepatitis B DNA increased 116.03 15.83 25 26339 146 50578614
Human immunodeficiency virus transmission 115.75 15.83 21 26343 39 50578721
Fatigue 112.90 15.83 122 26242 707479 49871281
Fanconi syndrome 112.51 15.83 36 26328 1100 50577660
Foetal growth restriction 106.33 15.83 57 26307 6570 50572190
Trisomy 21 106 15.83 27 26337 352 50578408
Lactic acidosis 101.40 15.83 105 26259 33250 50545510
Fall 101.34 15.83 25 26339 334907 50243853
Joint swelling 100.73 15.83 7 26357 245279 50333481
Premature delivery 99.37 15.83 89 26275 23574 50555186
Hypophosphataemia 96.23 15.83 58 26306 8356 50570404
Lipoatrophy 95.97 15.83 24 26340 289 50578471
Nephropathy toxic 93.52 15.83 56 26308 7973 50570787
Psychotic disorder 89.54 15.83 81 26283 21731 50557029
Normal newborn 89.37 15.83 51 26313 6640 50572120
Portal hypertension 86.58 15.83 40 26324 3352 50575408
Osteomalacia 86.36 15.83 26 26338 646 50578114
Polydactyly 86.21 15.83 22 26342 289 50578471
Glycosuria 85.54 15.83 29 26335 1065 50577695
Proteinuria 85.11 15.83 70 26294 16527 50562233
Hyperbilirubinaemia 84.49 15.83 56 26308 9514 50569246
Genotype drug resistance test positive 82.78 15.83 21 26343 269 50578491
Renal tubular dysfunction 82.25 15.83 22 26342 351 50578409
Mitochondrial cytopathy 82.05 15.83 20 26344 215 50578545
Peripheral swelling 81.37 15.83 7 26357 205929 50372831
Off label use 80.92 15.83 77 26287 474349 50104411
Ventricular septal defect 79.91 15.83 40 26324 4001 50574759
Placental disorder 77.95 15.83 29 26335 1401 50577359
Nasopharyngitis 77.77 15.83 6 26358 192921 50385839
Rheumatoid arthritis 77.07 15.83 8 26356 202542 50376218
Congenital umbilical hernia 76.36 15.83 20 26344 293 50578467
Amniotic cavity infection 76.14 15.83 27 26337 1136 50577624
Birth mark 76.00 15.83 17 26347 121 50578639
Hyperlactacidaemia 75.85 15.83 33 26331 2400 50576360
Ectopic kidney 75.33 15.83 15 26349 55 50578705
Infusion related reaction 75.33 15.83 3 26361 169554 50409206
Alpha 1 foetoprotein abnormal 71.50 15.83 14 26350 46 50578714
Abdominal discomfort 70.57 15.83 17 26347 231624 50347136
Premature separation of placenta 69.96 15.83 28 26336 1650 50577110
Product dose omission issue 68.06 15.83 8 26356 183830 50394930
Blood lactic acid increased 67.77 15.83 40 26324 5545 50573215
Retinoblastoma 66.47 15.83 14 26350 72 50578688
Jaundice 65.97 15.83 75 26289 26354 50552406
Rash maculo-papular 65.48 15.83 75 26289 26566 50552194
Alopecia 65.45 15.83 23 26341 245024 50333736
Fat tissue increased 64.54 15.83 20 26344 549 50578211
CSF HIV escape syndrome 64.37 15.83 14 26350 86 50578674
Hepatomegaly 62.74 15.83 49 26315 10744 50568016
Pulmonary tuberculosis 60.93 15.83 34 26330 4239 50574521
Systemic lupus erythematosus 60.77 15.83 3 26361 140619 50438141
Alanine aminotransferase increased 59.70 15.83 138 26226 88221 50490539
Oligohydramnios 59.03 15.83 37 26327 5713 50573047
Ergot poisoning 58.68 15.83 13 26351 88 50578672
Congenital anomaly 58.66 15.83 24 26340 1497 50577263
Small for dates baby 58.63 15.83 31 26333 3474 50575286
Ectopic pregnancy 58.01 15.83 27 26337 2300 50576460
Renal tubular disorder 56.82 15.83 27 26337 2410 50576350
Cholelithiasis 55.88 15.83 83 26281 37890 50540870
Placental insufficiency 55.58 15.83 22 26342 1259 50577501
Sinusitis 54.99 15.83 11 26353 170547 50408213
Stevens-Johnson syndrome 54.75 15.83 62 26302 21690 50557070
Meningitis cryptococcal 54.39 15.83 21 26343 1124 50577636
Hepatic failure 54.01 15.83 75 26289 32208 50546552
Aspartate aminotransferase increased 53.99 15.83 123 26241 77875 50500885
Completed suicide 53.42 15.83 4 26360 131885 50446875
Lymphadenopathy 53.33 15.83 76 26288 33423 50545337
Arthralgia 53.19 15.83 92 26272 438610 50140150
Hypertriglyceridaemia 53.04 15.83 34 26330 5457 50573303
Foetal distress syndrome 52.68 15.83 21 26343 1224 50577536
Umbilical cord abnormality 51.17 15.83 17 26347 586 50578174
Atrial septal defect 50.94 15.83 35 26329 6306 50572454
Malaria 49.10 15.83 13 26351 199 50578561
Constipation 48.60 15.83 18 26346 185690 50393070
Swelling 48.47 15.83 22 26342 200850 50377910
Drug intolerance 48.37 15.83 27 26337 219077 50359683
Hepatitis 48.09 15.83 70 26294 31383 50547377
Pain in extremity 47.93 15.83 43 26321 272822 50305938
Drug interaction 47.59 15.83 218 26146 199403 50379357
Anaemia macrocytic 46.72 15.83 24 26340 2535 50576225
Tuberculosis 46.48 15.83 40 26324 10043 50568717
Cleft lip and palate 46.46 15.83 14 26350 349 50578411
Ultrasound antenatal screen abnormal 45.49 15.83 11 26353 114 50578646
Dyspnoea 43.22 15.83 144 26220 547464 50031296
Cushing's syndrome 42.25 15.83 15 26349 633 50578127
Discomfort 41.93 15.83 4 26360 108376 50470384
Ultrasound scan abnormal 41.72 15.83 12 26352 253 50578507
Mitochondrial DNA deletion 41.59 15.83 7 26357 6 50578754
Low birth weight baby 41.52 15.83 30 26334 5851 50572909
HIV infection 40.90 15.83 12 26352 272 50578488
Ocular icterus 39.85 15.83 24 26340 3451 50575309
Blood bilirubin unconjugated increased 39.60 15.83 12 26352 305 50578455
Immune reconstitution inflammatory syndrome associated tuberculosis 39.05 15.83 12 26352 320 50578440
Rickets 38.17 15.83 8 26356 40 50578720
Drug hypersensitivity 37.91 15.83 45 26319 250965 50327795
Patent ductus arteriosus 37.76 15.83 24 26340 3796 50574964
Therapeutic product effect decreased 37.63 15.83 12 26352 136038 50442722
Neonatal disorder 36.61 15.83 13 26351 549 50578211
Cleft palate 36.47 15.83 15 26349 948 50577812
Gene mutation 35.62 15.83 16 26348 1255 50577505
Headache 35.44 15.83 140 26224 506395 50072365
Pregnancy on contraceptive 35.19 15.83 15 26349 1037 50577723
Gestational diabetes 35.19 15.83 30 26334 7435 50571325
Tuberculoma of central nervous system 34.82 15.83 11 26353 322 50578438
Death neonatal 34.28 15.83 10 26354 222 50578538
CD4 lymphocytes increased 33.92 15.83 9 26355 139 50578621
Hypouricaemia 33.92 15.83 9 26355 139 50578621
Isosporiasis 32.92 15.83 7 26357 38 50578722
Hepatic enzyme increased 32.68 15.83 150 26214 137230 50441530
Contusion 32.65 15.83 9 26355 112174 50466586
Hepatitis A 32.42 15.83 11 26353 405 50578355
Metabolic acidosis 32.32 15.83 66 26298 38759 50540001
Placental infarction 32.25 15.83 10 26354 275 50578485
Benign hydatidiform mole 32.01 15.83 8 26356 96 50578664
Atrial fibrillation 31.88 15.83 7 26357 101738 50477022
AIDS cholangiopathy 31.85 15.83 6 26358 15 50578745
Neural tube defect 31.60 15.83 9 26355 183 50578577
Cardiac malposition 30.91 15.83 7 26357 53 50578707
Multiple-drug resistance 30.73 15.83 20 26344 3294 50575466
Weight increased 30.67 15.83 36 26328 201855 50376905
Infection 30.64 15.83 27 26337 172927 50405833
Back pain 30.56 15.83 42 26322 219988 50358772
Influenza 30.51 15.83 5 26359 89533 50489227
Hydrops foetalis 30.37 15.83 10 26354 335 50578425
HIV-associated neurocognitive disorder 30.18 15.83 8 26356 123 50578637
Pericarditis 30.18 15.83 3 26361 78686 50500074
Renal tubular acidosis 29.79 15.83 15 26349 1519 50577241
Neutropenia 29.77 15.83 154 26210 147811 50430949
Lymphadenitis 29.55 15.83 18 26346 2642 50576118
Hepatosplenomegaly 29.21 15.83 17 26347 2295 50576465
Hepatic cytolysis 29.21 15.83 28 26336 8075 50570685
Neutropenia neonatal 28.57 15.83 7 26357 77 50578683
Bilirubin conjugated increased 28.41 15.83 17 26347 2415 50576345
Feeling abnormal 28.34 15.83 15 26349 125477 50453283
Chronic disease 28.33 15.83 7 26357 80 50578680
Infertility 28.25 15.83 11 26353 602 50578158
Ballismus 28.25 15.83 7 26357 81 50578679
Drug reaction with eosinophilia and systemic symptoms 28.15 15.83 52 26312 28372 50550388
Dyslipidaemia 28.10 15.83 24 26340 5964 50572796
Twin pregnancy 28.01 15.83 13 26351 1100 50577660
Postpartum haemorrhage 27.89 15.83 15 26349 1739 50577021
Gamma-glutamyltransferase increased 27.85 15.83 53 26311 29570 50549190
Prenatal screening test abnormal 27.66 15.83 5 26359 9 50578751
Gestational hypertension 27.51 15.83 16 26348 2157 50576603
Double outlet right ventricle 27.03 15.83 6 26358 41 50578719
Cerebral toxoplasmosis 26.86 15.83 11 26353 688 50578072
Ascites 26.42 15.83 58 26306 35803 50542957
Pruritus 26.32 15.83 69 26295 283499 50295261
Bicuspid pulmonary valve 26.24 15.83 4 26360 0 50578760
Anembryonic gestation 26.10 15.83 10 26354 524 50578236
Lymph node tuberculosis 26.02 15.83 11 26353 745 50578015
Hepatitis B surface antigen positive 25.99 15.83 6 26358 50 50578710
Diarrhoea 25.93 15.83 190 26174 588286 49990474
Cholestatic liver injury 25.90 15.83 15 26349 2006 50576754
Product use issue 25.68 15.83 24 26340 149451 50429309
Funisitis 25.64 15.83 5 26359 16 50578744
Vomiting 25.41 15.83 358 26006 460400 50118360
Malignant neoplasm progression 25.10 15.83 3 26361 68121 50510639
Ovarian failure 24.96 15.83 12 26352 1099 50577661
Hyperphosphaturia 24.57 15.83 5 26359 21 50578739
Blood pressure increased 24.53 15.83 20 26344 133112 50445648
Urinary tract infection 24.41 15.83 50 26314 223970 50354790
Neonatal aspiration 24.36 15.83 7 26357 147 50578613
Cytomegalovirus chorioretinitis 24.28 15.83 13 26351 1494 50577266
Muscle spasms 24.23 15.83 18 26346 125535 50453225
Retinal toxicity 24.20 15.83 12 26352 1176 50577584
Fat redistribution 24.01 15.83 4 26360 3 50578757
Acquired aminoaciduria 24.01 15.83 4 26360 3 50578757
Eyelid oedema 23.85 15.83 27 26337 9439 50569321
Kaposi's sarcoma 23.76 15.83 7 26357 161 50578599
Abortion missed 23.64 15.83 13 26351 1575 50577185
Alpha 1 foetoprotein increased 23.64 15.83 7 26357 164 50578596
Hypophosphataemic osteomalacia 23.64 15.83 7 26357 164 50578596
Hepatic displacement 23.54 15.83 5 26359 27 50578733
Fallot's tetralogy 23.50 15.83 6 26358 79 50578681
Foetal anaemia 23.09 15.83 5 26359 30 50578730
Cachexia 22.98 15.83 19 26345 4514 50574246
Isoimmune haemolytic disease 22.95 15.83 5 26359 31 50578729
Hepatitis B DNA assay positive 22.95 15.83 5 26359 31 50578729
Anaemia neonatal 22.87 15.83 8 26356 323 50578437
Musculoskeletal stiffness 22.82 15.83 20 26344 128461 50450299
Asthma 22.78 15.83 9 26355 89328 50489432
Haemorrhage in pregnancy 22.75 15.83 13 26351 1696 50577064
Lipase increased 22.61 15.83 25 26339 8516 50570244
Anxiety 22.61 15.83 36 26328 177570 50401190
Cardiac murmur 22.60 15.83 28 26336 10756 50568004
AIDS related complication 22.20 15.83 4 26360 7 50578753
Diastasis recti abdominis 22.18 15.83 5 26359 37 50578723
Pleocytosis 22.16 15.83 9 26355 551 50578209
Renal failure 22.14 15.83 112 26252 106521 50472239
Dyschezia 22.09 15.83 13 26351 1791 50576969
Migraine 21.98 15.83 6 26358 75274 50503486
Type III hyperlipidaemia 21.85 15.83 4 26360 8 50578752
Cholestasis of pregnancy 21.79 15.83 11 26353 1120 50577640
Blood creatine phosphokinase MB increased 21.69 15.83 11 26353 1131 50577629
Breech delivery 21.62 15.83 5 26359 42 50578718
Dizziness 21.55 15.83 100 26264 346269 50232491
Lipohypertrophy 21.37 15.83 9 26355 604 50578156
Antiviral drug level below therapeutic 21.31 15.83 5 26359 45 50578715
Myopathy toxic 21.22 15.83 8 26356 401 50578359
Blister 21.14 15.83 9 26355 85409 50493351
Psoriasis 21.10 15.83 5 26359 68995 50509765
Respiratory distress 20.99 15.83 48 26316 30441 50548319
Blood creatine phosphokinase increased 20.98 15.83 44 26320 26323 50552437
Aminoaciduria 20.97 15.83 6 26358 124 50578636
Intentional product use issue 20.88 15.83 7 26357 76911 50501849
Bovine tuberculosis 20.66 15.83 5 26359 52 50578708
Lower respiratory tract infection 20.60 15.83 12 26352 95189 50483571
Placenta praevia 20.60 15.83 10 26354 936 50577824
Pubertal failure 20.46 15.83 4 26360 13 50578747
Developmental delay 20.39 15.83 11 26353 1283 50577477
Spinal cord injury 20.27 15.83 9 26355 687 50578073
Breast neoplasm 20.24 15.83 11 26353 1302 50577458
Hydrocephalus 20.07 15.83 18 26346 4770 50573990
Influenza like illness 20.05 15.83 3 26361 57456 50521304
CSF protein increased 19.99 15.83 8 26356 471 50578289
Wheezing 19.98 15.83 4 26360 62043 50516717
Pallor 19.97 15.83 40 26324 23159 50555601
Ventricular hypoplasia 19.97 15.83 6 26358 148 50578612
Pyrexia 19.96 15.83 293 26071 379910 50198850
Osteoporosis 19.95 15.83 60 26304 44819 50533941
Hypotension 19.84 15.83 60 26304 235409 50343351
Carnitine deficiency 19.74 15.83 6 26358 154 50578606
Vertical infection transmission 19.68 15.83 3 26361 0 50578760
Loss of personal independence in daily activities 19.68 15.83 6 26358 70044 50508716
Portal vein thrombosis 19.66 15.83 13 26351 2199 50576561
Malaise 19.63 15.83 99 26265 335433 50243327
Death 19.61 15.83 95 26269 325284 50253476
Pharyngotonsillitis 19.60 15.83 6 26358 158 50578602
Disseminated Bacillus Calmette-Guerin infection 19.43 15.83 4 26360 18 50578742
Renal glycosuria 19.43 15.83 4 26360 18 50578742
Ebstein's anomaly 19.43 15.83 4 26360 18 50578742
Necrotising colitis 19.43 15.83 8 26356 507 50578253
Transaminases increased 19.37 15.83 44 26320 27780 50550980
Amenorrhoea 19.36 15.83 23 26341 8461 50570299
Varices oesophageal 19.17 15.83 14 26350 2775 50575985
Social avoidant behaviour 19.14 15.83 14 26350 2783 50575977
Meningitis tuberculous 19.08 15.83 8 26356 531 50578229
Insomnia 19.06 15.83 39 26325 174826 50403934
Eclampsia 19.02 15.83 7 26357 328 50578432
Pulmonary artery atresia 18.77 15.83 4 26360 22 50578738
Thyroid tuberculosis 18.77 15.83 4 26360 22 50578738
Toxicity to various agents 18.73 15.83 53 26311 212446 50366314
Acquired immunodeficiency syndrome 18.62 15.83 5 26359 81 50578679
Diaphragmatic aplasia 18.62 15.83 4 26360 23 50578737
Aqueductal stenosis 18.47 15.83 4 26360 24 50578736
Hemiataxia 18.47 15.83 4 26360 24 50578736
Placental necrosis 18.20 15.83 4 26360 26 50578734
Cryptococcosis 18.18 15.83 9 26355 879 50577881
Lactate pyruvate ratio increased 18.08 15.83 5 26359 91 50578669
Mycobacterium avium complex infection 18.08 15.83 13 26351 2517 50576243
Myelopathy 17.93 15.83 13 26351 2548 50576212
Acute stress disorder 17.89 15.83 6 26358 213 50578547
HELLP syndrome 17.88 15.83 9 26355 910 50577850
Therapeutic product effect incomplete 17.81 15.83 13 26351 91502 50487258
Hepatitis C 17.74 15.83 17 26347 4900 50573860
Delayed puberty 17.73 15.83 5 26359 98 50578662
Oxygen saturation decreased 17.68 15.83 8 26356 73240 50505520
Secondary hypogonadism 17.63 15.83 5 26359 100 50578660
Cervix operation 17.60 15.83 3 26361 3 50578757
Delivery 17.58 15.83 8 26356 647 50578113
Bronchitis 17.56 15.83 17 26347 104142 50474618
Osteoarthritis 17.35 15.83 7 26357 68599 50510161
Micrognathia 17.33 15.83 6 26358 235 50578525
Cleft lip 17.27 15.83 5 26359 108 50578652
Thrombosis 17.16 15.83 4 26360 55829 50522931
Acute lymphocytic leukaemia 17.13 15.83 12 26352 2229 50576531
Nasal congestion 17.09 15.83 3 26361 51117 50527643
Cervical dysplasia 16.96 15.83 13 26351 2772 50575988
Developmental coordination disorder 16.86 15.83 4 26360 38 50578722
Persistent left superior vena cava 16.86 15.83 4 26360 38 50578722
Acute fatty liver of pregnancy 16.76 15.83 4 26360 39 50578721
Genital prolapse 16.67 15.83 4 26360 40 50578720
Nodular regenerative hyperplasia 16.62 15.83 6 26358 266 50578494
Oropharyngeal pain 16.56 15.83 10 26354 77791 50500969
Blood alkaline phosphatase increased 16.52 15.83 50 26314 37476 50541284
Intentional overdose 16.43 15.83 6 26358 62498 50516262
Carbon dioxide combining power abnormal 16.39 15.83 3 26361 6 50578754
Growth hormone-producing pituitary tumour 16.39 15.83 3 26361 6 50578754
Infected vasculitis 16.39 15.83 3 26361 6 50578754
Glycocholic acid increased 16.39 15.83 3 26361 6 50578754
Anaphylactic reaction 16.37 15.83 4 26360 54051 50524709
Threatened labour 16.18 15.83 8 26356 779 50577981
Defaecation urgency 15.98 15.83 13 26351 3020 50575740
Foetal heart rate abnormal 15.96 15.83 7 26357 519 50578241
Neck pain 15.83 15.83 5 26359 57062 50521698

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Viral mutation identified 1707.49 12.38 450 44412 2038 29527627
Virologic failure 1494.97 12.38 417 44445 2430 29527235
Immune reconstitution inflammatory syndrome 1465.56 12.38 521 44341 7281 29522384
Pathogen resistance 1263.81 12.38 472 44390 7644 29522021
Drug resistance 926.61 12.38 510 44352 21030 29508635
Lipodystrophy acquired 793.22 12.38 261 44601 2833 29526832
Foetal exposure during pregnancy 691.37 12.38 500 44362 33367 29496298
Hepatitis B 609.14 12.38 250 44612 5247 29524418
Drug interaction 569.41 12.38 1047 43815 196338 29333327
Exposure during pregnancy 554.15 12.38 267 44595 8287 29521378
Depression 553.84 12.38 663 44199 84484 29445181
Mitochondrial toxicity 463.66 12.38 164 44698 2247 29527418
Hepatitis B DNA increased 365.12 12.38 95 44767 403 29529262
Osteomalacia 346.54 12.38 103 44759 773 29528892
Hepatitis B reactivation 337.85 12.38 141 44721 3088 29526577
Acquired gene mutation 313.84 12.38 104 44758 1154 29528511
Eyelid ptosis 291.47 12.38 147 44715 5039 29524626
Fanconi syndrome acquired 282.32 12.38 106 44756 1736 29527929
Viral load increased 257.29 12.38 102 44760 1947 29527718
Blood HIV RNA increased 248.84 12.38 83 44779 941 29528724
Progressive external ophthalmoplegia 217.27 12.38 80 44782 1237 29528428
Lipoatrophy 208.77 12.38 61 44801 428 29529237
Pinealoblastoma 199.64 12.38 48 44814 135 29529530
Premature baby 191.36 12.38 179 44683 17101 29512564
Hypophosphataemia 189.32 12.38 129 44733 7795 29521870
Hypertriglyceridaemia 188.90 12.38 126 44736 7349 29522316
Hepatic failure 177.94 12.38 229 44633 31283 29498382
Diplopia 171.18 12.38 151 44711 13367 29516298
Fanconi syndrome 164.53 12.38 69 44793 1529 29528136
Hepatic fibrosis 159.13 12.38 84 44778 3168 29526497
Genotype drug resistance test 154.68 12.38 33 44829 41 29529624
Renal tubular disorder 151.80 12.38 90 44772 4262 29525403
Kaposi's sarcoma 148.26 12.38 54 44808 808 29528857
CD4 lymphocytes decreased 147.97 12.38 64 44798 1534 29528131
Multiple-drug resistance 129.14 12.38 78 44784 3822 29525843
Osteoporosis 123.93 12.38 114 44748 10655 29519010
Off label use 121.36 12.38 168 44694 300632 29229033
Polydactyly 119.97 12.38 50 44812 1090 29528575
Meningitis cryptococcal 119.37 12.38 60 44802 2040 29527625
Treatment failure 118.48 12.38 206 44656 36733 29492932
Fall 117.79 12.38 61 44801 177117 29352548
Alanine aminotransferase increased 116.63 12.38 301 44561 70643 29459022
Gene mutation 114.09 12.38 47 44815 994 29528671
Retinal toxicity 111.26 12.38 36 44826 368 29529297
Trisomy 21 107.10 12.38 37 44825 470 29529195
Maternal drugs affecting foetus 104.12 12.38 68 44794 3825 29525840
Portal hypertension 100.91 12.38 64 44798 3422 29526243
HIV-associated neurocognitive disorder 98.45 12.38 31 44831 288 29529377
Treatment noncompliance 97.87 12.38 150 44712 24077 29505588
Blood phosphorus decreased 95.58 12.38 57 44805 2728 29526937
Loss of personal independence in daily activities 95.11 12.38 152 44710 25288 29504377
Product dose omission issue 95.00 12.38 16 44846 96367 29433298
Hepatic cirrhosis 94.37 12.38 113 44749 14331 29515334
Nephropathy toxic 94.09 12.38 98 44764 10658 29519007
Completed suicide 93.46 12.38 13 44849 90233 29439432
Blood lactic acid increased 92.81 12.38 74 44788 5692 29523973
Mycobacterium avium complex infection 92.66 12.38 52 44810 2217 29527448
Hyperlactacidaemia 92.40 12.38 55 44807 2623 29527042
Osteonecrosis 92.02 12.38 108 44754 13411 29516254
Death 90.89 12.38 245 44617 341839 29187826
Jaundice 89.56 12.38 160 44702 29136 29500529
Cytomegalovirus chorioretinitis 85.23 12.38 56 44806 3182 29526483
Pneumonia 84.49 12.38 230 44632 319942 29209723
Mitochondrial cytopathy 83.58 12.38 24 44838 157 29529508
Hyperlipidaemia 83.08 12.38 99 44763 12491 29517174
Renal tubular dysfunction 82.85 12.38 29 44833 384 29529281
Hypouricaemia 79.23 12.38 25 44837 234 29529431
Aspartate aminotransferase increased 77.92 12.38 233 44629 59492 29470173
Hypotension 77.75 12.38 109 44753 194245 29335420
Volvulus 77.20 12.38 37 44825 1132 29528533
Drug abuse 77.09 12.38 14 44848 79869 29449796
Peripheral swelling 76.97 12.38 5 44857 63734 29465931
Drug-induced liver injury 76.34 12.38 126 44736 21529 29508136
Dyspnoea 75.91 12.38 249 44613 326483 29203182
CSF HIV escape syndrome 74.13 12.38 22 44840 164 29529501
Neonatal disorder 73.82 12.38 32 44830 771 29528894
Proteinuria 72.66 12.38 104 44758 15700 29513965
Hepatitis C 72.29 12.38 78 44784 8832 29520833
Pulmonary tuberculosis 70.78 12.38 56 44806 4259 29525406
Acquired immunodeficiency syndrome 70.66 12.38 26 44836 401 29529264
Anaemia macrocytic 68.07 12.38 45 44817 2583 29527082
Hepatitis 68.04 12.38 117 44745 20666 29508999
HIV infection 67.88 12.38 34 44828 1147 29528518
Hepatomegaly 66.02 12.38 76 44786 9241 29520424
Renal impairment 65.08 12.38 270 44592 81063 29448602
Blood alkaline phosphatase increased 64.66 12.38 137 44725 28269 29501396
Fatigue 63.92 12.38 256 44606 316565 29213100
Lymphadenopathy 63.13 12.38 126 44736 24923 29504742
Glycosuria 62.54 12.38 32 44830 1130 29528535
Caesarean section 62.48 12.38 38 44824 1885 29527780
Ophthalmoplegia 61.85 12.38 36 44826 1646 29528019
Hepatic function abnormal 61.81 12.38 164 44698 39095 29490570
Oesophageal candidiasis 61.41 12.38 49 44813 3772 29525893
Hyperbilirubinaemia 61.05 12.38 93 44769 14841 29514824
Varices oesophageal 60.76 12.38 45 44817 3101 29526564
Congenital umbilical hernia 60.41 12.38 21 44841 272 29529393
Tuberculosis 60.14 12.38 64 44798 7132 29522533
Dyslipidaemia 59.90 12.38 59 44803 6002 29523663
Malignant neoplasm progression 59.42 12.38 19 44843 73840 29455825
Birth mark 58.79 12.38 18 44844 151 29529514
Congenital anomaly 58.52 12.38 32 44830 1296 29528369
Pain 58.29 12.38 107 44755 171325 29358340
Progressive multifocal leukoencephalopathy 58.24 12.38 69 44793 8650 29521015
Urine phosphorus increased 57.81 12.38 14 44848 41 29529624
Lactic acidosis 57.75 12.38 136 44726 30111 29499554
Blood pressure increased 57.60 12.38 20 44842 73783 29455882
Blood bilirubin increased 55.82 12.38 144 44718 33749 29495916
Constipation 55.25 12.38 55 44807 114105 29415560
Hepatocellular carcinoma 54.28 12.38 60 44802 6978 29522687
Lipohypertrophy 54.28 12.38 18 44844 200 29529465
Hepatosplenomegaly 52.06 12.38 44 44818 3673 29525992
Hepatic cancer 51.46 12.38 56 44806 6400 29523265
Calculus urinary 51.45 12.38 28 44834 1123 29528542
Pregnancy 51.10 12.38 18 44844 243 29529422
Atrial fibrillation 51.00 12.38 51 44811 105595 29424070
Blood triglycerides increased 49.77 12.38 78 44784 12756 29516909
Talipes 49.63 12.38 32 44830 1760 29527905
Genotype drug resistance test positive 48.84 12.38 26 44836 997 29528668
Human immunodeficiency virus transmission 48.04 12.38 11 44851 23 29529642
CD4 lymphocytes increased 46.26 12.38 16 44846 204 29529461
Gamma-glutamyltransferase increased 45.47 12.38 115 44747 26622 29503043
Cachexia 45.34 12.38 52 44810 6297 29523368
Hepatic encephalopathy 44.80 12.38 75 44787 12960 29516705
Cryptococcosis 44.77 12.38 31 44831 1921 29527744
Dandy-Walker syndrome 44.37 12.38 14 44848 131 29529534
Oesophageal varices haemorrhage 44.17 12.38 35 44827 2667 29526998
Pyelocaliectasis 44.16 12.38 25 44837 1084 29528581
Hepatitis B virus test 43.94 12.38 8 44854 0 29529665
Facial wasting 43.81 12.38 14 44848 137 29529528
Nasopharyngitis 43.49 12.38 18 44844 59647 29470018
Multiple fractures 42.87 12.38 26 44836 1283 29528382
Inappropriate schedule of product administration 42.44 12.38 8 44854 44464 29485201
Opportunistic infection 42.25 12.38 27 44835 1462 29528203
Optic nerve neoplasm 42.16 12.38 10 44852 26 29529639
Nephrolithiasis 42.08 12.38 108 44754 25226 29504439
Anaemia neonatal 42.00 12.38 16 44846 273 29529392
Infusion related reaction 41.66 12.38 8 44854 43878 29485787
Oral candidiasis 41.34 12.38 65 44797 10657 29519008
Congenital neoplasm 41.11 12.38 10 44852 30 29529635
Cerebral toxoplasmosis 40.99 12.38 26 44836 1390 29528275
Blood bilirubin unconjugated increased 40.93 12.38 19 44843 540 29529125
Basedow's disease 40.79 12.38 11 44851 55 29529610
Cryptorchism 40.27 12.38 29 44833 1913 29527752
Splenomegaly 39.89 12.38 72 44790 13207 29516458
Immune reconstitution inflammatory syndrome associated tuberculosis 39.82 12.38 17 44845 394 29529271
Small for dates baby 39.45 12.38 37 44825 3542 29526123
Bone density decreased 39.29 12.38 27 44835 1653 29528012
Cardiac failure congestive 39.25 12.38 35 44827 76546 29453119
Feeling abnormal 38.77 12.38 17 44845 54428 29475237
Ascites 38.74 12.38 133 44729 36486 29493179
Urine calcium increased 38.70 12.38 10 44852 41 29529624
Confusional state 38.16 12.38 86 44776 127791 29401874
Joint swelling 37.78 12.38 14 44848 49616 29480049
Rhabdomyosarcoma 37.51 12.38 9 44853 25 29529640
Mycobacterium avium complex immune restoration disease 37.25 12.38 9 44853 26 29529639
Aminoaciduria 37.14 12.38 12 44850 122 29529543
Pneumocystis jirovecii pneumonia 37.10 12.38 80 44782 16699 29512966
Mycobacterial infection 36.86 12.38 27 44835 1829 29527836
Acute hepatitis C 36.06 12.38 11 44851 91 29529574
Mitochondrial myopathy 35.90 12.38 13 44849 191 29529474
Cardio-respiratory arrest 35.71 12.38 16 44846 50585 29479080
Nodular regenerative hyperplasia 34.43 12.38 18 44844 665 29529000
Liver disorder 34.04 12.38 106 44756 27643 29502022
Wheezing 33.89 12.38 5 44857 33235 29496430
Hepatotoxicity 33.73 12.38 80 44782 17787 29511878
Blood phosphorus abnormal 33.69 12.38 11 44851 116 29529549
Osteoporotic fracture 33.27 12.38 20 44842 971 29528694
Cardiac arrest 33.16 12.38 49 44813 85542 29444123
Renal tubular acidosis 33.06 12.38 25 44837 1778 29527887
Transaminases increased 32.98 12.38 92 44770 22570 29507095
Cerebrovascular accident 32.86 12.38 41 44821 76870 29452795
Death neonatal 32.77 12.38 14 44848 325 29529340
Blood pyruvic acid increased 32.25 12.38 7 44855 10 29529655
Viraemia 31.79 12.38 20 44842 1054 29528611
Dizziness 31.71 12.38 164 44698 189520 29340145
Intentional product misuse 31.49 12.38 7 44855 34654 29495011
Thrombosis 31.34 12.38 13 44849 43032 29486633
Oesophageal atresia 31.32 12.38 15 44847 458 29529207
Hydrocele 31.29 12.38 25 44837 1928 29527737
Congenital hydronephrosis 31.14 12.38 17 44845 686 29528979
Anaemia 31.13 12.38 452 44410 200499 29329166
Contusion 30.97 12.38 5 44857 31090 29498575
Toxicity to various agents 30.83 12.38 147 44715 173514 29356151
Disease progression 30.67 12.38 48 44814 81868 29447797
Cushing's syndrome 30.52 12.38 14 44848 387 29529278
Flushing 30.41 12.38 4 44858 28988 29500677
Epistaxis 29.80 12.38 21 44841 51683 29477982
Hepatitis cholestatic 29.70 12.38 44 44818 6849 29522816
White matter lesion 29.58 12.38 16 44846 634 29529031
HIV lipodystrophy 29.57 12.38 7 44855 18 29529647
Osteopenia 29.53 12.38 34 44828 4134 29525531
Stevens-Johnson syndrome 29.14 12.38 72 44790 16425 29513240
Astrocytoma, low grade 29.03 12.38 8 44854 44 29529621
Therapeutic product effect decreased 28.74 12.38 5 44857 29446 29500219
HIV viraemia 28.74 12.38 8 44854 46 29529619
Tremor 28.58 12.38 42 44820 73496 29456169
Febrile neutropenia 28.44 12.38 82 44780 112158 29417507
Lactate pyruvate ratio increased 28.33 12.38 6 44856 7 29529658
Vanishing bile duct syndrome 28.23 12.38 15 44847 573 29529092
Somnolence 28.16 12.38 63 44799 93892 29435773
Drug ineffective 27.54 12.38 387 44475 362783 29166882
Muscle spasms 27.48 12.38 35 44827 65047 29464618
Mitochondrial DNA depletion 27.46 12.38 5 44857 0 29529665
Chronic obstructive pulmonary disease 27.29 12.38 14 44848 40941 29488724
Tubulointerstitial nephritis 27.04 12.38 73 44789 17570 29512095
Atrioventricular septal defect 27.01 12.38 10 44852 157 29529508
Hyperhidrosis 26.94 12.38 35 44827 64505 29465160
Injection site pain 26.70 12.38 8 44854 32438 29497227
Meningomyelocele 26.61 12.38 10 44852 164 29529501
Blood uric acid increased 26.57 12.38 38 44824 5730 29523935
Bone metabolism disorder 26.55 12.38 11 44851 236 29529429
Retroviral rebound syndrome 26.38 12.38 6 44856 12 29529653
Low set ears 26.35 12.38 13 44849 424 29529241
Product use in unapproved indication 26.24 12.38 58 44804 86817 29442848
Lymph node tuberculosis 26.16 12.38 13 44849 431 29529234
Hepatitis A 26.05 12.38 13 44849 435 29529230
Viral load decreased 25.96 12.38 7 44855 35 29529630
Cardiac disorder 25.95 12.38 12 44850 37251 29492414
Fat tissue increased 25.95 12.38 12 44850 338 29529327
Hypophosphataemic osteomalacia 25.86 12.38 9 44853 117 29529548
Congenital central nervous system anomaly 25.86 12.38 13 44849 442 29529223
Neurosyphilis 25.80 12.38 7 44855 36 29529629
Prenatal screening test abnormal 25.75 12.38 6 44856 14 29529651
Hypospadias 25.62 12.38 27 44835 2975 29526690
Beta 2 microglobulin urine increased 25.25 12.38 8 44854 76 29529589
Bone pain 24.99 12.38 73 44789 18379 29511286
Anxiety 24.97 12.38 58 44804 85307 29444358
HIV test positive 24.93 12.38 9 44853 131 29529534
Syncope 24.84 12.38 54 44808 81317 29448348
Neonatal asphyxia 24.78 12.38 11 44851 281 29529384
Limb deformity 24.46 12.38 13 44849 497 29529168
HIV wasting syndrome 24.45 12.38 8 44854 85 29529580
Pyrexia 24.32 12.38 589 44273 287033 29242632
Plasma cell myeloma 24.27 12.38 13 44849 37102 29492563
Cardiac failure 23.89 12.38 53 44809 79234 29450431
Blood glucose increased 23.59 12.38 33 44829 58951 29470714
Product use issue 23.49 12.38 26 44836 51418 29478247
Unevaluable event 23.43 12.38 8 44854 29843 29499822
Cellulitis 23.42 12.38 21 44841 45819 29483846
Congenital cytomegalovirus infection 23.34 12.38 6 44856 24 29529641
Toxoplasmosis 23.23 12.38 17 44845 1150 29528515
Anogenital warts 23.21 12.38 13 44849 552 29529113
Atypical mycobacterial infection 23.15 12.38 14 44848 687 29528978
Spider naevus 22.95 12.38 6 44856 26 29529639
Tuberculoid leprosy 22.83 12.38 7 44855 59 29529606
Anal cancer 22.46 12.38 11 44851 353 29529312
Stress 22.45 12.38 3 44859 21487 29508178
Incorrect dose administered 22.39 12.38 11 44851 32973 29496692
Amoebiasis 22.33 12.38 7 44855 64 29529601
Intracranial pressure increased 22.32 12.38 27 44835 3458 29526207
Urinary tract infection 22.10 12.38 48 44814 72306 29457359
Meningitis tuberculous 21.99 12.38 13 44849 612 29529053
Trimethylaminuria 21.99 12.38 5 44857 10 29529655
Withdrawal hepatitis 21.97 12.38 4 44858 0 29529665
Strongyloidiasis 21.91 12.38 22 44840 2290 29527375
Hepatitis D 21.63 12.38 6 44856 34 29529631
Live birth 21.47 12.38 9 44853 199 29529466
Parotid gland enlargement 21.45 12.38 10 44852 287 29529378
Hypercholesterolaemia 21.42 12.38 39 44823 7199 29522466
Cardiac murmur 21.33 12.38 37 44825 6576 29523089
Histoplasmosis disseminated 21.28 12.38 16 44846 1128 29528537
Chest discomfort 21.26 12.38 23 44839 45960 29483705
Antimitochondrial antibody positive 21.20 12.38 6 44856 37 29529628
Hepatitis B surface antigen positive 21.19 12.38 8 44854 133 29529532
Angioedema 21.13 12.38 11 44851 31904 29497761
Night blindness 20.95 12.38 9 44853 212 29529453
Blood creatine phosphokinase increased 20.94 12.38 119 44743 40525 29489140
Cryoglobulinaemia 20.92 12.38 10 44852 304 29529361
Blood creatinine increased 20.86 12.38 209 44653 84893 29444772
Umbilical cord abnormality 20.80 12.38 6 44856 40 29529625
Granulomatous rosacea 20.76 12.38 8 44854 141 29529524
Foetal growth restriction 20.65 12.38 27 44835 3739 29525926
Macrocytosis 20.46 12.38 14 44848 851 29528814
Influenza 20.44 12.38 20 44842 41861 29487804
Chest pain 20.30 12.38 94 44768 111879 29417786
Gynaecomastia 20.29 12.38 41 44821 8176 29521489
Urine phosphorus decreased 20.18 12.38 6 44856 45 29529620
Haematochezia 20.05 12.38 16 44846 36967 29492698
Neuromyopathy 19.97 12.38 14 44848 885 29528780
Exomphalos 19.97 12.38 8 44854 157 29529508
Primary syphilis 19.86 12.38 5 44857 18 29529647
Bacterial pyelonephritis 19.81 12.38 9 44853 243 29529422
Prostate cancer 19.76 12.38 7 44855 25520 29504145
Bradycardia 19.66 12.38 44 44818 65585 29464080
AIDS related complication 19.65 12.38 5 44857 19 29529646
Normal newborn 19.56 12.38 8 44854 166 29529499
Urticaria 19.54 12.38 33 44829 54627 29475038
Oropharyngeal pain 19.52 12.38 10 44852 29275 29500390
Diaphragmatic hernia 19.45 12.38 9 44853 254 29529411
Weight increased 19.41 12.38 56 44806 76611 29453054
Taeniasis 19.32 12.38 6 44856 53 29529612
Pulmonary embolism 19.31 12.38 56 44806 76478 29453187
Perinatal HIV infection 19.20 12.38 4 44858 4 29529661
Maternal condition affecting foetus 19.20 12.38 4 44858 4 29529661
Liver transplant rejection 19.10 12.38 19 44843 1955 29527710
Pancreatitis 19.08 12.38 103 44759 34411 29495254
Oropharyngeal candidiasis 18.93 12.38 12 44850 641 29529024
Pilonidal cyst congenital 18.88 12.38 5 44857 23 29529642
Hyperphosphatasaemia 18.88 12.38 5 44857 23 29529642
Visual field defect 18.78 12.38 27 44835 4089 29525576
Malaria 18.68 12.38 8 44854 187 29529478
Rectal haemorrhage 18.66 12.38 15 44847 34534 29495131
International normalised ratio increased 18.58 12.38 24 44838 44348 29485317
Developmental hip dysplasia 18.58 12.38 9 44853 282 29529383
Hyperkalaemia 18.52 12.38 41 44821 61351 29468314
Chordee 18.48 12.38 6 44856 62 29529603
Pruritus 18.40 12.38 103 44759 116746 29412919
Cerebral ventricle dilatation 18.33 12.38 13 44849 837 29528828
Agitation 18.31 12.38 31 44831 51273 29478392
Borderline leprosy 18.31 12.38 4 44858 6 29529659
Hepatitis C virus test 18.31 12.38 6 44856 64 29529601
Hospitalisation 18.12 12.38 26 44836 45962 29483703
Oxygen saturation decreased 18.11 12.38 25 44837 44912 29484753
Gastrointestinal haemorrhage 18.08 12.38 61 44801 79472 29450193
Asymptomatic viral hepatitis 18.07 12.38 5 44857 28 29529637
Blood uric acid decreased 18.06 12.38 9 44853 300 29529365
Hepatitis B DNA assay positive 17.99 12.38 6 44856 68 29529597
Abdominal discomfort 17.99 12.38 28 44834 47875 29481790
Interstitial lung disease 17.86 12.38 38 44824 57680 29471985
Wrong technique in product usage process 17.79 12.38 13 44849 31415 29498250
Lower respiratory tract infection 17.74 12.38 9 44853 26493 29503172
Sickle cell disease 17.73 12.38 7 44855 132 29529533
Meconium ileus 17.64 12.38 5 44857 31 29529634
Crystal urine 17.60 12.38 6 44856 73 29529592
Renal atrophy 17.60 12.38 14 44848 1073 29528592
Loss of anatomical alignment after fracture reduction 17.59 12.38 4 44858 8 29529657
Neonatal pneumothorax 17.59 12.38 4 44858 8 29529657
Subchondral insufficiency fracture 17.59 12.38 4 44858 8 29529657
Drug dependence 17.58 12.38 5 44857 20976 29508689
Cataract 17.56 12.38 6 44856 22372 29507293
Hepatic cytolysis 17.54 12.38 39 44823 8308 29521357
Bronchitis 17.54 12.38 18 44844 36850 29492815
Heart rate increased 17.42 12.38 20 44842 38918 29490747
Pneumonia aspiration 17.40 12.38 18 44844 36719 29492946
Psoriasis 17.39 12.38 14 44848 32213 29497452
Erosive duodenitis 17.34 12.38 15 44847 1292 29528373
Diverticulitis 17.29 12.38 3 44859 17701 29511964
Creutzfeldt-Jakob disease 17.24 12.38 5 44857 34 29529631
Lymphocytic infiltration 17.24 12.38 11 44851 594 29529071
Persistent foetal circulation 17.18 12.38 9 44853 334 29529331
Bulbar palsy 17.12 12.38 8 44854 231 29529434
White blood cell count increased 17.08 12.38 19 44843 37497 29492168
Optic atrophy 17.07 12.38 12 44850 762 29528903
ADAMTS13 activity decreased 17.03 12.38 6 44856 81 29529584
Encephalitis 16.98 12.38 33 44829 6397 29523268
Retinoblastoma 16.98 12.38 4 44858 10 29529655
Acquired aminoaciduria 16.98 12.38 4 44858 10 29529655
Haematoma 16.91 12.38 7 44855 23205 29506460
Alpha 1 foetoprotein increased 16.82 12.38 11 44851 620 29529045
Delirium 16.82 12.38 21 44841 39376 29490289
Femoral neck fracture 16.80 12.38 21 44841 2782 29526883
Hepatic enzyme increased 16.79 12.38 98 44764 33701 29495964
Glucose urine present 16.76 12.38 13 44849 960 29528705
Coccidioidomycosis 16.74 12.38 11 44851 625 29529040
Fracture malunion 16.70 12.38 4 44858 11 29529654
Blood pressure decreased 16.68 12.38 27 44835 45450 29484215
Bone marrow oedema 16.61 12.38 10 44852 487 29529178
Liver transplant 16.59 12.38 19 44843 2297 29527368
Dehydration 16.56 12.38 104 44758 114644 29415021
Arthropathy 16.53 12.38 6 44856 21548 29508117
Meconium stain 16.48 12.38 3 44859 0 29529665
Atypical mycobacterial lymphadenitis 16.48 12.38 3 44859 0 29529665
Gonadal dysgenesis 16.48 12.38 3 44859 0 29529665
Life expectancy shortened 16.43 12.38 5 44857 41 29529624
Polyneuropathy chronic 16.43 12.38 5 44857 41 29529624
Melaena 16.26 12.38 14 44848 31162 29498503
Optic nerve cupping 16.22 12.38 5 44857 43 29529622
Hepatitis viral 16.21 12.38 10 44852 509 29529156
Endocardial fibroelastosis 16.20 12.38 4 44858 13 29529652
Anaphylactic reaction 16.15 12.38 11 44851 27562 29502103
Speech disorder developmental 16.00 12.38 17 44845 1890 29527775
Acute on chronic liver failure 15.93 12.38 6 44856 99 29529566
Neutrophil count decreased 15.85 12.38 26 44836 43541 29486124
Dysmorphism 15.83 12.38 21 44841 2950 29526715
Optic disc haemorrhage 15.83 12.38 5 44857 47 29529618
Anaemia megaloblastic 15.80 12.38 7 44855 178 29529487
Depressive symptom 15.65 12.38 16 44846 1701 29527964
Back pain 15.65 12.38 91 44771 102193 29427472
Hepatitis B e antigen positive 15.64 12.38 5 44857 49 29529616
Protrusion tongue 15.62 12.38 7 44855 183 29529482
Non-Hodgkin's lymphoma 15.59 12.38 15 44847 1482 29528183
COVID-19 15.58 12.38 19 44843 35995 29493670
Anal cancer stage 0 15.56 12.38 4 44858 16 29529649
Respiratory arrest 15.54 12.38 10 44852 25823 29503842
Psychiatric decompensation 15.53 12.38 15 44847 1489 29528176
Optic neuropathy 15.51 12.38 16 44846 1719 29527946
Transient ischaemic attack 15.43 12.38 8 44854 23262 29506403
Macrocephaly 15.41 12.38 9 44853 414 29529251
Infection 15.39 12.38 62 44800 76689 29452976
Micrognathia 15.19 12.38 8 44854 300 29529365
Clostridium difficile infection 15.19 12.38 3 44859 16138 29513527
Ear malformation 15.17 12.38 8 44854 301 29529364
Aggression 15.11 12.38 19 44843 35522 29494143
Sepsis 15.08 12.38 141 44721 142541 29387124
Amylase increased 15.06 12.38 28 44834 5252 29524413
Glomerulonephritis proliferative 15.04 12.38 7 44855 200 29529465
Sickle cell anaemia 15.04 12.38 7 44855 200 29529465
Dyspnoea exertional 15.01 12.38 20 44842 36470 29493195
Renal glycosuria 15.00 12.38 4 44858 19 29529646
Full blood count decreased 14.99 12.38 3 44859 15989 29513676
Sinusitis 14.99 12.38 18 44844 34332 29495333
Musculoskeletal toxicity 14.96 12.38 6 44856 118 29529547
Adrenogenital syndrome 14.96 12.38 5 44857 57 29529608
Portal fibrosis 14.88 12.38 8 44854 313 29529352
Rhinorrhoea 14.87 12.38 7 44855 21512 29508153
Drug intolerance 14.85 12.38 32 44830 48347 29481318
Urinary retention 14.69 12.38 16 44846 31882 29497783
Liver tenderness 14.69 12.38 6 44856 124 29529541
Subacute sclerosing panencephalitis 14.67 12.38 4 44858 21 29529644
Creatinine renal clearance abnormal 14.61 12.38 7 44855 214 29529451
Anogenital dysplasia 14.60 12.38 6 44856 126 29529539
Myopia 14.59 12.38 12 44850 964 29528701
Overdose 14.46 12.38 67 44795 79752 29449913
Hepatitis B DNA decreased 14.40 12.38 3 44859 3 29529662
Tracheal fistula repair 14.40 12.38 3 44859 3 29529662
Retroviral infection 14.40 12.38 3 44859 3 29529662
Osteocalcin increased 14.40 12.38 3 44859 3 29529662
Hyperphosphaturia 14.37 12.38 5 44857 65 29529600
Fluid retention 14.34 12.38 9 44853 23551 29506114
Plasmablastic lymphoma 14.31 12.38 7 44855 224 29529441
Nervous system disorder 14.25 12.38 47 44815 12627 29517038
Central pain syndrome 14.23 12.38 5 44857 67 29529598
Congenital tuberculosis 14.22 12.38 4 44858 24 29529641
Basal cell carcinoma 14.22 12.38 4 44858 16906 29512759
Erythema elevatum diutinum 14.08 12.38 4 44858 25 29529640
Pancytopenia 14.01 12.38 190 44672 82978 29446687
Red blood cell schistocytes present 14.00 12.38 7 44855 235 29529430
Erythema 13.98 12.38 63 44799 75543 29454122
Scleral discolouration 13.95 12.38 7 44855 237 29529428
Osteodystrophy 13.94 12.38 3 44859 4 29529661
Late developer 13.94 12.38 3 44859 4 29529661
Nephropathy 13.89 12.38 27 44835 5236 29524429
Neck deformity 13.84 12.38 5 44857 73 29529592
Portal hypertensive gastropathy 13.78 12.38 9 44853 506 29529159
Glucose tolerance impaired 13.75 12.38 19 44843 2775 29526890
Developmental delay 13.73 12.38 18 44844 2500 29527165
Full blood count abnormal 13.70 12.38 3 44859 15010 29514655
Cardiogenic shock 13.64 12.38 6 44856 19184 29510481
Tracheal stenosis 13.38 12.38 6 44856 157 29529508
Spermatozoa progressive motility abnormal 13.34 12.38 4 44858 31 29529634
Graft infection 13.33 12.38 8 44854 387 29529278
Sleep apnoea syndrome 13.33 12.38 5 44857 17594 29512071
Molluscum contagiosum 13.30 12.38 7 44855 262 29529403
Nasal congestion 13.27 12.38 6 44856 18873 29510792
Hypoglycaemia 13.22 12.38 34 44828 48312 29481353
Ocular icterus 13.19 12.38 18 44844 2597 29527068
Hereditary optic atrophy 13.19 12.38 3 44859 6 29529659
Benign hepatic neoplasm 13.19 12.38 3 44859 6 29529659
Congenital pigmentation disorder 13.19 12.38 3 44859 6 29529659
Intentional overdose 13.10 12.38 24 44838 38504 29491161
Genital herpes 13.08 12.38 9 44853 552 29529113
Memory impairment 13.05 12.38 22 44840 36448 29493217
Musculoskeletal stiffness 13.03 12.38 23 44839 37435 29492230
Hepatic steatosis 13.03 12.38 51 44811 14895 29514770
C-reactive protein increased 12.99 12.38 30 44832 44233 29485432
Mobility decreased 12.94 12.38 12 44850 25768 29503897
Diabetes mellitus 12.92 12.38 104 44758 39727 29489938
Headache 12.92 12.38 186 44676 173821 29355844
Congenital hydrocephalus 12.88 12.38 5 44857 90 29529575
Birth trauma 12.88 12.38 3 44859 7 29529658
Total lung capacity decreased 12.86 12.38 9 44853 567 29529098
Body fat disorder 12.82 12.38 4 44858 36 29529629
Ergot poisoning 12.82 12.38 4 44858 36 29529629
Vision blurred 12.81 12.38 26 44836 40150 29489515
Stomatitis 12.72 12.38 23 44839 37090 29492575
Tracheo-oesophageal fistula 12.71 12.38 8 44854 422 29529243
Skin candida 12.67 12.38 8 44854 424 29529241
HIV associated nephropathy 12.63 12.38 7 44855 291 29529374
CD4 lymphocytes abnormal 12.62 12.38 4 44858 38 29529627
Pain in extremity 12.60 12.38 107 44755 110326 29419339
Congenital anaemia 12.59 12.38 3 44859 8 29529657
Extensor plantar response 12.59 12.38 9 44853 587 29529078
Diarrhoea 12.53 12.38 397 44465 332301 29197364
Congenital hearing disorder 12.53 12.38 5 44857 97 29529568
Asthma 12.50 12.38 20 44842 33829 29495836
Blood lactate dehydrogenase increased 12.49 12.38 60 44802 19149 29510516
Gout 12.48 12.38 5 44857 16906 29512759
Viral infection 12.48 12.38 50 44812 14760 29514905
Lymphoma 12.47 12.38 38 44824 9790 29519875
Choroiditis 12.43 12.38 11 44851 977 29528688
Blood pressure systolic increased 12.40 12.38 5 44857 16840 29512825

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Immune reconstitution inflammatory syndrome 2252.33 12.57 706 55793 11764 64430469
Viral mutation identified 2141.85 12.57 513 55986 2833 64439400
Virologic failure 2108.47 12.57 510 55989 2956 64439277
Drug resistance 1617.16 12.57 730 55769 34372 64407861
Pathogen resistance 1607.97 12.57 548 55951 11995 64430238
Exposure during pregnancy 1112.51 12.57 746 55753 76929 64365304
Lipodystrophy acquired 1023.93 12.57 297 56202 3730 64438503
Abortion spontaneous 961.70 12.57 460 56039 24683 64417550
Stillbirth 788.24 12.57 237 56262 3396 64438837
Blood HIV RNA increased 738.80 12.57 186 56313 1298 64440935
Hepatitis B 713.63 12.57 265 56234 7480 64434753
Mitochondrial toxicity 636.87 12.57 188 56311 2518 64439715
Hepatitis B reactivation 573.37 12.57 200 56299 4689 64437544
Abortion induced 539.16 12.57 205 56294 6183 64436050
Drug interaction 484.82 12.57 1013 55486 361070 64081163
Fanconi syndrome acquired 482.64 12.57 148 56351 2273 64439960
Hepatitis B DNA increased 473.10 12.57 110 56389 520 64441713
Acquired gene mutation 471.83 12.57 139 56360 1847 64440386
Osteomalacia 409.28 12.57 115 56384 1276 64440957
Eyelid ptosis 286.12 12.57 148 56351 9377 64432856
Viral load increased 281.09 12.57 99 56400 2388 64439845
Hypophosphataemia 268.71 12.57 165 56334 14555 64427678
Foetal exposure during pregnancy 267.47 12.57 112 56387 4364 64437869
Progressive external ophthalmoplegia 263.98 12.57 81 56418 1246 64440987
Hepatic failure 258.01 12.57 279 56220 55115 64387118
Lipoatrophy 248.80 12.57 66 56433 579 64441654
CD4 lymphocytes decreased 245.27 12.57 89 56410 2346 64439887
Fanconi syndrome 242.95 12.57 89 56410 2412 64439821
Depression 242.24 12.57 511 55988 182780 64259453
Pregnancy 223.15 12.57 168 56331 20697 64421536
Treatment noncompliance 216.61 12.57 227 56272 43255 64398978
Blood bilirubin increased 209.14 12.57 255 56244 57298 64384935
Nephropathy toxic 207.51 12.57 150 56349 17364 64424869
Live birth 197.91 12.57 123 56376 11081 64431152
Meningitis cryptococcal 192.31 12.57 79 56420 2930 64439303
Portal hypertension 187.84 12.57 97 56402 6122 64436111
CSF HIV escape syndrome 183.14 12.57 45 56454 280 64441953
Hepatic fibrosis 174.64 12.57 89 56410 5463 64436770
Hepatotoxicity 173.43 12.57 194 56305 39768 64402465
Fall 172.17 12.57 75 56424 416751 64025482
Renal tubular disorder 171.15 12.57 90 56409 5897 64436336
Multiple-drug resistance 169.72 12.57 92 56407 6410 64435823
Pain 157.53 12.57 152 56347 553359 63888874
Hypertriglyceridaemia 156.12 12.57 106 56393 11099 64431134
Kaposi's sarcoma 154.44 12.57 47 56452 702 64441531
Caesarean section 153.16 12.57 105 56394 11169 64431064
Alanine aminotransferase increased 152.47 12.57 360 56139 138671 64303562
Diplopia 151.98 12.57 150 56349 26615 64415618
Completed suicide 148.57 12.57 13 56486 224401 64217832
Jaundice 147.87 12.57 197 56302 48315 64393918
Proteinuria 147.54 12.57 150 56349 27573 64414660
Pulmonary tuberculosis 147.18 12.57 87 56412 7157 64435076
Peripheral swelling 144.40 12.57 10 56489 209143 64233090
Mitochondrial cytopathy 136.42 12.57 37 56462 356 64441877
Maternal exposure during pregnancy 135.48 12.57 275 56224 95609 64346624
Maternal drugs affecting foetus 133.11 12.57 51 56448 1569 64440664
Retinal toxicity 131.67 12.57 48 56451 1282 64440951
Genotype drug resistance test positive 131.25 12.57 45 56454 999 64441234
Joint swelling 131.02 12.57 17 56482 215365 64226868
Glycosuria 131.01 12.57 54 56445 2020 64440213
Hypomania 128.40 12.57 73 56426 5581 64436652
Lymphadenopathy 126.33 12.57 179 56320 46507 64395726
Hyperbilirubinaemia 126.30 12.57 122 56377 21083 64421150
Off label use 125.61 12.57 227 56272 632579 63809654
Renal tubular dysfunction 123.58 12.57 39 56460 661 64441572
Foetal death 122.53 12.57 72 56427 5858 64436375
Tuberculosis 117.73 12.57 95 56404 12943 64429290
Hepatitis C 114.02 12.57 87 56412 10928 64431305
Lactic acidosis 114.00 12.57 198 56301 61212 64381021
Hyperlactacidaemia 113.94 12.57 64 56435 4780 64437453
Rheumatoid arthritis 112.96 12.57 8 56491 164286 64277947
Mycobacterium avium complex infection 111.97 12.57 59 56440 3881 64438352
Aspartate aminotransferase increased 111.07 12.57 291 56208 119497 64322736
Fatigue 110.89 12.57 315 56184 748415 63693818
Gene mutation 110.82 12.57 48 56451 2034 64440199
Product dose omission issue 110.10 12.57 19 56480 194728 64247505
Nasopharyngitis 108.95 12.57 20 56479 196053 64246180
Hepatic cirrhosis 107.85 12.57 124 56375 26174 64416059
Infusion related reaction 107.55 12.57 10 56489 164457 64277776
HIV-associated neurocognitive disorder 105.29 12.57 29 56470 297 64441936
Jaundice cholestatic 104.39 12.57 75 56424 8595 64433638
Hepatomegaly 98.42 12.57 96 56403 16786 64425447
Immune reconstitution inflammatory syndrome associated tuberculosis 95.94 12.57 33 56466 740 64441493
Hypouricaemia 94.34 12.57 28 56471 382 64441851
Dyslipidaemia 93.48 12.57 72 56427 9170 64433063
Drug-induced liver injury 92.87 12.57 157 56342 47486 64394747
Premature rupture of membranes 92.25 12.57 51 56448 3693 64438540
Anaemia 92.17 12.57 607 55892 378073 64064160
Schizophrenia 91.69 12.57 77 56422 11091 64431142
Pinealoblastoma 89.26 12.57 19 56480 54 64442179
Premature labour 87.38 12.57 64 56435 7556 64434677
Hepatic function abnormal 86.73 12.57 181 56318 64132 64378101
Dyspnoea 85.90 12.57 332 56167 718342 63723891
Arthropathy 85.79 12.57 5 56494 120962 64321271
Urine phosphorus increased 85.51 12.57 19 56480 70 64442163
Osteoporosis 85.12 12.57 141 56358 41939 64400294
Osteonecrosis 85.02 12.57 114 56385 28115 64414118
Hepatocellular carcinoma 83.98 12.57 65 56434 8338 64433895
Psychotic disorder 81.14 12.57 124 56375 34454 64407779
Hepatitis 80.74 12.57 144 56355 45438 64396795
Renal impairment 80.68 12.57 281 56218 134736 64307497
Pre-eclampsia 79.86 12.57 56 56443 6175 64436058
Stevens-Johnson syndrome 79.22 12.57 122 56377 34127 64408106
Blood alkaline phosphatase increased 78.95 12.57 161 56338 56118 64386115
Constipation 78.81 12.57 52 56447 229285 64212948
Fat tissue increased 78.19 12.57 29 56470 814 64441419
Gamma-glutamyltransferase increased 75.56 12.57 145 56354 48365 64393868
Injection site pain 74.93 12.57 6 56493 111402 64330831
Blood phosphorus decreased 74.82 12.57 52 56447 5653 64436580
Synovitis 73.77 12.57 3 56496 99087 64343146
Abdominal discomfort 73.25 12.57 34 56465 182288 64259945
Blood bilirubin unconjugated increased 72.25 12.57 28 56471 889 64441344
Cytomegalovirus chorioretinitis 72.09 12.57 48 56451 4864 64437369
Blood lactic acid increased 71.86 12.57 65 56434 10336 64431897
Sinusitis 70.83 12.57 20 56479 145908 64296325
Hepatosplenomegaly 70.77 12.57 49 56450 5294 64436939
Retinoblastoma 68.40 12.57 16 56483 78 64442155
Ergot poisoning 66.73 12.57 17 56482 125 64442108
Varices oesophageal 65.50 12.57 46 56453 5084 64437149
Hypotension 64.88 12.57 149 56350 380825 64061408
Drug ineffective 64.86 12.57 451 56048 839796 63602437
Normal newborn 64.00 12.57 47 56452 5570 64436663
Blood pressure increased 63.62 12.57 36 56463 172516 64269717
Cachexia 62.50 12.57 57 56442 9160 64433073
Contusion 62.48 12.57 12 56487 113953 64328280
Ophthalmoplegia 61.66 12.57 35 56464 2667 64439566
Cryptococcosis 61.03 12.57 35 56464 2720 64439513
Hepatic encephalopathy 60.29 12.57 83 56416 20983 64421250
Calculus urinary 59.07 12.57 30 56469 1827 64440406
Acquired immunodeficiency syndrome 59.05 12.57 17 56482 207 64442026
Drug intolerance 58.87 12.57 47 56452 187945 64254288
Ascites 58.83 12.57 152 56347 61849 64380384
Lipohypertrophy 58.22 12.57 23 56476 769 64441464
Premature baby 57.98 12.57 36 56463 3236 64438997
Pneumocystis jirovecii pneumonia 57.78 12.57 94 56405 27540 64414693
Hyperlipidaemia 57.62 12.57 85 56414 22891 64419342
Therapeutic product effect decreased 57.50 12.57 15 56484 115336 64326897
HIV infection 56.75 12.57 24 56475 958 64441275
Feeling abnormal 56.69 12.57 23 56476 133579 64308654
Death 56.24 12.57 225 56274 482480 63959753
Systemic lupus erythematosus 55.66 12.57 3 56496 77609 64364624
Amniotic cavity infection 55.23 12.57 22 56477 752 64441481
Blood triglycerides increased 55.00 12.57 75 56424 18791 64423442
Alopecia 54.99 12.57 39 56460 165651 64276582
Splenomegaly 54.79 12.57 73 56426 17888 64424345
Drug abuse 54.23 12.57 24 56475 132350 64309883
Cushing's syndrome 54.16 12.57 23 56476 928 64441305
Lymph node tuberculosis 54.04 12.57 23 56476 933 64441300
Hepatitis A 53.90 12.57 22 56477 802 64441431
Cerebral toxoplasmosis 53.76 12.57 28 56471 1798 64440435
Facial wasting 53.31 12.57 13 56486 78 64442155
Cholelithiasis 53.28 12.57 121 56378 45385 64396848
Progressive multifocal leukoencephalopathy 50.92 12.57 71 56428 18161 64424072
Renal tubular acidosis 50.83 12.57 32 56467 2947 64439286
Transaminases increased 50.47 12.57 117 56382 44477 64397756
Urinary tract infection 50.45 12.57 78 56421 231518 64210715
Swelling 50.23 12.57 40 56459 160178 64282055
Injection site erythema 49.96 12.57 3 56496 70797 64371436
Premature delivery 49.86 12.57 71 56428 18518 64423715
Hypophosphataemic osteomalacia 49.85 12.57 16 56483 287 64441946
Mitochondrial DNA deletion 49.78 12.57 9 56490 6 64442227
Nodular regenerative hyperplasia 49.41 12.57 21 56478 849 64441384
Wound 49.05 12.57 5 56494 76472 64365761
Nephrolithiasis 48.77 12.57 114 56385 43569 64398664
Pyrexia 47.87 12.57 720 55779 557924 63884309
Alpha 1 foetoprotein abnormal 47.65 12.57 11 56488 50 64442183
Oesophageal varices haemorrhage 47.41 12.57 33 56466 3596 64438637
Oligohydramnios 46.99 12.57 31 56468 3093 64439140
Malignant neoplasm progression 46.97 12.57 20 56479 112851 64329382
Hepatic cancer 46.52 12.57 44 56455 7404 64434829
Blood creatinine increased 46.15 12.57 238 56261 135544 64306689
Ectopic pregnancy 46.09 12.57 24 56475 1540 64440693
Oesophageal candidiasis 45.62 12.57 45 56454 7972 64434261
Arthritis 45.57 12.57 9 56490 83805 64358428
Arthralgia 45.48 12.57 216 56283 442044 64000189
Rickets 45.25 12.57 11 56488 65 64442168
Aminoaciduria 45.17 12.57 14 56485 223 64442010
Hepatitis B surface antigen positive 44.73 12.57 13 56486 164 64442069
Pancreatitis 44.57 12.57 134 56365 59473 64382760
Meningitis tuberculous 44.48 12.57 21 56478 1090 64441143
Weight increased 44.44 12.57 74 56425 213274 64228959
Basedow's disease 44.21 12.57 14 56485 240 64441993
HIV viraemia 44.15 12.57 11 56488 73 64442160
Premature separation of placenta 43.90 12.57 21 56478 1123 64441110
Toxicity to various agents 43.85 12.57 167 56332 363346 64078887
Loss of personal independence in daily activities 43.42 12.57 151 56348 72303 64369930
Wheezing 43.08 12.57 9 56490 80570 64361663
Placental insufficiency 43.06 12.57 20 56479 1000 64441233
Atrial fibrillation 42.91 12.57 52 56447 171037 64271196
Placental disorder 42.87 12.57 19 56480 851 64441382
Pain in extremity 42.83 12.57 130 56369 302955 64139278
CD4 lymphocytes increased 42.82 12.57 14 56485 267 64441966
Renal failure 42.71 12.57 289 56210 181399 64260834
Influenza 42.56 12.57 20 56479 106511 64335722
Rash maculo-papular 42.27 12.57 113 56386 46913 64395320
Ocular icterus 41.54 12.57 35 56464 5063 64437170
Umbilical cord abnormality 41.18 12.57 12 56487 153 64442080
Product use issue 40.33 12.57 44 56455 151671 64290562
Headache 40.30 12.57 285 56214 529182 63913051
Acquired aminoaciduria 40.25 12.57 8 56491 14 64442219
Hepatitis B virus test 39.79 12.57 7 56492 3 64442230
Anaemia macrocytic 39.60 12.57 32 56467 4366 64437867
Hepatitis cholestatic 39.55 12.57 51 56448 12104 64430129
Mycobacterium avium complex immune restoration disease 38.92 12.57 8 56491 18 64442215
Malaria 38.86 12.57 14 56485 361 64441872
Oxygen saturation decreased 38.58 12.57 23 56476 107153 64335080
Granulomatous rosacea 38.38 12.57 12 56487 197 64442036
Oropharyngeal pain 38.18 12.57 15 56484 88852 64353381
Hepatic cytolysis 38.18 12.57 54 56445 13995 64428238
Urine calcium increased 37.87 12.57 10 56489 86 64442147
Inappropriate schedule of product administration 37.37 12.57 17 56482 92269 64349964
Pruritus 37.35 12.57 144 56355 312256 64129977
Optic nerve neoplasm 37.26 12.57 8 56491 24 64442209
Tuberculoma of central nervous system 36.95 12.57 15 56484 539 64441694
Intentional product misuse 36.79 12.57 9 56490 72286 64369947
Opportunistic infection 36.64 12.57 25 56474 2637 64439596
Withdrawal hepatitis 36.25 12.57 6 56493 0 64442233
Mitochondrial DNA depletion 36.25 12.57 6 56493 0 64442233
Impaired healing 36.19 12.57 5 56494 60468 64381765
Stomatitis 36.09 12.57 26 56473 109579 64332654
Gynaecomastia 34.67 12.57 34 56465 5982 64436251
Mitochondrial myopathy 34.56 12.57 12 56487 277 64441956
Oral candidiasis 34.45 12.57 68 56431 23144 64419089
Drug hypersensitivity 34.30 12.57 101 56398 237714 64204519
Heart rate decreased 34.30 12.57 4 56495 55063 64387170
Mycobacterial infection 34.04 12.57 25 56474 2963 64439270
Dizziness 33.96 12.57 229 56270 429934 64012299
Hepatitis B DNA assay positive 33.92 12.57 9 56490 79 64442154
Pancytopenia 33.69 12.57 228 56271 143081 64299152
Acute hepatitis C 33.68 12.57 11 56488 209 64442024
Nasal congestion 33.29 12.57 6 56493 59652 64382581
Muscle spasms 33.14 12.57 45 56454 140978 64301255
Hypercholesterolaemia 33.10 12.57 53 56446 15320 64426913
Lower respiratory tract infection 33.08 12.57 21 56478 94593 64347640
Anxiety 33.04 12.57 81 56418 202568 64239665
Hyperphosphaturia 32.78 12.57 9 56490 91 64442142
Malaise 32.76 12.57 208 56291 396039 64046194
Psoriasis 32.67 12.57 11 56488 71692 64370541
HIV test positive 32.43 12.57 9 56490 95 64442138
Viraemia 32.19 12.57 22 56477 2327 64439906
Treatment failure 31.86 12.57 193 56306 116623 64325610
Pregnancy on contraceptive 31.82 12.57 15 56484 776 64441457
Bronchitis 31.81 12.57 29 56470 108714 64333519
Liver disorder 31.79 12.57 111 56388 53240 64388993
Disseminated tuberculosis 31.72 12.57 26 56473 3619 64438614
Toxoplasmosis 31.40 12.57 22 56477 2422 64439811
Back pain 31.40 12.57 113 56386 250058 64192175
Diabetes mellitus 31.09 12.57 128 56371 66346 64375887
Strongyloidiasis 31.09 12.57 24 56475 3066 64439167
Blood phosphorus abnormal 30.89 12.57 11 56488 274 64441959
Asthma 30.82 12.57 23 56476 95202 64347031
Hepatic enzyme increased 30.70 12.57 207 56292 129736 64312497
Renal glycosuria 30.66 12.57 7 56492 30 64442203
White matter lesion 30.65 12.57 19 56480 1703 64440530
Anaphylactic reaction 30.48 12.57 11 56488 68653 64373580
Vanishing bile duct syndrome 30.38 12.57 17 56482 1260 64440973
Bilirubin conjugated increased 30.36 12.57 29 56470 4939 64437294
Neutropenia neonatal 30.29 12.57 7 56492 32 64442201
Cardio-respiratory arrest 30.28 12.57 25 56474 98368 64343865
Benign hydatidiform mole 30.28 12.57 8 56491 69 64442164
Cerebrovascular accident 30.26 12.57 46 56453 137537 64304696
Retroviral rebound syndrome 30.01 12.57 6 56493 11 64442222
Stress 29.91 12.57 8 56491 60526 64381707
Bone metabolism disorder 29.89 12.57 12 56487 419 64441814
Hyperphosphatasaemia 29.68 12.57 8 56491 75 64442158
Bone density decreased 29.67 12.57 40 56459 9912 64432321
Blood pressure fluctuation 29.42 12.57 5 56494 51866 64390367
Night blindness 29.26 12.57 12 56487 443 64441790
Somnolence 28.99 12.57 87 56412 203558 64238675
AIDS cholangiopathy 28.74 12.57 6 56493 15 64442218
HIV lipodystrophy 28.74 12.57 6 56493 15 64442218
Infection 28.52 12.57 76 56423 184804 64257429
Cardiac failure congestive 28.39 12.57 44 56455 130536 64311697
Musculoskeletal stiffness 28.26 12.57 40 56459 123166 64319067
Congenital anomaly 28.16 12.57 10 56489 247 64441986
Respiratory arrest 28.15 12.57 6 56493 52979 64389254
Confusional state 27.71 12.57 126 56373 261018 64181215
Rhinorrhoea 27.67 12.57 9 56490 59960 64382273
Amoebiasis 27.38 12.57 8 56491 103 64442130
Psoriatic arthropathy 27.31 12.57 3 56496 43278 64398955
Tuberculoid leprosy 27.31 12.57 8 56491 104 64442129
Cardiac arrest 27.19 12.57 59 56440 154005 64288228
Liver transplant 27.15 12.57 25 56474 4067 64438166
Thrombosis 27.10 12.57 14 56485 70628 64371605
Placental infarction 26.83 12.57 8 56491 111 64442122
Tremor 26.80 12.57 56 56443 148174 64294059
Flushing 26.76 12.57 18 56481 78630 64363603
Encephalitis 26.60 12.57 43 56456 12528 64429705
Hepatic steatosis 26.35 12.57 73 56426 30934 64411299
Unevaluable event 26.25 12.57 6 56493 50483 64391750
Migraine 26.24 12.57 11 56488 62666 64379567
HIV wasting syndrome 26.23 12.57 7 56492 63 64442170
Diarrhoea 26.11 12.57 461 56038 722243 63719990
Chronic obstructive pulmonary disease 25.91 12.57 15 56484 71033 64371200
Chronic kidney disease 25.89 12.57 110 56389 57809 64384424
Atypical mycobacterial lymphadenitis 25.83 12.57 5 56494 7 64442226
Beta 2 microglobulin urine increased 25.78 12.57 8 56491 128 64442105
Blister 25.63 12.57 20 56479 80947 64361286
Anogenital warts 25.49 12.57 13 56486 799 64441434
Epistaxis 25.48 12.57 29 56470 98102 64344131
Borderline leprosy 25.44 12.57 5 56494 8 64442225
Erythema 25.16 12.57 82 56417 186988 64255245
Rhabdomyosarcoma 24.95 12.57 8 56491 143 64442090
Blood uric acid increased 24.62 12.57 33 56466 8130 64434103
Hospitalisation 24.55 12.57 18 56481 75189 64367044
Hepatitis D 24.46 12.57 6 56493 37 64442196
Syncope 24.16 12.57 65 56434 157570 64284663
Glucose urine present 24.08 12.57 16 56483 1616 64440617
Intentional overdose 23.99 12.57 26 56473 89918 64352315
Cellulitis 23.97 12.57 28 56471 93629 64348604
Metabolic acidosis 23.83 12.57 124 56375 70834 64371399
Lymphocytic infiltration 23.75 12.57 15 56484 1389 64440844
Herpes simplex 23.61 12.57 37 56462 10499 64431734
Cholestatic liver injury 23.48 12.57 22 56477 3657 64438576
Chronic disease 23.48 12.57 7 56492 97 64442136
Liver transplant rejection 23.23 12.57 20 56479 2979 64439254
Urine phosphorus decreased 23.11 12.57 6 56493 48 64442185
Astrocytoma, low grade 23.11 12.57 6 56493 48 64442185
Hepatitis fulminant 23.09 12.57 28 56471 6246 64435987
Parotid gland enlargement 23.06 12.57 12 56487 769 64441464
Central nervous system lesion 23.01 12.57 39 56460 11810 64430423
Primary syphilis 22.81 12.57 5 56494 17 64442216
Bradycardia 22.80 12.57 43 56456 118176 64324057
Dermatitis exfoliative 22.71 12.57 36 56463 10316 64431917
Tubulointerstitial nephritis 22.64 12.57 69 56430 30840 64411393
Fluid retention 22.58 12.57 12 56487 59594 64382639
Taeniasis 22.58 12.57 6 56493 53 64442180
Molluscum contagiosum 22.56 12.57 10 56489 448 64441785
Hepatitis E 22.55 12.57 18 56481 2413 64439820
Isosporiasis 22.55 12.57 7 56492 112 64442121
Intracranial pressure increased 22.23 12.57 29 56470 6960 64435273
Osteoporotic fracture 21.98 12.57 21 56478 3577 64438656
Burning sensation 21.97 12.57 8 56491 49656 64392577
Blood bicarbonate decreased 21.89 12.57 24 56475 4805 64437428
Pericarditis 21.68 12.57 14 56485 62502 64379731
Viral load decreased 21.61 12.57 5 56494 23 64442210
Blood creatine phosphokinase increased 21.54 12.57 105 56394 58453 64383780
Cryoglobulinaemia 21.52 12.57 11 56488 679 64441554
Erosive duodenitis 21.32 12.57 15 56484 1663 64440570
Diverticulitis 21.30 12.57 4 56495 38614 64403619
Placenta praevia 21.28 12.57 11 56488 695 64441538
Anaemia neonatal 21.27 12.57 5 56494 25 64442208
Haematoma 21.23 12.57 7 56492 46243 64395990
Hot flush 21.22 12.57 7 56492 46228 64396005
Hyperhidrosis 21.09 12.57 49 56450 124871 64317362
Nephropathy 20.99 12.57 31 56468 8355 64433878
Anembryonic gestation 20.76 12.57 9 56490 382 64441851
Gestational diabetes 20.66 12.57 25 56474 5565 64436668
Swollen tongue 20.66 12.57 3 56496 34951 64407282
Hyponatraemia 20.66 12.57 64 56435 148275 64293958
Breech delivery 20.65 12.57 5 56494 29 64442204
Bulbar palsy 20.64 12.57 8 56491 254 64441979
Non-Hodgkin's lymphoma 20.60 12.57 14 56485 1467 64440766
Chest pain 20.44 12.57 122 56377 235858 64206375
Haematochezia 20.25 12.57 17 56482 66356 64375877
Retroviral infection 20.12 12.57 4 56495 7 64442226
Hypoglycaemia 19.81 12.57 30 56469 89862 64352371
Type III hyperlipidaemia 19.78 12.57 4 56495 8 64442225
Loss of anatomical alignment after fracture reduction 19.78 12.57 4 56495 8 64442225
Pneumonia aspiration 19.58 12.57 14 56485 59257 64382976
HIV associated nephropathy 19.56 12.57 8 56491 293 64441940
Cough 19.49 12.57 170 56329 301978 64140255
Memory impairment 19.47 12.57 28 56471 85654 64356579
Dehydration 19.34 12.57 111 56388 216652 64225581
Antimitochondrial antibody positive 19.27 12.57 6 56493 97 64442136
Lymphadenitis 19.26 12.57 20 56479 3765 64438468
Neuromyopathy 19.19 12.57 13 56486 1355 64440878
Helicobacter infection 19.09 12.57 5 56494 38357 64403876
Fibromyalgia 19.08 12.57 4 56495 35727 64406506
Histoplasmosis disseminated 18.98 12.57 15 56484 1983 64440250
Ballismus 18.92 12.57 7 56492 195 64442038
Disseminated Bacillus Calmette-Guerin infection 18.92 12.57 7 56492 195 64442038
Pneumonia 18.90 12.57 361 56138 559215 63883018
Urticaria 18.83 12.57 66 56433 147251 64294982
Discomfort 18.80 12.57 26 56473 80852 64361381
Hepatitis viral 18.73 12.57 11 56488 894 64441339
Cystitis 18.66 12.57 7 56492 42668 64399565
Abortion missed 18.53 12.57 12 56487 1160 64441073
Portal hypertensive gastropathy 18.53 12.57 12 56487 1160 64441073
Postpartum haemorrhage 18.53 12.57 13 56486 1434 64440799
Neck pain 18.48 12.57 16 56483 61517 64380716
Chest discomfort 18.45 12.57 47 56452 116059 64326174
Disease progression 18.43 12.57 63 56436 141617 64300616
Central nervous system immune reconstitution inflammatory response 18.35 12.57 5 56494 49 64442184
Lip swelling 18.26 12.57 3 56496 31904 64410329
Optic nerve cupping 18.17 12.57 5 56494 51 64442182
Blood lactate dehydrogenase increased 18.15 12.57 67 56432 33011 64409222
AIDS related complex 18.12 12.57 3 56496 0 64442233
Vertical infection transmission 18.12 12.57 3 56496 0 64442233
Prenatal screening test abnormal 18.12 12.57 3 56496 0 64442233
Alpha 1 foetoprotein increased 18.01 12.57 10 56489 730 64441503
Incorrect dose administered 18.01 12.57 16 56483 60749 64381484
Oropharyngeal candidiasis 17.99 12.57 13 56486 1502 64440731
Pubertal failure 17.95 12.57 4 56495 15 64442218
Erythema elevatum diutinum 17.95 12.57 4 56495 15 64442218
Trisomy 21 17.91 12.57 5 56494 54 64442179
Ultrasound scan abnormal 17.89 12.57 7 56492 228 64442005
Bacterial pyelonephritis 17.85 12.57 9 56490 540 64441693
CD4 lymphocytes 17.74 12.57 4 56495 16 64442217
Product use in unapproved indication 17.67 12.57 87 56412 176531 64265702
AIDS related complication 17.67 12.57 5 56494 57 64442176
Amylase increased 17.66 12.57 31 56468 9654 64432579
Balance disorder 17.56 12.57 29 56470 83897 64358336
Injury 17.51 12.57 14 56485 55978 64386255
Clostridium difficile infection 17.45 12.57 5 56494 36158 64406075
Nervous system disorder 17.35 12.57 52 56447 23026 64419207
Plasmodium falciparum infection 17.21 12.57 5 56494 63 64442170
Plasmablastic lymphoma 17.21 12.57 8 56491 401 64441832
Post inflammatory pigmentation change 17.13 12.57 8 56491 405 64441828
Paraparesis 16.92 12.57 18 56481 3484 64438749
Renal atrophy 16.91 12.57 13 56486 1651 64440582
International normalised ratio increased 16.90 12.57 27 56472 79140 64363093
Acute lymphocytic leukaemia 16.89 12.57 20 56479 4351 64437882
Choroiditis 16.87 12.57 11 56488 1076 64441157
Orthostatic hypotension 16.85 12.57 10 56489 46728 64395505
Anal cancer stage 0 16.85 12.57 4 56495 21 64442212
Vomiting 16.81 12.57 615 55884 550502 63891731
Gestational hypertension 16.79 12.57 13 56486 1668 64440565
Hypersplenism 16.70 12.57 8 56491 429 64441804
Blood uric acid decreased 16.70 12.57 11 56488 1095 64441138
Small for dates baby 16.67 12.57 8 56491 431 64441802
ADAMTS13 activity decreased 16.65 12.57 6 56493 155 64442078
Benign hepatic neoplasm 16.47 12.57 5 56494 74 64442159
Intentional product use issue 16.42 12.57 37 56462 95327 64346906
Albuminuria 16.39 12.57 9 56490 643 64441590
Drug reaction with eosinophilia and systemic symptoms 16.34 12.57 92 56407 54125 64388108
Rectal haemorrhage 16.34 12.57 18 56481 61799 64380434
Portal vein thrombosis 16.33 12.57 21 56478 4970 64437263
Red blood cells urine 16.32 12.57 9 56490 648 64441585
Influenza like illness 16.27 12.57 18 56481 61684 64380549
Neurosyphilis 16.26 12.57 4 56495 25 64442208
Musculoskeletal toxicity 16.26 12.57 6 56493 166 64442067
Psychiatric decompensation 16.25 12.57 15 56484 2448 64439785
Visual field defect 16.07 12.57 27 56472 8119 64434114
Paraesthesia 16.05 12.57 62 56437 134460 64307773
Kwashiorkor 16.05 12.57 3 56496 3 64442230
Funisitis 16.05 12.57 3 56496 3 64442230
Hepatitis B DNA decreased 16.05 12.57 3 56496 3 64442230
Cervix operation 16.05 12.57 3 56496 3 64442230
Wrong technique in product usage process 16.01 12.57 20 56479 64954 64377279
Bone pain 15.88 12.57 83 56416 47489 64394744
Eclampsia 15.74 12.57 6 56493 182 64442051
Dry skin 15.74 12.57 13 56486 51148 64391085
Ultrasound antenatal screen abnormal 15.63 12.57 4 56495 30 64442203
Viral hepatitis carrier 15.52 12.57 4 56495 31 64442202
Spermatozoa progressive motility abnormal 15.52 12.57 4 56495 31 64442202
Genital herpes 15.42 12.57 13 56486 1882 64440351
Drug dependence 15.37 12.57 5 56494 33307 64408926
Acute hepatic failure 15.27 12.57 54 56445 26058 64416175
Insomnia 15.23 12.57 106 56393 197730 64244503
Blood pressure decreased 15.21 12.57 33 56466 86166 64356067
Cardiac failure 15.17 12.57 62 56437 132311 64309922
Ileal ulcer 15.15 12.57 10 56489 998 64441235
Carnitine deficiency 15.12 12.57 6 56493 203 64442030
Osteoarthritis 15.09 12.57 20 56479 63316 64378917
Product prescribing error 15.07 12.57 6 56493 35263 64406970
Hyperphosphataemia 15.03 12.57 18 56481 3963 64438270
Ovarian failure 15.03 12.57 8 56491 537 64441696
Atypical mycobacterial infection 15.03 12.57 11 56488 1297 64440936
Portal vein occlusion 14.99 12.57 4 56495 36 64442197
Brain oedema 14.99 12.57 48 56451 22027 64420206
Dyspnoea exertional 14.94 12.57 26 56473 73704 64368529
Secondary adrenocortical insufficiency 14.92 12.57 14 56485 2331 64439902
Developmental delay 14.90 12.57 10 56489 1027 64441206
Subacute sclerosing panencephalitis 14.89 12.57 4 56495 37 64442196
Anogenital dysplasia 14.89 12.57 5 56494 104 64442129
Therapeutic product effect incomplete 14.86 12.57 44 56455 103438 64338795
Infected vasculitis 14.83 12.57 3 56496 6 64442227
Carbon dioxide combining power abnormal 14.83 12.57 3 56496 6 64442227
Glycocholic acid increased 14.83 12.57 3 56496 6 64442227
Acute fatty liver of pregnancy 14.79 12.57 4 56495 38 64442195
Heart rate irregular 14.78 12.57 3 56496 27410 64414823
Eyelid oedema 14.76 12.57 33 56466 12246 64429987
Glomerulonephritis proliferative 14.74 12.57 7 56492 368 64441865
Hepatitis B surface antibody positive 14.69 12.57 6 56493 219 64442014
Death neonatal 14.61 12.57 4 56495 40 64442193
Blood glucose increased 14.60 12.57 41 56458 98032 64344201
Limb discomfort 14.60 12.57 3 56496 27172 64415061
Gastrointestinal haemorrhage 14.52 12.57 63 56436 132249 64309984
Antiviral drug level below therapeutic 14.52 12.57 4 56495 41 64442192
Portal fibrosis 14.43 12.57 8 56491 582 64441651
Fat redistribution 14.38 12.57 5 56494 116 64442117
Lipase increased 14.37 12.57 36 56463 14366 64427867
CSF protein increased 14.32 12.57 10 56489 1095 64441138
Pleocytosis 14.30 12.57 10 56489 1097 64441136
Acute stress disorder 14.26 12.57 7 56492 396 64441837
Crystal urine 14.26 12.57 5 56494 119 64442114
Osteocalcin increased 14.23 12.57 3 56496 8 64442225
Visual impairment 14.23 12.57 27 56472 74050 64368183
Cytomegalovirus oesophagitis 14.18 12.57 8 56491 602 64441631
Myopia 14.18 12.57 12 56487 1746 64440487
Heart rate increased 14.14 12.57 42 56457 98633 64343600
Burkitt's lymphoma 14.14 12.57 5 56494 122 64442111
Breast cancer 14.12 12.57 4 56495 29144 64413089
Cholestasis 14.10 12.57 77 56422 44795 64397438
Hypervolaemia 14.08 12.57 8 56491 38277 64403956
Emotional distress 14.03 12.57 7 56492 36031 64406202
Hepatic necrosis 14.02 12.57 26 56473 8447 64433786
Bone marrow oedema 13.96 12.57 10 56489 1140 64441093
Antiviral drug level above therapeutic 13.95 12.57 4 56495 48 64442185
Graft infection 13.93 12.57 8 56491 623 64441610
Acute hepatitis B 13.90 12.57 7 56492 419 64441814
Red blood cell sedimentation rate increased 13.87 12.57 5 56494 31230 64411003
Genital ulceration 13.79 12.57 8 56491 635 64441598
Optic neuropathy 13.71 12.57 15 56484 2996 64439237
Blood creatine phosphokinase MB increased 13.61 12.57 14 56485 2607 64439626
Hyperintensity in brain deep nuclei 13.58 12.57 4 56495 53 64442180
Basal cell carcinoma 13.58 12.57 5 56494 30833 64411400
Upper respiratory tract infection 13.57 12.57 27 56472 72758 64369475
Blood pressure systolic increased 13.51 12.57 14 56485 49439 64392794
Osteodystrophy 13.51 12.57 3 56496 11 64442222
Pharyngotonsillitis 13.47 12.57 6 56493 272 64441961
Prurigo 13.45 12.57 10 56489 1207 64441026
Cervical dysplasia 13.39 12.57 12 56487 1884 64440349
Head injury 13.37 12.57 6 56493 32836 64409397
Colour vision tests abnormal 13.31 12.57 3 56496 12 64442221
Multiple fractures 13.24 12.57 21 56478 6019 64436214
Anaphylactic shock 13.22 12.57 5 56494 30323 64411910
Cerebellar syndrome 13.22 12.57 19 56480 4997 64437236
Acute on chronic liver failure 13.21 12.57 6 56493 285 64441948
COVID-19 13.17 12.57 23 56476 65117 64377116
Bovine tuberculosis 13.17 12.57 5 56494 150 64442083
Spinal cord injury 13.17 12.57 9 56490 952 64441281
Agitation 13.11 12.57 37 56462 88330 64353903
Spermatozoa progressive motility decreased 13.07 12.57 4 56495 61 64442172
Ear pain 13.04 12.57 3 56496 25133 64417100
Pulmonary embolism 13.02 12.57 75 56424 146281 64295952
Trimethylaminuria 12.98 12.57 5 56494 156 64442077
Acute HIV infection 12.95 12.57 4 56495 63 64442170
Subchondral insufficiency fracture 12.95 12.57 4 56495 63 64442170
Gastrooesophageal reflux disease 12.94 12.57 34 56465 83109 64359124
Pneumonitis 12.94 12.57 15 56484 50350 64391883
Neuroleptic malignant syndrome 12.94 12.57 3 56496 24993 64417240
Pathological fracture 12.90 12.57 26 56473 8979 64433254
Mesenteric vein thrombosis 12.85 12.57 10 56489 1292 64440941
Musculoskeletal pain 12.84 12.57 33 56466 81261 64360972
Melanaemia 12.83 12.57 4 56495 65 64442168
Fungal infection 12.82 12.57 7 56492 34244 64407989
Hepatitis D RNA positive 12.76 12.57 3 56496 15 64442218
Congenital diaphragmatic hernia 12.76 12.57 3 56496 15 64442218
Herpes virus infection 12.72 12.57 21 56478 6223 64436010
Neurocryptococcosis 12.60 12.57 3 56496 16 64442217

FDA Adverse Event Reporting System (Pediatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Neutropenia 40.77 39.38 22 527 190 83939

Pharmacologic Action:

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

Drug Use (View source of the data)

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




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 12.95 acidic
pKa2 4.18 Basic

Orange Book patent data (new drug applications)

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

Orange Book exclusivity data (new drug applications)

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

Bioactivity Summary:

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

External reference:

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

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
DELSTRIGO HUMAN PRESCRIPTION DRUG LABEL 3 0006-5007 TABLET, FILM COATED 300 mg ORAL NDA 32 sections
EPIVIRHBV HUMAN PRESCRIPTION DRUG LABEL 1 0173-0662 TABLET, FILM COATED 100 mg ORAL NDA 26 sections
EPIVIRHBV HUMAN PRESCRIPTION DRUG LABEL 1 0173-0663 SOLUTION 5 mg ORAL NDA 26 sections
LAMIVUDINE HUMAN PRESCRIPTION DRUG LABEL 1 0904-6583 TABLET, FILM COATED 150 mg ORAL ANDA 27 sections
Lamivudine HUMAN PRESCRIPTION DRUG LABEL 1 10135-605 SOLUTION 10 mg ORAL ANDA 25 sections
Combivir HUMAN PRESCRIPTION DRUG LABEL 2 16590-061 TABLET, FILM COATED 150 mg ORAL NDA 16 sections
EPIVIR HUMAN PRESCRIPTION DRUG LABEL 1 21695-367 TABLET, FILM COATED 150 mg ORAL NDA 26 sections
COMBIVIR HUMAN PRESCRIPTION DRUG LABEL 2 21695-846 TABLET, FILM COATED 150 mg ORAL NDA 26 sections
Lamivudine and Zidovudine HUMAN PRESCRIPTION DRUG LABEL 2 21695-996 TABLET, FILM COATED 150 mg ORAL ANDA 26 sections
lamivudine Human Prescription Drug Label 1 31722-001 TABLET, FILM COATED 100 mg ORAL ANDA 25 sections
LAMIVUDINE and ZIDOVUDINE Human Prescription Drug Label 2 31722-506 TABLET, FILM COATED 150 mg ORAL ANDA 25 sections
Lamivudine and Zidovudine HUMAN PRESCRIPTION DRUG LABEL 2 31722-739 TABLET, FILM COATED 150 mg ORAL ANDA 24 sections
Lamivudine Human Prescription Drug Label 1 31722-752 TABLET, FILM COATED 100 mg ORAL ANDA 28 sections
Lamivudine Human Prescription Drug Label 1 31722-753 TABLET, FILM COATED 150 mg ORAL ANDA 25 sections
Lamivudine Human Prescription Drug Label 1 31722-754 TABLET, FILM COATED 300 mg ORAL ANDA 25 sections
Lamivudine Human Prescription Drug Label 1 33342-001 TABLET, FILM COATED 150 mg ORAL ANDA 26 sections
Lamivudine Human Prescription Drug Label 1 33342-002 TABLET, FILM COATED 300 mg ORAL ANDA 26 sections
Lamivudine and Zidovudine Human Prescription Drug Label 2 33342-003 TABLET 150 mg ORAL ANDA 25 sections
Abacavir and Lamivudine Human Prescription Drug Label 2 35573-402 TABLET, FILM COATED 300 mg ORAL ANDA 29 sections
Abacavir and Lamivudine Human Prescription Drug Label 2 35573-430 TABLET, FILM COATED 300 mg ORAL ANDA 27 sections
Abacavir and Lamivudine HUMAN PRESCRIPTION DRUG LABEL 2 42291-115 TABLET, FILM COATED 300 mg ORAL ANDA 28 sections
Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Human Prescription Drug Label 3 42385-928 TABLET, FILM COATED 300 mg ORAL ANDA 30 sections
Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Human Prescription Drug Label 3 42385-929 TABLET, FILM COATED 300 mg ORAL ANDA 30 sections
LAMIVUDINE and ZIDOVUDINE HUMAN PRESCRIPTION DRUG LABEL 2 43063-900 TABLET, FILM COATED 150 mg ORAL ANDA 25 sections
SYMFI LO HUMAN PRESCRIPTION DRUG LABEL 3 49502-425 TABLET, FILM COATED 300 mg ORAL NDA 32 sections
CIMDUO HUMAN PRESCRIPTION DRUG LABEL 2 49502-450 TABLET, FILM COATED 300 mg ORAL NDA 29 sections
SYMFI HUMAN PRESCRIPTION DRUG LABEL 3 49502-475 TABLET, FILM COATED 300 mg ORAL NDA 31 sections
COMBIVIR HUMAN PRESCRIPTION DRUG LABEL 2 49702-202 TABLET, FILM COATED 150 mg ORAL NDA 25 sections
EPIVIR HUMAN PRESCRIPTION DRUG LABEL 1 49702-203 TABLET, FILM COATED 150 mg ORAL NDA 25 sections
EPIVIR HUMAN PRESCRIPTION DRUG LABEL 1 49702-204 TABLET, FILM COATED 300 mg ORAL NDA 25 sections