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 2121.32 16.80 1142 27840 154405 63305635
Abortion spontaneous 1380.09 16.80 587 28395 46608 63413432
Virologic failure 1328.05 16.80 277 28705 1585 63458455
Viral mutation identified 1277.81 16.80 267 28715 1543 63458497
Drug resistance 1103.34 16.80 409 28573 22524 63437516
Stillbirth 1059.81 16.80 296 28686 6454 63453586
Foetal exposure during pregnancy 915.10 16.80 392 28590 31570 63428470
Pathogen resistance 879.79 16.80 253 28729 6145 63453895
Immune reconstitution inflammatory syndrome 811.67 16.80 235 28747 5849 63454191
Abortion induced 687.23 16.80 234 28748 10008 63450032
Premature baby 438.66 16.80 206 28776 20529 63439511
Pregnancy 352.95 16.80 216 28766 36620 63423420
Blood HIV RNA increased 341.58 16.80 77 28905 662 63459378
Hepatitis B reactivation 334.73 16.80 102 28880 3035 63457005
Maternal exposure during pregnancy 319.84 16.80 445 28537 219617 63240423
Caesarean section 316.99 16.80 155 28827 16877 63443163
Hypomania 289.78 16.80 109 28873 6221 63453819
Live birth 283.76 16.80 165 28817 25465 63434575
Hepatotoxicity 282.23 16.80 188 28794 36853 63423187
Fanconi syndrome acquired 280.37 16.80 70 28912 966 63459074
Lipodystrophy acquired 275.69 16.80 74 28908 1378 63458662
Jaundice cholestatic 274.33 16.80 109 28873 7215 63452825
Blood bilirubin increased 269.79 16.80 183 28799 36957 63423083
Schizophrenia 254.91 16.80 113 28869 9839 63450201
Foetal death 253.66 16.80 116 28866 10864 63449176
Treatment noncompliance 197.99 16.80 152 28830 37173 63422867
Maternal drugs affecting foetus 189.31 16.80 76 28906 5166 63454874
CD4 lymphocytes decreased 180.84 16.80 53 28929 1374 63458666
Psychotic disorder 175.58 16.80 122 28860 25590 63434450
Premature rupture of membranes 168.66 16.80 69 28913 4924 63455116
Premature labour 161.29 16.80 89 28893 12415 63447625
Mitochondrial toxicity 147.83 16.80 36 28946 445 63459595
Pain 142.50 16.80 81 28901 740547 62719493
Foetal growth restriction 138.28 16.80 68 28914 7485 63452555
Pre-eclampsia 137.37 16.80 72 28910 9061 63450979
Anaemia 135.77 16.80 365 28617 293065 63166975
Fatigue 130.00 16.80 129 28853 887899 62572141
Drug ineffective 126.05 16.80 177 28805 1044588 62415452
Acquired gene mutation 122.33 16.80 36 28946 947 63459093
Cholelithiasis 120.34 16.80 123 28859 43802 63416238
Hepatitis B 119.68 16.80 50 28932 3762 63456278
Viral load increased 118.61 16.80 38 28944 1336 63458704
Human immunodeficiency virus transmission 118.52 16.80 21 28961 39 63460001
Fanconi syndrome 118.12 16.80 38 28944 1354 63458686
Trisomy 21 113.46 16.80 28 28954 367 63459673
Joint swelling 112.86 16.80 10 28972 327656 63132384
Hepatitis B DNA increased 107.67 16.80 25 28957 248 63459792
Premature delivery 105.94 16.80 97 28885 30184 63429856
Asthma-chronic obstructive pulmonary disease overlap syndrome 103.51 16.80 38 28944 2023 63458017
Fall 103.33 16.80 26 28956 392308 63067732
Lactic acidosis 100.88 16.80 105 28877 38182 63421858
Portal hypertension 99.82 16.80 44 28938 3775 63456265
Nephropathy toxic 99.53 16.80 59 28923 9420 63450620
Total lung capacity increased 99.29 16.80 38 28944 2272 63457768
Lipoatrophy 98.37 16.80 24 28958 299 63459741
Osteomalacia 95.86 16.80 28 28954 717 63459323
Infusion related reaction 94.95 16.80 4 28978 245517 63214523
Peripheral swelling 94.65 16.80 7 28975 265935 63194105
Polydactyly 93.44 16.80 23 28959 298 63459742
Nasopharyngitis 92.50 16.80 6 28976 254251 63205789
Hyperbilirubinaemia 92.37 16.80 60 28922 11254 63448786
Abdominal discomfort 91.03 16.80 18 28964 320867 63139173
Cardiac murmur 89.96 16.80 65 28917 14487 63445553
Alanine aminotransferase increased 88.52 16.80 165 28817 103605 63356435
Normal newborn 87.79 16.80 52 28930 8289 63451751
Glycosuria 87.49 16.80 29 28953 1137 63458903
Hypophosphataemia 86.97 16.80 58 28924 11368 63448672
Genotype drug resistance test positive 86.61 16.80 23 28959 410 63459630
Alopecia 85.75 16.80 24 28958 337512 63122528
Proteinuria 84.45 16.80 70 28912 19075 63440965
Rheumatoid arthritis 84.07 16.80 9 28973 253810 63206230
Mitochondrial cytopathy 83.69 16.80 20 28962 227 63459813
Aspartate aminotransferase increased 82.63 16.80 148 28834 90129 63369911
Systemic lupus erythematosus 82.14 16.80 3 28979 208915 63251125
Ventricular septal defect 81.88 16.80 40 28942 4338 63455702
Renal tubular dysfunction 81.78 16.80 22 28960 413 63459627
Placental disorder 80.26 16.80 29 28953 1475 63458565
Congenital umbilical hernia 78.98 16.80 20 28962 293 63459747
Product dose omission issue 78.39 16.80 8 28974 234305 63225735
Hyperlactacidaemia 78.28 16.80 34 28948 2815 63457225
Alpha 1 foetoprotein abnormal 77.74 16.80 15 28967 53 63459987
Amniotic cavity infection 77.45 16.80 27 28955 1236 63458804
Ectopic kidney 77.31 16.80 15 28967 55 63459985
Hepatomegaly 75.54 16.80 54 28928 11835 63448205
Off label use 75.43 16.80 120 28862 674342 62785698
Birth mark 73.09 16.80 17 28965 170 63459870
Jaundice 71.33 16.80 77 28905 29174 63430866
CSF HIV escape syndrome 70.96 16.80 15 28967 92 63459948
Premature separation of placenta 70.73 16.80 28 28954 1833 63458207
Retinoblastoma 68.15 16.80 14 28968 73 63459967
Sinusitis 67.96 16.80 11 28971 226642 63233398
Oligohydramnios 67.81 16.80 40 28942 6326 63453714
Atrial septal defect 67.18 16.80 41 28941 6897 63453143
Small for dates baby 66.37 16.80 33 28949 3718 63456322
Drug intolerance 66.28 16.80 29 28953 308632 63151408
Swelling 65.55 16.80 22 28960 275356 63184684
Arthralgia 64.94 16.80 100 28882 569610 62890430
Nasal polyps 64.47 16.80 38 28944 6001 63454039
Blood lactic acid increased 63.86 16.80 40 28942 7046 63452994
Fat tissue increased 63.66 16.80 20 28962 659 63459381
Pulmonary tuberculosis 63.37 16.80 34 28948 4483 63455557
Rash maculo-papular 62.56 16.80 75 28907 31821 63428219
Dyslipidaemia 62.30 16.80 40 28942 7353 63452687
Ectopic pregnancy 62.05 16.80 28 28954 2539 63457501
Lymphadenopathy 62.02 16.80 82 28900 38376 63421664
Congenital anomaly 61.54 16.80 25 28957 1751 63458289
Stevens-Johnson syndrome 61.40 16.80 66 28916 24884 63435156
Sarcoidosis 61.17 16.80 39 28943 7083 63452957
Hepatic cytolysis 61.11 16.80 53 28929 15354 63444686
Cleft lip and palate 60.77 16.80 19 28963 616 63459424
Discomfort 60.70 16.80 4 28978 167370 63292670
Hepatic failure 60.57 16.80 78 28904 35578 63424462
Ergot poisoning 60.39 16.80 13 28969 88 63459952
Arnold-Chiari malformation 59.91 16.80 19 28963 646 63459394
Renal tubular disorder 57.76 16.80 27 28955 2655 63457385
Hydrops foetalis 57.38 16.80 18 28964 590 63459450
Immune reconstitution inflammatory syndrome associated tuberculosis 56.99 16.80 16 28966 354 63459686
Placental insufficiency 55.88 16.80 22 28960 1419 63458621
Drug interaction 54.53 16.80 228 28754 228903 63231137
Foetal distress syndrome 53.91 16.80 21 28961 1317 63458723
Low birth weight baby 53.80 16.80 36 28946 7093 63452947
Meningitis cryptococcal 53.32 16.80 21 28961 1356 63458684
Hypertriglyceridaemia 53.08 16.80 34 28948 6225 63453815
Pain in extremity 51.94 16.80 45 28937 331441 63128599
Umbilical cord abnormality 51.79 16.80 17 28965 646 63459394
Constipation 51.75 16.80 19 28963 224924 63235116
Completed suicide 51.32 16.80 4 28978 145669 63314371
Dyspnoea 50.98 16.80 145 28837 661168 62798872
Malaria 50.33 16.80 13 28969 207 63459833
Ultrasound antenatal screen abnormal 50.31 16.80 12 28970 135 63459905
Chronic disease 49.00 16.80 12 28970 152 63459888
Pericarditis 48.13 16.80 3 28979 131576 63328464
Tuberculosis 47.39 16.80 40 28942 11171 63448869
Cushing's syndrome 47.23 16.80 16 28966 671 63459369
Therapeutic product effect decreased 46.71 16.80 15 28967 193172 63266868
Headache 46.51 16.80 142 28840 633099 62826941
Anaemia macrocytic 45.68 16.80 25 28957 3429 63456611
Meningomyelocele 44.89 16.80 15 28967 603 63459437
Hepatitis 44.01 16.80 71 28911 39717 63420323
Drug hypersensitivity 43.07 16.80 47 28935 310640 63149400
Mitochondrial DNA deletion 42.52 16.80 7 28975 6 63460034
Ultrasound scan abnormal 42.38 16.80 12 28970 274 63459766
Rhinitis allergic 41.85 16.80 38 28944 11689 63448351
Ocular icterus 41.66 16.80 24 28958 3632 63456408
Contusion 41.29 16.80 9 28973 150035 63310005
Necrotising colitis 41.29 16.80 14 28968 589 63459451
Product use issue 40.94 16.80 25 28957 220495 63239545
Hepatic enzyme increased 40.31 16.80 191 28791 202137 63257903
Cystostomy 39.95 16.80 9 28973 77 63459963
Macrocephaly 39.35 16.80 9 28973 83 63459957
Blood bilirubin unconjugated increased 38.95 16.80 12 28970 370 63459670
Patent ductus arteriosus 38.32 16.80 24 28958 4226 63455814
Neonatal disorder 37.82 16.80 13 28969 570 63459470
HIV infection 37.75 16.80 12 28970 411 63459629
Cleft palate 37.67 16.80 15 28967 997 63459043
Metabolic acidosis 37.56 16.80 71 28911 44998 63415042
Rickets 36.93 16.80 8 28974 56 63459984
Foetal growth abnormality 36.81 16.80 8 28974 57 63459983
Bronchiectasis 36.76 16.80 41 28941 16101 63443939
Weight increased 36.64 16.80 39 28943 260753 63199287
Spina bifida 36.45 16.80 14 28968 845 63459195
Renal tubular acidosis 36.33 16.80 17 28965 1675 63458365
Hydrocephalus 35.81 16.80 25 28957 5275 63454765
Tuberculoma of central nervous system 35.81 16.80 11 28971 336 63459704
Impaired healing 35.60 16.80 3 28979 102539 63357501
Gestational diabetes 35.57 16.80 30 28952 8366 63451674
Pregnancy on contraceptive 35.30 16.80 15 28967 1177 63458863
Vomiting 35.18 16.80 400 28582 559217 62900823
Hypouricaemia 34.68 16.80 9 28973 146 63459894
CD4 lymphocytes increased 34.51 16.80 9 28973 149 63459891
Isosporiasis 33.84 16.80 7 28975 38 63460002
Hydromyelia 33.57 16.80 6 28976 12 63460028
Gene mutation 33.52 16.80 16 28966 1649 63458391
Back pain 33.35 16.80 43 28939 264102 63195938
Blister 33.34 16.80 9 28973 129805 63330235
Influenza 33.19 16.80 5 28977 108717 63351323
AIDS cholangiopathy 32.65 16.80 6 28976 15 63460025
Pruritus 32.62 16.80 73 28909 361380 63098660
Placental infarction 32.57 16.80 10 28972 305 63459735
Infection 32.49 16.80 34 28948 229139 63230901
Neural tube defect 32.32 16.80 9 28973 193 63459847
Atrial fibrillation 32.08 16.80 7 28975 116629 63343411
Hepatitis A 32.01 16.80 11 28971 482 63459558
Cardiac malposition 31.60 16.80 7 28975 55 63459985
Drug reaction with eosinophilia and systemic symptoms 31.60 16.80 56 28926 33780 63426260
Hypophosphataemic osteomalacia 31.56 16.80 9 28973 211 63459829
Benign hydatidiform mole 31.54 16.80 8 28974 118 63459922
Ultrasound antenatal screen 31.32 16.80 9 28973 217 63459823
Postpartum haemorrhage 30.88 16.80 16 28966 1965 63458075
HIV-associated neurocognitive disorder 30.82 16.80 8 28974 130 63459910
Feeling abnormal 30.17 16.80 15 28967 148377 63311663
Trisomy 18 29.90 16.80 8 28974 147 63459893
Neutropenia neonatal 29.49 16.80 7 28975 77 63459963
Multiple-drug resistance 29.48 16.80 22 28960 5148 63454892
Congenital intestinal malformation 29.42 16.80 6 28976 30 63460010
Hepatosplenomegaly 29.36 16.80 17 28965 2597 63457443
Diarrhoea 29.28 16.80 199 28783 715167 62744873
Neutropenia 29.06 16.80 157 28825 174848 63285192
Lower respiratory tract infection 29.05 16.80 12 28970 132295 63327745
Twin pregnancy 29.00 16.80 13 28969 1160 63458880
Asthma 28.94 16.80 11 28971 127550 63332490
Fallot's tetralogy 28.93 16.80 7 28975 84 63459956
Ascites 28.92 16.80 60 28922 40668 63419372
Gamma-glutamyltransferase increased 28.84 16.80 54 28928 33977 63426063
Migraine 28.83 16.80 6 28976 103340 63356700
COVID-19 28.75 16.80 8 28974 113095 63346945
Isoimmune haemolytic disease 28.36 16.80 6 28976 37 63460003
Lymphadenitis 28.29 16.80 18 28964 3257 63456783
Bilirubin conjugated increased 28.09 16.80 17 28965 2817 63457223
Gestational hypertension 27.90 16.80 16 28966 2401 63457639
Blood pressure increased 27.87 16.80 20 28962 162042 63297998
Double outlet right ventricle 27.82 16.80 6 28976 41 63459999
Musculoskeletal stiffness 27.76 16.80 26 28956 184592 63275448
Prenatal screening test abnormal 27.35 16.80 5 28977 12 63460028
Necrotising enterocolitis neonatal 27.31 16.80 8 28974 207 63459833
Muscle spasms 27.21 16.80 19 28963 156131 63303909
Infertility 27.08 16.80 11 28971 770 63459270
Malignant neoplasm progression 26.93 16.80 3 28979 82118 63377922
Lymph node tuberculosis 26.84 16.80 11 28971 788 63459252
Anembryonic gestation 26.84 16.80 10 28972 555 63459485
Bicuspid pulmonary valve 26.77 16.80 4 28978 0 63460040
Loss of personal independence in daily activities 26.43 16.80 6 28976 97284 63362756
Dizziness 26.36 16.80 104 28878 429821 63030219
Funisitis 26.29 16.80 5 28977 16 63460024
Hepatitis B surface antigen positive 26.07 16.80 6 28976 57 63459983
Gastroschisis 25.77 16.80 9 28973 414 63459626
Ballismus 25.70 16.80 7 28975 138 63459902
Transaminases increased 25.62 16.80 49 28933 31318 63428722
Cholestasis of pregnancy 25.36 16.80 12 28970 1213 63458827
Blood cholesterol increased 25.14 16.80 6 28976 94026 63366014
Retinal toxicity 24.90 16.80 12 28970 1263 63458777
Micrognathia 24.89 16.80 8 28974 284 63459756
Anxiety 24.87 16.80 38 28944 217503 63242537
Renal failure 24.82 16.80 113 28869 117539 63342501
Neonatal aspiration 24.80 16.80 7 28975 158 63459882
Cerebral toxoplasmosis 24.70 16.80 11 28971 967 63459073
Kaposi's sarcoma 24.68 16.80 7 28975 161 63459879
Ovarian failure 24.59 16.80 12 28970 1298 63458742
Acquired aminoaciduria 24.53 16.80 4 28978 3 63460037
Eyelid oedema 24.52 16.80 27 28955 10452 63449588
Hyperphosphaturia 24.35 16.80 5 28977 26 63460014
Congenital hydrocephalus 24.31 16.80 7 28975 170 63459870
Abortion missed 24.28 16.80 13 28969 1706 63458334
Hepatic displacement 24.19 16.80 5 28977 27 63460013
Cholestatic liver injury 24.19 16.80 15 28967 2595 63457445
Fibromyalgia 23.86 16.80 4 28978 80416 63379624
Cytomegalovirus chorioretinitis 23.77 16.80 13 28969 1780 63458260
Osteoarthritis 23.75 16.80 7 28975 95336 63364704
Alpha 1 foetoprotein increased 23.68 16.80 7 28975 187 63459853
Hepatitis B DNA assay positive 23.61 16.80 5 28977 31 63460009
Anaemia neonatal 23.54 16.80 8 28974 339 63459701
Malaise 23.40 16.80 104 28878 415850 63044190
Foetal anaemia 23.20 16.80 6 28976 96 63459944
Neonatal respiratory distress syndrome 23.13 16.80 15 28967 2803 63457237
Genetic polymorphism 23.11 16.80 4 28978 6 63460034
Haemorrhage in pregnancy 22.91 16.80 13 28969 1912 63458128
Diastasis recti abdominis 22.84 16.80 5 28977 37 63460003
AIDS related complication 22.73 16.80 4 28978 7 63460033
Fat redistribution 22.73 16.80 4 28978 7 63460033
Congenital teratoma 22.73 16.80 4 28978 7 63460033
Blood creatine phosphokinase MB increased 22.41 16.80 11 28971 1205 63458835
Type III hyperlipidaemia 22.38 16.80 4 28978 8 63460032
Psoriasis 22.38 16.80 6 28976 86951 63373089
Lipase increased 22.29 16.80 25 28957 9875 63450165
Lipohypertrophy 21.81 16.80 9 28973 656 63459384
Respiratory distress 21.78 16.80 48 28934 33903 63426137
Aminoaciduria 21.76 16.80 6 28976 124 63459916
Varices oesophageal 21.62 16.80 15 28967 3133 63456907
Death neonatal 21.57 16.80 10 28972 965 63459075
Fontanelle bulging 21.49 16.80 4 28978 11 63460029
Insomnia 21.48 16.80 41 28941 215211 63244829
Bovine tuberculosis 21.32 16.80 5 28977 52 63459988
Cachexia 21.31 16.80 19 28963 5707 63454333
Osteoporosis 21.24 16.80 66 28916 57272 63402768
Antiviral drug level below therapeutic 21.15 16.80 5 28977 54 63459986
Placenta praevia 21.10 16.80 10 28972 1014 63459026
Pubertal failure 20.99 16.80 4 28978 13 63460027
HELLP syndrome 20.92 16.80 10 28972 1034 63459006
Dyschezia 20.80 16.80 13 28969 2281 63457759
Ventricular hypoplasia 20.75 16.80 6 28976 148 63459892
Breast neoplasm 20.71 16.80 11 28971 1421 63458619
Blood creatine phosphokinase increased 20.64 16.80 44 28938 30386 63429654
Influenza like illness 20.56 16.80 3 28979 66821 63393219
Memory impairment 20.50 16.80 11 28971 104247 63355793
Inappropriate schedule of product administration 20.40 16.80 11 28971 103954 63356086
Pharyngotonsillitis 20.38 16.80 6 28976 158 63459882
CSF protein increased 20.36 16.80 8 28974 513 63459527
Developmental delay 20.35 16.80 11 28971 1472 63458568
Carnitine deficiency 20.24 16.80 6 28976 162 63459878
Myopathy toxic 20.23 16.80 8 28974 522 63459518
Nasal congestion 20.08 16.80 3 28979 65657 63394383
Vertical infection transmission 20.08 16.80 3 28979 0 63460040
Hypotension 20.02 16.80 61 28921 272543 63187497
Social avoidant behaviour 19.97 16.80 14 28968 2974 63457066
Ebstein's anomaly 19.96 16.80 4 28978 18 63460022
Renal glycosuria 19.96 16.80 4 28978 18 63460022
Defaecation urgency 19.95 16.80 16 28966 4159 63455881
Breech delivery 19.89 16.80 5 28977 71 63459969
Pleocytosis 19.74 16.80 9 28973 836 63459204
Death 19.63 16.80 96 28886 374285 63085755
Therapeutic product effect incomplete 19.52 16.80 17 28965 125039 63335001
Exposure via breast milk 19.52 16.80 12 28970 2045 63457995
Oxygen saturation decreased 19.49 16.80 8 28974 88577 63371463
Meningitis tuberculous 19.36 16.80 8 28974 585 63459455
Thyroid tuberculosis 19.29 16.80 4 28978 22 63460018
Spinal cord injury 19.26 16.80 9 28973 884 63459156
Musculoskeletal pain 19.25 16.80 9 28973 92268 63367772
Portal vein thrombosis 19.17 16.80 13 28969 2617 63457423
Diaphragmatic aplasia 19.14 16.80 4 28978 23 63460017
Acquired immunodeficiency syndrome 19.11 16.80 5 28977 84 63459956
Eclampsia 19.02 16.80 7 28975 375 63459665
Aqueductal stenosis 19.00 16.80 4 28978 24 63460016
Hemiataxia 19.00 16.80 4 28978 24 63460016
Lung neoplasm malignant 18.99 16.80 33 28949 19600 63440440
Amenorrhoea 18.92 16.80 23 28959 9891 63450149
Lactate pyruvate ratio increased 18.73 16.80 5 28977 91 63459949
Pulmonary artery atresia 18.72 16.80 4 28978 26 63460014
Placental necrosis 18.72 16.80 4 28978 26 63460014
Hepatitis C 18.64 16.80 17 28965 5257 63454783
Sleep disorder 18.55 16.80 7 28975 81559 63378481
Oropharyngeal pain 18.53 16.80 10 28972 94477 63365563
Disseminated Bacillus Calmette-Guerin infection 18.47 16.80 4 28978 28 63460012
Blood alkaline phosphatase increased 18.33 16.80 52 28930 42915 63417125
Acute stress disorder 18.33 16.80 6 28976 226 63459814
Myelopathy 18.33 16.80 13 28969 2813 63457227
Bronchitis 18.30 16.80 18 28964 124917 63335123
Secondary hypogonadism 18.29 16.80 5 28977 100 63459940
Pallor 18.25 16.80 42 28940 30526 63429514
Urinary tract infection 18.20 16.80 61 28921 264623 63195417
Anaphylactic reaction 18.10 16.80 4 28978 66096 63393944
Delayed puberty 18.01 16.80 5 28977 106 63459934
Cervix operation 18.00 16.80 3 28979 3 63460037
Visual impairment 17.99 16.80 8 28974 84438 63375602
Adverse drug reaction 17.87 16.80 7 28975 79707 63380333
Rhodococcus infection 17.50 16.80 5 28977 118 63459922
Intentional overdose 17.48 16.80 6 28976 74146 63385894
Cleft lip 17.46 16.80 5 28977 119 63459921
Neck pain 17.43 16.80 5 28977 69313 63390727
Developmental coordination disorder 17.38 16.80 4 28978 38 63460002
Persistent left superior vena cava 17.38 16.80 4 28978 38 63460002
Acute lymphocytic leukaemia 17.31 16.80 12 28970 2504 63457536
Mycobacterium avium complex infection 17.29 16.80 13 28969 3075 63456965
Genital prolapse 17.20 16.80 4 28978 40 63460000
Cryptococcosis 17.05 16.80 9 28973 1148 63458892
Acute fatty liver of pregnancy 16.93 16.80 4 28978 43 63459997
Cervical dysplasia 16.83 16.80 13 28969 3201 63456839

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 1896.03 12.37 497 47825 2457 34906152
Virologic failure 1640.19 12.37 459 47863 3021 34905588
Immune reconstitution inflammatory syndrome 1590.79 12.37 557 47765 8202 34900407
Pathogen resistance 1409.72 12.37 520 47802 8962 34899647
Drug resistance 968.69 12.37 542 47780 25385 34883224
Lipodystrophy acquired 841.73 12.37 272 48050 3072 34905537
Depression 772.34 12.37 803 47519 96295 34812314
Foetal exposure during pregnancy 753.38 12.37 532 47790 37569 34871040
Drug interaction 752.24 12.37 1212 47110 224734 34683875
Hepatitis B 624.76 12.37 254 48068 5729 34902880
Exposure during pregnancy 585.22 12.37 273 48049 8661 34899948
Mitochondrial toxicity 502.46 12.37 175 48147 2524 34906085
Hepatitis B reactivation 415.83 12.37 168 48154 3723 34904886
Osteomalacia 369.00 12.37 107 48215 810 34907799
Hepatitis B DNA increased 361.97 12.37 95 48227 470 34908139
Acquired gene mutation 327.83 12.37 107 48215 1248 34907361
Eyelid ptosis 319.14 12.37 157 48165 5609 34903000
Fanconi syndrome acquired 287.53 12.37 107 48215 1884 34906725
Viral load increased 266.19 12.37 108 48214 2419 34906190
Blood HIV RNA increased 249.28 12.37 85 48237 1145 34907464
Progressive external ophthalmoplegia 240.23 12.37 86 48236 1349 34907260
Lipoatrophy 216.18 12.37 62 48260 449 34908160
Pinealoblastoma 213 12.37 50 48272 139 34908470
Hypertriglyceridaemia 197.52 12.37 131 48191 8317 34900292
Psychiatric decompensation 193.02 12.37 90 48232 2847 34905762
Premature baby 189.84 12.37 181 48141 19452 34889157
Hepatic failure 182.90 12.37 232 48090 34299 34874310
Diplopia 173.81 12.37 161 48161 16682 34891927
Fanconi syndrome 172.58 12.37 71 48251 1649 34906960
Hypophosphataemia 166.18 12.37 131 48191 10895 34897714
Multiple-drug resistance 164.62 12.37 98 48224 5141 34903468
Genotype drug resistance test 157.74 12.37 33 48289 41 34908568
CD4 lymphocytes decreased 155.00 12.37 66 48256 1675 34906934
Renal tubular disorder 154.15 12.37 90 48232 4553 34904056
Kaposi's sarcoma 151.89 12.37 54 48268 829 34907780
Polydactyly 149.24 12.37 58 48264 1155 34907454
Loss of personal independence in daily activities 146.58 12.37 204 48118 32975 34875634
Off label use 146.09 12.37 222 48100 419302 34489307
Depressive symptom 143.89 12.37 73 48249 2786 34905823
Hepatic fibrosis 141.69 12.37 85 48237 4522 34904087
Trisomy 21 136.54 12.37 45 48277 542 34908067
Depression suicidal 135.00 12.37 67 48255 2438 34906171
Tearfulness 133.94 12.37 68 48254 2599 34906010
Gene mutation 130.75 12.37 55 48267 1353 34907256
Alanine aminotransferase increased 129.99 12.37 321 48001 80494 34828115
Osteoporosis 122.84 12.37 117 48205 12551 34896058
Portal hypertension 119.91 12.37 73 48249 3989 34904620
Treatment noncompliance 118.51 12.37 169 48153 27931 34880678
Psychomotor skills impaired 117.37 12.37 71 48251 3835 34904774
Meningitis cryptococcal 116.96 12.37 60 48262 2344 34906265
Retinal toxicity 111.53 12.37 36 48286 404 34908205
Maternal drugs affecting foetus 111.29 12.37 69 48253 3896 34904713
Treatment failure 110.89 12.37 217 48105 46480 34862129
HIV-associated neurocognitive disorder 107.40 12.37 33 48289 311 34908298
Product dose omission issue 105.58 12.37 19 48303 119692 34788917
Cytomegalovirus chorioretinitis 99.58 12.37 62 48260 3527 34905082
Volvulus 94.97 12.37 46 48276 1586 34907023
Mycobacterium avium complex infection 94.97 12.37 53 48269 2458 34906151
Jaundice 94.41 12.37 163 48159 31719 34876890
Fall 94.38 12.37 85 48237 202800 34705809
Hyperlactacidaemia 93.67 12.37 56 48266 2960 34905649
Blood phosphorus decreased 93.47 12.37 57 48265 3124 34905485
Blood lactic acid increased 93.00 12.37 76 48246 6652 34901957
Completed suicide 92.37 12.37 13 48309 98155 34810454
Osteonecrosis 91.69 12.37 108 48214 14782 34893827
Aspartate aminotransferase increased 91.27 12.37 252 48070 67531 34841078
Hepatic cirrhosis 91.11 12.37 116 48206 17198 34891411
Nephropathy toxic 90.59 12.37 99 48223 12489 34896120
Hepatitis C 90.04 12.37 88 48234 9742 34898867
Pneumonia 89.75 12.37 234 48088 362393 34546216
Drug abuse 88.96 12.37 15 48307 99081 34809528
Peripheral swelling 85.65 12.37 5 48317 76536 34832073
Caesarean section 85.47 12.37 47 48275 2117 34906492
Dyspnoea 85.18 12.37 254 48068 376528 34532081
Mitochondrial cytopathy 84.38 12.37 24 48298 168 34908441
Renal tubular dysfunction 84.21 12.37 29 48293 403 34908206
Hyperlipidaemia 83.91 12.37 102 48220 14427 34894182
CSF HIV escape syndrome 83.29 12.37 24 48298 177 34908432
Acquired immunodeficiency syndrome 82.78 12.37 30 48292 488 34908121
Death 81.84 12.37 280 48042 397769 34510840
Hypouricaemia 81.23 12.37 25 48297 237 34908372
Fatigue 75.98 12.37 261 48061 370392 34538217
Neonatal disorder 75.66 12.37 32 48290 798 34907811
Hypotension 74.27 12.37 120 48202 221529 34687080
Varices oesophageal 73.04 12.37 52 48270 3703 34904906
Ophthalmoplegia 72.77 12.37 40 48282 1800 34906809
Dandy-Walker syndrome 72.60 12.37 22 48300 197 34908412
Dyslipidaemia 72.28 12.37 69 48253 7419 34901190
Progressive multifocal leukoencephalopathy 70.62 12.37 77 48245 9687 34898922
Pulmonary tuberculosis 70.58 12.37 56 48266 4698 34903911
HIV infection 69.75 12.37 35 48287 1304 34907305
Pain 69.32 12.37 110 48212 204565 34704044
Hepatitis 67.88 12.37 120 48202 23784 34884825
Drug-induced liver injury 67.22 12.37 133 48189 28699 34879910
Proteinuria 66.93 12.37 104 48218 18538 34890071
Anaemia macrocytic 66.10 12.37 45 48277 2981 34905628
Lymphadenopathy 66.00 12.37 131 48191 28332 34880277
Constipation 65.32 12.37 56 48266 136926 34771683
Hepatomegaly 64.99 12.37 76 48246 10320 34898289
Blood alkaline phosphatase increased 64.64 12.37 137 48185 31038 34877571
Tuberculosis 64.42 12.37 69 48253 8508 34900101
Blood pressure increased 63.98 12.37 21 48301 88081 34820528
Glycosuria 63.46 12.37 32 48290 1205 34907404
Hyperbilirubinaemia 63.34 12.37 96 48226 16747 34891862
Lactic acidosis 63.27 12.37 145 48177 34627 34873982
Hepatic function abnormal 62.75 12.37 168 48154 44195 34864414
Malignant neoplasm progression 62.18 12.37 22 48300 88024 34820585
Renal impairment 62.04 12.37 277 48045 94236 34814373
Congenital umbilical hernia 61.57 12.37 21 48301 283 34908326
Birth mark 60.33 12.37 18 48304 152 34908457
Congenital anomaly 59.87 12.37 32 48290 1361 34907248
Oesophageal candidiasis 59.38 12.37 49 48273 4347 34904262
Inappropriate schedule of product administration 59.17 12.37 8 48314 62288 34846321
Urine phosphorus increased 59.10 12.37 14 48308 41 34908568
Paranoia 59.03 12.37 78 48244 11990 34896619
Brain stem stroke 56.31 12.37 20 48302 306 34908303
Blood bilirubin increased 56.16 12.37 147 48175 38149 34870460
Hepatocellular carcinoma 55.67 12.37 60 48262 7449 34901160
Atrioventricular septal defect 54.67 12.37 18 48304 216 34908393
Atrial fibrillation 53.66 12.37 54 48268 122339 34786270
Ultrasound antenatal screen 52.57 12.37 22 48300 534 34908075
Psychotic disorder 52.48 12.37 109 48213 24343 34884266
Hydrops foetalis 52.15 12.37 25 48297 842 34907767
Lipohypertrophy 51.63 12.37 18 48304 260 34908349
Hepatosplenomegaly 51.22 12.37 44 48278 4125 34904484
Pregnancy 51.13 12.37 18 48304 268 34908341
Blood triglycerides increased 50.84 12.37 79 48243 14080 34894529
Talipes 50.29 12.37 32 48290 1891 34906718
Human immunodeficiency virus transmission 49.06 12.37 11 48311 23 34908586
Calculus urinary 48.63 12.37 28 48294 1379 34907230
Genotype drug resistance test positive 48.36 12.37 26 48296 1119 34907490
Infusion related reaction 47.66 12.37 8 48314 53049 34855560
CD4 lymphocytes increased 47.29 12.37 16 48306 210 34908399
Congenital central nervous system anomaly 46.97 12.37 21 48301 601 34908008
Gamma-glutamyltransferase increased 46.80 12.37 116 48206 29115 34879494
Nodular regenerative hyperplasia 46.51 12.37 24 48298 949 34907660
Hepatic cancer 46.01 12.37 57 48265 8218 34900391
Pyelocaliectasis 45.89 12.37 25 48297 1105 34907504
Trisomy 18 45.67 12.37 22 48300 749 34907860
Nasopharyngitis 45.26 12.37 20 48302 69948 34838661
Multiple fractures 45.19 12.37 27 48295 1425 34907184
Hepatitis B virus test 44.68 12.37 8 48314 0 34908609
Facial wasting 44.55 12.37 14 48308 143 34908466
Cachexia 44.03 12.37 52 48270 7134 34901475
Joint swelling 43.96 12.37 14 48308 59876 34848733
Pneumocystis jirovecii pneumonia 43.64 12.37 89 48233 19621 34888988
Cryptococcosis 43.63 12.37 32 48290 2387 34906222
Hepatic encephalopathy 43.35 12.37 75 48247 14610 34893999
Optic nerve neoplasm 43.08 12.37 10 48312 26 34908583
Oesophageal varices haemorrhage 42.35 12.37 35 48287 3111 34905498
Cleft lip and palate 42.17 12.37 22 48300 890 34907719
Congenital neoplasm 42.03 12.37 10 48312 30 34908579
Anaemia neonatal 42.00 12.37 16 48306 301 34908308
Opportunistic infection 41.89 12.37 27 48295 1631 34906978
Splenomegaly 41.77 12.37 75 48247 15042 34893567
Basedow's disease 41.64 12.37 11 48311 56 34908553
Cryptorchism 41.40 12.37 29 48293 2012 34906597
Cerebral toxoplasmosis 40.97 12.37 27 48295 1694 34906915
Blood bilirubin unconjugated increased 40.74 12.37 19 48303 601 34908008
Oral candidiasis 39.94 12.37 65 48257 12045 34896564
Psychomotor retardation 39.80 12.37 36 48286 3614 34904995
Immune reconstitution inflammatory syndrome associated tuberculosis 39.57 12.37 17 48305 441 34908168
Confusional state 39.48 12.37 88 48234 144072 34764537
Small for dates baby 39.45 12.37 37 48285 3890 34904719
Optic atrophy 39.29 12.37 21 48301 893 34907716
Urine calcium increased 39.05 12.37 10 48312 44 34908565
Bone density decreased 38.18 12.37 27 48295 1902 34906707
Osteopenia 38.17 12.37 40 48282 4809 34903800
Macrocephaly 37.88 12.37 17 48305 491 34908118
COVID-19 37.80 12.37 31 48291 77519 34831090
Wheezing 37.73 12.37 6 48316 41396 34867213
Life expectancy shortened 37.37 12.37 10 48312 54 34908555
Mycobacterium avium complex immune restoration disease 37.11 12.37 9 48313 30 34908579
Mitochondrial myopathy 37.02 12.37 13 48309 192 34908417
Acute hepatitis C 36.96 12.37 11 48311 92 34908517
Disease progression 36.61 12.37 58 48264 108019 34800590
Cardiac failure congestive 36.18 12.37 37 48285 83233 34825376
Nephrolithiasis 36.16 12.37 108 48214 30225 34878384
Rhabdomyosarcoma 35.45 12.37 9 48313 38 34908571
Cardio-respiratory arrest 35.43 12.37 16 48306 55257 34853352
Mycobacterial infection 35.32 12.37 28 48294 2346 34906263
Hepatotoxicity 35.17 12.37 86 48236 21399 34887210
Toxicity to various agents 35.15 12.37 150 48172 200212 34708397
Intentional product misuse 34.67 12.37 10 48312 45601 34863008
Blood phosphorus abnormal 34.11 12.37 11 48311 123 34908486
Hydrocele 34.05 12.37 26 48296 2061 34906548
Dizziness 33.95 12.37 171 48151 218350 34690259
Neurodevelopmental disorder 33.79 12.37 15 48307 422 34908187
Renal tubular acidosis 33.75 12.37 27 48295 2292 34906317
Somnolence 33.65 12.37 64 48258 111052 34797557
Prostate cancer 33.43 12.37 7 48315 39642 34868967
Death neonatal 33.14 12.37 14 48308 348 34908261
Osteoporotic fracture 33.14 12.37 20 48302 1075 34907534
White matter lesion 33.03 12.37 18 48304 796 34907813
Congenital hydronephrosis 31.96 12.37 17 48305 716 34907893
Therapeutic product effect decreased 31.73 12.37 5 48317 34738 34873871
Thrombosis 31.73 12.37 15 48307 50443 34858166
Liver disorder 31.61 12.37 109 48213 32888 34875721
Oesophageal atresia 31.49 12.37 15 48307 498 34908111
Blood pyruvic acid increased 31.43 12.37 7 48315 14 34908595
Cushing's syndrome 31.37 12.37 14 48308 399 34908210
Flushing 31.17 12.37 4 48318 32416 34876193
Feeling abnormal 31.16 12.37 25 48297 63210 34845399
Stress 31.05 12.37 3 48319 30344 34878265
Stevens-Johnson syndrome 30.93 12.37 75 48247 18564 34890045
HIV associated nephropathy 30.89 12.37 13 48309 320 34908289
Viraemia 30.88 12.37 20 48302 1218 34907391
Speech disorder developmental 30.71 12.37 25 48297 2175 34906434
Transaminases increased 30.56 12.37 94 48228 26729 34881880
Febrile neutropenia 30.23 12.37 93 48229 136756 34771853
HIV lipodystrophy 30.21 12.37 7 48315 18 34908591
Chronic obstructive pulmonary disease 30.06 12.37 15 48307 48903 34859706
Drug ineffective 30.02 12.37 448 47874 456303 34452306
Epistaxis 30.01 12.37 22 48300 58229 34850380
Astrocytoma, low grade 29.77 12.37 8 48314 44 34908565
Muscle spasms 29.64 12.37 36 48286 74965 34833644
HIV viraemia 29.47 12.37 8 48314 46 34908563
Ascites 29.40 12.37 135 48187 46436 34862173
Meningomyelocele 29.38 12.37 11 48311 197 34908412
Anaemia 29.34 12.37 469 47853 232866 34675743
Cerebrovascular accident 29.20 12.37 45 48277 84766 34823843
Aminoaciduria 29.19 12.37 12 48310 278 34908331
Lactate pyruvate ratio increased 28.88 12.37 6 48316 7 34908602
Injection site pain 28.83 12.37 9 48313 38996 34869613
Product use issue 28.71 12.37 27 48295 63189 34845420
Abortion spontaneous 28.60 12.37 13 48309 387 34908222
Cardiac arrest 28.58 12.37 56 48266 96103 34812506
Tremor 28.26 12.37 44 48278 82543 34826066
HIV test positive 28.22 12.37 10 48312 152 34908457
Hepatic cytolysis 28.09 12.37 62 48260 14434 34894175
Hepatitis cholestatic 28.05 12.37 44 48278 7903 34900706
Mitochondrial DNA depletion 27.93 12.37 5 48317 0 34908609
Contusion 27.58 12.37 8 48314 36356 34872253
Bone metabolism disorder 27.50 12.37 11 48311 237 34908372
Hypersplenism 27.20 12.37 13 48309 435 34908174
Retroviral rebound syndrome 26.94 12.37 6 48316 12 34908597
Cardiac disorder 26.84 12.37 13 48309 43113 34865496
Lymph node tuberculosis 26.73 12.37 13 48309 452 34908157
Low set ears 26.63 12.37 13 48309 456 34908153
Syncope 26.54 12.37 54 48268 91397 34817212
Pruritus 26.31 12.37 104 48218 141877 34766732
Neurosyphilis 26.28 12.37 7 48315 37 34908572
Viral load decreased 26.28 12.37 7 48315 37 34908572
Hypospadias 26.26 12.37 27 48295 3174 34905435
Haematochezia 26.09 12.37 16 48306 46518 34862091
Hypophosphataemic osteomalacia 25.94 12.37 9 48313 128 34908481
Bone pain 25.94 12.37 75 48247 20611 34887998
Hepatitis A 25.89 12.37 13 48309 485 34908124
Incorrect dose administered 25.54 12.37 12 48310 40503 34868106
Cardiac failure 25.54 12.37 55 48267 91193 34817416
Prenatal screening test abnormal 25.47 12.37 6 48316 17 34908592
Beta 2 microglobulin urine increased 25.35 12.37 8 48314 83 34908526
HIV wasting syndrome 25.09 12.37 8 48314 86 34908523
Urinary tract infection 24.95 12.37 49 48273 84032 34824577
Granulomatous rosacea 24.80 12.37 9 48313 147 34908462
Fat tissue increased 24.79 12.37 12 48310 413 34908196
Cellulitis 24.78 12.37 22 48300 52929 34855680
Pre-eclampsia 24.49 12.37 7 48315 50 34908559
Plasma cell myeloma 24.20 12.37 14 48308 42023 34866586
Chest discomfort 23.94 12.37 24 48298 54506 34854103
Limb deformity 23.77 12.37 13 48309 579 34908030
Neonatal asphyxia 23.70 12.37 11 48311 344 34908265
Anogenital warts 23.67 12.37 13 48309 584 34908025
Angioedema 23.67 12.37 11 48311 37363 34871246
Visual field defect 23.52 12.37 30 48292 4453 34904156
Blood triglycerides abnormal 23.51 12.37 10 48312 253 34908356
Spider naevus 23.51 12.37 6 48316 26 34908583
Tuberculoid leprosy 23.47 12.37 7 48315 59 34908550
Hyperhidrosis 23.43 12.37 43 48279 75649 34832960
Congenital cytomegalovirus infection 23.32 12.37 6 48316 27 34908582
Tubulointerstitial nephritis 23.32 12.37 73 48249 20951 34887658
Suicidal ideation 23.25 12.37 114 48208 40274 34868335
Secondary syphilis 23.07 12.37 7 48315 63 34908546
Amoebiasis 22.97 12.37 7 48315 64 34908545
Genital herpes 22.92 12.37 13 48309 622 34907987
Toxoplasmosis 22.81 12.37 17 48305 1299 34907310
Influenza 22.80 12.37 21 48301 49645 34858964
Strongyloidiasis 22.48 12.37 23 48299 2688 34905921
Trimethylaminuria 22.45 12.37 5 48317 10 34908599
Blood glucose increased 22.39 12.37 36 48286 66682 34841927
Hypercholesterolaemia 22.35 12.37 42 48280 8720 34899889
Withdrawal hepatitis 22.34 12.37 4 48318 0 34908609
Foetal growth restriction 22.31 12.37 28 48294 4089 34904520
Weight increased 22.15 12.37 61 48261 92972 34815637
Meningitis tuberculous 22.00 12.37 13 48309 672 34907937
Blood creatinine increased 21.92 12.37 214 48108 94762 34813847
Hepatitis B surface antigen positive 21.91 12.37 8 48314 133 34908476
Vanishing bile duct syndrome 21.91 12.37 15 48307 1003 34907606
Antimitochondrial antibody positive 21.75 12.37 6 48316 37 34908572
Oropharyngeal pain 21.62 12.37 11 48311 35474 34873135
Intracranial pressure increased 21.59 12.37 27 48295 3928 34904681
Unevaluable event 21.57 12.37 9 48313 32581 34876028
Chest pain 21.53 12.37 96 48226 126666 34781943
Bradycardia 21.48 12.37 45 48277 75373 34833236
Pulmonary embolism 21.25 12.37 59 48263 89687 34818922
Atypical mycobacterial infection 21.23 12.37 14 48308 879 34907730
Prescribed overdose 21.15 12.37 46 48276 10601 34898008
Pancreatitis 21.13 12.37 108 48214 38783 34869826
Oxygen saturation decreased 21.09 12.37 26 48296 53792 34854817
Anal cancer 20.93 12.37 11 48311 452 34908157
Psoriasis 20.86 12.37 14 48308 38798 34869811
Night blindness 20.82 12.37 9 48313 237 34908372
Urine phosphorus decreased 20.73 12.37 6 48316 45 34908564
Umbilical cord abnormality 20.62 12.37 6 48316 46 34908563
Live birth 20.62 12.37 9 48313 243 34908366
Blood creatine phosphokinase increased 20.61 12.37 119 48203 44738 34863871
Urticaria 20.61 12.37 34 48288 62343 34846266
Cardiac murmur 20.53 12.37 38 48284 7799 34900810
Lower respiratory tract infection 20.52 12.37 9 48313 31628 34876981
Hepatitis D 20.51 12.37 6 48316 47 34908562
Bacterial pyelonephritis 20.41 12.37 9 48313 249 34908360
Abdominal discomfort 20.35 12.37 32 48290 59803 34848806
Primary syphilis 20.32 12.37 5 48317 18 34908591
Histoplasmosis disseminated 20.11 12.37 16 48306 1347 34907262
Pyrexia 20.06 12.37 602 47720 332411 34576198
Normal newborn 20.06 12.37 8 48314 171 34908438
Diaphragmatic hernia 20.02 12.37 9 48313 261 34908348
Cardiogenic shock 19.92 12.37 6 48316 26612 34881997
AIDS related complication 19.91 12.37 5 48317 20 34908589
Macrocytosis 19.87 12.37 14 48308 980 34907629
Taeniasis 19.87 12.37 6 48316 53 34908556
Contraindicated product administered 19.82 12.37 3 48319 21478 34887131
Back pain 19.63 12.37 94 48228 121695 34786914
Perinatal HIV infection 19.58 12.37 4 48318 4 34908605
Maternal condition affecting foetus 19.58 12.37 4 48318 4 34908605
Liver transplant rejection 19.46 12.37 19 48303 2100 34906509
Cataract 19.42 12.37 6 48316 26180 34882429
Interstitial lung disease 19.40 12.37 38 48284 65244 34843365
Neuromyopathy 19.38 12.37 14 48308 1020 34907589
Agitation 19.23 12.37 31 48291 57368 34851241
Infection 19.21 12.37 63 48259 90852 34817757
Drug dependence 18.98 12.37 5 48317 24212 34884397
Developmental hip dysplasia 18.97 12.37 9 48313 296 34908313
Bronchitis 18.96 12.37 18 48304 41945 34866664
Hepatitis C virus test 18.86 12.37 6 48316 64 34908545
Pilonidal cyst congenital 18.84 12.37 5 48317 26 34908583
Borderline leprosy 18.69 12.37 4 48318 6 34908603
Exomphalos 18.60 12.37 8 48314 208 34908401
Heart rate increased 18.57 12.37 22 48300 46321 34862288
Asymptomatic viral hepatitis 18.53 12.37 5 48317 28 34908581
Rectal haemorrhage 18.50 12.37 17 48305 40232 34868377
Nervous system disorder 18.49 12.37 53 48269 14490 34894119
Hepatitis B DNA assay positive 18.45 12.37 6 48316 69 34908540
Malaria 18.36 12.37 8 48314 215 34908394
Cryoglobulinaemia 18.29 12.37 10 48312 445 34908164
Sickle cell disease 18.26 12.37 7 48315 134 34908475
Anaphylactic reaction 18.25 12.37 11 48311 32290 34876319
Blood pressure decreased 18.05 12.37 27 48295 51488 34857121
Gynaecomastia 18.01 12.37 42 48280 10138 34898471
Diverticulitis 18.00 12.37 3 48319 20001 34888608
Loss of anatomical alignment after fracture reduction 17.96 12.37 4 48318 8 34908601
Neonatal pneumothorax 17.96 12.37 4 48318 8 34908601
Subchondral insufficiency fracture 17.96 12.37 4 48318 8 34908601
Crystal urine 17.93 12.37 6 48316 76 34908533
Cerebral ventricle dilatation 17.92 12.37 13 48309 953 34907656
Blood uric acid decreased 17.82 12.37 9 48313 340 34908269
Pneumonia aspiration 17.76 12.37 19 48303 41884 34866725
Chordee 17.72 12.37 6 48316 79 34908530
Meconium ileus 17.70 12.37 5 48317 34 34908575
Transient ischaemic attack 17.68 12.37 8 48314 27605 34881004
Renal atrophy 17.68 12.37 14 48308 1171 34907438
Cryptosporidiosis infection 17.68 12.37 10 48312 476 34908133
Gastrointestinal haemorrhage 17.55 12.37 63 48259 88414 34820195
Bulbar palsy 17.51 12.37 8 48314 241 34908368
Delirium 17.50 12.37 21 48301 43970 34864639
Blood pressure systolic increased 17.50 12.37 5 48317 22947 34885662
Persistent foetal circulation 17.44 12.37 9 48313 356 34908253
C-reactive protein increased 17.40 12.37 30 48292 54068 34854541
International normalised ratio increased 17.37 12.37 24 48298 47303 34861306
Oropharyngeal candidiasis 17.36 12.37 12 48310 815 34907794
Asthma 17.36 12.37 20 48302 42636 34865973
Sepsis 17.36 12.37 147 48175 166414 34742195
Retinoblastoma 17.34 12.37 4 48318 10 34908599
Acquired aminoaciduria 17.34 12.37 4 48318 10 34908599
Sinusitis 17.30 12.37 19 48303 41383 34867226
Dehydration 17.26 12.37 107 48215 129862 34778747
Rhinorrhoea 17.13 12.37 7 48315 25661 34882948
Optic nerve disorder 17.12 12.37 11 48311 661 34907948
Creutzfeldt-Jakob disease 17.11 12.37 5 48317 39 34908570
Fracture malunion 17.07 12.37 4 48318 11 34908598
White blood cell count increased 17.06 12.37 19 48303 41132 34867477
ADAMTS13 activity decreased 17.06 12.37 6 48316 89 34908520
Toxic optic neuropathy 17.06 12.37 12 48310 838 34907771
Haematoma 17.06 12.37 7 48315 25598 34883011
Distributive shock 16.98 12.37 14 48308 1240 34907369
Parotid gland enlargement 16.98 12.37 10 48312 514 34908095
Polyneuropathy chronic 16.89 12.37 5 48317 41 34908568
Hepatic enzyme increased 16.88 12.37 102 48220 38978 34869631
Dyspnoea exertional 16.86 12.37 21 48301 43258 34865351
Rectosigmoid cancer metastatic 16.81 12.37 4 48318 12 34908597
Glucose urine present 16.79 12.37 13 48309 1052 34907557
Meconium stain 16.76 12.37 3 48319 0 34908609
Gonadal dysgenesis 16.76 12.37 3 48319 0 34908609
Clostridium difficile infection 16.64 12.37 3 48319 18895 34889714
Liver transplant 16.63 12.37 19 48303 2515 34906094
Alpha 1 foetoprotein increased 16.61 12.37 11 48311 696 34907913
Drug intolerance 16.58 12.37 36 48286 59534 34849075
Endocardial fibroelastosis 16.57 12.37 4 48318 13 34908596
Non-Hodgkin's lymphoma 16.54 12.37 15 48307 1510 34907099
Lymphocytic infiltration 16.50 12.37 11 48311 704 34907905
Acute on chronic liver failure 16.48 12.37 6 48316 99 34908510
Hyperphosphatasaemia 16.38 12.37 5 48317 46 34908563
Dysmorphism 16.37 12.37 21 48301 3135 34905474
Full blood count abnormal 16.36 12.37 3 48319 18665 34889944
Molluscum contagiosum 16.30 12.37 8 48314 284 34908325
Encephalitis 16.27 12.37 33 48289 7244 34901365
Melaena 16.19 12.37 15 48307 35365 34873244
Hepatitis B e antigen positive 16.10 12.37 5 48317 49 34908560
Protrusion tongue 15.93 12.37 7 48315 192 34908417
Anaemia megaloblastic 15.93 12.37 7 48315 192 34908417
Anal cancer stage 0 15.93 12.37 4 48318 16 34908593
Urinary retention 15.89 12.37 16 48306 36272 34872337
Nephropathy 15.89 12.37 29 48293 5888 34902721
Memory impairment 15.87 12.37 22 48300 43296 34865313
Nasal congestion 15.86 12.37 6 48316 23051 34885558
Neutrophil count decreased 15.84 12.37 29 48293 51075 34857534
Musculoskeletal stiffness 15.84 12.37 25 48297 46655 34861954
Hepatitis viral 15.83 12.37 10 48312 583 34908026
Coccidioidomycosis 15.80 12.37 11 48311 756 34907853
Ear malformation 15.77 12.37 8 48314 305 34908304
Micrognathia 15.75 12.37 8 48314 306 34908303
Product prescribing error 15.71 12.37 6 48316 22921 34885688
Hyponatraemia 15.67 12.37 60 48262 82631 34825978
Cytokine release syndrome 15.66 12.37 6 48316 22871 34885738
Full blood count decreased 15.65 12.37 3 48319 18085 34890524
Femoral neck fracture 15.59 12.37 21 48301 3286 34905323
Headache 15.56 12.37 190 48132 200445 34708164
Visceral leishmaniasis 15.55 12.37 10 48312 602 34908007
Glomerulonephritis proliferative 15.54 12.37 7 48315 204 34908405
Basal cell carcinoma 15.52 12.37 4 48318 19654 34888955
Neuroleptic malignant syndrome 15.46 12.37 3 48319 17931 34890678
Arthropathy 15.43 12.37 9 48313 26898 34881711
Renal glycosuria 15.37 12.37 4 48318 19 34908590
Paraesthesia 15.33 12.37 42 48280 64130 34844479
Portal fibrosis 15.30 12.37 8 48314 325 34908284
Disseminated tuberculosis 15.27 12.37 17 48305 2188 34906421
Respiratory arrest 15.22 12.37 10 48312 28033 34880576
Blood uric acid increased 15.19 12.37 38 48284 9586 34899023
Adrenogenital syndrome 15.19 12.37 5 48317 60 34908549
Optic nerve cupping 15.11 12.37 5 48317 61 34908548
Sickle cell anaemia 15.11 12.37 7 48315 218 34908391
Optic neuropathy 15.09 12.37 16 48306 1949 34906660
Subacute sclerosing panencephalitis 15.04 12.37 4 48318 21 34908588
Erosive duodenitis 14.98 12.37 15 48307 1709 34906900
Product use in unapproved indication 14.95 12.37 98 48224 117401 34791208
Liver tenderness 14.76 12.37 6 48316 135 34908474
Anogenital dysplasia 14.76 12.37 6 48316 135 34908474
Musculoskeletal toxicity 14.76 12.37 6 48316 135 34908474
Mobility decreased 14.72 12.37 12 48310 30116 34878493
Bone marrow oedema 14.69 12.37 10 48312 662 34907947
Hepatitis B DNA decreased 14.68 12.37 3 48319 3 34908606
Retroviral infection 14.68 12.37 3 48319 3 34908606
Osteocalcin increased 14.68 12.37 3 48319 3 34908606
Tracheal fistula repair 14.68 12.37 3 48319 3 34908606
Erythema 14.61 12.37 68 48254 88712 34819897
Congenital tuberculosis 14.59 12.37 4 48318 24 34908585
Red blood cell schistocytes present 14.54 12.37 7 48315 238 34908371
Hospitalisation 14.54 12.37 36 48286 56866 34851743
Central pain syndrome 14.48 12.37 5 48317 70 34908539
Amylase increased 14.47 12.37 28 48294 5940 34902669
Product quality issue 14.37 12.37 3 48319 17032 34891577
Vision blurred 14.32 12.37 26 48296 45937 34862672
Erythema elevatum diutinum 14.32 12.37 4 48318 26 34908583
Malabsorption 14.26 12.37 17 48305 2355 34906254
Overdose 14.25 12.37 71 48251 90988 34817621
Intentional overdose 14.25 12.37 24 48298 43650 34864959
Late developer 14.22 12.37 3 48319 4 34908605
Atypical mycobacterial lymphadenitis 14.22 12.37 3 48319 4 34908605
Creatinine renal clearance abnormal 14.20 12.37 7 48315 251 34908358
Hyperphosphaturia 14.17 12.37 5 48317 75 34908534
Ventricular fibrillation 14.16 12.37 7 48315 22947 34885662
Neck deformity 14.11 12.37 5 48317 76 34908533
Glucose tolerance impaired 14.11 12.37 20 48302 3284 34905325
Fluid retention 14.05 12.37 10 48312 26877 34881732
Scleral discolouration 14.04 12.37 7 48315 257 34908352
Myopia 13.98 12.37 12 48310 1124 34907485
Arthralgia 13.96 12.37 159 48163 169882 34738727
Pain in extremity 13.93 12.37 110 48212 126403 34782206
Optic disc haemorrhage 13.87 12.37 5 48317 80 34908529
Toxic neuropathy 13.87 12.37 9 48313 550 34908059
Ultrasound antenatal screen abnormal 13.82 12.37 5 48317 81 34908528
Lipids abnormal 13.71 12.37 8 48314 404 34908205
Spermatozoa progressive motility abnormal 13.71 12.37 4 48318 31 34908578
Lymphangiectasia 13.71 12.37 4 48318 31 34908578
Developmental delay 13.67 12.37 18 48304 2757 34905852
Pneumonitis 13.66 12.37 16 48306 33862 34874747
Disseminated mycobacterium avium complex infection 13.65 12.37 5 48317 84 34908525
Hypoglycaemia 13.63 12.37 35 48287 54605 34854004
Goitre 13.49 12.37 14 48308 1664 34906945
Benign hepatic neoplasm 13.47 12.37 3 48319 6 34908603
Congenital pigmentation disorder 13.47 12.37 3 48319 6 34908603
Wrong technique in product usage process 13.46 12.37 18 48304 35968 34872641
Osteonecrosis of jaw 13.45 12.37 4 48318 17885 34890724
Diarrhoea 13.38 12.37 424 47898 389488 34519121
Hyperkalaemia 13.37 12.37 50 48272 69339 34839270
Syphilis 13.29 12.37 8 48314 428 34908181
Stomatitis 13.29 12.37 24 48298 42490 34866119
Oedema peripheral 13.27 12.37 104 48218 119708 34788901
Post inflammatory pigmentation change 13.26 12.37 7 48315 290 34908319
Gout 13.26 12.37 5 48317 19248 34889361
Ocular icterus 13.25 12.37 18 48304 2839 34905770
Lip swelling 13.22 12.37 3 48319 16077 34892532
Congenital hydrocephalus 13.18 12.37 5 48317 93 34908516
Birth trauma 13.15 12.37 3 48319 7 34908602
Osteodystrophy 13.15 12.37 3 48319 7 34908602
Aggression 13.09 12.37 21 48301 38943 34869666
Orthostatic hypotension 13.07 12.37 10 48312 25909 34882700
Anaphylactic shock 13.06 12.37 3 48319 15938 34892671
Injection site erythema 13.01 12.37 3 48319 15896 34892713
Pancytopenia 12.96 12.37 194 48128 94963 34813646
Portal hypertensive gastropathy 12.93 12.37 9 48313 618 34907991
Hepatic steatosis 12.92 12.37 55 48267 18307 34890302
Heart rate irregular 12.90 12.37 3 48319 15804 34892805
Ergot poisoning 12.90 12.37 4 48318 39 34908570
Congenital anaemia 12.87 12.37 3 48319 8 34908601
Graft infection 12.86 12.37 8 48314 454 34908155
Congenital hearing disorder 12.84 12.37 5 48317 100 34908509
Sleep apnoea syndrome 12.83 12.37 6 48316 20315 34888294
Nausea 12.80 12.37 365 47957 339543 34569066
Platelet count decreased 12.76 12.37 105 48217 119612 34788997
Chronic kidney disease 12.70 12.37 99 48223 41111 34867498
Tracheo-oesophageal fistula 12.67 12.37 8 48314 466 34908143
Neutrophil count increased 12.59 12.37 4 48318 17142 34891467
Intestinal obstruction 12.58 12.37 8 48314 22814 34885795
Malaise 12.57 12.37 181 48141 185644 34722965
CD4 lymphocytes abnormal 12.55 12.37 4 48318 43 34908566
Skin candida 12.52 12.37 8 48314 476 34908133
Arthritis 12.43 12.37 15 48307 31331 34877278
COVID-19 pneumonia 12.38 12.37 4 48318 16963 34891646
Glucose urine 12.37 12.37 3 48319 10 34908599

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 2422.54 12.93 743 60920 13098 79669627
Viral mutation identified 2382.31 12.93 561 61102 3297 79679428
Virologic failure 2377.48 12.93 569 61094 3622 79679103
Pathogen resistance 1800.44 12.93 598 61065 13744 79668981
Drug resistance 1691.38 12.93 767 60896 41446 79641279
Exposure during pregnancy 1100.85 12.93 782 60881 100350 79582375
Lipodystrophy acquired 1089.13 12.93 308 61355 4017 79678708
Abortion spontaneous 1058.95 12.93 497 61166 29010 79653715
Stillbirth 832.47 12.93 245 61418 3710 79679015
Hepatitis B reactivation 771.37 12.93 256 61407 5852 79676873
Blood HIV RNA increased 740.04 12.93 189 61474 1619 79681106
Hepatitis B 738.11 12.93 268 61395 8064 79674661
Mitochondrial toxicity 695.49 12.93 202 61461 2912 79679813
Drug interaction 654.35 12.93 1158 60505 414025 79268700
Abortion induced 560.84 12.93 210 61453 6899 79675826
Fanconi syndrome acquired 502.35 12.93 152 61511 2542 79680183
Acquired gene mutation 486.05 12.93 142 61521 2091 79680634
Hepatitis B DNA increased 458.57 12.93 110 61553 705 79682020
Osteomalacia 434.92 12.93 119 61544 1361 79681364
Foetal exposure during pregnancy 377.89 12.93 149 61514 5641 79677084
Depression 368.14 12.93 626 61037 216164 79466561
Eyelid ptosis 311.74 12.93 158 61505 10886 79671839
Viral load increased 299.51 12.93 105 61558 2843 79679882
Progressive external ophthalmoplegia 293.06 12.93 87 61576 1358 79681367
Blood bilirubin increased 276.75 12.93 297 61366 65935 79616790
Hepatic failure 270.86 12.93 283 61380 60929 79621796
Lipoatrophy 267.17 12.93 69 61594 620 79682105
Fanconi syndrome 257.13 12.93 93 61570 2763 79679962
CD4 lymphocytes decreased 256.86 12.93 91 61572 2543 79680182
Treatment noncompliance 248.16 12.93 251 61412 52017 79630708
Hypophosphataemia 244.29 12.93 166 61497 19747 79662978
Psychotic disorder 240.21 12.93 222 61441 41180 79641545
Hepatotoxicity 231.81 12.93 240 61423 51112 79631613
Hypomania 224.87 12.93 112 61551 7432 79675293
Psychiatric decompensation 213.95 12.93 89 61574 3874 79678851
Nephropathy toxic 212.70 12.93 154 61509 20265 79662460
Caesarean section 209.55 12.93 127 61536 12408 79670317
Portal hypertension 207.37 12.93 104 61559 7004 79675721
Pregnancy 206.29 12.93 169 61494 26682 79656043
CSF HIV escape syndrome 201.25 12.93 48 61615 299 79682426
Alanine aminotransferase increased 192.82 12.93 403 61260 162167 79520558
Meningitis cryptococcal 190.16 12.93 79 61584 3427 79679298
Pain 188.33 12.93 161 61502 703641 78979084
Jaundice cholestatic 187.79 12.93 114 61549 11170 79671555
Multiple-drug resistance 180.94 12.93 102 61561 8706 79674019
Renal tubular disorder 174.93 12.93 90 61573 6396 79676329
Live birth 174.20 12.93 132 61531 18612 79664113
Peripheral swelling 168.43 12.93 10 61653 269607 79413118
Hypertriglyceridaemia 165.35 12.93 110 61553 12630 79670095
Maternal exposure during pregnancy 162.48 12.93 339 61324 136199 79546526
Hepatic fibrosis 162.38 12.93 89 61574 7191 79675534
Schizophrenia 162.06 12.93 117 61546 15323 79667402
Joint swelling 160.22 12.93 18 61645 288628 79394097
Kaposi's sarcoma 159.61 12.93 47 61616 712 79682013
Diplopia 157.51 12.93 160 61503 33306 79649419
Dyslipidaemia 157.18 12.93 103 61560 11530 79671195
Jaundice 157.18 12.93 200 61463 53149 79629576
Aspartate aminotransferase increased 150.91 12.93 332 61331 138309 79544416
Pulmonary tuberculosis 150.61 12.93 87 61576 7778 79674947
Fall 144.96 12.93 100 61563 487529 79195196
Proteinuria 143.23 12.93 150 61513 32352 79650373
Completed suicide 142.43 12.93 13 61650 245754 79436971
Depression suicidal 141.66 12.93 66 61597 3776 79678949
Infusion related reaction 139.47 12.93 10 61653 230227 79452498
Mitochondrial cytopathy 139.44 12.93 37 61626 373 79682352
Lymphadenopathy 138.85 12.93 188 61475 53059 79629666
Maternal drugs affecting foetus 137.41 12.93 51 61612 1632 79681093
Fatigue 136.37 12.93 326 61337 929401 78753324
Hepatitis C 135.86 12.93 95 61568 11830 79670895
Retinal toxicity 134.74 12.93 48 61615 1363 79681362
Glycosuria 134.72 12.93 54 61609 2134 79680591
Genotype drug resistance test positive 134.45 12.93 47 61616 1261 79681464
Nasopharyngitis 130.89 12.93 20 61643 253861 79428864
Psychomotor skills impaired 130.73 12.93 69 61594 5168 79677557
Tearfulness 129.60 12.93 72 61591 5973 79676752
Rheumatoid arthritis 129.37 12.93 8 61655 208462 79474263
Off label use 129.17 12.93 323 61340 906892 78775833
Foetal death 128.05 12.93 79 61584 7965 79674760
Hyperbilirubinaemia 127.92 12.93 124 61539 24394 79658331
Tuberculosis 125.93 12.93 100 61563 15098 79667627
Depressive symptom 125.53 12.93 72 61591 6351 79676374
Renal tubular dysfunction 124.36 12.93 39 61624 738 79681987
Lactic acidosis 124.20 12.93 207 61456 70152 79612573
Product dose omission issue 122.05 12.93 22 61641 247515 79435210
Hyperlactacidaemia 118.20 12.93 66 61597 5529 79677196
HIV-associated neurocognitive disorder 116.07 12.93 31 61632 321 79682404
Mycobacterium avium complex infection 113.11 12.93 60 61603 4540 79678185
Arthropathy 112.33 12.93 6 61657 177105 79505620
Hepatomegaly 107.11 12.93 100 61563 18774 79663951
Gene mutation 104.83 12.93 48 61615 2638 79680087
Synovitis 102.68 12.93 3 61660 150731 79531994
Cholelithiasis 101.15 12.93 161 61502 52503 79630222
Hepatic cirrhosis 99.87 12.93 129 61534 34777 79647948
Dyspnoea 98.00 12.93 338 61325 856687 78826038
Anaemia 97.61 12.93 633 61030 444382 79238343
Immune reconstitution inflammatory syndrome associated tuberculosis 97.44 12.93 33 61630 803 79681922
Premature rupture of membranes 97.03 12.93 52 61611 4017 79678708
Hypouricaemia 96.34 12.93 28 61635 404 79682321
Abdominal discomfort 95.79 12.93 37 61626 250690 79432035
Osteonecrosis 95.43 12.93 119 61544 30976 79651749
Pinealoblastoma 91.62 12.93 19 61644 54 79682671
Constipation 90.93 12.93 53 61610 282997 79399728
Premature labour 89.01 12.93 64 61599 8326 79674399
Sinusitis 88.86 12.93 21 61642 195480 79487245
Hepatic function abnormal 88.63 12.93 183 61480 72924 79609801
Stevens-Johnson syndrome 88.30 12.93 129 61534 39037 79643688
Urine phosphorus increased 87.44 12.93 19 61644 72 79682653
Hepatocellular carcinoma 87.08 12.93 65 61598 8956 79673769
Renal impairment 84.19 12.93 291 61372 157492 79525233
Drug intolerance 82.66 12.93 51 61612 264068 79418657
Cytomegalovirus chorioretinitis 82.55 12.93 52 61611 5438 79677287
Pre-eclampsia 82.33 12.93 57 61606 6984 79675741
Osteoporosis 82.17 12.93 149 61514 53963 79628762
Blood alkaline phosphatase increased 81.49 12.93 163 61500 63501 79619224
Systemic lupus erythematosus 80.42 12.93 3 61660 121146 79561579
Total lung capacity increased 80.17 12.93 38 61625 2260 79680465
Hydrops foetalis 80.14 12.93 28 61635 750 79681975
HIV viraemia 79.65 12.93 18 61645 85 79682640
Ultrasound antenatal screen 79.37 12.93 27 61636 666 79682059
Fat tissue increased 78.04 12.93 29 61634 931 79681794
Alopecia 77.65 12.93 41 61622 231314 79451411
Gamma-glutamyltransferase increased 77.30 12.93 146 61517 54534 79628191
Drug-induced liver injury 77.22 12.93 163 61500 65954 79616771
Hepatitis 76.56 12.93 147 61516 55580 79627145
Hepatic cytolysis 75.58 12.93 99 61564 27052 79655673
Cleft lip and palate 75.29 12.93 26 61637 672 79682053
Injection site pain 74.83 12.93 7 61656 129831 79552894
Ophthalmoplegia 74.49 12.93 39 61624 2873 79679852
Therapeutic product effect decreased 73.68 12.93 18 61645 163845 79518880
Acquired immunodeficiency syndrome 73.38 12.93 21 61642 286 79682439
Blood phosphorus decreased 73.35 12.93 52 61611 6616 79676109
Blood pressure increased 73.10 12.93 36 61627 211324 79471401
Blood bilirubin unconjugated increased 72.29 12.93 28 61635 1009 79681716
Blood lactic acid increased 71.31 12.93 67 61596 12677 79670048
Trisomy 18 70.82 12.93 24 61639 585 79682140
Hepatosplenomegaly 70.65 12.93 49 61614 6020 79676705
Swelling 70.40 12.93 40 61623 216671 79466054
Premature baby 70.22 12.93 41 61622 3739 79678986
Retinoblastoma 70.21 12.93 16 61647 79 79682646
Contusion 69.57 12.93 15 61648 148761 79533964
Varices oesophageal 68.88 12.93 48 61615 5943 79676782
Ergot poisoning 68.71 12.93 17 61646 126 79682599
Asthma-chronic obstructive pulmonary disease overlap syndrome 68.05 12.93 38 61625 3183 79679542
Wound 67.66 12.93 6 61657 116173 79566552
Pneumocystis jirovecii pneumonia 67.46 12.93 103 61560 32405 79650320
Loss of personal independence in daily activities 67.21 12.93 203 61460 102377 79580348
Arthralgia 66.90 12.93 223 61440 571580 79111145
Progressive multifocal leukoencephalopathy 66.69 12.93 81 61582 20519 79662206
Hyperlipidaemia 61.82 12.93 88 61575 26005 79656720
Normal newborn 61.75 12.93 48 61615 7024 79675701
Product use issue 60.94 12.93 44 61619 209778 79472947
Paranoia 60.63 12.93 75 61588 19357 79663368
Cryptococcosis 59.95 12.93 36 61627 3457 79679268
HIV infection 59.79 12.93 25 61638 1102 79681623
Cachexia 59.59 12.93 57 61606 11026 79671699
Hepatic encephalopathy 59.48 12.93 83 61580 24083 79658642
Cushing's syndrome 59.34 12.93 24 61639 971 79681754
Arthritis 59.28 12.93 9 61654 114871 79567854
Hypotension 59.16 12.93 161 61502 440156 79242569
Renal tubular acidosis 58.81 12.93 36 61627 3578 79679147
Lipohypertrophy 58.55 12.93 23 61640 861 79681864
Splenomegaly 58.27 12.93 76 61587 20678 79662047
Oligohydramnios 58.13 12.93 35 61628 3377 79679348
Drug ineffective 57.60 12.93 547 61116 1080366 78602359
Blood triglycerides increased 57.45 12.93 76 61587 20964 79661761
Hypophosphataemic osteomalacia 57.33 12.93 18 61645 342 79682383
Feeling abnormal 56.75 12.93 26 61637 159173 79523552
Amniotic cavity infection 56.48 12.93 22 61641 805 79681920
Inappropriate schedule of product administration 55.71 12.93 17 61646 133611 79549114
Ascites 55.71 12.93 156 61507 75406 79607319
Lymph node tuberculosis 55.50 12.93 23 61640 991 79681734
Headache 54.75 12.93 290 61373 653482 79029243
Calculus urinary 54.65 12.93 30 61633 2430 79680295
Facial wasting 54.50 12.93 13 61650 81 79682644
Transaminases increased 54.08 12.93 122 61541 51621 79631104
Premature delivery 53.92 12.93 78 61585 23389 79659336
Weight increased 53.79 12.93 82 61581 277304 79405421
Hepatitis A 53.28 12.93 22 61641 939 79681786
Alpha 1 foetoprotein abnormal 53.22 12.93 12 61651 56 79682669
Cerebral toxoplasmosis 53.02 12.93 29 61634 2333 79680392
Brain stem stroke 52.21 12.93 20 61643 699 79682026
Mitochondrial DNA deletion 50.90 12.93 9 61654 6 79682719
Renal failure 49.65 12.93 295 61368 200673 79482052
Pruritus 49.54 12.93 149 61514 394499 79288226
Blood creatinine increased 48.68 12.93 243 61420 154814 79527911
Injection site erythema 48.48 12.93 3 61660 78194 79604531
Nephrolithiasis 48.46 12.93 119 61544 53172 79629553
Psoriatic arthropathy 48.34 12.93 3 61660 77996 79604729
Pain in extremity 47.67 12.93 135 61528 364403 79318322
Death 47.56 12.93 251 61412 566263 79116462
Impaired healing 47.26 12.93 6 61657 87649 79595076
Malignant neoplasm progression 47.25 12.93 23 61640 135967 79546758
Pancreatitis 47.08 12.93 138 61525 68437 79614288
Oesophageal varices haemorrhage 46.51 12.93 33 61630 4203 79678522
Ectopic pregnancy 46.46 12.93 24 61639 1719 79681006
Influenza 46.45 12.93 21 61642 129585 79553140
Stomatitis 46.36 12.93 28 61635 146729 79535996
Lower respiratory tract infection 46.21 12.93 21 61642 129199 79553526
Hepatitis B surface antigen positive 46.19 12.93 13 61650 166 79682559
Drug abuse 46.09 12.93 35 61628 162656 79520069
Rickets 45.92 12.93 11 61652 70 79682655
Drug hypersensitivity 45.83 12.93 102 61561 298814 79383911
Basedow's disease 45.72 12.93 14 61649 244 79682481
Meningitis tuberculous 45.35 12.93 21 61642 1184 79681541
Asthma 45.22 12.93 24 61639 135071 79547654
Urinary tract infection 45.17 12.93 90 61573 274422 79408303
Oesophageal candidiasis 45.06 12.93 45 61618 9173 79673552
Tuberculoma of central nervous system 45.05 12.93 17 61646 570 79682155
Premature separation of placenta 44.68 12.93 21 61642 1225 79681500
Placental disorder 43.87 12.93 19 61644 914 79681811
Granulomatous rosacea 43.78 12.93 13 61650 203 79682522
CD4 lymphocytes increased 43.73 12.93 14 61649 284 79682441
Placental insufficiency 43.61 12.93 20 61643 1103 79681622
Toxicity to various agents 43.56 12.93 173 61490 421367 79261358
Ocular icterus 43.03 12.93 35 61628 5465 79677260
Nodular regenerative hyperplasia 42.92 12.93 21 61642 1340 79681385
Malaise 42.25 12.93 215 61448 489654 79193071
Pericarditis 42.13 12.93 14 61649 104222 79578503
HIV associated nephropathy 42.04 12.93 14 61649 323 79682402
Oropharyngeal pain 41.96 12.93 16 61647 109337 79573388
Atrial fibrillation 41.82 12.93 55 61608 197831 79484894
Oxygen saturation decreased 41.63 12.93 24 61639 129023 79553702
Acquired aminoaciduria 41.24 12.93 8 61655 14 79682711
Dizziness 41.03 12.93 239 61424 526202 79156523
Umbilical cord abnormality 40.80 12.93 12 61651 181 79682544
Hepatitis B virus test 40.67 12.93 7 61656 3 79682722
Rash maculo-papular 40.57 12.93 115 61548 55963 79626762
Blister 40.32 12.93 21 61642 119455 79563270
Nasal polyps 39.99 12.93 38 61625 7289 79675436
Heart rate decreased 39.96 12.93 4 61659 70312 79612413
Mycobacterium avium complex immune restoration disease 39.91 12.93 8 61655 18 79682707
Aminoaciduria 39.89 12.93 14 61649 380 79682345
COVID-19 39.68 12.93 38 61625 157636 79525089
Nasal congestion 39.48 12.93 6 61657 76546 79606179
Sarcoidosis 39.48 12.93 40 61623 8295 79674430
Pyrexia 39.46 12.93 740 60923 677969 79004756
Hepatitis cholestatic 39.31 12.93 51 61612 13801 79668924
Malaria 38.95 12.93 14 61649 408 79682317
Musculoskeletal stiffness 38.69 12.93 47 61616 174961 79507764
Muscle spasms 38.55 12.93 47 61616 174683 79508042
Chronic disease 38.42 12.93 11 61652 150 79682575
Hepatic cancer 38.39 12.93 44 61619 10485 79672240
Anaemia macrocytic 38.37 12.93 33 61630 5564 79677161
Optic nerve neoplasm 38.25 12.93 8 61655 24 79682701
Intentional product misuse 38.08 12.93 13 61650 95152 79587573
Psoriasis 38.06 12.93 11 61652 89576 79593149
White matter lesion 37.74 12.93 22 61641 2000 79680725
Urine calcium increased 37.49 12.93 10 61653 103 79682622
Back pain 37.33 12.93 116 61547 304064 79378661
Opportunistic infection 37.14 12.93 25 61638 2925 79679800
Helicobacter infection 37.03 12.93 5 61658 69699 79613026
Withdrawal hepatitis 36.99 12.93 6 61657 0 79682725
Mitochondrial DNA depletion 36.99 12.93 6 61657 0 79682725
Cardiac murmur 36.94 12.93 53 61610 15771 79666954
Infection 36.62 12.93 83 61580 241629 79441096
Bone metabolism disorder 36.16 12.93 14 61649 504 79682221
HIV test positive 35.80 12.93 10 61653 124 79682601
Pancytopenia 35.73 12.93 235 61428 165510 79517215
Mitochondrial myopathy 35.70 12.93 12 61651 285 79682440
Fibromyalgia 35.69 12.93 4 61659 64336 79618389
Disseminated tuberculosis 35.67 12.93 28 61635 4155 79678570
Psychomotor retardation 35.53 12.93 33 61630 6151 79676574
Stress 35.28 12.93 9 61654 79603 79603122
Blood pressure fluctuation 35.24 12.93 5 61658 67140 79615585
Strongyloidiasis 35.22 12.93 27 61636 3871 79678854
Acute hepatitis C 34.79 12.93 11 61652 214 79682511
Hepatitis B DNA assay positive 34.73 12.93 9 61654 82 79682643
Bronchitis 34.64 12.93 30 61633 130614 79552111
Cystostomy 34.64 12.93 9 61654 83 79682642
Spina bifida 34.62 12.93 10 61653 141 79682584
Mycobacterial infection 34.45 12.93 26 61637 3642 79679083
Confusional state 34.44 12.93 128 61535 317869 79364856
Anaphylactic reaction 34.28 12.93 11 61652 83732 79598993
Migraine 33.24 12.93 13 61650 87480 79595245
Discomfort 33.12 12.93 29 61634 125588 79557137
Gynaecomastia 33.03 12.93 35 61628 7646 79675079
Hepatic enzyme increased 32.98 12.93 248 61415 182362 79500363
Rhinorrhoea 32.95 12.93 9 61654 76065 79606660
Hyperphosphaturia 32.64 12.93 9 61654 106 79682619
Toxoplasmosis 31.92 12.93 22 61641 2675 79680050
Blood phosphorus abnormal 31.86 12.93 11 61652 284 79682441
Somnolence 31.58 12.93 88 61575 238893 79443832
Gastroschisis 31.53 12.93 7 61656 30 79682695
Renal glycosuria 31.53 12.93 7 61656 30 79682695
Pregnancy on contraceptive 31.52 12.93 15 61648 900 79681825
Chronic kidney disease 30.99 12.93 117 61546 66037 79616688
Neutropenia neonatal 30.99 12.93 7 61656 33 79682692
Optic atrophy 30.81 12.93 19 61644 1914 79680811
Bilirubin conjugated increased 30.75 12.93 29 61634 5510 79677215
Retroviral rebound syndrome 30.75 12.93 6 61657 11 79682714
Viraemia 30.70 12.93 22 61641 2847 79679878
Liver transplant 30.16 12.93 26 61637 4397 79678328
Diabetes mellitus 29.84 12.93 130 61533 78260 79604465
Benign hydatidiform mole 29.68 12.93 8 61655 86 79682639
AIDS cholangiopathy 29.49 12.93 6 61657 15 79682710
HIV lipodystrophy 29.49 12.93 6 61657 15 79682710
Cerebrovascular accident 29.04 12.93 47 61616 155245 79527480
Oral candidiasis 28.91 12.93 68 61595 29560 79653165
Cardio-respiratory arrest 28.66 12.93 25 61638 108485 79574240
Diarrhoea 28.66 12.93 494 61169 879995 78802730
Metabolic acidosis 28.52 12.93 133 61530 82396 79600329
Tuberculoid leprosy 28.29 12.93 8 61655 104 79682621
Night blindness 28.24 12.93 12 61651 551 79682174
Hyperphosphatasaemia 28.22 12.93 8 61655 105 79682620
Congenital intestinal malformation 28.21 12.93 6 61657 20 79682705
Amoebiasis 27.43 12.93 8 61655 117 79682608
Haematochezia 27.28 12.93 17 61646 87628 79595097
Foetal growth abnormality 27.16 12.93 6 61657 25 79682700
Vanishing bile duct syndrome 27.13 12.93 17 61646 1761 79680964
Placental infarction 27.12 12.93 8 61655 122 79682603
Rhinitis allergic 27.05 12.93 40 61623 12229 79670496
Memory impairment 26.88 12.93 28 61635 111706 79571019
Secondary syphilis 26.80 12.93 7 61656 66 79682659
Foetal growth restriction 26.78 12.93 18 61645 2101 79680624
Nervous system disorder 26.60 12.93 62 61601 26794 79655931
HIV wasting syndrome 26.52 12.93 7 61656 69 79682656
Respiratory arrest 26.49 12.93 6 61657 57544 79625181
Molluscum contagiosum 26.45 12.93 11 61652 478 79682247
Blood triglycerides abnormal 26.37 12.93 11 61652 482 79682243
Beta 2 microglobulin urine increased 26.25 12.93 8 61655 137 79682588
Intentional overdose 26.12 12.93 26 61637 105934 79576791
Erythema 26.09 12.93 87 61576 223203 79459522
Tremor 26.08 12.93 58 61605 170025 79512700
Injection site swelling 25.96 12.93 3 61660 47129 79635596
Hypercholesterolaemia 25.87 12.93 56 61607 23039 79659686
Herpes simplex 25.82 12.93 39 61624 12148 79670577
Injury 25.59 12.93 14 61649 77482 79605243
Paraesthesia 25.53 12.93 62 61601 176261 79506464
Illness 25.52 12.93 3 61660 46508 79636217
Encephalitis 25.46 12.93 43 61620 14717 79668008
Congenital anomaly 25.42 12.93 10 61653 376 79682349
Urticaria 25.36 12.93 67 61596 185134 79497591
Anogenital warts 25.30 12.93 13 61650 921 79681804
Rhabdomyosarcoma 25.28 12.93 8 61655 156 79682569
Thrombosis 25.24 12.93 17 61646 84083 79598642
Cough 25.20 12.93 173 61490 366616 79316109
Atypical mycobacterial lymphadenitis 25.02 12.93 5 61658 11 79682714
Hepatic steatosis 25.00 12.93 75 61588 37663 79645062
Dermatitis exfoliative 24.88 12.93 36 61627 10793 79671932
Glucose urine present 24.83 12.93 16 61647 1740 79680985
Genital herpes 24.67 12.93 17 61646 2067 79680658
Hyponatraemia 24.61 12.93 64 61599 177784 79504941
Bone density decreased 24.52 12.93 40 61623 13307 79669418
Syncope 24.51 12.93 65 61598 179384 79503341
Hepatitis fulminant 24.23 12.93 29 61634 7233 79675492
Suicidal ideation 24.19 12.93 120 61543 76220 79606505
Lymphocytic infiltration 24.08 12.93 15 61648 1538 79681187
Liver transplant rejection 24.01 12.93 20 61643 3228 79679497
Cardiac failure congestive 24.00 12.93 46 61617 142356 79540369
Urine phosphorus decreased 23.85 12.93 6 61657 48 79682677
Liver disorder 23.78 12.93 115 61548 72302 79610423
Epistaxis 23.54 12.93 31 61632 111484 79571241
Burning sensation 23.47 12.93 8 61655 58624 79624101
Post inflammatory pigmentation change 23.47 12.93 10 61653 462 79682263
Primary syphilis 23.43 12.93 5 61658 17 79682708
Astrocytoma, low grade 23.42 12.93 6 61657 52 79682673
Hepatitis E 23.36 12.93 19 61644 2967 79679758
Taeniasis 23.32 12.93 6 61657 53 79682672
Nephropathy 23.30 12.93 33 61630 9705 79673020
Osteoarthritis 23.20 12.93 20 61643 87289 79595436
Central nervous system lesion 23.13 12.93 39 61624 13329 79669396
Chest pain 23.12 12.93 126 61537 282178 79400547
Treatment failure 23.04 12.93 217 61446 170269 79512456
Blood bicarbonate decreased 22.94 12.93 24 61639 5167 79677558
Swollen tongue 22.74 12.93 3 61660 42567 79640158
Bradycardia 22.66 12.93 44 61619 135513 79547212
Flushing 22.52 12.93 21 61642 88247 79594478
Fluid retention 22.49 12.93 13 61650 69796 79612929
Meningomyelocele 22.23 12.93 5 61658 23 79682702
Viral load decreased 22.06 12.93 5 61658 24 79682701
Non-Hodgkin's lymphoma 21.97 12.93 14 61649 1493 79681232
Borderline leprosy 21.89 12.93 5 61658 25 79682700
Anaemia neonatal 21.89 12.93 5 61658 25 79682700
Placenta praevia 21.88 12.93 11 61652 744 79681981
Blood creatine phosphokinase increased 21.74 12.93 105 61558 65985 79616740
Parotid gland enlargement 21.70 12.93 12 61651 986 79681739
Neck pain 21.64 12.93 16 61647 75401 79607324
Lip swelling 21.57 12.93 3 61660 40908 79641817
Unevaluable event 21.54 12.93 8 61655 55577 79627148
Cystitis 21.45 12.93 7 61656 52725 79630000
Anembryonic gestation 21.31 12.93 9 61654 407 79682318
Osteoporotic fracture 21.28 12.93 21 61642 4219 79678506
Bulbar palsy 21.26 12.93 8 61655 266 79682459
Haematoma 21.11 12.93 7 61656 52188 79630537
Intracranial pressure increased 21.10 12.93 29 61634 8293 79674432
Hot flush 21.10 12.93 8 61655 54869 79627856
Incorrect dose administered 21.04 12.93 17 61646 76613 79606112
Mobility decreased 20.99 12.93 39 61624 122136 79560589
Osteonecrosis of jaw 20.94 12.93 4 61659 43222 79639503
Cryoglobulinaemia 20.86 12.93 11 61652 822 79681903
Breech delivery 20.85 12.93 5 61658 32 79682693
Gestational diabetes 20.78 12.93 25 61638 6268 79676457
Red blood cell sedimentation rate increased 20.73 12.93 5 61658 45937 79636788
Diverticulitis 20.73 12.93 5 61658 45931 79636794
Visual field defect 20.68 12.93 30 61633 9015 79673710
Cholestatic liver injury 20.34 12.93 22 61641 4919 79677806
Ileal ulcer 20.31 12.93 12 61651 1118 79681607
Type III hyperlipidaemia 20.28 12.93 4 61659 8 79682717
Loss of anatomical alignment after fracture reduction 20.28 12.93 4 61659 8 79682717
Isosporiasis 20.27 12.93 7 61656 181 79682544
Small for dates baby 20.14 12.93 9 61654 467 79682258
Dry mouth 20.13 12.93 23 61640 87996 79594729
Hospitalisation 20.09 12.93 26 61637 94210 79588515
Hepatitis D 20.07 12.93 6 61657 96 79682629
Erosive duodenitis 19.87 12.93 15 61648 2102 79680623
Hydrocephalus 19.60 12.93 29 61634 8871 79673854
Rhodococcus infection 19.54 12.93 8 61655 334 79682391
Red blood cells urine 19.53 12.93 10 61653 703 79682022
Blood pressure systolic increased 19.49 12.93 14 61649 66972 79615753
Cellulitis 19.47 12.93 34 61629 109026 79573699
Balance disorder 19.35 12.93 29 61634 98828 79583897
Localised infection 19.25 12.93 3 61660 37572 79645153
Antimitochondrial antibody positive 19.21 12.93 6 61657 112 79682613
Vomiting 19.19 12.93 661 61002 665167 79017558
Acute hepatic failure 19.15 12.93 59 61604 30054 79652671
Neuromyopathy 19.13 12.93 13 61650 1545 79681180
Disseminated Bacillus Calmette-Guerin infection 19.10 12.93 7 61656 216 79682509
Tubulointerstitial nephritis 19.06 12.93 69 61594 38166 79644559
Fat redistribution 18.96 12.93 6 61657 117 79682608
Abortion missed 18.91 12.93 12 61651 1271 79681454
Retroviral infection 18.89 12.93 4 61659 13 79682712
Postpartum haemorrhage 18.85 12.93 13 61650 1582 79681143
Chest discomfort 18.85 12.93 50 61613 137994 79544731
Therapeutic product effect incomplete 18.82 12.93 52 61611 141593 79541132
Orthostatic hypotension 18.75 12.93 10 61653 56154 79626571
Hypoglycaemia 18.75 12.93 31 61632 101563 79581162
Central nervous system immune reconstitution inflammatory response 18.62 12.93 5 61658 53 79682672
Bacterial pyelonephritis 18.61 12.93 9 61654 560 79682165
AIDS related complex 18.50 12.93 3 61660 0 79682725
Genetic polymorphism 18.50 12.93 3 61660 0 79682725
Vertical infection transmission 18.50 12.93 3 61660 0 79682725
Sleep apnoea syndrome 18.49 12.93 3 61660 36475 79646250
Histoplasmosis disseminated 18.46 12.93 15 61648 2338 79680387
Pubertal failure 18.44 12.93 4 61659 15 79682710
Hepatitis viral 18.40 12.93 11 61652 1047 79681678
Alpha 1 foetoprotein increased 18.36 12.93 10 61653 798 79681927
AIDS related complication 18.28 12.93 5 61658 57 79682668
Ultrasound scan abnormal 18.24 12.93 7 61656 246 79682479
Erythema elevatum diutinum 18.24 12.93 4 61659 16 79682709
CD4 lymphocytes 18.24 12.93 4 61659 16 79682709
Pneumonia aspiration 18.21 12.93 15 61648 66952 79615773
Optic nerve cupping 18.21 12.93 5 61658 58 79682667
Insomnia 18.16 12.93 113 61550 245057 79437668
Product prescribing error 18.14 12.93 6 61657 44807 79637918
Dehydration 18.07 12.93 115 61548 248072 79434653
Visual impairment 18.06 12.93 27 61636 92104 79590621
Trisomy 21 17.98 12.93 5 61658 61 79682664
Lymphadenitis 17.90 12.93 20 61643 4635 79678090
Portal hypertensive gastropathy 17.84 12.93 12 61651 1402 79681323
Oropharyngeal candidiasis 17.72 12.93 13 61650 1744 79680981
Hyperhidrosis 17.71 12.93 59 61604 151433 79531292
Upper respiratory tract infection 17.60 12.93 27 61636 91141 79591584
Paraparesis 17.55 12.93 18 61645 3785 79678940
Cardiac arrest 17.50 12.93 71 61592 172025 79510700
Brain oedema 17.48 12.93 51 61612 25212 79657513
Rectal haemorrhage 17.38 12.93 20 61643 76280 79606445
Anal cancer stage 0 17.35 12.93 4 61659 21 79682704
Drug dependence 17.32 12.93 5 61658 40764 79641961
Musculoskeletal pain 17.30 12.93 33 61630 102321 79580404
Blood lactate dehydrogenase increased 17.29 12.93 68 61595 39102 79643623
Renal atrophy 17.28 12.93 13 61650 1812 79680913
Amylase increased 17.18 12.93 31 61632 11178 79671547
Disease progression 16.96 12.93 79 61584 184283 79498442
Ballismus 16.95 12.93 7 61656 299 79682426
Gestational hypertension 16.94 12.93 13 61650 1866 79680859
Drug reaction with eosinophilia and systemic symptoms 16.94 12.93 96 61567 64148 79618577
Benign hepatic neoplasm 16.90 12.93 5 61658 77 79682648
Folliculitis 16.88 12.93 11 61652 55369 79627356
Acute lymphocytic leukaemia 16.84 12.93 20 61643 4949 79677776
Acute hepatitis B 16.79 12.93 8 61655 481 79682244
Clostridium difficile infection 16.78 12.93 6 61657 42679 79640046
Dyspepsia 16.71 12.93 37 61626 108650 79574075
Acute on chronic liver failure 16.62 12.93 7 61656 314 79682411
Ultrasound antenatal screen abnormal 16.50 12.93 5 61658 84 79682641
Ill-defined disorder 16.42 12.93 16 61647 65859 79616866
Kwashiorkor 16.42 12.93 3 61660 3 79682722
Hepatitis B DNA decreased 16.42 12.93 3 61660 3 79682722
Cervix operation 16.42 12.93 3 61660 3 79682722
Funisitis 16.42 12.93 3 61660 3 79682722
Blood uric acid decreased 16.42 12.93 11 61652 1277 79681448
Dry skin 16.39 12.93 17 61646 67978 79614747
Neurosyphilis 16.37 12.93 4 61659 28 79682697
ADAMTS13 activity decreased 16.34 12.93 6 61657 186 79682539
Cryptosporidiosis infection 16.34 12.93 9 61654 734 79681991
Heart rate increased 16.28 12.93 44 61619 120680 79562045
Albuminuria 16.27 12.93 9 61654 740 79681985
Sciatica 16.25 12.93 3 61660 33219 79649506
Plasmablastic lymphoma 16.23 12.93 8 61655 519 79682206
Abdominal pain upper 16.14 12.93 104 61559 223715 79459010
Influenza like illness 16.11 12.93 19 61644 71688 79611037
Pulmonary fibrosis 16.03 12.93 7 61656 44105 79638620
Viral hepatitis carrier 16.01 12.93 4 61659 31 79682694
Spermatozoa progressive motility abnormal 16.01 12.93 4 61659 31 79682694
Ear pain 16.01 12.93 3 61660 32866 79649859
Blood pressure decreased 16.01 12.93 33 61630 99433 79583292
Limb discomfort 16.00 12.93 3 61660 32847 79649878
Pathological fracture 15.97 12.93 29 61634 10508 79672217
Plasmodium falciparum infection 15.92 12.93 5 61658 95 79682630
Heart rate irregular 15.88 12.93 3 61660 32676 79650049
Bone pain 15.84 12.93 85 61578 55657 79627068
Portal vein thrombosis 15.83 12.93 21 61642 5806 79676919
Musculoskeletal toxicity 15.82 12.93 6 61657 204 79682521
Choroiditis 15.72 12.93 11 61652 1370 79681355
Dyspnoea exertional 15.67 12.93 27 61636 87046 79595679
Cardiac failure 15.67 12.93 64 61599 154778 79527947
Blood uric acid increased 15.66 12.93 33 61630 13327 79669398
Eclampsia 15.66 12.93 6 61657 210 79682515
Disseminated intravascular coagulation 15.64 12.93 62 61601 35780 79646945
Prenatal screening test abnormal 15.56 12.93 3 61660 5 79682720
Hypersensitivity 15.48 12.93 129 61534 262110 79420615
Hypersplenism 15.40 12.93 8 61655 580 79682145
Subacute sclerosing panencephalitis 15.38 12.93 4 61659 37 79682688
Bronchiectasis 15.31 12.93 45 61618 22341 79660384
Acute fatty liver of pregnancy 15.29 12.93 4 61659 38 79682687
Hyperbilirubinaemia neonatal 15.21 12.93 3 61660 6 79682719
Glycocholic acid increased 15.21 12.93 3 61660 6 79682719
Hydromyelia 15.21 12.93 3 61660 6 79682719
Carbon dioxide combining power abnormal 15.21 12.93 3 61660 6 79682719
Cholestasis 15.17 12.93 80 61583 52029 79630696
Transplant dysfunction 15.15 12.93 23 61640 7198 79675527
Basal cell carcinoma 15.13 12.93 5 61658 37370 79645355
Eyelid oedema 15.12 12.93 33 61630 13654 79669071
Toxic optic neuropathy 15.07 12.93 10 61653 1143 79681582
Ear infection 15.05 12.93 4 61659 34428 79648297
Hepatic necrosis 15.02 12.93 26 61637 9074 79673651
Glomerulonephritis proliferative 15.01 12.93 7 61656 401 79682324
Lipids abnormal 14.99 12.93 8 61655 613 79682112
Portal fibrosis 14.99 12.93 8 61655 613 79682112
Renal tubular necrosis 14.95 12.93 48 61615 24991 79657734
Dry eye 14.85 12.93 5 61658 36926 79645799
Colitis 14.84 12.93 21 61642 73286 79609439
Distributive shock 14.79 12.93 14 61649 2673 79680052
Burkitt's lymphoma 14.67 12.93 5 61658 124 79682601
Breast cancer 14.62 12.93 4 61659 33777 79648948
Osteocalcin increased 14.61 12.93 3 61660 8 79682717
Crystal urine 14.60 12.93 5 61658 126 79682599
Antiviral drug level below therapeutic 14.60 12.93 4 61659 46 79682679
International normalised ratio increased 14.59 12.93 27 61636 84694 79598031
Developmental delay 14.47 12.93 10 61653 1221 79681504
Hypertension 14.47 12.93 175 61488 330817 79351908
Acute stress disorder 14.45 12.93 7 61656 437 79682288
Rectosigmoid cancer metastatic 14.44 12.93 4 61659 48 79682677
CSF protein increased 14.41 12.93 10 61653 1230 79681495
Anogenital dysplasia 14.38 12.93 5 61658 132 79682593
Myopia 14.37 12.93 12 61651 1944 79680781
Ovarian failure 14.35 12.93 8 61655 668 79682057
Infected vasculitis 14.35 12.93 3 61660 9 79682716
Necrotising enterocolitis neonatal 14.35 12.93 3 61660 9 79682716
Hepatitis B surface antibody positive 14.27 12.93 6 61657 268 79682457
Anaphylactic shock 14.25 12.93 5 61658 35991 79646734
Blood creatine phosphokinase MB increased 14.25 12.93 14 61649 2797 79679928
Lipase increased 14.15 12.93 36 61627 16430 79666295
Herpes virus infection 14.15 12.93 22 61641 7027 79675698
Sleep disorder 14.15 12.93 28 61635 85649 79597076
Optic nerve disorder 14.14 12.93 10 61653 1267 79681458
Carnitine deficiency 14.13 12.93 6 61657 275 79682450
Pharyngotonsillitis 14.13 12.93 6 61657 275 79682450
Throat irritation 14.10 12.93 7 61656 40939 79641786
Blood glucose increased 13.97 12.93 44 61619 114931 79567794
Graft infection 13.97 12.93 8 61655 703 79682022
Portal vein occlusion 13.94 12.93 4 61659 55 79682670
Cerebellar syndrome 13.75 12.93 19 61644 5461 79677264
Limb injury 13.75 12.93 3 61660 29525 79653200
Obesity 13.70 12.93 5 61658 35120 79647605
Therapeutic response decreased 13.69 12.93 19 61644 66834 79615891
Colour vision tests abnormal 13.68 12.93 3 61660 12 79682713
Macrocephaly 13.62 12.93 4 61659 60 79682665
Medication error 13.57 12.93 20 61643 68622 79614103
Spermatozoa progressive motility decreased 13.56 12.93 4 61659 61 79682664
Prurigo 13.52 12.93 10 61653 1359 79681366
Emotional distress 13.52 12.93 7 61656 39962 79642763
Cytomegalovirus oesophagitis 13.48 12.93 8 61655 752 79681973
Colitis ulcerative 13.46 12.93 5 61658 34737 79647988
Optic neuropathy 13.45 12.93 15 61648 3469 79679256
Atypical mycobacterial infection 13.44 12.93 11 61652 1732 79680993
Secondary adrenocortical insufficiency 13.43 12.93 14 61649 3000 79679725
Hypomagnesaemia 13.40 12.93 10 61653 46901 79635824
Bovine tuberculosis 13.38 12.93 5 61658 163 79682562
Skin laceration 13.37 12.93 3 61660 28959 79653766
Multiple fractures 13.34 12.93 23 61640 8003 79674722
Cervical dysplasia 13.33 12.93 12 61651 2149 79680576
Melanaemia 13.32 12.93 4 61659 65 79682660
Pulmonary embolism 13.29 12.93 78 61585 171576 79511149
Wheezing 13.25 12.93 46 61617 116618 79566107
Vision blurred 13.24 12.93 40 61623 105858 79576867
Wrong technique in product usage process 13.21 12.93 23 61640 73852 79608873
Acute HIV infection 13.21 12.93 4 61659 67 79682658
Subchondral insufficiency fracture 13.21 12.93 4 61659 67 79682658
Leukopenia 13.18 12.93 143 61520 116370 79566355
Congenital diaphragmatic hernia 13.13 12.93 3 61660 15 79682710
Hepatitis D RNA positive 13.13 12.93 3 61660 15 79682710
Fungal infection 13.13 12.93 8 61655 41740 79640985
Obstructive airways disorder 13.11 12.93 4 61659 31455 79651270
Antiviral drug level above therapeutic 13.10 12.93 4 61659 69 79682656
Pleocytosis 13.07 12.93 10 61653 1429 79681296
Myelopathy 13.06 12.93 17 61646 4616 79678109
Interstitial lung disease 13.05 12.93 44 61619 112556 79570169
Joint injury 13.03 12.93 4 61659 31331 79651394
Syphilis 12.98 12.93 7 61656 547 79682178
Agitation 12.95 12.93 37 61626 99678 79583047

FDA Adverse Event Reporting System (Pediatric)

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

Pharmacologic Action:

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

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

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




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 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 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
EQ 600MG BASE;EQ 50MG BASE;300MG TRIUMEQ VIIV HLTHCARE N205551 Aug. 22, 2014 RX TABLET ORAL June 15, 2026 INFORMATION ADDED TO THE LABELING REGARDING THE RESULT OF STUDY 205860
EQ 60MG BASE;EQ 5MG BASE;30MG TRIUMEQ PD VIIV HLTHCARE N215413 March 30, 2022 RX TABLET, FOR SUSPENSION ORAL June 15, 2026 NEW PATIENT POPULATION
EQ 600MG BASE;EQ 50MG BASE;300MG TRIUMEQ VIIV HLTHCARE N205551 Aug. 22, 2014 RX TABLET ORAL Dec. 15, 2026 PEDIATRIC EXCLUSIVITY
EQ 60MG BASE;EQ 5MG BASE;30MG TRIUMEQ PD VIIV HLTHCARE N215413 March 30, 2022 RX TABLET, FOR SUSPENSION ORAL Dec. 15, 2026 PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

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

External reference:

IDSource
4020938 VUID
N0000148418 NUI
D00353 KEGG_DRUG
4020938 VANDF
C0209738 UMLSCUI
CHEBI:63577 CHEBI
3TC PDB_CHEM_ID
CHEMBL141 ChEMBL_ID
DB00709 DRUGBANK_ID
D019259 MESH_DESCRIPTOR_UI
60825 PUBCHEM_CID
12673 IUPHAR_LIGAND_ID
6908 INN_ID
2T8Q726O95 UNII
68244 RXNORM
186277 MMSL
4956 MMSL
d03858 MMSL
005079 NDDF
108698001 SNOMEDCT_US
386897000 SNOMEDCT_US

Pharmaceutical products:

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