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

Stem definitionDrug idCAS RN
uridine derivatives used as antiviral agents and as antineoplastics 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 µM/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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 -1.174 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 5.943 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 0.454 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 1.016 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 94.530 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 93.200 % High 1
herg hERG pIC50 3.331 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 1.265 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 3.342 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 87.940 % High 1
kinase-safety-class ACVR2B,BRAF,CAMK2D,CDK5,EIF2AK3,ERBB2,GRK2,ITK,MAP3K21,MAPK7,NTRK2,PDK1,PDK2,PRKDC,TEK 15
kinase-selectivity-class GRK2,MAP2K6 2
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 0.533 High 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 2.312 High 1
mh-clint Mouse hepatocyte intrinsic clearance 2.793 High 1
mppb Mouse plasma protein binding (% unbound) 95.830 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 1.758 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 0 High 1
pppb Pig plasma protein binding (% unbound) 94.940 % High 1
rat-kpuu-brain Rat brain Kpuu 0.014 % High 1
rh-clint Rat hepatocyte intrinsic clearance 2.070 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 98.220 % High 1
rppb Rat plasma protein binding (% unbound) 94.520 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 924.698 uM High 1

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 1771.98 18.39 1093 32097 237317 90357940
Virologic failure 1498.56 18.39 304 32886 1920 90593337
Viral mutation identified 1407.16 18.39 284 32906 1741 90593516
Abortion spontaneous 1219.56 18.39 525 32665 53531 90541726
Drug resistance 1110.47 18.39 418 32772 30031 90565226
Stillbirth 1039.45 18.39 284 32906 7159 90588098
Pathogen resistance 951.54 18.39 270 32920 7845 90587412
Foetal exposure during pregnancy 866.91 18.39 386 32804 42589 90552668
Immune reconstitution inflammatory syndrome 834.05 18.39 236 32954 6783 90588474
Abortion induced 632.35 18.39 216 32974 11672 90583585
Schizophrenia 614.09 18.39 224 32966 14690 90580567
Hypomania 482.31 18.39 164 33026 8733 90586524
Jaundice cholestatic 428.89 18.39 155 33035 9888 90585369
Blood bilirubin increased 395.49 18.39 228 32962 43242 90552015
Hepatotoxicity 389.48 18.39 230 32960 45612 90549645
Premature baby 389.24 18.39 188 33002 24889 90570368
Blood HIV RNA increased 378.00 18.39 82 33108 742 90594515
Hepatitis B reactivation 376.08 18.39 112 33078 3862 90591395
Foetal death 363.42 18.39 169 33021 20554 90574703
Cholelithiasis 360.68 18.39 230 32960 52276 90542981
Fanconi syndrome acquired 326.97 18.39 79 33111 1195 90594062
Caesarean section 318.00 18.39 149 33041 18428 90576829
Psychotic disorder 297.94 18.39 169 33021 31061 90564196
Lipodystrophy acquired 288.78 18.39 74 33116 1440 90593817
Maternal exposure during pregnancy 260.96 18.39 470 32720 359593 90235664
Asthma-chronic obstructive pulmonary disease overlap syndrome 260.38 18.39 89 33101 4810 90590447
Pregnancy 260.37 18.39 201 32989 61846 90533411
Treatment noncompliance 258.24 18.39 186 33004 51541 90543716
Total lung capacity increased 258.23 18.39 89 33101 4932 90590325
Cardiac murmur 230.88 18.39 119 33071 18075 90577182
CD4 lymphocytes decreased 197.27 18.39 55 33135 1492 90593765
Sarcoidosis 196.32 18.39 90 33100 10583 90584674
Nasal polyps 191.55 18.39 89 33101 10791 90584466
Maternal drugs affecting foetus 184.87 18.39 70 33120 5085 90590172
Premature rupture of membranes 162.23 18.39 65 33125 5493 90589764
Rhinitis allergic 155.12 18.39 89 33101 16696 90578561
Premature labour 151.23 18.39 81 33109 13295 90581962
Hepatitis B 146.44 18.39 57 33133 4462 90590795
Live birth 144.37 18.39 161 33029 78946 90516311
Anaemia 140.98 18.39 362 32828 352440 90242817
Bronchiectasis 138.96 18.39 92 33098 22238 90573019
Mitochondrial toxicity 134.28 18.39 34 33156 629 90594628
Nasopharyngitis 127.43 18.39 5 33185 407099 90188158
Peripheral swelling 126.24 18.39 6 33184 413100 90182157
Fanconi syndrome 125.94 18.39 41 33149 1902 90593355
Human immunodeficiency virus transmission 123.14 18.39 21 33169 39 90595218
Pre-eclampsia 122.37 18.39 66 33124 10982 90584275
Viral load increased 122.19 18.39 38 33152 1518 90593739
Foetal growth restriction 120.86 18.39 62 33128 9318 90585939
Acquired gene mutation 120.80 18.39 36 33154 1243 90594014
Abdominal discomfort 118.57 18.39 17 33173 477311 90117946
Temperature regulation disorder 118.13 18.39 71 33119 14508 90580749
Portal hypertension 116.84 18.39 49 33141 4652 90590605
Systemic lupus erythematosus 114.78 18.39 4 33186 361892 90233365
Hepatitis B DNA increased 111.65 18.39 25 33165 265 90594992
Alopecia 111.20 18.39 23 33167 495048 90100209
Osteomalacia 105.84 18.39 30 33160 865 90594392
Lipoatrophy 103.48 18.39 24 33166 301 90594956
Premature delivery 101.79 18.39 96 33094 38666 90556591
Lung neoplasm malignant 100.37 18.39 78 33112 24195 90571062
Dyslipidaemia 99.88 18.39 56 33134 10051 90585206
Fall 99.10 18.39 27 33163 481783 90113474
Nephropathy toxic 98.19 18.39 60 33130 12628 90582629
Alanine aminotransferase increased 96.48 18.39 163 33027 118175 90477082
Drug interaction 94.55 18.39 268 32922 276185 90319072
Lactic acidosis 94.27 18.39 104 33086 50359 90544898
Renal tubular dysfunction 92.60 18.39 24 33166 489 90594768
Genotype drug resistance test positive 90.81 18.39 23 33167 426 90594831
Aspartate aminotransferase increased 89.56 18.39 146 33044 102791 90492466
Swelling 89.00 18.39 22 33168 419036 90176221
Hyperbilirubinaemia 88.11 18.39 58 33132 13878 90581379
Sinusitis 85.66 18.39 12 33178 343076 90252181
Trisomy 21 85.46 18.39 22 33168 436 90594821
Hypophosphataemia 84.75 18.39 58 33132 14796 90580461
Discomfort 83.71 18.39 4 33186 274331 90320926
Immune reconstitution inflammatory syndrome associated tuberculosis 83.41 18.39 22 33168 481 90594776
Mitochondrial cytopathy 82.47 18.39 19 33171 231 90595026
Pericarditis 82.24 18.39 4 33186 270147 90325110
Congenital umbilical hernia 81.95 18.39 20 33170 316 90594941
Proteinuria 81.75 18.39 68 33122 23223 90572034
Hepatic enzyme increased 81.07 18.39 303 32887 360433 90234824
Hepatomegaly 80.72 18.39 54 33136 13272 90581985
Ectopic kidney 80.61 18.39 15 33175 55 90595202
Fatigue 79.95 18.39 192 32998 1153831 89441426
Glycosuria 79.77 18.39 27 33163 1415 90593842
Pain 78.71 18.39 154 33036 996187 89599070
Arthralgia 77.74 18.39 103 33087 778419 89816838
Birth mark 77.65 18.39 17 33173 161 90595096
Polydactyly 77.51 18.39 19 33171 306 90594951
Amniotic cavity infection 76.68 18.39 26 33164 1370 90593887
Ventricular septal defect 76.27 18.39 38 33152 5369 90589888
Product dose omission issue 75.70 18.39 9 33181 291678 90303579
CSF HIV escape syndrome 73.98 18.39 15 33175 94 90595163
Premature separation of placenta 73.73 18.39 29 33161 2333 90592924
Meningitis cryptococcal 73.43 18.39 27 33163 1806 90593451
Hyperlactacidaemia 73.31 18.39 34 33156 4102 90591155
Jaundice 73.15 18.39 74 33116 32443 90562814
Lymphadenopathy 73.10 18.39 87 33103 45688 90549569
Impaired healing 72.81 18.39 3 33187 234196 90361061
Food allergy 72.50 18.39 66 33124 25412 90569845
Retinoblastoma 71.89 18.39 14 33176 69 90595188
Pulmonary tuberculosis 71.23 18.39 35 33155 4799 90590458
Dyspnoea 69.67 18.39 136 33054 880819 89714438
Placental disorder 69.26 18.39 25 33165 1586 90593671
Chronic disease 69.11 18.39 16 33174 199 90595058
Atrial septal defect 69.04 18.39 41 33149 8193 90587064
Fat tissue increased 65.22 18.39 20 33170 762 90594495
Vomiting 64.56 18.39 501 32689 787792 89807465
Blood lactic acid increased 64.08 18.39 40 33150 8738 90586519
Ergot poisoning 64.04 18.39 13 33177 82 90595175
Blister 63.44 18.39 9 33181 254989 90340268
Contusion 62.18 18.39 9 33181 251207 90344050
Hepatic failure 60.97 18.39 74 33116 39654 90555603
Drug ineffective 60.93 18.39 281 32909 1384017 89211240
Fibromyalgia 59.86 18.39 4 33186 206265 90388992
Rash maculo-papular 59.20 18.39 74 33116 40859 90554398
Alpha 1 foetoprotein abnormal 58.76 18.39 11 33179 42 90595215
Arnold-Chiari malformation 58.34 18.39 18 33172 700 90594557
Blood cholesterol increased 57.64 18.39 5 33185 208007 90387250
Cleft lip and palate 57.42 18.39 18 33172 738 90594519
Stevens-Johnson syndrome 57.39 18.39 62 33128 29314 90565943
Hydrops foetalis 56.79 18.39 17 33173 596 90594661
Rash erythematous 56.14 18.39 92 33098 65012 90530245
Weight increased 55.64 18.39 43 33147 417884 90177373
Umbilical cord abnormality 55.00 18.39 17 33173 665 90594592
Pruritus 54.63 18.39 71 33119 541454 90053803
Malaria 53.59 18.39 13 33177 200 90595057
Lower respiratory tract infection 53.48 18.39 13 33177 250646 90344611
Chronic obstructive pulmonary disease 52.75 18.39 96 33094 73733 90521524
Renal tubular disorder 52.64 18.39 25 33165 3182 90592075
Therapeutic product effect decreased 50.89 18.39 19 33171 277552 90317705
Sleep disorder 49.22 18.39 7 33183 198023 90397234
Migraine 49.07 18.39 6 33184 190386 90404871
Tuberculosis 49.01 18.39 39 33151 12510 90582747
Injury 49.00 18.39 7 33183 197342 90397915
Normal newborn 48.63 18.39 51 33139 23311 90571946
Osteoarthritis 48.46 18.39 7 33183 195723 90399534
Immunodeficiency 48.44 18.39 69 33121 43165 90552092
Hypertriglyceridaemia 47.86 18.39 32 33158 7857 90587400
Hypophosphataemic osteomalacia 46.56 18.39 12 33178 239 90595018
Foetal distress syndrome 46.52 18.39 19 33171 1686 90593571
Ectopic pregnancy 46.37 18.39 23 33167 3218 90592039
Muscle spasms 44.92 18.39 18 33172 251865 90343392
Ocular icterus 44.70 18.39 24 33166 3956 90591301
Memory impairment 44.55 18.39 9 33181 197235 90398022
Mitochondrial DNA deletion 44.06 18.39 7 33183 6 90595251
Cushing's syndrome 43.58 18.39 14 33176 622 90594635
Cystostomy 43.28 18.39 9 33181 65 90595192
Oligohydramnios 43.18 18.39 29 33161 7172 90588085
Ultrasound antenatal screen abnormal 42.93 18.39 10 33180 128 90595129
Musculoskeletal stiffness 42.74 18.39 28 33162 296504 90298753
Coeliac disease 42.53 18.39 66 33124 44544 90550713
Malaise 42.40 18.39 95 33095 585891 90009366
Small for dates baby 42.16 18.39 25 33165 4982 90590275
Completed suicide 41.54 18.39 3 33187 145055 90450202
Neutropenia neonatal 41.52 18.39 9 33181 81 90595176
Blood bilirubin unconjugated increased 40.52 18.39 12 33178 405 90594852
Low birth weight baby 40.39 18.39 31 33159 9436 90585821
Influenza 39.54 18.39 3 33187 139261 90455996
Gene mutation 39.28 18.39 18 33172 2112 90593145
Dizziness 39.09 18.39 100 33090 589184 90006073
Patent ductus arteriosus 38.96 18.39 23 33167 4546 90590711
Anaemia macrocytic 38.94 18.39 23 33167 4549 90590708
Ill-defined disorder 38.64 18.39 10 33180 184881 90410376
Joint swelling 38.56 18.39 79 33111 503221 90092036
Dry mouth 38.37 18.39 10 33180 184049 90411208
Musculoskeletal pain 38.29 18.39 8 33182 171243 90424014
Foetal growth abnormality 38.20 18.39 8 33182 60 90595197
Stomatitis 38.17 18.39 27 33163 274671 90320586
Metabolic acidosis 38.01 18.39 71 33119 55605 90539652
Diarrhoea 37.49 18.39 197 32993 938993 89656264
Pregnancy on contraceptive 37.29 18.39 15 33175 1280 90593977
Hepatic cytolysis 37.10 18.39 51 33139 30865 90564392
Type 2 diabetes mellitus 37.10 18.39 14 33176 203230 90392027
Cleft palate 37.06 18.39 15 33175 1301 90593956
Hepatitis C 36.86 18.39 24 33166 5636 90589621
Rickets 36.81 18.39 8 33182 73 90595184
Placental insufficiency 36.80 18.39 16 33174 1659 90593598
Genetic polymorphism 36.40 18.39 6 33184 8 90595249
Neonatal disorder 36.38 18.39 12 33178 580 90594677
Anxiety 36.22 18.39 36 33154 309736 90285521
Isosporiasis 36.03 18.39 7 33183 34 90595223
Lymphadenitis 35.73 18.39 21 33169 4116 90591141
Joint range of motion decreased 35.63 18.39 4 33186 135639 90459618
Thrombocytopenia 35.48 18.39 161 33029 208564 90386693
Meningomyelocele 35.43 18.39 12 33178 630 90594627
Hydrocephalus 35.25 18.39 24 33166 6070 90589187
Isoimmune haemolytic disease 35.07 18.39 7 33183 40 90595217
Hydromyelia 34.89 18.39 6 33184 12 90595245
Placental infarction 34.77 18.39 10 33180 304 90594953
Confusional state 34.60 18.39 55 33135 386150 90209107
Insomnia 34.33 18.39 43 33147 333431 90261826
Cardiac malposition 34.11 18.39 7 33183 47 90595210
AIDS cholangiopathy 33.97 18.39 6 33184 15 90595242
Hypoaesthesia 33.96 18.39 39 33151 314171 90281086
Macrocephaly 33.77 18.39 9 33181 205 90595052
Urticaria 33.60 18.39 39 33151 312695 90282562
Neutropenia 33.52 18.39 167 33023 224737 90370520
Necrotising colitis 33.43 18.39 14 33176 1324 90593933
Ultrasound antenatal screen 33.29 18.39 9 33181 217 90595040
Gestational diabetes 33.25 18.39 29 33161 10553 90584704
Tuberculoma of central nervous system 33.10 18.39 10 33180 362 90594895
Dermatitis allergic 32.85 18.39 36 33154 17291 90577966
Pain in extremity 32.59 18.39 73 33117 450456 90144801
HIV-associated neurocognitive disorder 32.57 18.39 8 33182 130 90595127
Congenital anomaly 32.05 18.39 23 33167 6324 90588933
Hepatitis A 31.95 18.39 11 33179 607 90594650
Hypouricaemia 31.90 18.39 9 33181 255 90595002
Spina bifida 31.73 18.39 12 33178 868 90594389
Treatment failure 31.64 18.39 205 32985 303723 90291534
Postpartum haemorrhage 31.30 18.39 16 33174 2385 90592872
Neck pain 30.86 18.39 3 33187 113960 90481297
Liver injury 30.71 18.39 12 33178 170555 90424702
Hepatosplenomegaly 30.62 18.39 17 33173 2992 90592265
General physical health deterioration 30.48 18.39 52 33138 355063 90240194
Bilirubin conjugated increased 29.99 18.39 17 33173 3113 90592144
Mobility decreased 29.46 18.39 29 33161 250705 90344552
Congenital teratoma 29.42 18.39 5 33185 9 90595248
Adverse drug reaction 29.29 18.39 4 33186 116697 90478560
CD4 lymphocytes increased 29.27 18.39 8 33182 201 90595056
Loss of personal independence in daily activities 29.13 18.39 7 33183 136098 90459159
Renal tubular acidosis 28.95 18.39 15 33175 2300 90592957
Lymph node tuberculosis 28.87 18.39 11 33179 812 90594445
Double outlet right ventricle 28.77 18.39 6 33184 44 90595213
Anembryonic gestation 28.53 18.39 10 33180 582 90594675
Drug reaction with eosinophilia and systemic symptoms 28.53 18.39 54 33136 42704 90552553
Renal failure 28.48 18.39 109 33081 130898 90464359
Infertility 28.32 18.39 11 33179 856 90594401
Dyspepsia 28.15 18.39 19 33171 198141 90397116
Feeling abnormal 28.13 18.39 13 33177 167222 90428035
Necrotising enterocolitis neonatal 27.98 18.39 8 33182 238 90595019
Multiple-drug resistance 27.90 18.39 23 33167 7753 90587504
Gastroschisis 27.82 18.39 9 33181 409 90594848
Bicuspid pulmonary valve 27.65 18.39 4 33186 0 90595257
Hepatitis 27.54 18.39 72 33118 70667 90524590
Tetany 27.40 18.39 15 33175 2569 90592688
Funisitis 27.39 18.39 5 33185 16 90595241
Eyelid oedema 27.32 18.39 27 33163 11507 90583750
Hepatic displacement 27.16 18.39 5 33185 17 90595240
Ballismus 27.13 18.39 7 33183 140 90595117
COVID-19 27.07 18.39 14 33176 168829 90426428
Intentional product misuse 26.87 18.39 83 33107 89521 90505736
Ultrasound scan abnormal 26.71 18.39 8 33182 281 90594976
Gamma-glutamyltransferase increased 26.66 18.39 49 33141 37903 90557354
Oropharyngeal pain 26.54 18.39 5 33185 115182 90480075
Abdominal pain upper 26.50 18.39 51 33139 332623 90262634
Lung neoplasm 26.45 18.39 21 33169 6714 90588543
Fallot's tetralogy 26.43 18.39 6 33184 68 90595189
Kaposi's sarcoma 26.41 18.39 7 33183 156 90595101
Lipohypertrophy 26.37 18.39 10 33180 729 90594528
Retinal toxicity 26.17 18.39 12 33178 1410 90593847
Exposure via breast milk 26.11 18.39 14 33176 2301 90592956
Paraesthesia 26.05 18.39 32 33158 250294 90344963
Hepatitis B surface antigen positive 25.96 18.39 6 33184 74 90595183
Infusion related reaction 25.89 18.39 73 33117 416707 90178550
Obesity 25.59 18.39 4 33186 105503 90489754
Ascites 25.54 18.39 55 33135 47685 90547572
Alpha 1 foetoprotein increased 25.42 18.39 7 33183 181 90595076
Acquired aminoaciduria 25.41 18.39 4 33186 3 90595254
Benign hydatidiform mole 25.31 18.39 7 33183 184 90595073
Abortion missed 25.24 18.39 13 33177 1969 90593288
Congenital intestinal malformation 25.13 18.39 6 33184 86 90595171
Gestational hypertension 25.03 18.39 15 33175 3047 90592210
Cholestasis of pregnancy 24.99 18.39 12 33178 1565 90593692
Neonatal respiratory distress syndrome 24.85 18.39 15 33175 3086 90592171
Pyrexia 24.85 18.39 359 32831 660126 89935131
Renal impairment 24.82 18.39 90 33100 105331 90489926
Neural tube defect 24.72 18.39 7 33183 201 90595056
Drug level below therapeutic 24.72 18.39 19 33171 5795 90589462
Headache 24.70 18.39 200 32990 862546 89732711
Anaemia neonatal 24.66 18.39 8 33182 367 90594890
Blood creatine phosphokinase MB increased 24.58 18.39 11 33179 1221 90594036
Varices oesophageal 24.55 18.39 16 33174 3763 90591494
Ovarian failure 24.52 18.39 12 33178 1631 90593626
Twin pregnancy 24.49 18.39 11 33179 1232 90594025
Lipase increased 24.46 18.39 25 33165 11086 90584171
Congenital hydrocephalus 24.43 18.39 7 33183 210 90595047
Visual impairment 24.34 18.39 9 33181 132356 90462901
Sciatica 24.23 18.39 4 33186 101378 90493879
Blood pressure increased 24.11 18.39 22 33168 197195 90398062
Road traffic accident 24.11 18.39 5 33185 107621 90487636
Haemorrhage in pregnancy 24.05 18.39 13 33177 2172 90593085
Blood creatine phosphokinase increased 23.99 18.39 44 33146 33979 90561278
AIDS related complication 23.99 18.39 4 33186 6 90595251
Cachexia 23.96 18.39 20 33170 6858 90588399
Diastasis recti abdominis 23.94 18.39 5 33185 37 90595220
Malignant neoplasm progression 23.87 18.39 5 33185 106865 90488392
Hepatitis B DNA assay positive 23.82 18.39 5 33185 38 90595219
Gait inability 23.69 18.39 12 33178 146444 90448813
Adverse event 23.31 18.39 7 33183 117411 90477846
Type III hyperlipidaemia 23.26 18.39 4 33186 8 90595249
Inappropriate schedule of product administration 23.21 18.39 13 33177 149920 90445337
Cerebral toxoplasmosis 23.20 18.39 11 33179 1394 90593863
Atrial fibrillation 23.08 18.39 10 33180 133601 90461656
Hyperphosphaturia 22.97 18.39 5 33185 46 90595211
Aminoaciduria 22.84 18.39 6 33184 129 90595128
Fat redistribution 22.64 18.39 4 33186 10 90595247
HIV infection 22.54 18.39 8 33182 483 90594774
Foetal anaemia 22.54 18.39 6 33184 136 90595121
Gait disturbance 22.47 18.39 38 33152 260458 90334799
Neonatal aspiration 22.38 18.39 6 33184 140 90595117
Intentional product use issue 22.28 18.39 28 33162 216864 90378393
Respiratory distress 22.14 18.39 46 33144 38900 90556357
Therapeutic product effect incomplete 22.12 18.39 23 33167 193873 90401384
Renal glycosuria 22.11 18.39 4 33186 12 90595245
Trisomy 18 22.10 18.39 6 33184 147 90595110
Hepatitis cholestatic 22.08 18.39 21 33169 8540 90586717
Cholestatic liver injury 22.07 18.39 15 33175 3782 90591475
Rhodococcus infection 22.06 18.39 6 33184 148 90595109
Breast neoplasm 21.98 18.39 11 33179 1569 90593688
Micrognathia 21.94 18.39 7 33183 304 90594953
Pubertal failure 21.87 18.39 4 33186 13 90595244
Antiviral drug level below therapeutic 21.69 18.39 5 33185 61 90595196
Bovine tuberculosis 21.54 18.39 5 33185 63 90595194
Defaecation urgency 21.43 18.39 18 33172 6224 90589033
Diaphragmatic aplasia 21.42 18.39 4 33186 15 90595242
Transaminases increased 21.23 18.39 44 33146 37148 90558109
Gingival hypertrophy 21.22 18.39 12 33178 2188 90593069
Developmental delay 21.21 18.39 11 33179 1689 90593568
Injection site reaction 21.21 18.39 4 33186 92076 90503181
Ventricular hypoplasia 21.17 18.39 6 33184 173 90595084
Lower limb fracture 21.13 18.39 3 33187 85010 90510247
Social avoidant behaviour 21.08 18.39 14 33176 3399 90591858
Pharyngotonsillitis 21.07 18.39 6 33184 176 90595081
Carnitine deficiency 21.00 18.39 6 33184 178 90595079
Blood alkaline phosphatase increased 20.86 18.39 51 33139 48028 90547229
Acute lymphocytic leukaemia 20.84 18.39 13 33177 2835 90592422
Pulmonary artery atresia 20.84 18.39 4 33186 18 90595239
Myopathy toxic 20.80 18.39 8 33182 606 90594651
Dyschezia 20.77 18.39 13 33177 2852 90592405
Vertical infection transmission 20.74 18.39 3 33187 0 90595257
Liver transplant 20.64 18.39 12 33178 2305 90592952
Amnesia 20.60 18.39 7 33183 108498 90486759
Lactate pyruvate ratio increased 20.43 18.39 5 33185 80 90595177
Meningitis tuberculous 20.26 18.39 8 33182 650 90594607
Pallor 20.19 18.39 41 33149 34124 90561133
Cytomegalovirus chorioretinitis 20.16 18.39 12 33178 2407 90592850
Pleocytosis 20.11 18.39 9 33181 999 90594258
Bronchitis 19.98 18.39 16 33174 152911 90442346
Amenorrhoea 19.91 18.39 23 33167 11699 90583558
Pneumonia 19.87 18.39 336 32854 637723 89957534
Decreased immune responsiveness 19.84 18.39 20 33170 8728 90586529
Intentional overdose 19.74 18.39 5 33185 93829 90501428
Placental necrosis 19.74 18.39 4 33186 25 90595232
Splenomegaly 19.70 18.39 24 33166 12900 90582357
Thyroid tuberculosis 19.60 18.39 4 33186 26 90595231
Aqueductal stenosis 19.47 18.39 4 33186 27 90595230
Hemiataxia 19.47 18.39 4 33186 27 90595230
Hypotension 19.46 18.39 58 33132 325339 90269918
Spinal cord injury 19.29 18.39 9 33181 1100 90594157
Nervous system disorder 19.27 18.39 31 33159 21562 90573695
Blood albumin decreased 19.09 18.39 27 33163 16776 90578481
Muscular weakness 18.90 18.39 29 33161 206637 90388620
CSF protein increased 18.89 18.39 8 33182 778 90594479
Acquired immunodeficiency syndrome 18.88 18.39 5 33185 111 90595146
Bowel movement irregularity 18.77 18.39 17 33173 6497 90588760
Mycobacterium avium complex infection 18.77 18.39 14 33176 4084 90591173
Autoimmune hepatitis 18.75 18.39 21 33169 10330 90584927
Prescribed overdose 18.63 18.39 78 33112 97547 90497710
Myelopathy 18.59 18.39 13 33177 3431 90591826
Neuroendocrine tumour of the lung metastatic 18.51 18.39 5 33185 120 90595137
HELLP syndrome 18.50 18.39 9 33181 1208 90594049

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 2002.27 13.11 511 47901 2820 42570103
Virologic failure 1778.47 13.11 483 47929 3511 42569412
Immune reconstitution inflammatory syndrome 1613.98 13.11 556 47856 9587 42563336
Pathogen resistance 1469.36 13.11 535 47877 10915 42562008
Lipodystrophy acquired 993.21 13.11 297 48115 3153 42569770
Drug resistance 985.92 13.11 564 47848 33684 42539239
Depression 847.94 13.11 822 47590 110541 42462382
Drug interaction 825.81 13.11 1245 47167 265754 42307169
Foetal exposure during pregnancy 746.03 13.11 533 47879 46778 42526145
Hepatitis B 673.04 13.11 262 48150 6449 42566474
Exposure during pregnancy 559.42 13.11 246 48166 8302 42564621
Mitochondrial toxicity 525.33 13.11 171 48241 2444 42570479
Hepatitis B reactivation 495.64 13.11 189 48223 4389 42568534
Osteomalacia 393.68 13.11 107 48305 777 42572146
Hepatitis B DNA increased 386.50 13.11 97 48315 492 42572431
Eyelid ptosis 373.15 13.11 172 48240 6489 42566434
Fanconi syndrome acquired 362.29 13.11 122 48290 1948 42570975
Acquired gene mutation 332.33 13.11 107 48305 1473 42571450
Psychiatric decompensation 300.64 13.11 129 48283 4093 42568830
Progressive external ophthalmoplegia 262.18 13.11 87 48325 1324 42571599
Viral load increased 258.55 13.11 105 48307 2892 42570031
Depression suicidal 250.48 13.11 105 48307 3140 42569783
Tearfulness 249.40 13.11 107 48305 3393 42569530
Depressive symptom 245.94 13.11 109 48303 3744 42569179
Blood HIV RNA increased 244.21 13.11 85 48327 1506 42571417
Lipoatrophy 222.37 13.11 59 48353 386 42572537
Pinealoblastoma 217.85 13.11 49 48363 138 42572785
Psychomotor skills impaired 214.70 13.11 109 48303 5095 42567828
Hypertriglyceridaemia 196.90 13.11 130 48282 9996 42562927
Hepatic failure 192.84 13.11 227 48185 37873 42535050
Premature baby 185.10 13.11 176 48236 22977 42549946
Off label use 183.62 13.11 277 48135 638058 41934865
Fanconi syndrome 179.65 13.11 70 48342 1724 42571199
Diplopia 173.09 13.11 160 48252 20156 42552767
Polydactyly 166.84 13.11 60 48352 1174 42571749
Genotype drug resistance test 164.20 13.11 33 48379 41 42572882
Multiple-drug resistance 162.09 13.11 102 48310 7220 42565703
Renal tubular disorder 160.43 13.11 88 48324 4821 42568102
CD4 lymphocytes decreased 154.46 13.11 64 48348 1857 42571066
Hepatic fibrosis 147.36 13.11 83 48329 4789 42568134
Treatment noncompliance 143.78 13.11 195 48217 37477 42535446
Loss of personal independence in daily activities 142.46 13.11 225 48187 49591 42523332
Trisomy 21 141.40 13.11 44 48368 538 42572385
Kaposi's sarcoma 139.68 13.11 47 48365 748 42572175
Alanine aminotransferase increased 139.19 13.11 309 48103 88097 42484826
Portal hypertension 129.93 13.11 76 48336 4711 42568212
Paranoia 128.35 13.11 115 48297 13911 42559012
Gene mutation 125.41 13.11 54 48358 1727 42571196
Osteoporosis 122.35 13.11 115 48297 14791 42558132
Hypophosphataemia 118.10 13.11 132 48280 20813 42552110
Product dose omission issue 112.17 13.11 20 48392 154345 42418578
Maternal drugs affecting foetus 109.64 13.11 63 48349 3776 42569147
HIV-associated neurocognitive disorder 109.01 13.11 32 48380 316 42572607
Blood lactic acid increased 107.18 13.11 82 48330 7957 42564966
Retinal toxicity 103.95 13.11 34 48378 493 42572430
Osteonecrosis 103.49 13.11 108 48304 15757 42557166
Volvulus 103.48 13.11 49 48363 1964 42570959
Treatment failure 103.18 13.11 223 48189 62401 42510522
Psychotic disorder 102.17 13.11 145 48267 29063 42543860
Blood phosphorus decreased 100.05 13.11 58 48354 3535 42569388
Hepatic cirrhosis 97.35 13.11 116 48296 19586 42553337
Meningitis cryptococcal 96.77 13.11 55 48357 3228 42569695
Hepatitis C 94.53 13.11 84 48328 10049 42562874
Renal tubular dysfunction 92.43 13.11 30 48382 424 42572499
Aspartate aminotransferase increased 91.68 13.11 242 48170 76921 42496002
Jaundice 90.37 13.11 150 48262 34439 42538484
Dyslipidaemia 89.70 13.11 79 48333 9339 42563584
Caesarean section 89.46 13.11 45 48367 2061 42570862
Nephropathy toxic 87.94 13.11 102 48310 16736 42556187
Ophthalmoplegia 87.60 13.11 45 48367 2155 42570768
CSF HIV escape syndrome 87.14 13.11 24 48388 184 42572739
Dyspnoea 85.26 13.11 241 48171 442380 42130543
Pneumonia 84.17 13.11 226 48186 421923 42151000
Hypouricaemia 83.74 13.11 25 48387 263 42572660
Fall 83.49 13.11 86 48326 234434 42338489
Mycobacterium avium complex infection 82.00 13.11 48 48364 2979 42569944
Hyperlactacidaemia 80.63 13.11 55 48357 4461 42568462
Mitochondrial cytopathy 78.80 13.11 21 48391 140 42572783
Dandy-Walker syndrome 75.95 13.11 23 48389 255 42572668
Neonatal disorder 75.57 13.11 30 48382 777 42572146
Tuberculosis 75.47 13.11 74 48338 10025 42562898
Varices oesophageal 75.19 13.11 52 48360 4313 42568610
Death 75.14 13.11 279 48133 470906 42102017
Cytomegalovirus chorioretinitis 74.93 13.11 53 48359 4558 42568365
Peripheral swelling 74.22 13.11 8 48404 90262 42482661
Acquired immunodeficiency syndrome 73.59 13.11 26 48386 482 42572441
Pulmonary tuberculosis 73.08 13.11 56 48356 5445 42567478
Hepatic function abnormal 73.07 13.11 173 48239 51394 42521529
Blood alkaline phosphatase increased 72.56 13.11 134 48278 33463 42539460
Renal impairment 72.43 13.11 282 48130 109946 42462977
Pain 72.13 13.11 104 48308 244744 42328179
Fatigue 71.38 13.11 255 48157 435386 42137537
Hepatitis 70.78 13.11 118 48294 27182 42545741
Inappropriate schedule of product administration 70.56 13.11 12 48400 95890 42477033
Human immunodeficiency virus transmission 69.89 13.11 16 48396 50 42572873
Glycosuria 69.36 13.11 33 48379 1337 42571586
Drug abuse 69.03 13.11 17 48395 104754 42468169
Birth mark 68.28 13.11 19 48393 152 42572771
Lymphadenopathy 68.23 13.11 130 48282 33235 42539688
Progressive multifocal leukoencephalopathy 67.25 13.11 74 48338 11462 42561461
Congenital umbilical hernia 66.33 13.11 22 48390 334 42572589
Anaemia macrocytic 65.15 13.11 44 48368 3511 42569412
Proteinuria 64.54 13.11 103 48309 22880 42550043
Drug-induced liver injury 62.67 13.11 136 48276 38137 42534786
Hepatomegaly 62.56 13.11 72 48340 11713 42561210
Blood pressure increased 62.54 13.11 19 48393 101909 42471014
Hypotension 62.46 13.11 124 48288 257507 42315416
Constipation 61.79 13.11 56 48356 162235 42410688
Hepatocellular carcinoma 61.15 13.11 60 48352 8134 42564789
HIV infection 60.94 13.11 31 48381 1454 42571469
Genotype drug resistance test positive 57.91 13.11 28 48384 1176 42571747
Hepatic cancer 57.59 13.11 59 48353 8421 42564502
Completed suicide 57.37 13.11 19 48393 96446 42476477
Oesophageal candidiasis 57.16 13.11 49 48363 5586 42567337
Hyperlipidaemia 57.12 13.11 94 48318 21422 42551501
Hepatosplenomegaly 56.62 13.11 45 48367 4615 42568308
Hydrops foetalis 55.82 13.11 25 48387 880 42572043
Pregnancy 55.74 13.11 18 48394 250 42572673
Brain stem stroke 54.93 13.11 19 48393 330 42572593
Congenital anomaly 54.18 13.11 29 48383 1512 42571411
Suicidal ideation 54.09 13.11 148 48264 48013 42524910
Lipohypertrophy 53.57 13.11 18 48394 285 42572638
Calculus urinary 53.31 13.11 30 48382 1727 42571196
Ultrasound antenatal screen 52.93 13.11 21 48391 543 42572380
Blood bilirubin increased 52.69 13.11 135 48277 42117 42530806
Malignant neoplasm progression 52.29 13.11 29 48383 108371 42464552
Atrioventricular septal defect 51.69 13.11 17 48395 251 42572672
Gamma-glutamyltransferase increased 50.40 13.11 113 48299 32384 42540539
Facial wasting 49.98 13.11 14 48398 115 42572808
Blood triglycerides increased 49.89 13.11 75 48337 15821 42557102
Lactic acidosis 49.75 13.11 138 48274 45123 42527800
Urine phosphorus increased 49.67 13.11 14 48398 118 42572805
Nodular regenerative hyperplasia 49.29 13.11 24 48388 1024 42571899
Immune reconstitution inflammatory syndrome associated tuberculosis 48.89 13.11 20 48392 561 42572362
Congenital central nervous system anomaly 48.41 13.11 21 48391 684 42572239
Hyperbilirubinaemia 47.98 13.11 85 48327 20550 42552373
Basedow's disease 47.90 13.11 11 48401 35 42572888
Atrial fibrillation 47.60 13.11 53 48359 139540 42433383
Nasopharyngitis 47.45 13.11 18 48394 83978 42488945
Trisomy 18 47.38 13.11 22 48390 843 42572080
Bone density decreased 46.99 13.11 30 48382 2176 42570747
Hepatitis B virus test 46.25 13.11 8 48404 0 42572923
Cleft lip and palate 45.81 13.11 22 48390 910 42572013
Multiple fractures 45.80 13.11 26 48386 1522 42571401
Cryptococcosis 45.56 13.11 34 48378 3177 42569746
Optic nerve neoplasm 45.04 13.11 10 48402 26 42572897
Cryptorchism 44.26 13.11 28 48384 1999 42570924
Talipes 44.17 13.11 29 48383 2207 42570716
Psychomotor retardation 44.10 13.11 38 48374 4361 42568562
Congenital neoplasm 43.99 13.11 10 48402 30 42572893
Hepatic encephalopathy 43.87 13.11 72 48340 16370 42556553
Cerebral toxoplasmosis 43.38 13.11 28 48384 2070 42570853
Urine calcium increased 43.04 13.11 10 48402 34 42572889
Joint swelling 42.96 13.11 12 48400 68010 42504913
Pyelocaliectasis 42.59 13.11 24 48388 1385 42571538
Oral candidiasis 42.44 13.11 66 48346 14339 42558584
Blood bilirubin unconjugated increased 42.23 13.11 19 48393 676 42572247
Wheezing 42.22 13.11 6 48406 54775 42518148
Cachexia 42.15 13.11 49 48363 8055 42564868
Oesophageal varices haemorrhage 42.05 13.11 34 48378 3573 42569350
Macrocephaly 41.79 13.11 17 48395 470 42572453
Somnolence 41.43 13.11 60 48352 141045 42431878
Pruritus 41.42 13.11 96 48316 188675 42384248
Osteopenia 41.41 13.11 43 48369 6235 42566688
Thrombosis 39.85 13.11 14 48398 68497 42504426
Mycobacterium avium complex immune restoration disease 39.59 13.11 9 48403 27 42572896
Mitochondrial myopathy 39.52 13.11 13 48399 192 42572731
Drug ineffective 39.49 13.11 493 47919 629704 41943219
Stress 38.79 13.11 3 48409 44209 42528714
Renal tubular acidosis 38.75 13.11 29 48383 2721 42570202
CD4 lymphocytes increased 38.25 13.11 12 48400 151 42572772
Splenomegaly 38.07 13.11 69 48343 16978 42555945
Confusional state 37.76 13.11 84 48328 167513 42405410
Anaemia neonatal 37.48 13.11 15 48397 397 42572526
Pneumocystis jirovecii pneumonia 37.31 13.11 86 48326 25095 42547828
Optic atrophy 37.01 13.11 21 48391 1228 42571695
Injection site pain 36.87 13.11 10 48402 57788 42515135
COVID-19 36.35 13.11 47 48365 115901 42457022
Life expectancy shortened 36.30 13.11 9 48403 43 42572880
Neurodevelopmental disorder 35.95 13.11 15 48397 443 42572480
Death neonatal 35.80 13.11 14 48398 348 42572575
Prescribed overdose 35.01 13.11 57 48355 12870 42560053
Febrile neutropenia 34.95 13.11 102 48310 185601 42387322
Opportunistic infection 34.85 13.11 24 48388 1977 42570946
Rhabdomyosarcoma 34.58 13.11 9 48403 54 42572869
Infusion related reaction 34.39 13.11 13 48399 60793 42512130
Dizziness 34.31 13.11 156 48256 249098 42323825
Disease progression 34.02 13.11 70 48342 143586 42429337
Intentional product misuse 33.75 13.11 14 48398 61886 42511037
Blood phosphorus abnormal 33.66 13.11 11 48401 159 42572764
Feeling abnormal 33.17 13.11 19 48393 69767 42503156
Visceral leishmaniasis 33.12 13.11 19 48393 1135 42571788
White matter lesion 32.91 13.11 18 48394 980 42571943
Blood pyruvic acid increased 32.80 13.11 7 48405 14 42572909
HIV associated nephropathy 32.59 13.11 13 48399 341 42572582
Aminoaciduria 32.57 13.11 12 48400 252 42572671
Haematochezia 32.21 13.11 13 48399 58423 42514500
Cardiac disorder 32.10 13.11 8 48404 48924 42523999
Speech disorder developmental 31.98 13.11 24 48388 2261 42570662
Acute hepatitis C 31.79 13.11 10 48402 127 42572796
Lactate pyruvate ratio increased 31.63 13.11 6 48406 4 42572919
HIV lipodystrophy 31.58 13.11 7 48405 18 42572905
Hydrocele 31.50 13.11 25 48387 2558 42570365
Flushing 31.15 13.11 3 48409 37025 42535898
Hepatotoxicity 30.94 13.11 80 48332 25087 42547836
Abortion spontaneous 30.93 13.11 13 48399 391 42572532
Ascites 30.90 13.11 137 48275 56541 42516382
Congenital hydronephrosis 30.86 13.11 16 48396 781 42572142
Osteoporotic fracture 30.83 13.11 20 48392 1491 42571432
Mycobacterial infection 30.79 13.11 25 48387 2643 42570280
Beta 2 microglobulin urine increased 30.74 13.11 9 48403 88 42572835
Lymph node tuberculosis 30.73 13.11 14 48398 513 42572410
Incorrect dose administered 30.50 13.11 11 48401 52963 42519960
Meningomyelocele 30.40 13.11 11 48401 219 42572704
Secondary syphilis 30.38 13.11 9 48403 92 42572831
Viraemia 30.28 13.11 21 48391 1749 42571174
Transaminases increased 30.14 13.11 94 48318 32791 42540132
Cerebrovascular accident 29.82 13.11 40 48372 97120 42475803
HIV viraemia 29.81 13.11 8 48404 55 42572868
Cardiac failure congestive 29.71 13.11 32 48380 85570 42487353
Asthma 29.56 13.11 17 48395 62297 42510626
Mitochondrial DNA depletion 28.91 13.11 5 48407 0 42572923
Stevens-Johnson syndrome 28.83 13.11 72 48340 22106 42550817
Urticaria 28.80 13.11 25 48387 74011 42498912
Bone metabolism disorder 28.61 13.11 11 48401 261 42572662
Bone pain 28.60 13.11 75 48337 23717 42549206
Lower respiratory tract infection 28.50 13.11 6 48406 41200 42531723
Heart rate decreased 28.15 13.11 4 48408 36528 42536395
Retroviral rebound syndrome 28.11 13.11 6 48406 12 42572911
Low set ears 28.05 13.11 13 48399 496 42572427
Cushing's syndrome 28.03 13.11 12 48400 378 42572545
Muscle spasms 27.88 13.11 34 48378 86010 42486913
Cardio-respiratory arrest 27.81 13.11 16 48396 58620 42514303
Foetal growth restriction 27.57 13.11 32 48380 5251 42567672
Hepatitis cholestatic 27.54 13.11 44 48368 9780 42563143
HIV wasting syndrome 27.53 13.11 8 48404 76 42572847
Hypersplenism 27.34 13.11 13 48399 526 42572397
Contusion 27.28 13.11 7 48405 41978 42530945
Anaemia 27.13 13.11 458 47954 279820 42293103
Pre-eclampsia 26.90 13.11 7 48405 42 42572881
Blood creatinine increased 26.72 13.11 215 48197 109788 42463135
Hepatitis A 26.69 13.11 13 48399 555 42572368
Limb deformity 26.45 13.11 13 48399 566 42572357
Product use issue 26.29 13.11 29 48383 76722 42496201
Cytokine release syndrome 26.06 13.11 9 48403 44518 42528405
Granulomatous rosacea 26.03 13.11 9 48403 156 42572767
HIV test positive 25.93 13.11 9 48403 158 42572765
Angioedema 25.89 13.11 8 48404 42469 42530454
Tremor 25.79 13.11 44 48368 96885 42476038
Hypophosphataemic osteomalacia 25.72 13.11 9 48403 162 42572761
Spider naevus 25.69 13.11 6 48406 21 42572902
Syncope 25.65 13.11 46 48366 99360 42473563
Astrocytoma, low grade 25.55 13.11 8 48404 100 42572823
Influenza 25.42 13.11 20 48392 62155 42510768
Blood triglycerides abnormal 25.33 13.11 10 48402 255 42572668
Congenital cytomegalovirus infection 25.26 13.11 6 48406 23 42572900
Cardiac arrest 25.26 13.11 54 48358 109266 42463657
Hypospadias 24.55 13.11 25 48387 3542 42569381
Therapeutic product effect decreased 24.54 13.11 7 48405 39143 42533780
Meningitis tuberculous 24.49 13.11 13 48399 666 42572257
Small for dates baby 24.38 13.11 30 48382 5233 42567690
Tuberculoid leprosy 24.33 13.11 7 48405 64 42572859
Drug ineffective for unapproved indication 24.27 13.11 11 48401 46152 42526771
Blood creatine phosphokinase increased 24.23 13.11 114 48298 48224 42524699
Oxygen saturation decreased 23.79 13.11 23 48389 64664 42508259
Cardiac failure 23.69 13.11 54 48358 106802 42466121
Viral load decreased 23.65 13.11 6 48406 32 42572891
Hepatitis B surface antigen positive 23.45 13.11 8 48404 133 42572790
Trimethylaminuria 23.43 13.11 5 48407 10 42572913
Withdrawal hepatitis 23.13 13.11 4 48408 0 42572923
Genital herpes 23.09 13.11 13 48399 749 42572174
Chest discomfort 22.96 13.11 23 48389 63593 42509330
Antimitochondrial antibody positive 22.92 13.11 6 48406 37 42572886
Prostate cancer 22.91 13.11 11 48401 44632 42528291
Portal vein thrombosis 22.82 13.11 27 48385 4522 42568401
Drug intolerance 22.81 13.11 35 48377 80389 42492534
Vertical infection transmission 22.52 13.11 5 48407 13 42572910
Pancreatitis 22.39 13.11 103 48309 43165 42529758
Urine phosphorus decreased 22.39 13.11 6 48406 41 42572882
Nausea 22.34 13.11 317 48095 396482 42176441
Prenatal screening test abnormal 22.25 13.11 5 48407 14 42572909
Intracranial pressure increased 22.23 13.11 27 48385 4647 42568276
Cataract 22.12 13.11 4 48408 30600 42542323
Retroperitoneal disorder 22.02 13.11 6 48406 44 42572879
Hepatitis D RNA positive 21.99 13.11 5 48407 15 42572908
Night blindness 21.95 13.11 9 48403 254 42572669
Liver transplant rejection 21.80 13.11 20 48392 2493 42570430
Liver disorder 21.73 13.11 96 48316 39548 42533375
Disseminated tuberculosis 21.67 13.11 21 48391 2803 42570120
Bradycardia 21.66 13.11 40 48372 85444 42487479
Oesophageal atresia 21.58 13.11 11 48401 518 42572405
Nervous system disorder 21.49 13.11 55 48357 17140 42555783
Amylase increased 21.47 13.11 32 48380 6697 42566226
Chronic obstructive pulmonary disease 21.45 13.11 24 48388 63090 42509833
Gastroschisis 21.41 13.11 8 48404 175 42572748
Cellulitis 21.39 13.11 23 48389 61562 42511361
Fat tissue increased 21.29 13.11 11 48401 533 42572390
Rhinorrhoea 21.24 13.11 5 48407 31789 42541134
Anaphylactic reaction 21.23 13.11 11 48401 42732 42530191
Cardiogenic shock 21.21 13.11 7 48405 35633 42537290
Transient ischaemic attack 21.21 13.11 6 48406 33733 42539190
Abdominal discomfort 21.10 13.11 33 48379 75222 42497701
Fluid retention 21.07 13.11 5 48407 31614 42541309
Visual field defect 21.04 13.11 27 48385 4911 42568012
Taeniasis 21.04 13.11 6 48406 53 42572870
Oropharyngeal pain 21.03 13.11 11 48401 42499 42530424
Macrocytosis 20.89 13.11 14 48398 1103 42571820
Pulmonary embolism 20.85 13.11 68 48344 119544 42453379
Nephrolithiasis 20.81 13.11 90 48322 36740 42536183
Neuromyopathy 20.69 13.11 14 48398 1120 42571803
Heart rate increased 20.69 13.11 18 48394 53237 42519686
Psoriasis 20.68 13.11 15 48397 48589 42524334
Hyperhidrosis 20.66 13.11 45 48367 90467 42482456
Hepatitis C virus test 20.55 13.11 6 48406 58 42572865
Hepatitis D 20.46 13.11 6 48406 59 42572864
Dry skin 20.46 13.11 15 48397 48323 42524600
Perinatal HIV infection 20.36 13.11 4 48408 4 42572919
Maternal condition affecting foetus 20.36 13.11 4 48408 4 42572919
Herpes virus infection 20.34 13.11 23 48389 3669 42569254
Erythema 20.27 13.11 60 48352 108733 42464190
Exomphalos 20.09 13.11 8 48404 209 42572714
Malaria 20.05 13.11 8 48404 210 42572713
Attention deficit hyperactivity disorder 19.98 13.11 21 48391 3087 42569836
Strongyloidiasis 19.98 13.11 22 48390 3409 42569514
Unevaluable event 19.94 13.11 7 48405 34281 42538642
Back pain 19.92 13.11 88 48324 141688 42431235
Headache 19.88 13.11 175 48237 239194 42333729
Diaphragmatic hernia 19.88 13.11 9 48403 325 42572598
Lipids abnormal 19.88 13.11 10 48402 458 42572465
Primary syphilis 19.82 13.11 5 48407 26 42572897
Gynaecomastia 19.82 13.11 44 48368 12523 42560400
Bacterial pyelonephritis 19.80 13.11 9 48403 328 42572595
C-reactive protein increased 19.66 13.11 26 48386 63534 42509389
Bronchitis 19.52 13.11 15 48397 47186 42525737
Asymptomatic viral hepatitis 19.50 13.11 5 48407 28 42572895
Cerebral ventricle dilatation 19.37 13.11 13 48399 1026 42571897
Persistent foetal circulation 19.35 13.11 9 48403 346 42572577
Molluscum contagiosum 19.31 13.11 9 48403 348 42572575
Blood glucose increased 19.10 13.11 34 48378 73665 42499258
Crystal urine 19.09 13.11 6 48406 76 42572847
Epistaxis 19.02 13.11 29 48383 66797 42506126
Hepatitis B DNA assay positive 19.01 13.11 6 48406 77 42572846
Contraindicated product administered 18.94 13.11 3 48409 25269 42547654
Live birth 18.93 13.11 8 48404 244 42572679
Renal atrophy 18.90 13.11 14 48398 1293 42571630
Meconium ileus 18.80 13.11 5 48407 33 42572890
Liver transplant 18.78 13.11 19 48393 2672 42570251
Chest pain 18.77 13.11 88 48324 139442 42433481
Loss of anatomical alignment after fracture reduction 18.74 13.11 4 48408 8 42572915
Chordee 18.67 13.11 6 48406 82 42572841
Drug dependence 18.61 13.11 5 48407 29089 42543834
Illness 18.59 13.11 3 48409 24927 42547996
Chronic kidney disease 18.51 13.11 104 48308 47137 42525786
Neonatal pneumothorax 18.42 13.11 4 48408 9 42572914
Toxoplasmosis 18.42 13.11 15 48397 1592 42571331
Urinary tract infection 18.32 13.11 55 48357 99229 42473694
Floppy eyelid syndrome 18.31 13.11 5 48407 37 42572886
Optic nerve disorder 18.30 13.11 11 48401 717 42572206
Tracheo-oesophageal fistula 18.25 13.11 10 48402 546 42572377
Oropharyngeal candidiasis 18.23 13.11 12 48400 917 42572006
Anogenital warts 18.20 13.11 11 48401 724 42572199
Cryoglobulinaemia 18.19 13.11 10 48402 550 42572373
Hyponatraemia 18.15 13.11 57 48355 101405 42471518
Nephropathy 18.08 13.11 30 48382 6881 42566042
Amoebiasis 17.98 13.11 6 48406 93 42572830
Toxicity to various agents 17.95 13.11 170 48242 228966 42343957
Acquired aminoaciduria 17.85 13.11 4 48408 11 42572912
Fracture malunion 17.85 13.11 4 48408 11 42572912
Rectal haemorrhage 17.82 13.11 18 48394 49588 42523335
Sickle cell disease 17.79 13.11 7 48405 177 42572746
Ventricular fibrillation 17.78 13.11 6 48406 30117 42542806
Colitis ulcerative 17.71 13.11 4 48408 26171 42546752
Bulbar palsy 17.69 13.11 8 48404 288 42572635
Gout 17.61 13.11 5 48407 28050 42544873
Rectosigmoid cancer metastatic 17.60 13.11 4 48408 12 42572911
Creutzfeldt-Jakob disease 17.55 13.11 5 48407 44 42572879
Parotid gland enlargement 17.50 13.11 10 48402 593 42572330
Musculoskeletal stiffness 17.49 13.11 24 48388 57741 42515182
Endocardial fibroelastosis 17.35 13.11 4 48408 13 42572910
Meconium stain 17.35 13.11 3 48409 0 42572923
Adrenal androgen excess 17.35 13.11 3 48409 0 42572923
Gianotti-Crosti syndrome 17.35 13.11 3 48409 0 42572923
Gonadal dysgenesis 17.35 13.11 3 48409 0 42572923
Agitation 17.28 13.11 29 48383 64285 42508638
Micrognathia 17.24 13.11 8 48404 306 42572617
Nasal congestion 17.20 13.11 6 48406 29495 42543428
Adrenogenital syndrome 17.16 13.11 5 48407 48 42572875
Strabismus 17.16 13.11 17 48395 2331 42570592
Retinoblastoma 17.13 13.11 4 48408 14 42572909
Interstitial lung disease 17.10 13.11 40 48372 78422 42494501
Hepatitis B e antigen positive 17.07 13.11 5 48407 49 42572874
Anal cancer 17.05 13.11 9 48403 456 42572467
Middle ear inflammation 17.02 13.11 7 48405 199 42572724
Erosive duodenitis 17.02 13.11 15 48397 1774 42571149
Intentional overdose 17.01 13.11 20 48392 51436 42521487
Toxic optic neuropathy 17.00 13.11 12 48400 1028 42571895
Renal glycosuria 16.91 13.11 4 48408 15 42572908
Histoplasmosis disseminated 16.90 13.11 16 48396 2075 42570848
Renal aneurysm 16.89 13.11 7 48405 203 42572720
Blood uric acid decreased 16.89 13.11 9 48403 465 42572458
Polyneuropathy chronic 16.80 13.11 5 48407 52 42572871
Goitre 16.73 13.11 15 48397 1815 42571108
Glucose tolerance impaired 16.72 13.11 22 48390 4102 42568821
Hepatic steatosis 16.68 13.11 58 48354 21390 42551533
Developmental hip dysplasia 16.61 13.11 8 48404 333 42572590
Coccidioidomycosis 16.59 13.11 11 48401 851 42572072
Umbilical cord abnormality 16.55 13.11 5 48407 55 42572868
Orthostatic hypotension 16.52 13.11 7 48405 30563 42542360
AIDS related complication 16.51 13.11 4 48408 17 42572906
Blood triglycerides decreased 16.51 13.11 6 48406 121 42572802
Portal fibrosis 16.50 13.11 8 48404 338 42572585
Dehydration 16.48 13.11 94 48318 141673 42431250
Microalbuminuria 16.45 13.11 11 48401 863 42572060
Vanishing bile duct syndrome 16.44 13.11 15 48397 1856 42571067
Diverticulitis 16.41 13.11 3 48409 22770 42550153
Ear malformation 16.37 13.11 8 48404 344 42572579
Femoral neck fracture 16.37 13.11 22 48390 4187 42568736
Rash 16.36 13.11 219 48193 276735 42296188
Drug hypersensitivity 16.30 13.11 58 48354 99331 42473592
Clostridium difficile infection 16.30 13.11 3 48409 22656 42550267
Mobility decreased 16.22 13.11 10 48402 35296 42537627
Atypical mycobacterial infection 16.19 13.11 13 48399 1353 42571570
Glucose urine present 16.11 13.11 13 48399 1362 42571561
Memory impairment 16.10 13.11 20 48392 50202 42522721
Dry mouth 16.08 13.11 13 48399 39866 42533057
Optic nerve cupping 16.08 13.11 5 48407 61 42572862
Blood pressure decreased 15.95 13.11 26 48386 58306 42514617
Protrusion tongue 15.91 13.11 7 48405 236 42572687
Anogenital dysplasia 15.86 13.11 6 48406 136 42572787
Neurosyphilis 15.86 13.11 5 48407 64 42572859
Blood pressure systolic increased 15.78 13.11 6 48406 27962 42544961
Lymphocytic infiltration 15.66 13.11 11 48401 935 42571988
International normalised ratio increased 15.63 13.11 19 48393 48149 42524774
Transplant rejection 15.49 13.11 42 48370 13546 42559377
ADAMTS13 activity decreased 15.46 13.11 6 48406 146 42572777
Latent autoimmune diabetes in adults 15.39 13.11 6 48406 148 42572775
Congenital tuberculosis 15.37 13.11 4 48408 24 42572899
Glomerulonephritis proliferative 15.30 13.11 7 48405 259 42572664
Retroviral infection 15.27 13.11 3 48409 3 42572920
Tracheal fistula repair 15.27 13.11 3 48409 3 42572920
Hepatitis B DNA decreased 15.27 13.11 3 48409 3 42572920
Osteocalcin increased 15.27 13.11 3 48409 3 42572920
Musculoskeletal toxicity 15.24 13.11 6 48406 152 42572771
Hyperphosphatasaemia 15.13 13.11 5 48407 75 42572848
Neuroleptic malignant syndrome 15.11 13.11 3 48409 21469 42551454
Anal cancer stage 0 15.10 13.11 4 48408 26 42572897
Erythema elevatum diutinum 15.10 13.11 4 48408 26 42572897
Productive cough 15.04 13.11 22 48390 51545 42521378
Cryptosporidiosis infection 15.04 13.11 10 48402 777 42572146
Toxic neuropathy 14.98 13.11 9 48403 586 42572337
Hypercholesterolaemia 14.93 13.11 40 48372 12809 42560114
Hepatic enzyme increased 14.87 13.11 96 48316 45688 42527235
Subacute sclerosing panencephalitis 14.84 13.11 4 48408 28 42572895
Late developer 14.81 13.11 3 48409 4 42572919
Tubulointerstitial nephritis 14.79 13.11 73 48339 31475 42541448
Hyperphosphaturia 14.72 13.11 5 48407 82 42572841
Myopia 14.69 13.11 12 48400 1279 42571644
Psoriatic arthropathy 14.69 13.11 5 48407 24962 42547961
Ultrasound antenatal screen abnormal 14.66 13.11 5 48407 83 42572840
Sickle cell anaemia 14.66 13.11 7 48405 286 42572637
Hypomagnesaemia 14.65 13.11 7 48405 28481 42544442
Spermatozoa progressive motility abnormal 14.60 13.11 4 48408 30 42572893
Pulmonary fibrosis 14.60 13.11 6 48406 26675 42546248
Hepatitis viral 14.57 13.11 10 48402 819 42572104
Graft infection 14.45 13.11 8 48404 446 42572477
Optic neuropathy 14.44 13.11 16 48396 2496 42570427
White blood cell count increased 14.40 13.11 18 48394 45069 42527854
Urinary retention 14.40 13.11 16 48396 42198 42530725
Pain in extremity 14.38 13.11 106 48306 150498 42422425
Infection 14.30 13.11 72 48340 111996 42460927
Full blood count decreased 14.20 13.11 3 48409 20557 42552366
Plasma cell myeloma 14.17 13.11 20 48392 47558 42525365
Arthropathy 14.14 13.11 8 48404 29589 42543334
Gastrointestinal haemorrhage 14.12 13.11 60 48352 97666 42475257
Neutrophil count decreased 14.08 13.11 32 48380 63383 42509540
Product prescribing error 14.08 13.11 6 48406 26106 42546817
Tracheal stenosis 14.07 13.11 7 48405 313 42572610
Bone marrow oedema 14.06 13.11 10 48402 867 42572056
Lymphangiectasia 14.06 13.11 4 48408 35 42572888
Osteodystrophy 14.06 13.11 3 48409 6 42572917
Benign hepatic neoplasm 14.06 13.11 3 48409 6 42572917
Congenital pigmentation disorder 14.06 13.11 3 48409 6 42572917
Paraesthesia 14.05 13.11 40 48372 73419 42499504
Sinusitis 13.97 13.11 20 48392 47272 42525651
Dysgeusia 13.97 13.11 11 48401 34178 42538745
Product use in unapproved indication 13.95 13.11 138 48274 184318 42388605
Malaise 13.93 13.11 164 48248 211992 42360931
Borderline leprosy 13.86 13.11 4 48408 37 42572886
Post inflammatory pigmentation change 13.85 13.11 8 48404 484 42572439
Injection site erythema 13.84 13.11 3 48409 20192 42552731
Stillbirth 13.81 13.11 6 48406 196 42572727
Extensor plantar response 13.81 13.11 9 48403 676 42572247
Birth trauma 13.74 13.11 3 48409 7 42572916
Ergot poisoning 13.67 13.11 4 48408 39 42572884
Therapy partial responder 13.67 13.11 3 48409 20018 42552905
Wrong technique in product usage process 13.64 13.11 17 48395 42618 42530305
Non-Hodgkin's lymphoma 13.50 13.11 12 48400 1435 42571488
Coronary ostial stenosis 13.48 13.11 5 48407 107 42572816
Red blood cell schistocytes present 13.48 13.11 7 48405 343 42572580
Congenital anaemia 13.46 13.11 3 48409 8 42572915
Pancreas transplant rejection 13.45 13.11 6 48406 209 42572714
Foetal distress syndrome 13.45 13.11 11 48401 1175 42571748
Pneumococcal sepsis 13.44 13.11 12 48400 1443 42571480
Weight increased 13.42 13.11 70 48342 107913 42465010
Fat tissue decreased 13.36 13.11 5 48407 110 42572813
Anaphylactic shock 13.34 13.11 5 48407 23512 42549411
Arthralgia 13.34 13.11 159 48253 205079 42367844
COVID-19 pneumonia 13.30 13.11 4 48408 21609 42551314
Encephalitis 13.26 13.11 31 48381 9127 42563796
Stomatitis 13.24 13.11 23 48389 50306 42522617
Alpha 1 foetoprotein increased 13.16 13.11 9 48403 733 42572190
Respiratory arrest 13.13 13.11 8 48404 28416 42544507
Normal newborn 13.13 13.11 7 48405 362 42572561

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Virologic failure 2695.76 14.20 621 66453 4331 110517894
Viral mutation identified 2608.67 14.20 592 66482 3827 110518398
Immune reconstitution inflammatory syndrome 2531.44 14.20 754 66320 15472 110506753
Pathogen resistance 1941.90 14.20 628 66446 17044 110505181
Drug resistance 1757.52 14.20 799 66275 55575 110466650
Lipodystrophy acquired 1282.97 14.20 336 66738 4188 110518037
Abortion spontaneous 922.01 14.20 439 66635 33843 110488382
Hepatitis B reactivation 899.96 14.20 285 66789 7199 110515026
Exposure during pregnancy 886.69 14.20 766 66308 166658 110355567
Stillbirth 832.21 14.20 236 66838 4028 110518197
Hepatitis B 798.89 14.20 277 66797 9335 110512890
Blood HIV RNA increased 779.66 14.20 195 66879 1993 110520232
Drug interaction 776.30 14.20 1212 65862 498971 110023254
Mitochondrial toxicity 717.27 14.20 198 66876 3047 110519178
Fanconi syndrome acquired 619.62 14.20 174 66900 2860 110519365
Abortion induced 515.19 14.20 191 66883 7828 110514397
Acquired gene mutation 490.70 14.20 142 66932 2612 110519613
Hepatitis B DNA increased 479.90 14.20 110 66964 745 110521480
Osteomalacia 469.82 14.20 122 66952 1465 110520760
Schizophrenia 445.97 14.20 232 66842 21594 110500631
Psychotic disorder 436.34 14.20 310 66764 50627 110471598
Hypomania 396.20 14.20 169 66905 10041 110512184
Foetal exposure during pregnancy 385.98 14.20 152 66922 7353 110514872
Blood bilirubin increased 374.29 14.20 334 66740 75638 110446587
Eyelid ptosis 365.28 14.20 173 66901 13154 110509071
Psychiatric decompensation 340.05 14.20 129 66945 5636 110516589
Progressive external ophthalmoplegia 320.07 14.20 88 66986 1332 110520893
Treatment noncompliance 318.80 14.20 300 66774 72690 110449535
Depression 318.13 14.20 636 66438 316699 110205526
Jaundice cholestatic 317.82 14.20 162 66912 14446 110507779
Hepatotoxicity 312.80 14.20 279 66795 63121 110459104
Viral load increased 298.36 14.20 102 66972 3288 110518937
Cholelithiasis 293.05 14.20 269 66805 63153 110459072
Hepatic failure 289.67 14.20 277 66797 68462 110453763
CD4 lymphocytes decreased 279.49 14.20 94 66980 2880 110519345
Lipoatrophy 279.17 14.20 67 67007 567 110521658
Depression suicidal 273.94 14.20 105 66969 4719 110517506
Fanconi syndrome 271.60 14.20 96 66978 3423 110518802
Portal hypertension 257.98 14.20 119 66955 8518 110513707
Tearfulness 252.96 14.20 112 66962 7283 110514942
Psychomotor skills impaired 244.99 14.20 108 66966 6950 110515275
Depressive symptom 229.89 14.20 109 66965 8305 110513920
Nephropathy toxic 223.25 14.20 162 66912 27316 110494909
Foetal death 222.02 14.20 132 66942 15913 110506312
Total lung capacity increased 219.67 14.20 91 66983 5021 110517204
Caesarean section 218.59 14.20 124 66950 13693 110508532
Alanine aminotransferase increased 213.02 14.20 392 66682 183381 110338844
CSF HIV escape syndrome 211.49 14.20 48 67026 309 110521916
Hypophosphataemia 210.91 14.20 169 66905 33013 110489212
Dyslipidaemia 209.66 14.20 127 66947 15838 110506387
Asthma-chronic obstructive pulmonary disease overlap syndrome 200.77 14.20 91 66983 6253 110515972
Peripheral swelling 197.26 14.20 12 67062 404022 110118203
Multiple-drug resistance 178.23 14.20 107 66967 13128 110509097
Nasopharyngitis 177.61 14.20 17 67057 394344 110127881
Renal tubular disorder 172.17 14.20 86 66988 7343 110514882
Hepatic fibrosis 171.24 14.20 88 66986 7978 110514247
Meningitis cryptococcal 165.70 14.20 73 67001 4689 110517536
Aspartate aminotransferase increased 164.13 14.20 324 66750 159612 110362613
Pulmonary tuberculosis 163.67 14.20 89 66985 9050 110513175
Jaundice 160.89 14.20 189 66885 59047 110463178
Hepatitis C 159.92 14.20 98 66976 12475 110509750
Hypertriglyceridaemia 158.67 14.20 107 66967 16047 110506178
Diplopia 158.12 14.20 159 66915 41735 110480490
Lymphadenopathy 155.93 14.20 193 66881 63642 110458583
Kaposi's sarcoma 155.89 14.20 43 67031 659 110521566
Arthropathy 151.84 14.20 5 67069 287517 110234708
Sarcoidosis 147.24 14.20 93 66981 12486 110509739
Proteinuria 145.77 14.20 149 66925 39869 110482356
Maternal drugs affecting foetus 143.65 14.20 49 67025 1568 110520657
Genotype drug resistance test positive 142.31 14.20 47 67027 1359 110520866
Renal tubular dysfunction 141.43 14.20 42 67032 848 110521377
Tuberculosis 140.32 14.20 103 66971 17671 110504554
Paranoia 140.15 14.20 113 66961 22261 110499964
Mitochondrial cytopathy 139.70 14.20 35 67039 360 110521865
HIV-associated neurocognitive disorder 138.57 14.20 35 67039 373 110521852
Nasal polyps 138.25 14.20 91 66983 13109 110509116
Glycosuria 137.81 14.20 54 67020 2576 110519649
Pregnancy 135.47 14.20 161 66913 50906 110471319
Pain 134.92 14.20 233 66841 954722 109567503
Fall 132.94 14.20 103 66971 603379 109918846
Abdominal discomfort 131.32 14.20 38 67036 393820 110128405
Retinal toxicity 130.85 14.20 46 67028 1613 110520612
Systemic lupus erythematosus 125.77 14.20 7 67067 254331 110267894
Cardiac murmur 124.63 14.20 110 66964 24518 110497707
Product dose omission issue 123.21 14.20 23 67051 321759 110200466
Hyperbilirubinaemia 122.38 14.20 120 66954 30551 110491674
Immune reconstitution inflammatory syndrome associated tuberculosis 121.98 14.20 39 67035 1015 110521210
Rhinitis allergic 117.55 14.20 93 66981 17829 110504396
Lactic acidosis 115.12 14.20 204 66870 92607 110429618
Alopecia 113.06 14.20 40 67034 364713 110157512
Anaemia 112.94 14.20 640 66434 546446 109975779
Hepatomegaly 111.08 14.20 97 66977 21317 110500908
Osteonecrosis 109.27 14.20 118 66956 33623 110488602
Gene mutation 107.92 14.20 49 67025 3380 110518845
Dyspnoea 107.85 14.20 330 66744 1106542 109415683
Sinusitis 107.78 14.20 24 67050 296664 110225561
Mycobacterium avium complex infection 107.37 14.20 58 67016 5819 110516406
Swelling 106.26 14.20 40 67034 351001 110171224
Fatigue 105.82 14.20 381 66693 1215577 109306648
Wound 105.77 14.20 10 67064 234427 110287798
Psoriatic arthropathy 105.39 14.20 3 67071 196758 110325467
Completed suicide 105.08 14.20 12 67062 242369 110279856
Hyperlactacidaemia 103.89 14.20 64 67010 8222 110514003
Hepatic function abnormal 101.51 14.20 189 66885 89106 110433119
Maternal exposure during pregnancy 100.07 14.20 361 66713 254522 110267703
Renal impairment 99.26 14.20 295 66779 188150 110334075
Hepatocellular carcinoma 98.36 14.20 66 67008 9814 110512411
Pinealoblastoma 96.22 14.20 19 67055 54 110522171
Impaired healing 95.47 14.20 6 67068 196711 110325514
Contusion 95.27 14.20 14 67060 233347 110288878
Hypouricaemia 95.01 14.20 28 67046 550 110521675
Premature rupture of membranes 93.86 14.20 49 67025 4588 110517637
Blood alkaline phosphatase increased 91.96 14.20 159 66915 70776 110451449
Ophthalmoplegia 90.93 14.20 44 67030 3506 110518719
Helicobacter infection 89.92 14.20 5 67069 181872 110340353
Temperature regulation disorder 89.41 14.20 69 67005 12757 110509468
Pericarditis 87.49 14.20 14 67060 219100 110303125
Fibromyalgia 86.71 14.20 4 67070 170905 110351320
Hydrops foetalis 86.70 14.20 28 67046 753 110521472
Irritable bowel syndrome 86.16 14.20 3 67071 164212 110358013
Lower respiratory tract infection 85.64 14.20 21 67053 243085 110279140
Ultrasound antenatal screen 85.32 14.20 27 67047 679 110521546
Blood lactic acid increased 84.75 14.20 73 67001 15748 110506477
Acquired immunodeficiency syndrome 84.46 14.20 23 67051 335 110521890
Therapeutic product effect decreased 84.34 14.20 22 67052 244294 110277931
Stevens-Johnson syndrome 84.15 14.20 122 66952 46779 110475446
Blister 83.36 14.20 18 67056 227358 110294867
Stomatitis 83.10 14.20 30 67044 270212 110252013
Off label use 82.98 14.20 552 66522 1499633 109022592
Joint swelling 82.64 14.20 88 66986 442757 110079468
Pruritus 80.95 14.20 143 66931 581417 109940808
Fat tissue increased 80.86 14.20 29 67045 1079 110521146
HIV viraemia 80.68 14.20 18 67056 106 110522119
Blood phosphorus decreased 80.65 14.20 53 67021 7612 110514613
Cleft lip and palate 80.27 14.20 26 67048 706 110521519
Gamma-glutamyltransferase increased 80.23 14.20 138 66936 61171 110461054
Urine phosphorus increased 79.89 14.20 19 67055 154 110522071
Injection site pain 79.17 14.20 8 67066 177914 110344311
Premature labour 78.90 14.20 56 67018 9116 110513109
Hepatosplenomegaly 78.10 14.20 50 67024 6869 110515356
Arthralgia 76.81 14.20 231 66843 779401 109742824
Varices oesophageal 76.19 14.20 50 67024 7165 110515060
Trisomy 18 76.09 14.20 24 67050 597 110521628
Hypophosphataemic osteomalacia 75.48 14.20 22 67052 415 110521810
Blood bilirubin unconjugated increased 75.37 14.20 28 67046 1153 110521072
Retinoblastoma 74.60 14.20 16 67058 76 110522149
Ergot poisoning 73.54 14.20 17 67057 120 110522105
Pre-eclampsia 70.25 14.20 51 67023 8599 110513626
Progressive multifocal leukoencephalopathy 70.04 14.20 81 66993 24875 110497350
Bronchiectasis 69.99 14.20 98 66976 36395 110485830
Cytomegalovirus chorioretinitis 69.49 14.20 47 67027 7081 110515144
Loss of personal independence in daily activities 68.92 14.20 224 66850 149796 110372429
Folliculitis 68.55 14.20 10 67064 167643 110354582
Premature baby 67.31 14.20 40 67034 4815 110517410
Injury 67.12 14.20 13 67061 177252 110344973
Weight increased 67.08 14.20 94 66980 419550 110102675
Hepatic encephalopathy 66.69 14.20 84 66990 28172 110494053
Blood pressure increased 66.41 14.20 37 67037 258336 110263889
Dry mouth 65.30 14.20 20 67054 199928 110322297
Lipohypertrophy 64.75 14.20 24 67050 982 110521243
Urticaria 64.48 14.20 59 67015 318798 110203427
Muscle spasms 64.35 14.20 45 67029 278112 110244113
Migraine 64.13 14.20 13 67061 171639 110350586
Cryptococcosis 63.80 14.20 38 67036 4593 110517632
Malaise 63.34 14.20 203 66871 671616 109850609
Infusion related reaction 63.32 14.20 83 66991 381079 110141146
Renal tubular acidosis 63.17 14.20 38 67036 4677 110517548
Lymph node tuberculosis 62.57 14.20 24 67050 1080 110521145
Pneumocystis jirovecii pneumonia 62.33 14.20 101 66973 42634 110479591
Hepatic cirrhosis 62.20 14.20 131 66943 67495 110454730
Inappropriate schedule of product administration 61.93 14.20 23 67051 203614 110318611
Cachexia 61.67 14.20 56 67018 12949 110509276
Osteoporosis 60.43 14.20 151 66923 87001 110435224
Blood creatinine increased 60.20 14.20 245 66829 182644 110339581
Calculus urinary 60.09 14.20 32 67042 3120 110519105
Chronic disease 59.95 14.20 16 67058 215 110522010
Arthritis 59.95 14.20 14 67060 167572 110354653
Splenomegaly 59.69 14.20 74 67000 24424 110497801
Facial wasting 59.10 14.20 13 67061 71 110522154
Renal failure 59.02 14.20 283 66791 226291 110295934
Musculoskeletal stiffness 58.72 14.20 50 67024 279772 110242453
Ascites 58.37 14.20 155 66919 92653 110429572
Hepatitis cholestatic 57.87 14.20 62 67012 17504 110504721
Lung neoplasm malignant 57.77 14.20 86 66988 33756 110488469
Dizziness 57.76 14.20 223 66851 697970 109824255
Discomfort 57.74 14.20 29 67045 214678 110307547
Live birth 57.52 14.20 129 66945 69355 110452870
Confusional state 56.75 14.20 125 66949 468555 110053670
Osteoarthritis 56.59 14.20 20 67054 182603 110339622
Food allergy 56.40 14.20 65 67009 19883 110502342
Suicidal ideation 56.18 14.20 154 66920 93783 110428442
Amniotic cavity infection 56.04 14.20 21 67053 886 110521339
Cushing's syndrome 55.53 14.20 21 67053 909 110521316
Joint range of motion decreased 55.46 14.20 5 67069 121827 110400398
Mobility decreased 55.46 14.20 38 67036 237384 110284841
HIV infection 55.32 14.20 23 67051 1280 110520945
Blood triglycerides increased 54.68 14.20 70 67004 23856 110498369
Cerebral toxoplasmosis 54.60 14.20 30 67044 3112 110519113
Hepatitis A 54.54 14.20 22 67052 1133 110521092
Hepatic enzyme increased 54.40 14.20 357 66717 320535 110201690
Transaminases increased 53.95 14.20 119 66955 63271 110458954
Memory impairment 53.87 14.20 26 67048 196918 110325307
Influenza 53.29 14.20 18 67056 169083 110353142
Mitochondrial DNA deletion 53.08 14.20 9 67065 6 110522219
Feeling abnormal 52.33 14.20 22 67052 180689 110341536
Hepatitis 52.23 14.20 146 66928 89908 110432317
Brain stem stroke 51.62 14.20 19 67055 762 110521463
Premature delivery 51.08 14.20 77 66997 30555 110491670
Sleep disorder 50.24 14.20 29 67045 198615 110323610
Oesophageal varices haemorrhage 49.15 14.20 33 67041 4912 110517313
Meningitis tuberculous 49.06 14.20 21 67053 1257 110520968
Drug-induced liver injury 48.73 14.20 172 66902 119895 110402330
HIV associated nephropathy 48.58 14.20 15 67059 347 110521878
Hepatitis B surface antigen positive 48.48 14.20 13 67061 178 110522047
Ocular icterus 47.60 14.20 35 67039 6018 110516207
Basedow's disease 46.96 14.20 13 67061 202 110522023
Wound infection 46.62 14.20 3 67071 96462 110425763
Rickets 46.49 14.20 11 67063 87 110522138
Granulomatous rosacea 46.32 14.20 13 67061 213 110522012
Hypotension 46.11 14.20 163 66911 523686 109998539
Injection site erythema 45.30 14.20 3 67071 94173 110428052
Hepatic cancer 45.16 14.20 44 67030 11112 110511113
Oropharyngeal pain 45.13 14.20 13 67061 135263 110386962
Paraesthesia 45.10 14.20 61 67013 276460 110245765
Premature separation of placenta 44.79 14.20 21 67053 1559 110520666
Tuberculoma of central nervous system 44.46 14.20 16 67058 601 110521624
Sciatica 44.28 14.20 3 67071 92396 110429829
Nodular regenerative hyperplasia 44.16 14.20 21 67053 1610 110520615
Pyrexia 44.05 14.20 777 66297 897488 109624737
Ill-defined disorder 43.99 14.20 20 67054 156833 110365392
Oesophageal candidiasis 43.92 14.20 44 67030 11490 110510735
Aminoaciduria 43.87 14.20 14 67060 362 110521863
Acquired aminoaciduria 42.83 14.20 8 67066 15 110522210
Umbilical cord abnormality 42.79 14.20 12 67062 196 110522029
Immunodeficiency 42.62 14.20 81 66993 38757 110483468
Hepatitis B virus test 42.36 14.20 7 67067 3 110522222
Hyperlipidaemia 42.14 14.20 77 66997 35771 110486454
Malaria 42.12 14.20 14 67060 413 110521812
Treatment failure 41.96 14.20 300 66774 276934 110245291
Obesity 41.48 14.20 9 67065 113342 110408883
Gynaecomastia 41.39 14.20 39 67035 9451 110512774
Prescribed overdose 41.32 14.20 132 66942 87449 110434776
Mycobacterium avium complex immune restoration disease 41.26 14.20 8 67066 20 110522205
Alpha 1 foetoprotein abnormal 41.25 14.20 9 67065 47 110522178
Type 2 diabetes mellitus 40.55 14.20 29 67045 177203 110345022
Drug intolerance 40.26 14.20 120 66954 406392 110115833
Optic nerve neoplasm 40.19 14.20 8 67066 24 110522201
Nasal congestion 39.86 14.20 6 67068 98276 110423949
CD4 lymphocytes increased 39.79 14.20 13 67061 363 110521862
Chronic kidney disease 39.72 14.20 119 66955 76172 110446053
Pulmonary fibrosis 39.66 14.20 7 67067 102035 110420190
Urine calcium increased 39.39 14.20 10 67064 109 110522116
Pancreatitis 38.82 14.20 135 66939 93398 110428827
Disseminated tuberculosis 38.77 14.20 29 67045 5117 110517108
Headache 38.53 14.20 346 66728 882031 109640194
Opportunistic infection 38.50 14.20 25 67049 3518 110518707
Withdrawal hepatitis 38.45 14.20 6 67068 0 110522225
Mitochondrial DNA depletion 38.45 14.20 6 67068 0 110522225
Nervous system disorder 38.38 14.20 69 67005 31652 110490573
Road traffic accident 38.35 14.20 9 67065 107389 110414836
Oligohydramnios 38.13 14.20 26 67048 3968 110518257
COVID-19 38.03 14.20 56 67018 245004 110277221
Musculoskeletal pain 38.02 14.20 33 67041 182990 110339235
Rhinorrhoea 37.87 14.20 8 67066 102658 110419567
Rheumatoid arthritis 37.83 14.20 78 66996 299535 110222690
Psychomotor retardation 37.82 14.20 34 67040 7758 110514467
Dyspepsia 37.80 14.20 36 67038 190929 110331296
Bone metabolism disorder 37.69 14.20 14 67060 576 110521649
Abdominal pain upper 37.57 14.20 99 66975 349012 110173213
Cystostomy 37.41 14.20 9 67065 77 110522148
Grip strength decreased 37.29 14.20 3 67071 80171 110442054
Stress 37.28 14.20 9 67065 105339 110416886
Neck pain 37.27 14.20 14 67060 123116 110399109
Liver transplant 37.14 14.20 27 67047 4562 110517663
Malignant neoplasm progression 36.84 14.20 31 67043 174536 110347689
Pain in extremity 36.84 14.20 161 66913 486957 110035268
Placental disorder 36.65 14.20 16 67058 1005 110521220
Pancytopenia 36.59 14.20 235 66839 209378 110312847
White matter lesion 36.39 14.20 22 67052 2732 110519493
Blood cholesterol increased 36.39 14.20 35 67039 184750 110337475
Anaphylactic reaction 36.30 14.20 12 67062 114288 110407937
Nephrolithiasis 36.11 14.20 105 66969 66107 110456118
Illness 35.76 14.20 4 67070 82167 110440058
Death 35.54 14.20 263 66811 698606 109823619
Bronchitis 35.52 14.20 26 67048 157006 110365219
Secondary syphilis 35.29 14.20 9 67065 100 110522125
Hepatitis B DNA assay positive 35.29 14.20 9 67065 100 110522125
Spina bifida 35.23 14.20 10 67064 171 110522054
Viraemia 35.18 14.20 25 67049 4077 110518148
Ectopic pregnancy 34.68 14.20 20 67054 2277 110519948
Drug hypersensitivity 34.39 14.20 150 66924 453940 110068285
Renal glycosuria 34.24 14.20 7 67067 25 110522200
Oxygen saturation decreased 34.22 14.20 27 67047 156955 110365270
Pregnancy on contraceptive 33.62 14.20 15 67059 993 110521232
Mitochondrial myopathy 33.57 14.20 12 67062 442 110521783
Haematochezia 33.55 14.20 14 67060 115510 110406715
Mycobacterial infection 33.52 14.20 25 67049 4392 110517833
Gastroschisis 33.22 14.20 7 67067 30 110522195
Somnolence 33.04 14.20 83 66991 297366 110224859
Hyperphosphaturia 32.99 14.20 9 67065 132 110522093
Strongyloidiasis 32.97 14.20 26 67048 4960 110517265
Neutropenia neonatal 32.68 14.20 7 67067 33 110522192
Blood phosphorus abnormal 32.58 14.20 11 67063 341 110521884
Insomnia 32.51 14.20 111 66963 360479 110161746
Retroviral rebound syndrome 32.21 14.20 6 67068 11 110522214
Rash erythematous 32.14 14.20 116 66958 81716 110440509
Vertical infection transmission 32.04 14.20 5 67069 0 110522225
Anaemia macrocytic 31.82 14.20 30 67044 7273 110514952
Beta 2 microglobulin urine increased 31.81 14.20 9 67065 152 110522073
HIV test positive 31.59 14.20 9 67065 156 110522069
Metabolic acidosis 31.52 14.20 132 66942 99612 110422613
Heart rate decreased 31.46 14.20 6 67068 82750 110439475
Drug ineffective 31.30 14.20 694 66380 1519846 109002379
Red blood cell sedimentation rate increased 31.25 14.20 5 67069 78297 110443928
Contraindicated product administered 31.03 14.20 65 67009 248202 110274023
HIV lipodystrophy 30.94 14.20 6 67068 15 110522210
AIDS cholangiopathy 30.94 14.20 6 67068 15 110522210
C-reactive protein increased 30.79 14.20 53 67021 217866 110304359
Hepatic cytolysis 30.69 14.20 88 66986 54965 110467260
Rash maculo-papular 30.69 14.20 107 66967 74115 110448110
Diarrhoea 30.53 14.20 497 66577 1139008 109383217
Atrial fibrillation 30.52 14.20 58 67016 229584 110292641
Oral candidiasis 30.44 14.20 77 66997 44683 110477542
Optic atrophy 30.41 14.20 19 67055 2502 110519723
Urinary tract infection 30.40 14.20 99 66975 326183 110196042
Acute hepatitis C 30.31 14.20 10 67064 288 110521937
Diabetes mellitus 30.23 14.20 130 66944 99251 110422974
Night blindness 30.14 14.20 12 67062 597 110521628
Placental insufficiency 30.04 14.20 15 67059 1279 110520946
Vomiting 29.94 14.20 743 66331 909932 109612293
Bilirubin conjugated increased 29.90 14.20 27 67047 6197 110516028
Tuberculoid leprosy 29.87 14.20 8 67066 109 110522116
Molluscum contagiosum 29.71 14.20 12 67062 620 110521605
Congenital intestinal malformation 29.67 14.20 6 67068 20 110522205
Blood pressure fluctuation 29.37 14.20 5 67069 74819 110447406
Thrombocytopenia 29.25 14.20 332 66742 348553 110173672
Genetic polymorphism 29.11 14.20 5 67069 4 110522221
Hepatitis E 28.94 14.20 23 67051 4436 110517789
Adverse event 28.79 14.20 15 67059 108794 110413431
Foetal growth abnormality 28.61 14.20 6 67068 25 110522200
Colitis ulcerative 28.59 14.20 6 67068 77357 110444868
Placental infarction 28.45 14.20 8 67066 132 110522093
Visceral leishmaniasis 28.42 14.20 16 67058 1740 110520485
Toxoplasmosis 28.38 14.20 20 67054 3219 110519006
Hyperphosphatasaemia 28.28 14.20 8 67066 135 110522090
Rectal haemorrhage 28.21 14.20 19 67055 119814 110402411
Chest pain 28.08 14.20 125 66949 376250 110145975
Drug abuse 28.05 14.20 40 67034 177371 110344854
HIV wasting syndrome 27.94 14.20 7 67067 72 110522153
Genital herpes 27.75 14.20 18 67056 2529 110519696
Amylase increased 27.63 14.20 36 67038 12483 110509742
Lower limb fracture 27.53 14.20 6 67068 75342 110446883
Hypoaesthesia 27.46 14.20 98 66976 314125 110208100
Intentional overdose 27.38 14.20 24 67050 132477 110389748
Blood creatine phosphokinase increased 27.36 14.20 102 66972 72975 110449250
Dermatitis exfoliative 27.20 14.20 34 67040 11313 110510912
Liver transplant rejection 27.14 14.20 21 67053 3897 110518328
Lung disorder 27.10 14.20 42 67032 180005 110342220
Blood triglycerides abnormal 27.06 14.20 11 67063 578 110521647
Portal vein thrombosis 27.01 14.20 27 67047 7031 110515194
Strabismus 26.99 14.20 20 67054 3479 110518746
Normal newborn 26.97 14.20 48 67026 21848 110500377
Therapeutic product effect incomplete 26.80 14.20 60 67014 223745 110298480
Incorrect dose administered 26.38 14.20 15 67059 103626 110418599
Prescribed underdose 26.38 14.20 4 67070 65170 110457055
Burning sensation 26.35 14.20 5 67069 69207 110453018
Bone density decreased 26.28 14.20 40 67034 16002 110506223
Hepatitis fulminant 26.08 14.20 29 67045 8531 110513694
Rhabdomyosarcoma 26.08 14.20 8 67066 181 110522044
Benign hydatidiform mole 26.03 14.20 7 67067 97 110522128
Constipation 25.98 14.20 120 66954 357666 110164559
Herpes virus infection 25.87 14.20 29 67045 8609 110513616
Adverse drug reaction 25.85 14.20 16 67058 105543 110416682
Central nervous system lesion 25.79 14.20 39 67035 15514 110506711
Urine phosphorus decreased 25.76 14.20 6 67068 44 110522181
Retroperitoneal disorder 25.76 14.20 6 67068 44 110522181
Blood bicarbonate decreased 25.62 14.20 24 67050 5773 110516452
Dry skin 25.43 14.20 17 67057 107636 110414589
Hepatic steatosis 25.26 14.20 76 66998 48755 110473470
Cardio-respiratory arrest 25.15 14.20 20 67054 115816 110406409
Taeniasis 24.77 14.20 6 67068 53 110522172
Visual impairment 24.72 14.20 27 67047 134401 110387824
Cystitis 24.66 14.20 5 67069 66031 110456194
Viral load decreased 24.64 14.20 5 67069 17 110522208
Injection site swelling 24.54 14.20 4 67070 61786 110460439
Night sweats 24.54 14.20 27 67047 133956 110388269
Glucose urine present 24.50 14.20 16 67058 2273 110519952
Hepatitis D RNA positive 24.42 14.20 5 67069 18 110522207
Post inflammatory pigmentation change 24.13 14.20 11 67063 766 110521459
General physical health deterioration 24.08 14.20 155 66919 425140 110097085
Herpes simplex 24.00 14.20 38 67036 15726 110506499
Lung neoplasm 23.99 14.20 27 67047 8049 110514176
Lymphocytic infiltration 23.77 14.20 15 67059 2010 110520215
Swollen tongue 23.76 14.20 4 67070 60358 110461867
Osteoporotic fracture 23.40 14.20 22 67052 5315 110516910
Gait inability 23.34 14.20 29 67045 136347 110385878
Cough 23.30 14.20 174 66900 461467 110060758
Leukopenia 23.07 14.20 162 66912 148629 110373596
Anembryonic gestation 23.05 14.20 9 67065 425 110521800
Anogenital warts 22.98 14.20 12 67062 1124 110521101
Primary syphilis 22.94 14.20 5 67069 26 110522199
Ear infection 22.91 14.20 5 67069 62727 110459498
Amoebiasis 22.88 14.20 7 67067 157 110522068
Lymphadenitis 22.86 14.20 22 67052 5471 110516754
Encephalitis 22.82 14.20 41 67033 18798 110503427
Intracranial pressure increased 22.79 14.20 30 67044 10505 110511720
Tremor 22.78 14.20 56 67018 202176 110320049
Parotid gland enlargement 22.69 14.20 12 67062 1153 110521072
Hot flush 22.67 14.20 6 67068 66030 110456195
Foetal growth restriction 22.56 14.20 17 67057 3033 110519192
Injection site reaction 22.52 14.20 13 67061 89057 110433168
Red blood cells urine 22.47 14.20 10 67064 658 110521567
Visual field defect 22.28 14.20 29 67045 10043 110512182
Erosive duodenitis 22.08 14.20 15 67059 2276 110519949
Portal hypertensive gastropathy 22.06 14.20 14 67060 1894 110520331
Vanishing bile duct syndrome 21.99 14.20 17 67057 3151 110519074
Atypical mycobacterial lymphadenitis 21.92 14.20 5 67069 33 110522192
HIV infection CDC category C 21.92 14.20 5 67069 33 110522192
Anaemia neonatal 21.92 14.20 5 67069 33 110522192
Isosporiasis 21.72 14.20 7 67067 187 110522038
Rhodococcus infection 21.71 14.20 9 67065 497 110521728
Joint stiffness 21.46 14.20 7 67067 67236 110454989
Floppy eyelid syndrome 21.42 14.20 5 67069 37 110522188
Cerebrovascular accident 21.38 14.20 49 67025 181235 110340990
Nephropathy 21.25 14.20 33 67041 13434 110508791
Unmasking of previously unidentified disease 21.25 14.20 16 67058 2852 110519373
Type III hyperlipidaemia 21.24 14.20 4 67070 8 110522217
Loss of anatomical alignment after fracture reduction 21.24 14.20 4 67070 8 110522217
Acute hepatic failure 21.02 14.20 59 67015 36409 110485816
Bulbar palsy 20.92 14.20 8 67066 357 110521868
Hepatitis D 20.90 14.20 6 67068 107 110522118
Liver function test increased 20.90 14.20 14 67060 88534 110433691
Balance disorder 20.78 14.20 24 67050 116536 110405689
Transplant rejection 20.76 14.20 46 67028 24521 110497704
Gestational diabetes 20.76 14.20 24 67050 7365 110514860
Antimitochondrial antibody positive 20.75 14.20 6 67068 110 110522115
Hospitalisation 20.73 14.20 34 67040 142459 110379766
Brain oedema 20.63 14.20 53 67021 31045 110491180
Respiratory arrest 20.59 14.20 5 67069 58294 110463931
Renal injury 20.50 14.20 39 67035 18674 110503551
Neuromyopathy 20.44 14.20 13 67061 1766 110520459
Coeliac disease 20.28 14.20 65 67009 43122 110479103
Non-Hodgkin's lymphoma 20.17 14.20 12 67062 1447 110520778
Astrocytoma, low grade 20.12 14.20 6 67068 123 110522102
Hydrocephalus 20.10 14.20 28 67046 10347 110511878
Fat redistribution 20.03 14.20 6 67068 125 110522100
Middle ear inflammation 19.90 14.20 7 67067 246 110521979
Dermatitis allergic 19.87 14.20 42 67032 21682 110500543
Retroviral infection 19.85 14.20 4 67070 13 110522212
Postpartum haemorrhage 19.72 14.20 13 67061 1876 110520349
Bone pain 19.65 14.20 85 66989 65048 110457177
Abortion missed 19.59 14.20 12 67062 1525 110520700
Medication error 19.55 14.20 21 67053 105345 110416880
Borderline leprosy 19.49 14.20 5 67069 57 110522168
Cardiac disorder 19.47 14.20 11 67063 76269 110445956
Pubertal failure 19.41 14.20 4 67070 15 110522210
Blood lactate dehydrogenase increased 19.27 14.20 65 67009 44269 110477956
AIDS related complex 19.23 14.20 3 67071 0 110522225
Adrenal androgen excess 19.23 14.20 3 67071 0 110522225
Gianotti-Crosti syndrome 19.23 14.20 3 67071 0 110522225
Unevaluable event 19.19 14.20 6 67068 59221 110463004
Inflammation 19.14 14.20 57 67017 193181 110329044
Erythema elevatum diutinum 19.01 14.20 4 67070 17 110522208
Cryoglobulinaemia 18.95 14.20 11 67063 1268 110520957
Oropharyngeal candidiasis 18.90 14.20 13 67061 2013 110520212
Central nervous system immune reconstitution inflammatory response 18.75 14.20 5 67069 67 110522158
Cytomegalovirus infection 18.75 14.20 74 67000 54370 110467855
Renal aneurysm 18.69 14.20 7 67067 295 110521930
Infection 18.52 14.20 136 66938 362064 110160161
Paraparesis 18.46 14.20 18 67056 4548 110517677
Ballismus 18.40 14.20 7 67067 308 110521917
Acute lymphocytic leukaemia 18.38 14.20 20 67054 5745 110516480
Bradycardia 18.36 14.20 42 67032 155475 110366750
Colitis 18.32 14.20 21 67053 102302 110419923
Paradoxical drug reaction 18.28 14.20 26 67048 9791 110512434
Gastrointestinal disorder 18.25 14.20 80 66994 241872 110280353
Eyelid oedema 18.21 14.20 33 67041 15229 110506996
Congenital anomaly 18.17 14.20 10 67064 1041 110521184
Optic nerve cupping 18.16 14.20 5 67069 76 110522149
Meningomyelocele 18.16 14.20 4 67070 22 110522203
Diverticulitis 18.11 14.20 5 67069 53517 110468708
Ultrasound antenatal screen abnormal 17.93 14.20 5 67069 80 110522145
Disseminated Bacillus Calmette-Guerin infection 17.88 14.20 7 67067 333 110521892
Pneumococcal sepsis 17.87 14.20 13 67061 2199 110520026
Syncope 17.80 14.20 63 67011 202473 110319752
Ileal ulcer 17.76 14.20 12 67062 1805 110520420
Cardiac failure congestive 17.65 14.20 41 67033 150959 110371266
Benign hepatic neoplasm 17.53 14.20 5 67069 87 110522138
Acute hepatitis B 17.52 14.20 8 67066 559 110521666
Cholestatic liver injury 17.52 14.20 22 67052 7354 110514871
Bacterial pyelonephritis 17.51 14.20 9 67065 816 110521409
Hepatitis viral 17.50 14.20 11 67063 1464 110520761
Dry eye 17.47 14.20 6 67068 55787 110466438
Drug ineffective for unapproved indication 17.46 14.20 22 67052 102816 110419409
Cryptosporidiosis infection 17.38 14.20 10 67064 1133 110521092
Blood uric acid decreased 17.38 14.20 11 67063 1482 110520743
Trisomy 21 17.38 14.20 5 67069 90 110522135
Blood pressure systolic increased 17.19 14.20 15 67059 82976 110439249
Renal atrophy 17.18 14.20 13 67061 2333 110519892
Flushing 17.17 14.20 23 67051 104713 110417512
Hepatitis B DNA decreased 17.15 14.20 3 67071 3 110522222
Kwashiorkor 17.15 14.20 3 67071 3 110522222
Funisitis 17.15 14.20 3 67071 3 110522222
Cervix operation 17.15 14.20 3 67071 3 110522222
Multiple fractures 17.13 14.20 24 67050 8916 110513309
Influenza like illness 17.10 14.20 17 67057 88395 110433830
Spermatozoa progressive motility abnormal 17.09 14.20 4 67070 30 110522195
Feeling hot 17.08 14.20 18 67056 91088 110431137
Anal cancer stage 0 16.98 14.20 4 67070 31 110522194
Histoplasmosis disseminated 16.96 14.20 16 67058 3883 110518342
Pathological fracture 16.95 14.20 28 67046 12004 110510221
Transplant dysfunction 16.92 14.20 23 67051 8305 110513920
Heart rate increased 16.86 14.20 39 67035 143795 110378430
Nail disorder 16.85 14.20 7 67067 57928 110464297
Blood creatine phosphokinase MB increased 16.79 14.20 14 67060 2889 110519336
Viral hepatitis carrier 16.76 14.20 4 67070 33 110522192
Thrombosis 16.68 14.20 25 67049 108637 110413588
Disseminated intravascular coagulation 16.62 14.20 59 67015 41227 110480998
Musculoskeletal toxicity 16.61 14.20 6 67068 228 110521997
Choroiditis 16.59 14.20 11 67063 1604 110520621
Small for dates baby 16.34 14.20 8 67066 654 110521571
Drug dependence 16.33 14.20 5 67069 50015 110472210
Renal tubular necrosis 16.30 14.20 48 67026 30427 110491798
Orthostatic hypotension 16.28 14.20 10 67064 66239 110455986
Obstructive airways disorder 16.21 14.20 4 67070 46145 110476080
Blood albumin decreased 16.19 14.20 45 67029 27607 110494618
Crystal urine 16.14 14.20 5 67069 117 110522108
Tetany 16.08 14.20 15 67059 3589 110518636
Lipids abnormal 16.08 14.20 8 67066 677 110521548
Toxic optic neuropathy 16.00 14.20 10 67064 1318 110520907
Burkitt's lymphoma 15.94 14.20 5 67069 122 110522103
Hyperbilirubinaemia neonatal 15.93 14.20 3 67071 6 110522219
Glycocholic acid increased 15.93 14.20 3 67071 6 110522219
Carbon dioxide combining power abnormal 15.93 14.20 3 67071 6 110522219
Hydromyelia 15.93 14.20 3 67071 6 110522219
Acute fatty liver of pregnancy 15.89 14.20 4 67070 42 110522183
Portal fibrosis 15.86 14.20 8 67066 697 110521528
Asthma 15.85 14.20 88 66986 250203 110272022
Lipase increased 15.82 14.20 35 67039 18637 110503588
Albuminuria 15.79 14.20 9 67065 1002 110521223
Clostridium difficile infection 15.65 14.20 6 67068 52123 110470102
Cholestasis 15.64 14.20 79 66995 64439 110457786
Haematoma 15.56 14.20 8 67066 58468 110463757
Drug reaction with eosinophilia and systemic symptoms 15.54 14.20 94 66980 82001 110440224
Gestational hypertension 15.53 14.20 12 67062 2222 110520003
Prurigo 15.51 14.20 10 67064 1390 110520835
Product use issue 15.47 14.20 118 66956 311577 110210648
Limb discomfort 15.45 14.20 3 67071 40851 110481374
Lupus-like syndrome 15.42 14.20 3 67071 40789 110481436
Anaphylactic shock 15.36 14.20 6 67068 51540 110470685
Myopia 15.36 14.20 12 67062 2259 110519966
Multiple organ dysfunction syndrome 15.34 14.20 150 66924 151560 110370665
Osteocalcin increased 15.33 14.20 3 67071 8 110522217
Rectosigmoid cancer metastatic 15.33 14.20 4 67070 49 110522176
Osteonecrosis of jaw 15.32 14.20 5 67069 48012 110474213
Product prescribing error 15.26 14.20 6 67068 51325 110470900
Hypersplenism 15.23 14.20 8 67066 758 110521467
Sleep apnoea syndrome 15.23 14.20 3 67071 40444 110481781
Glomerulonephritis proliferative 15.22 14.20 7 67067 497 110521728
Leishmaniasis 15.16 14.20 7 67067 502 110521723
Developmental delay 15.10 14.20 10 67064 1455 110520770
Carnitine deficiency 15.04 14.20 6 67068 300 110521925
Disseminated mycobacterium avium complex infection 15.04 14.20 7 67067 511 110521714
AIDS related complication 15.04 14.20 4 67070 53 110522172
Graft infection 15.02 14.20 8 67066 780 110521445
Myopathy 14.99 14.20 41 67033 24919 110497306
Tubulointerstitial nephritis 14.99 14.20 69 67005 54215 110468010
Portal venous gas 14.86 14.20 7 67067 525 110521700
Pharyngotonsillitis 14.84 14.20 6 67068 311 110521914
Hypoglycaemia 14.83 14.20 30 67044 116074 110406151
CD4 lymphocytes 14.83 14.20 3 67071 10 110522215
Immunosuppressant drug level increased 14.82 14.20 26 67048 11698 110510527
Plasmablastic lymphoma 14.81 14.20 8 67066 802 110521423
Antiviral drug level below therapeutic 14.77 14.20 4 67070 57 110522168
Throat irritation 14.74 14.20 7 67067 53545 110468680
Chest discomfort 14.67 14.20 55 67019 173793 110348432
Hyponatraemia 14.63 14.20 75 66999 217578 110304647
ADAMTS13 activity decreased 14.62 14.20 6 67068 323 110521902
Macrocephaly 14.58 14.20 4 67070 60 110522165
Melanaemia 14.52 14.20 4 67070 61 110522164
Bovine tuberculosis 14.48 14.20 5 67069 166 110522059
Aplasia pure red cell 14.46 14.20 23 67051 9555 110512670
Liver injury 14.44 14.20 45 67029 150368 110371857
Acute stress disorder 14.44 14.20 7 67067 560 110521665
Infected vasculitis 14.40 14.20 3 67071 12 110522213
Anogenital dysplasia 14.34 14.20 5 67069 171 110522054
Alpha 1 foetoprotein increased 14.33 14.20 8 67066 856 110521369
Vaccination failure 14.32 14.20 12 67062 2494 110519731
Dehydration 14.26 14.20 105 66969 279406 110242819
Hepatitis C virus test 14.23 14.20 4 67070 66 110522159
Onychomycosis 14.21 14.20 3 67071 38528 110483697

FDA Adverse Event Reporting System (Pediatric)

None

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
ATC J05AR28 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
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000998 Antiviral Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D018894 Reverse Transcriptase Inhibitors
MeSH PA D019380 Anti-HIV Agents
MeSH PA D019384 Nucleic Acid Synthesis Inhibitors
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:33231 antitubercular agent
CHEBI has role CHEBI:35441 antiinfective agent
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:36044 antiviral drug
CHEBI has role CHEBI:50266 prodrug
CHEBI has role CHEBI:50904 allergen
CHEBI has role CHEBI:53756 HIV-1 reverse transcriptase inhibitor
CHEBI has role CHEBI:59897 EC 2.7.7.49 (RNA-directed DNA polymerase) inhibitor
CHEBI has role CHEBI:62868 hepatoprotective agent
CHEBI has role CHEBI:64946 anti-HIV agent
CHEBI has role CHEBI:64951 anti-HBV agent
CHEBI has role CHEBI:67079 anti-inflammatory agent

Related Drugs by ATC class:

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

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




🐶 Veterinary Drug Use

None

🐶 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 Aug. 30, 2032 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 Aug. 30, 2032 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 Aug. 30, 2032 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 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
EQ 50MG BASE;300MG DOVATO VIIV HLTHCARE N211994 April 8, 2019 RX TABLET ORAL April 5, 2027 NEW PATIENT POPULATION

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Deoxycytidine kinase Kinase WOMBAT-PK
Protein P Polyprotein INHIBITOR CHEMBL CHEMBL
Reverse transcriptase/RNaseH Enzyme INHIBITOR EC50 7.38 CHEMBL CHEMBL
Capsid protein Structural 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
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 24 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
ABACAVIR and LAMIVUDINE HUMAN PRESCRIPTION DRUG LABEL 2 31722-838 TABLET, FILM COATED 300 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 and Zidovudine Human Prescription Drug Label 2 33342-003 TABLET 150 mg ORAL ANDA 25 sections
Abacavir and Lamivudine Human Prescription Drug Label 2 33342-440 TABLET, FILM COATED 300 mg ORAL ANDA 27 sections
Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Human Prescription Drug Label 3 42385-928 TABLET, FILM COATED 300 mg ORAL ANDA 30 sections
Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Human Prescription Drug Label 3 42385-929 TABLET, FILM COATED 300 mg ORAL ANDA 30 sections
Abacavir and Lamivudine Human Prescription Drug Label 2 42385-962 TABLET, FILM COATED 300 mg ORAL ANDA 28 sections
LAMIVUDINE and ZIDOVUDINE HUMAN PRESCRIPTION DRUG LABEL 2 43063-900 TABLET, FILM COATED 150 mg ORAL ANDA 24 sections
LAMIVUDINE and ZIDOVUDINE HUMAN PRESCRIPTION DRUG LABEL 2 43063-900 TABLET, FILM COATED 150 mg ORAL ANDA 24 sections
SYMFI LO HUMAN PRESCRIPTION DRUG LABEL 3 49502-425 TABLET, FILM COATED 300 mg ORAL NDA 32 sections
CIMDUO HUMAN PRESCRIPTION DRUG LABEL 2 49502-450 TABLET, FILM COATED 300 mg ORAL NDA 29 sections
SYMFI HUMAN PRESCRIPTION DRUG LABEL 3 49502-475 TABLET, FILM COATED 300 mg ORAL NDA 31 sections
COMBIVIR HUMAN PRESCRIPTION DRUG LABEL 2 49702-202 TABLET, FILM COATED 150 mg ORAL NDA 25 sections
EPIVIR HUMAN PRESCRIPTION DRUG LABEL 1 49702-203 TABLET, FILM COATED 150 mg ORAL NDA 25 sections
EPIVIR HUMAN PRESCRIPTION DRUG LABEL 1 49702-204 TABLET, FILM COATED 300 mg ORAL NDA 25 sections