emtricitabine Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
nucleosides antiviral or antineoplastic agents, cytarabine or azacitidine derivatives 1003 143491-57-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • emtricitabine
  • coviracil
  • emtriva
A deoxycytidine analog and REVERSE TRANSCRIPTASE INHIBITOR with antiviral activity against HIV-1 and HEPATITIS B viruses. It is used to treat HIV INFECTIONS.
  • Molecular weight: 247.24
  • Formula: C8H10FN3O3S
  • CLOGP: -1.29
  • LIPINSKI: 0
  • HAC: 6
  • HDO: 2
  • TPSA: 88.15
  • ALOGS: -2.09
  • ROTB: 2

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.20 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 112 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 73 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 11.56 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Approvals:

DateAgencyCompanyOrphan
Oct. 24, 2003 EMA
July 2, 2003 FDA GILEAD
March 23, 2005 PMDA Japan Tobacco Inc.

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
Abortion spontaneous 2476.80 16.67 907 25031 45728 53277400
Maternal exposure during pregnancy 2458.67 16.67 1285 24653 154354 53168774
Foetal exposure during pregnancy 1540.92 16.67 593 25345 34122 53289006
Exposure during pregnancy 1072.79 16.67 697 25241 124163 53198965
Stillbirth 767.17 16.67 234 25704 6563 53316565
Abortion induced 683.09 16.67 240 25698 10586 53312542
Foetal death 585.01 16.67 206 25732 9141 53313987
Virologic failure 496.50 16.67 131 25807 2133 53320995
Premature baby 404.95 16.67 196 25742 19605 53303523
Blood HIV RNA increased 378.28 16.67 86 25852 719 53322409
Immune reconstitution inflammatory syndrome 348.51 16.67 127 25811 6219 53316909
Pregnancy 343.17 16.67 205 25733 31236 53291892
Viral mutation identified 306.43 16.67 88 25850 1986 53321142
Drug interaction 305.40 16.67 449 25489 218880 53104248
Viral load increased 293.29 16.67 79 25859 1396 53321732
Premature delivery 281.70 16.67 169 25769 25935 53297193
Live birth 269.01 16.67 136 25802 14923 53308205
Pathogen resistance 230.79 16.67 95 25843 6465 53316663
Drug resistance 209.55 16.67 127 25811 19835 53303293
Treatment noncompliance 203.78 16.67 151 25787 32884 53290244
Caesarean section 202.17 16.67 118 25820 17202 53305926
Spina bifida 184.78 16.67 48 25890 732 53322396
Premature labour 170.64 16.67 94 25844 12268 53310860
Fanconi syndrome acquired 169.26 16.67 48 25890 1033 53322095
Genotype drug resistance test positive 168.18 16.67 42 25896 542 53322586
Pre-eclampsia 165.92 16.67 82 25856 8565 53314563
Lipodystrophy acquired 165.78 16.67 52 25886 1598 53321530
CD4 lymphocytes decreased 160.09 16.67 51 25887 1650 53321478
Enlarged clitoris 150.28 16.67 30 25908 122 53323006
Pain 148.20 16.67 51 25887 588347 52734781
Premature rupture of membranes 135.55 16.67 60 25878 4880 53318248
Osteoporosis 134.60 16.67 138 25800 46322 53276806
Hyperandrogenism 128.08 16.67 25 25913 88 53323040
Renal tubular disorder 123.38 16.67 48 25890 2815 53320313
Immune reconstitution inflammatory syndrome associated tuberculosis 120.06 16.67 30 25908 388 53322740
Ventricular septal defect 116.68 16.67 52 25886 4298 53318830
Polydactyly 115.92 16.67 29 25909 377 53322751
Hyperbilirubinaemia 112.49 16.67 69 25869 11000 53312128
Ectopic pregnancy 110.53 16.67 44 25894 2743 53320385
HIV infection 109.70 16.67 30 25908 562 53322566
Hydrops foetalis 103.50 16.67 26 25912 344 53322784
Normal newborn 102.96 16.67 56 25882 7123 53316005
Gestational diabetes 102.41 16.67 58 25880 7981 53315147
Fanconi syndrome 96.75 16.67 32 25906 1168 53321960
Product dispensing error 94.39 16.67 60 25878 10180 53312948
Foetal growth restriction 92.03 16.67 52 25886 7122 53316006
Fatigue 90.53 16.67 135 25803 730371 52592757
Fall 86.74 16.67 33 25905 358407 52964721
Malaria 83.66 16.67 21 25917 277 53322851
Cerebral ventricle dilatation 81.00 16.67 27 25911 1010 53322118
Low birth weight baby 78.78 16.67 45 25893 6292 53316836
Congenital anomaly 76.43 16.67 29 25909 1588 53321540
Ectopic kidney 75.42 16.67 16 25922 93 53323035
Skull malformation 75.12 16.67 20 25918 337 53322791
Product use complaint 74.87 16.67 31 25907 2139 53320989
Autoimmune hepatitis 69.92 16.67 46 25892 8272 53314856
Oligohydramnios 69.83 16.67 41 25897 6035 53317093
Placenta praevia 69.75 16.67 24 25914 990 53322138
Twin pregnancy 68.56 16.67 25 25913 1224 53321904
Hepatocellular injury 67.47 16.67 78 25860 29908 53293220
Polyhydramnios 67.47 16.67 29 25909 2196 53320932
Foetal distress syndrome 66.22 16.67 25 25913 1350 53321778
Meningomyelocele 65.73 16.67 20 25918 554 53322574
Hepatitis fulminant 65.52 16.67 33 25905 3586 53319542
Atrial septal defect 64.94 16.67 41 25897 6873 53316255
Infusion related reaction 63.24 16.67 3 25935 155954 53167174
Anencephaly 62.59 16.67 16 25922 228 53322900
HIV test positive 61.98 16.67 12 25926 40 53323088
Joint swelling 61.20 16.67 19 25919 234619 53088509
Cushing's syndrome 60.28 16.67 20 25918 737 53322391
Lipohypertrophy 59.57 16.67 20 25918 765 53322363
Trisomy 21 58.95 16.67 17 25921 389 53322739
Anal atresia 58.46 16.67 17 25921 401 53322727
Cloacal exstrophy 58.18 16.67 14 25924 153 53322975
CD4 lymphocytes abnormal 57.45 16.67 11 25927 34 53323094
Maternal drugs affecting foetus 57.44 16.67 35 25903 5511 53317617
Renal colic 56.30 16.67 22 25916 1305 53321823
Sinusitis 55.45 16.67 8 25930 168556 53154572
Drug hypersensitivity 55.40 16.67 30 25908 265212 53057916
Nasopharyngitis 54.97 16.67 13 25925 192282 53130846
Ultrasound antenatal screen abnormal 54.90 16.67 13 25925 132 53322996
Drug intolerance 54.74 16.67 16 25922 205477 53117651
Congenital heart valve disorder 54.16 16.67 12 25926 88 53323040
Congenital genital malformation 54.12 16.67 13 25925 141 53322987
Neural tube defect 53.73 16.67 14 25924 216 53322912
Bladder agenesis 53.71 16.67 13 25925 146 53322982
Renal tubular necrosis 52.66 16.67 44 25894 11375 53311753
Genitalia external ambiguous 52.62 16.67 13 25925 160 53322968
Lactic acidosis 52.62 16.67 77 25861 37176 53285952
Congenital genital malformation female 51.05 16.67 10 25928 36 53323092
Cholestasis 50.57 16.67 66 25872 28629 53294499
Meconium stain 50.55 16.67 13 25925 190 53322938
Patent ductus arteriosus 50.54 16.67 29 25909 4089 53319039
Dyspnoea 50.33 16.67 134 25804 586098 52737030
Drug ineffective 50.33 16.67 216 25722 817029 52506099
Adrenal insufficiency 50.24 16.67 48 25890 14781 53308347
Coloboma 49.72 16.67 11 25927 80 53323048
Therapeutic product effect decreased 49.12 16.67 3 25935 125652 53197476
Premature separation of placenta 49.05 16.67 22 25916 1845 53321283
Rash maculo-papular 48.70 16.67 66 25872 29683 53293445
Sudden infant death syndrome 48.50 16.67 13 25925 225 53322903
Trisomy 18 48.40 16.67 10 25928 50 53323078
Tethered cord syndrome 48.02 16.67 13 25925 234 53322894
Proteinuria 47.52 16.67 51 25887 18017 53305111
Caudal regression syndrome 47.41 16.67 12 25926 164 53322964
Renal tubular acidosis 47.17 16.67 21 25917 1730 53321398
CSF HIV escape syndrome 47.16 16.67 11 25927 104 53323024
Neonatal respiratory arrest 47.16 16.67 10 25928 58 53323070
Osteonecrosis 46.64 16.67 61 25877 26514 53296614
Renal failure 46.63 16.67 145 25793 118307 53204821
HIV-associated neurocognitive disorder 46.31 16.67 12 25926 181 53322947
Abdominal discomfort 46.15 16.67 25 25913 221037 53102091
Acute kidney injury 46.00 16.67 244 25694 253624 53069504
Congenital hydrocephalus 45.83 16.67 12 25926 189 53322939
Gastrointestinal disorder congenital 45.57 16.67 11 25927 122 53323006
Gastrointestinal tube insertion 44.80 16.67 18 25920 1149 53321979
Spine malformation 44.77 16.67 13 25925 305 53322823
Adrenal suppression 44.39 16.67 17 25921 955 53322173
Macrocephaly 43.82 16.67 10 25928 85 53323043
Arthralgia 43.68 16.67 93 25845 439690 52883438
Contraindicated product administered 43.31 16.67 7 25931 135622 53187506
Umbilical cord abnormality 43.18 16.67 15 25923 637 53322491
Abnormal dreams 43.09 16.67 38 25900 10563 53312565
Pneumonia 42.21 16.67 84 25854 407085 52916043
Gastrointestinal malformation 42.02 16.67 11 25927 173 53322955
Hepatic cytolysis 41.89 16.67 33 25905 7852 53315276
Product storage error 41.66 16.67 41 25897 13089 53310039
Nephropathy toxic 41.55 16.67 34 25904 8538 53314590
Foetal malnutrition 41.02 16.67 10 25928 116 53323012
Gastrostomy 40.54 16.67 14 25924 584 53322544
Musculoskeletal stiffness 40.22 16.67 6 25932 123362 53199766
Cushingoid 40.20 16.67 31 25907 7151 53315977
Hydrocephalus 39.32 16.67 27 25911 5209 53317919
Pulmonary valve sclerosis 38.89 16.67 8 25930 39 53323089
Pregnancy with implant contraceptive 38.76 16.67 20 25918 2286 53320842
Complication of delivery 38.46 16.67 10 25928 153 53322975
Exomphalos 37.33 16.67 13 25925 556 53322572
Oesophageal atresia 36.87 16.67 13 25925 577 53322551
Drug reaction with eosinophilia and systemic symptoms 36.82 16.67 61 25877 32739 53290389
Systemic lupus erythematosus 36.78 16.67 8 25930 125406 53197722
Dysmorphism 36.34 16.67 19 25919 2231 53320897
Congenital pulmonary valve disorder 36.06 16.67 8 25930 59 53323069
Oesophageal candidiasis 35.99 16.67 26 25912 5434 53317694
Acute HIV infection 35.57 16.67 7 25931 26 53323102
Atrial fibrillation 35.12 16.67 6 25932 111646 53211482
Pain in extremity 34.79 16.67 53 25885 284997 53038131
Hypotension 34.23 16.67 44 25894 254032 53069096
Glycosuria 33.94 16.67 15 25923 1215 53321913
Pulmonary tuberculosis 33.92 16.67 24 25914 4857 53318271
Infection 33.76 16.67 21 25917 172184 53150944
Secondary adrenocortical insufficiency 33.52 16.67 15 25923 1251 53321877
Congenital skin dimples 32.99 16.67 9 25929 167 53322961
Central obesity 32.77 16.67 14 25924 1044 53322084
Product size issue 32.63 16.67 11 25927 426 53322702
Microcephaly 32.56 16.67 13 25925 816 53322312
Melanoderma 32.54 16.67 9 25929 176 53322952
Weight increased 31.95 16.67 189 25749 204378 53118750
Injection site pain 31.73 16.67 8 25930 113383 53209745
Cholestasis of pregnancy 30.98 16.67 14 25924 1195 53321933
Jaundice neonatal 30.93 16.67 13 25925 931 53322197
Pregnancy on contraceptive 30.54 16.67 14 25924 1235 53321893
Transaminases increased 29.83 16.67 53 25885 30079 53293049
Drug-induced liver injury 29.69 16.67 52 25886 29181 53293947
Renal tubular dysfunction 29.65 16.67 10 25928 388 53322740
Peripheral swelling 29.54 16.67 34 25904 206074 53117054
Anembryonic gestation 29.24 16.67 11 25927 588 53322540
Cough 29.23 16.67 50 25888 256843 53066285
Liver transplant 29.11 16.67 17 25921 2477 53320651
Hepatitis 29.01 16.67 56 25882 33838 53289290
Psoriasis 28.93 16.67 4 25934 87085 53236043
Abortion threatened 28.73 16.67 11 25927 617 53322511
Wound 28.61 16.67 5 25933 91552 53231576
Endometritis decidual 28.41 16.67 6 25932 34 53323094
Enanthema 28.19 16.67 10 25928 452 53322676
Congenital ectopic bladder 28.05 16.67 7 25931 90 53323038
Sepsis neonatal 27.67 16.67 10 25928 477 53322651
Blood phosphorus decreased 27.53 16.67 20 25918 4217 53318911
Amniotic cavity infection 27.23 16.67 13 25925 1257 53321871
Mitochondrial cytopathy 27.12 16.67 9 25929 332 53322796
Jaundice 27.08 16.67 51 25887 30262 53292866
Blood HIV RNA 27.03 16.67 5 25933 12 53323116
Adrenogenital syndrome 26.84 16.67 6 25932 46 53323082
Glomerular filtration rate decreased 26.70 16.67 32 25906 12735 53310393
Maternal exposure before pregnancy 26.40 16.67 22 25916 5664 53317464
Lower respiratory tract infection 26.28 16.67 6 25932 90975 53232153
Discomfort 26.21 16.67 7 25931 95465 53227663
Congenital central nervous system anomaly 26.14 16.67 9 25929 372 53322756
White blood cell count decreased 26.07 16.67 14 25924 124461 53198667
Face oedema 25.95 16.67 40 25898 20200 53302928
Potassium wasting nephropathy 25.60 16.67 6 25932 58 53323070
Hypophosphataemia 25.19 16.67 26 25912 8779 53314349
Arthritis 24.73 16.67 6 25932 87292 53235836
Placental chorioangioma 24.73 16.67 5 25933 22 53323106
Abortion 24.67 16.67 15 25923 2351 53320777
Influenza 24.34 16.67 8 25930 95371 53227757
Congenital musculoskeletal anomaly 23.91 16.67 9 25929 482 53322646
Contusion 23.86 16.67 12 25926 110720 53212408
Congenital umbilical hernia 23.80 16.67 9 25929 488 53322640
Blood pressure increased 23.78 16.67 20 25918 140459 53182669
Hepatotoxicity 23.78 16.67 46 25892 27834 53295294
Foetal malformation 23.72 16.67 7 25931 174 53322954
Large for dates baby 23.42 16.67 9 25929 510 53322618
Cardiac failure congestive 23.29 16.67 8 25930 92749 53230379
Exposure via body fluid 23.27 16.67 9 25929 519 53322609
Congenital choroid plexus cyst 23.09 16.67 8 25930 337 53322791
Coagulation factor V level decreased 23.02 16.67 8 25930 340 53322788
Drug level increased 22.95 16.67 38 25900 20383 53302745
Swelling 22.84 16.67 36 25902 191069 53132059
Spinocerebellar disorder 22.77 16.67 5 25933 35 53323093
Urinary tract infection 22.71 16.67 52 25886 239851 53083277
Viral load decreased 22.64 16.67 5 25933 36 53323092
Hyperadrenocorticism 22.56 16.67 8 25930 361 53322767
Hereditary optic atrophy 22.48 16.67 4 25934 7 53323121
Tremor 22.41 16.67 17 25921 125719 53197409
Hepatitis B DNA increased 22.38 16.67 7 25931 213 53322915
Hepatic failure 22.33 16.67 52 25886 35754 53287374
Coarctation of the aorta 22.33 16.67 9 25929 579 53322549
Constipation 22.21 16.67 39 25899 198373 53124755
Retinal toxicity 21.92 16.67 11 25927 1186 53321942
Abortion spontaneous incomplete 21.86 16.67 5 25933 43 53323085
Mental disability 21.76 16.67 6 25932 116 53323012
Flushing 21.75 16.67 4 25934 70596 53252532
Tubulointerstitial nephritis 21.70 16.67 33 25905 16471 53306657
Febrile neutropenia 21.68 16.67 12 25926 104924 53218204
Ataxia 21.58 16.67 31 25907 14706 53308422
Malaise 21.57 16.67 95 25843 357522 52965606
Glucocorticoids increased 21.29 16.67 6 25932 126 53323002
Prurigo 21.24 16.67 10 25928 937 53322191
Impaired healing 21.20 16.67 3 25935 64202 53258926
Herpes zoster 21.14 16.67 5 25933 74014 53249114
Foetal cardiac disorder 21.09 16.67 5 25933 51 53323077
Unwanted pregnancy 21.09 16.67 5 25933 51 53323077
Balance disorder 20.80 16.67 5 25933 73202 53249926
Preterm premature rupture of membranes 20.72 16.67 11 25927 1332 53321796
Muscle spasms 20.68 16.67 21 25917 134774 53188354
Stomatitis 20.61 16.67 11 25927 98147 53224981
Total bile acids increased 20.57 16.67 6 25932 143 53322985
Pregnancy on oral contraceptive 20.45 16.67 11 25927 1368 53321760
Eosinophilia 20.44 16.67 37 25901 21298 53301830
Back pain 20.42 16.67 53 25885 234194 53088934
Encephalocele 20.38 16.67 6 25932 148 53322980
Cardiac murmur 20.36 16.67 27 25911 11886 53311242
Chronic papillomatous dermatitis 20.35 16.67 5 25933 60 53323068
Malignant neoplasm progression 20.10 16.67 5 25933 71536 53251592
Platelet count decreased 20.07 16.67 14 25924 108085 53215043
Hepatitis C 20.07 16.67 20 25918 6481 53316647
High arched palate 20.06 16.67 5 25933 64 53323064
Haemolytic anaemia 19.95 16.67 25 25913 10414 53312714
Bradycardia 19.90 16.67 5 25933 71051 53252077
Syphilis 19.90 16.67 6 25932 161 53322967
Noonan syndrome 19.89 16.67 3 25935 0 53323128
HIV viraemia 19.89 16.67 3 25935 0 53323128
Viral load undetectable 19.89 16.67 3 25935 0 53323128
Eyelid oedema 19.73 16.67 25 25913 10529 53312599
Encephalomalacia 19.71 16.67 8 25930 524 53322604
Alpha 1 foetoprotein abnormal 19.71 16.67 5 25933 69 53323059
Congenital acrochordon 19.71 16.67 5 25933 69 53323059
Osteoarthritis 19.66 16.67 5 25933 70481 53252647
Hypertension 19.65 16.67 51 25887 225380 53097748
Postpartum haemorrhage 19.63 16.67 12 25926 1900 53321228
Cerebral toxoplasmosis 19.50 16.67 9 25929 806 53322322
Cytogenetic abnormality 19.44 16.67 8 25930 543 53322585
Porphyria non-acute 19.41 16.67 7 25931 332 53322796
Hyperphosphaturia 19.36 16.67 4 25934 20 53323108
Symmetrical drug-related intertriginous and flexural exanthema 19.25 16.67 7 25931 340 53322788
Epilepsy congenital 19.20 16.67 4 25934 21 53323107
Heart rate increased 19.16 16.67 8 25930 82307 53240821
Pericarditis 19.10 16.67 4 25934 64402 53258726
Umbilical cord prolapse 19.04 16.67 4 25934 22 53323106
ACTH stimulation test abnormal 19.04 16.67 4 25934 22 53323106
Nervous system disorder 18.96 16.67 32 25906 17432 53305696
Gait disturbance 18.90 16.67 30 25908 158812 53164316
Syncope 18.88 16.67 16 25922 111977 53211151
Chondroma 18.47 16.67 4 25934 26 53323102
Abortion infected 18.47 16.67 4 25934 26 53323102
Congenital foot malformation 18.43 16.67 6 25932 208 53322920
Placenta accreta 18.38 16.67 6 25932 210 53322918
Cystic lymphangioma 18.34 16.67 4 25934 27 53323101
Thymus hypoplasia 18.34 16.67 4 25934 27 53323101
Single umbilical artery 18.19 16.67 6 25932 217 53322911
Abortion missed 18.06 16.67 11 25927 1730 53321398
Congenital spinal cord anomaly 17.81 16.67 3 25935 3 53323125
Renal impairment 17.81 16.67 84 25854 83234 53239894
Osteopenia 17.80 16.67 32 25906 18323 53304805
Brachydactyly 17.79 16.67 5 25933 104 53323024
Bronchitis 17.66 16.67 17 25921 111882 53211246
Hepatic encephalopathy 17.63 16.67 24 25914 10835 53312293
Thrombosis 17.57 16.67 4 25934 60789 53262339
Peripheral nerve injury 17.46 16.67 7 25931 444 53322684
Osteomalacia 17.46 16.67 8 25930 705 53322423
Clinodactyly 17.44 16.67 5 25933 112 53323016
Ruptured ectopic pregnancy 17.39 16.67 7 25931 449 53322679
Loss of consciousness 17.28 16.67 18 25920 114194 53208934
Cleft lip 17.19 16.67 5 25933 118 53323010
Neonatal respiratory distress syndrome 17.18 16.67 13 25925 2914 53320214
Talipes 16.90 16.67 10 25928 1492 53321636
Toxic skin eruption 16.89 16.67 26 25912 13113 53310015
Cortisol decreased 16.78 16.67 9 25929 1112 53322016
Ultrasound scan abnormal 16.75 16.67 6 25932 279 53322849
Placental disorder 16.72 16.67 10 25928 1521 53321607

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
Immune reconstitution inflammatory syndrome 1228.11 11.86 490 51330 9069 32452637
Foetal exposure during pregnancy 859.63 11.86 629 51191 40672 32421034
Viral load increased 803.65 11.86 268 51552 2882 32458824
Osteoporosis 685.52 11.86 351 51469 11831 32449875
Blood HIV RNA increased 629.98 11.86 190 51630 1427 32460279
Acute HIV infection 531.67 11.86 116 51704 159 32461547
Virologic failure 471.74 11.86 190 51630 3597 32458109
Genotype drug resistance test positive 416.61 11.86 142 51678 1639 32460067
Product storage error 401.30 11.86 206 51614 6972 32454734
Fanconi syndrome acquired 396.50 11.86 145 51675 2085 32459621
Renal tubular disorder 331.03 11.86 163 51657 5039 32456667
Drug resistance 318.76 11.86 276 51544 22689 32439017
HIV infection 315.79 11.86 118 51702 1808 32459898
CD4 lymphocytes decreased 315.21 11.86 122 51698 2068 32459638
Drug interaction 304.63 11.86 898 50922 217287 32244419
Viral mutation identified 300.21 11.86 129 51691 2890 32458816
Abnormal dreams 277.71 11.86 172 51648 8392 32453314
Product dispensing error 250.70 11.86 146 51674 6359 32455347
HIV test positive 242.66 11.86 62 51758 226 32461480
Treatment noncompliance 212.71 11.86 239 51581 26963 32434743
Syphilis 205.71 11.86 64 51756 539 32461167
Gastrointestinal tube insertion 176.85 11.86 71 51749 1331 32460375
Pathogen resistance 175.52 11.86 135 51685 9375 32452331
Renal colic 145.22 11.86 67 51753 1784 32459922
Glycosuria 132.50 11.86 58 51762 1360 32460346
Proteinuria 123.02 11.86 145 51675 17210 32444496
Blood creatinine increased 121.63 11.86 383 51437 95749 32365957
Pneumonia 112.80 11.86 250 51570 355002 32106704
Nephrolithiasis 110.59 11.86 174 51646 27180 32434526
Osteoporotic fracture 109.09 11.86 48 51772 1140 32460566
Acute hepatitis C 108.66 11.86 30 51790 157 32461549
Glomerular filtration rate decreased 107.76 11.86 117 51703 12694 32449012
Hypotension 107.14 11.86 112 51708 215998 32245708
Fanconi syndrome 106.82 11.86 54 51766 1766 32459940
Osteonecrosis 104.98 11.86 131 51689 16491 32445215
Osteopenia 103.45 11.86 75 51745 4757 32456949
Premature baby 101.40 11.86 136 51684 18382 32443324
Dyspnoea 100.61 11.86 273 51547 361772 32099934
Fall 99.13 11.86 100 51720 196101 32265605
HIV-associated neurocognitive disorder 98.38 11.86 33 51787 361 32461345
Weight increased 98.24 11.86 325 51495 83338 32378368
Nephropathy toxic 95.11 11.86 106 51714 11840 32449866
Jaundice 92.25 11.86 182 51638 33976 32427730
Hypophosphataemia 90.74 11.86 90 51730 8785 32452921
Lipodystrophy acquired 90.07 11.86 62 51758 3620 32458086
Suicidal ideation 87.67 11.86 190 51630 37893 32423813
Malignant neoplasm progression 87.49 11.86 11 51809 78485 32383221
Dyslipidaemia 86.01 11.86 78 51742 6805 32454901
Depression 85.96 11.86 344 51476 96716 32364990
Polydactyly 85.16 11.86 41 51779 1204 32460502
Hyperbilirubinaemia 84.79 11.86 122 51698 17608 32444098
Viraemia 84.60 11.86 41 51779 1222 32460484
Trisomy 21 81.09 11.86 31 51789 507 32461199
Heterotaxia 79.70 11.86 23 51797 145 32461561
Product use complaint 78.30 11.86 39 51781 1235 32460471
CD4 lymphocytes abnormal 77.70 11.86 21 51799 100 32461606
Renal impairment 77.49 11.86 321 51499 91651 32370055
Nightmare 75.63 11.86 99 51721 13067 32448639
Cardiac failure congestive 75.25 11.86 21 51799 84831 32376875
Gene mutation 75.20 11.86 35 51785 951 32460755
Hepatitis C 75.11 11.86 100 51720 13418 32448288
Cytomegalovirus chorioretinitis 74.91 11.86 55 51765 3557 32458149
Depression suicidal 74.77 11.86 39 51781 1363 32460343
Disease progression 74.29 11.86 23 51797 86839 32374867
Low birth weight baby 73.50 11.86 72 51748 6922 32454784
Atrial fibrillation 73.17 11.86 48 51772 116656 32345050
Febrile neutropenia 72.53 11.86 51 51769 119515 32342191
Plasma cell myeloma 72.35 11.86 5 51815 57609 32404097
Psychiatric decompensation 72.15 11.86 39 51781 1467 32460239
Renal tubular dysfunction 70.66 11.86 27 51793 441 32461265
Acquired immunodeficiency syndrome 68.61 11.86 27 51793 479 32461227
Ocular icterus 65.65 11.86 48 51772 3084 32458622
Rash 62.59 11.86 557 51263 208776 32252930
Intentional dose omission 62.10 11.86 41 51779 2233 32459473
Developmental delay 61.34 11.86 43 51777 2585 32459121
Progressive multifocal leukoencephalopathy 59.99 11.86 75 51745 9456 32452250
Renal failure 59.30 11.86 392 51428 134086 32327620
Chlamydial infection 57.81 11.86 19 51801 194 32461512
Product dispensing issue 57.61 11.86 15 51805 60 32461646
Mycobacterium avium complex infection 57.32 11.86 43 51777 2874 32458832
Tearfulness 57.16 11.86 35 51785 1671 32460035
Infusion related reaction 57.12 11.86 4 51816 45595 32416111
Seroconversion test negative 57.02 11.86 12 51808 12 32461694
Constipation 56.55 11.86 71 51749 126302 32335404
Laryngomalacia 56.47 11.86 21 51799 317 32461389
Gonorrhoea 56.10 11.86 15 51805 68 32461638
Meningitis cryptococcal 55.93 11.86 38 51782 2171 32459535
Hypertriglyceridaemia 55.50 11.86 69 51751 8650 32453056
Renal tubular necrosis 52.97 11.86 93 51727 15885 32445821
Insurance issue 52.77 11.86 28 51792 1014 32460692
HIV viraemia 51.65 11.86 15 51805 97 32461609
Immune reconstitution inflammatory syndrome associated tuberculosis 51.59 11.86 22 51798 483 32461223
Drug abuse 50.27 11.86 33 51787 80210 32381496
Osteomalacia 49.37 11.86 26 51794 927 32460779
Hepatitis A 48.46 11.86 21 51799 480 32461226
Sepsis 48.39 11.86 114 51706 158720 32302986
Hepatitis B 48.31 11.86 55 51765 6286 32455420
Bone density decreased 48.20 11.86 33 51787 1909 32459797
Gastrostomy 48.15 11.86 24 51796 761 32460945
Diabetes mellitus 48.15 11.86 170 51650 45003 32416703
Rheumatoid arthritis 47.82 11.86 7 51813 44537 32417169
Interstitial lung disease 47.57 11.86 22 51798 64979 32396727
Anogenital warts 47.09 11.86 22 51798 603 32461103
Anal cancer 46.99 11.86 20 51800 437 32461269
Single umbilical artery 46.49 11.86 17 51803 244 32461462
Suicide attempt 46.11 11.86 150 51670 38094 32423612
Cough 46.09 11.86 95 51725 138722 32322984
Therapy cessation 45.25 11.86 87 51733 15926 32445780
CSF HIV escape syndrome 45.22 11.86 15 51805 158 32461548
Cortisol decreased 43.84 11.86 24 51796 926 32460780
Blood phosphorus decreased 43.78 11.86 38 51782 3128 32458578
Cardiac failure 43.67 11.86 49 51771 91624 32370082
Insomnia 43.28 11.86 291 51529 100057 32361649
Atypical mycobacterial infection 42.74 11.86 23 51797 857 32460849
Gene mutation identification test positive 42.73 11.86 15 51805 190 32461516
Pulmonary tuberculosis 42.71 11.86 46 51774 4943 32456763
Blood triglycerides increased 42.02 11.86 80 51740 14539 32447167
Blood pressure increased 41.67 11.86 39 51781 79315 32382391
Paranoia 41.30 11.86 67 51753 10732 32450974
Acute kidney injury 41.13 11.86 676 51144 292792 32168914
Gastrointestinal haemorrhage 40.77 11.86 47 51773 86835 32374871
Lipids increased 40.32 11.86 23 51797 962 32460744
Intercepted product dispensing error 40.26 11.86 12 51808 86 32461620
Depressive symptom 40.14 11.86 29 51791 1829 32459877
Seroconversion test positive 39.82 11.86 9 51811 16 32461690
Gynaecomastia 39.71 11.86 59 51761 8760 32452946
Neurosyphilis 39.31 11.86 11 51809 61 32461645
Wheezing 39.11 11.86 6 51814 36868 32424838
Death 39.00 11.86 406 51414 382111 32079595
Platelet count decreased 38.38 11.86 78 51742 114513 32347193
Completed suicide 38.30 11.86 55 51765 92462 32369244
Hepatic enzyme increased 38.28 11.86 138 51682 36899 32424807
Hypothalamic pituitary adrenal axis suppression 38.16 11.86 14 51806 203 32461503
Endotracheal intubation 37.72 11.86 32 51788 2553 32459153
Circumstance or information capable of leading to medication error 37.64 11.86 28 51792 1847 32459859
Renal disorder 37.12 11.86 106 51714 25077 32436629
False negative investigation result 37.08 11.86 13 51807 164 32461542
Toxicity to various agents 37.04 11.86 152 51668 177889 32283817
Kaposi's sarcoma 36.90 11.86 22 51798 1000 32460706
Chordee 36.64 11.86 11 51809 81 32461625
Bradycardia 36.60 11.86 36 51784 71526 32390180
Creatinine renal clearance decreased 36.42 11.86 36 51784 3498 32458208
Trisomy 18 36.28 11.86 14 51806 235 32461471
Ventricular hypoplasia 36.07 11.86 11 51809 86 32461620
Lymphoma 35.97 11.86 63 51757 10737 32450969
Shigella infection 35.84 11.86 9 51811 30 32461676
Cardiac arrest 35.82 11.86 62 51758 96714 32364992
Oxygen saturation decreased 35.63 11.86 16 51804 48083 32413623
Chronic kidney disease 35.58 11.86 142 51678 39833 32421873
Depressed mood 35.12 11.86 85 51735 18215 32443491
Sleep disorder 35.05 11.86 108 51712 26644 32435062
Adrenal suppression 34.90 11.86 19 51801 725 32460981
Blood pressure decreased 34.80 11.86 19 51801 51061 32410645
Congenital hearing disorder 34.51 11.86 11 51809 101 32461605
Hepatic cirrhosis 34.34 11.86 80 51740 16729 32444977
Beta 2 microglobulin urine increased 34.32 11.86 11 51809 103 32461603
Cardio-respiratory arrest 33.76 11.86 24 51796 55965 32405741
Therapeutic product effect incomplete 33.48 11.86 12 51808 41329 32420377
Pulmonary oedema 33.33 11.86 16 51804 46251 32415455
Laryngectomy 33.26 11.86 7 51813 7 32461699
Anogenital dysplasia 33.09 11.86 12 51808 168 32461538
Lipohypertrophy 32.55 11.86 14 51806 314 32461392
White blood cell count decreased 32.33 11.86 60 51760 91138 32370568
Pain 32.02 11.86 172 51648 187384 32274322
Fat tissue increased 31.33 11.86 15 51805 435 32461271
Blood creatine phosphokinase increased 30.91 11.86 149 51671 45327 32416379
Malaria 30.88 11.86 13 51807 276 32461430
Chromaturia 30.78 11.86 70 51750 14408 32447298
Pleural effusion 30.72 11.86 49 51771 78943 32382763
Product dose omission issue 30.58 11.86 273 51547 102302 32359404
Portal hypertension 30.53 11.86 35 51785 4029 32457677
Speech disorder developmental 30.40 11.86 24 51796 1730 32459976
Hepatitis cholestatic 30.06 11.86 50 51770 8175 32453531
Respiratory arrest 29.99 11.86 5 51815 28903 32432803
Hypospadias 29.91 11.86 30 51790 2967 32458739
Vanishing bile duct syndrome 29.84 11.86 17 51803 709 32460997
Hepatic cytolysis 29.58 11.86 50 51770 8283 32453423
Hepatitis 29.52 11.86 94 51726 23599 32438107
Respiratory failure 29.46 11.86 81 51739 107101 32354605
Nasopharyngitis 29.39 11.86 35 51785 63752 32397954
Atrioventricular septal defect 29.36 11.86 10 51810 115 32461591
CSF virus identified 29.28 11.86 8 51812 40 32461666
Chronic obstructive pulmonary disease 29.26 11.86 21 51799 48732 32412974
Hepatotoxicity 29.09 11.86 82 51738 19255 32442451
Psoriasis 28.83 11.86 19 51801 46104 32415602
Myalgia 28.36 11.86 224 51596 81006 32380700
Lower respiratory tract infection 28.32 11.86 6 51814 29237 32432469
Cerebral toxoplasmosis 28.31 11.86 22 51798 1550 32460156
Congenital anomaly 28.18 11.86 21 51799 1389 32460317
Secondary syphilis 28.06 11.86 8 51812 48 32461658
Oedema peripheral 27.92 11.86 91 51729 114000 32347706
Headache 27.80 11.86 453 51367 195744 32265962
Ventricular septal defect 27.63 11.86 32 51788 3725 32457981
Orthostatic hypotension 27.60 11.86 4 51816 25646 32436060
Haematochezia 27.57 11.86 14 51806 39194 32422512
Pancreatitis 27.39 11.86 127 51693 38024 32423682
Portal fibrosis 26.65 11.86 13 51807 393 32461313
Lactic acidosis 26.60 11.86 115 51705 33421 32428285
Blood HIV RNA 26.50 11.86 7 51813 30 32461676
Joint swelling 26.48 11.86 26 51794 51709 32409997
Hyperferritinaemia 26.32 11.86 13 51807 404 32461302
Cryptorchism 26.31 11.86 23 51797 1911 32459795
Inability to afford medication 26.30 11.86 18 51802 1041 32460665
Haemoglobin decreased 26.24 11.86 100 51720 119571 32342135
Dehydration 26.24 11.86 111 51709 128847 32332859
Karyotype analysis abnormal 25.96 11.86 8 51812 65 32461641
Hepatitis B DNA assay positive 25.75 11.86 8 51812 67 32461639
Acute respiratory failure 25.66 11.86 7 51813 28721 32432985
Epistaxis 25.35 11.86 31 51789 55824 32405882
Hepatitis B DNA increased 25.32 11.86 14 51806 551 32461155
Cushingoid 25.29 11.86 26 51794 2648 32459058
Pyelocaliectasis 25.28 11.86 19 51801 1273 32460433
Haemophilic arthropathy 25.28 11.86 10 51810 180 32461526
Congenital hydronephrosis 25.00 11.86 15 51805 690 32461016
Testicular germ cell tumour mixed 24.99 11.86 7 51813 39 32461667
Asthenia 24.97 11.86 248 51572 235696 32226010
Psychomotor skills impaired 24.88 11.86 25 51795 2478 32459228
Hepatitis syphilitic 24.87 11.86 5 51815 3 32461703
Infection 24.82 11.86 62 51758 84653 32377053
CD4 lymphocytes increased 24.70 11.86 11 51809 269 32461437
International normalised ratio increased 24.69 11.86 25 51795 49010 32412696
Faeces pale 24.54 11.86 20 51800 1509 32460197
Injection site pain 24.47 11.86 11 51809 33047 32428659
Hyperlipidaemia 24.29 11.86 64 51756 14447 32447259
Tuberculosis 24.14 11.86 47 51773 8682 32453024
Neonatal hyponatraemia 23.89 11.86 8 51812 87 32461619
Delirium 23.88 11.86 21 51799 44025 32417681
Back pain 23.58 11.86 94 51726 110959 32350747
Haemoptysis 23.53 11.86 12 51808 33513 32428193
Supernumerary nipple 23.50 11.86 7 51813 50 32461656
Mitochondrial myopathy 23.47 11.86 10 51810 219 32461487
Mobility decreased 23.43 11.86 8 51812 28401 32433305
Anal chlamydia infection 23.28 11.86 5 51815 6 32461700
Lipoatrophy 23.27 11.86 14 51806 647 32461059
Major depression 23.20 11.86 32 51788 4439 32457267
Ectopic kidney 23.03 11.86 7 51813 54 32461652
General physical health deterioration 22.95 11.86 100 51720 115159 32346547
Calculus urinary 22.95 11.86 18 51802 1285 32460421
AIDS related complication 22.85 11.86 6 51814 25 32461681
Dysphagia 22.82 11.86 172 51648 61304 32400402
Viral load 22.81 11.86 8 51812 101 32461605
Productive cough 22.79 11.86 13 51807 34103 32427603
Neuropsychiatric syndrome 22.74 11.86 8 51812 102 32461604
Liver function test increased 22.68 11.86 57 51763 12503 32449203
Drug-induced liver injury 22.64 11.86 87 51733 23976 32437730
Vertigo 22.20 11.86 87 51733 24196 32437510
White blood cell count increased 22.13 11.86 20 51800 41382 32420324
Nausea 22.10 11.86 668 51152 320181 32141525
Oesophageal candidiasis 22.02 11.86 31 51789 4383 32457323
Pancreatitis acute 21.88 11.86 94 51726 27241 32434465
Pneumonia aspiration 21.86 11.86 20 51800 41136 32420570
Product temperature excursion issue 21.74 11.86 5 51815 10 32461696
Alpha 1 foetoprotein abnormal 21.64 11.86 6 51814 32 32461674
Urinary tract infection 21.63 11.86 61 51759 80010 32381696
Tachycardia 21.55 11.86 60 51760 79028 32382678
Renal tubular acidosis 21.50 11.86 21 51799 2011 32459695
Psychotic disorder 21.47 11.86 83 51737 22937 32438769
Eye infection syphilitic 21.42 11.86 5 51815 11 32461695
Ventricular tachycardia 21.42 11.86 7 51813 25549 32436157
Foetal growth restriction 21.24 11.86 29 51791 3983 32457723
Haematocrit decreased 21.24 11.86 12 51808 31650 32430056
Congenital mitral valve incompetence 21.20 11.86 8 51812 126 32461580
Economic problem 21.13 11.86 18 51802 1444 32460262
Congenital umbilical hernia 21.12 11.86 12 51808 498 32461208
Porphyria non-acute 21.08 11.86 12 51808 500 32461206
Hypoglycaemia 20.88 11.86 34 51786 54348 32407358
Chest discomfort 20.64 11.86 30 51790 50200 32411506
Syncope 20.61 11.86 74 51746 90050 32371656
Mitochondrial cytopathy 20.56 11.86 9 51811 211 32461495
Therapy change 20.53 11.86 24 51796 2821 32458885
Therapeutic product effect decreased 20.46 11.86 12 51808 31005 32430701
Substance use 20.38 11.86 12 51808 533 32461173
Depressed level of consciousness 20.36 11.86 21 51799 40826 32420880
Heart rate increased 20.30 11.86 22 51798 41806 32419900
Congenital choroid plexus cyst 20.29 11.86 9 51811 218 32461488
Cytomegalovirus colitis 20.26 11.86 23 51797 2619 32459087
Hypomagnesaemia 20.07 11.86 3 51817 18802 32442904
Chills 19.99 11.86 61 51759 78023 32383683
Retinal toxicity 19.96 11.86 11 51809 430 32461276
Hydrocele 19.91 11.86 21 51799 2203 32459503
Malignant anorectal neoplasm 19.78 11.86 6 51814 46 32461660
Anomalous pulmonary venous connection 19.71 11.86 7 51813 92 32461614
Malaise 19.64 11.86 184 51636 176954 32284752
Nervous system disorder 19.61 11.86 58 51762 13991 32447715
Multiple-drug resistance 19.56 11.86 27 51793 3748 32457958
Schizophreniform disorder 19.50 11.86 7 51813 95 32461611
C-reactive protein increased 19.50 11.86 29 51791 48073 32413633
Blood bilirubin increased 19.50 11.86 117 51703 38667 32423039
Metabolic surgery 19.44 11.86 6 51814 49 32461657
Acute stress disorder 19.40 11.86 8 51812 161 32461545
Fat redistribution 19.31 11.86 8 51812 163 32461543
Genital herpes 19.04 11.86 12 51808 603 32461103
Urine phosphorus abnormal 19.01 11.86 4 51816 4 32461702
Erectile dysfunction 18.88 11.86 72 51748 19767 32441939
Intestinal congestion 18.82 11.86 5 51815 22 32461684
Hemiparaesthesia 18.74 11.86 6 51814 56 32461650
Alopecia 18.73 11.86 74 51746 20656 32441050
Psoriatic arthropathy 18.72 11.86 3 51817 17857 32443849
Decreased appetite 18.72 11.86 165 51655 160648 32301058
Mitochondrial toxicity 18.67 11.86 22 51798 2608 32459098
Polymicrogyria 18.64 11.86 5 51815 23 32461683
Product label on wrong product 18.64 11.86 5 51815 23 32461683
Drug screen false positive 18.62 11.86 13 51807 776 32460930
Eosinophilic pustular folliculitis 18.62 11.86 7 51813 109 32461597
Cerebellar syndrome 18.59 11.86 20 51800 2146 32459560
Hepatic necrosis 18.48 11.86 27 51793 3948 32457758
Osteonecrosis of jaw 18.42 11.86 4 51816 19162 32442544
Drug level increased 18.40 11.86 72 51748 20008 32441698
Periarthritis 18.38 11.86 15 51805 1134 32460572
Mental disorder 18.38 11.86 58 51762 14490 32447216
Dyspnoea exertional 18.35 11.86 21 51799 38940 32422766
Septic shock 18.31 11.86 53 51767 68936 32392770
Urinary retention 18.19 11.86 18 51802 35679 32426027
Cachexia 18.12 11.86 37 51783 7072 32454634
Product distribution issue 18.07 11.86 9 51811 285 32461421
Ureterolithiasis 17.86 11.86 19 51801 2013 32459693
Hyperphosphaturia 17.86 11.86 6 51814 66 32461640
Gastric bypass 17.84 11.86 9 51811 293 32461413
Bone density abnormal 17.69 11.86 6 51814 68 32461638
Night sweats 17.52 11.86 61 51759 16027 32445679
Full blood count decreased 17.51 11.86 3 51817 17007 32444699
Influenza 17.45 11.86 29 51791 45985 32415721
Mechanical ventilation 17.31 11.86 18 51802 1857 32459849
Gastrointestinal mucosal exfoliation 17.30 11.86 7 51813 134 32461572
Visceral leishmaniasis 17.25 11.86 11 51809 564 32461142
Lung disorder 17.23 11.86 17 51803 33737 32427969
Ultrasound foetal abnormal 17.07 11.86 4 51816 9 32461697
Neonatal asphyxia 17.06 11.86 9 51811 322 32461384
Transient ischaemic attack 16.98 11.86 10 51810 25784 32435922
Anaphylactic reaction 16.82 11.86 14 51806 30158 32431548
Exposure during pregnancy 16.78 11.86 42 51778 9187 32452519
Haemolytic anaemia 16.75 11.86 46 51774 10638 32451068
Glomerular filtration rate abnormal 16.70 11.86 12 51808 750 32460956
Psychomotor retardation 16.62 11.86 22 51798 2933 32458773
Gastroenteritis cryptosporidial 16.58 11.86 8 51812 236 32461470
Confusional state 16.58 11.86 147 51673 142968 32318738
Cholestasis 16.54 11.86 86 51734 26947 32434759
Treatment failure 16.51 11.86 113 51707 39050 32422656
Polydipsia 16.42 11.86 25 51795 3792 32457914
Hepatomegaly 16.37 11.86 45 51775 10412 32451294
Drug hypersensitivity 16.29 11.86 61 51759 73339 32388367
Toxoplasmosis 16.29 11.86 15 51805 1334 32460372
Transaminases increased 16.28 11.86 81 51739 24947 32436759
Condition aggravated 16.28 11.86 164 51656 155497 32306209
Vitamin D deficiency 16.24 11.86 32 51788 5962 32455744
Cardiac disorder 16.24 11.86 26 51794 41840 32419866
Blood corticotrophin decreased 16.19 11.86 7 51813 159 32461547
Intestinal malrotation 16.19 11.86 5 51815 41 32461665
Cleft lip and palate 16.05 11.86 9 51811 364 32461342
Hepatic fibrosis 15.99 11.86 24 51796 3594 32458112
Chronic hepatitis B 15.98 11.86 5 51815 43 32461663
Hyperhidrosis 15.89 11.86 59 51761 71109 32390597
Product residue present 15.88 11.86 21 51799 2797 32458909
Viral load abnormal 15.81 11.86 6 51814 96 32461610
Hydrops foetalis 15.81 11.86 8 51812 262 32461444
Drug level decreased 15.79 11.86 33 51787 6413 32455293
Blood oestrogen decreased 15.78 11.86 4 51816 14 32461692
Treponema test positive 15.78 11.86 4 51816 14 32461692
Skin dystrophy 15.78 11.86 4 51816 14 32461692
Mucosal inflammation 15.76 11.86 18 51802 33416 32428290
Dyskinesia 15.75 11.86 9 51811 23594 32438112
Peripheral swelling 15.70 11.86 56 51764 68289 32393417
Rash maculo-papular 15.69 11.86 87 51733 27935 32433771
Persistent left superior vena cava 15.56 11.86 4 51816 15 32461691
Foetal heart rate abnormal 15.43 11.86 7 51813 179 32461527
Congenital hydrocephalus 15.43 11.86 6 51814 103 32461603
Erythema 15.41 11.86 74 51746 83031 32378675
Megakaryocytes increased 15.40 11.86 5 51815 49 32461657
Cystic lymphangioma 15.36 11.86 4 51816 16 32461690
Burkitt's lymphoma 15.32 11.86 7 51813 182 32461524
Toxic skin eruption 15.31 11.86 47 51773 11567 32450139
Cellulitis 15.30 11.86 36 51784 50194 32411512
Seborrhoeic dermatitis 15.24 11.86 15 51805 1450 32460256
Feeding tube user 15.22 11.86 5 51815 51 32461655
Fluid retention 15.20 11.86 12 51808 26538 32435168
Unmasking of previously unidentified disease 15.16 11.86 11 51809 698 32461008
Rhabdomyolysis 15.16 11.86 169 51651 67096 32394610
Enanthema 15.14 11.86 9 51811 407 32461299
Hepatocellular injury 15.12 11.86 80 51740 25238 32436468
Central obesity 15.02 11.86 10 51810 552 32461154
Bone marrow oedema 15.02 11.86 10 51810 552 32461154
Rhinorrhoea 15.01 11.86 9 51811 22977 32438729
Oesophageal carcinoma 14.97 11.86 25 51795 4101 32457605
Endocrine ophthalmopathy 14.96 11.86 5 51815 54 32461652
Melaena 14.94 11.86 20 51800 34645 32427061
Endocarditis candida 14.92 11.86 6 51814 113 32461593
Stress fracture 14.81 11.86 12 51808 898 32460808
Acute myeloid leukaemia 14.80 11.86 6 51814 19168 32442538
Cell death 14.75 11.86 19 51801 2467 32459239
Hepatosplenomegaly 14.63 11.86 24 51796 3879 32457827
Hodgkin's disease 14.63 11.86 12 51808 914 32460792
Thrombosis 14.58 11.86 32 51788 45722 32415984
T-lymphocyte count decreased 14.52 11.86 7 51813 206 32461500
Jarisch-Herxheimer reaction 14.52 11.86 9 51811 439 32461267
Drug reaction with eosinophilia and systemic symptoms 14.46 11.86 95 51725 32390 32429316
Prurigo 14.46 11.86 11 51809 751 32460955
Varices oesophageal 14.39 11.86 23 51797 3638 32458068
Mycobacterium avium complex immune restoration disease 14.34 11.86 5 51815 62 32461644
Inclusion body myositis 14.32 11.86 4 51816 22 32461684
Maternal drugs affecting foetus 14.31 11.86 25 51795 4252 32457454
Alopecia areata 14.28 11.86 7 51813 214 32461492
Head lag abnormal 14.26 11.86 3 51817 3 32461703
Thymus hypoplasia 14.26 11.86 3 51817 3 32461703
Pruritus 14.25 11.86 286 51534 128416 32333290
Bone loss 14.18 11.86 10 51810 607 32461099
Disease risk factor 14.17 11.86 4 51816 23 32461683
Blood pressure systolic increased 14.17 11.86 5 51815 17391 32444315
Tremor 14.14 11.86 74 51746 81203 32380503
Deep vein thrombosis 14.11 11.86 53 51767 63660 32398046
Blood glucose increased 13.98 11.86 55 51765 65186 32396520
Cleft palate 13.92 11.86 10 51810 625 32461081
Glomerular filtration rate increased 13.84 11.86 7 51813 229 32461477
Lymphadenopathy 13.80 11.86 82 51738 27000 32434706
Bone marrow oedema syndrome 13.79 11.86 3 51817 4 32461702
Upper respiratory tract infection 13.75 11.86 16 51804 29457 32432249
Pneumocystis jirovecii pneumonia 13.67 11.86 63 51757 18807 32442899
Creatinine renal clearance abnormal 13.60 11.86 7 51813 238 32461468
Right aortic arch 13.50 11.86 4 51816 28 32461678
Posterior cortical atrophy 13.50 11.86 4 51816 28 32461678
Adrenogenital syndrome 13.47 11.86 5 51815 75 32461631
Neutrophil count decreased 13.41 11.86 35 51785 47104 32414602
Pain in extremity 13.38 11.86 123 51697 118778 32342928
Dyschromatopsia 13.37 11.86 8 51812 366 32461340
Glucose urine present 13.31 11.86 12 51808 1038 32460668
HIV associated nephropathy 13.31 11.86 8 51812 369 32461337
Hepatic steatosis 13.31 11.86 56 51764 16077 32445629
Product use in unapproved indication 13.23 11.86 83 51737 87121 32374585
Device related infection 13.22 11.86 6 51814 17927 32443779
Hepatic cancer 13.22 11.86 33 51787 7207 32454499
Tubulointerstitial nephritis 13.19 11.86 64 51756 19513 32442193
Osteoma 13.15 11.86 4 51816 31 32461675
End stage AIDS 13.04 11.86 4 51816 32 32461674
Ergot poisoning 12.95 11.86 5 51815 84 32461622
Stomatitis 12.93 11.86 28 51792 40201 32421505
Cerebral dysgenesis 12.93 11.86 4 51816 33 32461673
Rectal haemorrhage 12.92 11.86 25 51795 37398 32424308
Ejection fraction decreased 12.88 11.86 6 51814 17652 32444054
Blood bilirubin unconjugated increased 12.87 11.86 10 51810 704 32461002
Hyponatraemia 12.87 11.86 68 51752 74445 32387261
Unresponsive to stimuli 12.87 11.86 15 51805 27594 32434112
Renal aplasia 12.82 11.86 10 51810 708 32460998
Manufacturing product shipping issue 12.82 11.86 4 51816 34 32461672
Deafness congenital 12.79 11.86 5 51815 87 32461619
Liver function test abnormal 12.77 11.86 91 51729 31856 32429850
Subdural haematoma 12.77 11.86 8 51812 19945 32441761
Plethoric face 12.73 11.86 3 51817 7 32461699
Pulmonary valve disease 12.67 11.86 7 51813 275 32461431
Cerebrovascular accident 12.66 11.86 83 51737 86237 32375469
Cytokine release syndrome 12.66 11.86 3 51817 13532 32448174
Blood glucose decreased 12.66 11.86 3 51817 13531 32448175
Portal hypertensive gastropathy 12.62 11.86 9 51811 556 32461150
Oral candidiasis 12.58 11.86 45 51775 11982 32449724
Cataract 12.55 11.86 12 51808 24171 32437535
Alanine aminotransferase increased 12.52 11.86 185 51635 78294 32383412
Gastroenteritis 12.50 11.86 50 51770 14031 32447675
Human immunodeficiency virus transmission 12.43 11.86 4 51816 38 32461668
Hyperkalaemia 12.41 11.86 63 51757 69687 32392019
Loss of consciousness 12.40 11.86 79 51741 82628 32379078
Ankyloglossia congenital 12.33 11.86 7 51813 290 32461416
Hepatitis fulminant 12.31 11.86 23 51797 4120 32457586
Giardiasis 12.29 11.86 7 51813 292 32461414
Acute hepatic failure 12.29 11.86 47 51773 12922 32448784
Blood bilirubin decreased 12.24 11.86 7 51813 294 32461412
Respiratory depression 12.21 11.86 3 51817 13208 32448498
Neck pain 12.19 11.86 11 51809 22776 32438930
17-hydroxyprogesterone increased 12.19 11.86 3 51817 9 32461697
Eagle Barrett syndrome 12.19 11.86 3 51817 9 32461697
Phosphorus metabolism disorder 12.19 11.86 3 51817 9 32461697
Cytomegalovirus test positive 12.18 11.86 22 51798 3840 32457866
Talipes 12.17 11.86 15 51805 1863 32459843
Nephropathy 12.15 11.86 28 51792 5812 32455894
Red blood cell count decreased 12.03 11.86 16 51804 27797 32433909
Pulmonary fibrosis 12.02 11.86 6 51814 16968 32444738
Hyperadrenocorticism 12.02 11.86 5 51815 103 32461603
Hyperproteinaemia 12.02 11.86 6 51814 191 32461515
Glucocorticoid deficiency 12.01 11.86 7 51813 305 32461401
Opportunistic infection 11.99 11.86 14 51806 1643 32460063
Blood alkaline phosphatase increased 11.97 11.86 90 51730 32042 32429664
Swelling 11.96 11.86 27 51793 38195 32423511
Pulmonary hilar enlargement 11.95 11.86 3 51817 10 32461696
Hypophagia 11.94 11.86 12 51808 23611 32438095
Suspected counterfeit product 11.89 11.86 7 51813 311 32461395

Pharmacologic Action:

SourceCodeDescription
ATC J05AF09 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Nucleoside and nucleotide reverse transcriptase inhibitors
ATC J05AR03 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HIV infections, combinations
ATC J05AR06 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HIV infections, combinations
ATC J05AR08 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HIV infections, combinations
ATC J05AR09 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HIV infections, combinations
ATC J05AR17 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HIV infections, combinations
ATC J05AR18 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HIV infections, combinations
ATC J05AR19 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HIV infections, combinations
ATC J05AR20 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HIV infections, combinations
ATC J05AR22 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HIV infections, combinations
FDA CS M0015066 Nucleosides
FDA MoA N0000009947 Nucleoside Reverse Transcriptase Inhibitors
FDA EPC N0000175462 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
MeSH PA D019380 Anti-HIV Agents
MeSH PA D000890 Anti-Infective Agents
MeSH PA D044966 Anti-Retroviral Agents
MeSH PA D000998 Antiviral Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D019384 Nucleic Acid Synthesis Inhibitors
MeSH PA D018894 Reverse Transcriptase Inhibitors
CHEBI has role CHEBI:36044 anti-virus drug
CHEBI has role CHEBI:53756 reverse transcriptase inhibitor

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Human immunodeficiency virus infection indication 86406008 DOID:526
Coronavirus infection off-label use 186747009
Prevention of HIV Infection after Exposure off-label use
Osteomalacia contraindication 4598005 DOID:10573
Hypophosphatemia contraindication 4996001
Suicidal thoughts contraindication 6471006
Hypercholesterolemia contraindication 13644009
Torsades de pointes contraindication 31722008
Depressive disorder contraindication 35489007
Fanconi syndrome contraindication 40488004 DOID:1062
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Aggressive behavior contraindication 61372001
Chronic type B viral hepatitis contraindication 61977001
Kidney disease contraindication 90708001 DOID:557
Lactic acidosis contraindication 91273001 DOID:3650
Prolonged QT interval contraindication 111975006
Chronic hepatitis C contraindication 128302006
Seizure disorder contraindication 128613002
Liver function tests abnormal contraindication 166603001
Paranoid disorder contraindication 191667009
Steatosis of liver contraindication 197321007
Mania contraindication 231494001
Disease of liver contraindication 235856003 DOID:409
Pathological fracture contraindication 268029009
Pregnancy, function contraindication 289908002
Hypertriglyceridemia contraindication 302870006
Severe depression contraindication 310497006
Osteopenia contraindication 312894000
Breastfeeding (mother) contraindication 413712001
Obesity contraindication 414916001 DOID:9970
Congenital long QT syndrome contraindication 442917000

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 12.95 acidic
pKa2 2.57 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
150MG;150MG;200MG;EQ 10MG BASE GENVOYA GILEAD SCIENCES INC N207561 Nov. 5, 2015 RX TABLET ORAL 7803788 Feb. 2, 2022 TREATMENT OF HIV INFECTION
200MG;EQ 25MG BASE DESCOVY GILEAD SCIENCES INC N208215 April 4, 2016 RX TABLET ORAL 7803788 Feb. 2, 2022 TREATMENT OF HIV-1 INFECTION
200MG;EQ 25MG BASE;EQ 25MG BASE ODEFSEY GILEAD SCIENCES INC N208351 March 1, 2016 RX TABLET ORAL 7803788 Feb. 2, 2022 TREATMENT OF HIV INFECTION
EQ 30MG BASE;120MG;EQ 15MG BASE BIKTARVY GILEAD SCIENCES INC N210251 Oct. 7, 2021 RX TABLET ORAL 7803788 Feb. 2, 2022 TREATMENT OF HIV INFECTION
EQ 50MG BASE;200MG;EQ 25MG BASE BIKTARVY GILEAD SCIENCES INC N210251 Feb. 7, 2018 RX TABLET ORAL 7803788 Feb. 2, 2022 TREATMENT OF HIV INFECTION
150MG;800MG;200MG;EQ 10MG BASE SYMTUZA JANSSEN PRODS N210455 July 17, 2018 RX TABLET ORAL 7803788 Feb. 2, 2022 TREATMENT OF HIV-1 INFECTION IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 40 KG WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS
150MG;800MG;200MG;EQ 10MG BASE SYMTUZA JANSSEN PRODS N210455 July 17, 2018 RX TABLET ORAL 7803788 Feb. 2, 2022 TREATMENT OF HIV-1 INFECTION IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS
200MG;300MG TRUVADA GILEAD N021752 Aug. 2, 2004 RX TABLET ORAL 8592397 Jan. 13, 2024 METHOD OF TREATMENT OF ADULTS INFECTED WITH HIV-1
200MG;300MG TRUVADA GILEAD N021752 Aug. 2, 2004 RX TABLET ORAL 8592397 Jan. 13, 2024 TREATMENT OF HIV
200MG;300MG TRUVADA GILEAD N021752 Aug. 2, 2004 RX TABLET ORAL 8592397 Jan. 13, 2024 TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
200MG;300MG TRUVADA GILEAD N021752 Aug. 2, 2004 RX TABLET ORAL 8716264 Jan. 13, 2024 TREATMENT OF HIV INFECTION
200MG;300MG TRUVADA GILEAD N021752 Aug. 2, 2004 RX TABLET ORAL 9457036 Jan. 13, 2024 TREATMENT OF HIV INFECTION
200MG;300MG TRUVADA GILEAD N021752 Aug. 2, 2004 RX TABLET ORAL 9744181 Jan. 13, 2024 TREATMENT OF HIV INFECTION
600MG;200MG;300MG ATRIPLA GILEAD SCIENCES N021937 July 12, 2006 RX TABLET ORAL 8592397 Jan. 13, 2024 TREATMENT OF HIV-1 INFECTION IN ADULTS
600MG;200MG;300MG ATRIPLA GILEAD SCIENCES N021937 July 12, 2006 RX TABLET ORAL 8592397 Jan. 13, 2024 TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
600MG;200MG;300MG ATRIPLA GILEAD SCIENCES N021937 July 12, 2006 RX TABLET ORAL 8716264 Jan. 13, 2024 TREATMENT OF HIV INFECTION
600MG;200MG;300MG ATRIPLA GILEAD SCIENCES N021937 July 12, 2006 RX TABLET ORAL 9457036 Jan. 13, 2024 TREATMENT OF HIV INFECTION
600MG;200MG;300MG ATRIPLA GILEAD SCIENCES N021937 July 12, 2006 RX TABLET ORAL 9744181 Jan. 13, 2024 TREATMENT OF HIV INFECTION
200MG;EQ 25MG BASE;300MG COMPLERA GILEAD SCIENCES INC N202123 Aug. 10, 2011 RX TABLET ORAL 8592397 Jan. 13, 2024 TREATMENT OF HIV INFECTION
200MG;EQ 25MG BASE;300MG COMPLERA GILEAD SCIENCES INC N202123 Aug. 10, 2011 RX TABLET ORAL 8716264 Jan. 13, 2024 TREATMENT OF HIV INFECTION
200MG;EQ 25MG BASE;300MG COMPLERA GILEAD SCIENCES INC N202123 Aug. 10, 2011 RX TABLET ORAL 9457036 Jan. 13, 2024 TREATMENT OF HIV INFECTION
200MG;EQ 25MG BASE;300MG COMPLERA GILEAD SCIENCES INC N202123 Aug. 10, 2011 RX TABLET ORAL 9744181 Jan. 13, 2024 TREATMENT OF HIV INFECTION
150MG;150MG;200MG;300MG STRIBILD GILEAD SCIENCES INC N203100 Aug. 27, 2012 RX TABLET ORAL 8592397 Jan. 13, 2024 TREATMENT OF HIV INFECTION
150MG;150MG;200MG;300MG STRIBILD GILEAD SCIENCES INC N203100 Aug. 27, 2012 RX TABLET ORAL 8716264 Jan. 13, 2024 TREATMENT OF HIV INFECTION
150MG;150MG;200MG;300MG STRIBILD GILEAD SCIENCES INC N203100 Aug. 27, 2012 RX TABLET ORAL 9457036 Jan. 13, 2024 TREATMENT OF HIV INFECTION
150MG;150MG;200MG;300MG STRIBILD GILEAD SCIENCES INC N203100 Aug. 27, 2012 RX TABLET ORAL 9744181 Jan. 13, 2024 TREATMENT OF HIV INFECTION
200MG;EQ 25MG BASE;300MG COMPLERA GILEAD SCIENCES INC N202123 Aug. 10, 2011 RX TABLET ORAL 7125879 April 21, 2025 TREATMENT OF HIV INFECTION
200MG;EQ 25MG BASE;EQ 25MG BASE ODEFSEY GILEAD SCIENCES INC N208351 March 1, 2016 RX TABLET ORAL 7125879 April 21, 2025 TREATMENT OF HIV INFECTION
200MG;EQ 25MG BASE;300MG COMPLERA GILEAD SCIENCES INC N202123 Aug. 10, 2011 RX TABLET ORAL 8841310 Dec. 9, 2025 TREATMENT OF HIV INFECTION
600MG;200MG;300MG ATRIPLA GILEAD SCIENCES N021937 July 12, 2006 RX TABLET ORAL 9018192 June 13, 2026 TREATMENT OF HIV-1 INFECTION IN ADULTS
600MG;200MG;300MG ATRIPLA GILEAD SCIENCES N021937 July 12, 2006 RX TABLET ORAL 9018192 June 13, 2026 TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
600MG;200MG;300MG ATRIPLA GILEAD SCIENCES N021937 July 12, 2006 RX TABLET ORAL 9545414 June 13, 2026 TREATMENT OF HIV-1 INFECTION IN ADULTS
600MG;200MG;300MG ATRIPLA GILEAD SCIENCES N021937 July 12, 2006 RX TABLET ORAL 9545414 June 13, 2026 TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
150MG;150MG;200MG;300MG STRIBILD GILEAD SCIENCES INC N203100 Aug. 27, 2012 RX TABLET ORAL 7176220 Aug. 27, 2026 TREATMENT OF HIV INFECTION
150MG;150MG;200MG;EQ 10MG BASE GENVOYA GILEAD SCIENCES INC N207561 Nov. 5, 2015 RX TABLET ORAL 7176220 Aug. 27, 2026 TREATMENT OF HIV INFECTION
150MG;150MG;200MG;300MG STRIBILD GILEAD SCIENCES INC N203100 Aug. 27, 2012 RX TABLET ORAL 7635704 Oct. 26, 2026 TREATMENT OF HIV INFECTION
150MG;150MG;200MG;EQ 10MG BASE GENVOYA GILEAD SCIENCES INC N207561 Nov. 5, 2015 RX TABLET ORAL 7635704 Oct. 26, 2026 TREATMENT OF HIV INFECTION
150MG;150MG;200MG;300MG STRIBILD GILEAD SCIENCES INC N203100 Aug. 27, 2012 RX TABLET ORAL 8148374 Sept. 3, 2029 TREATMENT OF HIV INFECTION USING A COMPOSITION CONTAINING A PHARMACOKINETIC ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE
150MG;150MG;200MG;300MG STRIBILD GILEAD SCIENCES INC N203100 Aug. 27, 2012 RX TABLET ORAL 9891239 Sept. 3, 2029 TREATMENT OF HIV INFECTION
150MG;150MG;200MG;EQ 10MG BASE GENVOYA GILEAD SCIENCES INC N207561 Nov. 5, 2015 RX TABLET ORAL 8148374 Sept. 3, 2029 TREATMENT OF HIV INFECTION USING A COMPOSITION CONTAINING A PHARMACOKINETIC ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE
150MG;150MG;200MG;EQ 10MG BASE GENVOYA GILEAD SCIENCES INC N207561 Nov. 5, 2015 RX TABLET ORAL 9891239 Sept. 3, 2029 TREATMENT OF HIV INFECTION
150MG;800MG;200MG;EQ 10MG BASE SYMTUZA JANSSEN PRODS N210455 July 17, 2018 RX TABLET ORAL 8148374 Sept. 3, 2029 TREATMENT OF HIV-1 INFECTION USING A COMPOSITION CONTAINING A PHARMACOKINETIC ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY
150MG;800MG;200MG;EQ 10MG BASE SYMTUZA JANSSEN PRODS N210455 July 17, 2018 RX TABLET ORAL 8148374 Sept. 3, 2029 TREATMENT OF HIV-1 INFECTION USING A COMPOSITION CONTAINING A PHARMACOKINETIC ENHANCER THAT INIBITS CYTOCHROME P450 MONOOXYGENASE IN ADULTS WHO ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS
150MG;800MG;200MG;EQ 10MG BASE SYMTUZA JANSSEN PRODS N210455 July 17, 2018 RX TABLET ORAL 8148374 Sept. 3, 2029 TREATMENT OF HIV-1 INFECTION USING A COMPOSITION CONTAINING A PK ENHANCER THAT INHIBITS CY P450 MONOXYGENASE IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 40KG WHO ARE VIROLOGICALLY SUPPRESSED ON A STABLE ARV REGIMEN FOR AT LEAST 6 MONTHS
150MG;800MG;200MG;EQ 10MG BASE SYMTUZA JANSSEN PRODS N210455 July 17, 2018 RX TABLET ORAL 8148374 Sept. 3, 2029 TREATMENT OF HIV-1 INFECTION USING A COMPOSITION CONTAINING A PK ENHANCER THAT INHIBITS CY P450 MONOXYGENASE IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 40KG WHO HAVE NO PRIOR ARV TREATMENT HISTORY
150MG;800MG;200MG;EQ 10MG BASE SYMTUZA JANSSEN PRODS N210455 July 17, 2018 RX TABLET ORAL 8148374 Sept. 3, 2029 TX OF HIV1 INFECTION USING A COMPOSITION CONTAINING A PK ENHANCER THAT INHIBITS CY P450 MONOXYGENASE IN ADULTS & PEDIATRIC PATIENTS AT LEAST 40KG HAVING NO PRIOR ARV TX HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ARV REGIMEN FOR AT LEAST 6 MO
150MG;800MG;200MG;EQ 10MG BASE SYMTUZA JANSSEN PRODS N210455 July 17, 2018 RX TABLET ORAL 8148374 Sept. 3, 2029 TX OF HIV-1 INFECTION USING A COMPOSITION CONTAINING A PK ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENATES IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TX HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS
150MG;150MG;200MG;300MG STRIBILD GILEAD SCIENCES INC N203100 Aug. 27, 2012 RX TABLET ORAL 8633219 April 30, 2030 TREATMENT OF HIV INFECTION
150MG;150MG;200MG;EQ 10MG BASE GENVOYA GILEAD SCIENCES INC N207561 Nov. 5, 2015 RX TABLET ORAL 8633219 April 30, 2030 TREATMENT OF HIV INFECTION
150MG;150MG;200MG;EQ 10MG BASE GENVOYA GILEAD SCIENCES INC N207561 Nov. 5, 2015 RX TABLET ORAL 8754065 Aug. 15, 2032 TREATMENT OF HIV INFECTION
150MG;150MG;200MG;EQ 10MG BASE GENVOYA GILEAD SCIENCES INC N207561 Nov. 5, 2015 RX TABLET ORAL 9296769 Aug. 15, 2032 TREATMENT OF HIV INFECTION
120MG;EQ 15MG BASE DESCOVY GILEAD SCIENCES INC N208215 Jan. 7, 2022 RX TABLET ORAL 8754065 Aug. 15, 2032 TREATMENT OF HIV-1 INFECTION
120MG;EQ 15MG BASE DESCOVY GILEAD SCIENCES INC N208215 Jan. 7, 2022 RX TABLET ORAL 9296769 Aug. 15, 2032 TREATMENT OF HIV-1 INFECTION
200MG;EQ 25MG BASE DESCOVY GILEAD SCIENCES INC N208215 April 4, 2016 RX TABLET ORAL 8754065 Aug. 15, 2032 PROPHYLAXIS OF HIV-1 INFECTION
200MG;EQ 25MG BASE DESCOVY GILEAD SCIENCES INC N208215 April 4, 2016 RX TABLET ORAL 8754065 Aug. 15, 2032 TREATMENT OF HIV-1 INFECTION
200MG;EQ 25MG BASE DESCOVY GILEAD SCIENCES INC N208215 April 4, 2016 RX TABLET ORAL 8754065 Aug. 15, 2032 TREATMENT OF HIV INFECTION
200MG;EQ 25MG BASE DESCOVY GILEAD SCIENCES INC N208215 April 4, 2016 RX TABLET ORAL 9296769 Aug. 15, 2032 PROPHYLAXIS OF HIV-1 INFECTION
200MG;EQ 25MG BASE DESCOVY GILEAD SCIENCES INC N208215 April 4, 2016 RX TABLET ORAL 9296769 Aug. 15, 2032 TREATMENT OF HIV-1 INFECTION
200MG;EQ 25MG BASE DESCOVY GILEAD SCIENCES INC N208215 April 4, 2016 RX TABLET ORAL 9296769 Aug. 15, 2032 TREATMENT OF HIV INFECTION
200MG;EQ 25MG BASE;EQ 25MG BASE ODEFSEY GILEAD SCIENCES INC N208351 March 1, 2016 RX TABLET ORAL 8754065 Aug. 15, 2032 TREATMENT OF HIV INFECTION
200MG;EQ 25MG BASE;EQ 25MG BASE ODEFSEY GILEAD SCIENCES INC N208351 March 1, 2016 RX TABLET ORAL 9296769 Aug. 15, 2032 TREATMENT OF HIV INFECTION
EQ 30MG BASE;120MG;EQ 15MG BASE BIKTARVY GILEAD SCIENCES INC N210251 Oct. 7, 2021 RX TABLET ORAL 8754065 Aug. 15, 2032 TREATMENT OF HIV INFECTION
EQ 30MG BASE;120MG;EQ 15MG BASE BIKTARVY GILEAD SCIENCES INC N210251 Oct. 7, 2021 RX TABLET ORAL 9296769 Aug. 15, 2032 TREATMENT OF HIV INFECTION
EQ 50MG BASE;200MG;EQ 25MG BASE BIKTARVY GILEAD SCIENCES INC N210251 Feb. 7, 2018 RX TABLET ORAL 8754065 Aug. 15, 2032 TREATMENT OF HIV INFECTION
EQ 50MG BASE;200MG;EQ 25MG BASE BIKTARVY GILEAD SCIENCES INC N210251 Feb. 7, 2018 RX TABLET ORAL 9296769 Aug. 15, 2032 TREATMENT OF HIV INFECTION
150MG;800MG;200MG;EQ 10MG BASE SYMTUZA JANSSEN PRODS N210455 July 17, 2018 RX TABLET ORAL 8754065 Aug. 15, 2032 TREATMENT OF HIV-1 INFECTION IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 40 KG WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS
150MG;800MG;200MG;EQ 10MG BASE SYMTUZA JANSSEN PRODS N210455 July 17, 2018 RX TABLET ORAL 8754065 Aug. 15, 2032 TREATMENT OF HIV-1 INFECTION IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS
150MG;800MG;200MG;EQ 10MG BASE SYMTUZA JANSSEN PRODS N210455 July 17, 2018 RX TABLET ORAL 9296769 Aug. 15, 2032 TREATMENT OF HIV-1 INFECTION IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 40 KG WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS
150MG;800MG;200MG;EQ 10MG BASE SYMTUZA JANSSEN PRODS N210455 July 17, 2018 RX TABLET ORAL 9296769 Aug. 15, 2032 TREATMENT OF HIV-1 INFECTION IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS
EQ 30MG BASE;120MG;EQ 15MG BASE BIKTARVY GILEAD SCIENCES INC N210251 Oct. 7, 2021 RX TABLET ORAL 10385067 June 19, 2035 TREATMENT OF HIV INFECTION
EQ 50MG BASE;200MG;EQ 25MG BASE BIKTARVY GILEAD SCIENCES INC N210251 Feb. 7, 2018 RX TABLET ORAL 10385067 June 19, 2035 TREATMENT OF HIV INFECTION
150MG;800MG;200MG;EQ 10MG BASE SYMTUZA JANSSEN PRODS N210455 July 17, 2018 RX TABLET ORAL 10786518 July 19, 2038 TREATMENT OF HIV-1 INFECTION IN ADULT OR PEDIATRIC PATIENTS (>=40 KG) WITH <50 COPIES/ML HIV-1 RNA AFTER >= 6 MONTHS ON PRIOR ANTIRETROVIRAL REGIMEN AND NO KNOWN DARUNAVIR OR TENOFOVIR RESISTANCE-ASSOCIATED SUBSTITUTIONS

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 50MG BASE;200MG;EQ 25MG BASE BIKTARVY GILEAD SCIENCES INC N210251 Feb. 7, 2018 RX TABLET ORAL June 18, 2022 NEW PATIENT POPULATION
200MG;EQ 25MG BASE DESCOVY GILEAD SCIENCES INC N208215 April 4, 2016 RX TABLET ORAL Oct. 3, 2022 FOR USE IN AT RISK ADULTS AND ADOLESCENTS WEIGHING AT LEAST 35 KG FOR PRE-EXPOSURE PROPHYLAXIS TO REDUCE THE RISK OF HIV-1 INFECTION FROM SEXUAL ACQUISITION, EXCLUDING INDIVIDUALS AT RISK FROM RECEPTIVE VAGINAL SEX
EQ 30MG BASE;120MG;EQ 15MG BASE BIKTARVY GILEAD SCIENCES INC N210251 Oct. 7, 2021 RX TABLET ORAL Feb. 7, 2023 NEW CHEMICAL ENTITY
EQ 50MG BASE;200MG;EQ 25MG BASE BIKTARVY GILEAD SCIENCES INC N210251 Feb. 7, 2018 RX TABLET ORAL Feb. 7, 2023 NEW CHEMICAL ENTITY
EQ 50MG BASE;200MG;EQ 25MG BASE BIKTARVY GILEAD SCIENCES INC N210251 Feb. 7, 2018 RX TABLET ORAL Feb. 24, 2024 LABELING REVISIONS RELATED TO CLINICAL STUDIES
200MG;EQ 25MG BASE DESCOVY GILEAD SCIENCES INC N208215 April 4, 2016 RX TABLET ORAL Sept. 28, 2024 IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS, FOR THE TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS UNDER 12 YEARS OF AGE WEIGHING AT LEAST 35KG
200MG;EQ 25MG BASE DESCOVY GILEAD SCIENCES INC N208215 April 4, 2016 RX TABLET ORAL Sept. 28, 2024 IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS OTHER THAN PROTEASE INHIBITORS THAT REQUIRE A CYP3A INHIBITOR, FOR THE TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS UNDER 12 YEARS OF AGE WEIGHING AT LEAST 25KG AND LESS THAN 35KG
EQ 50MG BASE;200MG;EQ 25MG BASE BIKTARVY GILEAD SCIENCES INC N210251 Feb. 7, 2018 RX TABLET ORAL June 18, 2026 FOR HIV-1 INFECTION IN PEDIATRIC PTS AT LEAST 25 KG W/ NO ANTIRETROVIRAL (ARV) TX HX OR TO REPLACE CURRENT ARV REGIMEN FOR VIROLOGICALLY-SUPPRESSED ON STABLE ARV W/ NO HX TX FAILURE AND NO KNOWN SUBSTITUTIONS ASSOCIATED W/ RESISTANCE TO BIC, FTC, OR TAF
EQ 30MG BASE;120MG;EQ 15MG BASE BIKTARVY GILEAD SCIENCES INC N210251 Oct. 7, 2021 RX TABLET ORAL Oct. 7, 2028 A COMPLETE REGIMEN FOR THE TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) INFECTION IN PEDIATRIC PATIENTS WEIGHING 14 KG TO LESS THAN 25 KG WHO HAVE NO ANTIRETROVIRAL TREATMENT HISTORY OR TO REPLACE THE CURRENT ANTIRETROVIRAL REGIMEN IN THOSE WHO ARE VIROLOGICALLY-SUPPRESSED (HIV-1 RNA LESS THAN 50 COPIES PER ML) ON A STABLE ANTIRETROVIRAL REGIMEN WITH NO HISTORY OF TREATMENT FAILURE AND NO KNOWN SUBSTITUTIONS ASSOCIATED WITH RESISTANCE TO THE INDIVIDUAL COMPONENTS OF BIKTARVY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Reverse transcriptase/RNaseH Enzyme INHIBITOR CHEMBL CHEMBL

External reference:

IDSource
4021395 VUID
N0000148813 NUI
D01199 KEGG_DRUG
4021395 VANDF
C0909839 UMLSCUI
CHEBI:31536 CHEBI
ETV PDB_CHEM_ID
CHEMBL885 ChEMBL_ID
DB00879 DRUGBANK_ID
D000068679 MESH_DESCRIPTOR_UI
7822 INN_ID
60877 PUBCHEM_CID
11244 IUPHAR_LIGAND_ID
G70B4ETF4S UNII
276237 RXNORM
17421 MMSL
338322 MMSL
47041 MMSL
d04884 MMSL
001321 NDDF
404855005 SNOMEDCT_US
404856006 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate HUMAN PRESCRIPTION DRUG LABEL 3 0093-5234 TABLET, FILM COATED 200 mg ORAL ANDA 30 sections
Emtricitabine and Tenofovir Disoproxil Fumarate HUMAN PRESCRIPTION DRUG LABEL 2 0093-7607 TABLET, FILM COATED 200 mg ORAL ANDA 29 sections
Emtricitabine and Tenofovir Disoproxil Fumarate HUMAN PRESCRIPTION DRUG LABEL 2 0093-7704 TABLET, FILM COATED 200 mg ORAL ANDA 29 sections
Emtricitabine and Tenofovir Disoproxil Fumarate HUMAN PRESCRIPTION DRUG LABEL 2 0378-1930 TABLET, FILM COATED 200 mg ORAL ANDA 30 sections
Emtricitabine and Tenofovir Disoproxil Fumarate HUMAN PRESCRIPTION DRUG LABEL 2 0904-7172 TABLET, FILM COATED 200 mg ORAL ANDA 28 sections
Atripla HUMAN PRESCRIPTION DRUG LABEL 3 15584-0101 TABLET, FILM COATED 200 mg ORAL NDA 34 sections
Emtricitabine and tenofovir disoproxil fumarate HUMAN PRESCRIPTION DRUG LABEL 2 31722-560 TABLET, FILM COATED 200 mg ORAL ANDA 27 sections
Emtricitabine and tenofovir disoproxil fumarate Human Prescription Drug Label 2 33342-106 TABLET, FILM COATED 200 mg ORAL ANDA 28 sections
Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Human Prescription Drug Label 3 33342-138 TABLET, FILM COATED 200 mg ORAL ANDA 30 sections
Emtricitabine and Tenofovir Disoproxil Fumarate HUMAN PRESCRIPTION DRUG LABEL 2 42291-439 TABLET, FILM COATED 200 mg ORAL ANDA 26 sections
Efavirenz, emtricitabine and tenofovir disoproxil fumarate Human Prescription Drug Label 3 42385-915 TABLET, FILM COATED 200 mg ORAL ANDA 30 sections
Emtricitabine and Tenofovir Disoproxil Fumarate Human Prescription Drug Label 2 42385-953 TABLET, FILM COATED 200 mg ORAL ANDA 28 sections
Emtricitabine and Tenofovir Disoproxil Fumarate HUMAN PRESCRIPTION DRUG LABEL 2 42543-719 TABLET 200 mg ORAL ANDA 27 sections
Emtriva HUMAN PRESCRIPTION DRUG LABEL 1 46014-0601 CAPSULE 200 mg ORAL NDA 29 sections
Truvada HUMAN PRESCRIPTION DRUG LABEL 2 50090-0870 TABLET, FILM COATED 200 mg ORAL NDA 33 sections
Truvada HUMAN PRESCRIPTION DRUG LABEL 2 50090-0870 TABLET, FILM COATED 200 mg ORAL NDA 33 sections
Emtricitabine and Tenofovir Disoproxil Fumarate HUMAN PRESCRIPTION DRUG LABEL 2 51407-112 TABLET 200 mg ORAL ANDA 27 sections
Truvada HUMAN PRESCRIPTION DRUG LABEL 2 52959-969 TABLET, FILM COATED 200 mg ORAL NDA 31 sections
Atripla HUMAN PRESCRIPTION DRUG LABEL 3 53808-0208 TABLET, FILM COATED 200 mg ORAL NDA 31 sections
Emtriva HUMAN PRESCRIPTION DRUG LABEL 1 53808-0801 CAPSULE 200 mg ORAL NDA 29 sections
Truvada HUMAN PRESCRIPTION DRUG LABEL 2 53808-0805 TABLET, FILM COATED 200 mg ORAL NDA 31 sections
Stribild HUMAN PRESCRIPTION DRUG LABEL 4 53808-0887 TABLET, FILM COATED 200 mg ORAL NDA 30 sections
Emtriva HUMAN PRESCRIPTION DRUG LABEL 1 54868-4853 CAPSULE 200 mg ORAL NDA 30 sections
Truvada HUMAN PRESCRIPTION DRUG LABEL 2 54868-5141 TABLET, FILM COATED 200 mg ORAL NDA 31 sections
Atripla HUMAN PRESCRIPTION DRUG LABEL 3 54868-5643 TABLET, FILM COATED 200 mg ORAL NDA 31 sections
COMPLERA HUMAN PRESCRIPTION DRUG LABEL 3 54868-6360 TABLET, FILM COATED 200 mg ORAL NDA 32 sections
Symtuza HUMAN PRESCRIPTION DRUG LABEL 4 59676-800 TABLET, FILM COATED 200 mg ORAL NDA 34 sections
Emtricitabine and Tenofovir Disoproxil Fumarate HUMAN PRESCRIPTION DRUG LABEL 2 60219-2095 TABLET, FILM COATED 200 mg ORAL ANDA 26 sections
Emtricitabine and Tenofovir Disoproxil Fumarate HUMAN PRESCRIPTION DRUG LABEL 2 60505-4202 TABLET, FILM COATED 200 mg ORAL ANDA 26 sections
TRUVADA HUMAN PRESCRIPTION DRUG LABEL 2 61919-669 TABLET, FILM COATED 200 mg ORAL NDA 15 sections