emtricitabine 🐶 Veterinary Use | 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 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
fu (Fraction unbound in plasma) 1 % Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K

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 745.53 21.21 282 10048 46913 63431779
Exposure during pregnancy 511.22 21.21 316 10014 155231 63323461
Foetal exposure during pregnancy 450.45 21.21 176 10154 31786 63446906
Abortion induced 344.73 21.21 108 10222 10134 63468558
Immune reconstitution inflammatory syndrome 237.89 21.21 72 10258 6012 63472680
Stillbirth 230.51 21.21 72 10258 6678 63472014
Virologic failure 221.15 21.21 53 10277 1809 63476883
Blood HIV RNA increased 215.92 21.21 44 10286 695 63477997
Pregnancy 204.99 21.21 106 10224 36730 63441962
Premature baby 196.20 21.21 86 10244 20649 63458043
Viral mutation identified 181.70 21.21 45 10285 1765 63476927
Enlarged clitoris 174.89 21.21 29 10301 129 63478563
Drug interaction 164.46 21.21 194 10136 228937 63249755
Hyperandrogenism 155.43 21.21 25 10305 88 63478604
Drug resistance 136.24 21.21 69 10261 22864 63455828
Pathogen resistance 121.87 21.21 44 10286 6354 63472338
Maternal exposure during pregnancy 120.65 21.21 163 10167 219899 63258793
Premature labour 115.45 21.21 51 10279 12453 63466239
Hydrops foetalis 113.44 21.21 25 10305 583 63478109
Viral load increased 112.36 21.21 29 10301 1345 63477347
Hepatic cytolysis 111.35 21.21 53 10277 15354 63463338
CD4 lymphocytes decreased 92.24 21.21 25 10305 1402 63477290
Lipodystrophy acquired 91.81 21.21 25 10305 1427 63477265
Fanconi syndrome acquired 85.36 21.21 22 10308 1014 63477678
Premature rupture of membranes 79.12 21.21 30 10300 4963 63473729
Cushing's syndrome 78.71 21.21 19 10311 668 63478024
Renal tubular disorder 76.67 21.21 25 10305 2657 63476035
Spina bifida 74.49 21.21 19 10311 840 63477852
Caesarean section 72.31 21.21 41 10289 16991 63461701
Pain 70.73 21.21 17 10313 740611 62738081
Genotype drug resistance test positive 65.49 21.21 15 10315 418 63478274
Hyperbilirubinaemia 64.14 21.21 33 10297 11281 63467411
Oligohydramnios 62.11 21.21 27 10303 6339 63472353
Pre-eclampsia 61.68 21.21 30 10300 9103 63469589
Live birth 61.57 21.21 43 10287 25587 63453105
Acute kidney injury 60.87 21.21 133 10197 263282 63215410
Autoimmune hepatitis 60.64 21.21 29 10301 8481 63470211
Maternal drugs affecting foetus 60.33 21.21 25 10305 5217 63473475
Premature delivery 59.54 21.21 45 10285 30236 63448456
Immune reconstitution inflammatory syndrome associated tuberculosis 56.94 21.21 13 10317 357 63478335
Treatment noncompliance 55.33 21.21 47 10283 37278 63441414
Adrenal suppression 54.21 21.21 15 10315 909 63477783
CSF HIV escape syndrome 53.56 21.21 10 10320 97 63478595
Ultrasound antenatal screen abnormal 50.39 21.21 10 10320 137 63478555
Meningomyelocele 50.32 21.21 13 10317 605 63478087
Ultrasound antenatal screen 46.10 21.21 10 10320 216 63478476
Drug ineffective 45.02 21.21 63 10267 1044702 62433990
Congenital anomaly 44.54 21.21 15 10315 1761 63476931
Hepatitis B DNA increased 44.22 21.21 10 10320 263 63478429
Ventricular septal defect 44.12 21.21 19 10311 4359 63474333
Osteonecrosis 42.87 21.21 34 10296 24496 63454196
Foetal death 42.78 21.21 25 10305 10955 63467737
Congenital hydrocephalus 42.73 21.21 9 10321 168 63478524
Jaundice 41.65 21.21 36 10294 29215 63449477
Hepatitis fulminant 41.49 21.21 17 10313 3447 63475245
Melanoderma 41.37 21.21 9 10321 197 63478495
Renal tubular necrosis 40.96 21.21 25 10305 11853 63466839
Rash maculo-papular 40.92 21.21 37 10293 31859 63446833
Lipohypertrophy 39.95 21.21 11 10319 654 63478038
HIV infection 39.86 21.21 10 10320 413 63478279
Oesophageal candidiasis 39.44 21.21 19 10311 5644 63473048
Drug reaction with eosinophilia and systemic symptoms 39.05 21.21 37 10293 33799 63444893
Fatigue 38.74 21.21 53 10277 887975 62590717
Renal failure 38.73 21.21 69 10261 117583 63361109
Patent ductus arteriosus 38.14 21.21 17 10313 4233 63474459
Spinocerebellar disorder 38.03 21.21 6 10324 18 63478674
Renal tubular acidosis 37.40 21.21 13 10317 1679 63477013
Foetal growth restriction 37.04 21.21 20 10310 7533 63471159
Congenital genital malformation female 36.31 21.21 6 10324 26 63478666
Neural tube defect 35.99 21.21 8 10322 194 63478498
Fanconi syndrome 35.87 21.21 12 10318 1380 63477312
Hepatitis 35.78 21.21 38 10292 39750 63438942
Ectopic pregnancy 35.60 21.21 14 10316 2553 63476139
Malaria 35.31 21.21 8 10322 212 63478480
Placenta praevia 35.26 21.21 11 10319 1013 63477679
Renal colic 35.14 21.21 12 10318 1469 63477223
Gestational diabetes 35.06 21.21 20 10310 8376 63470316
Haemolytic anaemia 34.12 21.21 21 10309 10104 63468588
Adrenogenital syndrome 34 21.21 6 10324 41 63478651
Fall 33.63 21.21 11 10319 392323 63086369
Cholestasis 33.61 21.21 32 10298 29402 63449290
Hereditary optic atrophy 33.47 21.21 5 10325 9 63478683
Congenital pulmonary valve disorder 32.64 21.21 6 10324 53 63478639
Sudden infant death syndrome 32.61 21.21 8 10322 301 63478391
Peripheral swelling 32.34 21.21 3 10327 265939 63212753
Polydactyly 32.31 21.21 8 10322 313 63478379
Ectopic kidney 31.61 21.21 6 10324 64 63478628
Hydrocephalus 31.61 21.21 16 10314 5284 63473408
Blood phosphorus decreased 31.19 21.21 15 10315 4438 63474254
Aspartate aminotransferase increased 31.07 21.21 54 10276 90223 63388469
Polyhydramnios 30.14 21.21 12 10318 2259 63476433
Lactic acidosis 29.97 21.21 34 10296 38253 63440439
Anaemia 29.74 21.21 110 10220 293320 63185372
Central obesity 29.39 21.21 10 10320 1211 63477481
Abdominal discomfort 29.30 21.21 8 10322 320877 63157815
Eyelid oedema 28.53 21.21 19 10311 10460 63468232
Dermatitis exfoliative 28.30 21.21 15 10315 5444 63473248
Alanine aminotransferase increased 28.10 21.21 56 10274 103714 63374978
Porphyria non-acute 27.88 21.21 7 10323 290 63478402
Glucocorticoids increased 27.82 21.21 6 10324 126 63478566
Anencephaly 27.65 21.21 7 10323 300 63478392
Coarctation of the aorta 27.63 21.21 8 10322 571 63478121
HIV-associated neurocognitive disorder 27.55 21.21 6 10324 132 63478560
Encephalocele 27.38 21.21 6 10324 136 63478556
Tubulointerstitial nephritis 27.33 21.21 24 10306 19879 63458813
Cushingoid 27.08 21.21 17 10313 8468 63470224
Pregnancy on oral contraceptive 26.96 21.21 9 10321 1028 63477664
Trisomy 18 26.86 21.21 6 10324 149 63478543
Congenital genital malformation 26.82 21.21 6 10324 150 63478542
Neonatal respiratory arrest 26.55 21.21 5 10325 51 63478641
Cloacal exstrophy 26.45 21.21 6 10324 160 63478532
Caudal regression syndrome 26.07 21.21 6 10324 171 63478521
Nasopharyngitis 25.87 21.21 5 10325 254252 63224440
Folate deficiency 25.79 21.21 11 10319 2464 63476228
Chronic papillomatous dermatitis 25.73 21.21 5 10325 61 63478631
Osteomalacia 25.64 21.21 8 10322 737 63477955
Transaminases increased 24.79 21.21 28 10302 31339 63447353
Arthralgia 24.76 21.21 34 10296 569676 62909016
ACTH stimulation test abnormal 24.46 21.21 4 10326 16 63478676
Neonatal respiratory distress syndrome 24.42 21.21 11 10319 2807 63475885
Skin striae 24.31 21.21 9 10321 1392 63477300
Generalised anxiety disorder 24.23 21.21 10 10320 2064 63476628
Prurigo 24.05 21.21 8 10322 904 63477788
Cleft lip and palate 22.62 21.21 7 10323 628 63478064
Drug intolerance 22.59 21.21 11 10319 308650 63170042
Hypophosphataemia 22.49 21.21 17 10313 11409 63467283
Thymus hypoplasia 22.34 21.21 4 10326 30 63478662
Foetal cardiac disorder 22.34 21.21 4 10326 30 63478662
Umbilical cord abnormality 22.32 21.21 7 10323 656 63478036
Pulmonary tuberculosis 22.26 21.21 12 10318 4505 63474187
Proteinuria 22.21 21.21 21 10309 19124 63459568
Sinusitis 21.94 21.21 5 10325 226648 63252044
Pulmonary valve sclerosis 21.90 21.21 4 10326 34 63478658
HIV test positive 21.90 21.21 4 10326 34 63478658
Cholestasis of pregnancy 21.74 21.21 8 10322 1217 63477475
Abortion infected 21.69 21.21 4 10326 36 63478656
Brain herniation 21.63 21.21 11 10319 3666 63475026
Systemic lupus erythematosus 21.48 21.21 4 10326 208914 63269778
Adrenal insufficiency 21.45 21.21 20 10310 17895 63460797
Retinal toxicity 21.43 21.21 8 10322 1267 63477425
CD4 lymphocytes increased 21.38 21.21 5 10325 153 63478539
Bladder agenesis 21.35 21.21 5 10325 154 63478538
Anal atresia 21.24 21.21 6 10324 392 63478300
Face oedema 21.24 21.21 21 10309 20191 63458501

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 819.45 13.85 274 20461 8485 34927711
Psychiatric decompensation 406.99 13.85 124 20611 2813 34933383
Depression suicidal 314.23 13.85 98 20637 2407 34933789
Tearfulness 308.19 13.85 98 20637 2569 34933627
Virologic failure 286.46 13.85 99 20636 3381 34932815
Blood HIV RNA increased 273.32 13.85 75 20660 1155 34935041
Drug interaction 265.45 13.85 477 20258 225469 34710727
Depressive symptom 265.36 13.85 89 20646 2770 34933426
Fanconi syndrome acquired 245.98 13.85 77 20658 1914 34934282
Psychomotor skills impaired 227.30 13.85 86 20649 3820 34932376
Paranoia 208.98 13.85 114 20621 11954 34924242
Drug resistance 207.46 13.85 150 20585 25777 34910419
Viral load increased 200.68 13.85 70 20665 2457 34933739
Viral mutation identified 197.41 13.85 72 20663 2882 34933314
Pathogen resistance 168.12 13.85 91 20644 9391 34926805
Renal tubular disorder 162.59 13.85 71 20664 4572 34931624
Psychotic disorder 146.23 13.85 119 20616 24333 34911863
Genotype drug resistance test positive 140.25 13.85 44 20691 1101 34935095
Renal colic 138.59 13.85 49 20686 1790 34934406
CD4 lymphocytes decreased 137.36 13.85 48 20687 1693 34934503
Suicidal ideation 136.78 13.85 143 20592 40245 34895951
Psychomotor retardation 96.80 13.85 46 20689 3604 34932592
Acute HIV infection 90.84 13.85 18 20717 54 34936142
Fanconi syndrome 89.78 13.85 35 20700 1685 34934511
Foetal exposure during pregnancy 88.46 13.85 111 20624 37990 34898206
Osteonecrosis 85.91 13.85 71 20664 14819 34921377
HIV-associated neurocognitive disorder 85.89 13.85 23 20712 321 34935875
Renal tubular necrosis 78.66 13.85 69 20666 15611 34920585
Nephropathy toxic 72.57 13.85 60 20675 12528 34923668
Jaundice 71.01 13.85 91 20644 31791 34904405
Hepatic cytolysis 69.15 13.85 62 20673 14434 34921762
Cytomegalovirus chorioretinitis 65.15 13.85 35 20700 3554 34932642
Death 64.82 13.85 85 20650 397964 34538232
Acute kidney injury 64.61 13.85 353 20382 304635 34631561
Syphilis 62.91 13.85 19 20716 417 34935779
CSF HIV escape syndrome 62.52 13.85 16 20719 185 34936011
Lipodystrophy acquired 61.79 13.85 33 20702 3311 34932885
Proteinuria 61.26 13.85 65 20670 18577 34917619
Exposure during pregnancy 60.92 13.85 47 20688 8887 34927309
Kaposi's sarcoma 60.77 13.85 22 20713 861 34935335
Nephrolithiasis 60.47 13.85 82 20653 30251 34905945
Ultrasound antenatal screen 58.36 13.85 19 20716 537 34935659
Osteoporosis 58.10 13.85 53 20682 12615 34923581
Anxiety 57.91 13.85 159 20576 99269 34836927
Cleft lip and palate 56.39 13.85 21 20714 891 34935305
Trisomy 18 56.03 13.85 20 20715 751 34935445
Acquired immunodeficiency syndrome 55.58 13.85 18 20717 500 34935696
Hyperbilirubinaemia 50.57 13.85 56 20679 16787 34919409
Renal failure 50.37 13.85 181 20554 130376 34805820
Hypophosphataemia 50.31 13.85 46 20689 10980 34925216
Glycosuria 50.18 13.85 21 20714 1216 34934980
Hydrops foetalis 50.10 13.85 19 20716 848 34935348
Osteoporotic fracture 45.80 13.85 19 20716 1076 34935120
Osteomalacia 45.54 13.85 18 20717 899 34935297
Hepatitis B 44.16 13.85 33 20702 5950 34930246
Renal tubular dysfunction 42.27 13.85 14 20721 418 34935778
HIV infection 42.12 13.85 19 20716 1320 34934876
Gene mutation 41.21 13.85 19 20716 1389 34934807
Hepatitis C 40.97 13.85 39 20696 9791 34926405
Aspartate aminotransferase increased 40.03 13.85 109 20626 67674 34868522
Blood creatinine increased 39.47 13.85 135 20600 94841 34841355
Fall 38.70 13.85 38 20697 202847 34733349
Depression 38.60 13.85 136 20599 96962 34839234
Portal hypertension 38.27 13.85 26 20709 4036 34932160
Malignant neoplasm progression 38.00 13.85 4 20731 88042 34848154
Vanishing bile duct syndrome 37.04 13.85 16 20719 1002 34935194
Ocular icterus 36.10 13.85 22 20713 2835 34933361
Congenital hearing disorder 35.82 13.85 9 20726 96 34936100
Abnormal dreams 35.32 13.85 32 20703 7546 34928650
Meningitis cryptococcal 34.25 13.85 20 20715 2384 34933812
Anogenital warts 34.20 13.85 13 20722 584 34935612
Lactic acidosis 33.80 13.85 68 20667 34704 34901492
Progressive multifocal leukoencephalopathy 33.78 13.85 35 20700 9729 34926467
Anal cancer 33.61 13.85 12 20723 451 34935745
Mycobacterium avium complex infection 33.45 13.85 20 20715 2491 34933705
Cortisol decreased 32.34 13.85 15 20720 1112 34935084
Unmasking of previously unidentified disease 32.06 13.85 14 20721 900 34935296
Constipation 31.93 13.85 21 20714 136961 34799235
Peripheral swelling 31.73 13.85 4 20731 76537 34859659
Dyspnoea 31.70 13.85 116 20619 376666 34559530
Abortion spontaneous 31.44 13.85 11 20724 389 34935807
Hydrocele 31.43 13.85 18 20717 2069 34934127
Drug abuse 31.13 13.85 10 20725 99086 34837110
Alanine aminotransferase increased 31.08 13.85 112 20623 80703 34855493
Pulmonary tuberculosis 30.22 13.85 24 20711 4730 34931466
Treatment noncompliance 29.79 13.85 57 20678 28043 34908153
Hepatitis 29.79 13.85 52 20683 23852 34912344
Product dose omission issue 29.78 13.85 17 20718 119694 34816502
Cytomegalovirus colitis 29.07 13.85 19 20716 2765 34933431
Cachexia 28.98 13.85 28 20707 7158 34929038
Pneumonia 28.97 13.85 114 20621 362513 34573683
Disease progression 28.87 13.85 14 20721 108063 34828133
Dyslipidaemia 28.01 13.85 28 20707 7460 34928736
CSF virus identified 27.85 13.85 6 20729 30 34936166
Oesophageal candidiasis 27.54 13.85 22 20713 4374 34931822
White matter lesion 27.04 13.85 12 20723 802 34935394
Hypertriglyceridaemia 26.94 13.85 29 20706 8419 34927777
Hodgkin's disease 26.13 13.85 12 20723 869 34935327
Mitochondrial myopathy 25.62 13.85 8 20727 197 34935999
Megakaryocytes increased 25.43 13.85 6 20729 48 34936148
Burkitt's lymphoma 25.02 13.85 7 20728 116 34936080
Blood alkaline phosphatase increased 24.58 13.85 56 20679 31119 34905077
Product use issue 24.57 13.85 4 20731 63212 34872984
Febrile neutropenia 24.52 13.85 27 20708 136822 34799374
Blood phosphorus decreased 24.49 13.85 18 20717 3163 34933033
Atrial fibrillation 24.40 13.85 22 20713 122371 34813825
Hepatosplenomegaly 24.29 13.85 20 20715 4149 34932047
Blood bilirubin increased 24.02 13.85 63 20672 38233 34897963
Renal impairment 23.77 13.85 115 20620 94398 34841798
Liver function test abnormal 23.59 13.85 55 20680 31019 34905177
Hepatitis B DNA assay positive 23.47 13.85 6 20729 69 34936127
Cardiac failure congestive 23.46 13.85 10 20725 83260 34852936
Suicide attempt 23.17 13.85 63 20672 39053 34897143
Oral candidiasis 23.01 13.85 32 20703 12078 34924118
Haemophilic arthropathy 22.95 13.85 7 20728 159 34936037
Pancytopenia 22.66 13.85 114 20621 95043 34841153
Blood pressure increased 22.64 13.85 12 20723 88090 34848106
Rhabdomyolysis 22.51 13.85 90 20645 68073 34868123
Hypotension 22.24 13.85 63 20672 221586 34714610
Porphyria non-acute 22.21 13.85 9 20726 480 34935716
Lipoatrophy 21.82 13.85 9 20726 502 34935694
Tubulointerstitial nephritis 21.49 13.85 42 20693 20982 34915214
Supernumerary nipple 21.42 13.85 5 20730 38 34936158
Rash maculo-papular 21.21 13.85 50 20685 28401 34907795
Lymphadenopathy 21.20 13.85 50 20685 28413 34907783
Cerebral toxoplasmosis 21.10 13.85 13 20722 1708 34934488
Hepatotoxicity 20.85 13.85 42 20693 21443 34914753
Completed suicide 20.34 13.85 17 20718 98151 34838045
Therapeutic product effect incomplete 20.09 13.85 3 20732 50538 34885658
Stevens-Johnson syndrome 19.99 13.85 38 20697 18601 34917595
Atypical mycobacterial infection 19.91 13.85 10 20725 883 34935313
Pulmonary venous thrombosis 19.72 13.85 6 20729 135 34936061
Anogenital dysplasia 19.72 13.85 6 20729 135 34936061
Back pain 19.72 13.85 26 20709 121763 34814433
Influenza 19.62 13.85 3 20732 49663 34886533
Secondary syphilis 19.00 13.85 5 20730 65 34936131
Joint swelling 18.88 13.85 6 20729 59884 34876312
Nasopharyngitis 18.77 13.85 9 20726 69959 34866237
Cholestasis 18.63 13.85 46 20689 26902 34909294
Premature baby 18.60 13.85 38 20697 19595 34916601
Pain 18.51 13.85 61 20674 204614 34731582
Pneumocystis jirovecii pneumonia 18.50 13.85 38 20697 19672 34916524
AIDS related complication 18.41 13.85 4 20731 21 34936175
Congenital anomaly 18.31 13.85 11 20724 1382 34934814
Glucose urine present 18.25 13.85 10 20725 1055 34935141
Acute hepatic failure 18.03 13.85 31 20704 14043 34922153
Cushingoid 17.90 13.85 14 20721 2700 34933496
Rash 17.75 13.85 206 20529 222546 34713650
Neonatal asphyxia 17.74 13.85 7 20728 348 34935848
Beta 2 microglobulin urine increased 17.70 13.85 5 20730 86 34936110
Trisomy 21 17.43 13.85 8 20727 579 34935617
Nervous system disorder 17.29 13.85 31 20704 14512 34921684
Off label use 17.06 13.85 163 20572 419361 34516835
Polydactyly 17.04 13.85 10 20725 1203 34934993
Drug level decreased 16.83 13.85 22 20713 7824 34928372
Inappropriate schedule of product administration 16.73 13.85 8 20727 62288 34873908
Cushing's syndrome 16.71 13.85 7 20728 406 34935790
End stage AIDS 16.64 13.85 4 20731 35 34936161
Hemiparaesthesia 16.63 13.85 5 20730 108 34936088
Prurigo 16.59 13.85 8 20727 647 34935549
Pancreatitis acute 16.34 13.85 45 20690 28096 34908100
Nodular regenerative hyperplasia 16.30 13.85 9 20726 964 34935232
Ergot poisoning 16.25 13.85 4 20731 39 34936157
Gamma-glutamyltransferase increased 16.24 13.85 46 20689 29185 34907011
Crystal nephropathy 16.03 13.85 7 20728 450 34935746
Haemodialysis 15.94 13.85 25 20710 10501 34925695
Oxygen saturation decreased 15.91 13.85 6 20729 53812 34882384
Bradycardia 15.69 13.85 13 20722 75405 34860791
Adrenal atrophy 15.68 13.85 3 20732 7 34936189
Drug level increased 15.57 13.85 38 20697 22058 34914138
Nasal septum deviation 15.28 13.85 9 20726 1090 34935106
Antiviral drug level above therapeutic 15.27 13.85 4 20731 51 34936145
Lung transplant rejection 15.15 13.85 8 20727 784 34935412
Eagle Barrett syndrome 15.14 13.85 3 20732 9 34936187
Phosphorus metabolism disorder 15.14 13.85 3 20732 9 34936187
Fatigue 15.06 13.85 144 20591 370509 34565687
Multiple-drug resistance 15.00 13.85 17 20718 5222 34930974
Sepsis 14.80 13.85 50 20685 166511 34769685
Cough 14.80 13.85 43 20692 150097 34786099
Adrenogenital syndrome 14.61 13.85 4 20731 61 34936135
Pulmonary oedema 14.56 13.85 5 20730 47524 34888672
Seroconversion test positive 14.47 13.85 3 20732 12 34936184
Fibrous histiocytoma 14.29 13.85 5 20730 177 34936019
Pulmonary hilar enlargement 14.28 13.85 3 20732 13 34936183
Musculoskeletal stiffness 14.14 13.85 5 20730 46675 34889521
Toxicity to various agents 14.09 13.85 66 20669 200296 34735900
Haematochezia 14.07 13.85 5 20730 46529 34889667
Lymphoma 14.03 13.85 26 20709 12481 34923715
Drug ineffective 14.03 13.85 189 20546 456562 34479634
Mitochondrial cytopathy 14.02 13.85 5 20730 187 34936009
Varices oesophageal 13.97 13.85 14 20721 3741 34932455
Psoriasis 13.92 13.85 3 20732 38809 34897387
Portal hypertensive gastropathy 13.92 13.85 7 20728 620 34935576

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Immune reconstitution inflammatory syndrome 1019.10 15.26 303 22368 13538 79708179
Abortion spontaneous 587.97 15.26 244 22427 29263 79692454
Psychiatric decompensation 450.99 15.26 122 22549 3841 79717876
Virologic failure 444.23 15.26 122 22549 4069 79717648
Drug interaction 431.14 15.26 558 22113 414625 79307092
Blood HIV RNA increased 417.27 15.26 98 22573 1710 79720007
Viral mutation identified 416.77 15.26 114 22557 3744 79717973
Depression suicidal 348.48 15.26 99 22572 3743 79717974
Drug resistance 322.78 15.26 181 22490 42032 79679685
Tearfulness 304.24 15.26 99 22572 5946 79715771
Pathogen resistance 293.61 15.26 121 22550 14221 79707496
Abortion induced 284.60 15.26 98 22573 7011 79714706
Exposure during pregnancy 284.19 15.26 233 22438 100899 79620818
Psychomotor skills impaired 268.56 15.26 87 22584 5150 79716567
Depressive symptom 258.89 15.26 89 22582 6334 79715383
Paranoia 236.86 15.26 114 22557 19318 79702399
Viral load increased 231.87 15.26 68 22603 2880 79718837
Genotype drug resistance test positive 205.34 15.26 52 22619 1256 79720461
CD4 lymphocytes decreased 186.43 15.26 56 22615 2578 79719139
Fanconi syndrome acquired 185.19 15.26 56 22615 2638 79719079
Stillbirth 183.82 15.26 61 22610 3894 79717823
Psychotic disorder 175.33 15.26 122 22549 41280 79680437
Renal tubular disorder 168.49 15.26 65 22606 6421 79715296
CSF HIV escape syndrome 124.64 15.26 27 22644 320 79721397
Suicidal ideation 117.56 15.26 126 22545 76214 79645503
Renal colic 113.24 15.26 39 22632 2788 79718929
Fanconi syndrome 112.85 15.26 39 22632 2817 79718900
Nephropathy toxic 107.69 15.26 69 22602 20350 79701367
Lipodystrophy acquired 107.57 15.26 42 22629 4283 79717434
HIV-associated neurocognitive disorder 102.17 15.26 23 22648 329 79721388
Acute kidney injury 101.50 15.26 351 22320 519053 79202664
Ultrasound antenatal screen 101.16 15.26 26 22645 667 79721050
Jaundice 100.17 15.26 98 22573 53251 79668466
Psychomotor retardation 99.48 15.26 44 22627 6140 79715577
Renal tubular necrosis 97.21 15.26 70 22601 24969 79696748
Hydrops foetalis 88.72 15.26 24 22647 754 79720963
Pregnancy 88.43 15.26 68 22603 26783 79694934
Hepatic cytolysis 87.76 15.26 68 22603 27083 79694634
Cleft lip and palate 86.52 15.26 23 22648 675 79721042
Foetal exposure during pregnancy 86.12 15.26 39 22632 5751 79715966
Treatment noncompliance 85.29 15.26 89 22582 52179 79669538
Trisomy 18 84.77 15.26 22 22649 587 79721130
Acute HIV infection 84.19 15.26 15 22656 56 79721661
Hyperbilirubinaemia 82.73 15.26 63 22608 24455 79697262
Osteonecrosis 79.65 15.26 68 22603 31027 79690690
Maternal exposure during pregnancy 76.07 15.26 138 22533 136400 79585317
Renal tubular dysfunction 70.35 15.26 20 22651 757 79720960
Cushing's syndrome 69.75 15.26 21 22650 974 79720743
Proteinuria 67.24 15.26 63 22608 32439 79689278
Pain 65.87 15.26 62 22609 703740 79017977
Aspartate aminotransferase increased 64.74 15.26 130 22541 138511 79583206
Immune reconstitution inflammatory syndrome associated tuberculosis 64.49 15.26 19 22652 817 79720900
Cytomegalovirus chorioretinitis 63.23 15.26 31 22640 5459 79716258
Joint swelling 63.20 15.26 5 22666 288641 79433076
Nephrolithiasis 57.01 15.26 73 22598 53218 79668499
Premature rupture of membranes 56.09 15.26 26 22645 4043 79717674
Renal failure 56.04 15.26 154 22517 200814 79520903
Caesarean section 55.53 15.26 38 22633 12497 79709220
Infusion related reaction 53.29 15.26 3 22668 230234 79491483
Oesophageal candidiasis 53.23 15.26 33 22638 9185 79712532
Fall 52.99 15.26 37 22634 487592 79234125
Pulmonary tuberculosis 52.76 15.26 31 22640 7834 79713883
Gene mutation 52.71 15.26 22 22649 2664 79719053
Alanine aminotransferase increased 50.82 15.26 130 22541 162440 79559277
Hypophosphataemia 49.88 15.26 43 22628 19870 79701847
Anxiety 48.39 15.26 168 22503 248344 79473373
Oligohydramnios 47.65 15.26 22 22649 3390 79718327
Adrenal suppression 47.24 15.26 17 22654 1382 79720335
Cushingoid 47.22 15.26 31 22640 9521 79712196
Glycosuria 46.59 15.26 19 22652 2169 79719548
Peripheral swelling 46.38 15.26 10 22661 269607 79452110
Spina bifida 44.55 15.26 10 22661 141 79721576
Nasopharyngitis 44.53 15.26 9 22662 253872 79467845
Renal impairment 44.06 15.26 121 22550 157662 79564055
Meningitis cryptococcal 44.01 15.26 21 22650 3485 79718232
Portal hypertension 42.45 15.26 26 22645 7082 79714635
Abnormal dreams 42.23 15.26 31 22640 11381 79710336
Lactic acidosis 41.57 15.26 73 22598 70286 79651431
Blood phosphorus decreased 41.39 15.26 25 22646 6643 79715074
Megakaryocytes increased 41.36 15.26 9 22662 109 79721608
Hepatitis 41.25 15.26 64 22607 55663 79666054
Premature labour 40.92 15.26 27 22644 8363 79713354
Blood creatinine increased 40.43 15.26 116 22555 154941 79566776
Syphilis 40.16 15.26 12 22659 542 79721175
Cortisol decreased 39.98 15.26 17 22654 2155 79719562
Vanishing bile duct syndrome 39.79 15.26 16 22655 1762 79719955
Osteomalacia 39.03 15.26 15 22656 1465 79720252
Arthropathy 38.94 15.26 3 22668 177108 79544609
Cholestasis 38.78 15.26 60 22611 52049 79669668
Mycobacterium avium complex infection 38.62 15.26 21 22650 4579 79717138
Drug reaction with eosinophilia and systemic symptoms 38.40 15.26 67 22604 64177 79657540
Rash maculo-papular 38.19 15.26 62 22609 56016 79665701
Live birth 38.12 15.26 36 22635 18708 79703009
Haemolytic anaemia 37.73 15.26 35 22636 17785 79703932
CSF virus identified 37.63 15.26 7 22664 35 79721682
Pancytopenia 37.55 15.26 118 22553 165627 79556090
Tubulointerstitial nephritis 37.20 15.26 50 22621 38185 79683532
Autoimmune hepatitis 36.96 15.26 29 22642 11754 79709963
Central obesity 36.50 15.26 15 22656 1746 79719971
Progressive multifocal leukoencephalopathy 35.25 15.26 36 22635 20564 79701153
Ocular icterus 35.12 15.26 21 22650 5479 79716238
White matter lesion 34.51 15.26 15 22656 2007 79719710
Malaria 34.35 15.26 10 22661 412 79721305
Unmasking of previously unidentified disease 34.26 15.26 15 22656 2042 79719675
Hepatitis B 33.96 15.26 24 22647 8308 79713409
Completed suicide 33.43 15.26 14 22657 245753 79475964
Osteoporosis 33.08 15.26 57 22614 54055 79667662
Pre-eclampsia 32.75 15.26 22 22649 7019 79714698
Hepatotoxicity 32.59 15.26 55 22616 51297 79670420
Placenta praevia 32.52 15.26 11 22660 744 79720973
Kaposi's sarcoma 32.46 15.26 11 22660 748 79720969
Hepatitis C 32.43 15.26 27 22644 11898 79709819
Arthralgia 32.11 15.26 72 22599 571731 79149986
Abdominal discomfort 31.44 15.26 16 22655 250711 79471006
Musculoskeletal stiffness 31.10 15.26 6 22665 175002 79546715
Depression 31.04 15.26 133 22538 216657 79505060
Pneumocystis jirovecii pneumonia 30.85 15.26 42 22629 32466 79689251
Blood bilirubin increased 30.76 15.26 62 22609 66170 79655547
Cytomegalovirus colitis 30.21 15.26 18 22653 4667 79717050
Constipation 30.02 15.26 22 22649 283028 79438689
Premature delivery 29.70 15.26 35 22636 23432 79698285
Fatigue 29.63 15.26 150 22521 929577 78792140
Therapeutic product effect incomplete 29.51 15.26 3 22668 141642 79580075
Product dose omission issue 29.29 15.26 17 22654 247520 79474197
Hepatomegaly 28.75 15.26 31 22640 18843 79702874
Rhabdomyolysis 28.68 15.26 79 22592 103052 79618665
Mitochondrial myopathy 28.50 15.26 8 22663 289 79721428
Lung transplant rejection 28.24 15.26 12 22659 1519 79720198
Hepatitis B DNA increased 27.88 15.26 10 22661 805 79720912
Pain in extremity 27.61 15.26 38 22633 364500 79357217
Hepatitis fulminant 27.49 15.26 20 22651 7242 79714475
Foetal cardiac disorder 27.40 15.26 5 22666 22 79721695
Lipohypertrophy 27.09 15.26 10 22661 874 79720843
Hypertriglyceridaemia 26.93 15.26 25 22646 12715 79709002
Polydipsia 26.86 15.26 19 22652 6586 79715131
Ultrasound antenatal screen abnormal 26.84 15.26 6 22665 83 79721634
Death 26.66 15.26 78 22593 566436 79155281
Viraemia 26.62 15.26 14 22657 2855 79718862
Osteoporotic fracture 26.58 15.26 16 22655 4224 79717493
Blood alkaline phosphatase increased 26.52 15.26 57 22614 63607 79658110
Injection site pain 26.41 15.26 3 22668 129835 79591882
Renal tubular acidosis 26.25 15.26 15 22656 3599 79718118
Cerebral toxoplasmosis 26.20 15.26 13 22658 2349 79719368
Melanoderma 25.95 15.26 8 22663 402 79721315
Nervous system disorder 25.94 15.26 35 22636 26821 79694896
Retinal toxicity 25.83 15.26 11 22660 1400 79720317
Foetal death 25.67 15.26 20 22651 8024 79713693
Malignant neoplasm progression 25.61 15.26 4 22667 135986 79585731
Hereditary optic atrophy 25.08 15.26 5 22666 38 79721679
Dyslipidaemia 24.92 15.26 23 22648 11610 79710107
Contraindicated product administered 24.83 15.26 7 22664 157531 79564186
Red blood cell abnormality 24.76 15.26 9 22662 753 79720964
HIV infection 24.73 15.26 10 22661 1117 79720600
Contusion 24.61 15.26 6 22665 148770 79572947
Toxoplasmosis 24.57 15.26 13 22658 2684 79719033
Drug level increased 24.54 15.26 42 22629 39609 79682108
Glucocorticoids increased 24.40 15.26 6 22665 128 79721589
Adrenal insufficiency 24.34 15.26 35 22636 28452 79693265
Blood pressure increased 24.32 15.26 15 22656 211345 79510372
Dyspnoea 24.14 15.26 144 22527 856881 78864836
Aplasia pure red cell 24.02 15.26 19 22652 7791 79713926
Cachexia 23.91 15.26 22 22649 11061 79710656
Lower respiratory tract infection 23.89 15.26 4 22667 129216 79592501
Pregnancy on oral contraceptive 23.85 15.26 9 22662 836 79720881
Acquired immunodeficiency syndrome 23.78 15.26 7 22664 300 79721417
Sinusitis 23.73 15.26 13 22658 195488 79526229
Blood corticotrophin decreased 23.44 15.26 8 22663 556 79721161
Pulmonary venous thrombosis 23.41 15.26 6 22665 152 79721565
Anogenital warts 22.98 15.26 9 22662 925 79720792
Skin striae 22.76 15.26 11 22660 1877 79719840
Lymphadenopathy 22.55 15.26 48 22623 53199 79668518
Secondary syphilis 22.44 15.26 5 22666 68 79721649
Stomatitis 22.25 15.26 7 22664 146750 79574967
Anaemia 22.08 15.26 208 22463 444807 79276910
Oral candidiasis 21.88 15.26 34 22637 29594 79692123
Eyelid oedema 21.77 15.26 23 22648 13664 79708053
Oxygen saturation decreased 21.75 15.26 5 22666 129042 79592675
Drug ineffective 21.66 15.26 200 22471 1080713 78641004
Hepatosplenomegaly 21.36 15.26 16 22655 6053 79715664
Meningomyelocele 20.89 15.26 4 22667 24 79721693
Drug hypersensitivity 20.83 15.26 33 22638 298883 79422834
Drug level decreased 20.80 15.26 23 22648 14379 79707338
Meningitis tuberculous 20.76 15.26 9 22662 1196 79720521
ACTH stimulation test abnormal 20.75 15.26 4 22667 25 79721692
Polyhydramnios 20.67 15.26 10 22661 1710 79720007
Wound 20.60 15.26 4 22667 116175 79605542
Drug intolerance 20.52 15.26 27 22644 264092 79457625
Pancreatitis acute 20.19 15.26 44 22627 49560 79672157
Mobility decreased 20.06 15.26 5 22666 122170 79599547
Multiple-drug resistance 20.01 15.26 18 22653 8790 79712927
Calculus urinary 20.01 15.26 11 22660 2449 79719268
Systemic lupus erythematosus 19.81 15.26 5 22666 121144 79600573
Pericarditis 19.78 15.26 3 22668 104233 79617484
Prurigo 19.66 15.26 9 22662 1360 79720357
Burkitt's lymphoma 19.61 15.26 5 22666 124 79721593
Cardiac failure congestive 19.54 15.26 8 22663 142394 79579323
Gamma-glutamyltransferase increased 19.47 15.26 46 22625 54634 79667083
Anogenital dysplasia 19.31 15.26 5 22666 132 79721585
Dizziness 19.04 15.26 81 22590 526360 79195357
Pneumonia 18.52 15.26 111 22560 660135 79061582
Generalised anxiety disorder 18.36 15.26 10 22661 2187 79719530
Condition aggravated 18.18 15.26 77 22594 501047 79220670
Back pain 18.12 15.26 37 22634 304143 79417574
Skin lesion 18.04 15.26 38 22633 41806 79679911
Bradycardia 17.98 15.26 8 22663 135549 79586168
Maternal drugs affecting foetus 17.89 15.26 9 22662 1674 79720043
Mitochondrial cytopathy 17.76 15.26 6 22665 404 79721313
Anembryonic gestation 17.68 15.26 6 22665 410 79721307
Face oedema 17.67 15.26 30 22641 28106 79693611
Inappropriate schedule of product administration 17.55 15.26 8 22663 133620 79588097
Infection 17.49 15.26 26 22645 241686 79480031
Spinocerebellar disorder 17.34 15.26 3 22668 9 79721708
Anal cancer 17.16 15.26 7 22664 800 79720917
Antiviral drug level above therapeutic 17.07 15.26 4 22667 69 79721648
Nasal septum deviation 16.98 15.26 9 22662 1864 79719853
Cough 16.86 15.26 51 22620 366738 79354979
Cerebellar ataxia 16.77 15.26 9 22662 1912 79719805
Hepatorenal syndrome 16.76 15.26 12 22659 4237 79717480
Product use issue 16.76 15.26 21 22650 209801 79511916
Polyuria 16.73 15.26 21 22650 14993 79706724
Neural tube defect 16.67 15.26 3 22668 12 79721705
Congenital hydrocephalus 16.60 15.26 4 22667 78 79721639
Hemiparaesthesia 16.54 15.26 5 22666 235 79721482
Tuberculosis 16.53 15.26 21 22650 15177 79706540
Oesophageal carcinoma 16.52 15.26 18 22653 11066 79710651
C-reactive protein increased 16.52 15.26 8 22663 129019 79592698
Urticaria 16.46 15.26 17 22654 185184 79536533
Asthma 16.37 15.26 9 22662 135086 79586631
Carbon dioxide decreased 16.35 15.26 11 22660 3517 79718200
Haemorrhoids thrombosed 16.28 15.26 5 22666 248 79721469
Cholestasis of pregnancy 15.76 15.26 7 22664 986 79720731
Hypotension 15.76 15.26 68 22603 440249 79281468
Transaminases increased 15.75 15.26 41 22630 51702 79670015
Liver function test abnormal 15.60 15.26 47 22624 64428 79657289
Atrial fibrillation 15.60 15.26 20 22651 197866 79523851
Pyrexia 15.54 15.26 275 22396 678434 79043283
CD4 lymphocytes increased 15.47 15.26 5 22666 293 79721424
Social avoidant behaviour 15.43 15.26 12 22659 4802 79716915
Bronchitis 15.40 15.26 9 22662 130635 79591082
Depressed mood 15.36 15.26 39 22632 48441 79673276

FDA Adverse Event Reporting System (Pediatric)

None

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 antiviral drugs
CHEBI has role CHEBI:53756 reverse transcriptase inhibitors

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

DiseaseRelationSNOMED_IDDOID
Human immunodeficiency virus infection indication 86406008 DOID:526
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




🐶 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 2.57 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
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 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 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 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 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
60877 PUBCHEM_CID
11244 IUPHAR_LIGAND_ID
7822 INN_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
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 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
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 16714-534 TABLET, FILM COATED 200 mg ORAL ANDA 28 sections
Emtricitabine and tenofovir disoproxil fumarate Human Prescription Drug Label 2 16714-534 TABLET, FILM COATED 200 mg ORAL ANDA 28 sections
Emtricitabine and tenofovir disoproxil fumarate HUMAN PRESCRIPTION DRUG LABEL 2 31722-560 TABLET, FILM COATED 200 mg ORAL ANDA 27 sections
Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate HUMAN PRESCRIPTION DRUG LABEL 3 31722-736 TABLET, FILM COATED 200 mg ORAL ANDA 28 sections
Emtricitabine and tenofovir disoproxil fumarate Human Prescription Drug Label 2 33342-106 TABLET, FILM COATED 200 mg ORAL ANDA 28 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
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 50090-5957 TABLET, FILM COATED 200 mg ORAL ANDA 28 sections
Biktarvy HUMAN PRESCRIPTION DRUG LABEL 3 50090-6247 TABLET 200 mg ORAL NDA 33 sections
Emtricitabine and Tenofovir Disoproxil Fumarate Human Prescription Drug Label 2 50090-6494 TABLET, FILM COATED 200 mg ORAL ANDA 28 sections
Emtricitabine and Tenofovir Disoproxil Fumarate HUMAN PRESCRIPTION DRUG LABEL 2 51407-112 TABLET 200 mg ORAL ANDA 27 sections
Emtricitabine and Tenofovir Disoproxil Fumarate HUMAN PRESCRIPTION DRUG LABEL 2 51407-112 TABLET 200 mg ORAL ANDA 27 sections
Emtricitabine and Tenofovir Disoproxil Fumarate HUMAN PRESCRIPTION DRUG LABEL 2 51407-112 TABLET 200 mg ORAL ANDA 27 sections