emtricitabine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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
BA (Bioavailability) 93 %
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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2B,CDK5,EIF2AK3,GRK2,ITK,PDK1,PDK2,PRKDC 8
kinase-selectivity-class PDK1 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 0 High 1

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 747.67 22.68 265 9814 53791 90564577
Exposure during pregnancy 465.48 22.68 303 9776 238107 90380261
Foetal exposure during pregnancy 464.93 22.68 176 9903 42799 90575569
Abortion induced 343.09 22.68 102 9977 11786 90606582
Immune reconstitution inflammatory syndrome 277.62 22.68 77 10002 6942 90611426
Virologic failure 269.91 22.68 60 10019 2164 90616204
Blood HIV RNA increased 234.04 22.68 45 10034 779 90617589
Stillbirth 232.83 22.68 68 10011 7375 90610993
Drug interaction 218.13 22.68 206 9873 276247 90342121
Premature baby 208.57 22.68 85 9994 24992 90593376
Viral mutation identified 199.02 22.68 46 10033 1979 90616389
Enlarged clitoris 187.23 22.68 29 10050 122 90618246
Pregnancy 185.50 22.68 104 9975 61943 90556425
Hyperandrogenism 163.22 22.68 25 10054 96 90618272
Drug resistance 154.79 22.68 73 10006 30376 90587992
Pathogen resistance 135.84 22.68 46 10033 8069 90610299
Premature labour 127.35 22.68 50 10029 13326 90605042
Hydrops foetalis 122.71 22.68 25 10054 588 90617780
Viral load increased 119.74 22.68 29 10050 1527 90616841
Maternal exposure during pregnancy 108.04 22.68 164 9915 359899 90258469
Lipodystrophy acquired 100.21 22.68 25 10054 1489 90616879
Hepatic cytolysis 95.53 22.68 53 10026 30863 90587505
Fanconi syndrome acquired 94.23 22.68 23 10056 1251 90617117
Cushing's syndrome 87.36 22.68 19 10060 617 90617751
Premature rupture of membranes 87.13 22.68 30 10049 5528 90612840
Caesarean section 86.65 22.68 42 10037 18535 90599833
Spina bifida 75.98 22.68 18 10061 862 90617506
CD4 lymphocytes decreased 75.31 22.68 20 10059 1527 90616841
Acute kidney injury 74.34 22.68 130 9949 320257 90298111
Genotype drug resistance test positive 70.64 22.68 15 10064 434 90617934
Hyperbilirubinaemia 69.52 22.68 33 10046 13903 90604465
Autoimmune hepatitis 69.01 22.68 30 10049 10321 90608047
Pain 66.27 22.68 15 10064 996326 89622042
Renal tubular disorder 64.96 22.68 21 10058 3186 90615182
Treatment noncompliance 63.97 22.68 50 10029 51677 90566691
Pre-eclampsia 63.95 22.68 29 10050 11019 90607349
CSF HIV escape syndrome 63.94 22.68 11 10068 98 90618270
Maternal drugs affecting foetus 62.51 22.68 23 10056 5132 90613236
Oligohydramnios 61.85 22.68 25 10054 7176 90611192
Premature delivery 60.29 22.68 43 10036 38719 90579649
Adrenal suppression 58.55 22.68 15 10064 994 90617374
Immune reconstitution inflammatory syndrome associated tuberculosis 57.89 22.68 13 10066 490 90617878
Ultrasound antenatal screen abnormal 54.81 22.68 10 10069 128 90618240
Jaundice 50.40 22.68 36 10043 32481 90585887
Osteonecrosis 50.01 22.68 33 10046 26208 90592160
Renal failure 49.93 22.68 67 10012 130940 90487428
Ultrasound antenatal screen 49.89 22.68 10 10069 216 90618152
Meningomyelocele 49.57 22.68 12 10067 630 90617738
HIV infection 47.42 22.68 11 10068 480 90617888
Hepatitis B DNA increased 47.41 22.68 10 10069 280 90618088
Haemolytic anaemia 47.29 22.68 24 10055 11673 90606695
Ventricular septal defect 47.23 22.68 19 10060 5388 90612980
Foetal death 46.78 22.68 29 10050 20694 90597674
Oesophageal candidiasis 46.20 22.68 20 10059 6809 90611559
Drug reaction with eosinophilia and systemic symptoms 45.79 22.68 38 10041 42720 90575648
Hepatitis fulminant 45.62 22.68 17 10062 3928 90614440
Congenital hydrocephalus 44.32 22.68 9 10070 208 90618160
Patent ductus arteriosus 43.20 22.68 17 10062 4552 90613816
Lipohypertrophy 42.95 22.68 11 10068 728 90617640
Renal tubular necrosis 42.36 22.68 24 10055 14531 90603837
Renal tubular acidosis 42.21 22.68 14 10065 2301 90616067
Spinocerebellar disorder 40.31 22.68 6 10073 18 90618350
Foetal growth restriction 40.13 22.68 20 10059 9360 90609008
Neural tube defect 38.79 22.68 8 10071 200 90618168
Placenta praevia 38.37 22.68 11 10068 1114 90617254
Melanoderma 37.89 22.68 8 10071 225 90618143
Gestational diabetes 37.85 22.68 20 10059 10562 90607806
Rash maculo-papular 36.96 22.68 33 10046 40900 90577468
Aspartate aminotransferase increased 36.72 22.68 51 10028 102886 90515482
Fanconi syndrome 36.43 22.68 12 10067 1931 90616437
Osteomalacia 36.20 22.68 10 10069 885 90617483
Adrenogenital syndrome 35.45 22.68 6 10073 48 90618320
Polydactyly 35.24 22.68 8 10071 317 90618051
Sudden infant death syndrome 35.02 22.68 8 10071 326 90618042
Anaemia 34.88 22.68 102 9977 352700 90265668
Peripheral swelling 34.85 22.68 3 10076 413103 90205265
Congenital genital malformation female 34.25 22.68 6 10073 60 90618308
Renal colic 34.20 22.68 11 10068 1642 90616726
Ectopic pregnancy 33.98 22.68 13 10066 3228 90615140
Ectopic kidney 33.89 22.68 6 10073 64 90618304
Congenital pulmonary valve disorder 33.81 22.68 6 10073 65 90618303
Dermatitis exfoliative 33.52 22.68 15 10064 5521 90612847
Eyelid oedema 33.51 22.68 19 10060 11515 90606853
Encephalocele 32.95 22.68 7 10072 203 90618165
Malaria 32.85 22.68 7 10072 206 90618162
Alanine aminotransferase increased 32.68 22.68 52 10027 118286 90500082
Live birth 32.51 22.68 42 10037 79065 90539303
Fatigue 32.48 22.68 49 10030 1153974 89464394
Cholestasis 32.25 22.68 29 10050 36270 90582098
Hydrocephalus 32.14 22.68 15 10064 6079 90612289
Abdominal discomfort 32.01 22.68 7 10072 477321 90141047
Central obesity 31.86 22.68 10 10069 1380 90616988
Congenital anomaly 31.56 22.68 15 10064 6332 90612036
Lactic acidosis 31.11 22.68 33 10046 50430 90567938
Hereditary optic atrophy 30.52 22.68 5 10074 32 90618336
Porphyria non-acute 30.39 22.68 7 10072 296 90618072
Glucocorticoids increased 30.37 22.68 6 10073 120 90618248
Coarctation of the aorta 30.05 22.68 8 10071 616 90617752
Cushingoid 29.87 22.68 17 10062 10378 90607990
HIV-associated neurocognitive disorder 29.83 22.68 6 10073 132 90618236
Hepatitis 29.76 22.68 38 10041 70701 90547667
Pregnancy on oral contraceptive 29.69 22.68 9 10070 1106 90617262
Nasopharyngitis 29.34 22.68 5 10074 407099 90211269
Trisomy 18 29.21 22.68 6 10073 147 90618221
Cloacal exstrophy 28.72 22.68 6 10073 160 90618208
Fall 28.63 22.68 9 10070 481801 90136567
Congenital genital malformation 28.48 22.68 6 10073 167 90618201
Neonatal respiratory arrest 28.45 22.68 5 10074 51 90618317
Tubulointerstitial nephritis 28.12 22.68 23 10056 25320 90593048
Chronic papillomatous dermatitis 28.02 22.68 5 10074 56 90618312
Transaminases increased 27.82 22.68 27 10052 37165 90581203
Face oedema 27.65 22.68 22 10057 23296 90595072
Caudal regression syndrome 27.64 22.68 6 10073 193 90618175
Neonatal respiratory distress syndrome 27.44 22.68 11 10068 3090 90615278
Folate deficiency 27.22 22.68 11 10068 3154 90615214
Systemic lupus erythematosus 27.08 22.68 4 10075 361892 90256476
Prurigo 26.77 22.68 8 10071 937 90617431
Nephropathy toxic 26.73 22.68 17 10062 12671 90605697
Renal tubular dysfunction 26.73 22.68 7 10072 506 90617862
Hypophosphataemia 26.66 22.68 18 10061 14836 90603532
Skin striae 26.54 22.68 9 10070 1582 90616786
Polyhydramnios 26.08 22.68 10 10069 2498 90615870
Blood creatinine increased 25.88 22.68 43 10036 101343 90517025
Pulmonary tuberculosis 25.81 22.68 12 10067 4822 90613546
Proteinuria 25.56 22.68 21 10058 23270 90595098
ACTH stimulation test abnormal 25.42 22.68 4 10075 19 90618349
Blood phosphorus decreased 25.35 22.68 12 10067 5022 90613346
Generalised anxiety disorder 25.19 22.68 10 10069 2737 90615631
Hepatotoxicity 24.82 22.68 28 10051 45814 90572554
Umbilical cord abnormality 24.75 22.68 7 10072 675 90617693
Foetal cardiac disorder 24.36 22.68 4 10075 26 90618342
Brain herniation 24.22 22.68 11 10068 4189 90614179
Thymus hypoplasia 23.86 22.68 4 10075 30 90618338
Retinal toxicity 23.55 22.68 8 10071 1414 90616954
Anencephaly 23.50 22.68 6 10073 392 90617976
Pulmonary valve sclerosis 23.42 22.68 4 10075 34 90618334
Nephrolithiasis 23.26 22.68 28 10051 49057 90569311
Stevens-Johnson syndrome 23.24 22.68 22 10057 29354 90589014
Bladder agenesis 23.24 22.68 5 10074 154 90618214
Liver transplant 23.24 22.68 9 10070 2308 90616060
Secondary adrenocortical insufficiency 23.24 22.68 9 10070 2309 90616059
Abortion infected 23.21 22.68 4 10075 36 90618332
Drug ineffective 23.21 22.68 78 10001 1384220 89234148
Social avoidant behaviour 23.10 22.68 10 10069 3403 90614965
Sinusitis 23.05 22.68 5 10074 343083 90275285
Genitalia external ambiguous 23.03 22.68 5 10074 161 90618207
Anal atresia 22.77 22.68 6 10073 444 90617924
Cholestasis of pregnancy 22.74 22.68 8 10071 1569 90616799

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 885.22 14.07 287 20506 9856 42590686
Psychiatric decompensation 552.19 14.07 163 20630 4059 42596483
Depression suicidal 458.32 14.07 133 20660 3112 42597430
Tearfulness 457.12 14.07 135 20658 3365 42597177
Depressive symptom 401.90 14.07 125 20668 3728 42596814
Psychomotor skills impaired 353.31 14.07 122 20671 5082 42595460
Virologic failure 335.91 14.07 110 20683 3884 42596658
Drug interaction 315.73 14.07 507 20286 266492 42334050
Paranoia 302.01 14.07 144 20649 13882 42586660
Blood HIV RNA increased 277.90 14.07 77 20716 1514 42599028
Fanconi syndrome acquired 232.08 14.07 71 20722 1999 42598543
Psychotic disorder 222.52 14.07 152 20641 29056 42571486
Drug resistance 207.44 14.07 155 20638 34093 42566449
Suicidal ideation 206.52 14.07 178 20615 47983 42552559
Viral mutation identified 202.71 14.07 72 20721 3259 42597283
Pathogen resistance 179.97 14.07 95 20698 11355 42589187
Viral load increased 149.68 14.07 56 20737 2941 42597601
Renal tubular disorder 148.76 14.07 64 20729 4845 42595697
Renal colic 142.33 14.07 49 20744 2019 42598523
Genotype drug resistance test positive 133.70 14.07 41 20752 1163 42599379
CD4 lymphocytes decreased 130.20 14.07 45 20748 1876 42598666
Fanconi syndrome 98.71 14.07 36 20757 1758 42598784
Acute HIV infection 94.35 14.07 18 20775 54 42600488
Psychomotor retardation 94.13 14.07 45 20748 4354 42596188
Anxiety 93.04 14.07 189 20604 118371 42482171
HIV-associated neurocognitive disorder 90.08 14.07 23 20770 325 42600217
Lipodystrophy acquired 88.45 14.07 40 20753 3410 42597132
Osteonecrosis 85.43 14.07 67 20726 15798 42584744
Foetal exposure during pregnancy 83.46 14.07 109 20684 47202 42553340
Renal tubular necrosis 76.88 14.07 67 20726 18287 42582255
Jaundice 75.99 14.07 89 20704 34500 42566042
Exposure during pregnancy 71.06 14.07 47 20746 8501 42592041
Nephropathy toxic 67.59 14.07 60 20733 16778 42583764
Cytomegalovirus chorioretinitis 66.10 14.07 36 20757 4575 42595967
CSF HIV escape syndrome 65.08 14.07 16 20777 192 42600350
Acute kidney injury 63.53 14.07 349 20444 366988 42233554
Kaposi's sarcoma 63.22 14.07 21 20772 774 42599768
Ultrasound antenatal screen 61.75 14.07 19 20774 545 42599997
Syphilis 61.16 14.07 19 20774 563 42599979
Depression 61.02 14.07 154 20639 111209 42489333
Cleft lip and palate 59.95 14.07 21 20772 911 42599631
Acquired immunodeficiency syndrome 59.39 14.07 18 20775 490 42600052
Trisomy 18 57.60 14.07 20 20773 845 42599697
Osteoporosis 55.66 14.07 51 20742 14855 42585687
Death 55.01 14.07 91 20702 471094 42129448
Proteinuria 53.60 14.07 61 20732 22922 42577620
Nephrolithiasis 53.10 14.07 77 20716 36753 42563789
Hydrops foetalis 52.93 14.07 19 20774 886 42599656
Glycosuria 52.08 14.07 21 20772 1349 42599193
Unmasking of previously unidentified disease 50.75 14.07 20 20773 1209 42599333
Hyperbilirubinaemia 50.22 14.07 56 20737 20579 42579963
Osteomalacia 49.60 14.07 18 20775 866 42599676
Renal tubular dysfunction 48.46 14.07 15 20778 439 42600103
Renal failure 48.27 14.07 167 20626 143559 42456983
Hepatic cytolysis 47.55 14.07 62 20731 26782 42573760
Treatment noncompliance 47.53 14.07 74 20719 37598 42562944
Gene mutation 46.77 14.07 21 20772 1760 42598782
Hepatitis B 46.54 14.07 33 20760 6678 42593864
Portal hypertension 43.90 14.07 28 20765 4759 42595783
HIV infection 43.80 14.07 19 20774 1466 42599076
Hepatitis C 42.44 14.07 37 20756 10096 42590446
Osteoporotic fracture 40.26 14.07 18 20775 1493 42599049
Meningitis cryptococcal 39.90 14.07 23 20770 3260 42597282
Blood creatinine increased 39.72 14.07 131 20662 109872 42490670
Mycobacterium avium complex infection 38.91 14.07 22 20771 3005 42597537
Aspartate aminotransferase increased 38.42 14.07 103 20690 77060 42523482
Ocular icterus 38.42 14.07 22 20771 3079 42597463
Progressive multifocal leukoencephalopathy 38.33 14.07 37 20756 11499 42589043
Congenital hearing disorder 37.83 14.07 9 20784 93 42600449
Fall 36.93 14.07 36 20757 234484 42366058
Dyslipidaemia 36.68 14.07 33 20760 9385 42591157
Anogenital warts 34.04 14.07 13 20780 722 42599820
Malignant neoplasm progression 33.88 14.07 6 20787 108394 42492148
Alanine aminotransferase increased 33.45 14.07 107 20686 88299 42512243
Abortion spontaneous 33.44 14.07 11 20782 393 42600149
Pneumonia 33.25 14.07 101 20692 422048 42178494
Immune reconstitution inflammatory syndrome associated tuberculosis 33.24 14.07 12 20781 569 42599973
Cachexia 32.76 14.07 29 20764 8075 42592467
Cortisol decreased 32.26 14.07 15 20778 1363 42599179
Disease progression 32.03 14.07 15 20778 143641 42456901
Dyspnoea 32.01 14.07 110 20683 442511 42158031
Product dose omission issue 31.63 14.07 18 20775 154347 42446195
Off label use 31.53 14.07 183 20610 638152 41962390
Pulmonary tuberculosis 31.28 14.07 24 20769 5477 42595065
Hydrocele 31.13 14.07 18 20775 2565 42597977
Vanishing bile duct syndrome 30.74 14.07 16 20777 1855 42598687
Hodgkin's disease 29.10 14.07 12 20781 816 42599726
Hypophosphataemia 29.04 14.07 43 20750 20902 42579640
CSF virus identified 28.54 14.07 6 20787 33 42600509
Hepatitis 28.18 14.07 49 20744 27251 42573291
Anal cancer 28.09 14.07 10 20783 455 42600087
Secondary syphilis 27.74 14.07 7 20786 94 42600448
Seroconversion test positive 27.64 14.07 5 20788 10 42600532
Hypertriglyceridaemia 27.28 14.07 29 20764 10097 42590445
Mitochondrial myopathy 27.16 14.07 8 20785 197 42600345
White matter lesion 26.95 14.07 12 20781 986 42599556
Blood alkaline phosphatase increased 26.81 14.07 54 20739 33543 42566999
Oesophageal candidiasis 26.51 14.07 22 20771 5613 42594929
Febrile neutropenia 26.44 14.07 31 20762 185672 42414870
Burkitt's lymphoma 26.32 14.07 7 20786 117 42600425
Cytomegalovirus colitis 26.28 14.07 19 20774 3962 42596580
Peripheral swelling 26.11 14.07 6 20787 90264 42510278
Blood phosphorus decreased 25.68 14.07 18 20775 3575 42596967
Constipation 25.43 14.07 25 20768 162266 42438276
Lactic acidosis 25.17 14.07 63 20730 45198 42555344
Lipoatrophy 24.74 14.07 9 20784 436 42600106
Inappropriate schedule of product administration 24.69 14.07 8 20785 95894 42504648
Product use issue 24.52 14.07 4 20789 76747 42523795
Hepatitis B DNA assay positive 24.03 14.07 6 20787 77 42600465
Renal impairment 24.03 14.07 112 20681 110116 42490426
Porphyria non-acute 23.82 14.07 9 20784 485 42600057
Blood bilirubin increased 23.69 14.07 59 20734 42193 42558349
Hepatosplenomegaly 23.62 14.07 19 20774 4641 42595901
Oral candidiasis 23.55 14.07 32 20761 14373 42586169
Drug abuse 23.25 14.07 11 20782 104760 42495782
Pancytopenia 23.05 14.07 116 20677 117627 42482915
Supernumerary nipple 22.39 14.07 5 20788 38 42600504
Haemophilic arthropathy 21.26 14.07 7 20786 251 42600291
Back pain 20.89 14.07 23 20770 141753 42458789
Anogenital dysplasia 20.84 14.07 6 20787 136 42600406
Blood pressure increased 20.70 14.07 12 20781 101916 42498626
Atypical mycobacterial infection 20.51 14.07 11 20782 1355 42599187
Pulmonary hilar enlargement 20.28 14.07 4 20789 15 42600527
Hypothalamic pituitary adrenal axis suppression 20.15 14.07 7 20786 296 42600246
Therapeutic product effect incomplete 19.96 14.07 5 20788 70934 42529608
Pulmonary venous thrombosis 19.95 14.07 6 20787 159 42600383
AIDS related complication 19.88 14.07 4 20789 17 42600525
Hepatotoxicity 19.54 14.07 40 20753 25127 42575415
Suicide attempt 19.47 14.07 58 20735 46042 42554500
Abnormal dreams 19.36 14.07 22 20771 8249 42592293
Congenital anomaly 19.27 14.07 11 20782 1530 42599012
Hypotension 19.27 14.07 63 20730 257568 42342974
Atrial fibrillation 19.12 14.07 24 20769 139569 42460973
Trisomy 21 18.99 14.07 8 20785 574 42599968
Liver function test abnormal 18.98 14.07 46 20747 32345 42568197
Pancreatitis acute 18.96 14.07 47 20746 33517 42567025
Pain 18.92 14.07 59 20734 244789 42355753
Gamma-glutamyltransferase increased 18.88 14.07 46 20747 32451 42568091
Polydactyly 18.71 14.07 10 20783 1224 42599318
Haemodialysis 18.64 14.07 24 20769 10236 42590306
Cerebral toxoplasmosis 18.57 14.07 12 20781 2086 42598456
Cushing's syndrome 18.43 14.07 7 20786 383 42600159
Nasopharyngitis 18.36 14.07 9 20784 83987 42516555
Beta 2 microglobulin urine increased 18.35 14.07 5 20788 92 42600450
Premature baby 18.21 14.07 37 20756 23116 42577426
End stage AIDS 18.08 14.07 4 20789 29 42600513
Prurigo 17.84 14.07 8 20785 668 42599874
Fatigue 17.82 14.07 132 20661 435509 42165033
Cushingoid 17.45 14.07 14 20779 3408 42597134
Nodular regenerative hyperplasia 17.33 14.07 9 20784 1039 42599503
Drug level increased 17.30 14.07 39 20754 26161 42574381
Cardiac failure 17.26 14.07 16 20777 106840 42493702
Pneumocystis jirovecii pneumonia 17.21 14.07 38 20755 25143 42575399
Neonatal asphyxia 17.08 14.07 7 20786 469 42600073
Lymphadenopathy 17.06 14.07 45 20748 33320 42567222
Ergot poisoning 17.02 14.07 4 20789 39 42600503
Joint swelling 16.94 14.07 6 20787 68016 42532526
Sepsis 16.87 14.07 46 20747 199288 42401254
Acute hepatic failure 16.78 14.07 30 20763 17043 42583499
Nervous system disorder 16.63 14.07 30 20763 17165 42583377
Oesophageal carcinoma 16.55 14.07 22 20771 9674 42590868
Cholestasis 16.46 14.07 44 20749 32835 42567707
Multiple-drug resistance 16.33 14.07 19 20774 7303 42593239
Adrenal atrophy 16.27 14.07 3 20790 7 42600535
Adrenogenital syndrome 16.19 14.07 4 20789 49 42600493
Shigella infection 16.12 14.07 4 20789 50 42600492
Completed suicide 16.11 14.07 14 20779 96451 42504091
Cardiac failure congestive 16.11 14.07 11 20782 85591 42514951
Drug level decreased 16.06 14.07 22 20771 9955 42590587
Kaposi sarcoma inflammatory cytokine syndrome 15.94 14.07 5 20788 153 42600389
Mitochondrial cytopathy 15.85 14.07 5 20788 156 42600386
CD4 lymphocytes increased 15.79 14.07 5 20788 158 42600384
Eagle Barrett syndrome 15.72 14.07 3 20790 9 42600533
Intensive care unit acquired weakness 15.65 14.07 9 20784 1269 42599273
Nasal septum deviation 15.65 14.07 9 20784 1269 42599273
Oxygen saturation decreased 15.61 14.07 6 20787 64681 42535861
Rhabdomyolysis 15.35 14.07 77 20716 77942 42522600
Lymphoma 15.16 14.07 26 20767 14295 42586247
Antiviral drug level above therapeutic 15.03 14.07 4 20789 67 42600475
Crystal nephropathy 14.99 14.07 7 20786 642 42599900
Haematochezia 14.82 14.07 5 20788 58431 42542111
Hemiparaesthesia 14.81 14.07 5 20788 194 42600348
Dizziness 14.74 14.07 67 20726 249187 42351355
Stevens-Johnson syndrome 14.63 14.07 33 20760 22145 42578397
Influenza 14.62 14.07 6 20787 62169 42538373
Musculoskeletal stiffness 14.55 14.07 5 20788 57760 42542782
Lung transplant rejection 14.52 14.07 8 20785 1039 42599503
Psoriasis 14.52 14.07 3 20790 48601 42551941
Cough 14.41 14.07 42 20751 178061 42422481
HIV wasting syndrome 14.37 14.07 4 20789 80 42600462
Myalgia 14.35 14.07 88 20705 95992 42504550
Maculopathy 14.33 14.07 8 20785 1067 42599475
Skin lesion 14.25 14.07 37 20756 27137 42573405
Polydipsia 14.17 14.07 14 20779 4474 42596068
Cryptorchism 14.13 14.07 10 20783 2017 42598525
White blood cell count decreased 14.07 14.07 20 20773 110376 42490166

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 1153.52 16.16 323 22850 15903 110550223
Psychiatric decompensation 628.44 16.16 161 23012 5604 110560522
Abortion spontaneous 592.94 16.16 235 22938 34047 110532079
Drug interaction 564.12 16.16 604 22569 499579 110066547
Virologic failure 543.20 16.16 139 23034 4813 110561313
Depression suicidal 522.26 16.16 134 23039 4690 110561436
Tearfulness 470.02 16.16 135 23038 7260 110558866
Viral mutation identified 445.55 16.16 116 23057 4303 110561823
Blood HIV RNA increased 439.17 16.16 100 23073 2088 110564038
Psychomotor skills impaired 422.56 16.16 123 23050 6935 110559191
Depressive symptom 409.75 16.16 125 23048 8289 110557837
Paranoia 357.71 16.16 145 23028 22229 110543897
Drug resistance 353.08 16.16 191 22982 56183 110509943
Pathogen resistance 325.98 16.16 127 23046 17545 110548581
Abortion induced 282.13 16.16 93 23080 7926 110558200
Psychotic disorder 270.85 16.16 155 23018 50782 110515344
Exposure during pregnancy 230.87 16.16 226 22947 167198 110398928
Viral load increased 211.41 16.16 61 23112 3329 110562797
Suicidal ideation 195.37 16.16 160 23013 93777 110472349
Genotype drug resistance test positive 191.74 16.16 47 23126 1359 110564767
Fanconi syndrome acquired 191.02 16.16 55 23118 2979 110563147
Stillbirth 180.84 16.16 57 23116 4207 110561919
CD4 lymphocytes decreased 178.74 16.16 52 23121 2922 110563204
Renal tubular disorder 157.09 16.16 59 23114 7370 110558756
Lipodystrophy acquired 145.32 16.16 49 23124 4475 110561651
CSF HIV escape syndrome 137.99 16.16 28 23145 329 110565797
Acute kidney injury 127.35 16.16 355 22818 635075 109931051
Treatment noncompliance 122.52 16.16 110 23063 72880 110493246
Fanconi syndrome 120.51 16.16 40 23133 3479 110562647
Nephropathy toxic 115.73 16.16 72 23101 27406 110538720
Renal colic 115.45 16.16 38 23135 3220 110562906
Jaundice 115.00 16.16 97 23076 59139 110506987
Ultrasound antenatal screen 108.56 16.16 26 23147 680 110565446
HIV-associated neurocognitive disorder 105.78 16.16 23 23150 385 110565741
Psychomotor retardation 102.60 16.16 44 23129 7748 110558378
Renal tubular necrosis 99.32 16.16 68 23105 30407 110535719
Hydrops foetalis 95.89 16.16 24 23149 757 110565369
Immune reconstitution inflammatory syndrome associated tuberculosis 93.46 16.16 25 23148 1029 110565097
Trisomy 18 91.01 16.16 22 23151 599 110565527
Hyperbilirubinaemia 89.60 16.16 64 23109 30607 110535519
Acute HIV infection 88.76 16.16 15 23158 56 110566070
Foetal exposure during pregnancy 87.83 16.16 39 23134 7466 110558660
Cleft lip and palate 87.41 16.16 22 23151 710 110565416
Osteonecrosis 84.13 16.16 64 23109 33677 110532449
Renal tubular dysfunction 83.15 16.16 22 23151 868 110565258
Anxiety 78.19 16.16 202 22971 344876 110221250
Cushing's syndrome 77.48 16.16 21 23152 909 110565217
Aspartate aminotransferase increased 74.57 16.16 126 23047 159810 110406316
Joint swelling 70.53 16.16 6 23167 442839 110123287
Hepatic cytolysis 69.64 16.16 71 23102 54982 110511144
Pain 69.48 16.16 59 23114 954896 109611230
Pregnancy 68.52 16.16 68 23105 50999 110515127
Cytomegalovirus chorioretinitis 67.58 16.16 32 23141 7096 110559030
Infusion related reaction 67.15 16.16 3 23170 381159 110184967
Proteinuria 66.51 16.16 60 23113 39958 110526168
Caesarean section 65.34 16.16 39 23134 13778 110552348
Portal hypertension 64.64 16.16 33 23140 8604 110557522
Renal failure 63.46 16.16 144 23029 226430 110339696
Gene mutation 60.94 16.16 24 23149 3405 110562721
Alanine aminotransferase increased 60.85 16.16 125 23048 183648 110382478
Nephrolithiasis 60.51 16.16 72 23101 66140 110499986
Premature rupture of membranes 60.44 16.16 26 23147 4611 110561515
Oesophageal candidiasis 58.33 16.16 34 23139 11500 110554626
Pulmonary tuberculosis 57.25 16.16 31 23142 9108 110557018
Unmasking of previously unidentified disease 54.24 16.16 21 23152 2847 110563279
Pancytopenia 54.06 16.16 129 23044 209484 110356642
Nasopharyngitis 53.80 16.16 9 23164 394352 110171774
Meningitis cryptococcal 53.34 16.16 24 23149 4738 110561388
Glycosuria 52.39 16.16 20 23153 2610 110563516
Osteomalacia 50.22 16.16 17 23156 1570 110564556
Cushingoid 50.09 16.16 31 23142 11681 110554445
Maternal exposure during pregnancy 49.46 16.16 141 23032 254742 110311384
Peripheral swelling 49.33 16.16 12 23161 404022 110162104
Adrenal suppression 49.11 16.16 17 23156 1679 110564447
Blood creatinine increased 48.72 16.16 114 23059 182775 110383351
Renal impairment 48.62 16.16 116 23057 188329 110377797
Syphilis 48.58 16.16 14 23159 760 110565366
Mycobacterium avium complex infection 48.52 16.16 24 23149 5853 110560273
Arthropathy 48.32 16.16 3 23170 287519 110278607
Fall 47.98 16.16 34 23139 603448 109962678
Spina bifida 45.79 16.16 10 23163 171 110565955
Progressive multifocal leukoencephalopathy 44.62 16.16 39 23134 24917 110541209
Oligohydramnios 44.32 16.16 20 23153 3974 110562152
Premature labour 43.66 16.16 26 23147 9146 110556980
Autoimmune hepatitis 43.48 16.16 31 23142 14773 110551353
Hypophosphataemia 42.33 16.16 43 23130 33139 110532987
Haemolytic anaemia 42.12 16.16 35 23138 20885 110545241
Abdominal discomfort 42.05 16.16 15 23158 393843 110172283
Depression 41.99 16.16 154 23019 317181 110248945
Cholestasis 41.50 16.16 59 23114 64459 110501667
Dyslipidaemia 41.38 16.16 31 23142 15934 110550192
Cortisol decreased 40.61 16.16 17 23156 2819 110563307
Blood phosphorus decreased 39.83 16.16 23 23150 7642 110558484
CSF virus identified 39.76 16.16 7 23166 35 110566091
Lower respiratory tract infection 39.49 16.16 3 23170 243103 110323023
Ocular icterus 39.22 16.16 21 23152 6032 110560094
Lactic acidosis 39.16 16.16 70 23103 92741 110473385
Musculoskeletal stiffness 39.02 16.16 6 23167 279816 110286310
Systemic lupus erythematosus 38.99 16.16 4 23169 254334 110311792
Central obesity 38.83 16.16 15 23158 2021 110564105
Drug reaction with eosinophilia and systemic symptoms 38.66 16.16 65 23108 82030 110484096
Hepatitis B 37.49 16.16 24 23149 9588 110556538
Blood bilirubin increased 36.91 16.16 61 23112 75911 110490215
Drug hypersensitivity 36.84 16.16 25 23148 454065 110112061
Kaposi's sarcoma 36.61 16.16 11 23162 691 110565435
Mobility decreased 35.71 16.16 4 23169 237418 110328708
Vanishing bile duct syndrome 35.59 16.16 16 23157 3152 110562974
Placenta praevia 35.26 16.16 11 23162 784 110565342
Wound 35.14 16.16 4 23169 234433 110331693
Hepatotoxicity 35.05 16.16 54 23119 63346 110502780
Stomatitis 35.05 16.16 7 23166 270235 110295891
Pneumocystis jirovecii pneumonia 35.03 16.16 44 23129 42691 110523435
Pericarditis 34.77 16.16 3 23170 219111 110347015
White matter lesion 34.45 16.16 15 23158 2739 110563387
Sinusitis 33.96 16.16 10 23163 296678 110269448
Hepatitis C 33.90 16.16 25 23148 12548 110553578
Secondary syphilis 33.10 16.16 7 23166 102 110566024
Malaria 32.59 16.16 9 23164 418 110565708
Arthralgia 32.56 16.16 72 23101 779560 109786566
Pre-eclampsia 32.27 16.16 21 23152 8629 110557497
Seroconversion test positive 31.43 16.16 6 23167 50 110566076
Abnormal dreams 31.32 16.16 24 23149 12756 110553370
Contraindicated product administered 31.03 16.16 7 23166 248260 110317866
Disseminated tuberculosis 30.97 16.16 17 23156 5129 110560997
Cachexia 30.95 16.16 24 23149 12981 110553145
Blood alkaline phosphatase increased 30.56 16.16 54 23119 70881 110495245
Hepatitis B DNA increased 30.40 16.16 10 23163 845 110565281
Fatigue 30.05 16.16 142 23031 1215816 109350310
Hepatomegaly 29.62 16.16 29 23144 21385 110544741
Polydipsia 29.50 16.16 19 23154 7669 110558457
Hepatitis 29.48 16.16 61 23112 89993 110476133
Lung transplant rejection 29.08 16.16 12 23161 1919 110564207
Ultrasound antenatal screen abnormal 28.94 16.16 6 23167 79 110566047
Foetal cardiac disorder 28.93 16.16 5 23168 22 110566104
Lipohypertrophy 28.81 16.16 10 23163 996 110565130
Rash maculo-papular 28.80 16.16 54 23119 74168 110491958
Therapeutic product effect incomplete 28.60 16.16 6 23167 223799 110342327
Cytomegalovirus colitis 28.46 16.16 18 23155 7043 110559083
Hypertriglyceridaemia 28.38 16.16 25 23148 16129 110549997
Contusion 28.33 16.16 7 23166 233354 110332772
Drug level increased 28.30 16.16 42 23131 47677 110518449
Blood cholesterol increased 28.07 16.16 3 23170 184782 110381344
Impaired healing 27.92 16.16 4 23169 196713 110369413
Rhabdomyolysis 27.74 16.16 71 23102 120330 110445796
Osteoporotic fracture 27.70 16.16 16 23157 5321 110560805
Pain in extremity 27.62 16.16 37 23136 487081 110079045
Mitochondrial myopathy 27.55 16.16 8 23165 446 110565680
Premature delivery 27.47 16.16 33 23140 30599 110535527
Retinal toxicity 27.35 16.16 11 23162 1648 110564478
Tubulointerstitial nephritis 26.92 16.16 44 23129 54240 110511886
Nervous system disorder 26.54 16.16 33 23140 31688 110534438
Glucocorticoids increased 26.49 16.16 6 23167 122 110566004
Splenomegaly 26.36 16.16 29 23144 24469 110541657
HIV infection 26.28 16.16 10 23163 1293 110564833
Osteoporosis 26.17 16.16 57 23116 87095 110479031
Pancreatitis acute 26.11 16.16 46 23127 60228 110505898
Toxoplasmosis 26.07 16.16 13 23160 3226 110562900
Viraemia 25.93 16.16 14 23159 4088 110562038
Asthma 25.91 16.16 10 23163 250281 110315845
Pregnancy on oral contraceptive 25.71 16.16 9 23164 919 110565207
Eyelid oedema 25.59 16.16 23 23150 15239 110550887
Lymphadenopathy 25.47 16.16 47 23126 63788 110502338
Hepatitis fulminant 25.31 16.16 18 23155 8542 110557584
Urticaria 25.26 16.16 18 23155 318839 110247287
Drug intolerance 25.00 16.16 29 23144 406483 110159643
Acquired immunodeficiency syndrome 24.83 16.16 7 23166 351 110565775
Oesophageal carcinoma 24.70 16.16 20 23153 11504 110554622
Adrenal insufficiency 24.69 16.16 37 23136 42353 110523773
Foetal death 24.60 16.16 23 23150 16022 110550104
Skin lesion 24.46 16.16 41 23132 51590 110514536
Product dose omission issue 24.41 16.16 19 23154 321763 110244363
Injection site pain 24.38 16.16 4 23169 177918 110388208
Skin striae 24.35 16.16 11 23162 2190 110563936
Hypothalamic pituitary adrenal axis suppression 24.34 16.16 8 23165 674 110565452
Gamma-glutamyltransferase increased 24.28 16.16 45 23128 61264 110504862
Injury 24.25 16.16 4 23169 177261 110388865
Type 2 diabetes mellitus 24.25 16.16 4 23169 177228 110388898
Anogenital warts 23.93 16.16 9 23164 1127 110564999
Drug level decreased 23.59 16.16 24 23149 18524 110547602
Dyspnoea 23.54 16.16 136 23037 1106736 109459390
Cerebral toxoplasmosis 23.50 16.16 12 23161 3130 110562996
Dizziness 23.37 16.16 72 23101 698121 109868005
Infection 23.19 16.16 25 23148 362175 110203951
Osteoarthritis 23.12 16.16 5 23168 182618 110383508
Melanoderma 22.95 16.16 7 23166 463 110565663
Meningitis tuberculous 22.90 16.16 9 23164 1269 110564857
Hereditary optic atrophy 22.76 16.16 5 23168 88 110566038
Blood corticotrophin decreased 22.62 16.16 8 23165 842 110565284
Tuberculosis 22.61 16.16 23 23150 17751 110548375
Folliculitis 22.46 16.16 4 23169 167649 110398477
Pneumonia 22.44 16.16 101 23072 876613 109689513
Meningomyelocele 22.40 16.16 4 23169 22 110566104
Pulmonary venous thrombosis 22.31 16.16 6 23167 252 110565874
Multiple-drug resistance 22.29 16.16 20 23153 13215 110552911
Prurigo 22.11 16.16 9 23164 1391 110564735
C-reactive protein increased 22.08 16.16 9 23164 217910 110348216
ACTH stimulation test abnormal 21.97 16.16 4 23169 25 110566101
Swelling 21.63 16.16 25 23148 351016 110215110
Hepatosplenomegaly 21.50 16.16 15 23158 6904 110559222
Renal tubular acidosis 21.49 16.16 13 23160 4702 110561424
Anaemia 21.27 16.16 191 22982 546895 110019231
Burkitt's lymphoma 21.21 16.16 5 23168 122 110566004
Paradoxical drug reaction 20.97 16.16 17 23156 9800 110556326
Depressed mood 20.86 16.16 42 23131 60767 110505359
Maternal drugs affecting foetus 20.86 16.16 9 23164 1608 110564518
Face oedema 20.63 16.16 30 23143 33439 110532687
Calculus urinary 20.60 16.16 11 23162 3141 110562985
Malaise 20.60 16.16 72 23101 671747 109894379
Product use issue 20.53 16.16 21 23152 311674 110254452
Constipation 20.45 16.16 27 23146 357759 110208367
Completed suicide 20.10 16.16 13 23160 242368 110323758
Discomfort 19.98 16.16 10 23163 214697 110351429
Blood pressure increased 19.92 16.16 15 23158 258358 110307768
Mitochondrial cytopathy 19.78 16.16 6 23167 389 110565737
Malignant neoplasm progression 19.75 16.16 6 23167 174561 110391565
Inappropriate schedule of product administration 19.69 16.16 9 23164 203628 110362498
Anogenital dysplasia 19.59 16.16 5 23168 171 110565955
Inflammation 19.54 16.16 8 23165 193230 110372896
Kaposi sarcoma inflammatory cytokine syndrome 19.50 16.16 5 23168 174 110565952
Portal hypertensive gastropathy 19.43 16.16 9 23164 1899 110564227
Alopecia 19.38 16.16 29 23144 364724 110201402
Anembryonic gestation 19.23 16.16 6 23167 428 110565698
Oral candidiasis 19.18 16.16 34 23139 44726 110521400
Metabolic acidosis 19.14 16.16 55 23118 99689 110466437
Polyuria 19.09 16.16 21 23152 17717 110548409
Generalised anxiety disorder 19.02 16.16 10 23163 2769 110563357
Pyrexia 18.82 16.16 278 22895 897987 109668139
Influenza 18.80 16.16 6 23167 169095 110397031
Cerebellar ataxia 18.65 16.16 9 23164 2079 110564047
Gastroenteritis 18.63 16.16 31 23142 38769 110527357
Spinocerebellar disorder 18.26 16.16 3 23170 9 110566117
Nasal septum deviation 18.22 16.16 9 23164 2189 110563937
Congenital hydrocephalus 17.82 16.16 4 23169 78 110566048
Bursitis 17.62 16.16 3 23170 129915 110436211
Intensive care unit acquired weakness 17.61 16.16 9 23164 2350 110563776
Superinfection bacterial 17.46 16.16 9 23164 2392 110563734
Memory impairment 17.11 16.16 10 23163 196934 110369192
Shigella infection 17.07 16.16 4 23169 95 110566031
Neural tube defect 17.04 16.16 3 23170 15 110566111
Lipoatrophy 17.00 16.16 6 23167 628 110565498
Oxygen saturation decreased 16.70 16.16 6 23167 156976 110409150
Haemorrhoids thrombosed 16.60 16.16 5 23168 317 110565809
Polyhydramnios 16.27 16.16 8 23165 1925 110564201
Liver function test abnormal 16.23 16.16 41 23132 68909 110497217
Gestational diabetes 16.21 16.16 13 23160 7376 110558750
Cholestasis of pregnancy 16.18 16.16 7 23166 1258 110564868

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
ATC J05AR29 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 D000890 Anti-Infective Agents
MeSH PA D000998 Antiviral Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D018894 Reverse Transcriptase Inhibitors
MeSH PA D019380 Anti-HIV Agents
MeSH PA D019384 Nucleic Acid Synthesis Inhibitors
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:33231 antitubercular agent
CHEBI has role CHEBI:35441 antiinfective agent
CHEBI has role CHEBI:35705 immunosuppressive agent
CHEBI has role CHEBI:36044 antiviral drug
CHEBI has role CHEBI:50864 insulin-sensitizing drug
CHEBI has role CHEBI:53756 HIV-1 reverse transcriptase inhibitor
CHEBI has role CHEBI:64946 anti-HIV agent
CHEBI has role CHEBI:64951 anti-HBV agent

Related Drugs by ATC class:

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

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
600MG;200MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ATRIPLA GILEAD SCIENCES N021937 July 12, 2006 DISCN TABLET ORAL 9018192 June 13, 2026 TREATMENT OF HIV-1 INFECTION IN ADULTS
600MG;200MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ATRIPLA GILEAD SCIENCES N021937 July 12, 2006 DISCN TABLET ORAL 9018192 June 13, 2026 TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
600MG;200MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ATRIPLA GILEAD SCIENCES N021937 July 12, 2006 DISCN TABLET ORAL 9545414 June 13, 2026 TREATMENT OF HIV-1 INFECTION IN ADULTS
600MG;200MG;300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ATRIPLA GILEAD SCIENCES N021937 July 12, 2006 DISCN 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
200MG;EQ 25MG BASE DESCOVY GILEAD SCIENCES INC N208215 April 4, 2016 RX TABLET ORAL 12648911 June 29, 2036 PROPHYLAXIS OF HIV-1 INFECTION
200MG;EQ 25MG BASE DESCOVY GILEAD SCIENCES INC N208215 April 4, 2016 RX TABLET ORAL 12648911 June 29, 2036 TREATMENT OF HIV-1 INFECTION
EQ 30MG BASE;120MG;EQ 15MG BASE BIKTARVY GILEAD SCIENCES INC N210251 Oct. 7, 2021 RX TABLET ORAL 12594244 Nov. 8, 2036 TREATMENT OF HIV INFECTION
EQ 50MG BASE;200MG;EQ 25MG BASE BIKTARVY GILEAD SCIENCES INC N210251 Feb. 7, 2018 RX TABLET ORAL 12594244 Nov. 8, 2036 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, 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 Feb. 23, 2027 EXPANSION OF INDICATION TO USE OF BICTEGRAVIR/EMTRICITABINE/TENOFOVIR ALAFENAMIDE FOR THE TREATMENT OF HIV-1 INFECTION IN VIROLOGICALLY SUPPRESSED ADULTS AND PEDIATRIC PATIENTS ON A STABLE HIV-1 TREATMENT REGIMEN WITH NO KNOWN RESISTANCE TO BICTEGRAVIR OR TENOFOVIR
EQ 50MG BASE;200MG;EQ 25MG BASE BIKTARVY GILEAD SCIENCES INC N210251 Feb. 7, 2018 RX TABLET ORAL Feb. 23, 2027 EXPANSION OF INDICATION TO USE OF BICTEGRAVIR/EMTRICITABINE/TENOFOVIR ALAFENAMIDE FOR THE TREATMENT OF HIV-1 INFECTION IN VIROLOGICALLY SUPPRESSED ADULTS AND PEDIATRIC PATIENTS ON A STABLE HIV-1 TREATMENT REGIMEN WITH NO KNOWN RESISTANCE TO BICTEGRAVIR OR TENOFOVIR
EQ 50MG BASE;200MG;EQ 25MG BASE BIKTARVY GILEAD SCIENCES INC N210251 Feb. 7, 2018 RX TABLET ORAL April 24, 2027 REVISIONS TO THE LABELING TO INCLUDE INFORMATION FOR PREGNANT INDIVIDUALS
120MG;EQ 15MG BASE DESCOVY GILEAD SCIENCES INC N208215 Jan. 7, 2022 RX TABLET ORAL June 20, 2028 LABELING CHANGES TO INCLUDE THE RESULTS OF STUDY GS-US-216-0128 IN CERTAIN PEDIATRIC PATIENTS
200MG;EQ 25MG BASE DESCOVY GILEAD SCIENCES INC N208215 April 4, 2016 RX TABLET ORAL June 20, 2028 LABELING CHANGES TO INCLUDE THE RESULTS OF STUDY GS-US-216-0128 IN CERTAIN PEDIATRIC PATIENTS
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
120MG;EQ 15MG BASE DESCOVY GILEAD SCIENCES INC N208215 Jan. 7, 2022 RX TABLET ORAL Jan. 7, 2029 TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS UNDER 12 YEARS OF AGE WEIGHING AT LEAST 14 KG TO LESS THAN 25 KG
EQ 30MG BASE;120MG;EQ 15MG BASE BIKTARVY GILEAD SCIENCES INC N210251 Oct. 7, 2021 RX TABLET ORAL Feb. 23, 2031 TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) INFECTION IN PEDIATRIC PATIENTS WEIGHING AT LEAST 14 KG 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 KNOWN OR SUSPECTED SUBSTITUTIONS ASSOCIATED WITH RESISTANCE TO BICTEGRAVIR OR TENOFOVIR AND WITH KNOWN OR SUSPECTED SUBSTITUTIONS ASSOCIATED WITH RESISTANCE TO EMTRICITABINE
EQ 50MG BASE;200MG;EQ 25MG BASE BIKTARVY GILEAD SCIENCES INC N210251 Feb. 7, 2018 RX TABLET ORAL Feb. 23, 2031 TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) INFECTION IN PEDIATRIC PATIENTS WEIGHING AT LEAST 14 KG 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 KNOWN OR SUSPECTED SUBSTITUTIONS ASSOCIATED WITH RESISTANCE TO BICTEGRAVIR OR TENOFOVIR AND WITH KNOWN OR SUSPECTED SUBSTITUTIONS ASSOCIATED WITH RESISTANCE TO EMTRICITABINE
EQ 30MG BASE;120MG;EQ 15MG BASE BIKTARVY GILEAD SCIENCES INC N210251 Oct. 7, 2021 RX TABLET ORAL July 30, 2032 TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) INFECTION IN PEDIATRIC PATIENTSWEIGHING AT LEAST 14 KG WITH AN ANTIRETROVIRAL TREATMENT HISTORY AND NOT VIROLOGICALLY SUPPRESSED, WITH NO KNOWN OR SUSPECTED SUBSTITUTIONS ASSOCIATED WITH RESISTANCE TO THE INTEGRASE STRAND INHIBITOR CLASS, EMTRICITABINE, OR TENOFOVIR
EQ 50MG BASE;200MG;EQ 25MG BASE BIKTARVY GILEAD SCIENCES INC N210251 Feb. 7, 2018 RX TABLET ORAL July 30, 2032 TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) INFECTION IN PEDIATRIC PATIENTSWEIGHING AT LEAST 14 KG WITH AN ANTIRETROVIRAL TREATMENT HISTORY AND NOT VIROLOGICALLY SUPPRESSED, WITH NO KNOWN OR SUSPECTED SUBSTITUTIONS ASSOCIATED WITH RESISTANCE TO THE INTEGRASE STRAND INHIBITOR CLASS, EMTRICITABINE, OR TENOFOVIR

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
391845 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 29 sections
Emtricitabine and Tenofovir Disoproxil Fumarate HUMAN PRESCRIPTION DRUG LABEL 2 0093-7704 TABLET, FILM COATED 200 mg ORAL ANDA 28 sections
Emtricitabine, Rilpivirine, Tenofovir Disoproxil Fumarate HUMAN PRESCRIPTION DRUG LABEL 3 0378-5440 TABLET, FILM COATED 200 mg ORAL ANDA 29 sections
Emtricitabine and Tenofovir Disoproxil Fumarate HUMAN PRESCRIPTION DRUG LABEL 2 0904-7172 TABLET, FILM COATED 200 mg ORAL ANDA 27 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 26 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
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 42291-980 TABLET, FILM COATED 200 mg ORAL ANDA 28 sections
emtricitabine, rilpivirine and tenofovir disoproxil fumarate Human Prescription Drug Label 3 42385-801 TABLET, FILM COATED 200 mg ORAL ANDA 28 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 27 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 32 sections
ODEFSEY HUMAN PRESCRIPTION DRUG LABEL 3 50090-2340 TABLET 200 mg ORAL NDA 30 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 34 sections
Emtricitabine and Tenofovir Disoproxil Fumarate Human Prescription Drug Label 2 50090-6494 TABLET, FILM COATED 200 mg ORAL ANDA 27 sections
Emtricitabine and tenofovir disoproxil fumarate HUMAN PRESCRIPTION DRUG LABEL 2 50090-7719 TABLET, FILM COATED 200 mg ORAL ANDA 26 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
Emtricitabine and Tenofovir Disoproxil Fumarate Human Prescription Drug Label 2 53002-1653 TABLET, FILM COATED 200 mg ORAL ANDA 27 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