raltegravir 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
antivirals 2352 518048-05-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • MK0518
  • isentress
  • raltegravir
  • raltegravir potassium
  • MK-0518
Raltegravir inhibits the catalytic activity of HIV-1 integrase, an HIV-1 encoded enzyme that is required for viral replication. Inhibition of integrase prevents the covalent insertion, or integration, of unintegrated linear HIV-1 DNA into the host cell genome preventing the formation of the HIV-1 provirus. The provirus is required to direct the production of progeny virus, so inhibiting integration prevents propagation of the viral infection.
  • Molecular weight: 444.42
  • Formula: C20H21FN6O5
  • CLOGP: 1.47
  • LIPINSKI: 1
  • HAC: 11
  • HDO: 3
  • TPSA: 150.02
  • ALOGS: -3.66
  • ROTB: 6
  • Status: ONP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.80 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 9 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 25.72 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 31.80 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
S (Water solubility) 71 mg/mL Bocci G, Oprea TI, Benet LZ
fu (Fraction unbound in plasma) 0.15 % Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K

Approvals:

DateAgencyCompanyOrphan
June 24, 2008 PMDA Banyu Pharmaceutical Co., Ltd.
Dec. 20, 2007 EMA
Oct. 12, 2007 FDA MERCK SHARP DOHME

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Exposure during pregnancy 1186.38 21.97 550 9701 154997 63323774
Foetal exposure during pregnancy 743.86 21.97 254 9997 31708 63447063
Maternal exposure during pregnancy 383.32 21.97 302 9949 219760 63259011
Virologic failure 345.06 21.97 76 10175 1786 63476985
Abortion spontaneous 338.92 21.97 161 10090 47034 63431737
Premature baby 229.95 21.97 96 10155 20639 63458132
Immune reconstitution inflammatory syndrome 196.15 21.97 62 10189 6022 63472749
Pathogen resistance 193.08 21.97 62 10189 6336 63472435
Blood HIV RNA increased 186.98 21.97 39 10212 700 63478071
Viral mutation identified 182.05 21.97 45 10206 1765 63477006
Caesarean section 169.35 21.97 73 10178 16959 63461812
Lipodystrophy acquired 140.50 21.97 35 10216 1417 63477354
Drug reaction with eosinophilia and systemic symptoms 140.45 21.97 80 10171 33756 63445015
Spina bifida 136.88 21.97 31 10220 828 63477943
Premature delivery 134.91 21.97 75 10176 30206 63448565
Viral load increased 127.36 21.97 32 10219 1342 63477429
Premature labour 125.62 21.97 54 10197 12450 63466321
Treatment noncompliance 122.89 21.97 76 10175 37249 63441522
Abortion induced 108.73 21.97 46 10205 10196 63468575
Drug resistance 108.19 21.97 59 10192 22874 63455897
Renal dysplasia 104.33 21.97 20 10231 228 63478543
Ectopic kidney 100.11 21.97 16 10235 54 63478717
Foetal growth restriction 97.43 21.97 39 10212 7514 63471257
Genotype drug resistance test positive 93.21 21.97 20 10231 413 63478358
Foetal death 92.79 21.97 42 10209 10938 63467833
Live birth 86.41 21.97 53 10198 25577 63453194
Cloacal exstrophy 86.31 21.97 16 10235 150 63478621
Sudden infant death syndrome 82.19 21.97 17 10234 292 63478479
Congenital genital malformation 80.88 21.97 15 10236 141 63478630
Bladder agenesis 80.59 21.97 15 10236 144 63478627
Genitalia external ambiguous 79.95 21.97 15 10236 151 63478620
Caudal regression syndrome 78.99 21.97 15 10236 162 63478609
Meconium stain 77.08 21.97 15 10236 186 63478585
Hepatic cytolysis 76.45 21.97 41 10210 15366 63463405
Gastrointestinal disorder congenital 75.64 21.97 14 10237 130 63478641
Anal atresia 72.36 21.97 16 10235 382 63478389
Premature rupture of membranes 72.18 21.97 28 10223 4965 63473806
Tethered cord syndrome 71.91 21.97 15 10236 269 63478502
Gastroschisis 71.38 21.97 16 10235 407 63478364
Meningomyelocele 70.46 21.97 17 10234 601 63478170
Congenital heart valve disorder 69.59 21.97 12 10239 71 63478700
Neonatal respiratory arrest 67.16 21.97 11 10240 45 63478726
Hepatocellular injury 66.25 21.97 46 10205 27335 63451436
Gastrointestinal malformation 65.82 21.97 13 10238 175 63478596
Central obesity 63.47 21.97 18 10233 1203 63477568
Exomphalos 61.85 21.97 15 10236 542 63478229
Complication of delivery 60.65 21.97 12 10239 163 63478608
Congenital pulmonary valve disorder 59.58 21.97 10 10241 49 63478722
Umbilical cord abnormality 59.26 21.97 15 10236 648 63478123
Pain 59.13 21.97 23 10228 740605 62738166
Hemivertebra 57.99 21.97 11 10240 118 63478653
Immune reconstitution inflammatory syndrome associated tuberculosis 57.04 21.97 13 10238 357 63478414
Bacterial vulvovaginitis 56.54 21.97 15 10236 781 63477990
Pre-eclampsia 55.94 21.97 28 10223 9105 63469666
Bacillus infection 55.51 21.97 15 10236 838 63477933
Maternal drugs affecting foetus 53.82 21.97 23 10228 5219 63473552
Hydrocephalus 53.58 21.97 23 10228 5277 63473494
Alanine aminotransferase increased 52.83 21.97 74 10177 103696 63375075
Congenital anomaly 52.70 21.97 17 10234 1759 63477012
Single functional kidney 52.16 21.97 12 10239 344 63478427
Foetal growth abnormality 51.80 21.97 9 10242 56 63478715
Drug interaction 50.45 21.97 113 10138 229018 63249753
Cholestasis of pregnancy 50.14 21.97 15 10236 1210 63477561
Low birth weight baby 50.07 21.97 24 10227 7105 63471666
Pulmonary valve sclerosis 49.39 21.97 8 10243 30 63478741
CD4 lymphocytes decreased 47.88 21.97 15 10236 1412 63477359
Congenital choroid plexus cyst 47.86 21.97 11 10240 314 63478457
Congenital ectopic bladder 47.32 21.97 9 10242 98 63478673
Neural tube defect 47.29 21.97 10 10241 192 63478579
Aspartate aminotransferase increased 46.88 21.97 65 10186 90212 63388559
Generalised anxiety disorder 46.21 21.97 16 10235 2058 63476713
Ultrasound antenatal screen 46.17 21.97 10 10241 216 63478555
Stillbirth 45.22 21.97 22 10229 6728 63472043
Hyperbilirubinaemia 44.90 21.97 26 10225 11288 63467483
Anencephaly 43.12 21.97 10 10241 297 63478474
Congenital hydrocephalus 42.80 21.97 9 10242 168 63478603
Renal aplasia 42.71 21.97 10 10241 310 63478461
Cardiac murmur 41.30 21.97 27 10224 14525 63464246
Fall 41.08 21.97 7 10244 392327 63086444
Renal tubular dysfunction 39.66 21.97 10 10241 425 63478346
Mycoplasma genitalium infection 38.08 21.97 6 10245 18 63478753
Gestational diabetes 37.92 21.97 21 10230 8375 63470396
Cushingoid 37.71 21.97 21 10230 8464 63470307
Fatigue 37.04 21.97 54 10197 887974 62590797
Drug ineffective 36.72 21.97 71 10180 1044694 62434077
Viral load decreased 36.54 21.97 6 10245 25 63478746
Product size issue 36.44 21.97 9 10242 351 63478420
Trisomy 21 35.61 21.97 9 10242 386 63478385
CSF HIV escape syndrome 35.05 21.97 7 10244 100 63478671
Ventricular hypertrophy 35.02 21.97 15 10236 3421 63475350
Hepatitis fulminant 34.91 21.97 15 10236 3449 63475322
Sepsis neonatal 33.95 21.97 9 10242 467 63478304
Large for dates baby 33.82 21.97 9 10242 474 63478297
Hepatitis B DNA increased 33.66 21.97 8 10243 265 63478506
Oesophageal candidiasis 33.61 21.97 17 10234 5646 63473125
Arthralgia 33.35 21.97 26 10225 569684 62909087
Atrial septal defect 33.12 21.97 18 10233 6920 63471851
Abdominal discomfort 32.98 21.97 6 10245 320879 63157892
Nephropathy toxic 32.95 21.97 20 10231 9459 63469312
Antiviral drug level below therapeutic 32.68 21.97 6 10245 53 63478718
Dyspnoea 31.88 21.97 36 10215 661277 62817494
Mental disability 30.22 21.97 6 10245 83 63478688
Mitochondrial cytopathy 29.22 21.97 7 10244 240 63478531
Thymus hypoplasia 29.08 21.97 5 10246 29 63478742
Congenital intestinal malformation 28.79 21.97 5 10246 31 63478740
Eosinophilia 28.57 21.97 26 10225 22730 63456041
Congenital aortic stenosis 28.14 21.97 5 10246 36 63478735
Diastasis recti abdominis 28.02 21.97 5 10246 37 63478734
Microcephaly 27.90 21.97 9 10242 931 63477840
Drug hypersensitivity 27.56 21.97 8 10243 310679 63168092
Small for dates baby 27.48 21.97 13 10238 3738 63475033
Hydrops foetalis 27.31 21.97 8 10243 600 63478171
Cholestasis 26.44 21.97 28 10223 29406 63449365
Patent ductus arteriosus 25.93 21.97 13 10238 4237 63474534
Furuncle 25.81 21.97 15 10236 6551 63472220
Chronic papillomatous dermatitis 25.77 21.97 5 10246 61 63478710
Dermatitis exfoliative 25.60 21.97 14 10237 5445 63473326
Bronchopulmonary dysplasia 25.32 21.97 7 10244 426 63478345
Anaemia 25.30 21.97 104 10147 293326 63185445
Amniotic cavity infection 25.29 21.97 9 10242 1254 63477517
Musculoskeletal deformity 25.11 21.97 10 10241 1899 63476872
Heart disease congenital 25.05 21.97 9 10242 1290 63477481
Contraindicated product administered 24.81 21.97 3 10248 217645 63261126
Rash maculo-papular 24.59 21.97 28 10223 31868 63446903
Acute stress disorder 24.50 21.97 6 10245 226 63478545
Alopecia 24.43 21.97 12 10239 337524 63141247
Drug intolerance 23.85 21.97 10 10241 308651 63170120
Systemic lupus erythematosus 23.52 21.97 3 10248 208915 63269856
Ectopic ureter 23.20 21.97 3 10248 0 63478771
Lenticulostriatal vasculopathy 23.20 21.97 3 10248 0 63478771
Aqueductal stenosis 23.15 21.97 4 10247 24 63478747
Hemiataxia 23.15 21.97 4 10247 24 63478747
Congenital absence of bile ducts 22.74 21.97 4 10247 27 63478744
Congenital skin dimples 22.70 21.97 5 10246 117 63478654
Cleft lip and palate 22.67 21.97 7 10244 628 63478143
Brain injury 22.29 21.97 14 10237 7029 63471742
Abortion spontaneous incomplete 22.26 21.97 4 10247 31 63478740
HIV-associated neurocognitive disorder 22.09 21.97 5 10246 133 63478638
Hepatic failure 22.07 21.97 28 10223 35628 63443143
Aortic valve sclerosis 21.99 21.97 8 10243 1188 63477583

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
Depression 1100.02 15.29 693 19989 96405 34839844
Drug interaction 1081.14 15.29 959 19723 224987 34711262
Virologic failure 539.14 15.29 160 20522 3320 34932929
Psychiatric decompensation 428.77 15.29 129 20553 2808 34933441
Lipodystrophy acquired 403.92 15.29 127 20555 3217 34933032
Pathogen resistance 399.16 15.29 165 20517 9317 34926932
Foetal exposure during pregnancy 382.59 15.29 253 20429 37848 34898401
Immune reconstitution inflammatory syndrome 363.88 15.29 151 20531 8608 34927641
Mitochondrial toxicity 307.28 15.29 98 20584 2601 34933648
Depression suicidal 301.94 15.29 95 20587 2410 34933839
Loss of personal independence in daily activities 284.67 15.29 200 20482 32979 34903270
Viral mutation identified 282.54 15.29 94 20588 2860 34933389
Tearfulness 279.76 15.29 91 20591 2576 34933673
Progressive external ophthalmoplegia 271.07 15.29 77 20605 1358 34934891
Depressive symptom 257.67 15.29 87 20595 2772 34933477
Blood HIV RNA increased 245.93 15.29 69 20613 1161 34935088
Eyelid ptosis 231.34 15.29 97 20585 5669 34930580
Psychomotor skills impaired 206.01 15.29 80 20602 3826 34932423
Paranoia 195.49 15.29 109 20573 11959 34924290
Drug resistance 180.87 15.29 138 20544 25789 34910460
Suicidal ideation 138.89 15.29 144 20538 40244 34896005
Viral load increased 134.11 15.29 52 20630 2475 34933774
Psychotic disorder 117.79 15.29 105 20577 24347 34911902
Volvulus 117.46 15.29 42 20640 1590 34934659
Diplopia 113.80 15.29 88 20594 16755 34919494
Renal tubular disorder 103.72 15.29 52 20630 4591 34931658
CD4 lymphocytes decreased 100.17 15.29 38 20644 1703 34934546
HIV-associated neurocognitive disorder 95.49 15.29 25 20657 319 34935930
Hepatitis C 90.62 15.29 62 20620 9768 34926481
Psychomotor retardation 87.83 15.29 43 20639 3607 34932642
CSF HIV escape syndrome 82.63 15.29 20 20662 181 34936068
Gene mutation 74.80 15.29 29 20653 1379 34934870
Brain stem stroke 73.03 15.29 20 20662 306 34935943
Brachydactyly 72.48 15.29 18 20664 183 34936066
Drug reaction with eosinophilia and systemic symptoms 70.24 15.29 92 20590 32920 34903329
Genotype drug resistance test positive 69.53 15.29 26 20656 1119 34935130
Trisomy 18 67.64 15.29 23 20659 748 34935501
Osteoporotic fracture 66.99 15.29 25 20657 1070 34935179
Ultrasound antenatal screen 66.62 15.29 21 20661 535 34935714
Ophthalmoplegia 64.03 15.29 28 20654 1812 34934437
Cleft lip and palate 60.13 15.29 22 20660 890 34935359
Prescribed overdose 59.93 15.29 50 20632 10597 34925652
Hydrops foetalis 57.48 15.29 21 20661 846 34935403
Oesophageal atresia 51.75 15.29 17 20665 496 34935753
Hemivertebra 51.17 15.29 13 20669 146 34936103
Gastrointestinal tube insertion 50.20 15.29 21 20661 1218 34935031
Osteoporosis 48.67 15.29 48 20634 12620 34923629
Dyspnoea 48.16 15.29 94 20588 376688 34559561
Cytomegalovirus chorioretinitis 46.36 15.29 28 20654 3561 34932688
Genital herpes 44.41 15.29 16 20666 619 34935630
Treatment failure 44.01 15.29 90 20592 46607 34889642
Anxiety 43.92 15.29 144 20538 99284 34836965
Dyslipidaemia 43.88 15.29 36 20646 7452 34928797
Phalangeal hypoplasia 43.58 15.29 10 20672 70 34936179
Treatment noncompliance 43.07 15.29 67 20615 28033 34908216
Renal impairment 42.75 15.29 138 20544 94375 34841874
Hypotension 40.38 15.29 43 20639 221606 34714643
Pneumonia 40.09 15.29 98 20584 362529 34573720
Genital herpes simplex 38.83 15.29 10 20672 119 34936130
Oesophageal candidiasis 38.80 15.29 27 20655 4369 34931880
Drug level decreased 38.36 15.29 34 20648 7812 34928437
Hepatitis cholestatic 37.99 15.29 34 20648 7913 34928336
Anogenital dysplasia 37.95 15.29 10 20672 131 34936118
Laryngomalacia 37.55 15.29 12 20670 320 34935929
Drug abuse 36.82 15.29 7 20675 99089 34837160
Hepatic cytolysis 36.55 15.29 44 20638 14452 34921797
Acquired immunodeficiency syndrome 36.03 15.29 13 20669 505 34935744
Incorrect route of product administration 35.71 15.29 44 20638 14801 34921448
Atrial fibrillation 35.49 15.29 14 20668 122379 34813870
Premature baby 34.64 15.29 50 20632 19583 34916666
Completed suicide 34.28 15.29 8 20674 98160 34838089
Anal cancer 33.64 15.29 12 20670 451 34935798
Blood creatine phosphokinase increased 32.69 15.29 78 20604 44779 34891470
Superior mesenteric artery syndrome 31.98 15.29 8 20674 84 34936165
Abortion spontaneous 31.47 15.29 11 20671 389 34935860
Syphilis 30.54 15.29 11 20671 425 34935824
Low birth weight baby 30.45 15.29 30 20652 7875 34928374
HIV lipodystrophy 30.05 15.29 6 20676 19 34936230
Fanconi syndrome acquired 29.56 15.29 17 20665 1974 34934275
Hepatic cirrhosis 28.96 15.29 43 20639 17271 34918978
Progressive multifocal leukoencephalopathy 28.57 15.29 32 20650 9732 34926517
Polydactyly 28.31 15.29 14 20668 1199 34935050
Multiple-drug resistance 28.23 15.29 24 20658 5215 34931034
Congenital mitral valve incompetence 28.15 15.29 8 20674 141 34936108
Intestinal malrotation 28.04 15.29 6 20676 29 34936220
Back pain 27.80 15.29 19 20663 121770 34814479
Adverse event 27.52 15.29 44 20638 18833 34917416
Haemophilic arthropathy 27.30 15.29 8 20674 158 34936091
Lipohypertrophy 27.19 15.29 9 20673 269 34935980
Chronic hepatitis C 27.09 15.29 10 20672 415 34935834
Congenital skin dimples 26.84 15.29 8 20674 168 34936081
Congenital foot malformation 26.70 15.29 10 20672 432 34935817
Osteonecrosis 26.38 15.29 38 20644 14852 34921397
Laryngectomy 25.73 15.29 4 20678 0 34936249
Malignant neoplasm progression 25.63 15.29 10 20672 88036 34848213
HIV associated nephropathy 25.59 15.29 9 20673 324 34935925
Constipation 25.56 15.29 26 20656 136956 34799293
Febrile neutropenia 25.51 15.29 26 20656 136823 34799426
Infection 25.38 15.29 11 20671 90904 34845345
Nephropathy toxic 25.09 15.29 34 20648 12554 34923695
Confusional state 25.08 15.29 29 20653 144131 34792118
Strongyloidiasis 24.74 15.29 17 20665 2694 34933555
Acquired gene mutation 24.02 15.29 13 20669 1342 34934907
Congenital vesicoureteric reflux 23.94 15.29 5 20677 21 34936228
Dysphagia 23.72 15.29 86 20596 62295 34873954
Mycobacterium avium complex infection 23.52 15.29 16 20666 2495 34933754
Enanthema 23.39 15.29 9 20673 419 34935830
Respiratory failure 23.39 15.29 18 20664 108554 34827695
Disease progression 23.18 15.29 18 20664 108059 34828190
Drug ineffective 23.12 15.29 167 20515 456584 34479665
Hypersplenism 22.99 15.29 9 20673 439 34935810
Hyperlipidaemia 22.76 15.29 35 20647 14494 34921755
Urinary tract inflammation 22.56 15.29 7 20675 169 34936080
Exposure during pregnancy 22.33 15.29 27 20655 8907 34927342
COVID-19 22.26 15.29 9 20673 77541 34858708
Drug hypersensitivity 22.07 15.29 10 20672 80519 34855730
Pain 22.01 15.29 56 20626 204619 34731630
Acute hepatitis C 21.60 15.29 6 20676 97 34936152
Liver disorder 21.52 15.29 55 20627 32942 34903307
HIV infection 21.41 15.29 12 20670 1327 34934922
Toxicity to various agents 21.40 15.29 55 20627 200307 34735942
Infusion related reaction 21.37 15.29 3 20679 53054 34883195
Erosive duodenitis 21.11 15.29 13 20669 1711 34934538
Blood pressure increased 21.11 15.29 13 20669 88089 34848160
Hyperlactacidaemia 20.89 15.29 16 20666 3000 34933249
White matter lesion 20.82 15.29 10 20672 804 34935445
Hyperbilirubinaemia 20.22 15.29 36 20646 16807 34919442
Antiviral drug level above therapeutic 20.21 15.29 5 20677 50 34936199
Lipids abnormal 20.17 15.29 8 20674 404 34935845
Congenital cystic kidney disease 20.14 15.29 8 20674 406 34935843
Drug level increased 20.11 15.29 42 20640 22054 34914195
Cholestasis 19.78 15.29 47 20635 26901 34909348
Heart transplant rejection 19.60 15.29 11 20671 1220 34935029
Oxygen saturation decreased 19.56 15.29 4 20678 53814 34882435
Cardiac arrest 19.40 15.29 17 20665 96142 34840107
Immune reconstitution inflammatory syndrome associated tuberculosis 19.35 15.29 8 20674 450 34935799
Hepatic enzyme decreased 19.30 15.29 5 20677 61 34936188
Sepsis 19.14 15.29 44 20638 166517 34769732
Conductive deafness 18.68 15.29 7 20675 303 34935946
Portal hypertension 18.67 15.29 17 20665 4045 34932204
Hyperphagia 18.11 15.29 11 20671 1412 34934837
Chest discomfort 17.96 15.29 5 20677 54525 34881724
Hepatitis 17.88 15.29 42 20640 23862 34912387
Drug-induced liver injury 17.72 15.29 47 20635 28785 34907464
Jaundice 17.63 15.29 50 20632 31832 34904417
Glucose tolerance impaired 17.53 15.29 15 20667 3289 34932960
Diet noncompliance 17.50 15.29 6 20676 200 34936049
Meningomyelocele 17.45 15.29 6 20676 202 34936047
Peripheral swelling 17.38 15.29 12 20670 76529 34859720
Congenital syphilis 17.22 15.29 3 20679 3 34936246
Tracheal fistula repair 17.22 15.29 3 20679 3 34936246
Hypertriglyceridaemia 17.11 15.29 23 20659 8425 34927824
Maternal drugs affecting foetus 17.07 15.29 16 20666 3949 34932300
Dizziness 17.05 15.29 69 20613 218452 34717797
Choroiditis 17.05 15.29 10 20672 1205 34935044
Atypical mycobacterial infection 17.05 15.29 9 20673 884 34935365
Neuropsychiatric symptoms 16.96 15.29 9 20673 893 34935356
Dehydration 16.89 15.29 32 20650 129937 34806312
Glycosuria 16.88 15.29 10 20672 1227 34935022
Nephrocalcinosis 16.69 15.29 8 20674 640 34935609
Hemiparaesthesia 16.64 15.29 5 20677 108 34936141
Congenital renal disorder 16.51 15.29 5 20677 111 34936138
Myelocytosis 16.45 15.29 4 20678 37 34936212
Cardiomyopathy acute 16.45 15.29 4 20678 37 34936212
Cerebral ventricle dilatation 16.38 15.29 9 20673 957 34935292
Retinal toxicity 16.30 15.29 7 20675 433 34935816
Nephrolithiasis 16.22 15.29 47 20635 30286 34905963
Vertigo 16.07 15.29 42 20640 25494 34910755
Therapeutic product effect incomplete 15.98 15.29 5 20677 50536 34885713
Lymphocytic infiltration 15.94 15.29 8 20674 707 34935542
Abnormal dreams 15.92 15.29 21 20661 7557 34928692
Varices oesophageal 15.87 15.29 15 20667 3740 34932509
Intensive care unit acquired weakness 15.87 15.29 9 20673 1018 34935231
Cushingoid 15.80 15.29 13 20669 2701 34933548
Congenital hydronephrosis 15.75 15.29 8 20674 725 34935524
Heart rate increased 15.73 15.29 4 20678 46339 34889910
Birth trauma 15.69 15.29 3 20679 7 34936242
Myopathy 15.58 15.29 26 20656 11528 34924721
Hepatocellular injury 15.51 15.29 38 20644 22173 34914076
Haemoglobin decreased 15.46 15.29 30 20652 120742 34815507
Retinitis pigmentosa 15.43 15.29 4 20678 49 34936200
Lymphoma 15.36 15.29 27 20655 12480 34923769
Small for dates baby 15.30 15.29 15 20667 3912 34932337
Cardiac failure congestive 15.30 15.29 16 20666 83254 34852995

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Virologic failure 1135.29 15.53 262 24058 3929 79716139
Drug interaction 978.38 15.53 887 23433 414296 79305772
Pathogen resistance 750.88 15.53 246 24074 14096 79705972
Depression 738.02 15.53 574 23746 216216 79503852
Viral mutation identified 622.79 15.53 159 24161 3699 79716369
Blood HIV RNA increased 542.98 15.53 123 24197 1685 79718383
Lipodystrophy acquired 514.78 15.53 140 24180 4185 79715883
Immune reconstitution inflammatory syndrome 507.90 15.53 182 24138 13659 79706409
Psychiatric decompensation 475.02 15.53 129 24191 3834 79716234
Mitochondrial toxicity 357.53 15.53 98 24222 3016 79717052
Progressive external ophthalmoplegia 326.30 15.53 78 24242 1367 79718701
Depression suicidal 319.52 15.53 94 24226 3748 79716320
Drug resistance 287.27 15.53 172 24148 42041 79678027
Abortion spontaneous 284.26 15.53 151 24169 29356 79690712
Tearfulness 269.74 15.53 92 24228 5953 79714115
Exposure during pregnancy 261.76 15.53 229 24091 100903 79619165
Depressive symptom 252.76 15.53 89 24231 6334 79713734
Maternal exposure during pregnancy 238.84 15.53 249 24071 136289 79583779
Psychomotor skills impaired 238.75 15.53 81 24239 5156 79714912
Viral load increased 231.49 15.53 69 24251 2879 79717189
Foetal exposure during pregnancy 230.79 15.53 81 24239 5709 79714359
Eyelid ptosis 222.46 15.53 94 24226 10950 79709118
Paranoia 211.64 15.53 108 24212 19324 79700744
Loss of personal independence in daily activities 199.20 15.53 198 24122 102382 79617686
Drug reaction with eosinophilia and systemic symptoms 183.48 15.53 154 24166 64090 79655978
Genotype drug resistance test positive 135.58 15.53 38 24282 1270 79718798
Psychotic disorder 134.47 15.53 107 24213 41295 79678773
Suicidal ideation 124.06 15.53 134 24186 76206 79643862
Caesarean section 123.07 15.53 65 24255 12470 79707598
CSF HIV escape syndrome 122.75 15.53 27 24293 320 79719748
Treatment noncompliance 118.60 15.53 110 24210 52158 79667910
Diplopia 118.44 15.53 91 24229 33375 79686693
CD4 lymphocytes decreased 109.38 15.53 38 24282 2596 79717472
Ultrasound antenatal screen 109.05 15.53 28 24292 665 79719403
Renal tubular disorder 107.10 15.53 48 24272 6438 79713630
HIV-associated neurocognitive disorder 105.95 15.53 24 24296 328 79719740
Hepatitis C 103.56 15.53 57 24263 11868 79708200
Hydrops foetalis 101.08 15.53 27 24293 751 79719317
Gene mutation 97.26 15.53 35 24285 2651 79717417
Cleft lip and palate 94.37 15.53 25 24295 673 79719395
Hepatic cytolysis 94.26 15.53 73 24247 27078 79692990
Psychomotor retardation 93.37 15.53 43 24277 6141 79713927
Trisomy 18 92.87 15.53 24 24296 585 79719483
Premature labour 83.76 15.53 44 24276 8346 79711722
Premature delivery 79.08 15.53 62 24258 23405 79696663
Abortion induced 78.80 15.53 40 24280 7069 79712999
Renal impairment 74.66 15.53 155 24165 157628 79562440
Pain 72.46 15.53 65 24255 703737 79016331
Brain stem stroke 70.49 15.53 20 24300 699 79719369
Immune reconstitution inflammatory syndrome associated tuberculosis 67.51 15.53 20 24300 816 79719252
Hyperbilirubinaemia 66.31 15.53 57 24263 24461 79695607
Ophthalmoplegia 66.09 15.53 27 24293 2885 79717183
Nephropathy toxic 64.63 15.53 52 24268 20367 79699701
Foetal death 63.18 15.53 36 24284 8008 79712060
Spina bifida 60.41 15.53 13 24307 138 79719930
Aspartate aminotransferase increased 58.45 15.53 130 24190 138511 79581557
Oesophageal candidiasis 56.09 15.53 35 24285 9183 79710885
Premature rupture of membranes 54.35 15.53 26 24294 4043 79716025
Joint swelling 54.27 15.53 11 24309 288635 79431433
Dyspnoea 54.07 15.53 113 24207 856912 78863156
Osteoporotic fracture 53.33 15.53 26 24294 4214 79715854
Hepatocellular injury 53.14 15.53 69 24251 47524 79672544
Genital herpes 53.10 15.53 21 24299 2063 79718005
Premature baby 53.08 15.53 25 24295 3755 79716313
Central obesity 52.89 15.53 20 24300 1741 79718327
Alanine aminotransferase increased 51.98 15.53 137 24183 162433 79557635
Peripheral swelling 51.27 15.53 10 24310 269607 79450461
Drug hypersensitivity 51.05 15.53 14 24306 298902 79421166
Dyslipidaemia 50.99 15.53 36 24284 11597 79708471
Hepatitis cholestatic 49.72 15.53 38 24282 13814 79706254
Completed suicide 49.15 15.53 8 24312 245759 79474309
Syphilis 48.01 15.53 14 24306 540 79719528
Cushingoid 47.62 15.53 32 24288 9520 79710548
Live birth 47.51 15.53 42 24278 18702 79701366
Cytomegalovirus chorioretinitis 47.00 15.53 26 24294 5464 79714604
Bacterial vulvovaginitis 46.80 15.53 14 24306 591 79719477
Renal failure 45.71 15.53 150 24170 200818 79519250
Gastroschisis 44.52 15.53 8 24312 29 79720039
Multiple-drug resistance 42.70 15.53 29 24291 8779 79711289
Fanconi syndrome acquired 41.51 15.53 19 24301 2675 79717393
Abdominal discomfort 40.51 15.53 13 24307 250714 79469354
Renal dysplasia 40.40 15.53 8 24312 54 79720014
Infection 40.01 15.53 12 24308 241700 79478368
Prescribed overdose 39.32 15.53 53 24267 37830 79682238
Foetal growth abnormality 39.26 15.53 7 24313 24 79720044
Generalised anxiety disorder 38.65 15.53 17 24303 2180 79717888
Mitochondrial cytopathy 38.38 15.53 11 24309 399 79719669
Pulmonary tuberculosis 38.37 15.53 26 24294 7839 79712229
Hepatic cirrhosis 38.02 15.53 50 24270 34856 79685212
Bacillus infection 37.91 15.53 14 24306 1141 79718927
Stillbirth 37.38 15.53 20 24300 3935 79716133
Dermatitis exfoliative 37.32 15.53 29 24291 10800 79709268
Acquired immunodeficiency syndrome 36.81 15.53 10 24310 297 79719771
Cholestasis 35.64 15.53 60 24260 52049 79668019
HIV lipodystrophy 35.06 15.53 6 24314 15 79720053
Blood creatine phosphokinase increased 34.89 15.53 68 24252 66022 79654046
Anxiety 34.74 15.53 159 24161 248353 79471715
Genital herpes simplex 34.62 15.53 10 24310 373 79719695
Mycoplasma genitalium infection 34.26 15.53 6 24314 18 79720050
Back pain 33.79 15.53 26 24294 304154 79415914
Drug-induced liver injury 33.66 15.53 67 24253 66050 79654018
White matter lesion 33.49 15.53 15 24305 2007 79718061
Progressive multifocal leukoencephalopathy 33.15 15.53 36 24284 20564 79699504
Liver transplant 32.61 15.53 19 24301 4404 79715664
Cachexia 32.50 15.53 27 24293 11056 79709012
Strongyloidiasis 32.11 15.53 18 24302 3880 79716188
Confusional state 31.87 15.53 30 24290 317967 79402101
Sinusitis 31.82 15.53 10 24310 195491 79524577
Fall 31.76 15.53 63 24257 487566 79232502
Renal tubular dysfunction 31.45 15.53 11 24309 766 79719302
Superior mesenteric artery syndrome 31.40 15.53 8 24312 184 79719884
HIV associated nephropathy 31.36 15.53 9 24311 328 79719740
Therapeutic product effect decreased 31.30 15.53 6 24314 163857 79556211
Hepatitis B DNA increased 30.94 15.53 11 24309 804 79719264
Atrial fibrillation 30.68 15.53 11 24309 197875 79522193
Enanthema 30.50 15.53 11 24309 838 79719230
Nasopharyngitis 30.42 15.53 20 24300 253861 79466207
Drug intolerance 30.07 15.53 22 24298 264097 79455971
Antiviral drug level below therapeutic 29.87 15.53 6 24314 44 79720024
Foetal growth restriction 29.71 15.53 14 24306 2105 79717963
Contraindicated product administered 29.60 15.53 6 24314 157532 79562536
Pain in extremity 29.38 15.53 41 24279 364497 79355571
Mycobacterium avium complex infection 29.34 15.53 18 24302 4582 79715486
Pre-eclampsia 29.04 15.53 21 24299 7020 79713048
Acquired gene mutation 29.01 15.53 14 24306 2219 79717849
Anogenital dysplasia 28.89 15.53 7 24313 130 79719938
Drug ineffective 28.56 15.53 203 24117 1080710 78639358
Adrenal suppression 28.47 15.53 12 24308 1387 79718681
Arthralgia 28.47 15.53 85 24235 571718 79148350
Hypotension 27.71 15.53 58 24262 440259 79279809
Hepatic failure 27.59 15.53 59 24261 61153 79658915
Contusion 27.27 15.53 6 24314 148770 79571298
Congenital intestinal malformation 27.24 15.53 5 24315 21 79720047
Jaundice 27.08 15.53 54 24266 53295 79666773
Alopecia 26.68 15.53 19 24301 231336 79488732
Erosive duodenitis 26.68 15.53 13 24307 2104 79717964
Chest discomfort 26.48 15.53 5 24315 138039 79582029
Injection site pain 26.45 15.53 4 24316 129834 79590234
Lipohypertrophy 26.41 15.53 10 24310 874 79719194
Lower respiratory tract infection 26.28 15.53 4 24316 129216 79590852
Oxygen saturation decreased 26.24 15.53 4 24316 129043 79591025
Blood pressure increased 26.21 15.53 16 24304 211344 79508724
Toxic skin eruption 25.95 15.53 33 24287 22260 79697808
Lipids abnormal 25.94 15.53 9 24311 612 79719456
Nephrolithiasis 25.93 15.53 53 24267 53238 79666830
Face oedema 25.67 15.53 37 24283 28099 79691969
Eosinophilia 25.59 15.53 48 24272 45297 79674771
HIV viraemia 25.55 15.53 6 24314 97 79719971
Chronic hepatitis C 25.50 15.53 9 24311 644 79719424
Acute hepatitis C 25.45 15.53 7 24313 218 79719850
Therapeutic product effect incomplete 25.38 15.53 6 24314 141639 79578429
Cholestasis of pregnancy 25.28 15.53 10 24310 983 79719085
Retinal toxicity 25.09 15.53 11 24309 1400 79718668
Musculoskeletal stiffness 25.04 15.53 11 24309 174997 79545071
Pneumonia 25.02 15.53 110 24210 660136 79059932
Pancreatitis acute 24.93 15.53 50 24270 49554 79670514
Conductive deafness 24.86 15.53 7 24313 238 79719830
Acute stress disorder 24.77 15.53 8 24312 436 79719632
Nephrocalcinosis 24.43 15.53 11 24309 1491 79718577
Proteinuria 24.35 15.53 39 24281 32463 79687605
Rash maculo-papular 24.08 15.53 53 24267 56025 79664043
Hepatitis fulminant 24.06 15.53 19 24301 7243 79712825
HIV infection 24.05 15.53 10 24310 1117 79718951
COVID-19 24.04 15.53 9 24311 157665 79562403
Hepatic encephalopathy 23.85 15.53 33 24287 24133 79695935
Hepatitis B 23.81 15.53 20 24300 8312 79711756
Anal cancer 23.64 15.53 9 24311 798 79719270
Constipation 23.64 15.53 31 24289 283019 79437049
Single functional kidney 23.62 15.53 7 24313 286 79719782
Tuberculosis 23.48 15.53 26 24294 15172 79704896
Haemolytic anaemia 23.35 15.53 28 24292 17792 79702276
Pancytopenia 23.11 15.53 106 24214 165639 79554429
Fatigue 22.43 15.53 179 24141 929548 78790520
Pancreatitis 22.10 15.53 58 24262 68517 79651551
Choroiditis 22.10 15.53 10 24310 1371 79718697
Systemic lupus erythematosus 21.97 15.53 5 24315 121144 79598924
Osteoporosis 21.95 15.53 50 24270 54062 79666006
Hypertriglyceridaemia 21.79 15.53 23 24297 12717 79707351
Urticaria 21.63 15.53 15 24305 185186 79534882
Dysphagia 21.60 15.53 84 24236 122052 79598016
Abortion spontaneous incomplete 21.57 15.53 4 24316 18 79720050
Hyperlactacidaemia 21.52 15.53 16 24304 5579 79714489
Drug level decreased 21.16 15.53 24 24296 14378 79705690
General physical health deterioration 21.14 15.53 32 24288 275206 79444862
Mycobacterium avium complex immune restoration disease 20.90 15.53 4 24316 22 79720046
Phalangeal hypoplasia 20.61 15.53 4 24316 24 79720044
Viral load decreased 20.47 15.53 4 24316 25 79720043
Osteonecrosis 20.20 15.53 35 24285 31060 79689008
Product size issue 20.19 15.53 8 24312 790 79719278
Asthma 20.11 15.53 8 24312 135087 79584981
Urinary tract inflammation 20.04 15.53 6 24314 254 79719814
Heart rate increased 19.95 15.53 6 24314 120718 79599350
Hepatitis 19.90 15.53 49 24271 55678 79664390
Hepatitis acute 19.68 15.53 24 24296 15518 79704550
Product use issue 19.63 15.53 21 24299 209801 79510267
Malaise 19.53 15.53 80 24240 489789 79230279
Congenital foot malformation 19.49 15.53 4 24316 33 79720035
Chronic kidney disease 19.36 15.53 54 24266 66100 79653968
Brachydactyly 18.99 15.53 4 24316 38 79720030
Renal aplasia 18.93 15.53 5 24315 133 79719935
Swelling 18.85 15.53 23 24297 216688 79503380
Wound 18.79 15.53 6 24314 116173 79603895
Labelled drug-drug interaction issue 18.78 15.53 9 24311 1404 79718664
Incorrect route of product administration 18.50 15.53 36 24284 34893 79685175
Hepatotoxicity 18.18 15.53 45 24275 51307 79668761
Lymphadenopathy 18.15 15.53 46 24274 53201 79666867
Treatment failure 18.11 15.53 101 24219 170385 79549683
Hepatic enzyme decreased 18.02 15.53 5 24315 161 79719907
Blood creatinine increased 17.91 15.53 94 24226 154963 79565105
Renal colic 17.87 15.53 11 24309 2816 79717252
Pneumocystis jirovecii pneumonia 17.83 15.53 34 24286 32474 79687594
Loss of consciousness 17.83 15.53 15 24305 167928 79552140
Glycosuria 17.74 15.53 10 24310 2178 79717890
Congenital central nervous system anomaly 17.70 15.53 4 24316 54 79720014
Blood bilirubin increased 17.39 15.53 52 24268 66180 79653888
Diabetes mellitus 17.34 15.53 58 24262 78332 79641736
Oesophageal carcinoma 17.19 15.53 19 24301 11065 79709003
Impaired healing 17.18 15.53 3 24317 87652 79632416
Nervous system disorder 17.15 15.53 30 24290 26826 79693242
Polyhydramnios 17.11 15.53 9 24311 1711 79718357
Hepatic function abnormal 16.98 15.53 55 24265 73052 79647016
Mobility decreased 16.97 15.53 8 24312 122167 79597901
Stevens-Johnson syndrome 16.79 15.53 37 24283 39129 79680939
Foetal exposure during delivery 16.67 15.53 3 24317 11 79720057
Febrile neutropenia 16.65 15.53 28 24292 230971 79489097
Skin striae 16.32 15.53 9 24311 1879 79718189
Hemiparaesthesia 16.19 15.53 5 24315 235 79719833
Intensive care unit acquired weakness 16.12 15.53 9 24311 1924 79718144
Viral load abnormal 16.00 15.53 4 24316 85 79719983
Plasmablastic lymphoma 15.88 15.53 6 24314 521 79719547
Pericarditis 15.80 15.53 6 24314 104230 79615838
Neuropsychiatric symptoms 15.79 15.53 8 24312 1407 79718661
Product use in unapproved indication 15.59 15.53 130 24190 250229 79469839
Seborrhoeic dermatitis 15.54 15.53 9 24311 2064 79718004

FDA Adverse Event Reporting System (Pediatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Volvulus 41.18 34.23 14 334 59 89385

Pharmacologic Action:

SourceCodeDescription
ATC J05AJ01 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Integrase inhibitors
ATC J05AR16 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HIV infections, combinations
FDA MoA N0000000127 HIV Integrase Inhibitors
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 D019428 HIV Integrase Inhibitors
MeSH PA D019429 Integrase Inhibitors
FDA EPC N0000175887 Human Immunodeficiency Virus Integrase Strand Transfer Inhibitor
CHEBI has role CHEBI:36044 antiviral drugs

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

DiseaseRelationSNOMED_IDDOID
Human immunodeficiency virus infection indication 86406008 DOID:526
Disorder of muscle contraindication 129565002 DOID:423
Rhabdomyolysis contraindication 240131006
Breastfeeding (mother) contraindication 413712001




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.19 acidic
pKa2 10.89 acidic
pKa3 12.18 acidic
pKa4 2.3 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 400MG BASE ISENTRESS MSD SUB MERCK N022145 Oct. 12, 2007 RX TABLET ORAL 8852632 Jan. 28, 2028 TREATMENT OF HIV INFECTION
EQ 400MG BASE ISENTRESS MSD SUB MERCK N022145 Oct. 12, 2007 RX TABLET ORAL 7754731 March 11, 2029 TREATMENT OF HIV INFECTION
EQ 600MG BASE ISENTRESS HD MSD SUB MERCK N022145 May 26, 2017 RX TABLET ORAL 7754731 March 11, 2029 TREATMENT OF HIV INFECTION
EQ 100MG BASE ISENTRESS MSD SUB MERCK N203045 Dec. 21, 2011 RX TABLET, CHEWABLE ORAL 7754731 March 11, 2029 TREATMENT OF HIV INFECTION
EQ 25MG BASE ISENTRESS MSD SUB MERCK N203045 Dec. 21, 2011 RX TABLET, CHEWABLE ORAL 7754731 March 11, 2029 TREATMENT OF HIV INFECTION
EQ 100MG BASE/PACKET ISENTRESS MSD SUB MERCK N205786 Dec. 20, 2013 RX POWDER ORAL 7754731 March 11, 2029 TREATMENT OF HIV INFECTION
150MG;EQ 300MG BASE DUTREBIS MERCK SHARP DOHME N206510 Feb. 6, 2015 DISCN TABLET ORAL 7754731 March 11, 2029 TREATMENT OF HIV-1 INFECTION
EQ 400MG BASE ISENTRESS MSD SUB MERCK N022145 Oct. 12, 2007 RX TABLET ORAL 8771733 June 2, 2030 TREATMENT OF HIV INFECTION
EQ 600MG BASE ISENTRESS HD MSD SUB MERCK N022145 May 26, 2017 RX TABLET ORAL 8771733 June 2, 2030 TREATMENT OF HIV INFECTION
EQ 100MG BASE ISENTRESS MSD SUB MERCK N203045 Dec. 21, 2011 RX TABLET, CHEWABLE ORAL 8771733 June 2, 2030 TREATMENT OF HIV INFECTION
EQ 600MG BASE ISENTRESS HD MSD SUB MERCK N022145 May 26, 2017 RX TABLET ORAL 10772888 March 30, 2032 TREATMENT OF HIV-1 INFECTION

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
C-C chemokine receptor type 1 GPCR Ki 8.30 CHEMBL
Integrase Enzyme INHIBITOR IC50 8 CHEMBL CHEMBL
Gag-Pol polyprotein Polyprotein INHIBITOR IC50 7.52 WOMBAT-PK
Integrase Enzyme IC50 5.74 CHEMBL

External reference:

IDSource
D06676 KEGG_DRUG
871038-72-1 SECONDARY_CAS_RN
4026736 VANDF
C1966407 UMLSCUI
CHEBI:82960 CHEBI
RLT PDB_CHEM_ID
CHEMBL254316 ChEMBL_ID
CHEMBL518520 ChEMBL_ID
D000068898 MESH_DESCRIPTOR_UI
DB06817 DRUGBANK_ID
11571 IUPHAR_LIGAND_ID
8842 INN_ID
22VKV8053U UNII
54671008 PUBCHEM_CID
1235585 RXNORM
121359 MMSL
24597 MMSL
31069 MMSL
d07048 MMSL
012364 NDDF
012365 NDDF
1149432009 SNOMEDCT_US
429368003 SNOMEDCT_US
429707008 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
ISENTRESS HUMAN PRESCRIPTION DRUG LABEL 1 0006-0227 TABLET, FILM COATED 400 mg ORAL NDA 30 sections
ISENTRESS HUMAN PRESCRIPTION DRUG LABEL 1 0006-0227 TABLET, FILM COATED 400 mg ORAL NDA 30 sections
ISENTRESS HUMAN PRESCRIPTION DRUG LABEL 1 0006-0227 TABLET, FILM COATED 400 mg ORAL NDA 30 sections
ISENTRESS HUMAN PRESCRIPTION DRUG LABEL 1 0006-0473 TABLET, CHEWABLE 25 mg ORAL NDA 30 sections
ISENTRESS HUMAN PRESCRIPTION DRUG LABEL 1 0006-0473 TABLET, CHEWABLE 25 mg ORAL NDA 30 sections
ISENTRESS HUMAN PRESCRIPTION DRUG LABEL 1 0006-0473 TABLET, CHEWABLE 25 mg ORAL NDA 30 sections
ISENTRESS HUMAN PRESCRIPTION DRUG LABEL 1 0006-0477 TABLET, CHEWABLE 100 mg ORAL NDA 30 sections
ISENTRESS HUMAN PRESCRIPTION DRUG LABEL 1 0006-0477 TABLET, CHEWABLE 100 mg ORAL NDA 30 sections
ISENTRESS HUMAN PRESCRIPTION DRUG LABEL 1 0006-0477 TABLET, CHEWABLE 100 mg ORAL NDA 30 sections
ISENTRESS HUMAN PRESCRIPTION DRUG LABEL 1 0006-3080 TABLET, FILM COATED 600 mg ORAL NDA 30 sections
ISENTRESS HUMAN PRESCRIPTION DRUG LABEL 1 0006-3080 TABLET, FILM COATED 600 mg ORAL NDA 30 sections
ISENTRESS HUMAN PRESCRIPTION DRUG LABEL 1 0006-3080 TABLET, FILM COATED 600 mg ORAL NDA 30 sections
ISENTRESS HUMAN PRESCRIPTION DRUG LABEL 1 0006-3603 GRANULE, FOR SUSPENSION 100 mg ORAL NDA 30 sections
ISENTRESS HUMAN PRESCRIPTION DRUG LABEL 1 0006-3603 GRANULE, FOR SUSPENSION 100 mg ORAL NDA 30 sections
ISENTRESS HUMAN PRESCRIPTION DRUG LABEL 1 0006-3603 GRANULE, FOR SUSPENSION 100 mg ORAL NDA 30 sections
ISENTRESS HUMAN PRESCRIPTION DRUG LABEL 1 50090-1085 TABLET, FILM COATED 400 mg ORAL NDA 30 sections
ISENTRESS HUMAN PRESCRIPTION DRUG LABEL 1 50090-1085 TABLET, FILM COATED 400 mg ORAL NDA 30 sections
ISENTRESS HUMAN PRESCRIPTION DRUG LABEL 1 53002-1686 TABLET, FILM COATED 400 mg ORAL NDA 29 sections
ISENTRESS HUMAN PRESCRIPTION DRUG LABEL 1 53808-0650 TABLET, FILM COATED 400 mg ORAL NDA 28 sections
ISENTRESS HUMAN PRESCRIPTION DRUG LABEL 1 54868-0117 TABLET, FILM COATED 400 mg ORAL NDA 30 sections
ISENTRESS HUMAN PRESCRIPTION DRUG LABEL 1 61919-706 TABLET, FILM COATED 400 mg ORAL NDA 17 sections
ISENTRESS HUMAN PRESCRIPTION DRUG LABEL 1 61919-706 TABLET, FILM COATED 400 mg ORAL NDA 17 sections
ISENTRESS HUMAN PRESCRIPTION DRUG LABEL 1 66336-214 TABLET, FILM COATED 400 mg ORAL NDA 30 sections
ISENTRESS HUMAN PRESCRIPTION DRUG LABEL 1 67296-1235 TABLET, FILM COATED 400 mg ORAL NDA 18 sections
ISENTRESS HUMAN PRESCRIPTION DRUG LABEL 1 67296-1235 TABLET, FILM COATED 400 mg ORAL NDA 18 sections
ISENTRESS HUMAN PRESCRIPTION DRUG LABEL 1 68071-2113 TABLET, FILM COATED 400 mg ORAL NDA 29 sections
ISENTRESS HUMAN PRESCRIPTION DRUG LABEL 1 68071-2113 TABLET, FILM COATED 400 mg ORAL NDA 29 sections
ISENTRESS HUMAN PRESCRIPTION DRUG LABEL 1 70518-1621 TABLET, FILM COATED 400 mg ORAL NDA 30 sections
ISENTRESS HUMAN PRESCRIPTION DRUG LABEL 1 71205-777 TABLET, FILM COATED 400 mg ORAL NDA 30 sections
ISENTRESS HUMAN PRESCRIPTION DRUG LABEL 1 76519-1130 TABLET, FILM COATED 400 mg ORAL NDA 17 sections