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

Stem definitionDrug idCAS RN
antivirals 1904 129618-40-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • nevirapine hemihydrate
  • nevirapine
  • viramune
  • nevarapine
A potent, non-nucleoside reverse transcriptase inhibitor used in combination with nucleoside analogues for treatment of HIV INFECTIONS and AIDS.
  • Molecular weight: 266.30
  • Formula: C15H14N4O
  • CLOGP: 2.72
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 1
  • TPSA: 58.12
  • ALOGS: -3.41
  • ROTB: 1
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.40 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.10 mg/mL Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 21.46 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 93 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 1.30 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 0.30 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.32 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 53 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
June 21, 1996 FDA BOEHRINGER INGELHEIM

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
Drug resistance 712.96 29.16 220 8696 20322 56262829
Viral mutation identified 673.50 29.16 130 8786 1584 56281567
Exposure during pregnancy 630.16 29.16 342 8574 136000 56147151
Stillbirth 566.09 29.16 142 8774 6072 56277079
Virologic failure 550.66 29.16 110 8806 1616 56281535
Abortion spontaneous 543.25 29.16 218 8698 43535 56239616
Foetal exposure during pregnancy 452.64 29.16 178 8738 33645 56249506
Pregnancy 313.26 29.16 136 8780 32897 56250254
Pathogen resistance 293.81 29.16 84 8832 5916 56277235
Caesarean section 248.15 29.16 94 8822 15997 56267154
Stevens-Johnson syndrome 240.17 29.16 101 8815 22562 56260589
Abortion induced 234.58 29.16 79 8837 9566 56273585
Premature baby 201.49 29.16 85 8831 19120 56264031
Lipodystrophy acquired 201.17 29.16 46 8870 1311 56281840
Maternal exposure during pregnancy 199.53 29.16 194 8722 189359 56093792
Immune reconstitution inflammatory syndrome 184.78 29.16 58 8858 5616 56277535
Acquired gene mutation 125.76 29.16 29 8887 858 56282293
Portal hypertension 122.84 29.16 38 8878 3503 56279648
Viral load increased 120.78 29.16 30 8886 1224 56281927
Maternal drugs affecting foetus 117.04 29.16 40 8876 5053 56278098
Ventricular septal defect 108.94 29.16 36 8880 4102 56279049
Foetal death 100.10 29.16 41 8875 8546 56274605
Supernumerary nipple 94.75 29.16 15 8901 48 56283103
Rash maculo-papular 91.47 29.16 57 8859 28850 56254301
Acoustic stimulation tests abnormal 88.44 29.16 15 8901 81 56283070
Congenital naevus 84.80 29.16 16 8900 170 56282981
Amniotic cavity infection 82.42 29.16 22 8894 1196 56281955
Postpartum sepsis 81.85 29.16 11 8905 4 56283147
Blood HIV RNA increased 81.40 29.16 19 8897 593 56282558
Immune reconstitution inflammatory syndrome associated tuberculosis 79.15 29.16 17 8899 360 56282791
Low set ears 78.85 29.16 16 8900 254 56282897
CD4 lymphocytes decreased 75.19 29.16 21 8895 1354 56281797
Premature delivery 74.79 29.16 49 8867 27011 56256140
Toxic epidermal necrolysis 71.08 29.16 44 8872 21998 56261153
Malaria 70.12 29.16 14 8902 204 56282947
Conjunctivalisation 69.76 29.16 9 8907 0 56283151
Pain 67.50 29.16 12 8904 663172 55619979
Mitochondrial toxicity 67.12 29.16 15 8901 384 56282767
Drug ineffective 64.30 29.16 33 8883 918956 55364195
Premature rupture of membranes 63.30 29.16 25 8891 4740 56278411
Hyperlactacidaemia 62.10 29.16 21 8895 2567 56280584
Low birth weight baby 59.97 29.16 26 8890 6232 56276919
Hepatitis 58.58 29.16 47 8869 35394 56247757
Pre-eclampsia 58.41 29.16 28 8888 8458 56274693
Hemivertebra 58.20 29.16 11 8905 118 56283033
Live birth 57.85 29.16 37 8879 19568 56263583
Premature labour 57.78 29.16 31 8885 11851 56271300
Premature separation of placenta 57.32 29.16 18 8898 1742 56281409
Foetal growth restriction 56.82 29.16 26 8890 7073 56276078
Placental disorder 56.39 29.16 17 8899 1436 56281715
Hypertriglyceridaemia 55.20 29.16 24 8892 5792 56277359
Alanine aminotransferase increased 55.18 29.16 71 8845 93591 56189560
HIV infection 54.65 29.16 13 8903 441 56282710
Lactic acidosis 54.47 29.16 45 8871 35301 56247850
Uveal prolapse 54.26 29.16 7 8909 0 56283151
Eyelid scar 54.26 29.16 7 8909 0 56283151
Blood lactic acid increased 54.23 29.16 24 8892 6040 56277111
Hydrops foetalis 53.98 29.16 13 8903 465 56282686
Hepatomegaly 53.66 29.16 29 8887 11246 56271905
Nephropathy toxic 52.28 29.16 26 8890 8501 56274650
Hepatotoxicity 50.82 29.16 41 8875 31112 56252039
Hepatic cytolysis 48.99 29.16 27 8889 10879 56272272
Eyelid oedema 48.95 29.16 26 8890 9742 56273409
Lipoatrophy 48.45 29.16 11 8905 303 56282848
Varices oesophageal 48.41 29.16 18 8898 2898 56280253
Oligohydramnios 48.12 29.16 22 8894 5972 56277179
Congenital choroid plexus cyst 48.07 29.16 11 8905 314 56282837
Neural tube defect 47.59 29.16 10 8906 190 56282961
Drug reaction with eosinophilia and systemic symptoms 47.57 29.16 39 8877 30265 56252886
Neonatal disorder 46.94 29.16 12 8904 550 56282601
Retinoblastoma 46.39 29.16 9 8907 112 56283039
Mitochondrial cytopathy 45.98 29.16 10 8906 225 56282926
Fat tissue increased 45.87 29.16 12 8904 603 56282548
Anaemia 45.55 29.16 118 8798 267393 56015758
Acute HIV infection 44.07 29.16 6 8910 3 56283148
Ulcerative keratitis 43.88 29.16 16 8900 2439 56280712
Fatigue 43.32 29.16 37 8879 788515 55494636
Neutropenia neonatal 43.21 29.16 8 8908 76 56283075
Jaundice 42.57 29.16 35 8881 27259 56255892
Pyrexia 42.48 29.16 154 8762 418619 55864532
Pulmonary tuberculosis 40.94 29.16 18 8898 4458 56278693
Normal newborn 40.61 29.16 21 8895 7449 56275702
Developmental delay 40.41 29.16 13 8903 1359 56281792
Off label use 40.22 29.16 19 8897 556161 55726990
Left ventricular dilatation 38.85 29.16 10 8906 471 56282680
Congenital anomaly 38.40 29.16 13 8903 1594 56281557
CD4 lymphocytes increased 38.32 29.16 8 8908 147 56283004
Spinocerebellar disorder 38.19 29.16 6 8910 18 56283133
Atrial septal defect 37.42 29.16 19 8897 6487 56276664
Proteinuria 37.17 29.16 27 8889 17543 56265608
Portal vein thrombosis 36.75 29.16 14 8902 2409 56280742
Gamma-glutamyltransferase increased 36.75 29.16 34 8882 30971 56252180
Aspartate aminotransferase increased 35.73 29.16 54 8862 82548 56200603
Fall 35.13 29.16 7 8909 357503 55925648
HIV antibody positive 34.81 29.16 5 8911 6 56283145
Nodular regenerative hyperplasia 34.39 29.16 9 8907 453 56282698
Astrocytoma malignant 34.16 29.16 6 8910 41 56283110
Eosinophilia 33.96 29.16 27 8889 20050 56263101
Hereditary optic atrophy 33.61 29.16 5 8911 9 56283142
Arthralgia 33.48 29.16 19 8897 501650 55781501
Encephalocele 33.41 29.16 7 8909 131 56283020
Porphyria non-acute 33.09 29.16 8 8908 291 56282860
Foetal distress syndrome 33.06 29.16 11 8905 1279 56281872
Polydactyly 32.77 29.16 8 8908 303 56282848
Alopecia 32.77 29.16 4 8912 293454 55989697
Human immunodeficiency virus transmission 32.70 29.16 6 8910 54 56283097
Neonatal hepatomegaly 32.64 29.16 5 8911 12 56283139
Skin toxicity 32.57 29.16 15 8901 4138 56279013
Genotype drug resistance test positive 31.35 29.16 8 8908 364 56282787
Fallot's tetralogy 30.61 29.16 6 8910 79 56283072
Tuberculosis 30.52 29.16 20 8896 11009 56272142
Breast disorder 30.01 29.16 12 8904 2347 56280804
Hepatic displacement 29.48 29.16 5 8911 27 56283124
Spina bifida 29.41 29.16 9 8907 799 56282352

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
Lipodystrophy acquired 780.20 19.20 189 10851 3075 31683229
Foetal exposure during pregnancy 726.08 19.20 330 10710 40546 31645758
Mitochondrial toxicity 619.95 19.20 150 10890 2423 31683881
Virologic failure 511.16 19.20 134 10906 3031 31683273
Eyelid ptosis 503.84 19.20 149 10891 5306 31680998
Viral mutation identified 465.29 19.20 121 10919 2648 31683656
Diplopia 354.45 19.20 146 10894 14016 31672288
Progressive external ophthalmoplegia 329.14 19.20 80 10960 1314 31684990
Drug resistance 272.47 19.20 142 10898 23311 31662993
Exposure during pregnancy 268.41 19.20 104 10936 8494 31677810
Pathogen resistance 263.66 19.20 103 10937 8598 31677706
Dandy-Walker syndrome 256.83 19.20 47 10993 164 31686140
Speech disorder developmental 205.57 19.20 60 10980 2031 31684273
Developmental delay 200.99 19.20 62 10978 2543 31683761
Pinealoblastoma 172.63 19.20 33 11007 154 31686150
Premature baby 164.11 19.20 93 10947 17973 31668331
Volvulus 150.92 19.20 42 10998 1193 31685111
Polydactyly 147.72 19.20 41 10999 1153 31685151
Immune reconstitution inflammatory syndrome 147.62 19.20 67 10973 8111 31678193
Trisomy 21 141.12 19.20 34 11006 536 31685768
Congenital central nervous system anomaly 138.19 19.20 33 11007 500 31685804
Stevens-Johnson syndrome 120.07 19.20 75 10965 17297 31669007
Ophthalmoplegia 115.22 19.20 37 11003 1731 31684573
Neurodevelopmental disorder 108.80 19.20 26 11014 395 31685909
Macrocephaly 105.41 19.20 26 11014 454 31685850
Vanishing bile duct syndrome 89.26 19.20 24 11016 597 31685707
Portal hypertension 84.99 19.20 36 11004 3689 31682615
Brachydactyly 81.98 19.20 18 11022 183 31686121
Blood lactic acid increased 76.50 19.20 39 11001 6091 31680213
Attention deficit hyperactivity disorder 74.75 19.20 29 11011 2369 31683935
Acquired gene mutation 71.41 19.20 24 11016 1296 31685008
Nodular regenerative hyperplasia 70.64 19.20 22 11018 930 31685374
Caesarean section 66.03 19.20 25 11015 1911 31684393
Neonatal disorder 65.62 19.20 20 11020 786 31685518
Maternal drugs affecting foetus 64.22 19.20 30 11010 3873 31682431
Atrioventricular septal defect 63.84 19.20 15 11025 211 31686093
Small for dates baby 62.96 19.20 29 11011 3626 31682678
Gene mutation 62.07 19.20 21 11019 1157 31685147
Off label use 61.91 19.20 22 11018 347252 31339052
Multiple-drug resistance 60.29 19.20 30 11010 4450 31681854
Hypertriglyceridaemia 59.80 19.20 36 11004 7762 31678542
Viral load increased 59.57 19.20 24 11016 2165 31684139
Product residue present 58.61 19.20 25 11015 2605 31683699
Lipoatrophy 56.77 19.20 16 11024 476 31685828
Ventricular septal defect 56.62 19.20 27 11013 3650 31682654
Osteonecrosis 55.86 19.20 43 10997 13841 31672463
Congenital neoplasm 55.78 19.20 10 11030 30 31686274
HIV infection 55.54 19.20 21 11019 1599 31684705
Dyslipidaemia 55.49 19.20 32 11008 6374 31679930
Drug ineffective 55.30 19.20 35 11005 395538 31290766
Conjunctivalisation 48.74 19.20 7 11033 0 31686304
Fall 47.17 19.20 5 11035 186084 31500220
Blood HIV RNA increased 47.12 19.20 17 11023 1134 31685170
Varices oesophageal 46.65 19.20 23 11017 3343 31682961
Low birth weight baby 45.39 19.20 29 11011 6941 31679363
Mitochondrial myopathy 44.49 19.20 11 11029 194 31686110
Laryngomalacia 44.08 19.20 12 11028 313 31685991
Toxic epidermal necrolysis 43.16 19.20 43 10997 19481 31666823
Nephropathy toxic 43.15 19.20 34 11006 11319 31674985
Fanconi syndrome acquired 42.32 19.20 18 11022 1862 31684442
Hepatotoxicity 42.05 19.20 42 10998 19084 31667220
Speech disorder 40.55 19.20 46 10994 24155 31662149
HIV peripheral neuropathy 37.29 19.20 7 11033 29 31686275
Osteoporosis 36.28 19.20 31 11009 11552 31674752
Cerebellar hypoplasia 35.90 19.20 6 11034 10 31686294
Congenital umbilical hernia 35.79 19.20 10 11030 288 31686016
Ataxia 35.43 19.20 32 11008 12831 31673473
Hypotension 34.63 19.20 14 11026 204604 31481700
Portal vein thrombosis 34.38 19.20 19 11021 3488 31682816
Osteoporotic fracture 33.86 19.20 13 11027 1032 31685272
Treatment failure 33.73 19.20 55 10985 40737 31645567
Pneumonia 33.13 19.20 41 10999 335271 31351033
Bone metabolism disorder 32.91 19.20 9 11031 239 31686065
Blood triglycerides abnormal 32.73 19.20 9 11031 244 31686060
Hepatitis 32.08 19.20 39 11001 22027 31664277
Dysphagia 31.51 19.20 65 10975 57611 31628693
Hydrops foetalis 31.46 19.20 10 11030 452 31685852
Human immunodeficiency virus transmission 31.38 19.20 6 11034 28 31686276
Gamma-glutamyltransferase increased 30.81 19.20 43 10997 27782 31658522
Death neonatal 29.87 19.20 9 11031 340 31685964
Constipation 29.74 19.20 4 11036 123987 31562317
Pain 29.66 19.20 14 11026 186745 31499559
Meningitis cryptococcal 29.62 19.20 15 11025 2308 31683996
Pre-eclampsia 29.19 19.20 6 11034 43 31686261
Hepatomegaly 28.77 19.20 25 11015 9525 31676779
Low set ears 27.52 19.20 9 11031 446 31685858
Congenital anomaly 27.48 19.20 12 11028 1323 31684981
Alanine aminotransferase increased 27.43 19.20 72 10968 74584 31611720
Hepatic cirrhosis 26.60 19.20 30 11010 15644 31670660
Anaemia macrocytic 26.49 19.20 15 11025 2885 31683419
Rash 25.71 19.20 138 10902 201348 31484956
Protrusion tongue 25.70 19.20 7 11033 183 31686121
Aspartate aminotransferase increased 25.65 19.20 63 10977 62656 31623648
Tuberculosis 25.46 19.20 22 11018 8319 31677985
Congenital nose malformation 25.27 19.20 7 11033 195 31686109
Kaposi's sarcoma 25.14 19.20 10 11030 872 31685432
Blindness 24.75 19.20 26 11014 12525 31673779
Meconium ileus 24.69 19.20 5 11035 33 31686271
Hyperlactacidaemia 24.52 19.20 14 11026 2736 31683568
Liver function test abnormal 24.49 19.20 40 11000 29652 31656652
Syphilis 24.39 19.20 8 11032 400 31685904
Synostosis 24.36 19.20 6 11034 104 31686200
Product use in unapproved indication 24.26 19.20 3 11037 99168 31587136
Hepatic steatosis 24.08 19.20 29 11011 16210 31670094
Oral candidiasis 23.75 19.20 24 11016 11053 31675251
Aplasia cutis congenita 23.60 19.20 6 11034 119 31686185
Optic nerve cupping 23.52 19.20 5 11035 43 31686261
Loss of anatomical alignment after fracture reduction 23.46 19.20 4 11036 8 31686296
Subchondral insufficiency fracture 23.46 19.20 4 11036 8 31686296
Molluscum contagiosum 23.04 19.20 7 11033 272 31686032
Febrile neutropenia 22.88 19.20 7 11033 121842 31564462
Dyspnoea 22.88 19.20 54 10986 343425 31342879
Acquired immunodeficiency syndrome 22.75 19.20 8 11032 495 31685809
Anaemia neonatal 22.63 19.20 7 11033 289 31686015
Fracture malunion 22.57 19.20 4 11036 11 31686293
Glycosuria 22.17 19.20 10 11030 1190 31685114
Hepatitis cholestatic 22.12 19.20 19 11021 7127 31679177
Proteinuria 21.76 19.20 28 11012 16735 31669569
Acute HIV infection 21.50 19.20 5 11035 67 31686237
Umbilical hernia 21.34 19.20 15 11025 4199 31682105
Blood insulin increased 21.30 19.20 7 11033 352 31685952
Hypersplenism 21.06 19.20 7 11033 365 31685939
Hyperplasia adrenal 20.89 19.20 3 11037 0 31686304
Primary syphilis 20.86 19.20 4 11036 19 31686285
Elbow synostosis 20.69 19.20 4 11036 20 31686284
Chronic hepatitis C 20.63 19.20 7 11033 389 31685915
Atrial fibrillation 20.54 19.20 7 11033 113776 31572528
Embolism venous 20.52 19.20 10 11030 1417 31684887
Hepatic failure 20.43 19.20 39 11001 32663 31653641
Neutropenia neonatal 20.39 19.20 8 11032 673 31685631
Hypercholesterolaemia 20.21 19.20 19 11021 8011 31678293
CD4 lymphocytes increased 20.16 19.20 6 11034 217 31686087
Congenital tuberculosis 20.08 19.20 4 11036 24 31686280
Product dose omission issue 19.94 19.20 6 11034 105580 31580724
Pulmonary tuberculosis 19.84 19.20 15 11025 4696 31681608
Lactic acidosis 19.84 19.20 38 11002 31899 31654405
Congenital cytomegalovirus infection 19.80 19.20 4 11036 26 31686278
Cleft lip and palate 19.34 19.20 7 11033 471 31685833
Retinoblastoma 19.30 19.20 4 11036 30 31686274
Disease progression 19.29 19.20 4 11036 90460 31595844

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
Lipodystrophy acquired 1039.69 20.07 225 13646 3991 70910582
Virologic failure 791.29 20.07 177 13694 3673 70910900
Mitochondrial toxicity 777.73 20.07 166 13705 2744 70911829
Viral mutation identified 714.26 20.07 161 13710 3461 70911112
Drug resistance 647.90 20.07 253 13618 37937 70876636
Eyelid ptosis 493.57 20.07 148 13723 9954 70904619
Abortion spontaneous 472.14 20.07 182 13689 26297 70888276
Stillbirth 420.80 20.07 106 13765 3699 70910874
Progressive external ophthalmoplegia 380.16 20.07 81 13790 1323 70913250
Exposure during pregnancy 370.25 20.07 224 13647 87493 70827080
Diplopia 338.81 20.07 146 13725 28001 70886572
Immune reconstitution inflammatory syndrome 334.11 20.07 117 13754 12873 70901700
Pathogen resistance 327.78 20.07 116 13755 13163 70901410
Stevens-Johnson syndrome 304.77 20.07 146 13725 35761 70878812
Abortion induced 222.78 20.07 73 13798 6552 70908021
Pregnancy 214.88 20.07 101 13770 23680 70890893
Acquired gene mutation 205.15 20.07 53 13818 2045 70912528
Portal hypertension 188.30 20.07 64 13807 6428 70908145
Foetal exposure during pregnancy 184.96 20.07 61 13810 5584 70908989
Caesarean section 175.89 20.07 71 13800 11536 70903037
Viral load increased 151.91 20.07 44 13827 2612 70911961
Maternal exposure during pregnancy 138.64 20.07 140 13731 115205 70799368
Maternal drugs affecting foetus 124.84 20.07 34 13837 1610 70912963
Ophthalmoplegia 115.09 20.07 36 13835 2779 70911794
Conjunctivalisation 113.51 20.07 16 13855 9 70914564
Toxic epidermal necrolysis 103.27 20.07 75 13796 39482 70875091
Nephropathy toxic 98.35 20.07 55 13816 18459 70896114
Vanishing bile duct syndrome 93.45 20.07 26 13845 1333 70913240
Lipoatrophy 86.49 20.07 21 13850 626 70913947
Hepatotoxicity 79.26 20.07 67 13804 43919 70870654
Dyslipidaemia 77.25 20.07 38 13833 9822 70904751
Blood HIV RNA increased 75.81 20.07 23 13848 1603 70912970
Product residue present 73.93 20.07 27 13844 3343 70911230
Postpartum sepsis 72.04 20.07 10 13861 4 70914569
Pulmonary tuberculosis 69.83 20.07 33 13838 7812 70906761
Premature delivery 68.70 20.07 46 13825 21258 70893315
Proteinuria 68.38 20.07 52 13819 29322 70885251
Ulcerative keratitis 66.89 20.07 25 13846 3302 70911271
HIV infection 65.87 20.07 20 13851 1397 70913176
Fat tissue increased 65.82 20.07 18 13853 865 70913708
CD4 lymphocytes decreased 65.63 20.07 23 13848 2528 70912045
Pain 65.23 20.07 21 13850 628795 70285778
Blood lactic acid increased 64.30 20.07 35 13836 11138 70903435
Hepatomegaly 64.30 20.07 41 13830 17451 70897122
Hepatitis 64.27 20.07 63 13808 49917 70864656
Retinoblastoma 63.81 20.07 12 13859 99 70914474
Nodular regenerative hyperplasia 63.33 20.07 19 13852 1274 70913299
Alanine aminotransferase increased 62.34 20.07 107 13764 147373 70767200
Varices oesophageal 61.51 20.07 27 13844 5390 70909183
Off label use 59.52 20.07 36 13835 743024 70171549
Drug ineffective 59.47 20.07 58 13813 939694 69974879
Tuberculosis 57.57 20.07 36 13835 14812 70899761
Gamma-glutamyltransferase increased 56.24 20.07 59 13812 50626 70863947
Fall 55.45 20.07 10 13861 444086 70470487
Premature baby 55.42 20.07 22 13849 3417 70911156
Foetal death 54.78 20.07 26 13845 6213 70908360
Multiple-drug resistance 53.64 20.07 27 13844 7328 70907245
Immune reconstitution inflammatory syndrome associated tuberculosis 53.06 20.07 15 13856 815 70913758
Uveal prolapse 52.78 20.07 7 13864 0 70914573
Eyelid scar 52.78 20.07 7 13864 0 70914573
Rash maculo-papular 51.09 20.07 56 13815 50489 70864084
Pre-eclampsia 50.82 20.07 25 13846 6460 70908113
Acute HIV infection 49.81 20.07 9 13862 58 70914515
Hepatic cirrhosis 49.66 20.07 44 13827 30687 70883886
Osteonecrosis 49.63 20.07 43 13828 29117 70885456
Meningitis cryptococcal 49.17 20.07 20 13851 3308 70911265
Malaria 48.72 20.07 12 13859 380 70914193
Mitochondrial cytopathy 48.69 20.07 12 13859 381 70914192
Placental disorder 47.61 20.07 14 13857 876 70913697
Pyrexia 47.50 20.07 239 13632 606713 70307860
Aspartate aminotransferase increased 47.05 20.07 87 13784 126891 70787682
Mitochondrial myopathy 46.97 20.07 11 13860 280 70914293
Glycosuria 46.44 20.07 17 13854 2118 70912455
Jaundice 46.33 20.07 53 13818 50055 70864518
Oligohydramnios 46.26 20.07 19 13852 3221 70911352
Dandy-Walker syndrome 45.20 20.07 8 13863 45 70914528
Blindness 45.19 20.07 37 13834 23190 70891383
Fanconi syndrome acquired 43.65 20.07 17 13854 2510 70912063
Portal vein thrombosis 43.00 20.07 21 13850 5341 70909232
Pinealoblastoma 42.65 20.07 8 13863 65 70914508
Hepatic cytolysis 42.52 20.07 33 13838 19159 70895414
Anaemia 42.05 20.07 173 13698 403250 70511323
HIV peripheral neuropathy 40.25 20.07 7 13864 35 70914538
Drug reaction with eosinophilia and systemic symptoms 40.11 20.07 53 13818 57960 70856613
Rheumatoid arthritis 39.99 20.07 5 13866 291800 70622773
Eyelid oedema 39.88 20.07 27 13844 12700 70901873
Normal newborn 39.80 20.07 21 13850 6279 70908294
Hepatic failure 38.85 20.07 52 13819 57573 70857000
Joint swelling 38.19 20.07 3 13868 253208 70661365
Live birth 37.94 20.07 27 13844 13752 70900821
Hypercholesterolaemia 37.66 20.07 30 13841 18087 70896486
Congenital anomaly 36.12 20.07 9 13862 299 70914274
Genotype drug resistance test positive 35.49 20.07 12 13859 1184 70913389
Dysphagia 35.31 20.07 72 13799 112762 70801811
Premature labour 35.11 20.07 21 13850 7979 70906594
Hepatic steatosis 35.10 20.07 38 13833 33775 70880798
Hypertriglyceridaemia 34.51 20.07 24 13847 11787 70902786
Neutropenia neonatal 34.02 20.07 6 13865 33 70914540
Lactic acidosis 34.01 20.07 52 13819 64972 70849601
Fatigue 33.96 20.07 69 13802 824250 70090323
Blood triglycerides abnormal 33.10 20.07 9 13862 423 70914150
Osteoporosis 32.76 20.07 44 13827 48863 70865710
Hyperlactacidaemia 32.30 20.07 17 13854 5055 70909518
Ventricular septal defect 31.96 20.07 9 13862 482 70914091
Bone metabolism disorder 31.89 20.07 9 13862 486 70914087
Hypotension 31.71 20.07 20 13851 404361 70510212
Amniotic cavity infection 31.58 20.07 10 13861 803 70913770
Treatment noncompliance 31.34 20.07 42 13829 46532 70868041
Completed suicide 30.85 20.07 4 13867 227131 70687442
Nasopharyngitis 29.97 20.07 4 13867 222202 70692371
Conjunctival hyperaemia 29.77 20.07 15 13856 4078 70910495
Speech disorder developmental 29.70 20.07 9 13862 624 70913949
Placental insufficiency 28.87 20.07 10 13861 1061 70913512
Anaemia neonatal 28.75 20.07 5 13866 25 70914548
Developmental delay 28.63 20.07 10 13861 1088 70913485
Hepatitis cholestatic 28.56 20.07 22 13849 12628 70901945
Spina bifida 28.09 20.07 6 13865 99 70914474
Hydrops foetalis 28.00 20.07 7 13864 236 70914337
Molluscum contagiosum 27.74 20.07 8 13863 467 70914106
Lipase increased 26.99 20.07 23 13848 15223 70899350
Hereditary optic atrophy 26.95 20.07 5 13866 38 70914535
Hyperplasia adrenal 26.95 20.07 5 13866 38 70914535
Toxoplasmosis 26.40 20.07 12 13859 2598 70911975
Abdominal discomfort 26.39 20.07 5 13866 214653 70699920
Blood pressure increased 26.38 20.07 3 13868 188514 70726059
Loss of anatomical alignment after fracture reduction 25.77 20.07 4 13867 8 70914565
Astrocytoma malignant 25.63 20.07 5 13866 51 70914522
Optic nerve cupping 25.63 20.07 5 13866 51 70914522
Drug-induced liver injury 25.38 20.07 42 13829 56071 70858502
Product use in unapproved indication 25.15 20.07 5 13866 207473 70707100
Constipation 25.11 20.07 9 13862 252429 70662144
Osteoporotic fracture 25.00 20.07 13 13858 3771 70910802
Symblepharon 24.48 20.07 6 13865 186 70914387
Peripheral swelling 24.28 20.07 8 13863 236555 70678018
Premature separation of placenta 24.27 20.07 9 13862 1163 70913410
Congestive hepatopathy 24.10 20.07 13 13858 4061 70910512
Lymphadenopathy 24.08 20.07 38 13833 48753 70865820
Meningitis tuberculous 24.08 20.07 9 13862 1188 70913385
Borderline leprosy 23.93 20.07 4 13867 15 70914558
Pneumonia 23.58 20.07 51 13820 596181 70318392
Ultrasound antenatal screen abnormal 23.43 20.07 5 13866 82 70914491
Sinusitis 22.92 20.07 3 13868 169192 70745381
Dyspnoea 22.82 20.07 76 13795 769984 70144589
Splenomegaly 22.79 20.07 23 13848 18847 70895726
Febrile neutropenia 22.62 20.07 6 13865 204312 70710261
Syphilis 22.50 20.07 7 13864 530 70914043
Rash 22.13 20.07 173 13698 510389 70404184
Chronic hepatitis C 21.68 20.07 7 13864 598 70913975
Left ventricular dilatation 21.67 20.07 8 13863 1020 70913553
Alopecia 21.65 20.07 6 13865 198484 70716089
Brachydactyly 21.61 20.07 4 13867 30 70914543
Gene mutation 21.51 20.07 10 13861 2281 70912292
Disseminated tuberculosis 21.28 20.07 12 13859 4088 70910485
Strabismus 21.21 20.07 10 13861 2354 70912219
Transaminases increased 21.00 20.07 35 13836 46983 70867590
Kwashiorkor 20.54 20.07 3 13868 3 70914570
Back pain 20.44 20.07 14 13857 271138 70643435
Liver function test abnormal 20.29 20.07 40 13831 61106 70853467
Congenital retinoblastoma 20.08 20.07 3 13868 4 70914569
Syncope 20.07 20.07 4 13867 165705 70748868

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC J05AG01 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Non-nucleoside reverse transcriptase inhibitors
ATC J05AR05 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HIV infections, combinations
ATC J05AR07 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HIV infections, combinations
FDA MoA N0000009948 Non-Nucleoside Reverse Transcriptase Inhibitors
FDA EXT N0000175460 Non-Nucleoside Analog
FDA EPC N0000175463 Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor
FDA MoA N0000187064 Cytochrome P450 2B6 Inducers
FDA MoA N0000190118 Cytochrome P450 3A Inducers
CHEBI has role CHEBI:36044 antiviral drugs
CHEBI has role CHEBI:53756 reverse transcriptase 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 D065701 Cytochrome P-450 CYP3A Inducers
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D065606 Metabolic Side Effects of Drugs and Substances
MeSH PA D019384 Nucleic Acid Synthesis Inhibitors
MeSH PA D018894 Reverse Transcriptase Inhibitors

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

DiseaseRelationSNOMED_IDDOID
Human immunodeficiency virus infection indication 86406008 DOID:526
Lyell's toxic epidermal necrolysis, subepidermal type contraindication 23067006
Viral hepatitis C contraindication 50711007 DOID:1883
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Chronic type B viral hepatitis contraindication 61977001
Stevens-Johnson syndrome contraindication 73442001 DOID:0050426
Chronic hepatitis C contraindication 128302006
Liver function tests abnormal contraindication 166603001
Disease of liver contraindication 235856003 DOID:409
Drug-induced hepatitis contraindication 235876009
Rhabdomyolysis contraindication 240131006
Eruption of skin contraindication 271807003 DOID:0050486
Breastfeeding (mother) contraindication 413712001
Prevention of HIV Infection after Exposure contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.01 acidic
pKa2 2.45 Basic
pKa3 1.74 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
400MG VIRAMUNE XR BOEHRINGER INGELHEIM N201152 March 25, 2011 RX TABLET, EXTENDED RELEASE ORAL 8460704 March 12, 2029 TREATMENT OF HIV-1 BY ONCE DAILY ADMINISTRATION

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Reverse transcriptase/RNaseH Enzyme INHIBITOR Ki 6.40 CHEMBL CHEMBL
Gag-Pol polyprotein Polyprotein IC50 7.10 WOMBAT-PK
Pol polyprotein Enzyme IC50 7 CHEMBL
Reverse transcriptase Enzyme IC50 6.30 CHEMBL
Reverse transcriptase protein Unclassified Ki 5.40 CHEMBL

External reference:

IDSource
4020991 VUID
N0000148461 NUI
D00435 KEGG_DRUG
220988-26-1 SECONDARY_CAS_RN
4020991 VANDF
C0132326 UMLSCUI
CHEBI:63613 CHEBI
NEV PDB_CHEM_ID
CHEMBL57 ChEMBL_ID
DB00238 DRUGBANK_ID
D019829 MESH_DESCRIPTOR_UI
4463 PUBCHEM_CID
6815 INN_ID
99DK7FVK1H UNII
224890 RXNORM
175112 MMSL
5168 MMSL
6060 MMSL
d04029 MMSL
006062 NDDF
108704001 SNOMEDCT_US
386898005 SNOMEDCT_US
725663003 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Nevirapine HUMAN PRESCRIPTION DRUG LABEL 1 0378-4050 TABLET 200 mg ORAL ANDA 29 sections
Nevirapine HUMAN PRESCRIPTION DRUG LABEL 1 0378-4890 TABLET, EXTENDED RELEASE 400 mg ORAL ANDA 29 sections
Nevirapine HUMAN PRESCRIPTION DRUG LABEL 1 0378-6950 TABLET, EXTENDED RELEASE 100 mg ORAL ANDA 29 sections
Viramune HUMAN PRESCRIPTION DRUG LABEL 1 0597-0046 TABLET 200 mg ORAL NDA 27 sections
Viramune HUMAN PRESCRIPTION DRUG LABEL 1 0597-0046 TABLET 200 mg ORAL NDA 27 sections
Viramune HUMAN PRESCRIPTION DRUG LABEL 1 0597-0047 SUSPENSION 50 mg ORAL NDA 27 sections
Viramune HUMAN PRESCRIPTION DRUG LABEL 1 0597-0047 SUSPENSION 50 mg ORAL NDA 27 sections
Viramune HUMAN PRESCRIPTION DRUG LABEL 1 0597-0123 TABLET, EXTENDED RELEASE 400 mg ORAL NDA 35 sections
Viramune HUMAN PRESCRIPTION DRUG LABEL 1 0597-0123 TABLET, EXTENDED RELEASE 400 mg ORAL NDA 35 sections
Nevirapine HUMAN PRESCRIPTION DRUG LABEL 1 0781-5893 TABLET, EXTENDED RELEASE 400 mg ORAL ANDA 29 sections
Nevirapine Human Prescription Drug Label 1 31722-505 TABLET 200 mg ORAL ANDA 29 sections
Nevirapine Human Prescription Drug Label 1 31722-505 TABLET 200 mg ORAL ANDA 29 sections
Nevirapine Human Prescription Drug Label 1 33342-004 TABLET 200 mg ORAL ANDA 28 sections
Nevirapine Human Prescription Drug Label 1 33342-004 TABLET 200 mg ORAL ANDA 28 sections
NEVIRAPINE Human Prescription Drug Label 1 33342-238 TABLET, EXTENDED RELEASE 400 mg ORAL ANDA 29 sections
NEVIRAPINE Human Prescription Drug Label 1 33342-238 TABLET, EXTENDED RELEASE 400 mg ORAL ANDA 29 sections
NEVIRAPINE HUMAN PRESCRIPTION DRUG LABEL 1 42571-131 TABLET 200 mg ORAL ANDA 27 sections
NEVIRAPINE HUMAN PRESCRIPTION DRUG LABEL 1 42571-131 TABLET 200 mg ORAL ANDA 27 sections
nevirapine HUMAN PRESCRIPTION DRUG LABEL 1 53104-0166 TABLET 200 mg ORAL ANDA 26 sections
Nevirapine HUMAN PRESCRIPTION DRUG LABEL 1 53808-0680 TABLET 200 mg ORAL ANDA 29 sections
Viramune HUMAN PRESCRIPTION DRUG LABEL 1 53808-0808 TABLET 200 mg ORAL NDA 31 sections
nevirapine HUMAN PRESCRIPTION DRUG LABEL 1 53808-1069 TABLET 200 mg ORAL ANDA 28 sections
Viramune HUMAN PRESCRIPTION DRUG LABEL 1 54868-6370 TABLET, EXTENDED RELEASE 400 mg ORAL NDA 29 sections
Nevirapine HUMAN PRESCRIPTION DRUG LABEL 1 61442-470 TABLET, COATED 200 mg ORAL ANDA 29 sections
Nevirapine HUMAN PRESCRIPTION DRUG LABEL 1 64380-709 TABLET 200 mg ORAL ANDA 28 sections
Nevirapine HUMAN PRESCRIPTION DRUG LABEL 1 64380-709 TABLET 200 mg ORAL ANDA 28 sections
Nevirapine HUMAN PRESCRIPTION DRUG LABEL 1 65162-209 TABLET 200 mg ORAL ANDA 27 sections
Nevirapine Human Prescription Drug Label 1 65862-027 TABLET 200 mg ORAL ANDA 27 sections
Nevirapine Human Prescription Drug Label 1 65862-027 TABLET 200 mg ORAL ANDA 27 sections
Nevirapine Human Prescription Drug Label 1 65862-057 SUSPENSION 50 mg ORAL ANDA 28 sections