tenofovir disoproxil ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
antivirals 2593 201341-05-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • viread
  • tenofovir disoproxil
  • tenofovir disoproxil fumarate
Tenofovir disoproxil fumarate is the fumarate salt of the prodrug tenofovir disoproxil. Tenofovir disoproxil is absorbed and converted to the active substance tenofovir, which is a nucleoside monophosphate (nucleotide) analogue. Tenofovir is then converted to the active metabolite, tenofovir diphosphate, an obligate chain terminator, by constitutively expressed cellular enzymes. Tenofovir diphosphate has an intracellular half-life of 10 hours in activated and 50 hours in resting peripheral blood mononuclear cells (PBMCs). Tenofovir diphosphate inhibits HIV-1 reverse transcriptase and the HBV polymerase by direct binding competition with the natural deoxyribonucleotide substrate and, after incorporation into DNA, by DNA chain termination. Tenofovir diphosphate is a weak inhibitor of cellular polymerases alpha, beta, and gamma. At concentrations of up to 300 umol/l, tenofovir has also shown no effect on the synthesis of mitochondrial DNA or the production of lactic acid in in vitro assays.
  • Molecular weight: 519.45
  • Formula: C19H30N5O10P
  • CLOGP: 0.80
  • LIPINSKI: 2
  • HAC: 15
  • HDO: 1
  • TPSA: 185.44
  • ALOGS: -2.86
  • ROTB: 17

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.25 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Bocci G, Oprea TI, Benet LZ
S (Water solubility) 16.67 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 82 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 6.43 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 0.25 % Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K

Approvals:

DateAgencyCompanyOrphan
Feb. 4, 2002 EMA Gilead Sciences Ireland UC
Oct. 26, 2001 FDA GILEAD SCIENCES 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 1316.41 17.98 498 17750 46697 63424077
Exposure during pregnancy 718.91 17.98 484 17764 155063 63315711
Foetal exposure during pregnancy 674.28 17.98 276 17972 31686 63439088
Maternal exposure during pregnancy 518.30 17.98 459 17789 219603 63251171
Virologic failure 508.84 17.98 116 18132 1746 63469028
Fanconi syndrome acquired 505.60 17.98 104 18144 932 63469842
Stillbirth 461.51 17.98 140 18108 6610 63464164
Viral mutation identified 431.93 17.98 101 18147 1709 63469065
Pregnancy 381.70 17.98 194 18054 36642 63434132
Abortion induced 354.46 17.98 127 18121 10115 63460659
Drug resistance 319.64 17.98 148 18100 22785 63447989
Immune reconstitution inflammatory syndrome 302.60 17.98 99 18149 5985 63464789
Premature baby 270.95 17.98 128 18120 20607 63450167
Viral load increased 257.05 17.98 63 18185 1311 63469463
Blood HIV RNA increased 256.48 17.98 56 18192 683 63470091
Pathogen resistance 254.44 17.98 88 18160 6310 63464464
Osteoporosis 202.69 17.98 152 18096 57186 63413588
Renal tubular disorder 197.79 17.98 59 18189 2623 63468151
Caesarean section 185.93 17.98 93 18155 16939 63453835
Genotype drug resistance test positive 185.31 17.98 39 18209 394 63470380
Nephropathy toxic 179.84 17.98 76 18172 9403 63461371
Hepatitis B DNA increased 172.54 17.98 34 18214 239 63470535
Premature labour 171.98 17.98 80 18168 12424 63458350
Premature delivery 167.94 17.98 106 18142 30175 63440599
Renal tubular acidosis 159.28 17.98 45 18203 1647 63469127
Fanconi syndrome 149.26 17.98 41 18207 1351 63469423
Lipodystrophy acquired 147.55 17.98 41 18207 1411 63469363
Arthrodesis 145.01 17.98 47 18201 2754 63468020
Hepatic cytolysis 136.14 17.98 73 18175 15334 63455440
Hyperandrogenism 134.57 17.98 24 18224 89 63470685
CD4 lymphocytes decreased 134.54 17.98 38 18210 1389 63469385
Enlarged clitoris 132.83 17.98 25 18223 133 63470641
Glycosuria 132.73 17.98 36 18212 1130 63469644
Renal tubular dysfunction 129.10 17.98 29 18219 406 63470368
Live birth 127.97 17.98 84 18164 25546 63445228
Hypophosphataemia 126.49 17.98 63 18185 11363 63459411
Proteinuria 121.35 17.98 73 18175 19072 63451702
Osteomalacia 118.51 17.98 30 18218 715 63470059
Acute kidney injury 118.03 17.98 244 18004 263171 63207603
Hepatitis B reactivation 112.64 17.98 40 18208 3097 63467677
Premature rupture of membranes 104.68 17.98 43 18205 4950 63465824
Foetal death 102.57 17.98 54 18194 10926 63459848
Rebound effect 101.82 17.98 41 18207 4485 63466289
Renal failure 93.03 17.98 140 18108 117512 63353262
Cushing's syndrome 91.42 17.98 24 18224 663 63470111
Alanine aminotransferase increased 90.01 17.98 129 18119 103641 63367133
Treatment noncompliance 85.61 17.98 77 18171 37248 63433526
Renal tubular necrosis 85.00 17.98 49 18199 11829 63458945
Hydrops foetalis 84.57 17.98 22 18226 586 63470188
Pain 81.44 17.98 57 18191 740571 62730203
Oligohydramnios 76.11 17.98 37 18211 6329 63464445
Jaundice 74.40 17.98 64 18184 29187 63441587
Fatigue 74.30 17.98 88 18160 887940 62582834
Joint swelling 71.87 17.98 6 18242 327660 63143114
CSF HIV escape syndrome 71.73 17.98 14 18234 93 63470681
Hyperbilirubinaemia 71.32 17.98 43 18205 11271 63459503
Aspartate aminotransferase increased 67.90 17.98 105 18143 90172 63380602
Ultrasound antenatal screen abnormal 67.29 17.98 14 18234 133 63470641
Malaria 67.10 17.98 15 18233 205 63470569
Meningomyelocele 65.32 17.98 18 18230 600 63470174
Placental disorder 64.90 17.98 22 18226 1482 63469292
Maternal drugs affecting foetus 64.28 17.98 31 18217 5211 63465563
Osteonecrosis 63.05 17.98 54 18194 24476 63446298
Hypophosphataemic osteomalacia 61.67 17.98 14 18234 206 63470568
Pre-eclampsia 60.92 17.98 36 18212 9097 63461677
Placenta praevia 60.49 17.98 19 18229 1005 63469769
Blood phosphorus decreased 59.69 17.98 28 18220 4425 63466349
Infusion related reaction 58.22 17.98 3 18245 245518 63225256
Placental insufficiency 57.97 17.98 20 18228 1421 63469353
Congenital anomaly 57.58 17.98 21 18227 1755 63469019
Haemolytic anaemia 57.49 17.98 36 18212 10089 63460685
Hepatitis B 57.45 17.98 26 18222 3786 63466988
Renal colic 57.43 17.98 20 18228 1461 63469313
Foetal growth restriction 56.30 17.98 32 18216 7521 63463253
Congenital choroid plexus cyst 56.24 17.98 14 18234 311 63470463
Macrocephaly 55.37 17.98 11 18237 81 63470693
Blood creatinine increased 54.95 17.98 94 18154 87750 63383024
Hepatitis fulminant 53.39 17.98 24 18224 3440 63467334
Shoulder arthroplasty 53.14 17.98 25 18223 3977 63466797
Peripheral swelling 52.84 17.98 7 18241 265935 63204839
Fall 51.85 17.98 24 18224 392310 63078464
Hemivertebra 51.66 17.98 11 18237 118 63470656
Cleft lip and palate 51.32 17.98 15 18233 620 63470154
Limb operation 49.91 17.98 24 18224 4007 63466767
Nasopharyngitis 49.78 17.98 7 18241 254250 63216524
Neonatal respiratory distress syndrome 48.18 17.98 21 18227 2797 63467977
Congenital umbilical hernia 46.81 17.98 12 18236 301 63470473
Ectopic pregnancy 46.74 17.98 20 18228 2547 63468227
Arnold-Chiari malformation 46.31 17.98 14 18234 651 63470123
Lactic acidosis 46.18 17.98 56 18192 38231 63432543
Systemic lupus erythematosus 45.30 17.98 4 18244 208914 63261860
Metabolic acidosis 43.47 17.98 59 18189 45010 63425764
HIV infection 43.23 17.98 12 18236 411 63470363
Congenital hydrocephalus 42.86 17.98 10 18238 167 63470607
Sinusitis 42.62 17.98 7 18241 226646 63244128
Birth mark 42.32 17.98 10 18238 177 63470597
Gestational diabetes 40.63 17.98 27 18221 8369 63462405
Ultrasound antenatal screen 40.43 17.98 10 18238 216 63470558
Dyspnoea 40.31 17.98 81 18167 661232 62809542
Ventricular septal defect 39.38 17.98 21 18227 4357 63466417
Multiple-drug resistance 38.79 17.98 22 18226 5148 63465626
Hepatitis B DNA assay positive 38.63 17.98 7 18241 29 63470745
Transaminases increased 38.02 17.98 46 18202 31321 63439453
Acquired immunodeficiency syndrome 37.99 17.98 8 18240 81 63470693
Drug interaction 37.88 17.98 148 18100 228983 63241791
Patent ductus arteriosus 37.14 17.98 20 18228 4230 63466544
Arthralgia 37.13 17.98 67 18181 569643 62901131
Foetal distress syndrome 36.72 17.98 14 18234 1324 63469450
Hydromyelia 36.34 17.98 6 18242 12 63470762
Musculoskeletal stiffness 36.32 17.98 5 18243 184613 63286161
Drug intolerance 36.16 17.98 22 18226 308639 63162135
Normal newborn 36.02 17.98 25 18223 8316 63462458
Polyhydramnios 35.85 17.98 16 18232 2255 63468519
Rash maculo-papular 35.80 17.98 45 18203 31851 63438923
Immune reconstitution inflammatory syndrome associated tuberculosis 35.55 17.98 10 18238 360 63470414
AIDS cholangiopathy 35.42 17.98 6 18242 15 63470759
Antiviral drug level below therapeutic 35.18 17.98 7 18241 52 63470722
Human immunodeficiency virus transmission 35.06 17.98 7 18241 53 63470721
Spina bifida 34.86 17.98 12 18236 847 63469927
Blood creatine phosphokinase MB increased 34.36 17.98 13 18235 1203 63469571
Cholestasis of pregnancy 34.27 17.98 13 18235 1212 63469562
Adrenal suppression 34.00 17.98 12 18236 912 63469862
Hepatitis 33.77 17.98 49 18199 39739 63431035
Anaemia 33.71 17.98 170 18078 293260 63177514
Pulmonary tuberculosis 33.29 17.98 19 18229 4498 63466276
Pneumonia 33.20 17.98 50 18198 456717 63014057
Swelling 33.14 17.98 19 18229 275359 63195415
Viral load decreased 33.08 17.98 6 18242 25 63470749
Melanoderma 31.31 17.98 8 18240 198 63470576
Autoimmune hepatitis 31.00 17.98 23 18225 8487 63462287
Drug reaction with eosinophilia and systemic symptoms 30.67 17.98 43 18205 33793 63436981
Hepatitis D 30.59 17.98 6 18242 41 63470733
Cough 30.13 17.98 24 18224 292719 63178055
Umbilical cord abnormality 29.80 17.98 10 18238 653 63470121
Discomfort 29.67 17.98 6 18242 167368 63303406
Congenital pulmonary valve disorder 29.23 17.98 6 18242 53 63470721
Stomatitis 29.15 17.98 3 18245 138722 63332052
Rickets 28.74 17.98 6 18242 58 63470716
Hepatitis A 28.51 17.98 9 18239 484 63470290
Sudden infant death syndrome 28.10 17.98 8 18240 301 63470473
Blood creatine phosphokinase increased 28.07 17.98 39 18209 30391 63440383
Constipation 27.81 17.98 15 18233 224928 63245846
Polydactyly 27.80 17.98 8 18240 313 63470461
Condition aggravated 27.35 17.98 46 18202 402171 63068603
Oesophageal candidiasis 26.89 17.98 18 18230 5645 63465129
Eyelid oedema 26.78 17.98 23 18225 10456 63460318
Renal impairment 26.43 17.98 70 18178 88285 63382489
Foetal cardiac disorder 26.20 17.98 5 18243 29 63470745
Nephrogenic diabetes insipidus 26.19 17.98 10 18238 949 63469825
Hepatic failure 26.12 17.98 41 18207 35615 63435159
Headache 26.11 17.98 94 18154 633147 62837627
Lipohypertrophy 25.86 17.98 9 18239 656 63470118
HIV test positive 25.64 17.98 5 18243 33 63470741
Small for dates baby 25.58 17.98 15 18233 3736 63467038
Hydrocephalus 25.54 17.98 17 18231 5283 63465491
Abortion infected 25.39 17.98 5 18243 35 63470739
Vaginal ulceration 25.38 17.98 8 18240 428 63470346
Portal hypertension 25.33 17.98 15 18233 3804 63466970
Albuminuria 25.32 17.98 7 18241 236 63470538
Blood bilirubin increased 24.87 17.98 41 18207 37099 63433675
Gamma-glutamyltransferase increased 24.75 17.98 39 18209 33992 63436782
Benign hydatidiform mole 24.70 17.98 6 18242 120 63470654
Cholestasis 24.62 17.98 36 18212 29398 63441376
Mitochondrial toxicity 24.61 17.98 8 18240 473 63470301
Injection site pain 24.41 17.98 4 18244 129796 63340978
Type III hyperlipidaemia 24.23 17.98 4 18244 8 63470766
Congenital knee dislocation 24.23 17.98 4 18244 8 63470766
HIV-associated neurocognitive disorder 24.16 17.98 6 18242 132 63470642
Neonatal respiratory arrest 23.71 17.98 5 18243 51 63470723
Hepatotoxicity 23.62 17.98 40 18208 37001 63433773
Trisomy 18 23.46 17.98 6 18242 149 63470625
Congenital genital malformation 23.43 17.98 6 18242 150 63470624
Ocular icterus 23.31 17.98 14 18234 3642 63467132
Arthropathy 23.22 17.98 20 18228 234772 63236002
Coarctation of the aorta 23.15 17.98 8 18240 571 63470203
Cloacal exstrophy 23.06 17.98 6 18242 160 63470614
Chronic papillomatous dermatitis 22.89 17.98 5 18243 61 63470713
Product use issue 22.78 17.98 18 18230 220502 63250272
Caudal regression syndrome 22.67 17.98 6 18242 171 63470603
Ectopic kidney 22.60 17.98 5 18243 65 63470709
Nephrolithiasis 22.47 17.98 42 18206 41942 63428832
Rash 22.47 17.98 253 17995 560618 62910156
Blood bilirubin unconjugated increased 22.20 17.98 7 18241 375 63470399
ACTH stimulation test abnormal 22.19 17.98 4 18244 16 63470758
Trisomy 21 21.97 17.98 7 18241 388 63470386
Hepatic cirrhosis 21.78 17.98 31 18217 24703 63446071
Asthma 21.73 17.98 5 18243 127556 63343218
Mental disability 21.40 17.98 5 18243 84 63470690
Chronic kidney disease 21.35 17.98 43 18205 45355 63425419
Feeling abnormal 21.30 17.98 8 18240 148384 63322390
Blood pressure increased 21.23 17.98 10 18238 162052 63308722
Pulmonary embolism 21.06 17.98 4 18244 116680 63354094
Atrial fibrillation 21.04 17.98 4 18244 116632 63354142
Twin pregnancy 20.90 17.98 9 18239 1164 63469610
Blood alkaline phosphatase increased 20.57 17.98 41 18207 42926 63427848
Dermatitis exfoliative 20.44 17.98 15 18233 5444 63465330
COVID-19 20.15 17.98 4 18244 113099 63357675
Thymus hypoplasia 20.07 17.98 4 18244 30 63470744
Alopecia 19.94 17.98 42 18206 337494 63133280
Pulmonary valve sclerosis 19.62 17.98 4 18244 34 63470740
Eosinophilia 19.27 17.98 28 18220 22728 63448046
Lower respiratory tract infection 19.21 17.98 7 18241 132300 63338474
Tubulointerstitial nephritis 19.10 17.98 26 18222 19877 63450897
CSF test abnormal 19.05 17.98 6 18242 320 63470454
Influenza 19.05 17.98 4 18244 108718 63362056
Amniorrhoea 19.01 17.98 5 18243 139 63470635
Arthritis 18.86 17.98 5 18243 115916 63354858
Gait disturbance 18.85 17.98 15 18233 183163 63287611
Generalised anxiety disorder 18.80 17.98 10 18238 2064 63468710
Face oedema 18.79 17.98 26 18222 20186 63450588
Hypouricaemia 18.65 17.98 5 18243 150 63470624
Blister 18.62 17.98 7 18241 129807 63340967
Pregnancy on oral contraceptive 18.62 17.98 8 18240 1029 63469745
Bladder agenesis 18.52 17.98 5 18243 154 63470620
Chronic hepatitis B 18.52 17.98 6 18242 351 63470423
Genitalia external ambiguous 18.31 17.98 5 18243 161 63470613
Glycocholic acid increased 18.17 17.98 3 18245 6 63470768
Carbon dioxide combining power abnormal 18.17 17.98 3 18245 6 63470768
Growth hormone-producing pituitary tumour 18.17 17.98 3 18245 6 63470768
Product use in unapproved indication 18.01 17.98 15 18233 179065 63291709

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
Virologic failure 1033.24 12.61 295 33058 3185 34920393
Immune reconstitution inflammatory syndrome 926.28 12.61 339 33014 8420 34915158
Viral mutation identified 879.55 12.61 251 33102 2703 34920875
Fanconi syndrome acquired 832.81 12.61 221 33132 1770 34921808
Pathogen resistance 687.77 12.61 279 33074 9203 34914375
Lipodystrophy acquired 582.04 12.61 188 33165 3156 34920422
Mitochondrial toxicity 462.61 12.61 150 33203 2549 34921029
Renal tubular disorder 440.34 12.61 166 33187 4477 34919101
Osteoporosis 425.26 12.61 218 33135 12450 34911128
Viral load increased 403.04 12.61 133 33220 2394 34921184
Drug resistance 349.16 12.61 248 33105 25679 34897899
Fanconi syndrome 333.46 12.61 105 33248 1615 34921963
Hepatitis B 323.58 12.61 143 33210 5840 34917738
Foetal exposure during pregnancy 314.62 12.61 273 33080 37828 34885750
Eyelid ptosis 309.21 12.61 137 33216 5629 34917949
Blood HIV RNA increased 280.30 12.61 85 33268 1145 34922433
Hypophosphataemia 243.57 12.61 144 33209 10882 34912696
Progressive external ophthalmoplegia 238.77 12.61 78 33275 1357 34922221
Genotype drug resistance test positive 230.72 12.61 72 33281 1073 34922505
Nephropathy toxic 223.49 12.61 143 33210 12445 34911133
Acquired gene mutation 187.08 12.61 64 33289 1291 34922287
Glycosuria 184.84 12.61 62 33291 1175 34922403
Osteomalacia 177.82 12.61 56 33297 861 34922717
Proteinuria 175.18 12.61 144 33209 18498 34905080
Diplopia 172.88 12.61 137 33216 16706 34906872
Blood phosphorus decreased 168.66 12.61 75 33278 3106 34920472
Blood creatinine increased 162.62 12.61 310 33043 94666 34828912
Renal tubular dysfunction 161.94 12.61 44 33309 388 34923190
CD4 lymphocytes decreased 156.92 12.61 60 33293 1681 34921897
Hepatitis B DNA increased 154.67 12.61 45 33308 520 34923058
Osteonecrosis 148.30 12.61 119 33234 14771 34908807
Hepatitis B reactivation 133.51 12.61 68 33285 3823 34919755
Renal colic 129.42 12.61 53 33300 1786 34921792
Renal failure 125.65 12.61 339 33014 130218 34793360
Treatment failure 116.15 12.61 180 33173 46517 34877061
Renal tubular acidosis 114.42 12.61 52 33301 2267 34921311
Hepatic failure 107.49 12.61 148 33205 34383 34889195
Exposure during pregnancy 101.07 12.61 77 33276 8857 34914721
Jaundice 99.76 12.61 137 33216 31745 34891833
Renal impairment 97.54 12.61 252 33101 94261 34829317
HIV-associated neurocognitive disorder 96.84 12.61 28 33325 316 34923262
Pneumonia 91.43 12.61 128 33225 362499 34561079
Osteopenia 90.81 12.61 57 33296 4792 34918786
Renal tubular necrosis 82.97 12.61 88 33265 15592 34907986
Alanine aminotransferase increased 82.86 12.61 215 33138 80600 34842978
Volvulus 81.80 12.61 37 33316 1595 34921983
Nephrolithiasis 81.16 12.61 121 33232 30212 34893366
Hepatic cirrhosis 79.17 12.61 90 33263 17224 34906354
Acquired immunodeficiency syndrome 77.54 12.61 26 33327 492 34923086
Multiple-drug resistance 77.17 12.61 53 33300 5186 34918392
Hepatitis B DNA assay positive 76.07 12.61 17 33336 58 34923520
Osteoporotic fracture 75.15 12.61 31 33322 1064 34922514
Acute HIV infection 71.28 12.61 16 33337 56 34923522
Chronic kidney disease 70.99 12.61 135 33218 41075 34882503
Kaposi's sarcoma 70.95 12.61 28 33325 855 34922723
Dyspnoea 70.57 12.61 160 33193 376622 34546956
Hepatocellular carcinoma 70.50 12.61 58 33295 7451 34916127
Lactic acidosis 70.16 12.61 122 33231 34650 34888928
Aspartate aminotransferase increased 70.15 12.61 181 33172 67602 34855976
Hypotension 67.78 12.61 67 33286 221582 34701996
Premature baby 66.95 12.61 88 33265 19545 34904033
Treatment noncompliance 65.24 12.61 105 33248 27995 34895583
Hepatic cytolysis 64.00 12.61 74 33279 14422 34909156
Brain stem stroke 63.59 12.61 20 33333 306 34923272
Hepatitis 63.43 12.61 95 33258 23809 34899769
Ophthalmoplegia 62.66 12.61 32 33321 1808 34921770
Lipoatrophy 62.30 12.61 22 33331 489 34923089
Acute kidney injury 61.76 12.61 499 32854 304489 34619089
Drug interaction 61.49 12.61 397 32956 225549 34698029
Febrile neutropenia 61.18 12.61 27 33326 136822 34786756
Glomerular filtration rate decreased 60.32 12.61 68 33285 12893 34910685
Mitochondrial cytopathy 60.21 12.61 17 33336 175 34923403
Gene mutation 58.39 12.61 28 33325 1380 34922198
Death 57.35 12.61 192 33161 397857 34525721
Malignant neoplasm progression 57.28 12.61 8 33345 88038 34835540
HIV infection 56.66 12.61 27 33326 1312 34922266
Psychiatric decompensation 56.19 12.61 35 33318 2902 34920676
Off label use 56.02 12.61 209 33144 419315 34504263
Trisomy 21 55.68 12.61 21 33332 566 34923012
Portal hypertension 54.94 12.61 39 33314 4023 34919555
Depressive symptom 54.52 12.61 34 33319 2825 34920753
Tearfulness 54.12 12.61 33 33320 2634 34920944
Creatinine renal clearance decreased 51.69 12.61 35 33318 3346 34920232
Depression suicidal 50.85 12.61 31 33322 2474 34921104
Syphilis 50.24 12.61 18 33335 418 34923160
Anal cancer 49.18 12.61 18 33335 445 34923133
Fall 48.63 12.61 74 33279 202811 34720767
Varices oesophageal 48.37 12.61 35 33318 3720 34919858
Atrial fibrillation 47.50 12.61 29 33324 122364 34801214
Cytomegalovirus chorioretinitis 47.48 12.61 34 33319 3555 34920023
Beta 2 microglobulin urine increased 47.23 12.61 12 33341 79 34923499
Product dose omission issue 46.97 12.61 28 33325 119683 34803895
CSF HIV escape syndrome 46.26 12.61 14 33339 187 34923391
Ultrasound antenatal screen 45.97 12.61 18 33335 538 34923040
Disease progression 45.71 12.61 23 33330 108054 34815524
Drug abuse 45.15 12.61 19 33334 99077 34824501
Hyperbilirubinaemia 44.77 12.61 67 33286 16776 34906802
Congenital umbilical hernia 44.48 12.61 15 33338 289 34923289
Cleft lip and palate 43.57 12.61 20 33333 892 34922686
Constipation 43.46 12.61 40 33313 136942 34786636
Toxicity to various agents 43.44 12.61 78 33275 200284 34723294
Peripheral swelling 43.21 12.61 10 33343 76531 34847047
Completed suicide 42.87 12.61 20 33333 98148 34825430
Blood phosphorus abnormal 42.63 12.61 12 33341 122 34923456
Blood bilirubin increased 42.45 12.61 105 33248 38191 34885387
Blood lactic acid increased 41.46 12.61 41 33312 6687 34916891
Psychomotor skills impaired 40.55 12.61 32 33321 3874 34919704
Trisomy 18 40.29 12.61 18 33335 753 34922825
Blood pressure increased 39.96 12.61 17 33336 88085 34835493
Blood creatine phosphokinase increased 39.58 12.61 113 33240 44744 34878834
Lymphoma 39.48 12.61 54 33299 12453 34911125
Hypophosphataemic osteomalacia 37.89 12.61 11 33342 126 34923452
Brachydactyly 37.83 12.61 12 33341 189 34923389
Infusion related reaction 36.50 12.61 4 33349 53053 34870525
Congenital hearing disorder 36.14 12.61 10 33343 95 34923483
Hepatic cancer 36.11 12.61 42 33311 8233 34915345
Abnormal dreams 35.67 12.61 40 33313 7538 34916040
Hydrops foetalis 35.22 12.61 17 33336 850 34922728
COVID-19 35.11 12.61 15 33338 77535 34846043
Hepatitis C 34.97 12.61 45 33308 9785 34913793
Hyperphosphaturia 34.01 12.61 9 33344 71 34923507
Hepatic steatosis 33.91 12.61 62 33291 18300 34905278
Fatigue 33.47 12.61 212 33141 370441 34553137
Oesophageal atresia 33.44 12.61 14 33339 499 34923079
Oesophageal candidiasis 33.23 12.61 30 33323 4366 34919212
Congenital anomaly 32.87 12.61 19 33334 1374 34922204
Nephropathy 32.71 12.61 34 33319 5883 34917695
HIV wasting syndrome 32.57 12.61 9 33344 85 34923493
Polydactyly 32.56 12.61 18 33335 1195 34922383
Lymphadenopathy 32.56 12.61 79 33274 28384 34895194
Nasopharyngitis 32.53 12.61 13 33340 69955 34853623
Megakaryocytes increased 32.41 12.61 8 33345 46 34923532
Progressive multifocal leukoencephalopathy 32.10 12.61 43 33310 9721 34913857
Hemivertebra 32.04 12.61 10 33343 149 34923429
Blood alkaline phosphatase increased 31.96 12.61 83 33270 31092 34892486
Joint swelling 31.54 12.61 9 33344 59881 34863697
Anogenital warts 31.40 12.61 14 33339 583 34922995
Liver disorder 30.95 12.61 85 33268 32912 34890666
Hepatosplenomegaly 30.63 12.61 28 33325 4141 34919437
Cardiac failure congestive 30.56 12.61 21 33332 83249 34840329
Nodular regenerative hyperplasia 30.48 12.61 16 33337 957 34922621
Sepsis 30.03 12.61 72 33281 166489 34757089
Pain 29.86 12.61 98 33255 204577 34719001
Maternal drugs affecting foetus 29.85 12.61 27 33326 3938 34919640
Paranoia 29.25 12.61 46 33307 12022 34911556
Neurosyphilis 28.86 12.61 7 33346 37 34923541
Ocular icterus 28.78 12.61 23 33330 2834 34920744
Laryngomalacia 28.34 12.61 11 33342 321 34923257
Dysphagia 28.08 12.61 126 33227 62255 34861323
Tubulointerstitial nephritis 28.05 12.61 62 33291 20962 34902616
Hepatorenal syndrome 28.01 12.61 22 33331 2644 34920934
HIV test positive 27.74 12.61 9 33344 153 34923425
Bone pain 27.59 12.61 61 33292 20625 34902953
Haemophilic arthropathy 27.52 12.61 9 33344 157 34923421
Pulmonary tuberculosis 27.51 12.61 28 33325 4726 34918852
Hypertriglyceridaemia 27.46 12.61 37 33316 8411 34915167
Porphyria non-acute 27.44 12.61 12 33341 477 34923101
Product use issue 27.40 12.61 13 33340 63203 34860375
Birth mark 27.31 12.61 9 33344 161 34923417
Pulmonary oedema 27.24 12.61 6 33347 47523 34876055
Blood antidiuretic hormone increased 27.18 12.61 7 33346 49 34923529
Plasma cell myeloma 26.91 12.61 4 33349 42033 34881545
Diaphragmatic hernia 26.85 12.61 10 33343 260 34923318
Nervous system disorder 26.72 12.61 49 33304 14494 34909084
Oxygen saturation decreased 26.70 12.61 9 33344 53809 34869769
Hepatic fibrosis 26.41 12.61 27 33326 4580 34918998
Hodgkin's disease 26.22 12.61 14 33339 867 34922711
Hydrocele 25.85 12.61 19 33334 2068 34921510
Back pain 25.83 12.61 48 33305 121741 34801837
Cerebellar syndrome 25.73 12.61 20 33333 2368 34921210
Developmental hip dysplasia 25.66 12.61 10 33343 295 34923283
Meningomyelocele 25.53 12.61 9 33344 199 34923379
Influenza 25.18 12.61 8 33345 49658 34873920
CSF virus identified 25.01 12.61 6 33347 30 34923548
Talipes 24.94 12.61 18 33335 1905 34921673
Wheezing 24.19 12.61 5 33348 41397 34882181
Bradycardia 23.92 12.61 22 33331 75396 34848182
Hepatic encephalopathy 23.91 12.61 47 33306 14638 34908940
Epistaxis 23.72 12.61 13 33340 58238 34865340
Protein urine present 23.59 12.61 27 33326 5201 34918377
Retroviral rebound syndrome 23.39 12.61 5 33348 13 34923565
Liver function test abnormal 23.36 12.61 74 33279 31000 34892578
Atypical mycobacterial infection 23.28 12.61 13 33340 880 34922698
Dyslipidaemia 23.14 12.61 32 33321 7456 34916122
Abortion spontaneous 23.04 12.61 10 33343 390 34923188
Acute hepatitis C 22.96 12.61 7 33346 96 34923482
Therapeutic product effect decreased 22.96 12.61 3 33350 34740 34888838
Infection 22.88 12.61 32 33321 90883 34832695
Prostate cancer 22.73 12.61 5 33348 39644 34883934
Cachexia 22.64 12.61 31 33322 7155 34916423
Hepatitis B e antigen positive 22.60 12.61 6 33347 48 34923530
Gamma-glutamyltransferase increased 22.33 12.61 70 33283 29161 34894417
Pneumonitis 22.21 12.61 3 33350 33875 34889703
Injection site pain 22.19 12.61 5 33348 39000 34884578
Dialysis 22.17 12.61 39 33314 11169 34912409
Cerebral toxoplasmosis 22.07 12.61 16 33337 1705 34921873
Cryptorchism 21.79 12.61 17 33336 2024 34921554
AIDS related complication 21.75 12.61 5 33348 20 34923558
Burkitt's lymphoma 21.74 12.61 7 33346 116 34923462
Inappropriate schedule of product administration 21.19 12.61 17 33336 62279 34861299
Musculoskeletal stiffness 21.17 12.61 9 33344 46671 34876907
Cough 21.11 12.61 73 33280 150067 34773511
Secondary syphilis 21.06 12.61 6 33347 64 34923514
Oesophageal varices haemorrhage 20.94 12.61 20 33333 3126 34920452
Anaphylactic reaction 20.84 12.61 3 33350 32298 34891280
Polydipsia 20.75 12.61 22 33331 3893 34919685
Hyperhidrosis 20.73 12.61 25 33328 75667 34847911
Bone density decreased 20.44 12.61 16 33337 1913 34921665
Asymptomatic viral hepatitis 20.37 12.61 5 33348 28 34923550
Heart rate decreased 20.36 12.61 3 33350 31742 34891836
Blood pressure decreased 20.25 12.61 12 33341 51503 34872075
Cardiac failure 20.21 12.61 35 33318 91213 34832365
Creatinine renal clearance abnormal 20.10 12.61 8 33345 250 34923328
Myalgia 19.92 12.61 143 33210 83967 34839611
Polyuria 19.84 12.61 32 33321 8542 34915036
Chest discomfort 19.67 12.61 14 33339 54516 34869062
End stage AIDS 19.54 12.61 5 33348 34 34923544
Haematochezia 19.51 12.61 10 33343 46524 34877054
Syncope 19.42 12.61 36 33317 91415 34832163
Supernumerary nipple 19.06 12.61 5 33348 38 34923540
Blood bicarbonate decreased 18.85 12.61 17 33336 2470 34921108
Haemodialysis 18.75 12.61 35 33318 10491 34913087
Polyneuropathy chronic 18.72 12.61 5 33348 41 34923537
Immune reconstitution inflammatory syndrome associated tuberculosis 18.66 12.61 9 33344 449 34923129
Rhabdomyolysis 18.59 12.61 120 33233 68043 34855535
Cardiac arrest 18.58 12.61 40 33313 96119 34827459
Interstitial lung disease 18.48 12.61 21 33332 65261 34858317
Protrusion tongue 18.44 12.61 7 33346 192 34923386
Kidney fibrosis 18.42 12.61 16 33337 2212 34921366
Psychotic disorder 18.17 12.61 58 33295 24394 34899184
HIV associated nephropathy 18.13 12.61 8 33345 325 34923253
Portal fibrosis 18.13 12.61 8 33345 325 34923253
Lower respiratory tract infection 18.11 12.61 4 33349 31633 34891945
C-reactive protein increased 18.10 12.61 15 33338 54083 34869495
Rash maculo-papular 18.06 12.61 64 33289 28387 34895191
Blood triglycerides increased 18.04 12.61 41 33312 14118 34909460
Hepatic function abnormal 18.04 12.61 87 33266 44276 34879302
Perihepatic discomfort 17.87 12.61 3 33350 0 34923578
Pneumocystis jirovecii pneumonia 17.71 12.61 50 33303 19660 34903918
CD4 lymphocytes increased 17.58 12.61 7 33346 219 34923359
Lymphocytic infiltration 17.53 12.61 10 33343 705 34922873
Malaise 17.37 12.61 105 33248 185720 34737858
International normalised ratio increased 17.27 12.61 12 33341 47315 34876263
Small for dates baby 17.25 12.61 20 33333 3907 34919671
Pathological fracture 17.04 12.61 21 33332 4370 34919208
Adrenogenital syndrome 17.01 12.61 5 33348 60 34923518
Viraemia 17.00 12.61 12 33341 1226 34922352
Ventricular septal defect 16.94 12.61 20 33333 3981 34919597
Viral load 16.94 12.61 5 33348 61 34923517
Musculoskeletal toxicity 16.92 12.61 6 33347 135 34923443
Mycobacterium avium complex infection 16.78 12.61 16 33337 2495 34921083
Congenital naevus 16.68 12.61 4 33349 20 34923558
Tachycardia 16.60 12.61 35 33318 84737 34838841
Incorrect dose administered 16.55 12.61 9 33344 40506 34883072
Pleural effusion 16.53 12.61 33 33320 81513 34842065
Cushing's syndrome 16.48 12.61 8 33345 405 34923173
Pancreatitis 16.34 12.61 77 33276 38814 34884764
White matter lesion 16.33 12.61 10 33343 804 34922774
Glucose urine present 16.22 12.61 11 33342 1054 34922524
Lipohypertrophy 16.18 12.61 7 33346 271 34923307
Hepatic enzyme increased 16.15 12.61 77 33276 39003 34884575
Pneumonia aspiration 16.14 12.61 10 33343 41893 34881685
Congenital tuberculosis 16.06 12.61 4 33349 24 34923554
Pulmonary embolism 15.99 12.61 39 33314 89707 34833871
Neck deformity 15.93 12.61 5 33348 76 34923502
Antiviral drug level below therapeutic 15.79 12.61 3 33350 3 34923575
Congenital gastric anomaly 15.79 12.61 3 33350 3 34923575
Calculus urinary 15.63 12.61 12 33341 1395 34922183
White blood cell count increased 15.60 12.61 10 33343 41141 34882437
CSF glucose decreased 15.53 12.61 4 33349 28 34923550
Low set ears 15.52 12.61 8 33345 461 34923117
Muscle spasms 15.51 12.61 30 33323 74971 34848607
Haemoglobin decreased 15.48 12.61 61 33292 120711 34802867
Meningitis cryptococcal 15.46 12.61 15 33338 2389 34921189
Disseminated mycobacterium avium complex infection 15.46 12.61 5 33348 84 34923494
Hepatomegaly 15.41 12.61 32 33321 10364 34913214
Micrognathia 15.36 12.61 7 33346 307 34923271
Gastrointestinal haemorrhage 15.33 12.61 39 33314 88438 34835140
Meningitis tuberculous 15.26 12.61 9 33344 676 34922902
Amyotrophy 15.23 12.61 8 33345 479 34923099
Stress 15.18 12.61 5 33348 30342 34893236
Mucosal inflammation 15.18 12.61 9 33344 38613 34884965
Cellulitis 15.02 12.61 17 33336 52934 34870644
Platelet count decreased 15.00 12.61 61 33292 119656 34803922
Hepatitis B surface antibody positive 14.99 12.61 5 33348 93 34923485
Caesarean section 14.86 12.61 14 33339 2150 34921428
Transient ischaemic attack 14.81 12.61 4 33349 27609 34895969
Mitochondrial myopathy 14.74 12.61 6 33347 199 34923379
Chronic obstructive pulmonary disease 14.66 12.61 15 33338 48903 34874675
Therapeutic product effect incomplete 14.59 12.61 16 33337 50525 34873053
Laryngeal erythema 14.58 12.61 3 33350 6 34923572
Neonatal asphyxia 14.54 12.61 7 33346 348 34923230
Thrombosis 14.53 12.61 16 33337 50442 34873136
Sinusitis 14.45 12.61 11 33342 41391 34882187
Hemiparaesthesia 14.29 12.61 5 33348 108 34923470
Pleocytosis 14.29 12.61 8 33345 544 34923034
Viral load decreased 14.27 12.61 4 33349 40 34923538
Suicidal ideation 14.17 12.61 76 33277 40312 34883266
Cardiogenic shock 14.01 12.61 4 33349 26614 34896964
CD4 lymphocytes abnormal 14.01 12.61 4 33349 43 34923535
Drug dependence 13.99 12.61 3 33350 24214 34899364
Pharyngeal cancer 13.84 12.61 4 33349 45 34923533
Optic neuritis 13.72 12.61 17 33336 3557 34920021
VIIIth nerve injury 13.72 12.61 3 33350 9 34923569
Eagle Barrett syndrome 13.72 12.61 3 33350 9 34923569
Phosphorus metabolism disorder 13.72 12.61 3 33350 9 34923569
Vth nerve injury 13.72 12.61 3 33350 9 34923569
Blood creatinine abnormal 13.69 12.61 14 33339 2376 34921202
Stevens-Johnson syndrome 13.65 12.61 44 33309 18595 34904983
Hypospadias 13.55 12.61 16 33337 3185 34920393
Urine calcium increased 13.46 12.61 4 33349 50 34923528
Psychomotor retardation 13.44 12.61 17 33336 3633 34919945
Antiviral drug level above therapeutic 13.39 12.61 4 33349 51 34923527
Urine phosphorus increased 13.39 12.61 4 33349 51 34923527
Respiratory arrest 13.38 12.61 5 33348 28038 34895540
Cortisol decreased 13.38 12.61 10 33343 1117 34922461
Hypouricaemia 13.32 12.61 6 33347 256 34923322
Rhinorrhoea 13.25 12.61 4 33349 25664 34897914
Splenomegaly 13.24 12.61 38 33315 15079 34908499
Anogenital dysplasia 13.21 12.61 5 33348 136 34923442
Dizziness 13.21 12.61 139 33214 218382 34705196
Femoral neck fracture 13.13 12.61 16 33337 3291 34920287
Upper gastrointestinal haemorrhage 13.13 12.61 4 33349 25514 34898064
Congenital diaphragmatic hernia 13.13 12.61 6 33347 265 34923313
Vitamin D deficiency 13.08 12.61 23 33330 6585 34916993
Somnolence 13.07 12.61 58 33295 111058 34812520
Seroconversion test positive 13.05 12.61 3 33350 12 34923566
Cranial nerve palsies multiple 13.04 12.61 4 33349 56 34923522
Hypersplenism 13.00 12.61 7 33346 441 34923137
Blood pressure systolic increased 12.94 12.61 3 33350 22949 34900629
Cytokine release syndrome 12.88 12.61 3 33350 22874 34900704
Optic nerve cupping 12.67 12.61 4 33349 62 34923516
Hyperlactacidaemia 12.65 12.61 15 33338 3001 34920577
Renal disorder 12.63 12.61 53 33300 25427 34898151
Ureterolithiasis 12.62 12.61 13 33340 2226 34921352
Delirium 12.61 12.61 14 33339 43977 34879601

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 1151.58 13.48 288 37085 3903 79703112
Immune reconstitution inflammatory syndrome 1122.30 13.48 367 37006 13474 79693541
Fanconi syndrome acquired 1058.30 13.48 247 37126 2447 79704568
Abortion spontaneous 978.62 13.48 405 36968 29102 79677913
Viral mutation identified 848.37 13.48 222 37151 3636 79703379
Lipodystrophy acquired 725.51 13.48 201 37172 4124 79702891
Pathogen resistance 668.81 13.48 252 37121 14090 79692925
Blood HIV RNA increased 560.83 13.48 137 37236 1671 79705344
Drug resistance 550.19 13.48 305 37068 41908 79665107
Mitochondrial toxicity 546.65 13.48 150 37223 2964 79704051
Viral load increased 498.98 13.48 138 37235 2810 79704205
Renal tubular disorder 461.70 13.48 156 37217 6330 79700685
Exposure during pregnancy 447.40 13.48 374 36999 100758 79606257
Nephropathy toxic 439.44 13.48 207 37166 20212 79686803
Fanconi syndrome 416.55 13.48 119 37254 2737 79704278
Osteoporosis 371.25 13.48 260 37113 53852 79653163
Genotype drug resistance test positive 369.75 13.48 92 37281 1216 79705799
Stillbirth 365.86 13.48 116 37257 3839 79703176
Hepatitis B 333.32 13.48 131 37242 8201 79698814
Eyelid ptosis 310.67 13.48 135 37238 10909 79696106
Maternal exposure during pregnancy 301.31 13.48 345 37028 136193 79570822
Hypophosphataemia 298.63 13.48 158 37215 19755 79687260
Abortion induced 295.77 13.48 115 37258 6994 79700021
Progressive external ophthalmoplegia 292.98 13.48 78 37295 1367 79705648
Hepatitis B reactivation 265.47 13.48 102 37271 6006 79701009
Proteinuria 262.93 13.48 173 37200 32329 79674686
Glycosuria 260.97 13.48 78 37295 2110 79704905
CD4 lymphocytes decreased 242.57 13.48 77 37296 2557 79704458
Renal tubular dysfunction 236.51 13.48 58 37315 719 79706296
Hepatitis B DNA increased 233.75 13.48 58 37315 757 79706258
Acquired gene mutation 200.36 13.48 64 37309 2169 79704846
Blood creatinine increased 197.30 13.48 299 37074 154758 79552257
Renal tubular acidosis 192.27 13.48 70 37303 3544 79703471
Osteomalacia 186.26 13.48 55 37318 1425 79705590
Diplopia 171.48 13.48 135 37238 33331 79673684
Blood phosphorus decreased 160.22 13.48 73 37300 6595 79700420
Jaundice 156.69 13.48 157 37216 53192 79653823
Renal failure 155.32 13.48 311 37062 200657 79506358
Pregnancy 154.38 13.48 116 37257 26735 79680280
Caesarean section 148.08 13.48 85 37288 12450 79694565
Foetal exposure during pregnancy 144.21 13.48 65 37308 5725 79701290
Acute kidney injury 143.01 13.48 550 36823 518854 79188161
Treatment noncompliance 142.91 13.48 148 37225 52120 79654895
Osteonecrosis 141.43 13.48 117 37256 30978 79676037
Alanine aminotransferase increased 140.74 13.48 264 37109 162306 79544709
Renal tubular necrosis 134.76 13.48 104 37269 24935 79682080
Aspartate aminotransferase increased 132.47 13.48 235 37138 138406 79568609
Renal impairment 122.83 13.48 245 37128 157538 79549477
Chronic kidney disease 122.44 13.48 153 37220 66001 79641014
Hepatic failure 120.44 13.48 146 37227 61066 79645949
Drug interaction 117.71 13.48 444 36929 414739 79292276
CSF HIV escape syndrome 116.33 13.48 28 37345 319 79706696
Renal colic 114.99 13.48 45 37328 2782 79704233
Hepatic cytolysis 106.79 13.48 94 37279 27057 79679958
HIV-associated neurocognitive disorder 105.74 13.48 26 37347 326 79706689
Multiple-drug resistance 104.76 13.48 60 37313 8748 79698267
Joint swelling 102.10 13.48 9 37364 288637 79418378
Hypophosphataemic osteomalacia 95.16 13.48 24 37349 336 79706679
Pain 94.29 13.48 115 37258 703687 79003328
Arthrodesis 93.29 13.48 37 37336 2370 79704645
Hepatocellular carcinoma 92.95 13.48 56 37317 8965 79698050
Premature labour 91.44 13.48 54 37319 8336 79698679
Live birth 90.42 13.48 73 37300 18671 79688344
Lactic acidosis 86.99 13.48 134 37239 70225 79636790
Hepatitis B DNA assay positive 84.84 13.48 17 37356 74 79706941
Infusion related reaction 84.71 13.48 6 37367 230231 79476784
Ultrasound antenatal screen 83.92 13.48 25 37348 668 79706347
Premature delivery 83.91 13.48 77 37296 23390 79683625
Nephrolithiasis 82.65 13.48 113 37260 53178 79653837
Hepatic cirrhosis 81.60 13.48 91 37282 34815 79672200
Hyperbilirubinaemia 81.02 13.48 77 37296 24441 79682574
Peripheral swelling 77.46 13.48 16 37357 269601 79437414
Blood bilirubin increased 76.14 13.48 122 37251 66110 79640905
Nasopharyngitis 75.17 13.48 14 37359 253867 79453148
Cushing's syndrome 75.02 13.48 25 37348 970 79706045
Premature rupture of membranes 74.64 13.48 37 37336 4032 79702983
Pneumonia 73.43 13.48 123 37250 660123 79046892
Hydrops foetalis 72.69 13.48 23 37350 755 79706260
Acute HIV infection 70.62 13.48 14 37359 57 79706958
Rebound effect 69.69 13.48 43 37330 7183 79699832
Psychiatric decompensation 69.64 13.48 35 37338 3928 79703087
Dyspnoea 69.28 13.48 191 37182 856834 78850181
Ophthalmoplegia 67.19 13.48 31 37342 2881 79704134
Cleft lip and palate 66.73 13.48 21 37352 677 79706338
Gene mutation 66.40 13.48 30 37343 2656 79704359
Trisomy 18 65.28 13.48 20 37353 589 79706426
Portal hypertension 65.27 13.48 41 37332 7067 79699948
Pulmonary tuberculosis 63.90 13.48 42 37331 7823 79699192
Fall 63.81 13.48 81 37292 487548 79219467
Hepatitis 63.16 13.48 102 37271 55625 79651390
Lipoatrophy 62.85 13.48 20 37353 669 79706346
Brain stem stroke 62.01 13.48 20 37353 699 79706316
Blood creatine phosphokinase increased 61.74 13.48 111 37262 65979 79641036
Depression suicidal 59.03 13.48 31 37342 3811 79703204
Malaria 58.92 13.48 17 37356 405 79706610
Completed suicide 58.56 13.48 21 37352 245746 79461269
Tearfulness 58.37 13.48 36 37337 6009 79701006
Synovitis 58.23 13.48 3 37370 150731 79556284
Fatigue 58.06 13.48 232 37141 929495 78777520
Haemolytic anaemia 57.05 13.48 55 37318 17765 79689250
Placental disorder 56.90 13.48 20 37353 913 79706102
Oligohydramnios 56.65 13.48 29 37344 3383 79703632
Cytomegalovirus chorioretinitis 56.35 13.48 34 37339 5456 79701559
Psychomotor skills impaired 55.22 13.48 33 37340 5204 79701811
Mitochondrial cytopathy 54.95 13.48 16 37357 394 79706621
Foetal death 53.59 13.48 38 37335 8006 79699009
Placenta praevia 53.09 13.48 18 37355 737 79706278
Hypotension 52.69 13.48 78 37295 440239 79266776
Megakaryocytes increased 52.62 13.48 12 37361 106 79706909
Sinusitis 51.40 13.48 14 37359 195487 79511528
Immune reconstitution inflammatory syndrome associated tuberculosis 51.29 13.48 18 37355 818 79706197
Musculoskeletal stiffness 51.05 13.48 10 37363 174998 79532017
Blood pressure increased 50.45 13.48 18 37355 211342 79495673
Acquired immunodeficiency syndrome 50.24 13.48 14 37359 293 79706722
Glomerular filtration rate decreased 49.34 13.48 57 37316 22645 79684370
Depressive symptom 49.04 13.48 33 37340 6390 79700625
Constipation 47.27 13.48 38 37335 283012 79424003
Placental insufficiency 46.11 13.48 18 37355 1105 79705910
Blood alkaline phosphatase increased 44.92 13.48 95 37278 63569 79643446
Hepatic encephalopathy 44.86 13.48 56 37317 24110 79682905
Osteopenia 44.85 13.48 49 37324 18315 79688700
Hepatic cancer 44.52 13.48 38 37335 10491 79696524
Arthralgia 44.20 13.48 130 37243 571673 79135342
Varices oesophageal 43.88 13.48 30 37343 5961 79701054
Ocular icterus 43.78 13.48 29 37344 5471 79701544
Osteoporotic fracture 42.85 13.48 26 37347 4214 79702801
Oesophageal candidiasis 42.56 13.48 35 37338 9183 79697832
Hepatic function abnormal 42.51 13.48 101 37272 73006 79634009
Kaposi's sarcoma 41.48 13.48 15 37358 744 79706271
Malignant neoplasm progression 41.32 13.48 7 37366 135983 79571032
Contusion 40.35 13.48 10 37363 148766 79558249
Swelling 40.21 13.48 26 37347 216685 79490330
Nervous system disorder 40.21 13.48 56 37317 26800 79680215
Blood lactic acid increased 40.17 13.48 39 37334 12705 79694310
Wound 40.04 13.48 4 37369 116175 79590840
Systemic lupus erythematosus 39.67 13.48 5 37368 121144 79585871
Adrenal suppression 39 13.48 17 37356 1382 79705633
Febrile neutropenia 38.57 13.48 31 37342 230968 79476047
Wheezing 37.75 13.48 5 37368 116659 79590356
Pericarditis 37.51 13.48 3 37370 104233 79602782
Blood phosphorus abnormal 37.28 13.48 11 37362 284 79706731
Injection site pain 36.66 13.48 8 37365 129830 79577185
Hepatitis fulminant 36.55 13.48 29 37344 7233 79699782
Product use issue 36.51 13.48 27 37346 209795 79497220
Hepatic fibrosis 36.48 13.48 29 37344 7251 79699764
Atrial fibrillation 36.36 13.48 24 37349 197862 79509153
Oxygen saturation decreased 36.33 13.48 8 37365 129039 79577976
Paranoia 36.02 13.48 45 37328 19387 79687628
Cough 35.66 13.48 74 37299 366715 79340300
Beta 2 microglobulin urine increased 35.04 13.48 9 37364 136 79706879
COVID-19 35.02 13.48 15 37358 157659 79549356
Lymphadenopathy 34.75 13.48 77 37296 53170 79653845
Hepatic steatosis 34.75 13.48 63 37310 37675 79669340
Spina bifida 34.68 13.48 9 37364 142 79706873
Polydipsia 34.58 13.48 27 37346 6578 79700437
Abnormal dreams 34.25 13.48 34 37339 11378 79695637
Stomatitis 34.16 13.48 13 37360 146744 79560271
CSF virus identified 34.14 13.48 7 37366 35 79706980
Retroviral rebound syndrome 33.75 13.48 6 37367 11 79707004
Product dose omission issue 33.50 13.48 40 37333 247497 79459518
Gamma-glutamyltransferase increased 33.38 13.48 77 37296 54603 79652412
Anal cancer 33.37 13.48 13 37360 794 79706221
Rash maculo-papular 33.17 13.48 78 37295 56000 79651015
Hepatitis D 33.01 13.48 8 37365 94 79706921
Transaminases increased 32.84 13.48 74 37299 51669 79655346
Influenza 32.74 13.48 10 37363 129596 79577419
Lower respiratory tract infection 32.58 13.48 10 37363 129210 79577805
AIDS cholangiopathy 32.49 13.48 6 37367 15 79707000
Toxicity to various agents 32.42 13.48 96 37277 421444 79285571
Tubulointerstitial nephritis 31.67 13.48 61 37312 38174 79668841
Pulmonary embolism 31.29 13.48 21 37352 171633 79535382
Hepatitis C 31.20 13.48 33 37340 11892 79695123
Hypertriglyceridaemia 31.12 13.48 34 37339 12706 79694309
Psychotic disorder 30.62 13.48 63 37310 41339 79665676
Cerebral toxoplasmosis 30.55 13.48 17 37356 2345 79704670
Hepatorenal syndrome 30.47 13.48 21 37352 4228 79702787
Blood creatine phosphokinase MB increased 30.39 13.48 18 37355 2793 79704222
Malaise 29.97 13.48 123 37250 489746 79217269
Bradycardia 29.94 13.48 13 37360 135544 79571471
Polyuria 29.82 13.48 36 37337 14978 79692037
Off label use 29.78 13.48 277 37096 906938 78800077
Polyhydramnios 29.66 13.48 15 37358 1705 79705310
Blood antidiuretic hormone increased 29.56 13.48 7 37366 74 79706941
Progressive multifocal leukoencephalopathy 29.42 13.48 42 37331 20558 79686457
Ultrasound antenatal screen abnormal 28.90 13.48 7 37366 82 79706933
Blood bicarbonate decreased 28.88 13.48 22 37351 5169 79701846
Asthma 28.22 13.48 14 37359 135081 79571934
Arthropathy 28.05 13.48 25 37348 177086 79529929
Hepatosplenomegaly 27.92 13.48 23 37350 6046 79700969
Premature baby 27.86 13.48 19 37354 3761 79703254
HIV associated nephropathy 27.54 13.48 9 37364 328 79706687
Cholestasis 27.12 13.48 69 37304 52040 79654975
Lymphoma 27.02 13.48 37 37336 17423 79689592
Pre-eclampsia 26.93 13.48 24 37349 7017 79699998
Disease progression 26.90 13.48 28 37345 184334 79522681
Dialysis 26.89 13.48 38 37335 18424 79688591
Dysphagia 26.87 13.48 121 37252 122015 79585000
Syphilis 26.77 13.48 10 37363 544 79706471
Stress 26.77 13.48 3 37370 79609 79627406
Myalgia 26.41 13.48 163 37210 185478 79521537
Drug reaction with eosinophilia and systemic symptoms 26.39 13.48 78 37295 64166 79642849
Autoimmune hepatitis 26.30 13.48 30 37343 11753 79695262
HIV test positive 26.06 13.48 7 37366 127 79706888
Toxoplasmosis 25.88 13.48 16 37357 2681 79704334
Melanoderma 25.81 13.48 9 37364 401 79706614
Hepatotoxicity 25.69 13.48 67 37306 51285 79655730
Metabolic acidosis 25.57 13.48 91 37282 82438 79624577
Shoulder arthroplasty 25.39 13.48 17 37356 3265 79703750
Pain in extremity 25.23 13.48 87 37286 364451 79342564
Secondary syphilis 25.04 13.48 6 37367 67 79706948
Viraemia 24.97 13.48 16 37357 2853 79704162
Foetal cardiac disorder 24.91 13.48 5 37368 22 79706993
Calculus urinary 24.64 13.48 15 37358 2445 79704570
Blood HIV RNA 24.55 13.48 5 37368 24 79706991
Viral load decreased 24.55 13.48 5 37368 24 79706991
Rickets 24.42 13.48 6 37367 75 79706940
Maternal drugs affecting foetus 24.22 13.48 13 37360 1670 79705345
Drug-induced liver injury 24.11 13.48 77 37296 66040 79640975
Anaphylactic reaction 23.96 13.48 5 37368 83738 79623277
Cardiac failure congestive 23.90 13.48 19 37354 142383 79564632
Arthritis 23.85 13.48 12 37361 114868 79592147
Pathological fracture 23.81 13.48 27 37346 10510 79696505
Nephropathy 23.81 13.48 26 37347 9712 79697303
Pulmonary oedema 23.79 13.48 6 37367 88248 79618767
Ectopic pregnancy 23.79 13.48 13 37360 1730 79705285
Bronchitis 23.78 13.48 16 37357 130628 79576387
Back pain 23.56 13.48 69 37304 304111 79402904
Impaired healing 23.55 13.48 6 37367 87649 79619366
Benign hydatidiform mole 23.53 13.48 6 37367 88 79706927
Inappropriate schedule of product administration 23.49 13.48 17 37356 133611 79573404
Hepatomegaly 23.39 13.48 36 37337 18838 79688177
CSF test abnormal 23.35 13.48 9 37364 534 79706481
Heart rate decreased 22.78 13.48 3 37370 70313 79636702
Blister 22.61 13.48 14 37359 119462 79587553
Acute hepatitis C 22.47 13.48 7 37366 218 79706797
Urine calcium increased 22.43 13.48 6 37367 107 79706908
Mycobacterium avium complex infection 22.36 13.48 18 37355 4582 79702433
Pneumocystis jirovecii pneumonia 22.33 13.48 48 37325 32460 79674555
Hyperphosphaturia 22.33 13.48 6 37367 109 79706906
Type III hyperlipidaemia 22.27 13.48 4 37369 8 79707007
Urinary tract infection 22.19 13.48 61 37312 274451 79432564
Meningitis cryptococcal 22.06 13.48 16 37357 3490 79703525
Discomfort 22.05 13.48 16 37357 125601 79581414
Kidney fibrosis 21.94 13.48 16 37357 3519 79703496
Antiviral drug level below therapeutic 21.84 13.48 5 37368 45 79706970
Injection site erythema 21.70 13.48 5 37368 78192 79628823
Dyslipidaemia 21.66 13.48 27 37346 11606 79695409
Hypouricaemia 21.62 13.48 8 37365 424 79706591
Cerebellar syndrome 21.60 13.48 19 37354 5461 79701554
Dermatitis exfoliative 21.56 13.48 26 37347 10803 79696212
Hepatitis A 21.45 13.48 10 37363 951 79706064
Injury 21.42 13.48 5 37368 77491 79629524
Blood pressure systolic increased 21.36 13.48 3 37370 66983 79640032
Hyperlactacidaemia 21.25 13.48 19 37354 5576 79701439
Chest discomfort 21.24 13.48 20 37353 138024 79568991
Therapeutic product effect incomplete 21.24 13.48 21 37352 141624 79565391
Feeling abnormal 21.23 13.48 26 37347 159173 79547842
Eyelid oedema 21.17 13.48 29 37344 13658 79693357
Cholestasis of pregnancy 21.14 13.48 10 37363 983 79706032
Aplasia pure red cell 21.12 13.48 22 37351 7788 79699227
Normal newborn 21.09 13.48 21 37352 7051 79699964
Nasal congestion 21.04 13.48 5 37368 76547 79630468
Hyperhidrosis 21.00 13.48 24 37349 151468 79555547
Haemophilic arthropathy 20.91 13.48 6 37367 140 79706875
Loss of personal independence in daily activities 20.87 13.48 11 37362 102569 79604446
Liver function test abnormal 20.76 13.48 72 37301 64403 79642612
Dizziness 20.73 13.48 153 37220 526288 79180727
C-reactive protein increased 20.68 13.48 18 37355 129009 79578006
Retinal toxicity 20.59 13.48 11 37362 1400 79705615
Alopecia 20.56 13.48 49 37324 231306 79475709
Oropharyngeal pain 20.44 13.48 13 37360 109340 79597675
Red blood cell abnormality 20.40 13.48 9 37364 753 79706262
Rhabdomyolysis 20.35 13.48 99 37274 103032 79603983
Death 20.29 13.48 169 37204 566345 79140670
Helicobacter infection 20.28 13.48 4 37369 69700 79637315
Vitamin D deficiency 20.22 13.48 29 37344 14250 79692765
Pancreatitis acute 20.16 13.48 60 37313 49544 79657471
Limb operation 20.13 13.48 15 37358 3411 79703604
Pancreatitis 19.88 13.48 74 37299 68501 79638514
Lymphocytic infiltration 19.60 13.48 11 37362 1542 79705473
White matter lesion 19.41 13.48 12 37361 2010 79705005
Musculoskeletal pain 19.36 13.48 12 37361 102342 79604673
Syncope 19.34 13.48 34 37339 179415 79527600
Anaemia macrocytic 19.30 13.48 18 37355 5579 79701436
Drug abuse 19.24 13.48 29 37344 162662 79544353
Liver disorder 19.23 13.48 76 37297 72341 79634674
Blood triglycerides increased 19.21 13.48 35 37338 21005 79686010
Hyperphosphataemia 19.14 13.48 19 37354 6357 79700658
Cellulitis 19.00 13.48 14 37359 109046 79597969
Meningomyelocele 18.89 13.48 4 37369 24 79706991
Urine phosphorus increased 18.86 13.48 5 37368 86 79706929
Loss of consciousness 18.85 13.48 31 37342 167912 79539103
Portal fibrosis 18.80 13.48 8 37365 613 79706402
ACTH stimulation test abnormal 18.75 13.48 4 37369 25 79706990
Anogenital warts 18.65 13.48 9 37364 925 79706090
Weight increased 18.64 13.48 67 37306 277319 79429696
Cortisol decreased 18.63 13.48 12 37361 2160 79704855
Bone pain 18.60 13.48 63 37310 55679 79651336
Neurosyphilis 18.36 13.48 4 37369 28 79706987
Splenomegaly 18.29 13.48 34 37339 20720 79686295
Acute respiratory failure 18.22 13.48 3 37370 59538 79647477
Cardiac arrest 18.19 13.48 33 37340 172063 79534952
Nodular regenerative hyperplasia 18.16 13.48 10 37363 1351 79705664
Abortion infected 18.12 13.48 4 37369 30 79706985
Cachexia 17.93 13.48 24 37349 11059 79695956
Rash 17.93 13.48 375 36998 577983 79129032
Gynaecomastia 17.90 13.48 20 37353 7661 79699354
Abdominal pain upper 17.89 13.48 50 37323 223769 79483246
Creatinine renal clearance decreased 17.84 13.48 32 37341 18970 79688045
Blood bilirubin unconjugated increased 17.76 13.48 9 37364 1028 79705987
Disseminated tuberculosis 17.49 13.48 15 37358 4168 79702847
Ascites 17.47 13.48 76 37297 75486 79631529
Oesophageal varices haemorrhage 17.32 13.48 15 37358 4221 79702794
Mobility decreased 17.32 13.48 19 37354 122156 79584859
Rhinorrhoea 17.27 13.48 7 37366 76067 79630948
Nephrocalcinosis 17.24 13.48 10 37363 1492 79705523
Burkitt's lymphoma 17.14 13.48 5 37368 124 79706891
HIV infection 17.05 13.48 9 37364 1118 79705897
Pancytopenia 16.79 13.48 134 37239 165611 79541404
Ill-defined disorder 16.78 13.48 5 37368 65870 79641145
Liver transplant 16.76 13.48 15 37358 4408 79702607
Mitochondrial myopathy 16.72 13.48 6 37367 291 79706724
Hyperbilirubinaemia neonatal 16.71 13.48 3 37370 6 79707009
Hydromyelia 16.71 13.48 3 37370 6 79707009
Carbon dioxide combining power abnormal 16.71 13.48 3 37370 6 79707009
Glycocholic acid increased 16.71 13.48 3 37370 6 79707009
Pneumonitis 16.67 13.48 4 37369 60856 79646159
Chromaturia 16.53 13.48 37 37336 25709 79681306
Meningitis tuberculous 16.48 13.48 9 37364 1196 79705819
Pregnancy on oral contraceptive 16.44 13.48 8 37365 837 79706178
Urine uric acid increased 16.43 13.48 4 37369 48 79706967
Nephrogenic diabetes insipidus 16.38 13.48 11 37362 2123 79704892
Hodgkin's disease 16.31 13.48 8 37365 852 79706163
Psoriasis 16.27 13.48 11 37362 89576 79617439
Amylase increased 16.22 13.48 23 37350 11186 79695829
Blood corticotrophin decreased 16.20 13.48 7 37366 557 79706458
Lipohypertrophy 16.10 13.48 8 37365 876 79706139
CD4 lymphocytes abnormal 15.99 13.48 4 37369 54 79706961
Psychomotor retardation 15.98 13.48 17 37356 6167 79700848
Vth nerve injury 15.84 13.48 3 37370 9 79707006
Necrotising enterocolitis neonatal 15.84 13.48 3 37370 9 79707006
Glucose urine present 15.80 13.48 10 37363 1746 79705269
AIDS related complication 15.73 13.48 4 37369 58 79706957
Pharyngeal cancer 15.73 13.48 4 37369 58 79706957
Dry mouth 15.72 13.48 11 37362 88008 79619007
Optic nerve cupping 15.67 13.48 4 37369 59 79706956
Haematochezia 15.60 13.48 11 37362 87634 79619381
Muscle spasms 15.52 13.48 37 37336 174693 79532322
Upper respiratory tract infection 15.50 13.48 12 37361 91156 79615859
Erectile dysfunction 15.47 13.48 26 37347 14638 79692377
Pneumonia aspiration 15.47 13.48 6 37367 66961 79640054
Hyperproteinaemia 15.44 13.48 5 37368 177 79706838
Cystitis 15.39 13.48 3 37370 52729 79654286
Hypersensitivity 15.30 13.48 67 37306 262172 79444843
Anaemia 15.26 13.48 293 37080 444722 79262293
Prognathism 15.18 13.48 3 37370 12 79707003
Antiviral drug level above therapeutic 15.08 13.48 4 37369 69 79706946
Haemodialysis 15.06 13.48 29 37344 18139 79688876
HIV wasting syndrome 14.92 13.48 4 37369 72 79706943
Chronic obstructive pulmonary disease 14.83 13.48 11 37362 85408 79621607
Tuberculosis 14.79 13.48 26 37347 15172 79691843
Anembryonic gestation 14.76 13.48 6 37367 410 79706605
Congenital diaphragmatic hernia 14.63 13.48 3 37370 15 79707000
Blood pressure decreased 14.62 13.48 15 37358 99451 79607564
Disseminated mycobacterium avium complex infection 14.58 13.48 5 37368 212 79706803
Lipase increased 14.54 13.48 27 37346 16439 79690576
Bone density decreased 14.53 13.48 24 37349 13323 79693692
Unmasking of previously unidentified disease 14.36 13.48 10 37363 2047 79704968
Albuminuria 14.30 13.48 7 37366 742 79706273
Chronic hepatitis B 14.29 13.48 6 37367 445 79706570
Hemiparaesthesia 14.09 13.48 5 37368 235 79706780
Gestational diabetes 14.01 13.48 16 37357 6277 79700738
Bone marrow disorder 14.00 13.48 12 37361 3331 79703684
Total bile acids increased 13.96 13.48 4 37369 93 79706922
Hepatitis cholestatic 13.88 13.48 24 37349 13828 79693187
Haemorrhoids thrombosed 13.83 13.48 5 37368 248 79706767
Generalised anxiety disorder 13.76 13.48 10 37363 2187 79704828
Skin lesion 13.70 13.48 47 37326 41797 79665218
Muscle injury 13.69 13.48 3 37370 48558 79658457
Plasma cell myeloma 13.64 13.48 4 37369 53255 79653760
Cervix haemorrhage uterine 13.53 13.48 3 37370 23 79706992
Bone metabolism disorder 13.49 13.48 6 37367 512 79706503

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC J05AF07 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 J05AR11 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HIV infections, combinations
ATC J05AR12 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HIV infections, combinations
ATC J05AR24 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HIV infections, combinations
ATC J05AR27 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HIV infections, combinations
MeSH PA D019380 Anti-HIV Agents
MeSH PA D000890 Anti-Infective Agents
MeSH PA D044966 Anti-Retroviral Agents
MeSH PA D000998 Antiviral Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D019384 Nucleic Acid Synthesis Inhibitors
MeSH PA D018894 Reverse Transcriptase Inhibitors
CHEBI has role CHEBI:36044 antiviral drugs
CHEBI has role CHEBI:53756 reverse transcriptase inhibitors
CHEBI has role CHEBI:50266 Prodrugs

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

DiseaseRelationSNOMED_IDDOID
Chronic type B viral hepatitis indication 61977001
Human immunodeficiency virus infection indication 86406008 DOID:526
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
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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.86 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
200MG;300MG TRUVADA GILEAD N021752 Aug. 2, 2004 RX TABLET ORAL 8592397 Jan. 13, 2024 METHOD OF TREATMENT OF ADULTS INFECTED WITH HIV-1
200MG;300MG TRUVADA GILEAD N021752 Aug. 2, 2004 RX TABLET ORAL 8592397 Jan. 13, 2024 TREATMENT OF HIV
200MG;300MG TRUVADA GILEAD N021752 Aug. 2, 2004 RX TABLET ORAL 8592397 Jan. 13, 2024 TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
200MG;300MG TRUVADA GILEAD N021752 Aug. 2, 2004 RX TABLET ORAL 8716264 Jan. 13, 2024 TREATMENT OF HIV INFECTION
200MG;300MG TRUVADA GILEAD N021752 Aug. 2, 2004 RX TABLET ORAL 9457036 Jan. 13, 2024 TREATMENT OF HIV INFECTION
200MG;300MG TRUVADA GILEAD N021752 Aug. 2, 2004 RX TABLET ORAL 9744181 Jan. 13, 2024 TREATMENT OF HIV INFECTION
600MG;200MG;300MG ATRIPLA GILEAD SCIENCES N021937 July 12, 2006 RX TABLET ORAL 8592397 Jan. 13, 2024 TREATMENT OF HIV-1 INFECTION IN ADULTS
600MG;200MG;300MG ATRIPLA GILEAD SCIENCES N021937 July 12, 2006 RX TABLET ORAL 8592397 Jan. 13, 2024 TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
600MG;200MG;300MG ATRIPLA GILEAD SCIENCES N021937 July 12, 2006 RX TABLET ORAL 8716264 Jan. 13, 2024 TREATMENT OF HIV INFECTION
600MG;200MG;300MG ATRIPLA GILEAD SCIENCES N021937 July 12, 2006 RX TABLET ORAL 9457036 Jan. 13, 2024 TREATMENT OF HIV INFECTION
600MG;200MG;300MG ATRIPLA GILEAD SCIENCES N021937 July 12, 2006 RX TABLET ORAL 9744181 Jan. 13, 2024 TREATMENT OF HIV INFECTION
200MG;EQ 25MG BASE;300MG COMPLERA GILEAD SCIENCES INC N202123 Aug. 10, 2011 RX TABLET ORAL 8592397 Jan. 13, 2024 TREATMENT OF HIV INFECTION
200MG;EQ 25MG BASE;300MG COMPLERA GILEAD SCIENCES INC N202123 Aug. 10, 2011 RX TABLET ORAL 8716264 Jan. 13, 2024 TREATMENT OF HIV INFECTION
200MG;EQ 25MG BASE;300MG COMPLERA GILEAD SCIENCES INC N202123 Aug. 10, 2011 RX TABLET ORAL 9457036 Jan. 13, 2024 TREATMENT OF HIV INFECTION
200MG;EQ 25MG BASE;300MG COMPLERA GILEAD SCIENCES INC N202123 Aug. 10, 2011 RX TABLET ORAL 9744181 Jan. 13, 2024 TREATMENT OF HIV INFECTION
150MG;150MG;200MG;300MG STRIBILD GILEAD SCIENCES INC N203100 Aug. 27, 2012 RX TABLET ORAL 8592397 Jan. 13, 2024 TREATMENT OF HIV INFECTION
150MG;150MG;200MG;300MG STRIBILD GILEAD SCIENCES INC N203100 Aug. 27, 2012 RX TABLET ORAL 8716264 Jan. 13, 2024 TREATMENT OF HIV INFECTION
150MG;150MG;200MG;300MG STRIBILD GILEAD SCIENCES INC N203100 Aug. 27, 2012 RX TABLET ORAL 9457036 Jan. 13, 2024 TREATMENT OF HIV INFECTION
150MG;150MG;200MG;300MG STRIBILD GILEAD SCIENCES INC N203100 Aug. 27, 2012 RX TABLET ORAL 9744181 Jan. 13, 2024 TREATMENT OF HIV INFECTION
200MG;EQ 25MG BASE;300MG COMPLERA GILEAD SCIENCES INC N202123 Aug. 10, 2011 RX TABLET ORAL 7125879 April 21, 2025 TREATMENT OF HIV INFECTION
200MG;EQ 25MG BASE;300MG COMPLERA GILEAD SCIENCES INC N202123 Aug. 10, 2011 RX TABLET ORAL 8841310 Dec. 9, 2025 TREATMENT OF HIV INFECTION
600MG;200MG;300MG ATRIPLA GILEAD SCIENCES N021937 July 12, 2006 RX TABLET ORAL 9018192 June 13, 2026 TREATMENT OF HIV-1 INFECTION IN ADULTS
600MG;200MG;300MG ATRIPLA GILEAD SCIENCES N021937 July 12, 2006 RX TABLET ORAL 9018192 June 13, 2026 TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
600MG;200MG;300MG ATRIPLA GILEAD SCIENCES N021937 July 12, 2006 RX TABLET ORAL 9545414 June 13, 2026 TREATMENT OF HIV-1 INFECTION IN ADULTS
600MG;200MG;300MG ATRIPLA GILEAD SCIENCES N021937 July 12, 2006 RX TABLET ORAL 9545414 June 13, 2026 TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
150MG;150MG;200MG;300MG STRIBILD GILEAD SCIENCES INC N203100 Aug. 27, 2012 RX TABLET ORAL 7176220 Aug. 27, 2026 TREATMENT OF HIV INFECTION
150MG;150MG;200MG;300MG STRIBILD GILEAD SCIENCES INC N203100 Aug. 27, 2012 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;300MG STRIBILD GILEAD SCIENCES INC N203100 Aug. 27, 2012 RX TABLET ORAL 8633219 April 30, 2030 TREATMENT OF HIV INFECTION
100MG;300MG;300MG DELSTRIGO MSD MERCK CO N210807 Aug. 30, 2018 RX TABLET ORAL 8486975 Oct. 7, 2031 FOR THE TREATMENT OF HIV-1 INFECTION IN ADULT PATIENTS WITH NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY
100MG;300MG;300MG DELSTRIGO MSD MERCK CO N210807 Aug. 30, 2018 RX TABLET ORAL 8486975 Oct. 7, 2031 TREATMENT OF HIV-1 INFECTION IN ADULT PATIENTS AS A REPLACEMENT THERAPY IN VIROLOGICALLY SUPPRESSED ADULTS WITH NO HISTORY OF TREATMENT FAILURE AND NO KNOWN SUBSTITUTIONS ASSOCIATED WITH RESISTANCE TO THE INDIVIDUAL COMPONENTS OF DELSTRIGO
100MG;300MG;300MG DELSTRIGO MSD MERCK CO N210807 Aug. 30, 2018 RX TABLET ORAL 8486975 Oct. 7, 2031 TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS WEIGHING AT LEAST 35KG WITH NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR TO REPLACE THE CURRENT ANTIRETROVIRAL REGIMEN IN THOSE WHO ARE VIROLOGICALLY SUPPRESSED

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
100MG;300MG;300MG DELSTRIGO MSD MERCK CO N210807 Aug. 30, 2018 RX TABLET ORAL Aug. 30, 2023 NEW CHEMICAL ENTITY
100MG;300MG;300MG DELSTRIGO MSD MERCK CO N210807 Aug. 30, 2018 RX TABLET ORAL Jan. 27, 2025 NEW PATIENT POPULATION

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Reverse transcriptase/RNaseH Enzyme INHIBITOR CHEMBL CHEMBL
Gag-Pol polyprotein Polyprotein WOMBAT-PK

External reference:

IDSource
D01982 KEGG_DRUG
202138-50-9 SECONDARY_CAS_RN
4021279 VANDF
4021280 VANDF
C0384228 UMLSCUI
CHEBI:63718 CHEBI
CHEBI:63625 CHEBI
TFO PDB_CHEM_ID
CHEMBL1538 ChEMBL_ID
CHEMBL1486 ChEMBL_ID
D000068698 MESH_DESCRIPTOR_UI
DB00300 DRUGBANK_ID
F4YU4LON7I UNII
5481350 PUBCHEM_CID
DB14126 DRUGBANK_ID
117466 RXNORM
16193 MMSL
267164 MMSL
29323 MMSL
42402 MMSL
d04774 MMSL
009357 NDDF
009358 NDDF
017389 NDDF
385556006 SNOMEDCT_US
395264002 SNOMEDCT_US
421203005 SNOMEDCT_US
422091007 SNOMEDCT_US
206184-49-8 SECONDARY_CAS_RN
464205 PUBCHEM_CID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
DELSTRIGO HUMAN PRESCRIPTION DRUG LABEL 3 0006-5007 TABLET, FILM COATED 300 mg ORAL NDA 32 sections
DELSTRIGO HUMAN PRESCRIPTION DRUG LABEL 3 0006-5007 TABLET, FILM COATED 300 mg ORAL NDA 32 sections
Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate HUMAN PRESCRIPTION DRUG LABEL 3 0093-5234 TABLET, FILM COATED 300 mg ORAL ANDA 30 sections
Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate HUMAN PRESCRIPTION DRUG LABEL 3 0093-5234 TABLET, FILM COATED 300 mg ORAL ANDA 30 sections
Emtricitabine and Tenofovir Disoproxil Fumarate HUMAN PRESCRIPTION DRUG LABEL 2 0093-7607 TABLET, FILM COATED 300 mg ORAL ANDA 29 sections
Emtricitabine and Tenofovir Disoproxil Fumarate HUMAN PRESCRIPTION DRUG LABEL 2 0093-7704 TABLET, FILM COATED 300 mg ORAL ANDA 29 sections
Emtricitabine and Tenofovir Disoproxil Fumarate HUMAN PRESCRIPTION DRUG LABEL 2 0093-7704 TABLET, FILM COATED 300 mg ORAL ANDA 29 sections
Emtricitabine and Tenofovir Disoproxil Fumarate HUMAN PRESCRIPTION DRUG LABEL 2 0378-1930 TABLET, FILM COATED 300 mg ORAL ANDA 30 sections
tenofovir disproxil fumarate HUMAN PRESCRIPTION DRUG LABEL 1 0904-6821 TABLET 300 mg ORAL ANDA 27 sections
Emtricitabine and Tenofovir Disoproxil Fumarate HUMAN PRESCRIPTION DRUG LABEL 2 0904-7172 TABLET, FILM COATED 300 mg ORAL ANDA 28 sections
Emtricitabine and Tenofovir Disoproxil Fumarate HUMAN PRESCRIPTION DRUG LABEL 2 0904-7172 TABLET, FILM COATED 300 mg ORAL ANDA 28 sections
Atripla HUMAN PRESCRIPTION DRUG LABEL 3 15584-0101 TABLET, FILM COATED 300 mg ORAL NDA 34 sections
Emtricitabine and tenofovir disoproxil fumarate Human Prescription Drug Label 2 16714-534 TABLET, FILM COATED 300 mg ORAL ANDA 28 sections
Emtricitabine and tenofovir disoproxil fumarate Human Prescription Drug Label 2 16714-534 TABLET, FILM COATED 300 mg ORAL ANDA 28 sections
Tenofovir Disoproxil Fumarate Human Prescription Drug Label 1 16714-820 TABLET, FILM COATED 300 mg ORAL ANDA 27 sections
Tenofovir Disoproxil Fumarate Human Prescription Drug Label 1 31722-535 TABLET, FILM COATED 300 mg ORAL ANDA 30 sections
Tenofovir Disoproxil Fumarate Human Prescription Drug Label 1 31722-535 TABLET, FILM COATED 300 mg ORAL ANDA 30 sections
Emtricitabine and tenofovir disoproxil fumarate HUMAN PRESCRIPTION DRUG LABEL 2 31722-560 TABLET, FILM COATED 300 mg ORAL ANDA 27 sections
Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate HUMAN PRESCRIPTION DRUG LABEL 3 31722-736 TABLET, FILM COATED 300 mg ORAL ANDA 28 sections
tenofovir disproxil fumarate HUMAN PRESCRIPTION DRUG LABEL 1 33342-096 TABLET 300 mg ORAL ANDA 28 sections
tenofovir disproxil fumarate HUMAN PRESCRIPTION DRUG LABEL 1 33342-096 TABLET 300 mg ORAL ANDA 28 sections
tenofovir disproxil fumarate HUMAN PRESCRIPTION DRUG LABEL 1 33342-096 TABLET 300 mg ORAL ANDA 28 sections
Emtricitabine and tenofovir disoproxil fumarate Human Prescription Drug Label 2 33342-106 TABLET, FILM COATED 300 mg ORAL ANDA 28 sections
Emtricitabine and tenofovir disoproxil fumarate Human Prescription Drug Label 2 33342-106 TABLET, FILM COATED 300 mg ORAL ANDA 28 sections
Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate Human Prescription Drug Label 3 33342-138 TABLET, FILM COATED 300 mg ORAL ANDA 30 sections
Emtricitabine and Tenofovir Disoproxil Fumarate HUMAN PRESCRIPTION DRUG LABEL 2 42291-439 TABLET, FILM COATED 300 mg ORAL ANDA 26 sections
Emtricitabine and Tenofovir Disoproxil Fumarate HUMAN PRESCRIPTION DRUG LABEL 2 42291-439 TABLET, FILM COATED 300 mg ORAL ANDA 26 sections
Tenofovir Disoproxil Fumarate HUMAN PRESCRIPTION DRUG LABEL 1 42291-800 TABLET, FILM COATED 300 mg ORAL ANDA 27 sections
Tenofovir Disoproxil Fumarate Human Prescription Drug Label 1 42385-901 TABLET, FILM COATED 300 mg ORAL ANDA 28 sections
Efavirenz, emtricitabine and tenofovir disoproxil fumarate Human Prescription Drug Label 3 42385-915 TABLET, FILM COATED 300 mg ORAL ANDA 30 sections