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

Stem definitionDrug idCAS RN
HIV protease inhibitors 2391 155213-67-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • ABT538
  • ABT-538
  • ritonavir
  • norvir
Ritonavir is a peptidomimetic inhibitor of the HIV-1 protease. Inhibition of HIV protease renders the enzyme incapable of processing the Gag-Pol polyprotein precursor which leads to production of non-infectious immature HIV particles. Nirmatrelvir plus ritonavir (Paxlovid) has been approved for the treatment and post-exposure prophylaxis of coronavirus disease 2019 (COVID-19).
  • Molecular weight: 720.95
  • Formula: C37H48N6O5S2
  • CLOGP: 5.09
  • LIPINSKI: 2
  • HAC: 11
  • HDO: 4
  • TPSA: 145.78
  • ALOGS: -5.76
  • ROTB: 18

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
1.20 g O
0.80 g O
0.30 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 3.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 23.78 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 70 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
March 1, 1996 FDA ABBVIE
Aug. 25, 1996 EMA AbbVie Deutschland GmbH Co. KG
Feb. 10, 2022 PMDA PFIZER JAPAN 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
Exposure during pregnancy 1679.59 17.68 846 18408 120169 50465701
Foetal exposure during pregnancy 1610.15 17.68 540 18714 26819 50559051
Abortion spontaneous 1472.78 17.68 564 18690 41208 50544662
Maternal exposure during pregnancy 891.18 17.68 621 18633 159157 50426713
Premature baby 613.98 17.68 239 19015 18098 50567772
Stillbirth 601.93 17.68 178 19076 5774 50580096
Abortion induced 590.41 17.68 195 19059 9149 50576721
Live birth 539.15 17.68 211 19043 16197 50569673
Drug interaction 500.20 17.68 488 18766 199133 50386737
Premature delivery 390.10 17.68 187 19067 23476 50562394
Foetal death 347.53 17.68 127 19127 8053 50577817
Caesarean section 347.05 17.68 152 19102 15487 50570383
Pregnancy 300.76 17.68 169 19085 29408 50556462
Premature labour 259.32 17.68 113 19141 11363 50574507
Virologic failure 250.20 17.68 67 19187 1497 50584373
Premature rupture of membranes 231.87 17.68 81 19173 4499 50581371
Immune reconstitution inflammatory syndrome 224.50 17.68 83 19171 5433 50580437
Foetal growth restriction 206.20 17.68 82 19172 6545 50579325
Spina bifida 191.49 17.68 46 19208 651 50585219
Lipodystrophy acquired 162.05 17.68 46 19208 1283 50584587
CD4 lymphocytes decreased 161.70 17.68 46 19208 1293 50584577
Hyperbilirubinaemia 155.66 17.68 75 19179 9495 50576375
Cushing's syndrome 148.69 17.68 37 19217 611 50585259
Treatment noncompliance 143.64 17.68 107 19147 30043 50555827
Drug ineffective 141.76 17.68 68 19186 819265 49766605
Blood HIV RNA increased 139.38 17.68 34 19220 515 50585355
Viral load increased 136.16 17.68 39 19215 1124 50584746
Ventricular septal defect 129.19 17.68 51 19203 3990 50581880
Fanconi syndrome acquired 126.45 17.68 35 19219 888 50584982
Pre-eclampsia 118.72 17.68 59 19195 7985 50577885
Low birth weight baby 117.04 17.68 53 19201 5828 50580042
Adrenal suppression 110.01 17.68 31 19223 841 50585029
Pain 109.49 17.68 42 19212 578861 50007009
Polydactyly 108.96 17.68 25 19229 286 50585584
Gestational diabetes 107.94 17.68 54 19200 7411 50578459
Polyhydramnios 107.06 17.68 37 19217 1988 50583882
Congenital anomaly 105.10 17.68 34 19220 1487 50584383
Trisomy 21 104.05 17.68 25 19229 354 50585516
Cerebral ventricle dilatation 98.94 17.68 29 19225 908 50584962
Maternal drugs affecting foetus 98.65 17.68 45 19209 5032 50580838
Congenital naevus 98.63 17.68 21 19233 165 50585705
Placenta praevia 89.96 17.68 27 19227 919 50584951
Normal newborn 89.73 17.68 46 19208 6645 50579225
Fatigue 89.47 17.68 83 19171 707518 49878352
Pathogen resistance 87.74 17.68 43 19211 5646 50580224
Viral mutation identified 87.03 17.68 30 19224 1599 50584271
Low set ears 85.54 17.68 20 19234 250 50585620
Drug resistance 85.11 17.68 65 19189 18924 50566946
Fall 82.85 17.68 14 19240 334918 50250952
Supernumerary nipple 81.62 17.68 15 19239 48 50585822
Acoustic stimulation tests abnormal 81.36 17.68 16 19238 80 50585790
Joint swelling 80.23 17.68 3 19251 245283 50340587
Hepatocellular injury 73.19 17.68 68 19186 25879 50559991
Secondary adrenocortical insufficiency 72.71 17.68 24 19230 1119 50584751
Cholestasis of pregnancy 68.95 17.68 23 19231 1108 50584762
Renal tubular disorder 68.36 17.68 28 19226 2409 50583461
Patent ductus arteriosus 65.34 17.68 31 19223 3789 50582081
Congenital hydrocephalus 63.86 17.68 14 19240 128 50585742
Trisomy 18 62.00 17.68 11 19243 27 50585843
Nasopharyngitis 60.94 17.68 3 19251 192924 50392946
Renal colic 59.71 17.68 21 19233 1188 50584682
Meconium stain 59.44 17.68 14 19240 181 50585689
Dysmorphism 57.74 17.68 24 19230 2143 50583727
Macrocephaly 57.16 17.68 11 19243 48 50585822
Congenital choroid plexus cyst 57.10 17.68 15 19239 310 50585560
Ergot poisoning 56.97 17.68 12 19242 89 50585781
Eosinophilia 56.73 17.68 51 19203 18601 50567269
Cloacal exstrophy 56.56 17.68 13 19241 150 50585720
Premature separation of placenta 56.53 17.68 22 19232 1656 50584214
Umbilical cord abnormality 56.43 17.68 17 19237 586 50585284
Lipohypertrophy 56.15 17.68 17 19237 596 50585274
Neural tube defect 54.44 17.68 13 19241 179 50585691
Anal atresia 54.36 17.68 15 19239 376 50585494
Cushingoid 54.33 17.68 33 19221 6612 50579258
HIV infection 54.21 17.68 14 19240 270 50585600
Twin pregnancy 53.70 17.68 19 19235 1094 50584776
Atrial septal defect 53.16 17.68 32 19222 6309 50579561
Retinoblastoma 53.03 17.68 11 19243 75 50585795
Amniotic cavity infection 52.89 17.68 19 19235 1144 50584726
Tethered cord syndrome 51.83 17.68 13 19241 222 50585648
Bladder agenesis 51.77 17.68 12 19242 144 50585726
Foetal distress syndrome 51.62 17.68 19 19235 1226 50584644
Genitalia external ambiguous 51.25 17.68 12 19242 151 50585719
Swelling 50.49 17.68 8 19246 200864 50385006
Caudal regression syndrome 50.47 17.68 12 19242 162 50585708
Coloboma 49.90 17.68 10 19244 56 50585814
Fanconi syndrome 49.57 17.68 18 19236 1118 50584752
Congenital heart valve disorder 48.11 17.68 10 19244 69 50585801
Anencephaly 48.00 17.68 12 19242 202 50585668
Renal tubular acidosis 47.77 17.68 19 19235 1515 50584355
Gastrointestinal disorder congenital 47.69 17.68 11 19243 129 50585741
Portal hypertension 47.46 17.68 24 19230 3368 50582502
Mitochondrial cytopathy 46.89 17.68 12 19242 223 50585647
Congenital genital malformation 46.86 17.68 11 19243 140 50585730
Acute kidney injury 45.96 17.68 190 19064 227868 50358002
Peripheral swelling 45.88 17.68 11 19243 205925 50379945
CSF HIV escape syndrome 45.76 17.68 10 19244 90 50585780
Foetal malnutrition 45.66 17.68 10 19244 91 50585779
Neonatal respiratory arrest 45.60 17.68 9 19245 46 50585824
Exomphalos 44.98 17.68 14 19240 539 50585331
Dyspnoea 44.89 17.68 88 19166 547520 50038350
Gastrointestinal malformation 44.64 17.68 11 19243 174 50585696
Arthralgia 43.80 17.68 62 19192 438640 50147230
Ultrasound antenatal screen abnormal 43.53 17.68 10 19244 115 50585755
Sudden infant death syndrome 43.15 17.68 11 19243 201 50585669
Skin striae 42.92 17.68 16 19238 1070 50584800
Lactic acidosis 42.88 17.68 58 19196 33297 50552573
Hydrocephalus 42.31 17.68 25 19229 4763 50581107
Ichthyosis 42.13 17.68 8 19246 32 50585838
Placental disorder 42.06 17.68 17 19237 1413 50584457
Single umbilical artery 41.53 17.68 11 19243 235 50585635
Adrenal insufficiency 41.46 17.68 38 19216 14205 50571665
Hepatic cytolysis 41.36 17.68 30 19224 8073 50577797
Anembryonic gestation 41.27 17.68 13 19241 521 50585349
Alopecia 41.07 17.68 21 19233 245026 50340844
Foetal heart rate disorder 40.89 17.68 9 19245 84 50585786
Double outlet right ventricle 40.85 17.68 8 19246 39 50585831
Meningomyelocele 40.41 17.68 13 19241 558 50585312
Coarctation of the aorta 40.37 17.68 13 19241 560 50585310
Therapeutic product effect decreased 40.28 17.68 3 19251 136047 50449823
Cholestasis 40.25 17.68 49 19205 25352 50560518
Ectopic pregnancy 40.15 17.68 19 19235 2308 50583562
Congenital ectopic bladder 39.63 17.68 9 19245 98 50585772
Systemic lupus erythematosus 39.19 17.68 4 19250 140618 50445252
CSF test abnormal 38.80 17.68 11 19243 305 50585565
Anaemia 38.68 17.68 194 19060 252262 50333608
Abdominal discomfort 38.59 17.68 20 19234 231621 50354249
Hyperadrenocorticism 38.50 17.68 11 19243 314 50585556
Hemivertebra 37.96 17.68 9 19245 120 50585750
Constipation 37.47 17.68 12 19242 185696 50400174
Mitochondrial toxicity 37.45 17.68 11 19243 347 50585523
Cough 37.09 17.68 23 19231 241241 50344629
Placental insufficiency 36.89 17.68 15 19239 1266 50584604
Central obesity 36.56 17.68 14 19240 1008 50584862
Oesophageal candidiasis 36.26 17.68 23 19231 4971 50580899
Pregnancy on contraceptive 36.17 17.68 14 19240 1038 50584832
Hepatotoxicity 36.00 17.68 48 19206 27178 50558692
Oligohydramnios 35.69 17.68 24 19230 5726 50580144
Jaundice 35.57 17.68 47 19207 26382 50559488
Small for dates baby 35.50 17.68 20 19234 3485 50582385
Pain in extremity 35.49 17.68 31 19223 272834 50313036
Sepsis neonatal 35.46 17.68 11 19243 419 50585451
Infection 35.21 17.68 11 19243 172943 50412927
Genotype drug resistance test positive 35.18 17.68 10 19244 280 50585590
Osteoporosis 33.79 17.68 61 19193 44818 50541052
Nephropathy toxic 32.74 17.68 26 19228 8003 50577867
Endometritis decidual 32.69 17.68 6 19248 19 50585851
Threatened labour 32.59 17.68 12 19242 775 50585095
Pneumonia 32.53 17.68 59 19195 378342 50207528
Rash maculo-papular 32.24 17.68 45 19209 26596 50559274
Microcephaly 32.17 17.68 12 19242 804 50585066
Drug hypersensitivity 32.05 17.68 29 19225 250981 50334889
Muscle spasms 31.53 17.68 5 19249 125548 50460322
Left ventricular dilatation 31.34 17.68 10 19244 418 50585452
Transaminases increased 30.74 17.68 45 19209 27779 50558091
Discomfort 30.41 17.68 3 19251 108377 50477493
Pulmonary valve sclerosis 30.35 17.68 6 19248 31 50585839
Cerebral toxoplasmosis 30.22 17.68 11 19243 688 50585182
Lipoatrophy 30.05 17.68 9 19245 304 50585566
Congenital central nervous system anomaly 29.50 17.68 9 19245 324 50585546
Abortion threatened 29.01 17.68 10 19244 533 50585337
Condition aggravated 28.60 17.68 43 19211 297015 50288855
Renal tubular dysfunction 28.49 17.68 9 19245 364 50585506
Urinary tract infection 28.46 17.68 26 19228 223994 50361876
Cachexia 28.32 17.68 19 19235 4514 50581356
Potassium wasting nephropathy 28.31 17.68 6 19248 46 50585824
Congenital skin dimples 28.16 17.68 7 19247 115 50585755
Atrial fibrillation 28.07 17.68 3 19251 101742 50484128
Cardiac murmur 27.99 17.68 27 19227 10757 50575113
Congenital eye disorder 27.97 17.68 5 19249 13 50585857
Contraindicated product administered 27.70 17.68 11 19243 148947 50436923
HIV-associated neurocognitive disorder 27.67 17.68 7 19247 124 50585746
Product dose omission issue 27.58 17.68 18 19236 183820 50402050
Hypophosphataemia 27.56 17.68 24 19230 8390 50577480
Total bile acids increased 27.51 17.68 7 19247 127 50585743
Cardiac malposition 27.45 17.68 6 19248 54 50585816
Renal tubular necrosis 27.42 17.68 26 19228 10142 50575728
Headache 27.34 17.68 100 19154 506435 50079435
Bronchitis 26.49 17.68 4 19250 104155 50481715
Hypoaesthesia 26.06 17.68 8 19246 127249 50458621
Osteonecrosis 25.72 17.68 37 19217 22480 50563390
Blood bilirubin unconjugated increased 25.68 17.68 8 19246 309 50585561
Oesophageal atresia 25.44 17.68 9 19245 518 50585352
Mental disability 25.17 17.68 6 19248 82 50585788
Hepatic displacement 25.10 17.68 5 19249 27 50585843
Hyperlactacidaemia 24.96 17.68 14 19240 2419 50583451
Drug intolerance 24.90 17.68 28 19226 219076 50366794
Placental chorioangioma 24.73 17.68 4 19250 4 50585866
Musculoskeletal stiffness 24.70 17.68 9 19245 128472 50457398
Nephrolithiasis 24.66 17.68 46 19208 34647 50551223
Foetal anaemia 24.66 17.68 5 19249 30 50585840
Breast disorder 24.53 17.68 13 19241 2009 50583861
Isoimmune haemolytic disease 24.51 17.68 5 19249 31 50585839
Therapeutic product effect incomplete 24.49 17.68 3 19251 91512 50494358
Atrioventricular block complete 24.38 17.68 21 19233 7234 50578636
Death neonatal 23.70 17.68 7 19247 225 50585645
Gestational hypertension 23.65 17.68 13 19241 2160 50583710
Conduction disorder 23.55 17.68 11 19243 1297 50584573
Maxillonasal dysplasia 23.46 17.68 4 19250 7 50585863
Encephalomalacia 22.94 17.68 8 19246 441 50585429
Subchorionic haematoma 22.89 17.68 6 19248 123 50585747
Arthritis 22.83 17.68 3 19251 86718 50499152
Glucocorticoids increased 22.75 17.68 6 19248 126 50585744
Nodular regenerative hyperplasia 22.60 17.68 7 19247 265 50585605
Amniotic fluid volume decreased 22.54 17.68 8 19246 465 50585405
Congenital pulmonary valve disorder 22.49 17.68 5 19249 49 50585821
Bovine tuberculosis 22.23 17.68 5 19249 52 50585818
Off label use 22.22 17.68 99 19155 474327 50111543
Complication of delivery 22.03 17.68 6 19248 143 50585727
Congenital hand malformation 22.00 17.68 7 19247 290 50585580
Alpha 1 foetoprotein abnormal 21.97 17.68 5 19249 55 50585815
Immunosuppressant drug level increased 21.89 17.68 14 19240 3068 50582802
Retroplacental haematoma 21.87 17.68 6 19248 147 50585723
Prurigo 21.84 17.68 9 19245 786 50585084
Epilepsy congenital 21.72 17.68 4 19250 13 50585857
Dermatitis exfoliative generalised 21.71 17.68 14 19240 3112 50582758
Foetal malformation 21.35 17.68 6 19248 161 50585709
Transposition of the great vessels 21.25 17.68 6 19248 164 50585706
Back pain 21.01 17.68 32 19222 219998 50365872
Portal vein thrombosis 20.73 17.68 12 19242 2200 50583670
Feeling abnormal 20.63 17.68 11 19243 125481 50460389
Psychomotor retardation 20.57 17.68 14 19240 3404 50582466
Brachycephaly 20.51 17.68 4 19250 19 50585851
Mobility decreased 20.49 17.68 3 19251 79945 50505925
Coma hepatic 20.48 17.68 8 19246 608 50585262
Dizziness 20.26 17.68 66 19188 346303 50239567
Acquired immunodeficiency syndrome 20.18 17.68 5 19249 81 50585789
Generalised anxiety disorder 20.12 17.68 11 19243 1809 50584061
Pericarditis 20.06 17.68 3 19251 78686 50507184
Diaphragmatic aplasia 19.87 17.68 4 19250 23 50585847
Toxoplasmosis 19.75 17.68 10 19244 1407 50584463
Cortisol decreased 19.74 17.68 9 19245 1005 50584865
Aqueductal stenosis 19.72 17.68 4 19250 24 50585846
Thymus hypoplasia 19.72 17.68 4 19250 24 50585846
Hemiataxia 19.72 17.68 4 19250 24 50585846
High arched palate 19.43 17.68 5 19249 95 50585775
Clinodactyly 19.38 17.68 5 19249 96 50585774
Congenital absence of bile ducts 19.32 17.68 4 19250 27 50585843
Congenital genital malformation female 19.32 17.68 4 19250 27 50585843
Glycosuria 19.08 17.68 9 19245 1085 50584785
Pulmonary artery stenosis congenital 19.06 17.68 6 19248 240 50585630
HIV test positive 18.95 17.68 4 19250 30 50585840
Atrioventricular block first degree 18.94 17.68 17 19237 6184 50579686
Cleft lip 18.82 17.68 5 19249 108 50585762
Epidural lipomatosis 18.82 17.68 5 19249 108 50585762
Ultrasound scan abnormal 18.62 17.68 6 19248 259 50585611
Proteinuria 18.56 17.68 27 19227 16570 50569300
Brain stem auditory evoked response abnormal 18.55 17.68 3 19251 3 50585867
Skeletal dysplasia 18.55 17.68 3 19251 3 50585867
Jaundice neonatal 18.35 17.68 8 19246 803 50585067
Developmental coordination disorder 18.11 17.68 4 19250 38 50585832
Hepatitis C 18.10 17.68 15 19239 4902 50580968
Stomatitis 18.00 17.68 8 19246 101336 50484534
Foetal arrhythmia 17.98 17.68 5 19249 129 50585741
Hepatitis 17.89 17.68 38 19216 31415 50554455
Coagulation factor V level decreased 17.89 17.68 6 19248 294 50585576
Congenital cystic lung 17.75 17.68 4 19250 42 50585828

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
Foetal exposure during pregnancy 976.27 12.71 558 33075 33309 29507585
Drug interaction 631.14 12.71 935 32698 196450 29344444
Immune reconstitution inflammatory syndrome 597.71 12.71 251 33382 7551 29533343
Lipodystrophy acquired 504.82 12.71 173 33460 2921 29537973
Virologic failure 306.15 12.71 117 33516 2730 29538164
Progressive external ophthalmoplegia 284.35 12.71 91 33542 1226 29539668
Mitochondrial toxicity 284.31 12.71 106 33527 2305 29538589
Premature baby 279.53 12.71 198 33435 17082 29523812
Renal tubular disorder 274.14 12.71 122 33511 4230 29536664
Fanconi syndrome acquired 254.41 12.71 91 33542 1751 29539143
Osteoporosis 248.43 12.71 154 33479 10615 29530279
Exposure during pregnancy 211.80 12.71 128 33505 8426 29532468
Eyelid ptosis 197.64 12.71 103 33530 5083 29535811
Viral load increased 194.75 12.71 77 33556 1972 29538922
CD4 lymphocytes decreased 180.19 12.71 68 33565 1530 29539364
Trisomy 21 178.22 12.71 51 33582 456 29540438
Osteonecrosis 169.55 12.71 133 33500 13386 29527508
Hyperbilirubinaemia 168.31 12.71 138 33495 14796 29526098
Blood HIV RNA increased 150.56 12.71 53 33580 971 29539923
Hypertriglyceridaemia 147.77 12.71 97 33536 7378 29533516
Adrenal suppression 145.25 12.71 44 33589 488 29540406
Nephrolithiasis 139.95 12.71 158 33475 25176 29515718
Syphilis 136.09 12.71 38 33595 308 29540586
Cushing's syndrome 134.98 12.71 39 33594 362 29540532
Kaposi's sarcoma 128.21 12.71 45 33588 817 29540077
Polydactyly 123.08 12.71 47 33586 1093 29539801
HIV-associated neurocognitive disorder 116.22 12.71 33 33600 286 29540608
Lipoatrophy 102.32 12.71 33 33600 456 29540438
Psychiatric decompensation 97.39 12.71 43 33590 1461 29539433
Diplopia 97.16 12.71 97 33536 13421 29527473
Drug resistance 95.31 12.71 120 33513 21420 29519474
Glycosuria 94.35 12.71 39 33594 1123 29539771
Viral mutation identified 93.60 12.71 49 33584 2439 29538455
Jaundice 93.03 12.71 139 33494 29157 29511737
Fanconi syndrome 88.61 12.71 41 33592 1557 29539337
Depression suicidal 86.45 12.71 38 33595 1277 29539617
Mycobacterium avium complex infection 86.25 12.71 45 33588 2224 29538670
Hyperlipidaemia 86.19 12.71 88 33545 12502 29528392
Nephropathy toxic 82.54 12.71 80 33553 10676 29530218
Retinal toxicity 79.40 12.71 26 33607 378 29540516
Tearfulness 78.52 12.71 38 33595 1598 29539296
Dyslipidaemia 76.77 12.71 60 33573 6001 29534893
Heterotaxia 74.31 12.71 19 33614 105 29540789
Low birth weight baby 74.29 12.71 61 33572 6547 29534347
Congenital anomaly 73.41 12.71 34 33599 1294 29539600
Proteinuria 73.04 12.71 90 33543 15714 29525180
Hypophosphataemia 72.49 12.71 65 33568 7859 29533035
Hepatitis C 71.64 12.71 68 33565 8842 29532052
Ventricular septal defect 67.81 12.71 45 33588 3484 29537410
Laryngomalacia 64.99 12.71 21 33612 292 29540602
Cortisol decreased 64.47 12.71 27 33606 804 29540090
Atrial fibrillation 64.43 12.71 20 33613 105626 29435268
Fall 64.38 12.71 64 33569 177114 29363780
Renal colic 64.37 12.71 33 33600 1572 29539322
Dyspnoea 63.88 12.71 177 33456 326555 29214339
Hyperlactacidaemia 63.51 12.71 39 33594 2639 29538255
Blood triglycerides increased 62.41 12.71 75 33558 12759 29528135
Acquired immunodeficiency syndrome 62.39 12.71 22 33611 405 29540489
Pyelocaliectasis 60.08 12.71 28 33605 1081 29539813
Anal cancer 57.97 12.71 20 33613 344 29540550
Oesophageal candidiasis 57.65 12.71 42 33591 3779 29537115
Ophthalmoplegia 57.27 12.71 31 33602 1651 29539243
Cushingoid 56.53 12.71 35 33598 2403 29538491
Calculus urinary 56.04 12.71 27 33606 1124 29539770
Genotype drug resistance test positive 55.95 12.71 26 33607 997 29539897
Drug ineffective 55.64 12.71 219 33414 362951 29177943
Disease progression 54.65 12.71 13 33620 81903 29458991
Hypotension 54.12 12.71 86 33547 194268 29346626
Adrenal insufficiency 52.49 12.71 64 33569 11050 29529844
Renal impairment 51.64 12.71 206 33427 81127 29459767
Cerebral toxoplasmosis 50.74 12.71 27 33606 1389 29539505
Blood bilirubin increased 50.44 12.71 116 33517 33777 29507117
Drug level increased 49.71 12.71 82 33551 18705 29522189
Portal hypertension 49.62 12.71 37 33596 3449 29537445
Foetal growth restriction 49.25 12.71 38 33595 3728 29537166
Febrile neutropenia 48.80 12.71 34 33599 112206 29428688
Malignant neoplasm progression 48.72 12.71 12 33621 73847 29467047
Blood pressure increased 48.67 12.71 12 33621 73791 29467103
Atypical mycobacterial infection 48.50 12.71 21 33612 680 29540214
Ventricular hypoplasia 47.13 12.71 12 33621 65 29540829
Single umbilical artery 46.86 12.71 15 33618 202 29540692
Completed suicide 46.85 12.71 22 33611 90224 29450670
Blood bilirubin unconjugated increased 46.19 12.71 19 33614 540 29540354
Depressive symptom 45.88 12.71 27 33606 1690 29539204
Progressive multifocal leukoencephalopathy 45.78 12.71 53 33580 8666 29532228
Congenital hydronephrosis 45.20 12.71 20 33613 683 29540211
Pneumonia 44.69 12.71 200 33433 319972 29220922
Ergot poisoning 43.98 12.71 10 33623 30 29540864
Pathogen resistance 43.73 12.71 50 33583 8066 29532828
Chordee 43.61 12.71 11 33622 57 29540837
Cytomegalovirus chorioretinitis 43.06 12.71 33 33600 3205 29537689
Death 42.91 12.71 222 33411 341862 29199032
Genital herpes 42.76 12.71 18 33615 543 29540351
Cardiac failure congestive 42.39 12.71 17 33616 76564 29464330
Oesophageal atresia 42.25 12.71 17 33616 456 29540438
Renal tubular acidosis 42.10 12.71 26 33607 1777 29539117
Mitochondrial cytopathy 41.10 12.71 13 33620 168 29540726
Hyperadrenocorticism 41.05 12.71 11 33622 75 29540819
Hepatic cirrhosis 40.87 12.71 65 33568 14379 29526515
Hypospadias 40.82 12.71 31 33602 2971 29537923
Peripheral swelling 40.80 12.71 11 33622 63728 29477166
Anogenital dysplasia 40.73 12.71 12 33621 120 29540774
Drug abuse 40.65 12.71 20 33613 79863 29461031
Anogenital warts 39.33 12.71 17 33616 548 29540346
Lipohypertrophy 38.73 12.71 13 33620 205 29540689
Constipation 38.33 12.71 44 33589 114116 29426778
Hypercholesterolaemia 38.01 12.71 44 33589 7194 29533700
Atrioventricular septal defect 37.95 12.71 12 33621 155 29540739
Maternal drugs affecting foetus 37.73 12.71 33 33600 3860 29537034
Psychomotor skills impaired 37.33 12.71 28 33605 2633 29538261
Blood lactic acid increased 37.11 12.71 39 33594 5727 29535167
CSF HIV escape syndrome 36.67 12.71 12 33621 174 29540720
Vanishing bile duct syndrome 35.47 12.71 16 33617 572 29540322
Paranoia 34.43 12.71 49 33584 9828 29531066
Blood phosphorus decreased 34.04 12.71 27 33606 2758 29538136
Cachexia 34.02 12.71 39 33594 6310 29534584
Renal tubular dysfunction 34.00 12.71 14 33619 399 29540495
Pneumocystis jirovecii pneumonia 33.78 12.71 65 33568 16714 29524180
Fibrous histiocytoma 33.76 12.71 10 33623 102 29540792
Osteoporotic fracture 33.01 12.71 18 33615 973 29539921
Hepatitis 33.00 12.71 73 33560 20710 29520184
HIV infection 32.69 12.71 19 33614 1162 29539732
Karyotype analysis abnormal 32.65 12.71 8 33625 36 29540858
Porphyria non-acute 32.51 12.71 14 33619 447 29540447
Genital herpes simplex 32.37 12.71 10 33623 119 29540775
Gene mutation 32.18 12.71 18 33615 1023 29539871
Hepatomegaly 32.15 12.71 46 33587 9271 29531623
Off label use 31.88 12.71 206 33427 300594 29240300
Hepatitis B 31.55 12.71 35 33598 5462 29535432
Hypothalamic pituitary adrenal axis suppression 31.29 12.71 10 33623 134 29540760
Infusion related reaction 31.23 12.71 6 33627 43880 29497014
HIV wasting syndrome 31.10 12.71 9 33624 84 29540810
Secondary adrenocortical insufficiency 31.09 12.71 18 33615 1093 29539801
Oropharyngeal candidiasis 30.83 12.71 15 33618 638 29540256
Cryptorchism 30.79 12.71 22 33611 1920 29538974
Toxoplasmosis 30.26 12.71 18 33615 1149 29539745
Small for dates baby 30.08 12.71 28 33605 3551 29537343
Castleman's disease 30.07 12.71 7 33626 24 29540870
Treatment noncompliance 29.72 12.71 77 33556 24150 29516744
Haemophilic arthropathy 29.45 12.71 9 33624 103 29540791
Renal failure 29.40 12.71 233 33400 118366 29422528
Hemivertebra 29.37 12.71 9 33624 104 29540790
Mycobacterial infection 29.36 12.71 21 33612 1835 29539059
Foetal chromosome abnormality 29.20 12.71 6 33627 9 29540885
Ectopic kidney 29.03 12.71 7 33626 29 29540865
Liver disorder 28.86 12.71 83 33550 27666 29513228
Heart disease congenital 28.73 12.71 18 33615 1262 29539632
Hydrocele 28.40 12.71 21 33612 1932 29538962
Pain 28.33 12.71 100 33533 171332 29369562
Congenital nystagmus 28.10 12.71 6 33627 12 29540882
Multiple-drug resistance 28.04 12.71 28 33605 3872 29537022
Neonatal hyponatraemia 28.00 12.71 8 33625 71 29540823
Pulmonary malformation 27.80 12.71 7 33626 36 29540858
Foetal death 27.68 12.71 10 33623 198 29540696
Alanine aminotransferase increased 27.63 12.71 156 33477 70788 29470106
Anal cancer stage 0 27.47 12.71 6 33627 14 29540880
Blood corticotrophin decreased 27.41 12.71 9 33624 132 29540762
Psychotic disorder 27.39 12.71 67 33566 20287 29520607
Hodgkin's disease 27.07 12.71 15 33618 837 29540057
Haemorrhage 26.63 12.71 9 33624 45063 29495831
Blood creatine phosphokinase increased 26.61 12.71 104 33529 40540 29500354
Treponema test positive 26.56 12.71 5 33628 3 29540891
Acute kidney injury 26.52 12.71 436 33197 264831 29276063
Psychomotor retardation 26.40 12.71 24 33609 2952 29537942
Inappropriate schedule of product administration 26.06 12.71 9 33624 44463 29496431
Exomphalos 26.02 12.71 9 33624 156 29540738
Intentional product use issue 25.97 12.71 8 33625 42490 29498404
Blood antidiuretic hormone increased 25.96 12.71 7 33626 49 29540845
Fat tissue increased 25.91 12.71 11 33622 339 29540555
Sepsis 25.79 12.71 80 33553 142602 29398292
Feeling abnormal 25.68 12.71 15 33618 54430 29486464
Lactic acidosis 25.43 12.71 84 33549 30163 29510731
Blood alkaline phosphatase increased 24.89 12.71 80 33553 28326 29512568
Foetal distress syndrome 24.85 12.71 15 33618 984 29539910
Burkitt's lymphoma 24.71 12.71 8 33625 112 29540782
Malaria 24.55 12.71 9 33624 186 29540708
Product use issue 24.51 12.71 14 33619 51430 29489464
Joint swelling 24.38 12.71 13 33620 49617 29491277
Hepatic failure 24.29 12.71 85 33548 31427 29509467
Infection 24.24 12.71 31 33602 76720 29464174
Pancreatitis 23.98 12.71 90 33543 34424 29506470
CSF virus identified 23.97 12.71 6 33627 30 29540864
Opportunistic infection 23.91 12.71 17 33616 1472 29539422
Drug reaction with eosinophilia and systemic symptoms 23.77 12.71 78 33555 27914 29512980
Superior mesenteric artery syndrome 23.67 12.71 7 33626 71 29540823
Oral candidiasis 23.40 12.71 43 33590 10679 29530215
Secondary syphilis 23.34 12.71 6 33627 34 29540860
Dyschromatopsia 23.29 12.71 10 33623 317 29540577
Beta 2 microglobulin urine increased 23.16 12.71 7 33626 77 29540817
Therapeutic product effect incomplete 22.96 12.71 8 33625 39297 29501597
Coarctation of the aorta 22.83 12.71 11 33622 458 29540436
Chest discomfort 22.65 12.71 12 33621 45971 29494923
Cholelithiasis 22.55 12.71 59 33574 18613 29522281
Renal tubular necrosis 22.40 12.71 50 33583 14265 29526629
Epistaxis 22.00 12.71 16 33617 51688 29489206
Diaphragmatic hernia 21.94 12.71 9 33624 254 29540640
Pneumonitis 21.81 12.71 3 33630 28041 29512853
Drug level decreased 21.79 12.71 31 33602 6216 29534678
Aspartate aminotransferase increased 21.73 12.71 129 33504 59596 29481298
Acquired gene mutation 21.68 12.71 15 33618 1243 29539651
Jarisch-Herxheimer reaction 21.65 12.71 10 33623 378 29540516
Stillbirth 21.62 12.71 8 33625 170 29540724
Lymphadenopathy 21.45 12.71 70 33563 24979 29515915
Osteomalacia 21.39 12.71 13 33620 863 29540031
International normalised ratio increased 21.25 12.71 12 33621 44360 29496534
Kidney malformation 21.19 12.71 8 33625 180 29540714
Hepatotoxicity 21.11 12.71 56 33577 17811 29523083
Ocular icterus 21.10 12.71 20 33613 2595 29538299
Gastroschisis 21.05 12.71 7 33626 107 29540787
Neonatal asphyxia 21.03 12.71 9 33624 283 29540611
Lymphogranuloma venereum 20.89 12.71 4 33629 3 29540891
Interstitial lung disease 20.74 12.71 21 33612 57697 29483197
Leishmaniasis 20.71 12.71 9 33624 294 29540600
Blood cholesterol increased 20.62 12.71 51 33582 15544 29525350
Cardiac murmur 20.44 12.71 31 33602 6582 29534312
Depression 20.38 12.71 166 33467 84981 29455913
Persistent left superior vena cava 20.35 12.71 4 33629 4 29540890
Posterior cortical atrophy 20.35 12.71 4 33629 4 29540890
Hepatic cytolysis 20.17 12.71 35 33598 8312 29532582
Glucose urine present 20.14 12.71 13 33620 960 29539934
CD4 lymphocytes increased 19.97 12.71 8 33625 212 29540682
Intestinal malrotation 19.97 12.71 5 33628 25 29540869
Congenital renal disorder 19.85 12.71 6 33627 66 29540828
Suicidal ideation 19.69 12.71 85 33548 34631 29506263
Hepatitis B DNA assay positive 19.69 12.71 6 33627 68 29540826
Osteopenia 19.67 12.71 24 33609 4144 29536750
Encephalitis 19.67 12.71 30 33603 6400 29534494
Product dose omission issue 19.64 12.71 51 33582 96332 29444562
Gamma-glutamyltransferase increased 19.64 12.71 71 33562 26666 29514228
Central obesity 19.63 12.71 10 33623 470 29540424
Gastrointestinal haemorrhage 19.54 12.71 38 33595 79495 29461399
Urinary retention 19.49 12.71 6 33627 31892 29509002
Hyperuricaemia 19.48 12.71 31 33602 6858 29534036
Haematochezia 19.20 12.71 9 33624 36974 29503920
Urinary tract infection 19.17 12.71 33 33600 72321 29468573
Anomalous pulmonary venous connection 19.15 12.71 6 33627 75 29540819
Chlamydial infection 19.13 12.71 7 33626 144 29540750
Facial wasting 19.13 12.71 7 33626 144 29540750
Cardio-respiratory arrest 18.65 12.71 18 33615 50583 29490311
Vitamin D deficiency 18.64 12.71 27 33606 5502 29535392
Tubulointerstitial nephritis 18.56 12.71 53 33580 17590 29523304
Malignant anorectal neoplasm 18.54 12.71 5 33628 35 29540859
Retinal deposits 18.42 12.71 4 33629 9 29540885
Viral load decreased 18.30 12.71 5 33628 37 29540857
Pulmonary sequestration 18.30 12.71 5 33628 37 29540857
CD4 lymphocytes abnormal 18.30 12.71 5 33628 37 29540857
Immune reconstitution inflammatory syndrome associated tuberculosis 18.09 12.71 9 33624 402 29540492
Congenital coronary artery malformation 17.64 12.71 5 33628 43 29540851
HIV associated nephropathy 17.63 12.71 8 33625 290 29540604
Fontanelle bulging 17.59 12.71 4 33629 12 29540882
Seborrhoeic dermatitis 17.57 12.71 14 33619 1439 29539455
Retinal telangiectasia 17.34 12.71 3 33630 0 29540894
Umbilical cord vascular disorder 17.34 12.71 3 33630 0 29540894
Skin striae 17.15 12.71 9 33624 450 29540444
Intentional product misuse 17.14 12.71 9 33624 34652 29506242
Live birth 16.95 12.71 7 33626 201 29540693
Depressed mood 16.91 12.71 49 33584 16399 29524495
Injection site pain 16.68 12.71 8 33625 32438 29508456
Amylase increased 16.67 12.71 25 33608 5255 29535639
Neutrophil count decreased 16.64 12.71 15 33618 43552 29497342
Heart rate increased 16.63 12.71 12 33621 38926 29501968
Abdominal discomfort 16.56 12.71 18 33615 47885 29493009
Cardiac disorder 16.56 12.71 11 33622 37252 29503642
Psoriasis 16.49 12.71 8 33625 32219 29508675
Adrenogenital syndrome 16.38 12.71 5 33628 57 29540837
Fatigue 16.29 12.71 258 33375 316563 29224331
Intentional overdose 16.29 12.71 12 33621 38516 29502378
Nervous system disorder 16.29 12.71 41 33592 12633 29528261
Pleural effusion 16.27 12.71 36 33597 71872 29469022
Folate deficiency 16.22 12.71 12 33621 1105 29539789
Cerebrovascular accident 16.20 12.71 40 33593 76871 29464023
Product use in unapproved indication 16.19 12.71 48 33585 86827 29454067
Hepatocellular injury 16.11 12.71 57 33576 21186 29519708
Encephalitis viral 16.08 12.71 12 33621 1120 29539774
AIDS related complication 15.98 12.71 4 33629 20 29540874
Right aortic arch 15.98 12.71 4 33629 20 29540874
Muscle injury 15.88 12.71 12 33621 1141 29539753
Hypoglycaemia 15.81 12.71 19 33614 48327 29492567
Atrial septal defect 15.80 12.71 28 33605 6761 29534133
Hyperphosphaturia 15.78 12.71 5 33628 65 29540829
Pancytopenia 15.71 12.71 154 33479 83014 29457880
Central nervous system lymphoma 15.67 12.71 10 33623 724 29540170
Acute stress disorder 15.65 12.71 6 33627 141 29540753
Central pain syndrome 15.64 12.71 5 33628 67 29540827
Nephrocalcinosis 15.61 12.71 9 33624 542 29540352
Therapeutic product effect decreased 15.55 12.71 7 33626 29444 29511450
Hepatic cancer 15.51 12.71 27 33606 6429 29534465
Cardiac arrest 15.44 12.71 48 33585 85543 29455351
Hepatosplenomegaly 15.32 12.71 20 33613 3697 29537197
Eosinophilic pustular folliculitis 15.31 12.71 5 33628 72 29540822
Ultrasound antenatal screen 15.27 12.71 3 33630 3 29540891
ECG signs of ventricular hypertrophy 15.27 12.71 3 33630 3 29540891
Foetal cystic hygroma 15.27 12.71 3 33630 3 29540891
Immunoblastic lymphoma 15.27 12.71 3 33630 3 29540891
Retroviral infection 15.27 12.71 3 33630 3 29540891
17-hydroxyprogesterone increased 15.27 12.71 3 33630 3 29540891
Polymicrogyria 15.27 12.71 3 33630 3 29540891
Erythema elevatum diutinum 15.23 12.71 4 33629 25 29540869
Arthropathy 15.22 12.71 3 33630 21551 29519343
Congenital diaphragmatic hernia 15.19 12.71 7 33626 263 29540631
Crystal urine 15.19 12.71 5 33628 74 29540820
Hyperphagia 15.11 12.71 12 33621 1228 29539666
Oral herpes 15.09 12.71 22 33611 4510 29536384
Relapsing fever 15.09 12.71 6 33627 156 29540738
Lymphoma 15.01 12.71 34 33599 9794 29531100
Amyotrophy 14.94 12.71 8 33625 417 29540477
Transaminases increased 14.84 12.71 58 33575 22604 29518290
Post transplant distal limb syndrome 14.76 12.71 7 33626 281 29540613
Anaemia neonatal 14.74 12.71 7 33626 282 29540612
Blood pressure decreased 14.74 12.71 18 33615 45459 29495435
Normal newborn 14.67 12.71 6 33627 168 29540726
Lipids abnormal 14.60 12.71 7 33626 288 29540606
Parotid gland enlargement 14.56 12.71 7 33626 290 29540604
End stage AIDS 14.48 12.71 4 33629 31 29540863
Dizziness 14.42 12.71 142 33491 189542 29351352
Meconium ileus 14.37 12.71 4 33629 32 29540862
Wrong dose 14.31 12.71 8 33625 454 29540440
Congenital hydrocephalus 14.28 12.71 5 33628 90 29540804
COVID-19 14.24 12.71 12 33621 36002 29504892
Testicular mass 14.18 12.71 5 33628 92 29540802
Decreased appetite 14.11 12.71 102 33531 145240 29395654
Blood HIV RNA 14.05 12.71 3 33630 6 29540888
Congenital ureterocele 14.05 12.71 3 33630 6 29540888
Trisomy 15 14.05 12.71 3 33630 6 29540888
Portal fibrosis 14.04 12.71 7 33626 314 29540580
Spinal compression fracture 14.01 12.71 25 33608 6069 29534825
Acute hepatitis C 13.93 12.71 5 33628 97 29540797
Congenital hearing disorder 13.93 12.71 5 33628 97 29540797
Blood creatinine increased 13.90 12.71 153 33480 84949 29455945
Nephrogenic diabetes insipidus 13.83 12.71 11 33622 1128 29539766
Chest pain 13.77 12.71 73 33560 111900 29428994
Heart transplant rejection 13.73 12.71 11 33622 1140 29539754
Neurosyphilis 13.67 12.71 4 33629 39 29540855
Amoebic dysentery 13.58 12.71 4 33629 40 29540854
Chronic hepatitis C 13.56 12.71 7 33626 338 29540556
Kidney enlargement 13.54 12.71 9 33624 698 29540196
Genitalia external ambiguous 13.50 12.71 6 33627 207 29540687
Chronic obstructive pulmonary disease 13.49 12.71 16 33617 40939 29499955
Congenital anaemia 13.45 12.71 3 33630 8 29540886
Umbilical cord abnormality 13.40 12.71 4 33629 42 29540852
Confusional state 13.27 12.71 88 33545 127789 29413105
Congenital mitral valve incompetence 13.27 12.71 5 33628 112 29540782
Enanthema 13.27 12.71 7 33626 354 29540540
Intussusception 13.26 12.71 8 33625 524 29540370
Radius fracture 13.24 12.71 9 33624 725 29540169
Diabetes mellitus 13.20 12.71 84 33549 39747 29501147
Hypo HDL cholesterolaemia 13.19 12.71 3 33630 9 29540885
Oesophageal ulcer 13.19 12.71 17 33616 3103 29537791
Non-Hodgkin's lymphoma 13.14 12.71 12 33621 1485 29539409
Heart rate decreased 13.03 12.71 6 33627 24906 29515988
Femoral neck fracture 13.00 12.71 16 33617 2787 29538107
Neural tube defect 12.99 12.71 4 33629 47 29540847
Foetal cardiac disorder 12.95 12.71 3 33630 10 29540884
Duodenal atresia 12.95 12.71 3 33630 10 29540884
Electric shock 12.94 12.71 5 33628 120 29540774
Immunosuppressant drug level increased 12.87 12.71 21 33612 4744 29536150
Retinitis pigmentosa 12.84 12.71 4 33629 49 29540845
Ureterolithiasis 12.84 12.71 13 33620 1827 29539067
Bulbar palsy 12.84 12.71 6 33627 233 29540661

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
Abortion spontaneous 1249.29 13.33 496 38624 24647 64434965
Drug interaction 1228.47 13.33 1290 37830 360793 64098819
Exposure during pregnancy 939.50 13.33 585 38535 77090 64382522
Immune reconstitution inflammatory syndrome 787.07 13.33 293 38827 12177 64447435
Lipodystrophy acquired 662.02 13.33 195 38925 3832 64455780
Maternal exposure during pregnancy 636.41 13.33 500 38620 95384 64364228
Virologic failure 475.50 13.33 146 38974 3320 64456292
Abortion induced 465.73 13.33 167 38953 6221 64453391
Stillbirth 439.52 13.33 139 38981 3494 64456118
Live birth 358.86 13.33 162 38958 11042 64448570
Mitochondrial toxicity 358.56 13.33 111 39009 2595 64457017
Progressive external ophthalmoplegia 344.89 13.33 92 39028 1235 64458377
Fanconi syndrome acquired 340.67 13.33 104 39016 2317 64457295
Renal tubular disorder 317.62 13.33 124 38996 5863 64453749
Hyperbilirubinaemia 308.19 13.33 180 38940 21025 64438587
Adrenal suppression 265.97 13.33 75 39045 1252 64458360
Premature delivery 265.40 13.33 156 38964 18433 64441179
Viral load increased 259.28 13.33 85 39035 2402 64457210
Caesarean section 254.01 13.33 128 38992 11146 64448466
CD4 lymphocytes decreased 252.96 13.33 83 39037 2352 64457260
Cushing's syndrome 242.73 13.33 65 39055 886 64458726
Osteoporosis 215.28 13.33 189 38931 41891 64417721
Foetal exposure during pregnancy 210.54 13.33 85 39035 4391 64455221
Foetal death 209.94 13.33 92 39028 5838 64453774
Blood HIV RNA increased 201.36 13.33 62 39058 1422 64458190
Eyelid ptosis 193.88 13.33 101 39019 9424 64450188
Viral mutation identified 190.63 13.33 73 39047 3273 64456339
Pregnancy 190.34 13.33 132 38988 20733 64438879
Drug resistance 190.33 13.33 163 38957 34939 64424673
Premature rupture of membranes 172.31 13.33 70 39050 3674 64455938
Osteonecrosis 171.50 13.33 140 38980 28089 64431523
Nephrolithiasis 161.70 13.33 164 38956 43519 64416093
Premature labour 158.53 13.33 82 39038 7538 64452074
Syphilis 142.72 13.33 37 39083 441 64459171
Hypertriglyceridaemia 139.14 13.33 86 39034 11119 64448493
Nephropathy toxic 134.94 13.33 100 39020 17414 64442198
Treatment noncompliance 125.29 13.33 143 38977 43339 64416273
Jaundice 123.94 13.33 150 38970 48362 64411250
Fanconi syndrome 119.36 13.33 48 39072 2453 64457159
HIV-associated neurocognitive disorder 115.87 13.33 29 39091 297 64459315
Renal colic 111.76 13.33 45 39075 2307 64457305
Cushingoid 111.64 13.33 65 39055 7538 64452074
Pathogen resistance 111.22 13.33 78 39042 12465 64447147
CSF HIV escape syndrome 110.98 13.33 28 39092 297 64459315
Psychiatric decompensation 106.36 13.33 44 39076 2419 64457193
Lipoatrophy 104.95 13.33 31 39089 614 64458998
Portal hypertension 104.32 13.33 58 39062 6161 64453451
Pain 101.41 13.33 112 39008 553399 63906213
Fall 101.35 13.33 64 39056 416762 64042850
Mycobacterium avium complex infection 98.42 13.33 48 39072 3892 64455720
Secondary adrenocortical insufficiency 94.91 13.33 40 39080 2305 64457307
Ergot poisoning 94.52 13.33 21 39099 121 64459491
Diplopia 94.51 13.33 98 39022 26667 64432945
Acute kidney injury 90.64 13.33 522 38598 448718 64010894
Dyslipidaemia 90.26 13.33 61 39059 9181 64450431
Drug ineffective 89.84 13.33 240 38880 840007 63619605
Placenta praevia 89.49 13.33 28 39092 678 64458934
Premature baby 88.20 13.33 42 39078 3230 64456382
Polyhydramnios 86.71 13.33 33 39087 1454 64458158
Lipohypertrophy 86.32 13.33 28 39092 764 64458848
Depression suicidal 86.31 13.33 38 39082 2437 64457175
Glycosuria 86.02 13.33 36 39084 2038 64457574
Proteinuria 84.67 13.33 94 39026 27629 64431983
Adrenal insufficiency 84.23 13.33 85 39035 22402 64437210
Joint swelling 83.34 13.33 15 39105 215367 64244245
Hepatitis C 82.85 13.33 62 39058 10953 64448659
Hypophosphataemia 81.07 13.33 69 39051 14651 64444961
Peripheral swelling 79.99 13.33 15 39105 209138 64250474
Infusion related reaction 79.90 13.33 5 39115 164462 64295150
Renal tubular acidosis 79.57 13.33 38 39082 2941 64456671
Cortisol decreased 79.39 13.33 32 39088 1645 64457967
Retinal toxicity 79.30 13.33 30 39090 1300 64458312
Hyperadrenocorticism 77.83 13.33 21 39099 295 64459317
Calculus urinary 76.24 13.33 32 39088 1825 64457787
Kaposi's sarcoma 75.66 13.33 25 39095 724 64458888
Dyspnoea 75.42 13.33 207 38913 718467 63741145
Pre-eclampsia 75.27 13.33 47 39073 6184 64453428
Hyperlactacidaemia 72.68 13.33 42 39078 4802 64454810
Blood bilirubin unconjugated increased 70.70 13.33 25 39095 892 64458720
Gestational diabetes 69.64 13.33 43 39077 5547 64454065
Renal tubular dysfunction 69.25 13.33 23 39097 677 64458935
Tearfulness 68.74 13.33 40 39080 4633 64454979
Blood bilirubin increased 68.19 13.33 124 38996 57429 64402183
Genotype drug resistance test positive 63.88 13.33 24 39096 1020 64458592
Cerebral toxoplasmosis 63.56 13.33 28 39092 1798 64457814
Blood triglycerides increased 62.89 13.33 67 39053 18799 64440813
Acquired immunodeficiency syndrome 60.44 13.33 16 39104 208 64459404
Mitochondrial cytopathy 60.08 13.33 18 39102 375 64459237
Normal newborn 59.50 13.33 39 39081 5578 64454034
Hepatocellular injury 59.45 13.33 102 39018 45133 64414479
Ophthalmoplegia 58.87 13.33 30 39090 2672 64456940
Psychomotor retardation 57.65 13.33 37 39083 5106 64454506
Renal failure 57.22 13.33 240 38880 181448 64278164
Drug level increased 57.11 13.33 86 39034 34110 64425502
Psychomotor skills impaired 56.79 13.33 33 39087 3812 64455800
Lactic acidosis 56.56 13.33 119 39001 61291 64398321
Central obesity 56.16 13.33 24 39096 1431 64458181
Cholestasis of pregnancy 55.64 13.33 21 39099 904 64458708
Multiple-drug resistance 54.33 13.33 39 39081 6463 64453149
Swelling 54.24 13.33 15 39105 160203 64299409
Completed suicide 53.71 13.33 35 39085 224379 64235233
Renal impairment 53.65 13.33 192 38928 134825 64324787
Skin striae 53.26 13.33 23 39097 1407 64458205
Retinoblastoma 52.25 13.33 12 39108 82 64459530
Amniotic cavity infection 51.79 13.33 19 39101 755 64458857
Premature separation of placenta 51.31 13.33 21 39099 1123 64458489
Oesophageal candidiasis 51.29 13.33 41 39079 7976 64451636
Hepatotoxicity 51.06 13.33 89 39031 39873 64419739
Atrial fibrillation 50.93 13.33 20 39100 171069 64288543
Nasopharyngitis 49.10 13.33 29 39091 196044 64263568
Blood pressure increased 48.43 13.33 22 39098 172530 64287082
Pneumocystis jirovecii pneumonia 48.30 13.33 71 39049 27563 64432049
Synovitis 48.15 13.33 3 39117 99087 64360525
Renal tubular necrosis 47.91 13.33 63 39057 22047 64437565
Constipation 45.74 13.33 43 39077 229294 64230318
Arthralgia 45.05 13.33 129 38991 442131 64017481
Therapeutic product effect decreased 44.66 13.33 8 39112 115343 64344269
Toxoplasmosis 44.32 13.33 24 39096 2420 64457192
Abdominal discomfort 44.21 13.33 28 39092 182294 64277318
Hepatic failure 43.82 13.33 101 39019 55293 64404319
Hypercholesterolaemia 43.32 13.33 50 39070 15323 64444289
Drug reaction with eosinophilia and systemic symptoms 41.95 13.33 98 39022 54119 64405493
Infection 41.36 13.33 31 39089 184849 64274763
Hepatomegaly 41.15 13.33 51 39069 16831 64442781
Progressive multifocal leukoencephalopathy 41.14 13.33 53 39067 18179 64441433
Trisomy 21 40.78 13.33 9 39111 50 64459562
Spina bifida 40.49 13.33 9 39111 52 64459560
Injection site pain 40.47 13.33 9 39111 111399 64348213
Cachexia 40.43 13.33 38 39082 9179 64450433
Hepatitis 40.43 13.33 87 39033 45495 64414117
Hyperlipidaemia 40.10 13.33 59 39061 22917 64436695
Cytomegalovirus chorioretinitis 39.98 13.33 29 39091 4883 64454729
Immunosuppressant drug level increased 39.91 13.33 34 39086 7225 64452387
Alanine aminotransferase increased 39.42 13.33 178 38942 138853 64320759
HIV wasting syndrome 39.25 13.33 9 39111 61 64459551
Paranoia 39.21 13.33 49 39071 16303 64443309
Atypical mycobacterial infection 38.99 13.33 18 39102 1290 64458322
Therapeutic product effect incomplete 38.32 13.33 8 39112 103474 64356138
Maternal drugs affecting foetus 38.27 13.33 19 39101 1601 64458011
Hepatic cirrhosis 38.15 13.33 62 39058 26236 64433376
Hepatitis B 38.01 13.33 34 39086 7711 64451901
Twin pregnancy 36.13 13.33 15 39105 832 64458780
Anal cancer stage 0 35.96 13.33 7 39113 18 64459594
Aspartate aminotransferase increased 35.95 13.33 156 38964 119632 64339980
Pneumonia 35.50 13.33 197 38923 559379 63900233
Psychotic disorder 35.37 13.33 70 39050 34508 64425104
Depressive symptom 35.36 13.33 26 39094 4470 64455142
Blood creatine phosphokinase increased 35.02 13.33 96 39024 58462 64401150
Urinary tract infection 34.94 13.33 54 39066 231542 64228070
Transaminases increased 34.93 13.33 81 39039 44513 64415099
Feeling abnormal 34.52 13.33 19 39101 133583 64326029
Hypothalamic pituitary adrenal axis suppression 34.52 13.33 11 39109 283 64459329
Contusion 34.44 13.33 13 39107 113952 64345660
Alopecia 34.29 13.33 30 39090 165660 64293952
Genital herpes simplex 33.92 13.33 11 39109 300 64459312
Vanishing bile duct syndrome 33.23 13.33 16 39104 1261 64458351
Febrile neutropenia 33.12 13.33 39 39081 187618 64271994
Cough 33.08 13.33 85 39035 302063 64157549
Fat tissue increased 32.85 13.33 14 39106 829 64458783
Total bile acids increased 32.60 13.33 8 39112 75 64459537
CSF test abnormal 32.56 13.33 12 39108 483 64459129
Psoriasis 32.49 13.33 3 39117 71700 64387912
Inappropriate schedule of product administration 32.44 13.33 8 39112 92278 64367334
CSF virus identified 32.34 13.33 7 39113 35 64459577
Malignant neoplasm progression 32.28 13.33 14 39106 112857 64346755
Rash maculo-papular 32.10 13.33 81 39039 46945 64412667
Malaria 31.90 13.33 11 39109 364 64459248
Cardiac failure congestive 31.72 13.33 20 39100 130560 64329052
Fibrous histiocytoma 31.56 13.33 12 39108 527 64459085
Anembryonic gestation 31.45 13.33 11 39109 380 64459232
Blood lactic acid increased 31.29 13.33 35 39085 10366 64449246
Endometritis decidual 30.94 13.33 6 39114 15 64459597
HIV infection 30.80 13.33 14 39106 968 64458644
Blood alkaline phosphatase increased 30.46 13.33 89 39031 56190 64403422
Anogenital dysplasia 30.43 13.33 8 39112 101 64459511
Pregnancy on contraceptive 30.37 13.33 13 39107 778 64458834
Cholestasis 30.33 13.33 77 39043 44795 64414817
Pancreatitis 30.12 13.33 92 39028 59515 64400097
Disease progression 30.11 13.33 25 39095 141655 64317957
Drug hypersensitivity 29.98 13.33 62 39058 237753 64221859
Genital herpes 29.95 13.33 17 39103 1878 64457734
Pain in extremity 29.66 13.33 90 39030 302995 64156617
Anal cancer 29.66 13.33 12 39108 623 64458989
Fatigue 29.64 13.33 301 38819 748429 63711183
Sinusitis 29.50 13.33 27 39093 145901 64313711
Injection site erythema 29.47 13.33 4 39116 70796 64388816
Hypotension 29.41 13.33 125 38995 380849 64078763
Osteoporotic fracture 28.73 13.33 21 39099 3577 64456035
Heart rate increased 28.60 13.33 12 39108 98663 64360949
Contraindicated product administered 28.35 13.33 15 39105 107814 64351798
Blood corticotrophin decreased 27.91 13.33 10 39110 371 64459241
Chest discomfort 27.90 13.33 18 39102 116088 64343524
Death 27.89 13.33 175 38945 482530 63977082
Blood antidiuretic hormone increased 27.76 13.33 7 39113 74 64459538
Diabetes mellitus 27.64 13.33 96 39024 66378 64393234
Neutropenia neonatal 27.24 13.33 6 39114 33 64459579
Secondary syphilis 27.09 13.33 6 39114 34 64459578
Opportunistic infection 27.02 13.33 18 39102 2644 64456968
Facial wasting 26.96 13.33 7 39113 84 64459528
Erythema 26.91 13.33 45 39075 187025 64272587
Lower respiratory tract infection 26.63 13.33 12 39108 94602 64365010
Lymphadenopathy 26.40 13.33 75 39045 46611 64413001
Wound 26.17 13.33 7 39113 76470 64383142
Bronchitis 25.94 13.33 17 39103 108726 64350886
Hepatic cytolysis 25.86 13.33 37 39083 14012 64445600
Haemophilic arthropathy 25.64 13.33 7 39113 103 64459509
Labelled drug-drug interaction medication error 25.44 13.33 47 39073 22015 64437597
Product dose omission issue 25.20 13.33 50 39070 194697 64264915
Oropharyngeal candidiasis 25.05 13.33 14 39106 1501 64458111
Porphyria non-acute 24.91 13.33 11 39109 710 64458902
Burkitt's lymphoma 24.64 13.33 7 39113 120 64459492
Ectopic pregnancy 24.64 13.33 14 39106 1550 64458062
Gamma-glutamyltransferase increased 24.63 13.33 75 39045 48435 64411177
Encephalitis 24.46 13.33 34 39086 12537 64447075
Hypoglycaemia 24.38 13.33 12 39108 89880 64369732
Ocular icterus 24.27 13.33 22 39098 5076 64454536
Oesophageal atresia 24.19 13.33 6 39114 59 64459553
Rhabdomyolysis 24.19 13.33 115 39005 91611 64368001
Threatened labour 24.08 13.33 10 39110 555 64459057
Face oedema 23.98 13.33 49 39071 24712 64434900
Anogenital warts 23.66 13.33 11 39109 801 64458811
Castleman's disease 23.44 13.33 5 39115 23 64459589
Musculoskeletal pain 23.37 13.33 10 39110 81284 64378328
Chlamydial infection 23.24 13.33 9 39111 416 64459196
Pulmonary sequestration 23.10 13.33 5 39115 25 64459587
Anaemia neonatal 23.10 13.33 5 39115 25 64459587
Arthritis 23.02 13.33 11 39109 83803 64375809
Placental disorder 22.94 13.33 11 39109 859 64458753
Nodular regenerative hyperplasia 22.94 13.33 11 39109 859 64458753
Posterior cortical atrophy 22.86 13.33 4 39116 4 64459608
Placental chorioangioma 22.86 13.33 4 39116 4 64459608
Superior mesenteric artery syndrome 22.67 13.33 7 39113 162 64459450
Oxygen saturation decreased 22.66 13.33 19 39101 107157 64352455
Teratogenicity 22.52 13.33 6 39114 80 64459532
Stomatitis 22.48 13.33 20 39100 109585 64350027
HIV associated nephropathy 22.42 13.33 8 39112 293 64459319
Jarisch-Herxheimer reaction 22.20 13.33 10 39110 677 64458935
Blood phosphorus decreased 22.16 13.33 22 39098 5683 64453929
Dyschromatopsia 21.94 13.33 10 39110 696 64458916
Stress 21.76 13.33 5 39115 60529 64399083
Retroviral infection 21.59 13.33 4 39116 7 64459605
Pleural effusion 21.58 13.33 27 39093 126532 64333080
Wheezing 21.49 13.33 11 39109 80568 64379044
Pneumococcal sepsis 21.43 13.33 12 39108 1292 64458320
Product use issue 21.35 13.33 37 39083 151678 64307934
Intentional product use issue 21.30 13.33 16 39104 95348 64364264
Atypical mycobacterial lymphadenitis 21.24 13.33 4 39116 8 64459604
Death neonatal 21.19 13.33 5 39115 39 64459573
Blood creatinine increased 21.16 13.33 148 38972 135634 64323978
Immune reconstitution inflammatory syndrome associated tuberculosis 21.07 13.33 10 39110 763 64458849
Mobility decreased 21.05 13.33 13 39107 85827 64373785
Subchorionic haematoma 20.90 13.33 6 39114 107 64459505
Off label use 20.83 13.33 265 38855 632541 63827071
Intentional product misuse 20.61 13.33 9 39111 72286 64387326
Flushing 20.58 13.33 11 39109 78637 64380975
Meningitis cryptococcal 20.56 13.33 16 39104 2993 64456619
Pancytopenia 20.49 13.33 153 38967 143156 64316456
Nervous system disorder 20.40 13.33 44 39076 23034 64436578
Ascites 20.34 13.33 83 39037 61918 64397694
Musculoskeletal stiffness 20.27 13.33 27 39093 123179 64336433
CD4 lymphocytes abnormal 20.27 13.33 5 39115 48 64459564
Coagulation factor V level decreased 20.25 13.33 9 39111 590 64459022
Kidney fibrosis 20.14 13.33 16 39104 3085 64456527
Glucocorticoids increased 19.98 13.33 6 39114 126 64459486
Abortion threatened 19.96 13.33 8 39112 405 64459207
Anaemia 19.77 13.33 331 38789 378349 64081263
Benign prostatic hyperplasia 19.68 13.33 26 39094 9139 64450473
Malignant anorectal neoplasm 19.65 13.33 5 39115 55 64459557
Alpha 1 foetoprotein abnormal 19.57 13.33 5 39115 56 64459556
Generalised anxiety disorder 19.56 13.33 13 39107 1902 64457710
Pulmonary tuberculosis 19.47 13.33 23 39097 7221 64452391
Erythema elevatum diutinum 19.41 13.33 4 39116 15 64459597
Upper respiratory tract infection 19.31 13.33 10 39110 72775 64386837
Amniotic fluid volume decreased 19.28 13.33 7 39113 270 64459342
Retinal telangiectasia 19.23 13.33 3 39117 0 64459612
Hyperuricaemia 18.99 13.33 27 39093 10164 64449448
Tubulointerstitial nephritis 18.80 13.33 51 39069 30858 64428754
Potassium wasting nephropathy 18.70 13.33 6 39114 158 64459454
Testicular mass 18.68 13.33 5 39115 68 64459544
Hepatitis acute 18.65 13.33 31 39089 13358 64446254
Condition aggravated 18.53 13.33 141 38979 372285 64087327
Nephrocalcinosis 18.52 13.33 11 39109 1323 64458289
Varices oesophageal 18.49 13.33 19 39101 5111 64454501
Depression 18.46 13.33 181 38939 183110 64276502
Chest pain 18.45 13.33 77 39043 235903 64223709
Placental insufficiency 18.45 13.33 10 39110 1010 64458602
Dizziness 18.19 13.33 170 38950 429993 64029619
Oral candidiasis 18.00 13.33 42 39078 23170 64436442
HIV viraemia 17.98 13.33 5 39115 79 64459533
Liver disorder 17.96 13.33 72 39048 53279 64406333
Viral load decreased 17.87 13.33 4 39116 24 64459588
Chronic hepatitis C 17.85 13.33 8 39112 535 64459077
Hepatosplenomegaly 17.85 13.33 19 39101 5324 64454288
Rhinorrhoea 17.85 13.33 7 39113 59962 64399650
Haematochezia 17.79 13.33 9 39111 66364 64393248
Eosinophilia 17.61 13.33 57 39063 38019 64421593
Vitamin D deficiency 17.55 13.33 28 39092 11664 64447948
Drug intolerance 17.54 13.33 57 39063 187935 64271677
Pericarditis 17.48 13.33 8 39112 62508 64397104
Hepatitis B reactivation 17.43 13.33 18 39102 4871 64454741
Hepatic cancer 17.35 13.33 22 39098 7426 64452186
Hodgkin's disease 17.35 13.33 9 39111 832 64458780
5'nucleotidase increased 17.15 13.33 3 39117 3 64459609
ECG signs of ventricular hypertrophy 17.15 13.33 3 39117 3 64459609
Immunoblastic lymphoma 17.15 13.33 3 39117 3 64459609
Treponema test positive 17.15 13.33 3 39117 3 64459609
Chronic kidney disease 17.03 13.33 75 39045 57844 64401768
Haemolytic anaemia 17.02 13.33 33 39087 16020 64443592
Prurigo 16.80 13.33 10 39110 1207 64458405
Acquired gene mutation 16.79 13.33 12 39108 1974 64457638
Hepatitis cholestatic 16.74 13.33 28 39092 12127 64447485
Hepatic steatosis 16.74 13.33 49 39071 30958 64428654
Epistaxis 16.66 13.33 21 39099 98110 64361502
Tuberculosis 16.60 13.33 29 39091 13009 64446603
Eosinophilic pustular folliculitis 16.56 13.33 5 39115 107 64459505
Osteopenia 16.55 13.33 32 39088 15508 64444104
Drug level decreased 16.52 13.33 27 39093 11476 64448136
Pneumonitis 16.51 13.33 5 39115 50360 64409252
Glucose urine present 16.48 13.33 11 39109 1621 64457991
Congenital hydrocephalus 16.45 13.33 4 39116 36 64459576
Mycobacterial infection 16.44 13.33 14 39106 2974 64456638
Cell death 16.43 13.33 16 39104 4038 64455574
Discomfort 16.30 13.33 15 39105 80863 64378749
Gene mutation 16.28 13.33 12 39108 2070 64457542
Gestational hypertension 16.19 13.33 11 39109 1670 64457942
Burning sensation 16.15 13.33 5 39115 49659 64409953
Anticoagulation drug level increased 16.15 13.33 8 39112 671 64458941
Crystal urine 16.06 13.33 5 39115 119 64459493
Liver function test abnormal 16.04 13.33 75 39045 59326 64400286
Foetal distress syndrome 15.96 13.33 7 39113 445 64459167
Bulbar palsy 15.95 13.33 6 39114 256 64459356
White matter lesion 15.94 13.33 11 39109 1711 64457901
Foetal growth restriction 15.90 13.33 11 39109 1719 64457893
Splenomegaly 15.60 13.33 34 39086 17927 64441685
Osteomalacia 15.57 13.33 10 39110 1381 64458231
Foetal disorder 15.57 13.33 5 39115 132 64459480
CD4 lymphocytes increased 15.54 13.33 6 39114 275 64459337
Trichomoniasis 15.53 13.33 5 39115 133 64459479
Neck pain 15.53 13.33 9 39111 61524 64398088
Pneumonia pneumococcal 15.48 13.33 14 39106 3220 64456392
New onset diabetes after transplantation 15.46 13.33 5 39115 135 64459477
Seborrhoeic dermatitis 15.36 13.33 11 39109 1815 64457797
Lymphogranuloma venereum 15.33 13.33 3 39117 8 64459604
Back pain 15.30 13.33 89 39031 250082 64209530
Lipids abnormal 15.20 13.33 7 39113 499 64459113
Hepatic encephalopathy 15.13 13.33 37 39083 21029 64438583
Loss of personal independence in daily activities 15.12 13.33 13 39107 72441 64387171
Hypo HDL cholesterolaemia 15.07 13.33 3 39117 9 64459603
Nephrogenic diabetes insipidus 15.04 13.33 11 39109 1876 64457736
Post transplant distal limb syndrome 14.89 13.33 7 39113 523 64459089
Encephalitis viral 14.86 13.33 12 39108 2368 64457244
Complication of pregnancy 14.80 13.33 6 39114 313 64459299
Arterial spasm 14.75 13.33 5 39115 157 64459455
AIDS related complication 14.71 13.33 4 39116 58 64459554
Nasal congestion 14.67 13.33 9 39111 59649 64399963
Drug abuse 14.65 13.33 37 39083 132337 64327275
Acute myocardial infarction 14.61 13.33 82 39038 69636 64389976
Metabolic acidosis 14.57 13.33 83 39037 70875 64388737
Speech disorder developmental 14.53 13.33 7 39113 552 64459060
Conduction disorder 14.50 13.33 13 39107 2955 64456657
Intentional overdose 14.50 13.33 20 39100 89924 64369688
Dermatitis exfoliative 14.46 13.33 24 39096 10328 64449284
Anaemia of pregnancy 14.46 13.33 4 39116 62 64459550
Suicidal ideation 14.44 13.33 79 39041 66463 64393149
Prognathism 14.40 13.33 3 39117 12 64459600
Blood HIV RNA 14.40 13.33 3 39117 12 64459600
Wrong technique in product usage process 14.38 13.33 11 39109 64963 64394649
Amylase increased 14.27 13.33 23 39097 9662 64449950
Urinary retention 14.22 13.33 6 39114 49195 64410417
Cholelithiasis 14.21 13.33 60 39060 45446 64414166
Balance disorder 14.21 13.33 18 39102 83908 64375704
Portal fibrosis 14.17 13.33 7 39113 583 64459029
Haemoptysis 14.15 13.33 6 39114 49042 64410570
Eyelid oedema 13.96 13.33 26 39094 12253 64447359
Oesophageal ulcer 13.93 13.33 18 39102 6192 64453420
Intussusception 13.92 13.33 8 39112 905 64458707
Nephropathy 13.87 13.33 21 39099 8365 64451247
Paternal drugs affecting foetus 13.86 13.33 3 39117 15 64459597
Congenital diaphragmatic hernia 13.86 13.33 3 39117 15 64459597
Cardio-respiratory arrest 13.83 13.33 24 39096 98369 64361243
Osteoarthritis 13.67 13.33 11 39109 63325 64396287
Ureterolithiasis 13.66 13.33 13 39107 3188 64456424
Neutrophil count decreased 13.65 13.33 16 39104 77180 64382432
Interstitial lung disease 13.59 13.33 24 39096 97708 64361904
Acute stress disorder 13.45 13.33 6 39114 397 64459215
Hirsutism 13.45 13.33 8 39112 965 64458647
Acute haemorrhagic conjunctivitis 13.40 13.33 3 39117 18 64459594
Plasmablastic lymphoma 13.36 13.33 6 39114 403 64459209
Cerebrovascular accident 13.33 13.33 41 39079 137542 64322070

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC J05AE03 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Protease inhibitors
ATC J05AP52 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HCV infections
ATC J05AP53 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HCV infections
ATC J05AR10 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HIV infections, combinations
ATC J05AR23 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HIV infections, combinations
ATC J05AR26 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HIV infections, combinations
FDA MoA N0000000246 HIV Protease Inhibitors
FDA EPC N0000175889 Protease Inhibitor
FDA MoA N0000182137 Cytochrome P450 2D6 Inhibitors
FDA MoA N0000182141 Cytochrome P450 3A4 Inhibitors
FDA MoA N0000185503 P-Glycoprotein Inhibitors
FDA MoA N0000185507 Cytochrome P450 2C9 Inducers
FDA MoA N0000185607 Cytochrome P450 2C19 Inducers
FDA MoA N0000187064 Cytochrome P450 2B6 Inducers
FDA MoA N0000190113 Breast Cancer Resistance Protein Inhibitors
FDA MoA N0000190114 Cytochrome P450 3A Inhibitors
FDA MoA N0000190117 UDP Glucuronosyltransferases Inducers
FDA MoA N0000190118 Cytochrome P450 3A Inducers
FDA EPC N0000191001 Cytochrome P450 3A Inhibitor
FDA MoA N0000191266 Cytochrome P450 1A2 Inducers
CHEBI has role CHEBI:35660 HIV protease inhibitors
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:36044 antiviral drugs
CHEBI has role CHEBI:78298 environmental contaminants
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 D065692 Cytochrome P-450 CYP3A Inhibitors
MeSH PA D065607 Cytochrome P-450 Enzyme Inhibitors
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D017320 HIV Protease Inhibitors
MeSH PA D065606 Metabolic Side Effects of Drugs and Substances
MeSH PA D011480 Protease Inhibitors
MeSH PA D000084762 Viral Protease Inhibitors

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Human immunodeficiency virus infection indication 86406008 DOID:526
Chronic hepatitis C indication 128302006
COVID-19 indication 840539006
Prevention of HIV Infection after Exposure off-label use
Hypercholesterolemia contraindication 13644009
Hyperbilirubinemia contraindication 14783006 DOID:2741
Cirrhosis of liver contraindication 19943007 DOID:5082
Complete atrioventricular block contraindication 27885002
Hereditary factor VIII deficiency disease contraindication 28293008 DOID:12134
Torsades de pointes contraindication 31722008
Hyperuricemia contraindication 35885006 DOID:1920
Hereditary factor IX deficiency disease contraindication 41788008 DOID:12259
Hypokalemia contraindication 43339004
Conduction disorder of the heart contraindication 44808001
Chronic type B viral hepatitis contraindication 61977001
Diabetes mellitus contraindication 73211009 DOID:9351
Pancreatitis contraindication 75694006 DOID:4989
Hyperglycemia contraindication 80394007 DOID:4195
Cardiomyopathy contraindication 85898001 DOID:0050700
Gout contraindication 90560007 DOID:13189
Prolonged QT interval contraindication 111975006
Structural disorder of heart contraindication 128599005
Liver function tests abnormal contraindication 166603001
Hypomagnesemia contraindication 190855004
Second degree atrioventricular block contraindication 195042002
Acute pancreatitis contraindication 197456007 DOID:2913
Disease of liver contraindication 235856003 DOID:409
Mixed hyperlipidemia contraindication 267434003
Hypertriglyceridemia contraindication 302870006
Breastfeeding (mother) contraindication 413712001
Myocardial ischemia contraindication 414795007 DOID:3393
Congenital long QT syndrome contraindication 442917000
First Degree Atrioventricular Heart Block contraindication




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 12.39 acidic
pKa2 13.84 acidic
pKa3 3.62 Basic
pKa4 2.45 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** VIEKIRA XR ABBVIE INC N208624 July 22, 2016 DISCN TABLET, EXTENDED RELEASE ORAL 8501238 Sept. 17, 2028 USE OF DASABUVIR TO INHIBIT VIRAL REPLICATION FOR THE TREATMENT OF HCV INFECTION.
EQ 250MG BASE;12.5MG, 75MG, 50MG VIEKIRA PAK (COPACKAGED) ABBVIE INC N206619 Dec. 19, 2014 DISCN TABLET ORAL 9139536 Nov. 9, 2028 TREATMENT OF HCV INFECTION USING DASABUVIR
EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** VIEKIRA XR ABBVIE INC N208624 July 22, 2016 DISCN TABLET, EXTENDED RELEASE ORAL 9139536 Nov. 9, 2028 TREATMENT OF HCV INFECTION USING DASABUVIR
EQ 250MG BASE;12.5MG, 75MG, 50MG VIEKIRA PAK (COPACKAGED) ABBVIE INC N206619 Dec. 19, 2014 DISCN TABLET ORAL 8501238 Dec. 19, 2028 USE OF DASABUVIR TO INHIBIT VIRAL REPLICATION FOR THE TREATMENT OF HCV INFECTION.
EQ 250MG BASE;12.5MG, 75MG, 50MG VIEKIRA PAK (COPACKAGED) ABBVIE INC N206619 Dec. 19, 2014 DISCN TABLET ORAL 8188104 May 17, 2029 USE OF DASABUVIR TO INHIBIT VIRAL REPLICATION FOR THE TREATMENT OF HCV INFECTION.
EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** VIEKIRA XR ABBVIE INC N208624 July 22, 2016 DISCN TABLET, EXTENDED RELEASE ORAL 8188104 May 17, 2029 USE OF DASABUVIR TO INHIBIT VIRAL REPLICATION FOR THE TREATMENT OF HCV INFECTION.
EQ 250MG BASE;12.5MG, 75MG, 50MG VIEKIRA PAK (COPACKAGED) ABBVIE INC N206619 Dec. 19, 2014 DISCN TABLET ORAL 8642538 Sept. 10, 2029 TREATMENT OF HCV INFECTION USING PARITAPREVIR
12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TECHNIVIE ABBVIE INC N207931 July 24, 2015 DISCN TABLET ORAL 8642538 Sept. 10, 2029 TREATMENT OF HCV INFECTION USING PARITAPREVIR
EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** VIEKIRA XR ABBVIE INC N208624 July 22, 2016 DISCN TABLET, EXTENDED RELEASE ORAL 8642538 Sept. 10, 2029 TREATMENT OF HCV INFECTION USING PARITAPREVIR
EQ 250MG BASE;12.5MG, 75MG, 50MG VIEKIRA PAK (COPACKAGED) ABBVIE INC N206619 Dec. 19, 2014 DISCN TABLET ORAL 9006387 June 10, 2030 TREATMENT OF HCV INFECTION USING OMBITASVIR
12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TECHNIVIE ABBVIE INC N207931 July 24, 2015 DISCN TABLET ORAL 9006387 June 10, 2030 TREATMENT OF HCV INFECTION USING OMBITASVIR
EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** VIEKIRA XR ABBVIE INC N208624 July 22, 2016 DISCN TABLET, EXTENDED RELEASE ORAL 9006387 June 10, 2030 TREATMENT OF HCV INFECTION USING OMBITASVIR
EQ 250MG BASE;12.5MG, 75MG, 50MG VIEKIRA PAK (COPACKAGED) ABBVIE INC N206619 Dec. 19, 2014 DISCN TABLET ORAL 9044480 April 10, 2031 TREATMENT OF HCV INFECTION USING PARITAPREVIR
12.5MG;75MG;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TECHNIVIE ABBVIE INC N207931 July 24, 2015 DISCN TABLET ORAL 9044480 April 10, 2031 TREATMENT OF HCV INFECTION USING PARITAPREVIR
EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** VIEKIRA XR ABBVIE INC N208624 July 22, 2016 DISCN TABLET, EXTENDED RELEASE ORAL 9044480 April 10, 2031 TREATMENT OF HCV INFECTION USING PARITAPREVIR
EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** VIEKIRA XR ABBVIE INC N208624 July 22, 2016 DISCN TABLET, EXTENDED RELEASE ORAL 10201584 May 17, 2032 TREATMENT OF HCV INFECTION USING DASABUVIR/OMBITASVIR/PARITAPREVIR/RITONAVIR FIXED DOSE COMBINATION
EQ 250MG BASE;12.5MG, 75MG, 50MG VIEKIRA PAK (COPACKAGED) ABBVIE INC N206619 Dec. 19, 2014 DISCN TABLET ORAL 8466159 Sept. 4, 2032 TREATMENT OF HCV INFECTION USING PARITAPREVIR, OMBITASVIR, RITONAVIR, AND DASABUVIR WITH RIBAVIRIN.
EQ 250MG BASE;12.5MG, 75MG, 50MG VIEKIRA PAK (COPACKAGED) ABBVIE INC N206619 Dec. 19, 2014 DISCN TABLET ORAL 8492386 Sept. 4, 2032 TREATMENT OF HCV INFECTION USING PARITAPREVIR, OMBITASVIR, RITONAVIR, AND DASABUVIR, WITHOUT RIBAVIRIN
EQ 250MG BASE;12.5MG, 75MG, 50MG VIEKIRA PAK (COPACKAGED) ABBVIE INC N206619 Dec. 19, 2014 DISCN TABLET ORAL 8680106 Sept. 4, 2032 TREATMENT OF HCV INFECTION USING PARITAPREVIR, OMBITASVIR, RITONAVIR, AND DASABUVIR WITH RIBAVIRIN.
EQ 250MG BASE;12.5MG, 75MG, 50MG VIEKIRA PAK (COPACKAGED) ABBVIE INC N206619 Dec. 19, 2014 DISCN TABLET ORAL 8685984 Sept. 4, 2032 TREATMENT OF HCV INFECTION USING PARITAPREVIR, OMBITASVIR, RITONAVIR, AND DASABUVIR, WITHOUT RIBAVIRIN
EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** VIEKIRA XR ABBVIE INC N208624 July 22, 2016 DISCN TABLET, EXTENDED RELEASE ORAL 8466159 Sept. 4, 2032 TREATMENT OF HCV INFECTION USING PARITAPREVIR, OMBITASVIR, RITONAVIR, AND DASABUVIR WITH RIBAVIRIN.
EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** VIEKIRA XR ABBVIE INC N208624 July 22, 2016 DISCN TABLET, EXTENDED RELEASE ORAL 8492386 Sept. 4, 2032 TREATMENT OF HCV INFECTION USING PARITAPREVIR, OMBITASVIR, RITONAVIR, AND DASABUVIR, WITHOUT RIBAVIRIN
EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** VIEKIRA XR ABBVIE INC N208624 July 22, 2016 DISCN TABLET, EXTENDED RELEASE ORAL 8680106 Sept. 4, 2032 TREATMENT OF HCV INFECTION USING PARITAPREVIR, OMBITASVIR, RITONAVIR, AND DASABUVIR WITH RIBAVIRIN.
EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** VIEKIRA XR ABBVIE INC N208624 July 22, 2016 DISCN TABLET, EXTENDED RELEASE ORAL 8685984 Sept. 4, 2032 TREATMENT OF HCV INFECTION USING PARITAPREVIR, OMBITASVIR, RITONAVIR, AND DASABUVIR, WITHOUT RIBAVIRIN
EQ 250MG BASE;12.5MG, 75MG, 50MG VIEKIRA PAK (COPACKAGED) ABBVIE INC N206619 Dec. 19, 2014 DISCN TABLET ORAL 10201542 Oct. 18, 2033 TREATMENT OF HCV INFECTION USING DASABUVIR
EQ 250MG BASE;12.5MG, 75MG, 50MG VIEKIRA PAK (COPACKAGED) ABBVIE INC N206619 Dec. 19, 2014 DISCN TABLET ORAL 9629841 Oct. 18, 2033 TREATMENT OF HCV INFECTION USING DASABUVIR
EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** VIEKIRA XR ABBVIE INC N208624 July 22, 2016 DISCN TABLET, EXTENDED RELEASE ORAL 10105365 Jan. 2, 2035 TREATMENT OF HCV INFECTION USING DASABUVIR/OMBITASVIR/PARITAPREVIR/RITONAVIR FIXED DOSE COMBINATION
EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** VIEKIRA XR ABBVIE INC N208624 July 22, 2016 DISCN TABLET, EXTENDED RELEASE ORAL 9333204 Jan. 2, 2035 TREATMENT OF HCV INFECTION USING DASABUVIR/OMBITASVIR/PARITAPREVIR/RITONAVIR FIXED DOSE COMBINATION
EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** VIEKIRA XR ABBVIE INC N208624 July 22, 2016 DISCN TABLET, EXTENDED RELEASE ORAL 9744170 Jan. 2, 2035 TREATMENT OF HCV INFECTION USING DASABUVIR/OMBITASVIR/PARITAPREVIR/RITONAVIR FIXED DOSE COMBINATION

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Cytochrome P450 3A4 Enzyme IC50 7.55 WOMBAT-PK
Multidrug resistance protein 1 Transporter IC50 5.83 WOMBAT-PK
Cytochrome P450 2D6 Enzyme IC50 4.30 DRUG MATRIX
Nuclear receptor subfamily 1 group I member 2 Nuclear hormone receptor WOMBAT-PK
Kappa-type opioid receptor GPCR Ki 5.26 DRUG MATRIX
Cytochrome P450 2C9 Enzyme IC50 7.80 DRUG MATRIX
Vasopressin V1a receptor GPCR Ki 5.30 DRUG MATRIX
Thromboxane-A synthase Enzyme IC50 7.12 DRUG MATRIX
Solute carrier family 22 member 1 Transporter IC50 4.47 CHEMBL
Substance-K receptor GPCR Ki 6.06 DRUG MATRIX
Cytochrome P450 3A5 Enzyme INHIBITOR Ki 6.92 IUPHAR
UDP-glucuronosyltransferase 1-1 Enzyme INHIBITOR IC50 5.77 IUPHAR
Solute carrier family 22 member 2 Transporter IC50 4.61 CHEMBL
Multidrug and toxin extrusion protein 1 Transporter IC50 7.10 CHEMBL
Multidrug and toxin extrusion protein 2 Transporter IC50 5.36 CHEMBL
Mu-type opioid receptor GPCR Ki 4.58 DRUG MATRIX
Pol polyprotein Enzyme INHIBITOR Ki 10.82 CHEMBL CHEMBL
Gag-Pol polyprotein Polyprotein Ki 9.23 WOMBAT-PK
Protease Enzyme Ki 10.47 CHEMBL

External reference:

IDSource
4020963 VUID
N0000148436 NUI
D00427 KEGG_DRUG
4020963 VANDF
C0292818 UMLSCUI
CHEBI:45409 CHEBI
RIT PDB_CHEM_ID
CHEMBL163 ChEMBL_ID
D019438 MESH_DESCRIPTOR_UI
DB00503 DRUGBANK_ID
8804 IUPHAR_LIGAND_ID
7449 INN_ID
O3J8G9O825 UNII
392622 PUBCHEM_CID
196479 RXNORM
251788 MMSL
5431 MMSL
6452 MMSL
d03984 MMSL
005554 NDDF
108693005 SNOMEDCT_US
386896009 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Ritonavir HUMAN PRESCRIPTION DRUG LABEL 1 0054-0407 TABLET, FILM COATED 100 mg ORAL ANDA 30 sections
Ritonavir HUMAN PRESCRIPTION DRUG LABEL 1 0054-0407 TABLET, FILM COATED 100 mg ORAL ANDA 30 sections
Kaletra HUMAN PRESCRIPTION DRUG LABEL 2 0074-0522 TABLET, FILM COATED 25 mg ORAL NDA 32 sections
Kaletra HUMAN PRESCRIPTION DRUG LABEL 2 0074-1575 TABLET, FILM COATED 25 mg ORAL NDA 32 sections
Norvir HUMAN PRESCRIPTION DRUG LABEL 1 0074-1940 SOLUTION 80 mg ORAL NDA 29 sections
Kaletra HUMAN PRESCRIPTION DRUG LABEL 2 0074-2605 TABLET, FILM COATED 50 mg ORAL NDA 32 sections
Norvir HUMAN PRESCRIPTION DRUG LABEL 1 0074-3333 TABLET, FILM COATED 100 mg ORAL NDA 29 sections
Norvir HUMAN PRESCRIPTION DRUG LABEL 1 0074-3399 POWDER 100 mg ORAL NDA 29 sections
Kaletra HUMAN PRESCRIPTION DRUG LABEL 2 0074-3956 SOLUTION 20 mg ORAL NDA 32 sections
Kaletra HUMAN PRESCRIPTION DRUG LABEL 2 0074-6799 TABLET, FILM COATED 50 mg ORAL NDA 32 sections
Lopinavir-Ritonavir HUMAN PRESCRIPTION DRUG LABEL 2 0527-1947 SOLUTION 20 mg ORAL ANDA 27 sections
Lopinavir-Ritonavir HUMAN PRESCRIPTION DRUG LABEL 2 0527-1947 SOLUTION 20 mg ORAL ANDA 27 sections
Kaletra HUMAN PRESCRIPTION DRUG LABEL 2 11819-342 TABLET, FILM COATED 50 mg ORAL NDA 27 sections
Kaletra HUMAN PRESCRIPTION DRUG LABEL 2 21695-362 TABLET, FILM COATED 50 mg ORAL NDA 27 sections
Lopinavir and ritonavir HUMAN PRESCRIPTION DRUG LABEL 2 31722-556 TABLET, FILM COATED 50 mg ORAL ANDA 27 sections
Ritonavir Human Prescription Drug Label 1 31722-597 TABLET 100 mg ORAL ANDA 26 sections
Lopinavir and ritonavir HUMAN PRESCRIPTION DRUG LABEL 2 31722-603 TABLET, FILM COATED 25 mg ORAL ANDA 27 sections
Lopinavir and Ritonavir Human Prescription Drug Label 2 42385-933 TABLET, FILM COATED 25 mg ORAL ANDA 28 sections
Lopinavir and Ritonavir Human Prescription Drug Label 2 42385-934 TABLET, FILM COATED 50 mg ORAL ANDA 28 sections
Kaletra HUMAN PRESCRIPTION DRUG LABEL 2 53808-0276 TABLET, FILM COATED 50 mg ORAL NDA 27 sections
Norvir HUMAN PRESCRIPTION DRUG LABEL 1 53808-1119 TABLET, FILM COATED 100 mg ORAL NDA 28 sections
Kaletra HUMAN PRESCRIPTION DRUG LABEL 2 54868-5566 TABLET, FILM COATED 50 mg ORAL NDA 27 sections
Kaletra HUMAN PRESCRIPTION DRUG LABEL 2 55289-947 TABLET, FILM COATED 50 mg ORAL NDA 27 sections
Ritonavir HUMAN PRESCRIPTION DRUG LABEL 1 60687-364 TABLET, FILM COATED 100 mg ORAL ANDA 29 sections
Ritonavir HUMAN PRESCRIPTION DRUG LABEL 1 60687-420 TABLET, FILM COATED 100 mg ORAL ANDA 30 sections
Lopinavir and Ritonavir HUMAN PRESCRIPTION DRUG LABEL 2 65015-299 GRANULE 10 mg ORAL Export only 1 sections
Ritonavir HUMAN PRESCRIPTION DRUG LABEL 1 65162-061 TABLET 100 mg ORAL ANDA 28 sections
Ritonavir Human Prescription Drug Label 1 65862-687 TABLET, FILM COATED 100 mg ORAL ANDA 29 sections
Kaletra HUMAN PRESCRIPTION DRUG LABEL 2 66336-624 TABLET, FILM COATED 50 mg ORAL NDA 27 sections
Norvir HUMAN PRESCRIPTION DRUG LABEL 1 67296-1234 TABLET, FILM COATED 100 mg ORAL NDA 19 sections