ritonavir 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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
0.60 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 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 70 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2B,AXL,BRAF,CAMK2D,CDK5,CDK9,EIF2AK3,ERBB2,GRK2,ITK,MAPK7,NTRK2,PDK1,PDK2,PDK4,PIK3CB,PRKDC 17
kinase-selectivity-class GRK2 1
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 45.709 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 0 High 1
rat-kpuu-brain Rat brain Kpuu 0.003 % High 1

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
Abortion spontaneous 2311.23 19.02 789 26128 53267 90548263
Foetal exposure during pregnancy 2020.46 19.02 674 26243 42301 90559229
Exposure during pregnancy 2010.97 19.02 1101 25816 237309 90364221
Maternal exposure during pregnancy 971.01 19.02 822 26095 359241 90242289
Drug interaction 889.41 19.02 700 26217 275753 90325777
Abortion induced 858.23 19.02 259 26658 11629 90589901
Premature baby 799.31 19.02 295 26622 24782 90576748
Stillbirth 772.19 19.02 215 26702 7228 90594302
Virologic failure 489.61 19.02 117 26800 2107 90599423
Caesarean section 474.44 19.02 186 26731 18391 90583139
Premature delivery 468.17 19.02 229 26688 38533 90562997
Premature labour 391.79 19.02 148 26769 13228 90588302
Live birth 363.25 19.02 249 26668 78858 90522672
Foetal death 338.75 19.02 151 26766 20572 90580958
Pregnancy 322.53 19.02 211 26706 61836 90539694
Premature rupture of membranes 304.03 19.02 98 26819 5460 90596070
Lipodystrophy acquired 294.01 19.02 72 26845 1442 90600088
Immune reconstitution inflammatory syndrome 262.45 19.02 93 26824 6926 90594604
Foetal growth restriction 246.77 19.02 96 26821 9284 90592246
Cushing's syndrome 240.37 19.02 52 26865 584 90600946
Hyperbilirubinaemia 222.78 19.02 100 26817 13836 90587694
Treatment noncompliance 219.00 19.02 155 26762 51572 90549958
Blood HIV RNA increased 195.15 19.02 46 26871 778 90600752
CD4 lymphocytes decreased 184.99 19.02 50 26867 1497 90600033
Spina bifida 181.84 19.02 44 26873 836 90600694
Drug ineffective 178.84 19.02 95 26822 1384203 89217327
Pre-eclampsia 175.70 19.02 79 26838 10969 90590561
Ventricular septal defect 166.19 19.02 62 26855 5345 90596185
Pain 161.76 19.02 48 26869 996293 89605237
Maternal drugs affecting foetus 161.70 19.02 60 26857 5095 90596435
Viral load increased 161.53 19.02 45 26872 1511 90600019
Low birth weight baby 157.92 19.02 70 26847 9397 90592133
Gestational diabetes 156.70 19.02 72 26845 10510 90591020
Polydactyly 148.04 19.02 31 26886 294 90601236
Fanconi syndrome acquired 146.84 19.02 40 26877 1234 90600296
Viral mutation identified 145.51 19.02 44 26873 1981 90599549
Trisomy 21 137.45 19.02 31 26886 427 90601103
Adrenal suppression 136.71 19.02 36 26881 973 90600557
Acute kidney injury 132.41 19.02 293 26624 320094 90281436
Renal colic 132.14 19.02 39 26878 1614 90599916
Joint swelling 127.88 19.02 5 26912 503295 90098235
Pathogen resistance 125.78 19.02 57 26860 8058 90593472
Renal tubular disorder 125.63 19.02 44 26873 3163 90598367
Immunosuppressant drug level increased 123.44 19.02 48 26869 4632 90596898
Hepatic cytolysis 122.45 19.02 89 26828 30827 90570703
Drug resistance 121.39 19.02 88 26829 30361 90571169
Ectopic pregnancy 121.37 19.02 43 26874 3198 90598332
Polyhydramnios 116.14 19.02 39 26878 2469 90599061
Congenital naevus 115.30 19.02 23 26894 167 90601363
Placenta praevia 114.34 19.02 32 26885 1093 90600437
Cerebral ventricle dilatation 112.02 19.02 31 26886 1015 90600515
Fatigue 109.90 19.02 109 26808 1153914 89447616
Hepatocellular injury 109.35 19.02 81 26836 28877 90572653
Cholestasis of pregnancy 107.90 19.02 33 26884 1544 90599986
Umbilical cord abnormality 105.32 19.02 27 26890 655 90600875
Patent ductus arteriosus 103.55 19.02 42 26875 4527 90597003
Hydrocephalus 101.45 19.02 45 26872 6049 90595481
Genotype drug resistance test positive 100.77 19.02 24 26893 425 90601105
Nasopharyngitis 100.23 19.02 5 26912 407099 90194431
Arthropathy 95.21 19.02 3 26914 366239 90235291
Low set ears 95.18 19.02 21 26896 260 90601270
Jaundice 94.68 19.02 78 26839 32439 90569091
Lipohypertrophy 93.61 19.02 25 26892 714 90600816
Fall 92.35 19.02 16 26901 481794 90119736
Supernumerary nipple 91.06 19.02 16 26901 51 90601479
Acoustic stimulation tests abnormal 90.98 19.02 17 26900 83 90601447
Systemic lupus erythematosus 90.52 19.02 4 26913 361892 90239638
Atrial septal defect 88.54 19.02 45 26872 8189 90593341
Congenital genital malformation 87.52 19.02 18 26899 155 90601375
Congenital anomaly 87.18 19.02 41 26876 6306 90595224
Swelling 87.02 19.02 11 26906 419047 90182483
Amniotic cavity infection 86.19 19.02 27 26890 1369 90600161
Peripheral swelling 85.40 19.02 11 26906 413095 90188435
Trisomy 18 83.77 19.02 17 26900 136 90601394
Meconium stain 83.70 19.02 18 26899 196 90601334
HIV infection 83.52 19.02 21 26896 470 90601060
Anaemia 83.36 19.02 262 26655 352540 90248990
Cloacal exstrophy 82.39 19.02 17 26900 149 90601381
Sinusitis 82.00 19.02 5 26912 343083 90258447
Fanconi syndrome 81.29 19.02 28 26889 1915 90599615
Anal atresia 80.31 19.02 20 26897 430 90601100
Abdominal discomfort 79.05 19.02 22 26895 477306 90124224
Gastrointestinal disorder congenital 78.19 19.02 16 26901 134 90601396
Bladder agenesis 77.26 19.02 16 26901 143 90601387
Genitalia external ambiguous 76.57 19.02 16 26901 150 90601380
Mitochondrial cytopathy 75.45 19.02 17 26900 233 90601297
Congenital heart valve disorder 74.82 19.02 14 26903 69 90601461
Caudal regression syndrome 73.68 19.02 16 26901 183 90601347
Hepatotoxicity 73.60 19.02 79 26838 45763 90555767
Renal dysplasia 73.23 19.02 18 26899 366 90601164
Secondary adrenocortical insufficiency 72.77 19.02 27 26890 2291 90599239
Gastrointestinal malformation 72.67 19.02 16 26901 196 90601334
Normal newborn 72.14 19.02 58 26859 23304 90578226
Hand deformity 71.79 19.02 4 26913 296358 90305172
Infection 71.64 19.02 11 26906 362083 90239447
Alopecia 71.22 19.02 29 26888 495042 90106488
Exomphalos 70.90 19.02 19 26898 550 90600980
Cushingoid 70.75 19.02 42 26875 10353 90591177
Sudden infant death syndrome 70.55 19.02 17 26900 317 90601213
Microcephaly 69.99 19.02 23 26894 1361 90600169
Portal hypertension 69.64 19.02 32 26885 4669 90596861
Therapeutic product effect decreased 69.62 19.02 3 26914 277568 90323962
Premature separation of placenta 68.64 19.02 26 26891 2336 90599194
Arthralgia 67.82 19.02 79 26838 778443 89823087
Oligohydramnios 67.80 19.02 36 26881 7165 90594365
Ultrasound antenatal screen abnormal 67.72 19.02 14 26903 124 90601406
Pericarditis 67.49 19.02 3 26914 270148 90331382
Tethered cord syndrome 67.46 19.02 16 26901 278 90601252
Neural tube defect 67.45 19.02 15 26902 193 90601337
Placental disorder 66.56 19.02 23 26894 1588 90599942
Osteonecrosis 66.25 19.02 58 26859 26183 90575347
Cholestasis 66.24 19.02 67 26850 36232 90565298
Discomfort 65.53 19.02 4 26913 274331 90327199
Anembryonic gestation 65.50 19.02 18 26899 574 90600956
Foetal distress syndrome 65.28 19.02 23 26894 1682 90599848
Cardiac murmur 64.47 19.02 49 26868 18145 90583385
Nephrolithiasis 64.14 19.02 76 26841 49009 90552521
Hyperadrenocorticism 64.08 19.02 17 26900 473 90601057
Eosinophilia 64.01 19.02 59 26858 28474 90573056
Aspartate aminotransferase increased 62.82 19.02 111 26806 102826 90498704
Alanine aminotransferase increased 62.64 19.02 120 26797 118218 90483312
Retinoblastoma 62.28 19.02 12 26905 71 90601459
Placental insufficiency 61.87 19.02 22 26895 1653 90599877
Congenital hydrocephalus 61.40 19.02 14 26903 203 90601327
Alpha 1 foetoprotein abnormal 61.06 19.02 11 26906 42 90601488
Ergot poisoning 60.66 19.02 12 26905 83 90601447
Congenital choroid plexus cyst 60.16 19.02 15 26902 324 90601206
Dysmorphism 59.55 19.02 24 26893 2544 90598986
Meningomyelocele 59.53 19.02 17 26900 625 90600905
Lactic acidosis 59.22 19.02 74 26843 50389 90551141
Mobility decreased 58.87 19.02 4 26913 250730 90350800
Renal tubular acidosis 58.43 19.02 23 26894 2292 90599238
Contraindicated product administered 58.37 19.02 12 26905 320127 90281403
Oesophageal candidiasis 58.32 19.02 32 26885 6797 90594733
Hepatitis C 58.15 19.02 30 26887 5630 90595900
Dyspnoea 56.76 19.02 110 26807 880845 89720685
Musculoskeletal stiffness 56.43 19.02 10 26907 296522 90305008
Twin pregnancy 56.25 19.02 19 26898 1224 90600306
Small for dates baby 55.69 19.02 28 26889 4979 90596551
Skin striae 55.39 19.02 20 26897 1571 90599959
Hypoaesthesia 54.82 19.02 13 26904 314197 90287333
Mitochondrial toxicity 54.56 19.02 16 26901 647 90600883
Neonatal respiratory arrest 54.01 19.02 10 26907 46 90601484
Drug hypersensitivity 53.59 19.02 36 26881 463573 90137957
CSF HIV escape syndrome 53.15 19.02 11 26906 98 90601432
Congenital pulmonary valve disorder 51.64 19.02 10 26907 61 90601469
HIV-associated neurocognitive disorder 50.56 19.02 11 26906 127 90601403
Atrioventricular septal defect 49.84 19.02 13 26904 338 90601192
Rash maculo-papular 49.59 19.02 61 26856 40872 90560658
Foetal malnutrition 47.27 19.02 10 26907 100 90601430
Off label use 47.10 19.02 169 26748 1102083 89499447
Muscle spasms 46.83 19.02 9 26908 251874 90349656
Stomatitis 46.68 19.02 12 26905 274686 90326844
Central obesity 46.62 19.02 17 26900 1373 90600157
Coloboma 46.57 19.02 10 26907 108 90601422
Transaminases increased 45.99 19.02 56 26861 37136 90564394
Macrocephaly 45.76 19.02 11 26906 203 90601327
Single umbilical artery 45.61 19.02 12 26905 323 90601207
Single functional kidney 45.40 19.02 12 26905 329 90601201
Blood bilirubin increased 45.13 19.02 60 26857 43410 90558120
Blood cholesterol increased 44.27 19.02 5 26912 208007 90393523
Renal failure 43.32 19.02 110 26807 130897 90470633
Blood bilirubin unconjugated increased 43.01 19.02 12 26905 405 90601125
Therapeutic product effect incomplete 42.97 19.02 4 26913 193892 90407638
Drug intolerance 42.70 19.02 42 26875 447549 90153981
Ultrasound scan abnormal 42.47 19.02 11 26906 278 90601252
Coarctation of the aorta 42.45 19.02 13 26904 611 90600919
Nephropathy toxic 42.39 19.02 33 26884 12655 90588875
Glycosuria 42.36 19.02 16 26901 1426 90600104
Double outlet right ventricle 42.33 19.02 8 26909 42 90601488
Hypophosphataemia 41.92 19.02 35 26882 14819 90586711
Cardiac malposition 41.72 19.02 8 26909 46 90601484
Blister 41.70 19.02 12 26905 254986 90346544
Constipation 40.97 19.02 16 26901 280379 90321151
Ill-defined disorder 40.48 19.02 4 26913 184887 90416643
Condition aggravated 40.37 19.02 72 26845 595473 90006057
Hemivertebra 40.17 19.02 9 26908 120 90601410
Ultrasound antenatal screen 40.11 19.02 10 26907 216 90601314
Injection site pain 40.10 19.02 3 26914 173696 90427834
Talipes 39.99 19.02 16 26901 1664 90599866
CSF test abnormal 39.94 19.02 12 26905 528 90601002
Pain in extremity 39.92 19.02 45 26872 450484 90151046
Migraine 39.47 19.02 5 26912 190387 90411143
Musculoskeletal pain 39.41 19.02 3 26914 171248 90430282
Anencephaly 38.99 19.02 11 26906 387 90601143
Ichthyosis 38.78 19.02 8 26909 70 90601460
Sepsis neonatal 38.44 19.02 12 26905 601 90600929
Renal tubular necrosis 38.41 19.02 33 26884 14522 90587008
Pulmonary valve sclerosis 38.02 19.02 7 26910 31 90601499
Hepatitis B DNA increased 37.63 19.02 10 26907 280 90601250
Wheezing 37.49 19.02 12 26905 238068 90363462
Foetal heart rate disorder 37.24 19.02 9 26908 170 90601360
Congenital central nervous system anomaly 37.09 19.02 11 26906 463 90601067
Hepatitis cholestatic 37 19.02 26 26891 8535 90592995
Heart disease congenital 36.82 19.02 15 26902 1634 90599896
Alpha 1 foetoprotein increased 36.80 19.02 9 26908 179 90601351
Pregnancy on contraceptive 36.71 19.02 14 26903 1281 90600249
Isoimmune haemolytic disease 36.54 19.02 7 26910 40 90601490
Prenatal screening test abnormal 36.15 19.02 6 26911 12 90601518
Cough 35.90 19.02 34 26883 368928 90232602
Cortisol decreased 35.89 19.02 15 26902 1744 90599786
Congenital ectopic bladder 35.83 19.02 8 26909 105 90601425
Acquired immunodeficiency syndrome 35.62 19.02 8 26909 108 90601422
Amniotic fluid volume decreased 35.59 19.02 11 26906 533 90600997
Face oedema 35.35 19.02 39 26878 23279 90578251
Adrenal insufficiency 35.29 19.02 44 26873 29877 90571653
Metabolic acidosis 35.20 19.02 61 26856 55615 90545915
Headache 35.00 19.02 135 26782 862611 89738919
Cachexia 34.74 19.02 23 26894 6855 90594675
Abortion threatened 34.48 19.02 11 26906 592 90600938
Hydrops foetalis 34.30 19.02 11 26906 602 90600928
Endometritis decidual 34.18 19.02 6 26911 19 90601511
Threatened labour 33.95 19.02 12 26905 886 90600644
HELLP syndrome 33.94 19.02 13 26904 1204 90600326
Renal aplasia 33.83 19.02 10 26907 416 90601114
Proteinuria 33.67 19.02 38 26879 23253 90578277
Abortion of ectopic pregnancy 33.56 19.02 7 26910 65 90601465
Asthma 33.47 19.02 15 26902 242145 90359385
Left ventricular dilatation 33.42 19.02 11 26906 654 90600876
Dizziness 33.35 19.02 79 26838 589205 90012325
Congenital anomaly in offspring 33.11 19.02 8 26909 151 90601379
Sleep disorder 32.97 19.02 9 26908 198021 90403509
Product use issue 32.56 19.02 30 26887 329889 90271641
Eyelid oedema 32.18 19.02 27 26890 11507 90590023
Enzyme activity increased 32.15 19.02 5 26912 5 90601525
Cerebral toxoplasmosis 32.13 19.02 13 26904 1392 90600138
Renal tubular dysfunction 32.00 19.02 10 26907 503 90601027
Lipoatrophy 31.91 19.02 9 26908 316 90601214
Complication of delivery 31.57 19.02 8 26909 185 90601345
Product use in unapproved indication 31.53 19.02 32 26885 336204 90265326
Memory impairment 30.95 19.02 10 26907 197234 90404296
Product dose omission issue 30.63 19.02 25 26892 291662 90309868
Neonatal disorder 30.59 19.02 10 26907 582 90600948
Osteoarthritis 30.57 19.02 10 26907 195720 90405810
Osteomalacia 30.22 19.02 11 26906 884 90600646
Congenital skin dimples 30.06 19.02 7 26910 112 90601418
Oesophageal atresia 29.98 19.02 10 26907 620 90600910
Hepatic failure 29.78 19.02 47 26870 39681 90561849
Prurigo 29.64 19.02 11 26906 934 90600596
Dry mouth 29.47 19.02 9 26908 184050 90417480
COVID-19 29.40 19.02 7 26910 168836 90432694
Total bile acids increased 29.28 19.02 7 26910 126 90601404
Ventricular hypertrophy 29.26 19.02 16 26901 3375 90598155
Social avoidant behaviour 29.16 19.02 16 26901 3397 90598133
Hyperlactacidaemia 28.90 19.02 17 26900 4119 90597411
Inappropriate schedule of product administration 28.63 19.02 5 26912 149928 90451602
Pneumonia 28.38 19.02 96 26821 637963 89963567
Hepatic displacement 28.21 19.02 5 26912 17 90601513
ACTH stimulation test abnormal 27.99 19.02 5 26912 18 90601512
Gestational hypertension 27.96 19.02 15 26902 3047 90598483
Haemolytic anaemia 27.82 19.02 25 26892 11672 90589858
Placental infarction 27.71 19.02 8 26909 306 90601224
Blood lactic acid increased 27.54 19.02 22 26895 8756 90592774
Hypertriglyceridaemia 27.40 19.02 21 26896 7868 90593662
Congenital aortic valve incompetence 27.37 19.02 5 26912 21 90601509
Potassium wasting nephropathy 27.29 19.02 6 26911 73 90601457
Drug reaction with eosinophilia and systemic symptoms 27.23 19.02 47 26870 42711 90558819
Ventricular hypoplasia 27.22 19.02 7 26910 172 90601358
Congenital hand malformation 27.20 19.02 8 26909 327 90601203
Ocular icterus 26.87 19.02 16 26901 3964 90597566
Dyslipidaemia 26.84 19.02 23 26894 10084 90591446
Toxic skin eruption 26.76 19.02 28 26889 15746 90585784
Breast disorder 26.52 19.02 14 26903 2753 90598777
Mycobacterium avium complex infection 26.44 19.02 16 26901 4082 90597448
Toxicity to various agents 25.88 19.02 160 26757 287686 90313844
Placental chorioangioma 25.72 19.02 4 26913 4 90601526
Gait inability 25.64 19.02 6 26911 146450 90455080
Hepatosplenomegaly 25.42 19.02 14 26903 2995 90598535
Atrioventricular block complete 25.40 19.02 22 26895 9789 90591741
Sexually transmitted disease 25.36 19.02 7 26910 227 90601303
Congenital absence of bile ducts 25.35 19.02 5 26912 34 90601496
Congenital diaphragmatic hernia 25.24 19.02 7 26910 231 90601299
Upper respiratory tract infection 25.12 19.02 4 26913 128314 90473216
Complication of pregnancy 25.06 19.02 9 26908 696 90600834
Liver function test abnormal 24.99 19.02 50 26867 50795 90550735
Congenital aortic stenosis 24.98 19.02 5 26912 37 90601493
Congenital eye disorder 24.64 19.02 5 26912 40 90601490
Gamma-glutamyltransferase increased 24.53 19.02 42 26875 37910 90563620
Glucocorticoids increased 24.50 19.02 6 26911 120 90601410
Maxillonasal dysplasia 24.44 19.02 4 26913 7 90601523
Atrial fibrillation 24.35 19.02 5 26912 133606 90467924
Nervous system disorder 24.27 19.02 31 26886 21562 90579968
Subchorionic haematoma 23.87 19.02 6 26911 134 90601396
Bursitis 23.84 19.02 5 26912 131649 90469881
Foetal anaemia 23.79 19.02 6 26911 136 90601394
Large for dates baby 23.75 19.02 8 26909 511 90601019
Rhabdomyolysis 23.53 19.02 49 26868 51207 90550323
Fat redistribution 23.48 19.02 4 26913 10 90601520
Calculus urinary 23.41 19.02 11 26906 1687 90599843
Hepatomegaly 23.22 19.02 24 26893 13302 90588228
Conduction disorder 23.19 19.02 11 26906 1724 90599806
Therapy non-responder 23.15 19.02 6 26911 136698 90464832
Chest pain 23.13 19.02 37 26880 319608 90281922
Chronic papillomatous dermatitis 23.12 19.02 5 26912 56 90601474
Encephalomalacia 23.11 19.02 8 26909 555 90600975
Night sweats 23.09 19.02 5 26912 128761 90472769
HIV wasting syndrome 22.95 19.02 4 26913 12 90601518
Toxoplasmosis 22.89 19.02 11 26906 1774 90599756
Congenital genital malformation female 22.73 19.02 5 26912 61 90601469
Bovine tuberculosis 22.58 19.02 5 26912 63 90601467
Autoimmune hepatitis 22.43 19.02 21 26896 10330 90591200
Nystagmus 22.43 19.02 18 26899 7209 90594321
Drug level increased 22.43 19.02 34 26883 27728 90573802
Albuminuria 22.36 19.02 7 26910 354 90601176
Retroplacental haematoma 22.35 19.02 6 26911 175 90601355
Foetal heart rate abnormal 22.34 19.02 9 26908 953 90600577
Diaphragmatic aplasia 22.26 19.02 4 26913 15 90601515
Treatment failure 22.17 19.02 35 26882 303893 90297637
Blood alkaline phosphatase increased 22.11 19.02 46 26871 48033 90553497
Epilepsy congenital 22.06 19.02 4 26913 16 90601514
Bronchitis 21.88 19.02 9 26908 152918 90448612
Type 2 diabetes mellitus 21.86 19.02 17 26900 203227 90398303
Coma hepatic 21.80 19.02 8 26909 658 90600872
Psychomotor retardation 21.76 19.02 15 26902 4774 90596756
Mental disability 21.72 19.02 6 26911 195 90601335
Malignant neoplasm progression 21.68 19.02 3 26914 106867 90494663
Brachycephaly 21.50 19.02 4 26913 19 90601511
Congenital mitochondrial cytopathy 21.37 19.02 3 26914 0 90601530
Abortion 20.89 19.02 12 26905 2783 90598747
Necrotising enterocolitis neonatal 20.52 19.02 6 26911 240 90601290
Shortened cervix 20.48 19.02 6 26911 242 90601288
Cholelithiasis 20.47 19.02 47 26870 52459 90549071
Foetal cardiac disorder 20.44 19.02 4 26913 26 90601504
Aqueductal stenosis 20.31 19.02 4 26913 27 90601503
Hemiataxia 20.31 19.02 4 26913 27 90601503
Influenza 20.24 19.02 8 26909 139256 90462274
Sciatica 20.21 19.02 3 26914 101379 90500151
Confusional state 20.09 19.02 54 26863 386151 90215379
Abdominal pain upper 20.09 19.02 43 26874 332631 90268899
Febrile neutropenia 20.07 19.02 11 26906 158338 90443192
Back pain 19.99 19.02 40 26877 317135 90284395
Varices oesophageal 19.97 19.02 13 26904 3766 90597764
Thymus hypoplasia 19.94 19.02 4 26913 30 90601500
High arched palate 19.92 19.02 5 26912 111 90601419
Transposition of the great vessels 19.91 19.02 6 26911 267 90601263
Congenital foot malformation 19.91 19.02 6 26911 267 90601263
Hypersensitivity 19.79 19.02 69 26848 454608 90146922
Urinary tract infection 19.74 19.02 38 26879 305594 90295936
Chondroma 19.71 19.02 4 26913 32 90601498
Umbilical cord prolapse 19.71 19.02 4 26913 32 90601498
Dermatitis exfoliative generalised 19.67 19.02 15 26902 5578 90595952
Portal vein thrombosis 19.60 19.02 12 26905 3126 90598404
Strabismus 19.53 19.02 11 26906 2457 90599073
Intraventricular haemorrhage 19.52 19.02 11 26906 2458 90599072
Osteoporosis 19.43 19.02 68 26849 96463 90505067
Cytogenetic abnormality 19.37 19.02 7 26910 551 90600979
Blood pressure increased 19.37 19.02 18 26899 197199 90404331
Foetal malformation 19.35 19.02 6 26911 294 90601236
Neck pain 19.30 19.02 5 26912 113958 90487572
Malaise 19.29 19.02 99 26818 585887 90015643
Feeling abnormal 19.27 19.02 13 26904 167222 90434308
Foetal disorder 19.19 19.02 6 26911 302 90601228
Developmental coordination disorder 19.09 19.02 4 26913 38 90601492
Heart rate increased 19.03 19.02 5 26912 112897 90488633

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 1141.89 12.56 691 46965 46620 42527059
Drug interaction 980.60 12.56 1339 46317 265660 42308019
Immune reconstitution inflammatory syndrome 791.35 12.56 329 47327 9814 42563865
Lipodystrophy acquired 743.40 12.56 237 47419 3213 42570466
Virologic failure 428.09 12.56 163 47493 3831 42569848
Renal tubular disorder 378.59 12.56 158 47498 4751 42568928
Psychiatric decompensation 356.52 12.56 145 47511 4077 42569602
Depression suicidal 346.21 12.56 132 47524 3113 42570566
Exposure during pregnancy 340.74 12.56 174 47482 8374 42565305
Tearfulness 336.51 12.56 132 47524 3368 42570311
Premature baby 334.28 12.56 246 47410 22907 42550772
Mitochondrial toxicity 328.82 12.56 120 47536 2495 42571184
Fanconi syndrome acquired 317.18 12.56 110 47546 1960 42571719
Progressive external ophthalmoplegia 316.60 12.56 100 47556 1311 42572368
Depressive symptom 300.44 12.56 125 47531 3728 42569951
Osteonecrosis 269.13 12.56 186 47470 15679 42558000
Nephrolithiasis 266.35 12.56 263 47393 36567 42537112
Renal colic 256.68 12.56 94 47562 1974 42571705
Osteoporosis 253.42 12.56 175 47481 14731 42558948
Psychomotor skills impaired 252.16 12.56 121 47535 5083 42568596
CD4 lymphocytes decreased 244.68 12.56 89 47567 1832 42571847
Hyperbilirubinaemia 242.45 12.56 194 47462 20441 42553238
Eyelid ptosis 223.92 12.56 121 47535 6540 42567139
Trisomy 21 216.66 12.56 61 47595 521 42573158
Blood HIV RNA increased 199.99 12.56 73 47583 1518 42572161
Viral load increased 199.75 12.56 87 47569 2910 42570769
Cushing's syndrome 192.31 12.56 51 47605 339 42573340
Paranoia 191.14 12.56 144 47512 13882 42559797
Viral mutation identified 190.93 12.56 87 47569 3244 42570435
Kaposi's sarcoma 176.94 12.56 56 47600 739 42572940
Hypertriglyceridaemia 170.03 12.56 118 47538 10008 42563671
Jaundice 162.66 12.56 197 47459 34392 42539287
HIV-associated neurocognitive disorder 159.73 12.56 43 47613 305 42573374
Off label use 153.79 12.56 302 47354 638033 41935646
Drug ineffective 150.21 12.56 300 47356 629897 41943782
Lipoatrophy 149.26 12.56 43 47613 402 42573277
Adrenal suppression 146.75 12.56 51 47605 914 42572765
Syphilis 146.31 12.56 45 47611 537 42573142
Fanconi syndrome 145.94 12.56 60 47596 1734 42571945
Psychotic disorder 143.31 12.56 170 47486 29038 42544641
Polydactyly 134.51 12.56 51 47605 1183 42572496
Pathogen resistance 130.96 12.56 106 47550 11344 42562335
Blood bilirubin increased 124.68 12.56 192 47464 42060 42531619
Suicidal ideation 121.80 12.56 204 47452 47957 42525722
Drug resistance 120.37 12.56 169 47487 34079 42539600
Glycosuria 118.90 12.56 48 47608 1322 42572357
Mycobacterium avium complex infection 110.21 12.56 58 47598 2969 42570710
Acquired immunodeficiency syndrome 109.81 12.56 35 47621 473 42573206
Dyslipidaemia 105.20 12.56 86 47570 9332 42564347
Blood triglycerides increased 101.14 12.56 106 47550 15790 42557889
Hepatitis C 99.70 12.56 86 47570 10047 42563632
Disease progression 97.11 12.56 21 47635 143635 42430044
Calculus urinary 94.78 12.56 44 47612 1713 42571966
Genotype drug resistance test positive 93.65 12.56 39 47617 1165 42572514
Mitochondrial cytopathy 93.61 12.56 24 47632 137 42573542
Congenital anomaly 90.69 12.56 41 47615 1500 42572179
Diplopia 89.49 12.56 112 47544 20204 42553475
Immunosuppressant drug level increased 89.31 12.56 72 47584 7659 42566020
Proteinuria 87.65 12.56 118 47538 22865 42550814
Psychomotor retardation 87.60 12.56 57 47599 4342 42569337
Acute kidney injury 86.44 12.56 703 46953 366634 42207045
Dyspnoea 84.11 12.56 237 47419 442384 42131295
Nephropathy toxic 80.92 12.56 97 47559 16741 42556938
Laryngomalacia 80.18 12.56 25 47631 313 42573366
Febrile neutropenia 79.82 12.56 55 47601 185648 42388031
Hypotension 77.45 12.56 105 47551 257526 42316153
Malignant neoplasm progression 77.11 12.56 14 47642 108386 42465293
Retinal toxicity 76.86 12.56 27 47629 500 42573179
Hyperlipidaemia 76.81 12.56 107 47549 21409 42552270
Drug level increased 75.78 12.56 118 47538 26082 42547597
Progressive multifocal leukoencephalopathy 75.31 12.56 78 47578 11458 42562221
Heterotaxia 72.47 12.56 19 47637 120 42573559
Anal cancer 72.35 12.56 25 47631 440 42573239
Inappropriate schedule of product administration 71.28 12.56 11 47645 95891 42477788
Ventricular septal defect 70.89 12.56 50 47606 4349 42569330
Renal impairment 70.01 12.56 276 47380 109952 42463727
Hyperlactacidaemia 69.71 12.56 50 47606 4466 42569213
Cortisol decreased 69.67 12.56 33 47623 1345 42572334
Cytomegalovirus chorioretinitis 68.77 12.56 50 47606 4561 42569118
Atrial fibrillation 67.43 12.56 36 47620 139557 42434122
Maternal drugs affecting foetus 67.41 12.56 46 47610 3793 42569886
Trisomy 18 67.21 12.56 28 47628 837 42572842
Lipohypertrophy 66.01 12.56 21 47635 282 42573397
Congenital hydronephrosis 66.00 12.56 27 47629 770 42572909
Pyelocaliectasis 65.94 12.56 32 47624 1377 42572302
Cushingoid 64.87 12.56 43 47613 3379 42570300
Oesophageal candidiasis 64.07 12.56 52 47604 5583 42568096
Ultrasound antenatal screen 63.98 12.56 24 47632 540 42573139
Pancreatitis 63.74 12.56 146 47510 43122 42530557
Peripheral swelling 63.46 12.56 12 47644 90258 42483421
Portal hypertension 62.67 12.56 48 47608 4739 42568940
Anogenital dysplasia 62.61 12.56 17 47639 125 42573554
Ventricular hypoplasia 61.92 12.56 15 47641 65 42573614
Foetal chromosome abnormality 61.77 12.56 12 47644 11 42573668
Fall 61.38 12.56 105 47551 234415 42339264
Low birth weight baby 60.86 12.56 65 47591 9890 42563789
Aspartate aminotransferase increased 60.59 12.56 207 47449 76956 42496723
Alanine aminotransferase increased 59.91 12.56 226 47430 88180 42485499
Ergot poisoning 59.85 12.56 13 47643 30 42573649
Blood pressure increased 59.26 12.56 20 47636 101908 42471771
Brain stem stroke 59.13 12.56 20 47636 329 42573350
Blood bilirubin unconjugated increased 59.11 12.56 24 47632 671 42573008
Death 58.45 12.56 300 47356 470885 42102794
Hepatitis B 58.14 12.56 53 47603 6658 42567021
Adrenal insufficiency 57.21 12.56 87 47569 18837 42554842
Ocular icterus 56.46 12.56 38 47618 3063 42570616
COVID-19 55.84 12.56 30 47626 115918 42457761
HIV infection 55.62 12.56 29 47627 1456 42572223
Constipation 55.22 12.56 60 47596 162231 42411448
Ophthalmoplegia 55.15 12.56 33 47623 2167 42571512
Atypical mycobacterial infection 54.98 12.56 28 47628 1338 42572341
Hepatic cytolysis 54.07 12.56 103 47553 26741 42546938
Blood creatine phosphokinase increased 53.22 12.56 146 47510 48192 42525487
Pain 52.60 12.56 123 47533 244725 42328954
Cleft lip and palate 52.33 12.56 24 47632 908 42572771
Oesophageal atresia 51.01 12.56 20 47636 509 42573170
Gamma-glutamyltransferase increased 50.47 12.56 112 47544 32385 42541294
Hepatitis 50.43 12.56 101 47555 27199 42546480
Product dose omission issue 50.40 12.56 59 47597 154306 42419373
Single umbilical artery 50.01 12.56 16 47640 219 42573460
Hydrops foetalis 49.86 12.56 23 47633 882 42572797
Renal failure 49.44 12.56 302 47354 143424 42430255
Pneumonia 49.41 12.56 274 47382 421875 42151804
Porphyria non-acute 48.78 12.56 19 47637 475 42573204
Therapeutic product effect incomplete 48.66 12.56 10 47646 70929 42502750
Atrioventricular septal defect 47.95 12.56 16 47640 252 42573427
Cachexia 47.94 12.56 52 47604 8052 42565627
Hepatitis cholestatic 47.86 12.56 57 47599 9767 42563912
Genital herpes 47.16 12.56 21 47635 741 42572938
Treatment noncompliance 46.77 12.56 119 47537 37553 42536126
Hepatic cirrhosis 46.53 12.56 81 47575 19621 42554058
Drug abuse 46.36 12.56 30 47626 104741 42468938
Chordee 45.74 12.56 12 47644 76 42573603
Hepatomegaly 45.68 12.56 61 47595 11724 42561955
Hodgkin's disease 45.48 12.56 21 47635 807 42572872
Infusion related reaction 45.11 12.56 7 47649 60799 42512880
Completed suicide 44.94 12.56 26 47630 96439 42477240
Blood lactic acid increased 44.81 12.56 50 47606 7989 42565690
Foetal growth restriction 44.35 12.56 41 47615 5242 42568437
Hypophosphataemia 44.22 12.56 82 47574 20863 42552816
Condition aggravated 44.11 12.56 147 47509 260607 42313072
Hemivertebra 43.98 12.56 13 47643 134 42573545
Cerebral toxoplasmosis 43.78 12.56 28 47628 2070 42571609
Atrial septal defect 43.71 12.56 49 47607 7870 42565809
Pulmonary haemorrhage neonatal 43.37 12.56 9 47647 15 42573664
Lactic acidosis 43.32 12.56 130 47526 45131 42528548
Hepatocellular injury 43.02 12.56 87 47569 23591 42550088
Periventricular leukomalacia 41.67 12.56 12 47644 112 42573567
Caesarean section 41.23 12.56 27 47629 2079 42571600
Hyperadrenocorticism 40.43 12.56 13 47643 181 42573498
Heart disease congenital 39.75 12.56 23 47633 1419 42572260
CSF HIV escape syndrome 39.54 12.56 13 47643 195 42573484
Cholelithiasis 39.15 12.56 83 47573 23263 42550416
Hypospadias 38.63 12.56 32 47624 3535 42570144
Anogenital warts 38.38 12.56 18 47638 717 42572962
Cryptorchism 37.29 12.56 25 47631 2002 42571677
Burkitt's lymphoma 37.25 12.56 11 47645 113 42573566
Hepatic failure 37.00 12.56 110 47546 37990 42535689
Haemophilic arthropathy 36.80 12.56 13 47643 245 42573434
HIV wasting syndrome 36.77 12.56 10 47646 74 42573605
Anaphylactic reaction 36.51 12.56 3 47653 42740 42530939
Blood alkaline phosphatase increased 36.50 12.56 101 47555 33496 42540183
CD4 lymphocytes abnormal 36.44 12.56 9 47647 43 42573636
Oral candidiasis 36.36 12.56 61 47595 14344 42559335
HIV associated nephropathy 36.32 12.56 14 47642 340 42573339
Osteoporotic fracture 36.16 12.56 22 47634 1489 42572190
Pneumocystis jirovecii pneumonia 36.01 12.56 84 47572 25097 42548582
Cardiac failure congestive 35.88 12.56 26 47630 85576 42488103
Drug reaction with eosinophilia and systemic symptoms 35.78 12.56 116 47540 41959 42531720
Pneumonitis 35.43 12.56 3 47653 41715 42531964
Amyotrophy 35.37 12.56 15 47641 469 42573210
Joint swelling 35.15 12.56 16 47640 68006 42505673
Sepsis 34.63 12.56 111 47545 199223 42374456
Blood phosphorus decreased 34.34 12.56 30 47626 3563 42570116
Ureterolithiasis 34.20 12.56 26 47630 2538 42571141
Product use issue 33.91 12.56 22 47634 76729 42496950
Liver disorder 33.44 12.56 109 47547 39535 42534144
Foetal death 33.07 12.56 12 47644 245 42573434
Renal tubular dysfunction 32.95 12.56 14 47642 440 42573239
Gene mutation 32.84 12.56 22 47634 1759 42571920
Renal tubular acidosis 32.59 12.56 26 47630 2724 42570955
Genital herpes simplex 32.38 12.56 10 47646 121 42573558
Treponema test positive 32.35 12.56 6 47650 3 42573676
Osteomalacia 32.35 12.56 17 47639 867 42572812
Coarctation of the aorta 32.34 12.56 14 47642 461 42573218
Hypercholesterolaemia 31.88 12.56 54 47602 12795 42560884
Intentional product misuse 31.31 12.56 15 47641 61885 42511794
Myalgia 31.20 12.56 199 47457 95881 42477798
Malaria 31.15 12.56 11 47645 207 42573472
Stress 30.80 12.56 6 47650 44206 42529473
Hepatotoxicity 30.72 12.56 79 47577 25088 42548591
White matter lesion 30.42 12.56 17 47639 981 42572698
Castleman's disease 30.19 12.56 7 47649 24 42573655
Toxoplasmosis 29.99 12.56 20 47636 1587 42572092
Intestinal malrotation 29.97 12.56 7 47649 25 42573654
Chest discomfort 29.83 12.56 17 47639 63599 42510080
Infection 29.43 12.56 50 47606 112018 42461661
Renal tubular necrosis 29.33 12.56 64 47592 18290 42555389
Lymphadenopathy 29.29 12.56 93 47563 33272 42540407
Congenital renal disorder 29.29 12.56 9 47647 107 42573572
Ectopic kidney 29.15 12.56 7 47649 29 42573650
Mycobacterial infection 29.03 12.56 24 47632 2644 42571035
Lymphoma 28.90 12.56 55 47601 14266 42559413
Viral load decreased 28.77 12.56 7 47649 31 42573648
Drug ineffective for unapproved indication 28.72 12.56 8 47648 46155 42527524
Product use in unapproved indication 28.48 12.56 108 47548 184348 42389331
Stillbirth 28.13 12.56 10 47646 192 42573487
Hyperuricaemia 28.02 12.56 43 47613 9381 42564298
Pulmonary malformation 27.91 12.56 7 47649 36 42573643
Prenatal screening test abnormal 27.88 12.56 6 47650 13 42573666
Abortion spontaneous 27.81 12.56 12 47644 392 42573287
Interstitial lung disease 27.79 12.56 28 47628 78434 42495245
Karyotype analysis abnormal 27.65 12.56 8 47648 76 42573603
Hydrocele 27.62 12.56 23 47633 2560 42571119
Drug level decreased 27.55 12.56 44 47612 9933 42563746
Chronic hepatitis C 27.53 12.56 13 47643 526 42573153
Psoriasis 27.44 12.56 10 47646 48594 42525085
Fatigue 27.32 12.56 334 47322 435307 42138372
Heart rate increased 26.79 12.56 13 47643 53242 42520437
Wheezing 26.61 12.56 14 47642 54767 42518912
Scrotal cyst 26.61 12.56 9 47647 148 42573531
Neonatal hyponatraemia 26.60 12.56 8 47648 88 42573591
Beta 2 microglobulin urine increased 26.52 12.56 8 47648 89 42573590
Blood creatinine increased 26.50 12.56 212 47444 109791 42463888
Depression 26.49 12.56 214 47442 111149 42462530
Abdominal discomfort 26.49 12.56 27 47629 75228 42498451
Blood antidiuretic hormone increased 26.46 12.56 7 47649 46 42573633
Small for dates baby 26.40 12.56 31 47625 5232 42568447
Injection site pain 26.31 12.56 16 47640 57782 42515897
Central obesity 26.27 12.56 14 47642 735 42572944
Urinary tract inflammation 26.13 12.56 10 47646 238 42573441
Oropharyngeal candidiasis 26.09 12.56 15 47641 914 42572765
Hepatosplenomegaly 26.00 12.56 29 47627 4631 42569048
Peritoneal cyst 25.78 12.56 6 47650 21 42573658
Hepatic cancer 25.65 12.56 39 47617 8441 42565238
Neutrophil count decreased 25.62 12.56 20 47636 63395 42510284
Somnolence 25.61 12.56 77 47579 141028 42432651
Anal cancer stage 0 25.15 12.56 6 47650 24 42573655
Prurigo 24.74 12.56 13 47643 663 42573016
Fat tissue increased 24.39 12.56 12 47644 532 42573147
Facial wasting 24.27 12.56 8 47648 121 42573558
Hypothalamic pituitary adrenal axis suppression 24.19 12.56 10 47646 293 42573386
Multiple-drug resistance 24.04 12.56 35 47621 7287 42566392
Blood corticotrophin decreased 24.03 12.56 10 47646 298 42573381
Therapeutic product effect decreased 23.96 12.56 7 47649 39143 42534536
Opportunistic infection 23.88 12.56 19 47637 1982 42571697
Exomphalos 23.76 12.56 9 47647 208 42573471
CSF virus identified 23.59 12.56 6 47650 33 42573646
Feeling abnormal 23.48 12.56 26 47630 69760 42503919
Congenital mitral valve incompetence 23.46 12.56 8 47648 135 42573544
Cardiac failure 23.44 12.56 53 47603 106803 42466876
Nasopharyngitis 23.43 12.56 36 47620 83960 42489719
Cytogenetic abnormality 23.43 12.56 14 47642 917 42572762
Hepatitis B DNA assay positive 23.36 12.56 7 47649 76 42573603
Congenital aortic anomaly 23.36 12.56 7 47649 76 42573603
Diaphragmatic hernia 23.25 12.56 10 47646 324 42573355
Thalassaemia beta 23.19 12.56 4 47652 0 42573679
Secondary adrenocortical insufficiency 23.09 12.56 19 47637 2080 42571599
Haematochezia 22.89 12.56 19 47637 58417 42515262
Ear malformation 22.75 12.56 10 47646 342 42573337
Foetal distress syndrome 22.72 12.56 15 47641 1171 42572508
Nephrocalcinosis 22.64 12.56 13 47643 790 42572889
Enanthema 22.64 12.56 12 47644 623 42573056
Fibrous histiocytoma 22.64 12.56 10 47646 346 42573333
Swelling 22.57 12.56 17 47639 54868 42518811
CD4 lymphocytes increased 22.44 12.56 8 47648 155 42573524
International normalised ratio increased 22.40 12.56 13 47643 48155 42525524
Pleural effusion 22.30 12.56 47 47609 97119 42476560
Normal newborn 22.29 12.56 10 47646 359 42573320
Non-Hodgkin's lymphoma 22.28 12.56 16 47640 1431 42572248
Rash maculo-papular 22.25 12.56 92 47564 37411 42536268
Intraventricular haemorrhage neonatal 22.22 12.56 10 47646 362 42573317
Nervous system disorder 22.05 12.56 55 47601 17140 42556539
Spinal compression fracture 22.04 12.56 34 47622 7449 42566230
Glucose tolerance impaired 21.88 12.56 25 47631 4099 42569580
AIDS related complication 21.83 12.56 5 47651 16 42573663
Urinary retention 21.70 12.56 10 47646 42204 42531475
Superior mesenteric artery syndrome 21.67 12.56 7 47649 99 42573580
Maculopathy 21.58 12.56 14 47642 1061 42572618
Seborrhoeic dermatitis 21.53 12.56 18 47638 2014 42571665
Relapsing fever 21.37 12.56 8 47648 179 42573500
Labelled drug-drug interaction medication error 21.21 12.56 51 47605 15531 42558148
Kidney malformation 21.16 12.56 8 47648 184 42573495
Anxiety 21.12 12.56 214 47442 118346 42455333
Dizziness 21.00 12.56 178 47478 249076 42324603
Encephalitis 20.78 12.56 37 47619 9121 42564558
Congenital bowing of long bones 20.77 12.56 5 47651 21 42573658
Varices oesophageal 20.73 12.56 25 47631 4340 42569339
Vanishing bile duct syndrome 20.71 12.56 17 47639 1854 42571825
Haemoptysis 20.71 12.56 13 47643 46154 42527525
Anion gap abnormal 20.68 12.56 10 47646 427 42573252
Hypoglycaemia 20.47 12.56 22 47634 59832 42513847
Oesophageal ulcer 20.30 12.56 23 47633 3736 42569943
Epistaxis 20.26 12.56 27 47629 66799 42506880
Neonatal disorder 19.96 12.56 12 47644 795 42572884
Arthralgia 19.89 12.56 141 47515 205097 42368582
Cerebrovascular accident 19.87 12.56 50 47606 97110 42476569
Anomalous pulmonary venous connection 19.86 12.56 7 47649 131 42573548
Heart rate decreased 19.82 12.56 8 47648 36524 42537155
Congenital cerebral cyst 19.74 12.56 5 47651 27 42573652
Cranial nerve palsies multiple 19.71 12.56 6 47650 69 42573610
Volvulus 19.63 12.56 17 47639 1996 42571683
End stage AIDS 19.58 12.56 5 47651 28 42573651
Hypomagnesaemia 19.56 12.56 4 47652 28484 42545195
Lymphogranuloma venereum 19.53 12.56 4 47652 6 42573673
Hyperbilirubinaemia neonatal 19.20 12.56 12 47644 852 42572827
Crystal urine 19.18 12.56 6 47650 76 42573603
Osteopenia 19.16 12.56 29 47627 6249 42567430
Conductive deafness 19.09 12.56 10 47646 507 42573172
Live birth 19.05 12.56 8 47648 244 42573435
Amylase increased 19.02 12.56 30 47626 6699 42566980
Cardiogenic shock 19.02 12.56 8 47648 35632 42538047
Full blood count abnormal 18.92 12.56 5 47651 29871 42543808
Acquired gene mutation 18.85 12.56 15 47641 1565 42572114
Haemorrhage 18.84 12.56 24 47632 60539 42513140
Blood HIV RNA 18.80 12.56 4 47652 8 42573671
Neonatal seizure 18.78 12.56 10 47646 524 42573155
Thalassaemia alpha 18.75 12.56 5 47651 34 42573645
Myelocytosis 18.75 12.56 5 47651 34 42573645
Oxygen saturation decreased 18.75 12.56 27 47629 64660 42509019
Kidney enlargement 18.71 12.56 12 47644 891 42572788
HIV test positive 18.56 12.56 7 47649 160 42573519
Dyschromatopsia 18.52 12.56 10 47646 539 42573140
Glucose urine present 18.46 12.56 14 47642 1361 42572318
Cystitis noninfective 18.44 12.56 10 47646 544 42573135
Floppy eyelid syndrome 18.39 12.56 5 47651 37 42573642
Patent ductus arteriosus 18.32 12.56 21 47635 3455 42570224
Anaemia neonatal 18.21 12.56 9 47647 403 42573276
Product residue present 18.16 12.56 19 47637 2822 42570857
Congenital hydrocephalus 18.08 12.56 7 47649 172 42573507
Congenital nystagmus 18.01 12.56 6 47650 94 42573585
Intentional product use issue 17.99 12.56 33 47623 71800 42501879
Secondary syphilis 17.95 12.56 6 47650 95 42573584
Basedow's disease 17.94 12.56 5 47651 41 42573638
Malignant anorectal neoplasm 17.94 12.56 5 47651 41 42573638
Gastroschisis 17.93 12.56 7 47649 176 42573503
Anaemia macrocytic 17.93 12.56 21 47635 3534 42570145
Cough 17.92 12.56 121 47535 177982 42395697
Atypical mycobacterial lymphadenitis 17.91 12.56 4 47652 11 42573668
Lipids increased 17.75 12.56 13 47643 1199 42572480
Renal aplasia 17.72 12.56 11 47645 772 42572907
Chlamydial infection 17.69 12.56 8 47648 293 42573386
Chronic obstructive pulmonary disease 17.65 12.56 27 47629 63087 42510592
Leishmaniasis 17.54 12.56 9 47647 437 42573242
Cholestasis 17.45 12.56 78 47578 32801 42540878
Foetal cardiac disorder 17.42 12.56 4 47652 13 42573666
Sex chromosome abnormality 17.39 12.56 3 47653 0 42573679
Umbilical cord vascular disorder 17.39 12.56 3 47653 0 42573679
Retinal telangiectasia 17.39 12.56 3 47653 0 42573679
Gastrointestinal haemorrhage 17.24 12.56 54 47602 97672 42476007
Adrenogenital syndrome 17.24 12.56 5 47651 48 42573631
Cerebral ventricle dilatation 17.18 12.56 12 47644 1027 42572652
Encephalitis viral 17.16 12.56 14 47642 1514 42572165
Back pain 17.06 12.56 91 47565 141685 42431994
Kidney fibrosis 17.04 12.56 18 47638 2704 42570975
Neonatal asphyxia 16.98 12.56 9 47647 467 42573212
Neonatal respiratory distress syndrome 16.94 12.56 23 47633 4490 42569189
Alpha 1 foetoprotein abnormal 16.77 12.56 4 47652 16 42573663
Wrong dose 16.72 12.56 12 47644 1072 42572607
Pulmonary sequestration 16.71 12.56 5 47651 54 42573625
Transaminases increased 16.70 12.56 77 47579 32808 42540871
Umbilical cord abnormality 16.62 12.56 5 47651 55 42573624
Blood pyruvic acid increased 16.58 12.56 4 47652 17 42573662
Fontanelle bulging 16.58 12.56 4 47652 17 42573662
Liver function test abnormal 16.57 12.56 76 47580 32315 42541364
Congenital coronary artery malformation 16.46 12.56 5 47651 57 42573622
Posterior cortical atrophy 16.39 12.56 4 47652 18 42573661
Vitamin D deficiency 16.28 12.56 31 47625 8042 42565637
Death neonatal 16.28 12.56 8 47648 354 42573325
Pancytopenia 16.18 12.56 202 47454 117541 42456138
Acute hepatitis C 16.16 12.56 6 47650 131 42573548
Eczema 16.13 12.56 9 47647 34077 42539602
Tubulointerstitial nephritis 16.12 12.56 74 47582 31474 42542205
Genitalia external ambiguous 16.10 12.56 7 47649 233 42573446
Muscle injury 16.06 12.56 14 47642 1658 42572021
Diverticulitis 16.05 12.56 3 47653 22770 42550909
Right aortic arch 16.04 12.56 4 47652 20 42573659
Retinitis pigmentosa 16.04 12.56 4 47652 20 42573659
Peripheral motor neuropathy 16.03 12.56 16 47640 2248 42571431
Myelodysplastic syndrome 16.03 12.56 3 47653 22742 42550937
Obstructive airways disorder 15.95 12.56 4 47652 24755 42548924
Calculus urethral 15.95 12.56 6 47650 136 42573543
Meningitis cryptococcal 15.91 12.56 19 47637 3264 42570415
Cell death 15.80 12.56 18 47638 2941 42570738
Tachycardia 15.70 12.56 59 47597 101028 42472651
Hallucination 15.70 12.56 25 47631 57482 42516197
Cardiac disorder 15.63 12.56 19 47637 48913 42524766
Rhinorrhoea 15.63 12.56 8 47648 31786 42541893
Congenital diaphragmatic hernia 15.56 12.56 7 47649 253 42573426
Polydipsia 15.54 12.56 22 47634 4466 42569213
Tremor 15.43 12.56 56 47600 96873 42476806
Persistent left superior vena cava 15.43 12.56 4 47652 24 42573655
Intentional overdose 15.38 12.56 21 47635 51435 42522244
Blood pressure systolic increased 15.37 12.56 6 47650 27962 42545717
ECG signs of ventricular hypertrophy 15.32 12.56 3 47653 3 42573676
Congenital aplastic anaemia 15.32 12.56 3 47653 3 42573676
Foetal cystic hygroma 15.32 12.56 3 47653 3 42573676
Immunoblastic lymphoma 15.32 12.56 3 47653 3 42573676
Retroviral infection 15.32 12.56 3 47653 3 42573676
Polymicrogyria 15.32 12.56 3 47653 3 42573676
Foetal monitoring abnormal 15.32 12.56 3 47653 3 42573676
Immune reconstitution inflammatory syndrome associated tuberculosis 15.31 12.56 9 47647 572 42573107
Oropharyngeal cancer 15.27 12.56 5 47651 74 42573605
Hyperphosphatasaemia 15.21 12.56 5 47651 75 42573604
Erythema elevatum diutinum 15.16 12.56 4 47652 26 42573653
Congenital bladder anomaly 15.02 12.56 7 47649 275 42573404
Jarisch-Herxheimer reaction 15.00 12.56 10 47646 793 42572886
Upper respiratory tract infection 14.99 12.56 15 47641 42158 42531521
Musculoskeletal stiffness 14.95 12.56 26 47630 57739 42515940
Hyperphosphaturia 14.80 12.56 5 47651 82 42573597
Anal atresia 14.78 12.56 7 47649 285 42573394
Neuroleptic malignant syndrome 14.77 12.56 3 47653 21469 42552210
Ultrasound antenatal screen abnormal 14.74 12.56 5 47651 83 42573596
Congenital choroid plexus cyst 14.67 12.56 6 47650 171 42573508
Retinal deposits 14.66 12.56 4 47652 30 42573649
Myocardial infarction 14.65 12.56 207 47449 123802 42449877
Contraindicated product administered 14.60 12.56 5 47651 25267 42548412
Cleft palate 14.52 12.56 9 47647 630 42573049
Transient ischaemic attack 14.46 12.56 10 47646 33729 42539950
Urticaria 14.45 12.56 39 47617 73997 42499682
Mycobacterium avium complex immune restoration disease 14.44 12.56 4 47652 32 42573647
Confusional state 14.41 12.56 119 47537 167478 42406201
Acute stress disorder 14.38 12.56 6 47650 180 42573499
Depressed mood 14.37 12.56 58 47598 23326 42550353
Skin depigmentation 14.34 12.56 8 47648 460 42573219
Lipids abnormal 14.34 12.56 8 47648 460 42573219
Upper gastrointestinal haemorrhage 14.34 12.56 8 47648 30291 42543388
Hallucination, visual 14.33 12.56 3 47653 21017 42552662
Meconium ileus 14.22 12.56 4 47652 34 42573645
Pulmonary fibrosis 14.22 12.56 6 47650 26675 42547004
Wrong technique in product usage process 14.21 12.56 16 47640 42619 42531060
Metabolic acidosis 14.19 12.56 103 47553 51755 42521924
Urinary tract infection 14.12 12.56 60 47596 99224 42474455
Central nervous system lymphoma 14.12 12.56 12 47644 1373 42572306
Trisomy 15 14.10 12.56 3 47653 6 42573673
Congenital ureterocele 14.10 12.56 3 47653 6 42573673
Hyperphagia 14.10 12.56 13 47643 1657 42572022
Congenital hearing disorder 14.02 12.56 5 47651 97 42573582
Rhabdomyolysis 13.97 12.56 141 47515 77878 42495801
Palmar-plantar erythrodysaesthesia syndrome 13.91 12.56 3 47653 20579 42553100
Respiratory tract infection 13.90 12.56 6 47650 26316 42547363
Bradycardia 13.87 12.56 49 47607 85435 42488244
Mitochondrial myopathy 13.82 12.56 6 47650 199 42573480
Radius fracture 13.78 12.56 10 47646 909 42572770
Biliary colic 13.78 12.56 11 47645 1153 42572526
Lipase increased 13.76 12.56 34 47622 10532 42563147
Low set ears 13.71 12.56 8 47648 501 42573178
Localised infection 13.70 12.56 3 47653 20370 42553309
Tuberculosis 13.69 12.56 33 47623 10066 42563613
Lymphocyte count decreased 13.66 12.56 7 47649 27802 42545877
Portal fibrosis 13.66 12.56 7 47649 339 42573340
Folate deficiency 13.65 12.56 13 47643 1726 42571953
Stomatitis 13.62 12.56 22 47634 50307 42523372
Chronic kidney disease 13.60 12.56 95 47561 47146 42526533
Splenomegaly 13.60 12.56 46 47610 17001 42556678
Pancreatitis relapsing 13.57 12.56 8 47648 511 42573168
Drug hypersensitivity 13.57 12.56 61 47595 99328 42474351
Myositis 13.56 12.56 42 47614 14824 42558855
Testicular neoplasm 13.55 12.56 4 47652 41 42573638
Productive cough 13.53 12.56 23 47633 51544 42522135
Deafness congenital 13.52 12.56 5 47651 108 42573571
Congenital anaemia 13.50 12.56 3 47653 8 42573671
Diabetes mellitus 13.49 12.56 114 47542 59973 42513706
Abnormal dreams 13.40 12.56 29 47627 8242 42565437
Flushing 13.35 12.56 13 47643 37015 42536664
Erosive duodenitis 13.33 12.56 13 47643 1776 42571903
Congenital vesicoureteric reflux 13.30 12.56 4 47652 44 42573635
Vth nerve injury 13.24 12.56 3 47653 9 42573670
Hypo HDL cholesterolaemia 13.24 12.56 3 47653 9 42573670
Eagle Barrett syndrome 13.24 12.56 3 47653 9 42573670
Cataract 13.21 12.56 9 47647 30595 42543084
Encephalitis cytomegalovirus 13.18 12.56 11 47645 1228 42572451
Retroperitoneal disorder 13.14 12.56 4 47652 46 42573633
Intussusception 13.10 12.56 9 47647 750 42572929
Intestinal obstruction 13.10 12.56 7 47649 27151 42546528
Skin striae 13.06 12.56 9 47647 754 42572925
Urinary incontinence 13.03 12.56 4 47652 21664 42552015
Hepatitis A 12.90 12.56 8 47648 560 42573119
Herpes simplex 12.80 12.56 26 47630 7069 42566610
Nephrogenic diabetes insipidus 12.80 12.56 12 47644 1562 42572117
Neural tube defect 12.76 12.56 4 47652 51 42573628
Balance disorder 12.74 12.56 21 47635 47624 42526055
Haemolytic anaemia 12.72 12.56 36 47620 12091 42561588
Hypoxia 12.71 12.56 38 47618 69748 42503931
Pulmonary embolism 12.66 12.56 80 47576 119532 42454147
Nodular regenerative hyperplasia 12.61 12.56 10 47646 1038 42572641
VIIIth nerve injury 12.58 12.56 3 47653 12 42573667

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
Drug interaction 2132.34 14.23 1840 52543 498343 110036573
Abortion spontaneous 1914.59 14.23 696 53687 33586 110501330
Exposure during pregnancy 1038.14 14.23 770 53613 166654 110368262
Immune reconstitution inflammatory syndrome 1020.46 14.23 360 54023 15866 110519050
Lipodystrophy acquired 1004.59 14.23 265 54118 4259 110530657
Virologic failure 778.18 14.23 221 54162 4731 110530185
Abortion induced 669.12 14.23 220 54163 7799 110527117
Maternal exposure during pregnancy 569.40 14.23 663 53720 254220 110280696
Stillbirth 566.40 14.23 167 54216 4097 110530819
Renal tubular disorder 448.61 14.23 160 54223 7269 110527647
Mitochondrial toxicity 430.60 14.23 127 54256 3118 110531798
Hyperbilirubinaemia 428.60 14.23 236 54147 30435 110504481
Psychiatric decompensation 428.55 14.23 145 54238 5620 110529296
Fanconi syndrome acquired 408.11 14.23 120 54263 2914 110532002
Progressive external ophthalmoplegia 402.19 14.23 101 54282 1319 110533597
Depression suicidal 397.01 14.23 131 54252 4693 110530223
Viral mutation identified 359.65 14.23 119 54264 4300 110530616
Cushing's syndrome 354.43 14.23 84 54299 846 110534070
Tearfulness 349.50 14.23 133 54250 7262 110527654
Caesarean section 349.30 14.23 159 54224 13658 110521258
Nephrolithiasis 336.34 14.23 271 54112 65941 110468975
Psychomotor skills impaired 333.79 14.23 127 54256 6931 110527985
CD4 lymphocytes decreased 328.29 14.23 101 54282 2873 110532043
Foetal exposure during pregnancy 322.67 14.23 126 54257 7379 110527537
Blood HIV RNA increased 318.42 14.23 92 54291 2096 110532820
Adrenal suppression 308.95 14.23 85 54298 1611 110533305
Osteonecrosis 307.32 14.23 197 54186 33544 110501372
Viral load increased 307.08 14.23 99 54284 3291 110531625
Premature delivery 304.41 14.23 189 54194 30443 110504473
Depressive symptom 298.49 14.23 123 54260 8291 110526625
Renal colic 286.38 14.23 93 54290 3165 110531751
Drug resistance 280.51 14.23 228 54155 56146 110478770
Acute kidney injury 279.19 14.23 813 53570 634617 109900299
Pathogen resistance 266.35 14.23 143 54240 17529 110517387
Jaundice 262.41 14.23 224 54159 59012 110475904
Immunosuppressant drug level increased 244.10 14.23 118 54265 11606 110523310
Paranoia 234.92 14.23 143 54240 22231 110512685
Eyelid ptosis 232.66 14.23 119 54264 13208 110521708
Premature labour 223.82 14.23 103 54280 9069 110525847
Premature rupture of membranes 221.29 14.23 84 54299 4553 110530363
Treatment noncompliance 207.85 14.23 216 54167 72774 110462142
Psychotic disorder 206.21 14.23 183 54200 50754 110484162
Fanconi syndrome 201.95 14.23 73 54310 3446 110531470
HIV-associated neurocognitive disorder 188.02 14.23 43 54340 365 110534551
Foetal death 187.82 14.23 110 54273 15935 110518981
Live birth 173.82 14.23 192 54191 69292 110465624
Pain 172.42 14.23 131 54252 954824 109580092
Osteoporosis 170.05 14.23 212 54171 86940 110447976
Pregnancy 169.04 14.23 164 54219 50903 110484013
Blood bilirubin increased 168.13 14.23 197 54186 75775 110459141
Genotype drug resistance test positive 164.77 14.23 50 54333 1356 110533560
Hypertriglyceridaemia 161.30 14.23 100 54283 16054 110518862
Infusion related reaction 161.09 14.23 6 54377 381156 110153760
Joint swelling 152.80 14.23 19 54364 442826 110092090
Syphilis 151.26 14.23 41 54342 733 110534183
Nephropathy toxic 149.16 14.23 117 54266 27361 110507555
Drug ineffective 146.15 14.23 334 54049 1520206 109014710
Peripheral swelling 145.24 14.23 15 54368 404019 110130897
Portal hypertension 144.63 14.23 75 54308 8562 110526354
Mycobacterium avium complex infection 137.17 14.23 64 54319 5813 110529103
Cushingoid 136.31 14.23 80 54303 11632 110523284
Lipohypertrophy 136.22 14.23 40 54343 966 110533950
Hepatitis C 136.20 14.23 82 54301 12491 110522425
Psychomotor retardation 134.34 14.23 69 54314 7723 110527193
Lipoatrophy 125.85 14.23 34 54349 600 110534316
Suicidal ideation 125.08 14.23 190 54193 93747 110441169
CSF HIV escape syndrome 124.41 14.23 30 54353 327 110534589
Hepatocellular injury 123.31 14.23 138 54245 50504 110484412
Calculus urinary 121.80 14.23 49 54334 3103 110531813
Synovitis 120.53 14.23 3 54380 274089 110260827
Proteinuria 120.36 14.23 122 54261 39896 110495020
Arthropathy 119.85 14.23 5 54378 287517 110247399
Glycosuria 119.60 14.23 46 54337 2584 110532332
Alanine aminotransferase increased 117.28 14.23 271 54112 183502 110351414
Premature baby 116.82 14.23 54 54329 4801 110530115
Mitochondrial cytopathy 116.37 14.23 29 54354 366 110534550
Renal failure 113.90 14.23 305 54078 226269 110308647
Aspartate aminotransferase increased 113.43 14.23 246 54137 159690 110375226
Drug level increased 112.72 14.23 128 54255 47591 110487325
Swelling 111.92 14.23 19 54364 351022 110183894
Systemic lupus erythematosus 111.02 14.23 3 54380 254335 110280581
Renal impairment 110.62 14.23 269 54114 188176 110346740
Hepatic cytolysis 107.49 14.23 134 54249 54919 110479997
Pre-eclampsia 105.73 14.23 61 54322 8589 110526327
Ergot poisoning 105.42 14.23 22 54361 115 110534801
Placenta praevia 104.97 14.23 31 54352 764 110534152
Ultrasound antenatal screen 104.13 14.23 30 54353 676 110534240
Nasopharyngitis 100.97 14.23 34 54349 394327 110140589
Blood triglycerides increased 100.89 14.23 88 54295 23838 110511078
Abdominal discomfort 100.76 14.23 34 54349 393824 110141092
Kaposi's sarcoma 99.85 14.23 29 54354 673 110534243
Cortisol decreased 99.03 14.23 41 54342 2795 110532121
Diplopia 98.31 14.23 112 54271 41782 110493134
Dyslipidaemia 97.67 14.23 73 54310 15892 110519024
Blood bilirubin unconjugated increased 96.88 14.23 32 54351 1149 110533767
Lactic acidosis 96.71 14.23 168 54215 92643 110442273
Gestational diabetes 95.39 14.23 54 54329 7335 110527581
Hyperadrenocorticism 95.11 14.23 27 54356 576 110534340
Ectopic pregnancy 93.24 14.23 37 54346 2260 110532656
Therapeutic product effect decreased 90.59 14.23 8 54375 244308 110290608
Adrenal insufficiency 90.57 14.23 108 54275 42282 110492634
Secondary adrenocortical insufficiency 90.40 14.23 44 54339 4390 110530526
Off label use 89.08 14.23 408 53975 1499777 109035139
Wound 88.78 14.23 7 54376 234430 110300486
Polyhydramnios 88.58 14.23 34 54349 1899 110533017
Hyperlactacidaemia 87.07 14.23 53 54330 8233 110526683
Dyspnoea 85.71 14.23 270 54113 1106602 109428314
Fall 85.12 14.23 103 54280 603379 109931537
Hepatotoxicity 84.04 14.23 128 54255 63272 110471644
Hydrops foetalis 83.98 14.23 26 54357 755 110534161
Retinal toxicity 82.59 14.23 31 54352 1628 110533288
Alopecia 82.58 14.23 38 54345 364715 110170201
Infection 81.59 14.23 38 54345 362162 110172754
Arthralgia 81.42 14.23 163 54220 779469 109755447
Trisomy 18 81.05 14.23 24 54359 597 110534319
Amniotic cavity infection 80.16 14.23 26 54357 881 110534035
Hypophosphataemia 80.05 14.23 90 54293 33092 110501824
Renal tubular acidosis 79.11 14.23 41 54342 4674 110530242
Progressive multifocal leukoencephalopathy 78.56 14.23 78 54305 24878 110510038
Oesophageal candidiasis 77.93 14.23 56 54327 11478 110523438
Cleft lip and palate 77.16 14.23 24 54359 708 110534208
Hepatitis cholestatic 76.88 14.23 66 54317 17500 110517416
Pericarditis 76.50 14.23 9 54374 219105 110315811
Central obesity 76.43 14.23 31 54352 2005 110532911
Contraindicated product administered 75.74 14.23 15 54368 248252 110286664
Acquired immunodeficiency syndrome 74.83 14.23 20 54363 338 110534578
Therapeutic product effect incomplete 73.81 14.23 11 54372 223794 110311122
Renal tubular dysfunction 72.55 14.23 24 54359 866 110534050
Contusion 71.40 14.23 14 54369 233347 110301569
Lower respiratory tract infection 69.49 14.23 17 54366 243089 110291827
Gamma-glutamyltransferase increased 69.18 14.23 115 54268 61194 110473722
Maternal drugs affecting foetus 68.98 14.23 27 54356 1590 110533326
Pancreatitis 67.57 14.23 145 54238 93388 110441528
Renal tubular necrosis 67.35 14.23 79 54304 30396 110504520
Drug reaction with eosinophilia and systemic symptoms 67.22 14.23 134 54249 81961 110452955
Ocular icterus 66.91 14.23 40 54343 6013 110528903
Hepatic failure 65.91 14.23 120 54263 68619 110466297
Cytomegalovirus chorioretinitis 65.82 14.23 42 54341 7086 110527830
Hepatitis B 65.70 14.23 47 54336 9565 110525351
Wheezing 65.30 14.23 22 54361 255208 110279708
Mobility decreased 65.19 14.23 18 54365 237404 110297512
Inappropriate schedule of product administration 64.92 14.23 11 54372 203626 110331290
Stomatitis 64.58 14.23 26 54357 270216 110264700
Cholestasis of pregnancy 64.29 14.23 24 54359 1241 110533675
Hepatomegaly 63.87 14.23 65 54318 21349 110513567
Musculoskeletal stiffness 63.56 14.23 29 54354 279793 110255123
Cerebral toxoplasmosis 63.52 14.23 31 54352 3111 110531805
Ophthalmoplegia 62.83 14.23 32 54351 3518 110531398
Sinusitis 62.49 14.23 34 54349 296654 110238262
Drug hypersensitivity 62.41 14.23 79 54304 454011 110080905
Cholestasis 62.32 14.23 113 54270 64405 110470511
Blood creatine phosphokinase increased 61.90 14.23 121 54262 72956 110461960
Rash maculo-papular 61.79 14.23 122 54261 74100 110460816
Labelled drug-drug interaction medication error 61.52 14.23 74 54309 29228 110505688
Discomfort 61.39 14.23 15 54368 214692 110320224
Product use issue 61.02 14.23 39 54344 311656 110223260
Retinoblastoma 60.64 14.23 13 54370 79 110534837
Pneumocystis jirovecii pneumonia 60.52 14.23 89 54294 42646 110492270
Trisomy 21 60.22 14.23 13 54370 82 110534834
Brain stem stroke 59.44 14.23 20 54363 761 110534155
Multiple-drug resistance 58.47 14.23 50 54333 13185 110521731
Skin striae 57.74 14.23 26 54357 2175 110532741
Drug intolerance 57.67 14.23 69 54314 406443 110128473
Cholelithiasis 54.92 14.23 106 54277 63316 110471600
Musculoskeletal pain 53.88 14.23 12 54371 183011 110351905
Blood pressure increased 53.84 14.23 30 54353 258343 110276573
Constipation 53.71 14.23 58 54325 357728 110177188
Blood alkaline phosphatase increased 53.59 14.23 112 54271 70823 110464093
Anembryonic gestation 53.29 14.23 16 54367 418 110534498
Cachexia 53.16 14.23 47 54336 12958 110521958
Toxicity to various agents 53.06 14.23 411 53972 480144 110054772
Premature separation of placenta 52.34 14.23 22 54361 1558 110533358
Condition aggravated 52.12 14.23 186 54197 734650 109800266
HIV associated nephropathy 51.69 14.23 15 54368 347 110534569
Blood creatinine increased 49.89 14.23 200 54183 182689 110352227
Hyperlipidaemia 49.81 14.23 74 54309 35774 110499142
Alpha 1 foetoprotein abnormal 48.98 14.23 10 54373 46 110534870
Transaminases increased 48.95 14.23 101 54282 63289 110471627
Bursitis 48.84 14.23 4 54379 129914 110405002
Psoriasis 48.24 14.23 6 54377 139987 110394929
Toxoplasmosis 48.21 14.23 26 54357 3213 110531703
Fatigue 47.98 14.23 376 54007 1215582 109319334
Rhabdomyolysis 47.79 14.23 149 54234 120252 110414664
Injury 47.62 14.23 14 54369 177251 110357665
Anogenital dysplasia 47.27 14.23 12 54371 164 110534752
Blood lactic acid increased 47.14 14.23 48 54335 15773 110519143
Febrile neutropenia 46.82 14.23 52 54331 316715 110218201
Injection site pain 46.09 14.23 15 54368 177907 110357009
Disease progression 45.78 14.23 32 54351 244002 110290914
Genital herpes 45.20 14.23 23 54360 2524 110532392
Joint range of motion decreased 45.11 14.23 4 54379 121828 110413088
Malaria 45.01 14.23 14 54369 413 110534503
Hepatitis 44.96 14.23 121 54262 89933 110444983
Malignant neoplasm progression 44.72 14.23 15 54368 174552 110360364
Anaphylactic reaction 44.44 14.23 3 54380 114297 110420619
Diabetes mellitus 44.17 14.23 128 54255 99253 110435663
Arthritis 43.64 14.23 14 54369 167572 110367344
Pancytopenia 42.62 14.23 210 54173 209403 110325513
Blister 42.41 14.23 30 54353 227346 110307570
COVID-19 42.30 14.23 35 54348 245025 110289891
Metabolic acidosis 41.98 14.23 126 54257 99618 110435298
Dry mouth 41.96 14.23 23 54360 199925 110334991
Renal dysplasia 41.26 14.23 9 54374 60 110534856
Product dose omission issue 41.12 14.23 59 54324 321723 110213193
Anaemia 40.92 14.23 430 53953 546656 109988260
Impaired healing 40.75 14.23 23 54360 196694 110338222
Atrial fibrillation 40.64 14.23 32 54351 229610 110305306
HIV wasting syndrome 40.05 14.23 9 54374 70 110534846
Placental disorder 39.89 14.23 16 54367 1005 110533911
Osteoarthritis 39.81 14.23 20 54363 182603 110352313
Memory impairment 39.42 14.23 24 54359 196920 110337996
Ill-defined disorder 39.28 14.23 14 54369 156839 110378077
Hepatitis B DNA increased 39.04 14.23 15 54368 840 110534076
CD4 lymphocytes abnormal 38.40 14.23 9 54374 86 110534830
Chronic hepatitis C 38.20 14.23 14 54369 687 110534229
Face oedema 38.04 14.23 63 54320 33406 110501510
Muscle injury 38.04 14.23 11 54372 140796 110394120
Chronic kidney disease 37.57 14.23 102 54281 76189 110458727
Pain in extremity 37.42 14.23 119 54264 486999 110047917
Twin pregnancy 37.38 14.23 15 54368 943 110533973
Cough 36.72 14.23 111 54272 461530 110073386
Muscle spasms 36.54 14.23 50 54333 278107 110256809
Lymphadenopathy 36.22 14.23 90 54293 63745 110471171
HIV infection 36.13 14.23 16 54367 1287 110533629
Anal cancer 36.08 14.23 14 54369 805 110534111
Pulmonary fibrosis 36.08 14.23 4 54379 102038 110432878
Sleep disorder 36.01 14.23 27 54356 198617 110336299
Hypoaesthesia 35.98 14.23 62 54321 314161 110220755
Burkitt's lymphoma 35.80 14.23 9 54374 118 110534798
Folliculitis 35.60 14.23 19 54364 167634 110367282
Haemophilic arthropathy 35.51 14.23 10 54373 207 110534709
Atypical mycobacterial infection 35.45 14.23 20 54363 2698 110532218
Anal cancer stage 0 35.07 14.23 7 54376 28 110534888
Liver function test abnormal 34.78 14.23 93 54290 68857 110466059
Haemolytic anaemia 34.70 14.23 47 54336 20873 110514043
Neutropenia neonatal 34.14 14.23 7 54376 33 110534883
Heart rate increased 34.08 14.23 14 54369 143820 110391096
Myalgia 33.89 14.23 206 54177 222175 110312741
Encephalitis 33.83 14.23 44 54339 18795 110516121
CSF virus identified 33.80 14.23 7 54376 35 110534881
Nervous system disorder 33.78 14.23 58 54325 31663 110503253
Total bile acids increased 33.71 14.23 8 54375 81 110534835
Porphyria non-acute 33.56 14.23 13 54370 744 110534172
Ureterolithiasis 33.52 14.23 23 54360 4379 110530537
CSF test abnormal 33.32 14.23 13 54370 759 110534157
Placental insufficiency 33.04 14.23 15 54368 1279 110533637
Normal newborn 33.04 14.23 47 54336 21849 110513067
Inflammation 32.85 14.23 28 54355 193210 110341706
Spina bifida 32.64 14.23 9 54374 172 110534744
Upper respiratory tract infection 32.41 14.23 12 54371 131316 110403600
Endometritis decidual 32.20 14.23 6 54377 15 110534901
Blood corticotrophin decreased 32.10 14.23 13 54370 837 110534079
Fat tissue increased 31.99 14.23 14 54369 1094 110533822
Dizziness 31.77 14.23 207 54176 697986 109836930
Osteoporotic fracture 31.75 14.23 24 54359 5313 110529603
Varices oesophageal 31.35 14.23 27 54356 7188 110527728
Abortion of ectopic pregnancy 31.31 14.23 7 54376 53 110534863
Hypothalamic pituitary adrenal axis suppression 31.27 14.23 12 54371 670 110534246
Urticaria 31.23 14.23 69 54314 318788 110216128
Retinopathy 31.06 14.23 22 54361 4407 110530509
Type 2 diabetes mellitus 30.97 14.23 25 54358 177207 110357709
Pneumonia 30.92 14.23 279 54104 876435 109658481
Castleman's disease 30.92 14.23 6 54377 20 110534896
Glucocorticoids increased 30.82 14.23 8 54375 120 110534796
Stress 30.81 14.23 7 54376 105341 110429575
Prenatal screening test abnormal 30.74 14.23 5 54378 3 110534913
Opportunistic infection 30.56 14.23 20 54363 3523 110531393
Genital herpes simplex 30.39 14.23 11 54372 521 110534395
Hepatosplenomegaly 30.28 14.23 26 54357 6893 110528023
Foetal exposure during delivery 30.27 14.23 6 54377 23 110534893
Toxic skin eruption 30.21 14.23 51 54332 27464 110507452
Osteomalacia 30.12 14.23 15 54368 1572 110533344
Pregnancy on contraceptive 29.97 14.23 13 54370 995 110533921
Nodular regenerative hyperplasia 29.73 14.23 15 54368 1616 110533300
Blood antidiuretic hormone increased 29.58 14.23 7 54376 70 110534846
Urinary tract inflammation 29.53 14.23 10 54373 388 110534528
Completed suicide 29.45 14.23 46 54337 242335 110292581
Immune reconstitution inflammatory syndrome associated tuberculosis 29.41 14.23 13 54370 1041 110533875
Neck pain 29.15 14.23 12 54371 123118 110411798
Facial wasting 28.97 14.23 7 54376 77 110534839
Kidney fibrosis 28.93 14.23 21 54362 4371 110530545
Prurigo 28.86 14.23 14 54369 1386 110533530
Fibrous histiocytoma 28.86 14.23 12 54371 827 110534089
Feeling abnormal 28.56 14.23 28 54355 180683 110354233
Drug level decreased 28.26 14.23 40 54343 18508 110516408
Nephrocalcinosis 28.23 14.23 15 54368 1799 110533117
Chlamydial infection 28.21 14.23 11 54372 641 110534275
Injection site erythema 28.07 14.23 6 54377 94170 110440746
Conductive deafness 27.91 14.23 9 54374 299 110534617
Rhinorrhoea 27.77 14.23 8 54375 102658 110432258
Hyperuricaemia 27.76 14.23 35 54348 14496 110520420
Amniotic fluid volume decreased 27.52 14.23 9 54374 313 110534603
Amyotrophy 27.48 14.23 11 54372 687 110534229
Meningitis cryptococcal 27.41 14.23 21 54362 4741 110530175
Chest discomfort 27.40 14.23 27 54356 173821 110361095
Acute myocardial infarction 27.29 14.23 97 54286 83680 110451236
Enzyme activity increased 27.28 14.23 5 54378 11 110534905
Asthma 27.20 14.23 51 54332 250240 110284676
Tubulointerstitial nephritis 27.15 14.23 73 54310 54211 110480705
Umbilical cord abnormality 26.98 14.23 8 54375 200 110534716
Myocardial infarction 26.81 14.23 174 54209 191909 110343007
Migraine 26.67 14.23 27 54356 171625 110363291
Hypotension 26.59 14.23 150 54233 523699 110011217
Oxygen saturation decreased 26.37 14.23 23 54360 156959 110377957
HIV viraemia 26.26 14.23 7 54376 117 110534799
Lung disorder 26.10 14.23 30 54353 180017 110354899
Blood phosphorus decreased 26.07 14.23 25 54358 7640 110527276
Dermatitis exfoliative 26.05 14.23 30 54353 11317 110523599
Polydipsia 26.01 14.23 25 54358 7663 110527253
Hodgkin's disease 25.77 14.23 11 54372 809 110534107
Viral load decreased 25.69 14.23 5 54378 17 110534899
Drug level above therapeutic 25.53 14.23 30 54353 11558 110523358
Red blood cell sedimentation rate increased 25.46 14.23 4 54379 78298 110456618
Enanthema 25.39 14.23 12 54371 1122 110533794
Anogenital warts 25.37 14.23 12 54371 1124 110533792
Sciatica 25.36 14.23 7 54376 92392 110442524
Vanishing bile duct syndrome 25.19 14.23 17 54366 3151 110531765
Lipase increased 25.16 14.23 38 54345 18634 110516282
Blood HIV RNA 25.05 14.23 5 54378 20 110534896
Complication of pregnancy 24.87 14.23 9 54374 426 110534490
Hepatic cancer 24.78 14.23 29 54354 11127 110523789
Haematochezia 24.66 14.23 13 54370 115511 110419405
Coarctation of the aorta 24.59 14.23 6 54377 69 110534847
Congenital multiplex arthrogryposis 24.49 14.23 5 54378 23 110534893
Threatened labour 24.49 14.23 10 54373 658 110534258
Lymphoma 24.32 14.23 39 54344 20132 110514784
ACTH stimulation test abnormal 24.31 14.23 5 54378 24 110534892
Abortion threatened 24.25 14.23 9 54374 458 110534458
Treponema test positive 24.24 14.23 4 54379 3 110534913
Intentional product misuse 24.17 14.23 18 54365 132886 110402030
Pulmonary tuberculosis 24.14 14.23 26 54357 9113 110525803
Gait inability 24.12 14.23 19 54364 136357 110398559
Renal aplasia 24.08 14.23 7 54376 163 110534753
Bronchitis 24.05 14.23 25 54358 157007 110377909
Oropharyngeal candidiasis 24.00 14.23 14 54369 2012 110532904
Confusional state 23.89 14.23 134 54249 468546 110066370
Oligohydramnios 23.84 14.23 18 54365 3976 110530940
Single functional kidney 23.84 14.23 8 54375 302 110534614
Hepatic steatosis 23.76 14.23 65 54318 48766 110486150
Tuberculosis 23.71 14.23 36 54347 17738 110517178
Ventricular hypoplasia 23.70 14.23 4 54379 4 110534912
Placental chorioangioma 23.70 14.23 4 54379 4 110534912
Pulmonary sequestration 23.67 14.23 5 54378 28 110534888
Hepatic cirrhosis 23.50 14.23 80 54303 67546 110467370
Hepatic encephalopathy 22.97 14.23 46 54337 28210 110506706
Anaemia neonatal 22.97 14.23 5 54378 33 110534883
Atypical mycobacterial lymphadenitis 22.97 14.23 5 54378 33 110534883
Osteopenia 22.86 14.23 40 54343 22169 110512747
Seborrhoeic dermatitis 22.66 14.23 15 54368 2692 110532224
Nasal congestion 22.59 14.23 10 54373 98272 110436644
Splenomegaly 22.51 14.23 42 54341 24456 110510460
Floppy eyelid syndrome 22.47 14.23 5 54378 37 110534879
Basedow's disease 22.46 14.23 7 54376 208 110534708
Secondary syphilis 22.36 14.23 6 54377 103 110534813
Eosinophilia 22.34 14.23 71 54312 57865 110477051
Anion gap abnormal 22.33 14.23 10 54373 826 110534090
Mycobacterial infection 22.24 14.23 18 54365 4399 110530517
Superior mesenteric artery syndrome 22.20 14.23 7 54376 216 110534700
Amylase increased 22.11 14.23 29 54354 12490 110522426
Oesophageal atresia 22.10 14.23 6 54377 108 110534808
Night sweats 22.06 14.23 20 54363 133963 110400953
Liver function test increased 22.00 14.23 8 54375 88540 110446376
Cell death 21.83 14.23 20 54363 5771 110529145
Gene mutation 21.69 14.23 16 54367 3413 110531503
Oesophageal ulcer 21.64 14.23 23 54360 7941 110526975
Subchorionic haematoma 21.32 14.23 6 54377 124 110534792
Encephalitis viral 21.23 14.23 15 54368 2992 110531924
Oral candidiasis 21.20 14.23 59 54324 44701 110490215
Hypoplastic left heart syndrome 21.19 14.23 4 54379 11 110534905
Dyschromatopsia 20.99 14.23 11 54372 1283 110533633
Coagulation factor V level decreased 20.93 14.23 9 54374 674 110534242
Hypersensitivity 20.86 14.23 115 54268 403883 110131033
Foetal disorder 20.83 14.23 6 54377 135 110534781
Anticoagulation drug level increased 20.76 14.23 10 54373 975 110533941
Hypoglycaemia 20.76 14.23 16 54367 116088 110418828
Nystagmus 20.73 14.23 27 54356 11550 110523366
Retroviral infection 20.69 14.23 4 54379 13 110534903
Product use in unapproved indication 20.64 14.23 132 54251 447245 110087671
Pneumonitis 20.63 14.23 6 54377 76525 110458391
Chest pain 20.62 14.23 105 54278 376270 110158646
Back pain 20.61 14.23 103 54280 370893 110164023
Pneumococcal sepsis 20.34 14.23 13 54370 2199 110532717
Urinary tract infection 20.25 14.23 87 54296 326195 110208721
Malaise 20.23 14.23 222 54161 671597 109863319
White matter lesion 20.06 14.23 14 54369 2740 110532176
Beta 2 microglobulin urine increased 20.05 14.23 6 54377 155 110534761
Drug ineffective for unapproved indication 19.93 14.23 13 54370 102825 110432091
HIV test positive 19.90 14.23 6 54377 159 110534757
Autoimmune disorder 19.87 14.23 4 54379 65479 110469437
Retinal telangiectasia 19.85 14.23 3 54380 0 110534916
C-reactive protein increased 19.85 14.23 49 54334 217870 110317046
Erythema elevatum diutinum 19.85 14.23 4 54379 17 110534899
Headache 19.81 14.23 310 54073 882067 109652849
Obesity 19.79 14.23 16 54367 113335 110421581
Autoimmune hepatitis 19.77 14.23 30 54353 14774 110520142
Calculus urethral 19.76 14.23 6 54377 163 110534753
Non-Hodgkin's lymphoma 19.75 14.23 11 54372 1448 110533468
Sexually transmitted disease 19.73 14.23 6 54377 164 110534752
Posterior cortical atrophy 19.66 14.23 4 54379 18 110534898
Pleural effusion 19.49 14.23 36 54347 177673 110357243
Plasmablastic lymphoma 19.46 14.23 9 54374 801 110534115
Intentional product use issue 19.41 14.23 60 54323 247846 110287070
Potassium wasting nephropathy 19.23 14.23 6 54377 179 110534737
Malignant anorectal neoplasm 19.20 14.23 5 54378 76 110534840
Social avoidant behaviour 19.19 14.23 18 54365 5351 110529565
Vertigo 19.06 14.23 89 54294 86781 110448135
Cardiac failure congestive 18.97 14.23 28 54355 150972 110383944
Ultrasound antenatal screen abnormal 18.96 14.23 5 54378 80 110534836
Foetal cardiac disorder 18.85 14.23 4 54379 23 110534893
Influenza 18.77 14.23 34 54349 169067 110365849
Jarisch-Herxheimer reaction 18.76 14.23 10 54373 1207 110533709
Nail disorder 18.74 14.23 3 54380 57932 110476984
Death 18.70 14.23 237 54146 698632 109836284
Joint stiffness 18.63 14.23 5 54378 67238 110467678
Vitamin D deficiency 18.56 14.23 33 54350 18519 110516397
Portal vein thrombosis 18.50 14.23 20 54363 7038 110527878
Hepatic enzyme increased 18.45 14.23 88 54295 320804 110214112
Herpes simplex 18.35 14.23 30 54353 15734 110519182
Adverse drug reaction 18.30 14.23 15 54368 105544 110429372
Abdominal pain upper 18.23 14.23 99 54284 349012 110185904
Blood pressure systolic increased 18.22 14.23 9 54374 82982 110451934
Ascites 18.15 14.23 92 54291 92716 110442200
Pancreatitis acute 18.12 14.23 68 54315 60206 110474710
Foetal distress syndrome 18.12 14.23 8 54375 639 110534277
Flushing 18.01 14.23 15 54368 104721 110430195
Benign hydatidiform mole 17.96 14.23 5 54378 99 110534817
Erythema 17.91 14.23 78 54305 291369 110243547
Gestational hypertension 17.79 14.23 12 54371 2222 110532694
ECG signs of ventricular hypertrophy 17.78 14.23 3 54380 3 110534913
Immunoblastic lymphoma 17.78 14.23 3 54380 3 110534913
5'nucleotidase increased 17.78 14.23 3 54380 3 110534913
Eyelid oedema 17.71 14.23 29 54354 15233 110519683
Benign prostatic hyperplasia 17.68 14.23 32 54351 18202 110516714
Lipids abnormal 17.68 14.23 8 54375 677 110534239
Generalised anxiety disorder 17.65 14.23 13 54370 2766 110532150
Nephroangiosclerosis 17.60 14.23 7 54376 430 110534486
Hepatitis B reactivation 17.54 14.23 20 54363 7464 110527452
Glucose urine present 17.53 14.23 12 54371 2277 110532639
Erosive duodenitis 17.52 14.23 12 54371 2279 110532637
Teratogenicity 17.47 14.23 6 54377 243 110534673
Atrioventricular septal defect 17.47 14.23 5 54378 110 110534806
Rectal haemorrhage 17.33 14.23 20 54363 119813 110415103
Cranial nerve palsies multiple 17.29 14.23 6 54377 251 110534665
Crystal urine 17.18 14.23 5 54378 117 110534799
Peripheral motor neuropathy 17.17 14.23 15 54368 4071 110530845
Relapsing fever 17.14 14.23 7 54376 461 110534455
Therapy non-responder 17.13 14.23 32 54351 157275 110377641
Haemodialysis 17.06 14.23 31 54352 17688 110517228
Testicular mass 17.06 14.23 5 54378 120 110534796
Hepatitis acute 17.02 14.23 32 54351 18734 110516182
Coronary artery disease 16.89 14.23 75 54308 71615 110463301
Fat redistribution 16.82 14.23 5 54378 126 110534790
Cytomegalovirus test positive 16.82 14.23 19 54364 7017 110527899
Nephrogenic diabetes insipidus 16.81 14.23 12 54371 2433 110532483
Gynaecomastia 16.78 14.23 22 54361 9468 110525448
Ear pain 16.68 14.23 3 54380 53223 110481693
Gastrointestinal disorder 16.60 14.23 62 54321 241890 110293026
Placental infarction 16.50 14.23 5 54378 135 110534781
Acute hepatitis C 16.42 14.23 6 54377 292 110534624
Hyperglycaemia 16.40 14.23 84 54299 85006 110449910
Retroperitoneal disorder 16.39 14.23 4 54379 46 110534870
Hyperphosphatasaemia 16.39 14.23 5 54378 138 110534778
Colitis ulcerative 16.08 14.23 9 54374 77354 110457562
Hyperproteinaemia 16.00 14.23 6 54377 314 110534602
Electrocardiogram QT prolonged 16.00 14.23 100 54283 108860 110426056
Endometrial sarcoma 15.96 14.23 3 54380 8 110534908
Wrong dose 15.95 14.23 12 54371 2637 110532279
AIDS related complication 15.87 14.23 4 54379 53 110534863
Metabolic syndrome 15.86 14.23 13 54370 3234 110531682
Injection site bruising 15.83 14.23 3 54380 51260 110483656
Paraesthesia 15.80 14.23 76 54307 276445 110258471
Oropharyngeal cancer 15.75 14.23 5 54378 158 110534758
Vth nerve injury 15.70 14.23 3 54380 9 110534907
Hypo HDL cholesterolaemia 15.70 14.23 3 54380 9 110534907
Neutrophil count decreased 15.61 14.23 22 54361 120919 110413997
Blood triglycerides abnormal 15.59 14.23 7 54376 582 110534334
Acquired gene mutation 15.54 14.23 12 54371 2742 110532174
Arterial spasm 15.45 14.23 5 54378 168 110534748
Depressed mood 15.38 14.23 65 54318 60744 110474172
Heart rate decreased 15.31 14.23 11 54372 82745 110452171
Intentional overdose 15.29 14.23 26 54357 132475 110402441
Kaposi sarcoma inflammatory cytokine syndrome 15.29 14.23 5 54378 174 110534742
Haemoptysis 15.27 14.23 8 54375 71346 110463570
Hydrocephalus 15.26 14.23 22 54361 10353 110524563
Balance disorder 15.25 14.23 21 54362 116539 110418377
Lymphogranuloma venereum 15.24 14.23 3 54380 11 110534905
Bulbar palsy 15.24 14.23 6 54377 359 110534557
Dyspepsia 15.10 14.23 46 54337 190919 110343997
CD4 lymphocytes increased 15.06 14.23 6 54377 370 110534546
Cerebellar syndrome 15.04 14.23 17 54366 6285 110528631
Craniofacial deformity 15.03 14.23 3 54380 12 110534904
Myopathy 15.02 14.23 36 54347 24924 110509992
Strabismus 15.01 14.23 13 54370 3486 110531430
Acute HIV infection 15 14.23 4 54379 67 110534849
Adverse event 14.85 14.23 19 54364 108790 110426126
Prognathism 14.84 14.23 3 54380 13 110534903
Heart disease congenital 14.80 14.23 7 54376 655 110534261
Albuminuria 14.72 14.23 8 54375 1003 110533913
Shortened cervix 14.69 14.23 5 54378 197 110534719
Anaemia macrocytic 14.61 14.23 18 54365 7285 110527631
Megacolon 14.57 14.23 14 54369 4291 110530625
Drug exposure before pregnancy 14.54 14.23 7 54376 682 110534234
Meconium stain 14.49 14.23 3 54380 15 110534901
Paternal drugs affecting foetus 14.49 14.23 3 54380 15 110534901
Congenital diaphragmatic hernia 14.49 14.23 3 54380 15 110534901
Central nervous system lymphoma 14.48 14.23 12 54371 3032 110531884
Burning sensation 14.46 14.23 8 54375 69204 110465712
Foetal growth restriction 14.46 14.23 12 54371 3038 110531878
Blood bicarbonate decreased 14.45 14.23 16 54367 5781 110529135
Congenital hydrocephalus 14.43 14.23 4 54379 78 110534838
Osteonecrosis of jaw 14.43 14.23 3 54380 48014 110486902
New onset diabetes after transplantation 14.41 14.23 6 54377 415 110534501
Prescribed underdose 14.41 14.23 7 54376 65167 110469749
Hepatitis viral 14.39 14.23 9 54374 1466 110533450
Trichomoniasis 14.39 14.23 5 54378 210 110534706
Portal fibrosis 14.38 14.23 7 54376 698 110534218
Ear malformation 14.33 14.23 3 54380 16 110534900

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 J05AE30 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
MeSH PA D000890 Anti-Infective Agents
MeSH PA D000998 Antiviral Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D011480 Protease Inhibitors
MeSH PA D017320 HIV Protease Inhibitors
MeSH PA D019380 Anti-HIV Agents
MeSH PA D065607 Cytochrome P-450 Enzyme Inhibitors
MeSH PA D065692 Cytochrome P-450 CYP3A Inhibitors
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:33231 antitubercular agent
CHEBI has role CHEBI:33281 antimicrobial agent
CHEBI has role CHEBI:33282 antibacterial agent
CHEBI has role CHEBI:35441 antiinfective agent
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35620 vasodilator agent
CHEBI has role CHEBI:35660 HIV protease inhibitor
CHEBI has role CHEBI:35674 antihypertensive agent
CHEBI has role CHEBI:35703 xenobiotic
CHEBI has role CHEBI:36044 antiviral drug
CHEBI has role CHEBI:38068 antimalarial
CHEBI has role CHEBI:50864 insulin-sensitizing drug
CHEBI has role CHEBI:64946 anti-HIV agent
CHEBI has role CHEBI:64951 anti-HBV agent
CHEBI has role CHEBI:78298 environmental contaminant
CHEBI has role CHEBI:149553 anticoronaviral agent
CHEBI has role CHEBI:231911 renoprotective agent

Related Drugs by ATC class:

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asunaprevirbeclabuvirboceprevirdaclatasvirdasabuvirelbasvirglecaprevirgrazoprevirledipasvirombitasvirparitaprevirpibrentasvir show all 18 →
J05AR Antivirals for treatment of HIV infections, combinations 19 drugs
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Drug Use | Suggest Off label Use Form| |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




🐶 Veterinary Drug Use

None

🐶 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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
150MG;100MG PAXLOVID (COPACKAGED) PFIZER N217188 May 25, 2023 RX TABLET ORAL 11351149 Aug. 5, 2041 TREATMENT OF MILD-TO-MODERATE CORONAVIRUS DISEASE 2019 (COVID-19) IN ADULTS WHO ARE AT HIGH RISK FOR PROGRESSION TO SEVERE COVID-19, INCLUDING HOSPITALIZATION OR DEATH
150MG;100MG PAXLOVID (COPACKAGED) PFIZER N217188 May 25, 2023 RX TABLET ORAL 11541034 Oct. 31, 2041 TREATMENT OF MILD-TO-MODERATE CORONAVIRUS DISEASE 2019 (COVID-19) IN ADULTS WHO ARE AT HIGH RISK FOR PROGRESSION TO SEVERE COVID-19, INCLUDING HOSPITALIZATION OR DEATH

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
150MG;100MG PAXLOVID (COPACKAGED) PFIZER N217188 May 25, 2023 RX TABLET ORAL Jan. 31, 2028 NEW DOSING RECOMMENDATIONS IN PATIENTS WITH SEVERE RENAL IMPAIRMENT INCLUDINGTHOSE REQUIRING HEMODIALYSIS BASED ON DATA FROM STUDY C4671028
150MG;100MG PAXLOVID (COPACKAGED) PFIZER N217188 May 25, 2023 RX TABLET ORAL May 25, 2028 NEW CHEMICAL ENTITY

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
Sodium/bile acid cotransporter Transporter Ki 4.74 CHEMBL
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
O3J8G9O825 INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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 35 sections
Norvir HUMAN PRESCRIPTION DRUG LABEL 1 0074-2340 TABLET, FILM COATED 100 mg ORAL NDA 35 sections
Kaletra HUMAN PRESCRIPTION DRUG LABEL 2 0074-2605 TABLET, FILM COATED 50 mg ORAL NDA 32 sections
Kaletra HUMAN PRESCRIPTION DRUG LABEL 2 0074-3008 TABLET, FILM COATED 25 mg ORAL NDA 32 sections
Norvir HUMAN PRESCRIPTION DRUG LABEL 1 0074-3333 TABLET, FILM COATED 100 mg ORAL NDA 35 sections
Norvir HUMAN PRESCRIPTION DRUG LABEL 1 0074-3399 POWDER 100 mg ORAL NDA 35 sections
Kaletra HUMAN PRESCRIPTION DRUG LABEL 2 0074-3956 SOLUTION 20 mg ORAL NDA 32 sections
Kaletra HUMAN PRESCRIPTION DRUG LABEL 2 0074-4014 TABLET, FILM COATED 50 mg ORAL NDA 32 sections
Kaletra HUMAN PRESCRIPTION DRUG LABEL 2 0074-6799 TABLET, FILM COATED 50 mg ORAL NDA 32 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 33342-163 TABLET, FILM COATED 25 mg ORAL ANDA 28 sections
Lopinavir and Ritonavir Human Prescription Drug Label 2 33342-164 TABLET, FILM COATED 50 mg ORAL ANDA 28 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
Ritonavir HUMAN PRESCRIPTION DRUG LABEL 1 60687-420 TABLET, FILM COATED 100 mg ORAL ANDA 29 sections
Ritonavir HUMAN PRESCRIPTION DRUG LABEL 1 63629-5702 TABLET 100 mg ORAL ANDA 26 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 28 sections
Kaletra HUMAN PRESCRIPTION DRUG LABEL 2 66336-624 TABLET, FILM COATED 50 mg ORAL NDA 27 sections
Ritonavir HUMAN PRESCRIPTION DRUG LABEL 1 67046-1251 TABLET, FILM COATED 100 mg ORAL ANDA 27 sections