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

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

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

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

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
1.20 g O
0.60 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 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 70 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
March 1, 1996 FDA ABBVIE
Aug. 25, 1996 EMA AbbVie Deutschland GmbH Co. KG
Feb. 10, 2022 PMDA PFIZER JAPAN INC

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Abortion spontaneous 2110.24 18.23 767 24433 46428 63417394
Exposure during pregnancy 2081.78 18.23 1076 24124 154471 63309351
Foetal exposure during pregnancy 1897.86 18.23 642 24558 31320 63432502
Maternal exposure during pregnancy 922 18.23 733 24467 219329 63244493
Premature baby 752.82 18.23 290 24910 20445 63443377
Abortion induced 731.69 18.23 237 24963 10005 63453817
Stillbirth 713.84 18.23 211 24989 6539 63457283
Drug interaction 616.73 18.23 594 24606 228537 63235285
Live birth 529.84 18.23 240 24960 25390 63438432
Caesarean section 434.61 18.23 185 25015 16847 63446975
Premature delivery 417.93 18.23 215 24985 30066 63433756
Foetal death 382.03 18.23 149 25051 10831 63452991
Virologic failure 381.89 18.23 98 25102 1764 63462058
Pregnancy 373.00 18.23 213 24987 36623 63427199
Premature labour 349.69 18.23 145 25055 12359 63451463
Premature rupture of membranes 286.46 18.23 98 25102 4895 63458927
Lipodystrophy acquired 257.07 18.23 68 25132 1384 63462438
Immune reconstitution inflammatory syndrome 245.47 18.23 92 25108 5992 63457830
Foetal growth restriction 233.03 18.23 94 25106 7459 63456363
Cushing's syndrome 226.62 18.23 53 25147 634 63463188
Hyperbilirubinaemia 214.99 18.23 100 25100 11214 63452608
Drug ineffective 195.56 18.23 86 25114 1044679 62419143
Treatment noncompliance 189.57 18.23 140 25060 37185 63426637
Blood HIV RNA increased 181.82 18.23 45 25155 694 63463128
Spina bifida 180.00 18.23 46 25154 813 63463009
CD4 lymphocytes decreased 174.64 18.23 50 25150 1377 63462445
Pain 160.19 18.23 48 25152 740580 62723242
Pre-eclampsia 152.92 18.23 74 25126 9059 63454763
Low birth weight baby 151.11 18.23 68 25132 7061 63456761
Viral load increased 149.76 18.23 44 25156 1330 63462492
Ventricular septal defect 147.26 18.23 58 25142 4320 63459502
Maternal drugs affecting foetus 147.22 18.23 61 25139 5181 63458641
Gestational diabetes 146.55 18.23 70 25130 8326 63455496
Polydactyly 139.47 18.23 31 25169 290 63463532
Viral mutation identified 133.71 18.23 43 25157 1767 63462055
Fanconi syndrome acquired 129.92 18.23 37 25163 999 63462823
Adrenal suppression 129.51 18.23 36 25164 888 63462934
Trisomy 21 127.80 18.23 30 25170 365 63463457
Congenital anomaly 126.33 18.23 41 25159 1735 63462087
Renal colic 125.22 18.23 39 25161 1442 63462380
Hepatic cytolysis 124.26 18.23 77 25123 15330 63448492
Renal tubular disorder 120.85 18.23 44 25156 2638 63461184
Fatigue 117.93 18.23 108 25092 887920 62575902
Pathogen resistance 113.67 18.23 54 25146 6344 63457478
Joint swelling 109.08 18.23 5 25195 327661 63136161
Polyhydramnios 108.86 18.23 39 25161 2232 63461590
Normal newborn 108.58 18.23 57 25143 8284 63455538
Drug resistance 107.46 18.23 82 25118 22851 63440971
Placenta praevia 103.79 18.23 31 25169 993 63462829
Fall 103.71 18.23 16 25184 392318 63071504
Congenital naevus 103.18 18.23 22 25178 166 63463656
Cerebral ventricle dilatation 99.33 18.23 30 25170 999 63462823
Acute kidney injury 95.11 18.23 274 24926 263141 63200681
Genotype drug resistance test positive 94.72 18.23 24 25176 409 63463413
Cholestasis of pregnancy 94.17 18.23 30 25170 1195 63462627
Umbilical cord abnormality 93.70 18.23 26 25174 637 63463185
Hepatocellular injury 90.66 18.23 80 25120 27301 63436521
Lipohypertrophy 89.05 18.23 25 25175 640 63463182
Low set ears 84.70 18.23 20 25180 250 63463572
Nasopharyngitis 81.08 18.23 5 25195 254252 63209570
Supernumerary nipple 80.98 18.23 15 25185 48 63463774
Acoustic stimulation tests abnormal 80.68 18.23 16 25184 80 63463742
HIV infection 80.58 18.23 21 25179 402 63463420
Arthropathy 80.05 18.23 3 25197 234789 63229033
Patent ductus arteriosus 78.97 18.23 37 25163 4213 63459609
Trisomy 18 78.63 18.23 17 25183 138 63463684
Amniotic cavity infection 77.18 18.23 26 25174 1237 63462585
Renal dysplasia 75.86 18.23 18 25182 230 63463592
Jaundice 74.75 18.23 74 25126 29177 63434645
Meconium stain 74.23 18.23 17 25183 184 63463638
Swelling 73.24 18.23 11 25189 275367 63188455
Congenital genital malformation 72.94 18.23 16 25184 140 63463682
Atrial septal defect 72.51 18.23 41 25159 6897 63456925
Anal atresia 72.17 18.23 19 25181 379 63463443
Cloacal exstrophy 71.95 18.23 16 25184 150 63463672
Congenital heart valve disorder 70.77 18.23 14 25186 69 63463753
Mitochondrial cytopathy 70.75 18.23 17 25183 230 63463592
Sinusitis 70.66 18.23 5 25195 226648 63237174
Secondary adrenocortical insufficiency 70.24 18.23 25 25175 1403 63462419
Peripheral swelling 69.86 18.23 11 25189 265931 63197891
Gastrointestinal disorder congenital 68.61 18.23 15 25185 129 63463693
Premature separation of placenta 67.34 18.23 26 25174 1835 63461987
Bladder agenesis 67.13 18.23 15 25185 144 63463678
Sudden infant death syndrome 66.97 18.23 17 25183 292 63463530
Abdominal discomfort 66.95 18.23 22 25178 320863 63142959
Systemic lupus erythematosus 66.92 18.23 4 25196 208914 63254908
Genitalia external ambiguous 66.49 18.23 15 25185 151 63463671
Caudal regression syndrome 65.53 18.23 15 25185 162 63463660
Congenital hydrocephalus 65.53 18.23 15 25185 162 63463660
Cushingoid 64.87 18.23 41 25159 8444 63455378
Hyperadrenocorticism 64.72 18.23 17 25183 336 63463486
Foetal distress syndrome 64.21 18.23 23 25177 1315 63462507
Therapeutic product effect decreased 64.06 18.23 3 25197 193184 63270638
Cholestasis 63.52 18.23 68 25132 29366 63434456
Arthralgia 63.43 18.23 80 25120 569630 62894192
Ultrasound antenatal screen abnormal 62.79 18.23 14 25186 133 63463689
Renal tubular acidosis 62.51 18.23 24 25176 1668 63462154
Oligohydramnios 62.19 18.23 36 25164 6330 63457492
Placental disorder 61.59 18.23 23 25177 1481 63462341
Exomphalos 61.42 18.23 18 25182 539 63463283
Anembryonic gestation 61.17 18.23 18 25182 547 63463275
Alopecia 60.81 18.23 29 25171 337507 63126315
Fanconi syndrome 59.62 18.23 22 25178 1370 63462452
Immunosuppressant drug level increased 59.46 18.23 29 25171 3609 63460213
Gastrointestinal malformation 59.36 18.23 14 25186 174 63463648
Eosinophilia 58.94 18.23 58 25142 22698 63441124
Placental insufficiency 58.88 18.23 22 25178 1419 63462403
Anaemia 58.56 18.23 251 24949 293179 63170643
Tethered cord syndrome 58.48 18.23 15 25185 269 63463553
Neural tube defect 58.36 18.23 14 25186 188 63463634
Retinoblastoma 58.25 18.23 12 25188 75 63463747
Dyspnoea 58.16 18.23 109 25091 661204 62802618
Hydrocephalus 57.23 18.23 32 25168 5268 63458554
Congenital choroid plexus cyst 56.47 18.23 15 25185 310 63463512
Ergot poisoning 56.46 18.23 12 25188 89 63463733
Dysmorphism 55.42 18.23 24 25176 2272 63461550
Alpha 1 foetoprotein abnormal 55.14 18.23 11 25189 57 63463765
Mitochondrial toxicity 55.05 18.23 16 25184 465 63463357
Infection 54.78 18.23 12 25188 229161 63234661
Nephrolithiasis 54.55 18.23 75 25125 41909 63421913
Discomfort 54.22 18.23 3 25197 167371 63296451
Ectopic pregnancy 52.85 18.23 24 25176 2543 63461279
Small for dates baby 52.74 18.23 27 25173 3724 63460098
Skin striae 52.22 18.23 20 25180 1381 63462441
Twin pregnancy 51.94 18.23 19 25181 1154 63462668
Macrocephaly 51.83 18.23 11 25189 81 63463741
Neonatal respiratory arrest 51.11 18.23 10 25190 46 63463776
Meningomyelocele 51.10 18.23 16 25184 602 63463220
Contraindicated product administered 50.81 18.23 12 25188 217636 63246186
Lactic acidosis 50.65 18.23 69 25131 38218 63425604
Congenital pulmonary valve disorder 50.59 18.23 10 25190 49 63463773
CSF HIV escape syndrome 50.17 18.23 11 25189 96 63463726
Osteonecrosis 50.01 18.23 55 25145 24475 63439347
Portal hypertension 49.42 18.23 26 25174 3793 63460029
HIV-associated neurocognitive disorder 47.38 18.23 11 25189 127 63463695
Condition aggravated 47.34 18.23 54 25146 402163 63061659
Constipation 45.88 18.23 16 25184 224927 63238895
Coloboma 45.43 18.23 10 25190 89 63463733
Foetal malnutrition 45.23 18.23 10 25190 91 63463731
Single umbilical artery 45.09 18.23 12 25188 250 63463572
Hepatotoxicity 44.89 18.23 64 25136 36977 63426845
Oesophageal candidiasis 44.89 18.23 28 25172 5635 63458187
Microcephaly 44.51 18.23 16 25184 924 63462898
Central obesity 43.97 18.23 17 25183 1204 63462618
Musculoskeletal stiffness 43.44 18.23 10 25190 184608 63279214
Adrenal insufficiency 43.33 18.23 44 25156 17871 63445951
Anencephaly 43.20 18.23 12 25188 295 63463527
Drug hypersensitivity 43.15 18.23 36 25164 310651 63153171
Cough 43.07 18.23 32 25168 292711 63171111
CSF test abnormal 42.49 18.23 12 25188 314 63463508
Pain in extremity 41.77 18.23 42 25158 331444 63132378
Single functional kidney 41.45 18.23 12 25188 344 63463478
Drug intolerance 41.36 18.23 37 25163 308624 63155198
Pericarditis 40.70 18.23 3 25197 131576 63332246
Blood bilirubin unconjugated increased 40.61 18.23 12 25188 370 63463452
Double outlet right ventricle 40.51 18.23 8 25192 39 63463783
Foetal heart rate disorder 40.51 18.23 9 25191 84 63463738
Injection site pain 40.04 18.23 3 25197 129797 63334025
Coarctation of the aorta 39.69 18.23 13 25187 566 63463256
Aspartate aminotransferase increased 39.58 18.23 101 25099 90176 63373646
Pneumonia 39.45 18.23 76 25124 456691 63007131
Ultrasound scan abnormal 39.43 18.23 11 25189 275 63463547
Product dose omission issue 39.39 18.23 22 25178 234291 63229531
Alanine aminotransferase increased 39.34 18.23 110 25090 103660 63360162
Congenital ectopic bladder 39.25 18.23 9 25191 98 63463724
Transaminases increased 39.19 18.23 55 25145 31312 63432510
Cardiac malposition 38.30 18.23 8 25192 54 63463768
Therapeutic product effect incomplete 38.26 18.23 3 25197 125053 63338769
Ichthyosis 38.17 18.23 8 25192 55 63463767
Sepsis neonatal 38.01 18.23 12 25188 464 63463358
Glycosuria 37.64 18.23 15 25185 1151 63462671
Hemivertebra 37.58 18.23 9 25191 120 63463702
Congenital central nervous system anomaly 37.42 18.23 11 25189 333 63463489
Ultrasound antenatal screen 37.23 18.23 10 25190 216 63463606
Rash maculo-papular 37.02 18.23 54 25146 31842 63431980
Cortisol decreased 36.70 18.23 15 25185 1229 63462593
Off label use 36.63 18.23 141 25059 674321 62789501
Pulmonary valve sclerosis 36.00 18.23 7 25193 31 63463791
Muscle spasms 35.67 18.23 9 25191 156141 63307681
Acquired immunodeficiency syndrome 35.42 18.23 8 25192 81 63463741
Hepatitis B DNA increased 35.36 18.23 10 25190 263 63463559
Headache 35.27 18.23 131 25069 633110 62830712
Arthritis 34.86 18.23 3 25197 115918 63347904
Prenatal screening test abnormal 34.75 18.23 6 25194 11 63463811
Mobility decreased 34.18 18.23 4 25196 121155 63342667
Alpha 1 foetoprotein increased 33.93 18.23 9 25191 185 63463637
Pregnancy on contraceptive 33.90 18.23 14 25186 1178 63462644
Renal aplasia 33.79 18.23 10 25190 310 63463512
Cerebral toxoplasmosis 33.04 18.23 13 25187 965 63462857
Amniotic fluid volume decreased 33.03 18.23 11 25189 505 63463317
Hypoaesthesia 32.61 18.23 13 25187 168380 63295442
Atrial fibrillation 32.54 18.23 4 25196 116632 63347190
Endometritis decidual 32.44 18.23 6 25194 19 63463803
Cardiac murmur 32.06 18.23 34 25166 14518 63449304
Nephropathy toxic 31.97 18.23 28 25172 9451 63454371
Abortion threatened 31.92 18.23 11 25189 561 63463261
Dizziness 31.75 18.23 78 25122 429847 63033975
Hydrops foetalis 31.26 18.23 11 25189 597 63463225
Hypophosphataemia 31.23 18.23 30 25170 11396 63452426
Threatened labour 31.14 18.23 12 25188 842 63462980
Renal failure 31.02 18.23 110 25090 117542 63346280
Proteinuria 30.78 18.23 38 25162 19107 63444715
Congenital anomaly in offspring 30.46 18.23 8 25192 158 63463664
Hyperlactacidaemia 30.21 18.23 17 25183 2832 63460990
Complication of delivery 30.04 18.23 8 25192 167 63463655
Urinary tract infection 29.54 18.23 37 25163 264647 63199175
Lipoatrophy 29.39 18.23 9 25191 314 63463508
Left ventricular dilatation 29.38 18.23 10 25190 491 63463331
Osteoporosis 29.23 18.23 68 25132 57270 63406552
Isoimmune haemolytic disease 29.19 18.23 6 25194 37 63463785
Face oedema 29.14 18.23 38 25162 20174 63443648
Renal tubular necrosis 28.41 18.23 29 25171 11849 63451973
Oesophageal atresia 28.38 18.23 10 25190 545 63463277
Metabolic acidosis 28.14 18.23 58 25142 45011 63418811
Cachexia 27.97 18.23 21 25179 5705 63458117
Neonatal disorder 27.90 18.23 10 25190 573 63463249
Congenital skin dimples 27.87 18.23 7 25193 115 63463707
Feeling abnormal 27.85 18.23 12 25188 148380 63315442
Congenital eye disorder 27.76 18.23 5 25195 13 63463809
Potassium wasting nephropathy 27.61 18.23 6 25194 50 63463772
Dyslipidaemia 27.30 18.23 23 25177 7370 63456452
Hepatitis C 27.24 18.23 20 25180 5254 63458568
ACTH stimulation test abnormal 27.24 18.23 5 25195 15 63463807
Gestational hypertension 27.21 18.23 15 25185 2402 63461420
Hepatitis 26.99 18.23 53 25147 39735 63424087
Prurigo 26.92 18.23 11 25189 901 63462921
Total bile acids increased 26.76 18.23 7 25193 136 63463686
Renal tubular dysfunction 26.76 18.23 9 25191 426 63463396
Back pain 26.38 18.23 40 25160 264105 63199717
Hypertriglyceridaemia 26.32 18.23 21 25179 6238 63457584
Musculoskeletal pain 26.14 18.23 3 25197 92274 63371548
Blood lactic acid increased 26.07 18.23 22 25178 7064 63456758
Inappropriate schedule of product administration 25.74 18.23 5 25195 103960 63359862
Congenital hand malformation 25.70 18.23 8 25192 295 63463527
Migraine 25.52 18.23 5 25195 103341 63360481
Product use issue 25.47 18.23 30 25170 220490 63243332
Placental infarction 25.40 18.23 8 25192 307 63463515
Drug reaction with eosinophilia and systemic symptoms 25.33 18.23 47 25153 33789 63430033
Bronchitis 25.26 18.23 9 25191 124926 63338896
Congenital genital malformation female 24.89 18.23 5 25195 27 63463795
Hepatic displacement 24.89 18.23 5 25195 27 63463795
Mental disability 24.85 18.23 6 25194 83 63463739
Stomatitis 24.82 18.23 12 25188 138713 63325109
Ventricular hypertrophy 24.77 18.23 16 25184 3420 63460402
Toxic skin eruption 24.73 18.23 28 25172 12857 63450965
Haemolytic anaemia 24.73 18.23 25 25175 10100 63453722
Hepatitis cholestatic 24.58 18.23 21 25179 6857 63456965
Placental chorioangioma 24.56 18.23 4 25196 4 63463818
Talipes 24.34 18.23 12 25188 1528 63462294
Foetal anaemia 24.03 18.23 6 25194 96 63463726
Ocular icterus 23.86 18.23 16 25184 3640 63460182
Congenital aortic stenosis 23.66 18.23 5 25195 36 63463786
Complication of pregnancy 23.64 18.23 9 25191 611 63463211
Sexually transmitted disease 23.59 18.23 7 25193 219 63463603
Hepatosplenomegaly 23.47 18.23 14 25186 2600 63461222
Blood pressure increased 23.44 18.23 18 25182 162044 63301778
Foetal heart rate abnormal 23.40 18.23 9 25191 628 63463194
Fat redistribution 23.29 18.23 4 25196 7 63463815
Maxillonasal dysplasia 23.29 18.23 4 25196 7 63463815
Albuminuria 23.09 18.23 7 25193 236 63463586
Subchorionic haematoma 22.54 18.23 6 25194 125 63463697
Calculus urinary 22.52 18.23 11 25189 1373 63462449
Glucocorticoids increased 22.50 18.23 6 25194 126 63463696
Malignant neoplasm progression 22.46 18.23 3 25197 82118 63381704
Heart rate increased 22.36 18.23 5 25195 94233 63369589
Blood cholesterol increased 22.29 18.23 5 25195 94027 63369795
HELLP syndrome 22.25 18.23 10 25190 1034 63462788
Blister 22.07 18.23 12 25188 129802 63334020
Large for dates baby 22.04 18.23 8 25192 475 63463347
Osteomalacia 22.04 18.23 9 25191 736 63463086
Bovine tuberculosis 22.01 18.23 5 25195 52 63463770
Conduction disorder 21.91 18.23 11 25189 1456 63462366
Encephalomalacia 21.88 18.23 8 25192 485 63463337
Influenza 21.70 18.23 8 25192 108714 63355108
Epilepsy congenital 21.55 18.23 4 25196 13 63463809
Toxoplasmosis 21.52 18.23 11 25189 1512 63462310
Atrioventricular block complete 21.30 18.23 21 25179 8230 63455592
Breast disorder 21.30 18.23 13 25187 2517 63461305
Chronic papillomatous dermatitis 21.28 18.23 5 25195 61 63463761
Retroplacental haematoma 21.21 18.23 6 25194 158 63463664
Blood bilirubin increased 21.11 18.23 46 25154 37094 63426728
HIV wasting syndrome 20.90 18.23 4 25196 16 63463806
Nervous system disorder 20.66 18.23 31 25169 18735 63445087
Congenital mitochondrial cytopathy 20.50 18.23 3 25197 0 63463822
Brachycephaly 20.34 18.23 4 25196 19 63463803
Nystagmus 20.23 18.23 18 25182 6202 63457620
Upper respiratory tract infection 20.19 18.23 4 25196 82043 63381779
Shortened cervix 20.18 18.23 6 25194 189 63463633
Cellulitis 20.16 18.23 4 25196 81954 63381868
Ill-defined disorder 20.09 18.23 4 25196 81751 63382071
Febrile neutropenia 20.06 18.23 11 25189 118438 63345384
Foetal malformation 19.86 18.23 6 25194 200 63463622
Hepatomegaly 19.76 18.23 24 25176 11865 63451957
Death neonatal 19.71 18.23 9 25191 966 63462856
Diaphragmatic aplasia 19.70 18.23 4 25196 23 63463799
Necrotising enterocolitis neonatal 19.60 18.23 6 25194 209 63463613
Aqueductal stenosis 19.56 18.23 4 25196 24 63463798
Hemiataxia 19.56 18.23 4 25196 24 63463798
Congenital diaphragmatic hernia 19.52 18.23 6 25194 212 63463610
Anaemia of pregnancy 19.48 18.23 5 25195 90 63463732
Umbilical cord prolapse 19.28 18.23 4 25196 26 63463796
Injury 19.27 18.23 3 25197 73244 63390578
Coma hepatic 19.24 18.23 8 25192 685 63463137
Gamma-glutamyltransferase increased 19.17 18.23 42 25158 33989 63429833
Congenital absence of bile ducts 19.15 18.23 4 25196 27 63463795
High arched palate 19.07 18.23 5 25195 98 63463724
Rhabdomyolysis 19.07 18.23 49 25151 43902 63419920
Hepatic failure 18.96 18.23 43 25157 35613 63428209
Transposition of the great vessels 18.93 18.23 6 25194 235 63463587
Abortion 18.92 18.23 12 25188 2484 63461338
Eyelid oedema 18.81 18.23 22 25178 10457 63453365
Congenital foot malformation 18.81 18.23 6 25194 240 63463582
Foetal cardiac disorder 18.78 18.23 4 25196 30 63463792
Thymus hypoplasia 18.78 18.23 4 25196 30 63463792
Dermatitis exfoliative generalised 18.68 18.23 14 25186 3793 63460029
Pulmonary artery stenosis congenital 18.64 18.23 6 25194 247 63463575
Strabismus 18.64 18.23 11 25189 2003 63461819
New onset diabetes after transplantation 18.57 18.23 5 25195 109 63463713
Psychomotor retardation 18.48 18.23 14 25186 3856 63459966
Skeletal dysplasia 18.42 18.23 3 25197 3 63463819
Brain stem auditory evoked response abnormal 18.42 18.23 3 25197 3 63463819
Epidural lipomatosis 18.36 18.23 5 25195 114 63463708
Portal vein thrombosis 18.35 18.23 12 25188 2618 63461204
Generalised anxiety disorder 18.34 18.23 11 25189 2063 63461759
Chondroma 18.34 18.23 4 25196 34 63463788
HIV test positive 18.34 18.23 4 25196 34 63463788

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 1093.37 12.14 654 44334 37447 34874496
Immune reconstitution inflammatory syndrome 749.66 12.14 316 44672 8443 34903500
Drug interaction 740.06 12.14 1157 43831 224789 34687154
Lipodystrophy acquired 666.13 12.14 224 44764 3120 34908823
Virologic failure 381.41 12.14 150 44838 3330 34908613
Renal tubular disorder 365.68 12.14 158 44830 4485 34907458
Mitochondrial toxicity 319.38 12.14 123 44865 2576 34909367
Premature baby 319.31 12.14 237 44751 19396 34892547
Fanconi syndrome acquired 310.01 12.14 111 44877 1880 34910063
Exposure during pregnancy 305.11 12.14 172 44816 8762 34903181
Progressive external ophthalmoplegia 297.14 12.14 99 44889 1336 34910607
Nephrolithiasis 268.79 12.14 258 44730 30075 34881868
Psychiatric decompensation 257.97 12.14 108 44880 2829 34909114
Osteoporosis 252.19 12.14 173 44815 12495 34899448
Hyperbilirubinaemia 250.99 12.14 193 44795 16650 34895293
Renal colic 243.55 12.14 91 44897 1748 34910195
Osteonecrosis 240.41 12.14 179 44809 14711 34897232
Depression suicidal 236.52 12.14 97 44891 2408 34909535
CD4 lymphocytes decreased 230.01 12.14 86 44902 1655 34910288
Tearfulness 227.32 12.14 96 44892 2571 34909372
Trisomy 21 207.67 12.14 61 44927 526 34911417
Eyelid ptosis 204.99 12.14 114 44874 5652 34906291
Viral load increased 198.98 12.14 86 44902 2441 34909502
Depressive symptom 198.30 12.14 89 44899 2770 34909173
Cushing's syndrome 182.32 12.14 51 44937 362 34911581
Blood HIV RNA increased 178.11 12.14 65 44923 1165 34910778
Hypertriglyceridaemia 171.99 12.14 117 44871 8331 34903612
Viral mutation identified 170.65 12.14 81 44907 2873 34909070
Kaposi's sarcoma 163.43 12.14 56 44932 827 34911116
Psychomotor skills impaired 160.47 12.14 85 44903 3821 34908122
Jaundice 154.95 12.14 198 44790 31684 34880259
HIV-associated neurocognitive disorder 149.67 12.14 42 44946 302 34911641
Fanconi syndrome 143.54 12.14 61 44927 1659 34910284
Syphilis 139.83 12.14 42 44946 394 34911549
Adrenal suppression 135.40 12.14 45 44943 602 34911341
Drug resistance 132.29 12.14 165 44823 25762 34886181
Polydactyly 128.40 12.14 51 44937 1162 34910781
Paranoia 119.02 12.14 109 44879 11959 34899984
Glycosuria 117.12 12.14 48 44940 1189 34910754
Lipoatrophy 116.83 12.14 38 44950 473 34911470
Mycobacterium avium complex infection 109.86 12.14 57 44931 2454 34909489
Drug ineffective 106.56 12.14 273 44715 456478 34455465
Acquired immunodeficiency syndrome 104.31 12.14 35 44953 483 34911460
Blood bilirubin increased 103.94 12.14 181 44807 38115 34873828
Pathogen resistance 102.10 12.14 90 44898 9392 34902551
Dyslipidaemia 101.13 12.14 81 44907 7407 34904536
Hyperlipidaemia 100.19 12.14 108 44880 14421 34897522
Proteinuria 95.66 12.14 119 44869 18523 34893420
Diplopia 95.35 12.14 113 44875 16730 34895213
Hepatic cytolysis 95.16 12.14 105 44883 14391 34897552
Psychotic disorder 93.19 12.14 135 44853 24317 34887626
Calculus urinary 91.87 12.14 42 44946 1365 34910578
Blood triglycerides increased 90.26 12.14 101 44887 14058 34897885
Hepatitis C 89.63 12.14 85 44903 9745 34902198
Nephropathy toxic 89.31 12.14 95 44893 12493 34899450
Dyspnoea 88.67 12.14 224 44764 376558 34535385
Psychomotor retardation 87.51 12.14 56 44932 3594 34908349
Genotype drug resistance test positive 86.99 12.14 38 44950 1107 34910836
Mitochondrial cytopathy 86.08 12.14 24 44964 168 34911775
Congenital anomaly 86.02 12.14 40 44948 1353 34910590
Off label use 84.32 12.14 269 44719 419255 34492688
Hypotension 82.94 12.14 98 44890 221551 34690392
Disease progression 82.43 12.14 19 44969 108058 34803885
Suicidal ideation 82.40 12.14 169 44819 40219 34871724
Hyperlactacidaemia 81.70 12.14 50 44938 2966 34908977
Atrial fibrillation 77.95 12.14 30 44958 122363 34789580
Retinal toxicity 77.92 12.14 27 44961 413 34911530
Febrile neutropenia 77.03 12.14 40 44948 136809 34775134
Hypophosphataemia 76.08 12.14 82 44906 10944 34900999
Cytomegalovirus chorioretinitis 73.74 12.14 50 44938 3539 34908404
Malignant neoplasm progression 72.28 12.14 13 44975 88033 34823910
Cortisol decreased 71.58 12.14 33 44955 1094 34910849
Heterotaxia 71.38 12.14 19 44969 109 34911834
Anal cancer 69.02 12.14 25 44963 438 34911505
Cushingoid 68.46 12.14 43 44945 2671 34909272
Pyelocaliectasis 68.38 12.14 32 44956 1098 34910845
Ventricular septal defect 66.57 12.14 49 44939 3952 34907991
Trisomy 18 66.52 12.14 28 44960 743 34911200
Lipohypertrophy 64.88 12.14 21 44967 257 34911686
Fall 64.46 12.14 101 44887 202784 34709159
Low birth weight baby 63.91 12.14 64 44924 7841 34904102
Progressive multifocal leukoencephalopathy 62.83 12.14 70 44918 9694 34902249
Atypical mycobacterial infection 62.56 12.14 28 44960 865 34911078
Brain stem stroke 61.60 12.14 21 44967 305 34911638
Peripheral swelling 61.33 12.14 12 44976 76529 34835414
Laryngomalacia 61.22 12.14 21 44967 311 34911632
Congenital hydronephrosis 61.18 12.14 26 44962 707 34911236
Ultrasound antenatal screen 61.03 12.14 24 44964 532 34911411
Drug level increased 60.66 12.14 105 44883 21991 34889952
Anogenital dysplasia 60.36 12.14 17 44971 124 34911819
Oesophageal candidiasis 60.31 12.14 48 44940 4348 34907595
Maternal drugs affecting foetus 60.27 12.14 46 44942 3919 34908024
Foetal chromosome abnormality 60.09 12.14 12 44976 11 34911932
Completed suicide 59.35 12.14 26 44962 98142 34813801
Portal hypertension 59.28 12.14 46 44942 4016 34907927
Ventricular hypoplasia 58.93 12.14 15 44973 70 34911873
Blood pressure increased 58.78 12.14 20 44968 88082 34823861
Blood bilirubin unconjugated increased 58.50 12.14 24 44964 596 34911347
Death 58.40 12.14 289 44699 397760 34514183
Ergot poisoning 58.03 12.14 13 44975 30 34911913
Acute kidney injury 57.93 12.14 623 44365 304365 34607578
Ophthalmoplegia 56.32 12.14 33 44955 1807 34910136
Pneumonia 54.48 12.14 261 44727 362366 34549577
Ocular icterus 54.44 12.14 38 44950 2819 34909124
Drug abuse 54.22 12.14 30 44958 99066 34812877
Renal impairment 54.12 12.14 253 44735 94260 34817683
Hepatitis B 53.14 12.14 51 44937 5932 34906011
Constipation 52.86 12.14 59 44929 136923 34775020
Oesophageal atresia 52.32 12.14 21 44967 492 34911451
Pancreatitis 52.10 12.14 138 44850 38753 34873190
HIV infection 51.80 12.14 28 44960 1311 34910632
Aspartate aminotransferase increased 51.67 12.14 198 44790 67585 34844358
Hepatitis 49.89 12.14 101 44887 23803 34888140
Adrenal insufficiency 49.82 12.14 75 44913 13972 34897971
Cleft lip and palate 49.61 12.14 24 44964 888 34911055
Inappropriate schedule of product administration 49.41 12.14 10 44978 62286 34849657
Pain 48.51 12.14 121 44867 204554 34707389
Single umbilical artery 48.48 12.14 16 44972 209 34911734
Foetal growth restriction 48.21 12.14 41 44947 4076 34907867
Genital herpes 48.00 12.14 21 44967 614 34911329
Gamma-glutamyltransferase increased 47.87 12.14 112 44876 29119 34882824
Atrioventricular septal defect 47.87 12.14 16 44972 218 34911725
Cerebral toxoplasmosis 47.81 12.14 29 44959 1692 34910251
Hydrops foetalis 47.72 12.14 23 44965 844 34911099
Alanine aminotransferase increased 47.48 12.14 218 44770 80597 34831346
Blood creatine phosphokinase increased 47.28 12.14 146 44842 44711 34867232
Cachexia 47.06 12.14 52 44936 7134 34904809
Porphyria non-acute 46.38 12.14 19 44969 470 34911473
COVID-19 46.14 12.14 21 44967 77529 34834414
Periventricular leukomalacia 45.97 12.14 12 44976 63 34911880
Infusion related reaction 45.38 12.14 7 44981 53050 34858893
Pulmonary haemorrhage neonatal 44.69 12.14 9 44979 9 34911934
Chordee 44.48 12.14 12 44976 73 34911870
Hepatitis cholestatic 44.44 12.14 53 44935 7894 34904049
Hyperadrenocorticism 43.86 12.14 13 44975 116 34911827
Hepatomegaly 43.44 12.14 60 44928 10336 34901607
Cardiac failure congestive 43.02 12.14 27 44961 83243 34828700
Product use issue 42.77 12.14 14 44974 63202 34848741
Anogenital warts 42.72 12.14 19 44969 578 34911365
Renal failure 42.71 12.14 301 44687 130256 34781687
Product dose omission issue 42.52 12.14 55 44933 119656 34792287
Hypercholesterolaemia 41.88 12.14 54 44934 8708 34903235
Hodgkin's disease 41.44 12.14 21 44967 860 34911083
Blood lactic acid increased 41.18 12.14 47 44941 6681 34905262
Hemivertebra 41.18 12.14 13 44975 146 34911797
Drug reaction with eosinophilia and systemic symptoms 41.07 12.14 114 44874 32898 34879045
Hepatic cirrhosis 40.80 12.14 77 44911 17237 34894706
Therapeutic product effect incomplete 40.32 12.14 8 44980 50533 34861410
Osteoporotic fracture 39.87 12.14 22 44966 1073 34910870
Pneumocystis jirovecii pneumonia 38.45 12.14 81 44907 19629 34892314
Sepsis 38.26 12.14 100 44888 166461 34745482
CSF HIV escape syndrome 38.18 12.14 13 44975 188 34911755
Treatment noncompliance 37.92 12.14 100 44888 28000 34883943
Hypospadias 37.73 12.14 32 44956 3169 34908774
Heart disease congenital 37.53 12.14 23 44965 1367 34910576
Lactic acidosis 37.41 12.14 114 44874 34658 34877285
Caesarean section 37.13 12.14 27 44961 2137 34909806
Cholelithiasis 36.80 12.14 83 44905 21065 34890878
Liver disorder 36.26 12.14 109 44879 32888 34879055
Joint swelling 35.96 12.14 16 44972 59874 34852069
Blood phosphorus decreased 35.86 12.14 31 44957 3150 34908793
Burkitt's lymphoma 35.81 12.14 11 44977 112 34911831
Renal tubular acidosis 35.46 12.14 27 44961 2292 34909651
Hepatic failure 35.10 12.14 111 44877 34420 34877523
Gene mutation 34.74 12.14 22 44966 1386 34910557
Beta 2 microglobulin urine increased 34.59 12.14 10 44978 81 34911862
Hyperuricaemia 34.48 12.14 47 44941 7996 34903947
HIV wasting syndrome 34.27 12.14 10 44978 84 34911859
Infection 34.14 12.14 40 44948 90875 34821068
Ureterolithiasis 34.08 12.14 26 44962 2213 34909730
Amyotrophy 33.26 12.14 15 44973 472 34911471
Hepatocellular injury 33.03 12.14 82 44906 22129 34889814
Pneumonitis 32.59 12.14 3 44985 33875 34878068
Haemophilic arthropathy 32.57 12.14 11 44977 155 34911788
Oral candidiasis 32.52 12.14 57 44931 12053 34899890
Foetal death 32.47 12.14 12 44976 223 34911720
Blood alkaline phosphatase increased 32.41 12.14 101 44887 31074 34880869
Cryptorchism 31.73 12.14 24 44964 2017 34909926
Renal tubular dysfunction 31.72 12.14 14 44974 418 34911525
Hepatotoxicity 31.62 12.14 79 44909 21406 34890537
Treponema test positive 31.51 12.14 6 44982 3 34911940
White matter lesion 31.43 12.14 17 44971 797 34911146
Genital herpes simplex 31.15 12.14 10 44978 119 34911824
CD4 lymphocytes abnormal 31.14 12.14 8 44980 39 34911904
Toxoplasmosis 31.07 12.14 20 44968 1296 34910647
Anaphylactic reaction 30.70 12.14 3 44985 32298 34879645
Chest discomfort 30.56 12.14 16 44972 54514 34857429
Coarctation of the aorta 30.45 12.14 14 44974 461 34911482
Lymphadenopathy 30.32 12.14 93 44895 28370 34883573
Renal tubular necrosis 30.07 12.14 64 44924 15616 34896327
Karyotype analysis abnormal 30.04 12.14 8 44980 46 34911897
Immunosuppressant drug level increased 30.01 12.14 38 44950 6017 34905926
Hypothalamic pituitary adrenal axis suppression 29.87 12.14 10 44978 137 34911806
Fatigue 29.54 12.14 320 44668 370333 34541610
Osteomalacia 29.53 12.14 17 44971 900 34911043
Rash maculo-papular 29.41 12.14 92 44896 28359 34883584
Malaria 29.40 12.14 11 44977 212 34911731
Castleman's disease 29.21 12.14 7 44981 24 34911919
Hydrocele 29.08 12.14 23 44965 2064 34909879
Lymphoma 28.70 12.14 55 44933 12452 34899491
Mycobacterial infection 28.53 12.14 24 44964 2350 34909593
Small for dates baby 28.49 12.14 30 44958 3897 34908046
Intestinal malrotation 28.37 12.14 7 44981 28 34911915
Ectopic kidney 28.17 12.14 7 44981 29 34911914
Normal newborn 27.94 12.14 10 44978 169 34911774
International normalised ratio increased 27.86 12.14 13 44975 47314 34864629
Condition aggravated 27.80 12.14 140 44848 192056 34719887
Fibrous histiocytoma 27.78 12.14 10 44978 172 34911771
Stillbirth 27.67 12.14 10 44978 174 34911769
Interstitial lung disease 27.56 12.14 26 44962 65256 34846687
Tubulointerstitial nephritis 27.53 12.14 74 44914 20950 34890993
Intentional product use issue 27.46 12.14 22 44966 59794 34852149
Central obesity 27.01 12.14 14 44974 601 34911342
Pulmonary malformation 26.94 12.14 7 44981 36 34911907
Heart rate increased 26.86 12.14 13 44975 46330 34865613
Viral load decreased 26.78 12.14 7 44981 37 34911906
Anal cancer stage 0 26.74 12.14 6 44982 14 34911929
Secondary adrenocortical insufficiency 26.73 12.14 19 44969 1451 34910492
Blood corticotrophin decreased 26.20 12.14 10 44978 204 34911739
Neonatal hyponatraemia 26.18 12.14 8 44980 80 34911863
Congenital nystagmus 26.17 12.14 6 44982 16 34911927
Multiple-drug resistance 26.16 12.14 33 44955 5206 34906737
Prenatal screening test abnormal 25.90 12.14 6 44982 17 34911926
Oropharyngeal candidiasis 25.75 12.14 15 44973 812 34911131
Feeling abnormal 25.75 12.14 26 44962 63209 34848734
Fat tissue increased 25.61 12.14 12 44976 413 34911530
Enanthema 25.53 12.14 12 44976 416 34911527
Vanishing bile duct syndrome 25.35 12.14 16 44972 1002 34910941
Hepatosplenomegaly 25.30 12.14 29 44959 4140 34907803
Blood antidiuretic hormone increased 25.11 12.14 7 44981 49 34911894
Therapeutic product effect decreased 24.75 12.14 7 44981 34736 34877207
Haemorrhage 24.72 12.14 18 44970 51352 34860591
Opportunistic infection 24.68 12.14 19 44969 1639 34910304
Congenital renal disorder 24.00 12.14 8 44980 108 34911835
Diaphragmatic hernia 23.95 12.14 10 44978 260 34911683
Psoriasis 23.88 12.14 10 44978 38802 34873141
Nephrocalcinosis 23.54 12.14 13 44975 635 34911308
Prurigo 23.41 12.14 13 44975 642 34911301
Heart rate decreased 23.36 12.14 6 44982 31739 34880204
Intentional product misuse 23.26 12.14 15 44973 45596 34866347
CSF virus identified 23.23 12.14 6 44982 30 34911913
Abortion spontaneous 23.20 12.14 11 44977 389 34911554
Cardiac failure 23.12 12.14 52 44936 91196 34820747
Hepatitis B DNA assay positive 23.08 12.14 7 44981 68 34911875
Somnolence 23.06 12.14 70 44918 111046 34800897
Product use in unapproved indication 22.99 12.14 76 44912 117423 34794520
Abdominal discomfort 22.80 12.14 26 44962 59809 34852134
Hypoglycaemia 22.78 12.14 22 44966 54618 34857325
Pleural effusion 22.74 12.14 44 44944 81502 34830441
Thalassaemia beta 22.63 12.14 4 44984 0 34911943
Exomphalos 22.58 12.14 9 44979 207 34911736
Intraventricular haemorrhage neonatal 22.52 12.14 10 44978 303 34911640
Ear malformation 22.52 12.14 10 44978 303 34911640
Anomalous pulmonary venous connection 22.47 12.14 7 44981 75 34911868
Blood creatinine increased 22.29 12.14 203 44785 94773 34817170
Cytogenetic abnormality 22.12 12.14 14 44974 881 34911062
Seborrhoeic dermatitis 22.05 12.14 18 44970 1690 34910253
Congenital mitral valve incompetence 22.04 12.14 8 44980 141 34911802
Nervous system disorder 21.95 12.14 54 44934 14489 34897454
Dizziness 21.93 12.14 178 44810 218343 34693600
Encephalitis 21.85 12.14 36 44952 7241 34904702
Stress 21.83 12.14 6 44982 30341 34881602
Foetal distress syndrome 21.83 12.14 15 44973 1085 34910858
Osteopenia 21.80 12.14 29 44959 4820 34907123
Wrong dose 21.71 12.14 12 44976 587 34911356
Superior mesenteric artery syndrome 21.68 12.14 7 44981 85 34911858
Congenital aortic anomaly 21.68 12.14 7 44981 85 34911858
Haematochezia 21.50 12.14 17 44971 46517 34865426
Urinary retention 21.30 12.14 10 44978 36278 34875665
Congenital hydrocephalus 21.24 12.14 7 44981 91 34911852
Gastrointestinal haemorrhage 21.15 12.14 52 44936 88425 34823518
Spinal compression fracture 21.09 12.14 35 44953 7081 34904862
Varices oesophageal 20.93 12.14 25 44963 3730 34908213
Neutrophil count decreased 20.82 12.14 21 44967 51083 34860860
Cholestasis 20.74 12.14 79 44909 26869 34885074
Wheezing 20.59 12.14 14 44974 41388 34870555
Neonatal disorder 20.56 12.14 13 44975 817 34911126
Depression 20.53 12.14 203 44785 96895 34815048
Epistaxis 20.42 12.14 27 44961 58224 34853719
Atypical mycobacterial lymphadenitis 20.39 12.14 4 44984 3 34911940
Lymphogranuloma venereum 20.39 12.14 4 44984 3 34911940
AIDS related complication 20.26 12.14 5 44983 20 34911923
Nasopharyngitis 20.17 12.14 37 44951 69931 34842012
Cerebrovascular accident 20.15 12.14 50 44938 84761 34827182
Atrial septal defect 20.11 12.14 35 44953 7357 34904586
Kidney malformation 20.07 12.14 8 44980 184 34911759
Dyschromatopsia 19.93 12.14 10 44978 401 34911542
Glucose urine present 19.91 12.14 14 44974 1051 34910892
Cardiac murmur 19.90 12.14 36 44952 7801 34904142
Drug level decreased 19.87 12.14 36 44952 7810 34904133
Persistent left superior vena cava 19.86 12.14 4 44984 4 34911939
Non-Hodgkin's lymphoma 19.54 12.14 16 44972 1509 34910434
Secondary syphilis 19.28 12.14 6 44982 64 34911879
Anaemia neonatal 19.25 12.14 9 44979 308 34911635
Acquired gene mutation 19.03 12.14 15 44973 1340 34910603
Congenital bowing of long bones 18.89 12.14 5 44983 28 34911915
Leishmaniasis 18.86 12.14 9 44979 323 34911620
HIV associated nephropathy 18.83 12.14 9 44979 324 34911619
CD4 lymphocytes increased 18.81 12.14 8 44980 218 34911725
Hyperbilirubinaemia neonatal 18.75 12.14 12 44976 770 34911173
Cough 18.62 12.14 115 44873 150025 34761918
Tremor 18.62 12.14 50 44938 82537 34829406
Kidney enlargement 18.61 12.14 12 44976 780 34911163
Amylase increased 18.56 12.14 30 44958 5938 34906005
Transaminases increased 18.52 12.14 76 44912 26747 34885196
Hepatic cancer 18.51 12.14 36 44952 8239 34903704
Cardiac disorder 18.40 12.14 17 44971 43109 34868834
Crystal urine 18.35 12.14 6 44982 76 34911867
Myalgia 18.34 12.14 177 44811 83933 34828010
Neonatal asphyxia 18.28 12.14 9 44979 346 34911597
Pancytopenia 18.23 12.14 195 44793 94962 34816981
End stage AIDS 18.06 12.14 5 44983 34 34911909
Facial wasting 18.02 12.14 7 44981 150 34911793
Neonatal seizure 18.00 12.14 10 44978 494 34911449
Live birth 17.97 12.14 8 44980 244 34911699
Chlamydial infection 17.94 12.14 8 44980 245 34911698
Kidney fibrosis 17.94 12.14 18 44970 2210 34909733
Malignant anorectal neoplasm 17.93 12.14 5 44983 35 34911908
Blood pressure decreased 17.93 12.14 24 44964 51491 34860452
Blood HIV RNA 17.92 12.14 4 44984 9 34911934
Hallucination 17.92 12.14 24 44964 51474 34860469
Myelocytosis 17.81 12.14 5 44983 36 34911907
HIV test positive 17.81 12.14 7 44981 155 34911788
Swelling 17.73 12.14 17 44971 42349 34869594
Lipids increased 17.67 12.14 13 44975 1047 34910896
Vitamin D deficiency 17.61 12.14 31 44957 6577 34905366
Cardiac arrest 17.59 12.14 64 44924 96095 34815848
Urinary tract infection 17.41 12.14 53 44935 84028 34827915
Gastroschisis 17.36 12.14 7 44981 166 34911777
Pulmonary sequestration 17.35 12.14 5 44983 40 34911903
Urinary tract inflammation 17.24 12.14 7 44981 169 34911774
Injection site pain 17.09 12.14 15 44973 38990 34872953
Relapsing fever 17.09 12.14 7 44981 173 34911770
Cell death 17.09 12.14 18 44970 2339 34909604
Acute hepatitis C 17.01 12.14 6 44982 97 34911846
Umbilical cord vascular disorder 16.97 12.14 3 44985 0 34911943
Retinal telangiectasia 16.97 12.14 3 44985 0 34911943
Sex chromosome abnormality 16.97 12.14 3 44985 0 34911943
Foetal cardiac disorder 16.86 12.14 4 44984 13 34911930
Oxygen saturation decreased 16.85 12.14 27 44961 53791 34858152
Chronic obstructive pulmonary disease 16.81 12.14 23 44965 48895 34863048
Meningitis cryptococcal 16.79 12.14 18 44970 2386 34909557
Chronic hepatitis C 16.75 12.14 9 44979 416 34911527
Bradycardia 16.74 12.14 46 44942 75372 34836571
Maculopathy 16.68 12.14 12 44976 934 34911009
Umbilical cord abnormality 16.64 12.14 5 44983 47 34911896
Confusional state 16.56 12.14 113 44875 144047 34767896
Jarisch-Herxheimer reaction 16.52 12.14 10 44978 581 34911362
Renal aplasia 16.52 12.14 11 44977 755 34911188
Cerebral ventricle dilatation 16.45 12.14 12 44976 954 34910989
Neonatal respiratory distress syndrome 16.43 12.14 23 44965 4011 34907932
Oesophageal ulcer 16.41 12.14 21 44967 3360 34908583
Conductive deafness 16.39 12.14 8 44980 302 34911641
Arthralgia 16.37 12.14 140 44848 169901 34742042
Hypomagnesaemia 16.33 12.14 4 44984 21847 34890096
Diverticulitis 16.30 12.14 3 44985 20001 34891942
Fontanelle bulging 16.21 12.14 4 44984 16 34911927
Alpha 1 foetoprotein abnormal 16.21 12.14 4 44984 16 34911927
Encephalitis viral 16.13 12.14 13 44975 1199 34910744
Immune reconstitution inflammatory syndrome associated tuberculosis 16.12 12.14 9 44979 449 34911494
Encephalitis cytomegalovirus 16.11 12.14 10 44978 608 34911335
Blood pyruvic acid increased 16.02 12.14 4 44984 17 34911926
Syncope 15.99 12.14 62 44926 91389 34820554
Cranial nerve palsies multiple 15.93 12.14 5 44983 55 34911888
Folate deficiency 15.92 12.14 13 44975 1221 34910722
Haemoptysis 15.91 12.14 13 44975 34993 34876950
Diabetes mellitus 15.84 12.14 109 44879 46764 34865179
Posterior cortical atrophy 15.83 12.14 4 44984 18 34911925
Muscle injury 15.81 12.14 14 44974 1469 34910474
Central nervous system lymphoma 15.78 12.14 12 44976 1016 34910927
Congenital coronary artery malformation 15.54 12.14 5 44983 60 34911883
Adrenogenital syndrome 15.54 12.14 5 44983 60 34911883
Right aortic arch 15.49 12.14 4 44984 20 34911923
Polydipsia 15.47 12.14 22 44966 3893 34908050
Genitalia external ambiguous 15.41 12.14 7 44981 224 34911719
Myelodysplastic syndrome 15.40 12.14 3 44985 19205 34892738
Basedow's disease 15.39 12.14 5 44983 62 34911881
Myositis 15.32 12.14 42 44946 12028 34899915
Cardio-respiratory arrest 15.25 12.14 30 44958 55243 34856700
Chest pain 15.24 12.14 98 44890 126664 34785279
Back pain 15.24 12.14 93 44895 121696 34790247
Death neonatal 15.21 12.14 8 44980 354 34911589
Depressed mood 15.17 12.14 57 44931 19260 34892683
Congenital vesicoureteric reflux 15.17 12.14 4 44984 22 34911921
Calculus urethral 15.13 12.14 6 44982 136 34911807
Retinal deposits 15.02 12.14 4 44984 23 34911920
Patent ductus arteriosus 14.99 12.14 20 44968 3334 34908609
Arthropathy 14.91 12.14 8 44980 26899 34885044
Retroviral infection 14.90 12.14 3 44985 3 34911940
ECG signs of ventricular hypertrophy 14.90 12.14 3 44985 3 34911940
Foetal cystic hygroma 14.90 12.14 3 44985 3 34911940
Congenital aplastic anaemia 14.90 12.14 3 44985 3 34911940
Immunoblastic lymphoma 14.90 12.14 3 44985 3 34911940
17-hydroxyprogesterone increased 14.90 12.14 3 44985 3 34911940
Foetal monitoring abnormal 14.90 12.14 3 44985 3 34911940
Polymicrogyria 14.90 12.14 3 44985 3 34911940
Central pain syndrome 14.83 12.14 5 44983 70 34911873
Blood cholesterol increased 14.81 12.14 59 44929 20484 34891459
Volvulus 14.66 12.14 14 44974 1618 34910325
Eosinophilic pustular folliculitis 14.64 12.14 5 44983 73 34911870
Cardiogenic shock 14.63 12.14 8 44980 26610 34885333
Thalassaemia alpha 14.60 12.14 4 44984 26 34911917
Erythema elevatum diutinum 14.60 12.14 4 44984 26 34911917
Intentional overdose 14.55 12.14 21 44967 43653 34868290
Hyperphosphaturia 14.52 12.14 5 44983 75 34911868
Tachycardia 14.48 12.14 58 44930 84714 34827229
Wrong technique in product usage process 14.41 12.14 15 44973 35971 34875972
Congenital diaphragmatic hernia 14.34 12.14 7 44981 264 34911679
Hyperphagia 14.31 12.14 13 44975 1410 34910533
Hypoxia 14.28 12.14 31 44957 55064 34856879
Lipids abnormal 14.24 12.14 8 44980 404 34911539
Ultrasound antenatal screen abnormal 14.16 12.14 5 44983 81 34911862
Contraindicated product administered 14.10 12.14 5 44983 21476 34890467
Congenital bladder anomaly 14.06 12.14 7 44981 276 34911667
Blood pressure systolic increased 13.98 12.14 6 44982 22946 34888997
Neuroleptic malignant syndrome 13.96 12.14 3 44985 17931 34894012
Acute stress disorder 13.86 12.14 6 44982 171 34911772
Viraemia 13.82 12.14 12 44976 1226 34910717
Skin depigmentation 13.82 12.14 8 44980 428 34911515
Hallucination, visual 13.80 12.14 3 44985 17788 34894155
Post transplant distal limb syndrome 13.78 12.14 7 44981 288 34911655
Radius fracture 13.72 12.14 10 44978 794 34911149
Anal atresia 13.71 12.14 7 44981 291 34911652
Glucose tolerance impaired 13.70 12.14 19 44969 3285 34908658
Rhinorrhoea 13.70 12.14 8 44980 25660 34886283
Femoral neck fracture 13.69 12.14 19 44969 3288 34908655
Trisomy 15 13.68 12.14 3 44985 6 34911937
Congenital ureterocele 13.68 12.14 3 44985 6 34911937
Vertigo 13.60 12.14 67 44921 25469 34886474
Localised infection 13.58 12.14 3 44985 17584 34894359
Flushing 13.57 12.14 13 44975 32407 34879536
Meconium ileus 13.56 12.14 4 44984 35 34911908
Mycobacterium avium complex immune restoration disease 13.56 12.14 4 44984 35 34911908
Upper gastrointestinal haemorrhage 13.55 12.14 8 44980 25510 34886433
Nephropathy 13.55 12.14 26 44962 5891 34906052
Skin striae 13.51 12.14 9 44979 618 34911325
Congenital choroid plexus cyst 13.51 12.14 6 44982 182 34911761
Oral herpes 13.48 12.14 25 44963 5522 34906421
Glomerular filtration rate decreased 13.47 12.14 42 44946 12919 34899024
Abnormal dreams 13.47 12.14 30 44958 7548 34904395
Anaemia macrocytic 13.45 12.14 18 44970 3008 34908935
Giardiasis 13.43 12.14 7 44981 304 34911639
Chronic kidney disease 13.43 12.14 95 44893 41115 34870828
Haematocrit decreased 13.39 12.14 13 44975 32203 34879740
Biliary colic 13.31 12.14 11 44977 1051 34910892
Cleft palate 13.28 12.14 9 44979 636 34911307
Low set ears 13.28 12.14 8 44980 461 34911482
Testicular neoplasm 13.27 12.14 4 44984 38 34911905
Product residue present 13.24 12.14 17 44971 2729 34909214
Testicular mass 13.24 12.14 5 44983 99 34911844
Drug ineffective for unapproved indication 13.22 12.14 7 44981 23708 34888235
Pancreatitis relapsing 13.20 12.14 8 44980 466 34911477
Lipase increased 13.20 12.14 34 44954 9382 34902561
Congenital hearing disorder 13.19 12.14 5 44983 100 34911843
Nephrogenic diabetes insipidus 13.15 12.14 12 44976 1309 34910634
Deafness congenital 13.14 12.14 5 44983 101 34911842
Urticaria 13.14 12.14 39 44949 62338 34849605
Pneumonia aspiration 13.13 12.14 21 44967 41882 34870061
Tuberculosis 13.10 12.14 32 44956 8545 34903398
Loss of personal independence in daily activities 13.10 12.14 14 44974 33165 34878778
Amoebic dysentery 13.09 12.14 4 44984 40 34911903
Neurosyphilis 13.09 12.14 4 44984 40 34911903
Congenital anaemia 13.08 12.14 3 44985 8 34911935
Portal fibrosis 12.98 12.14 7 44981 326 34911617
Red blood cell count decreased 12.97 12.14 11 44977 29079 34882864
Toxic skin eruption 12.87 12.14 38 44950 11347 34900596
Transient ischaemic attack 12.86 12.14 10 44978 27603 34884340
Haemolytic anaemia 12.84 12.14 36 44952 10443 34901500
Hepatitis A 12.84 12.14 8 44980 490 34911453
Eagle Barrett syndrome 12.82 12.14 3 44985 9 34911934
Vth nerve injury 12.82 12.14 3 44985 9 34911934
VIIIth nerve injury 12.82 12.14 3 44985 9 34911934
Hypo HDL cholesterolaemia 12.82 12.14 3 44985 9 34911934
Alopecia totalis 12.82 12.14 3 44985 9 34911934
Rhabdomyolysis 12.73 12.14 139 44849 68024 34843919
Neuropsychiatric symptoms 12.70 12.14 10 44978 892 34911051
Palmar-plantar erythrodysaesthesia syndrome 12.69 12.14 3 44985 16792 34895151
Stomatitis 12.68 12.14 22 44966 42492 34869451
Decreased appetite 12.66 12.14 145 44843 166247 34745696
Erythema 12.62 12.14 65 44923 88715 34823228
Duodenal atresia 12.58 12.14 3 44985 10 34911933
Hyperphosphatasaemia 12.51 12.14 4 44984 47 34911896
Parotid gland enlargement 12.46 12.14 8 44980 516 34911427
Muscle spasms 12.38 12.14 52 44936 74949 34836994
Retinitis pigmentosa 12.35 12.14 4 44984 49 34911894
Intestinal obstruction 12.34 12.14 7 44981 22815 34889128
Neural tube defect 12.28 12.14 4 44984 50 34911893
Platelet count decreased 12.23 12.14 97 44891 119620 34792323
Herpes simplex 12.21 12.14 24 44964 5535 34906408
Splenomegaly 12.20 12.14 45 44943 15072 34896871
Multiple fractures 12.19 12.14 12 44976 1440 34910503
Liver function test abnormal 12.17 12.14 75 44913 30999 34880944
Balance disorder 12.16 12.14 21 44967 40633 34871310
Cystic lymphangioma 12.16 12.14 3 44985 12 34911931

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Abortion spontaneous 1770.98 13.40 676 49960 28831 79664921
Drug interaction 1512.03 13.40 1570 49066 413613 79280139
Exposure during pregnancy 1154.84 13.40 747 49889 100385 79593367
Immune reconstitution inflammatory syndrome 934.76 13.40 346 50290 13495 79680257
Lipodystrophy acquired 890.19 13.40 252 50384 4073 79689679
Maternal exposure during pregnancy 628.72 13.40 589 50047 135949 79557803
Virologic failure 628.25 13.40 191 50445 4000 79689752
Abortion induced 578.34 13.40 204 50432 6905 79686847
Stillbirth 540.91 13.40 168 50468 3787 79689965
Renal tubular disorder 429.91 13.40 160 50476 6326 79687426
Hyperbilirubinaemia 421.64 13.40 236 50400 24282 79669470
Mitochondrial toxicity 416.29 13.40 130 50506 2984 79690768
Fanconi syndrome acquired 379.20 13.40 117 50519 2577 79691175
Progressive external ophthalmoplegia 370.14 13.40 100 50536 1345 79692407
Live birth 334.77 13.40 185 50451 18559 79675193
Cushing's syndrome 332.36 13.40 85 50551 910 79692842
Viral mutation identified 322.52 13.40 113 50523 3745 79690007
Caesarean section 319.34 13.40 157 50479 12378 79681374
Nephrolithiasis 314.77 13.40 265 50371 53026 79640726
CD4 lymphocytes decreased 302.69 13.40 98 50538 2536 79691216
Foetal exposure during pregnancy 302.07 13.40 120 50516 5670 79688082
Psychiatric decompensation 300.63 13.40 108 50528 3855 79689897
Viral load increased 283.95 13.40 96 50540 2852 79690900
Adrenal suppression 276.49 13.40 79 50557 1320 79692432
Renal colic 276.00 13.40 93 50543 2734 79691018
Blood HIV RNA increased 273.52 13.40 83 50553 1725 79692027
Premature delivery 271.24 13.40 175 50461 23292 79670460
Depression suicidal 259.09 13.40 96 50540 3746 79690006
Drug resistance 253.56 13.40 212 50424 42001 79651751
Osteonecrosis 251.19 13.40 186 50450 30909 79662843
Jaundice 227.70 13.40 221 50415 53128 79640624
Pregnancy 226.78 13.40 165 50471 26686 79667066
Foetal death 226.76 13.40 108 50528 7936 79685816
Tearfulness 220.20 13.40 97 50539 5948 79687804
Psychomotor skills impaired 213.55 13.40 91 50545 5146 79688606
Premature rupture of membranes 211.10 13.40 84 50552 3985 79689767
Premature labour 207.49 13.40 103 50533 8287 79685465
Pathogen resistance 206.42 13.40 123 50513 14219 79679533
Eyelid ptosis 205.45 13.40 112 50524 10932 79682820
Osteoporosis 201.19 13.40 208 50428 53904 79639848
Depressive symptom 183.38 13.40 87 50549 6336 79687416
Fanconi syndrome 180.31 13.40 68 50568 2788 79690964
Acute kidney injury 176.62 13.40 724 49912 518680 79175072
HIV-associated neurocognitive disorder 167.73 13.40 40 50596 312 79693440
Treatment noncompliance 162.84 13.40 183 50453 52085 79641667
Hypertriglyceridaemia 159.63 13.40 100 50536 12640 79681112
Pain 158.62 13.40 129 50507 703673 78990079
Genotype drug resistance test positive 151.65 13.40 49 50587 1259 79692493
Drug ineffective 142.93 13.40 296 50340 1080617 78613135
Syphilis 140.30 13.40 38 50598 516 79693236
Paranoia 138.72 13.40 108 50528 19324 79674428
Nephropathy toxic 138.26 13.40 110 50526 20309 79673443
Hepatic cytolysis 138.01 13.40 124 50512 27027 79666725
Lipohypertrophy 131.23 13.40 40 50596 844 79692908
Cushingoid 129.90 13.40 79 50557 9473 79684279
Blood bilirubin increased 129.83 13.40 184 50452 66048 79627704
Psychomotor retardation 127.04 13.40 67 50569 6117 79687635
Joint swelling 121.49 13.40 19 50617 288627 79405125
Infusion related reaction 121.23 13.40 6 50630 230231 79463521
Peripheral swelling 119.92 13.40 15 50621 269602 79424150
Mycobacterium avium complex infection 118.29 13.40 58 50578 4542 79689210
CSF HIV escape syndrome 117.64 13.40 30 50606 317 79693435
Proteinuria 117.30 13.40 123 50513 32379 79661373
Psychotic disorder 115.57 13.40 137 50499 41265 79652487
Calculus urinary 114.58 13.40 47 50589 2413 79691339
Lipoatrophy 114.45 13.40 34 50602 655 79693097
Glycosuria 112.91 13.40 45 50591 2143 79691609
Portal hypertension 110.27 13.40 64 50572 7044 79686708
Mitochondrial cytopathy 107.95 13.40 29 50607 381 79693371
Premature baby 107.29 13.40 51 50585 3729 79690023
Hyperadrenocorticism 102.29 13.40 27 50609 330 79693422
Cortisol decreased 99.47 13.40 41 50595 2131 79691621
Ergot poisoning 98.88 13.40 22 50614 121 79693631
Placenta praevia 98.73 13.40 31 50605 724 79693028
Immunosuppressant drug level increased 98.61 13.40 65 50571 8962 79684790
Fall 98.19 13.40 99 50537 487530 79206222
Hepatitis C 97.77 13.40 72 50564 11853 79681899
Pre-eclampsia 97.72 13.40 59 50577 6982 79686770
Diplopia 97.16 13.40 113 50523 33353 79660399
Ultrasound antenatal screen 97.11 13.40 30 50606 663 79693089
Dyslipidaemia 97.10 13.40 71 50565 11562 79682190
Dyspnoea 95.21 13.40 257 50379 856768 78836984
Hyperlactacidaemia 93.81 13.40 53 50583 5542 79688210
Blood bilirubin unconjugated increased 92.94 13.40 32 50604 1005 79692747
Hepatocellular injury 92.93 13.40 132 50504 47461 79646291
Arthropathy 92.01 13.40 5 50631 177106 79516646
Kaposi's sarcoma 90.31 13.40 29 50607 730 79693022
Hypophosphataemia 89.66 13.40 85 50551 19828 79673924
Secondary adrenocortical insufficiency 89.65 13.40 42 50594 2972 79690780
Alanine aminotransferase increased 88.33 13.40 265 50371 162305 79531447
Aspartate aminotransferase increased 87.96 13.40 239 50397 138402 79555350
Blood triglycerides increased 87.55 13.40 86 50550 20954 79672798
Renal failure 86.94 13.40 303 50333 200665 79493087
Adrenal insufficiency 85.74 13.40 98 50538 28389 79665363
Gestational diabetes 85.45 13.40 52 50584 6241 79687511
Polyhydramnios 84.00 13.40 34 50602 1686 79692066
Synovitis 82.41 13.40 3 50633 150731 79543021
Renal tubular acidosis 82.41 13.40 42 50594 3572 79690180
Swelling 81.13 13.40 19 50617 216692 79477060
Retinal toxicity 79.76 13.40 31 50605 1380 79692372
Hydrops foetalis 77.55 13.40 26 50610 752 79693000
Drug level increased 77.45 13.40 110 50526 39541 79654211
Therapeutic product effect decreased 75.62 13.40 8 50628 163855 79529897
Trisomy 18 75.47 13.40 24 50612 585 79693167
Abdominal discomfort 74.43 13.40 33 50603 250694 79443058
Central obesity 73.12 13.40 31 50605 1730 79692022
Nasopharyngitis 72.91 13.40 35 50601 253846 79439906
Lactic acidosis 72.86 13.40 147 50489 70212 79623540
Acquired immunodeficiency syndrome 72.82 13.40 20 50616 287 79693465
Cleft lip and palate 72.25 13.40 24 50612 674 79693078
Amniotic cavity infection 72.11 13.40 25 50611 802 79692950
Suicidal ideation 71.44 13.40 153 50483 76187 79617565
Arthralgia 69.94 13.40 163 50473 571640 79122112
Cerebral toxoplasmosis 67.44 13.40 32 50604 2330 79691422
Renal tubular dysfunction 65.86 13.40 23 50613 754 79692998
Normal newborn 65.53 13.40 46 50590 7026 79686726
Systemic lupus erythematosus 64.25 13.40 3 50633 121146 79572606
Renal impairment 64.01 13.40 233 50403 157550 79536202
Infection 63.98 13.40 37 50599 241675 79452077
Cholestasis of pregnancy 63.98 13.40 24 50612 969 79692783
Drug reaction with eosinophilia and systemic symptoms 63.88 13.40 132 50504 64112 79629640
Hepatitis 63.23 13.40 121 50515 55606 79638146
Therapeutic product effect incomplete 62.65 13.40 8 50628 141637 79552115
Pancreatitis 62.52 13.40 136 50500 68439 79625313
Trisomy 21 61.63 13.40 13 50623 53 79693699
Cholestasis 61.42 13.40 115 50521 51994 79641758
Maternal drugs affecting foetus 61.27 13.40 27 50609 1656 79692096
Ophthalmoplegia 61.09 13.40 32 50604 2880 79690872
Ocular icterus 61.04 13.40 40 50596 5460 79688292
Hepatotoxicity 60.11 13.40 113 50523 51239 79642513
Brain stem stroke 59.86 13.40 21 50615 698 79693054
Blood pressure increased 59.37 13.40 30 50606 211330 79482422
Oesophageal candidiasis 58.87 13.40 48 50588 9170 79684582
Hepatitis B 58.79 13.40 46 50590 8286 79685466
Cytomegalovirus chorioretinitis 58.68 13.40 39 50597 5451 79688301
Gamma-glutamyltransferase increased 57.51 13.40 115 50521 54565 79639187
Constipation 57.42 13.40 57 50579 282993 79410759
Renal tubular necrosis 57.28 13.40 75 50561 24964 79668788
Progressive multifocal leukoencephalopathy 57.20 13.40 68 50568 20532 79673220
Hepatomegaly 56.91 13.40 65 50571 18809 79674943
Retinoblastoma 56.91 13.40 13 50623 82 79693670
Multiple-drug resistance 56.54 13.40 46 50590 8762 79684990
Hepatitis cholestatic 56.48 13.40 56 50580 13796 79679956
Hyperlipidaemia 56.37 13.40 76 50560 26017 79667735
Alopecia 56.30 13.40 39 50597 231316 79462436
Rash maculo-papular 55.49 13.40 115 50521 55963 79637789
Skin striae 55.20 13.40 26 50610 1862 79691890
Contraindicated product administered 54.78 13.40 16 50620 157522 79536230
Pneumocystis jirovecii pneumonia 54.58 13.40 84 50552 32424 79661328
Hepatic failure 54.21 13.40 120 50516 61092 79632660
Completed suicide 53.98 13.40 46 50590 245721 79448031
Contusion 53.81 13.40 14 50622 148762 79544990
Inappropriate schedule of product administration 53.52 13.40 10 50626 133618 79560134
Atrial fibrillation 52.77 13.40 30 50606 197856 79495896
Premature separation of placenta 51.95 13.40 22 50614 1224 79692528
Wound 50.33 13.40 7 50629 116172 79577580
Anembryonic gestation 49.93 13.40 16 50620 400 79693352
Off label use 49.70 13.40 355 50281 906860 78786892
Blood creatine phosphokinase increased 49.16 13.40 121 50515 65969 79627783
Fatigue 48.44 13.40 369 50267 929358 78764394
Product use issue 47.65 13.40 38 50598 209784 79483968
Febrile neutropenia 47.44 13.40 46 50590 230953 79462799
Anogenital dysplasia 47.21 13.40 12 50624 125 79693627
Condition aggravated 47.08 13.40 162 50474 500962 79192790
Malignant neoplasm progression 46.93 13.40 14 50622 135976 79557776
Toxoplasmosis 46.44 13.40 26 50610 2671 79691081
Disease progression 46.30 13.40 30 50606 184332 79509420
Product dose omission issue 45.59 13.40 54 50582 247483 79446269
Cachexia 45.55 13.40 45 50591 11038 79682714
Cough 45.22 13.40 104 50532 366685 79327067
Alpha 1 foetoprotein abnormal 44.49 13.40 10 50626 58 79693694
Drug hypersensitivity 44.37 13.40 76 50560 298840 79394912
Genital herpes 44.00 13.40 23 50613 2061 79691691
Sinusitis 43.65 13.40 36 50600 195465 79498287
Transaminases increased 43.10 13.40 99 50537 51644 79642108
Hypotension 42.95 13.40 140 50496 440177 79253575
Pneumonia 42.93 13.40 245 50391 660001 79033751
Blood alkaline phosphatase increased 42.61 13.40 112 50524 63552 79630200
Injection site pain 41.93 13.40 15 50621 129823 79563929
Musculoskeletal stiffness 41.91 13.40 30 50606 174978 79518774
Malaria 41.65 13.40 14 50622 408 79693344
Anaphylactic reaction 41.58 13.40 3 50633 83740 79610012
Drug intolerance 41.20 13.40 65 50571 264054 79429698
Hypercholesterolaemia 40.64 13.40 61 50575 23034 79670718
COVID-19 40.49 13.40 25 50611 157649 79536103
Blood lactic acid increased 40.32 13.40 45 50591 12699 79681053
Wheezing 40.28 13.40 12 50624 116652 79577100
Lower respiratory tract infection 39.94 13.40 16 50620 129204 79564548
Psoriasis 39.75 13.40 5 50631 89582 79604170
Discomfort 39.74 13.40 15 50621 125602 79568150
Pericarditis 39.26 13.40 9 50627 104227 79589525
Atypical mycobacterial infection 39.00 13.40 20 50616 1723 79692029
Heart rate increased 38.89 13.40 14 50622 120710 79573042
Hepatic cirrhosis 38.62 13.40 75 50561 34831 79658921
Feeling abnormal 38.50 13.40 27 50609 159172 79534580
HIV wasting syndrome 38.11 13.40 9 50627 67 79693685
Labelled drug-drug interaction medication error 37.66 13.40 65 50571 27585 79666167
Placental disorder 37.33 13.40 16 50620 917 79692835
Diabetes mellitus 37.20 13.40 122 50514 78268 79615484
Pain in extremity 36.87 13.40 114 50522 364424 79329328
Blood creatinine increased 36.81 13.40 195 50441 154862 79538890
Rhabdomyolysis 36.61 13.40 146 50490 102985 79590767
Hypothalamic pituitary adrenal axis suppression 36.61 13.40 12 50624 323 79693429
Anal cancer stage 0 35.64 13.40 7 50629 18 79693734
CD4 lymphocytes abnormal 35.09 13.40 8 50628 50 79693702
Twin pregnancy 34.65 13.40 15 50621 881 79692871
Renal dysplasia 34.55 13.40 8 50628 54 79693698
CSF test abnormal 34.53 13.40 13 50623 530 79693222
Arthritis 34.25 13.40 15 50621 114865 79578887
Blood corticotrophin decreased 34.05 13.40 13 50623 551 79693201
Stomatitis 34.04 13.40 26 50610 146731 79547021
Urinary tract infection 33.68 13.40 78 50558 274434 79419318
Burkitt's lymphoma 33.38 13.40 9 50627 120 79693632
Mobility decreased 33.32 13.40 18 50618 122157 79571595
Ectopic pregnancy 33.31 13.40 18 50618 1725 79692027
Injection site erythema 33.20 13.40 5 50631 78192 79615560
Face oedema 33.03 13.40 62 50574 28074 79665678
Hyperuricaemia 32.84 13.40 39 50597 11760 79681992
Anal cancer 32.82 13.40 14 50622 793 79692959
Musculoskeletal pain 32.75 13.40 12 50624 102342 79591410
Hepatitis B DNA increased 32.69 13.40 14 50622 801 79692951
Chest discomfort 32.61 13.40 24 50612 138020 79555732
Neutropenia neonatal 32.36 13.40 7 50629 33 79693719
Haemophilic arthropathy 32.27 13.40 9 50627 137 79693615
CSF virus identified 32.02 13.40 7 50629 35 79693717
Spina bifida 31.97 13.40 9 50627 142 79693610
Lymphadenopathy 31.96 13.40 90 50546 53157 79640595
Encephalitis 31.89 13.40 43 50593 14717 79679035
Bronchitis 31.79 13.40 22 50614 130622 79563130
Tubulointerstitial nephritis 31.67 13.40 73 50563 38162 79655590
Placental insufficiency 31.41 13.40 15 50621 1108 79692644
HIV infection 31.36 13.40 15 50621 1112 79692640
Haemolytic anaemia 31.26 13.40 47 50589 17773 79675979
Pancytopenia 31.20 13.40 196 50440 165549 79528203
Genital herpes simplex 31.17 13.40 11 50625 372 79693380
Oxygen saturation decreased 31.05 13.40 22 50614 129025 79564727
Ureterolithiasis 31.02 13.40 23 50613 3825 79689927
Total bile acids increased 31.00 13.40 8 50628 89 79693663
Endometritis decidual 30.67 13.40 6 50630 15 79693737
Cholelithiasis 30.62 13.40 88 50548 52576 79641176
Fat tissue increased 30.49 13.40 14 50622 946 79692806
Porphyria non-acute 30.48 13.40 13 50623 736 79693016
Toxic skin eruption 29.83 13.40 52 50584 22241 79671511
Death 29.80 13.40 224 50412 566290 79127462
Stress 29.73 13.40 7 50629 79605 79614147
Chronic kidney disease 29.65 13.40 101 50535 66053 79627699
Cardiac failure congestive 29.64 13.40 28 50608 142374 79551378
Prenatal screening test abnormal 29.47 13.40 5 50631 3 79693749
Opportunistic infection 29.24 13.40 20 50616 2930 79690822
Nervous system disorder 28.85 13.40 57 50579 26799 79666953
Castleman's disease 28.74 13.40 6 50630 23 79693729
Dizziness 28.72 13.40 206 50430 526235 79167517
Nodular regenerative hyperplasia 28.68 13.40 15 50621 1346 79692406
HIV associated nephropathy 28.66 13.40 10 50626 327 79693425
Glucocorticoids increased 28.43 13.40 8 50628 126 79693626
Kidney fibrosis 28.20 13.40 21 50615 3514 79690238
Pregnancy on contraceptive 27.99 13.40 13 50623 902 79692850
Anogenital warts 27.73 13.40 13 50623 921 79692831
Fibrous histiocytoma 27.69 13.40 12 50624 707 79693045
Hypoglycaemia 27.65 13.40 15 50621 101579 79592173
Vanishing bile duct syndrome 27.55 13.40 16 50620 1762 79691990
Hepatosplenomegaly 27.49 13.40 26 50610 6043 79687709
Blood antidiuretic hormone increased 27.45 13.40 7 50629 74 79693678
Nephrocalcinosis 27.29 13.40 15 50621 1487 79692265
Chlamydial infection 27.13 13.40 11 50625 548 79693204
Metabolic acidosis 27.04 13.40 114 50522 82415 79611337
Upper respiratory tract infection 27.03 13.40 12 50624 91156 79602596
Osteoporotic fracture 26.91 13.40 22 50614 4218 79689534
Haematochezia 26.84 13.40 11 50625 87634 79606118
Facial wasting 26.41 13.40 7 50629 87 79693665
Meningitis cryptococcal 26.14 13.40 20 50616 3486 79690266
Amyotrophy 26.03 13.40 11 50625 609 79693143
Amniotic fluid volume decreased 26.01 13.40 9 50627 287 79693465
Atypical mycobacterial lymphadenitis 26.00 13.40 5 50631 11 79693741
Rhinorrhoea 25.94 13.40 8 50628 76066 79617686
Varices oesophageal 25.88 13.40 25 50611 5966 79687786
Prurigo 25.78 13.40 14 50622 1355 79692397
Enanthema 25.77 13.40 12 50624 837 79692915
Umbilical cord abnormality 25.55 13.40 8 50628 185 79693567
Oesophageal atresia 25.51 13.40 7 50629 100 79693652
Blood phosphorus decreased 25.43 13.40 26 50610 6642 79687110
Pleural effusion 25.35 13.40 33 50603 145229 79548523
Back pain 24.23 13.40 105 50531 304075 79389677
Loss of personal independence in daily activities 24.01 13.40 18 50618 102562 79591190
Anaemia 23.86 13.40 406 50230 444609 79249143
Polydipsia 23.83 13.40 25 50611 6580 79687172
Complication of pregnancy 23.79 13.40 9 50627 372 79693380
Liver function test abnormal 23.46 13.40 92 50544 64383 79629369
Secondary syphilis 23.23 13.40 6 50630 67 79693685
Intentional product misuse 23.19 13.40 16 50620 95149 79598603
Coarctation of the aorta 23.15 13.40 6 50630 68 79693684
Blood HIV RNA 23.04 13.40 5 50631 24 79693728
ACTH stimulation test abnormal 23.04 13.40 5 50631 24 79693728
Viral load decreased 23.04 13.40 5 50631 24 79693728
Anaemia neonatal 22.87 13.40 5 50631 25 79693727
Abortion threatened 22.83 13.40 9 50627 416 79693336
Seborrhoeic dermatitis 22.82 13.40 15 50621 2058 79691694
Nasal congestion 22.81 13.40 10 50626 76542 79617210
Threatened labour 22.68 13.40 10 50626 614 79693138
Placental chorioangioma 22.68 13.40 4 50632 4 79693748
Ventricular hypoplasia 22.68 13.40 4 50632 4 79693748
Dyschromatopsia 22.62 13.40 11 50625 846 79692906
Hodgkin's disease 22.58 13.40 11 50625 849 79692903
Oropharyngeal candidiasis 22.53 13.40 14 50622 1743 79692009
Pulmonary sequestration 22.40 13.40 5 50631 28 79693724
Oligohydramnios 22.28 13.40 18 50618 3394 79690358
Chronic hepatitis C 22.25 13.40 10 50626 643 79693109
Retinopathy 22.23 13.40 19 50617 3872 79689880
Chest pain 22.15 13.40 98 50538 282206 79411546
Osteomalacia 22.09 13.40 13 50623 1467 79692285
Influenza 22.05 13.40 30 50606 129576 79564176
Eosinophilia 21.89 13.40 71 50565 45274 79648478
Treponema test positive 21.79 13.40 4 50632 6 79693746
Lipase increased 21.50 13.40 38 50598 16428 79677324
Pneumonitis 21.48 13.40 6 50630 60854 79632898
Superior mesenteric artery syndrome 21.48 13.40 7 50629 185 79693567
Flushing 21.29 13.40 15 50621 88253 79605499
Heart rate decreased 21.25 13.40 9 50627 70307 79623445
Lymphoma 21.15 13.40 39 50597 17421 79676331
Mycobacterial infection 21.14 13.40 18 50618 3650 79690102
Muscle spasms 21.13 13.40 50 50586 174680 79519072
Dermatitis exfoliative 21.08 13.40 30 50606 10799 79682953
Erythema 21.04 13.40 72 50564 223218 79470534
Cell death 21.04 13.40 20 50616 4679 79689073
Plasmablastic lymphoma 20.96 13.40 9 50627 518 79693234
Memory impairment 20.96 13.40 24 50612 111710 79582042
White matter lesion 20.73 13.40 14 50622 2008 79691744
Subchorionic haematoma 20.48 13.40 6 50630 110 79693642
Foetal exposure during delivery 20.45 13.40 4 50632 10 79693742
Pulmonary tuberculosis 20.26 13.40 25 50611 7840 79685912
Headache 20.19 13.40 293 50343 653479 79040273
Eosinophilic pustular folliculitis 20.18 13.40 6 50630 116 79693636
Hypoplastic left heart syndrome 20.17 13.40 4 50632 11 79693741
Immune reconstitution inflammatory syndrome associated tuberculosis 19.89 13.40 10 50626 826 79692926
Conductive deafness 19.80 13.40 7 50629 238 79693514
Tuberculosis 19.75 13.40 35 50601 15163 79678589
Oral candidiasis 19.69 13.40 52 50584 29576 79664176
Retroviral infection 19.67 13.40 4 50632 13 79693739
Teratogenicity 19.64 13.40 7 50629 244 79693508
HIV test positive 19.62 13.40 6 50630 128 79693624
Myalgia 19.60 13.40 192 50444 185449 79508303
Blood pressure systolic increased 19.57 13.40 9 50627 66977 79626775
Depression 19.48 13.40 217 50419 216573 79477179
Basedow's disease 19.45 13.40 7 50629 251 79693501
Renal aplasia 19.45 13.40 6 50630 132 79693620
Foetal disorder 19.45 13.40 6 50630 132 79693620
Coagulation factor V level decreased 19.41 13.40 9 50627 622 79693130
Neck pain 19.29 13.40 12 50624 75405 79618347
Beta 2 microglobulin urine increased 19.15 13.40 6 50630 139 79693613
Retinal telangiectasia 19.09 13.40 3 50633 0 79693752
Erythema elevatum diutinum 19.02 13.40 4 50632 16 79693736
Blister 19.00 13.40 29 50607 119447 79574305
Amylase increased 18.86 13.40 29 50607 11180 79682572
Balance disorder 18.80 13.40 21 50615 98836 79594916
Sexually transmitted disease 18.72 13.40 6 50630 150 79693602
Vitamin D deficiency 18.71 13.40 33 50603 14246 79679506
Posterior cortical atrophy 18.64 13.40 4 50632 18 79693734
Jarisch-Herxheimer reaction 18.62 13.40 10 50626 947 79692805
Single functional kidney 18.58 13.40 7 50629 286 79693466
Osteopenia 18.56 13.40 38 50598 18326 79675426
Liver disorder 18.51 13.40 93 50543 72324 79621428
Acute myocardial infarction 18.35 13.40 97 50539 76939 79616813
Pulmonary fibrosis 18.31 13.40 3 50633 44109 79649643
Foetal distress syndrome 18.26 13.40 8 50628 484 79693268
Pneumococcal sepsis 18.23 13.40 12 50624 1650 79692102
Potassium wasting nephropathy 18.22 13.40 6 50630 164 79693588
New onset diabetes after transplantation 18.22 13.40 6 50630 164 79693588
Testicular mass 18.19 13.40 5 50631 72 79693680
Hepatic steatosis 18.14 13.40 59 50577 37679 79656073
Malignant anorectal neoplasm 18.12 13.40 5 50631 73 79693679
Benign prostatic hyperplasia 18.09 13.40 29 50607 11583 79682169
Calculus urethral 18.05 13.40 6 50630 169 79693583
Wrong dose 18.02 13.40 12 50624 1682 79692070
Foetal cardiac disorder 17.83 13.40 4 50632 23 79693729
Osteonecrosis of jaw 17.81 13.40 3 50633 43223 79650529
Encephalitis viral 17.68 13.40 14 50622 2565 79691187
Glucose urine present 17.63 13.40 12 50624 1744 79692008
Splenomegaly 17.60 13.40 40 50596 20714 79673038
Ultrasound antenatal screen abnormal 17.47 13.40 5 50631 84 79693668
Generalised anxiety disorder 17.41 13.40 13 50623 2184 79691568
Interstitial lung disease 17.27 13.40 28 50608 112572 79581180
Drug level decreased 17.23 13.40 32 50604 14370 79679382
Red blood cell sedimentation rate increased 17.23 13.40 4 50632 45938 79647814
Benign hydatidiform mole 17.20 13.40 5 50631 89 79693663
Gene mutation 17.18 13.40 14 50622 2672 79691080
Malaise 17.11 13.40 214 50422 489655 79204097
ECG signs of ventricular hypertrophy 17.01 13.40 3 50633 3 79693749
5'nucleotidase increased 17.01 13.40 3 50633 3 79693749
Immunoblastic lymphoma 17.01 13.40 3 50633 3 79693749
Burning sensation 16.94 13.40 8 50628 58624 79635128
Gestational hypertension 16.89 13.40 12 50624 1867 79691885
Non-Hodgkin's lymphoma 16.82 13.40 11 50625 1496 79692256
HIV viraemia 16.75 13.40 5 50631 98 79693654
Drug level above therapeutic 16.73 13.40 24 50612 8699 79685053
Intentional overdose 16.58 13.40 26 50610 105934 79587818
Acute hepatitis C 16.57 13.40 6 50630 219 79693533
Injection site bruising 16.56 13.40 3 50633 40999 79652753
Ascites 16.55 13.40 93 50543 75469 79618283
Throat irritation 16.53 13.40 3 50633 40943 79652809
Lipids abnormal 16.48 13.40 8 50628 613 79693139
Injury 16.40 13.40 15 50621 77481 79616271
Ill-defined disorder 16.15 13.40 11 50625 65864 79627888
Oesophageal ulcer 16.12 13.40 21 50615 6954 79686798
Nephropathy 16.11 13.40 25 50611 9713 79684039
Gynaecomastia 16.02 13.40 22 50614 7659 79686093
Hepatic cancer 16.00 13.40 26 50610 10503 79683249
Cranial nerve palsies multiple 16.00 13.40 5 50631 115 79693637
Wrong technique in product usage process 15.99 13.40 14 50622 73861 79619891
Atrioventricular septal defect 15.96 13.40 5 50631 116 79693636
Epistaxis 15.94 13.40 29 50607 111486 79582266
Fat redistribution 15.87 13.40 5 50631 118 79693634
Craniofacial deformity 15.80 13.40 3 50633 6 79693746
Herpes simplex 15.75 13.40 28 50608 12159 79681593
Urinary tract inflammation 15.72 13.40 6 50630 254 79693498
Haemoptysis 15.63 13.40 8 50628 55991 79637761
Confusional state 15.63 13.40 128 50508 317869 79375883
Product use in unapproved indication 15.62 13.40 94 50542 250265 79443487
Foetal growth restriction 15.60 13.40 12 50624 2107 79691645
Placental infarction 15.60 13.40 5 50631 125 79693627
Crystal urine 15.56 13.40 5 50631 126 79693626
Nephrogenic diabetes insipidus 15.53 13.40 12 50624 2122 79691630
Hepatitis acute 15.52 13.40 32 50604 15510 79678242
Cytomegalovirus test positive 15.48 13.40 19 50617 5928 79687824
Bulbar palsy 15.42 13.40 6 50630 268 79693484
Sepsis 15.36 13.40 104 50532 269324 79424428
Hirsutism 15.21 13.40 10 50626 1372 79692380
Endometrial sarcoma 15.20 13.40 3 50633 8 79693744
Lymphogranuloma venereum 15.20 13.40 3 50633 8 79693744
Pancreatitis acute 15.08 13.40 67 50569 49537 79644215
Hepatitis B reactivation 15.07 13.40 19 50617 6089 79687663
Myelocytosis 15.07 13.40 4 50632 50 79693702
Osteoarthritis 15.06 13.40 20 50616 87289 79606463
Albuminuria 15.06 13.40 8 50628 741 79693011
Acquired gene mutation 15.05 13.40 12 50624 2221 79691531
Hepatitis viral 15.03 13.40 9 50627 1049 79692703
Cellulitis 15.02 13.40 29 50607 109031 79584721
Hypo HDL cholesterolaemia 14.94 13.40 3 50633 9 79693743
Vth nerve injury 14.94 13.40 3 50633 9 79693743
Ear malformation 14.94 13.40 3 50633 9 79693743
CD4 lymphocytes increased 14.93 13.40 6 50630 292 79693460
Anticoagulation drug level increased 14.84 13.40 8 50628 763 79692989
Central nervous system lymphoma 14.79 13.40 12 50624 2277 79691475
Anaemia macrocytic 14.76 13.40 18 50618 5579 79688173
Neutrophil count decreased 14.75 13.40 23 50613 93936 79599816
Eyelid oedema 14.64 13.40 29 50607 13658 79680094
Tremor 14.60 13.40 57 50579 170026 79523726
Cardiac failure 14.53 13.40 50 50586 154792 79538960
AIDS related complication 14.52 13.40 4 50632 58 79693694
Urinary retention 14.50 13.40 9 50627 56621 79637131
Productive cough 14.47 13.40 21 50615 88310 79605442
Arterial spasm 14.46 13.40 5 50631 159 79693593
Nystagmus 14.44 13.40 24 50612 9880 79683872
Shortened cervix 14.40 13.40 5 50631 161 79693591
Intentional product use issue 14.36 13.40 49 50587 152063 79541689
Prognathism 14.27 13.40 3 50633 12 79693740
International normalised ratio increased 14.02 13.40 20 50616 84701 79609051
Cerebrovascular accident 14.00 13.40 51 50585 155241 79538511
Emotional distress 13.99 13.40 4 50632 39965 79653787
Acute HIV infection 13.99 13.40 4 50632 67 79693685
Hyperproteinaemia 13.95 13.40 5 50631 177 79693575
Vertigo 13.81 13.40 83 50553 68999 79624753
Post transplant distal limb syndrome 13.76 13.40 7 50629 593 79693159
Inflammation 13.74 13.40 24 50612 93729 79600023
Paternal drugs affecting foetus 13.72 13.40 3 50633 15 79693737
Congenital diaphragmatic hernia 13.72 13.40 3 50633 15 79693737
Meconium stain 13.72 13.40 3 50633 15 79693737
Trichomoniasis 13.72 13.40 5 50631 186 79693566
Hepatic encephalopathy 13.68 13.40 40 50596 24126 79669626
Heart disease congenital 13.63 13.40 7 50629 605 79693147
Hypoaesthesia 13.61 13.40 63 50573 179289 79514463
Portal fibrosis 13.53 13.40 7 50629 614 79693138
Anaemia of pregnancy 13.47 13.40 4 50632 77 79693675
Injection site pruritus 13.45 13.40 5 50631 42278 79651474
Hepatorenal syndrome 13.43 13.40 15 50621 4234 79689518
Congenital hydrocephalus 13.42 13.40 4 50632 78 79693674
Drug exposure before pregnancy 13.41 13.40 7 50629 625 79693127

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
CHEBI has role CHEBI:35660 HIV protease inhibitors
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:36044 antiviral drugs
CHEBI has role CHEBI:78298 environmental contaminants
MeSH PA D019380 Anti-HIV Agents
MeSH PA D000890 Anti-Infective Agents
MeSH PA D044966 Anti-Retroviral Agents
MeSH PA D000998 Antiviral Agents
MeSH PA D065692 Cytochrome P-450 CYP3A Inhibitors
MeSH PA D065607 Cytochrome P-450 Enzyme Inhibitors
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D017320 HIV Protease Inhibitors
MeSH PA D065606 Metabolic Side Effects of Drugs and Substances
MeSH PA D011480 Protease Inhibitors
MeSH PA D000084762 Viral Protease Inhibitors

Drug Use | 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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 12.39 acidic
pKa2 13.84 acidic
pKa3 3.62 Basic
pKa4 2.45 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** VIEKIRA XR ABBVIE 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 May 25, 2028 NEW CHEMICAL ENTITY
300MG;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

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Ritonavir HUMAN PRESCRIPTION DRUG LABEL 1 0054-0407 TABLET, FILM COATED 100 mg ORAL ANDA 30 sections
Ritonavir HUMAN PRESCRIPTION DRUG LABEL 1 0054-0407 TABLET, FILM COATED 100 mg ORAL ANDA 30 sections
Kaletra HUMAN PRESCRIPTION DRUG LABEL 2 0074-0522 TABLET, FILM COATED 25 mg ORAL NDA 32 sections
Kaletra HUMAN PRESCRIPTION DRUG LABEL 2 0074-0522 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
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 38 sections
Norvir HUMAN PRESCRIPTION DRUG LABEL 1 0074-1940 SOLUTION 80 mg ORAL NDA 38 sections
Norvir HUMAN PRESCRIPTION DRUG LABEL 1 0074-1940 SOLUTION 80 mg ORAL NDA 38 sections
Norvir HUMAN PRESCRIPTION DRUG LABEL 1 0074-2340 TABLET, FILM COATED 100 mg ORAL NDA 38 sections
Norvir HUMAN PRESCRIPTION DRUG LABEL 1 0074-2340 TABLET, FILM COATED 100 mg ORAL NDA 38 sections
Kaletra HUMAN PRESCRIPTION DRUG LABEL 2 0074-2605 TABLET, FILM COATED 50 mg ORAL NDA 32 sections
Kaletra HUMAN PRESCRIPTION DRUG LABEL 2 0074-2605 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 38 sections
Norvir HUMAN PRESCRIPTION DRUG LABEL 1 0074-3333 TABLET, FILM COATED 100 mg ORAL NDA 38 sections
Norvir HUMAN PRESCRIPTION DRUG LABEL 1 0074-3333 TABLET, FILM COATED 100 mg ORAL NDA 38 sections
Norvir HUMAN PRESCRIPTION DRUG LABEL 1 0074-3399 POWDER 100 mg ORAL NDA 38 sections
Norvir HUMAN PRESCRIPTION DRUG LABEL 1 0074-3399 POWDER 100 mg ORAL NDA 38 sections
Norvir HUMAN PRESCRIPTION DRUG LABEL 1 0074-3399 POWDER 100 mg ORAL NDA 38 sections
Kaletra HUMAN PRESCRIPTION DRUG LABEL 2 0074-3956 SOLUTION 20 mg ORAL NDA 32 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 0074-6799 TABLET, FILM COATED 50 mg ORAL NDA 32 sections
Lopinavir-Ritonavir HUMAN PRESCRIPTION DRUG LABEL 2 0527-1947 SOLUTION 20 mg ORAL ANDA 27 sections
Lopinavir-Ritonavir HUMAN PRESCRIPTION DRUG LABEL 2 0527-1947 SOLUTION 20 mg ORAL ANDA 27 sections
Kaletra HUMAN PRESCRIPTION DRUG LABEL 2 11819-342 TABLET, FILM COATED 50 mg ORAL NDA 27 sections
Kaletra HUMAN PRESCRIPTION DRUG LABEL 2 21695-362 TABLET, FILM COATED 50 mg ORAL NDA 27 sections
Lopinavir and ritonavir HUMAN PRESCRIPTION DRUG LABEL 2 31722-556 TABLET, FILM COATED 50 mg ORAL ANDA 27 sections