emtricitabine Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
nucleosides antiviral or antineoplastic agents, cytarabine or azacitidine derivatives 1003 143491-57-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • emtricitabine
  • coviracil
  • emtriva
A deoxycytidine analog and REVERSE TRANSCRIPTASE INHIBITOR with antiviral activity against HIV-1 and HEPATITIS B viruses. It is used to treat HIV INFECTIONS.
  • Molecular weight: 247.24
  • Formula: C8H10FN3O3S
  • CLOGP: -1.29
  • LIPINSKI: 0
  • HAC: 6
  • HDO: 2
  • TPSA: 88.15
  • ALOGS: -2.09
  • ROTB: 2

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.20 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 112 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 73 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 11.56 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Approvals:

DateAgencyCompanyOrphan
Oct. 24, 2003 EMA
July 2, 2003 FDA GILEAD

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
Maternal exposure during pregnancy 2604.86 16.88 1194 22948 101355 46560565
Abortion spontaneous 2366.91 16.88 876 23266 42770 46619150
Foetal exposure during pregnancy 1420.85 16.88 550 23592 30197 46631723
Exposure during pregnancy 1047.23 16.88 666 23476 107546 46554374
Stillbirth 738.21 16.88 228 23914 6263 46655657
Abortion induced 613.21 16.88 222 23920 10038 46651882
Foetal death 548.08 16.88 196 23946 8547 46653373
Virologic failure 439.12 16.88 118 24024 1937 46659983
Premature baby 373.92 16.88 184 23958 17928 46643992
Pregnancy 356.83 16.88 204 23938 26933 46634987
Blood HIV RNULL increased 326.90 16.88 75 24067 612 46661308
Immune reconstitution inflammatory syndrome 309.07 16.88 115 24027 5610 46656310
Live birth 293.82 16.88 131 24011 10199 46651721
Premature delivery 263.81 16.88 156 23986 21913 46640007
Viral load increased 252.08 16.88 70 24072 1305 46660615
Viral mutation identified 251.27 16.88 75 24067 1824 46660096
Drug interaction 245.82 16.88 403 23739 202691 46459229
Caesarean section 200.06 16.88 118 24024 16485 46645435
Drug resistance 179.82 16.88 112 24030 17256 46644664
Pathogen resistance 179.20 16.88 79 24063 5981 46655939
Premature labour 159.37 16.88 89 24053 11210 46650710
Lipodystrophy acquired 158.97 16.88 50 24092 1455 46660465
Treatment noncompliance 158.91 16.88 128 24014 29603 46632317
Fanconi syndrome acquired 157.94 16.88 45 24097 924 46660996
CD4 lymphocytes decreased 151.56 16.88 49 24093 1561 46660359
Pre-eclampsia 149.52 16.88 76 24066 7918 46654002
Enlarged clitoris 147.66 16.88 30 24112 126 46661794
Spina bifida 131.86 16.88 36 24106 628 46661292
Hyperandrogenism 126.54 16.88 25 24117 88 46661832
Genotype drug resistance test positive 124.18 16.88 33 24109 517 46661403
Osteoporosis 122.80 16.88 127 24015 40481 46621439
Premature rupture of membranes 122.25 16.88 55 24087 4368 46657552
Pain 117.65 16.88 50 24092 476898 46185022
Renal tubular disorder 116.69 16.88 45 24097 2420 46659500
Polydactyly 116.43 16.88 29 24113 346 46661574
Immune reconstitution inflammatory syndrome associated tuberculosis 110.28 16.88 28 24114 363 46661557
HIV infection 107.82 16.88 30 24112 563 46661357
Ectopic pregnancy 107.67 16.88 43 24099 2539 46659381
Hydrops foetalis 103.05 16.88 26 24116 328 46661592
Hyperbilirubinaemia 102.22 16.88 65 24077 10373 46651547
Normal newborn 100.56 16.88 53 24089 5948 46655972
Ventricular septal defect 98.42 16.88 46 24096 3988 46657932
Fall 86.80 16.88 31 24111 329066 46332854
Foetal growth restriction 85.23 16.88 49 24093 6518 46655402
Gestational diabetes 83.52 16.88 50 24092 7169 46654751
Product dispensing error 76.99 16.88 52 24090 9181 46652739
Cerebral ventricle dilatation 76.31 16.88 26 24116 977 46660943
Skull malformation 74.23 16.88 20 24122 331 46661589
Fatigue 73.23 16.88 127 24015 608570 46053350
Low birth weight baby 71.74 16.88 41 24101 5393 46656527
Malaria 71.57 16.88 18 24124 224 46661696
Ectopic kidney 71.19 16.88 15 24127 78 46661842
Placenta praevia 70.82 16.88 24 24118 887 46661033
Autoimmune hepatitis 69.96 16.88 46 24096 7768 46654152
Congenital anomaly 68.41 16.88 27 24115 1545 46660375
Product use complaint 68.08 16.88 28 24114 1784 46660136
Hepatitis fulminant 65.52 16.88 33 24109 3369 46658551
Twin pregnancy 64.73 16.88 24 24118 1157 46660763
Hepatocellular injury 64.57 16.88 78 24064 29444 46632476
HIV test positive 62.71 16.88 12 24130 34 46661886
Atrial septal defect 60.92 16.88 39 24103 6293 46655627
Foetal distress syndrome 59.76 16.88 23 24119 1230 46660690
Meningomyelocele 58.78 16.88 18 24124 478 46661442
Lipohypertrophy 58.69 16.88 20 24122 752 46661168
Cushing's syndrome 58.46 16.88 20 24122 761 46661159
Trisomy 21 57.96 16.88 17 24125 388 46661532
Renal colic 55.99 16.88 22 24120 1244 46660676
Polyhydramnios 55.69 16.88 25 24117 1974 46659946
Maternal drugs affecting foetus 55.61 16.88 35 24107 5483 46656437
Fanconi syndrome 54.43 16.88 20 24122 940 46660980
Ultrasound antenatal screen abnormal 54.10 16.88 13 24129 132 46661788
Congenital heart valve disorder 53.42 16.88 12 24130 88 46661832
Drug hypersensitivity 53.20 16.88 30 24112 243795 46418125
CD4 lymphocytes abnormal 52.34 16.88 10 24132 28 46661892
Adrenal insufficiency 50.77 16.88 47 24095 13077 46648843
Renal tubular necrosis 50.53 16.88 43 24099 10716 46651204
Congenital genital malformation female 50.44 16.88 10 24132 36 46661884
Anal atresia 50.27 16.88 15 24127 364 46661556
Anencephaly 50.21 16.88 13 24129 183 46661737
Cloacal exstrophy 49.66 16.88 12 24130 125 46661795
Coloboma 49.17 16.88 11 24131 79 46661841
Patent ductus arteriosus 47.95 16.88 28 24114 3834 46658086
Sudden infant death syndrome 47.92 16.88 13 24129 221 46661699
Trisomy 18 47.79 16.88 10 24132 50 46661870
Rash maculo-papular 47.37 16.88 65 24077 27809 46634111
Neonatal respiratory arrest 46.54 16.88 10 24132 58 46661862
Cholestasis 46.14 16.88 63 24079 26830 46635090
Dyspnoea 45.83 16.88 127 24015 515421 46146499
Congenital genital malformation 45.66 16.88 11 24131 113 46661807
Bladder agenesis 45.23 16.88 11 24131 118 46661802
Neural tube defect 45.15 16.88 12 24130 188 46661732
Renal tubular acidosis 44.74 16.88 20 24122 1563 46660357
Lactic acidosis 44.49 16.88 70 24072 33839 46628081
Genitalia external ambiguous 44.10 16.88 11 24131 132 46661788
Adrenal suppression 43.73 16.88 17 24125 934 46660986
Oligohydramnios 43.71 16.88 30 24112 5435 46656485
Proteinuria 43.35 16.88 48 24094 16505 46645415
Nasopharyngitis 43.16 16.88 13 24129 153985 46507935
Renal failure 43.12 16.88 143 23999 113451 46548469
Premature separation of placenta 43.07 16.88 20 24122 1708 46660212
Pneumonia 42.87 16.88 81 24061 376239 46285681
Drug ineffective 42.27 16.88 194 23948 677644 45984276
Osteonecrosis 42.20 16.88 59 24083 25685 46636235
Sinusitis 42.16 16.88 8 24134 129760 46532160
Abnormal dreams 42.08 16.88 38 24104 10241 46651679
Meconium stain 42.02 16.88 11 24131 162 46661758
Acute HIV infection 41.13 16.88 7 24135 7 46661913
Foetal malnutrition 40.40 16.88 10 24132 116 46661804
Joint swelling 39.85 16.88 18 24124 166055 46495865
Caudal regression syndrome 39.64 16.88 10 24132 126 46661794
Tethered cord syndrome 39.55 16.88 11 24131 206 46661714
Acute kidney injury 39.40 16.88 232 23910 235623 46426297
Macrocephaly 38.63 16.88 9 24133 79 46661841
Pulmonary valve sclerosis 38.40 16.88 8 24134 39 46661881
Complication of delivery 38.28 16.88 10 24132 146 46661774
Dysmorphism 38.20 16.88 19 24123 1888 46660032
HIV-associated neurocognitive disorder 38.03 16.88 10 24132 150 46661770
Spine malformation 37.93 16.88 11 24131 241 46661679
Gastrointestinal tube insertion 37.64 16.88 16 24126 1107 46660813
Oesophageal atresia 37.50 16.88 13 24129 515 46661405
Pregnancy with implant contraceptive 37.24 16.88 19 24123 1993 46659927
Gastrointestinal disorder congenital 36.97 16.88 9 24133 97 46661823
Umbilical cord abnormality 35.83 16.88 13 24129 589 46661331
Oesophageal candidiasis 35.69 16.88 26 24116 5174 46656746
Congenital pulmonary valve disorder 35.57 16.88 8 24134 59 46661861
Nephropathy toxic 35.43 16.88 30 24112 7424 46654496
Drug intolerance 35.18 16.88 16 24126 147033 46514887
Pain in extremity 34.71 16.88 50 24092 258630 46403290
Atrial fibrillation 34.48 16.88 6 24136 103584 46558336
Arthralgia 34.47 16.88 87 24055 364516 46297404
Microcephaly 34.14 16.88 13 24129 675 46661245
Gastrointestinal malformation 33.69 16.88 9 24133 144 46661776
Pulmonary tuberculosis 33.26 16.88 24 24118 4707 46657213
Hypotension 33.17 16.88 43 24099 232546 46429374
Congenital skin dimples 33.01 16.88 9 24133 156 46661764
Melanoderma 32.91 16.88 9 24133 158 46661762
Product size issue 32.79 16.88 11 24131 394 46661526
Gastrostomy 32.67 16.88 12 24130 563 46661357
Injection site pain 31.97 16.88 8 24134 107144 46554776
Musculoskeletal stiffness 31.91 16.88 6 24136 97987 46563933
Therapeutic product effect decreased 31.78 16.88 3 24139 82598 46579322
Renal tubular dysfunction 31.69 16.88 10 24132 294 46661626
Cushingoid 31.40 16.88 26 24116 6240 46655680
Pregnancy on contraceptive 31.33 16.88 14 24128 1093 46660827
Jaundice neonatal 31.28 16.88 13 24129 850 46661070
Cholestasis of pregnancy 31.13 16.88 14 24128 1110 46660810
Secondary adrenocortical insufficiency 31.11 16.88 13 24129 862 46661058
Transaminases increased 30.61 16.88 53 24089 27708 46634212
Product storage error 30.54 16.88 34 24108 11758 46650162
Weight increased 30.20 16.88 166 23976 164307 46497613
Drug-induced liver injury 30.05 16.88 50 24092 25318 46636602
Psoriasis 29.86 16.88 3 24139 78601 46583319
Exomphalos 29.71 16.88 11 24131 528 46661392
Abdominal discomfort 29.64 16.88 21 24121 151144 46510776
Anembryonic gestation 28.76 16.88 11 24131 578 46661342
Hepatitis 28.59 16.88 56 24086 32159 46629761
Glycosuria 28.50 16.88 13 24129 1065 46660855
Drug reaction with eosinophilia and systemic symptoms 28.23 16.88 53 24089 29495 46632425
Hydrocephalus 28.18 16.88 22 24120 4855 46657065
Endometritis decidual 28.04 16.88 6 24136 34 46661886
Blood phosphorus decreased 28.00 16.88 20 24122 3860 46658060
Maternal exposure before pregnancy 27.61 16.88 21 24121 4460 46657460
Enanthema 27.61 16.88 10 24132 451 46661469
Mitochondrial cytopathy 27.53 16.88 9 24133 297 46661623
Amniotic cavity infection 27.40 16.88 13 24129 1165 46660755
Cardiac failure congestive 27.08 16.88 7 24135 91743 46570177
Jaundice 26.64 16.88 51 24091 28794 46633126
Adrenogenital syndrome 26.47 16.88 6 24136 46 46661874
Liver transplant 26.05 16.88 16 24126 2401 46659519
Congenital central nervous system anomaly 25.90 16.88 9 24133 359 46661561
Cough 25.78 16.88 50 24092 230199 46431721
Glomerular filtration rate decreased 25.73 16.88 31 24111 11663 46650257
White blood cell count decreased 25.63 16.88 13 24129 112218 46549702
Potassium wasting nephropathy 25.24 16.88 6 24136 58 46661862
Abortion threatened 25.04 16.88 10 24132 590 46661330
Abortion 24.52 16.88 15 24127 2235 46659685
Foetal malformation 24.46 16.88 7 24135 146 46661774
Placental chorioangioma 24.42 16.88 5 24137 22 46661898
Blood pressure increased 24.30 16.88 18 24124 126648 46535272
Influenza 24.17 16.88 8 24134 89262 46572658
Malaise 24.16 16.88 89 24053 331143 46330777
Tremor 24.10 16.88 15 24127 115624 46546296
Large for dates baby 23.88 16.88 9 24133 454 46661466
Contraindicated product administered 23.79 16.88 6 24136 79941 46581979
Infection 23.12 16.88 21 24121 133571 46528349
Face oedema 23.02 16.88 38 24104 19115 46642805
Tubulointerstitial nephritis 22.91 16.88 33 24109 14755 46647165
Hepatotoxicity 22.83 16.88 44 24098 24965 46636955
Arthritis 22.63 16.88 6 24136 77310 46584610
Blood HIV RNULL 22.61 16.88 4 24138 6 46661914
Coagulation factor V level decreased 22.61 16.88 8 24134 337 46661583
Hepatic failure 22.59 16.88 52 24090 33364 46628556
CSF HIV escape syndrome 22.59 16.88 5 24137 34 46661886
Spinocerebellar disorder 22.46 16.88 5 24137 35 46661885
Coarctation of the aorta 22.36 16.88 9 24133 542 46661378
Viral load decreased 22.34 16.88 5 24137 36 46661884
Hereditary optic atrophy 22.23 16.88 4 24138 7 46661913
Hypophosphataemia 22.17 16.88 23 24119 7344 46654576
Hepatitis B DNULL increased 22.14 16.88 7 24135 207 46661713
Urinary tract infection 22.01 16.88 51 24091 220215 46441705
Completed suicide 21.81 16.88 26 24116 145894 46516026
Abortion spontaneous incomplete 21.77 16.88 5 24137 41 46661879
Mental disability 21.69 16.88 6 24136 110 46661810
Febrile neutropenia 21.55 16.88 11 24131 94616 46567304
Sepsis neonatal 21.28 16.88 8 24134 401 46661519
Unwanted pregnancy 21.16 16.88 5 24137 47 46661873
Flushing 20.94 16.88 4 24138 64610 46597310
Prurigo 20.93 16.88 10 24132 910 46661010
Glucocorticoids increased 20.93 16.88 6 24136 126 46661794
Foetal cardiac disorder 20.79 16.88 5 24137 51 46661869
Muscle spasms 20.55 16.88 20 24122 123093 46538827
Total bile acids increased 20.54 16.88 6 24136 135 46661785
Single umbilical artery 20.49 16.88 6 24136 136 46661784
Herpes zoster 20.37 16.88 5 24137 67867 46594053
Symmetrical drug-related intertriginous and flexural exanthema 20.25 16.88 7 24135 275 46661645
Constipation 20.19 16.88 37 24105 174060 46487860
Encephalocele 20.17 16.88 6 24136 144 46661776
Pregnancy on oral contraceptive 20.15 16.88 11 24131 1323 46660597
Congenital umbilical hernia 20.07 16.88 8 24134 470 46661450
Chronic papillomatous dermatitis 20.05 16.88 5 24137 60 46661860
Cardiac murmur 19.98 16.88 27 24115 11377 46650543
Preterm premature rupture of membranes 19.91 16.88 10 24132 1015 46660905
High arched palate 19.90 16.88 5 24137 62 46661858
Congenital choroid plexus cyst 19.87 16.88 7 24135 291 46661629
Exposure via body fluid 19.81 16.88 8 24134 486 46661434
Peripheral swelling 19.78 16.88 32 24110 158039 46503881
Viral load undetectable 19.70 16.88 3 24139 0 46661920
HIV viraemia 19.70 16.88 3 24139 0 46661920
Noonan syndrome 19.70 16.88 3 24139 0 46661920
Congenital ectopic bladder 19.68 16.88 5 24137 65 46661855
Bradycardia 19.68 16.88 5 24137 66293 46595627
Postpartum haemorrhage 19.63 16.88 12 24130 1785 46660135
Gait disturbance 19.53 16.88 28 24114 145235 46516685
Platelet count decreased 19.46 16.88 14 24128 100010 46561910
Congenital acrochordon 19.40 16.88 5 24137 69 46661851
Alpha 1 foetoprotein abnormal 19.40 16.88 5 24137 69 46661851
Placenta accreta 19.29 16.88 6 24136 168 46661752
Thrombosis 19.20 16.88 3 24139 56066 46605854
Hypertension 19.18 16.88 46 24096 196310 46465610
Cytogenetic abnormality 19.15 16.88 8 24134 530 46661390
Back pain 19.13 16.88 51 24091 209988 46451932
Hyperphosphaturia 19.12 16.88 4 24138 20 46661900
Malignant neoplasm progression 19.07 16.88 5 24137 64921 46596999
Porphyria non-acute 19.03 16.88 7 24135 330 46661590
Eosinophilia 19.02 16.88 35 24107 19182 46642738
Umbilical cord prolapse 18.95 16.88 4 24138 21 46661899
Epilepsy congenital 18.95 16.88 4 24138 21 46661899
Balance disorder 18.89 16.88 5 24137 64516 46597404
Eyelid oedema 18.88 16.88 25 24117 10332 46651588
ACTH stimulation test abnormal 18.80 16.88 4 24138 22 46661898
Central obesity 18.75 16.88 9 24133 828 46661092
Loss of consciousness 18.75 16.88 17 24125 108221 46553699
Contusion 18.71 16.88 11 24131 87476 46574444
Syncope 18.71 16.88 16 24126 104787 46557133
Congenital foot malformation 18.65 16.88 6 24136 188 46661732
Ataxia 18.60 16.88 29 24113 13901 46648019
Abortion infected 18.50 16.88 4 24138 24 46661896
Chondroma 18.23 16.88 4 24138 26 46661894
Neonatal respiratory distress syndrome 18.15 16.88 13 24129 2520 46659400
Cystic lymphangioma 18.10 16.88 4 24138 27 46661893
Thymus hypoplasia 18.10 16.88 4 24138 27 46661893
Heart rate increased 18.09 16.88 8 24134 74783 46587137
Bronchitis 17.93 16.88 17 24125 105962 46555958
Cellulitis 17.83 16.88 7 24135 70281 46591639
Osteoarthritis 17.80 16.88 5 24137 62020 46599900
Hepatic encephalopathy 17.73 16.88 24 24118 10133 46651787
Congenital spinal cord anomaly 17.63 16.88 3 24139 3 46661917
Clinodactyly 17.62 16.88 5 24137 101 46661819
Osteomalacia 17.61 16.88 8 24134 649 46661271
Drug level increased 17.51 16.88 33 24109 18408 46643512
Dizziness 17.41 16.88 104 24038 340310 46321610
Congenital hydrocephalus 17.22 16.88 5 24137 110 46661810
Urine protein/creatinine ratio increased 17.13 16.88 6 24136 245 46661675
Congenital musculoskeletal anomaly 17.11 16.88 7 24135 440 46661480
Talipes 16.94 16.88 10 24132 1397 46660523
Cleft lip 16.93 16.88 5 24137 117 46661803
Liver injury 16.93 16.88 30 24112 15971 46645949
Osteopenia 16.92 16.88 31 24111 16930 46644990
Pulmonary oedema 16.91 16.88 3 24139 51102 46610818

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
Immune reconstitution inflammatory syndrome 1150.61 12.00 462 47597 8639 29895780
Foetal exposure during pregnancy 822.11 12.00 587 47472 36284 29868135
Viral load increased 735.21 12.00 245 47814 2609 29901810
Osteoporosis 679.63 12.00 335 47724 10328 29894091
Blood HIV RNULL increased 548.91 12.00 166 47893 1250 29903169
Acute HIV infection 511.97 12.00 112 47947 155 29904264
Fanconi syndrome acquired 385.13 12.00 140 47919 1963 29902456
Virologic failure 357.33 12.00 149 47910 3070 29901349
Renal tubular disorder 332.95 12.00 162 47897 4844 29899575
Product storage error 315.09 12.00 169 47890 6222 29898197
Drug interaction 305.95 12.00 853 47206 198715 29705704
Drug resistance 296.42 12.00 251 47808 19882 29884537
Genotype drug resistance test positive 295.51 12.00 107 47952 1482 29902937
CD4 lymphocytes decreased 285.48 12.00 112 47947 1958 29902461
Abnormal dreams 274.92 12.00 168 47891 7947 29896472
Viral mutation identified 240.19 12.00 106 47953 2520 29901899
HIV infection 232.66 12.00 91 47968 1577 29902842
Product dispensing error 223.04 12.00 131 47928 5758 29898661
HIV test positive 219.26 12.00 56 48003 202 29904217
Treatment noncompliance 179.65 12.00 212 47847 25041 29879378
Syphilis 175.00 12.00 51 48008 332 29904087
Gastrointestinal tube insertion 172.04 12.00 68 47991 1213 29903206
Renal colic 144.44 12.00 66 47993 1706 29902713
Pathogen resistance 138.62 12.00 112 47947 8298 29896121
Glycosuria 126.64 12.00 55 48004 1256 29903163
Proteinuria 123.94 12.00 141 47918 16004 29888415
Blood creatinine increased 118.72 12.00 369 47690 91006 29813413
Osteoporotic fracture 114.80 12.00 48 48011 995 29903424
Nephrolithiasis 111.01 12.00 166 47893 24644 29879775
Glomerular filtration rate decreased 109.65 12.00 112 47947 11250 29893169
Fanconi syndrome 107.76 12.00 54 48005 1721 29902698
Acute hepatitis C 105.45 12.00 29 48030 148 29904271
Pneumonia 105.12 12.00 239 47820 334067 29570352
Hypotension 96.37 12.00 108 47951 200457 29703962
Nephropathy toxic 95.70 12.00 101 47958 10538 29893881
Dyspnoea 94.77 12.00 251 47808 333044 29571375
Fall 90.61 12.00 95 47964 181777 29722642
Jaundice 90.45 12.00 176 47883 32310 29872109
Osteopenia 89.79 12.00 68 47991 4580 29899839
Osteonecrosis 88.49 12.00 119 47940 16016 29888403
Premature baby 88.35 12.00 121 47938 16570 29887849
Hyperbilirubinaemia 86.95 12.00 121 47938 16821 29887598
Lipodystrophy acquired 86.85 12.00 60 47999 3500 29900919
Polydactyly 85.21 12.00 41 48018 1194 29903225
Depression 84.14 12.00 327 47732 90110 29814309
Weight increased 80.67 12.00 284 47775 74629 29829790
Heterotaxia 79.54 12.00 23 48036 145 29904274
Malignant neoplasm progression 79.19 12.00 11 48048 72276 29832143
HIV-associated neurocognitive disorder 78.83 12.00 27 48032 314 29904105
CD4 lymphocytes abnormal 77.56 12.00 21 48038 100 29904319
Cardiac failure congestive 77.32 12.00 20 48039 84387 29820032
Hypophosphataemia 77.24 12.00 80 47979 8165 29896254
Suicidal ideation 76.51 12.00 175 47884 35939 29868480
Product use complaint 75.74 12.00 37 48022 1115 29903304
Cytomegalovirus chorioretinitis 74.87 12.00 53 48006 3215 29901204
Nightmare 73.88 12.00 94 47965 11982 29892437
Rash 72.41 12.00 541 47518 191348 29713071
Low birth weight baby 70.01 12.00 66 47993 6010 29898409
Disease progression 69.30 12.00 21 48038 79853 29824566
Renal impairment 69.22 12.00 293 47766 83891 29820528
Acquired immunodeficiency syndrome 68.02 12.00 27 48032 487 29903932
Hepatitis C 67.29 12.00 94 47965 13111 29891308
Plasma cell myeloma 66.64 12.00 5 48054 53457 29850962
Developmental delay 66.60 12.00 42 48017 2099 29902320
Atrial fibrillation 66.59 12.00 46 48013 108078 29796341
Febrile neutropenia 66.23 12.00 45 48014 106648 29797771
Ocular icterus 64.04 12.00 47 48012 3017 29901402
Viraemia 63.25 12.00 33 48026 1146 29903273
Dyslipidaemia 61.80 12.00 60 47999 5667 29898752
Laryngomalacia 60.79 12.00 21 48038 251 29904168
Insurance issue 58.36 12.00 28 48031 810 29903609
Progressive multifocal leukoencephalopathy 58.07 12.00 72 47987 8941 29895478
Depression suicidal 58.03 12.00 32 48027 1244 29903175
Psychiatric decompensation 57.13 12.00 32 48027 1283 29903136
Renal tubular necrosis 57.03 12.00 94 47965 15157 29889262
Death 56.75 12.00 339 47720 356944 29547475
Drug abuse 55.95 12.00 31 48028 82041 29822378
Meningitis cryptococcal 53.86 12.00 36 48023 1988 29902431
Renal failure 53.40 12.00 372 47687 128594 29775825
Intentional dose omission 52.11 12.00 31 48028 1394 29903025
Mycobacterium avium complex infection 50.91 12.00 39 48020 2672 29901747
Osteomalacia 50.39 12.00 26 48033 882 29903537
Infusion related reaction 49.97 12.00 4 48055 40560 29863859
Gene mutation 49.91 12.00 25 48034 796 29903623
Acute kidney injury 48.84 12.00 661 47398 273181 29631238
Constipation 48.66 12.00 66 47993 112840 29791579
HIV viraemia 48.32 12.00 14 48045 89 29904330
Immune reconstitution inflammatory syndrome associated tuberculosis 48.26 12.00 20 48039 405 29904014
Completed suicide 47.22 12.00 54 48005 99438 29804981
Single umbilical artery 46.70 12.00 17 48042 239 29904180
Gastrostomy 46.48 12.00 23 48036 713 29903706
Renal tubular dysfunction 46.15 12.00 19 48040 378 29904041
Bone density decreased 45.82 12.00 31 48028 1747 29902672
Product dispensing issue 45.61 12.00 12 48047 50 29904369
Blood phosphorus decreased 45.43 12.00 38 48021 2954 29901465
Hepatitis B 44.85 12.00 52 48007 6020 29898399
Gonorrhoea 44.69 12.00 13 48046 84 29904335
Toxicity to various agents 44.63 12.00 141 47918 177042 29727377
Cortisol decreased 44.46 12.00 24 48035 894 29903525
Diabetes mellitus 44.40 12.00 158 47901 41707 29862712
Anal cancer 44.27 12.00 19 48040 421 29903998
Chlamydial infection 44.22 12.00 15 48044 169 29904250
Insomnia 43.90 12.00 278 47781 93058 29811361
Suicide attempt 43.74 12.00 144 47915 36553 29867866
Pulmonary tuberculosis 43.48 12.00 46 48013 4811 29899608
Rheumatoid arthritis 43.42 12.00 7 48052 41190 29863229
Gene mutation identification test positive 43.37 12.00 15 48044 180 29904239
Cardio-respiratory arrest 43.05 12.00 19 48040 57287 29847132
Cardiac failure 42.11 12.00 43 48016 83375 29821044
Interstitial lung disease 42.10 12.00 22 48037 60175 29844244
Hypertriglyceridaemia 41.78 12.00 58 48001 8040 29896379
Sepsis 41.60 12.00 110 47949 146285 29758134
Tearfulness 41.54 12.00 28 48031 1568 29902851
Therapy cessation 40.89 12.00 81 47978 15056 29889363
Cough 40.78 12.00 88 47971 125554 29778865
Gynaecomastia 40.40 12.00 58 48001 8293 29896126
Trisomy 21 39.97 12.00 18 48041 449 29903970
Gastrointestinal haemorrhage 39.91 12.00 45 48014 83401 29821018
Hepatitis A 39.68 12.00 18 48041 457 29903962
Blood pressure increased 38.72 12.00 35 48024 71893 29832526
Cardiac arrest 38.28 12.00 56 48003 92794 29811625
Lipids increased 38.07 12.00 22 48037 937 29903482
Endotracheal intubation 36.96 12.00 31 48028 2419 29902000
Chordee 36.69 12.00 11 48048 80 29904339
Blood triglycerides increased 36.65 12.00 74 47985 13943 29890476
Kaposi's sarcoma 36.65 12.00 22 48037 1006 29903413
Sleep disorder 36.59 12.00 104 47955 24375 29880044
Trisomy 18 36.53 12.00 14 48045 229 29904190
Platelet count decreased 36.41 12.00 72 47987 106057 29798362
Shigella infection 35.78 12.00 9 48050 30 29904389
Creatinine renal clearance decreased 35.58 12.00 35 48024 3358 29901061
Hepatic enzyme increased 35.16 12.00 126 47933 33368 29871051
Congenital hearing disorder 34.93 12.00 11 48048 96 29904323
Adrenal suppression 34.77 12.00 18 48041 615 29903804
Hypothalamic pituitary adrenal axis suppression 34.53 12.00 13 48046 202 29904217
Speech disorder developmental 33.87 12.00 22 48037 1157 29903262
Wheezing 33.18 12.00 5 48054 30933 29873486
Renal disorder 33.13 12.00 98 47961 23486 29880933
Respiratory arrest 33.11 12.00 4 48055 29254 29875165
Paranoia 33.09 12.00 59 48000 10129 29894290
Anogenital dysplasia 32.76 12.00 12 48047 172 29904247
Product dose omission issue 32.57 12.00 255 47804 91376 29813043
Neurosyphilis 32.55 12.00 9 48050 47 29904372
Lipohypertrophy 32.54 12.00 14 48045 312 29904107
Hepatitis 32.46 12.00 94 47965 22262 29882157
Lymphoma 32.09 12.00 58 48001 10063 29894356
Circumstance or information capable of leading to medication error 31.97 12.00 24 48035 1595 29902824
Lower respiratory tract infection 31.90 12.00 3 48056 26711 29877708
Portal hypertension 31.72 12.00 35 48024 3838 29900581
Congenital anomaly 31.59 12.00 22 48037 1300 29903119
Inability to afford medication 31.14 12.00 18 48041 767 29903652
Hepatic cirrhosis 31.11 12.00 75 47984 15924 29888495
Atypical mycobacterial infection 30.86 12.00 18 48041 780 29903639
Pulmonary oedema 30.85 12.00 16 48043 43959 29860460
Lactic acidosis 30.72 12.00 115 47944 31098 29873321
Beta 2 microglobulin urine increased 30.64 12.00 10 48049 99 29904320
Bradycardia 30.60 12.00 36 48023 65490 29838929
Blood pressure decreased 30.34 12.00 19 48040 47056 29857363
Chromaturia 30.25 12.00 68 47991 13797 29890622
Oxygen saturation decreased 30.18 12.00 16 48043 43424 29860995
Seroconversion test positive 30.06 12.00 7 48052 15 29904404
CSF HIV escape syndrome 29.61 12.00 10 48049 111 29904308
Anogenital warts 29.37 12.00 15 48044 498 29903921
Myalgia 29.28 12.00 217 47842 76450 29827969
Pyelocaliectasis 29.28 12.00 19 48040 998 29903421
CSF virus identified 29.22 12.00 8 48051 40 29904379
Chronic obstructive pulmonary disease 29.21 12.00 19 48040 46107 29858312
Depressed mood 29.10 12.00 76 47983 16953 29887466
Ventricular septal defect 29.09 12.00 32 48027 3497 29900922
Cryptorchism 29.05 12.00 23 48036 1654 29902765
Respiratory failure 29.04 12.00 75 47984 100567 29803852
Hepatotoxicity 29 12.00 79 47980 18066 29886353
Nasopharyngitis 28.94 12.00 31 48028 58818 29845601
Intercepted product dispensing error 28.84 12.00 9 48050 76 29904343
Secondary syphilis 28.74 12.00 8 48051 43 29904376
Hepatitis cholestatic 28.73 12.00 48 48011 7824 29896595
Dehydration 28.55 12.00 102 47957 123437 29780982
Vanishing bile duct syndrome 28.33 12.00 16 48043 652 29903767
Pleural effusion 28.30 12.00 47 48012 74019 29830400
Pain 28.24 12.00 162 47897 172479 29731940
Chronic kidney disease 28.23 12.00 128 47931 37710 29866709
Fat tissue increased 28.16 12.00 13 48046 344 29904075
Hyperferritinaemia 27.42 12.00 13 48046 366 29904053
Therapeutic product effect incomplete 27.39 12.00 10 48049 33824 29870595
White blood cell count decreased 27.05 12.00 59 48000 83888 29820531
Drug-induced liver injury 26.71 12.00 85 47974 21189 29883230
Haemophilic arthropathy 26.70 12.00 10 48049 153 29904266
Portal fibrosis 26.54 12.00 13 48046 394 29904025
Psoriasis 26.25 12.00 18 48041 42488 29861931
Hepatitis B DNULL assay positive 25.70 12.00 8 48051 67 29904352
Orthostatic hypotension 25.43 12.00 4 48055 23975 29880444
Testicular germ cell tumour mixed 25.41 12.00 7 48052 36 29904383
Headache 25.35 12.00 422 47637 181884 29722535
Haemoglobin decreased 25.18 12.00 96 47963 114002 29790417
Faeces pale 25.03 12.00 20 48039 1457 29902962
Hepatitis syphilitic 24.84 12.00 5 48054 3 29904416
International normalised ratio increased 24.77 12.00 24 48035 47715 29856704
CD4 lymphocytes increased 24.63 12.00 11 48048 269 29904150
Congenital mitral valve incompetence 24.53 12.00 8 48051 79 29904340
Supernumerary nipple 24.23 12.00 7 48052 44 29904375
Mobility decreased 24.09 12.00 6 48053 25993 29878426
Congenital umbilical hernia 23.93 12.00 12 48047 383 29904036
Neonatal hyponatraemia 23.84 12.00 8 48051 87 29904332
Nausea 23.83 12.00 634 47425 296323 29608096
Epistaxis 23.79 12.00 30 48029 52951 29851468
Hepatitis B DNULL increased 23.37 12.00 13 48046 514 29903905
Hypospadias 23.32 12.00 25 48034 2654 29901765
Pancreatitis 23.28 12.00 118 47941 36372 29868047
Haematochezia 23.20 12.00 13 48046 34209 29870210
Economic problem 23.15 12.00 19 48040 1438 29902981
Depressive symptom 23.15 12.00 20 48039 1625 29902794
Pancreatitis acute 23.10 12.00 92 47967 25603 29878816
Cushingoid 23.05 12.00 24 48035 2463 29901956
Oesophageal candidiasis 23.00 12.00 31 48028 4179 29900240
Ectopic kidney 22.99 12.00 7 48052 54 29904365
Congenital hydronephrosis 22.88 12.00 14 48045 663 29903756
Injection site pain 22.83 12.00 10 48049 30300 29874119
AIDS related complication 22.81 12.00 6 48053 25 29904394
Tachycardia 22.80 12.00 53 48006 73686 29830733
Joint swelling 22.78 12.00 25 48034 46921 29857498
Oedema peripheral 22.74 12.00 90 47969 105742 29798677
Urinary tract infection 22.73 12.00 53 48006 73606 29830813
Neuropsychiatric syndrome 22.69 12.00 8 48051 102 29904317
Infection 22.66 12.00 58 48001 78016 29826403
Blood HIV RNULL 22.43 12.00 6 48053 27 29904392
Asthenia 22.41 12.00 237 47822 221053 29683366
Back pain 22.20 12.00 87 47972 102509 29801910
Cytomegalovirus colitis 22.13 12.00 23 48036 2356 29902063
Therapy change 22.10 12.00 24 48035 2585 29901834
Foetal growth restriction 22.07 12.00 28 48031 3557 29900862
Acute respiratory failure 22.03 12.00 7 48052 25843 29878576
Lipoatrophy 21.86 12.00 13 48046 584 29903835
Drug level increased 21.84 12.00 72 47987 18282 29886137
Haematocrit decreased 21.78 12.00 11 48048 30688 29873731
Metabolic surgery 21.75 12.00 6 48053 31 29904388
Eye infection syphilitic 21.71 12.00 5 48054 10 29904409
White blood cell count increased 21.70 12.00 19 48040 39654 29864765
Delirium 21.58 12.00 20 48039 40611 29863808
Porphyria non-acute 21.49 12.00 12 48047 478 29903941
Renal tubular acidosis 21.39 12.00 20 48039 1802 29902617
Depressed level of consciousness 21.28 12.00 18 48041 38204 29866215
Hydrocele 21.28 12.00 21 48038 2023 29902396
Calculus urinary 21.09 12.00 17 48042 1254 29903165
Blood bilirubin increased 20.99 12.00 115 47944 36521 29867898
Cerebral toxoplasmosis 20.92 12.00 18 48041 1454 29902965
Hyperhidrosis 20.92 12.00 48 48011 67042 29837377
Productive cough 20.85 12.00 11 48048 29942 29874477
Blood creatine phosphokinase increased 20.83 12.00 131 47928 43717 29860702
Haemoptysis 20.79 12.00 12 48047 31066 29873353
Mitochondrial cytopathy 20.78 12.00 9 48050 204 29904215
Pulmonary valve disease 20.31 12.00 7 48052 83 29904336
Vertigo 20.31 12.00 81 47978 22554 29881865
Genital herpes 20.28 12.00 12 48047 534 29903885
Septic shock 20.24 12.00 45 48014 63562 29840857
Liver function test increased 20.13 12.00 51 48008 11165 29893254
Cachexia 19.84 12.00 37 48022 6574 29897845
Hypoglycaemia 19.79 12.00 32 48027 50949 29853470
Periarthritis 19.78 12.00 15 48044 1012 29903407
Hyperlipidaemia 19.73 12.00 58 48001 13849 29890570
Oesophageal carcinoma 19.71 12.00 25 48034 3176 29901243
Dysphagia 19.69 12.00 157 47902 56541 29847878
Syncope 19.67 12.00 70 47989 84833 29819586
Anomalous pulmonary venous connection 19.66 12.00 7 48052 92 29904327
Pneumonia aspiration 19.59 12.00 19 48040 37761 29866658
Viral load 19.59 12.00 7 48052 93 29904326
Drug reaction with eosinophilia and systemic symptoms 19.51 12.00 94 47965 28394 29876025
Ventricular tachycardia 19.40 12.00 7 48052 23855 29880564
Mitochondrial toxicity 19.36 12.00 22 48037 2492 29901927
Malaise 19.34 12.00 173 47886 166789 29737630
Drug screen false positive 19.32 12.00 13 48046 726 29903693
Tuberculosis 19.19 12.00 41 48018 8036 29896383
Mitochondrial myopathy 19.12 12.00 8 48051 166 29904253
Cerebellar syndrome 19.06 12.00 20 48039 2072 29902347
Drug hypersensitivity 19.04 12.00 52 48007 68467 29835952
Urine phosphorus abnormal 18.98 12.00 4 48055 4 29904415
Hepatic necrosis 18.94 12.00 27 48032 3836 29900583
Polymicrogyria 18.61 12.00 5 48054 23 29904396
Cardiac disorder 18.53 12.00 22 48037 39871 29864548
Haemolytic anaemia 18.47 12.00 46 48013 9964 29894455
Gastric bypass 18.43 12.00 9 48050 271 29904148
Therapeutic product effect decreased 18.37 12.00 12 48047 29064 29875355
Heart rate increased 18.37 12.00 21 48038 38700 29865719
Cholestasis 18.31 12.00 84 47975 24866 29879553
Product distribution issue 18.28 12.00 8 48051 186 29904233
Rash maculo-papular 18.23 12.00 85 47974 25333 29879086
Chest discomfort 18.17 12.00 28 48031 45452 29858967
Retinal toxicity 18.13 12.00 10 48049 389 29904030
Erectile dysfunction 18.06 12.00 67 47992 18035 29886384
Gastroenteritis cryptosporidial 18.01 12.00 8 48051 193 29904226
Cerebrovascular accident 17.92 12.00 71 47988 83406 29821013
Osteonecrosis of jaw 17.84 12.00 4 48055 18614 29885805
Hyperphosphaturia 17.82 12.00 6 48053 66 29904353
Confusional state 17.75 12.00 135 47924 134699 29769720
Bone density abnormal 17.74 12.00 6 48053 67 29904352
Cleft lip and palate 17.67 12.00 9 48050 297 29904122
Decreased appetite 17.50 12.00 155 47904 149755 29754664
Congenital choroid plexus cyst 17.46 12.00 8 48051 208 29904211
Toxoplasmosis 17.41 12.00 14 48045 1029 29903390
Disease risk factor 17.37 12.00 4 48055 8 29904411
Chronic hepatitis B 17.36 12.00 5 48054 31 29904388
Hepatomegaly 17.33 12.00 45 48014 10002 29894417
Lung disorder 17.30 12.00 15 48044 31454 29872965
Night sweats 17.29 12.00 57 48002 14471 29889948
Mental disorder 17.12 12.00 54 48005 13395 29891024
Hypomagnesaemia 17.09 12.00 3 48056 16595 29887824
Fat redistribution 17.06 12.00 7 48052 138 29904281
Neonatal asphyxia 17.05 12.00 9 48050 320 29904099
Ultrasound foetal abnormal 17.05 12.00 4 48055 9 29904410
Drug level decreased 16.81 12.00 32 48027 5773 29898646
Unmasking of previously unidentified disease 16.79 12.00 11 48048 587 29903832
General physical health deterioration 16.74 12.00 93 47966 99851 29804568
Mechanical ventilation 16.72 12.00 17 48042 1697 29902722
Malaria 16.62 12.00 8 48051 233 29904186
Product residue present 16.62 12.00 21 48038 2657 29901762
Acute stress disorder 16.57 12.00 7 48052 149 29904270
Pruritus 16.54 12.00 274 47785 117930 29786489
Alopecia 16.52 12.00 68 47991 19207 29885212
Exposure during pregnancy 16.51 12.00 42 48017 9219 29895200
Alopecia areata 16.48 12.00 7 48052 151 29904268
Transient ischaemic attack 16.47 12.00 10 48049 25190 29879229
Blood corticotrophin decreased 16.44 12.00 7 48052 152 29904267
Psychomotor skills impaired 16.41 12.00 18 48041 1961 29902458
Lymphadenopathy 16.38 12.00 80 47979 24296 29880123
Psychotic disorder 16.21 12.00 73 47986 21442 29882977
Mucosal inflammation 16.21 12.00 15 48044 30479 29873940
Nervous system disorder 16.21 12.00 52 48007 13017 29891402
Endocarditis candida 16.19 12.00 6 48053 89 29904330
Intestinal malrotation 16.15 12.00 5 48054 41 29904378
Treatment failure 16.09 12.00 103 47956 34576 29869843
Hepatic fibrosis 16.07 12.00 24 48035 3556 29900863
Bone marrow oedema 15.98 12.00 10 48049 493 29903926
Dyspnoea exertional 15.97 12.00 20 48039 35410 29869009
Psoriatic arthropathy 15.90 12.00 3 48056 15758 29888661
Polydipsia 15.90 12.00 24 48035 3589 29900830
Ureterolithiasis 15.88 12.00 17 48042 1802 29902617
Chills 15.86 12.00 61 47998 72277 29832142
Full blood count decreased 15.84 12.00 3 48056 15714 29888705
Anaphylactic reaction 15.80 12.00 13 48046 27969 29876450
Hydrops foetalis 15.76 12.00 8 48051 262 29904157
Cell death 15.76 12.00 19 48040 2292 29902127
Skin dystrophy 15.75 12.00 4 48055 14 29904405
Blood oestrogen decreased 15.75 12.00 4 48055 14 29904405
Treponema test positive 15.75 12.00 4 48055 14 29904405
Deafness congenital 15.74 12.00 5 48054 45 29904374
Toxic skin eruption 15.68 12.00 46 48013 10969 29893450
Foetal heart rate abnormal 15.61 12.00 7 48052 173 29904246
Persistent left superior vena cava 15.54 12.00 4 48055 15 29904404
Feeding tube user 15.46 12.00 5 48054 48 29904371
Urinary retention 15.45 12.00 18 48041 32899 29871520
Glomerular filtration rate abnormal 15.41 12.00 10 48049 525 29903894
Congenital hydrocephalus 15.39 12.00 6 48053 103 29904316
Burkitt's lymphoma 15.35 12.00 7 48052 180 29904239
Enanthema 15.35 12.00 9 48050 394 29904025
Cystic lymphangioma 15.33 12.00 4 48055 16 29904403
C-reactive protein increased 15.32 12.00 29 48030 43444 29860975
Psychomotor retardation 15.31 12.00 19 48040 2360 29902059
Influenza 15.25 12.00 29 48030 43369 29861050
Hemiparaesthesia 15.19 12.00 5 48054 51 29904368
Megakaryocytes increased 15.10 12.00 5 48054 52 29904367
Endocrine ophthalmopathy 15.10 12.00 5 48054 52 29904367
Multiple-drug resistance 15.07 12.00 21 48038 2920 29901499
Dyschromatopsia 15.04 12.00 8 48051 289 29904130
Varices oesophageal 15.00 12.00 23 48036 3486 29900933
Prurigo 14.81 12.00 11 48048 719 29903700
Seborrhoeic dermatitis 14.81 12.00 14 48045 1279 29903140
Jarisch-Herxheimer reaction 14.73 12.00 9 48050 425 29903994
Neuroleptic malignant syndrome 14.64 12.00 4 48055 16291 29888128
Hepatocellular injury 14.62 12.00 80 47979 25391 29879028
Urethral valves 14.61 12.00 4 48055 20 29904399
T-lymphocyte count decreased 14.61 12.00 7 48052 202 29904217
Glucose urine present 14.53 12.00 12 48047 916 29903503
Eosinophilic pustular folliculitis 14.53 12.00 5 48054 59 29904360
Hodgkin's disease 14.49 12.00 12 48047 920 29903499
Bone loss 14.43 12.00 10 48049 586 29903833
Transaminases increased 14.36 12.00 75 47984 23382 29881037
Alpha 1 foetoprotein abnormal 14.29 12.00 4 48055 22 29904397
Cleft palate 14.25 12.00 10 48049 598 29903821
Anal chlamydia infection 14.24 12.00 3 48056 3 29904416
Head lag abnormal 14.24 12.00 3 48056 3 29904416
Thymus hypoplasia 14.24 12.00 3 48056 3 29904416
Maternal drugs affecting foetus 14.20 12.00 25 48034 4248 29900171
Cellulitis 14.16 12.00 34 48025 46750 29857669
Glomerular filtration rate increased 14.06 12.00 7 48052 220 29904199
Upper respiratory tract infection 14.04 12.00 14 48045 27462 29876957
Creatinine renal clearance abnormal 13.80 12.00 7 48052 229 29904190
Product temperature excursion issue 13.77 12.00 3 48056 4 29904415
Acute hepatic failure 13.71 12.00 46 48013 11781 29892638
Peripheral swelling 13.71 12.00 51 48008 61023 29843396
Fluid retention 13.64 12.00 12 48047 24986 29879433
Coronary artery disease 13.61 12.00 38 48021 49674 29854745
Erythema 13.56 12.00 71 47988 77380 29827039
Talipes 13.48 12.00 15 48044 1660 29902759
Right aortic arch 13.47 12.00 4 48055 28 29904391
Acute myeloid leukaemia 13.47 12.00 6 48053 18000 29886419
Hyperproteinaemia 13.35 12.00 6 48053 149 29904270
Thrombosis 13.33 12.00 30 48029 42201 29862218
Adrenal insufficiency 13.31 12.00 42 48017 10421 29893998
Adrenogenital syndrome 13.26 12.00 5 48054 78 29904341
Stress fracture 13.25 12.00 11 48048 846 29903573
Cerebral dysgenesis 13.23 12.00 4 48055 30 29904389
Blood bilirubin unconjugated increased 13.17 12.00 10 48049 676 29903743
Ejection fraction decreased 13.13 12.00 4 48055 15171 29889248
Osteoma 13.12 12.00 4 48055 31 29904388
Manufacturing product shipping issue 13.12 12.00 4 48055 31 29904388
Blood pressure systolic increased 13.04 12.00 4 48055 15106 29889313
Plethoric face 13.02 12.00 3 48056 6 29904413
End stage AIDS 13.01 12.00 4 48055 32 29904387
Tubulointerstitial nephritis 12.95 12.00 60 47999 17831 29886588
Blood bilirubin decreased 12.94 12.00 7 48052 262 29904157
Melaena 12.93 12.00 20 48039 32417 29872002
Ergot poisoning 12.92 12.00 5 48054 84 29904335
Oral candidiasis 12.78 12.00 43 48016 11028 29893391
Blood glucose increased 12.78 12.00 53 48006 61477 29842942
Portal hypertensive gastropathy 12.74 12.00 9 48050 544 29903875
Rhabdomyolysis 12.73 12.00 157 47902 63423 29840996
Tremor 12.68 12.00 70 47989 75293 29829126
Central obesity 12.67 12.00 9 48050 549 29903870
Liver function test abnormal 12.60 12.00 89 47970 30861 29873558
Rhinorrhoea 12.53 12.00 9 48050 20745 29883674
Blood alkaline phosphatase increased 12.51 12.00 90 47969 31397 29873022
Dyskinesia 12.50 12.00 10 48049 21824 29882595
Aspartate aminotransferase increased 12.44 12.00 156 47903 63266 29841153
Hyperkalaemia 12.42 12.00 59 48000 65951 29838468
Neural tube defect 12.40 12.00 4 48055 38 29904381
Gastroenteritis 12.33 12.00 48 48011 13218 29891201
Occipital neuralgia 12.31 12.00 4 48055 39 29904380
Nephropathy 12.30 12.00 27 48032 5389 29899030
Diarrhoea 12.26 12.00 654 47405 333449 29570970
Condition aggravated 12.22 12.00 152 47907 137714 29766705
Alanine aminotransferase increased 12.22 12.00 177 47882 74099 29830320
Device related infection 12.22 12.00 6 48053 17009 29887410
Hyperadrenocorticism 12.17 12.00 5 48054 99 29904320
17-hydroxyprogesterone increased 12.17 12.00 3 48056 9 29904410
Pulmonary hilar enlargement 12.17 12.00 3 48056 9 29904410
Phosphorus metabolism disorder 12.17 12.00 3 48056 9 29904410
Eagle Barrett syndrome 12.17 12.00 3 48056 9 29904410
Stomatitis 12.16 12.00 26 48033 37253 29867166
Loss of consciousness 12.15 12.00 76 47983 79299 29825120
Kidney malformation 12.12 12.00 5 48054 100 29904319
Haemorrhage 12.04 12.00 36 48023 46043 29858376
Haemorrhoids thrombosed 12.04 12.00 6 48053 189 29904230
Deep vein thrombosis 12.02 12.00 53 48006 60448 29843971

Pharmacologic Action:

SourceCodeDescription
ATC J05AF09 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Nucleoside and nucleotide reverse transcriptase inhibitors
ATC J05AR03 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HIV infections, combinations
ATC J05AR06 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HIV infections, combinations
ATC J05AR08 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HIV infections, combinations
ATC J05AR09 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HIV infections, combinations
ATC J05AR17 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HIV infections, combinations
ATC J05AR18 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HIV infections, combinations
ATC J05AR19 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HIV infections, combinations
ATC J05AR20 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HIV infections, combinations
ATC J05AR22 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HIV infections, combinations
FDA CS M0015066 Nucleosides
FDA MoA N0000009947 Nucleoside Reverse Transcriptase Inhibitors
FDA EPC N0000175462 Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
MeSH PA D019380 Anti-HIV Agents
MeSH PA D000890 Anti-Infective Agents
MeSH PA D044966 Anti-Retroviral Agents
MeSH PA D000998 Antiviral Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D019384 Nucleic Acid Synthesis Inhibitors
MeSH PA D018894 Reverse Transcriptase Inhibitors
CHEBI has role CHEBI:36044 anti-virus drug
CHEBI has role CHEBI:53756 reverse transcriptase inhibitor

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Human immunodeficiency virus infection indication 86406008 DOID:526
Coronavirus infection off-label use 186747009
Prevention of HIV Infection after Exposure off-label use
Osteomalacia contraindication 4598005 DOID:10573
Hypophosphatemia contraindication 4996001
Suicidal thoughts contraindication 6471006
Hypercholesterolemia contraindication 13644009
Torsades de pointes contraindication 31722008
Depressive disorder contraindication 35489007
Fanconi syndrome contraindication 40488004 DOID:1062
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Aggressive behavior contraindication 61372001
Chronic type B viral hepatitis contraindication 61977001
Kidney disease contraindication 90708001 DOID:557
Lactic acidosis contraindication 91273001 DOID:3650
Prolonged QT interval contraindication 111975006
Chronic hepatitis C contraindication 128302006
Seizure disorder contraindication 128613002
Liver function tests abnormal contraindication 166603001
Paranoid disorder contraindication 191667009
Steatosis of liver contraindication 197321007
Mania contraindication 231494001
Disease of liver contraindication 235856003 DOID:409
Pathological fracture contraindication 268029009
Pregnancy, function contraindication 289908002
Hypertriglyceridemia contraindication 302870006
Severe depression contraindication 310497006
Osteopenia contraindication 312894000
Breastfeeding (mother) contraindication 413712001
Obesity contraindication 414916001 DOID:9970
Congenital long QT syndrome contraindication 442917000

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 12.95 acidic
pKa2 2.57 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
200MG EMTRICITABINE CIPLA A091168 July 2, 2018 RX CAPSULE ORAL Feb. 27, 2021 PATENT CHALLENGE
100MG;150MG EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE AMNEAL PHARMS CO A209721 Aug. 22, 2018 RX TABLET ORAL March 9, 2021 PATENT CHALLENGE
133MG;200MG EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE AMNEAL PHARMS CO A209721 Aug. 22, 2018 RX TABLET ORAL March 9, 2021 PATENT CHALLENGE
167MG;250MG EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE AMNEAL PHARMS CO A209721 Aug. 22, 2018 RX TABLET ORAL March 9, 2021 PATENT CHALLENGE
150MG;800MG;200MG;EQ 10MG BASE SYMTUZA JANSSEN PRODS N210455 July 17, 2018 RX TABLET ORAL July 17, 2021 NEW COMBINULLTION
150MG;150MG;200MG;EQ 10MG BASE GENVOYA GILEAD SCIENCES INC N207561 Nov. 5, 2015 RX TABLET ORAL Dec. 10, 2021 DOSING RECOMMENDATION FOR THE USE OF ELVITEGRAVIR/COBICISTAT/EMTRICITABINE/TENOFOVIR ALAFENULLMIDE FIXED DOSE COMBINULLTION IN HIV-1 INFECTED ADULT PATIENTS WITH END-STAGE-RENULLL DISEASE WHO ARE RECEIVING CHRONIC HEMODIALYSIS
EQ 50MG BASE;200MG;EQ 25MG BASE BIKTARVY GILEAD SCIENCES INC N210251 Feb. 7, 2018 RX TABLET ORAL June 18, 2022 NEW PATIENT POPULATION
200MG;EQ 25MG BASE DESCOVY GILEAD SCIENCES INC N208215 April 4, 2016 RX TABLET ORAL Oct. 3, 2022 FOR USE IN AT RISK ADULTS AND ADOLESCENTS WEIGHING AT LEAST 35 KG FOR PRE-EXPOSURE PROPHYLAXIS TO REDUCE THE RISK OF HIV-1 INFECTION FROM SEXUAL ACQUISITION, EXCLUDING INDIVIDUALS AT RISK FROM RECEPTIVE VAGINULLL SEX
EQ 50MG BASE;200MG;EQ 25MG BASE BIKTARVY GILEAD SCIENCES INC N210251 Feb. 7, 2018 RX TABLET ORAL Feb. 7, 2023 NEW CHEMICAL ENTITY
EQ 50MG BASE;200MG;EQ 25MG BASE BIKTARVY GILEAD SCIENCES INC N210251 Feb. 7, 2018 RX TABLET ORAL Feb. 24, 2024 LABELING REVISIONS RELATED TO CLINICAL STUDIES
200MG;EQ 25MG BASE DESCOVY GILEAD SCIENCES INC N208215 April 4, 2016 RX TABLET ORAL Sept. 28, 2024 IN COMBINULLTION WITH OTHER ANTIRETROVIRAL AGENTS, FOR THE TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS UNDER 12 YEARS OF AGE WEIGHING AT LEAST 35KG
200MG;EQ 25MG BASE DESCOVY GILEAD SCIENCES INC N208215 April 4, 2016 RX TABLET ORAL Sept. 28, 2024 IN COMBINULLTION WITH OTHER ANTIRETROVIRAL AGENTS OTHER THAN PROTEASE INHIBITORS THAT REQUIRE A CYP3A INHIBITOR, FOR THE TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS UNDER 12 YEARS OF AGE WEIGHING AT LEAST 25KG AND LESS THAN 35KG
EQ 50MG BASE;200MG;EQ 25MG BASE BIKTARVY GILEAD SCIENCES INC N210251 Feb. 7, 2018 RX TABLET ORAL June 18, 2026 FOR HIV-1 INFECTION IN PEDIATRIC PTS AT LEAST 25 KG W/ NO ANTIRETROVIRAL (ARV) TX HX OR TO REPLACE CURRENT ARV REGIMEN FOR VIROLOGICALLY-SUPPRESSED ON STABLE ARV W/ NO HX TX FAILURE AND NO KNOWN SUBSTITUTIONS ASSOCIATED W/ RESISTANCE TO BIC, FTC, OR TAF

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Reverse transcriptase/RNaseH Enzyme INHIBITOR CHEMBL CHEMBL

External reference:

IDSource
4021395 VUID
N0000148813 NUI
D01199 KEGG_DRUG
4021395 VANDF
C0909841 UMLSCUI
CHEBI:31536 CHEBI
ETV PDB_CHEM_ID
CHEMBL885 ChEMBL_ID
DB00879 DRUGBANK_ID
D000068679 MESH_DESCRIPTOR_UI
60877 PUBCHEM_CID
11244 IUPHAR_LIGAND_ID
7822 INN_ID
G70B4ETF4S UNII
276237 RXNORM
17421 MMSL
338322 MMSL
47041 MMSL
d04884 MMSL
001321 NDDF
404855005 SNOMEDCT_US
404856006 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate HUMAN PRESCRIPTION DRUG LABEL 3 0093-5234 TABLET, FILM COATED 200 mg ORAL ANDA 30 sections
Emtricitabine and Tenofovir Disoproxil Fumarate HUMAN PRESCRIPTION DRUG LABEL 2 0093-7607 TABLET, FILM COATED 200 mg ORAL ANDA 29 sections
Emtricitabine and Tenofovir Disoproxil Fumarate HUMAN PRESCRIPTION DRUG LABEL 2 0093-7704 TABLET, FILM COATED 200 mg ORAL ANDA 29 sections
Emtricitabine and Tenofovir Disoproxil Fumarate HUMAN PRESCRIPTION DRUG LABEL 2 0378-1930 TABLET, FILM COATED 200 mg ORAL ANDA 30 sections
Atripla HUMAN PRESCRIPTION DRUG LABEL 3 15584-0101 TABLET, FILM COATED 200 mg ORAL NDA 34 sections
Emtricitabine and tenofovir disoproxil fumarate Human Prescription Drug Label 2 33342-106 TABLET, FILM COATED 200 mg ORAL ANDA 28 sections
Emtricitabine and Tenofovir Disoproxil Fumarate HUMAN PRESCRIPTION DRUG LABEL 2 42291-439 TABLET, FILM COATED 200 mg ORAL ANDA 26 sections
Emtricitabine and Tenofovir Disoproxil Fumarate Human Prescription Drug Label 2 42385-953 TABLET, FILM COATED 200 mg ORAL ANDA 28 sections
Emtricitabine and Tenofovir Disoproxil Fumarate HUMAN PRESCRIPTION DRUG LABEL 2 42543-719 TABLET 200 mg ORAL ANDA 27 sections
Emtriva HUMAN PRESCRIPTION DRUG LABEL 1 46014-0601 CAPSULE 200 mg ORAL NDA 29 sections
Truvada HUMAN PRESCRIPTION DRUG LABEL 2 50090-0870 TABLET, FILM COATED 200 mg ORAL NDA 33 sections
Truvada HUMAN PRESCRIPTION DRUG LABEL 2 50090-0870 TABLET, FILM COATED 200 mg ORAL NDA 33 sections
Emtricitabine and Tenofovir Disoproxil Fumarate HUMAN PRESCRIPTION DRUG LABEL 2 51407-112 TABLET 200 mg ORAL ANDA 27 sections
Truvada HUMAN PRESCRIPTION DRUG LABEL 2 52959-969 TABLET, FILM COATED 200 mg ORAL NDA 31 sections
Atripla HUMAN PRESCRIPTION DRUG LABEL 3 53808-0208 TABLET, FILM COATED 200 mg ORAL NDA 31 sections
Emtriva HUMAN PRESCRIPTION DRUG LABEL 1 53808-0801 CAPSULE 200 mg ORAL NDA 29 sections
Truvada HUMAN PRESCRIPTION DRUG LABEL 2 53808-0805 TABLET, FILM COATED 200 mg ORAL NDA 31 sections
Stribild HUMAN PRESCRIPTION DRUG LABEL 4 53808-0887 TABLET, FILM COATED 200 mg ORAL NDA 30 sections
Emtriva HUMAN PRESCRIPTION DRUG LABEL 1 54868-4853 CAPSULE 200 mg ORAL NDA 30 sections
Truvada HUMAN PRESCRIPTION DRUG LABEL 2 54868-5141 TABLET, FILM COATED 200 mg ORAL NDA 31 sections
Atripla HUMAN PRESCRIPTION DRUG LABEL 3 54868-5643 TABLET, FILM COATED 200 mg ORAL NDA 31 sections
COMPLERA HUMAN PRESCRIPTION DRUG LABEL 3 54868-6360 TABLET, FILM COATED 200 mg ORAL NDA 32 sections
Symtuza HUMAN PRESCRIPTION DRUG LABEL 4 59676-800 TABLET, FILM COATED 200 mg ORAL NDA 33 sections
Emtricitabine and Tenofovir Disoproxil Fumarate HUMAN PRESCRIPTION DRUG LABEL 2 60219-2095 TABLET, FILM COATED 200 mg ORAL ANDA 26 sections
Emtricitabine and Tenofovir Disoproxil Fumarate HUMAN PRESCRIPTION DRUG LABEL 2 60505-4202 TABLET, FILM COATED 200 mg ORAL ANDA 26 sections
TRUVADA HUMAN PRESCRIPTION DRUG LABEL 2 61919-669 TABLET, FILM COATED 200 mg ORAL NDA 15 sections
Emtriva HUMAN PRESCRIPTION DRUG LABEL 1 61958-0601 CAPSULE 200 mg ORAL NDA 30 sections
Emtriva HUMAN PRESCRIPTION DRUG LABEL 1 61958-0602 SOLUTION 10 mg ORAL NDA 30 sections
Truvada HUMAN PRESCRIPTION DRUG LABEL 2 61958-0701 TABLET, FILM COATED 200 mg ORAL NDA 33 sections
Truvada Access HUMAN PRESCRIPTION DRUG LABEL 2 61958-0702 TABLET, FILM COATED 200 mg ORAL Export only 31 sections