emtricitabine Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| nucleosides antiviral or antineoplastic agents, cytarabine or azacitidine derivatives | 1003 | 143491-57-0 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
A deoxycytidine analog and REVERSE TRANSCRIPTASE INHIBITOR with antiviral activity against HIV-1 and HEPATITIS B viruses. It is used to treat HIV INFECTIONS.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.20 | g | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| 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 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Oct. 24, 2003 | EMA | ||
| July 2, 2003 | FDA | GILEAD |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients 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 term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients 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:
| Source | Code | Description |
|---|---|---|
| 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)
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| 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 level | Dissociation constant | Type (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 strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 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:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Reverse transcriptase/RNaseH | Enzyme | INHIBITOR | CHEMBL | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 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:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| 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 |