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 | |
| March 23, 2005 | PMDA | Japan Tobacco Inc. |
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 |
|---|---|---|---|---|---|---|
| Abortion spontaneous | 2476.80 | 16.67 | 907 | 25031 | 45728 | 53277400 |
| Maternal exposure during pregnancy | 2458.67 | 16.67 | 1285 | 24653 | 154354 | 53168774 |
| Foetal exposure during pregnancy | 1540.92 | 16.67 | 593 | 25345 | 34122 | 53289006 |
| Exposure during pregnancy | 1072.79 | 16.67 | 697 | 25241 | 124163 | 53198965 |
| Stillbirth | 767.17 | 16.67 | 234 | 25704 | 6563 | 53316565 |
| Abortion induced | 683.09 | 16.67 | 240 | 25698 | 10586 | 53312542 |
| Foetal death | 585.01 | 16.67 | 206 | 25732 | 9141 | 53313987 |
| Virologic failure | 496.50 | 16.67 | 131 | 25807 | 2133 | 53320995 |
| Premature baby | 404.95 | 16.67 | 196 | 25742 | 19605 | 53303523 |
| Blood HIV RNA increased | 378.28 | 16.67 | 86 | 25852 | 719 | 53322409 |
| Immune reconstitution inflammatory syndrome | 348.51 | 16.67 | 127 | 25811 | 6219 | 53316909 |
| Pregnancy | 343.17 | 16.67 | 205 | 25733 | 31236 | 53291892 |
| Viral mutation identified | 306.43 | 16.67 | 88 | 25850 | 1986 | 53321142 |
| Drug interaction | 305.40 | 16.67 | 449 | 25489 | 218880 | 53104248 |
| Viral load increased | 293.29 | 16.67 | 79 | 25859 | 1396 | 53321732 |
| Premature delivery | 281.70 | 16.67 | 169 | 25769 | 25935 | 53297193 |
| Live birth | 269.01 | 16.67 | 136 | 25802 | 14923 | 53308205 |
| Pathogen resistance | 230.79 | 16.67 | 95 | 25843 | 6465 | 53316663 |
| Drug resistance | 209.55 | 16.67 | 127 | 25811 | 19835 | 53303293 |
| Treatment noncompliance | 203.78 | 16.67 | 151 | 25787 | 32884 | 53290244 |
| Caesarean section | 202.17 | 16.67 | 118 | 25820 | 17202 | 53305926 |
| Spina bifida | 184.78 | 16.67 | 48 | 25890 | 732 | 53322396 |
| Premature labour | 170.64 | 16.67 | 94 | 25844 | 12268 | 53310860 |
| Fanconi syndrome acquired | 169.26 | 16.67 | 48 | 25890 | 1033 | 53322095 |
| Genotype drug resistance test positive | 168.18 | 16.67 | 42 | 25896 | 542 | 53322586 |
| Pre-eclampsia | 165.92 | 16.67 | 82 | 25856 | 8565 | 53314563 |
| Lipodystrophy acquired | 165.78 | 16.67 | 52 | 25886 | 1598 | 53321530 |
| CD4 lymphocytes decreased | 160.09 | 16.67 | 51 | 25887 | 1650 | 53321478 |
| Enlarged clitoris | 150.28 | 16.67 | 30 | 25908 | 122 | 53323006 |
| Pain | 148.20 | 16.67 | 51 | 25887 | 588347 | 52734781 |
| Premature rupture of membranes | 135.55 | 16.67 | 60 | 25878 | 4880 | 53318248 |
| Osteoporosis | 134.60 | 16.67 | 138 | 25800 | 46322 | 53276806 |
| Hyperandrogenism | 128.08 | 16.67 | 25 | 25913 | 88 | 53323040 |
| Renal tubular disorder | 123.38 | 16.67 | 48 | 25890 | 2815 | 53320313 |
| Immune reconstitution inflammatory syndrome associated tuberculosis | 120.06 | 16.67 | 30 | 25908 | 388 | 53322740 |
| Ventricular septal defect | 116.68 | 16.67 | 52 | 25886 | 4298 | 53318830 |
| Polydactyly | 115.92 | 16.67 | 29 | 25909 | 377 | 53322751 |
| Hyperbilirubinaemia | 112.49 | 16.67 | 69 | 25869 | 11000 | 53312128 |
| Ectopic pregnancy | 110.53 | 16.67 | 44 | 25894 | 2743 | 53320385 |
| HIV infection | 109.70 | 16.67 | 30 | 25908 | 562 | 53322566 |
| Hydrops foetalis | 103.50 | 16.67 | 26 | 25912 | 344 | 53322784 |
| Normal newborn | 102.96 | 16.67 | 56 | 25882 | 7123 | 53316005 |
| Gestational diabetes | 102.41 | 16.67 | 58 | 25880 | 7981 | 53315147 |
| Fanconi syndrome | 96.75 | 16.67 | 32 | 25906 | 1168 | 53321960 |
| Product dispensing error | 94.39 | 16.67 | 60 | 25878 | 10180 | 53312948 |
| Foetal growth restriction | 92.03 | 16.67 | 52 | 25886 | 7122 | 53316006 |
| Fatigue | 90.53 | 16.67 | 135 | 25803 | 730371 | 52592757 |
| Fall | 86.74 | 16.67 | 33 | 25905 | 358407 | 52964721 |
| Malaria | 83.66 | 16.67 | 21 | 25917 | 277 | 53322851 |
| Cerebral ventricle dilatation | 81.00 | 16.67 | 27 | 25911 | 1010 | 53322118 |
| Low birth weight baby | 78.78 | 16.67 | 45 | 25893 | 6292 | 53316836 |
| Congenital anomaly | 76.43 | 16.67 | 29 | 25909 | 1588 | 53321540 |
| Ectopic kidney | 75.42 | 16.67 | 16 | 25922 | 93 | 53323035 |
| Skull malformation | 75.12 | 16.67 | 20 | 25918 | 337 | 53322791 |
| Product use complaint | 74.87 | 16.67 | 31 | 25907 | 2139 | 53320989 |
| Autoimmune hepatitis | 69.92 | 16.67 | 46 | 25892 | 8272 | 53314856 |
| Oligohydramnios | 69.83 | 16.67 | 41 | 25897 | 6035 | 53317093 |
| Placenta praevia | 69.75 | 16.67 | 24 | 25914 | 990 | 53322138 |
| Twin pregnancy | 68.56 | 16.67 | 25 | 25913 | 1224 | 53321904 |
| Hepatocellular injury | 67.47 | 16.67 | 78 | 25860 | 29908 | 53293220 |
| Polyhydramnios | 67.47 | 16.67 | 29 | 25909 | 2196 | 53320932 |
| Foetal distress syndrome | 66.22 | 16.67 | 25 | 25913 | 1350 | 53321778 |
| Meningomyelocele | 65.73 | 16.67 | 20 | 25918 | 554 | 53322574 |
| Hepatitis fulminant | 65.52 | 16.67 | 33 | 25905 | 3586 | 53319542 |
| Atrial septal defect | 64.94 | 16.67 | 41 | 25897 | 6873 | 53316255 |
| Infusion related reaction | 63.24 | 16.67 | 3 | 25935 | 155954 | 53167174 |
| Anencephaly | 62.59 | 16.67 | 16 | 25922 | 228 | 53322900 |
| HIV test positive | 61.98 | 16.67 | 12 | 25926 | 40 | 53323088 |
| Joint swelling | 61.20 | 16.67 | 19 | 25919 | 234619 | 53088509 |
| Cushing's syndrome | 60.28 | 16.67 | 20 | 25918 | 737 | 53322391 |
| Lipohypertrophy | 59.57 | 16.67 | 20 | 25918 | 765 | 53322363 |
| Trisomy 21 | 58.95 | 16.67 | 17 | 25921 | 389 | 53322739 |
| Anal atresia | 58.46 | 16.67 | 17 | 25921 | 401 | 53322727 |
| Cloacal exstrophy | 58.18 | 16.67 | 14 | 25924 | 153 | 53322975 |
| CD4 lymphocytes abnormal | 57.45 | 16.67 | 11 | 25927 | 34 | 53323094 |
| Maternal drugs affecting foetus | 57.44 | 16.67 | 35 | 25903 | 5511 | 53317617 |
| Renal colic | 56.30 | 16.67 | 22 | 25916 | 1305 | 53321823 |
| Sinusitis | 55.45 | 16.67 | 8 | 25930 | 168556 | 53154572 |
| Drug hypersensitivity | 55.40 | 16.67 | 30 | 25908 | 265212 | 53057916 |
| Nasopharyngitis | 54.97 | 16.67 | 13 | 25925 | 192282 | 53130846 |
| Ultrasound antenatal screen abnormal | 54.90 | 16.67 | 13 | 25925 | 132 | 53322996 |
| Drug intolerance | 54.74 | 16.67 | 16 | 25922 | 205477 | 53117651 |
| Congenital heart valve disorder | 54.16 | 16.67 | 12 | 25926 | 88 | 53323040 |
| Congenital genital malformation | 54.12 | 16.67 | 13 | 25925 | 141 | 53322987 |
| Neural tube defect | 53.73 | 16.67 | 14 | 25924 | 216 | 53322912 |
| Bladder agenesis | 53.71 | 16.67 | 13 | 25925 | 146 | 53322982 |
| Renal tubular necrosis | 52.66 | 16.67 | 44 | 25894 | 11375 | 53311753 |
| Genitalia external ambiguous | 52.62 | 16.67 | 13 | 25925 | 160 | 53322968 |
| Lactic acidosis | 52.62 | 16.67 | 77 | 25861 | 37176 | 53285952 |
| Congenital genital malformation female | 51.05 | 16.67 | 10 | 25928 | 36 | 53323092 |
| Cholestasis | 50.57 | 16.67 | 66 | 25872 | 28629 | 53294499 |
| Meconium stain | 50.55 | 16.67 | 13 | 25925 | 190 | 53322938 |
| Patent ductus arteriosus | 50.54 | 16.67 | 29 | 25909 | 4089 | 53319039 |
| Dyspnoea | 50.33 | 16.67 | 134 | 25804 | 586098 | 52737030 |
| Drug ineffective | 50.33 | 16.67 | 216 | 25722 | 817029 | 52506099 |
| Adrenal insufficiency | 50.24 | 16.67 | 48 | 25890 | 14781 | 53308347 |
| Coloboma | 49.72 | 16.67 | 11 | 25927 | 80 | 53323048 |
| Therapeutic product effect decreased | 49.12 | 16.67 | 3 | 25935 | 125652 | 53197476 |
| Premature separation of placenta | 49.05 | 16.67 | 22 | 25916 | 1845 | 53321283 |
| Rash maculo-papular | 48.70 | 16.67 | 66 | 25872 | 29683 | 53293445 |
| Sudden infant death syndrome | 48.50 | 16.67 | 13 | 25925 | 225 | 53322903 |
| Trisomy 18 | 48.40 | 16.67 | 10 | 25928 | 50 | 53323078 |
| Tethered cord syndrome | 48.02 | 16.67 | 13 | 25925 | 234 | 53322894 |
| Proteinuria | 47.52 | 16.67 | 51 | 25887 | 18017 | 53305111 |
| Caudal regression syndrome | 47.41 | 16.67 | 12 | 25926 | 164 | 53322964 |
| Renal tubular acidosis | 47.17 | 16.67 | 21 | 25917 | 1730 | 53321398 |
| CSF HIV escape syndrome | 47.16 | 16.67 | 11 | 25927 | 104 | 53323024 |
| Neonatal respiratory arrest | 47.16 | 16.67 | 10 | 25928 | 58 | 53323070 |
| Osteonecrosis | 46.64 | 16.67 | 61 | 25877 | 26514 | 53296614 |
| Renal failure | 46.63 | 16.67 | 145 | 25793 | 118307 | 53204821 |
| HIV-associated neurocognitive disorder | 46.31 | 16.67 | 12 | 25926 | 181 | 53322947 |
| Abdominal discomfort | 46.15 | 16.67 | 25 | 25913 | 221037 | 53102091 |
| Acute kidney injury | 46.00 | 16.67 | 244 | 25694 | 253624 | 53069504 |
| Congenital hydrocephalus | 45.83 | 16.67 | 12 | 25926 | 189 | 53322939 |
| Gastrointestinal disorder congenital | 45.57 | 16.67 | 11 | 25927 | 122 | 53323006 |
| Gastrointestinal tube insertion | 44.80 | 16.67 | 18 | 25920 | 1149 | 53321979 |
| Spine malformation | 44.77 | 16.67 | 13 | 25925 | 305 | 53322823 |
| Adrenal suppression | 44.39 | 16.67 | 17 | 25921 | 955 | 53322173 |
| Macrocephaly | 43.82 | 16.67 | 10 | 25928 | 85 | 53323043 |
| Arthralgia | 43.68 | 16.67 | 93 | 25845 | 439690 | 52883438 |
| Contraindicated product administered | 43.31 | 16.67 | 7 | 25931 | 135622 | 53187506 |
| Umbilical cord abnormality | 43.18 | 16.67 | 15 | 25923 | 637 | 53322491 |
| Abnormal dreams | 43.09 | 16.67 | 38 | 25900 | 10563 | 53312565 |
| Pneumonia | 42.21 | 16.67 | 84 | 25854 | 407085 | 52916043 |
| Gastrointestinal malformation | 42.02 | 16.67 | 11 | 25927 | 173 | 53322955 |
| Hepatic cytolysis | 41.89 | 16.67 | 33 | 25905 | 7852 | 53315276 |
| Product storage error | 41.66 | 16.67 | 41 | 25897 | 13089 | 53310039 |
| Nephropathy toxic | 41.55 | 16.67 | 34 | 25904 | 8538 | 53314590 |
| Foetal malnutrition | 41.02 | 16.67 | 10 | 25928 | 116 | 53323012 |
| Gastrostomy | 40.54 | 16.67 | 14 | 25924 | 584 | 53322544 |
| Musculoskeletal stiffness | 40.22 | 16.67 | 6 | 25932 | 123362 | 53199766 |
| Cushingoid | 40.20 | 16.67 | 31 | 25907 | 7151 | 53315977 |
| Hydrocephalus | 39.32 | 16.67 | 27 | 25911 | 5209 | 53317919 |
| Pulmonary valve sclerosis | 38.89 | 16.67 | 8 | 25930 | 39 | 53323089 |
| Pregnancy with implant contraceptive | 38.76 | 16.67 | 20 | 25918 | 2286 | 53320842 |
| Complication of delivery | 38.46 | 16.67 | 10 | 25928 | 153 | 53322975 |
| Exomphalos | 37.33 | 16.67 | 13 | 25925 | 556 | 53322572 |
| Oesophageal atresia | 36.87 | 16.67 | 13 | 25925 | 577 | 53322551 |
| Drug reaction with eosinophilia and systemic symptoms | 36.82 | 16.67 | 61 | 25877 | 32739 | 53290389 |
| Systemic lupus erythematosus | 36.78 | 16.67 | 8 | 25930 | 125406 | 53197722 |
| Dysmorphism | 36.34 | 16.67 | 19 | 25919 | 2231 | 53320897 |
| Congenital pulmonary valve disorder | 36.06 | 16.67 | 8 | 25930 | 59 | 53323069 |
| Oesophageal candidiasis | 35.99 | 16.67 | 26 | 25912 | 5434 | 53317694 |
| Acute HIV infection | 35.57 | 16.67 | 7 | 25931 | 26 | 53323102 |
| Atrial fibrillation | 35.12 | 16.67 | 6 | 25932 | 111646 | 53211482 |
| Pain in extremity | 34.79 | 16.67 | 53 | 25885 | 284997 | 53038131 |
| Hypotension | 34.23 | 16.67 | 44 | 25894 | 254032 | 53069096 |
| Glycosuria | 33.94 | 16.67 | 15 | 25923 | 1215 | 53321913 |
| Pulmonary tuberculosis | 33.92 | 16.67 | 24 | 25914 | 4857 | 53318271 |
| Infection | 33.76 | 16.67 | 21 | 25917 | 172184 | 53150944 |
| Secondary adrenocortical insufficiency | 33.52 | 16.67 | 15 | 25923 | 1251 | 53321877 |
| Congenital skin dimples | 32.99 | 16.67 | 9 | 25929 | 167 | 53322961 |
| Central obesity | 32.77 | 16.67 | 14 | 25924 | 1044 | 53322084 |
| Product size issue | 32.63 | 16.67 | 11 | 25927 | 426 | 53322702 |
| Microcephaly | 32.56 | 16.67 | 13 | 25925 | 816 | 53322312 |
| Melanoderma | 32.54 | 16.67 | 9 | 25929 | 176 | 53322952 |
| Weight increased | 31.95 | 16.67 | 189 | 25749 | 204378 | 53118750 |
| Injection site pain | 31.73 | 16.67 | 8 | 25930 | 113383 | 53209745 |
| Cholestasis of pregnancy | 30.98 | 16.67 | 14 | 25924 | 1195 | 53321933 |
| Jaundice neonatal | 30.93 | 16.67 | 13 | 25925 | 931 | 53322197 |
| Pregnancy on contraceptive | 30.54 | 16.67 | 14 | 25924 | 1235 | 53321893 |
| Transaminases increased | 29.83 | 16.67 | 53 | 25885 | 30079 | 53293049 |
| Drug-induced liver injury | 29.69 | 16.67 | 52 | 25886 | 29181 | 53293947 |
| Renal tubular dysfunction | 29.65 | 16.67 | 10 | 25928 | 388 | 53322740 |
| Peripheral swelling | 29.54 | 16.67 | 34 | 25904 | 206074 | 53117054 |
| Anembryonic gestation | 29.24 | 16.67 | 11 | 25927 | 588 | 53322540 |
| Cough | 29.23 | 16.67 | 50 | 25888 | 256843 | 53066285 |
| Liver transplant | 29.11 | 16.67 | 17 | 25921 | 2477 | 53320651 |
| Hepatitis | 29.01 | 16.67 | 56 | 25882 | 33838 | 53289290 |
| Psoriasis | 28.93 | 16.67 | 4 | 25934 | 87085 | 53236043 |
| Abortion threatened | 28.73 | 16.67 | 11 | 25927 | 617 | 53322511 |
| Wound | 28.61 | 16.67 | 5 | 25933 | 91552 | 53231576 |
| Endometritis decidual | 28.41 | 16.67 | 6 | 25932 | 34 | 53323094 |
| Enanthema | 28.19 | 16.67 | 10 | 25928 | 452 | 53322676 |
| Congenital ectopic bladder | 28.05 | 16.67 | 7 | 25931 | 90 | 53323038 |
| Sepsis neonatal | 27.67 | 16.67 | 10 | 25928 | 477 | 53322651 |
| Blood phosphorus decreased | 27.53 | 16.67 | 20 | 25918 | 4217 | 53318911 |
| Amniotic cavity infection | 27.23 | 16.67 | 13 | 25925 | 1257 | 53321871 |
| Mitochondrial cytopathy | 27.12 | 16.67 | 9 | 25929 | 332 | 53322796 |
| Jaundice | 27.08 | 16.67 | 51 | 25887 | 30262 | 53292866 |
| Blood HIV RNA | 27.03 | 16.67 | 5 | 25933 | 12 | 53323116 |
| Adrenogenital syndrome | 26.84 | 16.67 | 6 | 25932 | 46 | 53323082 |
| Glomerular filtration rate decreased | 26.70 | 16.67 | 32 | 25906 | 12735 | 53310393 |
| Maternal exposure before pregnancy | 26.40 | 16.67 | 22 | 25916 | 5664 | 53317464 |
| Lower respiratory tract infection | 26.28 | 16.67 | 6 | 25932 | 90975 | 53232153 |
| Discomfort | 26.21 | 16.67 | 7 | 25931 | 95465 | 53227663 |
| Congenital central nervous system anomaly | 26.14 | 16.67 | 9 | 25929 | 372 | 53322756 |
| White blood cell count decreased | 26.07 | 16.67 | 14 | 25924 | 124461 | 53198667 |
| Face oedema | 25.95 | 16.67 | 40 | 25898 | 20200 | 53302928 |
| Potassium wasting nephropathy | 25.60 | 16.67 | 6 | 25932 | 58 | 53323070 |
| Hypophosphataemia | 25.19 | 16.67 | 26 | 25912 | 8779 | 53314349 |
| Arthritis | 24.73 | 16.67 | 6 | 25932 | 87292 | 53235836 |
| Placental chorioangioma | 24.73 | 16.67 | 5 | 25933 | 22 | 53323106 |
| Abortion | 24.67 | 16.67 | 15 | 25923 | 2351 | 53320777 |
| Influenza | 24.34 | 16.67 | 8 | 25930 | 95371 | 53227757 |
| Congenital musculoskeletal anomaly | 23.91 | 16.67 | 9 | 25929 | 482 | 53322646 |
| Contusion | 23.86 | 16.67 | 12 | 25926 | 110720 | 53212408 |
| Congenital umbilical hernia | 23.80 | 16.67 | 9 | 25929 | 488 | 53322640 |
| Blood pressure increased | 23.78 | 16.67 | 20 | 25918 | 140459 | 53182669 |
| Hepatotoxicity | 23.78 | 16.67 | 46 | 25892 | 27834 | 53295294 |
| Foetal malformation | 23.72 | 16.67 | 7 | 25931 | 174 | 53322954 |
| Large for dates baby | 23.42 | 16.67 | 9 | 25929 | 510 | 53322618 |
| Cardiac failure congestive | 23.29 | 16.67 | 8 | 25930 | 92749 | 53230379 |
| Exposure via body fluid | 23.27 | 16.67 | 9 | 25929 | 519 | 53322609 |
| Congenital choroid plexus cyst | 23.09 | 16.67 | 8 | 25930 | 337 | 53322791 |
| Coagulation factor V level decreased | 23.02 | 16.67 | 8 | 25930 | 340 | 53322788 |
| Drug level increased | 22.95 | 16.67 | 38 | 25900 | 20383 | 53302745 |
| Swelling | 22.84 | 16.67 | 36 | 25902 | 191069 | 53132059 |
| Spinocerebellar disorder | 22.77 | 16.67 | 5 | 25933 | 35 | 53323093 |
| Urinary tract infection | 22.71 | 16.67 | 52 | 25886 | 239851 | 53083277 |
| Viral load decreased | 22.64 | 16.67 | 5 | 25933 | 36 | 53323092 |
| Hyperadrenocorticism | 22.56 | 16.67 | 8 | 25930 | 361 | 53322767 |
| Hereditary optic atrophy | 22.48 | 16.67 | 4 | 25934 | 7 | 53323121 |
| Tremor | 22.41 | 16.67 | 17 | 25921 | 125719 | 53197409 |
| Hepatitis B DNA increased | 22.38 | 16.67 | 7 | 25931 | 213 | 53322915 |
| Hepatic failure | 22.33 | 16.67 | 52 | 25886 | 35754 | 53287374 |
| Coarctation of the aorta | 22.33 | 16.67 | 9 | 25929 | 579 | 53322549 |
| Constipation | 22.21 | 16.67 | 39 | 25899 | 198373 | 53124755 |
| Retinal toxicity | 21.92 | 16.67 | 11 | 25927 | 1186 | 53321942 |
| Abortion spontaneous incomplete | 21.86 | 16.67 | 5 | 25933 | 43 | 53323085 |
| Mental disability | 21.76 | 16.67 | 6 | 25932 | 116 | 53323012 |
| Flushing | 21.75 | 16.67 | 4 | 25934 | 70596 | 53252532 |
| Tubulointerstitial nephritis | 21.70 | 16.67 | 33 | 25905 | 16471 | 53306657 |
| Febrile neutropenia | 21.68 | 16.67 | 12 | 25926 | 104924 | 53218204 |
| Ataxia | 21.58 | 16.67 | 31 | 25907 | 14706 | 53308422 |
| Malaise | 21.57 | 16.67 | 95 | 25843 | 357522 | 52965606 |
| Glucocorticoids increased | 21.29 | 16.67 | 6 | 25932 | 126 | 53323002 |
| Prurigo | 21.24 | 16.67 | 10 | 25928 | 937 | 53322191 |
| Impaired healing | 21.20 | 16.67 | 3 | 25935 | 64202 | 53258926 |
| Herpes zoster | 21.14 | 16.67 | 5 | 25933 | 74014 | 53249114 |
| Foetal cardiac disorder | 21.09 | 16.67 | 5 | 25933 | 51 | 53323077 |
| Unwanted pregnancy | 21.09 | 16.67 | 5 | 25933 | 51 | 53323077 |
| Balance disorder | 20.80 | 16.67 | 5 | 25933 | 73202 | 53249926 |
| Preterm premature rupture of membranes | 20.72 | 16.67 | 11 | 25927 | 1332 | 53321796 |
| Muscle spasms | 20.68 | 16.67 | 21 | 25917 | 134774 | 53188354 |
| Stomatitis | 20.61 | 16.67 | 11 | 25927 | 98147 | 53224981 |
| Total bile acids increased | 20.57 | 16.67 | 6 | 25932 | 143 | 53322985 |
| Pregnancy on oral contraceptive | 20.45 | 16.67 | 11 | 25927 | 1368 | 53321760 |
| Eosinophilia | 20.44 | 16.67 | 37 | 25901 | 21298 | 53301830 |
| Back pain | 20.42 | 16.67 | 53 | 25885 | 234194 | 53088934 |
| Encephalocele | 20.38 | 16.67 | 6 | 25932 | 148 | 53322980 |
| Cardiac murmur | 20.36 | 16.67 | 27 | 25911 | 11886 | 53311242 |
| Chronic papillomatous dermatitis | 20.35 | 16.67 | 5 | 25933 | 60 | 53323068 |
| Malignant neoplasm progression | 20.10 | 16.67 | 5 | 25933 | 71536 | 53251592 |
| Platelet count decreased | 20.07 | 16.67 | 14 | 25924 | 108085 | 53215043 |
| Hepatitis C | 20.07 | 16.67 | 20 | 25918 | 6481 | 53316647 |
| High arched palate | 20.06 | 16.67 | 5 | 25933 | 64 | 53323064 |
| Haemolytic anaemia | 19.95 | 16.67 | 25 | 25913 | 10414 | 53312714 |
| Bradycardia | 19.90 | 16.67 | 5 | 25933 | 71051 | 53252077 |
| Syphilis | 19.90 | 16.67 | 6 | 25932 | 161 | 53322967 |
| Noonan syndrome | 19.89 | 16.67 | 3 | 25935 | 0 | 53323128 |
| HIV viraemia | 19.89 | 16.67 | 3 | 25935 | 0 | 53323128 |
| Viral load undetectable | 19.89 | 16.67 | 3 | 25935 | 0 | 53323128 |
| Eyelid oedema | 19.73 | 16.67 | 25 | 25913 | 10529 | 53312599 |
| Encephalomalacia | 19.71 | 16.67 | 8 | 25930 | 524 | 53322604 |
| Alpha 1 foetoprotein abnormal | 19.71 | 16.67 | 5 | 25933 | 69 | 53323059 |
| Congenital acrochordon | 19.71 | 16.67 | 5 | 25933 | 69 | 53323059 |
| Osteoarthritis | 19.66 | 16.67 | 5 | 25933 | 70481 | 53252647 |
| Hypertension | 19.65 | 16.67 | 51 | 25887 | 225380 | 53097748 |
| Postpartum haemorrhage | 19.63 | 16.67 | 12 | 25926 | 1900 | 53321228 |
| Cerebral toxoplasmosis | 19.50 | 16.67 | 9 | 25929 | 806 | 53322322 |
| Cytogenetic abnormality | 19.44 | 16.67 | 8 | 25930 | 543 | 53322585 |
| Porphyria non-acute | 19.41 | 16.67 | 7 | 25931 | 332 | 53322796 |
| Hyperphosphaturia | 19.36 | 16.67 | 4 | 25934 | 20 | 53323108 |
| Symmetrical drug-related intertriginous and flexural exanthema | 19.25 | 16.67 | 7 | 25931 | 340 | 53322788 |
| Epilepsy congenital | 19.20 | 16.67 | 4 | 25934 | 21 | 53323107 |
| Heart rate increased | 19.16 | 16.67 | 8 | 25930 | 82307 | 53240821 |
| Pericarditis | 19.10 | 16.67 | 4 | 25934 | 64402 | 53258726 |
| Umbilical cord prolapse | 19.04 | 16.67 | 4 | 25934 | 22 | 53323106 |
| ACTH stimulation test abnormal | 19.04 | 16.67 | 4 | 25934 | 22 | 53323106 |
| Nervous system disorder | 18.96 | 16.67 | 32 | 25906 | 17432 | 53305696 |
| Gait disturbance | 18.90 | 16.67 | 30 | 25908 | 158812 | 53164316 |
| Syncope | 18.88 | 16.67 | 16 | 25922 | 111977 | 53211151 |
| Chondroma | 18.47 | 16.67 | 4 | 25934 | 26 | 53323102 |
| Abortion infected | 18.47 | 16.67 | 4 | 25934 | 26 | 53323102 |
| Congenital foot malformation | 18.43 | 16.67 | 6 | 25932 | 208 | 53322920 |
| Placenta accreta | 18.38 | 16.67 | 6 | 25932 | 210 | 53322918 |
| Cystic lymphangioma | 18.34 | 16.67 | 4 | 25934 | 27 | 53323101 |
| Thymus hypoplasia | 18.34 | 16.67 | 4 | 25934 | 27 | 53323101 |
| Single umbilical artery | 18.19 | 16.67 | 6 | 25932 | 217 | 53322911 |
| Abortion missed | 18.06 | 16.67 | 11 | 25927 | 1730 | 53321398 |
| Congenital spinal cord anomaly | 17.81 | 16.67 | 3 | 25935 | 3 | 53323125 |
| Renal impairment | 17.81 | 16.67 | 84 | 25854 | 83234 | 53239894 |
| Osteopenia | 17.80 | 16.67 | 32 | 25906 | 18323 | 53304805 |
| Brachydactyly | 17.79 | 16.67 | 5 | 25933 | 104 | 53323024 |
| Bronchitis | 17.66 | 16.67 | 17 | 25921 | 111882 | 53211246 |
| Hepatic encephalopathy | 17.63 | 16.67 | 24 | 25914 | 10835 | 53312293 |
| Thrombosis | 17.57 | 16.67 | 4 | 25934 | 60789 | 53262339 |
| Peripheral nerve injury | 17.46 | 16.67 | 7 | 25931 | 444 | 53322684 |
| Osteomalacia | 17.46 | 16.67 | 8 | 25930 | 705 | 53322423 |
| Clinodactyly | 17.44 | 16.67 | 5 | 25933 | 112 | 53323016 |
| Ruptured ectopic pregnancy | 17.39 | 16.67 | 7 | 25931 | 449 | 53322679 |
| Loss of consciousness | 17.28 | 16.67 | 18 | 25920 | 114194 | 53208934 |
| Cleft lip | 17.19 | 16.67 | 5 | 25933 | 118 | 53323010 |
| Neonatal respiratory distress syndrome | 17.18 | 16.67 | 13 | 25925 | 2914 | 53320214 |
| Talipes | 16.90 | 16.67 | 10 | 25928 | 1492 | 53321636 |
| Toxic skin eruption | 16.89 | 16.67 | 26 | 25912 | 13113 | 53310015 |
| Cortisol decreased | 16.78 | 16.67 | 9 | 25929 | 1112 | 53322016 |
| Ultrasound scan abnormal | 16.75 | 16.67 | 6 | 25932 | 279 | 53322849 |
| Placental disorder | 16.72 | 16.67 | 10 | 25928 | 1521 | 53321607 |
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 | 1228.11 | 11.86 | 490 | 51330 | 9069 | 32452637 |
| Foetal exposure during pregnancy | 859.63 | 11.86 | 629 | 51191 | 40672 | 32421034 |
| Viral load increased | 803.65 | 11.86 | 268 | 51552 | 2882 | 32458824 |
| Osteoporosis | 685.52 | 11.86 | 351 | 51469 | 11831 | 32449875 |
| Blood HIV RNA increased | 629.98 | 11.86 | 190 | 51630 | 1427 | 32460279 |
| Acute HIV infection | 531.67 | 11.86 | 116 | 51704 | 159 | 32461547 |
| Virologic failure | 471.74 | 11.86 | 190 | 51630 | 3597 | 32458109 |
| Genotype drug resistance test positive | 416.61 | 11.86 | 142 | 51678 | 1639 | 32460067 |
| Product storage error | 401.30 | 11.86 | 206 | 51614 | 6972 | 32454734 |
| Fanconi syndrome acquired | 396.50 | 11.86 | 145 | 51675 | 2085 | 32459621 |
| Renal tubular disorder | 331.03 | 11.86 | 163 | 51657 | 5039 | 32456667 |
| Drug resistance | 318.76 | 11.86 | 276 | 51544 | 22689 | 32439017 |
| HIV infection | 315.79 | 11.86 | 118 | 51702 | 1808 | 32459898 |
| CD4 lymphocytes decreased | 315.21 | 11.86 | 122 | 51698 | 2068 | 32459638 |
| Drug interaction | 304.63 | 11.86 | 898 | 50922 | 217287 | 32244419 |
| Viral mutation identified | 300.21 | 11.86 | 129 | 51691 | 2890 | 32458816 |
| Abnormal dreams | 277.71 | 11.86 | 172 | 51648 | 8392 | 32453314 |
| Product dispensing error | 250.70 | 11.86 | 146 | 51674 | 6359 | 32455347 |
| HIV test positive | 242.66 | 11.86 | 62 | 51758 | 226 | 32461480 |
| Treatment noncompliance | 212.71 | 11.86 | 239 | 51581 | 26963 | 32434743 |
| Syphilis | 205.71 | 11.86 | 64 | 51756 | 539 | 32461167 |
| Gastrointestinal tube insertion | 176.85 | 11.86 | 71 | 51749 | 1331 | 32460375 |
| Pathogen resistance | 175.52 | 11.86 | 135 | 51685 | 9375 | 32452331 |
| Renal colic | 145.22 | 11.86 | 67 | 51753 | 1784 | 32459922 |
| Glycosuria | 132.50 | 11.86 | 58 | 51762 | 1360 | 32460346 |
| Proteinuria | 123.02 | 11.86 | 145 | 51675 | 17210 | 32444496 |
| Blood creatinine increased | 121.63 | 11.86 | 383 | 51437 | 95749 | 32365957 |
| Pneumonia | 112.80 | 11.86 | 250 | 51570 | 355002 | 32106704 |
| Nephrolithiasis | 110.59 | 11.86 | 174 | 51646 | 27180 | 32434526 |
| Osteoporotic fracture | 109.09 | 11.86 | 48 | 51772 | 1140 | 32460566 |
| Acute hepatitis C | 108.66 | 11.86 | 30 | 51790 | 157 | 32461549 |
| Glomerular filtration rate decreased | 107.76 | 11.86 | 117 | 51703 | 12694 | 32449012 |
| Hypotension | 107.14 | 11.86 | 112 | 51708 | 215998 | 32245708 |
| Fanconi syndrome | 106.82 | 11.86 | 54 | 51766 | 1766 | 32459940 |
| Osteonecrosis | 104.98 | 11.86 | 131 | 51689 | 16491 | 32445215 |
| Osteopenia | 103.45 | 11.86 | 75 | 51745 | 4757 | 32456949 |
| Premature baby | 101.40 | 11.86 | 136 | 51684 | 18382 | 32443324 |
| Dyspnoea | 100.61 | 11.86 | 273 | 51547 | 361772 | 32099934 |
| Fall | 99.13 | 11.86 | 100 | 51720 | 196101 | 32265605 |
| HIV-associated neurocognitive disorder | 98.38 | 11.86 | 33 | 51787 | 361 | 32461345 |
| Weight increased | 98.24 | 11.86 | 325 | 51495 | 83338 | 32378368 |
| Nephropathy toxic | 95.11 | 11.86 | 106 | 51714 | 11840 | 32449866 |
| Jaundice | 92.25 | 11.86 | 182 | 51638 | 33976 | 32427730 |
| Hypophosphataemia | 90.74 | 11.86 | 90 | 51730 | 8785 | 32452921 |
| Lipodystrophy acquired | 90.07 | 11.86 | 62 | 51758 | 3620 | 32458086 |
| Suicidal ideation | 87.67 | 11.86 | 190 | 51630 | 37893 | 32423813 |
| Malignant neoplasm progression | 87.49 | 11.86 | 11 | 51809 | 78485 | 32383221 |
| Dyslipidaemia | 86.01 | 11.86 | 78 | 51742 | 6805 | 32454901 |
| Depression | 85.96 | 11.86 | 344 | 51476 | 96716 | 32364990 |
| Polydactyly | 85.16 | 11.86 | 41 | 51779 | 1204 | 32460502 |
| Hyperbilirubinaemia | 84.79 | 11.86 | 122 | 51698 | 17608 | 32444098 |
| Viraemia | 84.60 | 11.86 | 41 | 51779 | 1222 | 32460484 |
| Trisomy 21 | 81.09 | 11.86 | 31 | 51789 | 507 | 32461199 |
| Heterotaxia | 79.70 | 11.86 | 23 | 51797 | 145 | 32461561 |
| Product use complaint | 78.30 | 11.86 | 39 | 51781 | 1235 | 32460471 |
| CD4 lymphocytes abnormal | 77.70 | 11.86 | 21 | 51799 | 100 | 32461606 |
| Renal impairment | 77.49 | 11.86 | 321 | 51499 | 91651 | 32370055 |
| Nightmare | 75.63 | 11.86 | 99 | 51721 | 13067 | 32448639 |
| Cardiac failure congestive | 75.25 | 11.86 | 21 | 51799 | 84831 | 32376875 |
| Gene mutation | 75.20 | 11.86 | 35 | 51785 | 951 | 32460755 |
| Hepatitis C | 75.11 | 11.86 | 100 | 51720 | 13418 | 32448288 |
| Cytomegalovirus chorioretinitis | 74.91 | 11.86 | 55 | 51765 | 3557 | 32458149 |
| Depression suicidal | 74.77 | 11.86 | 39 | 51781 | 1363 | 32460343 |
| Disease progression | 74.29 | 11.86 | 23 | 51797 | 86839 | 32374867 |
| Low birth weight baby | 73.50 | 11.86 | 72 | 51748 | 6922 | 32454784 |
| Atrial fibrillation | 73.17 | 11.86 | 48 | 51772 | 116656 | 32345050 |
| Febrile neutropenia | 72.53 | 11.86 | 51 | 51769 | 119515 | 32342191 |
| Plasma cell myeloma | 72.35 | 11.86 | 5 | 51815 | 57609 | 32404097 |
| Psychiatric decompensation | 72.15 | 11.86 | 39 | 51781 | 1467 | 32460239 |
| Renal tubular dysfunction | 70.66 | 11.86 | 27 | 51793 | 441 | 32461265 |
| Acquired immunodeficiency syndrome | 68.61 | 11.86 | 27 | 51793 | 479 | 32461227 |
| Ocular icterus | 65.65 | 11.86 | 48 | 51772 | 3084 | 32458622 |
| Rash | 62.59 | 11.86 | 557 | 51263 | 208776 | 32252930 |
| Intentional dose omission | 62.10 | 11.86 | 41 | 51779 | 2233 | 32459473 |
| Developmental delay | 61.34 | 11.86 | 43 | 51777 | 2585 | 32459121 |
| Progressive multifocal leukoencephalopathy | 59.99 | 11.86 | 75 | 51745 | 9456 | 32452250 |
| Renal failure | 59.30 | 11.86 | 392 | 51428 | 134086 | 32327620 |
| Chlamydial infection | 57.81 | 11.86 | 19 | 51801 | 194 | 32461512 |
| Product dispensing issue | 57.61 | 11.86 | 15 | 51805 | 60 | 32461646 |
| Mycobacterium avium complex infection | 57.32 | 11.86 | 43 | 51777 | 2874 | 32458832 |
| Tearfulness | 57.16 | 11.86 | 35 | 51785 | 1671 | 32460035 |
| Infusion related reaction | 57.12 | 11.86 | 4 | 51816 | 45595 | 32416111 |
| Seroconversion test negative | 57.02 | 11.86 | 12 | 51808 | 12 | 32461694 |
| Constipation | 56.55 | 11.86 | 71 | 51749 | 126302 | 32335404 |
| Laryngomalacia | 56.47 | 11.86 | 21 | 51799 | 317 | 32461389 |
| Gonorrhoea | 56.10 | 11.86 | 15 | 51805 | 68 | 32461638 |
| Meningitis cryptococcal | 55.93 | 11.86 | 38 | 51782 | 2171 | 32459535 |
| Hypertriglyceridaemia | 55.50 | 11.86 | 69 | 51751 | 8650 | 32453056 |
| Renal tubular necrosis | 52.97 | 11.86 | 93 | 51727 | 15885 | 32445821 |
| Insurance issue | 52.77 | 11.86 | 28 | 51792 | 1014 | 32460692 |
| HIV viraemia | 51.65 | 11.86 | 15 | 51805 | 97 | 32461609 |
| Immune reconstitution inflammatory syndrome associated tuberculosis | 51.59 | 11.86 | 22 | 51798 | 483 | 32461223 |
| Drug abuse | 50.27 | 11.86 | 33 | 51787 | 80210 | 32381496 |
| Osteomalacia | 49.37 | 11.86 | 26 | 51794 | 927 | 32460779 |
| Hepatitis A | 48.46 | 11.86 | 21 | 51799 | 480 | 32461226 |
| Sepsis | 48.39 | 11.86 | 114 | 51706 | 158720 | 32302986 |
| Hepatitis B | 48.31 | 11.86 | 55 | 51765 | 6286 | 32455420 |
| Bone density decreased | 48.20 | 11.86 | 33 | 51787 | 1909 | 32459797 |
| Gastrostomy | 48.15 | 11.86 | 24 | 51796 | 761 | 32460945 |
| Diabetes mellitus | 48.15 | 11.86 | 170 | 51650 | 45003 | 32416703 |
| Rheumatoid arthritis | 47.82 | 11.86 | 7 | 51813 | 44537 | 32417169 |
| Interstitial lung disease | 47.57 | 11.86 | 22 | 51798 | 64979 | 32396727 |
| Anogenital warts | 47.09 | 11.86 | 22 | 51798 | 603 | 32461103 |
| Anal cancer | 46.99 | 11.86 | 20 | 51800 | 437 | 32461269 |
| Single umbilical artery | 46.49 | 11.86 | 17 | 51803 | 244 | 32461462 |
| Suicide attempt | 46.11 | 11.86 | 150 | 51670 | 38094 | 32423612 |
| Cough | 46.09 | 11.86 | 95 | 51725 | 138722 | 32322984 |
| Therapy cessation | 45.25 | 11.86 | 87 | 51733 | 15926 | 32445780 |
| CSF HIV escape syndrome | 45.22 | 11.86 | 15 | 51805 | 158 | 32461548 |
| Cortisol decreased | 43.84 | 11.86 | 24 | 51796 | 926 | 32460780 |
| Blood phosphorus decreased | 43.78 | 11.86 | 38 | 51782 | 3128 | 32458578 |
| Cardiac failure | 43.67 | 11.86 | 49 | 51771 | 91624 | 32370082 |
| Insomnia | 43.28 | 11.86 | 291 | 51529 | 100057 | 32361649 |
| Atypical mycobacterial infection | 42.74 | 11.86 | 23 | 51797 | 857 | 32460849 |
| Gene mutation identification test positive | 42.73 | 11.86 | 15 | 51805 | 190 | 32461516 |
| Pulmonary tuberculosis | 42.71 | 11.86 | 46 | 51774 | 4943 | 32456763 |
| Blood triglycerides increased | 42.02 | 11.86 | 80 | 51740 | 14539 | 32447167 |
| Blood pressure increased | 41.67 | 11.86 | 39 | 51781 | 79315 | 32382391 |
| Paranoia | 41.30 | 11.86 | 67 | 51753 | 10732 | 32450974 |
| Acute kidney injury | 41.13 | 11.86 | 676 | 51144 | 292792 | 32168914 |
| Gastrointestinal haemorrhage | 40.77 | 11.86 | 47 | 51773 | 86835 | 32374871 |
| Lipids increased | 40.32 | 11.86 | 23 | 51797 | 962 | 32460744 |
| Intercepted product dispensing error | 40.26 | 11.86 | 12 | 51808 | 86 | 32461620 |
| Depressive symptom | 40.14 | 11.86 | 29 | 51791 | 1829 | 32459877 |
| Seroconversion test positive | 39.82 | 11.86 | 9 | 51811 | 16 | 32461690 |
| Gynaecomastia | 39.71 | 11.86 | 59 | 51761 | 8760 | 32452946 |
| Neurosyphilis | 39.31 | 11.86 | 11 | 51809 | 61 | 32461645 |
| Wheezing | 39.11 | 11.86 | 6 | 51814 | 36868 | 32424838 |
| Death | 39.00 | 11.86 | 406 | 51414 | 382111 | 32079595 |
| Platelet count decreased | 38.38 | 11.86 | 78 | 51742 | 114513 | 32347193 |
| Completed suicide | 38.30 | 11.86 | 55 | 51765 | 92462 | 32369244 |
| Hepatic enzyme increased | 38.28 | 11.86 | 138 | 51682 | 36899 | 32424807 |
| Hypothalamic pituitary adrenal axis suppression | 38.16 | 11.86 | 14 | 51806 | 203 | 32461503 |
| Endotracheal intubation | 37.72 | 11.86 | 32 | 51788 | 2553 | 32459153 |
| Circumstance or information capable of leading to medication error | 37.64 | 11.86 | 28 | 51792 | 1847 | 32459859 |
| Renal disorder | 37.12 | 11.86 | 106 | 51714 | 25077 | 32436629 |
| False negative investigation result | 37.08 | 11.86 | 13 | 51807 | 164 | 32461542 |
| Toxicity to various agents | 37.04 | 11.86 | 152 | 51668 | 177889 | 32283817 |
| Kaposi's sarcoma | 36.90 | 11.86 | 22 | 51798 | 1000 | 32460706 |
| Chordee | 36.64 | 11.86 | 11 | 51809 | 81 | 32461625 |
| Bradycardia | 36.60 | 11.86 | 36 | 51784 | 71526 | 32390180 |
| Creatinine renal clearance decreased | 36.42 | 11.86 | 36 | 51784 | 3498 | 32458208 |
| Trisomy 18 | 36.28 | 11.86 | 14 | 51806 | 235 | 32461471 |
| Ventricular hypoplasia | 36.07 | 11.86 | 11 | 51809 | 86 | 32461620 |
| Lymphoma | 35.97 | 11.86 | 63 | 51757 | 10737 | 32450969 |
| Shigella infection | 35.84 | 11.86 | 9 | 51811 | 30 | 32461676 |
| Cardiac arrest | 35.82 | 11.86 | 62 | 51758 | 96714 | 32364992 |
| Oxygen saturation decreased | 35.63 | 11.86 | 16 | 51804 | 48083 | 32413623 |
| Chronic kidney disease | 35.58 | 11.86 | 142 | 51678 | 39833 | 32421873 |
| Depressed mood | 35.12 | 11.86 | 85 | 51735 | 18215 | 32443491 |
| Sleep disorder | 35.05 | 11.86 | 108 | 51712 | 26644 | 32435062 |
| Adrenal suppression | 34.90 | 11.86 | 19 | 51801 | 725 | 32460981 |
| Blood pressure decreased | 34.80 | 11.86 | 19 | 51801 | 51061 | 32410645 |
| Congenital hearing disorder | 34.51 | 11.86 | 11 | 51809 | 101 | 32461605 |
| Hepatic cirrhosis | 34.34 | 11.86 | 80 | 51740 | 16729 | 32444977 |
| Beta 2 microglobulin urine increased | 34.32 | 11.86 | 11 | 51809 | 103 | 32461603 |
| Cardio-respiratory arrest | 33.76 | 11.86 | 24 | 51796 | 55965 | 32405741 |
| Therapeutic product effect incomplete | 33.48 | 11.86 | 12 | 51808 | 41329 | 32420377 |
| Pulmonary oedema | 33.33 | 11.86 | 16 | 51804 | 46251 | 32415455 |
| Laryngectomy | 33.26 | 11.86 | 7 | 51813 | 7 | 32461699 |
| Anogenital dysplasia | 33.09 | 11.86 | 12 | 51808 | 168 | 32461538 |
| Lipohypertrophy | 32.55 | 11.86 | 14 | 51806 | 314 | 32461392 |
| White blood cell count decreased | 32.33 | 11.86 | 60 | 51760 | 91138 | 32370568 |
| Pain | 32.02 | 11.86 | 172 | 51648 | 187384 | 32274322 |
| Fat tissue increased | 31.33 | 11.86 | 15 | 51805 | 435 | 32461271 |
| Blood creatine phosphokinase increased | 30.91 | 11.86 | 149 | 51671 | 45327 | 32416379 |
| Malaria | 30.88 | 11.86 | 13 | 51807 | 276 | 32461430 |
| Chromaturia | 30.78 | 11.86 | 70 | 51750 | 14408 | 32447298 |
| Pleural effusion | 30.72 | 11.86 | 49 | 51771 | 78943 | 32382763 |
| Product dose omission issue | 30.58 | 11.86 | 273 | 51547 | 102302 | 32359404 |
| Portal hypertension | 30.53 | 11.86 | 35 | 51785 | 4029 | 32457677 |
| Speech disorder developmental | 30.40 | 11.86 | 24 | 51796 | 1730 | 32459976 |
| Hepatitis cholestatic | 30.06 | 11.86 | 50 | 51770 | 8175 | 32453531 |
| Respiratory arrest | 29.99 | 11.86 | 5 | 51815 | 28903 | 32432803 |
| Hypospadias | 29.91 | 11.86 | 30 | 51790 | 2967 | 32458739 |
| Vanishing bile duct syndrome | 29.84 | 11.86 | 17 | 51803 | 709 | 32460997 |
| Hepatic cytolysis | 29.58 | 11.86 | 50 | 51770 | 8283 | 32453423 |
| Hepatitis | 29.52 | 11.86 | 94 | 51726 | 23599 | 32438107 |
| Respiratory failure | 29.46 | 11.86 | 81 | 51739 | 107101 | 32354605 |
| Nasopharyngitis | 29.39 | 11.86 | 35 | 51785 | 63752 | 32397954 |
| Atrioventricular septal defect | 29.36 | 11.86 | 10 | 51810 | 115 | 32461591 |
| CSF virus identified | 29.28 | 11.86 | 8 | 51812 | 40 | 32461666 |
| Chronic obstructive pulmonary disease | 29.26 | 11.86 | 21 | 51799 | 48732 | 32412974 |
| Hepatotoxicity | 29.09 | 11.86 | 82 | 51738 | 19255 | 32442451 |
| Psoriasis | 28.83 | 11.86 | 19 | 51801 | 46104 | 32415602 |
| Myalgia | 28.36 | 11.86 | 224 | 51596 | 81006 | 32380700 |
| Lower respiratory tract infection | 28.32 | 11.86 | 6 | 51814 | 29237 | 32432469 |
| Cerebral toxoplasmosis | 28.31 | 11.86 | 22 | 51798 | 1550 | 32460156 |
| Congenital anomaly | 28.18 | 11.86 | 21 | 51799 | 1389 | 32460317 |
| Secondary syphilis | 28.06 | 11.86 | 8 | 51812 | 48 | 32461658 |
| Oedema peripheral | 27.92 | 11.86 | 91 | 51729 | 114000 | 32347706 |
| Headache | 27.80 | 11.86 | 453 | 51367 | 195744 | 32265962 |
| Ventricular septal defect | 27.63 | 11.86 | 32 | 51788 | 3725 | 32457981 |
| Orthostatic hypotension | 27.60 | 11.86 | 4 | 51816 | 25646 | 32436060 |
| Haematochezia | 27.57 | 11.86 | 14 | 51806 | 39194 | 32422512 |
| Pancreatitis | 27.39 | 11.86 | 127 | 51693 | 38024 | 32423682 |
| Portal fibrosis | 26.65 | 11.86 | 13 | 51807 | 393 | 32461313 |
| Lactic acidosis | 26.60 | 11.86 | 115 | 51705 | 33421 | 32428285 |
| Blood HIV RNA | 26.50 | 11.86 | 7 | 51813 | 30 | 32461676 |
| Joint swelling | 26.48 | 11.86 | 26 | 51794 | 51709 | 32409997 |
| Hyperferritinaemia | 26.32 | 11.86 | 13 | 51807 | 404 | 32461302 |
| Cryptorchism | 26.31 | 11.86 | 23 | 51797 | 1911 | 32459795 |
| Inability to afford medication | 26.30 | 11.86 | 18 | 51802 | 1041 | 32460665 |
| Haemoglobin decreased | 26.24 | 11.86 | 100 | 51720 | 119571 | 32342135 |
| Dehydration | 26.24 | 11.86 | 111 | 51709 | 128847 | 32332859 |
| Karyotype analysis abnormal | 25.96 | 11.86 | 8 | 51812 | 65 | 32461641 |
| Hepatitis B DNA assay positive | 25.75 | 11.86 | 8 | 51812 | 67 | 32461639 |
| Acute respiratory failure | 25.66 | 11.86 | 7 | 51813 | 28721 | 32432985 |
| Epistaxis | 25.35 | 11.86 | 31 | 51789 | 55824 | 32405882 |
| Hepatitis B DNA increased | 25.32 | 11.86 | 14 | 51806 | 551 | 32461155 |
| Cushingoid | 25.29 | 11.86 | 26 | 51794 | 2648 | 32459058 |
| Pyelocaliectasis | 25.28 | 11.86 | 19 | 51801 | 1273 | 32460433 |
| Haemophilic arthropathy | 25.28 | 11.86 | 10 | 51810 | 180 | 32461526 |
| Congenital hydronephrosis | 25.00 | 11.86 | 15 | 51805 | 690 | 32461016 |
| Testicular germ cell tumour mixed | 24.99 | 11.86 | 7 | 51813 | 39 | 32461667 |
| Asthenia | 24.97 | 11.86 | 248 | 51572 | 235696 | 32226010 |
| Psychomotor skills impaired | 24.88 | 11.86 | 25 | 51795 | 2478 | 32459228 |
| Hepatitis syphilitic | 24.87 | 11.86 | 5 | 51815 | 3 | 32461703 |
| Infection | 24.82 | 11.86 | 62 | 51758 | 84653 | 32377053 |
| CD4 lymphocytes increased | 24.70 | 11.86 | 11 | 51809 | 269 | 32461437 |
| International normalised ratio increased | 24.69 | 11.86 | 25 | 51795 | 49010 | 32412696 |
| Faeces pale | 24.54 | 11.86 | 20 | 51800 | 1509 | 32460197 |
| Injection site pain | 24.47 | 11.86 | 11 | 51809 | 33047 | 32428659 |
| Hyperlipidaemia | 24.29 | 11.86 | 64 | 51756 | 14447 | 32447259 |
| Tuberculosis | 24.14 | 11.86 | 47 | 51773 | 8682 | 32453024 |
| Neonatal hyponatraemia | 23.89 | 11.86 | 8 | 51812 | 87 | 32461619 |
| Delirium | 23.88 | 11.86 | 21 | 51799 | 44025 | 32417681 |
| Back pain | 23.58 | 11.86 | 94 | 51726 | 110959 | 32350747 |
| Haemoptysis | 23.53 | 11.86 | 12 | 51808 | 33513 | 32428193 |
| Supernumerary nipple | 23.50 | 11.86 | 7 | 51813 | 50 | 32461656 |
| Mitochondrial myopathy | 23.47 | 11.86 | 10 | 51810 | 219 | 32461487 |
| Mobility decreased | 23.43 | 11.86 | 8 | 51812 | 28401 | 32433305 |
| Anal chlamydia infection | 23.28 | 11.86 | 5 | 51815 | 6 | 32461700 |
| Lipoatrophy | 23.27 | 11.86 | 14 | 51806 | 647 | 32461059 |
| Major depression | 23.20 | 11.86 | 32 | 51788 | 4439 | 32457267 |
| Ectopic kidney | 23.03 | 11.86 | 7 | 51813 | 54 | 32461652 |
| General physical health deterioration | 22.95 | 11.86 | 100 | 51720 | 115159 | 32346547 |
| Calculus urinary | 22.95 | 11.86 | 18 | 51802 | 1285 | 32460421 |
| AIDS related complication | 22.85 | 11.86 | 6 | 51814 | 25 | 32461681 |
| Dysphagia | 22.82 | 11.86 | 172 | 51648 | 61304 | 32400402 |
| Viral load | 22.81 | 11.86 | 8 | 51812 | 101 | 32461605 |
| Productive cough | 22.79 | 11.86 | 13 | 51807 | 34103 | 32427603 |
| Neuropsychiatric syndrome | 22.74 | 11.86 | 8 | 51812 | 102 | 32461604 |
| Liver function test increased | 22.68 | 11.86 | 57 | 51763 | 12503 | 32449203 |
| Drug-induced liver injury | 22.64 | 11.86 | 87 | 51733 | 23976 | 32437730 |
| Vertigo | 22.20 | 11.86 | 87 | 51733 | 24196 | 32437510 |
| White blood cell count increased | 22.13 | 11.86 | 20 | 51800 | 41382 | 32420324 |
| Nausea | 22.10 | 11.86 | 668 | 51152 | 320181 | 32141525 |
| Oesophageal candidiasis | 22.02 | 11.86 | 31 | 51789 | 4383 | 32457323 |
| Pancreatitis acute | 21.88 | 11.86 | 94 | 51726 | 27241 | 32434465 |
| Pneumonia aspiration | 21.86 | 11.86 | 20 | 51800 | 41136 | 32420570 |
| Product temperature excursion issue | 21.74 | 11.86 | 5 | 51815 | 10 | 32461696 |
| Alpha 1 foetoprotein abnormal | 21.64 | 11.86 | 6 | 51814 | 32 | 32461674 |
| Urinary tract infection | 21.63 | 11.86 | 61 | 51759 | 80010 | 32381696 |
| Tachycardia | 21.55 | 11.86 | 60 | 51760 | 79028 | 32382678 |
| Renal tubular acidosis | 21.50 | 11.86 | 21 | 51799 | 2011 | 32459695 |
| Psychotic disorder | 21.47 | 11.86 | 83 | 51737 | 22937 | 32438769 |
| Eye infection syphilitic | 21.42 | 11.86 | 5 | 51815 | 11 | 32461695 |
| Ventricular tachycardia | 21.42 | 11.86 | 7 | 51813 | 25549 | 32436157 |
| Foetal growth restriction | 21.24 | 11.86 | 29 | 51791 | 3983 | 32457723 |
| Haematocrit decreased | 21.24 | 11.86 | 12 | 51808 | 31650 | 32430056 |
| Congenital mitral valve incompetence | 21.20 | 11.86 | 8 | 51812 | 126 | 32461580 |
| Economic problem | 21.13 | 11.86 | 18 | 51802 | 1444 | 32460262 |
| Congenital umbilical hernia | 21.12 | 11.86 | 12 | 51808 | 498 | 32461208 |
| Porphyria non-acute | 21.08 | 11.86 | 12 | 51808 | 500 | 32461206 |
| Hypoglycaemia | 20.88 | 11.86 | 34 | 51786 | 54348 | 32407358 |
| Chest discomfort | 20.64 | 11.86 | 30 | 51790 | 50200 | 32411506 |
| Syncope | 20.61 | 11.86 | 74 | 51746 | 90050 | 32371656 |
| Mitochondrial cytopathy | 20.56 | 11.86 | 9 | 51811 | 211 | 32461495 |
| Therapy change | 20.53 | 11.86 | 24 | 51796 | 2821 | 32458885 |
| Therapeutic product effect decreased | 20.46 | 11.86 | 12 | 51808 | 31005 | 32430701 |
| Substance use | 20.38 | 11.86 | 12 | 51808 | 533 | 32461173 |
| Depressed level of consciousness | 20.36 | 11.86 | 21 | 51799 | 40826 | 32420880 |
| Heart rate increased | 20.30 | 11.86 | 22 | 51798 | 41806 | 32419900 |
| Congenital choroid plexus cyst | 20.29 | 11.86 | 9 | 51811 | 218 | 32461488 |
| Cytomegalovirus colitis | 20.26 | 11.86 | 23 | 51797 | 2619 | 32459087 |
| Hypomagnesaemia | 20.07 | 11.86 | 3 | 51817 | 18802 | 32442904 |
| Chills | 19.99 | 11.86 | 61 | 51759 | 78023 | 32383683 |
| Retinal toxicity | 19.96 | 11.86 | 11 | 51809 | 430 | 32461276 |
| Hydrocele | 19.91 | 11.86 | 21 | 51799 | 2203 | 32459503 |
| Malignant anorectal neoplasm | 19.78 | 11.86 | 6 | 51814 | 46 | 32461660 |
| Anomalous pulmonary venous connection | 19.71 | 11.86 | 7 | 51813 | 92 | 32461614 |
| Malaise | 19.64 | 11.86 | 184 | 51636 | 176954 | 32284752 |
| Nervous system disorder | 19.61 | 11.86 | 58 | 51762 | 13991 | 32447715 |
| Multiple-drug resistance | 19.56 | 11.86 | 27 | 51793 | 3748 | 32457958 |
| Schizophreniform disorder | 19.50 | 11.86 | 7 | 51813 | 95 | 32461611 |
| C-reactive protein increased | 19.50 | 11.86 | 29 | 51791 | 48073 | 32413633 |
| Blood bilirubin increased | 19.50 | 11.86 | 117 | 51703 | 38667 | 32423039 |
| Metabolic surgery | 19.44 | 11.86 | 6 | 51814 | 49 | 32461657 |
| Acute stress disorder | 19.40 | 11.86 | 8 | 51812 | 161 | 32461545 |
| Fat redistribution | 19.31 | 11.86 | 8 | 51812 | 163 | 32461543 |
| Genital herpes | 19.04 | 11.86 | 12 | 51808 | 603 | 32461103 |
| Urine phosphorus abnormal | 19.01 | 11.86 | 4 | 51816 | 4 | 32461702 |
| Erectile dysfunction | 18.88 | 11.86 | 72 | 51748 | 19767 | 32441939 |
| Intestinal congestion | 18.82 | 11.86 | 5 | 51815 | 22 | 32461684 |
| Hemiparaesthesia | 18.74 | 11.86 | 6 | 51814 | 56 | 32461650 |
| Alopecia | 18.73 | 11.86 | 74 | 51746 | 20656 | 32441050 |
| Psoriatic arthropathy | 18.72 | 11.86 | 3 | 51817 | 17857 | 32443849 |
| Decreased appetite | 18.72 | 11.86 | 165 | 51655 | 160648 | 32301058 |
| Mitochondrial toxicity | 18.67 | 11.86 | 22 | 51798 | 2608 | 32459098 |
| Polymicrogyria | 18.64 | 11.86 | 5 | 51815 | 23 | 32461683 |
| Product label on wrong product | 18.64 | 11.86 | 5 | 51815 | 23 | 32461683 |
| Drug screen false positive | 18.62 | 11.86 | 13 | 51807 | 776 | 32460930 |
| Eosinophilic pustular folliculitis | 18.62 | 11.86 | 7 | 51813 | 109 | 32461597 |
| Cerebellar syndrome | 18.59 | 11.86 | 20 | 51800 | 2146 | 32459560 |
| Hepatic necrosis | 18.48 | 11.86 | 27 | 51793 | 3948 | 32457758 |
| Osteonecrosis of jaw | 18.42 | 11.86 | 4 | 51816 | 19162 | 32442544 |
| Drug level increased | 18.40 | 11.86 | 72 | 51748 | 20008 | 32441698 |
| Periarthritis | 18.38 | 11.86 | 15 | 51805 | 1134 | 32460572 |
| Mental disorder | 18.38 | 11.86 | 58 | 51762 | 14490 | 32447216 |
| Dyspnoea exertional | 18.35 | 11.86 | 21 | 51799 | 38940 | 32422766 |
| Septic shock | 18.31 | 11.86 | 53 | 51767 | 68936 | 32392770 |
| Urinary retention | 18.19 | 11.86 | 18 | 51802 | 35679 | 32426027 |
| Cachexia | 18.12 | 11.86 | 37 | 51783 | 7072 | 32454634 |
| Product distribution issue | 18.07 | 11.86 | 9 | 51811 | 285 | 32461421 |
| Ureterolithiasis | 17.86 | 11.86 | 19 | 51801 | 2013 | 32459693 |
| Hyperphosphaturia | 17.86 | 11.86 | 6 | 51814 | 66 | 32461640 |
| Gastric bypass | 17.84 | 11.86 | 9 | 51811 | 293 | 32461413 |
| Bone density abnormal | 17.69 | 11.86 | 6 | 51814 | 68 | 32461638 |
| Night sweats | 17.52 | 11.86 | 61 | 51759 | 16027 | 32445679 |
| Full blood count decreased | 17.51 | 11.86 | 3 | 51817 | 17007 | 32444699 |
| Influenza | 17.45 | 11.86 | 29 | 51791 | 45985 | 32415721 |
| Mechanical ventilation | 17.31 | 11.86 | 18 | 51802 | 1857 | 32459849 |
| Gastrointestinal mucosal exfoliation | 17.30 | 11.86 | 7 | 51813 | 134 | 32461572 |
| Visceral leishmaniasis | 17.25 | 11.86 | 11 | 51809 | 564 | 32461142 |
| Lung disorder | 17.23 | 11.86 | 17 | 51803 | 33737 | 32427969 |
| Ultrasound foetal abnormal | 17.07 | 11.86 | 4 | 51816 | 9 | 32461697 |
| Neonatal asphyxia | 17.06 | 11.86 | 9 | 51811 | 322 | 32461384 |
| Transient ischaemic attack | 16.98 | 11.86 | 10 | 51810 | 25784 | 32435922 |
| Anaphylactic reaction | 16.82 | 11.86 | 14 | 51806 | 30158 | 32431548 |
| Exposure during pregnancy | 16.78 | 11.86 | 42 | 51778 | 9187 | 32452519 |
| Haemolytic anaemia | 16.75 | 11.86 | 46 | 51774 | 10638 | 32451068 |
| Glomerular filtration rate abnormal | 16.70 | 11.86 | 12 | 51808 | 750 | 32460956 |
| Psychomotor retardation | 16.62 | 11.86 | 22 | 51798 | 2933 | 32458773 |
| Gastroenteritis cryptosporidial | 16.58 | 11.86 | 8 | 51812 | 236 | 32461470 |
| Confusional state | 16.58 | 11.86 | 147 | 51673 | 142968 | 32318738 |
| Cholestasis | 16.54 | 11.86 | 86 | 51734 | 26947 | 32434759 |
| Treatment failure | 16.51 | 11.86 | 113 | 51707 | 39050 | 32422656 |
| Polydipsia | 16.42 | 11.86 | 25 | 51795 | 3792 | 32457914 |
| Hepatomegaly | 16.37 | 11.86 | 45 | 51775 | 10412 | 32451294 |
| Drug hypersensitivity | 16.29 | 11.86 | 61 | 51759 | 73339 | 32388367 |
| Toxoplasmosis | 16.29 | 11.86 | 15 | 51805 | 1334 | 32460372 |
| Transaminases increased | 16.28 | 11.86 | 81 | 51739 | 24947 | 32436759 |
| Condition aggravated | 16.28 | 11.86 | 164 | 51656 | 155497 | 32306209 |
| Vitamin D deficiency | 16.24 | 11.86 | 32 | 51788 | 5962 | 32455744 |
| Cardiac disorder | 16.24 | 11.86 | 26 | 51794 | 41840 | 32419866 |
| Blood corticotrophin decreased | 16.19 | 11.86 | 7 | 51813 | 159 | 32461547 |
| Intestinal malrotation | 16.19 | 11.86 | 5 | 51815 | 41 | 32461665 |
| Cleft lip and palate | 16.05 | 11.86 | 9 | 51811 | 364 | 32461342 |
| Hepatic fibrosis | 15.99 | 11.86 | 24 | 51796 | 3594 | 32458112 |
| Chronic hepatitis B | 15.98 | 11.86 | 5 | 51815 | 43 | 32461663 |
| Hyperhidrosis | 15.89 | 11.86 | 59 | 51761 | 71109 | 32390597 |
| Product residue present | 15.88 | 11.86 | 21 | 51799 | 2797 | 32458909 |
| Viral load abnormal | 15.81 | 11.86 | 6 | 51814 | 96 | 32461610 |
| Hydrops foetalis | 15.81 | 11.86 | 8 | 51812 | 262 | 32461444 |
| Drug level decreased | 15.79 | 11.86 | 33 | 51787 | 6413 | 32455293 |
| Blood oestrogen decreased | 15.78 | 11.86 | 4 | 51816 | 14 | 32461692 |
| Treponema test positive | 15.78 | 11.86 | 4 | 51816 | 14 | 32461692 |
| Skin dystrophy | 15.78 | 11.86 | 4 | 51816 | 14 | 32461692 |
| Mucosal inflammation | 15.76 | 11.86 | 18 | 51802 | 33416 | 32428290 |
| Dyskinesia | 15.75 | 11.86 | 9 | 51811 | 23594 | 32438112 |
| Peripheral swelling | 15.70 | 11.86 | 56 | 51764 | 68289 | 32393417 |
| Rash maculo-papular | 15.69 | 11.86 | 87 | 51733 | 27935 | 32433771 |
| Persistent left superior vena cava | 15.56 | 11.86 | 4 | 51816 | 15 | 32461691 |
| Foetal heart rate abnormal | 15.43 | 11.86 | 7 | 51813 | 179 | 32461527 |
| Congenital hydrocephalus | 15.43 | 11.86 | 6 | 51814 | 103 | 32461603 |
| Erythema | 15.41 | 11.86 | 74 | 51746 | 83031 | 32378675 |
| Megakaryocytes increased | 15.40 | 11.86 | 5 | 51815 | 49 | 32461657 |
| Cystic lymphangioma | 15.36 | 11.86 | 4 | 51816 | 16 | 32461690 |
| Burkitt's lymphoma | 15.32 | 11.86 | 7 | 51813 | 182 | 32461524 |
| Toxic skin eruption | 15.31 | 11.86 | 47 | 51773 | 11567 | 32450139 |
| Cellulitis | 15.30 | 11.86 | 36 | 51784 | 50194 | 32411512 |
| Seborrhoeic dermatitis | 15.24 | 11.86 | 15 | 51805 | 1450 | 32460256 |
| Feeding tube user | 15.22 | 11.86 | 5 | 51815 | 51 | 32461655 |
| Fluid retention | 15.20 | 11.86 | 12 | 51808 | 26538 | 32435168 |
| Unmasking of previously unidentified disease | 15.16 | 11.86 | 11 | 51809 | 698 | 32461008 |
| Rhabdomyolysis | 15.16 | 11.86 | 169 | 51651 | 67096 | 32394610 |
| Enanthema | 15.14 | 11.86 | 9 | 51811 | 407 | 32461299 |
| Hepatocellular injury | 15.12 | 11.86 | 80 | 51740 | 25238 | 32436468 |
| Central obesity | 15.02 | 11.86 | 10 | 51810 | 552 | 32461154 |
| Bone marrow oedema | 15.02 | 11.86 | 10 | 51810 | 552 | 32461154 |
| Rhinorrhoea | 15.01 | 11.86 | 9 | 51811 | 22977 | 32438729 |
| Oesophageal carcinoma | 14.97 | 11.86 | 25 | 51795 | 4101 | 32457605 |
| Endocrine ophthalmopathy | 14.96 | 11.86 | 5 | 51815 | 54 | 32461652 |
| Melaena | 14.94 | 11.86 | 20 | 51800 | 34645 | 32427061 |
| Endocarditis candida | 14.92 | 11.86 | 6 | 51814 | 113 | 32461593 |
| Stress fracture | 14.81 | 11.86 | 12 | 51808 | 898 | 32460808 |
| Acute myeloid leukaemia | 14.80 | 11.86 | 6 | 51814 | 19168 | 32442538 |
| Cell death | 14.75 | 11.86 | 19 | 51801 | 2467 | 32459239 |
| Hepatosplenomegaly | 14.63 | 11.86 | 24 | 51796 | 3879 | 32457827 |
| Hodgkin's disease | 14.63 | 11.86 | 12 | 51808 | 914 | 32460792 |
| Thrombosis | 14.58 | 11.86 | 32 | 51788 | 45722 | 32415984 |
| T-lymphocyte count decreased | 14.52 | 11.86 | 7 | 51813 | 206 | 32461500 |
| Jarisch-Herxheimer reaction | 14.52 | 11.86 | 9 | 51811 | 439 | 32461267 |
| Drug reaction with eosinophilia and systemic symptoms | 14.46 | 11.86 | 95 | 51725 | 32390 | 32429316 |
| Prurigo | 14.46 | 11.86 | 11 | 51809 | 751 | 32460955 |
| Varices oesophageal | 14.39 | 11.86 | 23 | 51797 | 3638 | 32458068 |
| Mycobacterium avium complex immune restoration disease | 14.34 | 11.86 | 5 | 51815 | 62 | 32461644 |
| Inclusion body myositis | 14.32 | 11.86 | 4 | 51816 | 22 | 32461684 |
| Maternal drugs affecting foetus | 14.31 | 11.86 | 25 | 51795 | 4252 | 32457454 |
| Alopecia areata | 14.28 | 11.86 | 7 | 51813 | 214 | 32461492 |
| Head lag abnormal | 14.26 | 11.86 | 3 | 51817 | 3 | 32461703 |
| Thymus hypoplasia | 14.26 | 11.86 | 3 | 51817 | 3 | 32461703 |
| Pruritus | 14.25 | 11.86 | 286 | 51534 | 128416 | 32333290 |
| Bone loss | 14.18 | 11.86 | 10 | 51810 | 607 | 32461099 |
| Disease risk factor | 14.17 | 11.86 | 4 | 51816 | 23 | 32461683 |
| Blood pressure systolic increased | 14.17 | 11.86 | 5 | 51815 | 17391 | 32444315 |
| Tremor | 14.14 | 11.86 | 74 | 51746 | 81203 | 32380503 |
| Deep vein thrombosis | 14.11 | 11.86 | 53 | 51767 | 63660 | 32398046 |
| Blood glucose increased | 13.98 | 11.86 | 55 | 51765 | 65186 | 32396520 |
| Cleft palate | 13.92 | 11.86 | 10 | 51810 | 625 | 32461081 |
| Glomerular filtration rate increased | 13.84 | 11.86 | 7 | 51813 | 229 | 32461477 |
| Lymphadenopathy | 13.80 | 11.86 | 82 | 51738 | 27000 | 32434706 |
| Bone marrow oedema syndrome | 13.79 | 11.86 | 3 | 51817 | 4 | 32461702 |
| Upper respiratory tract infection | 13.75 | 11.86 | 16 | 51804 | 29457 | 32432249 |
| Pneumocystis jirovecii pneumonia | 13.67 | 11.86 | 63 | 51757 | 18807 | 32442899 |
| Creatinine renal clearance abnormal | 13.60 | 11.86 | 7 | 51813 | 238 | 32461468 |
| Right aortic arch | 13.50 | 11.86 | 4 | 51816 | 28 | 32461678 |
| Posterior cortical atrophy | 13.50 | 11.86 | 4 | 51816 | 28 | 32461678 |
| Adrenogenital syndrome | 13.47 | 11.86 | 5 | 51815 | 75 | 32461631 |
| Neutrophil count decreased | 13.41 | 11.86 | 35 | 51785 | 47104 | 32414602 |
| Pain in extremity | 13.38 | 11.86 | 123 | 51697 | 118778 | 32342928 |
| Dyschromatopsia | 13.37 | 11.86 | 8 | 51812 | 366 | 32461340 |
| Glucose urine present | 13.31 | 11.86 | 12 | 51808 | 1038 | 32460668 |
| HIV associated nephropathy | 13.31 | 11.86 | 8 | 51812 | 369 | 32461337 |
| Hepatic steatosis | 13.31 | 11.86 | 56 | 51764 | 16077 | 32445629 |
| Product use in unapproved indication | 13.23 | 11.86 | 83 | 51737 | 87121 | 32374585 |
| Device related infection | 13.22 | 11.86 | 6 | 51814 | 17927 | 32443779 |
| Hepatic cancer | 13.22 | 11.86 | 33 | 51787 | 7207 | 32454499 |
| Tubulointerstitial nephritis | 13.19 | 11.86 | 64 | 51756 | 19513 | 32442193 |
| Osteoma | 13.15 | 11.86 | 4 | 51816 | 31 | 32461675 |
| End stage AIDS | 13.04 | 11.86 | 4 | 51816 | 32 | 32461674 |
| Ergot poisoning | 12.95 | 11.86 | 5 | 51815 | 84 | 32461622 |
| Stomatitis | 12.93 | 11.86 | 28 | 51792 | 40201 | 32421505 |
| Cerebral dysgenesis | 12.93 | 11.86 | 4 | 51816 | 33 | 32461673 |
| Rectal haemorrhage | 12.92 | 11.86 | 25 | 51795 | 37398 | 32424308 |
| Ejection fraction decreased | 12.88 | 11.86 | 6 | 51814 | 17652 | 32444054 |
| Blood bilirubin unconjugated increased | 12.87 | 11.86 | 10 | 51810 | 704 | 32461002 |
| Hyponatraemia | 12.87 | 11.86 | 68 | 51752 | 74445 | 32387261 |
| Unresponsive to stimuli | 12.87 | 11.86 | 15 | 51805 | 27594 | 32434112 |
| Renal aplasia | 12.82 | 11.86 | 10 | 51810 | 708 | 32460998 |
| Manufacturing product shipping issue | 12.82 | 11.86 | 4 | 51816 | 34 | 32461672 |
| Deafness congenital | 12.79 | 11.86 | 5 | 51815 | 87 | 32461619 |
| Liver function test abnormal | 12.77 | 11.86 | 91 | 51729 | 31856 | 32429850 |
| Subdural haematoma | 12.77 | 11.86 | 8 | 51812 | 19945 | 32441761 |
| Plethoric face | 12.73 | 11.86 | 3 | 51817 | 7 | 32461699 |
| Pulmonary valve disease | 12.67 | 11.86 | 7 | 51813 | 275 | 32461431 |
| Cerebrovascular accident | 12.66 | 11.86 | 83 | 51737 | 86237 | 32375469 |
| Cytokine release syndrome | 12.66 | 11.86 | 3 | 51817 | 13532 | 32448174 |
| Blood glucose decreased | 12.66 | 11.86 | 3 | 51817 | 13531 | 32448175 |
| Portal hypertensive gastropathy | 12.62 | 11.86 | 9 | 51811 | 556 | 32461150 |
| Oral candidiasis | 12.58 | 11.86 | 45 | 51775 | 11982 | 32449724 |
| Cataract | 12.55 | 11.86 | 12 | 51808 | 24171 | 32437535 |
| Alanine aminotransferase increased | 12.52 | 11.86 | 185 | 51635 | 78294 | 32383412 |
| Gastroenteritis | 12.50 | 11.86 | 50 | 51770 | 14031 | 32447675 |
| Human immunodeficiency virus transmission | 12.43 | 11.86 | 4 | 51816 | 38 | 32461668 |
| Hyperkalaemia | 12.41 | 11.86 | 63 | 51757 | 69687 | 32392019 |
| Loss of consciousness | 12.40 | 11.86 | 79 | 51741 | 82628 | 32379078 |
| Ankyloglossia congenital | 12.33 | 11.86 | 7 | 51813 | 290 | 32461416 |
| Hepatitis fulminant | 12.31 | 11.86 | 23 | 51797 | 4120 | 32457586 |
| Giardiasis | 12.29 | 11.86 | 7 | 51813 | 292 | 32461414 |
| Acute hepatic failure | 12.29 | 11.86 | 47 | 51773 | 12922 | 32448784 |
| Blood bilirubin decreased | 12.24 | 11.86 | 7 | 51813 | 294 | 32461412 |
| Respiratory depression | 12.21 | 11.86 | 3 | 51817 | 13208 | 32448498 |
| Neck pain | 12.19 | 11.86 | 11 | 51809 | 22776 | 32438930 |
| 17-hydroxyprogesterone increased | 12.19 | 11.86 | 3 | 51817 | 9 | 32461697 |
| Eagle Barrett syndrome | 12.19 | 11.86 | 3 | 51817 | 9 | 32461697 |
| Phosphorus metabolism disorder | 12.19 | 11.86 | 3 | 51817 | 9 | 32461697 |
| Cytomegalovirus test positive | 12.18 | 11.86 | 22 | 51798 | 3840 | 32457866 |
| Talipes | 12.17 | 11.86 | 15 | 51805 | 1863 | 32459843 |
| Nephropathy | 12.15 | 11.86 | 28 | 51792 | 5812 | 32455894 |
| Red blood cell count decreased | 12.03 | 11.86 | 16 | 51804 | 27797 | 32433909 |
| Pulmonary fibrosis | 12.02 | 11.86 | 6 | 51814 | 16968 | 32444738 |
| Hyperadrenocorticism | 12.02 | 11.86 | 5 | 51815 | 103 | 32461603 |
| Hyperproteinaemia | 12.02 | 11.86 | 6 | 51814 | 191 | 32461515 |
| Glucocorticoid deficiency | 12.01 | 11.86 | 7 | 51813 | 305 | 32461401 |
| Opportunistic infection | 11.99 | 11.86 | 14 | 51806 | 1643 | 32460063 |
| Blood alkaline phosphatase increased | 11.97 | 11.86 | 90 | 51730 | 32042 | 32429664 |
| Swelling | 11.96 | 11.86 | 27 | 51793 | 38195 | 32423511 |
| Pulmonary hilar enlargement | 11.95 | 11.86 | 3 | 51817 | 10 | 32461696 |
| Hypophagia | 11.94 | 11.86 | 12 | 51808 | 23611 | 32438095 |
| Suspected counterfeit product | 11.89 | 11.86 | 7 | 51813 | 311 | 32461395 |
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)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 150MG;150MG;200MG;EQ 10MG BASE | GENVOYA | GILEAD SCIENCES INC | N207561 | Nov. 5, 2015 | RX | TABLET | ORAL | 7803788 | Feb. 2, 2022 | TREATMENT OF HIV INFECTION |
| 200MG;EQ 25MG BASE | DESCOVY | GILEAD SCIENCES INC | N208215 | April 4, 2016 | RX | TABLET | ORAL | 7803788 | Feb. 2, 2022 | TREATMENT OF HIV-1 INFECTION |
| 200MG;EQ 25MG BASE;EQ 25MG BASE | ODEFSEY | GILEAD SCIENCES INC | N208351 | March 1, 2016 | RX | TABLET | ORAL | 7803788 | Feb. 2, 2022 | TREATMENT OF HIV INFECTION |
| EQ 30MG BASE;120MG;EQ 15MG BASE | BIKTARVY | GILEAD SCIENCES INC | N210251 | Oct. 7, 2021 | RX | TABLET | ORAL | 7803788 | Feb. 2, 2022 | TREATMENT OF HIV INFECTION |
| EQ 50MG BASE;200MG;EQ 25MG BASE | BIKTARVY | GILEAD SCIENCES INC | N210251 | Feb. 7, 2018 | RX | TABLET | ORAL | 7803788 | Feb. 2, 2022 | TREATMENT OF HIV INFECTION |
| 150MG;800MG;200MG;EQ 10MG BASE | SYMTUZA | JANSSEN PRODS | N210455 | July 17, 2018 | RX | TABLET | ORAL | 7803788 | Feb. 2, 2022 | TREATMENT OF HIV-1 INFECTION IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 40 KG WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS |
| 150MG;800MG;200MG;EQ 10MG BASE | SYMTUZA | JANSSEN PRODS | N210455 | July 17, 2018 | RX | TABLET | ORAL | 7803788 | Feb. 2, 2022 | TREATMENT OF HIV-1 INFECTION IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS |
| 200MG;300MG | TRUVADA | GILEAD | N021752 | Aug. 2, 2004 | RX | TABLET | ORAL | 8592397 | Jan. 13, 2024 | METHOD OF TREATMENT OF ADULTS INFECTED WITH HIV-1 |
| 200MG;300MG | TRUVADA | GILEAD | N021752 | Aug. 2, 2004 | RX | TABLET | ORAL | 8592397 | Jan. 13, 2024 | TREATMENT OF HIV |
| 200MG;300MG | TRUVADA | GILEAD | N021752 | Aug. 2, 2004 | RX | TABLET | ORAL | 8592397 | Jan. 13, 2024 | TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER |
| 200MG;300MG | TRUVADA | GILEAD | N021752 | Aug. 2, 2004 | RX | TABLET | ORAL | 8716264 | Jan. 13, 2024 | TREATMENT OF HIV INFECTION |
| 200MG;300MG | TRUVADA | GILEAD | N021752 | Aug. 2, 2004 | RX | TABLET | ORAL | 9457036 | Jan. 13, 2024 | TREATMENT OF HIV INFECTION |
| 200MG;300MG | TRUVADA | GILEAD | N021752 | Aug. 2, 2004 | RX | TABLET | ORAL | 9744181 | Jan. 13, 2024 | TREATMENT OF HIV INFECTION |
| 600MG;200MG;300MG | ATRIPLA | GILEAD SCIENCES | N021937 | July 12, 2006 | RX | TABLET | ORAL | 8592397 | Jan. 13, 2024 | TREATMENT OF HIV-1 INFECTION IN ADULTS |
| 600MG;200MG;300MG | ATRIPLA | GILEAD SCIENCES | N021937 | July 12, 2006 | RX | TABLET | ORAL | 8592397 | Jan. 13, 2024 | TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER |
| 600MG;200MG;300MG | ATRIPLA | GILEAD SCIENCES | N021937 | July 12, 2006 | RX | TABLET | ORAL | 8716264 | Jan. 13, 2024 | TREATMENT OF HIV INFECTION |
| 600MG;200MG;300MG | ATRIPLA | GILEAD SCIENCES | N021937 | July 12, 2006 | RX | TABLET | ORAL | 9457036 | Jan. 13, 2024 | TREATMENT OF HIV INFECTION |
| 600MG;200MG;300MG | ATRIPLA | GILEAD SCIENCES | N021937 | July 12, 2006 | RX | TABLET | ORAL | 9744181 | Jan. 13, 2024 | TREATMENT OF HIV INFECTION |
| 200MG;EQ 25MG BASE;300MG | COMPLERA | GILEAD SCIENCES INC | N202123 | Aug. 10, 2011 | RX | TABLET | ORAL | 8592397 | Jan. 13, 2024 | TREATMENT OF HIV INFECTION |
| 200MG;EQ 25MG BASE;300MG | COMPLERA | GILEAD SCIENCES INC | N202123 | Aug. 10, 2011 | RX | TABLET | ORAL | 8716264 | Jan. 13, 2024 | TREATMENT OF HIV INFECTION |
| 200MG;EQ 25MG BASE;300MG | COMPLERA | GILEAD SCIENCES INC | N202123 | Aug. 10, 2011 | RX | TABLET | ORAL | 9457036 | Jan. 13, 2024 | TREATMENT OF HIV INFECTION |
| 200MG;EQ 25MG BASE;300MG | COMPLERA | GILEAD SCIENCES INC | N202123 | Aug. 10, 2011 | RX | TABLET | ORAL | 9744181 | Jan. 13, 2024 | TREATMENT OF HIV INFECTION |
| 150MG;150MG;200MG;300MG | STRIBILD | GILEAD SCIENCES INC | N203100 | Aug. 27, 2012 | RX | TABLET | ORAL | 8592397 | Jan. 13, 2024 | TREATMENT OF HIV INFECTION |
| 150MG;150MG;200MG;300MG | STRIBILD | GILEAD SCIENCES INC | N203100 | Aug. 27, 2012 | RX | TABLET | ORAL | 8716264 | Jan. 13, 2024 | TREATMENT OF HIV INFECTION |
| 150MG;150MG;200MG;300MG | STRIBILD | GILEAD SCIENCES INC | N203100 | Aug. 27, 2012 | RX | TABLET | ORAL | 9457036 | Jan. 13, 2024 | TREATMENT OF HIV INFECTION |
| 150MG;150MG;200MG;300MG | STRIBILD | GILEAD SCIENCES INC | N203100 | Aug. 27, 2012 | RX | TABLET | ORAL | 9744181 | Jan. 13, 2024 | TREATMENT OF HIV INFECTION |
| 200MG;EQ 25MG BASE;300MG | COMPLERA | GILEAD SCIENCES INC | N202123 | Aug. 10, 2011 | RX | TABLET | ORAL | 7125879 | April 21, 2025 | TREATMENT OF HIV INFECTION |
| 200MG;EQ 25MG BASE;EQ 25MG BASE | ODEFSEY | GILEAD SCIENCES INC | N208351 | March 1, 2016 | RX | TABLET | ORAL | 7125879 | April 21, 2025 | TREATMENT OF HIV INFECTION |
| 200MG;EQ 25MG BASE;300MG | COMPLERA | GILEAD SCIENCES INC | N202123 | Aug. 10, 2011 | RX | TABLET | ORAL | 8841310 | Dec. 9, 2025 | TREATMENT OF HIV INFECTION |
| 600MG;200MG;300MG | ATRIPLA | GILEAD SCIENCES | N021937 | July 12, 2006 | RX | TABLET | ORAL | 9018192 | June 13, 2026 | TREATMENT OF HIV-1 INFECTION IN ADULTS |
| 600MG;200MG;300MG | ATRIPLA | GILEAD SCIENCES | N021937 | July 12, 2006 | RX | TABLET | ORAL | 9018192 | June 13, 2026 | TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER |
| 600MG;200MG;300MG | ATRIPLA | GILEAD SCIENCES | N021937 | July 12, 2006 | RX | TABLET | ORAL | 9545414 | June 13, 2026 | TREATMENT OF HIV-1 INFECTION IN ADULTS |
| 600MG;200MG;300MG | ATRIPLA | GILEAD SCIENCES | N021937 | July 12, 2006 | RX | TABLET | ORAL | 9545414 | June 13, 2026 | TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER |
| 150MG;150MG;200MG;300MG | STRIBILD | GILEAD SCIENCES INC | N203100 | Aug. 27, 2012 | RX | TABLET | ORAL | 7176220 | Aug. 27, 2026 | TREATMENT OF HIV INFECTION |
| 150MG;150MG;200MG;EQ 10MG BASE | GENVOYA | GILEAD SCIENCES INC | N207561 | Nov. 5, 2015 | RX | TABLET | ORAL | 7176220 | Aug. 27, 2026 | TREATMENT OF HIV INFECTION |
| 150MG;150MG;200MG;300MG | STRIBILD | GILEAD SCIENCES INC | N203100 | Aug. 27, 2012 | RX | TABLET | ORAL | 7635704 | Oct. 26, 2026 | TREATMENT OF HIV INFECTION |
| 150MG;150MG;200MG;EQ 10MG BASE | GENVOYA | GILEAD SCIENCES INC | N207561 | Nov. 5, 2015 | RX | TABLET | ORAL | 7635704 | Oct. 26, 2026 | TREATMENT OF HIV INFECTION |
| 150MG;150MG;200MG;300MG | STRIBILD | GILEAD SCIENCES INC | N203100 | Aug. 27, 2012 | RX | TABLET | ORAL | 8148374 | Sept. 3, 2029 | TREATMENT OF HIV INFECTION USING A COMPOSITION CONTAINING A PHARMACOKINETIC ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE |
| 150MG;150MG;200MG;300MG | STRIBILD | GILEAD SCIENCES INC | N203100 | Aug. 27, 2012 | RX | TABLET | ORAL | 9891239 | Sept. 3, 2029 | TREATMENT OF HIV INFECTION |
| 150MG;150MG;200MG;EQ 10MG BASE | GENVOYA | GILEAD SCIENCES INC | N207561 | Nov. 5, 2015 | RX | TABLET | ORAL | 8148374 | Sept. 3, 2029 | TREATMENT OF HIV INFECTION USING A COMPOSITION CONTAINING A PHARMACOKINETIC ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE |
| 150MG;150MG;200MG;EQ 10MG BASE | GENVOYA | GILEAD SCIENCES INC | N207561 | Nov. 5, 2015 | RX | TABLET | ORAL | 9891239 | Sept. 3, 2029 | TREATMENT OF HIV INFECTION |
| 150MG;800MG;200MG;EQ 10MG BASE | SYMTUZA | JANSSEN PRODS | N210455 | July 17, 2018 | RX | TABLET | ORAL | 8148374 | Sept. 3, 2029 | TREATMENT OF HIV-1 INFECTION USING A COMPOSITION CONTAINING A PHARMACOKINETIC ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY |
| 150MG;800MG;200MG;EQ 10MG BASE | SYMTUZA | JANSSEN PRODS | N210455 | July 17, 2018 | RX | TABLET | ORAL | 8148374 | Sept. 3, 2029 | TREATMENT OF HIV-1 INFECTION USING A COMPOSITION CONTAINING A PHARMACOKINETIC ENHANCER THAT INIBITS CYTOCHROME P450 MONOOXYGENASE IN ADULTS WHO ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS |
| 150MG;800MG;200MG;EQ 10MG BASE | SYMTUZA | JANSSEN PRODS | N210455 | July 17, 2018 | RX | TABLET | ORAL | 8148374 | Sept. 3, 2029 | TREATMENT OF HIV-1 INFECTION USING A COMPOSITION CONTAINING A PK ENHANCER THAT INHIBITS CY P450 MONOXYGENASE IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 40KG WHO ARE VIROLOGICALLY SUPPRESSED ON A STABLE ARV REGIMEN FOR AT LEAST 6 MONTHS |
| 150MG;800MG;200MG;EQ 10MG BASE | SYMTUZA | JANSSEN PRODS | N210455 | July 17, 2018 | RX | TABLET | ORAL | 8148374 | Sept. 3, 2029 | TREATMENT OF HIV-1 INFECTION USING A COMPOSITION CONTAINING A PK ENHANCER THAT INHIBITS CY P450 MONOXYGENASE IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 40KG WHO HAVE NO PRIOR ARV TREATMENT HISTORY |
| 150MG;800MG;200MG;EQ 10MG BASE | SYMTUZA | JANSSEN PRODS | N210455 | July 17, 2018 | RX | TABLET | ORAL | 8148374 | Sept. 3, 2029 | TX OF HIV1 INFECTION USING A COMPOSITION CONTAINING A PK ENHANCER THAT INHIBITS CY P450 MONOXYGENASE IN ADULTS & PEDIATRIC PATIENTS AT LEAST 40KG HAVING NO PRIOR ARV TX HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ARV REGIMEN FOR AT LEAST 6 MO |
| 150MG;800MG;200MG;EQ 10MG BASE | SYMTUZA | JANSSEN PRODS | N210455 | July 17, 2018 | RX | TABLET | ORAL | 8148374 | Sept. 3, 2029 | TX OF HIV-1 INFECTION USING A COMPOSITION CONTAINING A PK ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENATES IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TX HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS |
| 150MG;150MG;200MG;300MG | STRIBILD | GILEAD SCIENCES INC | N203100 | Aug. 27, 2012 | RX | TABLET | ORAL | 8633219 | April 30, 2030 | TREATMENT OF HIV INFECTION |
| 150MG;150MG;200MG;EQ 10MG BASE | GENVOYA | GILEAD SCIENCES INC | N207561 | Nov. 5, 2015 | RX | TABLET | ORAL | 8633219 | April 30, 2030 | TREATMENT OF HIV INFECTION |
| 150MG;150MG;200MG;EQ 10MG BASE | GENVOYA | GILEAD SCIENCES INC | N207561 | Nov. 5, 2015 | RX | TABLET | ORAL | 8754065 | Aug. 15, 2032 | TREATMENT OF HIV INFECTION |
| 150MG;150MG;200MG;EQ 10MG BASE | GENVOYA | GILEAD SCIENCES INC | N207561 | Nov. 5, 2015 | RX | TABLET | ORAL | 9296769 | Aug. 15, 2032 | TREATMENT OF HIV INFECTION |
| 120MG;EQ 15MG BASE | DESCOVY | GILEAD SCIENCES INC | N208215 | Jan. 7, 2022 | RX | TABLET | ORAL | 8754065 | Aug. 15, 2032 | TREATMENT OF HIV-1 INFECTION |
| 120MG;EQ 15MG BASE | DESCOVY | GILEAD SCIENCES INC | N208215 | Jan. 7, 2022 | RX | TABLET | ORAL | 9296769 | Aug. 15, 2032 | TREATMENT OF HIV-1 INFECTION |
| 200MG;EQ 25MG BASE | DESCOVY | GILEAD SCIENCES INC | N208215 | April 4, 2016 | RX | TABLET | ORAL | 8754065 | Aug. 15, 2032 | PROPHYLAXIS OF HIV-1 INFECTION |
| 200MG;EQ 25MG BASE | DESCOVY | GILEAD SCIENCES INC | N208215 | April 4, 2016 | RX | TABLET | ORAL | 8754065 | Aug. 15, 2032 | TREATMENT OF HIV-1 INFECTION |
| 200MG;EQ 25MG BASE | DESCOVY | GILEAD SCIENCES INC | N208215 | April 4, 2016 | RX | TABLET | ORAL | 8754065 | Aug. 15, 2032 | TREATMENT OF HIV INFECTION |
| 200MG;EQ 25MG BASE | DESCOVY | GILEAD SCIENCES INC | N208215 | April 4, 2016 | RX | TABLET | ORAL | 9296769 | Aug. 15, 2032 | PROPHYLAXIS OF HIV-1 INFECTION |
| 200MG;EQ 25MG BASE | DESCOVY | GILEAD SCIENCES INC | N208215 | April 4, 2016 | RX | TABLET | ORAL | 9296769 | Aug. 15, 2032 | TREATMENT OF HIV-1 INFECTION |
| 200MG;EQ 25MG BASE | DESCOVY | GILEAD SCIENCES INC | N208215 | April 4, 2016 | RX | TABLET | ORAL | 9296769 | Aug. 15, 2032 | TREATMENT OF HIV INFECTION |
| 200MG;EQ 25MG BASE;EQ 25MG BASE | ODEFSEY | GILEAD SCIENCES INC | N208351 | March 1, 2016 | RX | TABLET | ORAL | 8754065 | Aug. 15, 2032 | TREATMENT OF HIV INFECTION |
| 200MG;EQ 25MG BASE;EQ 25MG BASE | ODEFSEY | GILEAD SCIENCES INC | N208351 | March 1, 2016 | RX | TABLET | ORAL | 9296769 | Aug. 15, 2032 | TREATMENT OF HIV INFECTION |
| EQ 30MG BASE;120MG;EQ 15MG BASE | BIKTARVY | GILEAD SCIENCES INC | N210251 | Oct. 7, 2021 | RX | TABLET | ORAL | 8754065 | Aug. 15, 2032 | TREATMENT OF HIV INFECTION |
| EQ 30MG BASE;120MG;EQ 15MG BASE | BIKTARVY | GILEAD SCIENCES INC | N210251 | Oct. 7, 2021 | RX | TABLET | ORAL | 9296769 | Aug. 15, 2032 | TREATMENT OF HIV INFECTION |
| EQ 50MG BASE;200MG;EQ 25MG BASE | BIKTARVY | GILEAD SCIENCES INC | N210251 | Feb. 7, 2018 | RX | TABLET | ORAL | 8754065 | Aug. 15, 2032 | TREATMENT OF HIV INFECTION |
| EQ 50MG BASE;200MG;EQ 25MG BASE | BIKTARVY | GILEAD SCIENCES INC | N210251 | Feb. 7, 2018 | RX | TABLET | ORAL | 9296769 | Aug. 15, 2032 | TREATMENT OF HIV INFECTION |
| 150MG;800MG;200MG;EQ 10MG BASE | SYMTUZA | JANSSEN PRODS | N210455 | July 17, 2018 | RX | TABLET | ORAL | 8754065 | Aug. 15, 2032 | TREATMENT OF HIV-1 INFECTION IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 40 KG WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS |
| 150MG;800MG;200MG;EQ 10MG BASE | SYMTUZA | JANSSEN PRODS | N210455 | July 17, 2018 | RX | TABLET | ORAL | 8754065 | Aug. 15, 2032 | TREATMENT OF HIV-1 INFECTION IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS |
| 150MG;800MG;200MG;EQ 10MG BASE | SYMTUZA | JANSSEN PRODS | N210455 | July 17, 2018 | RX | TABLET | ORAL | 9296769 | Aug. 15, 2032 | TREATMENT OF HIV-1 INFECTION IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 40 KG WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS |
| 150MG;800MG;200MG;EQ 10MG BASE | SYMTUZA | JANSSEN PRODS | N210455 | July 17, 2018 | RX | TABLET | ORAL | 9296769 | Aug. 15, 2032 | TREATMENT OF HIV-1 INFECTION IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS |
| EQ 30MG BASE;120MG;EQ 15MG BASE | BIKTARVY | GILEAD SCIENCES INC | N210251 | Oct. 7, 2021 | RX | TABLET | ORAL | 10385067 | June 19, 2035 | TREATMENT OF HIV INFECTION |
| EQ 50MG BASE;200MG;EQ 25MG BASE | BIKTARVY | GILEAD SCIENCES INC | N210251 | Feb. 7, 2018 | RX | TABLET | ORAL | 10385067 | June 19, 2035 | TREATMENT OF HIV INFECTION |
| 150MG;800MG;200MG;EQ 10MG BASE | SYMTUZA | JANSSEN PRODS | N210455 | July 17, 2018 | RX | TABLET | ORAL | 10786518 | July 19, 2038 | TREATMENT OF HIV-1 INFECTION IN ADULT OR PEDIATRIC PATIENTS (>=40 KG) WITH <50 COPIES/ML HIV-1 RNA AFTER >= 6 MONTHS ON PRIOR ANTIRETROVIRAL REGIMEN AND NO KNOWN DARUNAVIR OR TENOFOVIR RESISTANCE-ASSOCIATED SUBSTITUTIONS |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 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 VAGINAL SEX |
| EQ 30MG BASE;120MG;EQ 15MG BASE | BIKTARVY | GILEAD SCIENCES INC | N210251 | Oct. 7, 2021 | 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. 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 COMBINATION 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 COMBINATION 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 |
| EQ 30MG BASE;120MG;EQ 15MG BASE | BIKTARVY | GILEAD SCIENCES INC | N210251 | Oct. 7, 2021 | RX | TABLET | ORAL | Oct. 7, 2028 | A COMPLETE REGIMEN FOR THE TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) INFECTION IN PEDIATRIC PATIENTS WEIGHING 14 KG TO LESS THAN 25 KG WHO HAVE NO ANTIRETROVIRAL TREATMENT HISTORY OR TO REPLACE THE CURRENT ANTIRETROVIRAL REGIMEN IN THOSE WHO ARE VIROLOGICALLY-SUPPRESSED (HIV-1 RNA LESS THAN 50 COPIES PER ML) ON A STABLE ANTIRETROVIRAL REGIMEN WITH NO HISTORY OF TREATMENT FAILURE AND NO KNOWN SUBSTITUTIONS ASSOCIATED WITH RESISTANCE TO THE INDIVIDUAL COMPONENTS OF BIKTARVY |
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 |
| C0909839 | UMLSCUI |
| CHEBI:31536 | CHEBI |
| ETV | PDB_CHEM_ID |
| CHEMBL885 | ChEMBL_ID |
| DB00879 | DRUGBANK_ID |
| D000068679 | MESH_DESCRIPTOR_UI |
| 7822 | INN_ID |
| 60877 | PUBCHEM_CID |
| 11244 | IUPHAR_LIGAND_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 |
| Emtricitabine and Tenofovir Disoproxil Fumarate | HUMAN PRESCRIPTION DRUG LABEL | 2 | 0904-7172 | TABLET, FILM COATED | 200 mg | ORAL | ANDA | 28 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 | 31722-560 | TABLET, FILM COATED | 200 mg | ORAL | ANDA | 27 sections |
| Emtricitabine and tenofovir disoproxil fumarate | Human Prescription Drug Label | 2 | 33342-106 | TABLET, FILM COATED | 200 mg | ORAL | ANDA | 28 sections |
| Efavirenz, Emtricitabine and Tenofovir Disoproxil Fumarate | Human Prescription Drug Label | 3 | 33342-138 | TABLET, FILM COATED | 200 mg | ORAL | ANDA | 30 sections |
| Emtricitabine and Tenofovir Disoproxil Fumarate | HUMAN PRESCRIPTION DRUG LABEL | 2 | 42291-439 | TABLET, FILM COATED | 200 mg | ORAL | ANDA | 26 sections |
| Efavirenz, emtricitabine and tenofovir disoproxil fumarate | Human Prescription Drug Label | 3 | 42385-915 | TABLET, FILM COATED | 200 mg | ORAL | ANDA | 30 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 | 34 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 |