emtricitabine 🐶 Veterinary Use | 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 | 640.15 | 20.25 | 256 | 9524 | 41516 | 50553828 |
| Exposure during pregnancy | 485.10 | 20.25 | 297 | 9483 | 120718 | 50474626 |
| Foetal exposure during pregnancy | 412.76 | 20.25 | 166 | 9614 | 27193 | 50568151 |
| Abortion induced | 332.13 | 20.25 | 107 | 9673 | 9237 | 50586107 |
| Immune reconstitution inflammatory syndrome | 224.23 | 20.25 | 70 | 9710 | 5446 | 50589898 |
| Stillbirth | 223.11 | 20.25 | 71 | 9709 | 5881 | 50589463 |
| Pregnancy | 209.77 | 20.25 | 106 | 9674 | 29471 | 50565873 |
| Premature baby | 192.16 | 20.25 | 86 | 9694 | 18251 | 50577093 |
| Virologic failure | 190.61 | 20.25 | 47 | 9733 | 1517 | 50593827 |
| Enlarged clitoris | 170.27 | 20.25 | 29 | 9751 | 127 | 50595217 |
| Viral mutation identified | 163.93 | 20.25 | 42 | 9738 | 1587 | 50593757 |
| Blood HIV RNA increased | 162.34 | 20.25 | 34 | 9746 | 515 | 50594829 |
| Drug interaction | 154.30 | 20.25 | 191 | 9589 | 199430 | 50395914 |
| Hyperandrogenism | 151.13 | 20.25 | 25 | 9755 | 88 | 50595256 |
| Viral load increased | 107.36 | 20.25 | 28 | 9752 | 1135 | 50594209 |
| Drug resistance | 105.92 | 20.25 | 58 | 9722 | 18931 | 50576413 |
| Premature labour | 105.00 | 20.25 | 49 | 9731 | 11427 | 50583917 |
| Pathogen resistance | 101.35 | 20.25 | 39 | 9741 | 5650 | 50589694 |
| Maternal exposure during pregnancy | 95.59 | 20.25 | 135 | 9645 | 159643 | 50435701 |
| Lipodystrophy acquired | 89.74 | 20.25 | 25 | 9755 | 1304 | 50594040 |
| CD4 lymphocytes decreased | 89.56 | 20.25 | 25 | 9755 | 1314 | 50594030 |
| Fanconi syndrome acquired | 84.13 | 20.25 | 22 | 9758 | 901 | 50594443 |
| Hydrops foetalis | 82.85 | 20.25 | 18 | 9762 | 327 | 50595017 |
| Cushing's syndrome | 76.56 | 20.25 | 19 | 9761 | 629 | 50594715 |
| Renal tubular disorder | 74.80 | 20.25 | 25 | 9755 | 2412 | 50592932 |
| Premature rupture of membranes | 73.12 | 20.25 | 29 | 9751 | 4551 | 50590793 |
| Spina bifida | 70.26 | 20.25 | 18 | 9762 | 679 | 50594665 |
| Hepatic cytolysis | 69.20 | 20.25 | 33 | 9747 | 8070 | 50587274 |
| Live birth | 67.18 | 20.25 | 41 | 9739 | 16367 | 50578977 |
| Pain | 65.24 | 20.25 | 16 | 9764 | 578887 | 50016457 |
| Hyperbilirubinaemia | 63.99 | 20.25 | 33 | 9747 | 9537 | 50585807 |
| Pre-eclampsia | 60.40 | 20.25 | 30 | 9750 | 8014 | 50587330 |
| Oligohydramnios | 60.29 | 20.25 | 27 | 9753 | 5723 | 50589621 |
| Drug ineffective | 59.98 | 20.25 | 43 | 9737 | 819290 | 49776054 |
| Autoimmune hepatitis | 59.31 | 20.25 | 29 | 9751 | 7490 | 50587854 |
| Acute kidney injury | 58.38 | 20.25 | 133 | 9647 | 227925 | 50367419 |
| Maternal drugs affecting foetus | 56.96 | 20.25 | 25 | 9755 | 5052 | 50590292 |
| Immune reconstitution inflammatory syndrome associated tuberculosis | 56.12 | 20.25 | 13 | 9767 | 319 | 50595025 |
| Premature delivery | 53.57 | 20.25 | 41 | 9739 | 23622 | 50571722 |
| Adrenal suppression | 52.51 | 20.25 | 15 | 9765 | 857 | 50594487 |
| Ultrasound antenatal screen abnormal | 50.29 | 20.25 | 10 | 9770 | 115 | 50595229 |
| CSF HIV escape syndrome | 46.32 | 20.25 | 9 | 9771 | 91 | 50595253 |
| Foetal death | 45.63 | 20.25 | 25 | 9755 | 8155 | 50587189 |
| Congenital anomaly | 44.29 | 20.25 | 15 | 9765 | 1506 | 50593838 |
| Caesarean section | 44.23 | 20.25 | 31 | 9749 | 15608 | 50579736 |
| Ventricular septal defect | 42.44 | 20.25 | 19 | 9761 | 4022 | 50591322 |
| HIV infection | 42.11 | 20.25 | 10 | 9770 | 274 | 50595070 |
| Melanoderma | 41.71 | 20.25 | 9 | 9771 | 158 | 50595186 |
| Rash maculo-papular | 41.17 | 20.25 | 37 | 9743 | 26604 | 50568740 |
| Hepatitis fulminant | 40.66 | 20.25 | 17 | 9763 | 3051 | 50592293 |
| Renal tubular necrosis | 40.58 | 20.25 | 25 | 9755 | 10143 | 50585201 |
| Osteonecrosis | 40.29 | 20.25 | 34 | 9746 | 22483 | 50572861 |
| Meningomyelocele | 39.74 | 20.25 | 11 | 9769 | 560 | 50594784 |
| Jaundice | 39.46 | 20.25 | 36 | 9744 | 26393 | 50568951 |
| Lipohypertrophy | 38.97 | 20.25 | 11 | 9769 | 602 | 50594742 |
| Oesophageal candidiasis | 38.60 | 20.25 | 19 | 9761 | 4975 | 50590369 |
| Hepatitis | 37.78 | 20.25 | 38 | 9742 | 31415 | 50563929 |
| Treatment noncompliance | 37.27 | 20.25 | 37 | 9743 | 30113 | 50565231 |
| Drug reaction with eosinophilia and systemic symptoms | 37.22 | 20.25 | 36 | 9744 | 28388 | 50566956 |
| Patent ductus arteriosus | 37.08 | 20.25 | 17 | 9763 | 3803 | 50591541 |
| Renal tubular acidosis | 36.46 | 20.25 | 13 | 9767 | 1521 | 50593823 |
| Foetal growth restriction | 36.27 | 20.25 | 20 | 9760 | 6607 | 50588737 |
| Fanconi syndrome | 36.24 | 20.25 | 12 | 9768 | 1124 | 50594220 |
| Renal colic | 35.51 | 20.25 | 12 | 9768 | 1197 | 50594147 |
| Congenital genital malformation female | 35.46 | 20.25 | 6 | 9774 | 25 | 50595319 |
| Renal failure | 35.11 | 20.25 | 69 | 9711 | 106564 | 50488780 |
| Ectopic pregnancy | 34.59 | 20.25 | 14 | 9766 | 2313 | 50593031 |
| Fall | 34.38 | 20.25 | 11 | 9769 | 334921 | 50260423 |
| Placenta praevia | 34.26 | 20.25 | 11 | 9769 | 935 | 50594409 |
| Sudden infant death syndrome | 34.24 | 20.25 | 8 | 9772 | 204 | 50595140 |
| Malaria | 34.24 | 20.25 | 8 | 9772 | 204 | 50595140 |
| Gestational diabetes | 34.05 | 20.25 | 20 | 9760 | 7445 | 50587899 |
| Fatigue | 33.88 | 20.25 | 53 | 9727 | 707548 | 49887796 |
| Adrenogenital syndrome | 32.97 | 20.25 | 6 | 9774 | 41 | 50595303 |
| Cholestasis | 32.94 | 20.25 | 32 | 9748 | 25369 | 50569975 |
| Hereditary optic atrophy | 32.61 | 20.25 | 5 | 9775 | 9 | 50595335 |
| Haemolytic anaemia | 32.46 | 20.25 | 21 | 9759 | 9271 | 50586073 |
| Congenital pulmonary valve disorder | 32.14 | 20.25 | 6 | 9774 | 48 | 50595296 |
| Congenital hydrocephalus | 31.82 | 20.25 | 7 | 9773 | 135 | 50595209 |
| Polydactyly | 31.19 | 20.25 | 8 | 9772 | 303 | 50595041 |
| Spinocerebellar disorder | 30.83 | 20.25 | 5 | 9775 | 15 | 50595329 |
| Ectopic kidney | 30.58 | 20.25 | 6 | 9774 | 64 | 50595280 |
| Hydrocephalus | 30.54 | 20.25 | 16 | 9764 | 4772 | 50590572 |
| Polyhydramnios | 29.48 | 20.25 | 12 | 9768 | 2013 | 50593331 |
| Peripheral swelling | 29.11 | 20.25 | 3 | 9777 | 205933 | 50389411 |
| Lactic acidosis | 29.02 | 20.25 | 34 | 9746 | 33321 | 50562023 |
| Anaemia | 28.41 | 20.25 | 110 | 9670 | 252346 | 50342998 |
| Eyelid oedema | 27.31 | 20.25 | 19 | 9761 | 9447 | 50585897 |
| Tubulointerstitial nephritis | 27.28 | 20.25 | 23 | 9757 | 15188 | 50580156 |
| HIV-associated neurocognitive disorder | 26.84 | 20.25 | 6 | 9774 | 125 | 50595219 |
| Glucocorticoids increased | 26.79 | 20.25 | 6 | 9774 | 126 | 50595218 |
| Dermatitis exfoliative | 26.72 | 20.25 | 15 | 9765 | 5127 | 50590217 |
| Porphyria non-acute | 26.69 | 20.25 | 7 | 9773 | 290 | 50595054 |
| Coarctation of the aorta | 26.35 | 20.25 | 8 | 9772 | 565 | 50594779 |
| Pregnancy on oral contraceptive | 26.14 | 20.25 | 9 | 9771 | 949 | 50594395 |
| Congenital genital malformation | 25.99 | 20.25 | 6 | 9774 | 145 | 50595199 |
| Neonatal respiratory arrest | 25.78 | 20.25 | 5 | 9775 | 50 | 50595294 |
| Cushingoid | 25.65 | 20.25 | 16 | 9764 | 6629 | 50588715 |
| Central obesity | 25.57 | 20.25 | 9 | 9771 | 1013 | 50594331 |
| Cloacal exstrophy | 25.53 | 20.25 | 6 | 9774 | 157 | 50595187 |
| Chronic papillomatous dermatitis | 25.52 | 20.25 | 5 | 9775 | 53 | 50595291 |
| Caudal regression syndrome | 25.14 | 20.25 | 6 | 9774 | 168 | 50595176 |
| Skin striae | 25.04 | 20.25 | 9 | 9771 | 1077 | 50594267 |
| Neural tube defect | 24.55 | 20.25 | 6 | 9774 | 186 | 50595158 |
| Hypophosphataemia | 24.54 | 20.25 | 17 | 9763 | 8397 | 50586947 |
| ACTH stimulation test abnormal | 24.19 | 20.25 | 4 | 9776 | 14 | 50595330 |
| Generalised anxiety disorder | 23.83 | 20.25 | 10 | 9770 | 1810 | 50593534 |
| Prurigo | 23.78 | 20.25 | 8 | 9772 | 787 | 50594557 |
| Transaminases increased | 23.60 | 20.25 | 28 | 9752 | 27796 | 50567548 |
| Neonatal respiratory distress syndrome | 23.24 | 20.25 | 11 | 9769 | 2643 | 50592701 |
| Abdominal discomfort | 23.06 | 20.25 | 8 | 9772 | 231633 | 50363711 |
| Foetal cardiac disorder | 22.57 | 20.25 | 4 | 9776 | 23 | 50595321 |
| Abortion infected | 22.57 | 20.25 | 4 | 9776 | 23 | 50595321 |
| Hepatotoxicity | 22.44 | 20.25 | 27 | 9753 | 27199 | 50568145 |
| Adrenal insufficiency | 22.43 | 20.25 | 20 | 9760 | 14223 | 50581121 |
| Thymus hypoplasia | 22.43 | 20.25 | 4 | 9776 | 24 | 50595320 |
| Blood phosphorus decreased | 22.30 | 20.25 | 12 | 9768 | 3777 | 50591567 |
| Nasopharyngitis | 22.29 | 20.25 | 5 | 9775 | 192922 | 50402422 |
| Umbilical cord abnormality | 21.79 | 20.25 | 7 | 9773 | 596 | 50594748 |
| Proteinuria | 21.68 | 20.25 | 21 | 9759 | 16576 | 50578768 |
| HIV test positive | 21.65 | 20.25 | 4 | 9776 | 30 | 50595314 |
| Pulmonary valve sclerosis | 21.32 | 20.25 | 4 | 9776 | 33 | 50595311 |
| Cholestasis of pregnancy | 21.02 | 20.25 | 8 | 9772 | 1123 | 50594221 |
| Pulmonary tuberculosis | 20.95 | 20.25 | 12 | 9768 | 4261 | 50591083 |
| CD4 lymphocytes increased | 20.85 | 20.25 | 5 | 9775 | 143 | 50595201 |
| Arthralgia | 20.78 | 20.25 | 33 | 9747 | 438669 | 50156675 |
| Retinal toxicity | 20.64 | 20.25 | 8 | 9772 | 1180 | 50594164 |
| Renal tubular dysfunction | 20.60 | 20.25 | 6 | 9774 | 367 | 50594977 |
| Nephropathy toxic | 20.59 | 20.25 | 15 | 9765 | 8014 | 50587330 |
| Bladder agenesis | 20.59 | 20.25 | 5 | 9775 | 151 | 50595193 |
| Genitalia external ambiguous | 20.37 | 20.25 | 5 | 9775 | 158 | 50595186 |
| Anal atresia | 20.32 | 20.25 | 6 | 9774 | 385 | 50594959 |
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 | 776.77 | 14.00 | 261 | 18784 | 7541 | 29547941 |
| Fanconi syndrome acquired | 241.49 | 14.00 | 76 | 18969 | 1766 | 29553716 |
| Blood HIV RNA increased | 225.01 | 14.00 | 63 | 18982 | 961 | 29554521 |
| Virologic failure | 220.29 | 14.00 | 79 | 18966 | 2768 | 29552714 |
| Drug interaction | 186.49 | 14.00 | 399 | 18646 | 196986 | 29358496 |
| Viral load increased | 181.97 | 14.00 | 63 | 18982 | 1986 | 29553496 |
| Viral mutation identified | 173.71 | 14.00 | 64 | 18981 | 2424 | 29553058 |
| Drug resistance | 168.44 | 14.00 | 127 | 18918 | 21413 | 29534069 |
| Renal tubular disorder | 158.18 | 14.00 | 70 | 18975 | 4282 | 29551200 |
| Pathogen resistance | 143.64 | 14.00 | 80 | 18965 | 8036 | 29547446 |
| Renal colic | 141.18 | 14.00 | 49 | 18996 | 1556 | 29553926 |
| Psychiatric decompensation | 136.48 | 14.00 | 47 | 18998 | 1457 | 29554025 |
| Genotype drug resistance test positive | 120.85 | 14.00 | 39 | 19006 | 984 | 29554498 |
| CD4 lymphocytes decreased | 107.48 | 14.00 | 40 | 19005 | 1558 | 29553924 |
| Depression suicidal | 107.43 | 14.00 | 38 | 19007 | 1277 | 29554205 |
| Tearfulness | 102.94 | 14.00 | 39 | 19006 | 1597 | 29553885 |
| Fanconi syndrome | 89.49 | 14.00 | 35 | 19010 | 1563 | 29553919 |
| Acute HIV infection | 89.36 | 14.00 | 18 | 19027 | 54 | 29555428 |
| Osteonecrosis | 82.64 | 14.00 | 69 | 18976 | 13450 | 29542032 |
| HIV-associated neurocognitive disorder | 81.04 | 14.00 | 22 | 19023 | 297 | 29555185 |
| Renal tubular necrosis | 79.20 | 14.00 | 69 | 18976 | 14246 | 29541236 |
| Jaundice | 71.19 | 14.00 | 91 | 18954 | 29205 | 29526277 |
| Paranoia | 70.07 | 14.00 | 55 | 18990 | 9822 | 29545660 |
| Acute kidney injury | 68.43 | 14.00 | 344 | 18701 | 264923 | 29290559 |
| Foetal exposure during pregnancy | 68.23 | 14.00 | 96 | 18949 | 33771 | 29521711 |
| Nephropathy toxic | 68.03 | 14.00 | 56 | 18989 | 10700 | 29544782 |
| Nephrolithiasis | 66.83 | 14.00 | 82 | 18963 | 25252 | 29530230 |
| Cytomegalovirus chorioretinitis | 65.83 | 14.00 | 35 | 19010 | 3203 | 29552279 |
| Proteinuria | 65.78 | 14.00 | 65 | 18980 | 15739 | 29539743 |
| Hepatic cytolysis | 64.72 | 14.00 | 49 | 18996 | 8298 | 29547184 |
| Death | 63.96 | 14.00 | 76 | 18969 | 342008 | 29213474 |
| Depressive symptom | 63.61 | 14.00 | 28 | 19017 | 1689 | 29553793 |
| Hypophosphataemia | 60.29 | 14.00 | 46 | 18999 | 7878 | 29547604 |
| Osteoporosis | 59.75 | 14.00 | 52 | 18993 | 10717 | 29544765 |
| Kaposi's sarcoma | 59.52 | 14.00 | 22 | 19023 | 840 | 29554642 |
| Lipodystrophy acquired | 58.86 | 14.00 | 32 | 19013 | 3062 | 29552420 |
| Acquired immunodeficiency syndrome | 57.55 | 14.00 | 18 | 19027 | 409 | 29555073 |
| Syphilis | 56.92 | 14.00 | 17 | 19028 | 329 | 29555153 |
| CSF HIV escape syndrome | 52.78 | 14.00 | 14 | 19031 | 172 | 29555310 |
| Psychomotor skills impaired | 51.95 | 14.00 | 28 | 19017 | 2633 | 29552849 |
| Renal failure | 50.98 | 14.00 | 180 | 18865 | 118419 | 29437063 |
| Glycosuria | 49.78 | 14.00 | 21 | 19024 | 1141 | 29554341 |
| Exposure during pregnancy | 48.86 | 14.00 | 42 | 19003 | 8512 | 29546970 |
| Hyperbilirubinaemia | 48.84 | 14.00 | 54 | 18991 | 14880 | 29540602 |
| Osteoporotic fracture | 46.13 | 14.00 | 19 | 19026 | 972 | 29554510 |
| Suicidal ideation | 45.72 | 14.00 | 81 | 18964 | 34635 | 29520847 |
| Vanishing bile duct syndrome | 44.29 | 14.00 | 16 | 19029 | 572 | 29554910 |
| Hepatitis B | 42.01 | 14.00 | 32 | 19013 | 5465 | 29550017 |
| Gene mutation | 41.90 | 14.00 | 18 | 19027 | 1023 | 29554459 |
| Renal tubular dysfunction | 41.76 | 14.00 | 14 | 19031 | 399 | 29555083 |
| Blood creatinine increased | 41.68 | 14.00 | 135 | 18910 | 84967 | 29470515 |
| Psychotic disorder | 41.42 | 14.00 | 58 | 18987 | 20296 | 29535186 |
| Portal hypertension | 39.95 | 14.00 | 26 | 19019 | 3460 | 29552022 |
| Osteomalacia | 38.09 | 14.00 | 16 | 19029 | 860 | 29554622 |
| HIV infection | 36.59 | 14.00 | 17 | 19028 | 1164 | 29554318 |
| Malignant neoplasm progression | 36.33 | 14.00 | 3 | 19042 | 73856 | 29481626 |
| Ocular icterus | 36.23 | 14.00 | 22 | 19023 | 2593 | 29552889 |
| Hepatitis C | 35.87 | 14.00 | 36 | 19009 | 8874 | 29546608 |
| Fall | 35.59 | 14.00 | 37 | 19008 | 177141 | 29378341 |
| Abnormal dreams | 35.56 | 14.00 | 32 | 19013 | 6888 | 29548594 |
| Cortisol decreased | 35.54 | 14.00 | 15 | 19030 | 816 | 29554666 |
| Anal cancer | 35.47 | 14.00 | 12 | 19033 | 352 | 29555130 |
| Congenital hearing disorder | 35.35 | 14.00 | 9 | 19036 | 93 | 29555389 |
| Meningitis cryptococcal | 35.24 | 14.00 | 20 | 19025 | 2080 | 29553402 |
| Lactic acidosis | 32.86 | 14.00 | 65 | 18980 | 30182 | 29525300 |
| Hepatitis | 32.00 | 14.00 | 52 | 18993 | 20731 | 29534751 |
| Mycobacterium avium complex infection | 31.21 | 14.00 | 19 | 19026 | 2250 | 29553232 |
| Hydrocele | 31.17 | 14.00 | 18 | 19027 | 1935 | 29553547 |
| Dyslipidaemia | 31.09 | 14.00 | 28 | 19017 | 6033 | 29549449 |
| Unmasking of previously unidentified disease | 30.75 | 14.00 | 13 | 19032 | 710 | 29554772 |
| Pulmonary tuberculosis | 30.54 | 14.00 | 24 | 19021 | 4291 | 29551191 |
| Depression | 30.52 | 14.00 | 122 | 18923 | 85025 | 29470457 |
| Anogenital warts | 30.32 | 14.00 | 12 | 19033 | 553 | 29554929 |
| Cachexia | 29.98 | 14.00 | 28 | 19017 | 6321 | 29549161 |
| Aspartate aminotransferase increased | 29.45 | 14.00 | 95 | 18950 | 59630 | 29495852 |
| Dyspnoea | 28.04 | 14.00 | 112 | 18933 | 326620 | 29228862 |
| Hypertriglyceridaemia | 27.91 | 14.00 | 29 | 19016 | 7446 | 29548036 |
| Disease progression | 27.89 | 14.00 | 9 | 19036 | 81907 | 29473575 |
| Peripheral swelling | 27.77 | 14.00 | 4 | 19041 | 63735 | 29491747 |
| Atrial fibrillation | 27.53 | 14.00 | 17 | 19028 | 105629 | 29449853 |
| CSF virus identified | 27.36 | 14.00 | 6 | 19039 | 30 | 29555452 |
| Drug abuse | 26.80 | 14.00 | 9 | 19036 | 79874 | 29475608 |
| Oesophageal candidiasis | 26.50 | 14.00 | 21 | 19024 | 3800 | 29551682 |
| Constipation | 26.28 | 14.00 | 21 | 19024 | 114139 | 29441343 |
| Product dose omission issue | 25.82 | 14.00 | 15 | 19030 | 96368 | 29459114 |
| Blood bilirubin increased | 25.65 | 14.00 | 63 | 18982 | 33830 | 29521652 |
| Hodgkin's disease | 25.57 | 14.00 | 12 | 19033 | 840 | 29554642 |
| Suicide attempt | 25.39 | 14.00 | 63 | 18982 | 34047 | 29521435 |
| Blood phosphorus decreased | 25.31 | 14.00 | 18 | 19027 | 2767 | 29552715 |
| Haemophilic arthropathy | 25.10 | 14.00 | 7 | 19038 | 105 | 29555377 |
| Mitochondrial myopathy | 25.01 | 14.00 | 8 | 19037 | 196 | 29555286 |
| Cytomegalovirus colitis | 24.88 | 14.00 | 17 | 19028 | 2452 | 29553030 |
| Hepatosplenomegaly | 24.86 | 14.00 | 20 | 19025 | 3697 | 29551785 |
| Pneumonia | 24.85 | 14.00 | 114 | 18931 | 320058 | 29235424 |
| Renal impairment | 24.84 | 14.00 | 111 | 18934 | 81222 | 29474260 |
| Burkitt's lymphoma | 24.62 | 14.00 | 7 | 19038 | 113 | 29555369 |
| Tubulointerstitial nephritis | 24.30 | 14.00 | 42 | 19003 | 17601 | 29537881 |
| Progressive multifocal leukoencephalopathy | 24.24 | 14.00 | 29 | 19016 | 8690 | 29546792 |
| Oral candidiasis | 24.00 | 14.00 | 32 | 19013 | 10690 | 29544792 |
| Hepatotoxicity | 23.91 | 14.00 | 42 | 19003 | 17825 | 29537657 |
| Blood alkaline phosphatase increased | 23.87 | 14.00 | 55 | 18990 | 28351 | 29527131 |
| Treatment noncompliance | 23.87 | 14.00 | 50 | 18995 | 24177 | 29531305 |
| Rash maculo-papular | 23.78 | 14.00 | 50 | 18995 | 24239 | 29531243 |
| Cardiac failure congestive | 23.40 | 14.00 | 10 | 19035 | 76571 | 29478911 |
| Liver function test abnormal | 23.22 | 14.00 | 55 | 18990 | 28863 | 29526619 |
| Hepatitis B DNA assay positive | 23.06 | 14.00 | 6 | 19039 | 68 | 29555414 |
| Alanine aminotransferase increased | 22.55 | 14.00 | 98 | 18947 | 70846 | 29484636 |
| Cerebral toxoplasmosis | 22.46 | 14.00 | 13 | 19032 | 1403 | 29554079 |
| Pancytopenia | 22.09 | 14.00 | 109 | 18936 | 83059 | 29472423 |
| Porphyria non-acute | 22.00 | 14.00 | 9 | 19036 | 452 | 29555030 |
| Hypotension | 21.90 | 14.00 | 59 | 18986 | 194295 | 29361187 |
| Lipoatrophy | 21.49 | 14.00 | 9 | 19036 | 480 | 29555002 |
| Atypical mycobacterial infection | 21.43 | 14.00 | 10 | 19035 | 691 | 29554791 |
| Stevens-Johnson syndrome | 21.08 | 14.00 | 38 | 19007 | 16459 | 29539023 |
| Supernumerary nipple | 21.01 | 14.00 | 5 | 19040 | 38 | 29555444 |
| Megakaryocytes increased | 20.90 | 14.00 | 5 | 19040 | 39 | 29555443 |
| Rhabdomyolysis | 20.88 | 14.00 | 86 | 18959 | 60722 | 29494760 |
| Product use issue | 20.69 | 14.00 | 4 | 19041 | 51440 | 29504042 |
| Lymphadenopathy | 20.50 | 14.00 | 48 | 18997 | 25001 | 29530481 |
| Rash | 20.37 | 14.00 | 199 | 18846 | 189620 | 29365862 |
| Hemiparaesthesia | 20.36 | 14.00 | 5 | 19040 | 44 | 29555438 |
| Cholestasis | 20.35 | 14.00 | 46 | 18999 | 23416 | 29532066 |
| Completed suicide | 20.26 | 14.00 | 17 | 19028 | 90229 | 29465253 |
| Acute hepatic failure | 19.90 | 14.00 | 31 | 19014 | 11921 | 29543561 |
| Psychomotor retardation | 19.88 | 14.00 | 16 | 19029 | 2960 | 29552522 |
| Anogenital dysplasia | 19.63 | 14.00 | 6 | 19039 | 126 | 29555356 |
| Blood pressure increased | 19.04 | 14.00 | 12 | 19033 | 73791 | 29481691 |
| Febrile neutropenia | 18.75 | 14.00 | 27 | 19018 | 112213 | 29443269 |
| Nodular regenerative hyperplasia | 18.61 | 14.00 | 9 | 19036 | 674 | 29554808 |
| Neonatal asphyxia | 18.51 | 14.00 | 7 | 19038 | 285 | 29555197 |
| Glucose urine present | 18.33 | 14.00 | 10 | 19035 | 963 | 29554519 |
| AIDS related complication | 18.24 | 14.00 | 4 | 19041 | 20 | 29555462 |
| Cushingoid | 18.21 | 14.00 | 14 | 19031 | 2424 | 29553058 |
| Multiple-drug resistance | 18.03 | 14.00 | 17 | 19028 | 3883 | 29551599 |
| Congenital anomaly | 17.96 | 14.00 | 11 | 19034 | 1317 | 29554165 |
| Trisomy 21 | 17.92 | 14.00 | 8 | 19037 | 499 | 29554983 |
| Beta 2 microglobulin urine increased | 17.69 | 14.00 | 5 | 19040 | 79 | 29555403 |
| Premature baby | 17.41 | 14.00 | 36 | 19009 | 17244 | 29538238 |
| Influenza | 17.40 | 14.00 | 3 | 19042 | 41878 | 29513604 |
| Lymphoma | 17.08 | 14.00 | 26 | 19019 | 9802 | 29545680 |
| Pancreatitis acute | 17.06 | 14.00 | 44 | 19001 | 24341 | 29531141 |
| Polydactyly | 16.85 | 14.00 | 10 | 19035 | 1130 | 29554352 |
| End stage AIDS | 16.74 | 14.00 | 4 | 19041 | 31 | 29555451 |
| Pulmonary venous thrombosis | 16.73 | 14.00 | 5 | 19040 | 97 | 29555385 |
| Crystal nephropathy | 16.70 | 14.00 | 7 | 19038 | 374 | 29555108 |
| Prurigo | 16.43 | 14.00 | 8 | 19037 | 608 | 29554874 |
| Nasopharyngitis | 16.38 | 14.00 | 9 | 19036 | 59656 | 29495826 |
| Cushing's syndrome | 16.36 | 14.00 | 7 | 19038 | 394 | 29555088 |
| Fibrous histiocytoma | 16.27 | 14.00 | 5 | 19040 | 107 | 29555375 |
| Secondary syphilis | 16.21 | 14.00 | 4 | 19041 | 36 | 29555446 |
| Ergot poisoning | 16.21 | 14.00 | 4 | 19041 | 36 | 29555446 |
| Antiviral drug level above therapeutic | 16.21 | 14.00 | 4 | 19041 | 36 | 29555446 |
| White matter lesion | 16.02 | 14.00 | 8 | 19037 | 642 | 29554840 |
| Joint swelling | 15.94 | 14.00 | 6 | 19039 | 49624 | 29505858 |
| Oesophageal carcinoma | 15.83 | 14.00 | 17 | 19028 | 4530 | 29550952 |
| Eagle Barrett syndrome | 15.75 | 14.00 | 3 | 19042 | 6 | 29555476 |
| Back pain | 15.74 | 14.00 | 26 | 19019 | 102258 | 29453224 |
| Nasal septum deviation | 15.73 | 14.00 | 9 | 19036 | 950 | 29554532 |
| Gamma-glutamyltransferase increased | 15.47 | 14.00 | 45 | 19000 | 26692 | 29528790 |
| Anxiety | 15.47 | 14.00 | 101 | 18944 | 85264 | 29470218 |
| Haemodialysis | 15.44 | 14.00 | 25 | 19020 | 9929 | 29545553 |
| Adrenal atrophy | 15.44 | 14.00 | 3 | 19042 | 7 | 29555475 |
| Blood bilirubin decreased | 15.32 | 14.00 | 6 | 19039 | 269 | 29555213 |
| Lung transplant rejection | 15.21 | 14.00 | 8 | 19037 | 716 | 29554766 |
| Oxygen saturation decreased | 15.17 | 14.00 | 5 | 19040 | 44932 | 29510550 |
| Pain | 15.14 | 14.00 | 58 | 18987 | 171374 | 29384108 |
| Blood corticotrophin decreased | 15.13 | 14.00 | 5 | 19040 | 136 | 29555346 |
| Depressed mood | 15.11 | 14.00 | 33 | 19012 | 16415 | 29539067 |
| Varices oesophageal | 15.09 | 14.00 | 14 | 19031 | 3132 | 29552350 |
| Phosphorus metabolism disorder | 14.89 | 14.00 | 3 | 19042 | 9 | 29555473 |
| Cardio-respiratory arrest | 14.84 | 14.00 | 7 | 19038 | 50594 | 29504888 |
| Portal hypertensive gastropathy | 14.68 | 14.00 | 7 | 19038 | 508 | 29554974 |
| Pulmonary hilar enlargement | 14.65 | 14.00 | 3 | 19042 | 10 | 29555472 |
| Adrenogenital syndrome | 14.47 | 14.00 | 4 | 19041 | 58 | 29555424 |
| Drug ineffective | 14.46 | 14.00 | 157 | 18888 | 363013 | 29192469 |
| Seroconversion test positive | 14.23 | 14.00 | 3 | 19042 | 12 | 29555470 |
| Pulmonary oedema | 14.01 | 14.00 | 5 | 19040 | 42730 | 29512752 |
FDA Adverse Event Reporting System (Geriatric)
| 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 | 950.00 | 15.53 | 288 | 20375 | 12182 | 64465887 |
| Abortion spontaneous | 483.82 | 15.53 | 210 | 20453 | 24933 | 64453136 |
| Viral mutation identified | 368.55 | 15.53 | 103 | 20560 | 3243 | 64474826 |
| Virologic failure | 351.39 | 15.53 | 100 | 20563 | 3366 | 64474703 |
| Drug interaction | 323.82 | 15.53 | 482 | 20181 | 361601 | 64116468 |
| Blood HIV RNA increased | 310.26 | 15.53 | 76 | 20587 | 1408 | 64476661 |
| Abortion induced | 279.55 | 15.53 | 97 | 20566 | 6291 | 64471778 |
| Exposure during pregnancy | 276.56 | 15.53 | 216 | 20447 | 77459 | 64400610 |
| Pathogen resistance | 251.74 | 15.53 | 108 | 20555 | 12435 | 64465634 |
| Drug resistance | 247.72 | 15.53 | 149 | 20514 | 34953 | 64443116 |
| Viral load increased | 217.60 | 15.53 | 64 | 20599 | 2423 | 64475646 |
| Fanconi syndrome acquired | 184.50 | 15.53 | 56 | 20607 | 2365 | 64475704 |
| Stillbirth | 177.80 | 15.53 | 60 | 20603 | 3573 | 64474496 |
| Renal tubular disorder | 166.02 | 15.53 | 65 | 20598 | 5922 | 64472147 |
| CD4 lymphocytes decreased | 150.57 | 15.53 | 48 | 20615 | 2387 | 64475682 |
| Psychiatric decompensation | 145.93 | 15.53 | 47 | 20616 | 2416 | 64475653 |
| Genotype drug resistance test positive | 137.50 | 15.53 | 37 | 20626 | 1007 | 64477062 |
| Depression suicidal | 117.67 | 15.53 | 40 | 20623 | 2435 | 64475634 |
| Renal colic | 115.71 | 15.53 | 39 | 20624 | 2313 | 64475756 |
| Fanconi syndrome | 113.36 | 15.53 | 39 | 20624 | 2462 | 64475607 |
| CSF HIV escape syndrome | 106.69 | 15.53 | 24 | 20639 | 301 | 64477768 |
| Lipodystrophy acquired | 102.14 | 15.53 | 41 | 20622 | 3986 | 64474083 |
| Nephropathy toxic | 99.93 | 15.53 | 65 | 20598 | 17449 | 64460620 |
| Acute kidney injury | 98.90 | 15.53 | 342 | 20321 | 448898 | 64029171 |
| Jaundice | 98.17 | 15.53 | 98 | 20565 | 48414 | 64429655 |
| Renal tubular necrosis | 97.53 | 15.53 | 70 | 20593 | 22040 | 64456029 |
| Pregnancy | 96.52 | 15.53 | 68 | 20595 | 20797 | 64457272 |
| Tearfulness | 96.25 | 15.53 | 41 | 20622 | 4632 | 64473437 |
| HIV-associated neurocognitive disorder | 95.82 | 15.53 | 22 | 20641 | 304 | 64477765 |
| Hyperbilirubinaemia | 84.18 | 15.53 | 63 | 20600 | 21142 | 64456927 |
| Acute HIV infection | 83.27 | 15.53 | 15 | 20648 | 52 | 64478017 |
| Paranoia | 81.98 | 15.53 | 56 | 20607 | 16296 | 64461773 |
| Osteonecrosis | 76.30 | 15.53 | 67 | 20596 | 28162 | 64449907 |
| Renal tubular dysfunction | 70.05 | 15.53 | 20 | 20643 | 680 | 64477389 |
| Proteinuria | 69.38 | 15.53 | 63 | 20600 | 27660 | 64450409 |
| Cushing's syndrome | 68.21 | 15.53 | 21 | 20642 | 930 | 64477139 |
| Psychomotor skills impaired | 67.03 | 15.53 | 30 | 20633 | 3815 | 64474254 |
| Treatment noncompliance | 66.97 | 15.53 | 76 | 20587 | 43406 | 64434663 |
| Cytomegalovirus chorioretinitis | 62.99 | 15.53 | 31 | 20632 | 4881 | 64473188 |
| Nephrolithiasis | 61.66 | 15.53 | 73 | 20590 | 43610 | 64434459 |
| Immune reconstitution inflammatory syndrome associated tuberculosis | 59.41 | 15.53 | 18 | 20645 | 755 | 64477314 |
| Hypophosphataemia | 56.79 | 15.53 | 43 | 20620 | 14677 | 64463392 |
| Depressive symptom | 56.54 | 15.53 | 28 | 20635 | 4468 | 64473601 |
| Maternal exposure during pregnancy | 56.15 | 15.53 | 106 | 20557 | 95778 | 64382291 |
| Psychotic disorder | 55.92 | 15.53 | 62 | 20601 | 34516 | 64443553 |
| Renal failure | 54.27 | 15.53 | 154 | 20509 | 181534 | 64296535 |
| Pain | 53.74 | 15.53 | 59 | 20604 | 553452 | 63924617 |
| Premature rupture of membranes | 52.14 | 15.53 | 25 | 20638 | 3719 | 64474350 |
| Gene mutation | 52.12 | 15.53 | 21 | 20642 | 2061 | 64476008 |
| Pulmonary tuberculosis | 51.70 | 15.53 | 31 | 20632 | 7213 | 64470856 |
| Oesophageal candidiasis | 51.31 | 15.53 | 32 | 20631 | 7985 | 64470084 |
| Joint swelling | 50.98 | 15.53 | 5 | 20658 | 215377 | 64262692 |
| Live birth | 50.62 | 15.53 | 36 | 20627 | 11168 | 64466901 |
| Fall | 49.28 | 15.53 | 37 | 20626 | 416789 | 64061280 |
| Cushingoid | 47.78 | 15.53 | 30 | 20633 | 7573 | 64470496 |
| Oligohydramnios | 47.00 | 15.53 | 22 | 20641 | 3102 | 64474967 |
| Adrenal suppression | 46.14 | 15.53 | 17 | 20646 | 1310 | 64476759 |
| Glycosuria | 45.39 | 15.53 | 19 | 20644 | 2055 | 64476014 |
| Hepatitis | 45.23 | 15.53 | 64 | 20599 | 45518 | 64432551 |
| Meningitis cryptococcal | 44.68 | 15.53 | 21 | 20642 | 2988 | 64475081 |
| Vanishing bile duct syndrome | 43.08 | 15.53 | 16 | 20647 | 1261 | 64476808 |
| Cortisol decreased | 42.27 | 15.53 | 17 | 20646 | 1660 | 64476409 |
| Abnormal dreams | 41.61 | 15.53 | 31 | 20632 | 10325 | 64467744 |
| Blood creatinine increased | 41.41 | 15.53 | 116 | 20547 | 135666 | 64342403 |
| Hepatic cytolysis | 41.31 | 15.53 | 35 | 20628 | 14014 | 64464055 |
| Rash maculo-papular | 40.83 | 15.53 | 62 | 20601 | 46964 | 64431105 |
| Renal impairment | 40.83 | 15.53 | 115 | 20548 | 134902 | 64343167 |
| Portal hypertension | 40.24 | 15.53 | 25 | 20638 | 6194 | 64471875 |
| Cholestasis | 40.16 | 15.53 | 60 | 20603 | 44812 | 64433257 |
| Drug reaction with eosinophilia and systemic symptoms | 39.53 | 15.53 | 66 | 20597 | 54151 | 64423918 |
| Tubulointerstitial nephritis | 39.29 | 15.53 | 49 | 20614 | 30860 | 64447209 |
| Lactic acidosis | 38.58 | 15.53 | 70 | 20593 | 61340 | 64416729 |
| Peripheral swelling | 38.06 | 15.53 | 10 | 20653 | 209143 | 64268926 |
| Hepatotoxicity | 38.02 | 15.53 | 55 | 20608 | 39907 | 64438162 |
| Premature labour | 37.96 | 15.53 | 26 | 20637 | 7594 | 64470475 |
| Autoimmune hepatitis | 37.89 | 15.53 | 29 | 20634 | 10055 | 64468014 |
| CSF virus identified | 36.80 | 15.53 | 7 | 20656 | 35 | 64478034 |
| Pancytopenia | 36.62 | 15.53 | 115 | 20548 | 143194 | 64334875 |
| Megakaryocytes increased | 36.61 | 15.53 | 8 | 20655 | 87 | 64477982 |
| Mycobacterium avium complex infection | 36.53 | 15.53 | 20 | 20643 | 3920 | 64474149 |
| Nasopharyngitis | 36.40 | 15.53 | 9 | 20654 | 196064 | 64282005 |
| Haemolytic anaemia | 35.38 | 15.53 | 34 | 20629 | 16019 | 64462050 |
| Completed suicide | 35.07 | 15.53 | 14 | 20649 | 224400 | 64253669 |
| Blood phosphorus decreased | 34.57 | 15.53 | 22 | 20641 | 5683 | 64472386 |
| Malaria | 34.34 | 15.53 | 10 | 20653 | 365 | 64477704 |
| Ocular icterus | 34.28 | 15.53 | 21 | 20642 | 5077 | 64472992 |
| Spina bifida | 34.19 | 15.53 | 7 | 20656 | 54 | 64478015 |
| Central obesity | 34.10 | 15.53 | 14 | 20649 | 1441 | 64476628 |
| Osteoporosis | 33.08 | 15.53 | 53 | 20610 | 42027 | 64436042 |
| Pre-eclampsia | 32.80 | 15.53 | 22 | 20641 | 6209 | 64471860 |
| Unmasking of previously unidentified disease | 32.43 | 15.53 | 14 | 20649 | 1633 | 64476436 |
| Placenta praevia | 31.96 | 15.53 | 11 | 20652 | 695 | 64477374 |
| Syphilis | 31.95 | 15.53 | 10 | 20653 | 468 | 64477601 |
| Ultrasound antenatal screen abnormal | 31.88 | 15.53 | 6 | 20657 | 28 | 64478041 |
| Death | 31.79 | 15.53 | 67 | 20596 | 482638 | 63995431 |
| Blood bilirubin increased | 31.67 | 15.53 | 62 | 20601 | 57491 | 64420578 |
| Foetal exposure during pregnancy | 31.54 | 15.53 | 19 | 20644 | 4457 | 64473612 |
| Aspartate aminotransferase increased | 31.41 | 15.53 | 97 | 20566 | 119691 | 64358378 |
| Kaposi's sarcoma | 31.32 | 15.53 | 11 | 20652 | 738 | 64477331 |
| Osteomalacia | 31.30 | 15.53 | 13 | 20650 | 1378 | 64476691 |
| Drug ineffective | 29.51 | 15.53 | 154 | 20509 | 840093 | 63637976 |
| Premature delivery | 29.48 | 15.53 | 33 | 20630 | 18556 | 64459513 |
| Foetal death | 28.99 | 15.53 | 20 | 20643 | 5910 | 64472159 |
| Suicidal ideation | 28.83 | 15.53 | 65 | 20598 | 66477 | 64411592 |
| Hepatomegaly | 28.55 | 15.53 | 31 | 20632 | 16851 | 64461218 |
| Lung transplant rejection | 28.47 | 15.53 | 12 | 20651 | 1320 | 64476749 |
| Arthropathy | 28.11 | 15.53 | 3 | 20660 | 120964 | 64357105 |
| Hepatitis fulminant | 27.97 | 15.53 | 20 | 20643 | 6254 | 64471815 |
| Cerebral toxoplasmosis | 27.90 | 15.53 | 13 | 20650 | 1813 | 64476256 |
| Mitochondrial myopathy | 27.77 | 15.53 | 8 | 20655 | 281 | 64477788 |
| Viraemia | 27.68 | 15.53 | 14 | 20649 | 2335 | 64475734 |
| Foetal cardiac disorder | 27.61 | 15.53 | 5 | 20658 | 18 | 64478051 |
| Adrenal insufficiency | 27.55 | 15.53 | 35 | 20628 | 22452 | 64455617 |
| Product dose omission issue | 27.53 | 15.53 | 14 | 20649 | 194733 | 64283336 |
| Renal tubular acidosis | 27.28 | 15.53 | 15 | 20648 | 2964 | 64475105 |
| Osteoporotic fracture | 27.25 | 15.53 | 16 | 20647 | 3582 | 64474487 |
| Hypertriglyceridaemia | 27.12 | 15.53 | 25 | 20638 | 11180 | 64466889 |
| Dyslipidaemia | 27.12 | 15.53 | 23 | 20640 | 9219 | 64468850 |
| Lipohypertrophy | 27.00 | 15.53 | 10 | 20653 | 782 | 64477287 |
| Polydipsia | 26.98 | 15.53 | 19 | 20644 | 5802 | 64472267 |
| Hepatitis B | 26.34 | 15.53 | 21 | 20642 | 7724 | 64470345 |
| Cytomegalovirus colitis | 25.95 | 15.53 | 16 | 20647 | 3912 | 64474157 |
| Melanoderma | 25.95 | 15.53 | 8 | 20655 | 356 | 64477713 |
| Malignant neoplasm progression | 25.72 | 15.53 | 3 | 20660 | 112868 | 64365201 |
| Blood corticotrophin decreased | 25.59 | 15.53 | 8 | 20655 | 373 | 64477696 |
| Hepatitis C | 25.55 | 15.53 | 24 | 20639 | 10991 | 64467078 |
| Blood alkaline phosphatase increased | 25.53 | 15.53 | 56 | 20607 | 56223 | 64421846 |
| White matter lesion | 25.51 | 15.53 | 12 | 20651 | 1710 | 64476359 |
| Pain in extremity | 25.47 | 15.53 | 36 | 20627 | 303049 | 64175020 |
| Injection site pain | 25.29 | 15.53 | 3 | 20660 | 111405 | 64366664 |
| Hereditary optic atrophy | 25.24 | 15.53 | 5 | 20658 | 32 | 64478037 |
| Retinal toxicity | 25.19 | 15.53 | 11 | 20652 | 1319 | 64476750 |
| Cachexia | 25.14 | 15.53 | 22 | 20641 | 9195 | 64468874 |
| Acquired immunodeficiency syndrome | 25.14 | 15.53 | 7 | 20656 | 217 | 64477852 |
| Oral candidiasis | 25.13 | 15.53 | 34 | 20629 | 23178 | 64454891 |
| Constipation | 25.01 | 15.53 | 22 | 20641 | 229315 | 64248754 |
| Progressive multifocal leukoencephalopathy | 24.95 | 15.53 | 30 | 20633 | 18202 | 64459867 |
| Rhabdomyolysis | 24.71 | 15.53 | 75 | 20588 | 91651 | 64386418 |
| Depression | 24.58 | 15.53 | 120 | 20543 | 183171 | 64294898 |
| Skin striae | 24.43 | 15.53 | 11 | 20652 | 1419 | 64476650 |
| Toxoplasmosis | 24.31 | 15.53 | 13 | 20650 | 2431 | 64475638 |
| Oxygen saturation decreased | 24.05 | 15.53 | 3 | 20660 | 107173 | 64370896 |
| Alanine aminotransferase increased | 23.89 | 15.53 | 98 | 20565 | 138933 | 64339136 |
| Glucocorticoids increased | 23.77 | 15.53 | 6 | 20657 | 126 | 64477943 |
| Pregnancy on oral contraceptive | 23.61 | 15.53 | 9 | 20654 | 762 | 64477307 |
| Anaemia | 23.51 | 15.53 | 204 | 20459 | 378476 | 64099593 |
| Pneumocystis jirovecii pneumonia | 23.37 | 15.53 | 36 | 20627 | 27598 | 64450471 |
| Red blood cell abnormality | 22.92 | 15.53 | 8 | 20655 | 527 | 64477542 |
| Multiple-drug resistance | 22.91 | 15.53 | 18 | 20645 | 6484 | 64471585 |
| Musculoskeletal stiffness | 22.20 | 15.53 | 6 | 20657 | 123200 | 64354869 |
| Psychomotor retardation | 22.03 | 15.53 | 16 | 20647 | 5127 | 64472942 |
| Abdominal discomfort | 21.74 | 15.53 | 16 | 20647 | 182306 | 64295763 |
| Aplasia pure red cell | 21.71 | 15.53 | 18 | 20645 | 6996 | 64471073 |
| Calculus urinary | 21.69 | 15.53 | 11 | 20652 | 1846 | 64476223 |
| Eyelid oedema | 21.56 | 15.53 | 23 | 20640 | 12256 | 64465813 |
| Hepatosplenomegaly | 21.48 | 15.53 | 16 | 20647 | 5327 | 64472742 |
| Fatigue | 21.10 | 15.53 | 147 | 20516 | 748583 | 63729486 |
| Arthralgia | 21.06 | 15.53 | 72 | 20591 | 442188 | 64035881 |
| Polyhydramnios | 20.92 | 15.53 | 10 | 20653 | 1477 | 64476592 |
| Oesophageal carcinoma | 20.87 | 15.53 | 15 | 20648 | 4728 | 64473341 |
| Dyspnoea | 20.79 | 15.53 | 140 | 20523 | 718534 | 63759535 |
| Blood pressure increased | 20.75 | 15.53 | 15 | 20648 | 172537 | 64305532 |
| Lymphadenopathy | 20.66 | 15.53 | 46 | 20617 | 46640 | 64431429 |
| Cardiac failure congestive | 20.63 | 15.53 | 8 | 20655 | 130572 | 64347497 |
| ACTH stimulation test abnormal | 20.56 | 15.53 | 4 | 20659 | 23 | 64478046 |
| Meningitis tuberculous | 20.43 | 15.53 | 9 | 20654 | 1102 | 64476967 |
| Atrial fibrillation | 20.41 | 15.53 | 15 | 20648 | 171074 | 64306995 |
| Contraindicated product administered | 19.90 | 15.53 | 5 | 20658 | 107824 | 64370245 |
| Anogenital dysplasia | 19.86 | 15.53 | 5 | 20658 | 104 | 64477965 |
| Pancreatitis acute | 19.84 | 15.53 | 43 | 20620 | 42812 | 64435257 |
| Contusion | 19.70 | 15.53 | 6 | 20657 | 113959 | 64364110 |
| Pulmonary venous thrombosis | 19.68 | 15.53 | 5 | 20658 | 108 | 64477961 |
| Anogenital warts | 19.67 | 15.53 | 8 | 20655 | 804 | 64477265 |
| Prurigo | 19.64 | 15.53 | 9 | 20654 | 1208 | 64476861 |
| Caesarean section | 19.59 | 15.53 | 21 | 20642 | 11253 | 64466816 |
| Burkitt's lymphoma | 19.10 | 15.53 | 5 | 20658 | 122 | 64477947 |
| Hemiparaesthesia | 19.10 | 15.53 | 5 | 20658 | 122 | 64477947 |
| Secondary syphilis | 18.99 | 15.53 | 4 | 20659 | 36 | 64478033 |
| Pyrexia | 18.57 | 15.53 | 266 | 20397 | 558378 | 63919691 |
| Generalised anxiety disorder | 18.53 | 15.53 | 10 | 20653 | 1905 | 64476164 |
| Gamma-glutamyltransferase increased | 18.41 | 15.53 | 45 | 20618 | 48465 | 64429604 |
| Lower respiratory tract infection | 18.23 | 15.53 | 4 | 20659 | 94610 | 64383459 |
| HIV infection | 18.20 | 15.53 | 8 | 20655 | 974 | 64477095 |
| Anal cancer | 17.97 | 15.53 | 7 | 20656 | 628 | 64477441 |
| Antiviral drug level above therapeutic | 17.94 | 15.53 | 4 | 20659 | 48 | 64478021 |
| Drug level increased | 17.80 | 15.53 | 36 | 20627 | 34160 | 64443909 |
| Polyuria | 17.62 | 15.53 | 21 | 20642 | 12622 | 64465447 |
| Nasal septum deviation | 17.59 | 15.53 | 9 | 20654 | 1539 | 64476530 |
| Bradycardia | 17.46 | 15.53 | 8 | 20655 | 118211 | 64359858 |
| Anembryonic gestation | 17.34 | 15.53 | 6 | 20657 | 385 | 64477684 |
| Mitochondrial cytopathy | 17.31 | 15.53 | 6 | 20657 | 387 | 64477682 |
| Maternal drugs affecting foetus | 17.20 | 15.53 | 9 | 20654 | 1611 | 64476458 |
| Sinusitis | 17.14 | 15.53 | 13 | 20650 | 145915 | 64332154 |
| Stomatitis | 16.84 | 15.53 | 7 | 20656 | 109598 | 64368471 |
| Hepatorenal syndrome | 16.83 | 15.53 | 12 | 20651 | 3734 | 64474335 |
| Hypotension | 16.82 | 15.53 | 64 | 20599 | 380910 | 64097159 |
| Nervous system disorder | 16.69 | 15.53 | 28 | 20635 | 23050 | 64455019 |
| Carbon dioxide decreased | 16.66 | 15.53 | 11 | 20652 | 3024 | 64475045 |
| Depressed mood | 16.59 | 15.53 | 39 | 20624 | 40973 | 64437096 |
| Face oedema | 16.54 | 15.53 | 29 | 20634 | 24732 | 64453337 |
| Transaminases increased | 16.53 | 15.53 | 41 | 20622 | 44553 | 64433516 |
| Haemorrhoids thrombosed | 16.49 | 15.53 | 5 | 20658 | 210 | 64477859 |
| Cerebellar ataxia | 16.39 | 15.53 | 9 | 20654 | 1774 | 64476295 |
| Suicide attempt | 16.33 | 15.53 | 55 | 20608 | 70952 | 64407117 |
| Skin lesion | 16.20 | 15.53 | 36 | 20627 | 36446 | 64441623 |
| Cellulitis | 16.06 | 15.53 | 5 | 20658 | 93652 | 64384417 |
| Pneumonia | 15.66 | 15.53 | 110 | 20553 | 559466 | 63918603 |
| Drug hypersensitivity | 15.62 | 15.53 | 33 | 20630 | 237782 | 64240287 |
FDA Adverse Event Reporting System (Pediatric)
None
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 | antiviral drugs |
| CHEBI has role | CHEBI:53756 | reverse transcriptase inhibitors |
Drug Use | Suggest Off label Use Form| |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 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
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 |
| 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 |
| 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 | 16714-534 | TABLET, FILM COATED | 200 mg | ORAL | ANDA | 28 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 | 50090-5957 | TABLET, FILM COATED | 200 mg | ORAL | ANDA | 28 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 |
| Symtuza | HUMAN PRESCRIPTION DRUG LABEL | 4 | 59676-800 | TABLET, FILM COATED | 200 mg | ORAL | NDA | 34 sections |