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abacavir 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| antivirals carbocyclic nucleosides | 34 | 136470-78-5 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
a carbocyclic nucleoside with potent selective anti-HIV activity; structure given in first source
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.60 | g | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Benet LZ, Broccatelli F, Oprea TI |
| S (Water solubility) | 77 mg/mL | Benet LZ, Broccatelli F, Oprea TI |
| EoM (Fraction excreted unchanged in urine) | 1.20 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 29.93 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BA (Bioavailability) | 83 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
| Vd (Volume of distribution) | 0.84 L/kg | Lombardo F, Berellini G, Obach RS |
| CL (Clearance) | 13 mL/min/kg | Lombardo F, Berellini G, Obach RS |
| fu (Fraction unbound in plasma) | 0.50 % | Lombardo F, Berellini G, Obach RS |
| t_half (Half-life) | 1 hours | Lombardo F, Berellini G, Obach RS |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | 1.168 | High | 1 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 9.550 | High | 1 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 13.274 | 10^-6 cm/s | High | 1 |
| dh-clint | Dog hepatocyte intrinsic clearance | 3.281 | uL/min/10^6 cells | High | 1 |
| dppb | Dog plasma protein binding (% unbound) | 76.560 | % | High | 1 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 83.650 | % | High | 1 |
| herg | hERG pIC50 | 4.159 | pIC50 | High | 1 |
| hh-clint | Human hepatocyte intrinsic clearance | 1.172 | uL/min/10^6 cells | High | 1 |
| hlm-clint | Human liver microsomal intrinsic clearance | 3.184 | uL/min/mg protein | High | 1 |
| hppb | Human plasma protein binding (% unbound) | 67.480 | % | High | 1 |
| kinase-safety-class | ACVR2B,ALK,AURKA,AURKB,AXL,BLK,BMX,BRAF,CAMK2A,CAMK2B,CAMK2D,CAMK2G,CDK1,CDK14,CDK16,CDK19,CDK2,CDK3,CDK4,CDK5,CDK6,CDK7,CDK8,CDK9,CLK1,CLK2,CLK4,CSF1R,DDR1,DYRK1A,DYRK1B,DYRK2,EGFR,EIF2AK3,ERBB2,FLT3,GAK,GRK2,GSK3B,HASPIN,IRAK1,IRAK3,IRAK4,ITK,JAK1,KDR,LCK,MAP3K1,MAP3K10,MAP3K21,MAP3K7,MAP4K1,MAP4K3,MAP4K5,MAPK15,MAPK3,MAPK7,MARK4,MELK,MET,NTRK1,NTRK2,PDK1,PDK2,PDK4,PIK3CA,PIK3CD,PRKCD,PRKDC,SIK2,SIK3,SRC,STK33,SYK,TTK,TYRO3,ULK1 | 77 | |||
| kinase-selectivity-class | AXL,CAMK2B,CAMK2D,CDK1,CDK16,CDK2,CDK3,CDK4,CDK6,CDK7,CDK8,CDK9,CLK2,CLK4,DYRK1A,DYRK1B,EGFR,EIF2AK3,HASPIN,IRAK1,IRAK3,IRAK4,MAP3K21,MAP4K1,NTRK1,PDK1,PIK3CD,TTK | 28 | |||
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 7.656 | High | 1 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 18.535 | High | 1 | |
| mppb | Mouse plasma protein binding (% unbound) | 78.210 | High | 1 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 15.276 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pld-class | Phospholipidosis risk class (1 = positive, 0 = negative) | 0 | High | 1 | |
| pppb | Pig plasma protein binding (% unbound) | 80.870 | % | High | 1 |
| rh-clint | Rat hepatocyte intrinsic clearance | 9.419 | uL/min/10^6 cells | High | 1 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 93.580 | % | High | 1 |
| rppb | Rat plasma protein binding (% unbound) | 63.740 | % | High | 1 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 1000 | uM | High | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| July 8, 1999 | EMA | ||
| Dec. 17, 1998 | FDA | VIIV HLTHCARE |
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 |
|---|---|---|---|---|---|---|
| Food allergy | 709.46 | 46.64 | 242 | 17100 | 25236 | 90585869 |
| Schizophrenia | 658.17 | 46.64 | 201 | 17141 | 14713 | 90596392 |
| Immunodeficiency | 601.84 | 46.64 | 247 | 17095 | 42987 | 90568118 |
| Temperature regulation disorder | 582.13 | 46.64 | 182 | 17160 | 14397 | 90596708 |
| Foetal death | 577.45 | 46.64 | 197 | 17145 | 20526 | 90590579 |
| Exposure during pregnancy | 568.80 | 46.64 | 423 | 16919 | 237987 | 90373118 |
| Hypomania | 528.61 | 46.64 | 151 | 17191 | 8746 | 90602359 |
| Rash erythematous | 486.92 | 46.64 | 241 | 17101 | 64863 | 90546242 |
| Jaundice cholestatic | 467.15 | 46.64 | 141 | 17201 | 9902 | 90601203 |
| Cholelithiasis | 415.31 | 46.64 | 202 | 17140 | 52304 | 90558801 |
| Intentional product misuse | 411.92 | 46.64 | 240 | 17102 | 89364 | 90521741 |
| Prescribed overdose | 408.33 | 46.64 | 246 | 17096 | 97379 | 90513726 |
| Hepatic enzyme increased | 380.34 | 46.64 | 403 | 16939 | 360333 | 90250772 |
| Upper respiratory tract infection | 342.25 | 46.64 | 244 | 17098 | 128074 | 90483031 |
| Hyperhidrosis | 340.32 | 46.64 | 249 | 17093 | 136056 | 90475049 |
| Viral mutation identified | 325.74 | 46.64 | 76 | 17266 | 1949 | 90609156 |
| Psychotic disorder | 317.56 | 46.64 | 143 | 17199 | 31087 | 90580018 |
| Coeliac disease | 303.52 | 46.64 | 155 | 17187 | 44455 | 90566650 |
| Asthma-chronic obstructive pulmonary disease overlap syndrome | 299.26 | 46.64 | 85 | 17257 | 4814 | 90606291 |
| Total lung capacity increased | 297.19 | 46.64 | 85 | 17257 | 4936 | 90606169 |
| Hepatotoxicity | 296.65 | 46.64 | 154 | 17188 | 45688 | 90565417 |
| Overdose | 289.10 | 46.64 | 240 | 17102 | 157469 | 90453636 |
| Blood bilirubin increased | 286.94 | 46.64 | 148 | 17194 | 43322 | 90567783 |
| Thrombocytopenia | 277.88 | 46.64 | 265 | 17077 | 208460 | 90402645 |
| Fluid retention | 271.07 | 46.64 | 183 | 17159 | 87908 | 90523197 |
| Virologic failure | 262.41 | 46.64 | 65 | 17277 | 2159 | 90608946 |
| Sarcoidosis | 234.17 | 46.64 | 85 | 17257 | 10588 | 90600517 |
| Nasal polyps | 232.58 | 46.64 | 85 | 17257 | 10795 | 90600310 |
| Asthma | 202.15 | 46.64 | 240 | 17102 | 241920 | 90369185 |
| Rhinitis allergic | 196.85 | 46.64 | 85 | 17257 | 16700 | 90594405 |
| Pathogen resistance | 194.47 | 46.64 | 69 | 17273 | 8046 | 90603059 |
| Cardiac murmur | 193.47 | 46.64 | 86 | 17256 | 18108 | 90592997 |
| Psoriasis | 191.50 | 46.64 | 185 | 17157 | 147569 | 90463536 |
| Bronchiectasis | 176.64 | 46.64 | 86 | 17256 | 22244 | 90588861 |
| Product use issue | 172.28 | 46.64 | 260 | 17082 | 329659 | 90281446 |
| Bursitis | 150.48 | 46.64 | 154 | 17188 | 131500 | 90479605 |
| Drug resistance | 148.83 | 46.64 | 85 | 17257 | 30364 | 90580741 |
| Hypersensitivity | 143.71 | 46.64 | 287 | 17055 | 454390 | 90156715 |
| Immune reconstitution inflammatory syndrome | 139.54 | 46.64 | 52 | 17290 | 6967 | 90604138 |
| Hypertension | 138.87 | 46.64 | 284 | 17058 | 457248 | 90153857 |
| Lung neoplasm malignant | 138.42 | 46.64 | 75 | 17267 | 24198 | 90586907 |
| Rheumatoid arthritis | 133.10 | 46.64 | 244 | 17098 | 362370 | 90248735 |
| Treatment failure | 121.05 | 46.64 | 212 | 17130 | 303716 | 90307389 |
| Decreased immune responsiveness | 118.19 | 46.64 | 49 | 17293 | 8699 | 90602406 |
| Infusion related reaction | 113.93 | 46.64 | 248 | 17094 | 416532 | 90194573 |
| Pyrexia | 108.54 | 46.64 | 324 | 17018 | 660161 | 89950944 |
| Arthralgia | 104.80 | 46.64 | 13 | 17329 | 778509 | 89832596 |
| Lipodystrophy acquired | 100.30 | 46.64 | 28 | 17314 | 1486 | 90609619 |
| Treatment noncompliance | 97.22 | 46.64 | 80 | 17262 | 51647 | 90559458 |
| Chronic obstructive pulmonary disease | 94.68 | 46.64 | 92 | 17250 | 73737 | 90537368 |
| Blood HIV RNA increased | 91.78 | 46.64 | 23 | 17319 | 801 | 90610304 |
| Erythema | 87.43 | 46.64 | 157 | 17185 | 229089 | 90382016 |
| CD4 lymphocytes decreased | 81.80 | 46.64 | 24 | 17318 | 1523 | 90609582 |
| Joint swelling | 81.65 | 46.64 | 246 | 17096 | 503054 | 90108051 |
| Dyspnoea | 77.51 | 46.64 | 36 | 17306 | 880919 | 89730186 |
| Diarrhoea | 75.76 | 46.64 | 43 | 17299 | 939147 | 89671958 |
| Foetal exposure during pregnancy | 75.64 | 46.64 | 64 | 17278 | 42911 | 90568194 |
| Abdominal discomfort | 72.03 | 46.64 | 5 | 17337 | 477323 | 90133782 |
| Alopecia | 69.72 | 46.64 | 7 | 17335 | 495064 | 90116041 |
| Constipation | 66.62 | 46.64 | 158 | 17184 | 280237 | 90330868 |
| Peripheral swelling | 66.40 | 46.64 | 3 | 17339 | 413103 | 90198002 |
| Swelling | 64.36 | 46.64 | 4 | 17338 | 419054 | 90192051 |
| Contraindicated product administered | 64.09 | 46.64 | 169 | 17173 | 319970 | 90291135 |
| Dizziness | 61.99 | 46.64 | 18 | 17324 | 589266 | 90021839 |
| Infection | 61.49 | 46.64 | 180 | 17162 | 361914 | 90249191 |
| Rash | 60.46 | 46.64 | 306 | 17036 | 795794 | 89815311 |
| Back pain | 58.04 | 46.64 | 162 | 17180 | 317013 | 90294092 |
| Confusional state | 55.57 | 46.64 | 5 | 17337 | 386200 | 90224905 |
| Drug intolerance | 53.10 | 46.64 | 197 | 17145 | 447394 | 90163711 |
| Off label use | 53.09 | 46.64 | 376 | 16966 | 1101876 | 89509229 |
| Pruritus | 50.92 | 46.64 | 20 | 17322 | 541505 | 90069600 |
| Abdominal pain upper | 48.69 | 46.64 | 4 | 17338 | 332670 | 90278435 |
| Malaise | 48.34 | 46.64 | 26 | 17316 | 585960 | 90025145 |
| Weight increased | 47.29 | 46.64 | 11 | 17331 | 417916 | 90193189 |
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 |
|---|---|---|---|---|---|---|
| Lipodystrophy acquired | 687.49 | 16.36 | 170 | 13544 | 3280 | 42604341 |
| Immune reconstitution inflammatory syndrome | 482.60 | 16.36 | 164 | 13550 | 9979 | 42597642 |
| Virologic failure | 472.06 | 16.36 | 130 | 13584 | 3864 | 42603757 |
| Mitochondrial toxicity | 442.01 | 16.36 | 113 | 13601 | 2502 | 42605119 |
| Viral mutation identified | 364.12 | 16.36 | 102 | 13612 | 3229 | 42604392 |
| Progressive external ophthalmoplegia | 355.23 | 16.36 | 84 | 13630 | 1327 | 42606294 |
| Eyelid ptosis | 345.61 | 16.36 | 115 | 13599 | 6546 | 42601075 |
| Pathogen resistance | 250.80 | 16.36 | 105 | 13609 | 11345 | 42596276 |
| Diplopia | 190.64 | 16.36 | 104 | 13610 | 20212 | 42587409 |
| Drug resistance | 116.63 | 16.36 | 93 | 13621 | 34155 | 42573466 |
| Lipoatrophy | 114.64 | 16.36 | 27 | 13687 | 418 | 42607203 |
| Ophthalmoplegia | 114.12 | 16.36 | 38 | 13676 | 2162 | 42605459 |
| Drug interaction | 113.83 | 16.36 | 259 | 13455 | 266740 | 42340881 |
| Polydactyly | 113.30 | 16.36 | 33 | 13681 | 1201 | 42606420 |
| Blood HIV RNA increased | 100.88 | 16.36 | 32 | 13682 | 1559 | 42606062 |
| CSF HIV escape syndrome | 99.81 | 16.36 | 21 | 13693 | 187 | 42607434 |
| Dyslipidaemia | 98.93 | 16.36 | 52 | 13662 | 9366 | 42598255 |
| HIV-associated neurocognitive disorder | 89.04 | 16.36 | 21 | 13693 | 327 | 42607294 |
| Multiple-drug resistance | 78.53 | 16.36 | 41 | 13673 | 7281 | 42600340 |
| Off label use | 77.44 | 16.36 | 56 | 13658 | 638279 | 41969342 |
| Fanconi syndrome acquired | 77.37 | 16.36 | 28 | 13686 | 2042 | 42605579 |
| Foetal exposure during pregnancy | 76.59 | 16.36 | 85 | 13629 | 47226 | 42560395 |
| Renal impairment | 73.35 | 16.36 | 129 | 13585 | 110099 | 42497522 |
| Osteonecrosis | 64.74 | 16.36 | 48 | 13666 | 15817 | 42591804 |
| CD4 lymphocytes decreased | 64.46 | 16.36 | 24 | 13690 | 1897 | 42605724 |
| Hypertriglyceridaemia | 63.62 | 16.36 | 40 | 13674 | 10086 | 42597535 |
| Atrioventricular septal defect | 62.48 | 16.36 | 15 | 13699 | 253 | 42607368 |
| Viral load increased | 57.37 | 16.36 | 25 | 13689 | 2972 | 42604649 |
| Dandy-Walker syndrome | 56.84 | 16.36 | 14 | 13700 | 264 | 42607357 |
| Hyperlactacidaemia | 56.32 | 16.36 | 28 | 13686 | 4488 | 42603133 |
| Blood lactic acid increased | 56.21 | 16.36 | 34 | 13680 | 8005 | 42599616 |
| Oral candidiasis | 53.06 | 16.36 | 41 | 13673 | 14364 | 42593257 |
| Treatment noncompliance | 53.05 | 16.36 | 63 | 13651 | 37609 | 42570012 |
| Gene mutation | 51.64 | 16.36 | 20 | 13694 | 1761 | 42605860 |
| Trisomy 21 | 50.94 | 16.36 | 15 | 13699 | 567 | 42607054 |
| Mitochondrial myopathy | 50.51 | 16.36 | 12 | 13702 | 193 | 42607428 |
| Neurodevelopmental disorder | 49.91 | 16.36 | 14 | 13700 | 444 | 42607177 |
| Macrocephaly | 49.06 | 16.36 | 14 | 13700 | 473 | 42607148 |
| Acquired immunodeficiency syndrome | 48.47 | 16.36 | 14 | 13700 | 494 | 42607127 |
| Oesophageal candidiasis | 47.76 | 16.36 | 27 | 13687 | 5608 | 42602013 |
| Herpes virus infection | 46.36 | 16.36 | 23 | 13691 | 3669 | 42603952 |
| Cachexia | 45.92 | 16.36 | 30 | 13684 | 8074 | 42599547 |
| Nervous system disorder | 44.70 | 16.36 | 40 | 13674 | 17155 | 42590466 |
| Congenital central nervous system anomaly | 43.95 | 16.36 | 14 | 13700 | 691 | 42606930 |
| White matter lesion | 42.99 | 16.36 | 15 | 13699 | 983 | 42606638 |
| Progressive multifocal leukoencephalopathy | 42.85 | 16.36 | 33 | 13681 | 11503 | 42596118 |
| Mitochondrial cytopathy | 42.68 | 16.36 | 10 | 13704 | 151 | 42607470 |
| Life expectancy shortened | 41.38 | 16.36 | 8 | 13706 | 44 | 42607577 |
| Attention deficit hyperactivity disorder | 40.93 | 16.36 | 20 | 13694 | 3088 | 42604533 |
| Hyperlipidaemia | 40.69 | 16.36 | 42 | 13672 | 21474 | 42586147 |
| Transplant rejection | 40.14 | 16.36 | 34 | 13680 | 13554 | 42594067 |
| Kaposi's sarcoma | 38.33 | 16.36 | 13 | 13701 | 782 | 42606839 |
| Blood triglycerides increased | 37.46 | 16.36 | 35 | 13679 | 15861 | 42591760 |
| HIV infection | 37.18 | 16.36 | 15 | 13699 | 1470 | 42606151 |
| Genotype drug resistance test positive | 36.62 | 16.36 | 14 | 13700 | 1190 | 42606431 |
| Nephropathy toxic | 35.75 | 16.36 | 35 | 13679 | 16803 | 42590818 |
| Pre-eclampsia | 35.69 | 16.36 | 7 | 13707 | 42 | 42607579 |
| HIV associated nephropathy | 34.87 | 16.36 | 10 | 13704 | 344 | 42607277 |
| Calculus urinary | 34.75 | 16.36 | 15 | 13699 | 1742 | 42605879 |
| Facial wasting | 34.13 | 16.36 | 8 | 13706 | 121 | 42607500 |
| Hepatitis C | 33.36 | 16.36 | 27 | 13687 | 10106 | 42597515 |
| Portal hypertension | 32.83 | 16.36 | 20 | 13694 | 4767 | 42602854 |
| Bone metabolism disorder | 32.79 | 16.36 | 9 | 13705 | 263 | 42607358 |
| Fall | 31.78 | 16.36 | 18 | 13696 | 234502 | 42373119 |
| Fanconi syndrome | 31.22 | 16.36 | 14 | 13700 | 1780 | 42605841 |
| Speech disorder developmental | 30.98 | 16.36 | 15 | 13699 | 2270 | 42605351 |
| Retinal toxicity | 30.94 | 16.36 | 10 | 13704 | 517 | 42607104 |
| Bacterial pyelonephritis | 30.88 | 16.36 | 9 | 13705 | 328 | 42607293 |
| Renal tubular disorder | 29.85 | 16.36 | 19 | 13695 | 4890 | 42602731 |
| Trimethylaminuria | 29.72 | 16.36 | 5 | 13709 | 10 | 42607611 |
| Drug ineffective | 29.69 | 16.36 | 104 | 13610 | 630093 | 41977528 |
| Retroperitoneal disorder | 29.55 | 16.36 | 6 | 13708 | 44 | 42607577 |
| Myocardial infarction | 29.19 | 16.36 | 97 | 13617 | 123912 | 42483709 |
| Pyrexia | 28.91 | 16.36 | 221 | 13493 | 393821 | 42213800 |
| Enterovirus infection | 28.76 | 16.36 | 12 | 13702 | 1281 | 42606340 |
| Taeniasis | 28.56 | 16.36 | 6 | 13708 | 53 | 42607568 |
| Gamma-glutamyltransferase increased | 28.30 | 16.36 | 43 | 13671 | 32454 | 42575167 |
| HIV viraemia | 28.16 | 16.36 | 6 | 13708 | 57 | 42607564 |
| Choroiditis | 28.05 | 16.36 | 12 | 13702 | 1363 | 42606258 |
| Human immunodeficiency virus transmission | 27.89 | 16.36 | 6 | 13708 | 60 | 42607561 |
| Varices oesophageal | 26.80 | 16.36 | 17 | 13697 | 4348 | 42603273 |
| COVID-19 | 26.79 | 16.36 | 3 | 13711 | 115945 | 42491676 |
| Crystal urine | 26.59 | 16.36 | 6 | 13708 | 76 | 42607545 |
| Lactic acidosis | 26.29 | 16.36 | 50 | 13664 | 45211 | 42562410 |
| Primary syphilis | 26.10 | 16.36 | 5 | 13709 | 26 | 42607595 |
| Dyspnoea | 25.87 | 16.36 | 66 | 13648 | 442555 | 42165066 |
| Renal aneurysm | 25.55 | 16.36 | 7 | 13707 | 203 | 42607418 |
| Proteinuria | 25.29 | 16.36 | 34 | 13680 | 22949 | 42584672 |
| Coronary artery disease | 24.85 | 16.36 | 54 | 13660 | 53666 | 42553955 |
| Glycosuria | 24.83 | 16.36 | 11 | 13703 | 1359 | 42606262 |
| Mycobacterium avium complex infection | 24.30 | 16.36 | 14 | 13700 | 3013 | 42604608 |
| Brain oedema | 24.13 | 16.36 | 28 | 13686 | 16299 | 42591322 |
| Loss of anatomical alignment after fracture reduction | 23.78 | 16.36 | 4 | 13710 | 8 | 42607613 |
| Enterococcal infection | 23.66 | 16.36 | 24 | 13690 | 12015 | 42595606 |
| Heart transplant rejection | 23.64 | 16.36 | 11 | 13703 | 1523 | 42606098 |
| Pulmonary tuberculosis | 23.24 | 16.36 | 17 | 13697 | 5484 | 42602137 |
| Nephrocalcinosis | 23.22 | 16.36 | 9 | 13705 | 794 | 42606827 |
| Fracture malunion | 22.89 | 16.36 | 4 | 13710 | 11 | 42607610 |
| Glucose tolerance impaired | 22.71 | 16.36 | 15 | 13699 | 4109 | 42603512 |
| Musculoskeletal toxicity | 22.68 | 16.36 | 6 | 13708 | 152 | 42607469 |
| Coccidioidomycosis | 22.60 | 16.36 | 9 | 13705 | 853 | 42606768 |
| Endocardial fibroelastosis | 22.39 | 16.36 | 4 | 13710 | 13 | 42607608 |
| Jaundice | 22.33 | 16.36 | 40 | 13674 | 34549 | 42573072 |
| Pain | 21.91 | 16.36 | 28 | 13686 | 244820 | 42362801 |
| Hepatic function abnormal | 21.79 | 16.36 | 50 | 13664 | 51517 | 42556104 |
| Blood insulin increased | 21.66 | 16.36 | 7 | 13707 | 362 | 42607259 |
| Atrial fibrillation | 21.50 | 16.36 | 9 | 13705 | 139584 | 42468037 |
| Febrile neutropenia | 21.45 | 16.36 | 17 | 13697 | 185686 | 42421935 |
| Lymphadenopathy | 20.80 | 16.36 | 38 | 13676 | 33327 | 42574294 |
| Meningitis cryptococcal | 20.69 | 16.36 | 13 | 13701 | 3270 | 42604351 |
| Pancreatic failure | 20.58 | 16.36 | 9 | 13705 | 1078 | 42606543 |
| Hepatic fibrosis | 20.45 | 16.36 | 15 | 13699 | 4857 | 42602764 |
| Anogenital warts | 20.41 | 16.36 | 8 | 13706 | 727 | 42606894 |
| Post transplant distal limb syndrome | 20.19 | 16.36 | 7 | 13707 | 450 | 42607171 |
| Erythema elevatum diutinum | 20.12 | 16.36 | 4 | 13710 | 26 | 42607595 |
| Renal tubular necrosis | 19.96 | 16.36 | 27 | 13687 | 18327 | 42589294 |
| Coronary ostial stenosis | 19.70 | 16.36 | 5 | 13709 | 107 | 42607514 |
| Tuberculosis | 19.60 | 16.36 | 20 | 13694 | 10079 | 42597542 |
| Abdominal sepsis | 19.59 | 16.36 | 9 | 13705 | 1211 | 42606410 |
| Megacolon | 19.50 | 16.36 | 11 | 13703 | 2274 | 42605347 |
| Portal venous gas | 19.45 | 16.36 | 7 | 13707 | 502 | 42607119 |
| Peripheral swelling | 19.26 | 16.36 | 3 | 13711 | 90267 | 42517354 |
| Peripheral venous disease | 19.08 | 16.36 | 12 | 13702 | 3024 | 42604597 |
| Cerebral disorder | 19.03 | 16.36 | 12 | 13702 | 3038 | 42604583 |
| Acute myocardial infarction | 18.88 | 16.36 | 51 | 13663 | 58114 | 42549507 |
| Hepatitis A | 18.70 | 16.36 | 7 | 13707 | 561 | 42607060 |
| Renal infarct | 18.65 | 16.36 | 10 | 13704 | 1873 | 42605748 |
| Constipation | 18.56 | 16.36 | 15 | 13699 | 162276 | 42445345 |
| Blood pressure increased | 18.42 | 16.36 | 5 | 13709 | 101923 | 42505698 |
| Segmented hyalinising vasculitis | 18.33 | 16.36 | 4 | 13710 | 43 | 42607578 |
| Hepatitis B | 18.21 | 16.36 | 16 | 13698 | 6695 | 42600926 |
| Skin test negative | 18.16 | 16.36 | 4 | 13710 | 45 | 42607576 |
| Metabolic syndrome | 18.16 | 16.36 | 10 | 13704 | 1973 | 42605648 |
| Nephrolithiasis | 18.15 | 16.36 | 38 | 13676 | 36792 | 42570829 |
| Congenital pigmentation disorder | 17.83 | 16.36 | 3 | 13711 | 6 | 42607615 |
| Cerebral toxoplasmosis | 17.63 | 16.36 | 10 | 13704 | 2088 | 42605533 |
| Ophthalmic herpes simplex | 17.45 | 16.36 | 6 | 13708 | 376 | 42607245 |
| Tubulointerstitial nephritis | 17.27 | 16.36 | 34 | 13680 | 31514 | 42576107 |
| Induration | 17.23 | 16.36 | 8 | 13706 | 1102 | 42606519 |
| Hepatomegaly | 17.06 | 16.36 | 20 | 13694 | 11765 | 42595856 |
| Graft complication | 17.04 | 16.36 | 7 | 13707 | 719 | 42606902 |
| Hepatitis D | 17.04 | 16.36 | 4 | 13710 | 61 | 42607560 |
| Mesenteric artery thrombosis | 16.96 | 16.36 | 7 | 13707 | 727 | 42606894 |
| Blood alkaline phosphatase increased | 16.95 | 16.36 | 35 | 13679 | 33562 | 42574059 |
| Acute hepatic failure | 16.89 | 16.36 | 24 | 13690 | 17049 | 42590572 |
| Product dose omission issue | 16.75 | 16.36 | 15 | 13699 | 154350 | 42453271 |
| Cytomegalovirus chorioretinitis | 16.70 | 16.36 | 13 | 13701 | 4598 | 42603023 |
| Conjunctival pallor | 16.47 | 16.36 | 4 | 13710 | 71 | 42607550 |
| Graft infection | 16.44 | 16.36 | 6 | 13708 | 448 | 42607173 |
| Pneumonia | 16.42 | 16.36 | 75 | 13639 | 422074 | 42185547 |
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 |
|---|---|---|---|---|---|---|
| Lipodystrophy acquired | 768.65 | 21.12 | 184 | 25431 | 4340 | 110559344 |
| Viral mutation identified | 690.49 | 21.12 | 168 | 25447 | 4251 | 110559433 |
| Virologic failure | 686.48 | 21.12 | 171 | 25444 | 4781 | 110558903 |
| Immune reconstitution inflammatory syndrome | 595.40 | 21.12 | 199 | 25416 | 16027 | 110547657 |
| Schizophrenia | 571.02 | 21.12 | 208 | 25407 | 21618 | 110542066 |
| Hypomania | 487.78 | 21.12 | 153 | 25462 | 10057 | 110553627 |
| Foetal death | 484.18 | 21.12 | 170 | 25445 | 15875 | 110547809 |
| Mitochondrial toxicity | 479.65 | 21.12 | 118 | 25497 | 3127 | 110560557 |
| Temperature regulation disorder | 461.39 | 21.12 | 155 | 25460 | 12671 | 110551013 |
| Pathogen resistance | 427.43 | 21.12 | 159 | 25456 | 17513 | 110546171 |
| Food allergy | 401.62 | 21.12 | 157 | 25458 | 19791 | 110543893 |
| Jaundice cholestatic | 396.15 | 21.12 | 143 | 25472 | 14465 | 110549219 |
| Cholelithiasis | 393.65 | 21.12 | 221 | 25394 | 63201 | 110500483 |
| Progressive external ophthalmoplegia | 387.61 | 21.12 | 85 | 25530 | 1335 | 110562349 |
| Immunodeficiency | 353.94 | 21.12 | 175 | 25440 | 38663 | 110525021 |
| Eyelid ptosis | 304.38 | 21.12 | 115 | 25500 | 13212 | 110550472 |
| Total lung capacity increased | 288.16 | 21.12 | 87 | 25528 | 5025 | 110558659 |
| Asthma-chronic obstructive pulmonary disease overlap syndrome | 269.66 | 21.12 | 87 | 25528 | 6257 | 110557427 |
| Coeliac disease | 269.26 | 21.12 | 151 | 25464 | 43036 | 110520648 |
| Hepatic enzyme increased | 265.02 | 21.12 | 348 | 25267 | 320544 | 110243140 |
| Psychotic disorder | 261.57 | 21.12 | 157 | 25458 | 50780 | 110512904 |
| Hepatotoxicity | 251.71 | 21.12 | 166 | 25449 | 63234 | 110500450 |
| Blood bilirubin increased | 242.77 | 21.12 | 174 | 25441 | 75798 | 110487886 |
| Drug resistance | 241.93 | 21.12 | 155 | 25460 | 56219 | 110507465 |
| Exposure during pregnancy | 222.53 | 21.12 | 232 | 25383 | 167192 | 110396492 |
| Sarcoidosis | 211.55 | 21.12 | 87 | 25528 | 12492 | 110551192 |
| Nasal polyps | 207.50 | 21.12 | 87 | 25528 | 13113 | 110550571 |
| Prescribed overdose | 199.44 | 21.12 | 164 | 25451 | 87417 | 110476267 |
| Rash erythematous | 196.38 | 21.12 | 158 | 25457 | 81674 | 110482010 |
| Blood HIV RNA increased | 189.37 | 21.12 | 52 | 25563 | 2136 | 110561548 |
| Rhinitis allergic | 185.04 | 21.12 | 88 | 25527 | 17834 | 110545850 |
| Fluid retention | 176.84 | 21.12 | 158 | 25457 | 94149 | 110469535 |
| Cardiac murmur | 164.12 | 21.12 | 90 | 25525 | 24538 | 110539146 |
| Diplopia | 150.18 | 21.12 | 103 | 25512 | 41791 | 110521893 |
| Intentional product misuse | 141.48 | 21.12 | 164 | 25451 | 132740 | 110430944 |
| Bronchiectasis | 133.84 | 21.12 | 91 | 25524 | 36402 | 110527282 |
| Upper respiratory tract infection | 129.76 | 21.12 | 156 | 25459 | 131172 | 110432512 |
| CSF HIV escape syndrome | 129.39 | 21.12 | 27 | 25588 | 330 | 110563354 |
| Psoriasis | 128.14 | 21.12 | 160 | 25455 | 139833 | 110423851 |
| Treatment failure | 125.65 | 21.12 | 228 | 25387 | 277006 | 110286678 |
| Dyslipidaemia | 125.10 | 21.12 | 65 | 25550 | 15900 | 110547784 |
| Bursitis | 122.94 | 21.12 | 151 | 25464 | 129767 | 110433917 |
| Drug interaction | 120.77 | 21.12 | 319 | 25296 | 499864 | 110063820 |
| Hyperhidrosis | 111.40 | 21.12 | 174 | 25441 | 187124 | 110376560 |
| Treatment noncompliance | 111.21 | 21.12 | 109 | 25506 | 72881 | 110490803 |
| Lipoatrophy | 108.75 | 21.12 | 26 | 25589 | 608 | 110563076 |
| Decreased immune responsiveness | 107.88 | 21.12 | 50 | 25565 | 9556 | 110554128 |
| Lung neoplasm malignant | 106.86 | 21.12 | 77 | 25538 | 33765 | 110529919 |
| Ophthalmoplegia | 104.69 | 21.12 | 37 | 25578 | 3513 | 110560171 |
| CD4 lymphocytes decreased | 103.20 | 21.12 | 35 | 25580 | 2939 | 110560745 |
| Fanconi syndrome acquired | 98.62 | 21.12 | 34 | 25581 | 3000 | 110560684 |
| HIV-associated neurocognitive disorder | 98.01 | 21.12 | 22 | 25593 | 386 | 110563298 |
| Thrombocytopenia | 89.73 | 21.12 | 228 | 25387 | 348657 | 110215027 |
| Fall | 85.18 | 21.12 | 18 | 25597 | 603464 | 109960220 |
| Overdose | 83.54 | 21.12 | 174 | 25441 | 233620 | 110330064 |
| Arthralgia | 77.70 | 21.12 | 42 | 25573 | 779590 | 109784094 |
| Peripheral swelling | 77.13 | 21.12 | 4 | 25611 | 404030 | 110159654 |
| Dyspnoea | 77.01 | 21.12 | 86 | 25529 | 1106786 | 109456898 |
| Pyrexia | 71.57 | 21.12 | 402 | 25213 | 897863 | 109665821 |
| Multiple-drug resistance | 65.84 | 21.12 | 40 | 25575 | 13195 | 110550489 |
| Abdominal discomfort | 63.89 | 21.12 | 8 | 25607 | 393850 | 110169834 |
| Hypersensitivity | 61.96 | 21.12 | 220 | 25395 | 403778 | 110159906 |
| Nasopharyngitis | 61.62 | 21.12 | 9 | 25606 | 394352 | 110169332 |
| Swelling | 59.78 | 21.12 | 6 | 25609 | 351035 | 110212649 |
| Nephropathy toxic | 59.47 | 21.12 | 50 | 25565 | 27428 | 110536256 |
| Viral load increased | 58.87 | 21.12 | 24 | 25591 | 3366 | 110560318 |
| Renal impairment | 57.88 | 21.12 | 132 | 25483 | 188313 | 110375371 |
| Product use issue | 56.87 | 21.12 | 180 | 25435 | 311515 | 110252169 |
| Mitochondrial cytopathy | 56.52 | 21.12 | 14 | 25601 | 381 | 110563303 |
| Sinusitis | 56.41 | 21.12 | 3 | 25612 | 296685 | 110266999 |
| Hypertriglyceridaemia | 56.18 | 21.12 | 39 | 25576 | 16115 | 110547569 |
| Alopecia | 55.44 | 21.12 | 9 | 25606 | 364744 | 110198940 |
| Asthma | 54.61 | 21.12 | 154 | 25461 | 250137 | 110313547 |
| Blood lactic acid increased | 54.57 | 21.12 | 38 | 25577 | 15783 | 110547901 |
| Chronic obstructive pulmonary disease | 53.50 | 21.12 | 93 | 25522 | 109065 | 110454619 |
| Hypertension | 52.89 | 21.12 | 246 | 25369 | 509838 | 110053846 |
| Erythema | 50.16 | 21.12 | 165 | 25450 | 291282 | 110272402 |
| Cachexia | 49.03 | 21.12 | 33 | 25582 | 12972 | 110550712 |
| Contraindicated product administered | 48.63 | 21.12 | 147 | 25468 | 248120 | 110315564 |
| Hepatitis C | 47.63 | 21.12 | 32 | 25583 | 12541 | 110551143 |
| Abortion spontaneous | 46.34 | 21.12 | 48 | 25567 | 34234 | 110529450 |
| Hyperlactacidaemia | 46.32 | 21.12 | 27 | 25588 | 8259 | 110555425 |
| COVID-19 | 45.00 | 21.12 | 3 | 25612 | 245057 | 110318627 |
| Mitochondrial myopathy | 44.95 | 21.12 | 12 | 25603 | 442 | 110563242 |
| Dizziness | 44.46 | 21.12 | 58 | 25557 | 698135 | 109865549 |
| Systemic lupus erythematosus | 44.21 | 21.12 | 4 | 25611 | 254334 | 110309350 |
| Retinal toxicity | 44.05 | 21.12 | 16 | 25599 | 1643 | 110562041 |
| HIV viraemia | 42.76 | 21.12 | 9 | 25606 | 115 | 110563569 |
| HIV associated nephropathy | 42.73 | 21.12 | 11 | 25604 | 351 | 110563333 |
| Stomatitis | 42.59 | 21.12 | 6 | 25609 | 270236 | 110293448 |
| Completed suicide | 41.63 | 21.12 | 4 | 25611 | 242377 | 110321307 |
| Confusional state | 41.40 | 21.12 | 29 | 25586 | 468651 | 110095033 |
| Product dose omission issue | 40.69 | 21.12 | 12 | 25603 | 321770 | 110241914 |
| Mycobacterium avium complex infection | 40.59 | 21.12 | 22 | 25593 | 5855 | 110557829 |
| Mobility decreased | 40.56 | 21.12 | 4 | 25611 | 237418 | 110326266 |
| Musculoskeletal stiffness | 40.14 | 21.12 | 8 | 25607 | 279814 | 110283870 |
| Gastroschisis | 39.95 | 21.12 | 7 | 25608 | 30 | 110563654 |
| Rheumatoid arthritis | 39.91 | 21.12 | 156 | 25459 | 299457 | 110264227 |
| Drug hypersensitivity | 38.53 | 21.12 | 207 | 25408 | 453883 | 110109801 |
| Discomfort | 38.35 | 21.12 | 3 | 25612 | 214704 | 110348980 |
| Vomiting | 38.04 | 21.12 | 349 | 25266 | 910326 | 109653358 |
| Therapeutic product effect incomplete | 37.64 | 21.12 | 4 | 25611 | 223801 | 110339883 |
| Calculus urinary | 37.25 | 21.12 | 17 | 25598 | 3135 | 110560549 |
| Proteinuria | 36.99 | 21.12 | 46 | 25569 | 39972 | 110523712 |
| Pericarditis | 36.63 | 21.12 | 4 | 25611 | 219110 | 110344574 |
| Transplant rejection | 36.12 | 21.12 | 36 | 25579 | 24531 | 110539153 |
| Blood pressure increased | 35.80 | 21.12 | 8 | 25607 | 258365 | 110305319 |
| Brain oedema | 35.80 | 21.12 | 40 | 25575 | 31058 | 110532626 |
| Weight increased | 35.71 | 21.12 | 27 | 25588 | 419617 | 110144067 |
| Immunosuppressant drug level increased | 35.46 | 21.12 | 26 | 25589 | 11698 | 110551986 |
| Herpes virus infection | 35.18 | 21.12 | 23 | 25592 | 8615 | 110555069 |
| Renal tubular necrosis | 34.74 | 21.12 | 39 | 25576 | 30436 | 110533248 |
| Impaired healing | 34.44 | 21.12 | 3 | 25612 | 196714 | 110366970 |
| Foetal growth abnormality | 34.38 | 21.12 | 6 | 25609 | 25 | 110563659 |
| Atrial fibrillation | 34.14 | 21.12 | 6 | 25609 | 229636 | 110334048 |
| Acquired immunodeficiency syndrome | 33.27 | 21.12 | 9 | 25606 | 349 | 110563335 |
| Osteonecrosis | 33.15 | 21.12 | 40 | 25575 | 33701 | 110529983 |
| Foetal exposure during pregnancy | 33.07 | 21.12 | 21 | 25594 | 7484 | 110556200 |
| Renal tubular dysfunction | 32.96 | 21.12 | 11 | 25604 | 879 | 110562805 |
| Retching | 32.91 | 21.12 | 33 | 25582 | 22649 | 110541035 |
| Back pain | 32.74 | 21.12 | 171 | 25444 | 370825 | 110192859 |
| Dry mouth | 32.55 | 21.12 | 4 | 25611 | 199944 | 110363740 |
| Lung neoplasm | 31.66 | 21.12 | 21 | 25594 | 8055 | 110555629 |
| Genotype drug resistance test positive | 31.61 | 21.12 | 12 | 25603 | 1394 | 110562290 |
| Retroperitoneal disorder | 31.51 | 21.12 | 6 | 25609 | 44 | 110563640 |
| Central nervous system lesion | 31.00 | 21.12 | 27 | 25588 | 15526 | 110548158 |
| Constipation | 30.94 | 21.12 | 164 | 25451 | 357622 | 110206062 |
| Lactic acidosis | 30.70 | 21.12 | 67 | 25548 | 92744 | 110470940 |
| Muscle spasms | 30.67 | 21.12 | 13 | 25602 | 278144 | 110285540 |
| Pruritus | 30.56 | 21.12 | 55 | 25560 | 581505 | 109982179 |
| Taeniasis | 30.52 | 21.12 | 6 | 25609 | 53 | 110563631 |
| Progressive multifocal leukoencephalopathy | 30.28 | 21.12 | 33 | 25582 | 24923 | 110538761 |
| Febrile neutropenia | 30.14 | 21.12 | 18 | 25597 | 316749 | 110246935 |
| Choroiditis | 30.00 | 21.12 | 12 | 25603 | 1603 | 110562081 |
| White matter lesion | 29.88 | 21.12 | 14 | 25601 | 2740 | 110560944 |
| Stillbirth | 29.55 | 21.12 | 16 | 25599 | 4248 | 110559436 |
| Hyperbilirubinaemia | 29.54 | 21.12 | 36 | 25579 | 30635 | 110533049 |
| Pulmonary tuberculosis | 29.31 | 21.12 | 21 | 25594 | 9118 | 110554566 |
| HIV infection | 28.86 | 21.12 | 11 | 25604 | 1292 | 110562392 |
| Bone metabolism disorder | 28.83 | 21.12 | 9 | 25606 | 581 | 110563103 |
| HIV wasting syndrome | 28.78 | 21.12 | 6 | 25609 | 73 | 110563611 |
| Congenital intestinal malformation | 28.62 | 21.12 | 5 | 25610 | 21 | 110563663 |
| Facial wasting | 28.41 | 21.12 | 6 | 25609 | 78 | 110563606 |
| Anxiety | 28.34 | 21.12 | 23 | 25592 | 345055 | 110218629 |
| Hyperlipidaemia | 28.12 | 21.12 | 38 | 25577 | 35810 | 110527874 |
| Drug reaction with eosinophilia and systemic symptoms | 28.00 | 21.12 | 60 | 25555 | 82035 | 110481649 |
| Blood triglycerides increased | 27.93 | 21.12 | 31 | 25584 | 23895 | 110539789 |
| Blister | 27.80 | 21.12 | 9 | 25606 | 227367 | 110336317 |
| Primary syphilis | 27.74 | 21.12 | 5 | 25610 | 26 | 110563658 |
| Glycosuria | 27.40 | 21.12 | 13 | 25602 | 2617 | 110561067 |
| Kaposi's sarcoma | 27.29 | 21.12 | 9 | 25606 | 693 | 110562991 |
| Enterovirus infection | 26.76 | 21.12 | 13 | 25602 | 2757 | 110560927 |
| Urticaria | 26.50 | 21.12 | 21 | 25594 | 318836 | 110244848 |
| Genetic polymorphism | 26.24 | 21.12 | 4 | 25611 | 5 | 110563679 |
| Astrocytoma malignant | 26.22 | 21.12 | 5 | 25610 | 37 | 110563647 |
| Renal tubular disorder | 25.98 | 21.12 | 18 | 25597 | 7411 | 110556273 |
| Drug intolerance | 25.91 | 21.12 | 172 | 25443 | 406340 | 110157344 |
| Bacterial pyelonephritis | 25.86 | 21.12 | 9 | 25606 | 816 | 110562868 |
| Gastrooesophageal reflux disease | 25.83 | 21.12 | 96 | 25519 | 179880 | 110383804 |
| Arthritis | 25.75 | 21.12 | 4 | 25611 | 167582 | 110396102 |
| Lymphadenopathy | 25.73 | 21.12 | 50 | 25565 | 63785 | 110499899 |
| Injection site pain | 25.69 | 21.12 | 5 | 25610 | 177917 | 110385767 |
| Foetal growth restriction | 25.57 | 21.12 | 13 | 25602 | 3037 | 110560647 |
| Rash | 25.36 | 21.12 | 296 | 25319 | 820668 | 109743016 |
| Nausea | 25.36 | 21.12 | 414 | 25201 | 1235276 | 109328408 |
| Infusion related reaction | 25.34 | 21.12 | 163 | 25452 | 380999 | 110182685 |
| Renal aneurysm | 25.31 | 21.12 | 7 | 25608 | 295 | 110563389 |
| Meningitis cryptococcal | 25.26 | 21.12 | 15 | 25600 | 4747 | 110558937 |
| Loss of anatomical alignment after fracture reduction | 25.09 | 21.12 | 4 | 25611 | 8 | 110563676 |
| Inappropriate schedule of product administration | 25.00 | 21.12 | 8 | 25607 | 203629 | 110360055 |
| Osteoarthritis | 24.61 | 21.12 | 6 | 25609 | 182617 | 110381067 |
| Migraine | 24.42 | 21.12 | 5 | 25610 | 171647 | 110392037 |
| Ocular icterus | 24.36 | 21.12 | 16 | 25599 | 6037 | 110557647 |
| Death | 24.23 | 21.12 | 82 | 25533 | 698787 | 109864897 |
| Spina bifida | 23.83 | 21.12 | 6 | 25609 | 175 | 110563509 |
| Fanconi syndrome | 23.82 | 21.12 | 13 | 25602 | 3506 | 110560178 |
| Memory impairment | 23.72 | 21.12 | 8 | 25607 | 196936 | 110366748 |
| Portal hypertension | 23.55 | 21.12 | 18 | 25597 | 8619 | 110555065 |
| Pubertal failure | 23.25 | 21.12 | 4 | 25611 | 15 | 110563669 |
| Coronary artery disease | 22.86 | 21.12 | 51 | 25564 | 71639 | 110492045 |
| Erythema elevatum diutinum | 22.85 | 21.12 | 4 | 25611 | 17 | 110563667 |
| Nervous system disorder | 22.44 | 21.12 | 32 | 25583 | 31689 | 110531995 |
| Meningitis tuberculous | 22.03 | 21.12 | 9 | 25606 | 1269 | 110562415 |
| Syncope | 21.48 | 21.12 | 10 | 25605 | 202526 | 110361158 |
| Bronchitis | 21.47 | 21.12 | 5 | 25610 | 157027 | 110406657 |
| Ill-defined disorder | 21.43 | 21.12 | 5 | 25610 | 156848 | 110406836 |
| Enterococcal infection | 21.42 | 21.12 | 25 | 25590 | 20341 | 110543343 |
| Portal venous gas | 21.40 | 21.12 | 7 | 25608 | 525 | 110563159 |
| Hypotension | 21.35 | 21.12 | 57 | 25558 | 523792 | 110039892 |
| Abdominal pain upper | 21.17 | 21.12 | 30 | 25585 | 349081 | 110214603 |
| Social avoidant behaviour | 21.14 | 21.12 | 14 | 25601 | 5355 | 110558329 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | J05AF06 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Nucleoside and nucleotide reverse transcriptase inhibitors |
| ATC | J05AR02 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations |
| ATC | J05AR04 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations |
| ATC | J05AR13 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Antivirals for treatment of HIV infections, combinations |
| FDA MoA | N0000009947 | Nucleoside Reverse Transcriptase Inhibitors |
| FDA EPC | N0000175462 | Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor |
| CHEBI has role | CHEBI:50748 | antipsoriatic |
| CHEBI has role | CHEBI:64946 | anti-HIV agent |
| MeSH PA | D000890 | Anti-Infective Agents |
| MeSH PA | D000998 | Antiviral Agents |
| MeSH PA | D004791 | Enzyme Inhibitors |
| MeSH PA | D018894 | Reverse Transcriptase Inhibitors |
| MeSH PA | D019380 | Anti-HIV Agents |
| MeSH PA | D019384 | Nucleic Acid Synthesis Inhibitors |
| FDA MoA | N0000193954 | Cytochrome P450 1A1 Inhibitors |
| CHEBI has role | CHEBI:22587 | antiviral agent |
| CHEBI has role | CHEBI:33231 | antitubercular agent |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:36044 | antiviral drug |
| CHEBI has role | CHEBI:53756 | HIV-1 reverse transcriptase inhibitor |
| CHEBI has role | CHEBI:88188 | drug allergen |
Related Drugs by ATC class:
J05AF Nucleoside and nucleotide reverse transcriptase inhibitors 12 drugs
J05AR Antivirals for treatment of HIV infections, combinations 19 drugs
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 |
| Toxic amblyopia | contraindication | 965003 | |
| Myositis | contraindication | 26889001 | DOID:633 |
| Hepatic failure | contraindication | 59927004 | |
| Pancreatitis | contraindication | 75694006 | DOID:4989 |
| Large liver | contraindication | 80515008 | |
| Kidney disease | contraindication | 90708001 | DOID:557 |
| Lactic acidosis | contraindication | 91273001 | DOID:3650 |
| Disorder of muscle | contraindication | 129565002 | DOID:423 |
| Steatosis of liver | contraindication | 197321007 | |
| Acute pancreatitis | contraindication | 197456007 | DOID:2913 |
| Chronic pancreatitis | contraindication | 235494005 | |
| Disease of liver | contraindication | 235856003 | DOID:409 |
| Anemia | contraindication | 271737000 | DOID:2355 |
| Hypertriglyceridemia | contraindication | 302870006 | |
| Neutropenic disorder | contraindication | 303011007 | DOID:1227 |
| Bone marrow depression | contraindication | 307762000 | |
| Breastfeeding (mother) | contraindication | 413712001 | |
| Obesity | contraindication | 414916001 | DOID:9970 |
| HLA-B 5701 Positive Status | contraindication | ||
| Drug Resistance to Anti-retroviral Therapy | contraindication |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 13.09 | acidic |
| pKa2 | 5.64 | Basic |
| pKa3 | 0.88 | Basic |
| pKa4 | 0.28 | Basic |
Orange Book patent data (new drug applications)
None
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 600MG BASE;EQ 50MG BASE;300MG | TRIUMEQ | VIIV HLTHCARE | N205551 | Aug. 22, 2014 | RX | TABLET | ORAL | June 15, 2026 | INFORMATION ADDED TO THE LABELING REGARDING THE RESULT OF STUDY 205860 |
| EQ 60MG BASE;EQ 5MG BASE;30MG | TRIUMEQ PD | VIIV HLTHCARE | N215413 | March 30, 2022 | RX | TABLET, FOR SUSPENSION | ORAL | June 15, 2026 | NEW PATIENT POPULATION |
| EQ 600MG BASE;EQ 50MG BASE;300MG | TRIUMEQ | VIIV HLTHCARE | N205551 | Aug. 22, 2014 | RX | TABLET | ORAL | Dec. 15, 2026 | PEDIATRIC EXCLUSIVITY |
| EQ 60MG BASE;EQ 5MG BASE;30MG | TRIUMEQ PD | VIIV HLTHCARE | N215413 | March 30, 2022 | RX | TABLET, FOR SUSPENSION | ORAL | Dec. 15, 2026 | PEDIATRIC EXCLUSIVITY |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Reverse transcriptase/RNaseH | Enzyme | INHIBITOR | EC50 | 5.28 | CHEMBL | CHEMBL | |||
| Gag-Pol polyprotein | Polyprotein | EC50 | 5.28 | WOMBAT-PK | |||||
| Reverse transcriptase | Enzyme | IC50 | 6.89 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4029879 | VUID |
| N0000180961 | NUI |
| D00891 | KEGG_DRUG |
| 188062-50-2 | SECONDARY_CAS_RN |
| 190521 | RXNORM |
| C0663655 | UMLSCUI |
| CHEBI:421707 | CHEBI |
| 1KX | PDB_CHEM_ID |
| CHEMBL1380 | ChEMBL_ID |
| CHEMBL2106686 | ChEMBL_ID |
| CHEMBL4303288 | ChEMBL_ID |
| DB01048 | DRUGBANK_ID |
| D000099227 | MESH_DESCRIPTOR_UI |
| 441300 | PUBCHEM_CID |
| 11152 | IUPHAR_LIGAND_ID |
| 7544 | INN_ID |
| 168146-84-7 | SECONDARY_CAS_RN |
| WR2TIP26VS | UNII |
| 14010 | MMSL |
| 191490 | MMSL |
| 30504 | MMSL |
| 66957 | MMSL |
| 7865 | MMSL |
| d04376 | MMSL |
| 4021139 | VANDF |
| 4024130 | VANDF |
| 4029879 | VANDF |
| 007687 | NDDF |
| 007688 | NDDF |
| 116084008 | SNOMEDCT_US |
| 387005008 | SNOMEDCT_US |
| 412074007 | SNOMEDCT_US |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Abacavir Sulfate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-4105 | TABLET, FILM COATED | 300 mg | ORAL | ANDA | 28 sections |
| Abacavir | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0904-6874 | TABLET, FILM COATED | 300 mg | ORAL | ANDA | 27 sections |
| Abacavir | HUMAN PRESCRIPTION DRUG LABEL | 1 | 31722-557 | TABLET | 300 mg | ORAL | ANDA | 26 sections |
| Abacavir | Human Prescription Drug Label | 1 | 31722-562 | SOLUTION | 20 mg | ORAL | ANDA | 28 sections |
| ABACAVIR and LAMIVUDINE | HUMAN PRESCRIPTION DRUG LABEL | 2 | 31722-838 | TABLET, FILM COATED | 600 mg | ORAL | ANDA | 27 sections |
| Abacavir and Lamivudine | Human Prescription Drug Label | 2 | 33342-440 | TABLET, FILM COATED | 600 mg | ORAL | ANDA | 27 sections |
| Abacavir and Lamivudine | Human Prescription Drug Label | 2 | 42385-962 | TABLET, FILM COATED | 600 mg | ORAL | ANDA | 28 sections |
| Abacavir Sulfate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 48433-001 | TABLET, FILM COATED | 300 mg | ORAL | ANDA | 28 sections |
| ZIAGEN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 49702-222 | SOLUTION | 20 mg | ORAL | NDA | 26 sections |
| Triumeq | HUMAN PRESCRIPTION DRUG LABEL | 3 | 49702-231 | TABLET, FILM COATED | 600 mg | ORAL | NDA | 27 sections |
| Triumeq | HUMAN PRESCRIPTION DRUG LABEL | 3 | 49702-231 | TABLET, FILM COATED | 600 mg | ORAL | NDA | 27 sections |
| Abacavir | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50268-049 | TABLET | 300 mg | ORAL | ANDA | 27 sections |
| Abacavir Sulfate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 51079-204 | TABLET, FILM COATED | 300 mg | ORAL | ANDA | 28 sections |
| Abacavir Sulfate | HUMAN PRESCRIPTION DRUG LABEL | 1 | 53808-0627 | TABLET, FILM COATED | 300 mg | ORAL | ANDA | 30 sections |
| EPZICOM | HUMAN PRESCRIPTION DRUG LABEL | 2 | 53808-0767 | TABLET, FILM COATED | 600 mg | ORAL | NDA | 26 sections |
| ZIAGEN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 53808-0811 | TABLET, FILM COATED | 300 mg | ORAL | NDA | 29 sections |
| TRIZIVIR | HUMAN PRESCRIPTION DRUG LABEL | 3 | 53808-0990 | TABLET, FILM COATED | 300 mg | ORAL | NDA | 28 sections |
| EPZICOM | HUMAN PRESCRIPTION DRUG LABEL | 2 | 54868-5600 | TABLET, FILM COATED | 600 mg | ORAL | NDA | 26 sections |
| Abacavir | Human Prescription Drug Label | 1 | 64980-405 | SOLUTION | 20 mg | ORAL | ANDA | 27 sections |
| Abacavir | Human Prescription Drug Label | 1 | 65862-073 | TABLET, FILM COATED | 300 mg | ORAL | ANDA | 27 sections |
| Abacavir | Human Prescription Drug Label | 1 | 65862-089 | SOLUTION | 20 mg | ORAL | ANDA | 27 sections |
| Abacavir and Lamivudine | Human Prescription Drug Label | 2 | 65862-335 | TABLET, FILM COATED | 600 mg | ORAL | ANDA | 28 sections |
| Abacavir | HUMAN PRESCRIPTION DRUG LABEL | 1 | 67046-1602 | TABLET | 300 mg | ORAL | ANDA | 25 sections |
| Abacavir | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68084-021 | TABLET, FILM COATED | 300 mg | ORAL | ANDA | 27 sections |
| ABACAVIR, LAMIVUDINE AND ZIDOVUDINE | HUMAN PRESCRIPTION DRUG LABEL | 3 | 68180-286 | TABLET | 300 mg | ORAL | ANDA | 28 sections |
| Abacavir and Lamivudine | HUMAN PRESCRIPTION DRUG LABEL | 2 | 68180-288 | TABLET, FILM COATED | 600 mg | ORAL | ANDA | 26 sections |
| Abacavir and Lamivudine | HUMAN PRESCRIPTION DRUG LABEL | 2 | 69097-362 | TABLET, FILM COATED | 600 mg | ORAL | ANDA | 26 sections |
| Abacavir | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69097-514 | TABLET, FILM COATED | 300 mg | ORAL | ANDA | 25 sections |
| Abacavir | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72865-167 | TABLET | 300 mg | ORAL | ANDA | 26 sections |