ambrisentan 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| endothelin receptor antagonists | 4337 | 177036-94-1 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
an endothelin receptor antagonist that is selective for the endothelin type-A (ETA) receptor
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 7.50 | mg | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Benet LZ, Broccatelli F, Oprea TI |
| S (Water solubility) | 0.06 mg/mL | Benet LZ, Broccatelli F, Oprea TI |
| EoM (Fraction excreted unchanged in urine) | 5 % | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 0.38 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| March 23, 2021 | PMDA | GlaxoSmithKline K.K. | |
| June 20, 2019 | EMA | MYLAN SAS | |
| June 15, 2007 | FDA | GILEAD |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Dyspnoea | 4202.19 | 17.71 | 5321 | 101530 | 655992 | 62726179 |
| Fluid retention | 2463.18 | 17.71 | 1425 | 105426 | 58261 | 63323910 |
| Death | 2095.57 | 17.71 | 2844 | 104007 | 371537 | 63010634 |
| Nasal congestion | 1673.54 | 17.71 | 1156 | 105695 | 64504 | 63317667 |
| Headache | 1600.72 | 17.71 | 3370 | 103481 | 629871 | 62752300 |
| Pain in jaw | 1579.90 | 17.71 | 957 | 105894 | 42539 | 63339632 |
| Pulmonary arterial hypertension | 1298.38 | 17.71 | 672 | 106179 | 21905 | 63360266 |
| Oedema | 1196.40 | 17.71 | 1119 | 105732 | 96503 | 63285668 |
| Right ventricular failure | 1035.57 | 17.71 | 528 | 106323 | 16660 | 63365511 |
| Unevaluable event | 986.93 | 17.71 | 763 | 106088 | 50623 | 63331548 |
| Hypervolaemia | 941.70 | 17.71 | 590 | 106261 | 27823 | 63354348 |
| Oedema peripheral | 927.61 | 17.71 | 1354 | 105497 | 188157 | 63194014 |
| Flushing | 862.82 | 17.71 | 831 | 106020 | 74256 | 63307915 |
| Pulmonary hypertension | 855.30 | 17.71 | 615 | 106236 | 36508 | 63345663 |
| Dyspnoea exertional | 766.62 | 17.71 | 706 | 106145 | 59596 | 63322575 |
| Drug ineffective | 743.98 | 17.71 | 421 | 106430 | 1044344 | 62337827 |
| Chest pain | 583.31 | 17.71 | 1186 | 105665 | 214773 | 63167398 |
| Lung transplant | 551.17 | 17.71 | 205 | 106646 | 2923 | 63379248 |
| Dizziness | 513.45 | 17.71 | 1738 | 105113 | 428187 | 62953984 |
| Hospitalisation | 506.83 | 17.71 | 669 | 106182 | 84412 | 63297759 |
| Infusion site pain | 486.34 | 17.71 | 321 | 106530 | 16548 | 63365623 |
| Peripheral swelling | 469.00 | 17.71 | 1235 | 105616 | 264707 | 63117464 |
| Catheterisation cardiac | 467.91 | 17.71 | 203 | 106648 | 4400 | 63377771 |
| Oxygen saturation decreased | 431.02 | 17.71 | 632 | 106219 | 87953 | 63294218 |
| Palpitations | 413.83 | 17.71 | 707 | 106144 | 112063 | 63270108 |
| Syncope | 398.33 | 17.71 | 711 | 106140 | 116674 | 63265497 |
| Infusion related reaction | 378.44 | 17.71 | 7 | 106844 | 245514 | 63136657 |
| Pneumonia | 368.10 | 17.71 | 1631 | 105220 | 455136 | 62927035 |
| Alopecia | 367.72 | 17.71 | 63 | 106788 | 337473 | 63044698 |
| Diarrhoea | 359.16 | 17.71 | 2239 | 104612 | 713127 | 62669044 |
| Toxicity to various agents | 342.33 | 17.71 | 18 | 106833 | 247232 | 63134939 |
| Contraindicated product administered | 340.44 | 17.71 | 5 | 106846 | 217643 | 63164528 |
| Device related infection | 336.79 | 17.71 | 294 | 106557 | 23098 | 63359073 |
| Catheter site erythema | 328.12 | 17.71 | 155 | 106696 | 4121 | 63378050 |
| Therapy interrupted | 322.15 | 17.71 | 332 | 106519 | 32123 | 63350048 |
| Rheumatoid arthritis | 305.33 | 17.71 | 35 | 106816 | 253784 | 63128387 |
| Cardiac failure congestive | 293.30 | 17.71 | 544 | 106307 | 91889 | 63290282 |
| Malaise | 293.27 | 17.71 | 1429 | 105422 | 414525 | 62967646 |
| Hypotension | 291.55 | 17.71 | 1064 | 105787 | 271540 | 63110631 |
| Treatment failure | 290.37 | 17.71 | 10 | 106841 | 199033 | 63183138 |
| Arthropathy | 273.51 | 17.71 | 36 | 106815 | 234756 | 63147415 |
| Cardiac failure | 270.83 | 17.71 | 515 | 106336 | 88627 | 63293544 |
| Therapeutic product effect decreased | 270.74 | 17.71 | 13 | 106838 | 193174 | 63188997 |
| Scleroderma | 267.00 | 17.71 | 146 | 106705 | 5316 | 63376855 |
| Cough | 264.32 | 17.71 | 1083 | 105768 | 291660 | 63090511 |
| Respiratory failure | 260.94 | 17.71 | 548 | 106303 | 101310 | 63280861 |
| Vascular device infection | 260.26 | 17.71 | 159 | 106692 | 7153 | 63375018 |
| Glossodynia | 257.40 | 17.71 | 10 | 106841 | 178866 | 63203305 |
| Infusion site infection | 253.08 | 17.71 | 100 | 106751 | 1694 | 63380477 |
| Hypoxia | 240.72 | 17.71 | 391 | 106460 | 59401 | 63322770 |
| Infusion site erythema | 240.62 | 17.71 | 181 | 106670 | 11498 | 63370673 |
| Oxygen consumption increased | 238.72 | 17.71 | 121 | 106730 | 3763 | 63378408 |
| Off label use | 233.75 | 17.71 | 492 | 106359 | 673970 | 62708201 |
| Catheter site pruritus | 233.60 | 17.71 | 99 | 106752 | 2021 | 63380150 |
| Neutropenia | 221.09 | 17.71 | 20 | 106831 | 174985 | 63207186 |
| Maternal exposure during pregnancy | 218.72 | 17.71 | 51 | 106800 | 220011 | 63162160 |
| Drug interaction | 214.49 | 17.71 | 60 | 106791 | 229071 | 63153100 |
| Drug hypersensitivity | 212.67 | 17.71 | 130 | 106721 | 310557 | 63071614 |
| Product use in unapproved indication | 212.04 | 17.71 | 26 | 106825 | 179054 | 63203117 |
| Catheter site discharge | 211.87 | 17.71 | 91 | 106760 | 1922 | 63380249 |
| Central venous catheterisation | 211.12 | 17.71 | 98 | 106753 | 2501 | 63379670 |
| Catheter site pain | 200.00 | 17.71 | 115 | 106736 | 4620 | 63377551 |
| Therapy change | 195.62 | 17.71 | 124 | 106727 | 5957 | 63376214 |
| Catheter management | 183.42 | 17.71 | 93 | 106758 | 2894 | 63379277 |
| Rash | 179.47 | 17.71 | 427 | 106424 | 560444 | 62821727 |
| Pericarditis | 174.67 | 17.71 | 12 | 106839 | 131567 | 63250604 |
| Febrile neutropenia | 172.50 | 17.71 | 6 | 106845 | 118443 | 63263728 |
| Acute respiratory failure | 171.84 | 17.71 | 249 | 106602 | 34236 | 63347935 |
| Catheter placement | 169.76 | 17.71 | 81 | 106770 | 2203 | 63379968 |
| Nausea | 169.74 | 17.71 | 2185 | 104666 | 852286 | 62529885 |
| Epistaxis | 167.57 | 17.71 | 375 | 106476 | 72350 | 63309821 |
| Stomatitis | 167.02 | 17.71 | 19 | 106832 | 138706 | 63243465 |
| Wound | 161.86 | 17.71 | 38 | 106813 | 163225 | 63218946 |
| Musculoskeletal stiffness | 160.78 | 17.71 | 55 | 106796 | 184563 | 63197608 |
| Myalgia | 160.60 | 17.71 | 577 | 106274 | 145952 | 63236219 |
| Chest discomfort | 156.29 | 17.71 | 473 | 106378 | 109496 | 63272675 |
| Discomfort | 152.59 | 17.71 | 46 | 106805 | 167328 | 63214843 |
| Pulmonary arterial pressure increased | 151.01 | 17.71 | 87 | 106764 | 3508 | 63378663 |
| Device leakage | 150.69 | 17.71 | 112 | 106739 | 6984 | 63375187 |
| Infusion site discharge | 150.53 | 17.71 | 53 | 106798 | 639 | 63381532 |
| Dermatitis contact | 147.75 | 17.71 | 133 | 106718 | 10875 | 63371296 |
| Infusion site swelling | 147.09 | 17.71 | 126 | 106725 | 9644 | 63372527 |
| Therapeutic product effect incomplete | 143.57 | 17.71 | 20 | 106831 | 125036 | 63257135 |
| C-reactive protein increased | 140.76 | 17.71 | 4 | 106847 | 94703 | 63287468 |
| Transfusion | 139.07 | 17.71 | 149 | 106702 | 15068 | 63367103 |
| Hypertension | 137.01 | 17.71 | 161 | 106690 | 279142 | 63103029 |
| Psoriatic arthropathy | 135.53 | 17.71 | 4 | 106847 | 91516 | 63290655 |
| White blood cell count decreased | 132.78 | 17.71 | 35 | 106816 | 139069 | 63243102 |
| Hepatic enzyme increased | 131.05 | 17.71 | 90 | 106761 | 202238 | 63179933 |
| Catheter site infection | 130.76 | 17.71 | 89 | 106762 | 4825 | 63377346 |
| Therapy cessation | 129.14 | 17.71 | 204 | 106647 | 30253 | 63351918 |
| Drug intolerance | 128.10 | 17.71 | 201 | 106650 | 308460 | 63073711 |
| Blood cholesterol increased | 126.48 | 17.71 | 8 | 106843 | 94024 | 63288147 |
| Pain in extremity | 126.35 | 17.71 | 972 | 105879 | 330514 | 63051657 |
| Device dislocation | 124.28 | 17.71 | 183 | 106668 | 25522 | 63356649 |
| Haemoptysis | 124.01 | 17.71 | 194 | 106657 | 28532 | 63353639 |
| Helicobacter infection | 121.57 | 17.71 | 9 | 106842 | 92776 | 63289395 |
| Cardiac disorder | 121.51 | 17.71 | 266 | 106585 | 50550 | 63331621 |
| Exposure during pregnancy | 119.62 | 17.71 | 56 | 106795 | 155491 | 63226680 |
| Psoriasis | 118.16 | 17.71 | 7 | 106844 | 86950 | 63295221 |
| Abdominal distension | 116.94 | 17.71 | 366 | 106485 | 86249 | 63295922 |
| Malignant neoplasm progression | 116.70 | 17.71 | 5 | 106846 | 82116 | 63300055 |
| Impaired healing | 116.29 | 17.71 | 17 | 106834 | 102525 | 63279646 |
| Presyncope | 116.28 | 17.71 | 185 | 106666 | 27600 | 63354571 |
| Device alarm issue | 115.97 | 17.71 | 55 | 106796 | 1475 | 63380696 |
| Transplant evaluation | 112.61 | 17.71 | 50 | 106801 | 1147 | 63381024 |
| Joint swelling | 109.77 | 17.71 | 243 | 106608 | 327423 | 63054748 |
| Hypersensitivity | 109.14 | 17.71 | 204 | 106647 | 292481 | 63089690 |
| Confusional state | 108.82 | 17.71 | 143 | 106708 | 236237 | 63145934 |
| Pulmonary oedema | 107.90 | 17.71 | 266 | 106585 | 54607 | 63327564 |
| Osteoarthritis | 107.67 | 17.71 | 16 | 106835 | 95327 | 63286844 |
| Sinus congestion | 105.43 | 17.71 | 141 | 106710 | 17982 | 63364189 |
| Intentional dose omission | 105.30 | 17.71 | 96 | 106755 | 7979 | 63374192 |
| Catheter site rash | 105.24 | 17.71 | 42 | 106809 | 731 | 63381440 |
| Systemic lupus erythematosus | 103.94 | 17.71 | 119 | 106732 | 208799 | 63173372 |
| Catheter site haemorrhage | 102.76 | 17.71 | 65 | 106786 | 3110 | 63379061 |
| Lower respiratory tract infection | 102.71 | 17.71 | 47 | 106804 | 132260 | 63249911 |
| Intentional overdose | 100.65 | 17.71 | 6 | 106845 | 74146 | 63308025 |
| Complication associated with device | 95.58 | 17.71 | 130 | 106721 | 16848 | 63365323 |
| Drug abuse | 95.10 | 17.71 | 7 | 106844 | 72511 | 63309660 |
| Oxygen therapy | 92.26 | 17.71 | 53 | 106798 | 2125 | 63380046 |
| Catheter site swelling | 90.49 | 17.71 | 46 | 106805 | 1439 | 63380732 |
| Irritable bowel syndrome | 90.41 | 17.71 | 15 | 106836 | 82397 | 63299774 |
| Type 2 diabetes mellitus | 90.38 | 17.71 | 4 | 106847 | 63864 | 63318307 |
| Heart rate increased | 86.61 | 17.71 | 351 | 106500 | 93887 | 63288284 |
| Mobility decreased | 86.59 | 17.71 | 48 | 106803 | 121111 | 63261060 |
| Neuropathy peripheral | 84.22 | 17.71 | 43 | 106808 | 113624 | 63268547 |
| Injection site discharge | 83.80 | 17.71 | 37 | 106814 | 837 | 63381334 |
| Arthralgia | 82.48 | 17.71 | 591 | 106260 | 569119 | 62813052 |
| Pancytopenia | 82.42 | 17.71 | 30 | 106821 | 96903 | 63285268 |
| Anaphylactic reaction | 82.24 | 17.71 | 8 | 106843 | 66092 | 63316079 |
| Cor pulmonale | 81.75 | 17.71 | 48 | 106803 | 2006 | 63380165 |
| Urticaria | 80.77 | 17.71 | 96 | 106755 | 165706 | 63216465 |
| Electrocardiogram QT prolonged | 80.24 | 17.71 | 5 | 106846 | 59525 | 63322646 |
| Device occlusion | 79.54 | 17.71 | 79 | 106772 | 7308 | 63374863 |
| Fibromyalgia | 79.11 | 17.71 | 19 | 106832 | 80401 | 63301770 |
| Swelling | 78.28 | 17.71 | 757 | 106094 | 274621 | 63107550 |
| Blood pressure decreased | 78.04 | 17.71 | 264 | 106587 | 64758 | 63317413 |
| Cardiac operation | 76.70 | 17.71 | 55 | 106796 | 3243 | 63378928 |
| Blister | 76.01 | 17.71 | 64 | 106787 | 129750 | 63252421 |
| Acute kidney injury | 75.92 | 17.71 | 211 | 106640 | 263204 | 63118967 |
| Blood pressure increased | 75.61 | 17.71 | 97 | 106754 | 161965 | 63220206 |
| Catheter site vesicles | 75.58 | 17.71 | 26 | 106825 | 291 | 63381880 |
| Thrombocytopenia | 75.26 | 17.71 | 86 | 106765 | 151071 | 63231100 |
| Suicide attempt | 74.16 | 17.71 | 8 | 106843 | 60910 | 63321261 |
| General physical health deterioration | 73.59 | 17.71 | 142 | 106709 | 201260 | 63180911 |
| Infusion site haemorrhage | 73.33 | 17.71 | 64 | 106787 | 5022 | 63377149 |
| Dialysis | 73.08 | 17.71 | 89 | 106762 | 10338 | 63371833 |
| Exercise tolerance decreased | 72.95 | 17.71 | 66 | 106785 | 5431 | 63376740 |
| Device infusion issue | 71.71 | 17.71 | 44 | 106807 | 1994 | 63380177 |
| Sleep disorder due to general medical condition, insomnia type | 71.56 | 17.71 | 4 | 106847 | 52213 | 63329958 |
| Hyponatraemia | 70.79 | 17.71 | 51 | 106800 | 111849 | 63270322 |
| Depression | 70.53 | 17.71 | 140 | 106711 | 196352 | 63185819 |
| Pericardial effusion | 70.32 | 17.71 | 156 | 106695 | 29902 | 63352269 |
| Overdose | 69.53 | 17.71 | 55 | 106796 | 115023 | 63267148 |
| Injury | 68.80 | 17.71 | 19 | 106832 | 73228 | 63308943 |
| Feeling abnormal | 68.48 | 17.71 | 456 | 106395 | 147936 | 63234235 |
| Pruritus | 67.98 | 17.71 | 345 | 106506 | 361108 | 63021063 |
| Hot flush | 67.93 | 17.71 | 215 | 106636 | 50944 | 63331227 |
| Liver injury | 66.41 | 17.71 | 11 | 106840 | 60509 | 63321662 |
| Pulmonary veno-occlusive disease | 66.21 | 17.71 | 34 | 106817 | 1087 | 63381084 |
| Deep vein thrombosis | 64.66 | 17.71 | 30 | 106821 | 83770 | 63298401 |
| Liver function test abnormal | 64.45 | 17.71 | 203 | 106648 | 47978 | 63334193 |
| Dyspnoea at rest | 64.25 | 17.71 | 54 | 106797 | 4025 | 63378146 |
| Leukopenia | 63.90 | 17.71 | 25 | 106826 | 77265 | 63304906 |
| Device connection issue | 62.87 | 17.71 | 28 | 106823 | 647 | 63381524 |
| Multiple sclerosis relapse | 62.65 | 17.71 | 5 | 106846 | 48473 | 63333698 |
| Mechanical ventilation | 61.03 | 17.71 | 34 | 106817 | 1284 | 63380887 |
| Blood pressure systolic increased | 60.95 | 17.71 | 5 | 106846 | 47392 | 63334779 |
| Nasopharyngitis | 60.40 | 17.71 | 674 | 106177 | 253583 | 63128588 |
| Hypoaesthesia | 60.40 | 17.71 | 120 | 106731 | 168273 | 63213898 |
| Inflammation | 59.64 | 17.71 | 32 | 106819 | 82241 | 63299930 |
| Injection site reaction | 59.20 | 17.71 | 13 | 106838 | 58511 | 63323660 |
| Bradycardia | 58.40 | 17.71 | 25 | 106826 | 73202 | 63308969 |
| Terminal state | 57.58 | 17.71 | 40 | 106811 | 2242 | 63379929 |
| Walking distance test abnormal | 57.31 | 17.71 | 25 | 106826 | 549 | 63381622 |
| Intentional product use issue | 57.15 | 17.71 | 79 | 106772 | 127813 | 63254358 |
| Dizziness postural | 56.70 | 17.71 | 66 | 106785 | 7310 | 63374861 |
| Inappropriate schedule of product administration | 56.39 | 17.71 | 55 | 106796 | 103910 | 63278261 |
| Infusion site cellulitis | 56.36 | 17.71 | 19 | 106832 | 199 | 63381972 |
| Anaemia | 56.29 | 17.71 | 747 | 106104 | 292683 | 63089488 |
| Injection site pain | 56.19 | 17.71 | 82 | 106769 | 129718 | 63252453 |
| Catheter site inflammation | 56.12 | 17.71 | 28 | 106823 | 841 | 63381330 |
| Atrial flutter | 55.27 | 17.71 | 75 | 106776 | 9697 | 63372474 |
| Infusion site induration | 55.16 | 17.71 | 31 | 106820 | 1191 | 63380980 |
| Catheter site irritation | 55.06 | 17.71 | 24 | 106827 | 526 | 63381645 |
| Coma | 54.57 | 17.71 | 20 | 106831 | 64344 | 63317827 |
| Delirium | 53.68 | 17.71 | 10 | 106841 | 50531 | 63331640 |
| Cognitive disorder | 53.32 | 17.71 | 14 | 106837 | 55801 | 63326370 |
| Infusion site pruritus | 53.22 | 17.71 | 58 | 106793 | 5977 | 63376194 |
| Endotracheal intubation | 53.06 | 17.71 | 40 | 106811 | 2548 | 63379623 |
| Ear discomfort | 53.02 | 17.71 | 66 | 106785 | 7840 | 63374331 |
| Transplant | 52.39 | 17.71 | 26 | 106825 | 772 | 63381399 |
| Suicidal ideation | 51.91 | 17.71 | 20 | 106831 | 62401 | 63319770 |
| Chronic obstructive pulmonary disease | 51.74 | 17.71 | 226 | 106625 | 62460 | 63319711 |
| Localised oedema | 51.51 | 17.71 | 54 | 106797 | 5324 | 63376847 |
| Brain natriuretic peptide increased | 51.11 | 17.71 | 53 | 106798 | 5160 | 63377011 |
| Upper respiratory tract congestion | 51.07 | 17.71 | 36 | 106815 | 2066 | 63380105 |
| Hypothyroidism | 50.88 | 17.71 | 6 | 106845 | 42626 | 63339545 |
| Influenza | 50.68 | 17.71 | 335 | 106516 | 108387 | 63273784 |
| Blood glucose increased | 50.62 | 17.71 | 40 | 106811 | 83716 | 63298455 |
| Emergency care | 50.54 | 17.71 | 28 | 106823 | 1046 | 63381125 |
| Paracentesis | 50.39 | 17.71 | 27 | 106824 | 943 | 63381228 |
| Sedation | 50.16 | 17.71 | 4 | 106847 | 38805 | 63343366 |
| Depressed level of consciousness | 49.82 | 17.71 | 21 | 106830 | 62057 | 63320114 |
| Neoplasm progression | 49.27 | 17.71 | 3 | 106848 | 36425 | 63345746 |
| Agitation | 48.30 | 17.71 | 20 | 106831 | 59737 | 63322434 |
| Lung disorder | 48.03 | 17.71 | 220 | 106631 | 62041 | 63320130 |
| Metabolic acidosis | 47.69 | 17.71 | 9 | 106842 | 45060 | 63337111 |
| Drug-induced liver injury | 47.17 | 17.71 | 6 | 106845 | 40216 | 63341955 |
| Lactic acidosis | 46.67 | 17.71 | 5 | 106846 | 38282 | 63343889 |
| Alanine aminotransferase increased | 46.45 | 17.71 | 64 | 106787 | 103706 | 63278465 |
| Infusion site warmth | 46.18 | 17.71 | 32 | 106819 | 1786 | 63380385 |
| Sickle cell anaemia | 45.38 | 17.71 | 21 | 106830 | 532 | 63381639 |
| Ascites | 45.07 | 17.71 | 161 | 106690 | 40567 | 63341604 |
| Treatment noncompliance | 44.29 | 17.71 | 151 | 106700 | 37174 | 63344997 |
| Chronic respiratory failure | 44.21 | 17.71 | 32 | 106819 | 1915 | 63380256 |
| Vascular device occlusion | 43.13 | 17.71 | 14 | 106837 | 129 | 63382042 |
| Medication error | 43.07 | 17.71 | 17 | 106834 | 52267 | 63329904 |
| Therapeutic response decreased | 43.05 | 17.71 | 25 | 106826 | 61500 | 63320671 |
| Sinus disorder | 43.03 | 17.71 | 114 | 106737 | 24439 | 63357732 |
| Abortion spontaneous | 42.92 | 17.71 | 13 | 106838 | 47182 | 63334989 |
| Paraesthesia | 42.79 | 17.71 | 129 | 106722 | 156837 | 63225334 |
| Hallucination | 41.70 | 17.71 | 20 | 106831 | 54797 | 63327374 |
| Product use issue | 41.67 | 17.71 | 210 | 106641 | 220310 | 63161861 |
| Somnolence | 41.13 | 17.71 | 158 | 106693 | 178527 | 63203644 |
| Mouth ulceration | 41.00 | 17.71 | 4 | 106847 | 32980 | 63349191 |
| Loss of personal independence in daily activities | 40.61 | 17.71 | 63 | 106788 | 97227 | 63284944 |
| Vomiting | 40.57 | 17.71 | 1230 | 105621 | 558387 | 62823784 |
| Arthritis | 40.37 | 17.71 | 84 | 106767 | 115837 | 63266334 |
| Generalised oedema | 40.32 | 17.71 | 85 | 106766 | 15733 | 63366438 |
| Abdominal pain upper | 40.14 | 17.71 | 527 | 106324 | 205917 | 63176254 |
| Throat irritation | 39.27 | 17.71 | 146 | 106705 | 37501 | 63344670 |
| Oxygen consumption | 39.02 | 17.71 | 12 | 106839 | 91 | 63382080 |
| Weight increased | 38.62 | 17.71 | 635 | 106216 | 260157 | 63122014 |
| Prescribed underdose | 38.54 | 17.71 | 3 | 106848 | 29686 | 63352485 |
| Oxygen saturation abnormal | 38.47 | 17.71 | 38 | 106813 | 3491 | 63378680 |
| Plasma cell myeloma | 38.35 | 17.71 | 7 | 106844 | 35898 | 63346273 |
| Seizure | 38.35 | 17.71 | 106 | 106745 | 132528 | 63249643 |
| Intentional product misuse | 38.21 | 17.71 | 28 | 106823 | 60889 | 63321282 |
| Knee arthroplasty | 37.96 | 17.71 | 22 | 106829 | 54184 | 63327987 |
| Hepatotoxicity | 37.93 | 17.71 | 8 | 106843 | 37033 | 63345138 |
| Bone marrow failure | 37.91 | 17.71 | 3 | 106848 | 29287 | 63352884 |
| Central venous catheter removal | 37.54 | 17.71 | 17 | 106834 | 409 | 63381762 |
| Respiration abnormal | 37.43 | 17.71 | 50 | 106801 | 6367 | 63375804 |
| Contusion | 36.95 | 17.71 | 129 | 106722 | 149915 | 63232256 |
| Device breakage | 36.64 | 17.71 | 68 | 106783 | 11474 | 63370697 |
| Blood creatinine increased | 36.55 | 17.71 | 57 | 106794 | 87787 | 63294384 |
| Injection site erythema | 36.52 | 17.71 | 52 | 106799 | 83122 | 63299049 |
| Pain | 36.43 | 17.71 | 959 | 105892 | 739669 | 62642502 |
| Infusion site inflammation | 36.03 | 17.71 | 16 | 106835 | 367 | 63381804 |
| Device related sepsis | 35.50 | 17.71 | 39 | 106812 | 4055 | 63378116 |
| Injection site infection | 35.40 | 17.71 | 28 | 106823 | 1915 | 63380256 |
| Hyperkalaemia | 35.20 | 17.71 | 24 | 106827 | 54179 | 63327992 |
| Eczema | 35.14 | 17.71 | 6 | 106845 | 32285 | 63349886 |
| Pulmonary embolism | 34.67 | 17.71 | 92 | 106759 | 116592 | 63265579 |
| Hypoglycaemia | 34.67 | 17.71 | 30 | 106821 | 60035 | 63322136 |
| Foetal exposure during pregnancy | 34.64 | 17.71 | 6 | 106845 | 31956 | 63350215 |
| Ear congestion | 34.42 | 17.71 | 32 | 106819 | 2727 | 63379444 |
| Gastrointestinal haemorrhage | 34.19 | 17.71 | 244 | 106607 | 80932 | 63301239 |
| Thrombosis in device | 34.10 | 17.71 | 33 | 106818 | 2957 | 63379214 |
| Systemic scleroderma | 34.06 | 17.71 | 21 | 106830 | 960 | 63381211 |
| Osteoporosis | 33.88 | 17.71 | 28 | 106823 | 57310 | 63324861 |
| Hyperglycaemia | 33.85 | 17.71 | 14 | 106837 | 41853 | 63340318 |
| Catheter site warmth | 33.57 | 17.71 | 13 | 106838 | 208 | 63381963 |
| Emotional distress | 33.39 | 17.71 | 7 | 106844 | 32542 | 63349629 |
| Liver transplant | 33.37 | 17.71 | 29 | 106822 | 2262 | 63379909 |
| Asthma | 33.23 | 17.71 | 107 | 106744 | 127454 | 63254717 |
| No adverse event | 33.23 | 17.71 | 14 | 106837 | 41391 | 63340780 |
| Foot deformity | 33.04 | 17.71 | 4 | 106847 | 27849 | 63354322 |
| Application site pruritus | 32.91 | 17.71 | 37 | 106814 | 3947 | 63378224 |
| Product quality issue | 32.40 | 17.71 | 10 | 106841 | 35855 | 63346316 |
| Nocturnal dyspnoea | 32.17 | 17.71 | 22 | 106829 | 1202 | 63380969 |
| Disturbance in attention | 32.15 | 17.71 | 12 | 106839 | 38177 | 63343994 |
| Hypomagnesaemia | 32.03 | 17.71 | 5 | 106846 | 28732 | 63353439 |
| Nasal dryness | 31.94 | 17.71 | 39 | 106812 | 4542 | 63377629 |
| Prescribed overdose | 31.80 | 17.71 | 9 | 106842 | 34144 | 63348027 |
| Paranasal sinus discomfort | 31.72 | 17.71 | 38 | 106813 | 4338 | 63377833 |
| Right-to-left cardiac shunt | 31.67 | 17.71 | 13 | 106838 | 244 | 63381927 |
| Pneumonitis | 31.49 | 17.71 | 10 | 106841 | 35212 | 63346959 |
| Pulmonary hypertensive crisis | 31.18 | 17.71 | 14 | 106837 | 330 | 63381841 |
| Herpes zoster | 31.09 | 17.71 | 57 | 106794 | 82405 | 63299766 |
| Stevens-Johnson syndrome | 31.08 | 17.71 | 3 | 106848 | 24947 | 63357224 |
| Basal cell carcinoma | 30.90 | 17.71 | 5 | 106846 | 27986 | 63354185 |
| Infusion site vesicles | 30.77 | 17.71 | 16 | 106835 | 525 | 63381646 |
| Femur fracture | 30.61 | 17.71 | 16 | 106835 | 41740 | 63340431 |
| Catheter site cellulitis | 30.42 | 17.71 | 13 | 106838 | 271 | 63381900 |
| Disease complication | 30.34 | 17.71 | 32 | 106819 | 3177 | 63378994 |
| Premature delivery | 30.08 | 17.71 | 7 | 106844 | 30274 | 63351897 |
| Therapy non-responder | 29.59 | 17.71 | 224 | 106627 | 75677 | 63306494 |
| Cardiac failure high output | 29.53 | 17.71 | 13 | 106838 | 292 | 63381879 |
| Dizziness exertional | 29.50 | 17.71 | 14 | 106837 | 376 | 63381795 |
| Middle ear effusion | 29.37 | 17.71 | 28 | 106823 | 2463 | 63379708 |
| Hypercalcaemia | 29.24 | 17.71 | 6 | 106845 | 28316 | 63353855 |
| Blood potassium decreased | 29.13 | 17.71 | 144 | 106707 | 41882 | 63340289 |
| Biopsy liver | 29.13 | 17.71 | 14 | 106837 | 387 | 63381784 |
| Metastases to liver | 29.04 | 17.71 | 3 | 106848 | 23636 | 63358535 |
| Infusion site oedema | 29.03 | 17.71 | 18 | 106833 | 831 | 63381340 |
| Catheter removal | 28.83 | 17.71 | 14 | 106837 | 396 | 63381775 |
| Disease recurrence | 28.81 | 17.71 | 6 | 106845 | 28024 | 63354147 |
| Fatigue | 28.79 | 17.71 | 1795 | 105056 | 886233 | 62495938 |
| Product administration interrupted | 28.70 | 17.71 | 38 | 106813 | 4798 | 63377373 |
| Swelling face | 28.61 | 17.71 | 194 | 106657 | 63281 | 63318890 |
| Blood calcium decreased | 28.59 | 17.71 | 5 | 106846 | 26446 | 63355725 |
| Right ventricular enlargement | 28.58 | 17.71 | 13 | 106838 | 316 | 63381855 |
| Infusion site rash | 28.56 | 17.71 | 25 | 106826 | 1969 | 63380202 |
| Infection | 28.26 | 17.71 | 248 | 106603 | 228925 | 63153246 |
| Hepatitis | 28.07 | 17.71 | 16 | 106835 | 39772 | 63342399 |
| Oral herpes | 28.03 | 17.71 | 5 | 106846 | 26069 | 63356102 |
| Dry eye | 27.90 | 17.71 | 17 | 106834 | 40744 | 63341427 |
| Metapneumovirus infection | 27.73 | 17.71 | 19 | 106832 | 1041 | 63381130 |
| Pregnancy test positive | 27.58 | 17.71 | 10 | 106841 | 132 | 63382039 |
| Infusion site irritation | 27.53 | 17.71 | 18 | 106833 | 912 | 63381259 |
| Hip arthroplasty | 27.25 | 17.71 | 24 | 106827 | 47622 | 63334549 |
| Drug titration error | 27.01 | 17.71 | 17 | 106834 | 806 | 63381365 |
| Intracardiac pressure increased | 26.95 | 17.71 | 8 | 106843 | 53 | 63382118 |
| Catheter site scab | 26.82 | 17.71 | 11 | 106840 | 206 | 63381965 |
| Drug ineffective for unapproved indication | 26.57 | 17.71 | 12 | 106839 | 34051 | 63348120 |
| Renal disorder | 26.53 | 17.71 | 118 | 106733 | 32856 | 63349315 |
| Platelet count decreased | 26.50 | 17.71 | 103 | 106748 | 116019 | 63266152 |
| Angioedema | 26.44 | 17.71 | 25 | 106826 | 47940 | 63334231 |
| Cardiac output increased | 26.21 | 17.71 | 11 | 106840 | 219 | 63381952 |
| Intra-abdominal fluid collection | 26.19 | 17.71 | 26 | 106825 | 2403 | 63379768 |
| Blood pressure fluctuation | 25.69 | 17.71 | 24 | 106827 | 46293 | 63335878 |
| Hospice care | 25.51 | 17.71 | 47 | 106804 | 7885 | 63374286 |
| Bone disorder | 25.45 | 17.71 | 3 | 106848 | 21323 | 63360848 |
| Epilepsy | 25.45 | 17.71 | 7 | 106844 | 27058 | 63355113 |
| Live birth | 25.31 | 17.71 | 6 | 106845 | 25624 | 63356547 |
| Joint stiffness | 25.29 | 17.71 | 20 | 106831 | 41849 | 63340322 |
| Skin lesion | 25.28 | 17.71 | 10 | 106841 | 30711 | 63351460 |
| Encephalopathy | 25.21 | 17.71 | 17 | 106834 | 38603 | 63343568 |
| Heart transplant | 25.20 | 17.71 | 14 | 106837 | 526 | 63381645 |
| Acute right ventricular failure | 25.16 | 17.71 | 10 | 106841 | 172 | 63381999 |
| Pyrexia | 24.99 | 17.71 | 602 | 106249 | 469876 | 62912295 |
| Toxic epidermal necrolysis | 24.88 | 17.71 | 6 | 106845 | 25328 | 63356843 |
| Injection site swelling | 24.83 | 17.71 | 26 | 106825 | 47546 | 63334625 |
| Product substitution issue | 24.78 | 17.71 | 71 | 106780 | 15925 | 63366246 |
| Catheter site related reaction | 24.71 | 17.71 | 17 | 106834 | 938 | 63381233 |
| Device programming error | 24.67 | 17.71 | 9 | 106842 | 121 | 63382050 |
| Tracheostomy | 24.54 | 17.71 | 15 | 106836 | 675 | 63381496 |
| Wrong technique in product usage process | 24.49 | 17.71 | 42 | 106809 | 62298 | 63319873 |
| Obstructive airways disorder | 24.49 | 17.71 | 3 | 106848 | 20696 | 63361475 |
| Skin exfoliation | 24.30 | 17.71 | 22 | 106829 | 43080 | 63339091 |
| Obesity | 24.24 | 17.71 | 10 | 106841 | 29942 | 63352229 |
| Product dose omission issue | 24.19 | 17.71 | 540 | 106311 | 233773 | 63148398 |
| Mitral valve replacement | 24.16 | 17.71 | 11 | 106840 | 268 | 63381903 |
| Heart valve replacement | 23.97 | 17.71 | 14 | 106837 | 579 | 63381592 |
| Pancreatitis acute | 23.78 | 17.71 | 8 | 106843 | 27158 | 63355013 |
| White blood cell count increased | 23.75 | 17.71 | 28 | 106823 | 48533 | 63333638 |
| Osteonecrosis | 23.72 | 17.71 | 6 | 106845 | 24524 | 63357647 |
| Infusion site haematoma | 23.58 | 17.71 | 11 | 106840 | 284 | 63381887 |
| Orthostatic hypotension | 23.49 | 17.71 | 16 | 106835 | 36144 | 63346027 |
| Jaundice | 23.30 | 17.71 | 10 | 106841 | 29241 | 63352930 |
| Tubulointerstitial nephritis | 23.26 | 17.71 | 3 | 106848 | 19900 | 63362271 |
| Infusion site abscess | 23.20 | 17.71 | 10 | 106841 | 213 | 63381958 |
| Haemorrhage | 23.18 | 17.71 | 179 | 106672 | 60843 | 63321328 |
| Ill-defined disorder | 23.13 | 17.71 | 66 | 106785 | 81689 | 63300482 |
| Gastric disorder | 23.09 | 17.71 | 124 | 106727 | 37245 | 63344926 |
| Ventilation perfusion mismatch | 23.00 | 17.71 | 13 | 106838 | 505 | 63381666 |
| Sleep disorder | 22.97 | 17.71 | 66 | 106785 | 81500 | 63300671 |
| Catheterisation cardiac abnormal | 22.86 | 17.71 | 10 | 106841 | 221 | 63381950 |
| Respiratory tract congestion | 22.81 | 17.71 | 74 | 106777 | 17758 | 63364413 |
| Left ventricular failure | 22.61 | 17.71 | 37 | 106814 | 5650 | 63376521 |
| Respiratory distress | 22.59 | 17.71 | 115 | 106736 | 33836 | 63348335 |
| Product prescribing error | 22.57 | 17.71 | 8 | 106843 | 26281 | 63355890 |
| Drug eruption | 22.55 | 17.71 | 10 | 106841 | 28684 | 63353487 |
| Echocardiogram | 22.52 | 17.71 | 6 | 106845 | 25 | 63382146 |
| Ejection fraction decreased | 22.50 | 17.71 | 5 | 106846 | 22327 | 63359844 |
| CREST syndrome | 22.36 | 17.71 | 13 | 106838 | 533 | 63381638 |
| Carpal tunnel syndrome | 22.36 | 17.71 | 4 | 106847 | 20813 | 63361358 |
| Hallucination, visual | 22.34 | 17.71 | 3 | 106848 | 19295 | 63362876 |
| Premature baby | 22.24 | 17.71 | 4 | 106847 | 20731 | 63361440 |
| Head discomfort | 22.21 | 17.71 | 61 | 106790 | 13354 | 63368817 |
| Gamma-glutamyltransferase increased | 22.19 | 17.71 | 15 | 106836 | 34016 | 63348155 |
| Productive cough | 22.14 | 17.71 | 182 | 106669 | 63026 | 63319145 |
| Heart and lung transplant | 22.04 | 17.71 | 8 | 106843 | 106 | 63382065 |
| Life support | 21.92 | 17.71 | 10 | 106841 | 245 | 63381926 |
| Diabetic ketoacidosis | 21.89 | 17.71 | 4 | 106847 | 20501 | 63361670 |
| Psychotic disorder | 21.77 | 17.71 | 8 | 106843 | 25704 | 63356467 |
| Multiple sclerosis | 21.65 | 17.71 | 7 | 106844 | 24365 | 63357806 |
| Catheter site discolouration | 21.64 | 17.71 | 8 | 106843 | 112 | 63382059 |
| Stent placement | 21.51 | 17.71 | 29 | 106822 | 3726 | 63378445 |
| Catheter site extravasation | 21.35 | 17.71 | 11 | 106840 | 354 | 63381817 |
| Hypokalaemia | 21.25 | 17.71 | 96 | 106755 | 103708 | 63278463 |
| Hepatic steatosis | 21.12 | 17.71 | 11 | 106840 | 28758 | 63353413 |
| Eye swelling | 21.09 | 17.71 | 88 | 106763 | 23830 | 63358341 |
| Bronchitis | 21.05 | 17.71 | 311 | 106540 | 124624 | 63257547 |
| Cardiac flutter | 21.02 | 17.71 | 30 | 106821 | 4066 | 63378105 |
| Emergency care examination | 20.88 | 17.71 | 7 | 106844 | 72 | 63382099 |
| Dry skin | 20.84 | 17.71 | 40 | 106811 | 56847 | 63325324 |
| Cardiac failure acute | 20.68 | 17.71 | 48 | 106803 | 9475 | 63372696 |
| Biopsy lung | 20.57 | 17.71 | 9 | 106842 | 199 | 63381972 |
| Osteomyelitis | 20.56 | 17.71 | 9 | 106842 | 26011 | 63356160 |
| Aggression | 20.43 | 17.71 | 7 | 106844 | 23491 | 63358680 |
| Endarterectomy | 20.33 | 17.71 | 9 | 106842 | 205 | 63381966 |
| Pulmonary arterial pressure abnormal | 20.23 | 17.71 | 12 | 106839 | 511 | 63381660 |
| Portopulmonary hypertension | 20.22 | 17.71 | 8 | 106843 | 136 | 63382035 |
| Disorientation | 20.11 | 17.71 | 22 | 106829 | 39430 | 63342741 |
| Generalised tonic-clonic seizure | 20.00 | 17.71 | 12 | 106839 | 29004 | 63353167 |
| Abdominal cavity drainage | 19.97 | 17.71 | 11 | 106840 | 406 | 63381765 |
| Macular degeneration | 19.95 | 17.71 | 8 | 106843 | 24368 | 63357803 |
| Dyskinesia | 19.69 | 17.71 | 15 | 106836 | 31987 | 63350184 |
| Aphasia | 19.63 | 17.71 | 16 | 106835 | 32984 | 63349187 |
| Breast cancer | 19.55 | 17.71 | 32 | 106819 | 48351 | 63333820 |
| Oropharyngeal pain | 19.52 | 17.71 | 244 | 106607 | 94243 | 63287928 |
| Altered state of consciousness | 19.51 | 17.71 | 9 | 106842 | 25221 | 63356950 |
| Gastritis hypertrophic | 19.45 | 17.71 | 6 | 106845 | 46 | 63382125 |
| Abnormal behaviour | 19.30 | 17.71 | 6 | 106845 | 21420 | 63360751 |
| Withdrawal syndrome | 19.13 | 17.71 | 5 | 106846 | 19992 | 63362179 |
| Head injury | 19.08 | 17.71 | 94 | 106757 | 27302 | 63354869 |
| Diabetes mellitus | 18.95 | 17.71 | 41 | 106810 | 55769 | 63326402 |
| Atrial septal defect repair | 18.95 | 17.71 | 9 | 106842 | 242 | 63381929 |
| Device physical property issue | 18.91 | 17.71 | 20 | 106831 | 1992 | 63380179 |
| Aspartate aminotransferase increased | 18.77 | 17.71 | 83 | 106768 | 90194 | 63291977 |
| Nodule | 18.74 | 17.71 | 6 | 106845 | 21020 | 63361151 |
| Lymphopenia | 18.68 | 17.71 | 4 | 106847 | 18323 | 63363848 |
| Muscle twitching | 18.65 | 17.71 | 5 | 106846 | 19663 | 63362508 |
| Pulmonary pain | 18.55 | 17.71 | 26 | 106825 | 3464 | 63378707 |
| Muscular weakness | 18.55 | 17.71 | 125 | 106726 | 122228 | 63259943 |
| Pulmonary congestion | 18.54 | 17.71 | 68 | 106783 | 17350 | 63364821 |
| Catheter site induration | 18.51 | 17.71 | 6 | 106845 | 55 | 63382116 |
| Hemiparesis | 18.48 | 17.71 | 8 | 106843 | 23274 | 63358897 |
| Gastroenteritis viral | 18.46 | 17.71 | 84 | 106767 | 23616 | 63358555 |
| Decreased appetite | 18.43 | 17.71 | 553 | 106298 | 250499 | 63131672 |
| Bendopnoea | 18.20 | 17.71 | 5 | 106846 | 24 | 63382147 |
| Chronic right ventricular failure | 18.20 | 17.71 | 5 | 106846 | 24 | 63382147 |
| Atrial fibrillation | 17.98 | 17.71 | 286 | 106565 | 116350 | 63265821 |
| Pulmonary thrombosis | 17.96 | 17.71 | 43 | 106808 | 8659 | 63373512 |
| Cellulitis | 17.95 | 17.71 | 214 | 106637 | 81744 | 63300427 |
| Purulent discharge | 17.88 | 17.71 | 30 | 106821 | 4676 | 63377495 |
| Sickle cell disease | 17.87 | 17.71 | 6 | 106845 | 62 | 63382109 |
| Dysentery | 17.83 | 17.71 | 14 | 106837 | 947 | 63381224 |
| Gout | 17.82 | 17.71 | 56 | 106795 | 13215 | 63368956 |
| Vascular resistance pulmonary increased | 17.79 | 17.71 | 6 | 106845 | 63 | 63382108 |
| Cerebral infarction | 17.74 | 17.71 | 9 | 106842 | 23884 | 63358287 |
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 |
|---|---|---|---|---|---|---|
| Dyspnoea | 1336.72 | 22.89 | 1642 | 29312 | 375140 | 34550837 |
| Fluid retention | 979.95 | 22.89 | 477 | 30477 | 26410 | 34899567 |
| Death | 764.00 | 22.89 | 1300 | 29654 | 396749 | 34529228 |
| Headache | 595.43 | 22.89 | 805 | 30149 | 199830 | 34726147 |
| Oedema | 563.24 | 22.89 | 402 | 30552 | 45339 | 34880638 |
| Nasal congestion | 525.22 | 22.89 | 299 | 30655 | 22758 | 34903219 |
| Pulmonary arterial hypertension | 518.21 | 22.89 | 218 | 30736 | 8521 | 34917456 |
| Pain in jaw | 506.70 | 22.89 | 242 | 30712 | 12798 | 34913179 |
| Right ventricular failure | 403.22 | 22.89 | 183 | 30771 | 8601 | 34917376 |
| Pulmonary hypertension | 396.62 | 22.89 | 241 | 30713 | 20683 | 34905294 |
| Peripheral swelling | 347.94 | 22.89 | 382 | 30572 | 76159 | 34849818 |
| Oedema peripheral | 327.36 | 22.89 | 463 | 30491 | 119349 | 34806628 |
| Hypervolaemia | 318.05 | 22.89 | 205 | 30749 | 19504 | 34906473 |
| Flushing | 284.26 | 22.89 | 233 | 30721 | 32187 | 34893790 |
| Lung transplant | 210.67 | 22.89 | 76 | 30878 | 1948 | 34924029 |
| Unevaluable event | 208.79 | 22.89 | 196 | 30758 | 32394 | 34893583 |
| Swelling | 182.82 | 22.89 | 206 | 30748 | 42160 | 34883817 |
| Dyspnoea exertional | 180.92 | 22.89 | 207 | 30747 | 43072 | 34882905 |
| Oxygen saturation decreased | 180.23 | 22.89 | 230 | 30724 | 53588 | 34872389 |
| Infusion site pain | 163.40 | 22.89 | 76 | 30878 | 3775 | 34922202 |
| Toxicity to various agents | 162.67 | 22.89 | 3 | 30951 | 200359 | 34725618 |
| Dizziness | 152.77 | 22.89 | 482 | 30472 | 218039 | 34707938 |
| Therapy interrupted | 151.49 | 22.89 | 113 | 30841 | 13584 | 34912393 |
| Drug interaction | 146.77 | 22.89 | 15 | 30939 | 225931 | 34700046 |
| Neutropenia | 124.62 | 22.89 | 3 | 30951 | 156775 | 34769202 |
| Catheterisation cardiac | 123.50 | 22.89 | 56 | 30898 | 2621 | 34923356 |
| Hospitalisation | 116.91 | 22.89 | 193 | 30761 | 56709 | 34869268 |
| Pain in extremity | 100.30 | 22.89 | 292 | 30662 | 126221 | 34799756 |
| Syncope | 97.81 | 22.89 | 236 | 30718 | 91215 | 34834762 |
| Catheter site erythema | 93.25 | 22.89 | 38 | 30916 | 1365 | 34924612 |
| Weight increased | 90.96 | 22.89 | 232 | 30722 | 92801 | 34833176 |
| Hypoxia | 90.00 | 22.89 | 169 | 30785 | 54926 | 34871051 |
| Device related infection | 88.62 | 22.89 | 92 | 30862 | 17145 | 34908832 |
| Catheter management | 88.45 | 22.89 | 33 | 30921 | 932 | 34925045 |
| Cardiac failure congestive | 87.00 | 22.89 | 213 | 30741 | 83057 | 34842920 |
| Cardiac failure | 81.48 | 22.89 | 220 | 30734 | 91028 | 34834949 |
| Thrombocytopenia | 79.90 | 22.89 | 20 | 30934 | 156227 | 34769750 |
| Malaise | 78.51 | 22.89 | 349 | 30605 | 185476 | 34740501 |
| Product use in unapproved indication | 75.67 | 22.89 | 8 | 30946 | 117491 | 34808486 |
| Therapy change | 75.63 | 22.89 | 42 | 30912 | 3035 | 34922942 |
| Catheter site pruritus | 68.57 | 22.89 | 21 | 30933 | 317 | 34925660 |
| Myalgia | 68.37 | 22.89 | 196 | 30758 | 83914 | 34842063 |
| Central venous catheterisation | 68.13 | 22.89 | 30 | 30924 | 1309 | 34924668 |
| Catheter site discharge | 66.37 | 22.89 | 24 | 30930 | 619 | 34925358 |
| Acute respiratory failure | 66.31 | 22.89 | 107 | 30847 | 30821 | 34895156 |
| Drug abuse | 65.76 | 22.89 | 6 | 30948 | 99090 | 34826887 |
| Respiratory failure | 64.45 | 22.89 | 227 | 30727 | 108345 | 34817632 |
| Infusion site erythema | 64.14 | 22.89 | 34 | 30920 | 2239 | 34923738 |
| Oxygen consumption increased | 61.20 | 22.89 | 28 | 30926 | 1338 | 34924639 |
| Hypotension | 59.44 | 22.89 | 367 | 30587 | 221282 | 34704695 |
| Acute kidney injury | 56.42 | 22.89 | 116 | 30838 | 304872 | 34621105 |
| Diarrhoea | 56.36 | 22.89 | 559 | 30395 | 389353 | 34536624 |
| Drug ineffective | 56.11 | 22.89 | 212 | 30742 | 456539 | 34469438 |
| White blood cell count decreased | 55.45 | 22.89 | 9 | 30945 | 95436 | 34830541 |
| Pulmonary veno-occlusive disease | 55.34 | 22.89 | 20 | 30934 | 515 | 34925462 |
| Device alarm issue | 55.31 | 22.89 | 21 | 30933 | 623 | 34925354 |
| Liver transplant | 55.30 | 22.89 | 32 | 30922 | 2502 | 34923475 |
| Cor pulmonale | 53.88 | 22.89 | 22 | 30932 | 794 | 34925183 |
| Cough | 53.83 | 22.89 | 269 | 30685 | 149871 | 34776106 |
| Transplant evaluation | 52.65 | 22.89 | 19 | 30935 | 487 | 34925490 |
| Palpitations | 52.48 | 22.89 | 112 | 30842 | 39874 | 34886103 |
| Chest pain | 51.88 | 22.89 | 236 | 30718 | 126526 | 34799451 |
| Rhabdomyolysis | 48.41 | 22.89 | 3 | 30951 | 68160 | 34857817 |
| Abdominal discomfort | 48.17 | 22.89 | 139 | 30815 | 59696 | 34866281 |
| Overdose | 47.80 | 22.89 | 11 | 30943 | 91048 | 34834929 |
| Confusional state | 46.22 | 22.89 | 36 | 30918 | 144124 | 34781853 |
| Infusion site discharge | 45.87 | 22.89 | 12 | 30942 | 98 | 34925879 |
| Therapy cessation | 45.25 | 22.89 | 65 | 30889 | 16908 | 34909069 |
| Pancytopenia | 43.45 | 22.89 | 15 | 30939 | 95142 | 34830835 |
| Transfusion | 42.65 | 22.89 | 45 | 30909 | 8540 | 34917437 |
| Infusion site infection | 42.51 | 22.89 | 16 | 30938 | 463 | 34925514 |
| Catheter site rash | 41.75 | 22.89 | 13 | 30941 | 208 | 34925769 |
| Pulmonary arterial pressure increased | 41.68 | 22.89 | 21 | 30933 | 1244 | 34924733 |
| Vascular device infection | 40.71 | 22.89 | 32 | 30922 | 4153 | 34921824 |
| Sinus congestion | 40.31 | 22.89 | 36 | 30918 | 5569 | 34920408 |
| Infusion site haemorrhage | 40.07 | 22.89 | 19 | 30935 | 985 | 34924992 |
| Hyponatraemia | 39.58 | 22.89 | 12 | 30942 | 82679 | 34843298 |
| Dermatitis contact | 38.62 | 22.89 | 29 | 30925 | 3517 | 34922460 |
| Therapy non-responder | 38.58 | 22.89 | 98 | 30856 | 39048 | 34886929 |
| Dialysis | 37.61 | 22.89 | 48 | 30906 | 11160 | 34914817 |
| Catheter site inflammation | 37.33 | 22.89 | 12 | 30942 | 214 | 34925763 |
| Platelet count decreased | 36.98 | 22.89 | 31 | 30923 | 119686 | 34806291 |
| Pneumonia | 36.13 | 22.89 | 484 | 30470 | 362143 | 34563834 |
| Infusion related reaction | 35.76 | 22.89 | 3 | 30951 | 53054 | 34872923 |
| Fatigue | 35.41 | 22.89 | 491 | 30463 | 370162 | 34555815 |
| Infusion site swelling | 35.21 | 22.89 | 24 | 30930 | 2500 | 34923477 |
| Pyrexia | 34.35 | 22.89 | 165 | 30789 | 332848 | 34593129 |
| C-reactive protein increased | 34.00 | 22.89 | 4 | 30950 | 54094 | 34871883 |
| Ventilation perfusion mismatch | 33.33 | 22.89 | 9 | 30945 | 84 | 34925893 |
| Paracentesis | 32.99 | 22.89 | 13 | 30941 | 427 | 34925550 |
| Feeling abnormal | 32.26 | 22.89 | 126 | 30828 | 63109 | 34862868 |
| Hypertension | 30.49 | 22.89 | 46 | 30908 | 136397 | 34789580 |
| Epistaxis | 30.48 | 22.89 | 117 | 30837 | 58134 | 34867843 |
| Neuropathy peripheral | 30.40 | 22.89 | 18 | 30936 | 83245 | 34842732 |
| Lung disorder | 30.26 | 22.89 | 83 | 30871 | 34613 | 34891364 |
| Migraine | 30.24 | 22.89 | 55 | 30899 | 17423 | 34908554 |
| Infusion site warmth | 30.01 | 22.89 | 9 | 30945 | 126 | 34925851 |
| Liver function test abnormal | 29.79 | 22.89 | 77 | 30877 | 30997 | 34894980 |
| Pulmonary arterial pressure abnormal | 29.71 | 22.89 | 10 | 30944 | 207 | 34925770 |
| Catheter site pain | 29.47 | 22.89 | 17 | 30937 | 1321 | 34924656 |
| Therapeutic product effect incomplete | 28.82 | 22.89 | 5 | 30949 | 50536 | 34875441 |
| Faeces soft | 28.18 | 22.89 | 24 | 30930 | 3484 | 34922493 |
| Treatment failure | 28.03 | 22.89 | 4 | 30950 | 46693 | 34879284 |
| Device dislocation | 27.96 | 22.89 | 31 | 30923 | 6218 | 34919759 |
| Exercise tolerance decreased | 27.17 | 22.89 | 28 | 30926 | 5170 | 34920807 |
| Oxygen therapy | 26.98 | 22.89 | 14 | 30940 | 882 | 34925095 |
| Plasma cell myeloma | 26.69 | 22.89 | 3 | 30951 | 42034 | 34883943 |
| Catheter site discolouration | 26.55 | 22.89 | 6 | 30948 | 24 | 34925953 |
| Renal impairment | 26.20 | 22.89 | 27 | 30927 | 94486 | 34831491 |
| Electrocardiogram QT prolonged | 25.80 | 22.89 | 3 | 30951 | 40949 | 34885028 |
| Seizure | 25.77 | 22.89 | 33 | 30921 | 104824 | 34821153 |
| Feeding tube user | 25.77 | 22.89 | 7 | 30947 | 67 | 34925910 |
| Blood pressure decreased | 25.75 | 22.89 | 102 | 30852 | 51413 | 34874564 |
| Infusion site vesicles | 25.65 | 22.89 | 9 | 30945 | 212 | 34925765 |
| Catheter placement | 25.57 | 22.89 | 13 | 30941 | 785 | 34925192 |
| Complication associated with device | 25.52 | 22.89 | 29 | 30925 | 5977 | 34920000 |
| Nausea | 25.38 | 22.89 | 432 | 30522 | 339476 | 34586501 |
| Injection site discharge | 25.30 | 22.89 | 9 | 30945 | 221 | 34925756 |
| Chest discomfort | 24.90 | 22.89 | 105 | 30849 | 54425 | 34871552 |
| Stomatitis | 24.70 | 22.89 | 4 | 30950 | 42510 | 34883467 |
| Hyperglycaemia | 24.61 | 22.89 | 3 | 30951 | 39477 | 34886500 |
| Suicide attempt | 24.31 | 22.89 | 3 | 30951 | 39113 | 34886864 |
| Hypoglycaemia | 24.27 | 22.89 | 9 | 30945 | 54631 | 34871346 |
| Arterial catheterisation | 24.12 | 22.89 | 4 | 30950 | 0 | 34925977 |
| Hepatic function abnormal | 24.00 | 22.89 | 5 | 30949 | 44358 | 34881619 |
| Deep vein thrombosis | 23.96 | 22.89 | 14 | 30940 | 65234 | 34860743 |
| Delirium | 23.71 | 22.89 | 5 | 30949 | 43986 | 34881991 |
| Hallucination | 23.70 | 22.89 | 8 | 30946 | 51490 | 34874487 |
| Alanine aminotransferase increased | 23.65 | 22.89 | 22 | 30932 | 80793 | 34845184 |
| Acute myocardial infarction | 23.61 | 22.89 | 9 | 30945 | 53710 | 34872267 |
| Device occlusion | 23.50 | 22.89 | 29 | 30925 | 6516 | 34919461 |
| Blood pressure increased | 23.49 | 22.89 | 26 | 30928 | 88076 | 34837901 |
| Portopulmonary hypertension | 23.23 | 22.89 | 5 | 30949 | 15 | 34925962 |
| Intentional product misuse | 22.97 | 22.89 | 6 | 30948 | 45605 | 34880372 |
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 |
|---|---|---|---|---|---|---|
| Dyspnoea | 4511.65 | 18.80 | 5773 | 107797 | 851252 | 78779566 |
| Fluid retention | 2907.46 | 18.80 | 1583 | 111987 | 68226 | 79562592 |
| Headache | 2177.92 | 18.80 | 3561 | 110009 | 650211 | 78980607 |
| Nasal congestion | 2007.61 | 18.80 | 1288 | 112282 | 75264 | 79555554 |
| Pain in jaw | 1924.04 | 18.80 | 1048 | 112522 | 45103 | 79585715 |
| Death | 1854.10 | 18.80 | 3064 | 110506 | 563450 | 79067368 |
| Oedema | 1518.25 | 18.80 | 1300 | 112270 | 118280 | 79512538 |
| Pulmonary arterial hypertension | 1422.41 | 18.80 | 729 | 112841 | 27637 | 79603181 |
| Unevaluable event | 1085.81 | 18.80 | 780 | 112790 | 54805 | 79576013 |
| Oedema peripheral | 1077.03 | 18.80 | 1547 | 112023 | 250741 | 79380077 |
| Right ventricular failure | 1049.65 | 18.80 | 559 | 113011 | 22938 | 79607880 |
| Flushing | 1043.66 | 18.80 | 922 | 112648 | 87346 | 79543472 |
| Hypervolaemia | 1036.49 | 18.80 | 685 | 112885 | 42005 | 79588813 |
| Peripheral swelling | 849.66 | 18.80 | 1438 | 112132 | 268179 | 79362639 |
| Dyspnoea exertional | 849.42 | 18.80 | 817 | 112753 | 86256 | 79544562 |
| Pulmonary hypertension | 789.46 | 18.80 | 608 | 112962 | 47472 | 79583346 |
| Dizziness | 649.88 | 18.80 | 1929 | 111641 | 524512 | 79106306 |
| Toxicity to various agents | 520.72 | 18.80 | 18 | 113552 | 421522 | 79209296 |
| Lung transplant | 519.69 | 18.80 | 208 | 113362 | 4353 | 79626465 |
| Infusion site pain | 511.30 | 18.80 | 293 | 113277 | 13883 | 79616935 |
| Chest pain | 508.29 | 18.80 | 1192 | 112378 | 281112 | 79349706 |
| Drug ineffective | 478.55 | 18.80 | 503 | 113067 | 1080410 | 78550408 |
| Catheterisation cardiac | 464.26 | 18.80 | 205 | 113365 | 5523 | 79625295 |
| Oxygen saturation decreased | 445.47 | 18.80 | 718 | 112852 | 128329 | 79502489 |
| Palpitations | 424.18 | 18.80 | 695 | 112875 | 125915 | 79504903 |
| Drug interaction | 399.88 | 18.80 | 58 | 113512 | 415125 | 79215693 |
| Diarrhoea | 394.35 | 18.80 | 2364 | 111206 | 878125 | 78752693 |
| Catheter site erythema | 372.11 | 18.80 | 171 | 113399 | 5069 | 79625749 |
| Syncope | 365.21 | 18.80 | 796 | 112774 | 178653 | 79452165 |
| Malaise | 338.77 | 18.80 | 1487 | 112083 | 488382 | 79142436 |
| Neutropenia | 330.02 | 18.80 | 20 | 113550 | 287690 | 79343128 |
| Hospitalisation | 323.25 | 18.80 | 523 | 113047 | 93713 | 79537105 |
| Device related infection | 323.18 | 18.80 | 316 | 113254 | 33978 | 79596840 |
| Febrile neutropenia | 291.71 | 18.80 | 8 | 113562 | 230991 | 79399827 |
| Infusion related reaction | 290.64 | 18.80 | 8 | 113562 | 230229 | 79400589 |
| Cough | 284.81 | 18.80 | 1154 | 112416 | 365635 | 79265183 |
| Catheter site pruritus | 283.81 | 18.80 | 111 | 113459 | 2180 | 79628638 |
| Central venous catheterisation | 267.47 | 18.80 | 118 | 113452 | 3171 | 79627647 |
| Swelling | 265.00 | 18.80 | 793 | 112777 | 215918 | 79414900 |
| Oxygen consumption increased | 264.05 | 18.80 | 133 | 113437 | 4846 | 79625972 |
| Product use in unapproved indication | 247.88 | 18.80 | 32 | 113538 | 250327 | 79380491 |
| Catheter site discharge | 243.97 | 18.80 | 101 | 113469 | 2311 | 79628507 |
| Acute kidney injury | 242.19 | 18.80 | 230 | 113340 | 519174 | 79111644 |
| Infusion site erythema | 239.64 | 18.80 | 156 | 113414 | 9304 | 79621514 |
| Infusion site infection | 237.36 | 18.80 | 91 | 113479 | 1690 | 79629128 |
| Myalgia | 235.17 | 18.80 | 688 | 112882 | 184953 | 79445865 |
| Catheter management | 233.67 | 18.80 | 111 | 113459 | 3552 | 79627266 |
| Pain in extremity | 229.44 | 18.80 | 1077 | 112493 | 363461 | 79267357 |
| Nausea | 225.65 | 18.80 | 2213 | 111357 | 954983 | 78675835 |
| Catheter site pain | 223.04 | 18.80 | 122 | 113448 | 5274 | 79625544 |
| Hypotension | 209.95 | 18.80 | 1204 | 112366 | 439113 | 79191705 |
| Vascular device infection | 209.16 | 18.80 | 148 | 113422 | 10128 | 79620690 |
| Therapeutic product effect decreased | 205.63 | 18.80 | 6 | 113564 | 163857 | 79466961 |
| Scleroderma | 204.34 | 18.80 | 116 | 113454 | 5394 | 79625424 |
| Hypoxia | 201.92 | 18.80 | 451 | 113119 | 102792 | 79528026 |
| Drug abuse | 196.99 | 18.80 | 8 | 113562 | 162683 | 79468135 |
| Off label use | 193.87 | 18.80 | 655 | 112915 | 906560 | 78724258 |
| Treatment failure | 191.98 | 18.80 | 13 | 113557 | 170473 | 79460345 |
| Rheumatoid arthritis | 191.71 | 18.80 | 33 | 113537 | 208437 | 79422381 |
| Cardiac failure | 187.61 | 18.80 | 565 | 113005 | 154277 | 79476541 |
| Catheter placement | 186.28 | 18.80 | 89 | 113481 | 2885 | 79627933 |
| Therapy interrupted | 175.69 | 18.80 | 220 | 113350 | 31121 | 79599697 |
| Alopecia | 171.06 | 18.80 | 58 | 113512 | 231297 | 79399521 |
| Malignant neoplasm progression | 170.55 | 18.80 | 5 | 113565 | 135985 | 79494833 |
| Thrombocytopenia | 166.36 | 18.80 | 85 | 113485 | 265174 | 79365644 |
| Therapeutic product effect incomplete | 164.90 | 18.80 | 9 | 113561 | 141636 | 79489182 |
| Device alarm issue | 163.61 | 18.80 | 73 | 113497 | 2016 | 79628802 |
| Arthropathy | 162.91 | 18.80 | 28 | 113542 | 177083 | 79453735 |
| Acute respiratory failure | 162.80 | 18.80 | 299 | 113271 | 59242 | 79571576 |
| Infusion site swelling | 157.63 | 18.80 | 112 | 113458 | 7714 | 79623104 |
| White blood cell count decreased | 154.20 | 18.80 | 39 | 113531 | 188249 | 79442569 |
| Chest discomfort | 152.64 | 18.80 | 488 | 113082 | 137556 | 79493262 |
| C-reactive protein increased | 150.82 | 18.80 | 8 | 113562 | 129019 | 79501799 |
| Device dislocation | 149.90 | 18.80 | 185 | 113385 | 25785 | 79605033 |
| Therapy change | 149.28 | 18.80 | 106 | 113464 | 7293 | 79623525 |
| Cardiac failure congestive | 148.09 | 18.80 | 493 | 113077 | 141909 | 79488909 |
| Pulmonary arterial pressure increased | 147.98 | 18.80 | 88 | 113482 | 4467 | 79626351 |
| Drug hypersensitivity | 147.93 | 18.80 | 125 | 113445 | 298791 | 79332027 |
| Device leakage | 147.60 | 18.80 | 123 | 113447 | 10733 | 79620085 |
| Epistaxis | 147.57 | 18.80 | 420 | 113150 | 111095 | 79519723 |
| Transfusion | 142.99 | 18.80 | 164 | 113406 | 21166 | 79609652 |
| Stomatitis | 142.23 | 18.80 | 20 | 113550 | 146737 | 79484081 |
| Hypertension | 141.12 | 18.80 | 158 | 113412 | 330834 | 79299984 |
| Pancytopenia | 138.30 | 18.80 | 33 | 113537 | 165712 | 79465106 |
| Pneumonia | 137.07 | 18.80 | 1489 | 112081 | 658757 | 78972061 |
| Confusional state | 136.43 | 18.80 | 151 | 113419 | 317846 | 79312972 |
| Transplant evaluation | 131.94 | 18.80 | 59 | 113511 | 1638 | 79629180 |
| Fatigue | 129.12 | 18.80 | 1946 | 111624 | 927781 | 78703037 |
| Catheter site rash | 129.11 | 18.80 | 50 | 113520 | 955 | 79629863 |
| Infusion site discharge | 128.87 | 18.80 | 44 | 113526 | 576 | 79630242 |
| Sinus congestion | 125.06 | 18.80 | 148 | 113422 | 19748 | 79611070 |
| Catheter site infection | 124.89 | 18.80 | 92 | 113478 | 6703 | 79624115 |
| Weight increased | 124.48 | 18.80 | 747 | 112823 | 276639 | 79354179 |
| Overdose | 121.60 | 18.80 | 55 | 113515 | 184151 | 79446667 |
| Intentional overdose | 119.50 | 18.80 | 8 | 113562 | 105952 | 79524866 |
| Neutrophil count decreased | 119.50 | 18.80 | 3 | 113567 | 93956 | 79536862 |
| Abdominal distension | 118.88 | 18.80 | 408 | 113162 | 119242 | 79511576 |
| Feeling abnormal | 116.21 | 18.80 | 492 | 113078 | 158707 | 79472111 |
| Nasopharyngitis | 114.72 | 18.80 | 685 | 112885 | 253196 | 79377622 |
| Complication associated with device | 114.72 | 18.80 | 133 | 113437 | 17363 | 79613455 |
| Intentional dose omission | 111.86 | 18.80 | 96 | 113474 | 8721 | 79622097 |
| Hyponatraemia | 111.44 | 18.80 | 57 | 113513 | 177791 | 79453027 |
| Pericarditis | 108.91 | 18.80 | 11 | 113559 | 104225 | 79526593 |
| Musculoskeletal stiffness | 106.84 | 18.80 | 58 | 113512 | 174950 | 79455868 |
| Presyncope | 105.76 | 18.80 | 201 | 113369 | 40853 | 79589965 |
| Respiratory failure | 103.11 | 18.80 | 520 | 113050 | 180391 | 79450427 |
| Glossodynia | 102.70 | 18.80 | 13 | 113557 | 103324 | 79527494 |
| Psoriasis | 100.33 | 18.80 | 7 | 113563 | 89580 | 79541238 |
| Therapy cessation | 99.36 | 18.80 | 186 | 113384 | 37376 | 79593442 |
| Electrocardiogram QT prolonged | 98.56 | 18.80 | 8 | 113562 | 90378 | 79540440 |
| Leukopenia | 95.62 | 18.80 | 24 | 113546 | 116489 | 79514329 |
| Dermatitis contact | 95.30 | 18.80 | 97 | 113473 | 10936 | 79619882 |
| Psoriatic arthropathy | 93.84 | 18.80 | 4 | 113566 | 77995 | 79552823 |
| Pulmonary veno-occlusive disease | 93.23 | 18.80 | 46 | 113524 | 1602 | 79629216 |
| Cardiac disorder | 93.20 | 18.80 | 254 | 113316 | 65503 | 79565315 |
| Maternal exposure during pregnancy | 92.90 | 18.80 | 39 | 113531 | 136499 | 79494319 |
| Blood cholesterol increased | 92.44 | 18.80 | 7 | 113563 | 83713 | 79547105 |
| Anaphylactic reaction | 89.70 | 18.80 | 8 | 113562 | 83735 | 79547083 |
| Catheter site haemorrhage | 88.95 | 18.80 | 67 | 113503 | 5050 | 79625768 |
| Catheter site inflammation | 86.58 | 18.80 | 39 | 113531 | 1102 | 79629716 |
| Infusion site haemorrhage | 86.11 | 18.80 | 58 | 113512 | 3662 | 79627156 |
| Device occlusion | 85.95 | 18.80 | 95 | 113475 | 11771 | 79619047 |
| Bradycardia | 85.58 | 18.80 | 43 | 113527 | 135514 | 79495304 |
| Metabolic acidosis | 85.46 | 18.80 | 9 | 113561 | 82520 | 79548298 |
| Catheter site swelling | 85.12 | 18.80 | 45 | 113525 | 1815 | 79629003 |
| Neuropathy peripheral | 84.55 | 18.80 | 48 | 113522 | 141257 | 79489561 |
| Rash | 84.47 | 18.80 | 481 | 113089 | 577877 | 79052941 |
| Blood pressure increased | 83.51 | 18.80 | 107 | 113463 | 211253 | 79419565 |
| Suicide attempt | 83.47 | 18.80 | 10 | 113560 | 82922 | 79547896 |
| Blood pressure decreased | 83.39 | 18.80 | 321 | 113249 | 99145 | 79531673 |
| Deep vein thrombosis | 83.13 | 18.80 | 34 | 113536 | 120885 | 79509933 |
| Exercise tolerance decreased | 82.48 | 18.80 | 82 | 113488 | 8989 | 79621829 |
| Hot flush | 80.81 | 18.80 | 215 | 113355 | 54662 | 79576156 |
| Oxygen therapy | 80.60 | 18.80 | 50 | 113520 | 2740 | 79628078 |
| Discomfort | 79.07 | 18.80 | 40 | 113530 | 125577 | 79505241 |
| Delirium | 78.63 | 18.80 | 13 | 113557 | 84614 | 79546204 |
| Injection site discharge | 78.36 | 18.80 | 33 | 113537 | 789 | 79630029 |
| Hepatic enzyme increased | 77.93 | 18.80 | 87 | 113483 | 182523 | 79448295 |
| Paracentesis | 77.45 | 18.80 | 38 | 113532 | 1307 | 79629511 |
| Dialysis | 76.64 | 18.80 | 112 | 113458 | 18350 | 79612468 |
| Haemoptysis | 76.07 | 18.80 | 213 | 113357 | 55786 | 79575032 |
| Impaired healing | 76.02 | 18.80 | 16 | 113554 | 87639 | 79543179 |
| Osteoarthritis | 75.59 | 18.80 | 16 | 113554 | 87293 | 79543525 |
| Pulmonary oedema | 74.95 | 18.80 | 286 | 113284 | 87968 | 79542850 |
| Coma | 74.75 | 18.80 | 25 | 113545 | 100624 | 79530194 |
| Lactic acidosis | 74.61 | 18.80 | 7 | 113563 | 70352 | 79560466 |
| Lower respiratory tract infection | 72.96 | 18.80 | 47 | 113523 | 129173 | 79501645 |
| General physical health deterioration | 72.88 | 18.80 | 179 | 113391 | 275059 | 79355759 |
| Blood pressure systolic increased | 72.84 | 18.80 | 6 | 113564 | 66980 | 79563838 |
| Alanine aminotransferase increased | 72.10 | 18.80 | 75 | 113495 | 162495 | 79468323 |
| Abdominal pain upper | 71.22 | 18.80 | 554 | 113016 | 223265 | 79407553 |
| Helicobacter infection | 71.16 | 18.80 | 8 | 113562 | 69696 | 79561122 |
| Agitation | 70.25 | 18.80 | 27 | 113543 | 99688 | 79531130 |
| Catheter site vesicles | 70.23 | 18.80 | 24 | 113546 | 315 | 79630503 |
| Seizure | 70.13 | 18.80 | 100 | 113470 | 188734 | 79442084 |
| Depressed level of consciousness | 70.06 | 18.80 | 25 | 113545 | 96627 | 79534191 |
| Hyperkalaemia | 69.68 | 18.80 | 38 | 113532 | 114360 | 79516458 |
| Drug-induced liver injury | 69.00 | 18.80 | 7 | 113563 | 66110 | 79564708 |
| Exposure during pregnancy | 68.61 | 18.80 | 29 | 113541 | 101103 | 79529715 |
| Type 2 diabetes mellitus | 68.48 | 18.80 | 3 | 113567 | 57119 | 79573699 |
| Terminal state | 67.72 | 18.80 | 56 | 113514 | 4833 | 79625985 |
| Heart rate increased | 67.34 | 18.80 | 345 | 113225 | 120379 | 79510439 |
| Wound | 67.33 | 18.80 | 41 | 113529 | 116138 | 79514680 |
| Rash maculo-papular | 67.05 | 18.80 | 3 | 113567 | 56075 | 79574743 |
| Urticaria | 66.89 | 18.80 | 100 | 113470 | 185101 | 79445717 |
| Sinus disorder | 66.74 | 18.80 | 117 | 113453 | 22347 | 79608471 |
| Hypoglycaemia | 65.99 | 18.80 | 31 | 113539 | 101563 | 79529255 |
| Pericardial effusion | 65.91 | 18.80 | 179 | 113391 | 46058 | 79584760 |
| Intentional product misuse | 65.02 | 18.80 | 27 | 113543 | 95138 | 79535680 |
| Walking distance test abnormal | 64.96 | 18.80 | 28 | 113542 | 710 | 79630108 |
| Dyspnoea at rest | 64.53 | 18.80 | 65 | 113505 | 7237 | 79623581 |
| Brain natriuretic peptide increased | 64.03 | 18.80 | 71 | 113499 | 8829 | 79621989 |
| Infusion site warmth | 63.20 | 18.80 | 34 | 113536 | 1421 | 79629397 |
| Mobility decreased | 62.97 | 18.80 | 49 | 113521 | 122126 | 79508692 |
| Hyperglycaemia | 62.74 | 18.80 | 12 | 113558 | 70323 | 79560495 |
| Platelet count decreased | 62.05 | 18.80 | 114 | 113456 | 194550 | 79436268 |
| Liver injury | 61.75 | 18.80 | 5 | 113565 | 56609 | 79574209 |
| Device connection issue | 61.52 | 18.80 | 30 | 113540 | 1018 | 79629800 |
| Inappropriate schedule of product administration | 61.13 | 18.80 | 60 | 113510 | 133568 | 79497250 |
| Hallucination | 60.76 | 18.80 | 23 | 113547 | 85722 | 79545096 |
| Blood creatinine increased | 60.71 | 18.80 | 79 | 113491 | 154978 | 79475840 |
| Catheter site irritation | 60.54 | 18.80 | 25 | 113545 | 568 | 79630250 |
| Device breakage | 59.92 | 18.80 | 75 | 113495 | 10600 | 79620218 |
| Dizziness postural | 59.87 | 18.80 | 78 | 113492 | 11471 | 79619347 |
| Cor pulmonale | 58.91 | 18.80 | 38 | 113532 | 2230 | 79628588 |
| Upper respiratory tract congestion | 58.86 | 18.80 | 40 | 113530 | 2563 | 79628255 |
| Pulmonary embolism | 58.83 | 18.80 | 96 | 113474 | 171558 | 79459260 |
| Influenza | 58.65 | 18.80 | 350 | 113220 | 129256 | 79501562 |
| Hypocalcaemia | 58.63 | 18.80 | 3 | 113567 | 49921 | 79580897 |
| Cardiac operation | 58.41 | 18.80 | 52 | 113518 | 4960 | 79625858 |
| Device infusion issue | 58.03 | 18.80 | 38 | 113532 | 2288 | 79628530 |
| Intentional product use issue | 58.03 | 18.80 | 79 | 113491 | 152033 | 79478785 |
| Liver transplant | 57.83 | 18.80 | 49 | 113521 | 4374 | 79626444 |
| Infusion site pruritus | 56.69 | 18.80 | 47 | 113523 | 4071 | 79626747 |
| Suicidal ideation | 56.61 | 18.80 | 19 | 113551 | 76321 | 79554497 |
| Medication error | 56.58 | 18.80 | 14 | 113556 | 68628 | 79562190 |
| Infusion site induration | 56.35 | 18.80 | 29 | 113541 | 1106 | 79629712 |
| Inflammation | 55.85 | 18.80 | 32 | 113538 | 93721 | 79537097 |
| Bone marrow failure | 54.42 | 18.80 | 5 | 113565 | 51102 | 79579716 |
| Cognitive disorder | 54.36 | 18.80 | 16 | 113554 | 69910 | 79560908 |
| Throat irritation | 53.91 | 18.80 | 154 | 113416 | 40792 | 79590026 |
| Migraine | 53.73 | 18.80 | 257 | 113313 | 87236 | 79543582 |
| Hypothyroidism | 53.51 | 18.80 | 6 | 113564 | 52386 | 79578432 |
| Pyrexia | 53.30 | 18.80 | 665 | 112905 | 678044 | 78952774 |
| Infusion site cellulitis | 53.22 | 18.80 | 19 | 113551 | 286 | 79630532 |
| Pneumonitis | 52.99 | 18.80 | 11 | 113559 | 60849 | 79569969 |
| Ear discomfort | 52.54 | 18.80 | 63 | 113507 | 8520 | 79622298 |
| Drug intolerance | 52.53 | 18.80 | 196 | 113374 | 263923 | 79366895 |
| Lymphocyte count decreased | 52.07 | 18.80 | 4 | 113566 | 47285 | 79583533 |
| Emergency care | 51.81 | 18.80 | 27 | 113543 | 1057 | 79629761 |
| Product dose omission issue | 51.42 | 18.80 | 559 | 113011 | 246978 | 79383840 |
| Injury | 51.33 | 18.80 | 23 | 113547 | 77473 | 79553345 |
| Endotracheal intubation | 51.33 | 18.80 | 47 | 113523 | 4650 | 79626168 |
| Multiple sclerosis relapse | 51.06 | 18.80 | 4 | 113566 | 46529 | 79584289 |
| Liver function test abnormal | 50.72 | 18.80 | 204 | 113366 | 64271 | 79566547 |
| Blood glucose increased | 49.89 | 18.80 | 54 | 113516 | 114921 | 79515897 |
| Plasma cell myeloma | 49.88 | 18.80 | 8 | 113562 | 53251 | 79577567 |
| Pancreatitis acute | 49.87 | 18.80 | 6 | 113564 | 49598 | 79581220 |
| Mechanical ventilation | 49.85 | 18.80 | 37 | 113533 | 2727 | 79628091 |
| Depression | 49.14 | 18.80 | 152 | 113418 | 216638 | 79414180 |
| Somnolence | 49.06 | 18.80 | 175 | 113395 | 238806 | 79392012 |
| Product administration interrupted | 48.54 | 18.80 | 42 | 113528 | 3857 | 79626961 |
| Localised oedema | 48.07 | 18.80 | 58 | 113512 | 7894 | 79622924 |
| Renal impairment | 48.00 | 18.80 | 95 | 113475 | 157688 | 79473130 |
| Joint swelling | 47.66 | 18.80 | 230 | 113340 | 288416 | 79342402 |
| Hepatotoxicity | 47.45 | 18.80 | 8 | 113562 | 51344 | 79579474 |
| Sleep disorder due to general medical condition, insomnia type | 47.08 | 18.80 | 4 | 113566 | 43552 | 79587266 |
| Aggression | 46.95 | 18.80 | 8 | 113562 | 50950 | 79579868 |
| Therapy non-responder | 46.82 | 18.80 | 257 | 113313 | 92048 | 79538770 |
| Hepatitis | 46.65 | 18.80 | 11 | 113559 | 55716 | 79575102 |
| Treatment noncompliance | 46.53 | 18.80 | 172 | 113398 | 52096 | 79578722 |
| Injection site bruising | 46.50 | 18.80 | 3 | 113567 | 40999 | 79589819 |
| Hypomagnesaemia | 46.37 | 18.80 | 6 | 113564 | 46905 | 79583913 |
| Swelling face | 45.79 | 18.80 | 212 | 113358 | 71000 | 79559818 |
| Injection site reaction | 45.49 | 18.80 | 11 | 113559 | 54774 | 79576044 |
| Irritable bowel syndrome | 45.27 | 18.80 | 16 | 113554 | 62225 | 79568593 |
| Drug titration error | 44.54 | 18.80 | 25 | 113545 | 1137 | 79629681 |
| Central venous catheter removal | 44.15 | 18.80 | 19 | 113551 | 480 | 79630338 |
| Lung disorder | 44.06 | 18.80 | 229 | 113341 | 80328 | 79550490 |
| Stevens-Johnson syndrome | 44.02 | 18.80 | 3 | 113567 | 39163 | 79591655 |
| Jaundice | 43.74 | 18.80 | 11 | 113559 | 53338 | 79577480 |
| Toxic epidermal necrolysis | 43.35 | 18.80 | 6 | 113564 | 44575 | 79586243 |
| Infusion site vesicles | 43.32 | 18.80 | 19 | 113551 | 503 | 79630315 |
| Hypersensitivity | 43.27 | 18.80 | 209 | 113361 | 262030 | 79368788 |
| Pulmonary hypertensive crisis | 43.04 | 18.80 | 17 | 113553 | 343 | 79630475 |
| Mouth ulceration | 42.98 | 18.80 | 3 | 113567 | 38391 | 79592427 |
| Chronic respiratory failure | 42.66 | 18.80 | 35 | 113535 | 2987 | 79627831 |
| Blister | 42.65 | 18.80 | 65 | 113505 | 119411 | 79511407 |
| Vomiting | 42.07 | 18.80 | 1243 | 112327 | 664585 | 78966233 |
| Psychotic disorder | 41.64 | 18.80 | 5 | 113565 | 41397 | 79589421 |
| Multiple organ dysfunction syndrome | 41.42 | 18.80 | 67 | 113503 | 120179 | 79510639 |
| Injection site pain | 41.39 | 18.80 | 76 | 113494 | 129762 | 79501056 |
| Fibromyalgia | 41.21 | 18.80 | 20 | 113550 | 64320 | 79566498 |
| Epilepsy | 40.93 | 18.80 | 5 | 113565 | 40855 | 79589963 |
| Infusion site rash | 40.51 | 18.80 | 27 | 113543 | 1675 | 79629143 |
| Disease recurrence | 40.47 | 18.80 | 7 | 113563 | 44102 | 79586716 |
| Catheter site warmth | 40.40 | 18.80 | 15 | 113555 | 254 | 79630564 |
| Gamma-glutamyltransferase increased | 39.87 | 18.80 | 14 | 113556 | 54666 | 79576152 |
| Head discomfort | 39.83 | 18.80 | 73 | 113497 | 14429 | 79616389 |
| Emotional distress | 39.77 | 18.80 | 5 | 113565 | 39964 | 79590854 |
| Disseminated intravascular coagulation | 39.55 | 18.80 | 3 | 113567 | 35839 | 79594979 |
| Ear congestion | 39.53 | 18.80 | 33 | 113537 | 2886 | 79627932 |
| Nocturnal dyspnoea | 39.20 | 18.80 | 26 | 113544 | 1600 | 79629218 |
| Haematuria | 38.90 | 18.80 | 25 | 113545 | 68811 | 79562007 |
| Basal cell carcinoma | 38.89 | 18.80 | 4 | 113566 | 37371 | 79593447 |
| Catheterisation cardiac abnormal | 38.76 | 18.80 | 15 | 113555 | 286 | 79630532 |
| Injection site infection | 38.53 | 18.80 | 29 | 113541 | 2183 | 79628635 |
| Eczema | 38.52 | 18.80 | 6 | 113564 | 40812 | 79590006 |
| Blood pressure fluctuation | 38.47 | 18.80 | 24 | 113546 | 67121 | 79563697 |
| Catheter site discolouration | 38.43 | 18.80 | 12 | 113558 | 116 | 79630702 |
| Myocardial infarction | 38.34 | 18.80 | 134 | 113436 | 183995 | 79446823 |
| Incorrect route of product administration | 38.33 | 18.80 | 3 | 113567 | 34926 | 79595892 |
| Orthostatic hypotension | 38.26 | 18.80 | 16 | 113554 | 56148 | 79574670 |
| Nasal dryness | 37.39 | 18.80 | 39 | 113531 | 4524 | 79626294 |
| Encephalopathy | 37.37 | 18.80 | 25 | 113545 | 67372 | 79563446 |
| Diabetic ketoacidosis | 37.25 | 18.80 | 3 | 113567 | 34119 | 79596699 |
| Urinary retention | 37.20 | 18.80 | 17 | 113553 | 56613 | 79574205 |
| Acute myocardial infarction | 37.09 | 18.80 | 33 | 113537 | 77003 | 79553815 |
| Pulmonary arterial pressure abnormal | 36.95 | 18.80 | 19 | 113551 | 723 | 79630095 |
| Coronary artery disease | 36.70 | 18.80 | 24 | 113546 | 65450 | 79565368 |
| Asthma | 36.40 | 18.80 | 87 | 113483 | 135008 | 79495810 |
| Paranasal sinus discomfort | 36.36 | 18.80 | 38 | 113532 | 4418 | 79626400 |
| Cerebral infarction | 36.34 | 18.80 | 10 | 113560 | 45666 | 79585152 |
| Hypokalaemia | 36.30 | 18.80 | 96 | 113474 | 143944 | 79486874 |
| Eye swelling | 36.26 | 18.80 | 101 | 113469 | 26367 | 79604451 |
| Catheter removal | 36.06 | 18.80 | 18 | 113552 | 643 | 79630175 |
| White blood cell count increased | 35.90 | 18.80 | 32 | 113538 | 74601 | 79556217 |
| Therapeutic response decreased | 35.48 | 18.80 | 26 | 113544 | 66827 | 79563991 |
| Hypercalcaemia | 35.48 | 18.80 | 6 | 113564 | 38424 | 79592394 |
| Hallucination, visual | 35.39 | 18.80 | 3 | 113567 | 32726 | 79598092 |
| Product prescribing error | 35.30 | 18.80 | 10 | 113560 | 44803 | 79586015 |
| Proteinuria | 35.09 | 18.80 | 3 | 113567 | 32499 | 79598319 |
| Gastric disorder | 34.86 | 18.80 | 125 | 113445 | 37308 | 79593510 |
| Body temperature decreased | 34.61 | 18.80 | 3 | 113567 | 32142 | 79598676 |
| Bursitis | 34.44 | 18.80 | 5 | 113565 | 35839 | 79594979 |
| Drug eruption | 34.25 | 18.80 | 10 | 113560 | 43925 | 79586893 |
| Middle ear effusion | 34.16 | 18.80 | 28 | 113542 | 2387 | 79628431 |
| Right-to-left cardiac shunt | 34.03 | 18.80 | 13 | 113557 | 239 | 79630579 |
| Application site pruritus | 33.82 | 18.80 | 34 | 113536 | 3776 | 79627042 |
| Angioedema | 33.78 | 18.80 | 35 | 113535 | 76000 | 79554818 |
| Device related sepsis | 33.69 | 18.80 | 43 | 113527 | 6197 | 79624621 |
| Joint range of motion decreased | 33.52 | 18.80 | 4 | 113566 | 33278 | 79597540 |
| Prostate cancer | 33.50 | 18.80 | 4 | 113566 | 33264 | 79597554 |
| Thrombosis in device | 33.40 | 18.80 | 40 | 113530 | 5402 | 79625416 |
| Hypoaesthesia | 33.15 | 18.80 | 137 | 113433 | 179215 | 79451603 |
| Sickle cell anaemia | 33.06 | 18.80 | 17 | 113553 | 647 | 79630171 |
| Heart valve replacement | 33.05 | 18.80 | 19 | 113551 | 905 | 79629913 |
| Aspartate aminotransferase increased | 32.99 | 18.80 | 95 | 113475 | 138546 | 79492272 |
| Cardiac output increased | 32.88 | 18.80 | 13 | 113557 | 263 | 79630555 |
| Ascites | 32.86 | 18.80 | 202 | 113368 | 75360 | 79555458 |
| Ejection fraction decreased | 32.82 | 18.80 | 5 | 113565 | 34572 | 79596246 |
| Diabetes mellitus | 32.71 | 18.80 | 38 | 113532 | 78352 | 79552466 |
| Drug ineffective for unapproved indication | 32.71 | 18.80 | 16 | 113554 | 51222 | 79579596 |
| Disorientation | 32.57 | 18.80 | 25 | 113545 | 62751 | 79568067 |
| Lymphopenia | 32.50 | 18.80 | 3 | 113567 | 30554 | 79600264 |
| Dizziness exertional | 32.40 | 18.80 | 16 | 113554 | 558 | 79630260 |
| Faeces soft | 32.40 | 18.80 | 49 | 113521 | 8274 | 79622544 |
| Oropharyngeal pain | 32.19 | 18.80 | 266 | 113304 | 109087 | 79521731 |
| Atrial flutter | 32.10 | 18.80 | 85 | 113485 | 21540 | 79609278 |
| Generalised oedema | 32.01 | 18.80 | 90 | 113480 | 23619 | 79607199 |
| Oxygen saturation abnormal | 32.01 | 18.80 | 36 | 113534 | 4546 | 79626272 |
| Herpes zoster | 31.93 | 18.80 | 52 | 113518 | 93031 | 79537787 |
| Pruritus | 31.91 | 18.80 | 384 | 113186 | 394264 | 79236554 |
| Intra-abdominal fluid collection | 31.32 | 18.80 | 30 | 113540 | 3142 | 79627676 |
| Hepatic function abnormal | 30.98 | 18.80 | 35 | 113535 | 73072 | 79557746 |
| Ventilation perfusion mismatch | 30.76 | 18.80 | 16 | 113554 | 624 | 79630194 |
| Cardio-respiratory arrest | 30.75 | 18.80 | 68 | 113502 | 108442 | 79522376 |
| Aphasia | 30.74 | 18.80 | 14 | 113556 | 46718 | 79584100 |
| Generalised tonic-clonic seizure | 30.74 | 18.80 | 12 | 113558 | 43898 | 79586920 |
| Osteonecrosis | 30.67 | 18.80 | 4 | 113566 | 31091 | 79599727 |
| Altered state of consciousness | 30.64 | 18.80 | 12 | 113558 | 43810 | 79587008 |
| Paraesthesia | 30.56 | 18.80 | 138 | 113432 | 176185 | 79454633 |
| Hepatocellular injury | 30.17 | 18.80 | 15 | 113555 | 47578 | 79583240 |
| Tracheostomy | 29.84 | 18.80 | 20 | 113550 | 1252 | 79629566 |
| Product quality issue | 29.83 | 18.80 | 6 | 113564 | 33934 | 79596884 |
| Blood calcium decreased | 29.30 | 18.80 | 5 | 113565 | 31814 | 79599004 |
| Dysarthria | 29.07 | 18.80 | 32 | 113538 | 67590 | 79563228 |
| Oxygen consumption | 28.91 | 18.80 | 9 | 113561 | 86 | 79630732 |
| Prescribed underdose | 28.63 | 18.80 | 4 | 113566 | 29510 | 79601308 |
| Metapneumovirus infection | 28.03 | 18.80 | 22 | 113548 | 1762 | 79629056 |
| Catheter site scab | 27.75 | 18.80 | 11 | 113559 | 224 | 79630594 |
| Adrenal insufficiency | 27.31 | 18.80 | 4 | 113566 | 28483 | 79602335 |
| Intracardiac pressure increased | 27.28 | 18.80 | 7 | 113563 | 30 | 79630788 |
| Prescribed overdose | 27.11 | 18.80 | 10 | 113560 | 37873 | 79592945 |
| Colitis | 27.02 | 18.80 | 39 | 113531 | 73268 | 79557550 |
| Loss of personal independence in daily activities | 26.89 | 18.80 | 67 | 113503 | 102513 | 79528305 |
| Skin lesion | 26.81 | 18.80 | 13 | 113557 | 41831 | 79588987 |
| Infusion site inflammation | 26.77 | 18.80 | 12 | 113558 | 335 | 79630483 |
| Obstructive airways disorder | 26.75 | 18.80 | 6 | 113564 | 31453 | 79599365 |
| Feeding tube user | 26.70 | 18.80 | 9 | 113561 | 113 | 79630705 |
| Disturbance in attention | 26.65 | 18.80 | 20 | 113550 | 50781 | 79580037 |
| Vascular device occlusion | 26.61 | 18.80 | 12 | 113558 | 340 | 79630478 |
| Right ventricular dilatation | 26.55 | 18.80 | 22 | 113548 | 1904 | 79628914 |
| Atrial septal defect repair | 26.50 | 18.80 | 13 | 113557 | 447 | 79630371 |
| Life support | 26.47 | 18.80 | 13 | 113557 | 448 | 79630370 |
| Transplant | 26.46 | 18.80 | 17 | 113553 | 991 | 79629827 |
| Pneumonia aspiration | 26.32 | 18.80 | 34 | 113536 | 66933 | 79563885 |
| Right ventricular dysfunction | 26.17 | 18.80 | 25 | 113545 | 2610 | 79628208 |
| Bedridden | 26.13 | 18.80 | 55 | 113515 | 12024 | 79618794 |
| Oral herpes | 25.99 | 18.80 | 4 | 113566 | 27450 | 79603368 |
| Hospice care | 25.91 | 18.80 | 50 | 113520 | 10274 | 79620544 |
| Gastroenteritis viral | 25.80 | 18.80 | 86 | 113484 | 24745 | 79606073 |
| Dyskinesia | 25.65 | 18.80 | 16 | 113554 | 44757 | 79586061 |
| Infusion site oedema | 25.62 | 18.80 | 16 | 113554 | 887 | 79629931 |
| Obesity | 25.59 | 18.80 | 9 | 113561 | 35116 | 79595702 |
| Sinus bradycardia | 25.51 | 18.80 | 3 | 113567 | 25244 | 79605574 |
| Biopsy liver | 25.41 | 18.80 | 14 | 113556 | 614 | 79630204 |
| Renal disorder | 25.35 | 18.80 | 123 | 113447 | 41982 | 79588836 |
| Vasculitis | 25.32 | 18.80 | 3 | 113567 | 25099 | 79605719 |
| Medical device change | 25.18 | 18.80 | 13 | 113557 | 499 | 79630319 |
| Respiration abnormal | 25.02 | 18.80 | 42 | 113528 | 7746 | 79623072 |
| Skin exfoliation | 24.89 | 18.80 | 25 | 113545 | 55075 | 79575743 |
| Seasonal allergy | 24.88 | 18.80 | 65 | 113505 | 16341 | 79614477 |
| Infusion site abscess | 24.77 | 18.80 | 10 | 113560 | 214 | 79630604 |
| Mitral valve replacement | 24.75 | 18.80 | 12 | 113558 | 402 | 79630416 |
| Injection site erythema | 24.71 | 18.80 | 46 | 113524 | 78151 | 79552667 |
| Systemic lupus erythematosus | 24.65 | 18.80 | 89 | 113481 | 121060 | 79509758 |
| Subarachnoid haemorrhage | 24.49 | 18.80 | 3 | 113567 | 24462 | 79606356 |
| Blood alkaline phosphatase increased | 24.33 | 18.80 | 33 | 113537 | 63631 | 79567187 |
| Device physical property issue | 24.33 | 18.80 | 24 | 113546 | 2606 | 79628212 |
| Respiratory tract congestion | 24.30 | 18.80 | 73 | 113497 | 19881 | 79610937 |
| Abdominal cavity drainage | 24.30 | 18.80 | 15 | 113555 | 815 | 79630003 |
| Labelled drug-drug interaction medication error | 24.07 | 18.80 | 5 | 113565 | 27645 | 79603173 |
| Osteoporosis | 23.93 | 18.80 | 25 | 113545 | 54087 | 79576731 |
| Tumour lysis syndrome | 23.81 | 18.80 | 3 | 113567 | 23936 | 79606882 |
| Vascular resistance pulmonary increased | 23.77 | 18.80 | 8 | 113562 | 100 | 79630718 |
| Arthritis | 23.64 | 18.80 | 84 | 113486 | 114796 | 79516022 |
| Catheter site extravasation | 23.57 | 18.80 | 12 | 113558 | 447 | 79630371 |
| Colitis ulcerative | 23.50 | 18.80 | 10 | 113560 | 34732 | 79596086 |
| Feeling cold | 23.47 | 18.80 | 92 | 113478 | 28637 | 79602181 |
| Myelodysplastic syndrome | 23.43 | 18.80 | 7 | 113563 | 30294 | 79600524 |
| Echocardiogram | 23.33 | 18.80 | 6 | 113564 | 26 | 79630792 |
| Ischaemic stroke | 23.28 | 18.80 | 9 | 113561 | 33122 | 79597696 |
| CREST syndrome | 23.09 | 18.80 | 12 | 113558 | 467 | 79630351 |
| Withdrawal syndrome | 23.08 | 18.80 | 5 | 113565 | 26849 | 79603969 |
| Catheter site cellulitis | 23.00 | 18.80 | 12 | 113558 | 471 | 79630347 |
| Renal tubular necrosis | 22.91 | 18.80 | 4 | 113566 | 25035 | 79605783 |
| Infusion site irritation | 22.70 | 18.80 | 14 | 113556 | 759 | 79630059 |
| Peritonitis | 22.56 | 18.80 | 6 | 113564 | 28030 | 79602788 |
| Gout | 22.49 | 18.80 | 82 | 113488 | 24667 | 79606151 |
| Abortion spontaneous | 22.48 | 18.80 | 7 | 113563 | 29500 | 79601318 |
| Heart and lung transplant | 22.45 | 18.80 | 9 | 113561 | 189 | 79630629 |
| Nasal discomfort | 22.37 | 18.80 | 33 | 113537 | 5450 | 79625368 |
| Hepatic steatosis | 22.30 | 18.80 | 13 | 113557 | 37725 | 79593093 |
| Dysphagia | 22.12 | 18.80 | 94 | 113476 | 122042 | 79508776 |
| Blood albumin decreased | 21.91 | 18.80 | 4 | 113566 | 24239 | 79606579 |
| Foot deformity | 21.70 | 18.80 | 4 | 113566 | 24070 | 79606748 |
| Right ventricular enlargement | 21.68 | 18.80 | 13 | 113557 | 670 | 79630148 |
| Toxic skin eruption | 21.68 | 18.80 | 3 | 113567 | 22290 | 79608528 |
| Abdominal discomfort | 21.59 | 18.80 | 488 | 113082 | 250239 | 79380579 |
| Systemic scleroderma | 21.53 | 18.80 | 16 | 113554 | 1181 | 79629637 |
| Dysentery | 21.47 | 18.80 | 16 | 113554 | 1186 | 79629632 |
| Productive cough | 21.43 | 18.80 | 206 | 113364 | 88125 | 79542693 |
| Retching | 21.36 | 18.80 | 64 | 113506 | 17403 | 79613415 |
| Sickle cell disease | 21.36 | 18.80 | 8 | 113562 | 139 | 79630679 |
| Catheter site dryness | 21.30 | 18.80 | 6 | 113564 | 39 | 79630779 |
| Rhinorrhoea | 21.29 | 18.80 | 183 | 113387 | 75891 | 79554927 |
| Catheter site related reaction | 21.24 | 18.80 | 16 | 113554 | 1206 | 79629612 |
| Infusion site discolouration | 21.23 | 18.80 | 13 | 113557 | 696 | 79630122 |
| Internal haemorrhage | 21.22 | 18.80 | 42 | 113528 | 8791 | 79622027 |
| Poisoning | 21.13 | 18.80 | 5 | 113565 | 25267 | 79605551 |
| Blood urea increased | 21.07 | 18.80 | 23 | 113547 | 48767 | 79582051 |
| Cardiac failure high output | 21.05 | 18.80 | 10 | 113560 | 320 | 79630498 |
| Respiratory arrest | 20.83 | 18.80 | 31 | 113539 | 57519 | 79573299 |
| Hemiparesis | 20.83 | 18.80 | 11 | 113559 | 33722 | 79597096 |
| Heart transplant | 20.59 | 18.80 | 17 | 113553 | 1464 | 79629354 |
| Gastritis hypertrophic | 20.44 | 18.80 | 6 | 113564 | 46 | 79630772 |
| Hyperhidrosis | 20.44 | 18.80 | 129 | 113441 | 151363 | 79479455 |
| Hypoalbuminaemia | 20.39 | 18.80 | 3 | 113567 | 21294 | 79609524 |
| Ileus | 20.37 | 18.80 | 6 | 113564 | 26205 | 79604613 |
| No adverse event | 20.35 | 18.80 | 14 | 113556 | 37178 | 79593640 |
| Portopulmonary hypertension | 20.09 | 18.80 | 8 | 113562 | 165 | 79630653 |
| Sinus tachycardia | 20.05 | 18.80 | 14 | 113556 | 36894 | 79593924 |
| Blood potassium decreased | 20.00 | 18.80 | 124 | 113446 | 46388 | 79584430 |
| Annuloplasty | 19.99 | 18.80 | 4 | 113566 | 3 | 79630815 |
| Lymphadenopathy | 19.95 | 18.80 | 28 | 113542 | 53219 | 79577599 |
| Biopsy lung | 19.92 | 18.80 | 9 | 113561 | 256 | 79630562 |
| Acute respiratory distress syndrome | 19.90 | 18.80 | 20 | 113550 | 44047 | 79586771 |
| Diabetes mellitus inadequate control | 19.89 | 18.80 | 5 | 113565 | 24259 | 79606559 |
| Osteomyelitis | 19.88 | 18.80 | 11 | 113559 | 32854 | 79597964 |
| Diastolic hypotension | 19.61 | 18.80 | 8 | 113562 | 176 | 79630642 |
| Abnormal behaviour | 19.54 | 18.80 | 14 | 113556 | 36407 | 79594411 |
| Arthralgia | 19.34 | 18.80 | 644 | 112926 | 571159 | 79059659 |
| Full blood count decreased | 19.32 | 18.80 | 7 | 113563 | 26812 | 79604006 |
| Leukocytosis | 19.30 | 18.80 | 20 | 113550 | 43435 | 79587383 |
| Femur fracture | 19.28 | 18.80 | 16 | 113554 | 38636 | 79592182 |
| Blood pressure abnormal | 19.22 | 18.80 | 61 | 113509 | 17108 | 79613710 |
| Device issue | 19.15 | 18.80 | 83 | 113487 | 27025 | 79603793 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | C02KX02 | CARDIOVASCULAR SYSTEM ANTIHYPERTENSIVES OTHER ANTIHYPERTENSIVES Antihypertensives for pulmonary arterial hypertension |
| ATC | C02KX52 | CARDIOVASCULAR SYSTEM ANTIHYPERTENSIVES OTHER ANTIHYPERTENSIVES Antihypertensives for pulmonary arterial hypertension |
| FDA MoA | N0000175364 | Endothelin Receptor Antagonists |
| FDA EPC | N0000175581 | Endothelin Receptor Antagonist |
| MeSH PA | D000959 | Antihypertensive Agents |
| MeSH PA | D002317 | Cardiovascular Agents |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Pulmonary arterial hypertension | indication | 11399002 | |
| Body fluid retention | contraindication | 43498006 | |
| Chronic heart failure | contraindication | 48447003 | |
| Oligozoospermia | contraindication | 88311004 | |
| Pulmonary veno-occlusive disease | contraindication | 89420002 | DOID:5453 |
| Liver function tests abnormal | contraindication | 166603001 | |
| Edema | contraindication | 267038008 | |
| Anemia | contraindication | 271737000 | DOID:2355 |
| Pregnancy, function | contraindication | 289908002 | |
| Breastfeeding (mother) | contraindication | 413712001 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 3.3 | acidic |
| pKa2 | 2.68 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 10MG | LETAIRIS | GILEAD | N022081 | June 15, 2007 | RX | TABLET | ORAL | 8377933 | Dec. 11, 2027 | FOR THE TREATMENT OF PULMONARY HYPERTENSION (PAH) IN COMBINATION WITH TADALAFIL |
| 10MG | LETAIRIS | GILEAD | N022081 | June 15, 2007 | RX | TABLET | ORAL | 9474752 | Dec. 11, 2027 | FOR THE TREATMENT OF PULMONARY HYPERTENSION (PAH) IN COMBINATION WITH TADALAFIL |
| 5MG | LETAIRIS | GILEAD | N022081 | June 15, 2007 | RX | TABLET | ORAL | 8377933 | Dec. 11, 2027 | FOR THE TREATMENT OF PULMONARY HYPERTENSION (PAH) IN COMBINATION WITH TADALAFIL |
| 5MG | LETAIRIS | GILEAD | N022081 | June 15, 2007 | RX | TABLET | ORAL | 9474752 | Dec. 11, 2027 | FOR THE TREATMENT OF PULMONARY HYPERTENSION (PAH) IN COMBINATION WITH TADALAFIL |
| 10MG | LETAIRIS | GILEAD | N022081 | June 15, 2007 | RX | TABLET | ORAL | 9549926 | Oct. 14, 2031 | FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) IN COMBINATION WITH TADALAFIL, WHEREIN THE WEIGHT RATIO OF AMBRISENTAN TO TADALAFIL IS ABOUT 1:2 TO ABOUT 1:3 |
| 5MG | LETAIRIS | GILEAD | N022081 | June 15, 2007 | RX | TABLET | ORAL | 9549926 | Oct. 14, 2031 | FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) IN COMBINATION WITH TADALAFIL, WHEREIN THE WEIGHT RATIO OF AMBRISENTAN TO TADALAFIL IS ABOUT 1:2 TO ABOUT 1:3 |
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Endothelin-1 receptor | GPCR | ANTAGONIST | Ki | 9.65 | WOMBAT-PK | DRUG LABEL | |||
| Endothelin B receptor | GPCR | ANTAGONIST | Ki | 6.98 | WOMBAT-PK |
External reference:
| ID | Source |
|---|---|
| 4026238 | VUID |
| N0000179774 | NUI |
| D07077 | KEGG_DRUG |
| 4026238 | VANDF |
| C1176329 | UMLSCUI |
| CHEBI:135949 | CHEBI |
| CHEMBL1111 | ChEMBL_ID |
| DB06403 | DRUGBANK_ID |
| C467894 | MESH_SUPPLEMENTAL_RECORD_UI |
| 3951 | IUPHAR_LIGAND_ID |
| 8128 | INN_ID |
| HW6NV07QEC | UNII |
| 6918493 | PUBCHEM_CID |
| 358274 | RXNORM |
| 111024 | MMSL |
| 23940 | MMSL |
| 313847 | MMSL |
| d06841 | MMSL |
| 012216 | NDDF |
| 427735003 | SNOMEDCT_US |
| 428159003 | SNOMEDCT_US |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Ambrisentan | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-4270 | TABLET, FILM COATED | 5 mg | ORAL | ANDA | 29 sections |
| Ambrisentan | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-4271 | TABLET, FILM COATED | 10 mg | ORAL | ANDA | 29 sections |
| Ambrisentan | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0591-2405 | TABLET, FILM COATED | 5 mg | ORAL | ANDA | 27 sections |
| Ambrisentan | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0591-2406 | TABLET, FILM COATED | 10 mg | ORAL | ANDA | 27 sections |
| AMBRISENTAN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42794-051 | TABLET, FILM COATED | 5 mg | ORAL | ANDA | 19 sections |
| AMBRISENTAN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42794-051 | TABLET, FILM COATED | 5 mg | ORAL | ANDA | 19 sections |
| AMBRISENTAN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42794-052 | TABLET, FILM COATED | 10 mg | ORAL | ANDA | 19 sections |
| AMBRISENTAN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42794-052 | TABLET, FILM COATED | 10 mg | ORAL | ANDA | 19 sections |
| ambrisentan | Human Prescription Drug Label | 1 | 47335-236 | TABLET, FILM COATED | 5 mg | ORAL | ANDA | 30 sections |
| ambrisentan | Human Prescription Drug Label | 1 | 47335-237 | TABLET, FILM COATED | 10 mg | ORAL | ANDA | 30 sections |
| Ambrisentan | HUMAN PRESCRIPTION DRUG LABEL | 1 | 49884-353 | TABLET, FILM COATED | 5 mg | ORAL | ANDA | 27 sections |
| Ambrisentan | HUMAN PRESCRIPTION DRUG LABEL | 1 | 49884-353 | TABLET, FILM COATED | 5 mg | ORAL | ANDA | 27 sections |
| Ambrisentan | HUMAN PRESCRIPTION DRUG LABEL | 1 | 49884-354 | TABLET, FILM COATED | 10 mg | ORAL | ANDA | 27 sections |
| Ambrisentan | HUMAN PRESCRIPTION DRUG LABEL | 1 | 49884-354 | TABLET, FILM COATED | 10 mg | ORAL | ANDA | 27 sections |
| ambrisentan | Human Prescription Drug Label | 1 | 59651-494 | TABLET, FILM COATED | 5 mg | ORAL | ANDA | 28 sections |
| ambrisentan | Human Prescription Drug Label | 1 | 59651-495 | TABLET, FILM COATED | 10 mg | ORAL | ANDA | 28 sections |
| Ambrisentan | HUMAN PRESCRIPTION DRUG LABEL | 1 | 60505-4552 | TABLET, FILM COATED | 5 mg | ORAL | ANDA | 29 sections |
| Ambrisentan | HUMAN PRESCRIPTION DRUG LABEL | 1 | 60505-4552 | TABLET, FILM COATED | 5 mg | ORAL | ANDA | 29 sections |
| Ambrisentan | HUMAN PRESCRIPTION DRUG LABEL | 1 | 60505-4553 | TABLET, FILM COATED | 10 mg | ORAL | ANDA | 29 sections |
| Ambrisentan | HUMAN PRESCRIPTION DRUG LABEL | 1 | 60505-4553 | TABLET, FILM COATED | 10 mg | ORAL | ANDA | 29 sections |
| Letairis | HUMAN PRESCRIPTION DRUG LABEL | 1 | 61958-0801 | TABLET, FILM COATED | 5 mg | ORAL | NDA | 31 sections |
| Letairis | HUMAN PRESCRIPTION DRUG LABEL | 1 | 61958-0802 | TABLET, FILM COATED | 10 mg | ORAL | NDA | 31 sections |
| Ambrisentan | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69097-386 | TABLET, FILM COATED | 5 mg | ORAL | ANDA | 27 sections |
| Ambrisentan | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69097-386 | TABLET, FILM COATED | 5 mg | ORAL | ANDA | 27 sections |
| Ambrisentan | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69097-387 | TABLET, FILM COATED | 10 mg | ORAL | ANDA | 27 sections |
| Ambrisentan | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69097-387 | TABLET, FILM COATED | 10 mg | ORAL | ANDA | 27 sections |
| Ambrisentan | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70710-1179 | TABLET, FILM COATED | 5 mg | ORAL | ANDA | 23 sections |
| Ambrisentan | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70710-1179 | TABLET, FILM COATED | 5 mg | ORAL | ANDA | 23 sections |
| Ambrisentan | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70710-1179 | TABLET, FILM COATED | 5 mg | ORAL | ANDA | 23 sections |
| Ambrisentan | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70710-1180 | TABLET, FILM COATED | 10 mg | ORAL | ANDA | 23 sections |