ambrisentan ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
endothelin receptor antagonists 4337 177036-94-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • LU208075
  • LU 208075
  • ambrisentan
  • letairis
  • volibris
an endothelin receptor antagonist that is selective for the endothelin type-A (ETA) receptor
  • Molecular weight: 378.43
  • Formula: C22H22N2O4
  • CLOGP: 3.35
  • LIPINSKI: 0
  • HAC: 6
  • HDO: 1
  • TPSA: 81.54
  • ALOGS: -3.88
  • ROTB: 7

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
7.50 mg O

ADMET properties:

PropertyValueReference
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 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Approvals:

DateAgencyCompanyOrphan
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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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
No adverse event 33.23 17.71 14 106837 41391 63340780
Asthma 33.23 17.71 107 106744 127454 63254717
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
Chronic right ventricular failure 18.20 17.71 5 106846 24 63382147
Bendopnoea 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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients 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:

SourceCodeDescription
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|

DiseaseRelationSNOMED_IDDOID
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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 3.3 acidic
pKa2 2.68 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent 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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA 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:

IDSource
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:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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