selexipag 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
prostaglandins receptors agonists, non-prostanoids 5077 475086-01-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • selexipag
  • uptravi
  • ACT-293987
  • NS-304
  • ACT293987
an oral prostacyclin receptor (IP receptor) agonist that is structurally distinct from prostacyclin, indicated for the treatment of pulmonary arterial hypertension, selexipag is hydrolyzed by carboxylesterase 1 to yield its active metabolite, which is approximately 37-fold as potent as selexipag, selexipag and the active metabolite are selective for the IP receptor versus other prostanoid receptors (EP1-4, DP, FP and TP)
  • Molecular weight: 496.63
  • Formula: C26H32N4O4S
  • CLOGP: 4.18
  • LIPINSKI: 0
  • HAC: 8
  • HDO: 1
  • TPSA: 101.49
  • ALOGS: -5.06
  • ROTB: 11

  • Status: ONP

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

Drug dosage:

DoseUnitRoute
1.80 mg O

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Dec. 21, 2015 FDA ACTELION PHARMS LTD
Aug. 25, 2021 PMDA NIPPON SHINYAKU Co., Ltd

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
Pain in jaw 2732.47 18.68 1212 70457 42284 63375069
Headache 2638.24 18.68 3381 68288 629860 62787493
Diarrhoea 1106.09 18.68 2459 69210 712907 62704446
Myalgia 1095.09 18.68 1068 70601 145461 63271892
Dyspnoea 1027.73 18.68 2279 69390 659034 62758319
Fluid retention 929.69 18.68 666 71003 59020 63358333
Hospitalisation 880.19 18.68 745 70924 84336 63333017
Drug ineffective 717.24 18.68 155 71514 1044610 62372743
Dyspnoea exertional 633.48 18.68 533 71136 59769 63357584
Nausea 587.72 18.68 2198 69471 852273 62565080
Flushing 511.18 18.68 521 71148 74566 63342787
Therapy change 488.28 18.68 202 71467 5879 63411474
Right ventricular failure 466.04 18.68 272 71397 16916 63400437
Pain in extremity 398.34 18.68 1038 70631 330448 63086905
Transfusion 394.65 18.68 234 71435 14983 63402370
Death 382.95 18.68 1105 70564 373276 63044077
Pulmonary hypertension 379.10 18.68 323 71346 36800 63380553
Oxygen saturation decreased 370.81 18.68 478 71191 88107 63329246
Off label use 319.82 18.68 183 71486 674279 62743074
Oxygen consumption increased 298.27 18.68 125 71544 3759 63413594
Unevaluable event 291.84 18.68 324 71345 51062 63366291
Hypervolaemia 277.42 18.68 241 71428 28172 63389181
Dizziness 271.72 18.68 1080 70589 428845 62988508
Hypotension 270.87 18.68 797 70872 271807 63145546
Infusion related reaction 261.10 18.68 3 71666 245518 63171835
Toxicity to various agents 250.59 18.68 6 71663 247244 63170109
Decreased appetite 238.89 18.68 723 70946 250329 63167024
Maternal exposure during pregnancy 228.32 18.68 4 71665 220058 63197295
Drug hypersensitivity 216.04 18.68 44 71625 310643 63106710
Pulmonary arterial pressure increased 214.99 18.68 97 71572 3498 63413855
Nasal congestion 210.96 18.68 312 71357 65348 63352005
Alopecia 205.35 18.68 63 71606 337473 63079880
Treatment failure 204.92 18.68 4 71665 199039 63218314
Therapeutic product effect decreased 202.54 18.68 3 71666 193184 63224169
Rash 200.53 18.68 203 71466 560668 62856685
Catheterisation cardiac 195.09 18.68 98 71571 4505 63412848
Rheumatoid arthritis 193.87 18.68 28 71641 253791 63163562
Malaise 188.50 18.68 947 70722 415007 63002346
Arthropathy 176.77 18.68 27 71642 234765 63182588
Pulmonary arterial hypertension 176.34 18.68 169 71500 22408 63394945
Glossodynia 175.09 18.68 6 71663 178870 63238483
Cardiac failure 173.77 18.68 339 71330 88803 63328550
Neutropenia 170.84 18.68 6 71663 174999 63242354
Oedema 168.57 18.68 353 71316 97269 63320084
Drug interaction 160.14 18.68 32 71637 229099 63188254
Hepatic enzyme increased 159.99 18.68 20 71649 202308 63215045
Feeling abnormal 155.87 18.68 443 71226 147949 63269404
Concomitant disease aggravated 151.61 18.68 106 71563 9006 63408347
Hypersensitivity 149.16 18.68 72 71597 292613 63124740
Oedema peripheral 142.41 18.68 504 71165 189007 63228346
Scleroderma 138.99 18.68 83 71586 5379 63411974
Product dose omission issue 134.34 18.68 572 71097 233741 63183612
Palpitations 132.65 18.68 351 71318 112419 63304934
Brain natriuretic peptide increased 132.09 18.68 79 71590 5134 63412219
Syncope 127.70 18.68 355 71314 117030 63300323
Chest pain 127.52 18.68 532 71137 215427 63201926
Joint swelling 125.75 18.68 111 71558 327555 63089798
Pericarditis 120.29 18.68 7 71662 131572 63285781
Vomiting 119.56 18.68 1056 70613 558561 62858792
Stomatitis 116.53 18.68 11 71658 138714 63278639
Pneumonia 113.52 18.68 892 70777 455875 62961478
Systemic lupus erythematosus 111.67 18.68 48 71621 208870 63208483
Wound 111.55 18.68 24 71645 163239 63254114
Oxygen therapy 109.16 18.68 52 71617 2126 63415227
Therapeutic product effect incomplete 107.52 18.68 9 71660 125047 63292306
Pulmonary oedema 107.26 18.68 209 71460 54664 63362689
Blister 107.18 18.68 11 71658 129803 63287550
Hypoxia 105.24 18.68 218 71451 59574 63357779
Abdominal distension 99.20 18.68 267 71402 86348 63331005
Intentional product use issue 97.82 18.68 14 71655 127878 63289475
Thrombocytopenia 95.86 18.68 26 71643 151131 63266222
Product use issue 95.55 18.68 66 71603 220454 63196899
Impaired healing 95.13 18.68 5 71664 102537 63314816
Walking distance test abnormal 93.44 18.68 32 71637 542 63416811
Discomfort 91.77 18.68 37 71632 167337 63250016
Psoriatic arthropathy 89.76 18.68 3 71666 91517 63325836
Hypertension 89.75 18.68 110 71559 279193 63138160
Helicobacter infection 87.75 18.68 4 71665 92781 63324572
Pulmonary veno-occlusive disease 85.81 18.68 36 71633 1085 63416268
Blood pressure decreased 84.28 18.68 210 71459 64812 63352541
Product use in unapproved indication 83.87 18.68 49 71620 179031 63238322
Lung transplant 83.43 18.68 49 71620 3079 63414274
Acute kidney injury 83.31 18.68 105 71564 263310 63154043
Musculoskeletal stiffness 83.01 18.68 53 71616 184565 63232788
Dyspepsia 82.06 18.68 278 71391 101918 63315435
Malignant neoplasm progression 79.47 18.68 3 71666 82118 63335235
Exposure during pregnancy 76.55 18.68 40 71629 155507 63261846
Blood cholesterol increased 75.01 18.68 9 71660 94023 63323330
Neck pain 74.70 18.68 209 71460 69109 63348244
Epistaxis 73.25 18.68 214 71455 72511 63344842
Ascites 72.25 18.68 149 71520 40579 63376774
Faeces soft 71.69 18.68 56 71613 5636 63411717
N-terminal prohormone brain natriuretic peptide increased 71.55 18.68 39 71630 2122 63415231
Mobility decreased 71.09 18.68 24 71645 121135 63296218
Abdominal pain upper 71.08 18.68 437 71232 206007 63211346
Pericardial effusion 70.69 18.68 124 71545 29934 63387419
Transplant evaluation 70.63 18.68 32 71637 1165 63416188
Chest discomfort 70.44 18.68 278 71391 109691 63307662
Dialysis 70.19 18.68 72 71597 10355 63406998
Psoriasis 70.16 18.68 8 71661 86949 63330404
Urticaria 69.99 18.68 51 71618 165751 63251602
Cough 69.42 18.68 566 71103 292177 63125176
Dyspnoea at rest 69.14 18.68 48 71621 4031 63413322
Pruritus 68.63 18.68 196 71473 361257 63056096
Lower respiratory tract infection 68.15 18.68 32 71637 132275 63285078
Leukopenia 68.00 18.68 5 71664 77285 63340068
Therapy non-responder 66.77 18.68 213 71456 75688 63341665
Drug abuse 65.83 18.68 4 71665 72514 63344839
Drug titration error 64.91 18.68 27 71642 796 63416557
Migraine 63.57 18.68 258 71411 103088 63314265
Pain 62.80 18.68 1178 70491 739450 62677903
Infusion site pain 62.73 18.68 86 71583 16783 63400570
Confusional state 62.24 18.68 107 71562 236273 63181080
Bedridden 61.51 18.68 69 71600 10982 63406371
Hospice care 61.21 18.68 59 71610 7873 63409480
Asthma 61.00 18.68 34 71635 127527 63289826
Cardioversion 59.86 18.68 29 71640 1231 63416122
Injection site pain 58.69 18.68 37 71632 129763 63287590
Catheter site pain 58.37 18.68 46 71623 4689 63412664
Extra dose administered 58.23 18.68 52 71617 6298 63411055
Paracentesis 57.45 18.68 26 71643 944 63416409
Disease complication 57.31 18.68 39 71630 3170 63414183
Type 2 diabetes mellitus 56.56 18.68 4 71665 63864 63353489
Overdose 56.01 18.68 30 71639 115048 63302305
C-reactive protein increased 55.14 18.68 19 71650 94688 63322665
Condition aggravated 54.90 18.68 694 70975 401523 63015830
Productive cough 54.33 18.68 176 71493 63032 63354321
Liver injury 53.00 18.68 4 71665 60516 63356837
Osteoarthritis 52.36 18.68 21 71648 95322 63322031
Head discomfort 52.33 18.68 70 71599 13345 63404008
Cognitive disorder 50.90 18.68 3 71666 55812 63361541
Dizziness postural 49.77 18.68 51 71618 7325 63410028
Back pain 49.36 18.68 485 71184 263660 63153693
Irritable bowel syndrome 48.91 18.68 16 71653 82396 63334957
Atrial septal defect repair 48.82 18.68 16 71653 235 63417118
Catheter management 47.95 18.68 34 71635 2953 63414400
Left ventricular failure 47.12 18.68 44 71625 5643 63411710
Heart rate increased 47.06 18.68 221 71448 94017 63323336
Coma 47.04 18.68 8 71661 64356 63352997
Electrocardiogram QT prolonged 46.73 18.68 6 71663 59524 63357829
Presyncope 46.19 18.68 99 71570 27686 63389667
Deep vein thrombosis 45.14 18.68 19 71650 83781 63333572
Insomnia 45.08 18.68 405 71264 214847 63202506
Weight decreased 44.51 18.68 493 71176 276305 63141048
Muscle spasms 44.28 18.68 315 71354 155835 63261518
Pulmonary arterial pressure abnormal 44.11 18.68 18 71651 505 63416848
Hyponatraemia 43.94 18.68 37 71632 111863 63305490
Catheter placement 43.77 18.68 29 71640 2255 63415098
Peripheral swelling 43.37 18.68 475 71194 265467 63151886
Multiple sclerosis relapse 43.03 18.68 3 71666 48475 63368878
Seizure 42.80 18.68 52 71617 132582 63284771
Injury 42.11 18.68 15 71654 73232 63344121
Injection site erythema 41.48 18.68 21 71648 83153 63334200
Cardiac disorder 41.44 18.68 139 71530 50677 63366676
Injection site reaction 41.20 18.68 8 71661 58516 63358837
Mineral supplementation 40.98 18.68 19 71650 730 63416623
Disease progression 40.41 18.68 257 71412 122501 63294852
Haemoptysis 39.57 18.68 95 71574 28631 63388722
White blood cell count decreased 39.37 18.68 60 71609 139044 63278309
Rehabilitation therapy 39.21 18.68 24 71645 1626 63415727
Suicidal ideation 39.06 18.68 11 71658 62410 63354943
Rhabdomyolysis 38.21 18.68 3 71666 43948 63373405
Depression 37.63 18.68 106 71563 196386 63220967
Fibromyalgia 37.63 18.68 22 71647 80398 63336955
General physical health deterioration 37.59 18.68 110 71559 201292 63216061
Metapneumovirus infection 37.52 18.68 20 71649 1040 63416313
Catheter site erythema 37.21 18.68 34 71635 4242 63413111
Right ventricular enlargement 37.19 18.68 14 71655 315 63417038
Oxygen saturation abnormal 36.59 18.68 31 71638 3498 63413855
Agitation 36.53 18.68 11 71658 59746 63357607
Ill-defined disorder 36.00 18.68 24 71645 81731 63335622
Endarterectomy 35.11 18.68 12 71657 202 63417151
Right ventricular dysfunction 34.63 18.68 23 71646 1796 63415557
Pancytopenia 34.57 18.68 35 71634 96898 63320455
Emergency care 34.50 18.68 19 71650 1055 63416298
Catheterisation cardiac abnormal 34.21 18.68 12 71657 219 63417134
Exercise tolerance decreased 33.50 18.68 36 71633 5461 63411892
Right-to-left cardiac shunt 32.96 18.68 12 71657 245 63417108
Haemodynamic test abnormal 32.71 18.68 8 71661 36 63417317
Drug intolerance 32.24 18.68 210 71459 308451 63108902
Facial pain 32.19 18.68 49 71620 10512 63406841
Nocturnal dyspnoea 32.19 18.68 19 71650 1205 63416148
Atrial flutter 32.16 18.68 47 71622 9725 63407628
Haemoglobin decreased 32.12 18.68 277 71392 145208 63272145
Depressed level of consciousness 31.97 18.68 15 71654 62063 63355290
Iron deficiency anaemia 31.88 18.68 70 71599 19899 63397454
Therapeutic response decreased 31.48 18.68 15 71654 61510 63355843
Haemorrhoidal haemorrhage 31.47 18.68 31 71638 4248 63413105
Hyperkalaemia 31.33 18.68 11 71658 54192 63363161
Cardiac ablation 31.26 18.68 20 71649 1465 63415888
Flatulence 31.06 18.68 98 71571 34604 63382749
Cardiac failure high output 30.96 18.68 12 71657 293 63417060
Bursitis 30.92 18.68 3 71666 37038 63380315
Dysentery 30.87 18.68 17 71652 944 63416409
Blood pressure increased 30.60 18.68 88 71581 161974 63255379
Renal disorder 30.33 18.68 94 71575 32880 63384473
Infection 29.85 18.68 145 71524 229028 63188325
Vascular device infection 29.82 18.68 39 71630 7273 63410080
Pulmonary embolism 29.61 18.68 54 71615 116630 63300723
Intentional product misuse 29.46 18.68 16 71653 60901 63356452
Neuropathy peripheral 29.39 18.68 52 71617 113615 63303738
Wrong dose 29.34 18.68 18 71651 1225 63416128
Bradycardia 29.01 18.68 24 71645 73203 63344150
Hallucination 28.61 18.68 13 71656 54804 63362549
Blood pressure systolic increased 28.48 18.68 9 71660 47388 63369965
Influenza 28.33 18.68 215 71454 108507 63308846
Medication error 27.92 18.68 12 71657 52272 63365081
Hypoaesthesia 27.89 18.68 97 71572 168296 63249057
Systemic scleroderma 27.84 18.68 16 71653 965 63416388
Acute respiratory failure 27.82 18.68 94 71575 34391 63382962
Adverse event 27.77 18.68 150 71519 67409 63349944
Pulmonary congestion 27.74 18.68 61 71608 17357 63399996
Plasma cell myeloma 27.28 18.68 4 71665 35901 63381452
Mouth ulceration 26.69 18.68 3 71666 32981 63384372
Catheter site infection 26.19 18.68 30 71639 4884 63412469
Catheter site discharge 25.77 18.68 20 71649 1993 63415360
Angioedema 25.63 18.68 11 71658 47954 63369399
Localised oedema 25.62 18.68 31 71638 5347 63412006
Prescribed overdose 25.50 18.68 4 71665 34149 63383204
Intracardiac pressure increased 25.42 18.68 7 71662 54 63417299
Gout 25.25 18.68 50 71619 13221 63404132
Knee arthroplasty 25.12 18.68 15 71654 54191 63363162
Loss of consciousness 25.08 18.68 223 71446 117898 63299455
Swelling 25.02 18.68 195 71474 275183 63142170
Pleural effusion 24.66 18.68 185 71484 93025 63324328
Metabolic acidosis 24.62 18.68 10 71659 45059 63372294
Contusion 24.46 18.68 87 71582 149957 63267396
Cardiac operation 24.45 18.68 24 71645 3274 63414079
Tracheostomy 24.37 18.68 13 71656 677 63416676
Abdominal cavity drainage 24.14 18.68 11 71658 406 63416947
Blood creatine phosphokinase increased 24.04 18.68 3 71666 30427 63386926
Fatigue 24.02 18.68 1228 70441 886800 62530553
Alanine aminotransferase increased 23.76 18.68 51 71618 103719 63313634
Cardiac flutter 23.53 18.68 26 71643 4070 63413283
Liver transplant 23.50 18.68 20 71649 2271 63415082
Cardiac pacemaker insertion 23.37 18.68 26 71643 4100 63413253
Central venous catheterisation 23.27 18.68 21 71648 2578 63414775
Cardiac output increased 23.17 18.68 9 71660 221 63417132
Retching 22.99 18.68 51 71618 14594 63402759
Right ventricular dilatation 22.87 18.68 16 71653 1360 63415993
Concomitant disease progression 22.65 18.68 19 71650 2115 63415238
Injection site swelling 22.27 18.68 13 71656 47559 63369794
Sinusitis 22.25 18.68 157 71512 226496 63190857
Delirium 22.03 18.68 15 71654 50526 63366827
Swollen tongue 22.02 18.68 6 71663 34794 63382559
Stent placement 21.85 18.68 24 71645 3731 63413622
Drug-induced liver injury 21.85 18.68 9 71660 40213 63377140
Pyrexia 21.75 18.68 387 71282 470091 62947262
Lactic acidosis 21.73 18.68 8 71661 38279 63379074
Wrong technique in product usage process 21.67 18.68 23 71646 62317 63355036
Injection site pruritus 21.59 18.68 12 71657 45104 63372249
Cardiac monitoring 21.55 18.68 5 71664 17 63417336
Terminal state 21.54 18.68 19 71650 2263 63415090
Product supply issue 21.53 18.68 17 71652 1738 63415615
Pulmonary pain 21.52 18.68 23 71646 3467 63413886
N-terminal prohormone brain natriuretic peptide 21.49 18.68 6 71663 49 63417304
Hepatitis 21.46 18.68 9 71660 39779 63377574
Influenza like illness 21.42 18.68 139 71530 66685 63350668
Biopsy liver 21.41 18.68 10 71659 391 63416962
Arthralgia 21.37 18.68 815 70854 568895 62848458
Drug ineffective for unapproved indication 21.31 18.68 6 71663 34057 63383296
Pericardial drainage 21.30 18.68 9 71660 276 63417077
Obesity 21.28 18.68 4 71665 29948 63387405
Asthenia 21.22 18.68 575 71094 383029 63034324
Paraesthesia 21.19 18.68 98 71571 156868 63260485
Pulmonary artery dilatation 21.18 18.68 9 71660 280 63417073
Atrial fibrillation 21.17 18.68 213 71456 116423 63300930
Blood glucose increased 21.03 18.68 39 71630 83717 63333636
Inflammation 20.94 18.68 38 71631 82235 63335118
Device related infection 20.88 18.68 66 71603 23326 63394027
Cardiac failure acute 20.74 18.68 38 71631 9485 63407868
Catheter site pruritus 20.72 18.68 18 71651 2102 63415251
Encephalopathy 20.41 18.68 9 71660 38611 63378742
Catheter site rash 20.33 18.68 12 71657 761 63416592
Cerebrovascular accident 20.14 18.68 59 71610 107965 63309388
Osteoporosis 20.10 18.68 21 71648 57317 63360036
Abdominal discomfort 20.08 18.68 489 71180 320396 63096957
Hypoglycaemia 19.95 18.68 23 71646 60042 63357311
Respiratory failure 19.95 18.68 189 71480 101669 63315684
Diagnostic procedure 19.89 18.68 7 71662 129 63417224
Emotional distress 19.88 18.68 6 71663 32543 63384810
Skin exfoliation 19.87 18.68 12 71657 43090 63374263
Echocardiogram 19.85 18.68 5 71664 26 63417327
Myocardial infarction 19.77 18.68 53 71616 99840 63317513
Pulmonary hypertensive crisis 19.68 18.68 9 71660 335 63417018
Oral herpes 19.59 18.68 3 71666 26071 63391282
Premature delivery 19.58 18.68 5 71664 30276 63387077
Lymphocyte count decreased 19.55 18.68 5 71664 30252 63387101
Pulmonary endarterectomy 19.55 18.68 7 71662 136 63417217
Gastrointestinal surgery 19.29 18.68 8 71661 234 63417119
Hypocalcaemia 19.09 18.68 6 71663 31707 63385646
Lung disorder 19.04 18.68 128 71541 62133 63355220
Feeding tube user 18.97 18.68 5 71664 32 63417321
Paranasal sinus discomfort 18.88 18.68 24 71645 4352 63413001
Infusion site discharge 18.88 18.68 11 71658 681 63416672
Pregnancy 18.82 18.68 9 71660 36827 63380526
Transaminases increased 18.76 18.68 6 71663 31361 63385992

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
Pain in jaw 1071.64 23.07 377 21955 12663 34921936
Headache 1027.75 23.07 916 21416 199719 34734880
Diarrhoea 413.55 23.07 820 21512 389092 34545507
Dyspnoea 400.12 23.07 793 21539 375989 34558610
Myalgia 388.28 23.07 364 21968 83746 34850853
Fluid retention 366.82 23.07 223 22109 26664 34907935
Hospitalisation 306.97 23.07 269 22063 56633 34877966
Right ventricular failure 284.51 23.07 130 22202 8654 34925945
Pain in extremity 245.45 23.07 350 21982 126163 34808436
Pulmonary hypertension 233.76 23.07 153 22179 20771 34913828
Flushing 215.44 23.07 173 22159 32247 34902352
Dyspnoea exertional 192.95 23.07 184 22148 43095 34891504
Death 151.60 23.07 576 21756 397473 34537126
Oxygen saturation decreased 144.60 23.07 175 22157 53643 34880956
Drug ineffective 142.96 23.07 57 22275 456694 34477905
Therapy change 133.60 23.07 56 22276 3021 34931578
Toxicity to various agents 114.09 23.07 3 22329 200359 34734240
Nausea 113.08 23.07 472 21860 339436 34595163
Arthralgia 111.15 23.07 297 22035 169744 34764855
Catheterisation cardiac 110.49 23.07 47 22285 2630 34931969
Abdominal discomfort 99.12 23.07 154 22178 59681 34874918
Transfusion 96.36 23.07 63 22269 8522 34926077
Hypervolaemia 95.82 23.07 88 22244 19621 34914978
Concomitant disease aggravated 92.62 23.07 53 22279 5648 34928951
Drug interaction 91.35 23.07 17 22315 225929 34708670
Oedema 90.51 23.07 128 22204 45613 34888986
Peripheral swelling 82.45 23.07 163 22169 76378 34858221
Dizziness 77.57 23.07 310 22022 218211 34716388
Oxygen consumption increased 77.01 23.07 30 22302 1336 34933263
Faeces soft 74.68 23.07 39 22293 3469 34931130
Brain natriuretic peptide increased 74.66 23.07 46 22286 5613 34928986
Acute kidney injury 70.71 23.07 55 22277 304933 34629666
Hypotension 69.69 23.07 303 22029 221346 34713253
Pulmonary arterial hypertension 65.24 23.07 50 22282 8689 34925910
Nasal congestion 65.17 23.07 77 22255 22980 34911619
Malaise 64.59 23.07 262 22070 185563 34749036
Thrombocytopenia 62.57 23.07 12 22320 156235 34778364
Pain 59.92 23.07 274 22058 204401 34730198
Adverse event 58.31 23.07 66 22266 18811 34915788
Off label use 57.96 23.07 113 22219 419411 34515188
Migraine 55.51 23.07 62 22270 17416 34917183
Feeling abnormal 53.39 23.07 122 22210 63113 34871486
Unevaluable event 52.69 23.07 83 22249 32507 34902092
Pulmonary arterial pressure increased 51.51 23.07 22 22310 1243 34933356
Lung transplant 50.35 23.07 25 22307 1999 34932600
Cardiac failure 44.68 23.07 144 22188 91104 34843495
Oedema peripheral 44.01 23.07 172 22160 119640 34814959
Condition aggravated 43.27 23.07 239 22093 191957 34742642
Hypoxia 42.90 23.07 103 22229 54992 34879607
Abdominal distension 39.92 23.07 104 22228 58388 34876211
Product use in unapproved indication 39.36 23.07 13 22319 117486 34817113
Transplant evaluation 39.09 23.07 14 22318 492 34934107
Pancytopenia 38.73 23.07 7 22325 95150 34839449
Therapy non-responder 38.10 23.07 80 22252 39066 34895533
Dialysis 37.73 23.07 41 22291 11167 34923432
Catheter management 36.72 23.07 16 22316 949 34933650
Neck pain 36.14 23.07 61 22271 25288 34909311
Syncope 35.79 23.07 134 22198 91317 34843282
Pulmonary veno-occlusive disease 34.65 23.07 13 22319 522 34934077
Decreased appetite 34.19 23.07 202 22130 166190 34768409
White blood cell count decreased 32.95 23.07 10 22322 95435 34839164
Overdose 32.43 23.07 9 22323 91050 34843549
Oxygen therapy 31.33 23.07 14 22318 882 34933717
Myocardial infarction 30.38 23.07 20 22312 121065 34813534
Paracentesis 29.62 23.07 11 22321 429 34934170
Nasopharyngitis 29.45 23.07 105 22227 69863 34864736
Infusion site pain 28.67 23.07 22 22310 3829 34930770
Hospice care 28.05 23.07 28 22304 6912 34927687
Pulmonary oedema 27.92 23.07 80 22252 47449 34887150
Intentional product use issue 27.61 23.07 3 22329 59813 34874786
Drug hypersensitivity 26.80 23.07 9 22323 80520 34854079
Limb discomfort 26.53 23.07 34 22298 11013 34923586
Walking distance test abnormal 25.93 23.07 8 22324 175 34934424
Dyspepsia 25.76 23.07 66 22266 36666 34897933
Abdominal pain upper 25.70 23.07 102 22230 71388 34863211
Confusional state 25.31 23.07 33 22299 144127 34790472
Weight increased 25.26 23.07 122 22210 92911 34841688
Blood pressure decreased 24.92 23.07 81 22251 51434 34883165
Pulmonary arterial wedge pressure increased 24.91 23.07 7 22325 109 34934490
Hyponatraemia 24.61 23.07 11 22321 82680 34851919
Deep vein thrombosis 24.08 23.07 6 22326 65242 34869357
Terminal state 24.00 23.07 20 22312 3914 34930685
Pericardial effusion 23.52 23.07 50 22282 24612 34909987
Fatigue 23.45 23.07 349 21983 370304 34564295
Catheter placement 23.30 23.07 11 22321 787 34933812
Multiple organ dysfunction syndrome 23.07 23.07 10 22322 76556 34858043

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
Headache 3345.30 19.68 3737 79813 650035 79010803
Pain in jaw 3334.16 19.68 1389 82161 44762 79616076
Myalgia 1329.56 19.68 1278 82272 184363 79476475
Diarrhoea 1313.36 19.68 2853 80697 877636 78783202
Dyspnoea 1162.25 19.68 2675 80875 854350 78806488
Fluid retention 1090.39 19.68 758 82792 69051 79591787
Hospitalisation 795.66 19.68 712 82838 93524 79567314
Dyspnoea exertional 733.28 19.68 657 82893 86416 79574422
Nausea 681.63 19.68 2369 81181 954827 78706011
Right ventricular failure 668.92 19.68 374 83176 23123 79637715
Drug ineffective 653.39 19.68 166 83384 1080747 78580091
Flushing 619.74 19.68 602 82948 87666 79573172
Pain in extremity 566.71 19.68 1206 82344 363332 79297506
Pulmonary hypertension 524.04 19.68 421 83129 47659 79613179
Death 480.75 19.68 1491 82059 565023 79095815
Transfusion 445.55 19.68 278 83272 21052 79639786
Oxygen saturation decreased 405.40 19.68 583 82967 128464 79532374
Toxicity to various agents 398.74 19.68 9 83541 421531 79239307
Off label use 364.24 19.68 254 83296 906961 78753877
Therapy change 362.84 19.68 170 83380 7229 79653609
Oxygen consumption increased 332.49 19.68 142 83408 4837 79656001
Unevaluable event 318.61 19.68 340 83210 55245 79605593
Hypervolaemia 312.27 19.68 298 83252 42392 79618446
Dizziness 308.39 19.68 1227 82323 525214 79135624
Drug interaction 295.74 19.68 42 83508 415141 79245697
Neutropenia 272.46 19.68 6 83544 287704 79373134
Catheterisation cardiac 266.72 19.68 127 83423 5601 79655237
Nasal congestion 236.05 19.68 343 83207 76209 79584629
Pulmonary arterial pressure increased 233.72 19.68 108 83442 4447 79656391
Concomitant disease aggravated 229.05 19.68 153 83397 13014 79647824
Oedema 228.59 19.68 432 83118 119148 79541690
Hypotension 228.20 19.68 989 82561 439328 79221510
Pulmonary arterial hypertension 211.20 19.68 200 83350 28166 79632672
Decreased appetite 205.55 19.68 805 82745 341613 79319225
Malaise 205.13 19.68 1034 82516 488835 79172003
Acute kidney injury 201.83 19.68 150 83400 519254 79141584
Brain natriuretic peptide increased 201.11 19.68 122 83428 8778 79652060
Feeling abnormal 191.58 19.68 477 83073 158722 79502116
Product dose omission issue 173.53 19.68 612 82938 246925 79413913
Thrombocytopenia 170.75 19.68 35 83515 265224 79395614
Drug hypersensitivity 170.03 19.68 51 83499 298865 79361973
Oedema peripheral 167.70 19.68 613 82937 251675 79409163
Treatment failure 159.61 19.68 4 83546 170482 79490356
Cardiac failure 156.73 19.68 435 83115 154407 79506431
Drug abuse 147.97 19.68 5 83545 162686 79498152
Pain 140.27 19.68 1234 82316 702568 78958270
Product use in unapproved indication 134.78 19.68 47 83503 250312 79410526
Rheumatoid arthritis 133.12 19.68 28 83522 208442 79452396
Rash 132.73 19.68 253 83297 578105 79082733
Syncope 132.03 19.68 451 83099 178998 79481840
Faeces soft 128.84 19.68 90 83460 8233 79652605
Abdominal discomfort 128.64 19.68 562 82988 250165 79410673
Malignant neoplasm progression 128.02 19.68 3 83547 135987 79524851
Maternal exposure during pregnancy 124.86 19.68 4 83546 136534 79524304
Palpitations 122.51 19.68 350 83200 126260 79534578
Abdominal distension 120.90 19.68 336 83214 119314 79541524
Hepatic enzyme increased 117.67 19.68 24 83526 182586 79478252
Chest pain 116.49 19.68 594 82956 281710 79379128
Scleroderma 115.49 19.68 72 83478 5438 79655400
Arthropathy 114.70 19.68 23 83527 177088 79483750
Hypoxia 112.38 19.68 298 83252 102945 79557893
Intentional product use issue 111.45 19.68 14 83536 152098 79508740
Neck pain 111.43 19.68 245 83305 75172 79585666
Oxygen therapy 109.35 19.68 55 83495 2735 79658103
Therapeutic product effect incomplete 106.34 19.68 12 83538 141633 79519205
Alopecia 104.55 19.68 56 83494 231299 79429539
Lung transplant 104.27 19.68 63 83487 4498 79656340
Stomatitis 103.97 19.68 15 83535 146742 79514096
Peripheral swelling 102.07 19.68 554 82996 269063 79391775
Vomiting 101.85 19.68 1105 82445 664723 78996115
Hypersensitivity 101.32 19.68 76 83474 262163 79398675
Walking distance test abnormal 99.22 19.68 35 83515 703 79660135
Dyspepsia 98.92 19.68 294 83256 108393 79552445
Migraine 97.72 19.68 255 83295 87238 79573600
Intentional overdose 97.25 19.68 3 83547 105957 79554881
Leukopenia 95.14 19.68 7 83543 116506 79544332
Overdose 95.03 19.68 37 83513 184169 79476669
Rhabdomyolysis 94.37 19.68 3 83547 103128 79557710
Pulmonary veno-occlusive disease 93.78 19.68 42 83508 1606 79659232
Hypertension 92.50 19.68 127 83423 330865 79329973
Blood pressure decreased 92.37 19.68 271 83279 99195 79561643
Arthralgia 92.06 19.68 959 82591 570844 79089994
Confusional state 91.93 19.68 119 83431 317878 79342960
Abdominal pain upper 90.92 19.68 469 83081 223350 79437488
Pulmonary oedema 87.32 19.68 246 83304 88008 79572830
Transplant evaluation 86.32 19.68 40 83510 1657 79659181
Pericarditis 85.87 19.68 6 83544 104230 79556608
Neutrophil count decreased 85.03 19.68 3 83547 93956 79566882
Hospice care 83.02 19.68 76 83474 10248 79650590
Glossodynia 82.16 19.68 7 83543 103330 79557508
Blister 80.58 19.68 14 83536 119462 79541376
Infusion site pain 79.91 19.68 86 83464 14090 79646748
Fatigue 79.72 19.68 1391 82159 928336 78732502
Therapy non-responder 79.58 19.68 245 83305 92060 79568778
Coma 79.52 19.68 7 83543 100642 79560196
Joint swelling 79.39 19.68 112 83438 288534 79372304
Hyponatraemia 78.95 19.68 44 83506 177804 79483034
Paracentesis 78.85 19.68 35 83515 1310 79659528
Dialysis 77.17 19.68 96 83454 18366 79642472
Impaired healing 75.35 19.68 4 83546 87651 79573187
Condition aggravated 75.24 19.68 829 82721 500295 79160543
Pancytopenia 75.03 19.68 40 83510 165705 79495133
Insomnia 74.78 19.68 476 83074 244694 79416144
Bedridden 74.72 19.68 77 83473 12002 79648836
Pneumonia 74.49 19.68 1035 82515 659211 79001627
Dyspnoea at rest 73.31 19.68 61 83489 7241 79653597
Chest discomfort 72.67 19.68 312 83238 137732 79523106
N-terminal prohormone brain natriuretic peptide increased 72.62 19.68 51 83499 4704 79656134
Pericardial effusion 72.62 19.68 154 83396 46083 79614755
Catheter management 72.10 19.68 46 83504 3617 79657221
Drug titration error 70.58 19.68 31 83519 1131 79659707
Seizure 70.03 19.68 57 83493 188777 79472061
Cough 68.58 19.68 635 82915 366154 79294684
Head discomfort 68.11 19.68 80 83470 14422 79646416
Electrocardiogram QT prolonged 66.97 19.68 8 83542 90378 79570460
Catheter site pain 66.84 19.68 51 83499 5345 79655493
C-reactive protein increased 66.39 19.68 26 83524 129001 79531837
Dizziness postural 64.99 19.68 70 83480 11479 79649359
Cardioversion 64.08 19.68 35 83515 2063 79658775
Muscle spasms 64.01 19.68 356 83194 174374 79486464
Urticaria 62.56 19.68 61 83489 185140 79475698
Epistaxis 61.76 19.68 256 83294 111259 79549579
Psoriasis 61.51 19.68 10 83540 89577 79571261
Deep vein thrombosis 61.18 19.68 25 83525 120894 79539944
Bradycardia 60.93 19.68 33 83517 135524 79525314
Ascites 60.93 19.68 196 83354 75366 79585472
Blood cholesterol increased 60.60 19.68 8 83542 83712 79577126
Catheter placement 60.16 19.68 38 83512 2936 79657902
Back pain 59.06 19.68 531 83019 303649 79357189
Lower respiratory tract infection 58.75 19.68 31 83519 129189 79531649
Atrial septal defect repair 58.75 19.68 21 83529 439 79660399
White blood cell count decreased 56.95 19.68 68 83482 188220 79472618
Blood creatine phosphokinase increased 56.85 19.68 3 83547 66087 79594751
Myocardial infarction 56.22 19.68 66 83484 184063 79476775
Productive cough 55.53 19.68 211 83339 88120 79572718
Disease complication 55.38 19.68 44 83506 4893 79655945
Agitation 54.86 19.68 18 83532 99697 79561141
Helicobacter infection 54.65 19.68 5 83545 69699 79591139
Intentional product misuse 54.47 19.68 16 83534 95149 79565689
Asthma 52.33 19.68 39 83511 135056 79525782
Liver function test abnormal 52.27 19.68 4 83546 64471 79596367
Mobility decreased 51.70 19.68 32 83518 122143 79538695
Suicidal ideation 49.22 19.68 10 83540 76330 79584508
Extra dose administered 49.11 19.68 52 83498 8363 79652475
Musculoskeletal stiffness 48.99 19.68 67 83483 174941 79485897
Angioedema 48.94 19.68 10 83540 76025 79584813
Depressed level of consciousness 48.86 19.68 20 83530 96632 79564206
General physical health deterioration 48.80 19.68 138 83412 275100 79385738
Pruritus 48.78 19.68 230 83320 394418 79266420
Left ventricular failure 48.60 19.68 55 83495 9526 79651312
Injection site pain 48.37 19.68 39 83511 129799 79531039
Hyperkalaemia 48.35 19.68 30 83520 114368 79546470
Lactic acidosis 47.98 19.68 8 83542 70351 79590487
Cognitive disorder 47.57 19.68 8 83542 69918 79590920
Wound 47.02 19.68 32 83518 116147 79544691
Metabolic acidosis 47.01 19.68 14 83536 82515 79578323
Mineral supplementation 46.50 19.68 21 83529 819 79660019
Pulmonary embolism 45.79 19.68 68 83482 171586 79489252
Weight decreased 44.97 19.68 569 82981 354629 79306209
Catheter site erythema 44.94 19.68 40 83510 5200 79655638
Liver injury 44.55 19.68 4 83546 56610 79604228
Pyrexia 43.97 19.68 477 83073 678232 78982606
Multiple organ dysfunction syndrome 43.70 19.68 37 83513 120209 79540629
Acute myocardial infarction 42.21 19.68 14 83536 77022 79583816
Flatulence 42.15 19.68 119 83431 42605 79618233
Heart rate increased 41.58 19.68 242 83308 120482 79540356
Presyncope 41.14 19.68 115 83435 40939 79619899
Nasopharyngitis 40.78 19.68 426 83124 253455 79407383
Discomfort 40.56 19.68 43 83507 125574 79535264
Cardiac operation 40.50 19.68 37 83513 4975 79655863
Cerebrovascular accident 39.99 19.68 63 83487 155229 79505609
Blood pressure increased 39.69 19.68 103 83447 211257 79449581
Coronary artery disease 39.36 19.68 10 83540 65464 79595374
Pulmonary arterial pressure abnormal 39.34 19.68 18 83532 724 79660114
Terminal state 39.33 19.68 36 83514 4853 79655985
Encephalopathy 39.18 19.68 11 83539 67386 79593452
Iron deficiency anaemia 38.58 19.68 84 83466 25588 79635250
Hypoglycaemia 38.49 19.68 30 83520 101564 79559274
Hallucination 38.34 19.68 21 83529 85724 79575114
Cardiac disorder 38.01 19.68 153 83397 65604 79595234
Adverse event 37.97 19.68 144 83406 60070 79600768
Limb discomfort 37.95 19.68 97 83453 32753 79628085
Injection site reaction 37.87 19.68 6 83544 54779 79606059
Injury 37.64 19.68 17 83533 77479 79583359
Multiple sclerosis relapse 37.40 19.68 3 83547 46530 79614308
Osteoarthritis 36.75 19.68 23 83527 87286 79573552
Injection site erythema 36.68 19.68 18 83532 78179 79582659
Plasma cell myeloma 36.44 19.68 6 83544 53253 79607585
Cardiac ablation 36.36 19.68 25 83525 2228 79658610
Drug-induced liver injury 36.25 19.68 12 83538 66105 79594733
Delirium 36.03 19.68 22 83528 84605 79576233
Product use issue 35.87 19.68 107 83443 209715 79451123
Systemic lupus erythematosus 35.31 19.68 45 83505 121104 79539734
Atrial septal defect 35.03 19.68 23 83527 1899 79658939
Right ventricular dilatation 34.99 19.68 23 83527 1903 79658935
Gout 34.96 19.68 79 83471 24670 79636168
Alanine aminotransferase increased 34.69 19.68 74 83476 162496 79498342
Hepatitis 34.50 19.68 8 83542 55719 79605119
Pneumonitis 33.45 19.68 11 83539 60849 79599989
Pulmonary artery dilatation 33.39 19.68 14 83536 455 79660383
Exposure during pregnancy 33.34 19.68 34 83516 101098 79559740
Hypocalcaemia 33.33 19.68 6 83544 49918 79610920
Hyperglycaemia 33.28 19.68 16 83534 70319 79590519
Wrong dose 32.66 19.68 21 83529 1673 79659165
Disease recurrence 32.44 19.68 4 83546 44105 79616733
Drug ineffective for unapproved indication 32.44 19.68 7 83543 51231 79609607
Disease progression 32.30 19.68 315 83235 184047 79476791
Catheterisation cardiac abnormal 31.98 19.68 12 83538 289 79660549
Type 2 diabetes mellitus 31.97 19.68 10 83540 57112 79603726
Renal disorder 31.95 19.68 107 83443 41998 79618840
Abdominal cavity drainage 31.47 19.68 16 83534 814 79660024
Septic shock 31.44 19.68 50 83500 122751 79538087
Right ventricular enlargement 31.36 19.68 15 83535 668 79660170
Pulmonary congestion 31.28 19.68 80 83470 27020 79633818
Neuropathy peripheral 31.26 19.68 63 83487 141242 79519596
Eosinophilia 31.26 19.68 5 83545 45340 79615498
Systemic scleroderma 31.21 19.68 18 83532 1179 79659659
Cytomegalovirus infection 31.04 19.68 4 83546 42640 79618198
Swollen tongue 30.97 19.68 4 83546 42566 79618272
Nocturnal dyspnoea 30.97 19.68 20 83530 1606 79659232
Cardiac failure high output 30.91 19.68 12 83538 318 79660520
Rehabilitation therapy 30.70 19.68 21 83529 1856 79658982
Respiratory arrest 30.60 19.68 11 83539 57539 79603299
Haemodynamic test abnormal 30.57 19.68 8 83542 54 79660784
Blood pressure systolic increased 30.54 19.68 16 83534 66970 79593868
Jaundice 30.47 19.68 9 83541 53340 79607498
Right-to-left cardiac shunt 30.29 19.68 11 83539 241 79660597
Skin exfoliation 30.21 19.68 10 83540 55090 79605748
Blood lactate dehydrogenase increased 30.20 19.68 3 83547 39167 79621671
Emergency care 30.14 19.68 17 83533 1067 79659771
Exercise tolerance decreased 29.92 19.68 42 83508 9029 79651809
Pulmonary hypertensive crisis 29.90 19.68 12 83538 348 79660490
Psychotic disorder 29.85 19.68 4 83546 41398 79619440
Altered state of consciousness 29.84 19.68 5 83545 43817 79617021
Oxygen saturation abnormal 29.78 19.68 30 83520 4552 79656286
Haemoptysis 29.77 19.68 127 83423 55872 79604966
Irritable bowel syndrome 29.69 19.68 14 83536 62227 79598611
Influenza like illness 29.57 19.68 151 83399 71556 79589282
Cardiac output increased 29.32 19.68 11 83539 265 79660573
Influenza 29.19 19.68 234 83316 129372 79531466
Endarterectomy 29.18 19.68 12 83538 371 79660467
Stent placement 29.02 19.68 35 83515 6485 79654353
Pancreatitis acute 29.01 19.68 8 83542 49596 79611242
Medication error 29.00 19.68 18 83532 68624 79592214
Right ventricular dysfunction 28.52 19.68 23 83527 2612 79658226
Aggression 28.38 19.68 9 83541 50949 79609889
Restless legs syndrome 28.23 19.68 64 83486 20028 79640810
Stevens-Johnson syndrome 27.73 19.68 4 83546 39162 79621676
Dizziness exertional 27.56 19.68 13 83537 561 79660277
Transaminases increased 27.32 19.68 10 83540 51733 79609105
Fibromyalgia 27.01 19.68 17 83533 64323 79596515
Mouth ulceration 27.00 19.68 4 83546 38390 79622448
Catheter site pruritus 26.95 19.68 21 83529 2270 79658568
Metapneumovirus infection 26.93 19.68 19 83531 1765 79659073
Hot flush 26.55 19.68 121 83429 54756 79606082
Biopsy liver 26.45 19.68 13 83537 615 79660223
Emotional distress 26.26 19.68 5 83545 39964 79620874
Hepatic failure 25.93 19.68 16 83534 61196 79599642
Skin lesion 25.92 19.68 6 83544 41838 79619000
Catheter site rash 25.90 19.68 15 83535 990 79659848
Drug withdrawal syndrome 25.90 19.68 3 83547 34715 79626123
Depression 25.78 19.68 128 83422 216662 79444176
Musculoskeletal pain 25.38 19.68 189 83361 102165 79558673
Facial pain 25.29 19.68 46 83504 12304 79648534
Haematuria 25.23 19.68 21 83529 68815 79592023
Lymphocyte count decreased 25.21 19.68 9 83541 47280 79613558
Localised oedema 25.02 19.68 36 83514 7916 79652922
Device related infection 25.00 19.68 86 83464 34208 79626630
Hemiparesis 24.95 19.68 3 83547 33730 79627108
Gastric disorder 24.83 19.68 91 83459 37342 79623496
Catheter site infection 24.74 19.68 33 83517 6762 79654076
Diuretic therapy 24.66 19.68 9 83541 200 79660638
Cardiothoracic ratio increased 24.60 19.68 7 83543 67 79660771
Product supply issue 24.59 19.68 19 83531 2029 79658809
Gastrooesophageal reflux disease 24.45 19.68 190 83360 104056 79556782
Prescribed overdose 24.34 19.68 5 83545 37878 79622960
Dysarthria 24.33 19.68 21 83529 67601 79593237
Acute respiratory failure 24.29 19.68 125 83425 59416 79601422
Bone pain 24.13 19.68 119 83431 55623 79605215
Pericardial drainage 24.05 19.68 11 83539 442 79660396
Drug eruption 24.04 19.68 8 83542 43927 79616911
Obesity 23.93 19.68 4 83546 35121 79625717
Cardiac pacemaker insertion 23.89 19.68 30 83520 5792 79655046
Basal cell carcinoma 23.88 19.68 5 83545 37370 79623468
Therapeutic response decreased 23.76 19.68 21 83529 66832 79594006
Hereditary haemorrhagic telangiectasia 23.68 19.68 6 83544 35 79660803
Infusion site discharge 23.65 19.68 12 83538 608 79660230
Electrocardiogram ambulatory 23.45 19.68 4 83546 0 79660838
Dysentery 23.42 19.68 15 83535 1187 79659651
Blood pressure abnormal 23.36 19.68 54 83496 17115 79643723
Hypomagnesaemia 23.24 19.68 10 83540 46901 79613937
Haemorrhoidal haemorrhage 23.22 19.68 32 83518 6763 79654075
Cerebral haemorrhage 23.18 19.68 16 83534 57657 79603181
Product prescribing error 23.09 19.68 9 83541 44804 79616034
Concomitant disease progression 23.05 19.68 23 83527 3450 79657388
Infection 22.71 19.68 154 83396 241558 79419280
Hyperhidrosis 22.60 19.68 82 83468 151410 79509428
Pulmonary arterial wedge pressure increased 22.50 19.68 11 83539 514 79660324
Catheter site warmth 22.46 19.68 9 83541 260 79660578
Joint range of motion decreased 22.22 19.68 4 83546 33278 79627560
Blood potassium decreased 22.09 19.68 102 83448 46410 79614428
Loss of consciousness 22.05 19.68 271 83279 167672 79493166
Wrong technique in product usage process 21.98 19.68 27 83523 73848 79586990
Disorientation 21.98 19.68 20 83530 62756 79598082
Upper respiratory tract inflammation 21.90 19.68 24 83526 4011 79656827
Liver transplant 21.77 19.68 25 83525 4398 79656440
Infusion site erythema 21.65 19.68 37 83513 9423 79651415
Aphasia 21.55 19.68 11 83539 46721 79614117
Epilepsy 21.40 19.68 8 83542 40852 79619986
Feeding tube user 21.15 19.68 7 83543 115 79660723
Urinary retention 21.09 19.68 17 83533 56613 79604225
Vasodilatation 20.93 19.68 21 83529 3170 79657668
Haemoglobin decreased 20.93 19.68 338 83212 221781 79439057
Retching 20.61 19.68 52 83498 17415 79643423
Disseminated intravascular coagulation 20.56 19.68 6 83544 35836 79625002
Central venous catheterisation 20.40 19.68 21 83529 3268 79657570
Blood iron decreased 20.40 19.68 48 83502 15386 79645452
Leukocytosis 20.38 19.68 10 83540 43445 79617393
Diplopia 20.33 19.68 5 83545 33461 79627377
Tracheostomy 20.26 19.68 14 83536 1258 79659580
N-terminal prohormone brain natriuretic peptide 20.25 19.68 6 83544 67 79660771
Cardiac monitoring 20.22 19.68 5 83545 26 79660812
Hypokalaemia 20.17 19.68 80 83470 143960 79516878
Bendopnoea 20.06 19.68 5 83545 27 79660811
Hepatic cirrhosis 19.99 19.68 81 83469 34825 79626013
Paranasal sinus discomfort 19.96 19.68 24 83526 4432 79656406
Pulmonary pain 19.89 19.68 24 83526 4449 79656389
Catheter site discharge 19.87 19.68 18 83532 2394 79658444
Inflammation 19.72 19.68 43 83507 93710 79567128

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC B01AC27 BLOOD AND BLOOD FORMING ORGANS
ANTITHROMBOTIC AGENTS
ANTITHROMBOTIC AGENTS
Platelet aggregation inhibitors excl. heparin
FDA MoA N0000020068 Prostacyclin Receptor Agonists
MeSH PA D000959 Antihypertensive Agents
MeSH PA D002317 Cardiovascular Agents
FDA EPC N0000192339 Prostacyclin Receptor Agonist
CHEBI has role CHEBI:35620 vasodilator agents
CHEBI has role CHEBI:50266 Prodrugs
CHEBI has role CHEBI:50427 platelet aggregation inhibitors
CHEBI has role CHEBI:71031 orphan drugs
CHEBI has role CHEBI:90845 prostacyclin receptor agonists
CHEBI has role CHEBI:49103 drug metabolites

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Pulmonary arterial hypertension indication 11399002
Thromboembolic pulmonary hypertension indication 233947005




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.49 acidic
pKa2 5.13 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
0.2MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL 7205302 Oct. 31, 2026 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A PHARMACEUTICAL COMPOSITION COMPRISING SELEXIPAG
0.4MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL 7205302 Oct. 31, 2026 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A PHARMACEUTICAL COMPOSITION COMPRISING SELEXIPAG
0.6MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL 7205302 Oct. 31, 2026 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A PHARMACEUTICAL COMPOSITION COMPRISING SELEXIPAG
0.8MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL 7205302 Oct. 31, 2026 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A PHARMACEUTICAL COMPOSITION COMPRISING SELEXIPAG
1.2MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL 7205302 Oct. 31, 2026 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A PHARMACEUTICAL COMPOSITION COMPRISING SELEXIPAG
1.4MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL 7205302 Oct. 31, 2026 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A PHARMACEUTICAL COMPOSITION COMPRISING SELEXIPAG
1.6MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL 7205302 Oct. 31, 2026 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A PHARMACEUTICAL COMPOSITION COMPRISING SELEXIPAG
1MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL 7205302 Oct. 31, 2026 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A PHARMACEUTICAL COMPOSITION COMPRISING SELEXIPAG
1.8MG/VIAL UPTRAVI ACTELION N214275 July 29, 2021 RX POWDER INTRAVENOUS 7205302 Oct. 31, 2026 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A PHARMACEUTICAL COMPOSITION COMPRISING SELEXIPAG
0.2MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL 9173881 Aug. 12, 2029 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING SELEXIPAG IN COMBINATION WITH THE ENDOTHELIN RECEPTOR ANTAGONIST MACITENTAN
0.4MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL 9173881 Aug. 12, 2029 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING SELEXIPAG IN COMBINATION WITH THE ENDOTHELIN RECEPTOR ANTAGONIST MACITENTAN
0.6MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL 9173881 Aug. 12, 2029 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING SELEXIPAG IN COMBINATION WITH THE ENDOTHELIN RECEPTOR ANTAGONIST MACITENTAN
0.8MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL 9173881 Aug. 12, 2029 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING SELEXIPAG IN COMBINATION WITH THE ENDOTHELIN RECEPTOR ANTAGONIST MACITENTAN
1.2MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL 9173881 Aug. 12, 2029 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING SELEXIPAG IN COMBINATION WITH THE ENDOTHELIN RECEPTOR ANTAGONIST MACITENTAN
1.4MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL 9173881 Aug. 12, 2029 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING SELEXIPAG IN COMBINATION WITH THE ENDOTHELIN RECEPTOR ANTAGONIST MACITENTAN
1.6MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL 9173881 Aug. 12, 2029 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING SELEXIPAG IN COMBINATION WITH THE ENDOTHELIN RECEPTOR ANTAGONIST MACITENTAN
1MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL 9173881 Aug. 12, 2029 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING SELEXIPAG IN COMBINATION WITH THE ENDOTHELIN RECEPTOR ANTAGONIST MACITENTAN
1.8MG/VIAL UPTRAVI ACTELION N214275 July 29, 2021 RX POWDER INTRAVENOUS 9173881 Aug. 12, 2029 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING SELEXIPAG IN COMBINATION WITH THE ENDOTHELIN RECEPTOR ANTAGONIST MACITENTAN
0.2MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL 9284280 June 25, 2030 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A CRYSTALLINE FORM OF SELEXIPAG
0.4MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL 9284280 June 25, 2030 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A CRYSTALLINE FORM OF SELEXIPAG
0.6MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL 9284280 June 25, 2030 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A CRYSTALLINE FORM OF SELEXIPAG
0.8MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL 9284280 June 25, 2030 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A CRYSTALLINE FORM OF SELEXIPAG
1.2MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL 9284280 June 25, 2030 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A CRYSTALLINE FORM OF SELEXIPAG
1.4MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL 9284280 June 25, 2030 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A CRYSTALLINE FORM OF SELEXIPAG
1.6MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL 9284280 June 25, 2030 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A CRYSTALLINE FORM OF SELEXIPAG
1MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL 9284280 June 25, 2030 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A CRYSTALLINE FORM OF SELEXIPAG
1.8MG/VIAL UPTRAVI ACTELION N214275 July 29, 2021 RX POWDER INTRAVENOUS 9284280 June 25, 2030 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A CRYSTALLINE FORM OF SELEXIPAG
0.2MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL 10821108 Dec. 1, 2036 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A SOLID PREPARATION CONTAINING SELEXIPAG
0.2MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL 10828298 Dec. 1, 2036 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A TABLET CONTAINING SELEXIPAG
0.4MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL 10821108 Dec. 1, 2036 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A SOLID PREPARATION CONTAINING SELEXIPAG
0.4MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL 10828298 Dec. 1, 2036 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A TABLET CONTAINING SELEXIPAG
0.6MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL 10821108 Dec. 1, 2036 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A SOLID PREPARATION CONTAINING SELEXIPAG
0.6MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL 10828298 Dec. 1, 2036 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A TABLET CONTAINING SELEXIPAG
0.8MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL 10821108 Dec. 1, 2036 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A SOLID PREPARATION CONTAINING SELEXIPAG
0.8MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL 10828298 Dec. 1, 2036 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A TABLET CONTAINING SELEXIPAG
1.2MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL 10821108 Dec. 1, 2036 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A SOLID PREPARATION CONTAINING SELEXIPAG
1.2MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL 10828298 Dec. 1, 2036 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A TABLET CONTAINING SELEXIPAG
1.4MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL 10821108 Dec. 1, 2036 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A SOLID PREPARATION CONTAINING SELEXIPAG
1.4MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL 10828298 Dec. 1, 2036 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A TABLET CONTAINING SELEXIPAG
1.6MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL 10821108 Dec. 1, 2036 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A SOLID PREPARATION CONTAINING SELEXIPAG
1.6MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL 10828298 Dec. 1, 2036 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A TABLET CONTAINING SELEXIPAG
1MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL 10821108 Dec. 1, 2036 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A SOLID PREPARATION CONTAINING SELEXIPAG
1MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL 10828298 Dec. 1, 2036 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A TABLET CONTAINING SELEXIPAG

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Prostacyclin receptor GPCR AGONIST Ki 7.70 SCIENTIFIC LITERATURE DRUG LABEL
Prostaglandin E2 receptor EP2 subtype GPCR AGONIST Ki 5.24 IUPHAR
Prostaglandin E2 receptor EP4 subtype GPCR AGONIST Ki 5.31 IUPHAR
Prostaglandin D2 receptor GPCR EC50 7 CHEMBL
Prostacyclin receptor GPCR AGONIST Ki 5.68 IUPHAR

External reference:

IDSource
D09994 KEGG_DRUG
4035275 VANDF
CHEBI:90844 CHEBI
CHEBI:90848 CHEBI
CHEMBL238804 ChEMBL_ID
C523468 MESH_SUPPLEMENTAL_RECORD_UI
C531934 MESH_SUPPLEMENTAL_RECORD_UI
7552 IUPHAR_LIGAND_ID
DB11362 DRUGBANK_ID
1729002 RXNORM
237614 MMSL
31388 MMSL
d08407 MMSL
016638 NDDF
717359004 SNOMEDCT_US
781377007 SNOMEDCT_US
C2000145 UMLSCUI
C2606862 UMLSCUI
9231 INN_ID
9913767 PUBCHEM_CID
475085-57-5 SECONDARY_CAS_RN
9931891 PUBCHEM_CID
5852 IUPHAR_LIGAND_ID
5EXC0E384L UNII
E9PC7N0DID UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
UPTRAVI HUMAN PRESCRIPTION DRUG LABEL 1 66215-602 TABLET, COATED 200 ug ORAL NDA 32 sections
UPTRAVI HUMAN PRESCRIPTION DRUG LABEL 1 66215-602 TABLET, COATED 200 ug ORAL NDA 32 sections
UPTRAVI HUMAN PRESCRIPTION DRUG LABEL 1 66215-602 TABLET, COATED 200 ug ORAL NDA 32 sections
UPTRAVI HUMAN PRESCRIPTION DRUG LABEL 1 66215-604 TABLET, COATED 400 ug ORAL NDA 32 sections
UPTRAVI HUMAN PRESCRIPTION DRUG LABEL 1 66215-604 TABLET, COATED 400 ug ORAL NDA 32 sections
UPTRAVI HUMAN PRESCRIPTION DRUG LABEL 1 66215-604 TABLET, COATED 400 ug ORAL NDA 32 sections
UPTRAVI HUMAN PRESCRIPTION DRUG LABEL 1 66215-606 TABLET, COATED 600 ug ORAL NDA 32 sections
UPTRAVI HUMAN PRESCRIPTION DRUG LABEL 1 66215-606 TABLET, COATED 600 ug ORAL NDA 32 sections
UPTRAVI HUMAN PRESCRIPTION DRUG LABEL 1 66215-606 TABLET, COATED 600 ug ORAL NDA 32 sections
UPTRAVI HUMAN PRESCRIPTION DRUG LABEL 1 66215-608 TABLET, COATED 800 ug ORAL NDA 32 sections
UPTRAVI HUMAN PRESCRIPTION DRUG LABEL 1 66215-608 TABLET, COATED 800 ug ORAL NDA 32 sections
UPTRAVI HUMAN PRESCRIPTION DRUG LABEL 1 66215-608 TABLET, COATED 800 ug ORAL NDA 32 sections
UPTRAVI HUMAN PRESCRIPTION DRUG LABEL 1 66215-610 TABLET, COATED 1000 ug ORAL NDA 32 sections
UPTRAVI HUMAN PRESCRIPTION DRUG LABEL 1 66215-610 TABLET, COATED 1000 ug ORAL NDA 32 sections
UPTRAVI HUMAN PRESCRIPTION DRUG LABEL 1 66215-610 TABLET, COATED 1000 ug ORAL NDA 32 sections
UPTRAVI HUMAN PRESCRIPTION DRUG LABEL 1 66215-612 TABLET, COATED 1200 ug ORAL NDA 32 sections
UPTRAVI HUMAN PRESCRIPTION DRUG LABEL 1 66215-612 TABLET, COATED 1200 ug ORAL NDA 32 sections
UPTRAVI HUMAN PRESCRIPTION DRUG LABEL 1 66215-612 TABLET, COATED 1200 ug ORAL NDA 32 sections
UPTRAVI HUMAN PRESCRIPTION DRUG LABEL 1 66215-614 TABLET, COATED 1400 ug ORAL NDA 32 sections
UPTRAVI HUMAN PRESCRIPTION DRUG LABEL 1 66215-614 TABLET, COATED 1400 ug ORAL NDA 32 sections
UPTRAVI HUMAN PRESCRIPTION DRUG LABEL 1 66215-614 TABLET, COATED 1400 ug ORAL NDA 32 sections
UPTRAVI HUMAN PRESCRIPTION DRUG LABEL 1 66215-616 TABLET, COATED 1600 ug ORAL NDA 32 sections
UPTRAVI HUMAN PRESCRIPTION DRUG LABEL 1 66215-616 TABLET, COATED 1600 ug ORAL NDA 32 sections
UPTRAVI HUMAN PRESCRIPTION DRUG LABEL 1 66215-616 TABLET, COATED 1600 ug ORAL NDA 32 sections
UPTRAVI HUMAN PRESCRIPTION DRUG LABEL 1 66215-718 INJECTION, POWDER, FOR SOLUTION 1800 ug INTRAVENOUS NDA 32 sections
UPTRAVI HUMAN PRESCRIPTION DRUG LABEL 1 66215-718 INJECTION, POWDER, FOR SOLUTION 1800 ug INTRAVENOUS NDA 32 sections
UPTRAVI HUMAN PRESCRIPTION DRUG LABEL 1 66215-718 INJECTION, POWDER, FOR SOLUTION 1800 ug INTRAVENOUS NDA 32 sections