selexipag 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
1.80 mg O

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2B,AXL,BRAF,CDK5,EIF2AK3,ERBB2,GRK2,ITK,PDK1,PDK2,PDK4,PRKDC 12
pfas-class PFAS structural alert (1 = True, 0 = False) 0

Approvals:

DateAgencyCompanyOrphan
Aug. 25, 2021 PMDA NIPPON SHINYAKU Co., Ltd
Dec. 21, 2015 FDA ACTELION PHARMS 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 3303.22 18.95 1334 79757 46651 90500705
Headache 3006.68 18.95 3751 77340 858995 89688361
Diarrhoea 1373.48 18.95 2750 78341 936440 89610916
Myalgia 1305.01 18.95 1150 79941 173975 90373381
Dyspnoea 1241.96 18.95 2542 78549 878413 89668943
Hospitalisation 1001.37 18.95 865 80226 127235 90420121
Fluid retention 969.63 18.95 727 80364 87364 90459992
Dyspnoea exertional 854.76 18.95 623 80468 71665 90475691
Nausea 739.01 18.95 2418 78673 1107898 89439458
Right ventricular failure 704.70 18.95 344 80747 18861 90528495
Flushing 657.70 18.95 581 80510 87910 90459446
Drug ineffective 627.72 18.95 230 80861 1384068 89163288
Death 579.07 18.95 1266 79825 455285 90092071
Therapy change 539.41 18.95 222 80869 8100 90539256
Pulmonary hypertension 514.91 18.95 372 80719 42151 90505205
Oxygen saturation decreased 508.28 18.95 551 80540 106932 90440424
Pain in extremity 441.14 18.95 1130 79961 449399 90097957
Transfusion 425.78 18.95 238 80853 17250 90530106
Hypotension 420.56 18.95 910 80181 324487 90222869
Infusion related reaction 351.62 18.95 4 81087 416776 90130580
Oxygen consumption increased 351.26 18.95 138 80953 4451 90542905
Hypervolaemia 350.34 18.95 266 80825 32491 90514865
Unevaluable event 348.45 18.95 330 80761 54518 90492838
Dizziness 345.65 18.95 1234 79857 588050 89959306
Off label use 326.19 18.95 305 80786 1101947 89445409
Cardiac failure 304.67 18.95 430 80661 109066 90438290
Maternal exposure during pregnancy 288.98 18.95 7 81084 360056 90187300
Pulmonary arterial pressure increased 262.40 18.95 107 80984 3809 90543547
Contraindicated product administered 261.70 18.95 5 81086 320134 90227222
Catheterisation cardiac 257.40 18.95 113 80978 4843 90542513
Alopecia 256.05 18.95 64 81027 495007 90052349
Glossodynia 255.39 18.95 7 81084 321772 90225584
Drug hypersensitivity 253.58 18.95 53 81038 463556 90083800
Pulmonary arterial hypertension 250.33 18.95 199 80892 25988 90521368
Nasal congestion 240.06 18.95 333 80758 83081 90464275
Treatment failure 239.76 18.95 7 81084 303921 90243435
Decreased appetite 235.32 18.95 806 80285 375734 90171622
Hepatic enzyme increased 234.37 18.95 25 81066 360711 90186645
Syncope 229.99 18.95 420 80671 132243 90415113
Toxicity to various agents 229.39 18.95 6 81085 287840 90259516
Therapeutic product effect decreased 228.22 18.95 4 81087 277567 90269789
Arthropathy 226.52 18.95 30 81061 366212 90181144
Product dose omission issue 225.60 18.95 672 80419 291015 90256341
Feeling abnormal 225.13 18.95 476 80615 166759 90380597
Rheumatoid arthritis 216.55 18.95 33 81058 362581 90184775
Rash 211.52 18.95 241 80850 795859 89751497
Stomatitis 194.91 18.95 13 81078 274685 90272671
Pericarditis 194.01 18.95 12 81079 270139 90277217
Psoriatic arthropathy 188.89 18.95 3 81088 228332 90319024
Impaired healing 186.13 18.95 5 81086 234194 90313162
Helicobacter infection 183.51 18.95 4 81087 226846 90320510
Oedema peripheral 183.28 18.95 577 80514 257338 90290018
Hypersensitivity 183.20 18.95 89 81002 454588 90092768
Malaise 181.94 18.95 1016 80075 584970 89962386
Scleroderma 179.57 18.95 95 80996 6166 90541190
Palpitations 179.15 18.95 385 80706 136343 90411013
Wound 177.64 18.95 29 81062 302951 90244405
Brain natriuretic peptide increased 177.58 18.95 93 80998 5912 90541444
Blister 172.61 18.95 15 81076 254983 90292373
Pulmonary oedema 169.92 18.95 242 80849 61838 90485518
Systemic lupus erythematosus 166.51 18.95 58 81033 361838 90185518
Type 2 diabetes mellitus 162.78 18.95 4 81087 203240 90344116
Epistaxis 159.64 18.95 279 80812 84846 90462510
Neutropenia 158.49 18.95 11 81080 224893 90322463
Concomitant disease aggravated 156.10 18.95 108 80983 11410 90535946
Hypoxia 155.32 18.95 252 80839 72147 90475209
Pneumonia 148.82 18.95 1028 80063 637031 89910325
Blood cholesterol increased 147.08 18.95 10 81081 208002 90339354
Joint swelling 140.46 18.95 146 80945 503154 90044202
Pericardial effusion 137.08 18.95 167 80924 36666 90510690
Mobility decreased 136.25 18.95 29 81062 250705 90296651
Vomiting 135.53 18.95 1183 79908 787110 89760246
Liver injury 134.19 18.95 4 81087 170563 90376793
Product use in unapproved indication 133.56 18.95 67 81024 336169 90211187
Intentional product use issue 133.46 18.95 18 81073 216874 90330482
Drug interaction 132.94 18.95 41 81050 276412 90270944
Urticaria 132.44 18.95 57 81034 312677 90234679
Chest pain 131.17 18.95 600 80491 319045 90228311
Pulmonary veno-occlusive disease 131.03 18.95 50 81041 1488 90545868
Discomfort 129.57 18.95 42 81049 274293 90273063
Hypertension 127.32 18.95 133 80958 457399 90089957
Irritable bowel syndrome 125.79 18.95 18 81073 207430 90339926
Lower respiratory tract infection 120.82 18.95 37 81054 250622 90296734
Blood pressure decreased 119.58 18.95 229 80862 74666 90472690
Injury 117.64 18.95 18 81073 197331 90350025
Asthma 116.26 18.95 36 81055 242124 90305232
Fibromyalgia 115.93 18.95 22 81069 206247 90341109
Oxygen therapy 115.05 18.95 56 81035 3046 90544310
Musculoskeletal stiffness 114.91 18.95 61 81030 296471 90250885
Ascites 111.80 18.95 173 80918 47567 90499789
Cough 109.77 18.95 633 80458 368329 90179027
Lung transplant 108.66 18.95 57 81034 3635 90543721
Joint range of motion decreased 107.35 18.95 3 81088 135640 90411716
Confusional state 106.59 18.95 113 80978 386092 90161264
Osteoarthritis 105.58 18.95 23 81068 195707 90351649
Faeces soft 105.49 18.95 72 81019 7439 90539917
Bursitis 103.87 18.95 3 81088 131651 90415705
Walking distance test abnormal 103.84 18.95 33 81058 560 90546796
Product use issue 102.18 18.95 87 81004 329832 90217524
Thrombocytopenia 100.24 18.95 31 81060 208694 90338662
Dyspnoea at rest 97.39 18.95 58 81033 4733 90542623
Psoriasis 96.48 18.95 10 81081 147744 90399612
Therapeutic product effect incomplete 96.40 18.95 27 81064 193869 90353487
Exposure during pregnancy 95.40 18.95 47 81044 238363 90308993
Ill-defined disorder 95.23 18.95 24 81067 184867 90362489
C-reactive protein increased 94.48 18.95 23 81068 181366 90365990
Abdominal distension 94.30 18.95 294 80797 130307 90417049
Oedema 92.74 18.95 390 80701 199905 90347451
Chest discomfort 89.52 18.95 300 80791 138065 90409291
N-terminal prohormone brain natriuretic peptide increased 87.95 18.95 46 81045 2916 90544440
Back pain 87.75 18.95 534 80557 316641 90230715
Pruritus 87.36 18.95 225 80866 541300 90006056
Pain 86.01 18.95 1308 79783 995033 89552323
Infusion site pain 84.23 18.95 96 80995 19642 90527714
Dialysis 83.27 18.95 74 81017 11255 90536101
Malignant neoplasm progression 82.29 18.95 3 81088 106867 90440489
Transplant evaluation 80.79 18.95 34 81057 1312 90546044
Hypercholesterolaemia 77.11 18.95 3 81088 100889 90446467
Bedridden 76.92 18.95 73 81018 12075 90535281
Obesity 74.76 18.95 5 81086 105502 90441854
Productive cough 74.70 18.95 193 80898 76870 90470486
Lip dry 73.91 18.95 4 81087 100951 90446405
Heart rate increased 72.32 18.95 244 80847 112658 90434698
Cardiac disorder 71.97 18.95 158 80933 56714 90490642
Prescribed overdose 71.06 18.95 4 81087 97621 90449735
General physical health deterioration 70.89 18.95 131 80960 354984 90192372
Grip strength decreased 69.92 18.95 3 81088 92573 90454783
Disease complication 69.81 18.95 43 81048 3729 90543627
Presyncope 68.58 18.95 111 80980 31694 90515662
Hospice care 68.58 18.95 62 81029 9642 90537714
Left ventricular failure 68.52 18.95 53 81038 6647 90540709
Catheter site pain 67.92 18.95 49 81042 5530 90541826
Haemoptysis 67.42 18.95 113 80978 33207 90514149
Cardioversion 67.16 18.95 30 81061 1340 90546016
Acute kidney injury 66.81 18.95 115 80976 320272 90227084
Dizziness postural 64.29 18.95 58 81033 8995 90538361
Drug titration error 63.57 18.95 28 81063 1209 90546147
Leukopenia 62.78 18.95 8 81083 100702 90446654
Paracentesis 62.63 18.95 26 81065 969 90546387
Hypoaesthesia 62.62 18.95 116 80975 314094 90233262
Inflammation 61.76 18.95 42 81049 178550 90368806
Abdominal pain upper 60.94 18.95 507 80584 332167 90215189
Weight decreased 59.78 18.95 560 80531 379350 90168006
Haemoglobin decreased 59.04 18.95 294 80797 161662 90385694
Night sweats 58.52 18.95 21 81070 128745 90418611
Wound infection 58.39 18.95 12 81079 106390 90440966
Live birth 58.33 18.95 3 81088 79104 90468252
Drug abuse 58.06 18.95 4 81087 82343 90465013
Fatigue 57.76 18.95 1394 79697 1152629 89394727
Head discomfort 57.45 18.95 72 81019 16261 90531095
Overdose 57.38 18.95 35 81056 157674 90389682
Catheter management 57.18 18.95 35 81056 3001 90544355
Extra dose administered 54.35 18.95 53 81038 9065 90538291
Neck pain 53.56 18.95 223 80868 113740 90433616
Injection site pain 53.49 18.95 46 81045 173653 90373703
Depression 53.07 18.95 119 80972 300482 90246874
Atrial septal defect repair 52.30 18.95 16 81075 238 90547118
Metapneumovirus infection 52.23 18.95 25 81066 1310 90546046
Mineral supplementation 51.72 18.95 21 81070 739 90546617
Injection site reaction 51.33 18.95 10 81081 92070 90455286
Epilepsy 50.12 18.95 7 81084 82199 90465157
Pulmonary hypertensive crisis 49.78 18.95 18 81073 459 90546897
Pulmonary fibrosis 49.77 18.95 17 81074 107486 90439870
Delirium 49.19 18.95 16 81075 104343 90443013
Flatulence 49.06 18.95 112 80979 41255 90506101
Infection 48.49 18.95 164 80927 361930 90185426
Rehabilitation therapy 48.40 18.95 27 81064 1947 90545409
Pleural effusion 47.90 18.95 213 80878 111778 90435578
Cardiac failure congestive 47.85 18.95 195 80896 98499 90448857
Pulmonary congestion 47.71 18.95 72 81019 19361 90527995
Catheter placement 47.29 18.95 29 81062 2495 90544861
Loss of consciousness 47.22 18.95 249 80842 139989 90407367
Peripheral venous disease 47.02 18.95 9 81082 83912 90463444
Oxygen saturation abnormal 46.22 18.95 35 81056 4253 90543103
Atrial fibrillation 46.20 18.95 239 80852 133372 90413984
Drug-induced liver injury 45.96 18.95 12 81079 90306 90457050
Pulmonary arterial pressure abnormal 45.47 18.95 18 81073 592 90546764
Disease progression 45.36 18.95 267 80824 156348 90391008
Systemic scleroderma 45.25 18.95 24 81067 1565 90545791
Right ventricular enlargement 44.90 18.95 17 81074 495 90546861
Gait inability 44.83 18.95 39 81052 146417 90400939
Electrocardiogram QT prolonged 44.57 18.95 6 81085 72450 90474906
Swelling 44.56 18.95 208 80883 418850 90128506
Cognitive disorder 44.53 18.95 5 81086 69402 90477954
Renal disorder 44.34 18.95 102 80989 37757 90509599
Wheezing 43.87 18.95 92 80999 237988 90309368
Atrial flutter 43.67 18.95 51 81040 10707 90536649
Drug intolerance 43.67 18.95 229 80862 447362 90099994
Dyspepsia 43.45 18.95 315 80776 197845 90349511
Catheter site erythema 42.13 18.95 35 81056 4859 90542497
Influenza 42.00 18.95 240 80851 139024 90408332
Respiratory failure 41.76 18.95 213 80878 118205 90429151
Facial pain 41.49 18.95 55 81036 13127 90534229
Right ventricular dysfunction 41.35 18.95 26 81065 2338 90545018
Insomnia 41.21 18.95 468 80623 333006 90214350
Central venous catheterisation 39.82 18.95 27 81064 2759 90544597
Cardiac failure high output 39.22 18.95 15 81076 449 90546907
Contusion 39.19 18.95 106 80985 251110 90296246
Nocturnal dyspnoea 38.90 18.95 21 81070 1419 90545937
Right ventricular dilatation 38.31 18.95 22 81069 1677 90545679
Coma 38.22 18.95 9 81082 72623 90474733
Medication error 38.13 18.95 14 81077 84638 90462718
Right-to-left cardiac shunt 38.06 18.95 13 81078 279 90547077
Acute respiratory failure 38.04 18.95 104 80987 42814 90504542
Sinusitis 37.83 18.95 168 80923 342920 90204436
Cardiac operation 37.71 18.95 30 81061 3919 90543437
Catheterisation cardiac abnormal 37.46 18.95 13 81078 293 90547063
Peripheral swelling 37.22 18.95 547 80544 412559 90134797
Endarterectomy 37.05 18.95 12 81079 217 90547139
Anaemia 37.00 18.95 480 80611 352322 90195034
Emergency care 36.97 18.95 21 81070 1568 90545788
Decreased activity 36.92 18.95 41 81050 8151 90539205
Intentional product misuse 36.83 18.95 17 81074 89587 90457769
Blood potassium decreased 36.81 18.95 110 80981 47617 90499739
Hepatitis 36.76 18.95 9 81082 70730 90476626
Paraesthesia 36.56 18.95 109 80982 250217 90297139
Gastric disorder 35.90 18.95 87 81004 33297 90514059
Hot flush 35.84 18.95 126 80965 59362 90487994
Ventilation perfusion mismatch 35.68 18.95 15 81076 577 90546779
Cardiac ablation 35.61 18.95 21 81070 1683 90545673
Drug ineffective for unapproved indication 35.58 18.95 8 81083 66636 90480720
Multiple sclerosis relapse 35.57 18.95 3 81088 52302 90495054
Condition aggravated 35.47 18.95 738 80353 594807 89952549
Knee arthroplasty 35.42 18.95 15 81076 83167 90464189
Therapeutic response decreased 35.40 18.95 18 81073 89711 90457645
Deep vein thrombosis 35.22 18.95 19 81072 91601 90455755
Haemodynamic test abnormal 35.12 18.95 8 81083 33 90547323
Vascular device infection 34.78 18.95 48 81043 11904 90535452
Rhabdomyolysis 34.69 18.95 3 81088 51253 90496103
Hyponatraemia 34.67 18.95 41 81050 133497 90413859
Gout 33.87 18.95 57 81034 16802 90530554
Haemorrhoidal haemorrhage 33.72 18.95 32 81059 5291 90542065
Dysentery 32.69 18.95 17 81074 1065 90546291
Exercise tolerance decreased 32.68 18.95 37 81054 7514 90539842
Iron deficiency anaemia 32.53 18.95 68 81023 23594 90523762
Autoimmune disorder 32.42 18.95 14 81077 76730 90470626
White blood cell count decreased 32.12 18.95 63 81028 167046 90380310
Catheter site infection 32.09 18.95 32 81059 5622 90541734
Liver transplant 32.04 18.95 22 81069 2295 90545061
Liver function test abnormal 31.78 18.95 4 81087 50841 90496515
Influenza like illness 31.27 18.95 149 80942 80462 90466894
Retching 31.08 18.95 59 81032 19100 90528256
Therapy non-responder 30.93 18.95 219 80872 136485 90410871
Seizure 30.69 18.95 56 81035 152573 90394783
Colitis ulcerative 30.67 18.95 8 81083 60258 90487098
Osteoporosis 30.40 18.95 25 81066 96506 90450850
Suicidal ideation 30.37 18.95 14 81077 73841 90473515
Pregnancy 30.16 18.95 9 81082 62038 90485318
Device related infection 29.67 18.95 69 81022 25717 90521639
Localised oedema 29.65 18.95 32 81059 6162 90541194
Cardiac flutter 29.61 18.95 28 81063 4610 90542746
Seasonal allergy 29.24 18.95 64 81027 22919 90524437
Catheter site discharge 28.96 18.95 21 81070 2388 90544968
Cardiac pacemaker insertion 28.89 18.95 27 81064 4380 90542976
Hyperkalaemia 28.83 18.95 11 81080 64953 90482403
Gastrointestinal haemorrhage 28.17 18.95 157 80934 90091 90457265
Immunodeficiency 28.02 18.95 3 81088 43231 90504125
Illness 27.89 18.95 146 80945 81823 90465533
Wrong dose 27.82 18.95 19 81072 1965 90545391
Intracardiac pressure increased 27.75 18.95 7 81084 48 90547308
Pyrexia 27.72 18.95 420 80671 660065 89887291
Migraine 27.60 18.95 276 80815 190116 90357240
Cardiac failure acute 27.60 18.95 43 81048 11886 90535470
Sciatica 27.54 18.95 30 81061 101352 90446004
Accidental exposure to product 27.31 18.95 3 81088 42363 90504993
Agitation 27.16 18.95 13 81078 67085 90480271
Lower limb fracture 26.79 18.95 22 81069 84991 90462365
Pericardial drainage 26.78 18.95 10 81081 280 90547076
Blood pressure systolic decreased 26.63 18.95 37 81054 9233 90538123
Neoplasm progression 26.62 18.95 4 81087 44482 90502874
Tracheostomy 26.59 18.95 13 81078 714 90546642
Bone pain 26.58 18.95 118 80973 61865 90485491
Blood pressure abnormal 26.48 18.95 56 81035 19589 90527767
Hallucination 26.36 18.95 13 81078 65946 90481410
Systolic dysfunction 26.14 18.95 18 81073 1886 90545470
Arthralgia 25.89 18.95 894 80197 777628 89769728
Injection site erythema 25.83 18.95 30 81061 98472 90448884
Concomitant disease progression 25.80 18.95 19 81072 2213 90545143
Blood pressure systolic increased 25.69 18.95 10 81081 58335 90489021
Angioedema 25.61 18.95 13 81078 64863 90482493
Abdominal cavity drainage 25.55 18.95 11 81080 449 90546907
Hepatotoxicity 25.50 18.95 5 81086 45837 90501519
Sluggishness 25.45 18.95 29 81062 5930 90541426
Mouth ulceration 25.34 18.95 3 81088 39971 90507385
Catheter site pruritus 25.28 18.95 19 81072 2283 90545073
No adverse event 24.84 18.95 15 81076 67967 90479389
Blood pressure increased 24.59 18.95 92 80999 197125 90350231
Amnesia 24.42 18.95 37 81054 108468 90438888
Stent placement 24.25 18.95 24 81067 4179 90543177
Depressed level of consciousness 23.99 18.95 18 81073 72766 90474590
Terminal state 23.94 18.95 20 81071 2798 90544558
Road traffic accident 23.93 18.95 37 81054 107589 90439767
Cardiac output increased 23.92 18.95 11 81080 526 90546830
Metabolic acidosis 23.77 18.95 10 81081 55666 90491690
Portal hypertension 23.77 18.95 25 81066 4676 90542680
Plasma cell myeloma 23.69 18.95 4 81087 40824 90506532
Swollen tongue 23.58 18.95 6 81085 45950 90501406
Skin exfoliation 23.43 18.95 16 81075 67897 90479459
Biopsy liver 23.08 18.95 10 81081 415 90546941
N-terminal prohormone brain natriuretic peptide 22.87 18.95 6 81085 49 90547307
Right ventricular systolic pressure increased 22.84 18.95 11 81080 584 90546772
Cardiac monitoring 22.71 18.95 5 81086 17 90547339
Pancytopenia 22.54 18.95 46 81045 120217 90427139
Asthenia 22.51 18.95 631 80460 533120 90014236
CREST syndrome 22.46 18.95 11 81080 606 90546750
Catheter site rash 22.27 18.95 12 81079 808 90546548
Marasmus 22.23 18.95 12 81079 811 90546545
Product administered to patient of inappropriate age 22.21 18.95 24 81067 4629 90542727
Renal impairment 22.19 18.95 166 80925 105255 90442101
Injection site swelling 22.15 18.95 13 81078 59826 90487530
Muscle spasms 22.05 18.95 332 80759 251551 90295805
Pulmonary pain 22.03 18.95 25 81066 5089 90542267
Nasal dryness 21.89 18.95 26 81065 5557 90541799
Blood iron decreased 21.71 18.95 49 81042 17910 90529446
Lactic acidosis 21.65 18.95 9 81082 50454 90496902
Limb discomfort 21.54 18.95 79 81012 37981 90509375
Trismus 21.51 18.95 24 81067 4797 90542559
Scleroderma associated digital ulcer 21.33 18.95 5 81086 24 90547332
Internal haemorrhage 21.21 18.95 27 81064 6193 90541163
Disease recurrence 21.17 18.95 4 81087 37649 90509707
Onychomycosis 20.95 18.95 4 81087 37372 90509984
Dizziness exertional 20.93 18.95 10 81081 522 90546834
Diagnostic procedure 20.91 18.95 7 81084 141 90547215
Gastrointestinal surgery 20.84 18.95 8 81083 242 90547114
Medical procedure 20.68 18.95 10 81081 536 90546820
Right atrial pressure increased 20.68 18.95 7 81084 146 90547210
Pulmonary endarterectomy 20.50 18.95 7 81084 150 90547206
Pulse abnormal 20.45 18.95 19 81072 3060 90544296
Echocardiogram 20.40 18.95 5 81086 30 90547326
Joint stiffness 20.21 18.95 24 81067 78018 90469338
Toothache 19.83 18.95 54 81037 22176 90525180
Dermatitis contact 19.78 18.95 40 81051 13555 90533801
Arthritis 19.61 18.95 80 81011 167235 90380121
Vasodilatation 19.55 18.95 18 81073 2866 90544490
Faeces discoloured 19.23 18.95 52 81039 21268 90526088
Hypocalcaemia 19.09 18.95 7 81084 42361 90504995

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 1218.90 22.63 419 24999 14083 42581834
Headache 1155.96 22.63 1026 24392 238343 42357574
Diarrhoea 478.44 22.63 923 24495 459926 42135991
Dyspnoea 459.82 22.63 887 24531 441734 42154183
Myalgia 431.04 22.63 397 25021 95683 42500234
Fluid retention 426.47 22.63 254 25164 31365 42564552
Hospitalisation 348.48 22.63 315 25103 74015 42521902
Right ventricular failure 336.88 22.63 147 25271 9408 42586509
Pulmonary hypertension 298.71 22.63 182 25236 23387 42572530
Pain in extremity 255.25 22.63 377 25041 150227 42445690
Flushing 245.89 22.63 192 25226 36836 42559081
Dyspnoea exertional 233.76 22.63 212 25206 49936 42545981
Death 187.44 22.63 660 24758 470525 42125392
Oxygen saturation decreased 169.88 22.63 201 25217 64486 42531431
Drug ineffective 146.29 22.63 99 25319 630098 41965819
Therapy change 141.04 22.63 62 25356 4033 42591884
Catheterisation cardiac 128.63 22.63 52 25366 2742 42593175
Nausea 126.04 22.63 518 24900 396281 42199636
Toxicity to various agents 122.55 22.63 3 25415 229133 42366784
Hypervolaemia 118.05 22.63 103 25315 23022 42572895
Arthralgia 116.58 22.63 326 25092 204912 42391005
Abdominal discomfort 106.99 22.63 174 25244 75081 42520836
Oedema 102.27 22.63 140 25278 51861 42544056
Transfusion 98.06 22.63 67 25351 10447 42585470
Drug interaction 96.07 22.63 21 25397 266978 42328939
Peripheral swelling 95.08 22.63 183 25235 90087 42505830
Concomitant disease aggravated 94.14 22.63 55 25363 6531 42589386
Dizziness 90.68 22.63 340 25078 248914 42347003
Acute kidney injury 85.85 22.63 57 25361 367280 42228637
Pulmonary arterial hypertension 85.84 22.63 61 25357 10126 42585791
Oxygen consumption increased 83.75 22.63 33 25385 1626 42594291
Faeces soft 83.64 22.63 46 25372 4866 42591051
Brain natriuretic peptide increased 82.43 22.63 51 25367 6719 42589198
Hypotension 79.64 22.63 334 25084 257297 42338620
Nasal congestion 72.97 22.63 89 25329 29412 42566505
Malaise 72.64 22.63 284 25134 211872 42384045
Pain 68.42 22.63 308 25110 244540 42351377
Thrombocytopenia 68.32 22.63 15 25403 190264 42405653
Cardiac failure 67.80 22.63 177 25241 106679 42489238
Off label use 66.66 22.63 180 25238 638155 41957762
Pulmonary arterial pressure increased 65.25 22.63 27 25391 1511 42594406
Lung transplant 62.89 22.63 30 25388 2356 42593561
Adverse event 62.86 22.63 74 25344 23566 42572351
Feeling abnormal 62.14 22.63 132 25286 69654 42526263
Unevaluable event 53.80 22.63 83 25335 34205 42561712
Oedema peripheral 53.02 22.63 190 25228 135886 42460031
Product use in unapproved indication 52.75 22.63 22 25396 184434 42411483
Pulmonary veno-occlusive disease 48.19 22.63 17 25401 613 42595304
Pancytopenia 47.16 22.63 7 25411 117736 42478181
Syncope 45.93 22.63 147 25271 99259 42496658
Drug abuse 44.92 22.63 5 25413 104766 42491151
Hypoxia 44.63 22.63 116 25302 69670 42526247
Migraine 41.96 22.63 63 25355 25351 42570566
Dialysis 41.33 22.63 43 25375 11943 42583974
Paracentesis 40.64 22.63 14 25404 470 42595447
Abdominal distension 40.61 22.63 114 25304 71621 42524296
Transplant evaluation 39.57 22.63 14 25404 509 42595408
Oxygen therapy 38.64 22.63 18 25400 1340 42594577
Blood pressure decreased 38.37 22.63 98 25320 58234 42537683
Infusion site pain 37.99 22.63 29 25389 5366 42590551
Decreased appetite 37.12 22.63 219 25199 192918 42402999
Catheter management 36.75 22.63 16 25402 1016 42594901
Overdose 36.35 22.63 9 25409 105255 42490662
Therapy non-responder 35.46 22.63 90 25328 53269 42542648
Nasopharyngitis 35.02 22.63 120 25298 83876 42512041
Catheter placement 34.79 22.63 15 25403 930 42594987
Neck pain 34.22 22.63 63 25355 29951 42565966
Fatigue 34.13 22.63 403 25015 435238 42160679
Pulmonary oedema 33.49 22.63 88 25330 53184 42542733
White blood cell count decreased 33.47 22.63 12 25406 110384 42485533
Weight increased 32.45 22.63 139 25279 107844 42488073
Limb discomfort 32.34 22.63 39 25379 12728 42583189
Dyspepsia 32.02 22.63 74 25344 41278 42554639
Intentional product use issue 31.89 22.63 3 25415 71830 42524087
Drug hypersensitivity 31.53 22.63 10 25408 99379 42496538
Abdominal pain upper 30.99 22.63 114 25304 82495 42513422
Confusional state 30.47 22.63 33 25385 167564 42428353
Multiple organ dysfunction syndrome 30.36 22.63 10 25408 97025 42498892
Pericardial effusion 30.34 22.63 59 25359 29216 42566701
Pulmonary arterial wedge pressure increased 29.42 22.63 8 25410 118 42595799
Restless legs syndrome 28.77 22.63 32 25386 9582 42586335
Myocardial infarction 27.86 22.63 20 25398 123989 42471928
Condition aggravated 27.32 22.63 256 25162 260498 42335419
Terminal state 27.31 22.63 22 25396 4401 42591516
Hospice care 26.62 22.63 29 25389 8484 42587433
Walking distance test abnormal 26.30 22.63 8 25410 179 42595738
Dyspnoea at rest 25.95 22.63 21 25397 4228 42591689
Deep vein thrombosis 25.76 22.63 7 25411 76950 42518967
Seizure 25.10 22.63 21 25397 120540 42475377
Pulmonary embolism 24.70 22.63 21 25397 119591 42476326
Hyponatraemia 24.63 22.63 15 25403 101447 42494470
Intentional product misuse 24.05 22.63 4 25414 61896 42534021
Chest discomfort 23.19 22.63 87 25331 63529 42532388
Pulmonary congestion 23.17 22.63 37 25381 15693 42580224
Ventilation perfusion mismatch 22.75 22.63 7 25411 163 42595754

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
Pain in jaw 3957.57 18.69 1524 92068 49653 110446054
Headache 3700.80 18.69 4106 89486 878271 109617436
Diarrhoea 1585.91 18.69 3164 90428 1136341 109359366
Myalgia 1561.24 18.69 1378 92214 221003 110274704
Dyspnoea 1402.23 18.69 2958 90634 1103914 109391793
Fluid retention 1210.60 18.69 836 92756 93471 110402236
Dyspnoea exertional 938.32 18.69 746 92846 103314 110392393
Right ventricular failure 937.91 18.69 452 93140 25502 110470205
Hospitalisation 848.25 18.69 806 92786 141687 110354020
Nausea 811.16 18.69 2583 91009 1233107 109262600
Flushing 755.45 18.69 660 92932 104076 110391631
Pulmonary hypertension 699.86 18.69 486 93106 54734 110440973
Death 635.13 18.69 1645 91947 697224 109798483
Pain in extremity 615.33 18.69 1305 92287 485813 110009894
Drug ineffective 613.51 18.69 262 93330 1520278 108975429
Oxygen saturation decreased 532.32 18.69 660 92932 156322 110339385
Transfusion 467.58 18.69 283 93309 25189 110470518
Therapy change 409.84 18.69 190 93402 9807 110485900
Hypervolaemia 379.29 18.69 323 93269 49137 110446570
Off label use 378.96 18.69 429 93163 1499756 108995951
Oxygen consumption increased 377.77 18.69 152 93440 5533 110490174
Dizziness 375.41 18.69 1369 92223 696824 109798883
Unevaluable event 373.04 18.69 346 93246 58881 110436826
Toxicity to various agents 364.25 18.69 9 93583 480546 110015161
Hypotension 352.63 18.69 1108 92484 522741 109972966
Catheterisation cardiac 338.50 18.69 144 93448 6047 110489660
Infusion related reaction 306.09 18.69 3 93589 381159 110114548
Cardiac failure 292.90 18.69 550 93042 187076 110308631
Pulmonary arterial hypertension 283.63 18.69 229 93363 32339 110463368
Pulmonary arterial pressure increased 279.48 18.69 119 93473 5008 110490699
Neutropenia 272.98 18.69 10 93582 374610 110121097
Nasal congestion 268.85 18.69 372 93220 97910 110397797
Feeling abnormal 262.71 18.69 514 93078 180197 110315510
Drug interaction 258.85 18.69 54 93538 500129 109995578
Product dose omission issue 240.84 18.69 707 92885 321075 110174632
Brain natriuretic peptide increased 238.38 18.69 137 93455 11072 110484635
Concomitant disease aggravated 238.16 18.69 157 93435 16207 110479500
Decreased appetite 221.36 18.69 892 92700 474954 110020753
Drug hypersensitivity 217.19 18.69 58 93534 454032 110041675
Oedema peripheral 216.87 18.69 691 92901 327969 110167738
Syncope 213.75 18.69 506 93086 202030 110293677
Treatment failure 206.91 18.69 6 93586 277228 110218479
Malaise 200.04 18.69 1106 92486 670713 109824994
Contraindicated product administered 194.59 18.69 3 93589 248264 110247443
Product use in unapproved indication 194.38 18.69 68 93524 447309 110048398
Therapeutic product effect decreased 187.20 18.69 4 93588 244312 110251395
Maternal exposure during pregnancy 184.95 18.69 7 93585 254876 110240831
Acute kidney injury 183.36 18.69 161 93431 635269 109860438
Thrombocytopenia 177.67 18.69 39 93553 348846 110146861
Faeces soft 176.50 18.69 113 93479 11097 110484610
Hepatic enzyme increased 173.60 18.69 31 93561 320861 110174846
Stomatitis 167.76 18.69 17 93575 270225 110225482
Pain 164.55 18.69 1373 92219 953582 109542125
Oedema 163.34 18.69 468 93124 209508 110286199
Arthropathy 161.70 18.69 25 93567 287497 110208210
Alopecia 155.74 18.69 57 93535 364696 110131011
Rheumatoid arthritis 155.59 18.69 32 93560 299581 110196126
Glossodynia 154.81 18.69 8 93584 221996 110273711
Palpitations 154.28 18.69 385 93207 158827 110336880
Hypoxia 152.52 18.69 338 93254 129177 110366530
Pulmonary veno-occlusive disease 151.64 18.69 60 93532 2088 110493619
Rash 150.54 18.69 292 93300 820672 109675035
Intentional product use issue 147.80 18.69 18 93574 247888 110247819
Impaired healing 147.71 18.69 4 93588 196713 110298994
Scleroderma 146.98 18.69 82 93510 6259 110489448
Pericarditis 146.40 18.69 10 93582 219104 110276603
Pulmonary oedema 142.16 18.69 283 93309 100376 110395331
Pericardial effusion 140.82 18.69 206 93386 57011 110438696
Blood pressure decreased 137.36 18.69 302 93290 114789 110380918
Blister 136.80 18.69 16 93576 227360 110268347
Chest pain 133.46 18.69 651 92941 375724 110119983
Hypersensitivity 130.79 18.69 91 93501 403907 110091800
Lung transplant 129.78 18.69 71 93521 5215 110490492
Confusional state 128.86 18.69 124 93468 468556 110027151
Malignant neoplasm progression 125.92 18.69 5 93587 174562 110321145
Helicobacter infection 125.41 18.69 7 93585 181870 110313837
Fatigue 123.43 18.69 1569 92023 1214389 109281318
Hypertension 122.50 18.69 151 93441 509933 109985774
Blood cholesterol increased 121.80 18.69 9 93583 184776 110310931
Drug abuse 118.79 18.69 8 93584 177403 110318304
Epistaxis 117.71 18.69 307 93285 130065 110365642
Vomiting 117.30 18.69 1231 92361 909444 109586263
Oxygen therapy 116.62 18.69 61 93531 4092 110491615
Abdominal distension 114.27 18.69 367 93225 174736 110320971
Type 2 diabetes mellitus 113.02 18.69 10 93582 177222 110318485
Walking distance test abnormal 110.20 18.69 36 93556 710 110494997
Urticaria 109.73 18.69 67 93525 318790 110176917
Liver injury 109.54 18.69 4 93588 150409 110345298
Lower respiratory tract infection 108.90 18.69 35 93557 243071 110252636
Therapeutic product effect incomplete 106.12 18.69 29 93563 223776 110271931
Asthma 102.02 18.69 42 93550 250249 110245458
Joint swelling 101.23 18.69 136 93456 442709 110052998
Cough 101.19 18.69 703 92889 460938 110034769
Infusion site pain 100.53 18.69 97 93495 17322 110478385
C-reactive protein increased 100.07 18.69 30 93562 217889 110277818
Arthralgia 99.87 18.69 1053 92539 778579 109717128
Mobility decreased 99.79 18.69 38 93554 237384 110258323
Pneumonia 99.03 18.69 1155 92437 875559 109620148
Intentional overdose 98.34 18.69 3 93589 132498 110363209
Wound 97.74 18.69 38 93554 234399 110261308
Back pain 97.20 18.69 591 93001 370405 110125302
Transplant evaluation 94.77 18.69 41 93551 1794 110493913
N-terminal prohormone brain natriuretic peptide increased 94.63 18.69 61 93531 6060 110489647
Dialysis 94.40 18.69 99 93493 19520 110476187
Chest discomfort 93.81 18.69 342 93250 173506 110322201
Dyspnoea at rest 93.08 18.69 68 93524 8278 110487429
Abdominal discomfort 92.39 18.69 610 92982 393248 110102459
Fibromyalgia 91.33 18.69 17 93575 170892 110324815
Overdose 90.90 18.69 42 93550 233752 110261955
Irritable bowel syndrome 90.66 18.69 15 93577 164200 110331507
Leukopenia 90.66 18.69 10 93582 148781 110346926
Hospice care 90.59 18.69 79 93513 12394 110483313
Peripheral swelling 89.52 18.69 617 92975 403417 110092290
Systemic lupus erythematosus 89.52 18.69 52 93540 254286 110241421
Neutrophil count decreased 88.82 18.69 3 93589 120938 110374769
Rhabdomyolysis 88.37 18.69 3 93589 120398 110375309
Ascites 88.36 18.69 223 93369 92585 110403122
Paracentesis 88.09 18.69 36 93556 1364 110494343
Joint range of motion decreased 86.16 18.69 4 93588 121828 110373879
Injury 85.87 18.69 22 93570 177243 110318464
Bedridden 85.58 18.69 79 93513 13346 110482361
Osteoarthritis 84.10 18.69 25 93567 182598 110313109
Anaphylactic reaction 83.36 18.69 3 93589 114297 110381410
Catheter management 83.04 18.69 47 93545 3688 110492019
Abdominal pain upper 82.64 18.69 542 93050 348569 110147138
Psoriasis 79.06 18.69 12 93580 139981 110355726
Left ventricular failure 78.45 18.69 70 93522 11319 110484388
Neck pain 78.43 18.69 256 93336 122874 110372833
Dizziness postural 78.06 18.69 78 93514 14531 110481176
Obesity 76.20 18.69 5 93587 113346 110382361
Musculoskeletal stiffness 74.58 18.69 76 93516 279746 110215961
Catheter placement 74.41 18.69 42 93550 3278 110492429
General physical health deterioration 72.89 18.69 157 93435 425138 110070569
Head discomfort 72.64 18.69 85 93507 18915 110476792
Coma 71.61 18.69 8 93584 117861 110377846
Insomnia 71.37 18.69 536 93056 360054 110135653
Suicide attempt 71.20 18.69 4 93588 103390 110392317
Cardioversion 70.64 18.69 36 93556 2287 110493420
Hyponatraemia 70.41 18.69 49 93543 217604 110278103
Dyspepsia 68.78 18.69 332 93260 190633 110305074
Catheter site pain 68.46 18.69 51 93541 6395 110489312
Myelosuppression 67.03 18.69 3 93589 94337 110401370
Drug titration error 66.56 18.69 31 93561 1616 110494091
Disease complication 66.17 18.69 48 93544 5779 110489928
Heart rate increased 65.35 18.69 268 93324 143566 110352141
Pruritus 65.27 18.69 262 93330 581298 109914409
Weight decreased 64.94 18.69 643 92949 467414 110028293
Discomfort 64.74 18.69 52 93540 214655 110281052
Electrocardiogram QT prolonged 64.69 18.69 8 93584 108952 110386755
Ill-defined disorder 64.42 18.69 26 93566 156827 110338880
Productive cough 63.45 18.69 227 93365 114078 110381629
Intentional product misuse 63.40 18.69 17 93575 132887 110362820
Right-to-left cardiac shunt 61.75 18.69 19 93573 306 110495401
Pancytopenia 61.67 18.69 52 93540 209561 110286146
Pulmonary congestion 61.50 18.69 101 93491 30865 110464842
Atrial septal defect repair 60.73 18.69 21 93571 496 110495211
Mineral supplementation 60.49 18.69 24 93568 841 110494866
Lip dry 60.28 18.69 7 93585 100076 110395631
Hot flush 59.06 18.69 155 93437 65881 110429826
Cardiac disorder 58.25 18.69 169 93423 76111 110419596
Hypercholesterolaemia 58.24 18.69 5 93587 90832 110404875
Presyncope 57.98 18.69 128 93464 48759 110446948
Drug-induced liver injury 57.96 18.69 15 93577 120052 110375655
Drug ineffective for unapproved indication 57.64 18.69 9 93583 102829 110392878
Flatulence 56.79 18.69 132 93460 52017 110443690
Seizure 56.76 18.69 62 93530 221123 110274584
Delirium 56.07 18.69 22 93570 135003 110360704
Prescribed overdose 55.66 18.69 5 93587 87576 110408131
Inflammation 54.36 18.69 50 93542 193188 110302519
Deep vein thrombosis 53.02 18.69 26 93566 139861 110355846
Grip strength decreased 52.55 18.69 4 93588 80170 110415537
Cardiac operation 51.85 18.69 42 93550 5953 110489754
Limb discomfort 50.76 18.69 109 93483 40745 110454962
Night sweats 50.63 18.69 25 93567 133958 110361749
Right ventricular dilatation 50.28 18.69 29 93563 2358 110493349
Hepatitis 50.21 18.69 8 93584 90046 110405661
Angioedema 50.11 18.69 11 93581 98489 110397218
Lactic acidosis 50.07 18.69 9 93583 92802 110402905
Exposure during pregnancy 49.90 18.69 41 93551 167383 110328324
Systemic scleroderma 49.83 18.69 27 93565 1945 110493762
White blood cell count decreased 49.81 18.69 73 93519 229317 110266390
Product use issue 49.38 18.69 120 93472 311575 110184132
Epilepsy 49.37 18.69 12 93580 100197 110395510
Suicidal ideation 48.79 18.69 10 93582 93927 110401780
Peripheral venous disease 47.98 18.69 7 93585 84110 110411597
Injection site pain 47.76 18.69 48 93544 177874 110317833
Extra dose administered 47.49 18.69 55 93537 12104 110483603
Catheter site erythema 47.48 18.69 40 93552 5988 110489719
Injection site reaction 47.28 18.69 9 93583 89061 110406646
Blood creatine phosphokinase increased 46.91 18.69 4 93588 73073 110422634
Haemoptysis 46.91 18.69 150 93442 71204 110424503
Live birth 46.89 18.69 3 93589 69481 110426226
Wound infection 46.66 18.69 12 93580 96453 110399254
Gastric disorder 46.13 18.69 93 93499 33264 110462443
Cognitive disorder 46.11 18.69 9 93583 87502 110408205
Agitation 45.99 18.69 19 93573 113032 110382675
Cardiac failure high output 45.88 18.69 17 93575 493 110495214
Condition aggravated 45.33 18.69 873 92719 733963 109761744
Metabolic acidosis 45.29 18.69 14 93578 99730 110395977
Therapy non-responder 44.60 18.69 256 93336 157051 110338656
Pulmonary hypertensive crisis 43.95 18.69 16 93576 441 110495266
Loss of consciousness 43.53 18.69 300 93292 196006 110299701
Terminal state 43.40 18.69 37 93555 5630 110490077
Restless legs syndrome 43.19 18.69 76 93516 24550 110471157
Cardiac ablation 42.13 18.69 27 93565 2655 110493052
Pulmonary embolism 42.08 18.69 73 93519 214401 110281306
Hyperkalaemia 42.05 18.69 32 93560 135764 110359943
Pulmonary arterial pressure abnormal 41.84 18.69 19 93573 934 110494773
Ventilation perfusion mismatch 41.79 18.69 18 93574 779 110494928
Bradycardia 41.69 18.69 42 93550 155475 110340232
Migraine 41.47 18.69 268 93324 171384 110324323
Pyrexia 41.15 18.69 525 93067 897740 109597967
Liver function test abnormal 41.08 18.69 5 93587 68945 110426762
Colitis ulcerative 40.67 18.69 8 93584 77355 110418352
Right ventricular enlargement 40.59 18.69 19 93573 1002 110494705
Cardiac failure congestive 40.39 18.69 242 93350 150758 110344949
Skin exfoliation 40.34 18.69 12 93580 87639 110408068
Neoplasm progression 40.22 18.69 4 93588 64591 110431116
Renal disorder 40.09 18.69 112 93480 49367 110446340
Nocturnal dyspnoea 40.09 18.69 23 93569 1852 110493855
Influenza 39.63 18.69 262 93330 168839 110326868
Haemoglobin decreased 39.59 18.69 352 93240 248375 110247332
Abdominal cavity drainage 39.48 18.69 18 93574 893 110494814
Depressed level of consciousness 39.42 18.69 23 93569 112255 110383452
Metapneumovirus infection 39.37 18.69 25 93567 2419 110493288
Pleural effusion 39.05 18.69 271 93321 177438 110318269
Iron deficiency anaemia 38.98 18.69 84 93508 31475 110464232
Influenza like illness 38.78 18.69 163 93429 88249 110407458
Multiple organ dysfunction syndrome 38.39 18.69 43 93549 151667 110344040
Depression 38.11 18.69 139 93453 317196 110178511
Medication error 37.83 18.69 21 93571 105345 110390362
Bone marrow failure 37.59 18.69 3 93589 57845 110437862
Encephalopathy 37.48 18.69 11 93581 81044 110414663
Catheterisation cardiac abnormal 37.40 18.69 13 93579 312 110495395
Rehabilitation therapy 37.06 18.69 23 93569 2138 110493569
Muscle spasms 37.01 18.69 379 93213 277778 110217929
Hepatotoxicity 36.80 18.69 5 93587 63395 110432312
Atrial septal defect 36.64 18.69 23 93569 2182 110493525
Myocardial infarction 36.22 18.69 67 93525 192016 110303691
Catheter site pruritus 35.69 18.69 23 93569 2283 110493424
Device related infection 35.58 18.69 93 93499 39426 110456281
Wheezing 35.33 18.69 105 93487 255125 110240582
Hallucination 35.30 18.69 21 93571 101411 110394296
Pulmonary arterial wedge pressure increased 35.23 18.69 15 93577 631 110495076
Bone pain 34.99 18.69 128 93464 65005 110430702
Blood potassium decreased 34.88 18.69 113 93479 54001 110441706
Right ventricular dysfunction 34.64 18.69 26 93566 3297 110492410
Blood pressure increased 34.55 18.69 108 93484 258265 110237442
Swollen tongue 34.48 18.69 5 93587 60357 110435350
Plasma cell myeloma 34.17 18.69 6 93586 62930 110432777
Gout 33.89 18.69 87 93505 36479 110459228
Hypocalcaemia 33.86 18.69 7 93585 65359 110430348
Oxygen saturation abnormal 33.81 18.69 32 93560 5579 110490128
Acute respiratory failure 33.20 18.69 139 93453 75121 110420586
Liver transplant 33.19 18.69 29 93563 4560 110491147
Facial pain 33.15 18.69 52 93540 15287 110480420
Haemodynamic test abnormal 32.80 18.69 8 93584 50 110495657
Cardiac output increased 32.70 18.69 14 93578 597 110495110
Eosinophilia 32.63 18.69 5 93587 57931 110437776
Acute myocardial infarction 32.62 18.69 15 93577 83762 110411945
Dizziness exertional 32.60 18.69 15 93577 760 110494947
Disease recurrence 32.56 18.69 6 93586 60778 110434929
Cardiac pacemaker insertion 32.49 18.69 33 93559 6268 110489439
Infection 32.42 18.69 177 93415 362023 110133684
Altered state of consciousness 32.39 18.69 5 93587 57621 110438086
Right atrial pressure increased 32.39 18.69 12 93580 348 110495359
Cytomegalovirus infection 32.31 18.69 4 93588 54440 110441267
Tubulointerstitial nephritis 32.19 18.69 4 93588 54280 110441427
Stent placement 32.15 18.69 35 93557 7199 110488508
Multiple sclerosis relapse 31.57 18.69 3 93589 50237 110445470
Localised oedema 31.55 18.69 39 93553 9184 110486523
Central venous catheterisation 31.31 18.69 26 93566 3816 110491891
Catheter site rash 31.29 18.69 16 93576 1024 110494683
Hypoaesthesia 31.27 18.69 148 93444 314075 110181632
Endarterectomy 31.13 18.69 12 93580 389 110495318
Seasonal allergy 30.94 18.69 58 93534 19664 110476043
Pneumonitis 30.91 18.69 13 93579 76518 110419189
Hyperglycaemia 30.49 18.69 17 93575 85073 110410634
Anaphylactic shock 30.08 18.69 4 93588 51542 110444165
Disease progression 29.87 18.69 327 93265 243707 110252000
Cardiothoracic ratio increased 29.76 18.69 8 93584 77 110495630
Haemorrhoid operation 29.51 18.69 12 93580 449 110495258
Injection site erythema 29.40 18.69 22 93570 94154 110401553
Hepatocellular injury 29.38 18.69 4 93588 50638 110445069
Cerebrovascular accident 29.32 18.69 69 93523 181215 110314492
Pericardial drainage 29.08 18.69 12 93580 466 110495241
Emergency care 28.88 18.69 17 93575 1436 110494271
Biopsy liver 28.61 18.69 13 93579 640 110495067
Wrong dose 28.23 18.69 21 93571 2628 110493079
Pancreatitis acute 28.20 18.69 8 93584 60266 110435441
Pulmonary fibrosis 27.99 18.69 27 93565 102015 110393692
Septic shock 27.92 18.69 57 93535 157471 110338236
Vasodilatation 27.77 18.69 24 93568 3720 110491987
Coronary artery disease 27.66 18.69 13 93579 71677 110424030
Catheter site infection 27.64 18.69 34 93558 7966 110487741
Exercise tolerance decreased 27.61 18.69 42 93550 12025 110483682
Retching 27.58 18.69 60 93532 22622 110473085
Mouth ulceration 27.46 18.69 4 93588 48134 110447573
Internal haemorrhage 27.33 18.69 38 93554 10033 110485674
Blood iron decreased 27.08 18.69 54 93538 19160 110476547
Blood pressure abnormal 26.91 18.69 59 93533 22365 110473342
Transaminases increased 26.86 18.69 10 93582 63380 110432327
Hemiparesis 26.61 18.69 3 93589 43900 110451807
Diuretic therapy 26.54 18.69 9 93583 200 110495507
Stevens-Johnson syndrome 26.52 18.69 4 93588 46897 110448810
Concomitant disease progression 26.49 18.69 23 93569 3587 110492120
Blood pressure systolic increased 26.41 18.69 19 93573 82972 110412735
Toothache 26.02 18.69 60 93532 23515 110472192
Haemorrhoidal haemorrhage 25.74 18.69 33 93559 8060 110487647
Pneumocystis jirovecii pneumonia 25.70 18.69 3 93589 42732 110452975
CREST syndrome 25.65 18.69 11 93581 471 110495236
Bendopnoea 25.63 18.69 7 93585 72 110495635
Blood pressure systolic decreased 25.56 18.69 43 93549 13398 110482309
Nasopharyngitis 25.44 18.69 472 93120 393889 110101818
Pulmonary artery dilatation 25.37 18.69 12 93580 648 110495059
Psychotic disorder 25.28 18.69 6 93586 50931 110444776
Infusion site erythema 25.10 18.69 40 93552 11919 110483788
Atrial flutter 24.88 18.69 60 93532 24202 110471505
Therapeutic response decreased 24.80 18.69 27 93565 96472 110399235
Hypomagnesaemia 24.79 18.69 10 93582 60360 110435347
Rhinorrhoea 24.61 18.69 160 93432 102506 110393201
Upper respiratory tract inflammation 24.58 18.69 24 93568 4347 110491360
Blood lactate dehydrogenase increased 24.57 18.69 4 93588 44330 110451377
Dysarthria 24.57 18.69 21 93571 84100 110411607
Dysentery 24.55 18.69 15 93577 1356 110494351
Alanine aminotransferase increased 24.43 18.69 77 93515 183696 110312011
Lymphocyte count decreased 24.30 18.69 9 93583 57234 110438473
Electrocardiogram ambulatory 24.30 18.69 4 93588 0 110495707
Portal hypertension 24.06 18.69 33 93559 8604 110487103
Jaundice 24.02 18.69 10 93582 59226 110436481
Skin lesion 23.88 18.69 7 93585 51624 110444083
Aspiration pleural cavity 23.67 18.69 16 93576 1721 110493986
Autoimmune disorder 23.58 18.69 13 93579 65470 110430237
Infusion site swelling 23.48 18.69 35 93557 9842 110485865
Basal cell carcinoma 23.14 18.69 5 93587 45265 110450442
Tracheostomy 23.07 18.69 15 93577 1512 110494195
Emotional distress 22.83 18.69 5 93587 44842 110450865
Osteoporosis 22.83 18.69 24 93568 87128 110408579
Colitis 22.76 18.69 32 93560 102291 110393416
Haematuria 22.72 18.69 22 93570 82983 110412724
Nasal dryness 22.60 18.69 26 93566 5680 110490027
Neuropathy peripheral 22.53 18.69 77 93515 179200 110316507
Catheter site warmth 22.46 18.69 9 93583 324 110495383
Aggression 22.44 18.69 11 93581 59199 110436508
Hypoglycaemia 22.33 18.69 40 93552 116064 110379643
Drug withdrawal syndrome 22.09 18.69 3 93589 38051 110457656
Contusion 22.01 18.69 112 93480 233249 110262458
Gait inability 21.98 18.69 52 93540 136324 110359383
Drug eruption 21.85 18.69 9 93583 53650 110442057
N-terminal prohormone brain natriuretic peptide 21.85 18.69 6 93586 63 110495644
Knee arthroplasty 21.83 18.69 14 93578 64934 110430773
Prostate cancer 21.77 18.69 3 93589 37638 110458069
Respiratory failure 21.69 18.69 278 93314 215054 110280653
Marasmus 21.68 18.69 15 93577 1676 110494031
Inappropriate schedule of product administration 21.39 18.69 94 93498 203543 110292164
Cardiac monitoring 21.28 18.69 5 93587 26 110495681
Poor quality sleep 21.23 18.69 62 93530 28015 110467692
Injection site swelling 21.21 18.69 13 93579 61777 110433930
Faeces discoloured 21.08 18.69 70 93522 33878 110461829
Feeling cold 21.03 18.69 70 93522 33917 110461790
No adverse event 20.88 18.69 19 93573 73820 110421887
Acute hepatic failure 20.87 18.69 3 93589 36465 110459242
Aphasia 20.83 18.69 12 93580 58985 110436722
Cardiac flutter 20.76 18.69 25 93567 5732 110489975
Pulmonary pain 20.55 18.69 26 93566 6267 110489440
Polypectomy 20.47 18.69 14 93578 1535 110494172
Hyperlipidaemia 20.40 18.69 3 93589 35845 110459862
Leukocytosis 20.40 18.69 10 93582 53818 110441889
Respiratory arrest 20.38 18.69 12 93580 58287 110437420
Cataract operation 20.32 18.69 25 93567 5858 110489849
Drug intolerance 20.30 18.69 233 93359 406279 110089428
Feeding tube user 20.30 18.69 7 93585 164 110495543
Product prescribing error 20.28 18.69 9 93583 51322 110444385
Hepatic failure 20.27 18.69 17 93575 68722 110426985
Illness 20.27 18.69 129 93463 82042 110413665
Onychomycosis 20.22 18.69 4 93588 38527 110457180
Diet noncompliance 20.22 18.69 10 93582 596 110495111
Hereditary haemorrhagic telangiectasia 20.21 18.69 6 93586 85 110495622
Pregnancy 20.10 18.69 9 93583 51058 110444649
Intracardiac pressure increased 20.01 18.69 5 93587 35 110495672
Cardiac failure acute 19.99 18.69 55 93537 24023 110471684
Eczema 19.97 18.69 19 93573 72274 110423433
Right ventricular systolic pressure increased 19.93 18.69 12 93580 1057 110494650
Catheter site discharge 19.90 18.69 18 93574 2961 110492746
Sluggishness 19.71 18.69 28 93564 7539 110488168
Scleroderma associated digital ulcer 19.65 18.69 5 93587 38 110495669
Diagnostic procedure 19.61 18.69 7 93585 182 110495525
Catheter site irritation 19.55 18.69 10 93582 640 110495067
Decreased activity 19.41 18.69 34 93558 10940 110484767
Hyperhidrosis 19.35 18.69 87 93505 187211 110308496
Brain natriuretic peptide abnormal 19.04 18.69 11 93581 897 110494810
Dry skin 19.03 18.69 39 93553 107614 110388093
Hallucination, visual 19.01 18.69 5 93587 39600 110456107
Diplopia 18.80 18.69 6 93586 41888 110453819
Amnesia 18.79 18.69 38 93554 105370 110390337
Rash erythematous 18.79 18.69 25 93567 81807 110413900

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 agent
CHEBI has role CHEBI:35674 antihypertensive agent
CHEBI has role CHEBI:50249 anticoagulant
CHEBI has role CHEBI:50266 prodrug
CHEBI has role CHEBI:50427 platelet aggregation inhibitor
CHEBI has role CHEBI:71031 orphan drug
CHEBI has role CHEBI:90845 prostacyclin receptor agonist
CHEBI has role CHEBI:49103 drug metabolite

Related Drugs by ATC class:

B01AC Platelet aggregation inhibitors excl. heparin 24 drugs
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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
0.15MG UPTRAVI ACTELION N207947 May 23, 2026 RX TABLET ORAL 7205302 Oct. 31, 2026 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A PHARMACEUTICAL COMPOSITION COMPRISING SELEXIPAG
0.1MG UPTRAVI ACTELION N207947 May 23, 2026 RX TABLET ORAL 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 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
0.15MG UPTRAVI ACTELION N207947 May 23, 2026 RX TABLET ORAL 9173881 Aug. 12, 2029 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING SELEXIPAG IN COMBINATION WITH THE ENDOTHELIN RECEPTOR ANTAGONIST MACITENTAN
0.1MG UPTRAVI ACTELION N207947 May 23, 2026 RX TABLET ORAL 9173881 Aug. 12, 2029 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING SELEXIPAG IN COMBINATION WITH THE ENDOTHELIN RECEPTOR ANTAGONIST MACITENTAN
0.2MG 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
0.15MG UPTRAVI ACTELION N207947 May 23, 2026 RX TABLET ORAL 9284280 June 25, 2030 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A CRYSTALLINE FORM OF SELEXIPAG
0.1MG UPTRAVI ACTELION N207947 May 23, 2026 RX TABLET ORAL 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 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
0.15MG UPTRAVI ACTELION N207947 May 23, 2026 RX TABLET ORAL 10821108 Dec. 1, 2036 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A SOLID PREPARATION CONTAINING SELEXIPAG
0.15MG UPTRAVI ACTELION N207947 May 23, 2026 RX TABLET ORAL 10828298 Dec. 1, 2036 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A TABLET CONTAINING SELEXIPAG
0.1MG UPTRAVI ACTELION N207947 May 23, 2026 RX TABLET ORAL 10821108 Dec. 1, 2036 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A SOLID PREPARATION CONTAINING SELEXIPAG
0.1MG UPTRAVI ACTELION N207947 May 23, 2026 RX TABLET ORAL 10828298 Dec. 1, 2036 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION COMPRISING ADMINISTERING A TABLET CONTAINING 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)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
0.15MG UPTRAVI ACTELION N207947 May 23, 2026 RX TABLET ORAL May 23, 2029 NEW STRENGTH
0.1MG UPTRAVI ACTELION N207947 May 23, 2026 RX TABLET ORAL May 23, 2029 NEW STRENGTH
0.2MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL May 23, 2029 NEW PATIENT POPULATION
0.4MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL May 23, 2029 NEW PATIENT POPULATION
0.6MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL May 23, 2029 NEW PATIENT POPULATION
0.8MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL May 23, 2029 NEW PATIENT POPULATION
1.2MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL May 23, 2029 NEW PATIENT POPULATION
1.4MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL May 23, 2029 NEW PATIENT POPULATION
1.6MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL May 23, 2029 NEW PATIENT POPULATION
1MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL May 23, 2029 NEW PATIENT POPULATION
0.15MG UPTRAVI ACTELION N207947 May 23, 2026 RX TABLET ORAL Nov. 23, 2029 PEDIATRIC EXCLUSIVITY
0.1MG UPTRAVI ACTELION N207947 May 23, 2026 RX TABLET ORAL Nov. 23, 2029 PEDIATRIC EXCLUSIVITY
0.2MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL Nov. 23, 2029 PEDIATRIC EXCLUSIVITY
0.4MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL Nov. 23, 2029 PEDIATRIC EXCLUSIVITY
0.6MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL Nov. 23, 2029 PEDIATRIC EXCLUSIVITY
0.8MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL Nov. 23, 2029 PEDIATRIC EXCLUSIVITY
1.2MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL Nov. 23, 2029 PEDIATRIC EXCLUSIVITY
1.4MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL Nov. 23, 2029 PEDIATRIC EXCLUSIVITY
1.6MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL Nov. 23, 2029 PEDIATRIC EXCLUSIVITY
1MG UPTRAVI ACTELION N207947 Dec. 21, 2015 RX TABLET ORAL Nov. 23, 2029 PEDIATRIC EXCLUSIVITY

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
CHEMBL238804 ChEMBL_ID
C523468 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
CHEMBL239226 ChEMBL_ID
9231 INN_ID
475085-57-5 SECONDARY_CAS_RN
9913767 PUBCHEM_CID
9931891 PUBCHEM_CID
5852 IUPHAR_LIGAND_ID
5EXC0E384L UNII
C531934 MESH_SUPPLEMENTAL_RECORD_UI
CHEBI:90848 CHEBI
5EXC0E384L INXIGHT DRUGS

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 66215-604 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 66215-608 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 66215-612 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 66215-616 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 66215-910 TABLET, FILM COATED 100 ug ORAL NDA 32 sections
UPTRAVI HUMAN PRESCRIPTION DRUG LABEL 1 66215-915 TABLET, FILM COATED 150 ug ORAL NDA 32 sections
Selexipag HUMAN PRESCRIPTION DRUG LABEL 1 70710-1551 TABLET, FILM COATED 200 ug ORAL ANDA 25 sections
Selexipag HUMAN PRESCRIPTION DRUG LABEL 1 70710-1552 TABLET, FILM COATED 400 ug ORAL ANDA 25 sections
Selexipag HUMAN PRESCRIPTION DRUG LABEL 1 70710-1553 TABLET, FILM COATED 600 ug ORAL ANDA 25 sections
Selexipag HUMAN PRESCRIPTION DRUG LABEL 1 70710-1554 TABLET, FILM COATED 800 ug ORAL ANDA 25 sections
Selexipag HUMAN PRESCRIPTION DRUG LABEL 1 70710-1555 TABLET, FILM COATED 1000 ug ORAL ANDA 25 sections
Selexipag HUMAN PRESCRIPTION DRUG LABEL 1 70710-1556 TABLET, FILM COATED 1200 ug ORAL ANDA 25 sections
Selexipag HUMAN PRESCRIPTION DRUG LABEL 1 70710-1557 TABLET, FILM COATED 1400 ug ORAL ANDA 25 sections
Selexipag HUMAN PRESCRIPTION DRUG LABEL 1 70710-1558 TABLET, FILM COATED 1600 ug ORAL ANDA 25 sections
Selexipag HUMAN PRESCRIPTION DRUG LABEL 1 70771-1793 TABLET, FILM COATED 200 ug ORAL ANDA 25 sections
Selexipag HUMAN PRESCRIPTION DRUG LABEL 1 70771-1794 TABLET, FILM COATED 400 ug ORAL ANDA 25 sections
Selexipag HUMAN PRESCRIPTION DRUG LABEL 1 70771-1795 TABLET, FILM COATED 600 ug ORAL ANDA 25 sections
Selexipag HUMAN PRESCRIPTION DRUG LABEL 1 70771-1796 TABLET, FILM COATED 800 ug ORAL ANDA 25 sections
Selexipag HUMAN PRESCRIPTION DRUG LABEL 1 70771-1797 TABLET, FILM COATED 1000 ug ORAL ANDA 25 sections
Selexipag HUMAN PRESCRIPTION DRUG LABEL 1 70771-1798 TABLET, FILM COATED 1200 ug ORAL ANDA 25 sections
Selexipag HUMAN PRESCRIPTION DRUG LABEL 1 70771-1799 TABLET, FILM COATED 1400 ug ORAL ANDA 25 sections
Selexipag HUMAN PRESCRIPTION DRUG LABEL 1 70771-1800 TABLET, FILM COATED 1600 ug ORAL ANDA 25 sections