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

Stem definitionDrug idCAS RN
guanylate cyclase activators and stimulators 4807 625115-55-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • adempas
  • BAY 63-2521
  • riociguat
guanylate cyclase stimulator
  • Molecular weight: 422.42
  • Formula: C20H19FN8O2
  • CLOGP: 2.06
  • LIPINSKI: 0
  • HAC: 10
  • HDO: 2
  • TPSA: 138.07
  • ALOGS: -3.79
  • ROTB: 5
  • Status: ONP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
4.50 mg O

ADMET properties:

PropertyValueReference
Vd (Volume of distribution) 0.44 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 0.74 mL/min/kg Lombardo F, Berellini G, Obach RS
t_half (Half-life) 9.10 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Oct. 8, 2013 FDA BAYER HLTHCARE

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
Hospitalisation 1862.03 20.69 1090 57549 66847 50479638
Dyspnoea 1088.55 20.69 2118 56521 545490 50000995
Death 1057.48 20.69 1569 57070 323810 50222675
Fluid retention 1038.05 20.69 676 57963 49973 50496512
Dyspnoea exertional 861.42 20.69 605 58034 50628 50495857
Hypotension 810.17 20.69 1168 57471 234301 50312184
Pain in jaw 627.57 20.69 446 58193 37982 50508503
Headache 627.10 20.69 1626 57013 504909 50041576
Pulmonary arterial hypertension 619.12 20.69 350 58289 19969 50526516
Drug ineffective 597.66 20.69 115 58524 819218 49727267
Dizziness 508.98 20.69 1189 57450 345180 50201305
Oedema peripheral 473.83 20.69 736 57903 157225 50389260
Dyspepsia 390.77 20.69 455 58184 73642 50472843
Oxygen saturation decreased 371.66 20.69 441 58198 72807 50473678
Hypervolaemia 305.31 20.69 246 58393 25253 50521232
Pulmonary hypertension 303.30 20.69 275 58364 33142 50513343
Oedema 295.72 20.69 385 58254 69796 50476689
Right ventricular failure 279.12 20.69 193 58446 15700 50530785
Blood pressure decreased 277.54 20.69 333 58306 55576 50490909
Transfusion 258.40 20.69 170 58469 12735 50533750
Nasal congestion 246.41 20.69 300 58339 50820 50495665
Diarrhoea 239.31 20.69 1323 57316 587153 49959332
Nausea 221.67 20.69 1483 57156 703915 49842570
Toxicity to various agents 218.44 20.69 6 58633 212493 50333992
Off label use 203.70 20.69 152 58487 474274 50072211
Catheterisation cardiac 186.74 20.69 92 58547 3948 50542537
Chest pain 186.13 20.69 537 58102 176345 50370140
Infusion related reaction 181.25 20.69 3 58636 169554 50376931
Drug hypersensitivity 180.20 20.69 36 58603 250974 50295511
Pulmonary arterial pressure increased 178.24 20.69 84 58555 3264 50543221
Epistaxis 174.73 20.69 286 58353 63668 50482817
Rheumatoid arthritis 173.48 20.69 17 58622 202533 50343952
Infusion site pain 169.11 20.69 129 58510 12217 50534268
Drug interaction 167.74 20.69 18 58621 199603 50346882
Maternal exposure during pregnancy 166.09 20.69 4 58635 159774 50386711
Peripheral swelling 163.26 20.69 567 58072 205369 50341116
Palpitations 162.04 20.69 346 58293 94160 50452325
Cough 160.04 20.69 627 58012 240637 50305848
Oxygen therapy 156.83 20.69 64 58575 1748 50544737
Neutropenia 156.56 20.69 3 58636 147962 50398523
Abdominal distension 156.25 20.69 293 58346 72610 50473875
Dizziness postural 155.73 20.69 94 58545 6051 50540434
Catheter site erythema 150.42 20.69 79 58560 3883 50542602
Pulmonary endarterectomy 148.39 20.69 34 58605 104 50546381
Rash 147.82 20.69 174 58465 437297 50109188
Contraindicated product administered 146.69 20.69 6 58633 148952 50397533
Catheter management 143.60 20.69 68 58571 2671 50543814
Therapy change 143.03 20.69 84 58555 5141 50541344
Syncope 140.99 20.69 345 58294 102657 50443828
Alopecia 139.12 20.69 55 58584 244992 50301493
Arthropathy 138.53 20.69 12 58627 157894 50388591
Lung transplant 129.58 20.69 64 58575 2761 50543724
Catheter site pruritus 128.25 20.69 57 58582 1930 50544555
Flushing 122.56 20.69 252 58387 66763 50479722
Gastrooesophageal reflux disease 122.06 20.69 272 58367 76156 50470329
Exposure during pregnancy 118.71 20.69 5 58634 121010 50425475
Unevaluable event 115.11 20.69 198 58441 45868 50500617
Oxygen consumption increased 110.57 20.69 62 58577 3474 50543011
Catheter site pain 109.65 20.69 63 58576 3699 50542786
Haemoptysis 107.12 20.69 140 58499 25433 50521052
Hepatic enzyme increased 104.34 20.69 17 58622 137363 50409122
Transplant evaluation 104.07 20.69 41 58598 1019 50545466
Blood pressure systolic decreased 101.46 20.69 70 58569 5669 50540816
Hypoxia 93.17 20.69 192 58447 50931 50495554
Product dose omission issue 91.90 20.69 439 58200 183399 50363086
Blood pressure diastolic decreased 89.89 20.69 104 58535 16677 50529808
Malaise 89.67 20.69 680 57959 334852 50211633
Hypersensitivity 89.41 20.69 71 58568 215090 50331395
Presyncope 88.47 20.69 124 58515 24074 50522411
Emergency care 88.03 20.69 34 58605 800 50545685
Endarterectomy 86.68 20.69 23 58616 147 50546338
Vomiting 86.25 20.69 863 57776 459895 50086590
Vascular device infection 85.91 20.69 57 58582 4327 50542158
Feeling abnormal 83.69 20.69 327 58312 125165 50421320
Central venous catheterisation 82.37 20.69 43 58596 2087 50544398
Catheter site haemorrhage 81.74 20.69 47 58592 2763 50543722
Dyspnoea at rest 80.26 20.69 51 58588 3596 50542889
Catheter site discharge 78.84 20.69 40 58599 1828 50544657
Catheter site swelling 78.63 20.69 36 58603 1308 50545177
Musculoskeletal stiffness 77.64 20.69 26 58613 128455 50418030
Heart rate increased 74.85 20.69 228 58411 77022 50469463
Pericarditis 74.74 20.69 4 58635 78685 50467800
Thrombocytopenia 73.46 20.69 28 58611 127645 50418840
Productive cough 72.56 20.69 177 58462 52517 50493968
Therapeutic product effect incomplete 72.51 20.69 10 58629 91505 50454980
Wound 72.10 20.69 17 58622 105777 50440708
Device related infection 71.00 20.69 103 58536 20632 50525853
Systemic lupus erythematosus 69.76 20.69 38 58601 140584 50405901
Blood pressure abnormal 68.27 20.69 79 58560 12668 50533817
Overdose 68.01 20.69 16 58623 99711 50446774
Acute kidney injury 66.35 20.69 101 58538 227957 50318528
Product use in unapproved indication 65.63 20.69 26 58613 115793 50430692
Ascites 64.52 20.69 134 58505 35727 50510758
Walking distance test abnormal 64.24 20.69 24 58615 514 50545971
Psoriasis 64.02 20.69 4 58635 68996 50477489
Rehabilitation therapy 63.97 20.69 31 58608 1282 50545203
Decreased appetite 63.91 20.69 425 58214 200498 50345987
Pericardial effusion 62.61 20.69 109 58530 25480 50521005
Pulmonary thrombosis 62.44 20.69 59 58580 7482 50539003
Device alarm issue 62.34 20.69 31 58608 1357 50545128
Medical procedure 61.86 20.69 20 58619 273 50546212
Hypertension 60.03 20.69 95 58544 211108 50335377
Catheter site rash 59.69 20.69 25 58614 730 50545755
Pneumonia 59.59 20.69 685 57954 377716 50168769
Impaired healing 59.31 20.69 6 58633 69780 50476705
Angioplasty 59.25 20.69 29 58610 1226 50545259
Drug intolerance 57.26 20.69 104 58535 219000 50327485
Infusion site erythema 56.97 20.69 60 58579 8667 50537818
Abdominal pain upper 54.94 20.69 344 58295 158965 50387520
White blood cell count decreased 54.39 20.69 34 58605 116688 50429797
Pruritus 52.97 20.69 161 58478 283407 50263078
Urticaria 52.22 20.69 44 58595 129517 50416968
Hyponatraemia 52.18 20.69 23 58616 96116 50450369
Blood cholesterol increased 51.83 20.69 3 58636 55212 50491273
Lower respiratory tract infection 51.32 20.69 23 58616 95178 50451307
Chest discomfort 51.11 20.69 228 58411 92494 50453991
Infusion site infection 50.62 20.69 28 58611 1527 50544958
Anaphylactic reaction 50.55 20.69 3 58636 54052 50492433
Catheter site infection 50.52 20.69 41 58598 4245 50542240
Localised oedema 50.00 20.69 43 58596 4824 50541661
Diastolic hypotension 49.84 20.69 13 58626 77 50546408
Pulmonary oedema 49.80 20.69 147 58492 48791 50497694
Blood potassium decreased 49.68 20.69 123 58516 36822 50509663
Cardiac failure 48.92 20.69 196 58443 75844 50470641
Mineral supplementation 48.17 20.69 21 58618 678 50545807
Confusional state 47.90 20.69 89 58550 185839 50360646
Pancytopenia 47.38 20.69 19 58620 84011 50462474
Internal haemorrhage 47.37 20.69 40 58599 4377 50542108
Blister 47.05 20.69 20 58619 85398 50461087
Osteoarthritis 46.78 20.69 11 58628 68595 50477890
C-reactive protein increased 46.65 20.69 10 58629 66464 50480021
Lung disorder 46.00 20.69 135 58504 44664 50501821
Constipation 45.93 20.69 370 58269 185338 50361147
Depressed level of consciousness 45.38 20.69 4 58635 51949 50494536
Suicidal ideation 43.99 20.69 6 58633 55379 50491106
Discomfort 43.44 20.69 37 58602 108343 50438142
Brain natriuretic peptide increased 42.50 20.69 38 58601 4489 50541996
Seizure 41.70 20.69 45 58594 117829 50428656
Dialysis 41.60 20.69 53 58586 9385 50537100
Catheter placement 41.32 20.69 27 58612 1997 50544488
Device leakage 41.22 20.69 42 58597 5836 50540649
Cardiac failure congestive 40.99 20.69 200 58439 84182 50462303
Infusion site discharge 40.53 20.69 18 58621 608 50545877
Product supply issue 40.16 20.69 22 58617 1177 50545308
Depression 40.16 20.69 82 58557 165341 50381144
Blood pressure increased 39.61 20.69 58 58581 133074 50413411
Catheter site related reaction 39.41 20.69 19 58620 777 50545708
Coma 39.02 20.69 9 58630 56870 50489615
Device occlusion 38.59 20.69 41 58598 5982 50540503
Retching 38.48 20.69 60 58579 12802 50533683
Pain in extremity 38.07 20.69 483 58156 272382 50274103
Helicobacter infection 38.05 20.69 6 58633 49696 50496789
Disease complication 37.94 20.69 29 58610 2753 50543732
Drug titration error 37.77 20.69 17 58622 593 50545892
Rales 37.76 20.69 52 58587 9926 50536559
Device infusion issue 37.47 20.69 22 58617 1345 50545140
Flatulence 37.44 20.69 96 58543 29362 50517123
Product use issue 37.22 20.69 73 58566 149402 50397083
Liver function test abnormal 37.19 20.69 4 58635 44335 50502150
Infection 36.88 20.69 92 58547 172862 50373623
Paracentesis 36.88 20.69 19 58620 897 50545588
Catheter site irritation 36.87 20.69 16 58623 511 50545974
Scleroderma 36.80 20.69 36 58603 4765 50541720
Pulmonary artery therapeutic procedure 36.38 20.69 8 58631 19 50546466
Injection site erythema 36.06 20.69 21 58618 74915 50471570
Deep vein thrombosis 36.05 20.69 20 58619 73284 50473201
Dizziness exertional 35.61 20.69 14 58625 346 50546139
Fatigue 35.03 20.69 1069 57570 706532 49839953
Weight increased 34.65 20.69 372 58267 201519 50344966
Dermatitis contact 34.14 20.69 46 58593 8600 50537885
Seasonal allergy 33.94 20.69 61 58578 14615 50531870
Haemoglobin decreased 33.93 20.69 258 58381 126958 50419527
Product availability issue 33.49 20.69 24 58615 2064 50544421
Therapeutic response decreased 33.35 20.69 7 58632 47224 50499261
Alanine aminotransferase increased 33.21 20.69 32 58607 88327 50458158
Myalgia 32.52 20.69 251 58388 124068 50422417
Device dislocation 32.48 20.69 75 58564 21471 50525014
Mobility decreased 32.39 20.69 27 58612 79921 50466564
Gout 32.24 20.69 52 58587 11418 50535067
Abortion spontaneous 32.07 20.69 5 58634 41767 50504718
Incorrect product administration duration 31.64 20.69 46 58593 9229 50537256
Cerebrovascular accident 31.47 20.69 38 58601 94642 50451843
Lung operation 31.37 20.69 11 58628 195 50546290
Hospice care 31.29 20.69 36 58603 5736 50540749
Bradycardia 31.08 20.69 18 58621 64408 50482077
Catheter site vesicles 30.73 20.69 12 58627 291 50546194
Joint swelling 30.72 20.69 163 58476 245123 50301362
Injection site pain 30.51 20.69 51 58588 110973 50435512
Acute respiratory failure 29.79 20.69 87 58552 28695 50517790
Arthralgia 29.46 20.69 346 58293 438356 50108129
Pulmonary pain 29.11 20.69 23 58616 2292 50544193
Paraesthesia 28.84 20.69 60 58579 120183 50426302
Product prescribing issue 28.73 20.69 18 58621 1238 50545247
Asthma 28.49 20.69 37 58602 89300 50457185
Pain 28.48 20.69 486 58153 578417 49968068
Asthenia 28.33 20.69 523 58116 318519 50227966
Nasal dryness 27.73 20.69 27 58612 3552 50542933
Hypoaesthesia 27.66 20.69 67 58572 127190 50419295
Myocardial infarction 27.25 20.69 38 58601 88989 50457496
Osteoporosis 27.23 20.69 9 58630 44870 50501615
Pyrexia 27.03 20.69 296 58343 379907 50166578
Irritable bowel syndrome 26.83 20.69 13 58626 51428 50495057
Wrong dose 26.56 20.69 15 58624 852 50545633
Infusion site swelling 26.56 20.69 37 58602 7139 50539346
Infusion site induration 26.46 20.69 15 58624 858 50545627
Weight decreased 26.45 20.69 381 58258 220864 50325621
Renal disorder 26.44 20.69 81 58558 27424 50519061
Critical illness 26.35 20.69 9 58630 147 50546338
Hepatitis 25.96 20.69 3 58636 31450 50515035
Choking 25.92 20.69 40 58599 8458 50538027
Exercise tolerance decreased 25.75 20.69 30 58609 4844 50541641
Gastric disorder 25.65 20.69 84 58555 29464 50517021
Generalised oedema 25.50 20.69 52 58587 13679 50532806
Cardiac pacemaker insertion 25.43 20.69 26 58613 3627 50542858
Cardiac operation 25.33 20.69 23 58616 2772 50543713
Biopsy liver 24.76 20.69 11 58628 372 50546113
Concomitant disease aggravated 24.56 20.69 38 58601 8053 50538432
Complication associated with device 24.32 20.69 53 58586 14602 50531883
Dry eye 24.28 20.69 4 58635 32091 50514394
Head injury 24.28 20.69 72 58567 23948 50522537
Coronary artery disease 24.13 20.69 3 58636 29723 50516762
Hallucination 24.02 20.69 12 58627 46645 50499840
Hyperkalaemia 23.82 20.69 13 58626 48076 50498409
Device connection issue 23.52 20.69 12 58627 555 50545930
Metabolic acidosis 23.19 20.69 8 58631 38817 50507668
Aspartate aminotransferase increased 23.17 20.69 34 58605 77964 50468521
Injury 23.13 20.69 14 58625 48911 50497574
General physical health deterioration 23.04 20.69 86 58553 142348 50404137
Blood iron decreased 22.78 20.69 45 58594 11570 50534915
Cardiac failure acute 22.64 20.69 37 58602 8213 50538272
Right ventricular dilatation 22.62 20.69 14 58625 942 50545543
Sinus congestion 22.58 20.69 50 58589 13921 50532564
Delirium 22.58 20.69 8 58631 38184 50508301
Medication error 22.33 20.69 7 58632 36097 50510388
Blood glucose increased 22.27 20.69 30 58609 71294 50475191
Vascular device occlusion 22.27 20.69 6 58633 41 50546444
Infusion site haemorrhage 22.05 20.69 22 58617 2982 50543503
Diabetes mellitus 21.86 20.69 15 58624 49018 50497467
Hypoglycaemia 21.82 20.69 18 58621 53563 50492922
Agitation 21.66 20.69 18 58621 53366 50493119
Extra dose administered 21.58 20.69 28 58611 5048 50541437
Drug therapy 21.42 20.69 5 58634 17 50546468
Catheter site extravasation 21.36 20.69 9 58630 267 50546218
Catheter site inflammation 21.35 20.69 12 58627 675 50545810
Sinus disorder 21.26 20.69 58 58581 18400 50528085
Loss of consciousness 21.11 20.69 199 58440 104154 50442331
Pulmonary artery occlusion 20.99 20.69 5 58634 19 50546466
Ear discomfort 20.93 20.69 32 58607 6712 50539773
Clostridium difficile infection 20.91 20.69 71 58568 25368 50521117

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
Hospitalisation 663.17 25.89 391 18032 45597 29510507
Death 597.83 25.89 883 17540 341201 29214903
Fluid retention 438.32 25.89 237 18186 23323 29532781
Dyspnoea 368.74 25.89 695 17728 326037 29230067
Dyspnoea exertional 273.92 25.89 207 18216 36283 29519821
Pulmonary arterial hypertension 240.00 25.89 109 18314 7340 29548764
Hypotension 232.29 25.89 425 17998 193929 29362175
Pain in jaw 227.17 25.89 121 18302 11520 29544584
Headache 200.77 25.89 375 18048 173632 29382472
Pulmonary hypertension 188.98 25.89 127 18296 18481 29537623
Right ventricular failure 185.58 25.89 93 18330 7797 29548307
Oedema 172.57 25.89 166 18257 40317 29515787
Peripheral swelling 165.40 25.89 201 18222 63538 29492566
Dizziness 161.96 25.89 361 18062 189323 29366781
Oedema peripheral 156.85 25.89 252 18171 103305 29452799
Oxygen saturation decreased 145.64 25.89 159 18264 44778 29511326
Pulmonary endarterectomy 142.70 25.89 27 18396 54 29556050
Hypervolaemia 139.22 25.89 103 18320 17442 29538662
Dyspepsia 127.32 25.89 123 18300 30002 29526102
Nasal congestion 111.25 25.89 93 18330 18786 29537318
Drug ineffective 104.68 25.89 48 18375 363122 29192982
Drug interaction 83.37 25.89 12 18411 197373 29358731
Transfusion 69.73 25.89 48 18375 7250 29548854
Catheter management 64.44 25.89 23 18400 821 29555283
Abdominal distension 64.28 25.89 108 18315 45803 29510301
Swelling 61.83 25.89 92 18331 35191 29520913
Infusion site pain 61.55 25.89 32 18391 2893 29553211
Haemoptysis 59.87 25.89 84 18339 30466 29525638
Off label use 59.50 25.89 60 18363 300740 29255364
Weight increased 57.48 25.89 139 18284 76528 29479576
Syncope 57.28 25.89 144 18279 81227 29474877
Endarterectomy 56.33 25.89 14 18409 135 29555969
Nausea 56.13 25.89 339 18084 288916 29267188
Blood pressure decreased 55.87 25.89 101 18322 45376 29510728
Oxygen consumption increased 55.01 25.89 23 18400 1264 29554840
Oxygen therapy 52.69 25.89 19 18404 699 29555405
Pulmonary arterial pressure increased 51.83 25.89 21 18402 1065 29555039
Pain in extremity 50.17 25.89 167 18256 110266 29445838
Infusion site erythema 49.34 25.89 23 18400 1641 29554463
Thrombocytopenia 48.78 25.89 12 18411 134811 29421293
Abdominal discomfort 47.31 25.89 97 18326 47806 29508298
Gastrooesophageal reflux disease 46.63 25.89 76 18347 31420 29524684
Catheterisation cardiac 46.58 25.89 24 18399 2129 29553975
Epistaxis 45.63 25.89 100 18323 51604 29504500
Blood pressure abnormal 45.35 25.89 36 18387 6754 29549350
Lung transplant 45.14 25.89 22 18401 1734 29554370
Cough 45.12 25.89 177 18246 126550 29429554
Blood pressure systolic decreased 43.26 25.89 28 18395 3816 29552288
Gastrointestinal disorder 40.78 25.89 68 18355 28638 29527466
Diarrhoea 39.11 25.89 346 18077 332352 29223752
Drug abuse 38.40 25.89 3 18420 79880 29476224
Dizziness postural 37.01 25.89 29 18394 5338 29550766
Transplant evaluation 36.21 25.89 13 18410 472 29555632
Thrombectomy 36.10 25.89 9 18414 88 29556016
Blood pressure diastolic decreased 36.08 25.89 32 18391 6990 29549114
Overdose 35.70 25.89 4 18419 79815 29476289
Dyspnoea at rest 35.16 25.89 23 18400 3191 29552913
Acute kidney injury 34.51 25.89 71 18352 265196 29290908
Catheter site pain 34.24 25.89 16 18407 1148 29554956
Seizure 34.23 25.89 8 18415 93115 29462989
Pulmonary thrombosis 33.89 25.89 30 18393 6535 29549569
Unevaluable event 33.75 25.89 64 18359 29787 29526317
Surgery 33.52 25.89 39 18384 11740 29544364
Lung disorder 32.99 25.89 64 18359 30298 29525806
Flushing 32.59 25.89 62 18361 28930 29527174
Malaise 31.41 25.89 188 18235 159414 29396690
Terminal state 31.08 25.89 22 18401 3472 29552632
Dialysis 31.07 25.89 35 18388 10173 29545931
Angioplasty 31.02 25.89 14 18409 927 29555177
Product use in unapproved indication 30.88 25.89 8 18415 86867 29469237
Feeling abnormal 30.86 25.89 89 18334 54356 29501748
Pyrexia 29.55 25.89 87 18336 287535 29268569
Therapy change 29.42 25.89 19 18404 2579 29553525
Cardiac operation 29.17 25.89 19 18404 2617 29553487
Lung operation 28.21 25.89 7 18416 67 29556037
Productive cough 27.04 25.89 60 18363 31199 29524905
Ascites 26.98 25.89 66 18357 36553 29519551
Drug hypersensitivity 26.94 25.89 5 18418 68401 29487703
Chest pain 26.73 25.89 139 18284 111834 29444270
Concomitant disease aggravated 26.20 25.89 23 18400 4955 29551149
Rehabilitation therapy 25.89 25.89 11 18412 629 29555475

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
Hospitalisation 2222.60 20.86 1241 69069 73966 64354456
Death 1487.80 20.86 2196 68114 480509 63947913
Fluid retention 1320.35 20.86 817 69493 58789 64369633
Dyspnoea 1267.91 20.86 2552 67758 716122 63712300
Dyspnoea exertional 964.03 20.86 730 69580 73000 64355422
Headache 803.16 20.86 1772 68538 527695 63900727
Hypotension 763.30 20.86 1432 68878 379542 64048880
Pulmonary arterial hypertension 740.49 20.86 416 69894 24951 64403471
Pain in jaw 722.51 20.86 486 69824 40269 64388153
Dizziness 607.58 20.86 1401 68909 428762 63999660
Oedema peripheral 566.00 20.86 902 69408 209415 64219007
Drug ineffective 502.42 20.86 148 70162 840099 63588323
Dyspepsia 453.00 20.86 496 69814 79816 64348606
Pulmonary hypertension 434.82 20.86 367 69943 42772 64385650
Oxygen saturation decreased 421.78 20.86 551 69759 106625 64321797
Oedema 417.96 20.86 508 69802 91427 64336995
Right ventricular failure 406.78 20.86 267 70043 21204 64407218
Hypervolaemia 400.92 20.86 333 69977 37952 64390470
Toxicity to various agents 366.21 20.86 6 70304 363507 64064915
Peripheral swelling 308.07 20.86 694 69616 208459 64219963
Transfusion 300.64 20.86 207 70103 17787 64410635
Drug interaction 293.58 20.86 28 70282 362055 64066367
Nasal congestion 284.64 20.86 338 69972 59320 64369102
Nausea 268.57 20.86 1613 68697 784187 63644235
Off label use 268.51 20.86 181 70129 632625 63795797
Blood pressure decreased 266.82 20.86 395 69915 85804 64342618
Pulmonary endarterectomy 251.18 20.86 56 70254 158 64428264
Diarrhoea 246.38 20.86 1483 68827 721221 63707201
Neutropenia 236.90 20.86 5 70305 239619 64188803
Catheterisation cardiac 210.72 20.86 104 70206 4769 64423653
Abdominal distension 202.44 20.86 370 69940 95624 64332798
Pulmonary arterial pressure increased 190.44 20.86 92 70218 4024 64424398
Infusion site pain 188.90 20.86 126 70184 10271 64418151
Chest pain 187.15 20.86 624 69686 235356 64193066
Epistaxis 186.74 20.86 362 69948 97769 64330653
Cough 178.30 20.86 726 69584 301422 64127000
Oxygen therapy 169.14 20.86 71 70239 2222 64426200
Catheter management 167.44 20.86 79 70231 3276 64425146
Dizziness postural 164.80 20.86 113 70197 9639 64418783
Syncope 163.41 20.86 458 69852 157177 64271245
Palpitations 158.34 20.86 351 69959 104137 64324285
Unevaluable event 157.04 20.86 232 70078 50257 64378165
Product dose omission issue 151.68 20.86 512 69798 194235 64234187
Drug hypersensitivity 146.71 20.86 39 70271 237776 64190646
Catheter site erythema 145.41 20.86 81 70229 4768 64423654
Acute kidney injury 144.88 20.86 166 70144 449074 63979348
Gastrooesophageal reflux disease 144.08 20.86 295 70015 82848 64345574
Lung transplant 140.89 20.86 75 70235 4033 64424389
Thrombocytopenia 137.49 20.86 37 70273 223764 64204658
Oxygen consumption increased 133.23 20.86 75 70235 4506 64423916
Catheter site pruritus 130.52 20.86 58 70252 2090 64426332
Therapy change 129.15 20.86 83 70227 6351 64422071
Flushing 128.02 20.86 272 70038 78376 64350046
Rheumatoid arthritis 127.09 20.86 15 70295 164279 64264143
Drug abuse 126.10 20.86 4 70306 132370 64296052
Overdose 124.85 20.86 14 70296 159552 64268870
Catheter site pain 124.23 20.86 71 70239 4391 64424031
Feeling abnormal 121.91 20.86 371 69939 133231 64295191
Blood pressure abnormal 117.76 20.86 109 70201 14326 64414096
Haemoptysis 117.47 20.86 200 70110 48848 64379574
Malaise 116.18 20.86 784 69526 395463 64032959
Transplant evaluation 114.14 20.86 48 70262 1509 64426913
Blood pressure diastolic decreased 114.03 20.86 131 70179 22170 64406252
Endarterectomy 112.28 20.86 32 70278 295 64428127
Blood pressure systolic decreased 112.09 20.86 86 70224 8734 64419688
Rash 108.35 20.86 210 70100 458339 63970083
Product use in unapproved indication 105.10 20.86 31 70279 176587 64251835
Emergency care 104.49 20.86 39 70271 888 64427534
Stomatitis 101.99 20.86 4 70306 109601 64318821
Contraindicated product administered 96.85 20.86 5 70305 107824 64320598
Fatigue 95.23 20.86 1238 69072 747492 63680930
Pancytopenia 93.21 20.86 21 70289 143288 64285134
Vomiting 92.62 20.86 962 69348 550155 63878267
Hepatic enzyme increased 90.87 20.86 16 70294 129927 64298495
Weight increased 90.13 20.86 465 69845 212883 64215539
Infusion site erythema 89.50 20.86 68 70242 6805 64421617
Arthropathy 88.85 20.86 13 70297 120954 64307468
Catheter site discharge 88.56 20.86 45 70265 2196 64426226
Maternal exposure during pregnancy 87.54 20.86 4 70306 95880 64332542
Medical procedure 85.27 20.86 25 70285 257 64428165
Heart rate increased 82.58 20.86 266 70044 98409 64330013
Productive cough 82.03 20.86 219 70091 72984 64355438
Rehabilitation therapy 80.10 20.86 37 70273 1461 64426961
Central venous catheterisation 80.04 20.86 45 70265 2696 64425726
Hyponatraemia 79.62 20.86 31 70279 148308 64280114
Pulmonary thrombosis 79.24 20.86 76 70234 10442 64417980
Presyncope 78.68 20.86 139 70171 34950 64393472
Abdominal pain upper 78.47 20.86 388 69922 174642 64253780
Vascular device infection 77.96 20.86 60 70250 6120 64422302
Walking distance test abnormal 76.55 20.86 29 70281 689 64427733
Pain in extremity 76.10 20.86 578 69732 302507 64125915
Blood potassium decreased 75.51 20.86 148 70162 40251 64388171
Catheter site haemorrhage 74.75 20.86 52 70258 4539 64423883
Abdominal discomfort 74.64 20.86 394 69916 181928 64246494
Dyspnoea at rest 74.54 20.86 59 70251 6270 64422152
Confusional state 74.18 20.86 106 70204 261038 64167384
Electrocardiogram QT prolonged 73.57 20.86 3 70307 79445 64348977
Hypoxia 73.19 20.86 237 70073 87912 64340510
Hypertension 72.89 20.86 106 70204 259155 64169267
Angioplasty 70.00 20.86 35 70275 1650 64426772
Therapeutic product effect incomplete 69.66 20.86 14 70296 103468 64324954
White blood cell count decreased 69.55 20.86 43 70267 157794 64270628
Ascites 68.97 20.86 185 70125 61816 64366606
Seizure 68.78 20.86 49 70261 166843 64261579
Catheter site swelling 68.14 20.86 34 70276 1596 64426826
Lung disorder 67.40 20.86 181 70129 60519 64367903
Pyrexia 66.17 20.86 349 69961 558295 63870127
C-reactive protein increased 65.67 20.86 12 70298 94897 64333525
Exposure during pregnancy 65.57 20.86 5 70305 77670 64350752
Suicide attempt 64.69 20.86 3 70307 71004 64357418
Constipation 64.20 20.86 449 69861 228888 64199534
Device alarm issue 63.39 20.86 34 70276 1856 64426566
Device related infection 63.16 20.86 117 70193 30509 64397913
Dialysis 60.31 20.86 83 70227 16837 64411585
Bradycardia 59.74 20.86 27 70283 118192 64310230
Myocardial infarction 59.25 20.86 56 70254 165765 64262657
Coma 58.67 20.86 12 70298 87603 64340819
Urticaria 58.44 20.86 45 70265 147272 64281150
Diastolic hypotension 58.26 20.86 16 70294 127 64428295
Glossodynia 58.09 20.86 3 70307 64693 64363729
Alopecia 57.99 20.86 57 70253 165633 64262789
Musculoskeletal stiffness 57.93 20.86 31 70279 123175 64305247
Hyperkalaemia 57.89 20.86 19 70291 101110 64327312
Depressed level of consciousness 56.98 20.86 10 70300 81426 64346996
Psoriasis 56.80 20.86 6 70304 71697 64356725
Pericarditis 55.81 20.86 3 70307 62513 64365909
Hypersensitivity 55.51 20.86 80 70230 196372 64232050
Catheter site rash 55.36 20.86 25 70285 936 64427486
Paracentesis 54.82 20.86 27 70283 1232 64427190
Lactic acidosis 54.66 20.86 3 70307 61407 64367015
Suicidal ideation 54.20 20.86 5 70305 66537 64361885
Lung operation 52.64 20.86 16 70294 188 64428234
Chest discomfort 52.44 20.86 258 70052 115848 64312574
Alanine aminotransferase increased 52.00 20.86 45 70265 138986 64289436
Delirium 51.82 20.86 7 70303 69187 64359235
Deep vein thrombosis 51.64 20.86 25 70285 105157 64323265
Brain natriuretic peptide increased 51.62 20.86 52 70258 7581 64420841
Metabolic acidosis 51.23 20.86 8 70302 70950 64357472
Pulmonary artery therapeutic procedure 51.04 20.86 11 70299 25 64428397
Localised oedema 50.50 20.86 50 70260 7141 64421281
Mineral supplementation 50.24 20.86 22 70288 765 64427657
Flatulence 49.72 20.86 116 70194 35550 64392872
Internal haemorrhage 49.61 20.86 51 70259 7616 64420806
Infusion site infection 49.04 20.86 27 70283 1553 64426869
Pericardial effusion 48.66 20.86 122 70188 39132 64389290
Catheter placement 48.49 20.86 32 70278 2561 64425861
Decreased appetite 48.47 20.86 494 69816 280795 64147627
Catheter site infection 48.40 20.86 44 70266 5649 64422773
Pruritus 47.26 20.86 178 70132 312222 64116200
Pneumonia 46.89 20.86 863 69447 558713 63869709
Infusion site discharge 46.87 20.86 19 70291 543 64427879
Cardiac failure congestive 46.60 20.86 272 70038 130308 64298114
Blood pressure increased 46.10 20.86 73 70237 172479 64255943
Incorrect product administration duration 46.02 20.86 55 70255 9703 64418719
Acute myocardial infarction 45.75 20.86 10 70300 69708 64358714
Cardiac arrest 44.24 20.86 62 70248 154002 64274420
Product supply issue 44.00 20.86 24 70286 1355 64427067
Agitation 43.38 20.86 21 70289 88346 64340076
Concomitant disease aggravated 43.23 20.86 58 70252 11484 64416938
Coronary artery disease 43.21 20.86 7 70303 60426 64367996
Blood cholesterol increased 42.89 20.86 3 70307 50063 64378359
Renal disorder 42.88 20.86 109 70201 35256 64393166
Myalgia 42.86 20.86 308 70002 158309 64270113
Lower respiratory tract infection 42.75 20.86 25 70285 94589 64333833
Hospice care 42.75 20.86 47 70263 7578 64420844
Cognitive disorder 42.64 20.86 5 70305 55082 64373340
Catheter site related reaction 42.44 20.86 21 70289 968 64427454
Multiple allergies 41.90 20.86 41 70269 5773 64422649
Gastric disorder 41.84 20.86 96 70214 29101 64399321
Product availability issue 41.73 20.86 27 70283 2089 64426333
Device dislocation 41.30 20.86 79 70231 21099 64407323
Terminal state 41.06 20.86 36 70274 4408 64424014
Cerebrovascular accident 40.88 20.86 54 70256 137529 64290893
Cardiac operation 40.67 20.86 35 70275 4179 64424243
Device occlusion 40.52 20.86 52 70258 9861 64418561
Scleroderma 40.49 20.86 37 70273 4781 64423641
General physical health deterioration 40.46 20.86 103 70207 204322 64224100
Drug titration error 40.45 20.86 20 70290 920 64427502
Thrombectomy 40.42 20.86 14 70296 255 64428167
Cardio-respiratory arrest 40.37 20.86 29 70281 98364 64330058
Rales 40.34 20.86 65 70245 15164 64413258
Hypoglycaemia 40.27 20.86 24 70286 89868 64338554
Infusion site swelling 40.24 20.86 39 70271 5426 64422996
Liver function test abnormal 40.05 20.86 8 70302 59393 64369029
Hyperglycaemia 39.49 20.86 9 70301 60959 64367463
Gout 39.47 20.86 78 70232 21335 64407087
Impaired healing 39.02 20.86 9 70301 60464 64367958
Multiple organ dysfunction syndrome 38.92 20.86 32 70278 101381 64327041
Retching 38.90 20.86 64 70246 15192 64413230
Device infusion issue 38.58 20.86 24 70286 1734 64426688
Interstitial lung disease 38.56 20.86 30 70280 97702 64330720
Angioedema 38.34 20.86 10 70300 61811 64366611
Swelling 38.15 20.86 302 70008 159916 64268506
Nasopharyngitis 37.98 20.86 353 69957 195720 64232702
Catheter site vesicles 37.83 20.86 14 70296 311 64428111
Aspartate aminotransferase increased 37.69 20.86 45 70265 119743 64308679
Cholestasis 37.56 20.86 3 70307 44869 64383553
Exercise tolerance decreased 37.25 20.86 44 70266 7666 64420756
Catheter site irritation 36.93 20.86 16 70294 542 64427880
Seasonal allergy 36.60 20.86 54 70256 11672 64416750
Device leakage 36.39 20.86 45 70265 8221 64420201
Hallucination 36.18 20.86 17 70293 72771 64355651
Jaundice 36.11 20.86 5 70305 48507 64379915
Dizziness exertional 35.98 20.86 15 70295 461 64427961
Hepatitis 35.63 20.86 4 70306 45578 64382844
Nasal dryness 35.49 20.86 30 70280 3496 64424926
Sickle cell anaemia with crisis 35.47 20.86 36 70274 5296 64423126
Hepatocellular injury 35.28 20.86 4 70306 45231 64383191
Diuretic therapy 34.56 20.86 11 70299 152 64428270
Disease complication 34.45 20.86 32 70278 4223 64424199
Lymphocyte count decreased 33.30 20.86 3 70307 40696 64387726
Therapeutic response decreased 33.21 20.86 8 70302 52180 64376242
Mobility decreased 33.05 20.86 27 70283 85813 64342609
Pulmonary oedema 32.82 20.86 171 70139 78503 64349919
Infusion site haemorrhage 32.58 20.86 24 70286 2291 64426131
Drug intolerance 31.84 20.86 102 70208 187890 64240532
Loss of consciousness 31.74 20.86 273 70037 148092 64280330
Sinus disorder 31.66 20.86 62 70248 16846 64411576
Head injury 31.60 20.86 93 70217 32749 64395673
Product prescribing issue 31.39 20.86 23 70287 2178 64426244
Cerebral infarction 31.10 20.86 4 70306 41040 64387382
Blood iron decreased 31.04 20.86 51 70259 12091 64416331
Diabetes mellitus 30.84 20.86 17 70293 66457 64361965
Agranulocytosis 30.79 20.86 3 70307 38226 64390196
Cardiac failure 30.68 20.86 248 70062 132125 64296297
Pulmonary pain 30.24 20.86 24 70286 2560 64425862
Infusion site irritation 29.77 20.86 13 70297 449 64427973
Abnormal weight gain 29.04 20.86 22 70288 2191 64426231
Drug-induced liver injury 28.99 20.86 8 70302 47635 64380787
Emotional distress 28.58 20.86 3 70307 36035 64392387
Hypokalaemia 28.54 20.86 56 70254 121847 64306575
Weight decreased 28.30 20.86 453 69857 285286 64143136
Blister 28.14 20.86 28 70282 80939 64347483
Transaminases increased 28.06 20.86 7 70303 44587 64383835
Infusion site abscess 27.86 20.86 10 70300 203 64428219
Medication error 27.53 20.86 10 70300 49956 64378466
Encephalopathy 27.35 20.86 15 70295 58804 64369618
Device connection issue 27.22 20.86 15 70295 864 64427558
Osteoarthritis 26.86 20.86 18 70292 63318 64365104
Infection 26.86 20.86 107 70203 184773 64243649
Depression 26.67 20.86 106 70204 183185 64245237
Complication associated with device 26.67 20.86 54 70256 15026 64413396
Choking 26.58 20.86 44 70266 10494 64417928
Type 2 diabetes mellitus 26.55 20.86 3 70307 34017 64394405
Pulmonary arterial wedge pressure increased 26.51 20.86 12 70298 452 64427970
Sickle cell anaemia 26.48 20.86 13 70297 589 64427833
Surgery 26.30 20.86 79 70231 28134 64400288
Drug eruption 26.25 20.86 4 70306 36132 64392290
Asthenia 26.25 20.86 631 69679 427413 64001009
Acute respiratory failure 26.23 20.86 116 70194 49818 64378604
Haematuria 25.90 20.86 17 70293 60454 64367968
Cardiac disorder 25.87 20.86 125 70185 55691 64372731
Blood glucose increased 25.70 20.86 42 70268 98031 64330391
Product prescribing error 25.40 20.86 4 70306 35265 64393157
Gastrointestinal disorder 25.26 20.86 176 70134 89533 64338889
Atrial septal defect 25.23 20.86 18 70292 1635 64426787
Platelet count decreased 25.04 20.86 96 70214 167615 64260807
Right ventricular dilatation 25.02 20.86 17 70293 1428 64426994
Injury 25 20.86 15 70295 55977 64372445
Mouth ulceration 24.97 20.86 3 70307 32441 64395981
Wrong dose 24.88 20.86 16 70294 1225 64427197
Disseminated intravascular coagulation 24.88 20.86 3 70307 32345 64396077
Wound 24.84 20.86 28 70282 76449 64351973
Cardiac pacemaker insertion 24.82 20.86 29 70281 4994 64423428
Gamma-glutamyltransferase increased 24.62 20.86 11 70299 48499 64379923
Helicobacter infection 24.18 20.86 6 70304 38356 64390066
Abdominal cavity drainage 24.09 20.86 13 70297 718 64427704
Sickle cell disease 24.06 20.86 8 70302 128 64428294
Asthma 23.83 20.86 42 70268 95183 64333239
Influenza 23.82 20.86 198 70112 106333 64322089
Dysarthria 23.73 20.86 18 70292 59388 64369034
Intestinal obstruction 23.56 20.86 90 70220 36196 64392226
Hepatic steatosis 23.54 20.86 3 70307 31004 64397418
Vascular resistance pulmonary decreased 23.29 20.86 7 70303 79 64428343
Traumatic fracture 22.82 20.86 13 70297 799 64427623
Psychotic disorder 22.60 20.86 5 70305 34573 64393849
Respiratory arrest 22.55 20.86 15 70295 52970 64375452
Infusion site induration 22.51 20.86 13 70297 820 64427602
Sinus congestion 22.38 20.86 51 70259 15388 64413034
Pneumonia aspiration 22.37 20.86 19 70291 59252 64369170
Vascular device occlusion 22.26 20.86 6 70304 44 64428378
Osteoporosis 22.22 20.86 9 70301 42071 64386351
Ear discomfort 21.97 20.86 33 70277 7247 64421175
Infusion site warmth 21.94 20.86 14 70296 1058 64427364
Hypercalcaemia 21.66 20.86 4 70306 31412 64397010
Epilepsy 21.61 20.86 5 70305 33526 64394896
Hypomagnesaemia 21.42 20.86 7 70303 37369 64391053
Nocturnal dyspnoea 21.38 20.86 15 70295 1327 64427095
Blood alkaline phosphatase increased 21.29 20.86 18 70292 56261 64372161
Product use issue 21.28 20.86 89 70221 151626 64276796
Ejection fraction decreased 21.27 20.86 3 70307 28704 64399718
Intra-abdominal fluid collection 21.16 20.86 20 70290 2697 64425725
No adverse event 21.12 20.86 3 70307 28558 64399864
Septic shock 20.94 20.86 53 70257 105384 64323038
Erythema 20.88 20.86 119 70191 186951 64241471

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C02KX05 CARDIOVASCULAR SYSTEM
ANTIHYPERTENSIVES
OTHER ANTIHYPERTENSIVES
Antihypertensives for pulmonary arterial hypertension
MeSH PA D020536 Enzyme Activators
FDA MoA N0000190484 Guanylate Cyclase Stimulators
FDA EPC N0000190485 Soluble Guanylate Cyclase Stimulator
CHEBI has role CHEBI:35674 antihypertensive drugs
CHEBI has role CHEBI:76022 soluble guanylyl cyclase activators

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

DiseaseRelationSNOMED_IDDOID
Pulmonary arterial hypertension indication 11399002
Chronic thromboembolic pulmonary hypertension indication 233947005
Pregnancy, function contraindication 289908002




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 3.68 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
0.5MG ADEMPAS BAYER HLTHCARE N204819 Oct. 8, 2013 RX TABLET ORAL 10662188 Feb. 18, 2034 TREATMENT OF ADULTS WITH PERSISTENT/RECURRENT CHRONIC THROMBOEMBOLIC PULMONARY HYPERTENSION (CTEPH), (WHO GROUP 4) AFTER SURGICAL TREATMENT, OR INOPERABLE CTEPH, TO IMPROVE EXERCISE CAPACITY AND WHO FUNCTIONAL CLASS
0.5MG ADEMPAS BAYER HLTHCARE N204819 Oct. 8, 2013 RX TABLET ORAL 10662188 Feb. 18, 2034 TREATMENT OF ADULTS WITH PULMONARY HYPERTENSION (PAH), (WHO GROUP 1), TO IMPROVE EXERCISE CAPACITY, WHO FUNCTIONAL CLASS AND TO DELAY CLINICAL WORSENING
0.5MG ADEMPAS BAYER HLTHCARE N204819 Oct. 8, 2013 RX TABLET ORAL 11203593 Feb. 18, 2034 TREATMENT OF ADULTS WITH PERSISTENT/RECURRENT CHRONIC THROMBOEMBOLIC PULMONARY HYPERTENSION (CTEPH), (WHO GROUP 4) AFTER SURGICAL TREATMENT, OR INOPERABLE CTEPH, TO IMPROVE EXERCISE CAPACITY AND WHO FUNCTIONAL CLASS
0.5MG ADEMPAS BAYER HLTHCARE N204819 Oct. 8, 2013 RX TABLET ORAL 11203593 Feb. 18, 2034 TREATMENT OF ADULTS WITH PULMONARY HYPERTENSION (PAH), (WHO GROUP 1), TO IMPROVE EXERCISE CAPACITY, WHO FUNCTIONAL CLASS AND TO DELAY CLINICAL WORSENING
1.5MG ADEMPAS BAYER HLTHCARE N204819 Oct. 8, 2013 RX TABLET ORAL 10662188 Feb. 18, 2034 TREATMENT OF ADULTS WITH PERSISTENT/RECURRENT CHRONIC THROMBOEMBOLIC PULMONARY HYPERTENSION (CTEPH), (WHO GROUP 4) AFTER SURGICAL TREATMENT, OR INOPERABLE CTEPH, TO IMPROVE EXERCISE CAPACITY AND WHO FUNCTIONAL CLASS
1.5MG ADEMPAS BAYER HLTHCARE N204819 Oct. 8, 2013 RX TABLET ORAL 10662188 Feb. 18, 2034 TREATMENT OF ADULTS WITH PULMONARY HYPERTENSION (PAH), (WHO GROUP 1), TO IMPROVE EXERCISE CAPACITY, WHO FUNCTIONAL CLASS AND TO DELAY CLINICAL WORSENING
1.5MG ADEMPAS BAYER HLTHCARE N204819 Oct. 8, 2013 RX TABLET ORAL 11203593 Feb. 18, 2034 TREATMENT OF ADULTS WITH PERSISTENT/RECURRENT CHRONIC THROMBOEMBOLIC PULMONARY HYPERTENSION (CTEPH), (WHO GROUP 4) AFTER SURGICAL TREATMENT, OR INOPERABLE CTEPH, TO IMPROVE EXERCISE CAPACITY AND WHO FUNCTIONAL CLASS
1.5MG ADEMPAS BAYER HLTHCARE N204819 Oct. 8, 2013 RX TABLET ORAL 11203593 Feb. 18, 2034 TREATMENT OF ADULTS WITH PULMONARY HYPERTENSION (PAH), (WHO GROUP 1), TO IMPROVE EXERCISE CAPACITY, WHO FUNCTIONAL CLASS AND TO DELAY CLINICAL WORSENING
1MG ADEMPAS BAYER HLTHCARE N204819 Oct. 8, 2013 RX TABLET ORAL 10662188 Feb. 18, 2034 TREATMENT OF ADULTS WITH PERSISTENT/RECURRENT CHRONIC THROMBOEMBOLIC PULMONARY HYPERTENSION (CTEPH), (WHO GROUP 4) AFTER SURGICAL TREATMENT, OR INOPERABLE CTEPH, TO IMPROVE EXERCISE CAPACITY AND WHO FUNCTIONAL CLASS
1MG ADEMPAS BAYER HLTHCARE N204819 Oct. 8, 2013 RX TABLET ORAL 10662188 Feb. 18, 2034 TREATMENT OF ADULTS WITH PULMONARY HYPERTENSION (PAH), (WHO GROUP 1), TO IMPROVE EXERCISE CAPACITY, WHO FUNCTIONAL CLASS AND TO DELAY CLINICAL WORSENING
1MG ADEMPAS BAYER HLTHCARE N204819 Oct. 8, 2013 RX TABLET ORAL 11203593 Feb. 18, 2034 TREATMENT OF ADULTS WITH PERSISTENT/RECURRENT CHRONIC THROMBOEMBOLIC PULMONARY HYPERTENSION (CTEPH), (WHO GROUP 4) AFTER SURGICAL TREATMENT, OR INOPERABLE CTEPH, TO IMPROVE EXERCISE CAPACITY AND WHO FUNCTIONAL CLASS
1MG ADEMPAS BAYER HLTHCARE N204819 Oct. 8, 2013 RX TABLET ORAL 11203593 Feb. 18, 2034 TREATMENT OF ADULTS WITH PULMONARY HYPERTENSION (PAH), (WHO GROUP 1), TO IMPROVE EXERCISE CAPACITY, WHO FUNCTIONAL CLASS AND TO DELAY CLINICAL WORSENING
2.5MG ADEMPAS BAYER HLTHCARE N204819 Oct. 8, 2013 RX TABLET ORAL 10662188 Feb. 18, 2034 TREATMENT OF ADULTS WITH PERSISTENT/RECURRENT CHRONIC THROMBOEMBOLIC PULMONARY HYPERTENSION (CTEPH), (WHO GROUP 4) AFTER SURGICAL TREATMENT, OR INOPERABLE CTEPH, TO IMPROVE EXERCISE CAPACITY AND WHO FUNCTIONAL CLASS
2.5MG ADEMPAS BAYER HLTHCARE N204819 Oct. 8, 2013 RX TABLET ORAL 10662188 Feb. 18, 2034 TREATMENT OF ADULTS WITH PULMONARY HYPERTENSION (PAH), (WHO GROUP 1), TO IMPROVE EXERCISE CAPACITY, WHO FUNCTIONAL CLASS AND TO DELAY CLINICAL WORSENING
2.5MG ADEMPAS BAYER HLTHCARE N204819 Oct. 8, 2013 RX TABLET ORAL 11203593 Feb. 18, 2034 TREATMENT OF ADULTS WITH PERSISTENT/RECURRENT CHRONIC THROMBOEMBOLIC PULMONARY HYPERTENSION (CTEPH), (WHO GROUP 4) AFTER SURGICAL TREATMENT, OR INOPERABLE CTEPH, TO IMPROVE EXERCISE CAPACITY AND WHO FUNCTIONAL CLASS
2.5MG ADEMPAS BAYER HLTHCARE N204819 Oct. 8, 2013 RX TABLET ORAL 11203593 Feb. 18, 2034 TREATMENT OF ADULTS WITH PULMONARY HYPERTENSION (PAH), (WHO GROUP 1), TO IMPROVE EXERCISE CAPACITY, WHO FUNCTIONAL CLASS AND TO DELAY CLINICAL WORSENING
2MG ADEMPAS BAYER HLTHCARE N204819 Oct. 8, 2013 RX TABLET ORAL 10662188 Feb. 18, 2034 TREATMENT OF ADULTS WITH PERSISTENT/RECURRENT CHRONIC THROMBOEMBOLIC PULMONARY HYPERTENSION (CTEPH), (WHO GROUP 4) AFTER SURGICAL TREATMENT, OR INOPERABLE CTEPH, TO IMPROVE EXERCISE CAPACITY AND WHO FUNCTIONAL CLASS
2MG ADEMPAS BAYER HLTHCARE N204819 Oct. 8, 2013 RX TABLET ORAL 10662188 Feb. 18, 2034 TREATMENT OF ADULTS WITH PULMONARY HYPERTENSION (PAH), (WHO GROUP 1), TO IMPROVE EXERCISE CAPACITY, WHO FUNCTIONAL CLASS AND TO DELAY CLINICAL WORSENING
2MG ADEMPAS BAYER HLTHCARE N204819 Oct. 8, 2013 RX TABLET ORAL 11203593 Feb. 18, 2034 TREATMENT OF ADULTS WITH PERSISTENT/RECURRENT CHRONIC THROMBOEMBOLIC PULMONARY HYPERTENSION (CTEPH), (WHO GROUP 4) AFTER SURGICAL TREATMENT, OR INOPERABLE CTEPH, TO IMPROVE EXERCISE CAPACITY AND WHO FUNCTIONAL CLASS
2MG ADEMPAS BAYER HLTHCARE N204819 Oct. 8, 2013 RX TABLET ORAL 11203593 Feb. 18, 2034 TREATMENT OF ADULTS WITH PULMONARY HYPERTENSION (PAH), (WHO GROUP 1), TO IMPROVE EXERCISE CAPACITY, WHO FUNCTIONAL CLASS AND TO DELAY CLINICAL WORSENING

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Guanylate cyclase soluble subunit beta-1 Enzyme POSITIVE ALLOSTERIC MODULATOR MEC 7.52 SCIENTIFIC LITERATURE SCIENTIFIC LITERATURE
cAMP-specific 3',5'-cyclic phosphodiesterase 7B Enzyme IC50 5.54 SCIENTIFIC LITERATURE

External reference:

IDSource
D09572 KEGG_DRUG
4032785 VANDF
CHEBI:76018 CHEBI
GZO PDB_CHEM_ID
CHEMBL2107834 ChEMBL_ID
C542595 MESH_SUPPLEMENTAL_RECORD_UI
5257 IUPHAR_LIGAND_ID
8857 INN_ID
DB08931 DRUGBANK_ID
RU3FE2Y4XI UNII
11304743 PUBCHEM_CID
1439816 RXNORM
207043 MMSL
29792 MMSL
d08140 MMSL
015236 NDDF
713333001 SNOMEDCT_US
715490004 SNOMEDCT_US
C2717561 UMLSCUI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Adempas HUMAN PRESCRIPTION DRUG LABEL 1 50419-250 TABLET, FILM COATED 0.50 mg ORAL NDA 29 sections
Adempas HUMAN PRESCRIPTION DRUG LABEL 1 50419-251 TABLET, FILM COATED 1 mg ORAL NDA 29 sections
Adempas HUMAN PRESCRIPTION DRUG LABEL 1 50419-252 TABLET, FILM COATED 1.50 mg ORAL NDA 29 sections
Adempas HUMAN PRESCRIPTION DRUG LABEL 1 50419-253 TABLET, FILM COATED 2 mg ORAL NDA 29 sections
Adempas HUMAN PRESCRIPTION DRUG LABEL 1 50419-254 TABLET, FILM COATED 2.50 mg ORAL NDA 29 sections