treprostinil Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
prostaglandins 2720 81846-19-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • treprost
  • treprostinil
  • uniprost
  • treprostinil sodium
  • 15AU81
  • LRX-15
  • UT-15
  • treprostinil diolamine
  • Molecular weight: 390.52
  • Formula: C23H34O5
  • CLOGP: 3.72
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 3
  • TPSA: 86.99
  • ALOGS: -4.73
  • ROTB: 10

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
4.30 mg P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 4 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 6.15 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 0.23 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 10.70 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.09 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 0.82 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
April 3, 2020 EMA SciPharm Sarl
May 21, 2002 FDA UNITED THERAP

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
Pulmonary arterial hypertension 3384.31 18.02 1474 110814 25648 53211130
Dyspnoea 2761.43 18.02 4617 107671 581615 52655163
Infusion site pain 2673.77 18.02 987 111301 10846 53225932
Fluid retention 1903.91 18.02 1269 111019 53132 53183646
Headache 1457.54 18.02 3363 108925 533458 52703320
Right ventricular failure 1371.91 18.02 682 111606 16161 53220617
Infusion site erythema 1323.31 18.02 547 111741 8275 53228503
Fluid overload 1305.46 18.02 782 111506 27049 53209729
Pulmonary hypertension 1268.48 18.02 855 111433 36415 53200363
Pain in jaw 1212.52 18.02 860 111428 39809 53196969
Drug ineffective 1049.57 18.02 224 112064 817021 52419757
Infusion site infection 1027.95 18.02 294 111994 1283 53235495
Dyspnoea exertional 982.87 18.02 860 111428 54140 53182638
Device related infection 862.91 18.02 559 111729 22227 53214551
Infusion site swelling 843.53 18.02 371 111917 6583 53230195
Vascular device infection 737.77 18.02 296 111992 4125 53232653
Flushing 690.44 18.02 796 111492 69804 53166974
Oxygen saturation decreased 682.35 18.02 824 111464 75901 53160877
Diarrhoea 658.62 18.02 2825 109463 622721 52614057
Death 638.00 18.02 1920 110368 355312 52881466
Cough 606.53 18.02 1530 110758 255363 52981415
Catheter site pain 596.20 18.02 247 112041 3754 53233024
Dermatitis contact 591.43 18.02 315 111973 8637 53228141
Infusion site discharge 573.95 18.02 153 112135 481 53236297
Rheumatoid arthritis 525.88 18.02 35 112253 314496 52922282
Dizziness 519.39 18.02 1840 110448 370419 52866359
Infusion site haemorrhage 509.10 18.02 200 112088 2627 53234151
Chest pain 499.76 18.02 1181 111107 189004 53047774
Catheter site erythema 490.67 18.02 218 112070 3964 53232814
Syncope 445.78 18.02 825 111463 111168 53125610
Device dislocation 445.43 18.02 381 111907 23216 53213562
Nasal congestion 416.96 18.02 537 111751 52750 53184028
Therapy change 391.24 18.02 204 112084 5348 53231430
Nausea 385.23 18.02 2809 109479 753282 52483496
Toxicity to various agents 351.00 18.02 30 112258 219568 53017210
Oedema 349.03 18.02 589 111699 73757 53163021
Drug interaction 322.16 18.02 41 112247 219288 53017490
Injection site discharge 320.51 18.02 89 112199 340 53236438
Infusion site induration 320.38 18.02 105 112183 779 53235999
Hospitalisation 312.84 18.02 547 111741 70465 53166313
Hypoxia 307.52 18.02 475 111813 55205 53181573
Device infusion issue 296.47 18.02 108 112180 1135 53235643
Alopecia 293.74 18.02 67 112221 234516 53002262
Hypotension 292.92 18.02 1183 111105 252893 52983885
Infusion site warmth 292.89 18.02 113 112175 1409 53235369
Lung transplant 292.56 18.02 138 112150 2896 53233882
Oxygen consumption increased 291.21 18.02 147 112141 3594 53233184
Pulmonary arterial pressure increased 291.07 18.02 144 112144 3368 53233410
Neutropenia 286.94 18.02 11 112277 159174 53077604
Rash 285.09 18.02 312 111976 445879 52790899
Infusion related reaction 283.80 18.02 10 112278 155947 53080831
Catheter site pruritus 274.93 18.02 117 112171 1907 53234871
Drug hypersensitivity 272.13 18.02 109 112179 265133 52971645
Palpitations 269.84 18.02 637 111651 101711 53135067
Oedema peripheral 269.44 18.02 881 111407 169906 53066872
Infusion site pruritus 258.43 18.02 136 112152 3634 53233144
Device leakage 257.05 18.02 160 112128 5920 53230858
Catheter site haemorrhage 256.36 18.02 125 112163 2830 53233948
Catheter site discharge 252.47 18.02 110 112178 1904 53234874
Catheter management 245.49 18.02 120 112168 2732 53234046
Treatment failure 241.73 18.02 6 112282 128397 53108381
Infusion site irritation 241.04 18.02 78 112210 553 53236225
Arthropathy 224.06 18.02 20 112268 141433 53095345
Catheter site infection 222.82 18.02 136 112152 4856 53231922
Therapeutic product effect decreased 222.01 18.02 10 112278 125645 53111133
Infusion site abscess 213.15 18.02 55 112233 146 53236632
Catheter site swelling 208.59 18.02 87 112201 1345 53235433
Throat irritation 207.62 18.02 293 111995 31388 53205390
Scleroderma 200.63 18.02 128 112160 4947 53231831
Febrile neutropenia 197.13 18.02 5 112283 104931 53131847
Infusion site cellulitis 194.52 18.02 50 112238 130 53236648
Maternal exposure during pregnancy 189.68 18.02 47 112241 155592 53081186
Joint swelling 185.65 18.02 134 112154 234504 53002274
Catheter placement 183.28 18.02 89 112199 1996 53234782
Device related sepsis 182.42 18.02 107 112181 3548 53233230
Malaise 181.89 18.02 1331 110957 356286 52880492
Catheterisation cardiac 180.94 18.02 112 112176 4102 53232676
Glossodynia 180.43 18.02 7 112281 100284 53136494
Blood pressure decreased 178.32 18.02 399 111889 61470 53175308
Therapeutic product effect incomplete 177.85 18.02 3 112285 91781 53144997
Injection site infection 171.60 18.02 80 112208 1633 53235145
Device issue 168.87 18.02 218 112070 21440 53215338
Transfusion 164.24 18.02 172 112116 13515 53223263
Hepatic enzyme increased 161.96 18.02 34 112254 126161 53110617
Hypertension 161.67 18.02 142 112146 225289 53011489
Feeling abnormal 161.16 18.02 637 111651 134664 53102114
White blood cell count decreased 160.86 18.02 33 112255 124442 53112336
Central venous catheterisation 158.26 18.02 81 112207 2040 53234738
Dyspnoea at rest 158.08 18.02 100 112188 3807 53232971
Epistaxis 155.95 18.02 404 111884 68306 53168472
Haemoptysis 155.84 18.02 240 112048 27799 53208979
Presyncope 155.22 18.02 231 112057 25963 53210815
Hypersensitivity 154.34 18.02 130 112158 210535 53026243
Stomatitis 152.42 18.02 15 112273 98143 53138635
Infusion site discolouration 150.04 18.02 55 112233 589 53236189
Abdominal distension 142.52 18.02 430 111858 79360 53157418
Product use in unapproved indication 140.54 18.02 32 112256 112257 53124521
Infusion site oedema 140.44 18.02 50 112238 489 53236289
Exposure during pregnancy 140.38 18.02 44 112244 124816 53111962
Product dose omission issue 138.42 18.02 780 111508 190840 53045938
Chest discomfort 138.31 18.02 493 111795 99202 53137576
Therapy non-responder 137.30 18.02 313 111975 48807 53187971
Cardiac failure 137.09 18.02 445 111843 85399 53151379
Leukopenia 136.11 18.02 4 112284 73459 53163319
Psoriasis 136.03 18.02 13 112275 87076 53149702
Complication associated with device 135.99 18.02 169 112119 15996 53220782
Infusion site reaction 134.54 18.02 73 112215 2077 53234701
Musculoskeletal stiffness 134.25 18.02 46 112242 123322 53113456
Pain in extremity 134.05 18.02 1042 111246 284008 52952770
Transplant evaluation 131.65 18.02 58 112230 1032 53235746
Pulmonary oedema 131.40 18.02 325 111963 53398 53183380
Device occlusion 129.18 18.02 110 112178 6655 53230123
Unevaluable event 124.84 18.02 303 111985 49195 53187583
Pneumonia 123.40 18.02 1354 110934 405815 52830963
Catheter site rash 121.00 18.02 50 112238 754 53236024
Ascites 119.81 18.02 261 112027 39474 53197304
Dizziness postural 119.60 18.02 105 112183 6620 53230158
Pruritus 117.08 18.02 280 112008 293552 52943226
Infusion site inflammation 115.67 18.02 36 112252 221 53236557
C-reactive protein increased 114.85 18.02 7 112281 67879 53168899
Acute kidney injury 113.43 18.02 227 112061 253641 52983137
Intentional overdose 110.55 18.02 8 112280 67197 53169581
Pericardial effusion 109.62 18.02 202 112086 27076 53209702
Heart rate increased 109.01 18.02 401 111887 81914 53154864
Drug abuse 107.22 18.02 8 112280 65518 53171260
Device alarm issue 106.55 18.02 56 112232 1492 53235286
Acute respiratory failure 105.48 18.02 215 112073 31043 53205735
Productive cough 105.33 18.02 310 111978 56419 53180359
Infusion site rash 104.29 18.02 50 112238 1089 53235689
Catheter site irritation 103.25 18.02 39 112249 457 53236321
Vomiting 101.83 18.02 1538 110750 495601 52741177
Depression 100.81 18.02 143 112145 182909 53053869
Lower respiratory tract infection 98.84 18.02 34 112254 90947 53145831
Pancytopenia 98.75 18.02 34 112254 90894 53145884
Discomfort 98.13 18.02 39 112249 95433 53141345
Catheter site inflammation 96.12 18.02 41 112247 672 53236106
Arthralgia 95.30 18.02 540 111748 439243 52797535
Electrocardiogram QT prolonged 94.86 18.02 6 112282 56397 53180381
Osteoarthritis 94.61 18.02 17 112271 70469 53166309
Blood cholesterol increased 94.27 18.02 4 112284 52985 53183793
Urticaria 93.28 18.02 89 112199 135796 53100982
Drug titration error 92.29 18.02 39 112249 624 53236154
Infusion site vesicles 91.94 18.02 34 112254 374 53236404
Wound 89.92 18.02 40 112248 91517 53145261
Neutrophil count decreased 89.77 18.02 3 112285 49095 53187683
Thrombosis in device 89.32 18.02 64 112224 3001 53233777
Infusion site discomfort 88.45 18.02 40 112248 759 53236019
Pulmonary veno-occlusive disease 87.71 18.02 43 112245 985 53235793
Suicide attempt 87.44 18.02 10 112278 58158 53178620
Walking distance test abnormal 85.29 18.02 35 112253 518 53236260
Anaphylactic reaction 85.28 18.02 11 112277 58315 53178463
Confusional state 84.72 18.02 176 112112 194045 53042733
Respiratory failure 84.64 18.02 427 111861 100085 53136693
Plasma cell myeloma 83.90 18.02 4 112284 47870 53188908
Cardiac failure congestive 83.77 18.02 402 111886 92355 53144423
Pericarditis 83.33 18.02 17 112271 64389 53172389
Catheter site vesicles 82.62 18.02 29 112259 271 53236507
Respiration abnormal 80.29 18.02 77 112211 5441 53231337
Depressed level of consciousness 80.22 18.02 10 112278 54418 53182360
Catheter site related reaction 80.13 18.02 38 112250 807 53235971
Bradycardia 79.91 18.02 25 112263 71031 53165747
Device connection issue 77.61 18.02 36 112252 726 53236052
Infusion site nodule 77.44 18.02 41 112247 1109 53235669
Purulent discharge 76.88 18.02 72 112216 4938 53231840
Treatment noncompliance 75.69 18.02 195 112093 32840 53203938
Device breakage 75.62 18.02 102 112186 10465 53226313
Asthma 75.22 18.02 71 112217 108901 53127877
Hyponatraemia 74.69 18.02 71 112217 108536 53128242
Device use error 73.03 18.02 73 112215 5426 53231352
Neuropathy peripheral 72.68 18.02 66 112222 103121 53133657
Overdose 72.27 18.02 72 112216 107664 53129114
Suicidal ideation 72.27 18.02 19 112269 60492 53176286
Angioedema 72.20 18.02 4 112284 42072 53194706
Device malfunction 71.87 18.02 124 112164 15784 53220994
Blood pressure increased 71.28 18.02 116 112172 140363 53096415
Disease progression 70.92 18.02 411 111877 101509 53135269
Seasonal allergy 70.18 18.02 120 112168 15165 53221613
Right ventricular dysfunction 69.43 18.02 43 112245 1576 53235202
Pulmonary hypertensive crisis 69.33 18.02 23 112265 178 53236600
Coma 69.00 18.02 22 112266 61761 53175017
Systemic lupus erythematosus 68 18.02 99 112189 125315 53111463
Thrombocytopenia 67.21 18.02 118 112170 138609 53098169
Alanine aminotransferase increased 66.76 18.02 61 112227 95034 53141744
Cognitive disorder 66.55 18.02 8 112280 44770 53192008
Decreased appetite 66.32 18.02 718 111570 214256 53022522
Device use issue 64.77 18.02 44 112244 1892 53234886
Infusion site pustule 63.99 18.02 15 112273 22 53236756
Infusion site extravasation 63.73 18.02 72 112216 6160 53230618
Catheter site warmth 63.60 18.02 22 112266 196 53236582
Impaired healing 63.11 18.02 28 112260 64177 53172601
Device programming error 62.48 18.02 17 112271 59 53236719
Intentional product misuse 61.93 18.02 14 112274 49378 53187400
Vascular device occlusion 61.41 18.02 15 112273 29 53236749
Deep vein thrombosis 60.84 18.02 51 112237 82862 53153916
Wrong dose 60.63 18.02 32 112256 860 53235918
Lactic acidosis 59.67 18.02 5 112283 37248 53199530
Brain natriuretic peptide increased 59.27 18.02 62 112226 4863 53231915
Cor pulmonale 59.02 18.02 42 112246 1948 53234830
Oropharyngeal pain 58.02 18.02 330 111958 80938 53155840
Emergency care 57.29 18.02 31 112257 877 53235901
Inflammation 56.03 18.02 25 112263 57111 53179667
Blood pressure systolic increased 55.59 18.02 5 112283 35172 53201606
Injury 55.43 18.02 19 112269 50952 53185826
Atrial flutter 54.55 18.02 83 112205 9508 53227270
Internal haemorrhage 54.53 18.02 58 112230 4638 53232140
Retching 54.49 18.02 102 112186 13831 53222947
Type 2 diabetes mellitus 54.37 18.02 3 112285 31667 53205111
Product quality issue 54.08 18.02 7 112281 37016 53199762
Seizure 53.42 18.02 121 112167 129388 53107390
Helicobacter infection 53.35 18.02 9 112279 39060 53197718
Metabolic acidosis 52.90 18.02 12 112276 42230 53194548
Pulmonary arterial pressure abnormal 52.57 18.02 24 112264 466 53236312
Agitation 52.44 18.02 29 112259 58597 53178181
Foetal exposure during pregnancy 52.09 18.02 6 112282 34709 53202069
Hypoglycaemia 51.63 18.02 30 112258 58983 53177795
Bone marrow failure 51.25 18.02 3 112285 30112 53206666
Hypoaesthesia 51.09 18.02 129 112159 132866 53103912
Osteoporosis 51.07 18.02 17 112271 46443 53190335
Injection site bruising 50.68 18.02 9 112279 37637 53199141
Diabetes mellitus 50.67 18.02 25 112263 53874 53182904
Device expulsion 50.64 18.02 3 112285 29810 53206968
Rash maculo-papular 50.52 18.02 3 112285 29746 53207032
Sedation 50.37 18.02 3 112285 29672 53207106
Dizziness exertional 49.96 18.02 22 112266 391 53236387
Gamma-glutamyltransferase increased 49.85 18.02 6 112282 33549 53203229
Device physical property issue 49.30 18.02 36 112252 1739 53235039
Hepatic function abnormal 49.29 18.02 9 112279 36890 53199888
Exercise tolerance decreased 48.82 18.02 58 112230 5237 53231541
Localised oedema 48.70 18.02 58 112230 5251 53231527
Generalised tonic-clonic seizure 48.53 18.02 3 112285 28755 53208023
Subcutaneous drug absorption impaired 48.53 18.02 12 112276 25 53236753
Device maintenance issue 48.30 18.02 10 112278 4 53236774
Blood glucose increased 48.19 18.02 55 112233 77306 53159472
Blister 47.96 18.02 57 112231 78696 53158082
Pulmonary embolism 47.95 18.02 106 112182 114336 53122442
Catheter site extravasation 47.90 18.02 20 112268 310 53236468
Paracentesis 47.52 18.02 28 112260 936 53235842
Respiratory tract congestion 47.11 18.02 99 112189 14600 53222178
Hypocalcaemia 46.82 18.02 4 112284 29333 53207445
Medical device site haemorrhage 46.20 18.02 12 112276 33 53236745
Hyperkalaemia 45.48 18.02 29 112259 54227 53182551
Injection site erosion 45.39 18.02 13 112275 57 53236721
Multiple sclerosis 45.32 18.02 3 112285 27150 53209628
Lung disorder 45.01 18.02 210 112078 47669 53189109
Paraesthesia 44.97 18.02 129 112159 127386 53109392
Somnolence 44.83 18.02 191 112097 167543 53069235
Sinus congestion 44.38 18.02 96 112192 14442 53222336
Red blood cell sedimentation rate increased 44.30 18.02 4 112284 28053 53208725
Infusion site injury 43.80 18.02 10 112278 12 53236766
Breast cancer 43.31 18.02 25 112263 49333 53187445
Product administration interrupted 43.30 18.02 25 112263 804 53235974
Hallucination 42.17 18.02 31 112257 53807 53182971
Fibromyalgia 42.10 18.02 20 112268 44055 53192723
Rales 41.99 18.02 79 112209 10753 53226025
Oxygen therapy 41.93 18.02 34 112254 1920 53234858
Therapeutic response decreased 41.87 18.02 24 112264 47545 53189233
Dysphagia 41.58 18.02 71 112217 84326 53152452
Wrong technique in product usage process 41.54 18.02 39 112249 59993 53176785
Cardiac failure high output 40.98 18.02 17 112271 259 53236519
Loss of personal independence in daily activities 40.97 18.02 52 112236 69763 53167015
Delirium 40.82 18.02 18 112270 41411 53195367
Hepatic steatosis 40.78 18.02 4 112284 26255 53210523
Ill-defined disorder 40.67 18.02 27 112261 49417 53187361
Acute right ventricular failure 40.32 18.02 15 112273 168 53236610
Hyperglycaemia 40.16 18.02 17 112271 40067 53196711
Terminal state 40.07 18.02 36 112252 2340 53234438
Cerebral infarction 39.93 18.02 3 112285 24441 53212337
Oxygen saturation abnormal 39.87 18.02 39 112249 2823 53233955
Sleep disorder due to general medical condition, insomnia type 39.75 18.02 3 112285 24346 53212432
Injection site reaction 39.38 18.02 30 112258 51136 53185642
Femur fracture 39.32 18.02 17 112271 39568 53197210
Bacteraemia 38.98 18.02 95 112193 15454 53221324
Swollen tongue 38.58 18.02 9 112279 31071 53205707
Agranulocytosis 38.56 18.02 3 112285 23746 53213032
Blood creatinine increased 38.51 18.02 72 112216 82590 53154188
Rhinovirus infection 38.41 18.02 44 112244 3821 53232957
Drug intolerance 38.31 18.02 264 112024 205229 53031549
Dyspepsia 38.18 18.02 287 112001 77313 53159465
Basal cell carcinoma 38.00 18.02 3 112285 23466 53213312
Aggression 37.87 18.02 3 112285 23400 53213378
Mobility decreased 37.72 18.02 64 112224 76207 53160571
Renal impairment 37.56 18.02 74 112214 83244 53153534
Intentional product use issue 37.56 18.02 59 112229 72435 53164343
Knee arthroplasty 37.40 18.02 12 112276 33557 53203221
No adverse event 37.23 18.02 18 112270 39247 53197531
Product prescribing error 37.14 18.02 3 112285 23028 53213750
Psychotic disorder 37.13 18.02 4 112284 24381 53212397
Infusion site scar 36.55 18.02 15 112273 222 53236556
Pulmonary artery aneurysm 36.05 18.02 10 112278 38 53236740
Chronic respiratory failure 35.93 18.02 30 112258 1766 53235012
Sinus disorder 35.62 18.02 103 112185 18551 53218227
Disturbance in attention 35.39 18.02 14 112274 34369 53202409
Peripheral swelling 35.37 18.02 620 111668 205488 53031290
Jaundice 35.28 18.02 10 112278 30303 53206475
Drug-induced liver injury 35.24 18.02 9 112279 29224 53207554
Emotional distress 35.22 18.02 12 112276 32305 53204473
Infusion site haematoma 35.10 18.02 15 112273 247 53236531
Cardiac ablation 34.85 18.02 26 112262 1298 53235480
Abdominal pain upper 34.81 18.02 517 111771 165774 53071004
Dialysis 34.72 18.02 71 112217 10271 53226507
Drug dependence 34.07 18.02 3 112285 21469 53215309
Disease complication 34.00 18.02 38 112250 3212 53233566
Off label use 33.85 18.02 747 111541 471465 52765313
Drug eruption 33.78 18.02 6 112282 25088 53211690
Cardiac disorder 33.69 18.02 191 112097 46775 53190003
Pancreatitis acute 33.54 18.02 7 112281 26102 53210676
Weight decreased 33.54 18.02 687 111601 234261 53002517
Injection site irritation 33.27 18.02 44 112244 4428 53232350
Drug withdrawal syndrome 33.07 18.02 9 112279 28013 53208765
Disease recurrence 33.03 18.02 3 112285 20943 53215835
Infusion site dryness 33.00 18.02 7 112281 4 53236774
Hepatitis 32.96 18.02 15 112273 33879 53202899
Epilepsy 32.91 18.02 7 112281 25760 53211018
Infusion site dermatitis 32.91 18.02 8 112280 15 53236763
Endotracheal intubation 32.86 18.02 32 112256 2304 53234474
Hepatotoxicity 32.82 18.02 9 112279 27871 53208907
Platelet count decreased 32.76 18.02 117 112171 107982 53128796
Drug ineffective for unapproved indication 32.59 18.02 3 112285 20717 53216061
Catheter site scab 32.53 18.02 13 112275 179 53236599
Gout 32.42 18.02 77 112211 12322 53224456
Hypercalcaemia 32.39 18.02 6 112282 24342 53212436
Respiratory distress 32.26 18.02 149 112139 33678 53203100
Dysarthria 32.24 18.02 23 112265 40545 53196233
Head discomfort 32.12 18.02 74 112214 11610 53225168
Eczema 32.08 18.02 6 112282 24176 53212602
Metastases to liver 31.55 18.02 4 112284 21492 53215286
Pulmonary pain 31.50 18.02 31 112257 2261 53234517
Balance disorder 31.32 18.02 67 112221 73140 53163638
Clostridium difficile infection 31.28 18.02 129 112159 27764 53209014
Catheter site erosion 31.26 18.02 10 112278 68 53236710
Aspartate aminotransferase increased 31.11 18.02 83 112205 83946 53152832
Bursitis 31.11 18.02 5 112283 22487 53214291
Dyskinesia 31.10 18.02 14 112274 31819 53204959
Arthritis 31.00 18.02 88 112200 87210 53149568
Aphasia 30.91 18.02 13 112275 30765 53206013
Skin lesion 30.73 18.02 11 112277 28718 53208060
Irritable bowel syndrome 30.60 18.02 28 112260 43604 53193174
Cerebrovascular accident 30.45 18.02 116 112172 105058 53131720
Infusion site mass 30.41 18.02 22 112266 1047 53235731
Sleep disorder 30.41 18.02 48 112240 58822 53177956
Liver injury 30.38 18.02 5 112283 22098 53214680
Hypokalaemia 30.23 18.02 103 112185 96414 53140364
Hyperlipidaemia 30.23 18.02 3 112285 19512 53217266
Ventilation perfusion mismatch 30.21 18.02 13 112275 218 53236560
Right ventricular enlargement 30.06 18.02 14 112274 285 53236493
Cardiac failure acute 30.03 18.02 62 112226 9030 53227748
Bone disorder 29.99 18.02 4 112284 20679 53216099
Incorrect drug administration rate 29.91 18.02 31 112257 2405 53234373
Catheter site discolouration 29.91 18.02 11 112277 119 53236659
Medical device change 29.81 18.02 15 112273 364 53236414
Catheterisation cardiac abnormal 29.73 18.02 13 112275 227 53236551
Sepsis 29.38 18.02 452 111836 145977 53090801
Altered state of consciousness 29.27 18.02 8 112280 24828 53211950
Catheter site nodule 29.23 18.02 9 112279 53 53236725
Administration site odour 29.14 18.02 8 112280 29 53236749
Hallucination, visual 28.90 18.02 3 112285 18829 53217949
Bendopnoea 28.84 18.02 7 112281 13 53236765
Medical device site odour 28.57 18.02 6 112282 3 53236775
Diabetic ketoacidosis 28.53 18.02 4 112284 19911 53216867
Extra dose administered 28.48 18.02 45 112243 5325 53231453
Intentional medical device removal by patient 28.45 18.02 13 112275 253 53236525
Viral infection 28.43 18.02 139 112149 32156 53204622
Ejection fraction decreased 28.40 18.02 4 112284 19844 53216934
Sickle cell anaemia with crisis 28.36 18.02 41 112247 4486 53232292
Cardiac output increased 28.30 18.02 11 112277 140 53236638
Dry eye 28.17 18.02 18 112270 33626 53203152
Paranasal sinus hypersecretion 28.00 18.02 35 112253 3331 53233447
Cardioversion 27.94 18.02 22 112266 1191 53235587
Coronary artery disease 27.85 18.02 18 112270 33419 53203359
Inappropriate schedule of product administration 27.69 18.02 74 112214 74804 53161974
Nocturnal dyspnoea 27.66 18.02 21 112267 1077 53235701
Heart and lung transplant 27.37 18.02 10 112278 106 53236672
Fracture 27.32 18.02 3 112285 18016 53218762
Hypervolaemia 27.31 18.02 28 112260 2145 53234633
Injection site pustule 27.20 18.02 9 112279 69 53236709
Product leakage 27.10 18.02 16 112272 537 53236241
Urinary retention 27.06 18.02 13 112275 28453 53208325
Muscular weakness 26.96 18.02 115 112173 100877 53135901
Right ventricular systolic pressure increased 26.86 18.02 16 112272 546 53236232
Hypothyroidism 26.74 18.02 22 112266 36085 53200693
Blood potassium decreased 26.72 18.02 161 112127 40299 53196479
Nasal dryness 26.69 18.02 36 112252 3693 53233085
Migraine 26.34 18.02 272 112016 80145 53156633
Sickle cell anaemia 25.89 18.02 16 112272 584 53236194
Suture related complication 25.86 18.02 11 112277 179 53236599
Cardio-respiratory arrest 25.79 18.02 53 112235 58705 53178073
Transaminases increased 25.40 18.02 16 112272 30116 53206662
Colitis 25.37 18.02 30 112258 41522 53195256
Speech disorder 25.33 18.02 27 112261 39154 53197624
Erythema 25.29 18.02 210 112078 156759 53080019
Flatulence 25.18 18.02 132 112156 31385 53205393
Application site pruritus 25.16 18.02 37 112251 4112 53232666
Cataract 25.12 18.02 41 112247 49579 53187199
Visual acuity reduced 25.11 18.02 8 112280 22477 53214301
Incorrect route of product administration 25.05 18.02 5 112283 19239 53217539
Gastrointestinal haemorrhage 25.03 18.02 269 112019 80061 53156717
Eosinophilia 24.90 18.02 7 112281 21328 53215450
Myalgia 24.86 18.02 407 111881 133084 53103694
Catheter site dermatitis 24.81 18.02 8 112280 56 53236722
Cor pulmonale chronic 24.80 18.02 11 112277 199 53236579
Oral herpes 24.62 18.02 7 112281 21172 53215606
Gait disturbance 24.47 18.02 215 112073 158627 53078151
Echocardiogram abnormal 24.40 18.02 20 112268 1147 53235631
Joint stiffness 24.28 18.02 17 112271 30266 53206512
Diagnostic procedure 24.26 18.02 9 112279 100 53236678
Liver transplant 24.13 18.02 28 112260 2466 53234312
Medical procedure 24.04 18.02 12 112276 286 53236492
Abnormal behaviour 24.03 18.02 8 112280 21858 53214920
Diuretic therapy 23.94 18.02 9 112279 104 53236674
Diplopia 23.89 18.02 7 112281 20758 53216020
Transplant 23.89 18.02 16 112272 672 53236106
Product communication issue 23.86 18.02 12 112276 291 53236487
Asthenia 23.85 18.02 916 111372 342674 52894104
Medication error 23.58 18.02 25 112263 36340 53200438
Intracardiac pressure increased 23.37 18.02 7 112281 37 53236741
Haemodynamic test abnormal 23.37 18.02 7 112281 37 53236741
Skin exfoliation 23.18 18.02 25 112263 36058 53200720
Platelet count increased 23.06 18.02 3 112285 15804 53220974
Tendonitis 23.03 18.02 4 112284 17002 53219776
Right ventricular dilatation 22.98 18.02 18 112270 967 53235811
Pneumonia aspiration 22.90 18.02 23 112265 34278 53202500
Urinary tract infection 22.90 18.02 361 111927 239542 52997236
Full blood count decreased 22.80 18.02 11 112277 24018 53212760
Contusion 22.79 18.02 138 112150 110594 53126184
Sleep study 22.71 18.02 6 112282 18 53236760
Exposure via skin contact 22.69 18.02 10 112278 178 53236600
Decreased activity 22.69 18.02 41 112247 5410 53231368
Joint range of motion decreased 22.69 18.02 5 112283 17951 53218827
Acute myocardial infarction 22.51 18.02 22 112266 33213 53203565
Acute hepatic failure 22.50 18.02 4 112284 16716 53220062
Rhinorrhoea 22.44 18.02 191 112097 53387 53183391
Hip arthroplasty 21.87 18.02 16 112272 27846 53208932
Skin irritation 21.85 18.02 52 112236 8332 53228446
Mood swings 21.83 18.02 5 112283 17481 53219297
Vertigo 21.83 18.02 54 112234 56027 53180751
Spinal osteoarthritis 21.81 18.02 3 112285 15154 53221624
Ear congestion 21.68 18.02 24 112264 2007 53234771
Hemiparesis 21.68 18.02 9 112279 21466 53215312
Metapneumovirus infection 21.66 18.02 16 112272 787 53235991
Administration site infection 21.47 18.02 5 112283 7 53236771
Malabsorption from injection site 21.39 18.02 6 112282 24 53236754
Herpes zoster 21.19 18.02 82 112206 73937 53162841
Leukocytosis 21.03 18.02 13 112275 24721 53212057
Catheter removal 21.01 18.02 12 112276 378 53236400
Dysentery 20.98 18.02 16 112272 826 53235952
Product label confusion 20.50 18.02 13 112275 497 53236281
Loss of consciousness 20.44 18.02 346 111942 113866 53122912
Acne 20.30 18.02 10 112278 21576 53215202
Haematuria 20.16 18.02 18 112270 28371 53208407
Rash erythematous 20.08 18.02 30 112258 37593 53199185
General physical health deterioration 20.03 18.02 205 112083 146737 53090041
Encephalopathy 19.99 18.02 29 112259 36779 53199999
Myocardial infarction 19.83 18.02 125 112163 99229 53137549
Withdrawal syndrome 19.63 18.02 8 112280 19293 53217485
Cardiac operation 19.60 18.02 27 112261 2826 53233952
Therapeutic response unexpected 19.55 18.02 6 112282 17264 53219514
Sinusitis 19.50 18.02 244 112044 168320 53068458
Live birth 19.42 18.02 4 112284 15055 53221723
Catheter site cellulitis 19.32 18.02 10 112278 258 53236520
Photosensitivity reaction 19.29 18.02 3 112285 13825 53222953
Cystitis 19.28 18.02 44 112244 46944 53189834
Abdominal pain lower 19.24 18.02 13 112275 23580 53213198
Cardiomyopathy 19.23 18.02 6 112282 17082 53219696
Secretion discharge 19.09 18.02 57 112231 10449 53226329
Peritonitis 19.00 18.02 11 112277 21676 53215102
Vascular resistance pulmonary increased 18.99 18.02 6 112282 39 53236739
Liver function test abnormal 18.93 18.02 46 112242 48025 53188753
Portopulmonary hypertension 18.93 18.02 8 112280 128 53236650
Infusion site thrombosis 18.93 18.02 7 112281 77 53236701
Product substitution issue 18.90 18.02 5 112283 15861 53220917
Faeces soft 18.81 18.02 32 112256 4027 53232751
Cardiac pacemaker insertion 18.78 18.02 31 112257 3806 53232972
Disseminated intravascular coagulation 18.75 18.02 9 112279 19710 53217068
Carpal tunnel syndrome 18.67 18.02 7 112281 17760 53219018
Balloon atrial septostomy 18.53 18.02 7 112281 82 53236696
Obesity 18.48 18.02 6 112282 16656 53220122
Myelodysplastic syndrome 18.48 18.02 6 112282 16654 53220124
Pulmonary arterial pressure decreased 18.46 18.02 7 112281 83 53236695
Infusion site cyst 18.43 18.02 4 112284 3 53236775
Infusion site lymphadenopathy 18.43 18.02 4 112284 3 53236775
Infusion site erosion 18.43 18.02 4 112284 3 53236775
Hypertensive crisis 18.41 18.02 4 112284 14502 53222276
Pain 18.26 18.02 1033 111255 587365 52649413
Blood culture positive 18.24 18.02 34 112254 4595 53232183
Pulmonary artery occlusion 18.24 18.02 5 112283 18 53236760
Musculoskeletal disorder 18.21 18.02 7 112281 17492 53219286
Influenza 18.20 18.02 292 111996 95087 53141691
Diet noncompliance 18.19 18.02 10 112278 292 53236486
Catheter site abscess 18.13 18.02 6 112282 46 53236732
Pneumonitis 18.12 18.02 23 112265 30865 53205913
Obstructive airways disorder 18.09 18.02 7 112281 17422 53219356
Diabetes mellitus inadequate control 18.05 18.02 4 112284 14306 53222472
Administration site discharge 18.03 18.02 5 112283 19 53236759

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
Pulmonary arterial hypertension 1396.22 23.32 481 32569 9340 32471136
Infusion site pain 982.00 23.32 278 32772 2708 32477768
Dyspnoea 945.50 23.32 1465 31585 360580 32119896
Fluid retention 704.82 23.32 399 32651 26151 32454325
Right ventricular failure 625.57 23.32 257 32793 8206 32472270
Pulmonary hypertension 598.40 23.32 328 32722 20166 32460310
Headache 569.20 23.32 837 32213 195360 32285116
Pain in jaw 491.19 23.32 245 32805 12381 32468095
Infusion site erythema 486.32 23.32 144 32906 1662 32478814
Fluid overload 467.48 23.32 275 32775 19346 32461130
Oxygen saturation decreased 361.78 23.32 336 32714 47763 32432713
Flushing 332.80 23.32 266 32784 30861 32449615
Dyspnoea exertional 290.60 23.32 271 32779 38690 32441786
Infusion site infection 245.88 23.32 61 32989 334 32480142
Infusion site haemorrhage 218.90 23.32 61 32989 556 32479920
Infusion site swelling 199.96 23.32 74 32976 1770 32478706
Cough 198.29 23.32 436 32614 138381 32342095
Diarrhoea 198.24 23.32 812 32238 363990 32116486
Device related infection 193.14 23.32 154 32896 17779 32462697
Device dislocation 187.75 23.32 101 32949 5962 32474514
Vascular device infection 186.52 23.32 77 32973 2483 32477993
Oxygen consumption increased 186.45 23.32 65 32985 1301 32479175
Death 182.78 23.32 819 32231 381698 32098778
Drug interaction 178.42 23.32 11 33039 218174 32262302
Drug ineffective 173.73 23.32 87 32963 383390 32097086
Therapy change 165.65 23.32 73 32977 2772 32477704
Catheter site pain 162.84 23.32 57 32993 1155 32479321
Oedema 155.67 23.32 210 32840 44937 32435539
Toxicity to various agents 155.00 23.32 6 33044 178035 32302441
Catheter site erythema 153.85 23.32 55 32995 1188 32479288
Lung transplant 145.76 23.32 60 32990 1920 32478556
Infusion site discharge 143.22 23.32 31 33019 80 32480396
Dermatitis contact 142.22 23.32 70 32980 3428 32477048
Pain in extremity 131.18 23.32 338 32712 118563 32361913
Nasal congestion 129.81 23.32 130 32920 20221 32460255
Hypoxia 129.78 23.32 208 32842 51924 32428552
Nausea 122.54 23.32 645 32405 320204 32160272
Dizziness 122.35 23.32 478 32572 209140 32271336
Therapy non-responder 120.39 23.32 157 32893 32497 32447979
Catheter management 112.84 23.32 40 33010 842 32479634
Oedema peripheral 112.33 23.32 311 32739 113780 32366696
Infusion site warmth 108.62 23.32 25 33025 93 32480383
Syncope 107.48 23.32 264 32786 89860 32390616
Throat irritation 94.77 23.32 79 32971 9699 32470777
Infusion site cellulitis 86.70 23.32 19 33031 53 32480423
Device infusion issue 84.74 23.32 30 33020 629 32479847
Catheter site pruritus 84.19 23.32 25 33025 291 32480185
Pulmonary arterial pressure increased 84.09 23.32 35 33015 1152 32479324
Injection site discharge 79.57 23.32 19 33031 86 32480390
Infusion site induration 77.75 23.32 22 33028 213 32480263
Feeling abnormal 77.34 23.32 182 32868 60241 32420235
Catheterisation cardiac 76.92 23.32 40 33010 2201 32478275
Infusion site irritation 76.66 23.32 20 33030 138 32480338
Pancytopenia 76.29 23.32 4 33046 91231 32389245
Catheter site discharge 76.22 23.32 27 33023 567 32479909
Hospitalisation 75.61 23.32 159 32891 48812 32431664
Abdominal discomfort 73.41 23.32 164 32886 52460 32428016
Catheter site rash 71.30 23.32 20 33030 187 32480289
Injection site infection 71.15 23.32 29 33021 904 32479572
Thrombocytopenia 70.93 23.32 31 33019 148268 32332208
Catheter site swelling 67.38 23.32 21 33029 291 32480185
Product use in unapproved indication 66.59 23.32 6 33044 87198 32393278
Complication associated with device 65.03 23.32 52 32998 6020 32474456
Peripheral swelling 64.89 23.32 184 32866 68161 32412315
Acute kidney injury 64.17 23.32 126 32924 293342 32187134
Infusion site discomfort 62.69 23.32 16 33034 100 32480376
Chest pain 62.65 23.32 271 32779 123866 32356610
Central venous catheterisation 60.58 23.32 27 33023 1053 32479423
Transplant evaluation 60.08 23.32 22 33028 510 32479966
Catheter placement 59.90 23.32 24 33026 715 32479761
Hypotension 59.29 23.32 399 32651 215711 32264765
Device leakage 59.03 23.32 44 33006 4592 32475884
Catheter site infection 58.76 23.32 36 33014 2718 32477758
Infusion site rash 58.56 23.32 19 33031 302 32480174
Transfusion 57.75 23.32 54 32996 7714 32472762
Abdominal distension 57.64 23.32 147 32903 51148 32429328
Rhabdomyolysis 56.06 23.32 3 33047 67262 32413214
Device issue 55.10 23.32 56 32994 8856 32471620
Heart rate increased 54.60 23.32 127 32923 41701 32438775
Infusion site inflammation 54.36 23.32 12 33038 35 32480441
Ventilation perfusion mismatch 53.88 23.32 13 33037 62 32480414
Infusion site abscess 53.80 23.32 11 33039 19 32480457
Drug abuse 52.81 23.32 9 33041 80234 32400242
Infusion site oedema 52.40 23.32 15 33035 152 32480324
White blood cell count decreased 50.47 23.32 15 33035 91183 32389293
Haemoptysis 49.59 23.32 107 32943 33418 32447058
Productive cough 49.45 23.32 108 32942 34008 32446468
Leukopenia 49.12 23.32 3 33047 60119 32420357
Catheter site haemorrhage 46.66 23.32 29 33021 2246 32478230
Catheterisation cardiac abnormal 45.33 23.32 11 33039 54 32480422
Device breakage 44.82 23.32 27 33023 1977 32478499
Infusion site scar 44.60 23.32 9 33041 14 32480462
Hypertension 44.52 23.32 41 33009 131709 32348767
Plasma cell myeloma 43.87 23.32 4 33046 57610 32422866
Infusion site reaction 41.67 23.32 19 33031 782 32479694
Weight increased 41.66 23.32 182 32868 83481 32396995
Cardiac failure 41.59 23.32 194 32856 91479 32388997
Myocardial infarction 41.42 23.32 40 33010 125636 32354840
Infusion site pruritus 41.40 23.32 18 33032 661 32479815
Product administration interrupted 41.17 23.32 14 33036 259 32480217
Confusional state 41.15 23.32 51 32999 143064 32337412
Malaise 40.39 23.32 313 32737 176825 32303651
Exercise tolerance decreased 40.22 23.32 35 33015 4553 32475923
Product dose omission issue 39.38 23.32 207 32843 102368 32378108
Hallucination 39.15 23.32 4 33046 52615 32427861
Infusion site vesicles 38.99 23.32 12 33038 159 32480317
Walking distance test abnormal 38.85 23.32 12 33038 161 32480315
Catheter site irritation 38.11 23.32 11 33039 115 32480361
Device malfunction 37.30 23.32 46 33004 8993 32471483
Right ventricular dysfunction 37.26 23.32 19 33031 1003 32479473
Internal haemorrhage 37.07 23.32 34 33016 4738 32475738
Drug titration error 36.70 23.32 15 33035 471 32480005
Neutrophil count decreased 36.64 23.32 3 33047 47136 32433340
Pulmonary arterial pressure abnormal 36.62 23.32 12 33038 197 32480279
Respiratory failure 36.25 23.32 209 32841 106973 32373503
Acute respiratory failure 36.14 23.32 86 32964 28642 32451834
Device physical property issue 35.60 23.32 17 33033 778 32479698
Anaemia 35.53 23.32 113 32937 223511 32256965
Condition aggravated 35.44 23.32 275 32775 155386 32325090
Neuropathy peripheral 35.36 23.32 17 33033 76965 32403511
Palpitations 35.24 23.32 98 32952 35871 32444605
Blood creatine phosphokinase increased 35.05 23.32 3 33047 45473 32435003
Terminal state 34.93 23.32 30 33020 3834 32476642
Respiration abnormal 34.90 23.32 27 33023 2978 32477498
Device related sepsis 34.15 23.32 25 33025 2538 32477938
Overdose 33.25 23.32 24 33026 87053 32393423
Rash 33.09 23.32 106 32944 209227 32271249
Psoriasis 33.07 23.32 4 33046 46119 32434357
Chest discomfort 32.82 23.32 119 32931 50111 32430365
C-reactive protein increased 32.52 23.32 5 33045 48097 32432379
Ascites 32.24 23.32 102 32948 40089 32440387
Device alarm issue 31.93 23.32 16 33034 814 32479662
Haematuria 30.57 23.32 6 33044 48355 32432121
Cor pulmonale 30.25 23.32 15 33035 746 32479730
Hypoglycaemia 29.98 23.32 9 33041 54373 32426103
Drug hypersensitivity 29.67 23.32 19 33031 73381 32407095
Hepatic function abnormal 29.56 23.32 5 33045 44835 32435641
Sickle cell anaemia with crisis 29.34 23.32 23 33027 2586 32477890
Cardiac ablation 29.33 23.32 14 33036 640 32479836
Rheumatoid arthritis 29.29 23.32 5 33045 44539 32435937
Blood pressure decreased 29.23 23.32 116 32934 50964 32429512
Treatment failure 29.07 23.32 3 33047 39160 32441316
Swelling 28.84 23.32 95 32955 38127 32442349
Therapeutic product effect incomplete 28.64 23.32 4 33046 41337 32439139
Foetal exposure during pregnancy 28.60 23.32 4 33046 41297 32439179
Dizziness exertional 28.34 23.32 9 33041 133 32480343
Hyperkalaemia 28.27 23.32 18 33032 69732 32410744
Infusion site nodule 28.04 23.32 8 33042 80 32480396
Coronary artery disease 27.81 23.32 8 33042 49698 32430778
Cardiac output increased 27.67 23.32 7 33043 42 32480434
Agitation 27.27 23.32 12 33038 57224 32423252
Acute myocardial infarction 27.18 23.32 11 33039 55138 32425338
Platelet count decreased 26.90 23.32 47 33003 114544 32365932
Asthma 26.75 23.32 6 33044 44059 32436417
Delirium 26.74 23.32 6 33044 44040 32436436
Oropharyngeal pain 26.46 23.32 81 32969 31271 32449205
Deep vein thrombosis 26.43 23.32 16 33034 63697 32416779
Oxygen saturation abnormal 26.09 23.32 16 33034 1210 32479266
Catheter site discolouration 25.72 23.32 6 33044 24 32480452
Liver transplant 25.57 23.32 22 33028 2818 32477658
Catheter removal 25.45 23.32 9 33041 188 32480288
Hyponatraemia 25.37 23.32 23 33027 74490 32405986
Diuretic therapy 25.34 23.32 6 33044 26 32480450
Presyncope 25.32 23.32 55 32995 17246 32463230
Malignant atrophic papulosis 25.09 23.32 5 33045 7 32480469
Gout 24.57 23.32 57 32993 18671 32461805
Jaundice 24.39 23.32 3 33047 34155 32446321
Blood pressure increased 24.16 23.32 27 33023 79327 32401149
Fatigue 23.94 23.32 494 32556 350207 32130269
Blood creatinine increased 23.88 23.32 38 33012 96094 32384382
Infusion site scab 23.57 23.32 4 33046 0 32480476
Device maintenance issue 23.57 23.32 4 33046 0 32480476
Infusion site bruising 23.55 23.32 10 33040 346 32480130
Interstitial lung disease 23.43 23.32 19 33031 64982 32415494

Pharmacologic Action:

SourceCodeDescription
ATC B01AC21 BLOOD AND BLOOD FORMING ORGANS
ANTITHROMBOTIC AGENTS
ANTITHROMBOTIC AGENTS
Platelet aggregation inhibitors excl. heparin
FDA CS M0017817 Prostaglandins I
FDA PE N0000009909 Vasodilation
FDA EPC N0000175416 Prostacycline Vasodilator
MeSH PA D000959 Antihypertensive Agents
MeSH PA D002317 Cardiovascular Agents
CHEBI has role CHEBI:35554 cardiovascular drugs
CHEBI has role CHEBI:35620 vasodilator
CHEBI has role CHEBI:35674 antihypertensive
CHEBI has role CHEBI:50427 platelet aggregation inhibitors
CHEBI has role CHEBI:55347 vitamin K antagonists
CHEBI has role CHEBI:85234 human blood serum metabolites

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Pulmonary arterial hypertension indication 11399002
Disorder of lung contraindication 19829001 DOID:850
Low blood pressure contraindication 45007003
Blood coagulation disorder contraindication 64779008 DOID:1247
Kidney disease contraindication 90708001 DOID:557
Disease of liver contraindication 235856003 DOID:409

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 3.4 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
10MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 9199908 May 24, 2024 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE WATER FOR INJECTION OR 0.9% SODIUM CHLORIDE INJECTION PRIOR TO ADMINISTRATION
1MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 9199908 May 24, 2024 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE WATER FOR INJECTION OR 0.9% SODIUM CHLORIDE INJECTION PRIOR TO ADMINISTRATION
2.5MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 9199908 May 24, 2024 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE WATER FOR INJECTION OR 0.9% SODIUM CHLORIDE INJECTION PRIOR TO ADMINISTRATION
20MG/ML REMODULIN UNITED THERAP N021272 July 30, 2021 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 9199908 May 24, 2024 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE WATER FOR INJECTION OR 0.9% SODIUM CHLORIDE INJECTION PRIOR TO ADMINISTRATION
5MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 9199908 May 24, 2024 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE WATER FOR INJECTION OR 0.9% SODIUM CHLORIDE INJECTION PRIOR TO ADMINISTRATION
EQ 0.125MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL 9278901 May 24, 2024 USE OF ORENITRAM FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1).
EQ 0.25MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL 9278901 May 24, 2024 USE OF ORENITRAM FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1).
EQ 1MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL 9278901 May 24, 2024 USE OF ORENITRAM FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1).
EQ 2.5MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL 9278901 May 24, 2024 USE OF ORENITRAM FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1).
EQ 5MG BASE ORENITRAM UNITED THERAP N203496 Oct. 7, 2016 RX TABLET, EXTENDED RELEASE ORAL 9278901 May 24, 2024 USE OF ORENITRAM FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1).
EQ 0.125MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL 7544713 July 14, 2024 USE OF ORENITRAM FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1).
EQ 0.25MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL 7544713 July 14, 2024 USE OF ORENITRAM FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1).
EQ 1MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL 7544713 July 14, 2024 USE OF ORENITRAM FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1).
EQ 2.5MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL 7544713 July 14, 2024 USE OF ORENITRAM FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1).
EQ 5MG BASE ORENITRAM UNITED THERAP N203496 Oct. 7, 2016 RX TABLET, EXTENDED RELEASE ORAL 7544713 July 14, 2024 USE OF ORENITRAM FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1).
10MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 10695308 Dec. 16, 2024 A METHOD OF TREATING A HUMAN PATIENT SUFFERING FROM PULMONARY HYPERTENSION
10MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 9713599 Dec. 16, 2024 A METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING PARENTERALLY ADMINISTERING A FORMULATION COMPRISING A) 0.1 TO 5% W/V OF TREPROSTINIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND B) A CITRATE BUFFER
1MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 10695308 Dec. 16, 2024 A METHOD OF TREATING A HUMAN PATIENT SUFFERING FROM PULMONARY HYPERTENSION
1MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 9713599 Dec. 16, 2024 A METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING PARENTERALLY ADMINISTERING A FORMULATION COMPRISING A) 0.1 TO 5% W/V OF TREPROSTINIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND B) A CITRATE BUFFER
2.5MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 10695308 Dec. 16, 2024 A METHOD OF TREATING A HUMAN PATIENT SUFFERING FROM PULMONARY HYPERTENSION
2.5MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 9713599 Dec. 16, 2024 A METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING PARENTERALLY ADMINISTERING A FORMULATION COMPRISING A) 0.1 TO 5% W/V OF TREPROSTINIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND B) A CITRATE BUFFER
20MG/ML REMODULIN UNITED THERAP N021272 July 30, 2021 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 10695308 Dec. 16, 2024 A METHOD OF TREATING A HUMAN PATIENT SUFFERING FROM PULMONARY HYPERTENSION
20MG/ML REMODULIN UNITED THERAP N021272 July 30, 2021 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 9713599 Dec. 16, 2024 A METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING PARENTERALLY ADMINISTERING A FORMULATION COMPRISING A) 0.1 TO 5% W/V OF TREPROSTINIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND B) A CITRATE BUFFER
5MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 10695308 Dec. 16, 2024 A METHOD OF TREATING A HUMAN PATIENT SUFFERING FROM PULMONARY HYPERTENSION
5MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 9713599 Dec. 16, 2024 A METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING PARENTERALLY ADMINISTERING A FORMULATION COMPRISING A) 0.1 TO 5% W/V OF TREPROSTINIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND B) A CITRATE BUFFER
100MG/20ML (5MG/ML) REMODULIN UNITED THERAP N208276 July 30, 2018 DISCN SOLUTION INTRAVENOUS, SUBCUTANEOUS 9713599 Dec. 16, 2024 A METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING PARENTERALLY ADMINISTERING A FORMULATION COMPRISING A) 0.1 TO 5% W/V OF TREPROSTINIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND B) A CITRATE BUFFER
200MG/20ML (10MG/ML) REMODULIN UNITED THERAP N208276 July 30, 2018 DISCN SOLUTION INTRAVENOUS, SUBCUTANEOUS 9713599 Dec. 16, 2024 A METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING PARENTERALLY ADMINISTERING A FORMULATION COMPRISING A) 0.1 TO 5% W/V OF TREPROSTINIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND B) A CITRATE BUFFER
20MG/20ML (1MG/ML) REMODULIN UNITED THERAP N208276 July 30, 2018 DISCN SOLUTION INTRAVENOUS, SUBCUTANEOUS 9713599 Dec. 16, 2024 A METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING PARENTERALLY ADMINISTERING A FORMULATION COMPRISING A) 0.1 TO 5% W/V OF TREPROSTINIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND B) A CITRATE BUFFER
50MG/20ML (2.5MG/ML) REMODULIN UNITED THERAP N208276 July 30, 2018 DISCN SOLUTION INTRAVENOUS, SUBCUTANEOUS 9713599 Dec. 16, 2024 A METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING PARENTERALLY ADMINISTERING A FORMULATION COMPRISING A) 0.1 TO 5% W/V OF TREPROSTINIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND B) A CITRATE BUFFER
EQ 0.125MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL 9393203 April 27, 2026 METHOD OF TREATING PULMONARY HYPERTENSION BY ORALLY ADMINISTERING A FORMULATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF TREPROSTINIL
EQ 0.25MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL 9393203 April 27, 2026 METHOD OF TREATING PULMONARY HYPERTENSION BY ORALLY ADMINISTERING A FORMULATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF TREPROSTINIL
EQ 1MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL 9393203 April 27, 2026 METHOD OF TREATING PULMONARY HYPERTENSION BY ORALLY ADMINISTERING A FORMULATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF TREPROSTINIL
EQ 2.5MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL 9393203 April 27, 2026 METHOD OF TREATING PULMONARY HYPERTENSION BY ORALLY ADMINISTERING A FORMULATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF TREPROSTINIL
EQ 5MG BASE ORENITRAM UNITED THERAP N203496 Oct. 7, 2016 RX TABLET, EXTENDED RELEASE ORAL 9393203 April 27, 2026 METHOD OF TREATING PULMONARY HYPERTENSION BY ORALLY ADMINISTERING A FORMULATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF TREPROSTINIL
0.6MG/ML TYVASO UNITED THERAP N022387 July 30, 2009 RX SOLUTION INHALATION 10376525 May 14, 2027 METHOD OF TREATING PULMONARY HYPERTENSION BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE
0.6MG/ML TYVASO UNITED THERAP N022387 July 30, 2009 RX SOLUTION INHALATION 10716793 May 14, 2027 METHOD OF TREATING PULMONARY HYPERTENSION BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE
0.6MG/ML TYVASO UNITED THERAP N022387 July 30, 2009 RX SOLUTION INHALATION 9358240 May 5, 2028 METHOD OF TREATING PULMONARY HYPERTENSION BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE
10MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 8653137 Sept. 5, 2028 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
10MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 8658694 Sept. 5, 2028 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
1MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 8653137 Sept. 5, 2028 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
1MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 8658694 Sept. 5, 2028 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
2.5MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 8653137 Sept. 5, 2028 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
2.5MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 8658694 Sept. 5, 2028 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
20MG/ML REMODULIN UNITED THERAP N021272 July 30, 2021 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 8653137 Sept. 5, 2028 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
20MG/ML REMODULIN UNITED THERAP N021272 July 30, 2021 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 8658694 Sept. 5, 2028 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
5MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 8653137 Sept. 5, 2028 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
5MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 8658694 Sept. 5, 2028 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
10MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 7999007 March 29, 2029 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
1MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 7999007 March 29, 2029 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
2.5MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 7999007 March 29, 2029 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
20MG/ML REMODULIN UNITED THERAP N021272 July 30, 2021 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 7999007 March 29, 2029 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
5MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 7999007 March 29, 2029 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
EQ 0.125MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL 8747897 Aug. 11, 2031 A METHOD OF ORAL DELIVERY OF TREPROSTINIL COMPRISING ADMINISTERING AN ORAL OSMOTIC PHARMACEUTICAL DOSAGE FORM
EQ 0.125MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL 8747897 Aug. 11, 2031 A METHOD OF TREATING PULMONARY HYPERTENSION AND PULMONARY ARTERIAL HYPERTENSION BY ADMINISTERING AN ORAL OSMOTIC PHARMACEUTICAL DOSAGE FORM
EQ 0.25MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL 8747897 Aug. 11, 2031 A METHOD OF ORAL DELIVERY OF TREPROSTINIL COMPRISING ADMINISTERING AN ORAL OSMOTIC PHARMACEUTICAL DOSAGE FORM
EQ 0.25MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL 8747897 Aug. 11, 2031 A METHOD OF TREATING PULMONARY HYPERTENSION AND PULMONARY ARTERIAL HYPERTENSION BY ADMINISTERING AN ORAL OSMOTIC PHARMACEUTICAL DOSAGE FORM
EQ 1MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL 8747897 Aug. 11, 2031 A METHOD OF ORAL DELIVERY OF TREPROSTINIL COMPRISING ADMINISTERING AN ORAL OSMOTIC PHARMACEUTICAL DOSAGE FORM
EQ 1MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL 8747897 Aug. 11, 2031 A METHOD OF TREATING PULMONARY HYPERTENSION AND PULMONARY ARTERIAL HYPERTENSION BY ADMINISTERING AN ORAL OSMOTIC PHARMACEUTICAL DOSAGE FORM
EQ 2.5MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL 8747897 Aug. 11, 2031 A METHOD OF ORAL DELIVERY OF TREPROSTINIL COMPRISING ADMINISTERING AN ORAL OSMOTIC PHARMACEUTICAL DOSAGE FORM
EQ 2.5MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL 8747897 Aug. 11, 2031 A METHOD OF TREATING PULMONARY HYPERTENSION AND PULMONARY ARTERIAL HYPERTENSION BY ADMINISTERING AN ORAL OSMOTIC PHARMACEUTICAL DOSAGE FORM
EQ 5MG BASE ORENITRAM UNITED THERAP N203496 Oct. 7, 2016 RX TABLET, EXTENDED RELEASE ORAL 8747897 Aug. 11, 2031 A METHOD OF ORAL DELIVERY OF TREPROSTINIL COMPRISING ADMINISTERING AN ORAL OSMOTIC PHARMACEUTICAL DOSAGE FORM
EQ 5MG BASE ORENITRAM UNITED THERAP N203496 Oct. 7, 2016 RX TABLET, EXTENDED RELEASE ORAL 8747897 Aug. 11, 2031 A METHOD OF TREATING PULMONARY HYPERTENSION AND PULMONARY ARTERIAL HYPERTENSION BY ADMINISTERING AN ORAL OSMOTIC PHARMACEUTICAL DOSAGE FORM

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 0.125MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL Oct. 18, 2022 INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO DELAY DISEASE PROGRESSION
EQ 0.25MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL Oct. 18, 2022 INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO DELAY DISEASE PROGRESSION
EQ 1MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL Oct. 18, 2022 INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO DELAY DISEASE PROGRESSION
EQ 2.5MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL Oct. 18, 2022 INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO DELAY DISEASE PROGRESSION
EQ 5MG BASE ORENITRAM UNITED THERAP N203496 Oct. 7, 2016 RX TABLET, EXTENDED RELEASE ORAL Oct. 18, 2022 INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO DELAY DISEASE PROGRESSION
0.6MG/ML TYVASO UNITED THERAP N022387 July 30, 2009 RX SOLUTION INHALATION March 31, 2024 INDICATION FOR THE TREATMENT OF PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL LUNG DISEASE TO IMPROVE EXERCISE ABILITY
EQ 0.125MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL Oct. 18, 2026 INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO DELAY DISEASE PROGRESSION
EQ 0.25MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL Oct. 18, 2026 INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO DELAY DISEASE PROGRESSION
EQ 1MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL Oct. 18, 2026 INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO DELAY DISEASE PROGRESSION
EQ 2.5MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL Oct. 18, 2026 INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO DELAY DISEASE PROGRESSION
EQ 5MG BASE ORENITRAM UNITED THERAP N203496 Oct. 7, 2016 RX TABLET, EXTENDED RELEASE ORAL Oct. 18, 2026 INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO DELAY DISEASE PROGRESSION

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Prostacyclin receptor GPCR AGONIST EC50 8.72 IUPHAR CHEMBL
Prostaglandin E2 receptor EP2 subtype GPCR AGONIST Ki 8.40 IUPHAR
Prostaglandin E2 receptor EP1 subtype GPCR AGONIST Ki 6.70 IUPHAR
Prostaglandin E2 receptor EP3 subtype GPCR AGONIST Ki 5.60 IUPHAR
Prostaglandin E2 receptor EP4 subtype GPCR AGONIST EC50 6.70 IUPHAR
Prostaglandin D2 receptor GPCR AGONIST Ki 8.40 IUPHAR

External reference:

IDSource
4021349 VUID
N0000148769 NUI
D06213 KEGG_DRUG
289480-64-4 SECONDARY_CAS_RN
4021349 VANDF
C1145760 UMLSCUI
CHEBI:50861 CHEBI
CHEMBL1237119 ChEMBL_ID
DB00374 DRUGBANK_ID
C427248 MESH_SUPPLEMENTAL_RECORD_UI
6918140 PUBCHEM_CID
5820 IUPHAR_LIGAND_ID
C054809 MESH_SUPPLEMENTAL_RECORD_UI
8170 INN_ID
RUM6K67ESG UNII
1927409 RXNORM
16706 MMSL
26646 MMSL
79759 MMSL
d04802 MMSL
009648 NDDF
009649 NDDF
015333 NDDF
385681001 SNOMEDCT_US
385682008 SNOMEDCT_US
443570007 SNOMEDCT_US
CHEMBL2107815 ChEMBL_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 0703-0666 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 26 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 0703-0676 INJECTION, SOLUTION 50 mg INTRAVENOUS ANDA 26 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 0703-0686 INJECTION, SOLUTION 100 mg INTRAVENOUS ANDA 26 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 0703-0696 INJECTION, SOLUTION 200 mg INTRAVENOUS ANDA 26 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 0781-3420 INJECTION 20 mg SUBCUTANEOUS ANDA 26 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 0781-3425 INJECTION 50 mg SUBCUTANEOUS ANDA 26 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 0781-3427 INJECTION 100 mg SUBCUTANEOUS ANDA 26 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 0781-3430 INJECTION 200 mg SUBCUTANEOUS ANDA 26 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 42023-206 INJECTION, SOLUTION 1 mg INTRAVENOUS ANDA 26 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 42023-207 INJECTION, SOLUTION 2.50 mg INTRAVENOUS ANDA 26 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 42023-208 INJECTION, SOLUTION 5 mg INTRAVENOUS ANDA 26 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 42023-209 INJECTION, SOLUTION 10 mg INTRAVENOUS ANDA 26 sections
Treprostinil Human Prescription Drug Label 1 62332-514 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 26 sections
Treprostinil Human Prescription Drug Label 1 62332-515 INJECTION, SOLUTION 50 mg INTRAVENOUS ANDA 26 sections
Treprostinil Human Prescription Drug Label 1 62332-516 INJECTION, SOLUTION 100 mg INTRAVENOUS ANDA 26 sections
Treprostinil Human Prescription Drug Label 1 62332-517 INJECTION, SOLUTION 200 mg INTRAVENOUS ANDA 26 sections
Remodulin HUMAN PRESCRIPTION DRUG LABEL 1 66302-101 INJECTION, SOLUTION 20 mg INTRAVENOUS NDA 28 sections
Remodulin HUMAN PRESCRIPTION DRUG LABEL 1 66302-102 INJECTION, SOLUTION 50 mg INTRAVENOUS NDA 28 sections
Remodulin HUMAN PRESCRIPTION DRUG LABEL 1 66302-105 INJECTION, SOLUTION 100 mg INTRAVENOUS NDA 28 sections
Remodulin HUMAN PRESCRIPTION DRUG LABEL 1 66302-110 INJECTION, SOLUTION 200 mg INTRAVENOUS NDA 28 sections
Remodulin HUMAN PRESCRIPTION DRUG LABEL 1 66302-120 INJECTION, SOLUTION 400 mg INTRAVENOUS NDA 28 sections
TYVASO HUMAN PRESCRIPTION DRUG LABEL 1 66302-206 INHALANT 1.74 mg ORAL NDA 33 sections
Orenitram HUMAN PRESCRIPTION DRUG LABEL 1 66302-300 TABLET, EXTENDED RELEASE 0.13 mg ORAL NDA 31 sections
Orenitram HUMAN PRESCRIPTION DRUG LABEL 1 66302-302 TABLET, EXTENDED RELEASE 0.25 mg ORAL NDA 31 sections
Orenitram HUMAN PRESCRIPTION DRUG LABEL 1 66302-310 TABLET, EXTENDED RELEASE 1 mg ORAL NDA 31 sections
Orenitram HUMAN PRESCRIPTION DRUG LABEL 1 66302-325 TABLET, EXTENDED RELEASE 2.50 mg ORAL NDA 31 sections
Orenitram HUMAN PRESCRIPTION DRUG LABEL 1 66302-350 TABLET, EXTENDED RELEASE 5 mg ORAL NDA 31 sections