treprostinil 🐶 Veterinary Use | 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 µM/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
Dyspnoea 2858.88 17.41 4654 107822 542954 49949694
Infusion site pain 2605.79 17.41 994 111482 11352 50481296
Fluid retention 1925.98 17.41 1270 111206 49379 50443269
Pulmonary arterial hypertension 1593.45 17.41 816 111660 19503 50473145
Headache 1500.32 17.41 3394 109082 503141 49989507
Hypervolaemia 1403.57 17.41 810 111666 24689 50467959
Right ventricular failure 1386.10 17.41 686 111790 15207 50477441
Infusion site erythema 1310.30 17.41 550 111926 8177 50484471
Pain in jaw 1225.82 17.41 865 111611 37563 50455085
Drug ineffective 1130.73 17.41 228 112248 819105 49673543
Pulmonary hypertension 1125.98 17.41 778 111698 32639 50460009
Infusion site infection 1020.64 17.41 295 112181 1260 50491388
Dyspnoea exertional 1011.42 17.41 868 111608 50365 50442283
Device related infection 885.82 17.41 560 111916 20175 50472473
Infusion site swelling 825.59 17.41 375 112101 6801 50485847
Vascular device infection 745.13 17.41 302 112174 4082 50488566
Death 707.16 17.41 1943 110533 323436 50169212
Flushing 700.71 17.41 803 111673 66212 50426436
Oxygen saturation decreased 696.60 17.41 836 111640 72412 50420236
Diarrhoea 687.64 17.41 2849 109627 585627 49907021
Cough 643.57 17.41 1557 110919 239707 50252941
Catheter site pain 604.68 17.41 249 112227 3513 50489135
Dermatitis contact 599.63 17.41 320 112156 8326 50484322
Infusion site discharge 567.62 17.41 153 112323 473 50492175
Dizziness 547.07 17.41 1850 110626 344519 50148129
Chest pain 519.50 17.41 1186 111290 175696 50316952
Catheter site erythema 493.79 17.41 219 112257 3743 50488905
Infusion site haemorrhage 493.59 17.41 202 112274 2802 50489846
Syncope 465.70 17.41 827 111649 102175 50390473
Device dislocation 457.55 17.41 381 112095 21165 50471483
Nausea 417.60 17.41 2832 109644 702566 49790082
Nasal congestion 413.01 17.41 538 111938 50582 50442066
Therapy change 395.31 17.41 205 112271 5020 50487628
Oedema 363.81 17.41 599 111877 69582 50423066
Toxicity to various agents 360.48 17.41 30 112446 212469 50280179
Alopecia 340.38 17.41 66 112410 244981 50247667
Infusion related reaction 334.85 17.41 9 112467 169548 50323100
Hypoxia 328.73 17.41 482 111994 50641 50442007
Infusion site induration 328.07 17.41 108 112368 765 50491883
Rheumatoid arthritis 324.02 17.41 36 112440 202514 50290134
Injection site discharge 323.21 17.41 90 112386 325 50492323
Hypotension 319.51 17.41 1198 111278 234271 50258377
Hospitalisation 313.96 17.41 551 111925 67386 50425262
Lung transplant 310.33 17.41 143 112333 2682 50489966
Rash 309.93 17.41 310 112166 437161 50055487
Drug interaction 305.76 17.41 41 112435 199580 50293068
Device infusion issue 302.33 17.41 114 112362 1253 50491395
Pulmonary arterial pressure increased 299.09 17.41 147 112329 3201 50489447
Oxygen consumption increased 291.47 17.41 147 112329 3389 50489259
Infusion site warmth 289.89 17.41 112 112364 1322 50491326
Oedema peripheral 289.32 17.41 889 111587 157072 50335576
Palpitations 288.40 17.41 644 111832 93862 50398786
Neutropenia 280.95 17.41 11 112465 147954 50344694
Treatment failure 276.73 17.41 6 112470 137631 50355017
Arthropathy 274.15 17.41 20 112456 157886 50334762
Catheter site pruritus 270.87 17.41 117 112359 1870 50490778
Drug hypersensitivity 266.95 17.41 112 112364 250898 50241750
Therapeutic product effect decreased 258.68 17.41 10 112466 136040 50356608
Catheter site discharge 257.95 17.41 111 112365 1757 50490891
Device leakage 256.51 17.41 161 112315 5717 50486931
Catheter site haemorrhage 252.87 17.41 124 112352 2686 50489962
Infusion site pruritus 248.69 17.41 137 112339 3800 50488848
Catheter management 243.89 17.41 120 112356 2619 50490029
Catheter site infection 237.83 17.41 137 112339 4149 50488499
Infusion site irritation 237.60 17.41 78 112398 547 50492101
Joint swelling 226.72 17.41 132 112344 245154 50247494
Glossodynia 221.39 17.41 8 112468 115561 50377087
Throat irritation 213.25 17.41 298 112178 29941 50462707
Infusion site abscess 210.73 17.41 55 112421 144 50492504
Maternal exposure during pregnancy 209.49 17.41 49 112427 159729 50332919
Catheter site swelling 209.35 17.41 87 112389 1257 50491391
Scleroderma 200.75 17.41 128 112348 4673 50487975
Infusion site cellulitis 200.10 17.41 52 112424 133 50492515
Malaise 194.98 17.41 1344 111132 334188 50158460
Febrile neutropenia 193.42 17.41 5 112471 97662 50394986
Hepatic enzyme increased 192.70 17.41 36 112440 137344 50355304
Blood pressure decreased 192.22 17.41 400 112076 55509 50437139
Therapeutic product effect incomplete 187.93 17.41 3 112473 91512 50401136
Device related sepsis 184.66 17.41 108 112368 3367 50489281
Catheterisation cardiac 182.20 17.41 113 112363 3927 50488721
Catheter placement 181.18 17.41 89 112387 1935 50490713
Hypersensitivity 179.43 17.41 130 112346 215031 50277617
Device issue 176.66 17.41 220 112256 19752 50472896
Feeling abnormal 172.72 17.41 642 111834 124850 50367798
Injection site infection 172.18 17.41 81 112395 1595 50491053
Stomatitis 169.81 17.41 15 112461 101329 50391319
Epistaxis 165.72 17.41 409 112067 63545 50429103
Haemoptysis 165.58 17.41 242 112234 25331 50467317
Transfusion 164.86 17.41 172 112304 12733 50479915
Cardiac failure 163.99 17.41 454 112022 75586 50417062
Dyspnoea at rest 161.92 17.41 101 112375 3546 50489102
Presyncope 161.06 17.41 232 112244 23966 50468682
Central venous catheterisation 159.48 17.41 83 112393 2047 50490601
White blood cell count decreased 158.61 17.41 33 112443 116689 50375959
Hypertension 158.12 17.41 142 112334 211061 50281587
Abdominal distension 156.94 17.41 435 112041 72468 50420180
Product use in unapproved indication 156.86 17.41 33 112443 115786 50376862
Musculoskeletal stiffness 154.02 17.41 47 112429 128434 50364214
Infusion site discolouration 152.68 17.41 56 112420 566 50492082
Chest discomfort 148.74 17.41 499 111977 92223 50400425
Pulmonary oedema 148.59 17.41 333 112143 48605 50444043
Complication associated with device 148.54 17.41 173 112303 14482 50478166
Exposure during pregnancy 145.54 17.41 44 112432 120971 50371677
Pneumonia 136.84 17.41 1362 111114 377039 50115609
Infusion site oedema 136.18 17.41 50 112426 507 50492141
Product dose omission issue 136.14 17.41 784 111692 183054 50309594
Device occlusion 135.11 17.41 110 112366 5913 50486735
Pain in extremity 133.68 17.41 1050 111426 271815 50220833
Ascites 132.03 17.41 264 112212 35597 50457051
Leukopenia 131.68 17.41 4 112472 67524 50425124
Discomfort 131.06 17.41 39 112437 108341 50384307
Transplant evaluation 130.17 17.41 58 112418 1002 50491646
Unevaluable event 129.40 17.41 304 112172 45762 50446886
Infusion site reaction 129.07 17.41 73 112403 2133 50490515
Therapy non-responder 127.64 17.41 322 112154 50700 50441948
Wound 124.46 17.41 40 112436 105754 50386894
Pruritus 124.45 17.41 279 112197 283289 50209359
Dizziness postural 122.86 17.41 105 112371 6040 50486608
Catheter site rash 121.41 17.41 50 112426 705 50491943
C-reactive protein increased 119.49 17.41 7 112469 66467 50426181
Pericarditis 118.38 17.41 17 112459 78672 50413976
Vomiting 117.73 17.41 1550 110926 459208 50033440
Lower respiratory tract infection 115.57 17.41 34 112442 95167 50397481
Device alarm issue 115.26 17.41 58 112418 1330 50491318
Arthralgia 113.27 17.41 546 111930 438156 50054492
Productive cough 112.96 17.41 314 112162 52380 50440268
Infusion site inflammation 112.93 17.41 36 112440 227 50492421
Heart rate increased 112.78 17.41 403 112073 76847 50415801
Pericardial effusion 112.26 17.41 203 112273 25386 50467262
Acute respiratory failure 112.13 17.41 217 112259 28565 50464083
Psoriasis 108.37 17.41 13 112463 68987 50423661
Intentional overdose 108.16 17.41 8 112468 62496 50430152
Catheter site irritation 105.95 17.41 41 112435 486 50492162
Blood cholesterol increased 105.09 17.41 4 112472 55211 50437437
Drug abuse 102.60 17.41 8 112468 59838 50432810
Systemic lupus erythematosus 99.94 17.41 99 112377 140523 50352125
Respiratory failure 99.40 17.41 434 112042 90747 50401901
Osteoarthritis 98.27 17.41 17 112459 68589 50424059
Infusion site rash 96.78 17.41 51 112425 1291 50491357
Catheter site inflammation 95.44 17.41 41 112435 646 50492002
Acute kidney injury 94.69 17.41 231 112245 227827 50264821
Urticaria 93.47 17.41 90 112386 129471 50363177
Drug titration error 93.37 17.41 39 112437 571 50492077
Pancytopenia 93.26 17.41 35 112441 83995 50408653
Cardiac failure congestive 93.01 17.41 403 112073 83979 50408669
Electrocardiogram QT prolonged 91.64 17.41 6 112470 51880 50440768
Infusion site vesicles 90.96 17.41 34 112442 364 50492284
Thrombosis in device 90.28 17.41 63 112413 2678 50489970
Depression 88.91 17.41 144 112332 165279 50327369
Neutrophil count decreased 88.75 17.41 3 112473 46023 50446625
Walking distance test abnormal 87.77 17.41 36 112440 502 50492146
Confusional state 87.27 17.41 176 112300 185752 50306896
Infusion site discomfort 85.80 17.41 41 112435 837 50491811
Treatment noncompliance 84.69 17.41 199 112277 29951 50462697
Catheter site vesicles 84.57 17.41 30 112446 273 50492375
Purulent discharge 84.53 17.41 73 112403 4259 50488389
Respiration abnormal 83.77 17.41 78 112398 5024 50487624
Catheter site related reaction 83.40 17.41 39 112437 757 50491891
Anaphylactic reaction 82.90 17.41 11 112465 54044 50438604
Device connection issue 82.61 17.41 35 112441 532 50492116
Pulmonary veno-occlusive disease 81.72 17.41 41 112435 934 50491714
Helicobacter infection 78.95 17.41 9 112467 49693 50442955
Suicide attempt 78.21 17.41 11 112465 51721 50440927
Device breakage 77.83 17.41 101 112375 9446 50483202
Impaired healing 77.55 17.41 29 112447 69757 50422891
Depressed level of consciousness 76.35 17.41 12 112464 51941 50440707
Infusion site nodule 76.12 17.41 41 112435 1086 50491562
Device malfunction 75.48 17.41 127 112349 14994 50477654
Device use error 74.19 17.41 74 112402 5192 50487456
Decreased appetite 73.72 17.41 726 111750 200197 50292451
Disease progression 73.58 17.41 413 112063 95453 50397195
Bradycardia 71.21 17.41 27 112449 64399 50428249
Blood pressure increased 70.49 17.41 117 112359 133015 50359633
Cognitive disorder 70.06 17.41 8 112468 44115 50448533
Overdose 69.93 17.41 71 112405 99656 50392992
Seasonal allergy 68.96 17.41 120 112356 14556 50478092
Neuropathy peripheral 68.86 17.41 68 112408 96689 50395959
Pulmonary hypertensive crisis 68.78 17.41 23 112453 172 50492476
Suicidal ideation 68.65 17.41 19 112457 55366 50437282
Right ventricular dysfunction 68.54 17.41 43 112433 1525 50491123
Device programming error 67.67 17.41 18 112458 52 50492596
Angioedema 67.60 17.41 4 112472 37672 50454976
Coma 66 17.41 22 112454 56857 50435791
Blister 64.35 17.41 57 112419 85361 50407287
Alanine aminotransferase increased 64.15 17.41 61 112415 88298 50404350
Type 2 diabetes mellitus 63.71 17.41 3 112473 34372 50458276
Hyponatraemia 63.45 17.41 72 112404 96067 50396581
Infusion site pustule 63.18 17.41 15 112461 22 50492626
Device use issue 62.75 17.41 44 112432 1885 50490763
Catheter site warmth 62.53 17.41 22 112454 195 50492453
Thrombocytopenia 61.47 17.41 119 112357 127554 50365094
Inflammation 61.01 17.41 25 112451 56887 50435761
Oropharyngeal pain 60.90 17.41 337 112139 77464 50415184
Brain natriuretic peptide increased 60.81 17.41 62 112414 4465 50488183
Blood pressure systolic increased 60.03 17.41 5 112471 35444 50457204
Intentional product misuse 59.88 17.41 15 112461 46719 50445929
Wrong dose 59.84 17.41 32 112444 835 50491813
Vascular device occlusion 59.61 17.41 15 112461 32 50492616
Cor pulmonale 58.97 17.41 42 112434 1845 50490803
Emergency care 58.18 17.41 31 112445 803 50491845
Drug intolerance 57.95 17.41 270 112206 218834 50273814
Sleep disorder due to general medical condition, insomnia type 57.47 17.41 3 112473 31444 50461204
Atrial flutter 56.81 17.41 83 112393 8680 50483968
Injury 56.63 17.41 19 112457 48906 50443742
Sedation 55.69 17.41 3 112473 30607 50462041
Lactic acidosis 55.67 17.41 5 112471 33350 50459298
Infusion site extravasation 55.62 17.41 73 112403 6903 50485745
Retching 55.09 17.41 101 112375 12761 50479887
Internal haemorrhage 54.85 17.41 58 112418 4359 50488289
Plasma cell myeloma 54.21 17.41 4 112472 31318 50461330
Ill-defined disorder 53.91 17.41 27 112449 54627 50438021
Asthma 53.59 17.41 72 112404 89265 50403383
Injection site bruising 52.89 17.41 9 112467 36759 50455889
Pulmonary arterial pressure abnormal 52.82 17.41 24 112452 435 50492213
Osteoporosis 52.70 17.41 17 112459 44862 50447786
Hypoaesthesia 52.67 17.41 129 112347 127128 50365520
Device expulsion 51.89 17.41 3 112473 28819 50463829
Dizziness exertional 51.71 17.41 22 112454 338 50492310
Deep vein thrombosis 51.60 17.41 52 112424 73252 50419396
Metabolic acidosis 50.64 17.41 12 112464 38813 50453835
Catheter site extravasation 50.30 17.41 20 112456 256 50492392
Red blood cell sedimentation rate increased 50.22 17.41 4 112472 29412 50463236
Device physical property issue 50.06 17.41 36 112440 1606 50491042
Bone marrow failure 49.36 17.41 3 112473 27621 50465027
Off label use 49.00 17.41 751 111725 473675 50018973
Exercise tolerance decreased 48.49 17.41 57 112419 4817 50487831
Intentional product use issue 48.19 17.41 60 112416 76858 50415790
Fibromyalgia 47.82 17.41 20 112456 44958 50447690
Hypoglycaemia 47.77 17.41 30 112446 53551 50439097
Device maintenance issue 47.76 17.41 10 112466 4 50492644
Blood glucose increased 47.51 17.41 53 112423 71271 50421377
Paracentesis 47.43 17.41 28 112448 888 50491760
Mobility decreased 47.38 17.41 65 112411 79883 50412765
Rash maculo-papular 47.28 17.41 3 112473 26638 50466010
Medical device site haemorrhage 47.25 17.41 12 112464 27 50492621
Diabetes mellitus 47.21 17.41 25 112451 49008 50443640
Respiratory tract congestion 46.91 17.41 100 112376 14099 50478549
Localised oedema 46.90 17.41 56 112420 4811 50487837
Generalised tonic-clonic seizure 46.58 17.41 3 112473 26307 50466341
Injection site erosion 46.31 17.41 14 112462 72 50492576
Seizure 46.07 17.41 123 112353 117751 50374897
Foetal exposure during pregnancy 45.94 17.41 4 112472 27355 50465293
Loss of personal independence in daily activities 45.63 17.41 53 112423 69997 50422651
Lung disorder 45.59 17.41 209 112267 44590 50448058
Therapeutic response decreased 45.59 17.41 24 112452 47207 50445441
Irritable bowel syndrome 45.58 17.41 29 112447 51412 50441236
Gamma-glutamyltransferase increased 45.48 17.41 6 112470 29617 50463031
Knee arthroplasty 44.98 17.41 12 112464 35834 50456814
Hypocalcaemia 44.81 17.41 4 112472 26812 50465836
Agitation 44.75 17.41 32 112444 53352 50439296
Acute right ventricular failure 44.69 17.41 16 112460 150 50492498
Paraesthesia 44.38 17.41 129 112347 120114 50372534
Product quality issue 43.41 17.41 8 112468 30850 50461798
Infusion site injury 43.26 17.41 10 112466 12 50492636
Oxygen therapy 42.56 17.41 34 112442 1778 50490870
Sinus congestion 42.30 17.41 95 112381 13876 50478772
Rales 42.29 17.41 78 112398 9900 50482748
Terminal state 42.07 17.41 36 112440 2074 50490574
Product administration interrupted 41.94 17.41 27 112449 1002 50491646
Injection site reaction 41.93 17.41 30 112446 50002 50442646
Wrong technique in product usage process 40.66 17.41 38 112438 55472 50437176
Basal cell carcinoma 40.37 17.41 3 112473 23353 50469295
Cardiac failure high output 40.27 17.41 17 112459 256 50492392
Bacteraemia 40.24 17.41 95 112381 14338 50478310
Hyperkalaemia 40.08 17.41 29 112447 48060 50444588
Somnolence 39.77 17.41 193 112283 154792 50337856
Rhinovirus infection 39.68 17.41 44 112432 3490 50489158
Dyspepsia 39.42 17.41 291 112185 73806 50418842
Respiratory distress 39.40 17.41 153 112323 30336 50462312
Femur fracture 39.28 17.41 17 112459 37447 50455201
Hepatic function abnormal 39.05 17.41 12 112464 32669 50459979
Delirium 38.99 17.41 18 112458 38174 50454474
Chronic respiratory failure 38.64 17.41 31 112445 1631 50491017
Subcutaneous drug absorption impaired 38.56 17.41 13 112463 100 50492548
Cardiac disorder 38.30 17.41 193 112283 42786 50449862
Liver injury 38.14 17.41 5 112471 24801 50467847
Oxygen saturation abnormal 38.12 17.41 38 112438 2664 50489984
Pulmonary embolism 37.61 17.41 109 112367 101595 50391053
Sepsis 37.47 17.41 456 112020 132469 50360179
Hepatic steatosis 37.29 17.41 5 112471 24379 50468269
Intentional medical device removal by patient 37.27 17.41 13 112463 112 50492536
Disease complication 37.19 17.41 38 112438 2744 50489904
Swollen tongue 37.04 17.41 9 112467 28621 50464027
Breast cancer 36.89 17.41 25 112451 42865 50449783
Cerebral infarction 36.71 17.41 3 112473 21601 50471047
Weight decreased 36.67 17.41 693 111783 220552 50272096
Dysphagia 36.65 17.41 73 112403 77445 50415203
Dialysis 36.56 17.41 71 112405 9367 50483281
Agranulocytosis 36.33 17.41 3 112473 21418 50471230
Drug-induced liver injury 36.02 17.41 9 112467 28086 50464562
Hyperglycaemia 35.88 17.41 18 112458 36387 50456261
Arthritis 35.80 17.41 88 112388 86633 50406015
Blood creatinine increased 35.77 17.41 72 112404 76088 50416560
Aggression 35.69 17.41 3 112473 21113 50471535
Product prescribing error 35.37 17.41 3 112473 20958 50471690
Abdominal pain upper 35.21 17.41 523 111953 158786 50333862
Infusion site haematoma 34.59 17.41 15 112461 242 50492406
Head discomfort 34.57 17.41 76 112400 10943 50481705
Psychotic disorder 34.51 17.41 4 112472 21808 50470840
Multiple sclerosis 34.40 17.41 3 112473 20490 50472158
Hepatotoxicity 34.37 17.41 9 112467 27217 50465431
Cardiac failure acute 34.35 17.41 64 112412 8186 50484462
Cardiac ablation 34.12 17.41 26 112450 1268 50491380
Hallucination 34.10 17.41 32 112444 46625 50446023
Clostridium difficile infection 33.97 17.41 129 112347 25310 50467338
Injection site irritation 33.88 17.41 45 112431 4305 50488343
Gout 33.62 17.41 77 112399 11393 50481255
Endotracheal intubation 33.58 17.41 32 112444 2122 50490526
Disease recurrence 33.54 17.41 3 112473 20078 50472570
Drug eruption 33.47 17.41 6 112470 23600 50469048
Renal impairment 33.46 17.41 74 112402 75587 50417061
Drug ineffective for unapproved indication 33.43 17.41 4 112472 21277 50471371
Catheterisation cardiac abnormal 33.09 17.41 14 112462 212 50492436
Hypercalcaemia 32.97 17.41 6 112470 23346 50469302
Disturbance in attention 32.93 17.41 14 112462 31172 50461476
Balance disorder 32.92 17.41 67 112409 70523 50422125
Drug dependence 32.87 17.41 3 112473 19756 50472892
Sinus disorder 32.86 17.41 103 112373 18355 50474293
Bursitis 32.77 17.41 5 112471 22130 50470518
Infusion site dryness 32.62 17.41 7 112469 4 50492644
Sleep disorder 32.52 17.41 48 112428 57235 50435413
Infusion site dermatitis 32.48 17.41 8 112468 15 50492633
Catheter site erosion 31.93 17.41 10 112466 59 50492589
Catheter site scab 31.91 17.41 13 112463 178 50492470
Hepatitis 31.84 17.41 15 112461 31438 50461210
Pancreatitis acute 31.77 17.41 7 112469 23805 50468843
Eczema 31.69 17.41 6 112470 22696 50469952
Emotional distress 31.69 17.41 12 112464 28651 50463997
Medical device change 31.27 17.41 15 112461 309 50492339
Pulmonary artery aneurysm 31.21 17.41 9 112467 38 50492610
No adverse event 31.05 17.41 18 112458 33560 50459088
Metastases to liver 31.04 17.41 4 112472 20100 50472548
Infusion site scar 30.75 17.41 15 112461 321 50492327
Dysarthria 30.60 17.41 23 112453 37380 50455268
Viral infection 30.58 17.41 140 112336 29846 50462802
Catheter site discolouration 30.45 17.41 11 112465 106 50492542
Asthenia 30.44 17.41 926 111550 318116 50174532
Platelet count decreased 30.36 17.41 118 112358 100608 50392040
Drug withdrawal syndrome 30.34 17.41 9 112467 25072 50467576
Blood potassium decreased 30.22 17.41 162 112314 36783 50455865
Migraine 30.01 17.41 277 112199 75003 50417645
Extra dose administered 29.94 17.41 46 112430 5030 50487618
Skin lesion 29.86 17.41 11 112465 26716 50465932
Pulmonary pain 29.82 17.41 31 112445 2284 50490364
Aphasia 29.76 17.41 13 112463 28481 50464167
Ventilation perfusion mismatch 29.69 17.41 13 112463 215 50492433
Right ventricular enlargement 29.42 17.41 14 112462 283 50492365
Jaundice 29.32 17.41 11 112465 26418 50466230
Aspartate aminotransferase increased 29.26 17.41 83 112393 77915 50414733
Contusion 29.17 17.41 139 112337 112044 50380604
Gastrointestinal haemorrhage 28.83 17.41 269 112207 73052 50419596
Catheter site nodule 28.75 17.41 9 112467 53 50492595
Hip arthroplasty 28.58 17.41 16 112460 30413 50462235
Dry eye 28.56 17.41 18 112458 32077 50460571
Bendopnoea 28.46 17.41 7 112469 13 50492635
Paranasal sinus hypersecretion 28.40 17.41 35 112441 3107 50489541
Bone disorder 28.31 17.41 4 112472 18748 50473900
Medical device site odour 28.24 17.41 6 112470 3 50492645
Hyperlipidaemia 28.19 17.41 3 112473 17487 50475161
Cardiac output increased 28.16 17.41 11 112465 134 50492514
Nocturnal dyspnoea 28.09 17.41 21 112455 995 50491653
Cardioversion 28 17.41 22 112454 1123 50491525
Sickle cell anaemia with crisis 27.97 17.41 42 112434 4501 50488147
Administration site odour 27.89 17.41 8 112468 33 50492615
Ejection fraction decreased 27.84 17.41 4 112472 18516 50474132
Nasal dryness 27.83 17.41 37 112439 3542 50489106
Sinusitis 27.66 17.41 244 112232 170314 50322334
Epilepsy 27.48 17.41 7 112469 21560 50471088
Right ventricular systolic pressure increased 27.43 17.41 16 112460 496 50492152
Myalgia 27.40 17.41 408 112068 123911 50368737
Sickle cell anaemia 27.37 17.41 16 112460 498 50492150
Inappropriate schedule of product administration 27.27 17.41 76 112400 71755 50420893
Infusion site mass 27.22 17.41 22 112454 1170 50491478
Injection site pustule 27.19 17.41 9 112467 65 50492583
Dyskinesia 27.12 17.41 14 112462 27847 50464801
Heart and lung transplant 27.01 17.41 10 112466 104 50492544
Product leakage 26.86 17.41 16 112460 516 50492132
Fracture 26.85 17.41 3 112473 16830 50475818
Incorrect drug administration rate 26.80 17.41 31 112445 2575 50490073
Diabetic ketoacidosis 26.55 17.41 4 112472 17868 50474780
Cataract 26.50 17.41 40 112436 47260 50445388
Liver transplant 26.48 17.41 28 112448 2104 50490544
Application site pruritus 26.42 17.41 37 112439 3722 50488926
Hallucination, visual 26.34 17.41 3 112473 16579 50476069
Peripheral swelling 26.29 17.41 621 111855 205315 50287333
Altered state of consciousness 26.26 17.41 8 112468 21902 50470746
Suture related complication 26.21 17.41 11 112465 163 50492485
Medication error 26.10 17.41 25 112451 36079 50456569
Flatulence 26.05 17.41 132 112344 29326 50463322
Coronary artery disease 26.00 17.41 17 112459 29709 50462939
Hypokalaemia 25.93 17.41 104 112372 87888 50404760
Oral herpes 25.88 17.41 7 112469 20718 50471930
Echocardiogram abnormal 25.87 17.41 21 112455 1124 50491524
Muscular weakness 25.72 17.41 116 112360 94897 50397751
Joint stiffness 25.62 17.41 18 112458 30290 50462358
Joint range of motion decreased 25.61 17.41 5 112471 18507 50474141
Pain 25.60 17.41 1040 111436 577863 49914785
Product use issue 25.51 17.41 211 112265 149264 50343384
Loss of consciousness 25.19 17.41 348 112128 104005 50388643
Decreased activity 25.14 17.41 43 112433 5144 50487504
Catheter site dermatitis 24.38 17.41 8 112468 56 50492592
Urinary retention 24.27 17.41 14 112462 26176 50466472
Hypothyroidism 24.24 17.41 24 112452 34101 50458547
Tendonitis 24.22 17.41 4 112472 16701 50475947
Transaminases increased 24.22 17.41 16 112460 27808 50464840
Cerebrovascular accident 24.21 17.41 118 112358 94562 50398086
Erythema 23.94 17.41 209 112267 146205 50346443
Transplant 23.92 17.41 16 112460 634 50492014
Incorrect route of product administration 23.89 17.41 6 112470 18660 50473988
Product communication issue 23.84 17.41 13 112463 353 50492295
Diagnostic procedure 23.78 17.41 9 112467 100 50492548
Gait disturbance 23.71 17.41 216 112260 149789 50342859
Diuretic therapy 23.70 17.41 9 112467 101 50492547
Live birth 23.63 17.41 4 112472 16404 50476244
Medical procedure 23.62 17.41 12 112464 281 50492367
Cardio-respiratory arrest 23.59 17.41 53 112423 53839 50438809
Infusion site erosion 23.21 17.41 5 112471 3 50492645
Diplopia 23.14 17.41 7 112469 19253 50473395
Speech disorder 23.03 17.41 27 112449 35521 50457127
Intracardiac pressure increased 22.99 17.41 7 112469 37 50492611
Haemodynamic test abnormal 22.99 17.41 7 112469 37 50492611
Visual acuity reduced 22.99 17.41 8 112468 20131 50472517
Skin irritation 22.79 17.41 52 112424 7675 50484973
Sleep study 22.64 17.41 6 112470 17 50492631
Right ventricular dilatation 22.59 17.41 18 112458 938 50491710
Platelet count increased 22.19 17.41 3 112473 14537 50478111
Acute hepatic failure 22.19 17.41 4 112472 15673 50476975
Colitis 22.15 17.41 32 112444 38497 50454151
Abnormal behaviour 22.12 17.41 8 112468 19650 50472998
Full blood count decreased 22.09 17.41 11 112465 22335 50470313
Infection 22.04 17.41 262 112214 172692 50319956
Eosinophilia 22.01 17.41 7 112469 18645 50474003
Malabsorption from injection site 21.91 17.41 6 112470 20 50492628
Catheter site abscess 21.69 17.41 6 112470 21 50492627
Exposure via skin contact 21.67 17.41 10 112466 188 50492460
Dry throat 21.62 17.41 42 112434 5542 50487106
Dysentery 21.46 17.41 16 112460 755 50491893
Catheter removal 21.30 17.41 12 112464 348 50492300
Spinal osteoarthritis 21.29 17.41 3 112473 14089 50478559
Skin exfoliation 21.28 17.41 26 112450 33586 50459062
Hemiparesis 21.17 17.41 9 112467 20039 50472609
Rhinorrhoea 21.16 17.41 191 112285 51392 50441256
Urinary tract infection 20.92 17.41 361 112115 223659 50268989
General physical health deterioration 20.85 17.41 209 112267 142225 50350423
Blood calcium decreased 20.76 17.41 10 112466 20696 50471952
Pneumonia aspiration 20.68 17.41 23 112453 30981 50461667
Mood swings 20.67 17.41 5 112471 15949 50476699
Metapneumovirus infection 20.55 17.41 16 112460 806 50491842
Device data issue 20.45 17.41 4 112472 0 50492648
Cardiac operation 20.37 17.41 28 112448 2767 50489881
Obesity 20.33 17.41 6 112470 16769 50475879
Cyanosis 20.27 17.41 77 112399 15107 50477541
Catheter site cellulitis 20.12 17.41 10 112466 223 50492425
Administration site infection 20.09 17.41 5 112471 10 50492638
Herpes zoster 20.02 17.41 85 112391 70701 50421947
Adverse drug reaction 19.81 17.41 60 112416 55162 50437486
Secretion discharge 19.65 17.41 57 112419 9734 50482914
Leukocytosis 19.63 17.41 13 112463 22566 50470082
Musculoskeletal disorder 19.62 17.41 7 112469 17342 50475306
Product label confusion 19.60 17.41 13 112463 508 50492140
Vertigo 19.55 17.41 55 112421 51777 50440871
Orthostatic hypotension 19.52 17.41 22 112454 29459 50463189
Renal disorder 19.45 17.41 116 112360 27389 50465259
Blood pressure fluctuation 19.39 17.41 31 112445 35792 50456856
Cystitis 19.36 17.41 44 112432 44520 50448128
Ear congestion 19.22 17.41 23 112453 1980 50490668
Acute myocardial infarction 19.22 17.41 22 112454 29251 50463397
Rash erythematous 19.02 17.41 30 112446 34822 50457826
Influenza 19.00 17.41 292 112184 89246 50403402
Photosensitivity reaction 18.93 17.41 3 112473 12908 50479740
Acne 18.84 17.41 10 112466 19585 50473063
Carpal tunnel syndrome 18.79 17.41 7 112469 16886 50475762
Therapeutic response unexpected 18.73 17.41 6 112470 15909 50476739
Blood culture positive 18.66 17.41 34 112442 4274 50488374
Cardiac pacemaker insertion 18.65 17.41 31 112445 3622 50489026
Diet noncompliance 18.60 17.41 10 112466 264 50492384
Immunodeficiency 18.53 17.41 5 112471 14823 50477825
Pneumonitis 18.50 17.41 23 112453 29487 50463161
Withdrawal syndrome 18.41 17.41 8 112468 17582 50475066
Balloon atrial septostomy 18.40 17.41 7 112469 79 50492569
Pulmonary arterial pressure decreased 18.40 17.41 7 112469 79 50492569
Liver function test abnormal 18.29 17.41 45 112431 44294 50448354
Impaired work ability 18.22 17.41 4 112472 13636 50479012
Infusion site cyst 18.21 17.41 4 112472 3 50492645
Infusion site lymphadenopathy 18.21 17.41 4 112472 3 50492645
Haematuria 18.21 17.41 18 112458 25595 50467053
Cardiomyopathy 18.13 17.41 6 112470 15580 50477068
Vascular resistance pulmonary increased 18.04 17.41 6 112470 44 50492604
Heart valve replacement 18.00 17.41 12 112464 473 50492175
Abdominal cavity drainage 17.87 17.41 11 112465 377 50492271
Pulmonary artery occlusion 17.76 17.41 5 112471 19 50492629
Exposure via eye contact 17.68 17.41 4 112472 4 50492644
Infusion site thrombosis 17.58 17.41 7 112469 90 50492558
Product storage error 17.56 17.41 3 112473 12221 50480427
Encephalopathy 17.48 17.41 30 112446 33681 50458967
Conjunctivitis 17.45 17.41 7 112469 16138 50476510

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
Infusion site pain 965.18 23.03 279 32879 2646 29538723
Dyspnoea 964.81 23.03 1475 31683 325257 29216112
Fluid retention 726.48 23.03 404 32754 23156 29518213
Pulmonary arterial hypertension 643.25 23.03 260 32898 7189 29534180
Right ventricular failure 628.79 23.03 260 32898 7630 29533739
Headache 598.18 23.03 847 32311 173160 29368209
Pulmonary hypertension 521.79 23.03 300 32858 18308 29523061
Hypervolaemia 505.70 23.03 288 32870 17257 29524112
Pain in jaw 490.23 23.03 246 32912 11395 29529974
Infusion site erythema 484.03 23.03 144 33014 1520 29539849
Oxygen saturation decreased 362.74 23.03 341 32817 44596 29496773
Flushing 330.72 23.03 268 32890 28724 29512645
Dyspnoea exertional 288.81 23.03 274 32884 36216 29505153
Infusion site infection 241.40 23.03 62 33096 356 29541013
Cough 211.14 23.03 449 32709 126278 29415091
Device dislocation 206.27 23.03 101 33057 4426 29536943
Infusion site haemorrhage 203.69 23.03 61 33097 659 29540710
Death 203.67 23.03 838 32320 341246 29200123
Diarrhoea 202.79 23.03 821 32337 331877 29209492
Device related infection 198.46 23.03 154 33004 15482 29525887
Infusion site swelling 191.89 23.03 74 33084 1796 29539573
Oxygen consumption increased 191.65 23.03 67 33091 1220 29540149
Vascular device infection 184.17 23.03 78 33080 2427 29538942
Drug ineffective 182.86 23.03 90 33068 363080 29178289
Drug interaction 172.11 23.03 13 33145 197372 29343997
Therapy change 168.38 23.03 74 33084 2524 29538845
Toxicity to various agents 168.36 23.03 6 33152 173655 29367714
Oedema 163.67 23.03 214 32944 40269 29501100
Catheter site pain 159.63 23.03 57 33101 1107 29540262
Dermatitis contact 155.28 23.03 73 33085 2919 29538450
Lung transplant 150.46 23.03 61 33097 1695 29539674
Catheter site erythema 149.99 23.03 55 33103 1156 29540213
Infusion site discharge 141.33 23.03 31 33127 76 29541293
Hypoxia 133.53 23.03 211 32947 47168 29494201
Nausea 128.57 23.03 651 32507 288604 29252765
Nasal congestion 127.31 23.03 130 33028 18749 29522620
Pain in extremity 126.96 23.03 339 32819 110094 29431275
Dizziness 126.15 23.03 482 32676 189202 29352167
Therapy non-responder 116.59 23.03 158 33000 30753 29510616
Catheter management 114.49 23.03 41 33117 803 29540566
Oedema peripheral 114.10 23.03 313 32845 103244 29438125
Syncope 111.42 23.03 267 32891 81104 29460265
Infusion site warmth 107.70 23.03 25 33133 86 29541283
Throat irritation 103.84 23.03 83 33075 8702 29532667
Injection site discharge 88.80 23.03 21 33137 80 29541289
Device infusion issue 84.04 23.03 30 33128 582 29540787
Pulmonary arterial pressure increased 83.78 23.03 35 33123 1051 29540318
Catheter site pruritus 82.17 23.03 25 33133 286 29541083
Feeling abnormal 81.40 23.03 185 32973 54260 29487109
Infusion site cellulitis 78.64 23.03 19 33139 81 29541288
Infusion site induration 78.06 23.03 22 33136 188 29541181
Pancytopenia 76.77 23.03 4 33154 83164 29458205
Injection site infection 76.16 23.03 31 33127 870 29540499
Catheter site discharge 75.10 23.03 27 33131 535 29540834
Catheterisation cardiac 74.74 23.03 40 33118 2113 29539256
Abdominal discomfort 72.97 23.03 164 32994 47739 29493630
Hospitalisation 71.79 23.03 159 32999 45829 29495540
Thrombocytopenia 71.26 23.03 31 33127 134792 29406577
Catheter site rash 70.85 23.03 20 33138 172 29541197
Product use in unapproved indication 69.53 23.03 8 33150 86867 29454502
Infusion site irritation 69.37 23.03 20 33138 187 29541182
Catheter site infection 68.44 23.03 37 33121 1995 29539374
Complication associated with device 67.73 23.03 52 33106 5139 29536230
Catheter site swelling 65.95 23.03 21 33137 282 29541087
Chest pain 64.17 23.03 272 32886 111701 29429668
Hypotension 63.22 23.03 403 32755 193951 29347418
Peripheral swelling 62.63 23.03 185 32973 63554 29477815
Acute kidney injury 61.93 23.03 128 33030 265139 29276230
Drug abuse 59.98 23.03 9 33149 79874 29461495
Transplant evaluation 59.96 23.03 22 33136 463 29540906
Abdominal distension 59.92 23.03 148 33010 45763 29495606
Infusion site discomfort 59.82 23.03 16 33142 110 29541259
Catheter placement 59.22 23.03 24 33134 666 29540703
Central venous catheterisation 59.12 23.03 27 33131 1009 29540360
Device issue 56.88 23.03 56 33102 7724 29533645
Transfusion 56.11 23.03 54 33104 7244 29534125
Rhabdomyolysis 55.87 23.03 3 33155 60805 29480564
Infusion site rash 54.39 23.03 19 33139 345 29541024
Device leakage 54.25 23.03 43 33115 4452 29536917
Heart rate increased 53.45 23.03 128 33030 38810 29502559
Infusion site inflammation 53.45 23.03 12 33146 34 29541335
Ventilation perfusion mismatch 53.15 23.03 13 33145 59 29541310
Infusion site abscess 53.10 23.03 11 33147 18 29541351
Infusion site oedema 52.53 23.03 15 33143 135 29541234
Haemoptysis 51.52 23.03 109 33049 30441 29510928
Productive cough 49.81 23.03 109 33049 31150 29510219
Catheter site haemorrhage 49.41 23.03 30 33128 2018 29539351
White blood cell count decreased 49.31 23.03 16 33142 83346 29458023
Cardiac failure 47.25 23.03 195 32963 79092 29462277
Leukopenia 46.99 23.03 4 33154 55199 29486170
Catheterisation cardiac abnormal 46.09 23.03 11 33147 44 29541325
Device breakage 45.99 23.03 27 33131 1707 29539662
Infusion site pruritus 44.29 23.03 18 33140 503 29540866
Weight increased 42.14 23.03 184 32974 76483 29464886
Walking distance test abnormal 41.86 23.03 13 33145 160 29541209
Malaise 41.79 23.03 314 32844 159288 29382081
Infusion site reaction 41.23 23.03 19 33139 725 29540644
Hypertension 41.17 23.03 42 33116 116572 29424797
Product administration interrupted 40.69 23.03 15 33143 320 29541049
Drug titration error 40.27 23.03 16 33142 421 29540948
Confusional state 39.79 23.03 51 33107 127826 29413543
Exercise tolerance decreased 39.71 23.03 35 33123 4196 29537173
Right ventricular dysfunction 39.66 23.03 20 33138 933 29540436
Pulmonary arterial pressure abnormal 39.63 23.03 13 33145 193 29541176
Infusion site vesicles 38.77 23.03 12 33146 146 29541223
Infusion site scar 37.91 23.03 9 33149 35 29541334
Catheter site irritation 37.49 23.03 11 33147 110 29541259
Device physical property issue 37.40 23.03 17 33141 628 29540741
Product dose omission issue 37.08 23.03 209 32949 96174 29445195
Respiratory failure 36.96 23.03 210 32948 96921 29444448
Neuropathy peripheral 36.44 23.03 17 33141 71010 29470359
Myocardial infarction 36.41 23.03 42 33116 110254 29431115
Internal haemorrhage 36.40 23.03 34 33124 4393 29536976
Palpitations 36.25 23.03 99 33059 32505 29508864
Hallucination 36.05 23.03 4 33154 44708 29496661
Device malfunction 35.93 23.03 46 33112 8461 29532908
Device alarm issue 35.85 23.03 16 33142 566 29540803
Acute respiratory failure 35.37 23.03 86 33072 26316 29515053
Respiration abnormal 35.30 23.03 27 33131 2653 29538716
Terminal state 35.00 23.03 30 33128 3464 29537905
Neutrophil count decreased 34.87 23.03 4 33154 43563 29497806
Anaemia 34.52 23.03 113 33045 200838 29340531
Blood creatine phosphokinase increased 34.43 23.03 3 33155 40641 29500728
Overdose 33.97 23.03 24 33134 79795 29461574
Chest discomfort 33.86 23.03 121 33037 45862 29495507
Ascites 33.78 23.03 104 33054 36515 29504854
C-reactive protein increased 33.18 23.03 5 33153 44258 29497111
Device related sepsis 32.56 23.03 25 33133 2470 29538899
Rash 32.41 23.03 107 33051 189712 29351657
Condition aggravated 32.37 23.03 277 32881 146018 29395351
Blood pressure decreased 31.23 23.03 117 33041 45360 29496009
Haematuria 30.86 23.03 6 33152 44133 29497236
Treatment failure 30.56 23.03 3 33155 36936 29504433
Therapeutic product effect incomplete 30.49 23.03 4 33154 39301 29502068
Cor pulmonale 30.19 23.03 15 33143 678 29540691
Hypoglycaemia 29.08 23.03 9 33149 48337 29493032
Swelling 28.72 23.03 96 33062 35187 29506182
Plasma cell myeloma 28.27 23.03 4 33154 37111 29504258
Dizziness exertional 28.26 23.03 9 33149 121 29541248
Hepatic function abnormal 28.16 23.03 5 33153 39254 29502115
Liver transplant 27.61 23.03 22 33136 2294 29539075
Sickle cell anaemia with crisis 27.37 23.03 23 33135 2585 29538784
Drug hypersensitivity 27.27 23.03 22 33136 68384 29472985
Infusion site nodule 27.00 23.03 8 33150 83 29541286
Cardiac output increased 26.99 23.03 7 33151 42 29541327
Coronary artery disease 26.98 23.03 8 33150 44182 29497187
Cardiac ablation 26.81 23.03 14 33144 703 29540666
Device connection issue 26.78 23.03 11 33147 316 29541053
Agitation 26.75 23.03 12 33146 51292 29490077
Hyperkalaemia 26.73 23.03 18 33140 61374 29479995
Delirium 26.22 23.03 6 33152 39391 29501978
Fatigue 26.13 23.03 499 32659 316322 29225047
Deep vein thrombosis 26.12 23.03 16 33142 57383 29483986
Acute myocardial infarction 25.77 23.03 11 33147 48427 29492942
Presyncope 25.50 23.03 56 33102 16033 29525336
Hyponatraemia 25.43 23.03 23 33135 67610 29473759
Catheter site discolouration 25.14 23.03 6 33152 24 29541345
Oxygen saturation abnormal 25.06 23.03 16 33142 1176 29540193
Foetal exposure during pregnancy 24.99 23.03 4 33154 33863 29507506
Catheter removal 24.81 23.03 9 33149 183 29541186
Platelet count decreased 24.76 23.03 50 33108 104622 29436747
Device occlusion 24.76 23.03 31 33127 5577 29535792
Diuretic therapy 24.75 23.03 6 33152 26 29541343
Gout 24.72 23.03 57 33101 16854 29524515
Blood pressure increased 24.45 23.03 28 33130 73775 29467594
Oropharyngeal pain 24.11 23.03 80 33078 29205 29512164
Urticaria 23.83 23.03 16 33142 54644 29486725
Psoriasis 23.34 23.03 4 33154 32223 29509146
Blood pressure systolic decreased 23.27 23.03 25 33133 3819 29537550
Device maintenance issue 23.18 23.03 4 33154 0 29541369
Infusion site scab 23.18 23.03 4 33154 0 29541369

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Dyspnoea 3114.03 18.38 5143 117034 713531 63663024
Infusion site pain 2740.03 18.38 946 121231 9451 64367104
Fluid retention 2407.69 18.38 1464 120713 58142 64318413
Pulmonary arterial hypertension 1996.41 18.38 970 121207 24397 64352158
Headache 1706.19 18.38 3342 118835 526125 63850430
Hypervolaemia 1692.04 18.38 997 121180 37288 64339267
Right ventricular failure 1686.26 18.38 820 121357 20651 64355904
Pulmonary hypertension 1423.69 18.38 933 121244 42206 64334349
Infusion site erythema 1411.52 18.38 520 121657 6353 64370202
Pain in jaw 1400.23 18.38 904 121273 39851 64336704
Infusion site infection 957.89 18.38 272 121905 1308 64375247
Dyspnoea exertional 948.93 18.38 916 121261 72814 64303741
Death 920.03 18.38 2481 119696 480224 63896331
Device related infection 920.01 18.38 625 121552 30001 64346554
Drug ineffective 849.85 18.38 270 121907 839977 63536578
Infusion site swelling 840.56 18.38 335 121842 5130 64371425
Oxygen saturation decreased 795.29 18.38 997 121180 106179 64270376
Flushing 795.23 18.38 858 121319 77790 64298765
Vascular device infection 794.01 18.38 333 121844 5847 64370708
Catheter site pain 691.39 18.38 275 121902 4187 64372368
Diarrhoea 660.17 18.38 2906 119271 719798 63656757
Cough 616.35 18.38 1595 120582 300553 64076002
Catheter site erythema 568.91 18.38 245 121932 4604 64371951
Toxicity to various agents 563.24 18.38 31 122146 363482 64013073
Dizziness 562.93 18.38 1940 120237 428223 63948332
Infusion site haemorrhage 549.51 18.38 195 121982 2120 64374435
Drug interaction 531.08 18.38 41 122136 362042 64014513
Device dislocation 510.48 18.38 378 121799 20800 64355755
Chest pain 497.55 18.38 1262 120915 234718 64141837
Syncope 481.61 18.38 977 121200 156658 64219897
Oedema 474.45 18.38 718 121459 91217 64285338
Nausea 462.90 18.38 2797 119380 783003 63593552
Infusion site discharge 433.97 18.38 117 122060 445 64376110
Lung transplant 412.27 18.38 186 121991 3922 64372633
Nasal congestion 412.12 18.38 536 121641 59122 64317433
Neutropenia 402.79 18.38 11 122166 239613 64136942
Therapy change 400.15 18.38 210 121967 6224 64370331
Hypoxia 367.77 18.38 625 121552 87524 64289031
Oxygen consumption increased 365.52 18.38 177 122000 4404 64372151
Dermatitis contact 362.45 18.38 221 121956 8779 64367776
Oedema peripheral 351.27 18.38 1033 121144 209284 64167271
Hospitalisation 348.37 18.38 559 121618 74648 64301907
Febrile neutropenia 338.66 18.38 3 122174 187654 64188901
Infusion site warmth 319.28 18.38 107 122070 965 64375590
Injection site discharge 318.44 18.38 87 122090 352 64376203
Catheter management 308.67 18.38 143 122034 3212 64373343
Catheter site pruritus 297.01 18.38 122 122055 2026 64374529
Infusion site induration 295.90 18.38 95 122082 738 64375817
Pulmonary arterial pressure increased 295.52 18.38 148 122029 3968 64372587
Catheter site discharge 295.37 18.38 123 122054 2118 64374437
Catheter site infection 282.41 18.38 160 122017 5533 64371022
Device leakage 277.77 18.38 181 121996 8085 64368470
Infusion related reaction 274.62 18.38 8 122169 164459 64212096
Palpitations 270.71 18.38 606 121571 103882 64272673
Infusion site irritation 264.17 18.38 76 122101 386 64376169
Hypotension 259.37 18.38 1412 120765 379562 63996993
Device infusion issue 246.99 18.38 101 122076 1657 64374898
Catheterisation cardiac 244.55 18.38 138 122039 4735 64371820
Catheter site haemorrhage 243.98 18.38 135 122042 4456 64372099
Infusion site abscess 240.54 18.38 60 122117 153 64376402
Catheter site swelling 237.07 18.38 96 122081 1534 64375021
Throat irritation 232.22 18.38 298 121879 32413 64344142
Catheter placement 224.56 18.38 106 122071 2487 64374068
Infusion site pruritus 221.00 18.38 105 122072 2501 64374054
Product use in unapproved indication 220.92 18.38 35 122142 176583 64199972
Infusion site cellulitis 220.38 18.38 59 122118 217 64376338
Device related sepsis 216.36 18.38 130 122047 5025 64371530
Feeling abnormal 215.91 18.38 649 121528 132953 64243602
Product dose omission issue 213.64 18.38 831 121346 193916 64182639
Transfusion 213.36 18.38 214 121963 17780 64358775
Central venous catheterisation 209.95 18.38 103 122074 2638 64373917
Rheumatoid arthritis 209.04 18.38 31 122146 164263 64212292
Drug abuse 208.77 18.38 10 122167 132364 64244191
Injection site infection 208.20 18.38 91 122086 1774 64374781
Rash 208.04 18.38 343 121834 458206 63918349
Acute kidney injury 205.70 18.38 334 121843 448906 63927649
Pain in extremity 199.10 18.38 1113 121064 301972 64074583
Drug hypersensitivity 198.97 18.38 101 122076 237714 64138841
Malaise 192.16 18.38 1346 120831 394901 63981654
Treatment failure 190.29 18.38 7 122170 116809 64259746
Complication associated with device 187.41 18.38 184 121993 14896 64361659
Therapeutic product effect decreased 184.23 18.38 8 122169 115343 64261212
Therapeutic product effect incomplete 176.61 18.38 4 122173 103478 64273077
Scleroderma 175.49 18.38 111 122066 4707 64371848
White blood cell count decreased 170.94 18.38 44 122133 157793 64218762
Transplant evaluation 170.66 18.38 75 122102 1482 64375073
Device issue 169.73 18.38 212 121965 22436 64354119
Abdominal distension 167.15 18.38 479 121698 95515 64281040
Pancytopenia 165.00 18.38 35 122142 143274 64233281
Infusion site oedema 160.47 18.38 56 122121 577 64375978
Rhabdomyolysis 158.70 18.38 3 122174 91723 64284832
Leukopenia 158.50 18.38 8 122169 101234 64275321
Alopecia 156.51 18.38 59 122118 165631 64210924
Unevaluable event 153.93 18.38 313 121864 50176 64326379
Presyncope 153.13 18.38 254 121923 34835 64341720
Catheter site rash 151.55 18.38 60 122117 901 64375654
Haemoptysis 150.64 18.38 305 121872 48743 64327812
Cardiac failure 149.24 18.38 570 121607 131803 64244752
Hypertension 147.67 18.38 164 122013 259097 64117458
Blood pressure decreased 146.08 18.38 426 121751 85773 64290782
Stomatitis 145.75 18.38 18 122159 109587 64266968
Arthropathy 142.45 18.38 28 122149 120939 64255616
Chest discomfort 140.08 18.38 511 121666 115595 64260960
Thrombocytopenia 137.11 18.38 133 122044 223668 64152887
C-reactive protein increased 135.42 18.38 12 122165 94897 64281658
Intentional overdose 135.02 18.38 9 122168 89935 64286620
Epistaxis 133.14 18.38 449 121728 97682 64278873
Device occlusion 128.89 18.38 124 122053 9789 64366766
Joint swelling 127.35 18.38 132 122045 215250 64161305
Infusion site rash 126.83 18.38 55 122122 1051 64375504
Hepatic enzyme increased 126.56 18.38 44 122133 129899 64246656
Heart rate increased 125.59 18.38 442 121735 98233 64278322
Acute respiratory failure 125.19 18.38 286 121891 49648 64326907
Pulmonary oedema 122.14 18.38 377 121800 78297 64298258
Electrocardiogram QT prolonged 122.10 18.38 7 122170 79441 64297114
Device alarm issue 121.26 18.38 63 122114 1827 64374728
Catheter site irritation 121.13 18.38 44 122133 514 64376041
Infusion site reaction 120.99 18.38 65 122112 2021 64374534
Depressed level of consciousness 119.77 18.38 9 122168 81427 64295128
Vomiting 117.41 18.38 1574 120603 549543 63827012
Therapy non-responder 116.79 18.38 331 121846 65568 64310987
Pneumonia 116.68 18.38 1592 120585 557984 63818571
Confusional state 115.74 18.38 198 121979 260946 64115609
Neutrophil count decreased 115.06 18.38 8 122169 77188 64299367
Ascites 112.40 18.38 314 121863 61687 64314868
Bradycardia 111.78 18.38 42 122135 118177 64258378
Overdose 110.90 18.38 84 122093 159482 64217073
Infusion site inflammation 110.67 18.38 33 122144 194 64376361
Infusion site discolouration 110.48 18.38 41 122136 511 64376044
Pruritus 110.33 18.38 270 121907 312130 64064425
Musculoskeletal stiffness 109.61 18.38 48 122129 123158 64253397
Productive cough 106.48 18.38 343 121834 72860 64303695
Pericardial effusion 106.44 18.38 232 121945 39022 64337533
Catheter site inflammation 105.13 18.38 46 122131 899 64375656
Dyspnoea at rest 103.44 18.38 90 122087 6239 64370316
Hypersensitivity 102.52 18.38 133 122044 196319 64180236
Urticaria 99.27 18.38 80 122097 147237 64229318
Catheter site vesicles 99.01 18.38 33 122144 292 64376263
Device breakage 98.09 18.38 101 122076 8654 64367901
Dizziness postural 97.70 18.38 106 122071 9646 64366909
Suicide attempt 96.03 18.38 11 122166 70996 64305559
Respiratory failure 95.87 18.38 577 121600 160606 64215949
Drug titration error 95.71 18.38 43 122134 897 64375658
Device connection issue 95.24 18.38 42 122135 837 64375718
Anaphylactic reaction 94.47 18.38 10 122167 68654 64307901
Respiration abnormal 93.66 18.38 85 122092 6230 64370325
Lactic acidosis 92.59 18.38 6 122171 61404 64315151
Maternal exposure during pregnancy 92.44 18.38 33 122144 95851 64280704
Metabolic acidosis 91.11 18.38 13 122164 70945 64305610
Blood creatine phosphokinase increased 90.47 18.38 5 122172 58553 64318002
Infusion site nodule 89.91 18.38 29 122148 229 64376326
Hyponatraemia 89.82 18.38 89 122088 148250 64228305
Right ventricular dysfunction 88.44 18.38 54 122123 2149 64374406
Device malfunction 88.40 18.38 136 122041 17497 64359058
Coma 88.22 18.38 28 122149 87587 64288968
Walking distance test abnormal 86.59 18.38 37 122140 681 64375874
Hyperkalaemia 85.92 18.38 42 122135 101087 64275468
Psoriasis 85.66 18.38 16 122161 71687 64304868
Cardiac failure congestive 85.14 18.38 479 121698 130101 64246454
Cor pulmonale 84.80 18.38 51 122126 1974 64374581
Infusion site discomfort 84.29 18.38 37 122140 729 64375826
Neuropathy peripheral 84.06 18.38 60 122117 117465 64259090
Glossodynia 82.72 18.38 12 122165 64684 64311871
Angioedema 82.55 18.38 10 122167 61811 64314744
Peripheral swelling 82.24 18.38 677 121500 208476 64168079
Infusion site vesicles 81.64 18.38 30 122147 363 64376192
Hypoglycaemia 81.58 18.38 34 122143 89858 64286697
Cognitive disorder 81.25 18.38 6 122171 55081 64321474
Agitation 80.88 18.38 33 122144 88334 64288221
Intentional product misuse 80.47 18.38 19 122158 72276 64304279
Alanine aminotransferase increased 80.13 18.38 87 122090 138944 64237611
Lower respiratory tract infection 77.82 18.38 41 122136 94573 64281982
Bone marrow failure 77.63 18.38 3 122174 47949 64328606
Catheter site warmth 76.75 18.38 26 122151 243 64376312
Pericarditis 76.75 18.38 13 122164 62503 64314052
Blood pressure increased 76.24 18.38 131 122046 172421 64204134
Rash maculo-papular 75.94 18.38 3 122174 47023 64329532
Catheter site related reaction 75.26 18.38 37 122140 952 64375603
Delirium 73.52 18.38 20 122157 69174 64307381
Hepatic function abnormal 73.39 18.38 16 122161 64297 64312258
Hepatocellular injury 72.66 18.38 3 122174 45232 64331323
Depression 72.31 18.38 149 122028 183142 64193413
Oropharyngeal pain 71.75 18.38 346 121831 88521 64288034
Thrombosis in device 70.82 18.38 66 122111 5005 64371550
Pulmonary veno-occlusive disease 70.46 18.38 40 122137 1388 64375167
Suicidal ideation 69.28 18.38 20 122157 66522 64310033
Deep vein thrombosis 68.52 18.38 59 122118 105123 64271432
Aggression 68.29 18.38 5 122172 46227 64330328
Hyperglycaemia 67.90 18.38 16 122161 60952 64315603
Osteoarthritis 67.87 18.38 18 122159 63318 64313237
Cardiac disorder 67.54 18.38 246 121931 55570 64320985
Device physical property issue 67.51 18.38 45 122132 2088 64374467
Gamma-glutamyltransferase increased 66.90 18.38 7 122170 48503 64328052
Lung disorder 66.39 18.38 259 121918 60441 64316114
Pulmonary arterial pressure abnormal 66.12 18.38 30 122147 641 64375914
Disease progression 65.89 18.38 477 121700 141203 64235352
Dizziness exertional 65.69 18.38 27 122150 449 64376106
Inflammation 65.50 18.38 21 122156 65279 64311276
Multiple sclerosis relapse 65.17 18.38 3 122174 41132 64335423
Discomfort 65.12 18.38 36 122141 80842 64295713
Wrong dose 64.59 18.38 36 122141 1205 64375350
Generalised tonic-clonic seizure 62.84 18.38 3 122174 39854 64336701
Internal haemorrhage 62.67 18.38 75 122102 7592 64368963
Plasma cell myeloma 62.64 18.38 7 122170 46068 64330487
Terminal state 62.37 18.38 58 122119 4386 64372169
Hallucination 62.17 18.38 30 122147 72758 64303797
Cerebral infarction 61.90 18.38 4 122173 41040 64335515
Blood pressure systolic increased 61.33 18.38 10 122167 49443 64327112
Intentional product use issue 60.30 18.38 55 122122 95309 64281246
Agranulocytosis 59.88 18.38 3 122174 38226 64338329
Sedation 59.79 18.38 5 122172 41457 64335098
Retching 59.39 18.38 105 122072 15151 64361404
Product administration interrupted 59.20 18.38 33 122144 1105 64375450
Infusion site pustule 59.12 18.38 15 122162 42 64376513
Exposure during pregnancy 59.11 18.38 37 122140 77638 64298917
Sickle cell anaemia with crisis 58.81 18.38 61 122116 5271 64371284
Drug-induced liver injury 58.28 18.38 10 122167 47633 64328922
Renal impairment 58.27 18.38 104 122073 134913 64241642
Seizure 58.24 18.38 145 122032 166747 64209808
Blood creatinine increased 58.23 18.38 105 122072 135677 64240878
Catheter site extravasation 57.75 18.38 23 122154 351 64376204
Oxygen therapy 57.65 18.38 42 122135 2251 64374304
Device use error 57.38 18.38 66 122111 6405 64370150
Emergency care 56.90 18.38 30 122147 897 64375658
Treatment noncompliance 56.34 18.38 196 121981 43286 64333269
Acute myocardial infarction 56.18 18.38 31 122146 69687 64306868
Abdominal pain upper 56.12 18.38 542 121635 174488 64202067
Blood glucose increased 55.80 18.38 62 122115 98011 64278544
Device programming error 55.49 18.38 16 122161 82 64376473
Localised oedema 54.97 18.38 68 122109 7123 64369432
Haematuria 54.66 18.38 23 122154 60448 64316107
Atrial flutter 54.20 18.38 116 122061 19264 64357291
Pulmonary hypertensive crisis 53.99 18.38 21 122156 300 64376255
Dysphagia 53.97 18.38 74 122103 106738 64269817
Jaundice 53.50 18.38 13 122164 48499 64328056
Altered state of consciousness 53.49 18.38 5 122172 37897 64338658
Paracentesis 53.48 18.38 32 122145 1227 64375328
Off label use 53.27 18.38 861 121316 631945 63744610
Oxygen saturation abnormal 52.83 18.38 48 122129 3523 64373032
Cardiac ablation 52.77 18.38 36 122141 1736 64374819
Exercise tolerance decreased 52.76 18.38 69 122108 7641 64368914
Myocardial infarction 51.89 18.38 152 122025 165669 64210886
Coronary artery disease 51.47 18.38 25 122152 60408 64316147
Seasonal allergy 51.30 18.38 85 122092 11641 64364914
Ventilation perfusion mismatch 51.15 18.38 20 122157 290 64376265
Drug dependence 50.98 18.38 3 122174 33309 64343246
Hepatitis 50.69 18.38 12 122165 45570 64330985
Hypocalcaemia 50.55 18.38 9 122168 41744 64334811
Arthralgia 50.51 18.38 565 121612 441695 63934860
Psychotic disorder 50.33 18.38 4 122173 34574 64341981
Pancreatitis acute 50.26 18.38 10 122167 42845 64333710
Platelet count decreased 50.14 18.38 157 122020 167554 64209001
Type 2 diabetes mellitus 49.34 18.38 4 122173 34016 64342539
Disease complication 49.32 18.38 50 122127 4205 64372350
Helicobacter infection 49.31 18.38 7 122170 38355 64338200
Catheterisation cardiac abnormal 49.01 18.38 19 122158 269 64376286
Impaired healing 48.56 18.38 27 122150 60446 64316109
Dysarthria 48.47 18.38 26 122151 59380 64317175
Injury 47.94 18.38 23 122154 55969 64320586
Acute right ventricular failure 47.65 18.38 19 122158 291 64376264
Hepatotoxicity 47.55 18.38 9 122168 39953 64336602
Diabetes mellitus 47.44 18.38 34 122143 66440 64310115
Sinus congestion 47.37 18.38 96 122081 15343 64361212
Pulmonary embolism 47.37 18.38 132 122045 146224 64230331
Cardio-respiratory arrest 46.91 18.38 71 122106 98322 64278233
Vascular device occlusion 46.20 18.38 12 122165 38 64376517
Swollen tongue 45.82 18.38 6 122171 34948 64341607
Somnolence 45.78 18.38 214 121963 203431 64173124
Brain natriuretic peptide increased 45.67 18.38 64 122113 7569 64368986
Respiratory tract congestion 45.48 18.38 97 122080 16068 64360487
Multiple organ dysfunction syndrome 44.76 18.38 77 122100 101336 64275219
Hypercalcaemia 44.72 18.38 4 122173 31412 64345143
Blood potassium decreased 44.67 18.38 173 122004 40226 64336329
Eosinophilia 44.41 18.38 9 122168 38067 64338488
Red blood cell sedimentation rate increased 44.40 18.38 4 122173 31231 64345324
Sickle cell anaemia 44.26 18.38 22 122155 580 64375975
Asthma 44.17 18.38 70 122107 95155 64281400
Device maintenance issue 44.14 18.38 9 122168 4 64376551
Tubulointerstitial nephritis 43.83 18.38 4 122173 30905 64345650
Injection site bruising 43.69 18.38 8 122169 36365 64340190
Diuretic therapy 43.56 18.38 15 122162 148 64376407
Drug eruption 43.29 18.38 8 122169 36128 64340427
Ischaemic stroke 43.29 18.38 3 122174 29032 64347523
Respiratory distress 43.13 18.38 205 121972 52126 64324429
Aphasia 43.12 18.38 12 122165 40894 64335661
Catheter site discolouration 43.03 18.38 14 122163 114 64376441
Migraine 42.87 18.38 233 121944 62444 64314111
Wound 42.79 18.38 49 122128 76428 64300127
Pneumonia aspiration 42.71 18.38 30 122147 59241 64317314
Chronic respiratory failure 42.47 18.38 37 122140 2569 64373986
Disease recurrence 42.30 18.38 5 122172 31505 64345050
Liver transplant 41.90 18.38 45 122132 4047 64372508
Hepatic steatosis 41.43 18.38 5 122172 31002 64345553
Hallucination, visual 41.14 18.38 3 122174 27831 64348724
Epilepsy 41.09 18.38 7 122170 33524 64343031
Urinary retention 40.93 18.38 21 122156 49180 64327375
Loss of consciousness 40.66 18.38 445 121732 147920 64228635
Device use issue 40.34 18.38 31 122146 1802 64374753
Gout 40.32 18.38 110 122067 21303 64355252
Drug intolerance 40.25 18.38 201 121976 187791 64188764
Transaminases increased 40.24 18.38 17 122160 44577 64331978
Viral infection 40.16 18.38 155 122022 35985 64340570
Application site pruritus 39.96 18.38 41 122136 3498 64373057
Osteoporosis 39.67 18.38 15 122162 42065 64334490
Liver injury 39.57 18.38 5 122172 29927 64346628
Drug withdrawal syndrome 39.54 18.38 6 122171 31285 64345270
Hypokalaemia 39.40 18.38 110 122067 121793 64254762
Sinus disorder 39.25 18.38 94 122083 16814 64359741
Interstitial lung disease 38.90 18.38 79 122098 97653 64278902
Dyspepsia 38.82 18.38 273 121904 80039 64296516
Aspartate aminotransferase increased 38.79 18.38 108 122069 119680 64256875
Sleep disorder due to general medical condition, insomnia type 38.35 18.38 3 122174 26267 64350288
Fatigue 38.04 18.38 1757 120420 746973 63629582
Catheter site erosion 37.58 18.38 11 122166 60 64376495
Inappropriate schedule of product administration 37.24 18.38 74 122103 92212 64284343
Infusion site dryness 37.15 18.38 8 122169 7 64376548
Infusion site injury 37.15 18.38 8 122169 7 64376548
Diabetic ketoacidosis 37.09 18.38 6 122171 29839 64346716
Disturbance in attention 36.51 18.38 16 122161 41058 64335497
Medical device change 36.44 18.38 18 122159 468 64376087
Abdominal discomfort 36.26 18.38 515 121662 181807 64194748
Blister 36.17 18.38 61 122116 80906 64295649
Wrong technique in product usage process 35.95 18.38 42 122135 64932 64311623
Colitis 35.73 18.38 35 122142 58639 64317916
Influenza 35.66 18.38 333 121844 106198 64270357
Pneumonitis 35.62 18.38 26 122151 50339 64326216
Myelodysplastic syndrome 35.52 18.38 5 122172 27574 64348981
Muscular weakness 35.43 18.38 123 122054 127215 64249340
Acute hepatic failure 35.41 18.38 4 122173 26108 64350447
Erythema 35.10 18.38 209 121968 186861 64189694
Medication error 35.07 18.38 26 122151 49940 64326615
Catheter site nodule 35.05 18.38 10 122167 49 64376506
Eczema 34.71 18.38 7 122170 29713 64346842
Infusion site haematoma 34.55 18.38 14 122163 224 64376331
Subcutaneous drug absorption impaired 34.47 18.38 8 122169 13 64376542
Rhinovirus infection 34.46 18.38 50 122127 6106 64370449
Skin lesion 34.40 18.38 13 122164 36469 64340086
Therapeutic response decreased 34.31 18.38 29 122148 52159 64324396
Hypothyroidism 34.05 18.38 17 122160 40440 64336115
Myelosuppression 34.01 18.38 3 122174 23827 64352728
Cardiac failure acute 33.86 18.38 87 122090 16257 64360298
Injection site irritation 33.83 18.38 36 122141 3204 64373351
Weight increased 33.80 18.38 580 121597 212768 64163787
Anaemia 33.53 18.38 510 121667 378170 63998385
Paranasal sinus hypersecretion 33.39 18.38 35 122142 3061 64373494
Respiratory depression 33.33 18.38 3 122174 23440 64353115
Fibromyalgia 33.25 18.38 13 122164 35718 64340837
Infusion site scar 33.10 18.38 14 122163 251 64376304
Ejection fraction decreased 33.04 18.38 7 122170 28700 64347855
Purulent discharge 32.99 18.38 46 122131 5415 64371140
Catheter site scab 32.85 18.38 13 122164 195 64376360
Mobility decreased 32.80 18.38 71 122106 85769 64290786
Body temperature decreased 32.70 18.38 5 122172 25923 64350632
Posterior reversible encephalopathy syndrome 32.45 18.38 3 122174 22943 64353612
Balance disorder 32.42 18.38 69 122108 83857 64292698
Osteonecrosis 32.25 18.38 7 122170 28222 64348333
Emotional distress 32.10 18.38 14 122163 36024 64340531
Bacteraemia 32.04 18.38 118 122059 26793 64349762
Injection site pustule 31.92 18.38 10 122167 71 64376484
Paraesthesia 31.63 18.38 139 122038 134383 64242172
Blood pressure fluctuation 31.51 18.38 31 122146 51840 64324715
Proteinuria 31.42 18.38 7 122170 27716 64348839
Right ventricular systolic pressure increased 31.41 18.38 20 122157 858 64375697
Hypoaesthesia 31.35 18.38 146 122031 138962 64237593
Inappropriate antidiuretic hormone secretion 31.29 18.38 3 122174 22286 64354269
Catheter removal 31.05 18.38 17 122160 549 64376006
Head discomfort 31.00 18.38 69 122108 11765 64364790
Ataxia 30.93 18.38 3 122174 22081 64354474
Brain oedema 30.92 18.38 3 122174 22072 64354483
Myalgia 30.72 18.38 446 121731 158171 64218384
Melaena 30.29 18.38 34 122143 53514 64323041
Loss of personal independence in daily activities 30.19 18.38 57 122120 72397 64304158
Cardiac output increased 30.14 18.38 12 122165 183 64376372
Heart and lung transplant 30.14 18.38 12 122165 183 64376372
Leukocytosis 30.08 18.38 17 122160 37723 64338832
Hyperlipidaemia 29.98 18.38 4 122173 22972 64353583
Dialysis 29.97 18.38 85 122092 16835 64359720
Diplopia 29.85 18.38 7 122170 26758 64349797
Incorrect drug administration rate 29.80 18.38 31 122146 2688 64373867
Cyanosis 29.68 18.38 101 122076 22054 64354501
Flatulence 29.59 18.38 140 122037 35526 64341029
Drug ineffective for unapproved indication 29.51 18.38 11 122166 31122 64345433
Skin exfoliation 29.44 18.38 25 122152 44860 64331695
Injection site reaction 29.39 18.38 27 122150 46637 64329918
Infusion site mass 29.38 18.38 20 122157 961 64375594
Pulmonary pain 29.29 18.38 30 122147 2554 64374001
Device expulsion 29.27 18.38 3 122174 21133 64355422
Product quality issue 29.15 18.38 10 122167 29789 64346766
Pulmonary artery aneurysm 29.08 18.38 11 122166 145 64376410
Visual acuity reduced 28.54 18.38 8 122169 27133 64349422
Rales 28.44 18.38 78 122099 15151 64361404
Endotracheal intubation 28.44 18.38 36 122141 3859 64372696
Labelled drug-drug interaction medication error 28.41 18.38 4 122173 22058 64354497
Dyskinesia 28.29 18.38 20 122157 39368 64337187
Gastroenteritis viral 28.26 18.38 92 122085 19637 64356918
Nocturnal dyspnoea 28.02 18.38 22 122155 1320 64375235
Pulmonary arterial pressure decreased 27.99 18.38 10 122167 111 64376444
General physical health deterioration 27.92 18.38 250 121927 204175 64172380
Intentional medical device removal by patient 27.85 18.38 13 122164 297 64376258
Tendonitis 27.78 18.38 3 122174 20279 64356276
Cardiac operation 27.73 18.38 37 122140 4177 64372378
Decreased appetite 27.64 18.38 713 121464 280576 64095979
Condition aggravated 27.57 18.38 911 121266 371515 64005040
Infusion site bruising 27.52 18.38 23 122154 1509 64375046
Hemiparesis 27.51 18.38 11 122166 29816 64346739
Encephalopathy 27.50 18.38 43 122134 58776 64317779
Bursitis 27.42 18.38 4 122173 21481 64355074
Angina pectoris 27.32 18.38 27 122150 45054 64331501
Blood urea increased 27.27 18.38 26 122151 44127 64332428
Clostridium difficile infection 27.18 18.38 138 122039 36025 64340530
Ill-defined disorder 27.14 18.38 26 122151 44026 64332529
Speech disorder 27.13 18.38 31 122146 48410 64328145
Abnormal behaviour 27.01 18.38 15 122162 33607 64342948
Disorientation 26.88 18.38 40 122137 55788 64320767
Catheter site dermatitis 26.87 18.38 9 122168 81 64376474
Skin irritation 26.83 18.38 56 122121 9138 64367417
Hypomagnesaemia 26.82 18.38 19 122158 37357 64339198
Cerebrovascular accident 26.71 18.38 152 122025 137431 64239124
Infusion site dermatitis 26.56 18.38 6 122171 8 64376547
Decreased activity 26.14 18.38 48 122129 7132 64369423
Orthostatic hypotension 26.08 18.38 30 122147 46708 64329847
Blood pressure abnormal 26.04 18.38 73 122104 14362 64362193
Catheter site abscess 25.68 18.38 7 122170 28 64376527
Blood iron decreased 25.54 18.38 65 122112 12077 64364478
Administration site infection 25.40 18.38 6 122171 11 64376544
Diagnostic procedure 25.33 18.38 10 122167 149 64376406
Cardioversion 25.30 18.38 24 122153 1861 64374694
Chronic obstructive pulmonary disease 25.25 18.38 225 121952 70823 64305732
Secretion discharge 25.11 18.38 64 122113 11900 64364655
Platelet count increased 25.01 18.38 3 122174 18693 64357862
Nasal dryness 24.82 18.38 32 122145 3494 64373061
Administration site pain 24.80 18.38 13 122164 384 64376171
Prostate cancer 24.55 18.38 4 122173 19791 64356764
Abdominal cavity drainage 24.54 18.38 16 122161 715 64375840
Nightmare 24.40 18.38 5 122172 20988 64355567
Rash erythematous 24.25 18.38 34 122143 48599 64327956
Atrial septal defect 24.02 18.38 22 122155 1631 64374924
Vasculitis 23.97 18.38 3 122174 18092 64358463
Pyrexia 23.73 18.38 843 121334 557801 63818754
Ileus 23.72 18.38 7 122170 22959 64353596
Obesity 23.69 18.38 5 122172 20557 64355998
Heart valve operation 23.31 18.38 10 122167 186 64376369
Sickle cell disease 23.24 18.38 9 122168 127 64376428
Tremor 23.09 18.38 175 122002 148055 64228500
Irritable bowel syndrome 23.09 18.38 22 122155 37347 64339208
Infusion site scab 22.94 18.38 7 122170 45 64376510
Medical procedure 22.81 18.38 11 122166 271 64376284
Hyperbilirubinaemia 22.77 18.38 6 122171 21199 64355356
Arthritis 22.61 18.38 82 122095 83732 64292823
Stent placement 22.54 18.38 39 122138 5532 64371023
White blood cell count increased 22.51 18.38 58 122119 65956 64310599
Disseminated intravascular coagulation 22.49 18.38 17 122160 32331 64344224
Incorrect route of product administration 22.48 18.38 8 122169 23290 64353265
Myocardial ischaemia 22.40 18.38 8 122169 23243 64353312
Cardiomyopathy 22.34 18.38 10 122167 25346 64351209
Accidental exposure to product 22.30 18.38 11 122166 26353 64350202
Poisoning 22 18.38 7 122170 21872 64354683
Hallucination, auditory 21.98 18.38 3 122174 16936 64359619
Asthenia 21.96 18.38 1006 121171 427038 63949517
Extra dose administered 21.94 18.38 43 122134 6707 64369848
Rehabilitation therapy 21.89 18.38 20 122157 1478 64375077
Dry eye 21.83 18.38 14 122163 29005 64347550
Metastases to liver 21.80 18.38 9 122168 23932 64352623
Haemodynamic test abnormal 21.73 18.38 7 122170 55 64376500
Joint range of motion decreased 21.69 18.38 5 122172 19338 64357217
Bone disorder 21.67 18.38 3 122174 16756 64359799
Cataract 21.64 18.38 40 122137 51222 64325333
Administration site odour 21.63 18.38 6 122171 26 64376529
Thrombotic microangiopathy 21.49 18.38 3 122174 16652 64359903
Concomitant disease aggravated 21.44 18.38 59 122118 11483 64365072
Multiple allergies 21.33 18.38 39 122138 5775 64370780
Diet noncompliance 21.23 18.38 12 122165 413 64376142
Femur fracture 21.20 18.38 20 122157 34115 64342440
Withdrawal syndrome 21.12 18.38 9 122168 23483 64353072
Infusion site erosion 21.08 18.38 4 122173 0 64376555
Medical device site odour 21.08 18.38 4 122173 0 64376555
Multiple sclerosis 21.03 18.38 5 122172 18936 64357619
Paranoia 20.97 18.38 3 122174 16349 64360206
Blood culture positive 20.75 18.38 46 122131 7822 64368733
Fracture 20.73 18.38 5 122172 18750 64357805
Nephropathy toxic 20.72 18.38 4 122173 17510 64359045
Oral herpes 20.71 18.38 8 122169 22144 64354411
Coagulopathy 20.66 18.38 18 122159 31902 64344653
Mechanical ventilation 20.66 18.38 24 122153 2354 64374201
Renal tubular necrosis 20.64 18.38 8 122169 22102 64354453
Balloon atrial septostomy 20.59 18.38 8 122169 114 64376441
Right ventricular dilatation 20.55 18.38 19 122158 1426 64375129
Cor pulmonale chronic 20.46 18.38 10 122167 254 64376301
Cardiac failure high output 20.35 18.38 10 122167 257 64376298
Cardiac pacemaker insertion 20.11 18.38 35 122142 4988 64371567
Right atrial pressure increased 20.03 18.38 10 122167 266 64376289
Renal disorder 19.98 18.38 125 122052 35240 64341315
Hypertensive crisis 19.90 18.38 5 122172 18243 64358312
Suture related complication 19.86 18.38 10 122167 271 64376284
Full blood count decreased 19.75 18.38 9 122168 22573 64353982
Product communication issue 19.71 18.38 12 122165 475 64376080
Blood calcium decreased 19.68 18.38 12 122165 25542 64351013
Transplant 19.65 18.38 15 122162 863 64375692
Application site hypersensitivity 19.63 18.38 10 122167 278 64376277
Conjunctivitis 19.62 18.38 7 122170 20347 64356208
Tracheostomy malfunction 19.46 18.38 8 122169 133 64376422
Dysentery 19.44 18.38 15 122162 877 64375678
Dry throat 19.42 18.38 39 122138 6193 64370362
Staphylococcal infection 19.31 18.38 163 122014 50515 64326040
Pulmonary endarterectomy 19.31 18.38 9 122168 205 64376350
Atrial septal defect repair 19.29 18.38 11 122166 385 64376170
Nasopharyngitis 19.24 18.38 497 121680 195576 64180979
Infusion site extravasation 19.20 18.38 41 122136 6796 64369759
Mydriasis 19.20 18.38 3 122174 15309 64361246
Ear congestion 19.18 18.38 22 122155 2128 64374427
Right ventricular enlargement 19.18 18.38 12 122165 499 64376056
Portopulmonary hypertension 19.04 18.38 8 122169 141 64376414
Knee arthroplasty 19.01 18.38 14 122163 26985 64349570
Hypoalbuminaemia 18.98 18.38 5 122172 17669 64358886
Peritonitis 18.92 18.38 12 122165 25011 64351544
Liver function test abnormal 18.89 18.38 54 122123 59347 64317208
Aspiration pleural cavity 18.75 18.38 18 122159 1417 64375138
Faeces soft 18.67 18.38 37 122140 5818 64370737
Catheter site cellulitis 18.62 18.38 11 122166 412 64376143
Coordination abnormal 18.61 18.38 3 122174 14961 64361594
Sleep study 18.55 18.38 5 122172 19 64376536
Product label confusion 18.52 18.38 10 122167 314 64376241
Injection site haemorrhage 18.49 18.38 93 122084 24185 64352370
Metapneumovirus infection 18.47 18.38 18 122159 1443 64375112
Therapy cessation 18.45 18.38 115 122062 32374 64344181
Glomerular filtration rate decreased 18.41 18.38 7 122170 19565 64356990
Weight decreased 18.39 18.38 688 121489 285051 64091504

FDA Adverse Event Reporting System (Pediatric)

None

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 agent
CHEBI has role CHEBI:35620 vasodilator agents
CHEBI has role CHEBI:35674 antihypertensive drugs
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 | Suggest Off label Use Form| |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




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

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 EP1 subtype GPCR AGONIST Ki 6.70 IUPHAR
Prostaglandin E2 receptor EP3 subtype GPCR AGONIST Ki 5.60 IUPHAR
Prostaglandin E2 receptor EP2 subtype GPCR AGONIST Ki 8.40 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
830354-48-8 SECONDARY_CAS_RN
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 66302-101 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 66302-102 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 66302-105 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 66302-110 INJECTION, SOLUTION 200 mg INTRAVENOUS NDA 28 sections
Remodulin HUMAN PRESCRIPTION DRUG LABEL 1 66302-120 INJECTION, SOLUTION 400 mg INTRAVENOUS NDA 28 sections
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
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