treprostinil 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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
Treprostinil is a prostacyclin analogue. The major pharmacologic actions of treprostinil are direct vasodilation of pulmonary and systemic arterial vascular beds and inhibition of platelet aggregation.
  • 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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2A,ACVR2B,AURKA,AXL,BRAF,BTK,CAMK2D,CDK5,CDK9,DYRK1B,EGFR,EIF2AK3,ERBB2,GRK2,IKBKB,ITK,JAK3,MAP2K6,MAP3K21,MAPK7,MAPKAPK2,NTRK2,PDK1,PDK2,PDK4,PIK3CB,PIK3CG,PIM2,PRKDC,STK33,SYK,TEK,TGFBR1,ZAP70 34
kinase-selectivity-class AXL,EIF2AK3,GRK2 3
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 0 High 1

Approvals:

DateAgencyCompanyOrphan
April 3, 2020 EMA SciPharm Sarl
May 21, 2002 FDA UNITED THERAP
Dec. 23, 2022 PMDA Mochida Pharmaceutical Co., Ltd.

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Dyspnoea 3836.74 18.17 5595 131367 875360 89616125
Infusion site pain 3139.27 18.17 1165 135797 18573 90472912
Fluid retention 2185.74 18.17 1464 135498 86627 90404858
Hypervolaemia 1926.95 18.17 956 136006 31801 90459684
Headache 1897.59 18.17 4072 132890 858674 89632811
Pulmonary arterial hypertension 1842.10 18.17 864 136098 25323 90466162
Right ventricular failure 1831.41 18.17 784 136178 18421 90473064
Pain in jaw 1731.24 18.17 1012 135950 46973 90444512
Pulmonary hypertension 1719.28 18.17 966 135996 41557 90449928
Infusion site erythema 1582.83 18.17 641 136321 13029 90478456
Dyspnoea exertional 1440.86 18.17 1051 135911 71237 90420248
Infusion site infection 1244.66 18.17 356 136606 2304 90489181
Death 1161.49 18.17 2294 134668 454257 90037228
Device related infection 1088.84 18.17 603 136359 25183 90466302
Drug ineffective 1083.29 18.17 375 136587 1383923 89107562
Cough 1049.73 18.17 1945 135017 367017 90124468
Oxygen saturation decreased 1028.39 18.17 1025 135937 106458 90385027
Flushing 1017.44 18.17 934 136028 87557 90403928
Vascular device infection 1009.25 18.17 448 136514 11504 90479981
Diarrhoea 996.96 18.17 3392 133570 935798 89555687
Infusion site swelling 937.55 18.17 423 136539 11297 90480188
Dermatitis contact 784.91 18.17 392 136570 13203 90478282
Dizziness 726.22 18.17 2243 134719 587041 89904444
Syncope 716.47 18.17 941 136021 131722 90359763
Catheter site pain 695.51 18.17 276 136686 5303 90486182
Hypotension 670.59 18.17 1502 135460 323895 90167590
Nausea 670.02 18.17 3372 133590 1106944 89384541
Catheter site erythema 623.68 18.17 246 136716 4648 90486837
Device dislocation 620.55 18.17 455 136507 31027 90460458
Chest pain 594.17 18.17 1417 135545 318228 90173257
Hypoxia 576.27 18.17 626 136336 71773 90419712
Infusion related reaction 549.24 18.17 18 136944 416762 90074723
Infusion site haemorrhage 535.81 18.17 227 136735 5184 90486301
Infusion site discharge 527.90 18.17 181 136781 2254 90489231
Alopecia 506.96 18.17 73 136889 494998 89996487
Therapy change 495.28 18.17 245 136717 8077 90483408
Oxygen consumption increased 469.35 18.17 197 136765 4392 90487093
Arthropathy 468.11 18.17 20 136942 366222 90125263
Nasal congestion 467.69 18.17 603 136359 82811 90408674
Lung transplant 433.68 18.17 175 136787 3517 90487968
Contraindicated product administered 432.01 18.17 11 136951 320128 90171357
Glossodynia 430.69 18.17 12 136950 321767 90169718
Palpitations 421.99 18.17 748 136214 135980 90355505
Device infusion issue 415.08 18.17 155 136807 2507 90488978
Epistaxis 407.85 18.17 570 136392 84555 90406930
Pulmonary arterial pressure increased 396.79 18.17 167 136795 3749 90487736
Hepatic enzyme increased 393.87 18.17 43 136919 360693 90130792
Hospitalisation 389.12 18.17 696 136266 127404 90364081
Rheumatoid arthritis 388.95 18.17 46 136916 362568 90128917
Rash 387.65 18.17 380 136582 795720 89695765
Device leakage 384.63 18.17 220 136742 9771 90481714
Infusion site induration 381.79 18.17 127 136835 1432 90490053
Therapeutic product effect decreased 372.73 18.17 10 136952 277561 90213924
Treatment failure 368.14 18.17 23 136939 303905 90187580
Catheter site discharge 363.72 18.17 137 136825 2272 90489213
Catheter site pruritus 351.50 18.17 132 136830 2170 90489315
Oedema peripheral 343.80 18.17 1011 135951 256904 90234581
Infusion site warmth 332.97 18.17 125 136837 2053 90489432
Product use in unapproved indication 331.60 18.17 55 136907 336181 90155304
Pericarditis 328.49 18.17 20 136942 270131 90221354
Catheter site haemorrhage 320.91 18.17 141 136821 3527 90487958
Feeling abnormal 319.44 18.17 750 136212 166485 90325000
Stomatitis 317.66 18.17 26 136936 274672 90216813
Blood pressure decreased 315.65 18.17 472 136490 74423 90417062
Throat irritation 311.21 18.17 376 136586 48319 90443166
Cardiac failure 311.03 18.17 578 136384 108918 90382567
Toxicity to various agents 309.88 18.17 36 136926 287810 90203675
Wound 306.79 18.17 46 136916 302934 90188551
Helicobacter infection 297.89 18.17 10 136952 226840 90264645
Hypersensitivity 296.44 18.17 159 136803 454518 90036967
Infusion site irritation 294.97 18.17 101 136861 1252 90490233
Joint swelling 294.60 18.17 200 136762 503100 89988385
Blood cholesterol increased 293.25 18.17 4 136958 208008 90283477
Haemoptysis 293.16 18.17 304 136658 33016 90458469
Infusion site pruritus 293.14 18.17 161 136801 6604 90484881
Drug hypersensitivity 292.33 18.17 169 136793 463440 90028045
Injection site discharge 288.05 18.17 101 136861 1350 90490135
Catheter site infection 285.56 18.17 149 136813 5505 90485980
Scleroderma 285.15 18.17 154 136808 6107 90485378
Pericardial effusion 285.15 18.17 314 136648 36519 90454966
Neutropenia 284.85 18.17 13 136949 224891 90266594
Pulmonary oedema 284.43 18.17 407 136555 61673 90429812
Catheter management 282.87 18.17 122 136840 2914 90488571
Type 2 diabetes mellitus 277.87 18.17 6 136956 203238 90288247
Hypertension 274.23 18.17 177 136785 457355 90034130
Musculoskeletal stiffness 272.10 18.17 58 136904 296474 90195011
Device issue 271.66 18.17 276 136686 29261 90462224
Complication associated with device 268.62 18.17 228 136734 19221 90472264
Catheterisation cardiac 265.83 18.17 136 136826 4820 90486665
Injection site infection 265.19 18.17 108 136854 2224 90489261
Catheter site swelling 258.27 18.17 99 136863 1726 90489759
Chest discomfort 254.93 18.17 612 136350 137753 90353732
Respiratory failure 253.77 18.17 556 136406 117862 90373623
Discomfort 253.05 18.17 53 136909 274282 90217203
Drug interaction 251.75 18.17 55 136907 276398 90215087
Systemic lupus erythematosus 250.16 18.17 117 136845 361779 90129706
Lower respiratory tract infection 249.30 18.17 40 136922 250619 90240866
Impaired healing 243.01 18.17 33 136929 234166 90257319
Maternal exposure during pregnancy 241.89 18.17 121 136841 359942 90131543
C-reactive protein increased 241.71 18.17 7 136955 181382 90310103
Haemoglobin increased 236.33 18.17 145 136817 7336 90484149
Fibromyalgia 234.38 18.17 21 136941 206248 90285237
Infusion site cellulitis 233.91 18.17 62 136900 288 90491197
Therapeutic product effect incomplete 233.72 18.17 15 136947 193881 90297604
Osteoarthritis 230.52 18.17 17 136945 195713 90295772
Device related sepsis 229.81 18.17 122 136840 4671 90486814
Infusion site abscess 229.67 18.17 62 136900 313 90491172
Acute respiratory failure 227.60 18.17 302 136660 42616 90448869
Ascites 226.07 18.17 318 136644 47422 90444063
Device malfunction 222.67 18.17 212 136750 20765 90470720
Liver injury 222.22 18.17 8 136954 170559 90320926
Injury 221.80 18.17 21 136941 197328 90294157
Central venous catheterisation 221.01 18.17 100 136862 2686 90488799
Presyncope 220.41 18.17 256 136706 31549 90459936
Febrile neutropenia 215.16 18.17 5 136957 158344 90333141
Irritable bowel syndrome 211.07 18.17 31 136931 207417 90284068
Dyspnoea at rest 210.29 18.17 115 136847 4676 90486809
Catheter placement 207.87 18.17 93 136869 2431 90489054
Blister 205.05 18.17 65 136897 254933 90236552
Heart rate increased 200.04 18.17 492 136470 112410 90379075
Off label use 199.86 18.17 923 136039 1101329 89390156
Device alarm issue 199.75 18.17 83 136879 1802 90489683
Urticaria 198.40 18.17 113 136849 312621 90178864
Pneumonia 191.60 18.17 1630 135332 636429 89855056
Cardiac failure congestive 188.72 18.17 443 136519 98251 90393234
Unevaluable event 188.63 18.17 315 136647 54533 90436952
Transfusion 188.02 18.17 178 136784 17310 90474175
Malaise 187.66 18.17 1519 135443 584467 89907018
Device occlusion 187.03 18.17 136 136826 9146 90482339
Product dose omission issue 186.86 18.17 904 136058 290783 90200702
Joint range of motion decreased 181.57 18.17 5 136957 135638 90355847
Oedema 180.95 18.17 689 136273 199606 90291879
Sleep disorder due to general medical condition, insomnia type 179.11 18.17 3 136959 128691 90362794
Productive cough 179.05 18.17 374 136588 76689 90414796
Mobility decreased 177.96 18.17 78 136884 250656 90240829
Pain in extremity 177.62 18.17 1227 135735 449302 90042183
Exposure during pregnancy 175.91 18.17 70 136892 238340 90253145
Bursitis 175.68 18.17 5 136957 131649 90359836
Pruritus 174.47 18.17 347 136615 541178 89950307
Infusion site discolouration 171.94 18.17 64 136898 1025 90490460
Vomiting 167.08 18.17 1872 135090 786421 89705064
Ill-defined disorder 165.82 18.17 38 136924 184853 90306632
Inflammation 165.66 18.17 34 136928 178558 90312927
Psoriasis 165.28 18.17 16 136946 147738 90343747
Asthma 164.62 18.17 80 136882 242080 90249405
Abdominal distension 161.54 18.17 499 136463 130102 90361383
Dizziness postural 156.47 18.17 121 136841 8932 90482553
Confusional state 155.44 18.17 214 136748 385991 90105494
Catheter site rash 154.86 18.17 55 136907 765 90490720
Device maintenance issue 154.55 18.17 40 136922 166 90491319
Pulmonary hypertensive crisis 154.26 18.17 48 136914 429 90491056
Transplant evaluation 151.91 18.17 62 136900 1284 90490201
Intentional product use issue 148.41 18.17 71 136891 216821 90274664
Infusion site inflammation 148.22 18.17 48 136914 494 90490991
Hypoaesthesia 146.69 18.17 155 136807 314055 90177430
Device use error 145.94 18.17 106 136856 7115 90484370
Sleep disorder 144.68 18.17 59 136903 197971 90293514
Catheter site irritation 143.86 18.17 49 136913 597 90490888
White blood cell count decreased 139 18.17 40 136922 167069 90324416
Device connection issue 137.27 18.17 53 136909 943 90490542
Purulent discharge 136.56 18.17 91 136871 5314 90486171
Arthralgia 135.98 18.17 660 136302 777862 89713623
Respiration abnormal 134.52 18.17 105 136857 7858 90483627
Lip dry 134.08 18.17 4 136958 100951 90390534
Drug titration error 132.87 18.17 55 136907 1182 90490303
Leukopenia 130.20 18.17 5 136957 100705 90390780
Infusion site oedema 128.52 18.17 53 136909 1128 90490357
Obesity 124.66 18.17 9 136953 105498 90385987
Pulmonary veno-occlusive disease 124.52 18.17 56 136906 1482 90490003
Treatment noncompliance 122.43 18.17 253 136709 51474 90440011
Right ventricular dysfunction 121.39 18.17 63 136899 2301 90489184
Walking distance test abnormal 120.49 18.17 42 136920 551 90490934
Grip strength decreased 118.31 18.17 5 136957 92571 90398914
Device breakage 116.14 18.17 124 136838 13920 90477565
Gastrointestinal haemorrhage 115.46 18.17 349 136613 89899 90401586
Thrombosis in device 113.79 18.17 66 136896 3009 90488476
Depression 113.59 18.17 174 136788 300427 90191058
Sepsis 113.37 18.17 555 136407 179259 90312226
Infusion site discomfort 112.63 18.17 55 136907 1761 90489724
Prescribed overdose 110.69 18.17 10 136952 97615 90393870
Infusion site rash 110.08 18.17 60 136902 2423 90489062
Oropharyngeal pain 108.72 18.17 402 136560 114785 90376700
Seasonal allergy 108.64 18.17 153 136809 22830 90468655
Intentional overdose 108.06 18.17 9 136953 93825 90397660
Catheter site inflammation 107.72 18.17 44 136918 913 90490572
Red blood cell sedimentation rate increased 107.11 18.17 4 136958 82591 90408894
Catheter site vesicles 106.81 18.17 35 136927 375 90491110
Therapy non-responder 100.20 18.17 441 136521 136263 90355222
Atrial flutter 99.76 18.17 101 136861 10657 90480828
Catheter site related reaction 99.27 18.17 43 136919 1038 90490447
Infusion site vesicles 98.81 18.17 37 136925 603 90490882
Delirium 98.57 18.17 19 136943 104340 90387145
Cardiac disorder 96.64 18.17 244 136718 56628 90434857
Cardiac failure high output 94.80 18.17 33 136929 431 90491054
Infusion site nodule 94.49 18.17 48 136914 1675 90489810
Epilepsy 94.34 18.17 8 136954 82198 90409287
Peripheral venous disease 94.07 18.17 9 136953 83912 90407573
Gait inability 92.68 18.17 53 136909 146403 90345082
Wound infection 91.22 18.17 24 136938 106378 90385107
Anaphylactic reaction 89.16 18.17 13 136949 87511 90403974
Acute right ventricular failure 89.08 18.17 27 136935 219 90491266
Drug-induced liver injury 88.42 18.17 15 136947 90303 90401182
Night sweats 88.29 18.17 42 136920 128724 90362761
Osteoporosis 88.21 18.17 19 136943 96512 90394973
Neutrophil count decreased 87.77 18.17 5 136957 71527 90419958
Paraesthesia 86.08 18.17 154 136808 250172 90241313
Vascular device occlusion 85.96 18.17 30 136932 395 90491090
Device physical property issue 85.63 18.17 53 136909 2723 90488762
Internal haemorrhage 84.00 18.17 72 136890 6148 90485337
Weight decreased 83.68 18.17 910 136052 379000 90112485
Electrocardiogram QT prolonged 83.29 18.17 7 136955 72449 90419036
Knee arthroplasty 83.26 18.17 13 136949 83169 90408316
Intentional product misuse 83.19 18.17 17 136945 89587 90401898
Disease progression 82.54 18.17 460 136502 156155 90335330
Brain natriuretic peptide increased 82.10 18.17 70 136892 5935 90485550
Pancytopenia 81.27 18.17 40 136922 120223 90371262
General physical health deterioration 80.08 18.17 272 136690 354843 90136642
Sciatica 79.40 18.17 27 136935 101355 90390130
Loss of consciousness 79.36 18.17 420 136542 139818 90351667
Respiratory distress 79.01 18.17 179 136783 38767 90452718
Catheter site warmth 78.40 18.17 24 136938 202 90491283
Device programming error 78.38 18.17 25 136937 244 90491241
Contusion 78.16 18.17 164 136798 251052 90240433
Sinusitis 77.21 18.17 263 136699 342825 90148660
Nail disorder 76.11 18.17 3 136959 59064 90432421
Retching 75.37 18.17 117 136845 19042 90472443
Localised oedema 74.24 18.17 67 136895 6127 90485358
Catheter site extravasation 74.16 18.17 27 136935 405 90491080
Device use issue 73.89 18.17 54 136908 3659 90487826
Drug abuse 73.65 18.17 17 136945 82330 90409155
Infusion site pustule 72.17 18.17 16 136946 27 90491458
Pulmonary artery aneurysm 71.96 18.17 18 136944 63 90491422
Wheezing 71.92 18.17 158 136804 237922 90253563
Cognitive disorder 71.42 18.17 10 136952 69397 90422088
Suicide attempt 70.63 18.17 14 136948 75385 90416100
Cor pulmonale 70.40 18.17 42 136920 2018 90489467
Device failure 69.97 18.17 68 136894 6829 90484656
Decreased appetite 68.72 18.17 870 136092 375670 90115815
Drug intolerance 67.62 18.17 398 136564 447193 90044292
Bendopnoea 67.20 18.17 17 136945 63 90491422
Loss of personal independence in daily activities 67.04 18.17 64 136898 136041 90355444
Device power source issue 65.34 18.17 30 136932 834 90490651
Dizziness exertional 65.19 18.17 26 136936 506 90490979
Pulmonary arterial pressure abnormal 65.11 18.17 27 136935 583 90490902
Rales 64.15 18.17 98 136864 15729 90475756
Pulmonary fibrosis 63.70 18.17 42 136920 107461 90384024
Depressed level of consciousness 63.18 18.17 16 136946 72768 90418717
Myalgia 63.01 18.17 467 136495 174658 90316827
Angioedema 63.01 18.17 11 136951 64865 90426620
Abortion spontaneous 62.75 18.17 5 136957 54051 90437434
Myelosuppression 62.09 18.17 5 136957 53586 90437899
Blood potassium decreased 61.43 18.17 185 136777 47542 90443943
Paracentesis 61.31 18.17 30 136932 965 90490520
Live birth 60.35 18.17 22 136940 79085 90412400
Hip arthroplasty 60.19 18.17 20 136942 76188 90415297
Arthritis 60.18 18.17 100 136862 167215 90324270
Disease complication 59.98 18.17 48 136914 3724 90487761
Infusion site extravasation 59.93 18.17 76 136886 10252 90481233
Bacteraemia 59.88 18.17 115 136847 22185 90469300
Exercise tolerance decreased 59.51 18.17 65 136897 7486 90483999
Chronic respiratory failure 59.44 18.17 42 136920 2699 90488786
Muscular weakness 59.30 18.17 141 136821 206525 90284960
Autoimmune disorder 59.13 18.17 21 136941 76723 90414762
Joint stiffness 59.03 18.17 22 136940 78020 90413465
Cardiac failure acute 58.75 18.17 81 136881 11848 90479637
Oxygen saturation abnormal 58.65 18.17 50 136912 4238 90487247
Emergency care 58.52 18.17 34 136928 1555 90489930
Sedation 57.21 18.17 4 136958 48167 90443318
Right-to-left cardiac shunt 56.72 18.17 20 136942 272 90491213
Wrong dose 56.48 18.17 36 136926 1948 90489537
Head discomfort 55.06 18.17 93 136869 16240 90475245
Lactic acidosis 55.03 18.17 6 136956 50457 90441028
Blood pressure systolic increased 54.30 18.17 11 136951 58334 90433151
Product quality issue 54.17 18.17 26 136936 79299 90412186
Hepatitis 53.41 18.17 20 136942 70719 90420766
Infusion site reaction 53.37 18.17 100 136862 18939 90472546
Product use issue 53.24 18.17 287 136675 329632 90161853
Injection site irritation 53.11 18.17 55 136907 5960 90485525
Echocardiogram abnormal 53.09 18.17 32 136930 1567 90489918
Therapy cessation 52.63 18.17 147 136815 36214 90455271
Thrombocytopenia 52.56 18.17 152 136810 208573 90282912
Catheterisation cardiac abnormal 52.06 18.17 19 136943 287 90491198
Cyanosis 51.83 18.17 100 136862 19355 90472130
Terminal state 51.63 18.17 39 136923 2779 90488706
Medication error 51.62 18.17 32 136930 84620 90406865
Product leakage 51.51 18.17 30 136932 1378 90490107
Dialysis 51.45 18.17 74 136888 11255 90480230
Alanine aminotransferase increased 51.21 18.17 62 136900 118276 90373209
Clostridium difficile infection 50.96 18.17 145 136817 36100 90455385
Suicidal ideation 50.75 18.17 24 136938 73831 90417654
Oxygen therapy 50.45 18.17 40 136922 3062 90488423
Blood pressure increased 50.11 18.17 143 136819 197074 90294411
Suture related complication 50.06 18.17 19 136943 322 90491163
Amnesia 50.04 18.17 54 136908 108451 90383034
Injection site erosion 49.69 18.17 14 136948 85 90491400
Coeliac disease 49.42 18.17 5 136957 44605 90446880
Therapeutic response decreased 49.30 18.17 38 136924 89691 90401794
Viral infection 49.09 18.17 156 136806 41258 90450227
Hypocalcaemia 48.95 18.17 4 136958 42364 90449121
Medical device site haemorrhage 48.94 18.17 13 136949 61 90491424
Infection 48.49 18.17 334 136628 361760 90129725
Rhinovirus infection 48.16 18.17 52 136910 5911 90485574
Acute kidney injury 47.76 18.17 286 136676 320101 90171384
Swelling 47.43 18.17 405 136557 418653 90072832
Intentional medical device removal by patient 47.34 18.17 15 136947 143 90491342
Colitis ulcerative 47.27 18.17 16 136946 60250 90431235
Device expulsion 46.85 18.17 4 136958 40882 90450603
Plasma cell myeloma 46.77 18.17 4 136958 40824 90450661
Atrial fibrillation 46.75 18.17 354 136608 133257 90358228
Coma 46.34 18.17 26 136936 72606 90418879
Ventilation perfusion mismatch 46.17 18.17 21 136941 571 90490914
Flatulence 45.59 18.17 152 136810 41215 90450270
Neuropathy peripheral 45.51 18.17 86 136876 136884 90354601
Drug ineffective for unapproved indication 45.27 18.17 22 136940 66622 90424863
Eczema 45.17 18.17 12 136950 52858 90438627
Metabolic acidosis 45.05 18.17 14 136948 55662 90435823
Staphylococcal infection 44.80 18.17 168 136794 48271 90443214
Overdose 44.12 18.17 109 136853 157600 90333885
Disability 44.03 18.17 5 136957 40740 90450745
Decreased activity 43.96 18.17 58 136904 8134 90483351
Respiratory tract congestion 43.87 18.17 115 136847 27295 90464190
Asthenia 43.59 18.17 1085 135877 532666 89958819
Extra dose administered 43.54 18.17 61 136901 9057 90482428
Dry mouth 43.50 18.17 138 136824 183921 90307564
Catheter site scab 43.46 18.17 16 136946 248 90491237
Cholestasis 43.15 18.17 3 136959 36296 90455189
Liver function test increased 42.84 18.17 39 136923 84816 90406669
Right ventricular enlargement 42.59 18.17 19 136943 493 90490992
Hyponatraemia 42.50 18.17 86 136876 133452 90358033
Incorrect route of product administration 42.29 18.17 12 136950 50614 90440871
Pleural effusion 42.19 18.17 302 136660 111689 90379796
Onychomycosis 41.90 18.17 4 136958 37372 90454113
Rash maculo-papular 41.87 18.17 6 136956 40927 90450558
Gout 41.70 18.17 84 136878 16775 90474710
Agranulocytosis 41.30 18.17 3 136959 34999 90456486
No adverse event 41.03 18.17 26 136936 67956 90423529
Dehydration 41.00 18.17 462 136500 193985 90297500
Cellulitis 40.83 18.17 257 136705 91080 90400405
Infusion site haematoma 40.76 18.17 16 136946 298 90491187
Immunodeficiency 40.55 18.17 8 136954 43226 90448259
Joint dislocation 40.27 18.17 9 136953 44573 90446912
Liver transplant 40.11 18.17 31 136931 2286 90489199
Injection site reaction 40.10 18.17 48 136914 92032 90399453
Administration site odour 39.98 18.17 10 136952 35 90491450
Road traffic accident 39.93 18.17 63 136899 107563 90383922
Medical device change 39.90 18.17 16 136946 316 90491169
Application site pruritus 39.61 18.17 40 136922 4207 90487278
Injection site haemorrhage 39.53 18.17 113 136849 28205 90463280
Incorrect drug administration rate 39.50 18.17 44 136918 5179 90486306
Memory impairment 39.23 18.17 159 136803 197085 90294400
Cardiac ablation 39.03 18.17 27 136935 1677 90489808
Haemorrhage 38.70 18.17 207 136755 69162 90422323
Generalised tonic-clonic seizure 38.44 18.17 4 136958 34899 90456586
Catheter site discolouration 38.29 18.17 12 136950 110 90491375
Sickle cell anaemia with crisis 38.14 18.17 51 136911 7246 90484239
Renal disorder 38.13 18.17 135 136827 37724 90453761
Macular degeneration 37.84 18.17 6 136956 37964 90453521
Gamma-glutamyltransferase increased 37.82 18.17 6 136956 37946 90453539
Therapy interrupted 37.72 18.17 163 136799 49945 90441540
Disease recurrence 37.42 18.17 6 136956 37647 90453838
Bone marrow failure 37.34 18.17 3 136959 32218 90459267
Paranasal sinus hypersecretion 37.31 18.17 40 136922 4511 90486974
Right ventricular systolic pressure increased 36.84 18.17 18 136944 577 90490908
Right ventricular dilatation 36.76 18.17 26 136936 1673 90489812
Infusion site injury 36.76 18.17 11 136951 85 90491400
Unevaluable device issue 36.66 18.17 8 136954 12 90491473
Head injury 36.53 18.17 117 136845 31071 90460414
Cardiac operation 36.48 18.17 37 136925 3912 90487573
Swollen tongue 36.39 18.17 12 136950 45944 90445541
Basal cell carcinoma 36.33 18.17 4 136958 33385 90458100
Infusion site dryness 36.27 18.17 8 136954 13 90491472
Nocturnal dyspnoea 35.79 18.17 24 136938 1416 90490069
Catheter site erosion 35.74 18.17 10 136952 59 90491426
Influenza 35.55 18.17 344 136618 138920 90352565
Lower limb fracture 35.25 18.17 46 136916 84967 90406518
Dry eye 35.18 18.17 22 136940 57909 90433576
Bradycardia 35.15 18.17 45 136917 83802 90407683
Inappropriate schedule of product administration 35.02 18.17 113 136849 149820 90341665
Sinus congestion 35.00 18.17 106 136856 27318 90464167
Underdose 34.95 18.17 19 136943 53998 90437487
Foetal exposure during pregnancy 34.42 18.17 11 136951 42964 90448521
Hepatic steatosis 34.31 18.17 7 136955 36938 90454547
Infusion site dermatitis 34.27 18.17 8 136954 19 90491466
Heart and lung transplant 34.25 18.17 11 136951 110 90491375
Endotracheal intubation 33.81 18.17 33 136929 3331 90488154
Infusion site scar 33.58 18.17 17 136945 589 90490896
Injection site pustule 33.39 18.17 11 136951 120 90491365
Pulmonary haemorrhage 33.02 18.17 50 136912 7963 90483522
Injection site bruising 32.98 18.17 19 136943 52288 90439197
Hepatotoxicity 32.90 18.17 14 136948 45828 90445657
Catheter site dermatitis 32.79 18.17 10 136952 83 90491402
Sickle cell anaemia 32.65 18.17 17 136945 625 90490860
Laryngitis 32.62 18.17 18 136944 50735 90440750
Diabetes mellitus 32.53 18.17 30 136932 64845 90426640
Walking aid user 32.41 18.17 7 136955 35499 90455986
Back injury 32.26 18.17 15 136947 46607 90444878
Nasal dryness 32.26 18.17 41 136921 5542 90485943
Skin exfoliation 32.21 18.17 33 136929 67880 90423605
Cardioversion 32.06 18.17 22 136940 1348 90490137
Unintentional medical device removal 32.04 18.17 46 136916 6984 90484501
Supraventricular tachycardia 31.93 18.17 74 136888 16262 90475223
Product prescribing error 31.83 18.17 4 136958 30141 90461344
Catheter site nodule 31.76 18.17 9 136953 56 90491429
Hyperglycaemia 31.45 18.17 19 136943 50951 90440534
Multiple epiphyseal dysplasia 31.41 18.17 10 136952 97 90491388
Multiple sclerosis 31.16 18.17 3 136959 27837 90463648
Gait disturbance 31.15 18.17 248 136714 260248 90231237
Hypercalcaemia 30.75 18.17 7 136955 34233 90457252
Liver disorder 30.74 18.17 88 136874 121181 90370304
Cardiogenic shock 30.69 18.17 94 136868 24374 90467111
Product administration interrupted 30.61 18.17 62 136900 12430 90479055
Infusion site erosion 30.55 18.17 6 136956 3 90491482
Medical device site odour 30.55 18.17 6 136956 3 90491482
Skeletal dysplasia 30.53 18.17 10 136952 107 90491378
Blood culture positive 30.50 18.17 38 136924 5034 90486451
Hepatic function abnormal 30.36 18.17 16 136946 46272 90445213
Vasodilatation 30.32 18.17 29 136933 2855 90488630
Hyperkalaemia 30.32 18.17 32 136930 64932 90426553
Hepatocellular injury 30.20 18.17 4 136958 28954 90462531
Hypoglycaemia 29.79 18.17 37 136925 69811 90421674
Transplant 29.78 18.17 19 136943 1030 90490455
Blood glucose increased 29.74 18.17 62 136900 95184 90396301
Catheter site cellulitis 29.33 18.17 13 136949 332 90491153
Heart rate irregular 29.30 18.17 92 136870 24176 90467309
Infusion site mass 28.87 18.17 25 136937 2164 90489321
Pulmonary pain 28.67 18.17 37 136925 5077 90486408
Intracardiac pressure increased 28.62 18.17 8 136954 47 90491438
Drug level increased 28.56 18.17 4 136958 27758 90463727
Drug dependence 28.42 18.17 5 136957 29322 90462163
Deep vein thrombosis 28.31 18.17 60 136902 91560 90399925
Skin irritation 28.12 18.17 63 136899 13540 90477945
Puncture site pain 27.93 18.17 9 136953 91 90491394
Cardiac output decreased 27.78 18.17 18 136944 1002 90490483
Administration site infection 27.66 18.17 7 136955 26 90491459
Dysarthria 27.55 18.17 25 136937 54457 90437028
Respiratory tract irritation 27.49 18.17 14 136948 491 90490994
Adverse drug reaction 27.21 18.17 88 136874 116613 90374872
Disturbance in attention 27.11 18.17 19 136943 47090 90444395
Vascular resistance pulmonary increased 26.94 18.17 8 136954 60 90491425
Psychotic disorder 26.84 18.17 7 136955 31223 90460262
Medical procedure 26.46 18.17 14 136948 532 90490953
Dry throat 26.40 18.17 45 136917 7915 90483570
Pregnancy 26.32 18.17 33 136929 62014 90429471
Diet noncompliance 26.31 18.17 13 136949 427 90491058
Pain 26.21 18.17 1235 135727 995106 89496379
Haemodynamic test abnormal 26.15 18.17 7 136955 34 90491451
Hypothyroidism 26.13 18.17 25 136937 53102 90438383
Oral herpes 26.12 18.17 9 136953 33515 90457970
Pancreatitis acute 26.12 18.17 8 136954 32107 90459378
Blood pressure abnormal 26.08 18.17 77 136885 19568 90471917
N-terminal prohormone brain natriuretic peptide increased 26.00 18.17 27 136935 2935 90488550
Sinus disorder 25.88 18.17 112 136850 34335 90457150
Pulmonary artery occlusion 25.82 18.17 7 136955 36 90491449
Secretion discharge 25.75 18.17 67 136895 15829 90475656
Metastases to liver 25.65 18.17 6 136956 28801 90462684
Metastases to bone 25.49 18.17 4 136958 25501 90465984
Gastroenteritis viral 25.39 18.17 102 136860 30253 90461232
Infusion site lymphadenopathy 25.14 18.17 5 136957 3 90491482
Drug eruption 25.11 18.17 11 136951 35396 90456089
Sleep study 24.94 18.17 6 136956 17 90491468
Normal newborn 24.91 18.17 3 136959 23359 90468126
Patient dissatisfaction with device 24.73 18.17 8 136954 82 90491403
Diuretic therapy 24.72 18.17 9 136953 135 90491350
Catheter removal 24.64 18.17 12 136950 382 90491103
Fatigue 24.61 18.17 2043 134919 1151980 89339505
Infusion site cyst 24.55 18.17 5 136957 4 90491481
Hallucination, visual 24.54 18.17 3 136959 23089 90468396
Diagnostic procedure 24.48 18.17 9 136953 139 90491346
Dysentery 24.44 18.17 17 136945 1065 90490420
Skin lesion 24.38 18.17 13 136949 37352 90454133
Suture rupture 24.28 18.17 10 136952 212 90491273
Colitis 24.04 18.17 43 136919 69899 90421586
Musculoskeletal pain 23.87 18.17 156 136806 171095 90320390
Cardiac output increased 23.87 18.17 13 136949 524 90490961
Brachydactyly 23.69 18.17 10 136952 226 90491259
Injection site cellulitis 23.43 18.17 19 136943 1502 90489983
Cardiac pacemaker insertion 23.34 18.17 31 136931 4376 90487109
Dysphagia 23.27 18.17 89 136873 112189 90379296
Tracheostomy malfunction 23.07 18.17 7 136955 57 90491428
Stent placement 22.93 18.17 30 136932 4173 90487312
Sluggishness 22.89 18.17 36 136926 5923 90485562
Cerebral infarction 22.79 18.17 6 136956 26590 90464895
Infusion site thrombosis 22.48 18.17 9 136953 177 90491308
Aphasia 22.43 18.17 19 136943 42793 90448692
Gastric disorder 22.42 18.17 105 136857 33279 90458206
Agitation 22.40 18.17 42 136920 67056 90424429
Breast cancer 22.38 18.17 29 136933 53732 90437753
Ejection fraction decreased 22.35 18.17 6 136956 26247 90465238
Bone disorder 22.27 18.17 4 136958 23116 90468369
Chronic obstructive pulmonary disease 22.21 18.17 189 136773 73640 90417845
Paraesthesia oral 22.20 18.17 10 136952 31649 90459836
Emotional distress 22.15 18.17 14 136948 36648 90454837
Coordination abnormal 22.15 18.17 3 136959 21353 90470132
Painful respiration 22.10 18.17 25 136937 2993 90488492
Hyperlipidaemia 22.00 18.17 4 136958 22912 90468573
Device data issue 21.99 18.17 4 136958 0 90491485
Jugular vein distension 21.98 18.17 16 136946 1077 90490408
Rhinorrhoea 21.96 18.17 217 136745 88099 90403386
Therapeutic response shortened 21.95 18.17 4 136958 22875 90468610
Infusion site hypersensitivity 21.95 18.17 6 136956 32 90491453
Taste disorder 21.92 18.17 37 136925 61509 90429976
Portopulmonary hypertension 21.91 18.17 8 136954 121 90491364
Blood creatinine increased 21.91 18.17 79 136883 101307 90390178
Diabetic ketoacidosis 21.90 18.17 5 136957 24402 90467083
Drug titration 21.80 18.17 6 136956 33 90491452
Vasculitis 21.70 18.17 4 136958 22689 90468796
Eosinophilia 21.65 18.17 8 136954 28525 90462960
Blood iron decreased 21.60 18.17 68 136894 17891 90473594
Acute hepatic failure 21.53 18.17 4 136958 22557 90468928
Rash erythematous 21.51 18.17 41 136921 65063 90426422
Hallucination 21.39 18.17 42 136920 65917 90425568
Balloon atrial septostomy 21.12 18.17 7 136955 78 90491407
Cataract 20.81 18.17 49 136913 72043 90419442
Device information output issue 20.74 18.17 11 136951 420 90491065
Pulmonary arterial pressure decreased 20.72 18.17 7 136955 83 90491402
Abdominal discomfort 20.70 18.17 556 136406 476772 90014713
Renal failure 20.66 18.17 295 136667 130712 90360773
Systemic scleroderma 20.66 18.17 18 136944 1571 90489914
Infusion site scab 20.65 18.17 7 136955 84 90491401
Patient-device incompatibility 20.56 18.17 9 136953 223 90491262
Altered state of consciousness 20.53 18.17 11 136951 31521 90459964
Malabsorption from injection site 20.32 18.17 6 136956 44 90491441
Renal impairment 20.31 18.17 86 136876 105335 90386150
Peripheral swelling 20.13 18.17 789 136173 412317 90079168
Transaminases increased 20.11 18.17 16 136946 37176 90454309
Abdominal cavity drainage 20.07 18.17 11 136951 449 90491036
Device related thrombosis 20.05 18.17 20 136942 2073 90489412
Device wireless communication issue 19.93 18.17 7 136955 94 90491391
Incorrect dose administered by device 19.78 18.17 33 136929 5704 90485781
Visual impairment 19.78 18.17 118 136844 132247 90359238
Back pain 19.73 18.17 623 136339 316552 90174933
Ear discomfort 19.71 18.17 46 136916 10154 90481331
Gastric haemorrhage 19.52 18.17 37 136925 7066 90484419
Product communication issue 19.51 18.17 17 136945 1484 90490001
Cardiomegaly 19.50 18.17 68 136894 18857 90472628
Pericardiotomy 19.47 18.17 5 136957 20 90491465
Ear congestion 19.45 18.17 25 136937 3417 90488068
Tubulointerstitial nephritis 19.41 18.17 7 136955 25336 90466149
Pulmonary vascular resistance abnormality 19.35 18.17 7 136955 103 90491382
Device allergy 19.34 18.17 6 136956 53 90491432
Blood viscosity decreased 19.34 18.17 6 136956 53 90491432
Faeces soft 19.27 18.17 38 136924 7473 90484012
Aspartate aminotransferase increased 19.21 18.17 85 136877 102852 90388633
Skin fissures 19.20 18.17 4 136958 20805 90470680
Cardiac flutter 19.19 18.17 29 136933 4609 90486876
Myoclonus 19.17 18.17 3 136959 19165 90472320
Rehabilitation therapy 19.16 18.17 19 136943 1955 90489530
Metapneumovirus infection 19.15 18.17 16 136946 1319 90490166
Spinal osteoarthritis 19.14 18.17 3 136959 19145 90472340
Polyuria 19.10 18.17 45 136917 9995 90481490
Mood swings 19.06 18.17 4 136958 20698 90470787
Malabsorption from administration site 18.93 18.17 7 136955 110 90491375
Fracture 18.88 18.17 5 136957 22071 90469414
Recalled product administered 18.87 18.17 13 136949 802 90490683
Application site hypersensitivity 18.85 18.17 9 136953 274 90491211
Right ventricular hypertrophy 18.84 18.17 13 136949 804 90490681
Sickle cell disease 18.81 18.17 7 136955 112 90491373
Illness 18.76 18.17 198 136764 81771 90409714
Diplopia 18.72 18.17 10 136952 28704 90462781
Administration site pain 18.63 18.17 15 136947 1174 90490311
Nervousness 18.57 18.17 101 136861 33955 90457530
Acne 18.48 18.17 10 136952 28497 90462988
Pulmonary arterial wedge pressure increased 18.43 18.17 10 136952 400 90491085
Administration site discharge 18.40 18.17 5 136957 26 90491459
Critical illness 18.38 18.17 9 136953 290 90491195
Balance disorder 18.21 18.17 80 136882 97000 90394485

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
Dyspnoea 1224.43 23.22 1786 39190 440835 42139524
Infusion site pain 1139.23 23.22 352 40624 5043 42575316
Fluid retention 849.79 23.22 470 40506 31149 42549210
Right ventricular failure 756.05 23.22 300 40676 9255 42571104
Headache 724.50 23.22 1012 39964 238357 42342002
Pulmonary hypertension 724.17 23.22 383 40593 23186 42557173
Pulmonary arterial hypertension 686.38 23.22 285 40691 9902 42570457
Hypervolaemia 602.59 23.22 337 40639 22788 42557571
Pain in jaw 598.94 23.22 288 40688 14214 42566145
Infusion site erythema 526.13 23.22 178 40798 3444 42576915
Oxygen saturation decreased 428.81 23.22 411 40565 64276 42516083
Flushing 399.62 23.22 311 40665 36717 42543642
Dyspnoea exertional 355.87 23.22 331 40645 49817 42530542
Cough 317.04 23.22 593 40383 177510 42402849
Infusion site infection 285.86 23.22 74 40902 526 42579833
Death 264.07 23.22 1019 39957 470166 42110193
Diarrhoea 251.10 23.22 988 39988 459861 42120498
Drug ineffective 242.08 23.22 155 40821 630042 41950317
Device dislocation 231.09 23.22 124 40852 7707 42572652
Oxygen consumption increased 230.97 23.22 79 40897 1580 42578779
Infusion site haemorrhage 226.52 23.22 73 40903 1204 42579155
Infusion site swelling 217.90 23.22 91 40885 3201 42577158
Drug interaction 202.69 23.22 14 40962 266985 42313374
Hypoxia 199.28 23.22 288 40688 69498 42510861
Vascular device infection 198.00 23.22 103 40873 6007 42574352
Device related infection 196.53 23.22 160 40816 20119 42560240
Oedema 196.45 23.22 246 40730 51755 42528604
Lung transplant 195.91 23.22 77 40899 2309 42578050
Dermatitis contact 193.61 23.22 92 40884 4411 42575948
Toxicity to various agents 193.23 23.22 6 40970 229130 42351229
Therapy change 192.55 23.22 89 40887 4006 42576353
Dizziness 168.41 23.22 574 40402 248680 42331679
Febrile neutropenia 163.65 23.22 3 40973 185700 42394659
Syncope 158.07 23.22 316 40660 99090 42481269
Catheter site pain 157.62 23.22 60 40916 1647 42578712
Therapy non-responder 156.36 23.22 223 40753 53136 42527223
Nausea 153.43 23.22 769 40207 396030 42184329
Infusion site discharge 151.77 23.22 41 40935 350 42580009
Catheter site erythema 148.32 23.22 58 40918 1715 42578644
Oedema peripheral 135.88 23.22 360 40616 135716 42444643
Pain in extremity 134.07 23.22 382 40594 150222 42430137
Throat irritation 124.49 23.22 102 40874 12934 42567425
Nasal congestion 123.41 23.22 147 40829 29354 42551005
Pulmonary arterial pressure increased 117.08 23.22 47 40929 1491 42578868
Catheter management 116.33 23.22 42 40934 990 42579369
Hypotension 110.55 23.22 515 40461 257116 42323243
Product use in unapproved indication 109.72 23.22 22 40954 184434 42395925
Device infusion issue 106.11 23.22 40 40936 1068 42579291
Infusion site warmth 102.96 23.22 27 40949 203 42580156
Infusion site irritation 101.40 23.22 30 40946 366 42579993
Infusion site cellulitis 101.07 23.22 25 40951 144 42580215
Feeling abnormal 96.96 23.22 210 40766 69576 42510783
Haemoglobin increased 94.08 23.22 60 40916 5146 42575213
Pancytopenia 92.74 23.22 5 40971 117738 42462621
Injection site infection 91.25 23.22 36 40940 1090 42579269
Chest pain 91.04 23.22 318 40658 139212 42441147
Catheter site pruritus 88.12 23.22 26 40950 314 42580045
Catheterisation cardiac 84.54 23.22 45 40931 2749 42577610
Infusion site reaction 82.48 23.22 35 40941 1281 42579078
Thrombocytopenia 80.86 23.22 41 40935 190238 42390121
Catheter site discharge 79.79 23.22 30 40946 795 42579564
Hospitalisation 79.57 23.22 202 40774 74128 42506231
Peripheral swelling 79.26 23.22 228 40748 90042 42490317
Complication associated with device 78.30 23.22 59 40917 6622 42573737
Acute kidney injury 76.09 23.22 149 40827 367188 42213171
Infusion site induration 74.62 23.22 24 40952 393 42579966
Haemoptysis 73.55 23.22 147 40829 46020 42534339
Injection site discharge 73.08 23.22 25 40951 500 42579859
Infusion site inflammation 71.16 23.22 16 40960 56 42580303
Abdominal discomfort 70.87 23.22 195 40781 75060 42505299
Device maintenance issue 70.30 23.22 16 40960 60 42580299
Cardiac failure 70.05 23.22 244 40732 106612 42473747
Catheter site rash 69.90 23.22 20 40956 215 42580144
Transplant evaluation 69.28 23.22 24 40952 499 42579860
Infusion site discomfort 67.31 23.22 22 40954 380 42579979
Device issue 66.06 23.22 73 40903 13436 42566923
Infusion site abscess 64.68 23.22 14 40962 39 42580320
Catheterisation cardiac abnormal 64.18 23.22 15 40961 65 42580294
Drug abuse 63.29 23.22 12 40964 104759 42475600
Rhabdomyolysis 62.41 23.22 3 40973 78016 42502343
Catheter site swelling 62.32 23.22 23 40953 578 42579781
Ventilation perfusion mismatch 62.12 23.22 17 40959 153 42580206
Infusion site rash 60.02 23.22 23 40953 643 42579716
Device alarm issue 59.61 23.22 24 40952 767 42579592
Catheter site infection 59.38 23.22 37 40939 3046 42577313
Heart rate increased 59.35 23.22 147 40829 53108 42527251
Central venous catheterisation 58.93 23.22 30 40946 1671 42578688
Catheter placement 58.79 23.22 25 40951 920 42579439
Pulmonary arterial pressure abnormal 58.52 23.22 19 40957 321 42580038
Epistaxis 56.91 23.22 167 40809 66659 42513700
Walking distance test abnormal 56 23.22 16 40960 171 42580188
Leukopenia 53.59 23.22 5 40971 74741 42505618
White blood cell count decreased 52.85 23.22 20 40956 110376 42469983
Catheter site haemorrhage 52.69 23.22 32 40944 2516 42577843
Right ventricular dysfunction 52.18 23.22 26 40950 1383 42578976
Hypertension 51.35 23.22 51 40925 167153 42413206
Neuropathy peripheral 51.24 23.22 17 40959 101836 42478523
Blood pressure decreased 50.84 23.22 147 40829 58185 42522174
Infusion site scar 50.74 23.22 10 40966 14 42580345
Device physical property issue 50.74 23.22 26 40950 1468 42578891
Abdominal distension 49.78 23.22 167 40809 71568 42508791
Respiratory failure 49.62 23.22 249 40727 127883 42452476
Acute respiratory failure 49.50 23.22 113 40863 38745 42541614
Malaise 48.80 23.22 360 40616 211796 42368563
Productive cough 47.91 23.22 133 40843 51434 42528925
Anaemia 47.17 23.22 127 40849 280151 42300208
Device breakage 46.74 23.22 34 40942 3615 42576744
Transfusion 46.62 23.22 54 40922 10460 42569899
Device malfunction 45.98 23.22 58 40918 12269 42568090
Pulmonary hypertensive crisis 45.68 23.22 14 40962 194 42580165
Weight increased 45.49 23.22 215 40761 107768 42472591
Therapeutic product effect incomplete 45.31 23.22 7 40969 70932 42509427
Infusion site pruritus 44.49 23.22 22 40954 1151 42579208
Infusion site discolouration 43.77 23.22 14 40962 225 42580134
C-reactive protein increased 43.63 23.22 5 40971 63555 42516804
Neutrophil count decreased 43.50 23.22 5 40971 63410 42516949
Infusion site vesicles 43.32 23.22 13 40963 167 42580192
Chest discomfort 43.16 23.22 147 40829 63469 42516890
Device leakage 42.57 23.22 51 40925 10234 42570125
Rash 42.57 23.22 131 40845 276823 42303536
Dizziness postural 41.39 23.22 44 40932 7751 42572608
Exercise tolerance decreased 40.95 23.22 39 40937 6027 42574332
Terminal state 40.95 23.22 34 40942 4389 42575970
Internal haemorrhage 40.74 23.22 37 40939 5384 42574975
Drug titration error 40.46 23.22 18 40958 740 42579619
Palpitations 40.45 23.22 124 40852 50673 42529686
Treatment failure 40.41 23.22 6 40970 62618 42517741
Device occlusion 40.17 23.22 45 40931 8405 42571954
Intentional product misuse 39.78 23.22 6 40970 61894 42518465
Pericardial effusion 39.37 23.22 87 40889 29188 42551171
Catheter site irritation 38.98 23.22 11 40965 112 42580247
Hyponatraemia 38.57 23.22 25 40951 101437 42478922
Ascites 38.47 23.22 131 40845 56547 42523812
Hallucination 38.30 23.22 5 40971 57502 42522857
Fatigue 38.26 23.22 609 40367 435032 42145327
Asthma 37.91 23.22 7 40969 62307 42518052
Infusion site oedema 37.27 23.22 15 40961 479 42579880
Confusional state 37.23 23.22 65 40911 167532 42412827
Cor pulmonale 35.84 23.22 17 40959 811 42579548
Blood creatine phosphokinase increased 35.27 23.22 3 40973 48335 42532024
Respiration abnormal 35.21 23.22 30 40946 4012 42576347
Treatment noncompliance 34.82 23.22 97 40879 37575 42542784
Dizziness exertional 34.18 23.22 12 40964 260 42580099
Pulmonary veno-occlusive disease 33.75 23.22 15 40961 615 42579744
Pruritus 33.67 23.22 83 40893 188688 42391671
Pulmonary oedema 33.45 23.22 120 40856 53152 42527207
Hyperkalaemia 33.15 23.22 18 40958 80440 42499919
Hyperglycaemia 33.05 23.22 3 40973 45856 42534503
Lactic acidosis 32.51 23.22 3 40973 45258 42535101
Swelling 32.24 23.22 121 40855 54764 42525595
Cardiac output increased 32.21 23.22 8 40968 47 42580312
Device related sepsis 32.13 23.22 28 40948 3859 42576500
Foetal exposure during pregnancy 31.78 23.22 4 40972 47307 42533052
Blood pressure increased 31.37 23.22 31 40945 101897 42478462
Suicide attempt 30.72 23.22 4 40972 46096 42534263
Deep vein thrombosis 30.58 23.22 18 40958 76939 42503420
Psoriasis 30.57 23.22 5 40971 48599 42531760
Hypoglycaemia 30.07 23.22 10 40966 59844 42520515
Liver transplant 29.85 23.22 23 40953 2668 42577691
Infusion site scab 29.74 23.22 5 40971 0 42580359
Oropharyngeal pain 29.50 23.22 99 40877 42411 42537948
Cardiac failure high output 29.44 23.22 8 40968 70 42580289
Catheter removal 29.09 23.22 10 40966 203 42580156
Hepatic function abnormal 28.90 23.22 7 40969 51560 42528799
Pulmonary arterial pressure decreased 28.79 23.22 6 40970 13 42580346
Coma 28.62 23.22 8 40968 53546 42526813
Agitation 28.59 23.22 13 40963 64301 42516058
Haematuria 28.44 23.22 10 40966 57789 42522570
Overdose 28.04 23.22 36 40940 105228 42475131
Echocardiogram abnormal 26.39 23.22 16 40960 1254 42579105
Product dose omission issue 26.34 23.22 245 40731 154120 42426239
Drug-induced liver injury 26.29 23.22 3 40973 38270 42542089
Dyspnoea at rest 26.21 23.22 26 40950 4223 42576136
Infusion site nodule 26.10 23.22 8 40968 111 42580248
Delirium 25.99 23.22 9 40967 52510 42527849
Plasma cell myeloma 25.62 23.22 7 40969 47571 42532788
Intentional product use issue 25.57 23.22 19 40957 71814 42508545
Therapy cessation 25.52 23.22 59 40917 20391 42559968
Rheumatoid arthritis 25.32 23.22 5 40971 42435 42537924
Pulmonary capillary haemangiomatosis 25.31 23.22 6 40970 28 42580331
Sickle cell anaemia with crisis 24.90 23.22 27 40949 4863 42575496
Loss of consciousness 24.88 23.22 163 40813 92191 42488168
Aggression 24.73 23.22 6 40970 44157 42536202
Therapeutic product effect decreased 24.69 23.22 4 40972 39146 42541213
Diuretic therapy 24.65 23.22 6 40970 32 42580327
Blood pressure systolic decreased 24.47 23.22 27 40949 4960 42575399
Oxygen saturation abnormal 24.42 23.22 18 40958 1953 42578406
Device use error 24.38 23.22 22 40954 3175 42577184
Stomatitis 24.27 23.22 9 40967 50320 42530039
Renal impairment 24.24 23.22 43 40933 110185 42470174
Vomiting 24.22 23.22 402 40574 289321 42291038
Seasonal allergy 24.05 23.22 34 40942 8021 42572338
Respiratory tract congestion 23.81 23.22 33 40943 7645 42572714
Infusion site pustule 23.79 23.22 4 40972 0 42580359
Myelosuppression 23.66 23.22 5 40971 40456 42539903
Cardiac ablation 23.63 23.22 15 40961 1275 42579084
Cardiac failure congestive 23.62 23.22 152 40824 85450 42494909
Localised oedema 23.41 23.22 24 40952 4054 42576305
Pulmonary embolism 23.40 23.22 50 40926 119562 42460797
Urticaria 23.38 23.22 22 40954 74014 42506345

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 3973.23 18.31 5887 136093 1100985 109346334
Infusion site pain 3122.14 18.31 1077 140903 16342 110430977
Fluid retention 2716.13 18.31 1622 140358 92685 110354634
Pulmonary arterial hypertension 2261.06 18.31 1013 140967 31555 110415764
Right ventricular failure 2212.14 18.31 933 141047 25021 110422298
Hypervolaemia 2150.40 18.31 1116 140864 48344 110398975
Pulmonary hypertension 2034.80 18.31 1116 140864 54104 110393215
Headache 1974.53 18.31 3814 138166 878563 109568756
Pain in jaw 1788.66 18.31 999 140981 50178 110397141
Infusion site erythema 1579.30 18.31 590 141390 11369 110435950
Death 1427.91 18.31 2912 139068 695957 109751362
Dyspnoea exertional 1267.94 18.31 1058 140922 103002 110344317
Infusion site infection 1116.42 18.31 305 141675 1967 110445352
Device related infection 1085.34 18.31 660 141320 38859 110408460
Oxygen saturation decreased 1064.47 18.31 1154 140826 155828 110291491
Flushing 1048.14 18.31 952 141028 103784 110343535
Cough 901.62 18.31 1891 140089 459750 109987569
Vascular device infection 895.07 18.31 433 141547 16079 110431240
Infusion site swelling 877.82 18.31 366 141614 9511 110437808
Drug ineffective 866.22 18.31 439 141541 1520101 108927218
Diarrhoea 864.42 18.31 3306 138674 1136199 109311120
Catheter site pain 749.96 18.31 290 141690 6156 110441163
Syncope 740.36 18.31 1094 140886 201442 110245877
Dizziness 692.27 18.31 2216 139764 695977 109751342
Catheter site erythema 647.67 18.31 256 141724 5772 110441547
Device dislocation 641.53 18.31 437 141543 31267 110416052
Nausea 616.99 18.31 3166 138814 1232524 109214795
Hypoxia 596.31 18.31 782 141198 128733 110318586
Chest pain 592.69 18.31 1416 140564 374959 110072360
Infusion site haemorrhage 578.44 18.31 219 141761 4379 110442940
Hypotension 527.71 18.31 1673 140307 522176 109925143
Lung transplant 517.69 18.31 210 141770 5076 110442243
Oxygen consumption increased 502.92 18.31 210 141770 5475 110441844
Therapy change 478.79 18.31 241 141739 9756 110437563
Toxicity to various agents 477.03 18.31 37 141943 480518 109966801
Drug interaction 458.18 18.31 53 141927 500130 109947189
Nasal congestion 450.06 18.31 592 141388 97690 110349629
Dermatitis contact 448.31 18.31 258 141722 13695 110433624
Infusion related reaction 426.40 18.31 14 141966 381148 110066171
Neutropenia 425.44 18.31 12 141968 374608 110072711
Oedema peripheral 420.82 18.31 1144 140836 327516 110119803
Infusion site discharge 404.34 18.31 135 141845 1838 110445481
Pulmonary arterial pressure increased 386.17 18.31 169 141811 4958 110442361
Febrile neutropenia 380.26 18.31 5 141975 316762 110130557
Catheter site discharge 375.13 18.31 142 141838 2837 110444482
Hospitalisation 374.45 18.31 663 141317 141830 110305489
Catheter site pruritus 368.49 18.31 131 141849 2175 110445144
Product use in unapproved indication 366.48 18.31 66 141914 447311 110000008
Catheter management 347.38 18.31 143 141837 3592 110443727
Palpitations 338.95 18.31 677 141303 158535 110288784
Infusion site warmth 338.40 18.31 115 141865 1658 110445661
Feeling abnormal 336.23 18.31 727 141253 179984 110267335
Infusion site induration 329.81 18.31 106 141874 1270 110446049
Oedema 326.69 18.31 787 141193 209189 110238130
Device infusion issue 315.55 18.31 126 141854 2919 110444400
Catheter site infection 314.66 18.31 169 141811 7831 110439488
Catheterisation cardiac 310.48 18.31 154 141826 6037 110441282
Infusion site irritation 304.25 18.31 96 141884 1079 110446240
Epistaxis 295.19 18.31 569 141411 129803 110317516
Injection site discharge 291.66 18.31 98 141882 1362 110445957
Catheter site haemorrhage 291.14 18.31 145 141835 5735 110441584
Complication associated with device 290.63 18.31 226 141754 19847 110427472
Device leakage 289.03 18.31 206 141774 15842 110431477
Cardiac failure 288.37 18.31 700 141280 186926 110260393
Throat irritation 277.29 18.31 343 141637 53209 110394110
Therapeutic product effect decreased 276.64 18.31 8 141972 244308 110203011
Alopecia 275.51 18.31 65 141915 364688 110082631
Contraindicated product administered 274.46 18.31 10 141970 248257 110199062
Pericardial effusion 273.29 18.31 352 141628 56865 110390454
Rash 267.96 18.31 400 141580 820564 109626755
Treatment failure 267.60 18.31 24 141956 277210 110170109
Arthropathy 266.77 18.31 29 141951 287493 110159826
Stomatitis 264.64 18.31 22 141958 270220 110177099
Infusion site abscess 261.07 18.31 67 141913 326 110446993
Hepatic enzyme increased 259.11 18.31 49 141931 320843 110126476
Catheter site swelling 257.74 18.31 101 141879 2223 110445096
Rheumatoid arthritis 256.82 18.31 39 141941 299574 110147745
Blood pressure decreased 256.49 18.31 499 141481 114592 110332727
Infusion site cellulitis 255.94 18.31 68 141912 388 110446931
Injection site infection 253.87 18.31 103 141877 2490 110444829
Catheter placement 251.87 18.31 110 141870 3210 110444109
Device related sepsis 249.93 18.31 143 141837 7504 110439815
Haemoptysis 248.25 18.31 377 141603 70977 110376342
Pulmonary oedema 247.31 18.31 455 141525 100204 110347115
Scleroderma 243.93 18.31 132 141848 6209 110441110
Central venous catheterisation 242.71 18.31 112 141868 3730 110443589
Infusion site pruritus 237.67 18.31 120 141860 4888 110442431
Therapeutic product effect incomplete 237.49 18.31 12 141968 223793 110223526
Drug hypersensitivity 236.90 18.31 145 141835 453945 109993374
Product dose omission issue 233.03 18.31 923 141057 320859 110126460
Transfusion 232.19 18.31 220 141760 25252 110422067
Pain in extremity 230.02 18.31 1232 140748 485886 109961433
Glossodynia 229.09 18.31 14 141966 221990 110225329
C-reactive protein increased 227.13 18.31 13 141967 217906 110229413
Hypertension 225.61 18.31 194 141786 509890 109937429
Respiratory failure 224.62 18.31 697 141283 214635 110232684
Device issue 220.00 18.31 246 141734 34289 110413030
Unevaluable event 219.00 18.31 322 141658 58905 110388414
Off label use 218.57 18.31 1089 140891 1499096 108948223
Acute respiratory failure 218.33 18.31 366 141614 74894 110372425
Pericarditis 208.68 18.31 20 141960 219094 110228225
Transplant evaluation 204.39 18.31 80 141900 1755 110445564
Chest discomfort 204.28 18.31 587 141393 173261 110274058
Musculoskeletal stiffness 195.80 18.31 58 141922 279764 110167555
Folliculitis 195.46 18.31 4 141976 167649 110279670
Helicobacter infection 195.38 18.31 9 141971 181868 110265451
Heart rate increased 194.16 18.31 511 141469 143323 110303996
Type 2 diabetes mellitus 192.93 18.31 8 141972 177224 110270095
Presyncope 191.26 18.31 273 141707 48614 110398705
Pneumonia 186.76 18.31 1830 140150 874884 109572435
Cardiac failure congestive 186.33 18.31 519 141461 150481 110296838
Device occlusion 183.84 18.31 154 141826 15031 110432288
Malaise 182.44 18.31 1479 140501 670340 109776979
Hypersensitivity 180.58 18.31 152 141828 403846 110043473
Lower respiratory tract infection 180.21 18.31 45 141935 243061 110204258
Catheter site rash 177.31 18.31 62 141918 978 110446341
Joint swelling 174.12 18.31 187 141793 442658 110004661
Urticaria 170.18 18.31 99 141881 318758 110128561
Fibromyalgia 169.83 18.31 13 141967 170896 110276423
Osteoarthritis 167.88 18.31 19 141961 182604 110264715
Drug abuse 166.81 18.31 17 141963 177394 110269925
Device alarm issue 166.15 18.31 75 141905 2371 110444948
Liver injury 163.01 18.31 7 141973 150406 110296913
Inflammation 161.38 18.31 27 141953 193211 110254108
Pulmonary hypertensive crisis 159.61 18.31 47 141933 410 110446909
Impaired healing 158.82 18.31 30 141950 196687 110250632
Intentional product use issue 156.73 18.31 61 141919 247845 110199474
Abdominal distension 156.62 18.31 538 141442 174565 110272754
Ascites 156.31 18.31 359 141621 92449 110354870
Device malfunction 155.88 18.31 178 141802 25380 110421939
Catheter site irritation 155.49 18.31 50 141930 600 110446719
Vomiting 155.21 18.31 1818 140162 908857 109538462
Pancytopenia 154.97 18.31 39 141941 209574 110237745
Leukopenia 154.65 18.31 9 141971 148782 110298537
Confusional state 153.92 18.31 227 141753 468453 109978866
Wound 152.71 18.31 55 141925 234382 110212937
White blood cell count decreased 152.54 18.31 52 141928 229338 110217981
Dyspnoea at rest 149.97 18.31 107 141873 8239 110439080
Injury 149.74 18.31 24 141956 177241 110270078
Pruritus 147.81 18.31 330 141650 581230 109866089
Discomfort 147.48 18.31 46 141934 214661 110232658
Bursitis 144.35 18.31 5 141975 129913 110317406
Infusion site discolouration 143.48 18.31 51 141929 846 110446473
Infusion site oedema 142.19 18.31 58 141922 1422 110445897
Right ventricular dysfunction 141.43 18.31 74 141906 3249 110444070
Productive cough 140.11 18.31 392 141588 113913 110333406
Rhabdomyolysis 139.83 18.31 3 141977 120398 110326921
Dizziness postural 138.55 18.31 129 141851 14480 110432839
Acute kidney injury 137.87 18.31 391 141589 635039 109812280
Irritable bowel syndrome 136.99 18.31 23 141957 164192 110283127
Device connection issue 136.48 18.31 54 141926 1220 110446099
Joint range of motion decreased 134.28 18.31 5 141975 121827 110325492
Respiration abnormal 132.43 18.31 106 141874 9703 110437616
Intentional overdose 131.86 18.31 10 141970 132491 110314828
Asthma 131.70 18.31 79 141901 250212 110197107
Infusion site rash 131.66 18.31 63 141917 2280 110445039
Infusion site inflammation 131.31 18.31 41 141939 444 110446875
Device breakage 129.46 18.31 121 141859 13648 110433671
Maternal exposure during pregnancy 125.18 18.31 87 141893 254796 110192523
Blister 125.02 18.31 68 141912 227308 110220011
Thrombocytopenia 124.53 18.31 159 141821 348726 110098593
Psoriasis 122.73 18.31 17 141963 139976 110307343
Cardiac disorder 121.80 18.31 289 141691 75991 110371328
Pulmonary veno-occlusive disease 121.44 18.31 58 141922 2090 110445229
Sleep disorder due to general medical condition, insomnia type 121.26 18.31 3 141977 105640 110341679
Catheter site inflammation 120.52 18.31 49 141931 1191 110446128
Catheter site vesicles 119.91 18.31 37 141943 384 110446935
Mobility decreased 117.98 18.31 80 141900 237342 110209977
Neutrophil count decreased 117.92 18.31 10 141970 120931 110326388
Lip dry 114.28 18.31 3 141977 100080 110347239
Walking distance test abnormal 113.99 18.31 41 141939 705 110446614
Obesity 111.54 18.31 9 141971 113342 110333977
Intentional product misuse 110.00 18.31 19 141961 132885 110314434
Device maintenance issue 109.05 18.31 26 141954 87 110447232
Ill-defined disorder 107.00 18.31 34 141946 156819 110290500
Electrocardiogram QT prolonged 106.26 18.31 9 141971 108951 110338368
Infusion site discomfort 105.07 18.31 50 141930 1787 110445532
Drug titration error 104.00 18.31 48 141932 1599 110445720
Oropharyngeal pain 102.60 18.31 394 141586 134882 110312437
Systemic lupus erythematosus 102.58 18.31 105 141875 254233 110193086
Infusion site nodule 102.02 18.31 33 141947 404 110446915
Delirium 101.98 18.31 24 141956 135001 110312318
Cor pulmonale 100.25 18.31 52 141928 2242 110445077
Depressed level of consciousness 99.93 18.31 13 141967 112265 110335054
Epilepsy 98.48 18.31 8 141972 100201 110347118
Anaphylactic reaction 97.60 18.31 15 141965 114285 110333034
Drug-induced liver injury 97.56 18.31 18 141962 120049 110327270
Therapy non-responder 96.35 18.31 429 141551 156878 110290441
Loss of consciousness 94.78 18.31 500 141480 195806 110251513
Sleep disorder 94.65 18.31 70 141910 198574 110248745
Pulmonary arterial pressure abnormal 93.79 18.31 38 141942 915 110446404
Device use error 93.49 18.31 84 141896 9005 110438314
Device physical property issue 93.04 18.31 59 141921 3735 110443584
Thrombosis in device 92.75 18.31 67 141913 5260 110442059
Internal haemorrhage 89.90 18.31 86 141894 9985 110437334
Acute right ventricular failure 89.41 18.31 30 141950 415 110446904
Depression 89.03 18.31 170 141810 317165 110130154
Myelosuppression 88.77 18.31 9 141971 94331 110352988
Suicide attempt 87.30 18.31 14 141966 103380 110343939
Lactic acidosis 86.95 18.31 9 141971 92802 110354517
Atrial flutter 86.92 18.31 130 141850 24132 110423187
Infusion site vesicles 86.26 18.31 32 141948 603 110446716
Hypoaesthesia 85.84 18.31 171 141809 314052 110133267
Catheter site warmth 85.36 18.31 27 141953 306 110447013
Catheter site related reaction 84.46 18.31 40 141940 1414 110445905
Red blood cell sedimentation rate increased 83.66 18.31 4 141976 78298 110369021
Cognitive disorder 83.25 18.31 8 141972 87503 110359816
Metabolic acidosis 83.11 18.31 14 141966 99730 110347589
Grip strength decreased 82.84 18.31 5 141975 80169 110367150
Exposure during pregnancy 81.06 18.31 58 141922 167366 110279953
Blood potassium decreased 81.01 18.31 200 141780 53914 110393405
Prescribed overdose 80.75 18.31 9 141971 87572 110359747
Terminal state 80.28 18.31 63 141917 5604 110441715
Angioedema 79.53 18.31 15 141965 98485 110348834
Localised oedema 79.02 18.31 77 141903 9146 110438173
Neuropathy peripheral 78.13 18.31 69 141911 179208 110268111
Overdose 77.87 18.31 112 141868 233682 110213637
Cardiac failure high output 77.82 18.31 28 141952 482 110446837
Retching 77.66 18.31 119 141861 22563 110424756
Respiratory distress 77.41 18.31 229 141751 68645 110378674
Treatment noncompliance 76.69 18.31 237 141743 72753 110374566
Dizziness exertional 76.61 18.31 31 141949 744 110446575
Seasonal allergy 75.46 18.31 109 141871 19613 110427706
Hyponatraemia 74.75 18.31 102 141878 217551 110229768
Peripheral venous disease 74.23 18.31 10 141970 84107 110363212
Blood creatine phosphokinase increased 74.19 18.31 5 141975 73072 110374247
Drug intolerance 72.87 18.31 272 141708 406240 110041079
Rash maculo-papular 72.73 18.31 6 141974 74216 110373103
Infusion site pustule 72.64 18.31 15 141965 19 110447300
Bradycardia 72.54 18.31 56 141924 155461 110291858
Paraesthesia 72.53 18.31 154 141826 276367 110170952
Arthralgia 72.06 18.31 647 141333 778985 109668334
Coma 71.23 18.31 31 141949 117838 110329481
Hyperkalaemia 71.21 18.31 43 141937 135753 110311566
Inappropriate schedule of product administration 70.37 18.31 95 141885 203542 110243777
Disease complication 70.34 18.31 59 141921 5768 110441551
Vascular device occlusion 70.22 18.31 28 141952 646 110446673
Sedation 70.07 18.31 5 141975 69678 110377641
Cholestasis 69.90 18.31 3 141977 64515 110382804
Night sweats 69.46 18.31 43 141937 133940 110313379
Peripheral swelling 67.79 18.31 805 141175 403229 110044090
Paracentesis 67.76 18.31 34 141946 1366 110445953
Osteoporosis 66.78 18.31 15 141965 87137 110360182
Brain natriuretic peptide increased 66.55 18.31 77 141903 11132 110436187
Muscular weakness 66.32 18.31 137 141843 248331 110198988
Blood pressure systolic increased 66.23 18.31 13 141967 82978 110364341
Hepatitis 66.06 18.31 17 141963 90037 110357282
Catheterisation cardiac abnormal 65.65 18.31 22 141958 303 110447016
Blood pressure increased 65.20 18.31 147 141833 258226 110189093
Oxygen saturation abnormal 64.01 18.31 55 141925 5556 110441763
Catheter site extravasation 63.93 18.31 25 141955 547 110446772
Pulmonary artery aneurysm 63.22 18.31 19 141961 179 110447140
Ventilation perfusion mismatch 62.39 18.31 27 141953 770 110446549
Nail disorder 61.77 18.31 3 141977 57932 110389387
Right-to-left cardiac shunt 61.71 18.31 21 141959 304 110447015
Bone marrow failure 61.66 18.31 3 141977 57845 110389474
Fatigue 61.64 18.31 2017 139963 1213941 109233378
Myalgia 61.41 18.31 492 141488 221889 110225430
Emergency care 60.82 18.31 32 141948 1421 110445898
Hyperglycaemia 60.65 18.31 17 141963 85073 110362246
Oxygen therapy 60.63 18.31 47 141933 4106 110443213
Agranulocytosis 60.49 18.31 5 141975 61755 110385564
Exercise tolerance decreased 60.38 18.31 76 141904 11991 110435328
Hypoglycaemia 59.17 18.31 38 141942 116066 110331253
Sickle cell anaemia with crisis 59.09 18.31 67 141913 9478 110437841
Cardiac failure acute 58.04 18.31 108 141872 23970 110423349
Generalised tonic-clonic seizure 57.76 18.31 3 141977 54677 110392642
Wrong dose 57.12 18.31 38 141942 2611 110444708
Purulent discharge 56.73 18.31 57 141923 7026 110440293
Chronic respiratory failure 56.61 18.31 44 141936 3859 110443460
Liver transplant 56.50 18.31 47 141933 4542 110442777
Hepatic function abnormal 56.36 18.31 22 141958 89273 110358046
Suicidal ideation 56.29 18.31 25 141955 93912 110353407
Loss of personal independence in daily activities 55.98 18.31 66 141914 149954 110297365
Medication error 55.76 18.31 33 141947 105333 110341986
Wound infection 55.75 18.31 27 141953 96438 110350881
Alanine aminotransferase increased 55.50 18.31 94 141886 183679 110263640
General physical health deterioration 55.21 18.31 320 141660 424975 110022344
Bendopnoea 55.09 18.31 14 141966 65 110447254
Disease progression 54.90 18.31 516 141464 243518 110203801
Hypocalcaemia 54.85 18.31 9 141971 65357 110381962
Device programming error 54.81 18.31 20 141960 359 110446960
Sleep disorder due to a general medical condition 54.60 18.31 3 141977 52109 110395210
Cardiac ablation 54.30 18.31 37 141943 2645 110444674
Eczema 54.28 18.31 13 141967 72280 110375039
Tubulointerstitial nephritis 54.28 18.31 4 141976 54280 110393039
Gastrointestinal haemorrhage 54.05 18.31 381 141599 165137 110282182
Swollen tongue 53.68 18.31 7 141973 60355 110386964
Sepsis 52.60 18.31 647 141333 326699 110120620
Gamma-glutamyltransferase increased 52.44 18.31 8 141972 61301 110386018
Agitation 52.35 18.31 41 141939 113010 110334309
Colitis ulcerative 52.34 18.31 17 141963 77346 110369973
Multiple sclerosis relapse 52.31 18.31 3 141977 50237 110397082
Product quality issue 52.27 18.31 17 141963 77282 110370037
Application site pruritus 52.04 18.31 43 141937 4117 110443202
Disease recurrence 51.83 18.31 8 141972 60776 110386543
Sciatica 51.69 18.31 27 141953 92372 110354947
Wheezing 51.66 18.31 162 141818 255068 110192251
Drug ineffective for unapproved indication 50.59 18.31 35 141945 102803 110344516
Altered state of consciousness 50.49 18.31 7 141973 57619 110389700
Plasma cell myeloma 49.92 18.31 10 141970 62926 110384393
Sickle cell anaemia 49.34 18.31 23 141957 784 110446535
Viral infection 48.98 18.31 165 141815 52974 110394345
Deep vein thrombosis 48.58 18.31 65 141915 139822 110307497
Product administration interrupted 48.54 18.31 66 141914 11226 110436093
Haemoglobin increased 47.99 18.31 59 141921 9088 110438231
Cyanosis 47.81 18.31 113 141867 29628 110417691
Gait inability 47.74 18.31 63 141917 136313 110311006
Hepatocellular injury 47.20 18.31 5 141975 50637 110396682
Influenza 47.15 18.31 375 141605 168726 110278593
Device use issue 47.10 18.31 39 141941 3745 110443574
Medical device change 46.95 18.31 19 141961 456 110446863
Onychomadesis 46.72 18.31 3 141977 45660 110401659
Drug dependence 46.47 18.31 5 141975 50015 110397304
Cerebral infarction 46.13 18.31 6 141974 51832 110395487
Catheter site discolouration 46.11 18.31 14 141966 137 110447182
Infusion site reaction 46.03 18.31 82 141898 17600 110429719
Hypothyroidism 45.94 18.31 18 141962 72881 110374438
Live birth 45.73 18.31 16 141964 69468 110377851
Diuretic therapy 45.62 18.31 15 141965 194 110447125
Hallucination 45.45 18.31 38 141942 101394 110345925
Incorrect route of product administration 45.28 18.31 13 141967 64048 110383271
Psychotic disorder 45.08 18.31 6 141974 50931 110396388
Arthritis 45.05 18.31 92 141888 167494 110279825
Diabetes mellitus 44.82 18.31 37 141943 99344 110347975
Dialysis 44.81 18.31 86 141894 19533 110427786
Knee arthroplasty 44.42 18.31 14 141966 64934 110382385
Eosinophilia 44.33 18.31 10 141970 57926 110389393
Injection site irritation 43.86 18.31 42 141938 4882 110442437
Coeliac disease 43.71 18.31 3 141977 43184 110404135
Injection site haemorrhage 43.16 18.31 116 141864 32912 110414407
Rales 43.07 18.31 97 141883 24642 110422677
Head discomfort 43.04 18.31 83 141897 18917 110428402
Pancreatitis acute 43.03 18.31 12 141968 60262 110387057
Flatulence 42.94 18.31 156 141824 51993 110395326
Hepatotoxicity 42.77 18.31 14 141966 63386 110383933
Hepatic steatosis 42.62 18.31 6 141974 48825 110398494
Contusion 42.53 18.31 155 141825 233206 110214113
Respiratory tract congestion 41.97 18.31 110 141870 30747 110416572
Autoimmune disorder 41.54 18.31 16 141964 65467 110381852
Catheter site erosion 41.36 18.31 11 141969 63 110447256
Cellulitis 41.09 18.31 290 141690 125726 110321593
Dysarthria 40.89 18.31 29 141951 84092 110363227
Renal impairment 40.72 18.31 116 141864 188329 110258990
Dysphagia 40.71 18.31 85 141895 153515 110293804
Weight decreased 40.48 18.31 834 141146 467223 109980096
Clostridium difficile infection 40.46 18.31 153 141827 51976 110395343
Aggression 40.07 18.31 13 141967 59197 110388122
Infusion site haematoma 39.38 18.31 15 141965 305 110447014
Hallucination, visual 39.36 18.31 3 141977 39602 110407717
Right ventricular dilatation 39.24 18.31 29 141951 2358 110444961
Pulmonary arterial pressure decreased 39.11 18.31 12 141968 122 110447197
Intentional medical device removal by patient 39.08 18.31 17 141963 491 110446828
Infusion site dryness 38.80 18.31 8 141972 10 110447309
Catheter site scab 38.70 18.31 14 141966 245 110447074
Ischaemic stroke 38.65 18.31 4 141976 41259 110406060
Haematuria 38.56 18.31 30 141950 82975 110364344
Bacteraemia 38.52 18.31 131 141849 42259 110405060
Therapy cessation 38.48 18.31 136 141844 44721 110402598
Paranasal sinus hypersecretion 38.42 18.31 38 141942 4596 110442723
Catheter site nodule 38.41 18.31 10 141970 52 110447267
Heart and lung transplant 38.21 18.31 13 141967 188 110447131
Colitis 38.18 18.31 45 141935 102278 110345041
Gastroenteritis viral 38.15 18.31 107 141873 31119 110416200
Incorrect drug administration rate 38.13 18.31 41 141939 5467 110441852
Catheter removal 38.07 18.31 18 141962 634 110446685
Skin exfoliation 37.86 18.31 34 141946 87617 110359702
Sinus congestion 37.83 18.31 105 141875 30354 110416965
Transaminases increased 37.78 18.31 17 141963 63373 110383946
Gout 37.72 18.31 118 141862 36448 110410871
Drug eruption 37.72 18.31 11 141969 53648 110393671
Right ventricular systolic pressure increased 37.66 18.31 21 141959 1048 110446271
Injection site pustule 37.56 18.31 11 141969 94 110447225
Blood glucose increased 37.10 18.31 71 141909 132425 110314894
Decreased appetite 37.01 18.31 835 141145 475011 109972308
Cardiac operation 36.97 18.31 42 141938 5953 110441366
No adverse event 36.49 18.31 25 141955 73814 110373505
Dehydration 36.43 18.31 532 141448 278979 110168340
Staphylococcal infection 36.40 18.31 182 141798 69762 110377557
Blood pressure abnormal 35.83 18.31 85 141895 22339 110424980
Renal disorder 35.77 18.31 142 141838 49337 110397982
Blood creatinine increased 35.66 18.31 118 141862 182771 110264548
Injection site reaction 35.62 18.31 37 141943 89033 110358286
Infusion site injury 35.57 18.31 8 141972 19 110447300
Onychomycosis 35.42 18.31 4 141976 38527 110408792
Decreased activity 35.37 18.31 56 141924 10918 110436401
Unevaluable device issue 35.29 18.31 7 141973 6 110447313
Extra dose administered 35.06 18.31 59 141921 12100 110435219
Rhinovirus infection 35.06 18.31 58 141922 11731 110435588
Infusion site scar 34.89 18.31 15 141965 421 110446898
Diabetic ketoacidosis 34.82 18.31 6 141974 42052 110405267
Gastric disorder 34.74 18.31 108 141872 33249 110414070
Therapeutic response decreased 34.36 18.31 44 141936 96455 110350864
Administration site infection 34.21 18.31 8 141972 24 110447295
Blood iron decreased 34.20 18.31 76 141904 19138 110428181
Device failure 33.87 18.31 44 141936 7163 110440156
Hypercalcaemia 33.85 18.31 9 141971 46648 110400671
Amnesia 33.62 18.31 52 141928 105356 110341963
Nocturnal dyspnoea 33.60 18.31 24 141956 1851 110445468
Blood culture positive 33.45 18.31 49 141931 8927 110438392
Nightmare 33.40 18.31 5 141975 38858 110408461
Pulmonary capillary haemangiomatosis 33.39 18.31 10 141970 93 110447226
Aphasia 33.36 18.31 17 141963 58980 110388339
Suture related complication 33.03 18.31 14 141966 379 110446940
Acute hepatic failure 32.99 18.31 4 141976 36464 110410855
Joint stiffness 32.92 18.31 23 141957 67220 110380099
Catheter site dermatitis 32.74 18.31 10 141970 100 110447219
Pneumonitis 32.68 18.31 30 141950 76501 110370818
Urinary retention 32.60 18.31 25 141955 69658 110377661
Chronic obstructive pulmonary disease 32.60 18.31 246 141734 108912 110338407
Posterior reversible encephalopathy syndrome 32.46 18.31 3 141977 33858 110413461
Inappropriate antidiuretic hormone secretion 32.45 18.31 3 141977 33848 110413471
Intracardiac pressure increased 32.44 18.31 8 141972 32 110447287
Administration site odour 32.44 18.31 8 141972 32 110447287
Supraventricular tachycardia 32.14 18.31 86 141894 24336 110422983
Prostate cancer 31.99 18.31 5 141975 37636 110409683
Nasal dryness 31.89 18.31 38 141942 5668 110441651
Skin irritation 31.85 18.31 67 141913 16252 110431067
Myelodysplastic syndrome 31.81 18.31 5 141975 37479 110409840
Infusion site hypersensitivity 31.50 18.31 8 141972 37 110447282
Cardioversion 31.14 18.31 25 141955 2298 110445021
Seizure 31.10 18.31 162 141818 221023 110226296
Asthenia 31.00 18.31 1128 140852 687871 109759448
Coronary artery disease 30.73 18.31 28 141952 71662 110375657
Jaundice 30.71 18.31 19 141961 59217 110388102
Stent placement 30.67 18.31 42 141938 7192 110440127
Disturbance in attention 30.62 18.31 21 141959 61974 110385345
Right ventricular enlargement 30.47 18.31 18 141962 1003 110446316
Proteinuria 30.43 18.31 7 141973 40011 110407308
Atrial septal defect 30.13 18.31 24 141956 2181 110445138
Pulmonary fibrosis 30.07 18.31 53 141927 101989 110345330
Vasculitis 29.96 18.31 5 141975 35868 110411451
Head injury 29.94 18.31 122 141858 42895 110404424
Hyperlipidaemia 29.93 18.31 5 141975 35843 110411476
Pleural effusion 29.72 18.31 354 141626 177355 110269964
Immunodeficiency 29.13 18.31 7 141973 38831 110408488
Skin lesion 29.01 18.31 15 141965 51616 110395703
Patient-device incompatibility 28.95 18.31 11 141969 222 110447097
Dry mouth 28.93 18.31 145 141835 199803 110247516
Multiple organ dysfunction syndrome 28.81 18.31 99 141881 151611 110295708
Dry eye 28.78 18.31 18 141962 55775 110391544
Injection site bruising 28.64 18.31 15 141965 51248 110396071
Infusion site mass 28.42 18.31 21 141959 1707 110445612
Infusion site erosion 28.30 18.31 5 141975 0 110447319
Medical device site odour 28.30 18.31 5 141975 0 110447319
Device power source issue 28.14 18.31 19 141961 1338 110445981
Endotracheal intubation 28.08 18.31 37 141943 6107 110441212
Pulmonary embolism 28.00 18.31 161 141819 214313 110233006
Ataxia 27.99 18.31 3 141977 30105 110417214
Sinus disorder 27.88 18.31 99 141881 32629 110414690
Vascular resistance pulmonary increased 27.84 18.31 9 141971 110 110447209
Ejection fraction decreased 27.62 18.31 9 141971 40871 110406448
Right atrial pressure increased 27.54 18.31 12 141968 348 110446971
Hip arthroplasty 27.44 18.31 19 141961 55794 110391525
Diagnostic procedure 27.43 18.31 10 141970 179 110447140
Accidental exposure to product 27.40 18.31 15 141965 49993 110397326
Secretion discharge 27.36 18.31 72 141908 20172 110427147
Sinus bradycardia 27.25 18.31 3 141977 29480 110417839
Diet noncompliance 27.24 18.31 14 141966 592 110446727
Body temperature decreased 27.03 18.31 7 141973 36928 110410391
Abdominal cavity drainage 27.03 18.31 16 141964 895 110446424
Sinusitis 26.98 18.31 247 141733 296441 110150878
Diplopia 26.97 18.31 10 141970 41884 110405435
Aspartate aminotransferase increased 26.71 18.31 110 141870 159826 110287493
Hypomagnesaemia 26.58 18.31 23 141957 60347 110386972
Device expulsion 26.49 18.31 4 141976 30887 110416432
Infusion site dermatitis 26.46 18.31 6 141974 15 110447304
Rehabilitation therapy 26.33 18.31 22 141958 2139 110445180
Vasodilatation 26.15 18.31 28 141952 3716 110443603
Echocardiogram abnormal 26.11 18.31 24 141956 2650 110444669
Acute myocardial infarction 26.08 18.31 42 141938 83735 110363584
Infusion site scab 26.02 18.31 8 141972 82 110447237
Cardiac pacemaker insertion 25.84 18.31 36 141944 6265 110441054
Hemiparesis 25.81 18.31 12 141968 43891 110403428
Heart valve operation 25.73 18.31 10 141970 215 110447104
Disability 25.72 18.31 4 141976 30219 110417100
Administration site pain 25.72 18.31 15 141965 816 110446503
Memory impairment 25.62 18.31 148 141832 196796 110250523
Respiratory depression 25.56 18.31 5 141975 31996 110415323
Dry throat 25.55 18.31 44 141936 9194 110438125
Injection site cellulitis 25.52 18.31 21 141959 1999 110445320
Portopulmonary hypertension 25.34 18.31 9 141971 149 110447170
Liver function test increased 25.19 18.31 47 141933 88501 110358818
Catheter site cellulitis 25.05 18.31 13 141967 561 110446758
Concomitant disease aggravated 25.04 18.31 61 141919 16303 110431016
Pneumonia aspiration 25.03 18.31 41 141939 81192 110366127
COVID-19 24.98 18.31 198 141782 244862 110202457
Haemodynamic test abnormal 24.88 18.31 7 141973 51 110447268
Abdominal pain upper 24.78 18.31 605 141375 348506 110098813
Underdose 24.75 18.31 27 141953 63527 110383792
Hip fracture 24.71 18.31 100 141880 35051 110412268
Application site hypersensitivity 24.69 18.31 11 141969 337 110446982
Labelled drug-drug interaction medication error 24.66 18.31 4 141976 29298 110418021
Erythema 24.64 18.31 247 141733 291200 110156119
Somnolence 24.36 18.31 254 141726 297195 110150124
Respiratory syncytial virus infection 24.34 18.31 56 141924 14428 110432891
Leukocytosis 24.32 18.31 20 141960 53808 110393511
Pulmonary endarterectomy 24.30 18.31 10 141970 251 110447068
Cardiac output increased 24.29 18.31 13 141967 598 110446721
Tracheostomy malfunction 24.24 18.31 9 141971 170 110447149
Haemorrhage 24.17 18.31 226 141754 106466 110340853
Right ventricular hypertrophy 24.11 18.31 19 141961 1700 110445619
Blood pressure fluctuation 23.77 18.31 37 141943 74787 110372532
Balloon atrial septostomy 23.69 18.31 8 141972 113 110447206
N-terminal prohormone brain natriuretic peptide increased 23.66 18.31 34 141946 6087 110441232
Impaired work ability 23.65 18.31 3 141977 26416 110420903
Hallucination, auditory 23.62 18.31 3 141977 26394 110420925
Osteonecrosis 23.56 18.31 7 141973 33734 110413585
Hypothermia 23.51 18.31 3 141977 26299 110421020
Back injury 23.49 18.31 16 141964 47383 110399936
Dysentery 23.31 18.31 17 141963 1354 110445965
Sickle cell disease 23.27 18.31 9 141971 191 110447128
Medical procedure 23.16 18.31 12 141968 516 110446803
Pregnancy 23.04 18.31 19 141961 51048 110396271
Infusion site bruising 22.98 18.31 26 141954 3668 110443651
Jugular vein distension 22.97 18.31 18 141962 1598 110445721
Product leakage 22.95 18.31 18 141962 1600 110445719
Adrenal insufficiency 22.82 18.31 13 141967 42377 110404942
Pulmonary haemorrhage 22.72 18.31 59 141921 16397 110430922
Cardiac discomfort 22.69 18.31 17 141963 1411 110445908
Critical illness 22.64 18.31 12 141968 541 110446778
Dermatitis atopic 22.62 18.31 3 141977 25538 110421781
Nephropathy toxic 22.57 18.31 4 141976 27474 110419845
Suture rupture 22.41 18.31 13 141967 700 110446619
Obstructive airways disorder 22.31 18.31 16 141964 46133 110401186
Coordination abnormal 22.25 18.31 3 141977 25225 110422094
Sluggishness 22.20 18.31 37 141943 7530 110439789
Hypoalbuminaemia 22.17 18.31 5 141975 28969 110418350
Transplant 22.13 18.31 16 141964 1258 110446061
Conjunctivitis 21.86 18.31 8 141972 33784 110413535
Pyrexia 21.84 18.31 937 141043 897328 109549991
Systemic scleroderma 21.83 18.31 19 141961 1953 110445366
Aspiration pleural cavity 21.82 18.31 18 141962 1719 110445600
Mechanical ventilation 21.82 18.31 24 141956 3283 110444036
Blood pressure systolic decreased 21.53 18.31 51 141929 13390 110433929
Pulmonary pain 21.52 18.31 33 141947 6260 110441059
Ear congestion 21.46 18.31 25 141955 3640 110443679
Impaired quality of life 21.38 18.31 6 141974 30011 110417308
Skin fissures 21.36 18.31 3 141977 24455 110422864
Platelet count increased 21.27 18.31 4 141976 26330 110420989
Emotional distress 21.09 18.31 16 141964 44831 110402488
Rash erythematous 21.08 18.31 46 141934 81786 110365533
Cardiac output decreased 21.04 18.31 19 141961 2050 110445269
Oral herpes 21.00 18.31 10 141970 36070 110411249
Tendonitis 20.99 18.31 4 141976 26079 110421240
Wrong technique in product usage process 20.97 18.31 51 141929 87297 110360022
Pulmonary artery dilatation 20.65 18.31 12 141968 648 110446671
Angina pectoris 20.57 18.31 30 141950 62265 110385054
Atrial septal defect repair 20.55 18.31 11 141969 506 110446813
Encephalopathy 20.52 18.31 46 141934 81009 110366310
Puncture site pain 20.37 18.31 8 141972 177 110447142
Hyperbilirubinaemia 20.29 18.31 7 141973 30664 110416655
Balance disorder 20.20 18.31 79 141901 116481 110330838
Visual acuity reduced 20.18 18.31 8 141972 32165 110415154
Application site irritation 20.12 18.31 18 141962 1919 110445400
Paraesthesia oral 20.11 18.31 9 141971 33662 110413657
Injection site erythema 20.10 18.31 197 141783 93979 110353340
Dry skin 19.93 18.31 71 141909 107582 110339737
White blood cell count increased 19.91 18.31 61 141919 96781 110350538
Sleep study 19.89 18.31 5 141975 22 110447297
Sinus headache 19.75 18.31 31 141949 6001 110441318
Pulmonary artery occlusion 19.65 18.31 6 141974 60 110447259
Blood pressure systolic abnormal 19.60 18.31 4 141976 24846 110422473
Faeces soft 19.57 18.31 44 141936 11166 110436153
Hernia repair 19.56 18.31 20 141960 2516 110444803
Medical device site haemorrhage 19.54 18.31 8 141972 198 110447121
Cardiac flutter 19.42 18.31 30 141950 5727 110441592
Device related thrombosis 19.25 18.31 23 141957 3439 110443880
Administration site discharge 19.21 18.31 5 141975 26 110447293
Platelet count decreased 19.19 18.31 196 141784 230247 110217072
Cor pulmonale chronic 19.11 18.31 10 141970 439 110446880
Joint dislocation 19.11 18.31 10 141970 34180 110413139
Atrial fibrillation 19.10 18.31 407 141573 229235 110218084
Orthostatic hypotension 18.99 18.31 35 141945 66214 110381105
Immunoglobulin therapy 18.98 18.31 4 141976 6 110447313
Blood viscosity decreased 18.97 18.31 6 141974 68 110447251
Hypertransaminasaemia 18.93 18.31 4 141976 24251 110423068
Poisoning 18.65 18.31 7 141973 29098 110418221
Heart rate irregular 18.41 18.31 90 141890 34184 110413135
Normal newborn 18.40 18.31 3 141977 21893 110425426

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:35526 hypoglycemic agent
CHEBI has role CHEBI:35554 cardiovascular drug
CHEBI has role CHEBI:35620 vasodilator agent
CHEBI has role CHEBI:35674 antihypertensive agent
CHEBI has role CHEBI:50249 anticoagulant
CHEBI has role CHEBI:50427 platelet aggregation inhibitor
CHEBI has role CHEBI:55347 vitamin K antagonist
CHEBI has role CHEBI:85234 human blood serum metabolite
CHEBI has role CHEBI:233423 antifibrotic agent

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

DiseaseRelationSNOMED_IDDOID
Pulmonary arterial hypertension indication 11399002
Thromboembolic pulmonary hypertension indication 233947005
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
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
0.016MG/INH TYVASO DPI UNITED THERAP N214324 May 23, 2022 RX POWDER INHALATION 11357782 May 14, 2027 METHOD OF TREATING PULMONARY HYPERTENSION BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE
0.032MG/INH TYVASO DPI UNITED THERAP N214324 May 23, 2022 RX POWDER INHALATION 11357782 May 14, 2027 METHOD OF TREATING PULMONARY HYPERTENSION BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE
0.048MG/INH TYVASO DPI UNITED THERAP N214324 May 23, 2022 RX POWDER INHALATION 11357782 May 14, 2027 METHOD OF TREATING PULMONARY HYPERTENSION BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE
0.064MG/INH TYVASO DPI UNITED THERAP N214324 May 23, 2022 RX POWDER INHALATION 11357782 May 14, 2027 METHOD OF TREATING PULMONARY HYPERTENSION BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE
0.08MG/INH TYVASO DPI UNITED THERAP N214324 Oct. 24, 2024 RX POWDER INHALATION 11357782 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
0.1MG/ML REMODULIN UNITED THERAP N021272 Sept. 28, 2023 DISCN INJECTABLE INTRAVENOUS, 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
0.1MG/ML REMODULIN UNITED THERAP N021272 Sept. 28, 2023 DISCN INJECTABLE INTRAVENOUS, 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
0.2MG/ML REMODULIN UNITED THERAP N021272 Sept. 28, 2023 DISCN INJECTABLE INTRAVENOUS, 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
0.2MG/ML REMODULIN UNITED THERAP N021272 Sept. 28, 2023 DISCN INJECTABLE INTRAVENOUS, 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
0.4MG/ML REMODULIN UNITED THERAP N021272 Sept. 28, 2023 RX INJECTABLE INTRAVENOUS, 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
0.4MG/ML REMODULIN UNITED THERAP N021272 Sept. 28, 2023 RX INJECTABLE INTRAVENOUS, 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 INTRAVENOUS, 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 INTRAVENOUS, 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 INTRAVENOUS, 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 INTRAVENOUS, 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 INTRAVENOUS, 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 INTRAVENOUS, 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 DISCN INJECTABLE INTRAVENOUS, 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 DISCN INJECTABLE INTRAVENOUS, 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 INTRAVENOUS, 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 INTRAVENOUS, 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
0.1MG/ML REMODULIN UNITED THERAP N021272 Sept. 28, 2023 DISCN INJECTABLE INTRAVENOUS, 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
0.2MG/ML REMODULIN UNITED THERAP N021272 Sept. 28, 2023 DISCN INJECTABLE INTRAVENOUS, 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
0.4MG/ML REMODULIN UNITED THERAP N021272 Sept. 28, 2023 RX INJECTABLE INTRAVENOUS, 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
10MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE INTRAVENOUS, 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 INTRAVENOUS, 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 INTRAVENOUS, 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 DISCN INJECTABLE INTRAVENOUS, 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 INTRAVENOUS, 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
EQ 0.0265MG BASE/INH YUTREPIA LIQUIDIA TECH N213005 May 23, 2025 RX POWDER INHALATION 10898494 May 5, 2037 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION OR PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL DISEASE BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY USING AN INHALATION DEVICE
EQ 0.0265MG BASE/INH YUTREPIA LIQUIDIA TECH N213005 May 23, 2025 RX POWDER INHALATION 11660304 May 5, 2037 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION OR PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL DISEASE BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY USING AN INHALATION DEVICE
EQ 0.0265MG BASE/INH YUTREPIA LIQUIDIA TECH N213005 May 23, 2025 RX POWDER INHALATION 11712442 May 5, 2037 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION OR PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL DISEASE BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY USING AN INHALATION DEVICE
EQ 0.053MG BASE/INH YUTREPIA LIQUIDIA TECH N213005 May 23, 2025 RX POWDER INHALATION 10898494 May 5, 2037 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION OR PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL DISEASE BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY USING AN INHALATION DEVICE
EQ 0.053MG BASE/INH YUTREPIA LIQUIDIA TECH N213005 May 23, 2025 RX POWDER INHALATION 11660304 May 5, 2037 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION OR PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL DISEASE BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY USING AN INHALATION DEVICE
EQ 0.053MG BASE/INH YUTREPIA LIQUIDIA TECH N213005 May 23, 2025 RX POWDER INHALATION 11712442 May 5, 2037 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION OR PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL DISEASE BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY USING AN INHALATION DEVICE
EQ 0.0795MG BASE/INH YUTREPIA LIQUIDIA TECH N213005 May 23, 2025 RX POWDER INHALATION 10898494 May 5, 2037 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION OR PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL DISEASE BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY USING AN INHALATION DEVICE
EQ 0.0795MG BASE/INH YUTREPIA LIQUIDIA TECH N213005 May 23, 2025 RX POWDER INHALATION 11660304 May 5, 2037 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION OR PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL DISEASE BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY USING AN INHALATION DEVICE
EQ 0.0795MG BASE/INH YUTREPIA LIQUIDIA TECH N213005 May 23, 2025 RX POWDER INHALATION 11712442 May 5, 2037 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION OR PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL DISEASE BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY USING AN INHALATION DEVICE
EQ 0.106MG BASE/INH YUTREPIA LIQUIDIA TECH N213005 May 23, 2025 RX POWDER INHALATION 10898494 May 5, 2037 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION OR PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL DISEASE BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY USING AN INHALATION DEVICE
EQ 0.106MG BASE/INH YUTREPIA LIQUIDIA TECH N213005 May 23, 2025 RX POWDER INHALATION 11660304 May 5, 2037 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION OR PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL DISEASE BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY USING AN INHALATION DEVICE
EQ 0.106MG BASE/INH YUTREPIA LIQUIDIA TECH N213005 May 23, 2025 RX POWDER INHALATION 11712442 May 5, 2037 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION OR PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL DISEASE BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY USING AN INHALATION DEVICE
0.6MG/ML TYVASO UNITED THERAP N022387 July 30, 2009 RX SOLUTION INHALATION 11826327 Feb. 3, 2042 METHOD OF TREATING PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL LUNG DISEASE BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE
0.016MG/INH TYVASO DPI UNITED THERAP N214324 May 23, 2022 RX POWDER INHALATION 11826327 Feb. 3, 2042 METHOD OF TREATING PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL LUNG DISEASE BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE
0.032MG/INH TYVASO DPI UNITED THERAP N214324 May 23, 2022 RX POWDER INHALATION 11826327 Feb. 3, 2042 METHOD OF TREATING PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL LUNG DISEASE BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE
0.048MG/INH TYVASO DPI UNITED THERAP N214324 May 23, 2022 RX POWDER INHALATION 11826327 Feb. 3, 2042 METHOD OF TREATING PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL LUNG DISEASE BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE
0.064MG/INH TYVASO DPI UNITED THERAP N214324 May 23, 2022 RX POWDER INHALATION 11826327 Feb. 3, 2042 METHOD OF TREATING PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL LUNG DISEASE BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE
0.08MG/INH TYVASO DPI UNITED THERAP N214324 Oct. 24, 2024 RX POWDER INHALATION 11826327 Feb. 3, 2042 METHOD OF TREATING PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL LUNG DISEASE BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE

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, 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
EQ 0.0265MG BASE/INH YUTREPIA LIQUIDIA TECH N213005 May 23, 2025 RX POWDER INHALATION May 23, 2028 NEW PRODUCT
EQ 0.053MG BASE/INH YUTREPIA LIQUIDIA TECH N213005 May 23, 2025 RX POWDER INHALATION May 23, 2028 NEW PRODUCT
EQ 0.0795MG BASE/INH YUTREPIA LIQUIDIA TECH N213005 May 23, 2025 RX POWDER INHALATION May 23, 2028 NEW PRODUCT
EQ 0.106MG BASE/INH YUTREPIA LIQUIDIA TECH N213005 May 23, 2025 RX POWDER INHALATION May 23, 2028 NEW PRODUCT

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
4021349 VANDF
C1145760 UMLSCUI
CHEBI:50861 CHEBI
Y9J PDB_CHEM_ID
CHEMBL1237119 ChEMBL_ID
DB00374 DRUGBANK_ID
CHEMBL561157 ChEMBL_ID
C427248 MESH_SUPPLEMENTAL_RECORD_UI
6918140 PUBCHEM_CID
5820 IUPHAR_LIGAND_ID
8170 INN_ID
289480-64-4 SECONDARY_CAS_RN
RUM6K67ESG UNII
1927409 RXNORM
16706 MMSL
26646 MMSL
30181 MMSL
40830 MMSL
79759 MMSL
d04802 MMSL
009648 NDDF
009649 NDDF
015333 NDDF
385681001 SNOMEDCT_US
385682008 SNOMEDCT_US
443570007 SNOMEDCT_US
CHEMBL2107815 ChEMBL_ID
830354-48-8 SECONDARY_CAS_RN
C054809 MESH_SUPPLEMENTAL_RECORD_UI
RUM6K67ESG INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 0703-0666 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 25 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 0703-0676 INJECTION, SOLUTION 50 mg INTRAVENOUS ANDA 25 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 0703-0686 INJECTION, SOLUTION 100 mg INTRAVENOUS ANDA 25 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 0703-0696 INJECTION, SOLUTION 200 mg INTRAVENOUS ANDA 25 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 0781-3420 INJECTION 20 mg SUBCUTANEOUS ANDA 25 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 0781-3425 INJECTION 50 mg SUBCUTANEOUS ANDA 25 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 0781-3427 INJECTION 100 mg SUBCUTANEOUS ANDA 25 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 0781-3430 INJECTION 200 mg SUBCUTANEOUS ANDA 25 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 43598-646 INJECTION, SOLUTION 50 mg SUBCUTANEOUS ANDA 27 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 43598-647 INJECTION, SOLUTION 100 mg SUBCUTANEOUS ANDA 27 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 43598-648 INJECTION, SOLUTION 200 mg SUBCUTANEOUS ANDA 27 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 43598-649 INJECTION, SOLUTION 20 mg SUBCUTANEOUS ANDA 27 sections
Treprostinil Human Prescription Drug Label 1 62332-514 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 25 sections
Treprostinil Human Prescription Drug Label 1 62332-515 INJECTION, SOLUTION 50 mg INTRAVENOUS ANDA 25 sections
Treprostinil Human Prescription Drug Label 1 62332-516 INJECTION, SOLUTION 100 mg INTRAVENOUS ANDA 25 sections
Treprostinil Human Prescription Drug Label 1 62332-517 INJECTION, SOLUTION 200 mg INTRAVENOUS ANDA 25 sections
Remodulin HUMAN PRESCRIPTION DRUG LABEL 1 66302-101 INJECTION, SOLUTION 20 mg INTRAVENOUS NDA 28 sections
Remodulin HUMAN PRESCRIPTION DRUG LABEL 1 66302-102 INJECTION, SOLUTION 50 mg INTRAVENOUS NDA 28 sections
Remodulin HUMAN PRESCRIPTION DRUG LABEL 1 66302-105 INJECTION, SOLUTION 100 mg INTRAVENOUS NDA 28 sections
Remodulin HUMAN PRESCRIPTION DRUG LABEL 1 66302-110 INJECTION, SOLUTION 200 mg INTRAVENOUS NDA 28 sections
Remodulin HUMAN PRESCRIPTION DRUG LABEL 1 66302-111 INJECTION, SOLUTION 2 mg INTRAVENOUS NDA 28 sections
Remodulin HUMAN PRESCRIPTION DRUG LABEL 1 66302-112 INJECTION, SOLUTION 4 mg INTRAVENOUS NDA 28 sections
Remodulin HUMAN PRESCRIPTION DRUG LABEL 1 66302-114 INJECTION, SOLUTION 8 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 32 sections
Orenitram HUMAN PRESCRIPTION DRUG LABEL 1 66302-302 TABLET, EXTENDED RELEASE 0.25 mg ORAL NDA 32 sections
Orenitram HUMAN PRESCRIPTION DRUG LABEL 1 66302-310 TABLET, EXTENDED RELEASE 1 mg ORAL NDA 32 sections
Orenitram HUMAN PRESCRIPTION DRUG LABEL 1 66302-325 TABLET, EXTENDED RELEASE 2.50 mg ORAL NDA 32 sections