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

Stem definitionDrug idCAS RN
prostaglandins 1034 35121-78-9

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • epoprostenol
  • epoprostenol sodium
  • prostacyclin
  • vasocyclin
  • Prostaglandin I2
A prostaglandin that is a powerful vasodilator and inhibits platelet aggregation. It is biosynthesized enzymatically from PROSTAGLANDIN ENDOPEROXIDES in human vascular tissue. The sodium salt has been also used to treat primary pulmonary hypertension (HYPERTENSION, PULMONARY).
  • Molecular weight: 352.47
  • Formula: C20H32O5
  • CLOGP: 2.08
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 3
  • TPSA: 86.99
  • ALOGS: -3.41
  • ROTB: 10

  • Status: OFP

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

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Sept. 20, 1995 FDA GLAXOSMITHKLINE LLC

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Pain in jaw 3231.17 18.61 1350 67840 42146 63377686
Catheter site erythema 1990.35 18.61 531 68659 3745 63416087
Catheter management 1620.85 18.61 419 68771 2568 63417264
Catheter site pruritus 1496.21 18.61 367 68823 1753 63418079
Device related infection 1463.95 18.61 644 68546 22748 63397084
Flushing 1402.83 18.61 924 68266 74163 63345669
Right ventricular failure 1215.53 18.61 516 68674 16672 63403160
Catheter site discharge 1134.12 18.61 291 68899 1722 63418110
Catheter site pain 1089.88 18.61 340 68850 4395 63415437
Dyspnoea exertional 1048.47 18.61 710 68480 59592 63360240
Catheter site infection 1015.46 18.61 325 68865 4589 63415243
Fluid retention 1000.28 18.61 687 68503 58999 63360833
Dyspnoea 949.09 18.61 2162 67028 659151 62760681
Device leakage 868.57 18.61 317 68873 6779 63413053
Device alarm issue 851.25 18.61 219 68971 1311 63418521
Lung transplant 734.05 18.61 228 68962 2900 63416932
Hypervolaemia 717.65 18.61 424 68766 27989 63391843
Catheter placement 702.06 18.61 205 68985 2079 63417753
Device occlusion 697.55 18.61 273 68917 7114 63412718
Catheter site haemorrhage 689.01 18.61 218 68972 2957 63416875
Drug ineffective 685.60 18.61 153 69037 1044612 62375220
Central venous catheterisation 658.82 18.61 201 68989 2398 63417434
Catheter site rash 649.11 18.61 154 69036 619 63419213
Hospitalisation 635.71 18.61 611 68579 84470 63335362
Pulmonary hypertension 569.40 18.61 405 68785 36718 63383114
Headache 563.59 18.61 1736 67454 631505 62788327
Catheter site swelling 553.90 18.61 155 69035 1330 63418502
Complication associated with device 491.58 18.61 277 68913 16701 63403131
Diarrhoea 443.35 18.61 1740 67450 713626 62706206
Pulmonary arterial hypertension 411.45 18.61 274 68916 22303 63397529
Catheter site inflammation 409.32 18.61 109 69081 760 63419072
Death 400.47 18.61 1098 68092 373283 63046549
Off label use 370.48 18.61 137 69053 674325 62745507
Catheter site irritation 366.73 18.61 91 69099 459 63419373
Therapy change 353.06 18.61 159 69031 5922 63413910
Vascular device infection 343.17 18.61 165 69025 7147 63412685
Transplant evaluation 326.65 18.61 98 69092 1099 63418733
Palpitations 319.94 18.61 496 68694 112274 63307558
Device dislocation 316.83 18.61 246 68944 25459 63394373
Device infusion issue 313.79 18.61 108 69082 1930 63417902
Device breakage 306.44 18.61 178 69012 11364 63408468
Transfusion 292.58 18.61 191 68999 15026 63404806
Ascites 269.51 18.61 274 68916 40454 63379378
Catheter site vesicles 265.35 18.61 63 69127 254 63419578
Infusion related reaction 247.26 18.61 4 69186 245517 63174315
Paracentesis 237.24 18.61 73 69117 897 63418935
Dermatitis contact 236.00 18.61 148 69042 10860 63408972
Alopecia 231.17 18.61 44 69146 337492 63082340
Catheter site related reaction 229.89 18.61 71 69119 884 63418948
Toxicity to various agents 220.59 18.61 12 69178 247238 63172594
Nausea 220.22 18.61 1635 67555 852836 62566996
Contraindicated product administered 217.26 18.61 4 69186 217644 63202188
Oedema 214.54 18.61 383 68807 97239 63322593
Pulmonary arterial pressure increased 211.87 18.61 95 69095 3500 63416332
Rheumatoid arthritis 209.92 18.61 18 69172 253801 63166031
Emergency care 209.43 18.61 68 69122 1006 63418826
Arthropathy 207.59 18.61 12 69178 234780 63185052
Device connection issue 204.85 18.61 60 69130 615 63419217
Catheterisation cardiac 204.33 18.61 100 69090 4503 63415329
Chest pain 202.56 18.61 605 68585 215354 63204478
Hypoxia 202.55 18.61 286 68904 59506 63360326
Device malfunction 196.69 18.61 160 69030 17697 63402135
Thrombosis in device 195.53 18.61 85 69105 2905 63416927
Therapeutic product effect decreased 195.09 18.61 3 69187 193184 63226648
Oxygen saturation decreased 193.94 18.61 347 68843 88238 63331594
Treatment failure 189.71 18.61 6 69184 199037 63220795
Joint swelling 187.17 18.61 62 69128 327604 63092228
Catheter removal 186.35 18.61 50 69140 360 63419472
Drug hypersensitivity 178.83 18.61 58 69132 310629 63109203
Medical device change 172.56 18.61 45 69145 286 63419546
Device physical property issue 171.21 18.61 69 69121 1943 63417889
Glossodynia 164.91 18.61 7 69183 178869 63240963
Drug interaction 156.48 18.61 30 69160 229101 63190731
Drug intolerance 152.35 18.61 73 69117 308588 63111244
Musculoskeletal stiffness 147.50 18.61 15 69175 184603 63235229
Hepatic enzyme increased 145.79 18.61 23 69167 202305 63217527
Cardiac failure 144.86 18.61 308 68882 88834 63330998
Hypotension 142.98 18.61 632 68558 271972 63147860
Haemoptysis 142.36 18.61 166 69024 28560 63391272
Oxygen consumption increased 142.00 18.61 74 69116 3810 63416022
Application site pruritus 140.23 18.61 74 69116 3910 63415922
Product use issue 138.20 18.61 35 69155 220485 63199347
Catheter site scab 135.17 18.61 34 69156 183 63419649
Central venous catheter removal 134.28 18.61 39 69151 387 63419445
Neutropenia 132.84 18.61 17 69173 174988 63244844
Hypertension 131.90 18.61 70 69120 279233 63140599
Blood culture positive 130.93 18.61 75 69115 4660 63415172
Discomfort 130.13 18.61 15 69175 167359 63252473
Dyspnoea at rest 127.44 18.61 70 69120 4009 63415823
Stomatitis 122.82 18.61 7 69183 138718 63281114
Maternal exposure during pregnancy 119.80 18.61 45 69145 220017 63199815
Catheter site warmth 114.99 18.61 30 69160 191 63419641
Product use in unapproved indication 113.00 18.61 28 69162 179052 63240780
Unevaluable event 112.02 18.61 201 68989 51185 63368647
Abdominal distension 111.55 18.61 273 68917 86342 63333490
Febrile neutropenia 111.30 18.61 4 69186 118445 63301387
Skin irritation 110.90 18.61 89 69101 9652 63410180
Device issue 110.52 18.61 133 69057 23648 63396184
Pericarditis 109.61 18.61 9 69181 131570 63288262
Intentional product use issue 105.84 18.61 9 69181 127883 63291949
Device related sepsis 105.65 18.61 62 69128 4032 63415800
Blood culture negative 103.66 18.61 26 69164 138 63419694
Oedema peripheral 102.00 18.61 443 68747 189068 63230764
Product administration interrupted 96.13 18.61 62 69128 4774 63415058
Catheter site discolouration 96.04 18.61 23 69167 97 63419735
Wound 94.68 18.61 30 69160 163233 63256599
Nasal congestion 94.34 18.61 216 68974 65444 63354388
Scleroderma 93.98 18.61 64 69126 5398 63414434
Therapeutic product effect incomplete 92.85 18.61 13 69177 125043 63294789
Heart and lung transplant 92.01 18.61 22 69168 92 63419740
Abdominal cavity drainage 91.98 18.61 29 69161 388 63419444
Weight decreased 89.84 18.61 562 68628 276236 63143596
Application site irritation 89.79 18.61 42 69148 1708 63418124
Staphylococcus test positive 87.59 18.61 54 69136 3842 63415990
Gastritis hypertrophic 85.76 18.61 18 69172 34 63419798
Blood pressure increased 85.11 18.61 35 69155 162027 63257805
Catheter site cellulitis 85.11 18.61 25 69165 259 63419573
Malaise 84.13 18.61 755 68435 415199 63004633
Systemic lupus erythematosus 83.93 18.61 63 69127 208855 63210977
Pulmonary veno-occlusive disease 83.66 18.61 35 69155 1086 63418746
Injection site pain 82.44 18.61 20 69170 129780 63290052
Duodenal ulcer perforation 81.73 18.61 3 69187 87206 63332626
Syncope 79.61 18.61 295 68895 117090 63302742
Catheter culture positive 78.29 18.61 21 69169 151 63419681
Mobility decreased 78.26 18.61 18 69172 121141 63298691
Pulmonary oedema 78.26 18.61 180 69010 54693 63365139
Osteoarthritis 78.09 18.61 7 69183 95336 63324496
Impaired healing 77.69 18.61 10 69180 102532 63317300
Transplant 77.10 18.61 30 69160 768 63419064
Inappropriate schedule of product administration 76.72 18.61 11 69179 103954 63315878
Hypersensitivity 75.28 18.61 127 69063 292558 63127274
Psoriasis 75.11 18.61 5 69185 86952 63332880
Hyperthyroidism 74.71 18.61 86 69104 14587 63405245
Pneumonia 72.35 18.61 788 68402 455979 62963853
Confusional state 72.12 18.61 91 69099 236289 63183543
Pericardial effusion 71.23 18.61 122 69068 29936 63389896
Pain in extremity 70.74 18.61 609 68581 330877 63088955
Arthralgia 69.64 18.61 352 68838 569358 62850474
Investigation 68.64 18.61 34 69156 1571 63418261
White blood cell count decreased 68.38 18.61 33 69157 139071 63280761
Vomiting 67.98 18.61 918 68272 558699 62861133
Heart rate increased 66.56 18.61 240 68950 93998 63325834
Drug abuse 66.26 18.61 3 69187 72515 63347317
Aspiration pleural cavity 64.47 18.61 27 69163 840 63418992
Oxygen therapy 64.27 18.61 36 69154 2142 63417690
Walking distance test abnormal 64.16 18.61 24 69166 550 63419282
Application site erythema 63.33 18.61 48 69142 4787 63415045
Disease progression 62.98 18.61 283 68907 122475 63297357
Liver transplant 62.57 18.61 36 69154 2255 63417577
Emergency care examination 62.49 18.61 15 69175 64 63419768
Presyncope 62.23 18.61 110 69080 27675 63392157
Cardiac ablation 62.16 18.61 31 69159 1454 63418378
Depression 61.65 18.61 74 69116 196418 63223414
Pain 59.11 18.61 520 68670 740108 62679724
Blood potassium decreased 56.79 18.61 135 69055 41891 63377941
Infusion site infection 56.63 18.61 31 69159 1763 63418069
Respiratory failure 56.18 18.61 240 68950 101618 63318214
Catheter site nodule 55.44 18.61 13 69177 49 63419783
Clostridium difficile infection 55.19 18.61 109 69081 29813 63390019
Fibromyalgia 53.86 18.61 11 69179 80409 63339423
Epistaxis 53.73 18.61 188 69002 72537 63347295
Catheter site dermatitis 51.37 18.61 13 69177 72 63419760
Injury 51.22 18.61 9 69181 73238 63346594
Intentional product misuse 51.18 18.61 4 69186 60913 63358919
Lower respiratory tract infection 50.46 18.61 42 69148 132265 63287567
Gait disturbance 50.34 18.61 76 69114 183102 63236730
Acute right ventricular failure 50.09 18.61 15 69175 167 63419665
Irritable bowel syndrome 49.83 18.61 14 69176 82398 63337434
Coma 49.42 18.61 6 69184 64358 63355474
Infusion site erythema 48.91 18.61 62 69128 11617 63408215
Staphylococcal infection 48.85 18.61 126 69064 41130 63378702
Injection site reaction 48.73 18.61 4 69186 58520 63361312
Decreased appetite 47.74 18.61 450 68740 250602 63169230
Cough 47.61 18.61 508 68682 292235 63127597
Somnolence 47.33 18.61 76 69114 178609 63241223
Pulmonary haemorrhage 46.90 18.61 48 69142 7133 63412699
Acute kidney injury 46.69 18.61 140 69050 263275 63156557
Platelet transfusion 46.54 18.61 21 69169 785 63419047
Anaphylactic reaction 46.48 18.61 8 69182 66092 63353740
Dizziness 46.37 18.61 691 68499 429234 62990598
Immunoglobulin G4 related disease 46.19 18.61 12 69178 75 63419757
Application site hypersensitivity 45.82 18.61 15 69175 228 63419604
Catheter site induration 45.26 18.61 11 69179 50 63419782
Wrong technique in product usage process 45.06 18.61 7 69183 62333 63357499
Vascular device occlusion 44.67 18.61 13 69177 130 63419702
Electrocardiogram QT prolonged 44.62 18.61 6 69184 59524 63360308
C-reactive protein increased 44.25 18.61 24 69166 94683 63325149
Right ventricular dilatation 44.05 18.61 24 69166 1352 63418480
Catheter site erosion 43.92 18.61 11 69179 58 63419774
Pruritus 43.68 18.61 224 68966 361229 63058603
Suicide attempt 43.67 18.61 7 69183 60911 63358921
Injection site erythema 43.58 18.61 18 69172 83156 63336676
Catheter site extravasation 43.51 18.61 16 69174 349 63419483
Suicidal ideation 42.93 18.61 8 69182 62413 63357419
Catheter site hypersensitivity 42.66 18.61 12 69178 105 63419727
Chest discomfort 42.52 18.61 234 68956 109735 63310097
Concomitant disease aggravated 42.39 18.61 51 69139 9061 63410771
Disease complication 42.34 18.61 32 69158 3177 63416655
Application site rash 42.34 18.61 29 69161 2469 63417363
Condition aggravated 42.01 18.61 643 68547 401574 63018258
Pulmonary arterial pressure abnormal 41.29 18.61 17 69173 506 63419326
General physical health deterioration 40.98 18.61 100 69090 201302 63218530
Right ventricular dysfunction 40.35 18.61 25 69165 1794 63418038
Caesarean section 40.18 18.61 69 69121 16963 63402869
Hallucination 39.97 18.61 6 69184 54811 63365021
Overdose 39.76 18.61 40 69150 115038 63304794
Catheter site urticaria 39.71 18.61 9 69181 28 63419804
Pulmonary alveolar haemorrhage 39.54 18.61 36 69154 4632 63415200
Thyroidectomy 39.45 18.61 21 69169 1129 63418703
Underdose 39.06 18.61 90 69100 27366 63392466
Catheter site bruise 38.90 18.61 16 69174 475 63419357
Cardiac failure high output 38.70 18.61 14 69176 291 63419541
Leukopenia 38.49 18.61 18 69172 77272 63342560
Lung assist device therapy 38.07 18.61 11 69179 107 63419725
Ear discomfort 38.01 18.61 45 69145 7861 63411971
Therapeutic embolisation 37.83 18.61 12 69178 164 63419668
COVID-19 37.18 18.61 41 69149 113062 63306770
Knee arthroplasty 37.16 18.61 7 69183 54199 63365633
Endotracheal intubation 36.82 18.61 27 69163 2561 63417271
Cognitive disorder 36.62 18.61 8 69182 55807 63364025
Blister 36.49 18.61 53 69137 129761 63290071
Hypoaesthesia 36.35 18.61 81 69109 168312 63251520
Suture related complication 36.32 18.61 12 69178 188 63419644
Sleep disorder 36.20 18.61 22 69168 81544 63338288
Loss of personal independence in daily activities 35.73 18.61 32 69158 97258 63322574
Urticaria 35.58 18.61 80 69110 165722 63254110
Pancytopenia 35.46 18.61 32 69158 96901 63322931
Catheter site oedema 35.39 18.61 9 69181 51 63419781
Blood glucose increased 35.25 18.61 24 69166 83732 63336100
Blood pressure systolic increased 34.99 18.61 5 69185 47392 63372440
First bite syndrome 34.98 18.61 7 69183 9 63419823
Asthma 34.96 18.61 53 69137 127508 63292324
Atrial flutter 34.93 18.61 48 69142 9724 63410108
Depressed level of consciousness 34.92 18.61 12 69178 62066 63357766
Ventilation perfusion mismatch 34.76 18.61 15 69175 503 63419329
Catheterisation cardiac abnormal 34.62 18.61 12 69178 219 63419613
Catheter site dryness 34.58 18.61 8 69182 28 63419804
Balance disorder 34.46 18.61 25 69165 84397 63335435
Congestive hepatopathy 33.74 18.61 27 69163 2915 63416917
Pulmonary embolism 33.43 18.61 47 69143 116637 63303195
Hypoglycaemia 33.12 18.61 12 69178 60053 63359779
Seizure 32.73 18.61 59 69131 132575 63287257
Mineral supplementation 32.43 18.61 16 69174 733 63419099
Osteoporosis 32.40 18.61 11 69179 57327 63362505
Dizziness postural 32.23 18.61 40 69150 7336 63412496
Paraesthesia 31.87 18.61 78 69112 156888 63262944
Bacteraemia 31.75 18.61 63 69127 17285 63402547
Biopsy liver 31.54 18.61 13 69177 388 63419444
Deep vein thrombosis 31.45 18.61 27 69163 83773 63336059
Nasopharyngitis 31.09 18.61 418 68772 253839 63165993
Abortion spontaneous 30.49 18.61 7 69183 47188 63372644
Hyponatraemia 30.18 18.61 47 69143 111853 63307979
Systemic-pulmonary artery shunt 30.15 18.61 7 69183 25 63419807
Contusion 30.12 18.61 75 69115 149969 63269863
Arthritis 30.03 18.61 50 69140 115871 63303961
Myocardial infarction 29.86 18.61 39 69151 99854 63319978
Catheter site thrombosis 29.84 18.61 10 69180 164 63419668
Concomitant disease progression 29.76 18.61 22 69168 2112 63417720
Dry mouth 29.33 18.61 25 69165 77838 63341994
Dysphagia 29.24 18.61 32 69158 88553 63331279
Female sterilisation 29.22 18.61 14 69176 601 63419231
Inflammation 29.10 18.61 28 69162 82245 63337587
Brain natriuretic peptide increased 29.00 18.61 32 69158 5181 63414651
Myalgia 28.99 18.61 265 68925 146264 63273568
Mechanical ventilation 28.95 18.61 18 69172 1300 63418532
Application site odour 28.26 18.61 7 69183 35 63419797
Drug-induced liver injury 27.99 18.61 5 69185 40217 63379615
Blood pressure fluctuation 27.75 18.61 8 69182 46309 63373523
Balloon atrial septostomy 27.67 18.61 8 69182 78 63419754
Hyperglycaemia 27.47 18.61 6 69184 41861 63377971
Culture positive 27.22 18.61 12 69178 424 63419408
Tri-iodothyronine increased 27.01 18.61 9 69181 145 63419687
Cerebrovascular accident 26.70 18.61 48 69142 107976 63311856
Biopsy bone marrow 26.51 18.61 11 69179 334 63419498
Terminal state 26.29 18.61 21 69169 2261 63417571
Device related thrombosis 26.25 18.61 19 69171 1766 63418066
Product deposit 26.23 18.61 10 69180 242 63419590
Cholecystectomy 26.17 18.61 44 69146 10633 63409199
Bradycardia 25.81 18.61 25 69165 73202 63346630
Jugular vein distension 25.62 18.61 15 69175 971 63418861
Echocardiogram abnormal 25.53 18.61 17 69173 1381 63418451
Catheter site abscess 25.31 18.61 6 69184 24 63419808
No adverse event 25.09 18.61 7 69183 41398 63378434
Delirium 24.81 18.61 12 69178 50529 63369303
Tracheostomy 24.80 18.61 13 69177 677 63419155
Muscular weakness 24.67 18.61 61 69129 122292 63297540
Therapeutic procedure 24.67 18.61 14 69176 854 63418978
Cardioversion 24.66 18.61 16 69174 1244 63418588
Stent placement 24.34 18.61 25 69165 3730 63416102
Prescribed overdose 24.31 18.61 4 69186 34149 63385683
Orthostatic hypotension 24.09 18.61 5 69185 36155 63383677
Biopsy lymph gland 24.06 18.61 6 69184 31 63419801
Hospice care 24.01 18.61 36 69154 7896 63411936
Application site reaction 23.79 18.61 13 69177 737 63419095
Infusion site pruritus 23.64 18.61 31 69159 6004 63413828
Upper respiratory tract congestion 23.49 18.61 19 69171 2083 63417749
Cardiac output decreased 23.20 18.61 14 69176 958 63418874
Sepsis 23.13 18.61 262 68928 152861 63266971
Cardiac disorder 22.99 18.61 113 69077 50703 63369129
Adverse drug reaction 22.94 18.61 32 69158 79682 63340150
Urinary retention 22.83 18.61 3 69187 30298 63389534
Swollen tongue 22.80 18.61 5 69185 34795 63385037
Supraventricular tachycardia 22.79 18.61 49 69141 14222 63405610
Acute respiratory failure 22.79 18.61 86 69104 34399 63385433
Emotional distress 22.75 18.61 4 69186 32545 63387287
Urinary tract infection 22.72 18.61 182 69008 264502 63155330
Dry eye 22.72 18.61 8 69182 40753 63379079
Abdominal discomfort 22.60 18.61 232 68958 320653 63099179
Coronary artery disease 22.58 18.61 4 69186 32373 63387459
Cardiac flutter 22.54 18.61 25 69165 4071 63415761
Silent thyroiditis 22.53 18.61 7 69183 89 63419743
Infusion site rash 22.23 18.61 18 69172 1976 63417856
Injection site pruritus 21.71 18.61 11 69179 45105 63374727
Pulmonary artery dilatation 21.49 18.61 9 69181 280 63419552
Orthopnoea 21.25 18.61 30 69160 6231 63413601
Drug delivery system malfunction 21.15 18.61 14 69176 1126 63418706
Catheter site scar 21.06 18.61 4 69186 3 63419829
Culture negative 21.06 18.61 4 69186 3 63419829
N-terminal prohormone brain natriuretic peptide increased 20.97 18.61 18 69172 2143 63417689
Oral pain 20.95 18.61 3 69187 28391 63391441
Goitre 20.89 18.61 29 69161 5932 63413900
Dysentery 20.79 18.61 13 69177 948 63418884
Drain placement 20.71 18.61 6 69184 59 63419773
Disease recurrence 20.59 18.61 3 69187 28027 63391805
Joint range of motion decreased 20.57 18.61 5 69185 32423 63387409
Catheter site mass 20.53 18.61 5 69185 23 63419809
Lactic acidosis 20.52 18.61 8 69182 38279 63381553
Endarterectomy 20.52 18.61 8 69182 206 63419626
Respiratory tract haemorrhage 20.52 18.61 10 69180 446 63419386
Ill-defined disorder 20.49 18.61 36 69154 81719 63338113
Dialysis 20.46 18.61 39 69151 10388 63409444
Visual impairment 20.44 18.61 38 69152 84408 63335424
Agitation 20.37 18.61 21 69169 59736 63360096
Insomnia 20.37 18.61 144 69046 215108 63204724
Femur fracture 20.36 18.61 10 69180 41746 63378086
Chronic right ventricular failure 20.35 18.61 5 69185 24 63419808
Drug titration 20.18 18.61 5 69185 25 63419807
Incorrect route of product administration 20.02 18.61 3 69187 27449 63392383
Cardiac output increased 19.96 18.61 8 69182 222 63419610
Cor pulmonale 19.71 18.61 17 69173 2037 63417795
Pulmonary capillary haemangiomatosis 19.56 18.61 5 69185 29 63419803
Biopsy skin 19.55 18.61 6 69184 73 63419759
Right atrial dilatation 19.46 18.61 11 69179 666 63419166
Therapeutic response decreased 19.46 18.61 23 69167 61502 63358330
Infusion site pain 19.43 18.61 51 69139 16818 63403014
Internal haemorrhage 19.42 18.61 26 69164 5139 63414693
Vertigo 19.36 18.61 22 69168 59865 63359967
Blood pressure decreased 19.17 18.61 129 69061 64893 63354939
Pituitary enlargement 19.14 18.61 5 69185 32 63419800
Dizziness exertional 18.90 18.61 9 69181 381 63419451
Hepatitis 18.70 18.61 10 69180 39778 63380054
Device use error 18.67 18.61 27 69163 5734 63414098
Retching 18.66 18.61 46 69144 14599 63405233

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Pain in jaw 1146.39 24.61 374 17317 12666 34926574
Catheter management 608.11 24.61 132 17559 833 34938407
Right ventricular failure 469.35 24.61 174 17517 8610 34930630
Catheter site erythema 466.04 24.61 114 17577 1289 34937951
Fluid retention 412.69 24.61 222 17469 26665 34912575
Device related infection 380.49 24.61 182 17509 17055 34922185
Catheter site pruritus 345.30 24.61 69 17622 269 34938971
Device occlusion 332.57 24.61 125 17566 6420 34932820
Device alarm issue 306.34 24.61 70 17621 574 34938666
Catheter placement 301.75 24.61 72 17619 726 34938514
Lung transplant 291.81 24.61 85 17606 1939 34937301
Headache 289.44 24.61 426 17265 200209 34739031
Flushing 275.55 24.61 183 17508 32237 34907003
Dyspnoea 274.00 24.61 592 17099 376190 34563050
Catheter site infection 225.74 24.61 74 17617 2523 34936717
Catheter site discharge 222.44 24.61 54 17637 589 34938651
Hypervolaemia 221.92 24.61 133 17558 19576 34919664
Dyspnoea exertional 209.17 24.61 174 17517 43105 34896135
Pulmonary hypertension 197.00 24.61 126 17565 20798 34918442
Catheter site pain 196.44 24.61 57 17634 1281 34937959
Complication associated with device 194.71 24.61 83 17608 5923 34933317
Catheter site haemorrhage 183.78 24.61 61 17630 2163 34937077
Device dislocation 168.95 24.61 76 17615 6173 34933067
Central venous catheterisation 161.51 24.61 49 17642 1290 34937950
Catheter site rash 149.15 24.61 32 17659 189 34939051
Device leakage 134.61 24.61 66 17625 6509 34932731
Pulmonary arterial hypertension 130.64 24.61 71 17620 8668 34930572
Oxygen saturation decreased 130.16 24.61 148 17543 53670 34885570
Hospitalisation 126.77 24.61 150 17541 56752 34882488
Catheter removal 116.27 24.61 26 17665 191 34939049
Catheter site inflammation 109.81 24.61 25 17666 201 34939039
Transplant evaluation 108.44 24.61 29 17662 477 34938763
Catheter site irritation 107.17 24.61 22 17669 101 34939139
Medical device change 98.02 24.61 21 17670 123 34939117
Pulmonary veno-occlusive disease 97.56 24.61 27 17664 508 34938732
Drug interaction 97.28 24.61 4 17687 225942 34713298
Paracentesis 93.26 24.61 25 17666 415 34938825
Catheter site swelling 91.68 24.61 24 17667 362 34938878
Thrombosis in device 88.46 24.61 40 17651 3285 34935955
Pain in extremity 83.35 24.61 192 17499 126321 34812919
Toxicity to various agents 81.62 24.61 5 17686 200357 34738883
Device infusion issue 80.06 24.61 26 17665 859 34938381
Therapy change 78.65 24.61 36 17655 3041 34936199
Oedema 78.62 24.61 106 17585 45635 34893605
Device breakage 78.57 24.61 33 17658 2267 34936973
Heart and lung transplant 73.58 24.61 15 17676 66 34939174
Ascites 72.65 24.61 103 17588 46468 34892772
Hypoxia 71.82 24.61 112 17579 54983 34884257
Transfusion 71.71 24.61 48 17643 8537 34930703
Device connection issue 71.64 24.61 20 17671 389 34938851
Vascular device infection 68.14 24.61 36 17655 4149 34935091
Neutropenia 66.68 24.61 3 17688 156775 34782465
Blood culture positive 66.35 24.61 37 17654 4746 34934494
Condition aggravated 63.99 24.61 228 17463 191968 34747272
Diarrhoea 62.06 24.61 372 17319 389540 34549700
Oxygen consumption increased 61.84 24.61 24 17667 1342 34937898
Catheterisation cardiac 61.22 24.61 29 17662 2648 34936592
Device physical property issue 61.12 24.61 21 17670 828 34938412
Concomitant disease aggravated 60.32 24.61 37 17654 5664 34933576
Pulmonary arterial pressure increased 60.03 24.61 23 17668 1242 34937998
Off label use 58.77 24.61 76 17615 419448 34519792
Death 57.83 24.61 371 17320 397678 34541562
Febrile neutropenia 56.96 24.61 3 17688 136846 34802394
Liver transplant 56.57 24.61 27 17664 2507 34936733
Haemoptysis 55.43 24.61 78 17613 34928 34904312
Product administration interrupted 55.25 24.61 24 17667 1791 34937449
Product deposit 53.82 24.61 16 17675 392 34938848
Device malfunction 52.55 24.61 43 17648 10378 34928862
Device related sepsis 48.64 24.61 26 17665 3067 34936173
Abdominal distension 47.86 24.61 97 17594 58395 34880845
Catheter site vesicles 47.36 24.61 9 17682 25 34939215
Blood culture negative 41.64 24.61 8 17683 24 34939216
Pulmonary oedema 39.08 24.61 79 17612 47450 34891790
Cardiac failure 39.03 24.61 118 17573 91130 34848110
Device issue 38.45 24.61 35 17656 9742 34929498
Dermatitis contact 37.47 24.61 23 17668 3523 34935717
Nausea 37.11 24.61 296 17395 339612 34599628
Drug ineffective 34.86 24.61 117 17574 456634 34482606
Oxygen therapy 34.48 24.61 14 17677 882 34938358
Catheter site scab 34.46 24.61 6 17685 8 34939232
Pulmonary endarterectomy 34.04 24.61 8 17683 75 34939165
Micrococcus test positive 33.29 24.61 6 17685 11 34939229
Spinal cord ischaemia 33.05 24.61 8 17683 86 34939154
Abdominal cavity drainage 32.76 24.61 11 17680 404 34938836
Right-to-left cardiac shunt 32.17 24.61 8 17683 97 34939143
White blood cell count decreased 32.02 24.61 5 17686 95440 34843800
Catheter culture positive 31.23 24.61 6 17685 18 34939222
Palpitations 31.14 24.61 65 17626 39921 34899319
Catheter site dermatitis 30.60 24.61 5 17686 3 34939237
Catheter site dryness 30.60 24.61 5 17686 3 34939237
Catheter site mass 30.52 24.61 6 17685 21 34939219
Lung assist device therapy 30.10 24.61 6 17685 23 34939217
Drug delivery system malfunction 29.53 24.61 10 17681 377 34938863
Epistaxis 28.42 24.61 79 17612 58172 34881068
Oedema peripheral 28.40 24.61 128 17563 119684 34819556
Catheter site extravasation 27.42 24.61 7 17684 95 34939145
Catheter site related reaction 27.38 24.61 9 17682 309 34938931
Vascular device occlusion 26.68 24.61 8 17683 202 34939038
Emergency care 26.66 24.61 9 17682 336 34938904
Central venous catheter removal 26.38 24.61 6 17685 48 34939192
Nasal congestion 26.10 24.61 44 17647 23013 34916227
Catheter site warmth 25.95 24.61 6 17685 52 34939188
Overdose 25.94 24.61 7 17684 91052 34848188
Balloon atrial septostomy 25.55 24.61 5 17686 17 34939223
Product use in unapproved indication 25.27 24.61 14 17677 117485 34821755
Staphylococcus test positive 24.66 24.61 17 17674 3169 34936071

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Pain in jaw 3798.11 17.91 1502 77720 44649 79620517
Catheter site erythema 2179.89 17.91 584 78638 4656 79660510
Catheter management 1902.74 17.91 487 78735 3176 79661990
Catheter site pruritus 1645.06 17.91 395 78827 1896 79663270
Device related infection 1630.92 17.91 758 78464 33536 79631630
Right ventricular failure 1494.95 17.91 637 78585 22860 79642306
Flushing 1473.36 17.91 978 78244 87290 79577876
Fluid retention 1290.83 17.91 825 78397 68984 79596182
Catheter site discharge 1239.46 17.91 318 78904 2094 79663072
Catheter site pain 1152.27 17.91 358 78864 5038 79660128
Catheter site infection 1095.02 17.91 364 78858 6431 79658735
Dyspnoea 1051.88 17.91 2491 76731 854534 78810632
Dyspnoea exertional 1022.66 17.91 779 78443 86294 79578872
Device alarm issue 1017.81 17.91 264 78958 1825 79663341
Catheter placement 934.43 17.91 266 78956 2708 79662458
Device leakage 917.94 17.91 361 78861 10495 79654671
Lung transplant 896.22 17.91 284 78938 4277 79660889
Device occlusion 886.82 17.91 361 78861 11505 79653661
Hypervolaemia 829.71 17.91 521 78701 42169 79622997
Headache 813.21 17.91 1913 77309 651859 79013307
Catheter site haemorrhage 756.72 17.91 257 78965 4860 79660306
Central venous catheterisation 752.03 17.91 230 78992 3059 79662107
Catheter site rash 689.14 17.91 167 79055 838 79664328
Pulmonary hypertension 655.81 17.91 471 78751 47609 79617557
Complication associated with device 635.94 17.91 322 78900 17174 79647992
Hospitalisation 589.46 17.91 589 78633 93647 79571519
Catheter site swelling 573.70 17.91 164 79058 1696 79663470
Catheter site inflammation 482.99 17.91 129 79093 1012 79664154
Drug ineffective 477.15 17.91 241 78981 1080672 78584494
Device dislocation 454.94 17.91 297 78925 25673 79639493
Pulmonary arterial hypertension 454.86 17.91 307 78915 28059 79637107
Diarrhoea 445.87 17.91 1888 77334 878601 78786565
Off label use 407.87 17.91 197 79025 907018 78758148
Death 405.91 17.91 1359 77863 565155 79100011
Device breakage 404.12 17.91 202 79020 10473 79654693
Catheter site irritation 383.45 17.91 94 79128 499 79664667
Device infusion issue 364.31 17.91 122 79100 2204 79662962
Toxicity to various agents 351.57 17.91 16 79206 421524 79243642
Transplant evaluation 347.19 17.91 109 79113 1588 79663578
Palpitations 318.09 17.91 501 78721 126109 79539057
Transfusion 316.26 17.91 220 79002 21110 79644056
Therapy change 309.86 17.91 150 79072 7249 79657917
Drug interaction 307.40 17.91 29 79193 415154 79250012
Paracentesis 294.50 17.91 91 79131 1254 79663912
Nausea 282.40 17.91 1766 77456 955430 78709736
Oedema 276.87 17.91 456 78766 119124 79546042
Vascular device infection 274.25 17.91 154 79068 10122 79655044
Dermatitis contact 266.70 17.91 155 79067 10878 79654288
Thrombosis in device 260.59 17.91 121 79101 5321 79659845
Oxygen saturation decreased 259.17 17.91 462 78760 128585 79536581
Catheter site vesicles 256.51 17.91 61 79161 278 79664888
Ascites 253.66 17.91 343 78879 75219 79589947
Catheter removal 252.86 17.91 69 79153 592 79664574
Medical device change 245.97 17.91 64 79158 448 79664718
Catheterisation cardiac 230.47 17.91 113 79109 5615 79659551
Device malfunction 229.85 17.91 182 79040 21266 79643900
Catheter site related reaction 223.20 17.91 72 79150 1150 79664016
Device connection issue 221.44 17.91 69 79153 979 79664187
Neutropenia 221.31 17.91 17 79205 287693 79377473
Pulmonary arterial pressure increased 217.24 17.91 101 79121 4454 79660712
Device physical property issue 213.65 17.91 85 79137 2545 79662621
Emergency care 210.86 17.91 67 79155 1017 79664149
Hypoxia 203.88 17.91 367 78855 102876 79562290
Infusion related reaction 201.20 17.91 6 79216 230231 79434935
Febrile neutropenia 198.37 17.91 7 79215 230992 79434174
Blood culture positive 176.60 17.91 108 79114 8321 79656845
Chest pain 176.00 17.91 648 78574 281656 79383510
Oxygen consumption increased 161.73 17.91 85 79137 4894 79660272
Product administration interrupted 154.13 17.91 76 79146 3823 79661343
Application site pruritus 149.82 17.91 74 79148 3736 79661430
Device issue 148.59 17.91 158 79064 26950 79638216
Therapeutic product effect decreased 147.97 17.91 3 79219 163860 79501306
Rheumatoid arthritis 147.83 17.91 17 79205 208453 79456713
Device related sepsis 146.41 17.91 86 79136 6154 79659012
Catheter site scab 145.62 17.91 36 79186 199 79664967
Haemoptysis 145.22 17.91 225 78997 55774 79609392
Central venous catheter removal 144.96 17.91 42 79180 457 79664709
Pulmonary veno-occlusive disease 143.47 17.91 56 79166 1592 79663574
Heart and lung transplant 141.39 17.91 34 79188 164 79665002
Drug abuse 139.40 17.91 5 79217 162686 79502480
Product use in unapproved indication 137.74 17.91 39 79183 250320 79414846
Hypertension 136.14 17.91 80 79142 330912 79334254
Arthropathy 134.63 17.91 11 79211 177100 79488066
Treatment failure 134.12 17.91 9 79213 170477 79494689
Blood culture negative 132.94 17.91 33 79189 186 79664980
Abdominal distension 130.23 17.91 334 78888 119316 79545850
Unevaluable event 129.92 17.91 213 79009 55372 79609794
Drug hypersensitivity 129.05 17.91 68 79154 298848 79366318
Catheter site warmth 121.41 17.91 32 79190 237 79664929
Stomatitis 120.78 17.91 6 79216 146751 79518415
Alopecia 120.13 17.91 40 79182 231315 79433851
Oedema peripheral 118.79 17.91 531 78691 251757 79413409
Pain in extremity 118.28 17.91 691 78531 363847 79301319
Acute kidney injury 116.91 17.91 211 79011 519193 79145973
Cardiac failure 115.99 17.91 378 78844 154464 79510702
Joint swelling 114.17 17.91 73 79149 288573 79376593
Hepatic enzyme increased 113.16 17.91 22 79200 182588 79482578
Musculoskeletal stiffness 112.95 17.91 19 79203 174989 79490177
Intentional product use issue 111.42 17.91 11 79211 152101 79513065
Skin irritation 109.03 17.91 90 79132 11150 79654016
Abdominal cavity drainage 108.39 17.91 38 79184 792 79664374
Contraindicated product administered 106.46 17.91 15 79207 157523 79507643
Dyspnoea at rest 105.15 17.91 74 79148 7228 79657938
Application site irritation 103.31 17.91 45 79177 1699 79663467
Malaise 103.22 17.91 835 78387 489034 79176132
Catheter culture positive 101.05 17.91 27 79195 212 79664954
Scleroderma 98.87 17.91 64 79158 5446 79659720
Staphylococcus test positive 98.75 17.91 68 79154 6413 79658753
Product use issue 97.75 17.91 43 79179 209779 79455387
Confusional state 96.65 17.91 104 79118 317893 79347273
Nasal congestion 96.34 17.91 226 78996 76326 79588840
Pulmonary oedema 93.57 17.91 244 78978 88010 79577156
Inappropriate schedule of product administration 92.00 17.91 12 79210 133616 79531550
Hypotension 91.87 17.91 749 78473 439568 79225598
Liver transplant 90.94 17.91 56 79166 4367 79660799
White blood cell count decreased 90.24 17.91 37 79185 188251 79476915
Drug intolerance 89.98 17.91 78 79144 264041 79401125
Gastritis hypertrophic 87.42 17.91 18 79204 34 79665132
Catheter site discolouration 86.37 17.91 21 79201 107 79665059
Therapeutic product effect incomplete 85.80 17.91 18 79204 141627 79523539
Weight decreased 83.33 17.91 621 78601 354577 79310589
Blood pressure increased 82.80 17.91 54 79168 211306 79453860
Catheter site cellulitis 82.30 17.91 27 79195 456 79664710
Infusion site infection 80.32 17.91 38 79184 1743 79663423
Neutrophil count decreased 80.08 17.91 3 79219 93956 79571210
Investigation 78.82 17.91 41 79181 2310 79662856
Oxygen therapy 77.68 17.91 43 79179 2747 79662419
Transplant 76.42 17.91 31 79191 977 79664189
Heart rate increased 75.80 17.91 278 78944 120446 79544720
Condition aggravated 75.51 17.91 795 78427 500329 79164837
Pericarditis 75.13 17.91 8 79214 104228 79560938
Overdose 74.99 17.91 45 79177 184161 79481005
Hyperthyroidism 74.74 17.91 101 79121 22108 79643058
Coma 74.43 17.91 7 79215 100642 79564524
Concomitant disease aggravated 74.38 17.91 78 79144 13089 79652077
Glossodynia 74.30 17.91 8 79214 103329 79561837
Pancytopenia 74.03 17.91 36 79186 165709 79499457
Catheter site dermatitis 73.99 17.91 18 79204 92 79665074
Injection site pain 73.67 17.91 19 79203 129819 79535347
Vomiting 73.01 17.91 994 78228 664834 79000332
Somnolence 70.55 17.91 80 79142 238901 79426265
Discomfort 70.10 17.91 19 79203 125598 79539568
Pericardial effusion 69.99 17.91 147 79075 46090 79619076
Psoriasis 69.65 17.91 5 79217 89582 79575584
Mobility decreased 69.09 17.91 18 79204 122157 79543009
Syncope 68.69 17.91 356 78866 179093 79486073
Electrocardiogram QT prolonged 67.60 17.91 6 79216 90380 79574786
Myocardial infarction 66.89 17.91 51 79171 184078 79481088
Intentional product misuse 66.83 17.91 8 79214 95157 79570009
Infusion site erythema 66.28 17.91 63 79159 9397 79655769
Cardiac ablation 66.25 17.91 36 79186 2217 79662949
Product deposit 66.04 17.91 24 79198 557 79664609
Aspiration pleural cavity 65.35 17.91 32 79190 1585 79663581
Epistaxis 65.19 17.91 251 78971 111264 79553902
Application site erythema 64.92 17.91 48 79174 5062 79660104
Psoriatic arthropathy 64.77 17.91 3 79219 77996 79587170
Walking distance test abnormal 63.97 17.91 25 79197 713 79664453
Catheter site extravasation 63.74 17.91 22 79200 437 79664729
Leukopenia 62.48 17.91 19 79203 116494 79548672
Disease progression 61.95 17.91 353 78869 184009 79481157
Hallucination 60.73 17.91 7 79215 85738 79579428
Hyponatraemia 59.96 17.91 53 79169 177795 79487371
COVID-19 59.44 17.91 42 79180 157632 79507534
Osteoarthritis 57.38 17.91 9 79213 87300 79577866
Helicobacter infection 56.86 17.91 3 79219 69701 79595465
Anaphylactic reaction 56.50 17.91 8 79214 83735 79581431
Hypoglycaemia 55.51 17.91 16 79206 101578 79563588
Catheter site dryness 55.16 17.91 12 79210 33 79665133
Thyroidectomy 54.80 17.91 24 79198 918 79664248
Blood potassium decreased 53.86 17.91 133 79089 46379 79618787
Duodenal ulcer perforation 53.54 17.91 3 79219 66208 79598958
Suicide attempt 53.50 17.91 9 79213 82923 79582243
Depression 53.34 17.91 83 79139 216707 79448459
Blood glucose increased 52.83 17.91 24 79198 114951 79550215
Presyncope 52.50 17.91 122 79100 40932 79624234
Hypersensitivity 52.44 17.91 114 79108 262125 79403041
Underdose 52.05 17.91 107 79115 33044 79632122
Emergency care examination 51.84 17.91 14 79208 115 79665051
Application site rash 51.64 17.91 30 79192 2102 79663064
General physical health deterioration 51.52 17.91 124 79098 275114 79390052
Impaired healing 51.33 17.91 12 79210 87643 79577523
Pulmonary embolism 51.15 17.91 57 79165 171597 79493569
Blood creatine phosphokinase increased 50.49 17.91 4 79218 66086 79599080
Lung assist device therapy 50.12 17.91 14 79208 132 79665034
Vascular device occlusion 49.38 17.91 17 79205 335 79664831
Dizziness 49.30 17.91 765 78457 525676 79139490
Nasopharyngitis 49.17 17.91 425 78797 253456 79411710
Drug reaction with eosinophilia and systemic symptoms 48.77 17.91 4 79218 64240 79600926
Balloon atrial septostomy 47.90 17.91 13 79209 109 79665057
Wrong technique in product usage process 47.69 17.91 8 79214 73867 79591299
Drug delivery system malfunction 47.41 17.91 20 79202 697 79664469
Catheter site induration 47.21 17.91 11 79211 45 79665121
Deep vein thrombosis 47.19 17.91 31 79191 120888 79544278
Gait disturbance 46.83 17.91 84 79138 207422 79457744
Hyperglycaemia 46.79 17.91 7 79215 70328 79594838
Pulmonary arterial pressure abnormal 46.75 17.91 20 79202 722 79664444
Cardiac failure high output 46.54 17.91 16 79206 314 79664852
Depressed level of consciousness 46.27 17.91 19 79203 96633 79568533
Bradycardia 46.17 17.91 40 79182 135517 79529649
Blood pressure systolic increased 46.13 17.91 6 79216 66980 79598186
Staphylococcal infection 46.04 17.91 145 79077 58150 79607016
Pneumonia 45.94 17.91 915 78307 659331 79005835
Immunoglobulin G4 related disease 45.85 17.91 15 79207 251 79664915
Maternal exposure during pregnancy 45.65 17.91 41 79181 136497 79528669
C-reactive protein increased 45.26 17.91 37 79185 128990 79536176
Catheter site mass 45.25 17.91 11 79211 56 79665110
Wound 45.04 17.91 30 79192 116149 79549017
Injury 44.61 17.91 11 79211 77485 79587681
Liver injury 44.47 17.91 3 79219 56611 79608555
Cognitive disorder 44.20 17.91 8 79214 69918 79595248
Suicidal ideation 43.63 17.91 11 79211 76329 79588837
Suture related complication 43.55 17.91 15 79207 296 79664870
Injection site erythema 43.30 17.91 12 79210 78185 79586981
Delirium 43.25 17.91 15 79207 84612 79580554
Drug-induced liver injury 43.03 17.91 7 79215 66110 79599056
Injection site reaction 42.75 17.91 3 79219 54782 79610384
Coronary artery disease 42.46 17.91 7 79215 65467 79599699
Tri-iodothyronine increased 42.32 17.91 14 79208 243 79664923
Clostridium difficile infection 42.17 17.91 115 79107 42570 79622596
Blood pressure fluctuation 41.76 17.91 8 79214 67137 79598029
Metabolic acidosis 41.54 17.91 15 79207 82514 79582652
Catheter site nodule 41.45 17.91 10 79212 49 79665117
Acute right ventricular failure 41.36 17.91 15 79207 346 79664820
Agitation 41.07 17.91 24 79198 99691 79565475
Right ventricular dysfunction 40.98 17.91 28 79194 2607 79662559
Disease complication 40.67 17.91 36 79186 4901 79660265
Cough 40.63 17.91 549 78673 366240 79298926
Catheter site urticaria 40.54 17.91 9 79213 28 79665138
Lactic acidosis 40.48 17.91 10 79212 70349 79594817
Seizure 40.35 17.91 79 79143 188755 79476411
Sedation 40.04 17.91 3 79219 51892 79613274
Angioedema 39.69 17.91 13 79209 76022 79589144
Catheter site hypersensitivity 39.55 17.91 11 79211 102 79665064
Fibromyalgia 39.31 17.91 8 79214 64332 79600834
Dysphagia 39.26 17.91 38 79184 122098 79543068
Caesarean section 39.16 17.91 55 79167 12480 79652686
Acute myocardial infarction 38.78 17.91 14 79208 77022 79588144
Application site hypersensitivity 38.72 17.91 14 79208 320 79664846
Hyperkalaemia 38.66 17.91 34 79188 114364 79550802
Therapeutic procedure 38.24 17.91 18 79204 816 79664350
Catheter site bruise 37.89 17.91 15 79207 443 79664723
Congestive hepatopathy 37.15 17.91 33 79189 4514 79660652
Arthralgia 37.14 17.91 376 78846 571427 79093739
Goitre 37.13 17.91 36 79186 5503 79659663
Brain natriuretic peptide increased 37.07 17.91 45 79177 8855 79656311
Biopsy bone marrow 37 17.91 14 79208 365 79664801
Asthma 36.90 17.91 48 79174 135047 79530119
Infusion site pain 36.79 17.91 57 79165 14119 79651047
Ear discomfort 36.74 17.91 44 79178 8539 79656627
Orthostatic hypotension 36.43 17.91 6 79216 56158 79609008
Catheterisation cardiac abnormal 36.34 17.91 13 79209 288 79664878
Catheter site oedema 35.73 17.91 10 79212 95 79665071
Pulmonary haemorrhage 35.19 17.91 57 79165 14660 79650506
Balance disorder 35.10 17.91 28 79194 98829 79566337
Cholecystectomy 34.99 17.91 45 79177 9387 79655779
Sleep disorder 34.75 17.91 21 79201 85656 79579510
Catheter site erosion 34.71 17.91 9 79213 62 79665104
Urinary retention 34.69 17.91 7 79215 56623 79608543
Platelet transfusion 34.34 17.91 24 79198 2318 79662848
Lower respiratory tract infection 34.19 17.91 47 79175 129173 79535993
Aggression 34.06 17.91 5 79217 50953 79614213
Chest discomfort 33.80 17.91 244 78978 137800 79527366
Tracheostomy 33.76 17.91 19 79203 1253 79663913
Dry mouth 33.75 17.91 23 79199 87996 79577170
Agranulocytosis 33.64 17.91 3 79219 45027 79620139
Infusion site rash 33.60 17.91 21 79201 1681 79663485
Respiratory failure 33.52 17.91 300 78922 180611 79484555
Pruritus 32.96 17.91 243 78979 394405 79270761
Paraesthesia 32.53 17.91 80 79142 176243 79488923
Mineral supplementation 32.09 17.91 16 79206 824 79664342
Chest tube insertion 32.08 17.91 10 79212 142 79665024
Retching 31.80 17.91 60 79162 17407 79647759
Loss of personal independence in daily activities 31.73 17.91 33 79189 102547 79562619
Cerebrovascular accident 31.44 17.91 67 79155 155225 79509941
Decreased appetite 31.38 17.91 496 78726 341922 79323244
Multiple allergies 31.35 17.91 45 79177 10415 79654751
Hepatocellular injury 31.06 17.91 5 79217 47588 79617578
Catheter site granuloma 30.87 17.91 8 79214 55 79665111
Mechanical ventilation 30.78 17.91 24 79198 2740 79662426
Injection site swelling 30.65 17.91 5 79217 47127 79618039
Endotracheal intubation 30.50 17.91 30 79192 4667 79660499
Pulmonary capillary haemangiomatosis 30.38 17.91 8 79214 59 79665107
Disease recurrence 30.26 17.91 4 79218 44105 79621061
Biopsy liver 30.18 17.91 14 79208 614 79664552
Hypokalaemia 30.13 17.91 61 79161 143979 79521187
Cardiac output increased 29.89 17.91 11 79211 265 79664901
Therapeutic embolisation 29.86 17.91 13 79209 490 79664676
Endarterectomy 29.80 17.91 12 79210 371 79664795
Dysarthria 29.71 17.91 15 79207 67607 79597559
Urticaria 29.69 17.91 90 79132 185111 79480055
Silent thyroiditis 29.43 17.91 10 79212 189 79664977
Micrococcus test positive 29.25 17.91 6 79216 11 79665155
Catheter site thrombosis 28.96 17.91 11 79211 290 79664876
Swollen tongue 28.87 17.91 4 79218 42566 79622600
Right ventricular dilatation 28.85 17.91 20 79202 1906 79663260
Cholestasis 28.84 17.91 8 79214 52101 79613065
Systemic-pulmonary artery shunt 28.74 17.91 7 79215 36 79665130
Drug level increased 28.68 17.91 3 79219 39648 79625518
Dyskinesia 28.56 17.91 5 79217 44768 79620398
Drug resistance 28.55 17.91 4 79218 42209 79622957
Feeling abnormal 28.47 17.91 262 78960 158937 79506229
Cardiac disorder 28.35 17.91 135 79087 65622 79599544
Inflammation 28.06 17.91 31 79191 93722 79571444
Infusion site pruritus 28.04 17.91 27 79195 4091 79661075
Interstitial lung disease 27.78 17.91 43 79179 112557 79552609
Haematuria 27.74 17.91 17 79205 68819 79596347
Culture positive 27.69 17.91 16 79206 1110 79664056
Mouth ulceration 27.52 17.91 3 79219 38391 79626775
Epilepsy 27.33 17.91 4 79218 40856 79624310
Cardioversion 27.31 17.91 20 79202 2078 79663088
Infusion site discharge 27.26 17.91 13 79209 607 79664559
Right-to-left cardiac shunt 27.13 17.91 10 79212 242 79664924
Dysentery 26.72 17.91 16 79206 1186 79663980
Hepatitis 26.60 17.91 11 79211 55716 79609450
Muscular weakness 26.56 17.91 77 79145 160652 79504514
Colonoscopy 26.35 17.91 19 79203 1928 79663238
Hypomagnesaemia 26.34 17.91 7 79215 46904 79618262
Plasma cell myeloma 26.26 17.91 10 79212 53249 79611917
Dialysis 25.98 17.91 57 79165 18405 79646761
Disturbance in attention 25.96 17.91 9 79213 50792 79614374
Cor pulmonale 25.92 17.91 20 79202 2248 79662918
Blood lactate dehydrogenase increased 25.82 17.91 4 79218 39166 79626000
Biopsy lymph gland 25.70 17.91 8 79214 113 79665053
Diabetes mellitus 25.65 17.91 24 79198 78366 79586800
Cardiac flutter 25.61 17.91 28 79194 4926 79660240
Irritable bowel syndrome 25.60 17.91 15 79207 62226 79602940
Pulmonary alveolar haemorrhage 25.54 17.91 43 79179 11414 79653752
Osteoporosis 25.32 17.91 11 79211 54101 79611065
Hypocalcaemia 25.25 17.91 9 79213 49915 79615251
Application site odour 24.94 17.91 6 79216 29 79665137
Acute respiratory failure 24.78 17.91 121 79101 59420 79605746
First bite syndrome 24.77 17.91 6 79216 30 79665136
Hypoaesthesia 24.76 17.91 93 79129 179259 79485907
Hospice care 24.70 17.91 40 79182 10284 79654882
Hepatic steatosis 24.55 17.91 4 79218 37734 79627432
Obesity 24.54 17.91 3 79219 35122 79630044
Application site reaction 24.50 17.91 13 79209 763 79664403
Atrial septal defect repair 24.45 17.91 11 79211 449 79664717
Concomitant disease progression 24.09 17.91 23 79199 3450 79661716
Application site vesicles 24.06 17.91 16 79206 1424 79663742
Dizziness postural 23.98 17.91 42 79180 11507 79653659
Ventilation perfusion mismatch 23.89 17.91 12 79210 628 79664538
Blood pressure decreased 23.87 17.91 175 79047 99291 79565875
Thyroxine free increased 23.82 17.91 15 79207 1217 79663949
Altered state of consciousness 23.75 17.91 7 79215 43815 79621351
Biopsy thyroid gland 23.66 17.91 4 79218 0 79665166
Diabetic ketoacidosis 23.63 17.91 3 79219 34119 79631047
Cardiac operation 23.63 17.91 27 79195 4985 79660181
Cerebral infarction 23.50 17.91 8 79214 45668 79619498
Seasonal allergy 23.48 17.91 51 79171 16355 79648811
Device use error 23.45 17.91 32 79190 7069 79658097
Female sterilisation 22.98 17.91 9 79213 258 79664908
Device related thrombosis 22.98 17.91 20 79202 2663 79662503
Catheter site scar 22.92 17.91 5 79217 14 79665152
Arthritis 22.89 17.91 50 79172 114830 79550336
Encephalopathy 22.80 17.91 20 79202 67377 79597789
Ischaemic stroke 22.73 17.91 3 79219 33128 79632038
Spinal cord ischaemia 22.72 17.91 8 79214 169 79664997
Medication error 22.47 17.91 21 79201 68621 79596545
Neuropathy peripheral 22.41 17.91 69 79153 141236 79523930
Catheter site abscess 22.36 17.91 6 79216 48 79665118
Dizziness exertional 22.13 17.91 11 79211 563 79664603
Incorrect route of product administration 22.06 17.91 4 79218 34925 79630241
Wound treatment 22.04 17.91 8 79214 185 79664981
Ventricular assist device insertion 22.04 17.91 6 79216 51 79665115
Intra-abdominal fluid collection 21.99 17.91 21 79201 3151 79662015
Myalgia 21.82 17.91 281 78941 185360 79479806
Renal impairment 21.66 17.91 82 79140 157701 79507465
Knee arthroplasty 21.53 17.91 8 79214 43240 79621926
Exercise tolerance decreased 21.51 17.91 35 79187 9036 79656130
Upper respiratory tract congestion 21.48 17.91 19 79203 2584 79662582
Diuretic therapy 21.42 17.91 8 79214 201 79664965
Jugular vein distension 21.40 17.91 15 79207 1455 79663711
Abnormal behaviour 21.29 17.91 5 79217 36416 79628750
Obstructive airways disorder 21.23 17.91 3 79219 31456 79633710
Tremor 21.08 17.91 92 79130 169991 79495175
Bacteraemia 20.93 17.91 76 79146 32748 79632418
Osteonecrosis 20.90 17.91 3 79219 31092 79634074
Culture negative 20.89 17.91 4 79218 4 79665162
Pulmonary endarterectomy 20.88 17.91 8 79214 216 79664950
Terminal state 20.82 17.91 25 79197 4864 79660302
Renal disorder 20.80 17.91 90 79132 42015 79623151
Systemic lupus erythematosus 20.78 17.91 57 79165 121092 79544074
Localised oedema 20.67 17.91 32 79190 7920 79657246
Prescribed overdose 20.62 17.91 6 79216 37877 79627289
Transaminases increased 20.54 17.91 13 79209 51730 79613436
Myelodysplastic syndrome 20.19 17.91 3 79219 30298 79634868
Acute hepatic failure 20.02 17.91 3 79219 30110 79635056
Proteinuria 19.94 17.91 4 79218 32498 79632668
Echocardiogram abnormal 19.87 17.91 17 79205 2211 79662955
Blood creatinine increased 19.75 17.91 83 79139 154974 79510192
Sinus disorder 19.72 17.91 58 79164 22406 79642760
Body temperature decreased 19.63 17.91 4 79218 32141 79633025
Stent placement 19.47 17.91 28 79194 6492 79658674
Chills 19.44 17.91 244 78978 159990 79505176
Vertigo 19.43 17.91 24 79198 69058 79596108
Right ventricular systolic pressure increased 19.32 17.91 12 79210 950 79664216
Blister 19.18 17.91 58 79164 119418 79545748
Atrial flutter 19.14 17.91 56 79166 21569 79643597
Biopsy skin 19.13 17.91 6 79216 87 79665079
Chronic respiratory failure 19.06 17.91 19 79203 3003 79662163
Emotional distress 18.90 17.91 8 79214 39961 79625205
Cardiac pacemaker insertion 18.87 17.91 26 79196 5796 79659370
Cardiomyopathy 18.83 17.91 3 79219 28771 79636395
Suture rupture 18.75 17.91 10 79212 593 79664573
Middle ear effusion 18.69 17.91 17 79205 2398 79662768
Diagnostic procedure 18.66 17.91 7 79215 178 79664988
Joint range of motion decreased 18.62 17.91 5 79217 33277 79631889
Speech disorder 18.61 17.91 16 79206 54429 79610737
Pulmonary tumour thrombotic microangiopathy 18.59 17.91 6 79216 96 79665070
Abdominal pain upper 18.55 17.91 319 78903 223500 79441666
Drug titration 18.39 17.91 4 79218 11 79665155
Pneumonitis 18.35 17.91 20 79202 60840 79604326
Angioplasty 18.24 17.91 15 79207 1848 79663318
Aphasia 18.20 17.91 12 79210 46720 79618446
Vasodilatation 18.20 17.91 19 79203 3172 79661994
Heart rate decreased 18.17 17.91 26 79196 70290 79594876
Pulmonary artery dilatation 18.12 17.91 9 79213 460 79664706
Colitis ulcerative 18.02 17.91 6 79216 34736 79630430

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC B01AC09 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
MeSH PA D006401 Hematologic Agents
MeSH PA D010975 Platelet Aggregation Inhibitors
CHEBI has role CHEBI:75771 Mus musculus metabolites
CHEBI has role CHEBI:77746 Homo sapiens metabolite

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

DiseaseRelationSNOMED_IDDOID
Pulmonary arterial hypertension indication 11399002
Cough indication 49727002
Allergic rhinitis indication 61582004
Nasal discharge indication 64531003
Nasal congestion indication 68235000
Rhinitis indication 70076002 DOID:4483
Pulmonary hypertension indication 70995007 DOID:6432
Common cold indication 82272006 DOID:10459
Pulmonary edema contraindication 19242006 DOID:11396
Chronic heart failure contraindication 48447003
Blood coagulation disorder contraindication 64779008 DOID:1247




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.75 acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Prostaglandin E2 receptor EP1 subtype GPCR AGONIST Ki 4.80 IUPHAR IUPHAR
Prostacyclin receptor GPCR AGONIST Ki 7.80 IUPHAR CHEMBL
P2Y purinoceptor 12 GPCR WOMBAT-PK
Prostaglandin E2 receptor EP4 subtype GPCR AGONIST Ki 5.10 IUPHAR

External reference:

IDSource
4024020 VUID
N0000022025 NUI
D00106 KEGG_DRUG
61849-14-7 SECONDARY_CAS_RN
4020958 VANDF
4024020 VANDF
C0033567 UMLSCUI
CHEBI:15552 CHEBI
CHEMBL1139 ChEMBL_ID
DB01240 DRUGBANK_ID
CHEMBL962 ChEMBL_ID
D011464 MESH_DESCRIPTOR_UI
5282411 PUBCHEM_CID
4725 INN_ID
DCR9Z582X0 UNII
104463 RXNORM
137029 MMSL
29551 MMSL
4669 MMSL
d03842 MMSL
003963 NDDF
003964 NDDF
108593000 SNOMEDCT_US
108594006 SNOMEDCT_US
372513003 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
FLOLAN HUMAN PRESCRIPTION DRUG LABEL 1 0173-0517 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 0.50 mg INTRAVENOUS NDA 25 sections
FLOLAN HUMAN PRESCRIPTION DRUG LABEL 1 0173-0517 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 0.50 mg INTRAVENOUS NDA 25 sections
FLOLAN HUMAN PRESCRIPTION DRUG LABEL 1 0173-0519 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 1.50 mg INTRAVENOUS NDA 25 sections
FLOLAN HUMAN PRESCRIPTION DRUG LABEL 1 0173-0519 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 1.50 mg INTRAVENOUS NDA 25 sections
Epoprostenol Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0703-1985 INJECTION, POWDER, FOR SOLUTION 0.50 mg INTRAVENOUS ANDA 23 sections
Epoprostenol Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0703-1985 INJECTION, POWDER, FOR SOLUTION 0.50 mg INTRAVENOUS ANDA 23 sections
Epoprostenol Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0703-1995 INJECTION, POWDER, FOR SOLUTION 1.50 mg INTRAVENOUS ANDA 23 sections
Epoprostenol Sodium HUMAN PRESCRIPTION DRUG LABEL 1 0703-1995 INJECTION, POWDER, FOR SOLUTION 1.50 mg INTRAVENOUS ANDA 23 sections
epoprostenol Human Prescription Drug Label 1 62756-059 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 0.50 mg INTRAVENOUS ANDA 25 sections
epoprostenol Human Prescription Drug Label 1 62756-060 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 1.50 mg INTRAVENOUS ANDA 25 sections
Veletri HUMAN PRESCRIPTION DRUG LABEL 1 66215-402 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 1.50 mg INTRAVENOUS NDA 28 sections
Veletri HUMAN PRESCRIPTION DRUG LABEL 1 66215-402 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 1.50 mg INTRAVENOUS NDA 28 sections
Veletri HUMAN PRESCRIPTION DRUG LABEL 1 66215-402 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 1.50 mg INTRAVENOUS NDA 28 sections
Veletri HUMAN PRESCRIPTION DRUG LABEL 1 66215-403 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 0.50 mg INTRAVENOUS NDA 28 sections
Veletri HUMAN PRESCRIPTION DRUG LABEL 1 66215-403 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 0.50 mg INTRAVENOUS NDA 28 sections
Veletri HUMAN PRESCRIPTION DRUG LABEL 1 66215-403 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 0.50 mg INTRAVENOUS NDA 28 sections