epoprostenol 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: 2.33
  • 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 3006.48 18.47 1311 65691 39358 53242706
Catheter site erythema 1904.38 18.47 526 66476 3656 53278408
Pulmonary arterial hypertension 1884.86 18.47 838 66164 26284 53255780
Catheter management 1571.61 18.47 417 66585 2435 53279629
Catheter site pruritus 1436.56 18.47 362 66640 1662 53280402
Device related infection 1339.81 18.47 627 66375 22159 53259905
Flushing 1242.23 18.47 884 66118 69716 53212348
Right ventricular failure 1110.62 18.47 502 66500 16341 53265723
Catheter site discharge 1083.55 18.47 289 66713 1725 53280339
Catheter site pain 1077.75 18.47 335 66667 3666 53278398
Dyspnoea exertional 995.50 18.47 701 66301 54299 53227765
Catheter site infection 933.65 18.47 317 66685 4675 53277389
Fluid retention 928.37 18.47 669 66333 53732 53228332
Dyspnoea 841.82 18.47 2091 64911 584141 52697923
Device leakage 839.06 18.47 308 66694 5772 53276292
Device alarm issue 761.51 18.47 207 66795 1341 53280723
Lung transplant 696.81 18.47 225 66777 2809 53279255
Pulmonary hypertension 685.52 18.47 480 66522 36790 53245274
Catheter site haemorrhage 661.79 18.47 215 66787 2740 53279324
Catheter placement 661.38 18.47 198 66804 1887 53280177
Drug ineffective 644.34 18.47 125 66877 817120 52464944
Fluid overload 635.48 18.47 410 66592 27421 53254643
Central venous catheterisation 619.44 18.47 189 66813 1932 53280132
Catheter site rash 616.35 18.47 153 66849 651 53281413
Hospitalisation 591.30 18.47 577 66425 70435 53211629
Device occlusion 554.07 18.47 235 66767 6530 53275534
Catheter site swelling 533.27 18.47 154 66848 1278 53280786
Headache 509.99 18.47 1652 65350 535169 52746895
Complication associated with device 423.72 18.47 260 66742 15905 53266159
Catheter site inflammation 415.37 18.47 109 66893 604 53281460
Diarrhoea 373.25 18.47 1660 65342 623886 52658178
Catheter site irritation 353.30 18.47 89 66913 407 53281657
Device infusion issue 330.14 18.47 103 66899 1140 53280924
Rheumatoid arthritis 322.50 18.47 18 66984 314513 52967551
Vascular device infection 320.76 18.47 141 66861 4280 53277784
Death 318.63 18.47 1078 65924 356154 52925910
Off label use 315.09 18.47 101 66901 472111 52809953
Transplant evaluation 313.47 18.47 96 66906 994 53281070
Therapy change 311.29 18.47 148 66854 5404 53276660
Device breakage 289.82 18.47 175 66827 10392 53271672
Device dislocation 287.78 18.47 238 66764 23359 53258705
Palpitations 284.54 18.47 482 66520 101866 53180198
Transfusion 281.53 18.47 189 66813 13498 53268566
Catheter site vesicles 244.63 18.47 60 66942 240 53281824
Oedema 234.78 18.47 371 66631 73975 53208089
Dermatitis contact 232.04 18.47 143 66859 8809 53273255
Paracentesis 227.50 18.47 73 66929 891 53281173
Toxicity to various agents 223.60 18.47 13 66989 219585 53062479
Catheter site related reaction 215.98 18.47 68 66934 777 53281287
Ascites 204.66 18.47 251 66751 39484 53242580
Pulmonary arterial pressure increased 204.18 18.47 96 66906 3416 53278648
Emergency care 203.02 18.47 66 66936 842 53281222
Catheterisation cardiac 187.57 18.47 96 66906 4118 53277946
Device connection issue 185.15 18.47 59 66943 703 53281361
Drug interaction 181.63 18.47 29 66973 219300 53062764
Hypoxia 181.49 18.47 282 66720 55398 53226666
Infusion related reaction 180.61 18.47 3 66999 155954 53126110
Chest pain 177.87 18.47 584 66418 189601 53092463
Drug hypersensitivity 176.06 18.47 57 66945 265185 53016879
Oxygen saturation decreased 175.47 18.47 332 66670 76393 53205671
Nausea 170.38 18.47 1567 65435 754524 52527540
Thrombosis in device 169.66 18.47 81 66921 2984 53279080
Alopecia 169.34 18.47 43 66959 234540 53047524
Catheter removal 168.01 18.47 47 66955 343 53281721
Device physical property issue 166.68 18.47 68 66934 1707 53280357
Neutropenia 163.29 18.47 9 66993 159176 53122888
Device malfunction 160.51 18.47 144 66858 15764 53266300
Medical device change 160.20 18.47 45 66957 334 53281730
Therapeutic product effect decreased 143.10 18.47 3 66999 125652 53156412
Joint swelling 142.83 18.47 58 66944 234580 53047484
Treatment failure 139.08 18.47 5 66997 128398 53153666
Oxygen consumption increased 134.74 18.47 74 66928 3667 53278397
Central venous catheter removal 133.73 18.47 39 66963 336 53281728
Arthropathy 133.52 18.47 12 66990 141441 53140623
Catheter site scab 124.67 18.47 32 66970 160 53281904
Hypertension 124.31 18.47 64 66938 225367 53056697
Blood culture positive 122.65 18.47 75 66927 4554 53277510
Dyspnoea at rest 120.99 18.47 70 66932 3837 53278227
Haemoptysis 120.57 18.47 162 66840 27877 53254187
Application site pruritus 117.09 18.47 70 66932 4079 53277985
Febrile neutropenia 113.93 18.47 4 66998 104932 53177132
Cardiac failure 111.03 18.47 296 66706 85548 53196516
Catheter site warmth 106.50 18.47 29 66973 189 53281875
Musculoskeletal stiffness 105.06 18.47 15 66987 123353 53158711
Device related sepsis 104.01 18.47 62 66940 3593 53278471
Drug intolerance 103.73 18.47 65 66937 205428 53076636
Hypotension 103.69 18.47 608 66394 253468 53028596
Blood culture negative 101.13 18.47 26 66976 131 53281933
Skin irritation 101.01 18.47 84 66918 8300 53273764
Glossodynia 98.83 18.47 7 66995 100284 53181780
Product use issue 97.96 18.47 27 66975 139557 53142507
Device issue 97.52 18.47 128 66874 21530 53260534
Unevaluable event 97.18 18.47 201 66801 49297 53232767
Maternal exposure during pregnancy 97.07 18.47 37 66965 155602 53126462
Stomatitis 96.30 18.47 7 66995 98151 53183913
Nasal congestion 91.55 18.47 205 66797 53082 53228982
Injection site pain 91.55 18.47 16 66986 113375 53168689
Hepatic enzyme increased 91.23 18.47 23 66979 126172 53155892
Product use in unapproved indication 90.32 18.47 16 66986 112273 53169791
Abdominal distension 90.21 18.47 262 66740 79528 53202536
Psoriasis 89.03 18.47 5 66997 87084 53194980
Oedema peripheral 88.86 18.47 437 66565 170350 53111714
Heart and lung transplant 88.53 18.47 22 66980 94 53281970
Blood pressure increased 86.60 18.47 34 66968 140445 53141619
Catheter site discolouration 86.04 18.47 22 66980 108 53281956
Abdominal cavity drainage 84.01 18.47 28 66974 388 53281676
Gastritis hypertrophic 83.21 18.47 18 66984 34 53282030
Weight decreased 83.09 18.47 542 66460 234406 53047658
Catheter site cellulitis 83.04 18.47 25 66977 243 53281821
Application site irritation 81.61 18.47 42 66960 1822 53280242
Scleroderma 80.92 18.47 60 66942 5015 53277049
Staphylococcus test positive 80.87 18.47 54 66948 3819 53278245
Catheter culture positive 78.89 18.47 21 66981 124 53281940
Therapeutic product effect incomplete 78.51 18.47 11 66991 91773 53190291
White blood cell count decreased 76.93 18.47 30 66972 124445 53157619
Discomfort 75.92 18.47 14 66988 95458 53186606
Depression 75.67 18.47 71 66931 182981 53099083
Pulmonary veno-occlusive disease 75.25 18.47 33 66969 995 53281069
Transplant 73.76 18.47 29 66973 659 53281405
Condition aggravated 73.06 18.47 629 66373 296505 52985559
Malaise 72.84 18.47 727 66275 356890 52925174
Hyperthyroidism 71.21 18.47 85 66917 12988 53269076
Drug abuse 69.41 18.47 3 66999 65523 53216541
Confusional state 67.42 18.47 87 66915 194134 53087930
Leukopenia 67.27 18.47 7 66995 73456 53208608
Inappropriate schedule of product administration 66.38 18.47 8 66994 74870 53207194
Acute kidney injury 66.36 18.47 137 66865 253731 53028333
Intentional product use issue 66.14 18.47 7 66995 72487 53209577
Disease progression 65.00 18.47 277 66725 101643 53180421
Osteoarthritis 63.81 18.47 7 66995 70479 53211585
Investigation 63.38 18.47 34 66968 1607 53280457
Aspiration pleural cavity 62.29 18.47 27 66975 791 53281273
Walking distance test abnormal 61.72 18.47 24 66978 529 53281535
Somnolence 61.51 18.47 72 66930 167662 53114402
Cardiac ablation 61.36 18.47 31 66971 1293 53280771
Emergency care examination 60.19 18.47 15 66987 65 53281999
Pericardial effusion 59.79 18.47 116 66886 27162 53254902
Heart rate increased 59.03 18.47 232 66770 82083 53199981
Pain in extremity 58.71 18.47 581 66421 284469 52997595
Syncope 58.50 18.47 287 66715 111706 53170358
Oxygen therapy 57.83 18.47 34 66968 1920 53280144
Pneumonia 56.62 18.47 769 66233 406400 52875664
Coma 56.27 18.47 6 66996 61777 53220287
Injection site erythema 55.97 18.47 14 66988 77235 53204829
Overdose 55.82 18.47 33 66969 107703 53174361
Product administration interrupted 55.51 18.47 25 66977 804 53281260
Application site erythema 55.17 18.47 48 66954 5043 53277021
Liver transplant 55.04 18.47 36 66966 2458 53279606
Pulmonary oedema 54.65 18.47 170 66832 53553 53228511
Wrong technique in product usage process 54.25 18.47 6 66996 60026 53222038
Catheter site nodule 53.61 18.47 13 66989 49 53282015
Infusion site infection 53.52 18.47 30 66972 1547 53280517
Pericarditis 52.17 18.47 9 66993 64397 53217667
Acute right ventricular failure 52.12 18.47 16 66986 167 53281897
Injection site reaction 52.10 18.47 3 66999 51163 53230901
Vomiting 51.83 18.47 894 66108 496245 52785819
Presyncope 50.96 18.47 106 66896 26088 53255976
Hypersensitivity 50.65 18.47 119 66883 210546 53071518
Gait disturbance 50.26 18.47 76 66926 158766 53123298
Arthralgia 50.18 18.47 335 66667 439448 52842616
Electrocardiogram QT prolonged 50.06 18.47 6 66996 56397 53225667
Suicidal ideation 50.02 18.47 8 66994 60503 53221561
Anaphylactic reaction 49.85 18.47 7 66995 58319 53223745
Impaired healing 49.80 18.47 10 66992 64195 53217869
Clostridium difficile infection 49.80 18.47 109 66893 27784 53254280
Suicide attempt 49.67 18.47 7 66995 58161 53223903
Hallucination 49.62 18.47 5 66997 53833 53228231
Mobility decreased 49.44 18.47 17 66985 76254 53205810
Pain 48.96 18.47 488 66514 587910 52694154
Platelet transfusion 48.46 18.47 22 66980 721 53281343
Catheter site dermatitis 48.15 18.47 12 66990 52 53282012
Wound 47.49 18.47 28 66974 91529 53190535
Infusion site erythema 47.46 18.47 57 66945 8765 53273299
Intentional product misuse 47.09 18.47 4 66998 49388 53232676
Seizure 44.93 18.47 58 66944 129451 53152613
Application site hypersensitivity 44.54 18.47 15 66987 215 53281849
Ventilation perfusion mismatch 44.48 18.47 15 66987 216 53281848
Pulmonary haemorrhage 44.38 18.47 49 66953 6884 53275180
Catheter site induration 43.71 18.47 11 66991 50 53282014
Nasopharyngitis 43.02 18.47 399 66603 191896 53090168
Catheter site extravasation 42.87 18.47 16 66986 314 53281750
Hyponatraemia 42.68 18.47 44 66958 108563 53173501
Right ventricular dilatation 42.56 18.47 22 66980 963 53281101
Blood glucose increased 42.52 18.47 22 66980 77339 53204725
Decreased appetite 42.19 18.47 434 66568 214540 53067524
Hypoglycaemia 42.16 18.47 11 66991 59002 53223062
Blood potassium decreased 42.04 18.47 129 66873 40331 53241733
Staphylococcal infection 42.03 18.47 125 66877 38423 53243641
Myocardial infarction 41.66 18.47 38 66964 99316 53182748
Pancytopenia 41.54 18.47 32 66970 90896 53191168
Catheter site erosion 41.03 18.47 11 66991 67 53281997
Pulmonary embolism 41 18.47 50 66952 114392 53167672
Immunoglobulin G4 related disease 40.76 18.47 11 66991 69 53281995
Catheter site hypersensitivity 40.68 18.47 12 66990 108 53281956
Pulmonary arterial pressure abnormal 40.04 18.47 17 66985 473 53281591
Pruritus 39.70 18.47 212 66790 293620 52988444
Injury 39.40 18.47 8 66994 50963 53231101
Deep vein thrombosis 39.40 18.47 28 66974 82885 53199179
Systemic lupus erythematosus 38.71 18.47 61 66941 125353 53156711
Cerebrovascular accident 38.69 18.47 45 66957 105129 53176935
Catheter site bruise 38.60 18.47 15 66987 330 53281734
Dysphagia 38.17 18.47 30 66972 84367 53197697
Cardiac failure high output 38.13 18.47 14 66988 262 53281802
Disease complication 37.98 18.47 32 66970 3218 53278846
Epistaxis 37.96 18.47 179 66823 68531 53213533
Depressed level of consciousness 37.29 18.47 11 66991 54417 53227647
Balance disorder 37.11 18.47 23 66979 73184 53208880
Therapeutic embolisation 36.91 18.47 12 66990 153 53281911
Lung assist device therapy 36.88 18.47 10 66992 64 53282000
Abortion spontaneous 36.72 18.47 7 66995 46628 53235436
Endotracheal intubation 35.87 18.47 27 66975 2309 53279755
Thyroidectomy 35.77 18.47 20 66982 1026 53281038
Asthma 35.57 18.47 51 66951 108921 53173143
Catheter site oedema 35.40 18.47 9 66993 43 53282021
Concomitant disease aggravated 35.30 18.47 49 66953 8689 53273375
Suture related complication 35.25 18.47 12 66990 178 53281886
Dizziness 35.02 18.47 659 66343 371600 52910464
Cough 34.31 18.47 482 66520 256411 53025653
Catheter site urticaria 34.15 18.47 8 66994 25 53282039
Plasma cell myeloma 34.05 18.47 9 66993 47865 53234199
First bite syndrome 33.99 18.47 7 66995 9 53282055
Mineral supplementation 33.37 18.47 16 66986 595 53281469
Duodenal ulcer perforation 33.13 18.47 3 66999 35180 53246884
Cognitive disorder 32.65 18.47 8 66994 44770 53237294
Ear discomfort 32.63 18.47 43 66959 7258 53274806
Bradycardia 32.46 18.47 25 66977 71031 53211033
Application site rash 32.45 18.47 27 66975 2669 53279395
Catheter site dryness 32.23 18.47 8 66994 34 53282030
Infusion site pruritus 31.99 18.47 31 66971 3739 53278325
Urticaria 31.65 18.47 78 66924 135807 53146257
Hyperglycaemia 31.59 18.47 6 66996 40078 53241986
Respiratory failure 31.35 18.47 225 66777 100287 53181777
Lower respiratory tract infection 31.28 18.47 41 66961 90940 53191124
C-reactive protein increased 30.86 18.47 24 66978 67862 53214202
Osteoporosis 30.73 18.47 10 66992 46450 53235614
No adverse event 30.69 18.47 6 66996 39259 53242805
Bacteraemia 30.33 18.47 63 66939 15486 53266578
Urinary tract infection 30.26 18.47 177 66825 239726 53042338
Emotional distress 29.78 18.47 3 66999 32314 53249750
Pulmonary alveolar haemorrhage 29.43 18.47 32 66970 4418 53277646
Catheter site thrombosis 29.21 18.47 10 66992 151 53281913
Biopsy liver 29.16 18.47 13 66989 408 53281656
Catheterisation cardiac abnormal 28.87 18.47 11 66991 229 53281835
Chest discomfort 28.72 18.47 219 66783 99476 53182588
Congestive hepatopathy 28.69 18.47 25 66977 2631 53279433
Coronary artery disease 28.60 18.47 4 66998 33433 53248631
Paraesthesia 28.31 18.47 75 66927 127440 53154624
Blood pressure systolic increased 28.30 18.47 5 66997 35172 53246892
Systemic-pulmonary artery shunt 28.15 18.47 7 66995 30 53282034
Tremor 27.88 18.47 74 66928 125662 53156402
Right ventricular dysfunction 27.76 18.47 20 66982 1599 53280465
Atrial flutter 27.69 18.47 46 66956 9545 53272519
Dizziness postural 27.60 18.47 38 66964 6687 53275377
Agitation 27.59 18.47 20 66982 58606 53223458
Hypoaesthesia 27.46 18.47 81 66921 132914 53149150
Injection site pruritus 27.42 18.47 9 66993 41580 53240484
Female sterilisation 27.36 18.47 14 66988 600 53281464
Application site odour 27.11 18.47 7 66995 36 53282028
Product deposit 27.09 18.47 10 66992 190 53281874
Fibromyalgia 26.60 18.47 11 66991 44064 53238000
Sleep disorder 26.53 18.47 21 66981 58849 53223215
Infusion site rash 26.51 18.47 17 66985 1122 53280942
Balloon atrial septostomy 26.28 18.47 8 66994 81 53281983
Concomitant disease progression 26.25 18.47 22 66980 2196 53279868
Multiple allergies 26.23 18.47 42 66960 8453 53273611
Tri-iodothyronine increased 26.23 18.47 9 66993 137 53281927
Device related thrombosis 26.20 18.47 18 66984 1334 53280730
Biopsy bone marrow 26.18 18.47 11 66991 298 53281766
Echocardiogram abnormal 26.13 18.47 17 66985 1150 53280914
Swollen tongue 25.93 18.47 4 66998 31076 53250988
Caesarean section 25.76 18.47 63 66939 17257 53264807
Disturbance in attention 25.35 18.47 6 66996 34377 53247687
Urinary retention 25.33 18.47 3 66999 28463 53253601
Culture positive 25.26 18.47 12 66990 437 53281627
Hypokalaemia 25.24 18.47 52 66950 96465 53185599
Jugular vein distension 24.96 18.47 15 66987 882 53281182
Lactic acidosis 24.67 18.47 8 66994 37245 53244819
Tracheostomy 24.66 18.47 13 66989 593 53281471
Loss of personal independence in daily activities 24.47 18.47 31 66971 69784 53212280
Cholecystectomy 24.32 18.47 44 66958 9771 53272293
Mechanical ventilation 24.25 18.47 17 66985 1301 53280763
Hospice care 24.20 18.47 34 66968 6096 53275968
Adrenocorticotropic hormone deficiency 24.04 18.47 10 66992 264 53281800
Vertigo 24.04 18.47 21 66981 56060 53226004
Biopsy lymph gland 23.89 18.47 6 66996 27 53282037
Multiple sclerosis 23.82 18.47 3 66999 27150 53254914
Foetal exposure during pregnancy 23.81 18.47 7 66995 34708 53247356
Femur fracture 23.69 18.47 10 66992 39575 53242489
Dry mouth 23.53 18.47 24 66978 59526 53222538
Oral pain 23.46 18.47 3 66999 26834 53255230
General physical health deterioration 23.33 18.47 100 66902 146842 53135222
Metabolic acidosis 23.23 18.47 12 66990 42230 53239834
Cardioversion 23.15 18.47 16 66986 1197 53280867
Angioedema 23.07 18.47 12 66990 42064 53240000
Insomnia 23.06 18.47 139 66863 186933 53095131
Terminal state 22.96 18.47 21 66981 2355 53279709
Portopulmonary hypertension 22.95 18.47 8 66994 128 53281936
Upper respiratory tract congestion 22.85 18.47 19 66983 1876 53280188
Blood pressure fluctuation 22.82 18.47 8 66994 35462 53246602
Dyskinesia 22.61 18.47 6 66996 31827 53250237
Knee arthroplasty 22.60 18.47 7 66995 33562 53248502
Hepatocellular injury 22.57 18.47 5 66997 29981 53252083
Delirium 22.44 18.47 12 66990 41417 53240647
Therapeutic procedure 22.41 18.47 14 66988 883 53281181
Stent placement 22.35 18.47 25 66977 3562 53278502
Orthostatic hypotension 22.32 18.47 5 66997 29748 53252316
Cardiac output increased 22.13 18.47 8 66994 143 53281921
Infusion site pain 21.98 18.47 47 66955 11786 53270278
Drug-induced liver injury 21.75 18.47 5 66997 29228 53252836
Speech disorder 21.74 18.47 11 66991 39170 53242894
Irritable bowel syndrome 21.71 18.47 14 66988 43618 53238446
Application site reaction 21.64 18.47 13 66989 764 53281300
Aphasia 21.49 18.47 6 66996 30772 53251292
Muscular weakness 21.22 18.47 61 66941 100931 53181133
Catheter site abscess 21.19 18.47 6 66996 46 53282018
Cholestasis 21.17 18.47 5 66997 28690 53253374
Diabetes mellitus 20.98 18.47 22 66980 53877 53228187
Dry eye 20.95 18.47 8 66994 33636 53248428
Endarterectomy 20.93 18.47 8 66994 168 53281896
N-terminal prohormone brain natriuretic peptide increased 20.73 18.47 18 66984 1886 53280178
Dysentery 20.68 18.47 13 66989 829 53281235
Catheter site mass 20.59 18.47 5 66997 19 53282045
Culture negative 20.49 18.47 4 66998 3 53282061
Catheter site scar 20.49 18.47 4 66998 3 53282061
Brain natriuretic peptide increased 20.47 18.47 28 66974 4897 53277167
Cardiac flutter 20.47 18.47 24 66978 3598 53278466
Arthritis 20.41 18.47 50 66952 87248 53194816
Packed red blood cell transfusion 20.38 18.47 19 66983 2184 53279880
Contusion 20.37 18.47 71 66931 110661 53171403
Hyperkalaemia 20.18 18.47 23 66979 54233 53227831
Visual impairment 20.17 18.47 38 66964 72874 53209190
Epilepsy 20.01 18.47 4 66998 25763 53256301
Irritability 19.88 18.47 7 66995 30946 53251118
Myalgia 19.65 18.47 255 66747 133236 53148828
Chronic right ventricular failure 19.65 18.47 5 66997 24 53282040
Pulmonary capillary haemangiomatosis 19.48 18.47 5 66997 25 53282039
Suture insertion 19.47 18.47 7 66995 123 53281941
Drain placement 19.43 18.47 6 66996 64 53282000
Fall 19.40 18.47 325 66677 358115 52923949
Silent thyroiditis 19.18 18.47 6 66996 67 53281997
Pituitary enlargement 19.16 18.47 5 66997 27 53282037
Therapeutic response decreased 18.99 18.47 19 66983 47550 53234514
Dysarthria 18.88 18.47 14 66988 40554 53241510
Biopsy skin 18.71 18.47 6 66996 73 53281991
Cardiac output decreased 18.70 18.47 13 66989 982 53281082
Right atrial dilatation 18.63 18.47 11 66991 626 53281438

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 1065.18 25.66 354 16676 12272 32484224
Pulmonary arterial hypertension 662.15 25.66 233 16797 9588 32486908
Catheter management 609.78 25.66 131 16899 751 32495745
Catheter site erythema 475.88 25.66 114 16916 1129 32495367
Right ventricular failure 458.85 25.66 171 16859 8292 32488204
Fluid retention 394.34 25.66 217 16813 26333 32470163
Device related infection 355.88 25.66 178 16852 17755 32478741
Catheter site pruritus 347.57 25.66 69 16961 247 32496249
Catheter placement 289.17 25.66 69 16961 670 32495826
Lung transplant 286.37 25.66 84 16946 1896 32494600
Device alarm issue 281.20 25.66 69 16961 761 32495735
Pulmonary hypertension 262.19 25.66 152 16878 20342 32476154
Dyspnoea 254.65 25.66 573 16457 361472 32135024
Headache 253.14 25.66 403 16627 195794 32300702
Flushing 252.64 25.66 173 16857 30954 32465542
Device occlusion 243.19 25.66 102 16928 6756 32489740
Catheter site discharge 224.85 25.66 54 16976 540 32495956
Dyspnoea exertional 209.33 25.66 169 16861 38792 32457704
Fluid overload 208.05 25.66 129 16901 19492 32477004
Catheter site infection 203.33 25.66 70 16960 2684 32493812
Catheter site pain 200.08 25.66 57 16973 1155 32495341
Complication associated with device 171.72 25.66 77 16953 5995 32490501
Central venous catheterisation 161.36 25.66 47 16983 1033 32495463
Catheter site haemorrhage 160.88 25.66 56 16974 2219 32494277
Device dislocation 156.04 25.66 72 16958 5991 32490505
Catheter site rash 150.14 25.66 32 16998 175 32496321
Device leakage 147.93 25.66 64 16966 4572 32491924
Oxygen saturation decreased 125.69 25.66 140 16890 47959 32448537
Hospitalisation 115.20 25.66 135 16895 48836 32447660
Catheter removal 112.37 25.66 25 17005 172 32496324
Catheter site irritation 105.88 25.66 22 17008 104 32496392
Catheter site inflammation 105.47 25.66 25 17005 235 32496261
Transplant evaluation 101.38 25.66 28 17002 504 32495992
Drug interaction 97.23 25.66 4 17026 218181 32278315
Catheter site swelling 95.93 25.66 24 17006 288 32496208
Medical device change 94.97 25.66 21 17009 140 32496356
Paracentesis 94.47 25.66 25 17005 380 32496116
Pulmonary veno-occlusive disease 89.30 25.66 25 17005 474 32496022
Device infusion issue 86.73 25.66 26 17004 633 32495863
Thrombosis in device 84.82 25.66 40 16990 3494 32493002
Pain in extremity 78.05 25.66 184 16846 118717 32377779
Condition aggravated 77.50 25.66 217 16813 155444 32341052
Therapy change 77.00 25.66 35 16995 2810 32493686
Transfusion 74.58 25.66 48 16982 7720 32488776
Vascular device infection 74.08 25.66 33 16997 2527 32493969
Ascites 73.95 25.66 98 16932 40093 32456403
Oedema 73.88 25.66 104 16926 45043 32451453
Toxicity to various agents 73.86 25.66 5 17025 178036 32318460
Heart and lung transplant 72.71 25.66 15 17015 68 32496428
Device breakage 71.66 25.66 30 17000 1974 32494522
Device connection issue 64.68 25.66 20 17010 542 32495954
Blood culture positive 63.33 25.66 37 16993 5008 32491488
Neutropenia 61.98 25.66 3 17027 142172 32354324
Hypoxia 61.22 25.66 103 16927 52029 32444467
Concomitant disease aggravated 59.44 25.66 37 16993 5616 32490880
Device physical property issue 57.86 25.66 20 17010 775 32495721
Oxygen consumption increased 57.55 25.66 23 17007 1343 32495153
Death 56.93 25.66 368 16662 382149 32114347
Diarrhoea 56.15 25.66 354 16676 364448 32132048
Catheterisation cardiac 55.74 25.66 26 17004 2215 32494281
Product deposit 55.39 25.66 15 17015 250 32496246
Abdominal distension 54.54 25.66 97 16933 51198 32445298
Device malfunction 54.45 25.66 42 16988 8997 32487499
Pulmonary arterial pressure increased 53.55 25.66 21 17009 1166 32495330
Febrile neutropenia 50.62 25.66 3 17027 119563 32376933
Drug ineffective 50.49 25.66 77 16953 383400 32113096
Haemoptysis 50.10 25.66 74 16956 33451 32463045
Device related sepsis 49.47 25.66 25 17005 2538 32493958
Liver transplant 47.05 25.66 25 17005 2815 32493681
Catheter site vesicles 46.29 25.66 9 17021 28 32496468
Off label use 44.77 25.66 57 16973 306263 32190233
Blood culture negative 41.36 25.66 8 17022 24 32496472
Device issue 36.23 25.66 33 16997 8879 32487617
Oxygen therapy 36.23 25.66 14 17016 747 32495749
Nausea 35.08 25.66 287 16743 320562 32175934
Dermatitis contact 34.53 25.66 22 17008 3476 32493020
Pulmonary endarterectomy 34.06 25.66 8 17022 72 32496424
Abdominal cavity drainage 33.86 25.66 11 17019 351 32496145
Cardiac failure 33.59 25.66 115 16915 91558 32404938
Micrococcus test positive 33.09 25.66 6 17024 11 32496485
Pulmonary oedema 32.91 25.66 74 16956 46193 32450303
Spinal cord ischaemia 32.61 25.66 8 17022 88 32496408
Palpitations 31.95 25.66 63 16967 35906 32460590
White blood cell count decreased 31.54 25.66 5 17025 91193 32405303
Catheter culture positive 30.78 25.66 6 17024 19 32496477
Catheter site mass 30.32 25.66 6 17024 21 32496475
Catheter site dermatitis 28.84 25.66 5 17025 6 32496490
Catheter site scab 28.76 25.66 6 17024 29 32496467
Oedema peripheral 28.63 25.66 127 16903 113964 32382532
Disease progression 28.42 25.66 105 16925 86757 32409739
Catheter site related reaction 27.98 25.66 9 17021 278 32496218
Central venous catheter removal 27.97 25.66 6 17024 34 32496462
Catheter site dryness 27.63 25.66 5 17025 9 32496487
Epistaxis 26.84 25.66 77 16953 55778 32440718
Nasal congestion 26.28 25.66 42 16988 20309 32476187
Catheter site extravasation 26.00 25.66 7 17023 114 32496382
Brain natriuretic peptide increased 25.94 25.66 20 17010 4280 32492216
Myocardial infarction 25.88 25.66 17 17013 125659 32370837
Catheter site warmth 25.75 25.66 6 17024 52 32496444

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 metabolite
CHEBI has role CHEBI:77746 H. sapiens metabolites

Drug Use (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

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 0173-0519 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 0703-1995 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 66215-403 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 0.50 mg INTRAVENOUS NDA 28 sections