epoprostenol 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2A,ACVR2B,AXL,BRAF,BTK,CAMK2D,CDK5,CDK9,DYRK1B,EGFR,EIF2AK3,ERBB2,GRK2,ITK,JAK3,MAP2K6,MAP3K21,MAPK7,NTRK2,PDK1,PDK2,PDK4,PIK3CB,PIM2,PRKDC,STK33,SYK,TEK,TGFBR1,ZAP70 30
kinase-selectivity-class AXL,EIF2AK3,GRK2,MAP2K6 4
pfas-class PFAS structural alert (1 = True, 0 = False) 0

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 3638.77 20.31 1364 66830 46621 90513632
Catheter site erythema 2044.90 20.31 517 67677 4377 90555876
Catheter management 1773.50 20.31 420 67774 2616 90557637
Flushing 1631.41 20.31 944 67250 87547 90472706
Catheter site pruritus 1558.56 20.31 359 67835 1943 90558310
Device related infection 1484.23 20.31 601 67593 25185 90535068
Dyspnoea exertional 1166.41 20.31 708 67486 71580 90488673
Right ventricular failure 1161.61 20.31 464 67730 18741 90541512
Catheter site discharge 1123.50 20.31 278 67916 2131 90558122
Catheter site pain 1119.63 20.31 331 67863 5248 90555005
Device occlusion 1047.47 20.31 355 67839 8927 90551326
Catheter site infection 1037.31 20.31 313 67881 5341 90554912
Dyspnoea 1032.87 20.31 2128 66066 878827 89681426
Device alarm issue 993.31 20.31 240 67954 1645 90558608
Fluid retention 962.85 20.31 676 67518 87415 90472838
Device leakage 888.57 20.31 320 67874 9671 90550582
Catheter placement 775.70 20.31 209 67985 2315 90557938
Lung transplant 766.87 20.31 225 67969 3467 90556786
Hypervolaemia 762.81 20.31 408 67786 32349 90527904
Catheter site haemorrhage 741.97 20.31 219 67975 3449 90556804
Hospitalisation 712.33 20.31 662 67532 127438 90432815
Catheter site rash 696.84 20.31 154 68040 666 90559587
Central venous catheterisation 686.73 20.31 194 68000 2592 90557661
Headache 661.85 20.31 1768 66426 860978 89699275
Pulmonary hypertension 561.20 20.31 367 67827 42156 90518097
Diarrhoea 542.45 20.31 1740 66454 937450 89622803
Catheter site swelling 541.50 20.31 147 68047 1678 90558575
Complication associated with device 529.26 20.31 269 67925 19180 90541073
Drug ineffective 516.83 20.31 200 67994 1384098 89176155
Therapy change 420.95 20.31 177 68017 8145 90552108
Pulmonary arterial hypertension 420.58 20.31 256 67938 25931 90534322
Catheter site inflammation 418.94 20.31 105 68089 852 90559401
Death 418.43 20.31 1003 67191 455548 90104705
Catheter site irritation 411.98 20.31 96 68098 550 90559703
Off label use 399.61 20.31 166 68028 1102086 89458167
Vascular device infection 383.64 20.31 185 68009 11767 90548486
Device dislocation 370.28 20.31 253 67941 31229 90529024
Palpitations 360.14 20.31 478 67716 136250 90424003
Transplant evaluation 346.59 20.31 97 68097 1249 90559004
Device breakage 335.45 20.31 178 68016 13866 90546387
Transfusion 322.68 20.31 187 68007 17301 90542952
Device infusion issue 308.85 20.31 104 68090 2558 90557695
Infusion related reaction 288.62 20.31 5 68189 416775 90143478
Nausea 284.76 20.31 1608 66586 1108708 89451545
Ascites 283.02 20.31 256 67938 47484 90512769
Dermatitis contact 273.98 20.31 154 68040 13441 90546812
Catheter site vesicles 272.44 20.31 63 68131 347 90559906
Oxygen saturation decreased 244.16 20.31 350 67844 107133 90453120
Paracentesis 243.91 20.31 69 68125 926 90559327
Alopecia 241.85 20.31 41 68153 495030 90065223
Catheterisation cardiac 239.30 20.31 102 68092 4854 90555399
Thrombosis in device 238.20 20.31 89 68105 2986 90557267
Hypoxia 236.50 20.31 282 67912 72117 90488136
Device malfunction 231.17 20.31 162 68032 20815 90539438
Arthropathy 226.48 20.31 12 68182 366230 90194023
Catheter site related reaction 224.99 20.31 66 68128 1015 90559238
Product administration interrupted 223.63 20.31 131 68063 12361 90547892
Hypotension 218.04 20.31 637 67557 324760 90235493
Pulmonary arterial pressure increased 217.31 20.31 89 68105 3827 90556426
Emergency care 216.12 20.31 70 68124 1519 90558734
Glossodynia 214.35 20.31 6 68188 321773 90238480
Contraindicated product administered 213.14 20.31 6 68188 320133 90240120
Rheumatoid arthritis 206.40 20.31 18 68176 362596 90197657
Joint swelling 199.88 20.31 65 68129 503235 90057018
Hepatic enzyme increased 199.74 20.31 20 68174 360716 90199537
Device connection issue 195.01 20.31 58 68136 938 90559315
Treatment failure 190.93 20.31 9 68185 303919 90256334
Device physical property issue 188.56 20.31 73 68121 2703 90557550
Chest pain 186.29 20.31 596 67598 319049 90241204
Medical device change 183.80 20.31 44 68150 288 90559965
Drug hypersensitivity 182.09 20.31 61 68133 463548 90096705
Toxicity to various agents 179.28 20.31 9 68185 287837 90272416
Oxygen consumption increased 178.07 20.31 81 68113 4508 90555745
Catheter removal 176.31 20.31 44 68150 350 90559903
Stomatitis 176.29 20.31 7 68187 274691 90285562
Pericarditis 166.50 20.31 9 68185 270142 90290111
Hypertension 163.32 20.31 70 68124 457462 90102791
Application site pruritus 161.76 20.31 74 68120 4173 90556080
Cardiac failure 160.18 20.31 292 67902 109204 90451049
Musculoskeletal stiffness 160.12 20.31 18 68176 296514 90263739
Unevaluable event 152.37 20.31 197 67997 54651 90505602
Discomfort 152.37 20.31 15 68179 274320 90285933
Duodenal ulcer perforation 151.66 20.31 3 68191 221285 90338968
Catheter site scab 151.40 20.31 36 68158 228 90560025
Product use in unapproved indication 151.12 20.31 34 68160 336202 90224051
Drug intolerance 140.85 20.31 81 68113 447510 90112743
Impaired healing 140.66 20.31 9 68185 234190 90326063
Blood culture positive 140.41 20.31 71 68123 5001 90555252
Skin irritation 135.95 20.31 99 68095 13504 90546749
Dyspnoea at rest 135.36 20.31 68 68126 4723 90555530
Central venous catheter removal 135.19 20.31 37 68157 436 90559817
Type 2 diabetes mellitus 134.52 20.31 4 68190 203240 90357013
Maternal exposure during pregnancy 133.45 20.31 52 68142 360011 90200242
Wound 133.43 20.31 32 68162 302948 90257305
Mobility decreased 130.97 20.31 17 68177 250717 90309536
Catheter site warmth 130.55 20.31 31 68163 195 90560058
Device issue 127.27 20.31 133 68061 29404 90530849
Haemoptysis 124.24 20.31 139 68055 33181 90527072
Syncope 121.51 20.31 292 67902 132371 90427882
Systemic lupus erythematosus 120.38 20.31 61 68133 361835 90198418
Injury 120.26 20.31 7 68187 197342 90362911
Intentional product use issue 120.05 20.31 12 68182 216880 90343373
Osteoarthritis 119.10 20.31 7 68187 195723 90364530
Nasal congestion 118.88 20.31 220 67974 83194 90477059
Irritable bowel syndrome 118.77 20.31 10 68184 207438 90352815
Drug interaction 118.24 20.31 31 68163 276422 90283831
Fibromyalgia 115.25 20.31 11 68183 206258 90353995
Device related sepsis 115.15 20.31 61 68133 4732 90555521
Product use issue 113.69 20.31 53 68141 329866 90230387
Pericardial effusion 112.94 20.31 139 68055 36694 90523559
Vascular device occlusion 111.12 20.31 31 68163 394 90559859
Oedema peripheral 108.98 20.31 433 67761 257482 90302771
Blood culture negative 107.85 20.31 26 68168 176 90560077
Pulmonary veno-occlusive disease 106.44 20.31 41 68153 1497 90558756
Weight decreased 106.38 20.31 565 67629 379345 90180908
Neutropenia 104.57 20.31 21 68173 224883 90335370
Oedema 103.62 20.31 359 67835 199936 90360317
Catheter site cellulitis 103.33 20.31 28 68166 317 90559936
Underdose 102.75 20.31 162 68032 53855 90506398
Scleroderma 102.52 20.31 62 68132 6199 90554054
Febrile neutropenia 101.67 20.31 4 68190 158345 90401908
Staphylococcus test positive 100.72 20.31 54 68140 4291 90555962
Abdominal cavity drainage 99.77 20.31 29 68165 431 90559822
Pulmonary oedema 99.03 20.31 172 68022 61908 90498345
Heart and lung transplant 98.82 20.31 22 68172 99 90560154
Catheter site discolouration 98.64 20.31 22 68172 100 90560153
Abdominal distension 98.35 20.31 267 67927 130334 90429919
Liver injury 98.25 20.31 8 68186 170559 90389694
Therapeutic product effect incomplete 96.90 20.31 15 68179 193881 90366372
Confusional state 96.59 20.31 89 68105 386116 90174137
Drug delivery system malfunction 96.23 20.31 37 68157 1344 90558909
Psoriasis 93.96 20.31 4 68190 147750 90412503
Application site irritation 93.48 20.31 40 68154 1921 90558332
Respiratory failure 93.10 20.31 246 67948 118172 90442081
Gastritis hypertrophic 92.41 20.31 18 68176 34 90560219
Lower respiratory tract infection 91.52 20.31 37 68157 250622 90309631
Hypersensitivity 90.61 20.31 126 68068 454551 90105702
Heart rate increased 90.25 20.31 236 67958 112666 90447587
Hyperthyroidism 89.00 20.31 88 68106 18222 90542031
Malaise 88.43 20.31 747 67447 585239 89975014
Epistaxis 87.39 20.31 196 67998 84929 90475324
Pain in extremity 87.30 20.31 609 67585 449920 90110333
Presyncope 86.39 20.31 113 68081 31692 90528561
Catheter culture positive 84.83 20.31 21 68173 161 90560092
Joint range of motion decreased 82.05 20.31 5 68189 135638 90424615
Sleep disorder 81.30 20.31 24 68170 198006 90362247
Blood potassium decreased 79.75 20.31 135 68059 47592 90512661
General physical health deterioration 78.42 20.31 91 68103 355024 90205229
Liver transplant 77.79 20.31 37 68157 2280 90557973
Pneumonia 76.38 20.31 774 67420 637285 89922968
Transplant 76.31 20.31 29 68165 1020 90559233
C-reactive protein increased 76.28 20.31 21 68173 181368 90378885
Blister 76.14 20.31 49 68145 254949 90305304
Asthma 75.83 20.31 44 68150 242116 90318137
Depression 71.95 20.31 72 68122 300529 90259724
Application site erythema 71.22 20.31 46 68148 5162 90555091
Inflammation 70.87 20.31 23 68171 178569 90381684
Inappropriate schedule of product administration 69.68 20.31 14 68180 149919 90410334
Disease progression 69.38 20.31 267 67927 156348 90403905
Aspiration pleural cavity 69.08 20.31 26 68168 890 90559363
Cardiac ablation 69.04 20.31 31 68163 1673 90558580
Cough 68.06 20.31 493 67701 368469 90191784
Hypoaesthesia 67.77 20.31 82 68112 314128 90246125
Urticaria 67.05 20.31 82 68112 312652 90247601
Blood pressure increased 64.39 20.31 34 68160 197183 90363070
Walking distance test abnormal 64.21 20.31 22 68172 571 90559682
Dizziness 63.05 20.31 699 67495 588585 89971668
Vomiting 62.90 20.31 885 67309 787408 89772845
Injection site pain 62.80 20.31 26 68168 173673 90386580
Dry mouth 62.69 20.31 30 68164 184029 90376224
Cardiac failure high output 61.31 20.31 20 68174 444 90559809
Staphylococcal infection 60.69 20.31 121 68073 48318 90511935
Clostridium difficile infection 59.86 20.31 102 68092 36143 90524110
Infusion site erythema 59.68 20.31 62 68132 13608 90546645
Catheter site nodule 59.63 20.31 13 68181 52 90560201
Ill-defined disorder 58.72 20.31 33 68161 184858 90375395
Chest discomfort 58.13 20.31 232 67962 138133 90422120
Prescribed overdose 57.85 20.31 4 68190 97621 90462632
Myalgia 57.77 20.31 273 67921 174852 90385401
Emergency care examination 57.41 20.31 15 68179 146 90560107
Lip dry 57.40 20.31 5 68189 100950 90459303
White blood cell count decreased 57.28 20.31 27 68167 167082 90393171
Oxygen therapy 56.75 20.31 33 68161 3069 90557184
Application site rash 55.85 20.31 31 68163 2638 90557615
Catheter site dermatitis 54.99 20.31 13 68181 80 90560173
Arthralgia 53.39 20.31 355 67839 778167 89782086
Acute respiratory failure 52.32 20.31 106 68088 42812 90517441
Intentional product misuse 52.15 20.31 4 68190 89600 90470653
Pruritus 52.14 20.31 220 67974 541305 90018948
Caesarean section 52 20.31 67 68127 18510 90541743
Disease complication 50.80 20.31 33 68161 3739 90556514
Right ventricular dilatation 50.61 20.31 25 68169 1674 90558579
Platelet transfusion 50.61 20.31 22 68172 1098 90559155
Drug-induced liver injury 49.94 20.31 5 68189 90313 90469940
Catheter site induration 49.32 20.31 11 68183 50 90560203
Catheter site bruise 49.27 20.31 18 68176 566 90559687
Injection site reaction 48.64 20.31 6 68188 92074 90468179
Gait inability 48.17 20.31 25 68169 146431 90413822
Pulmonary fibrosis 47.98 20.31 11 68183 107492 90452761
Catheter site erosion 47.97 20.31 11 68183 58 90560195
Delirium 47.95 20.31 10 68184 104349 90455904
Catheter site hypersensitivity 47.70 20.31 12 68182 99 90560154
Pulmonary alveolar haemorrhage 47.48 20.31 38 68156 5960 90554293
Gait disturbance 47.17 20.31 77 68117 260419 90299834
Catheter site extravasation 46.67 20.31 16 68178 416 90559837
Pulmonary arterial pressure abnormal 44.86 20.31 17 68177 593 90559660
Application site hypersensitivity 44.82 20.31 14 68180 269 90559984
Contusion 44.79 20.31 75 68119 251141 90309112
Catheter site urticaria 43.04 20.31 9 68185 28 90560225
Right ventricular dysfunction 42.86 20.31 25 68169 2339 90557914
Wheezing 42.52 20.31 71 68123 238009 90322244
Acute right ventricular failure 42.46 20.31 13 68181 233 90560020
Ear discomfort 42.28 20.31 45 68149 10155 90550098
Sciatica 42.12 20.31 12 68182 101370 90458883
Ventilation perfusion mismatch 41.75 20.31 16 68178 576 90559677
Pain 41.35 20.31 516 67678 995825 89564428
Concomitant disease aggravated 41.14 20.31 47 68147 11471 90548782
Thyroidectomy 41.06 20.31 20 68174 1299 90558954
Anaphylactic reaction 41.02 20.31 8 68186 87516 90472737
Osteoporosis 40.90 20.31 11 68183 96520 90463733
Cardiac disorder 40.53 20.31 114 68080 56758 90503495
Atrial flutter 40.30 20.31 45 68149 10713 90549540
Knee arthroplasty 40.28 20.31 7 68187 83175 90477078
Wound infection 39.97 20.31 15 68179 106387 90453866
Suture related complication 38.29 20.31 13 68181 328 90559925
Catheter site thrombosis 38.09 20.31 14 68180 448 90559805
Electrocardiogram QT prolonged 37.59 20.31 5 68189 72451 90487802
First bite syndrome 37.57 20.31 7 68187 9 90560244
Catheter site dryness 37.53 20.31 8 68186 28 90560225
Decreased appetite 37.18 20.31 440 67754 376100 90184153
Brain natriuretic peptide increased 37.14 20.31 33 68161 5972 90554281
Lung assist device therapy 36.76 20.31 10 68184 115 90560138
Concomitant disease progression 36.28 20.31 22 68172 2210 90558043
Autoimmune disorder 35.99 20.31 7 68187 76737 90483516
Paraesthesia 35.80 20.31 85 68109 250241 90310012
Haemorrhage 35.53 20.31 124 68070 69245 90491008
Biopsy liver 35.49 20.31 13 68181 412 90559841
Night sweats 35.43 20.31 27 68167 128739 90431514
Condition aggravated 35.42 20.31 637 67557 594908 89965345
Coma 35.41 20.31 6 68188 72626 90487627
Overdose 35.22 20.31 40 68154 157669 90402584
Infusion site infection 35.16 20.31 23 68171 2637 90557616
Suicide attempt 35.11 20.31 7 68187 75392 90484861
Amnesia 34.97 20.31 19 68175 108486 90451767
Leukopenia 34.92 20.31 16 68178 100694 90459559
Endotracheal intubation 34.79 20.31 25 68169 3339 90556914
Muscular weakness 34.75 20.31 64 68130 206602 90353651
Gastrointestinal haemorrhage 34.48 20.31 147 68047 90101 90470152
Hepatitis 34.15 20.31 6 68188 70733 90489520
Sepsis 34.09 20.31 242 67952 179572 90380681
Injection site swelling 33.91 20.31 3 68191 59836 90500417
Therapeutic embolisation 33.48 20.31 11 68183 250 90560003
Blood pressure decreased 33.40 20.31 128 68066 74767 90485486
Depressed level of consciousness 33.38 20.31 7 68187 72777 90487476
N-terminal prohormone brain natriuretic peptide increased 32.92 20.31 23 68171 2939 90557314
Biopsy bone marrow 32.53 20.31 12 68182 388 90559865
Dizziness postural 32.43 20.31 37 68157 9016 90551237
Device related thrombosis 32.41 20.31 20 68174 2073 90558180
No adverse event 32.31 20.31 6 68188 67976 90492277
Cholecystectomy 32.28 20.31 42 68152 11713 90548540
Feeling abnormal 32.24 20.31 226 67968 167009 90393244
Suicidal ideation 32.08 20.31 8 68186 73847 90486406
Bacteraemia 31.98 20.31 59 68135 22241 90538012
Catheterisation cardiac abnormal 31.76 20.31 11 68183 295 90559958
Memory impairment 31.49 20.31 63 68131 197181 90363072
Mineral supplementation 31.34 20.31 14 68180 746 90559507
Immunoglobulin G4 related disease 31.20 20.31 9 68185 130 90560123
Hallucination 30.97 20.31 6 68188 65953 90494300
Seasonal allergy 30.71 20.31 59 68135 22924 90537329
Thyrotoxic crisis 30.52 20.31 16 68178 1215 90559038
Hospice care 30.35 20.31 37 68157 9667 90550586
Culture positive 30.33 20.31 12 68182 471 90559782
Abortion spontaneous 29.86 20.31 3 68191 54053 90506200
Stent placement 29.85 20.31 25 68169 4178 90556075
Arthritis 29.77 20.31 50 68144 167265 90392988
Cardiac flutter 29.71 20.31 26 68168 4612 90555641
Injection site erythema 29.28 20.31 19 68175 98483 90461770
Terminal state 29.27 20.31 21 68173 2797 90557456
Investigation 29.25 20.31 17 68177 1580 90558673
Cognitive disorder 29.23 20.31 8 68186 69399 90490854
Echocardiogram abnormal 29.23 20.31 17 68177 1582 90558671
Wrong technique in product usage process 28.77 20.31 9 68185 71562 90488691
Acute kidney injury 28.47 20.31 134 68060 320253 90240000
Supraventricular tachycardia 28.34 20.31 47 68147 16289 90543964
Catheter site oedema 28.12 20.31 7 68187 55 90560198
Blood pressure systolic increased 28.05 20.31 5 68189 58340 90501913
Hypopituitarism 27.78 20.31 17 68177 1736 90558517
Mechanical ventilation 27.73 20.31 16 68178 1466 90558787
Gastrointestinal disorder 27.38 20.31 100 68094 256587 90303666
Dialysis 27.33 20.31 38 68156 11291 90548962
Systemic-pulmonary artery shunt 27.32 20.31 6 68188 25 90560228
Respiratory tract haemorrhage 27.10 20.31 11 68183 462 90559791
Insomnia 27.04 20.31 144 68050 333330 90226923
Pallor 26.85 20.31 71 68123 34094 90526159
Multiple allergies 26.84 20.31 44 68150 15102 90545151
Pulmonary vasculitis 26.74 20.31 9 68185 221 90560032
Pancytopenia 26.31 20.31 31 68163 120232 90440021
Orthopnoea 26.31 20.31 29 68165 6806 90553447
Pleural effusion 26.26 20.31 159 68035 111832 90448421
Injection site bruising 26.22 20.31 4 68190 52303 90507950
Product deposit 26.17 20.31 10 68184 357 90559896
Blood glucose increased 26.16 20.31 20 68174 95226 90465027
Somnolence 26.08 20.31 76 68118 209008 90351245
Balloon atrial septostomy 25.93 20.31 7 68187 78 90560175
Loss of personal independence in daily activities 25.79 20.31 39 68155 136066 90424187
Application site odour 25.65 20.31 6 68188 35 90560218
Upper respiratory tract congestion 25.45 20.31 18 68176 2344 90557909
Abdominal discomfort 25.02 20.31 234 67960 477094 90083159
Internal haemorrhage 25.00 20.31 27 68167 6193 90554060
Infusion site pruritus 24.83 20.31 28 68166 6737 90553516
Goitre 24.82 20.31 28 68166 6739 90553514
Right ventricular systolic pressure increased 24.67 20.31 11 68183 584 90559669
Chills 24.64 20.31 177 68017 131804 90428449
Infusion site pain 24.35 20.31 49 68145 19689 90540564
Retching 24.16 20.31 48 68146 19111 90541142
Visual impairment 24.06 20.31 39 68155 132326 90427927
Pulmonary capillary haemangiomatosis 24.01 20.31 6 68188 48 90560205
Erythema 23.99 20.31 271 67923 228975 90331278
Dysentery 23.83 20.31 13 68181 1069 90559184
Cardioversion 23.55 20.31 14 68180 1356 90558897
Congestive hepatopathy 23.55 20.31 19 68175 3014 90557239
Balance disorder 23.49 20.31 23 68171 97057 90463196
Swelling 23.46 20.31 202 67992 418856 90141397
Device use error 23.35 20.31 28 68166 7193 90553060
Joint dislocation 23.31 20.31 3 68191 44579 90515674
Influenza 23.31 20.31 182 68012 139082 90421171
Female sterilisation 23.21 20.31 11 68183 672 90559581
Productive cough 23.14 20.31 117 68077 76946 90483307
Chronic respiratory failure 23.06 20.31 18 68176 2723 90557530
Incorrect route of product administration 22.95 20.31 5 68189 50621 90509632
Endarterectomy 22.88 20.31 8 68186 221 90560032
Dizziness exertional 22.58 20.31 10 68184 522 90559731
Tracheostomy 22.56 20.31 11 68183 716 90559537
Culture negative 22.54 20.31 4 68190 3 90560250
Catheter site scar 22.54 20.31 4 68190 3 90560250
Infusion site rash 22.41 20.31 17 68177 2466 90557787
Back injury 22.40 20.31 4 68190 46618 90513635
Catheter site mass 22.37 20.31 5 68189 23 90560230
Hip arthroplasty 22.24 20.31 15 68179 76193 90484060
Road traffic accident 22.22 20.31 29 68165 107597 90452656
COVID-19 22.07 20.31 60 68134 168783 90391470
Tri-iodothyronine increased 22.07 20.31 8 68186 246 90560007
Dry eye 22.04 20.31 8 68186 57923 90502330
Colitis ulcerative 21.80 20.31 9 68185 60257 90499996
Cardiac output decreased 21.76 20.31 12 68182 1008 90559245
Medication error 21.73 20.31 19 68175 84633 90475620
Localised oedema 21.66 20.31 25 68169 6169 90554084
Adverse drug reaction 21.57 20.31 34 68160 116667 90443586
Product quality issue 21.35 20.31 17 68177 79308 90480945
Silent thyroiditis 21.19 20.31 7 68187 162 90560091
Respiratory distress 21.15 20.31 71 68123 38875 90521378
Biopsy skin 21.04 20.31 6 68188 83 90560170
Pulmonary haemorrhage 21.03 20.31 28 68166 7985 90552268
Jugular vein distension 20.99 20.31 12 68182 1081 90559172
Biopsy lymph gland 20.98 20.31 5 68189 32 90560221
Purulent discharge 20.92 20.31 23 68171 5382 90554871
Therapeutic response decreased 20.86 20.31 22 68172 89707 90470546
Exercise tolerance decreased 20.77 20.31 27 68167 7524 90552729
Drug titration 20.72 20.31 5 68189 34 90560219
Deep vein thrombosis 20.71 20.31 23 68171 91597 90468656
Joint stiffness 20.66 20.31 17 68177 78025 90482228
Renal disorder 20.54 20.31 69 68125 37790 90522463
Colonoscopy 20.49 20.31 14 68180 1726 90558527
Dysphagia 20.48 20.31 33 68161 112245 90448008
Intra-abdominal fluid collection 20.37 20.31 17 68177 2827 90557426
Drain placement 20.35 20.31 6 68188 94 90560159

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 1211.34 25.92 381 17217 14121 42589616
Catheter management 626.05 25.92 132 17466 900 42602837
Device occlusion 483.27 25.92 167 17431 8283 42595454
Right ventricular failure 433.36 25.92 159 17439 9396 42594341
Catheter site erythema 432.42 25.92 108 17490 1665 42602072
Fluid retention 407.17 25.92 217 17381 31402 42572335
Device related infection 366.12 25.92 175 17423 20104 42583633
Catheter site pruritus 365.11 25.92 70 17528 270 42603467
Device alarm issue 344.13 25.92 77 17521 714 42603023
Catheter placement 309.45 25.92 73 17525 872 42602865
Headache 308.72 25.92 433 17165 238936 42364801
Lung transplant 290.63 25.92 84 17514 2302 42601435
Flushing 287.37 25.92 183 17415 36845 42566892
Dyspnoea 278.33 25.92 581 17017 442040 42161697
Catheter site discharge 225.06 25.92 55 17543 770 42602967
Dyspnoea exertional 224.20 25.92 177 17421 49971 42553766
Hypervolaemia 222.04 25.92 131 17467 22994 42580743
Catheter site infection 215.93 25.92 71 17527 3012 42600725
Complication associated with device 188.95 25.92 79 17519 6602 42597135
Catheter site haemorrhage 187.82 25.92 61 17537 2487 42601250
Device dislocation 180.08 25.92 80 17518 7751 42595986
Catheter site pain 172.44 25.92 52 17546 1655 42602082
Pulmonary hypertension 166.78 25.92 110 17488 23459 42580278
Central venous catheterisation 155.55 25.92 48 17550 1653 42602084
Catheter site rash 147.89 25.92 31 17567 204 42603533
Pulmonary arterial hypertension 145.42 25.92 75 17523 10112 42593625
Oxygen saturation decreased 135.99 25.92 150 17448 64537 42539200
Hospitalisation 133.71 25.92 159 17439 74171 42529566
Device leakage 122.18 25.92 67 17531 10218 42593519
Catheter removal 116.35 25.92 25 17573 188 42603549
Transplant evaluation 113.34 25.92 29 17569 494 42603243
Thrombosis in device 112.35 25.92 44 17554 3102 42600635
Product administration interrupted 111.82 25.92 50 17548 4916 42598821
Catheter site irritation 111.63 25.92 22 17576 101 42603636
Catheter site inflammation 111.20 25.92 25 17573 237 42603500
Paracentesis 110.61 25.92 28 17570 456 42603281
Therapy change 97.89 25.92 43 17555 4052 42599685
Medical device change 97.43 25.92 20 17578 117 42603620
Underdose 92.47 25.92 67 17531 16599 42587138
Pulmonary veno-occlusive disease 84.87 25.92 24 17574 606 42603131
Oedema 83.33 25.92 105 17493 51896 42551841
Pain in extremity 82.63 25.92 188 17410 150416 42453321
Catheterisation cardiac 78.85 25.92 33 17565 2761 42600976
Toxicity to various agents 78.19 25.92 4 17594 229132 42374605
Diarrhoea 76.99 25.92 384 17214 460465 42143272
Device breakage 76.63 25.92 35 17563 3614 42600123
Device infusion issue 75.50 25.92 25 17573 1083 42602654
Device connection issue 74.69 25.92 21 17577 519 42603218
Vascular device infection 73.10 25.92 40 17558 6070 42597667
Catheter site swelling 72.46 25.92 21 17577 580 42603157
Hypoxia 71.81 25.92 114 17484 69672 42534065
Ascites 70.27 25.92 101 17497 56577 42547160
Transfusion 69.35 25.92 47 17551 10467 42593270
Concomitant disease aggravated 64.97 25.92 38 17560 6548 42597189
Device malfunction 64.85 25.92 48 17550 12279 42591458
Off label use 64.53 25.92 103 17495 638232 41965505
Febrile neutropenia 64.11 25.92 3 17595 185700 42418037
Oxygen consumption increased 58.52 25.92 23 17575 1636 42602101
Drug delivery system malfunction 58.17 25.92 17 17581 484 42603253
Vascular device occlusion 57.58 25.92 15 17583 275 42603462
Product deposit 55.45 25.92 16 17582 435 42603302
Blood culture positive 54.77 25.92 31 17567 5022 42598715
Device physical property issue 53.71 25.92 21 17577 1473 42602264
Pulmonary arterial pressure increased 53.12 25.92 21 17577 1517 42602220
Heart and lung transplant 52.93 25.92 11 17587 69 42603668
Condition aggravated 51.92 25.92 229 17369 260525 42343212
Liver transplant 50.87 25.92 24 17574 2667 42601070
Catheter site vesicles 49.19 25.92 9 17589 25 42603712
Nausea 48.95 25.92 305 17293 396494 42207243
Death 48.42 25.92 346 17252 470839 42132898
Device related sepsis 48.03 25.92 26 17572 3861 42599876
Abdominal distension 44.30 25.92 94 17504 71641 42532096
Haemoptysis 38.90 25.92 69 17529 46098 42557639
Device issue 38.62 25.92 37 17561 13472 42590265
Blood culture negative 38.52 25.92 8 17590 50 42603687
Oxygen therapy 38.19 25.92 16 17582 1342 42602395
Dermatitis contact 36.72 25.92 23 17575 4480 42599257
Pulmonary oedema 35.45 25.92 72 17526 53200 42550537
Spinal cord ischaemia 34.67 25.92 8 17590 86 42603651
Catheter site scab 34.51 25.92 6 17592 11 42603726
Abdominal cavity drainage 33.91 25.92 11 17587 446 42603291
Product use in unapproved indication 33.77 25.92 17 17581 184439 42419298
Catheter culture positive 33.25 25.92 6 17592 15 42603722
Catheter site mass 31.74 25.92 6 17592 21 42603716
Catheter site dryness 31.62 25.92 5 17593 3 42603734
Catheter site dermatitis 31.62 25.92 5 17593 3 42603734
Cardiac failure high output 30.70 25.92 7 17591 71 42603666
Catheter site related reaction 30.56 25.92 10 17588 417 42603320
Nasal congestion 30.04 25.92 48 17550 29453 42574284
White blood cell count decreased 29.58 25.92 5 17593 110391 42493346
Epistaxis 28.66 25.92 76 17522 66750 42536987
Micrococcus test positive 28.15 25.92 5 17593 11 42603726
Oedema peripheral 28.13 25.92 121 17477 135955 42467782
Catheter site discolouration 27.27 25.92 6 17592 51 42603686
Balloon atrial septostomy 26.56 25.92 5 17593 17 42603720
Pancytopenia 26.23 25.92 8 17590 117735 42486002
Palpitations 26.22 25.92 62 17536 50735 42553002
Malaise 25.98 25.92 163 17435 211993 42391744

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 4153.69 19.82 1503 76394 49674 110461728
Catheter site erythema 2204.60 19.82 565 77332 5463 110505939
Catheter management 2059.74 19.82 487 77410 3248 110508154
Catheter site pruritus 1739.24 19.82 388 77509 1918 110509484
Device related infection 1662.81 19.82 723 77174 38796 110472606
Flushing 1639.08 19.82 982 76915 103754 110407648
Right ventricular failure 1469.75 19.82 587 77310 25367 110486035
Fluid retention 1290.76 19.82 812 77085 93495 110417907
Device occlusion 1285.99 19.82 461 77436 14724 110496678
Catheter site discharge 1211.35 19.82 304 77593 2675 110508727
Device alarm issue 1173.15 19.82 285 77612 2161 110509241
Catheter site pain 1167.33 19.82 348 77549 6098 110505304
Dyspnoea exertional 1150.54 19.82 784 77113 103276 110408126
Dyspnoea 1139.12 19.82 2438 75459 1104434 109406968
Catheter site infection 1101.52 19.82 350 77547 7650 110503752
Catheter placement 1024.51 19.82 272 77625 3048 110508354
Lung transplant 938.19 19.82 281 77616 5005 110506397
Device leakage 911.91 19.82 364 77533 15684 110495718
Hypervolaemia 886.91 19.82 507 77390 48953 110462449
Headache 884.94 19.82 1926 75971 880451 109630951
Catheter site haemorrhage 804.31 19.82 256 77641 5624 110505778
Central venous catheterisation 746.19 19.82 219 77678 3623 110507779
Catheter site rash 740.59 19.82 167 77730 873 110510529
Complication associated with device 640.31 19.82 303 77594 19770 110491632
Pulmonary hypertension 635.91 19.82 427 77470 54793 110456609
Hospitalisation 633.09 19.82 632 77265 141861 110369541
Catheter site swelling 543.03 19.82 153 77744 2171 110509231
Diarrhoea 532.03 19.82 1882 76015 1137623 109373779
Device dislocation 517.83 19.82 306 77591 31398 110480004
Catheter site inflammation 496.43 19.82 125 77772 1115 110510287
Pulmonary arterial hypertension 484.43 19.82 296 77601 32272 110479130
Off label use 462.31 19.82 242 77655 1499943 109011459
Catheter site irritation 433.78 19.82 99 77798 551 110510851
Device breakage 424.31 19.82 203 77694 13566 110497836
Death 416.50 19.82 1256 76641 697613 109813789
Therapy change 381.67 19.82 171 77726 9826 110501576
Transplant evaluation 375.75 19.82 109 77788 1726 110509676
Drug ineffective 366.90 19.82 321 77576 1520219 108991183
Transfusion 342.12 19.82 217 77680 25255 110486147
Nausea 342.02 19.82 1742 76155 1233948 109277454
Device infusion issue 341.16 19.82 114 77783 2931 110508471
Palpitations 333.85 19.82 482 77415 158730 110352672
Thrombosis in device 320.60 19.82 126 77771 5201 110506201
Paracentesis 317.28 19.82 90 77807 1310 110510092
Product administration interrupted 316.38 19.82 156 77741 11136 110500266
Oxygen saturation decreased 314.28 19.82 465 77432 156517 110354885
Dermatitis contact 296.36 19.82 160 77737 13793 110497609
Vascular device infection 287.07 19.82 166 77731 16346 110495056
Toxicity to various agents 283.80 19.82 13 77884 480542 110030860
Catheterisation cardiac 282.23 19.82 120 77777 6071 110505331
Medical device change 267.35 19.82 63 77834 412 110510990
Catheter site vesicles 264.23 19.82 61 77836 360 110511042
Device malfunction 261.87 19.82 184 77713 25374 110486028
Ascites 260.41 19.82 324 77573 92484 110418918
Catheter removal 252.46 19.82 64 77833 588 110510814
Drug interaction 251.57 19.82 29 77868 500154 110011248
Hypoxia 241.19 19.82 371 77526 129144 110382258
Infusion related reaction 240.12 19.82 6 77891 381156 110130246
Device connection issue 222.89 19.82 67 77830 1207 110510195
Pulmonary arterial pressure increased 222.57 19.82 96 77801 5031 110506371
Device physical property issue 222.22 19.82 88 77809 3706 110507696
Catheter site related reaction 218.36 19.82 68 77829 1386 110510016
Emergency care 214.21 19.82 67 77830 1386 110510016
Neutropenia 192.66 19.82 20 77877 374600 110136802
Febrile neutropenia 192.19 19.82 7 77890 316760 110194642
Chest pain 190.95 19.82 641 77256 375734 110135668
Oxygen consumption increased 187.97 19.82 88 77809 5597 110505805
Oedema 182.71 19.82 435 77462 209541 110301861
Product use in unapproved indication 181.07 19.82 46 77851 447331 110064071
Blood culture positive 179.73 19.82 99 77798 8877 110502525
Unevaluable event 172.92 19.82 211 77686 59016 110452386
Application site pruritus 167.91 19.82 74 77823 4086 110507316
Stomatitis 163.83 19.82 6 77891 270236 110241166
Pulmonary veno-occlusive disease 162.35 19.82 60 77837 2088 110509314
Device issue 162.07 19.82 158 77739 34377 110477025
Hypertension 161.14 19.82 79 77818 510005 110001397
Catheter site scab 159.75 19.82 37 77860 222 110511180
Arthropathy 159.72 19.82 11 77886 287511 110223891
Therapeutic product effect decreased 157.13 19.82 3 77894 244313 110267089
Hepatic enzyme increased 155.40 19.82 21 77876 320871 110190531
Device related sepsis 152.17 19.82 84 77813 7563 110503839
Rheumatoid arthritis 151.46 19.82 17 77880 299596 110211806
Alopecia 150.49 19.82 36 77861 364717 110146685
Treatment failure 147.27 19.82 13 77884 277221 110234181
Hypotension 146.24 19.82 742 77155 523107 109988295
Drug hypersensitivity 143.90 19.82 70 77827 454020 110057382
Underdose 141.31 19.82 198 77699 63356 110448046
Drug delivery system malfunction 141.26 19.82 45 77852 990 110510412
Central venous catheter removal 136.46 19.82 38 77859 515 110510887
Blood culture negative 135.81 19.82 33 77864 250 110511152
Cardiac failure 132.24 19.82 359 77538 187267 110324135
Joint swelling 131.83 19.82 74 77823 442771 110068631
Heart and lung transplant 130.83 19.82 30 77867 171 110511231
Catheter site warmth 130.48 19.82 33 77864 300 110511102
Glossodynia 127.77 19.82 7 77890 221997 110289405
Oedema peripheral 127.20 19.82 513 77384 328147 110183255
Musculoskeletal stiffness 127.06 19.82 22 77875 279800 110231602
Skin irritation 125.71 19.82 99 77798 16220 110495182
Pain in extremity 125.56 19.82 675 77222 486443 110024959
Intentional product use issue 125.46 19.82 14 77883 247892 110263510
Psoriatic arthropathy 124.21 19.82 3 77894 196758 110314644
Contraindicated product administered 123.20 19.82 15 77882 248252 110263150
Pericarditis 122.80 19.82 8 77889 219106 110292296
Vascular device occlusion 120.31 19.82 36 77861 638 110510764
Abdominal cavity drainage 117.74 19.82 38 77859 873 110510529
Nasal congestion 114.35 19.82 229 77668 98053 110413349
Haemoptysis 113.05 19.82 190 77707 71164 110440238
Dyspnoea at rest 111.79 19.82 71 77826 8275 110503127
Pulmonary oedema 111.72 19.82 230 77667 100429 110410973
Syncope 111.58 19.82 355 77542 202181 110309221
Mobility decreased 111.52 19.82 17 77880 237405 110273997
Duodenal ulcer perforation 111.07 19.82 3 77894 177697 110333705
Confusional state 111.04 19.82 100 77797 468580 110042822
Pericardial effusion 110.81 19.82 167 77730 57050 110454352
Abdominal distension 110.59 19.82 322 77575 174781 110336621
Application site irritation 110.21 19.82 44 77853 1893 110509509
Staphylococcus test positive 109.58 19.82 67 77830 7303 110504099
Catheter culture positive 109.49 19.82 27 77870 219 110511183
Scleroderma 108.22 19.82 63 77834 6278 110505124
Malaise 107.58 19.82 825 77072 670994 109840408
Drug abuse 107.29 19.82 4 77893 177407 110333995
Liver transplant 106.97 19.82 56 77841 4533 110506869
Drug intolerance 100.82 19.82 83 77814 406429 110104973
Heart rate increased 100.11 19.82 274 77623 143560 110367842
Catheter site cellulitis 99.61 19.82 30 77867 544 110510858
Therapeutic product effect incomplete 98.57 19.82 19 77878 223786 110287616
Weight decreased 98.02 19.82 614 77283 467443 110043959
Impaired healing 97.31 19.82 12 77885 196705 110314697
Discomfort 95.04 19.82 18 77879 214689 110296713
Gastritis hypertrophic 93.59 19.82 18 77879 34 110511368
Osteoarthritis 93.18 19.82 10 77887 182613 110328789
Epistaxis 92.37 19.82 250 77647 130122 110381280
Catheter site discolouration 90.10 19.82 21 77876 130 110511272
Injury 89.70 19.82 10 77887 177255 110334147
Inappropriate schedule of product administration 88.18 19.82 18 77879 203619 110307783
Fibromyalgia 88.12 19.82 9 77888 170900 110340502
Cardiac failure high output 85.69 19.82 26 77871 484 110510918
Acute kidney injury 85.26 19.82 202 77695 635228 109876174
Psoriasis 81.85 19.82 4 77893 139989 110371413
Concomitant disease aggravated 80.79 19.82 77 77820 16287 110495115
Wound 80.73 19.82 32 77865 234405 110276997
Catheter site dermatitis 80.15 19.82 18 77879 92 110511310
Transplant 79.71 19.82 31 77866 1243 110510159
White blood cell count decreased 79.51 19.82 31 77866 229359 110282043
Irritable bowel syndrome 78.86 19.82 11 77886 164204 110347198
Hyperthyroidism 78.59 19.82 100 77797 29161 110482241
Liver injury 77.34 19.82 8 77889 150405 110360997
Sleep disorder 77.31 19.82 22 77875 198622 110312780
Asthma 77.09 19.82 40 77857 250251 110261151
Product use issue 76.81 19.82 64 77833 311631 110199771
General physical health deterioration 75.65 19.82 114 77783 425181 110086221
Oxygen therapy 75.51 19.82 43 77854 4110 110507292
Blood potassium decreased 75.17 19.82 136 77761 53978 110457424
Cardiac ablation 72.00 19.82 36 77861 2646 110508756
Presyncope 70.64 19.82 125 77772 48762 110462640
Aspiration pleural cavity 70.43 19.82 31 77866 1706 110509696
Blood pressure increased 70.14 19.82 48 77849 258325 110253077
Vomiting 69.99 19.82 962 76935 909713 109601689
C-reactive protein increased 69.86 19.82 33 77864 217886 110293516
Joint range of motion decreased 69.60 19.82 4 77893 121828 110389574
Product deposit 69.57 19.82 24 77873 681 110510721
Dry mouth 69.33 19.82 27 77870 199921 110311481
Lower respiratory tract infection 68.93 19.82 43 77854 243063 110268339
Application site erythema 68.43 19.82 45 77852 5565 110505837
Maternal exposure during pregnancy 68.33 19.82 48 77849 254835 110256567
Hypersensitivity 67.39 19.82 113 77784 403885 110107517
Obesity 67.04 19.82 3 77894 113348 110398054
Catheter site extravasation 66.41 19.82 22 77875 550 110510852
Infusion site erythema 66.24 19.82 60 77837 11899 110499503
Intentional product misuse 65.98 19.82 8 77889 132896 110378506
Inflammation 65.51 19.82 27 77870 193211 110318191
Walking distance test abnormal 64.45 19.82 23 77874 723 110510679
Overdose 64.04 19.82 43 77854 233751 110277651
Condition aggravated 63.40 19.82 793 77104 734043 109777359
Application site rash 63.17 19.82 32 77865 2418 110508984
Dizziness 61.31 19.82 756 77141 697437 109813965
Pancytopenia 60.92 19.82 36 77861 209577 110301825
Drug-induced liver injury 60.17 19.82 7 77890 120060 110391342
Infusion site infection 59.54 19.82 30 77867 2242 110509160
Depression 59.42 19.82 82 77815 317253 110194149
Catheter site dryness 59.27 19.82 12 77885 33 110511369
Respiratory failure 59.19 19.82 304 77593 215028 110296374
Feeling abnormal 58.95 19.82 268 77629 180443 110330959
Coma 58.75 19.82 7 77890 117862 110393540
Thyroidectomy 58.72 19.82 24 77873 1098 110510304
Epilepsy 58.14 19.82 3 77894 100206 110411196
Injection site pain 56.94 19.82 27 77870 177895 110333507
Disease progression 56.63 19.82 329 77568 243705 110267697
Delirium 56.28 19.82 13 77884 135012 110376390
Electrocardiogram QT prolonged 55.49 19.82 6 77891 108954 110402448
Leukopenia 55.14 19.82 18 77879 148773 110362629
Systemic lupus erythematosus 54.71 19.82 59 77838 254279 110257123
Anaphylactic reaction 54.07 19.82 8 77889 114292 110397110
Urticaria 53.33 19.82 89 77808 318768 110192634
Cough 52.90 19.82 527 77370 461114 110050288
Pneumonia 51.83 19.82 886 77011 875828 109635574
Somnolence 51.65 19.82 81 77816 297368 110214034
Staphylococcal infection 51.41 19.82 136 77761 69808 110441594
Caesarean section 50.00 19.82 55 77842 13762 110497640
Lip dry 49.74 19.82 6 77891 100077 110411325
Catheter site induration 48.85 19.82 11 77886 57 110511345
Pulmonary arterial pressure abnormal 48.56 19.82 20 77877 933 110510469
Injection site reaction 47.75 19.82 4 77893 89066 110422336
Emergency care examination 47.66 19.82 14 77883 232 110511170
Blister 47.52 19.82 54 77843 227322 110284080
Balloon atrial septostomy 47.45 19.82 12 77885 109 110511293
Catheter site mass 47.35 19.82 11 77886 67 110511335
COVID-19 47.21 19.82 62 77835 244998 110266404
Hypoaesthesia 46.94 19.82 94 77803 314129 110197273
Catheter site bruise 46.48 19.82 17 77880 574 110510828
Disease complication 46.28 19.82 36 77861 5791 110505611
Hallucination 45.96 19.82 8 77889 101424 110409978
Clostridium difficile infection 45.27 19.82 108 77789 52021 110459381
Suture related complication 45.17 19.82 15 77882 378 110511024
Catheter site nodule 44.38 19.82 10 77887 52 110511350
Pulmonary capillary haemangiomatosis 44.31 19.82 11 77886 92 110511310
Goitre 44.29 19.82 36 77861 6168 110505234
Acute respiratory failure 44.25 19.82 135 77762 75125 110436277
Myalgia 44.15 19.82 288 77609 222093 110289309
Lung assist device therapy 43.98 19.82 12 77885 150 110511252
Catheter site hypersensitivity 43.89 19.82 11 77886 96 110511306
Right ventricular dysfunction 43.84 19.82 28 77869 3295 110508107
Catheter site urticaria 43.63 19.82 9 77888 28 110511374
Cardiac disorder 43.15 19.82 135 77762 76145 110435257
Pruritus 43.14 19.82 237 77660 581323 109930079
Hyponatraemia 43.03 19.82 54 77843 217599 110293803
Depressed level of consciousness 42.64 19.82 13 77884 112265 110399137
Blood glucose increased 42.56 19.82 20 77877 132476 110378926
Biopsy bone marrow 42.54 19.82 15 77882 455 110510947
Chest discomfort 42.03 19.82 237 77660 173611 110337791
Wheezing 41.97 19.82 72 77825 255158 110256244
Prescribed overdose 41.73 19.82 6 77891 87575 110423827
Infusion site pain 41.30 19.82 56 77841 17363 110494039
Brain natriuretic peptide increased 41.22 19.82 45 77852 11164 110500238
Ear discomfort 41.09 19.82 45 77852 11204 110500198
Suicide attempt 41.06 19.82 11 77886 103383 110408019
Hepatitis 41.02 19.82 7 77890 90047 110421355
Gait disturbance 40.89 19.82 84 77813 278124 110233278
Paraesthesia 40.21 19.82 84 77813 276437 110234965
Blood creatine phosphokinase increased 39.96 19.82 3 77894 73074 110438328
Hypoglycaemia 39.71 19.82 16 77881 116088 110395314
Pulmonary embolism 39.56 19.82 56 77841 214418 110296984
Dialysis 39.03 19.82 58 77839 19561 110491841
Application site hypersensitivity 38.87 19.82 13 77884 335 110511067
Blood pressure systolic increased 38.82 19.82 6 77891 82985 110428417
Seasonal allergy 38.80 19.82 58 77839 19664 110491738
Drug reaction with eosinophilia and systemic symptoms 38.25 19.82 6 77891 82089 110429313
Catheter site thrombosis 38.16 19.82 15 77882 619 110510783
Retching 38.06 19.82 62 77835 22620 110488782
Multiple allergies 37.92 19.82 45 77852 12218 110499184
Sedation 37.71 19.82 3 77894 69680 110441722
Platelet transfusion 37.59 19.82 24 77873 2822 110508580
Catheter site erosion 37.42 19.82 9 77888 65 110511337
Wrong technique in product usage process 37.22 19.82 8 77889 87340 110424062
Coronary artery disease 36.37 19.82 4 77893 71686 110439716
Blood pressure decreased 36.27 19.82 169 77728 114922 110396480
Bradycardia 35.80 19.82 34 77863 155483 110355919
Catheterisation cardiac abnormal 35.74 19.82 12 77885 313 110511089
Acute right ventricular failure 35.74 19.82 13 77884 432 110510970
Cholecystectomy 35.65 19.82 41 77856 10768 110500634
Suicidal ideation 35.45 19.82 11 77886 93926 110417476
Cognitive disorder 35.34 19.82 9 77888 87502 110423900
Deep vein thrombosis 35.34 19.82 28 77869 139859 110371543
Agitation 34.89 19.82 18 77879 113033 110398369
Gait inability 34.82 19.82 27 77870 136349 110375053
Lactic acidosis 34.79 19.82 11 77886 92800 110418602
Angioedema 34.63 19.82 13 77884 98487 110412915
Myocardial infarction 34.59 19.82 51 77846 192032 110319370
Sciatica 34.55 19.82 11 77886 92388 110419014
Biopsy liver 34.28 19.82 14 77883 639 110510763
Ill-defined disorder 34.15 19.82 36 77861 156817 110354585
Tri-iodothyronine increased 34.12 19.82 12 77885 361 110511041
Infusion site rash 34.07 19.82 21 77876 2322 110509080
Right ventricular dilatation 33.71 19.82 21 77876 2366 110509036
Metabolic acidosis 33.70 19.82 14 77883 99730 110411672
Mineral supplementation 33.66 19.82 15 77882 850 110510552
Hyperkalaemia 33.28 19.82 28 77869 135768 110375634
Muscular weakness 33.24 19.82 79 77818 248389 110263013
Immunoglobulin G4 related disease 32.73 19.82 12 77885 408 110510994
Injection site erythema 32.17 19.82 13 77884 94163 110417239
Silent thyroiditis 32.16 19.82 11 77886 304 110511098
Cardiac flutter 32.11 19.82 29 77868 5728 110505674
Arthralgia 32.08 19.82 373 77524 779259 109732143
Ventilation perfusion mismatch 31.59 19.82 14 77883 783 110510619
Osteoporosis 31.49 19.82 11 77886 87141 110424261
Chills 31.46 19.82 236 77661 190344 110321058
Decreased appetite 31.41 19.82 490 77407 475356 110036046
Chest tube insertion 31.11 19.82 9 77888 141 110511261
Therapeutic procedure 31.02 19.82 15 77882 1025 110510377
Tracheostomy 31.00 19.82 17 77880 1510 110509892
Endotracheal intubation 30.50 19.82 29 77868 6115 110505287
Wound infection 30.31 19.82 15 77882 96450 110414952
Concomitant disease progression 30.20 19.82 23 77874 3587 110507815
Catheter site oedema 30.16 19.82 9 77888 158 110511244
Night sweats 30.02 19.82 30 77867 133953 110377449
Dysentery 29.89 19.82 16 77881 1355 110510047
Catheter site granuloma 29.77 19.82 8 77889 94 110511308
Blood pressure fluctuation 29.64 19.82 8 77889 74816 110436586
Endarterectomy 29.57 19.82 11 77886 390 110511012
Culture positive 29.46 19.82 15 77882 1146 110510256
Cholestasis 29.42 19.82 5 77892 64513 110446889
Renal disorder 29.31 19.82 89 77808 49390 110462012
Cardioversion 29.23 19.82 19 77878 2304 110509098
Swollen tongue 29.07 19.82 4 77893 60358 110451044
Therapeutic embolisation 28.77 19.82 12 77885 578 110510824
Nasopharyngitis 28.70 19.82 413 77484 393948 110117454
Hyperglycaemia 28.65 19.82 12 77885 85078 110426324
Congestive hepatopathy 28.54 19.82 26 77871 5194 110506208
Dysphagia 28.42 19.82 40 77857 153560 110357842
Orthostatic hypotension 28.37 19.82 6 77891 66243 110445159
Medication error 28.01 19.82 20 77877 105346 110406056
Cytomegalovirus infection 27.71 19.82 3 77894 54441 110456961
Colitis ulcerative 27.55 19.82 10 77887 77353 110434049
Colonoscopy 27.55 19.82 18 77879 2202 110509200
Mechanical ventilation 27.51 19.82 21 77876 3286 110508116
Exercise tolerance decreased 27.41 19.82 38 77859 12029 110499373
Localised oedema 27.13 19.82 33 77864 9190 110502212
Interstitial lung disease 27.08 19.82 35 77862 139299 110372103
Incorrect route of product administration 27.03 19.82 6 77891 64055 110447347
Arthritis 26.88 19.82 48 77849 167538 110343864
Atrial septal defect repair 26.85 19.82 11 77886 506 110510896
Loss of personal independence in daily activities 26.84 19.82 40 77857 149980 110361422
Investigation 26.74 19.82 18 77879 2314 110509088
Device related thrombosis 26.66 19.82 21 77876 3441 110507961
Urinary retention 26.58 19.82 8 77889 69675 110441727
Thyrotoxic crisis 26.44 19.82 17 77880 2023 110509379
Acute myocardial infarction 26.36 19.82 13 77884 83764 110427638
First bite syndrome 26.35 19.82 6 77891 33 110511369
Thyroxine free increased 26.26 19.82 15 77882 1442 110509960
Diabetes mellitus 26.24 19.82 19 77878 99362 110412040
Aggression 26.11 19.82 5 77892 59205 110452197
Contusion 26.10 19.82 81 77816 233280 110278122
Autoimmune disorder 25.94 19.82 7 77890 65476 110445926
Systemic-pulmonary artery shunt 25.90 19.82 6 77891 36 110511366
Device use error 25.90 19.82 32 77865 9057 110502345
Injection site bruising 25.65 19.82 3 77894 51260 110460142
Injection site swelling 25.64 19.82 6 77891 61784 110449618
Dizziness exertional 25.63 19.82 12 77885 763 110510639
Amnesia 25.51 19.82 22 77875 105386 110406016
Micrococcus test positive 25.49 19.82 5 77892 11 110511391
Cardiac operation 25.48 19.82 26 77871 5969 110505433
Application site vesicles 25.27 19.82 15 77882 1549 110509853
Atrial flutter 25.23 19.82 54 77843 24208 110487194
Hypokalaemia 25.21 19.82 57 77840 182391 110329011
Cardiac output increased 25.08 19.82 11 77886 600 110510802
Pulmonary fibrosis 25.05 19.82 21 77876 102021 110409381
Biopsy thyroid gland 25.04 19.82 4 77893 0 110511402
Disease recurrence 25.03 19.82 6 77891 60778 110450624
Terminal state 24.86 19.82 25 77872 5642 110505760
Stent placement 24.81 19.82 28 77869 7206 110504196
Wound treatment 24.62 19.82 8 77889 188 110511214
Biopsy lymph gland 24.48 19.82 7 77890 105 110511297
Chronic respiratory failure 24.45 19.82 21 77876 3882 110507520
Cardiac pacemaker insertion 24.41 19.82 26 77871 6275 110505127
Drug resistance 24.36 19.82 5 77892 56369 110455033
Right-to-left cardiac shunt 24.27 19.82 9 77888 316 110511086
Diuretic therapy 24.11 19.82 8 77889 201 110511201
Hepatic steatosis 24.08 19.82 3 77894 48828 110462574
Orthopnoea 23.99 19.82 34 77863 10987 110500415
Catheter site scar 23.90 19.82 5 77892 17 110511385
Seizure 23.87 19.82 78 77819 221107 110290295
Knee arthroplasty 23.81 19.82 8 77889 64940 110446462
Dysarthria 23.66 19.82 15 77882 84106 110427296
Infusion site pruritus 23.65 19.82 23 77874 4985 110506417
Hospice care 23.56 19.82 36 77861 12437 110498965
Dyskinesia 23.43 19.82 4 77893 51442 110459960
Drug level increased 23.37 19.82 3 77894 47716 110463686
Dizziness postural 23.26 19.82 39 77858 14570 110496832
N-terminal prohormone brain natriuretic peptide increased 23.25 19.82 25 77872 6096 110505306
Altered state of consciousness 23.13 19.82 6 77891 57620 110453782
Bacteraemia 23.03 19.82 74 77823 42316 110469086
Balance disorder 22.94 19.82 29 77868 116531 110394871
Hepatocellular injury 22.93 19.82 4 77893 50638 110460764
Hypomagnesaemia 22.90 19.82 7 77890 60363 110451039
Spinal cord ischaemia 22.90 19.82 8 77889 236 110511166
Intra-abdominal fluid collection 22.84 19.82 20 77877 3794 110507608
Supraventricular tachycardia 22.73 19.82 52 77845 24370 110487032
Erythema 22.72 19.82 309 77588 291138 110220264
Upper respiratory tract congestion 22.59 19.82 18 77879 2999 110508403
Hypocalcaemia 22.36 19.82 9 77888 65357 110446045
Echocardiogram abnormal 22.29 19.82 17 77880 2657 110508745
Haemorrhage 22.28 19.82 140 77757 106552 110404850
Infusion site discharge 22.08 19.82 15 77882 1958 110509444
Right ventricular systolic pressure increased 21.98 19.82 12 77885 1057 110510345
Premature delivery 21.94 19.82 59 77838 30573 110480829
Application site odour 21.73 19.82 5 77892 29 110511373
Application site reaction 21.66 19.82 11 77886 836 110510566
Subclavian vein stenosis 21.38 19.82 4 77893 6 110511396
Blood lactate dehydrogenase increased 21.21 19.82 3 77894 44331 110467071
Culture negative 20.65 19.82 4 77893 8 110511394
Haematuria 20.48 19.82 17 77880 82988 110428414
Disturbance in attention 20.46 19.82 9 77888 61986 110449416
Nocturnal dyspnoea 20.37 19.82 14 77883 1861 110509541
Product quality issue 20.12 19.82 15 77882 77284 110434118
Cor pulmonale 20.04 19.82 15 77882 2279 110509123
Pulmonary haemorrhage 19.92 19.82 39 77858 16417 110494985
Biopsy skin 19.86 19.82 6 77891 110 110511292

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:22587 antiviral agent
CHEBI has role CHEBI:35674 antihypertensive agent
CHEBI has role CHEBI:50249 anticoagulant
CHEBI has role CHEBI:63726 neuroprotective agent
CHEBI has role CHEBI:75771 mouse metabolite

Related Drugs by ATC class:

B01AC Platelet aggregation inhibitors excl. heparin 24 drugs
abciximabacetylsalicylic acidaloxiprinberaprostcangrelorcarbasalate calciumcilostazolclopidogrelcloricromendipyridamoleditazoleeptifibatide show all 24 →

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
373305006 SNOMEDCT_US
65484006 SNOMEDCT_US
DCR9Z582X0 INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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
EPOPROSTENOL HUMAN PRESCRIPTION DRUG LABEL 1 67457-587 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 0.50 mg INTRAVENOUS ANDA 26 sections
EPOPROSTENOL HUMAN PRESCRIPTION DRUG LABEL 1 67457-588 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 1.50 mg INTRAVENOUS ANDA 26 sections
Epoprostenol Human Prescription Drug Label 1 68083-642 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 1.50 mg INTRAVENOUS ANDA 25 sections
Epoprostenol Human Prescription Drug Label 1 68083-707 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 0.50 mg INTRAVENOUS ANDA 25 sections