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

Stem definitionDrug idCAS RN
prostaglandins 2720 81846-19-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • treprost
  • treprostinil
  • uniprost
  • treprostinil sodium
  • 15AU81
  • LRX-15
  • UT-15
  • treprostinil diolamine
Treprostinil is a prostacyclin analogue. The major pharmacologic actions of treprostinil are direct vasodilation of pulmonary and systemic arterial vascular beds and inhibition of platelet aggregation.
  • Molecular weight: 390.52
  • Formula: C23H34O5
  • CLOGP: 3.72
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 3
  • TPSA: 86.99
  • ALOGS: -4.73
  • ROTB: 10
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
4.30 mg P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 4 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 6.15 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 0.23 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 10.70 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.09 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 0.82 hours Lombardo F, Berellini G, Obach RS

Approvals:

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

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Dyspnoea 3214.76 17.21 4989 115360 656324 62712349
Infusion site pain 2705.02 17.21 1065 119284 15804 63352869
Fluid retention 2099.08 17.21 1343 119006 58343 63310330
Pulmonary arterial hypertension 1670.36 17.21 828 119521 21749 63346924
Headache 1625.84 17.21 3642 116707 629599 62739074
Hypervolaemia 1546.00 17.21 848 119501 27565 63341108
Right ventricular failure 1543.32 17.21 720 119629 16468 63352205
Pain in jaw 1379.74 17.21 918 119431 42578 63326095
Infusion site erythema 1373.62 17.21 591 119758 11088 63357585
Pulmonary hypertension 1323.20 17.21 843 119506 36280 63332393
Drug ineffective 1202.94 17.21 261 120088 1044504 62324169
Infusion site infection 1092.70 17.21 310 120039 1484 63367189
Dyspnoea exertional 1076.10 17.21 901 119448 59401 63309272
Device related infection 941.36 17.21 574 119775 22818 63345855
Death 868.79 17.21 2075 118274 372306 62996367
Infusion site swelling 835.89 17.21 396 119953 9374 63359299
Vascular device infection 807.39 17.21 354 119995 6958 63361715
Flushing 806.26 17.21 846 119503 74241 63294432
Diarrhoea 783.82 17.21 3042 117307 712324 62656349
Oxygen saturation decreased 777.80 17.21 898 119451 87687 63280986
Cough 758.02 17.21 1695 118654 291048 63077625
Dermatitis contact 661.07 17.21 351 119998 10657 63358016
Infusion site discharge 634.13 17.21 165 120184 527 63368146
Catheter site pain 607.65 17.21 255 120094 4480 63364193
Dizziness 601.02 17.21 1983 118366 427942 62940731
Chest pain 554.31 17.21 1247 119102 214712 63153961
Catheter site erythema 541.10 17.21 228 120121 4048 63364625
Syncope 522.81 17.21 857 119492 116528 63252145
Device dislocation 495.56 17.21 402 119947 25303 63343370
Nausea 488.21 17.21 3018 117331 851453 62517220
Infusion site haemorrhage 453.01 17.21 212 120137 4874 63363799
Therapy change 431.64 17.21 217 120132 5864 63362809
Hypotension 424.24 17.21 1306 119043 271298 63097375
Alopecia 423.01 17.21 67 120282 337469 63031204
Nasal congestion 418.05 17.21 567 119782 65093 63303580
Infusion related reaction 414.07 17.21 11 120338 245510 63123163
Contraindicated product administered 395.50 17.21 3 120346 217645 63151028
Hypoxia 392.34 17.21 524 119825 59268 63309405
Arthropathy 363.77 17.21 20 120329 234772 63133901
Toxicity to various agents 357.02 17.21 30 120319 247220 63121453
Oxygen consumption increased 355.54 17.21 165 120184 3719 63364954
Rash 351.71 17.21 328 120021 560543 62808130
Rheumatoid arthritis 350.04 17.21 37 120312 253782 63114891
Lung transplant 343.86 17.21 151 120198 2977 63365696
Infusion site induration 336.43 17.21 115 120234 1107 63367566
Palpitations 335.62 17.21 692 119657 112078 63256595
Device infusion issue 331.01 17.21 130 120219 1908 63366765
Oedema 330.14 17.21 632 119717 96990 63271683
Hospitalisation 326.92 17.21 582 119767 84499 63284174
Therapeutic product effect decreased 320.73 17.21 10 120339 193177 63175496
Pulmonary arterial pressure increased 320.63 17.21 150 120199 3445 63365228
Infusion site warmth 320.22 17.21 123 120226 1695 63366978
Treatment failure 317.74 17.21 14 120335 199029 63169644
Oedema peripheral 317.13 17.21 932 119417 188579 63180094
Device leakage 305.67 17.21 182 120167 6914 63361759
Glossodynia 297.87 17.21 9 120340 178867 63189806
Catheter site pruritus 295.06 17.21 121 120228 1999 63366674
Injection site discharge 291.35 17.21 95 120254 779 63367894
Catheter site discharge 287.36 17.21 117 120232 1896 63366777
Drug interaction 281.23 17.21 48 120301 229083 63139590
Neutropenia 280.33 17.21 12 120337 174993 63193680
Catheter site haemorrhage 269.40 17.21 128 120221 3047 63365626
Drug hypersensitivity 263.41 17.21 130 120219 310557 63058116
Hepatic enzyme increased 262.86 17.21 36 120313 202292 63166381
Catheter site infection 256.96 17.21 143 120206 4771 63363902
Catheter management 255.22 17.21 121 120228 2866 63365807
Infusion site irritation 254.00 17.21 87 120262 843 63367830
Throat irritation 251.59 17.21 333 120016 37314 63331359
Joint swelling 250.48 17.21 156 120193 327510 63041163
Scleroderma 229.83 17.21 138 120211 5324 63363349
Infusion site pruritus 229.69 17.21 143 120206 5892 63362781
Catheter site swelling 224.68 17.21 90 120259 1395 63367278
Blood pressure decreased 221.00 17.21 422 119927 64600 63304073
Infusion site cellulitis 219.34 17.21 56 120293 162 63368511
Hypersensitivity 218.64 17.21 143 120206 292542 63076131
Therapeutic product effect incomplete 216.95 17.21 4 120345 125052 63243621
Maternal exposure during pregnancy 213.94 17.21 75 120274 219987 63148686
Haemoptysis 213.74 17.21 268 120081 28458 63340215
Infusion site abscess 213.20 17.21 55 120294 168 63368505
Cardiac failure 210.77 17.21 499 119850 88643 63280030
Product use in unapproved indication 207.98 17.21 43 120306 179037 63189636
Catheterisation cardiac 205.95 17.21 121 120228 4482 63364191
Epistaxis 205.40 17.21 437 119912 72288 63296385
Injection site infection 204.56 17.21 91 120258 1852 63366821
Musculoskeletal stiffness 203.04 17.21 50 120299 184568 63184105
Device issue 201.57 17.21 237 120112 23544 63345129
Feeling abnormal 201.31 17.21 679 119670 147713 63220960
Febrile neutropenia 200.71 17.21 5 120344 118444 63250229
Malaise 197.89 17.21 1407 118942 414547 62954126
Stomatitis 196.95 17.21 18 120331 138707 63229966
Device related sepsis 194.78 17.21 112 120237 3982 63364691
Chest discomfort 194.50 17.21 552 119797 109417 63259256
Catheter placement 190.49 17.21 91 120258 2193 63366480
Hypertension 187.10 17.21 153 120196 279150 63089523
Pulmonary oedema 186.30 17.21 356 119993 54517 63314156
Pericarditis 184.33 17.21 18 120331 131561 63237112
Discomfort 182.75 17.21 46 120303 167328 63201345
Wound 181.91 17.21 43 120306 163220 63205453
Presyncope 181.38 17.21 243 120106 27542 63341131
Complication associated with device 176.10 17.21 188 120161 16790 63351883
Abdominal distension 175.37 17.21 457 119892 86158 63282515
Transfusion 169.43 17.21 175 120174 15042 63353631
Dyspnoea at rest 168.89 17.21 102 120247 3977 63364696
Pneumonia 164.92 17.21 1450 118899 455317 62913356
Central venous catheterisation 162.03 17.21 85 120264 2514 63366159
Ascites 162.00 17.21 283 120066 40445 63328228
White blood cell count decreased 160.26 17.21 34 120315 139070 63229603
Pain in extremity 159.62 17.21 1125 119224 330361 63038312
Blood cholesterol increased 159.19 17.21 4 120345 94028 63274645
Exposure during pregnancy 156.38 17.21 50 120299 155497 63213176
Systemic lupus erythematosus 151.99 17.21 105 120244 208813 63159860
Infusion site discolouration 151.00 17.21 58 120291 799 63367874
C-reactive protein increased 149.94 17.21 7 120342 94700 63273973
Device alarm issue 146.29 17.21 67 120282 1463 63367210
Unevaluable event 144.16 17.21 308 120041 51078 63317595
Device occlusion 143.31 17.21 116 120233 7271 63361402
Transplant evaluation 142.07 17.21 61 120288 1136 63367537
Lower respiratory tract infection 141.28 17.21 38 120311 132269 63236404
Helicobacter infection 140.25 17.21 9 120340 92776 63275897
Pruritus 139.69 17.21 298 120051 361155 63007518
Vomiting 138.92 17.21 1645 118704 557972 62810701
Respiratory failure 138.86 17.21 467 119882 101391 63267282
Catheter site rash 138.65 17.21 53 120296 720 63367953
Heart rate increased 137.36 17.21 442 119907 93796 63274877
Product dose omission issue 134.36 17.21 831 119518 233482 63135191
Acute respiratory failure 133.75 17.21 237 120112 34248 63334425
Arthralgia 133.66 17.21 591 119758 569119 62799554
Dizziness postural 132.99 17.21 111 120238 7265 63361408
Infusion site reaction 131.49 17.21 83 120266 3504 63365169
Productive cough 129.45 17.21 335 120014 62873 63305800
Infusion site inflammation 129.16 17.21 42 120307 341 63368332
Pericardial effusion 128.93 17.21 216 120133 29842 63338831
Leukopenia 128.19 17.21 4 120345 77286 63291387
Infusion site oedema 126.88 17.21 51 120298 798 63367875
Therapy non-responder 125.47 17.21 372 119977 75529 63293144
Osteoarthritis 123.66 17.21 17 120332 95326 63273347
Catheter site irritation 121.72 17.21 44 120305 506 63368167
Cardiac failure congestive 119.16 17.21 416 119933 92017 63276656
Device malfunction 117.80 17.21 157 120192 17700 63350973
Device maintenance issue 117.45 17.21 24 120325 11 63368662
Psoriasis 116.41 17.21 14 120335 86943 63281730
Purulent discharge 113.31 17.21 84 120265 4622 63364051
Drug titration error 111.23 17.21 46 120303 777 63367896
Intentional overdose 109.71 17.21 8 120341 74144 63294529
Walking distance test abnormal 108.89 17.21 41 120308 533 63368140
Impaired healing 108.43 17.21 30 120319 102512 63266161
Respiration abnormal 106.34 17.21 92 120257 6325 63362348
Drug abuse 104.00 17.21 9 120340 72509 63296164
Type 2 diabetes mellitus 103.48 17.21 4 120345 63864 63304809
Urticaria 103.45 17.21 97 120252 165705 63202968
Blister 102.96 17.21 59 120290 129755 63238918
Off label use 102.05 17.21 805 119544 673657 62695016
Pulmonary hypertensive crisis 101.09 17.21 34 120315 310 63368363
Device connection issue 98.98 17.21 40 120309 635 63368038
Confusional state 97.08 17.21 188 120161 236192 63132481
Thrombosis in device 96.82 17.21 64 120285 2926 63365747
Infusion site rash 96.06 17.21 55 120294 1939 63366734
Treatment noncompliance 94.80 17.21 215 120134 37110 63331563
Pulmonary veno-occlusive disease 94.51 17.21 45 120304 1076 63367597
Neutrophil count decreased 93.25 17.21 3 120346 56403 63312270
Catheter site inflammation 92.45 17.21 41 120308 828 63367845
Intentional product use issue 92 17.21 65 120284 127827 63240846
Fibromyalgia 91.90 17.21 20 120329 80400 63288273
Catheter site vesicles 91.85 17.21 31 120318 286 63368387
Device breakage 91.18 17.21 111 120238 11431 63357242
Liver injury 91.07 17.21 6 120343 60514 63308159
Pancytopenia 90.80 17.21 35 120314 96898 63271775
Device use error 90.25 17.21 80 120269 5681 63362992
Infusion site vesicles 89.59 17.21 35 120314 506 63368167
Electrocardiogram QT prolonged 89.29 17.21 6 120343 59524 63309149
Infusion site discomfort 86.48 17.21 46 120303 1400 63367273
Catheter site related reaction 85.63 17.21 40 120309 915 63367758
Sleep disorder due to general medical condition, insomnia type 85.53 17.21 3 120346 52214 63316459
Anaphylactic reaction 85.20 17.21 12 120337 66088 63302585
Depression 82.65 17.21 154 120195 196338 63172335
Acute kidney injury 82.32 17.21 242 120107 263173 63105500
Inflammation 81.67 17.21 27 120322 82246 63286427
Asthma 81.49 17.21 73 120276 127488 63241185
Injury 80.15 17.21 20 120329 73227 63295446
Infusion site nodule 79.60 17.21 44 120305 1448 63367225
Mobility decreased 79.01 17.21 68 120281 121091 63247582
Irritable bowel syndrome 78.45 17.21 29 120320 82383 63286290
Decreased appetite 77.26 17.21 771 119578 250281 63118392
Cognitive disorder 77.19 17.21 8 120341 55807 63312866
Device programming error 77.07 17.21 22 120327 108 63368565
Depressed level of consciousness 76.08 17.21 13 120336 62065 63306608
Oropharyngeal pain 75.53 17.21 367 119982 94120 63274553
Vascular device occlusion 74.99 17.21 22 120327 121 63368552
Ill-defined disorder 74.15 17.21 31 120318 81724 63286949
Suicide attempt 74.13 17.21 13 120336 60905 63307768
Right ventricular dysfunction 74.05 17.21 45 120304 1774 63366899
Abortion spontaneous 73.06 17.21 4 120345 47191 63321482
Blood pressure systolic increased 70.43 17.21 5 120344 47392 63321281
Catheter site warmth 69.55 17.21 23 120326 198 63368475
Atrial flutter 69.24 17.21 89 120260 9683 63358990
Brain natriuretic peptide increased 69.23 17.21 66 120283 5147 63363526
Drug intolerance 68.71 17.21 326 120023 308335 63060338
Hypoaesthesia 68.17 17.21 135 120214 168258 63200415
Intentional product misuse 67.89 17.21 16 120333 60901 63307772
Red blood cell sedimentation rate increased 67.25 17.21 4 120345 43978 63324695
Neuropathy peripheral 65.73 17.21 71 120278 113596 63255077
Infusion site pustule 65.55 17.21 15 120334 22 63368651
Catheter site extravasation 65.37 17.21 25 120324 340 63368333
Seasonal allergy 65.10 17.21 131 120218 20819 63347854
Knee arthroplasty 65.02 17.21 12 120337 54194 63314479
Device physical property issue 64.99 17.21 43 120306 1969 63366704
Disease progression 64.45 17.21 426 119923 122332 63246341
Bradycardia 64.45 17.21 29 120320 73198 63295475
Angioedema 63.51 17.21 8 120341 47957 63320716
Alanine aminotransferase increased 63.20 17.21 62 120287 103708 63264965
Blood pressure increased 62.99 17.21 133 120216 161929 63206744
Suicidal ideation 62.81 17.21 20 120329 62401 63306272
Retching 62.47 17.21 105 120244 14540 63354133
Internal haemorrhage 62.24 17.21 62 120287 5103 63363570
Cor pulmonale 61.79 17.21 42 120307 2012 63366661
Acute right ventricular failure 61.55 17.21 20 120329 162 63368511
Device use issue 61.21 17.21 46 120303 2584 63366089
Emergency care 60.96 17.21 33 120316 1041 63367632
Loss of personal independence in daily activities 60.56 17.21 57 120292 97233 63271440
Hyponatraemia 60.27 17.21 74 120275 111826 63256847
Wrong dose 59.12 17.21 34 120315 1209 63367464
Coma 59.02 17.21 24 120325 64340 63304333
Osteoporosis 58.36 17.21 18 120331 57320 63311353
Thrombocytopenia 57.95 17.21 125 120224 151032 63217641
Sedation 57.94 17.21 4 120345 38805 63329868
Dizziness exertional 56.81 17.21 23 120326 367 63368306
Device expulsion 53.93 17.21 3 120346 34919 63333754
Product use issue 53.80 17.21 225 120124 220295 63148378
Exercise tolerance decreased 53.72 17.21 59 120290 5438 63363235
Paraesthesia 53.62 17.21 138 120211 156828 63211845
Pulmonary arterial pressure abnormal 53.47 17.21 24 120325 499 63368174
Localised oedema 53.04 17.21 58 120291 5320 63363353
Plasma cell myeloma 52.74 17.21 4 120345 35901 63332772
Overdose 52.17 17.21 86 120263 114992 63253681
Bursitis 52.02 17.21 5 120344 37036 63331637
Lactic acidosis 51.64 17.21 6 120343 38281 63330392
Sepsis 50.35 17.21 477 119872 152646 63216027
Rales 50.17 17.21 88 120261 12609 63356064
Respiratory distress 50.11 17.21 160 120189 33791 63334882
Paracentesis 50.09 17.21 28 120321 942 63367731
Metabolic acidosis 49.90 17.21 12 120337 45057 63323616
Respiratory tract congestion 48.97 17.21 106 120243 17726 63350947
Injection site erosion 48.51 17.21 14 120335 72 63368601
Cardiac disorder 48.50 17.21 208 120141 50608 63318065
Rash maculo-papular 48.47 17.21 3 120346 31893 63336780
Cardiac failure high output 47.93 17.21 19 120330 286 63368387
Delirium 47.74 17.21 18 120331 50523 63318150
Arthritis 47.71 17.21 92 120257 115829 63252844
Blood glucose increased 47.67 17.21 53 120296 83703 63284970
Infusion site extravasation 47.50 17.21 77 120272 10349 63358324
Right-to-left cardiac shunt 47.46 17.21 18 120331 239 63368434
Medical device site haemorrhage 47.44 17.21 12 120337 33 63368640
Therapeutic response decreased 47.30 17.21 29 120320 61496 63307177
Sleep disorder 47.10 17.21 51 120298 81515 63287158
Subcutaneous drug absorption impaired 46.08 17.21 16 120333 162 63368511
Drug-induced liver injury 45.95 17.21 10 120339 40212 63328461
Gastrointestinal haemorrhage 45.85 17.21 287 120062 80889 63287784
Hypocalcaemia 45.29 17.21 4 120345 31709 63336964
Chronic respiratory failure 45.19 17.21 34 120315 1913 63366760
Weight decreased 45.03 17.21 756 119593 276042 63092631
Hip arthroplasty 44.95 17.21 17 120332 47629 63321044
Injection site bruising 44.78 17.21 12 120337 41898 63326775
Terminal state 44.61 17.21 36 120313 2246 63366427
Deep vein thrombosis 44.51 17.21 56 120293 83744 63284929
Gamma-glutamyltransferase increased 44.27 17.21 6 120343 34025 63334648
Cholestasis 44.04 17.21 3 120346 29431 63339242
Oxygen therapy 43.94 17.21 35 120314 2143 63366530
Joint range of motion decreased 43.94 17.21 5 120344 32423 63336250
Sinusitis 43.86 17.21 251 120098 226402 63142271
Bone marrow failure 43.78 17.21 3 120346 29287 63339386
Diabetes mellitus 43.33 17.21 26 120323 55784 63312889
Generalised tonic-clonic seizure 43.29 17.21 3 120346 29013 63339660
Injection site irritation 42.82 17.21 50 120299 4928 63363745
Hepatotoxicity 42.74 17.21 9 120340 37032 63331641
Sinus congestion 42.29 17.21 101 120248 18022 63350651
Contusion 41.81 17.21 145 120204 149899 63218774
Cardiac failure acute 41.58 17.21 69 120280 9454 63359219
Basal cell carcinoma 41.45 17.21 3 120346 27988 63340685
Clostridium difficile infection 41.45 17.21 138 120211 29784 63338889
Disease complication 41.42 17.21 40 120309 3169 63365504
Hypoglycaemia 41.27 17.21 32 120317 60033 63308640
Pulmonary artery aneurysm 41.17 17.21 11 120338 40 63368633
Bacteraemia 40.83 17.21 97 120252 17251 63351422
Foetal exposure during pregnancy 40.73 17.21 6 120343 31956 63336717
General physical health deterioration 40.62 17.21 220 120129 201182 63167491
Blood potassium decreased 40.08 17.21 172 120177 41854 63326819
Asthenia 39.87 17.21 980 119369 382624 62986049
Inappropriate schedule of product administration 39.81 17.21 86 120263 103879 63264794
Rhinovirus infection 39.81 17.21 46 120303 4483 63364190
Dialysis 39.57 17.21 71 120278 10356 63358317
Loss of consciousness 38.83 17.21 368 119981 117753 63250920
Intentional medical device removal by patient 38.51 17.21 13 120336 120 63368553
Product prescribing error 38.41 17.21 3 120346 26286 63342387
Medication error 38.34 17.21 26 120323 52258 63316415
Oxygen saturation abnormal 38.23 17.21 40 120309 3489 63365184
Infusion site haematoma 38.22 17.21 16 120333 279 63368394
Prescribed overdose 38.00 17.21 9 120340 34144 63334529
Lung disorder 37.60 17.21 224 120125 62037 63306636
Hepatic steatosis 37.60 17.21 5 120344 28764 63339909
Head discomfort 37.13 17.21 80 120269 13335 63355338
Swollen tongue 37.11 17.21 10 120339 34790 63333883
Myalgia 37.11 17.21 433 119916 146096 63222577
Eczema 36.94 17.21 8 120341 32283 63336390
Medical device change 36.45 17.21 16 120333 315 63368358
Seizure 36.40 17.21 129 120220 132505 63236168
Agranulocytosis 36.36 17.21 3 120346 25131 63343542
Disease recurrence 36.33 17.21 5 120344 28025 63340648
Hepatitis 36.21 17.21 15 120334 39773 63328900
Extra dose administered 36.13 17.21 52 120297 6298 63362375
Agitation 36.03 17.21 36 120313 59721 63308952
Hyperkalaemia 35.84 17.21 30 120319 54173 63314500
Catheter site scab 35.80 17.21 14 120335 203 63368470
Infusion site injury 35.56 17.21 10 120339 46 63368627
Hepatic function abnormal 35.46 17.21 13 120336 37129 63331544
Obesity 35.13 17.21 7 120342 29945 63338728
Multiple sclerosis 35.00 17.21 3 120346 24369 63344304
Catheterisation cardiac abnormal 34.95 17.21 14 120335 217 63368456
Psychotic disorder 34.75 17.21 4 120345 25708 63342965
Product leakage 34.74 17.21 21 120328 820 63367853
Joint stiffness 34.68 17.21 18 120331 41851 63326822
Hyperglycaemia 34.67 17.21 18 120331 41849 63326824
Cardiac ablation 34.62 17.21 26 120323 1459 63367214
Hypercalcaemia 34.55 17.21 6 120343 28316 63340357
Gout 34.31 17.21 77 120272 13194 63355479
Liver transplant 34.28 17.21 31 120318 2260 63366413
Echocardiogram abnormal 33.76 17.21 25 120324 1373 63367300
Infusion site dermatitis 33.74 17.21 8 120341 15 63368658
Infusion site dryness 33.74 17.21 7 120342 4 63368669
Catheter site erosion 33.50 17.21 10 120339 59 63368614
Injection site reaction 33.33 17.21 37 120312 58487 63310186
Right ventricular enlargement 33.33 17.21 15 120334 314 63368359
Device power source issue 33.28 17.21 18 120331 567 63368106
Femur fracture 33.06 17.21 19 120330 41737 63326936
Drug eruption 33.05 17.21 7 120342 28687 63339986
Breast cancer 32.96 17.21 26 120323 48357 63320316
Endotracheal intubation 32.92 17.21 32 120317 2556 63366117
Pain 32.83 17.21 1113 119236 739515 62629158
Blood creatinine increased 32.54 17.21 74 120275 87770 63280903
Viral infection 32.52 17.21 144 120205 35519 63333154
Administration site odour 32.44 17.21 9 120340 39 63368634
Hallucination 31.95 17.21 34 120315 54783 63313890
Catheter site discolouration 31.89 17.21 11 120338 109 63368564
Dry eye 31.63 17.21 19 120330 40742 63327931
Cerebral infarction 31.59 17.21 4 120345 23889 63344784
Right ventricular systolic pressure increased 31.59 17.21 17 120332 530 63368143
Cardiac output increased 31.57 17.21 13 120336 217 63368456
Flatulence 31.55 17.21 140 120209 34562 63334111
Infection 31.54 17.21 280 120069 228893 63139780
Grip strength decreased 31.32 17.21 3 120346 22284 63346389
Metastases to liver 31.15 17.21 4 120345 23635 63345038
Incorrect route of product administration 31.00 17.21 7 120342 27445 63341228
Application site pruritus 30.96 17.21 38 120311 3946 63364727
Aggression 30.91 17.21 4 120345 23494 63345179
Balance disorder 30.56 17.21 72 120277 84350 63284323
Pancreatitis acute 30.54 17.21 7 120342 27159 63341514
Epilepsy 30.37 17.21 7 120342 27058 63341615
Drug dependence 30.28 17.21 5 120344 24478 63344195
Catheter site nodule 30.16 17.21 9 120340 53 63368620
Emotional distress 30.06 17.21 12 120337 32537 63336136
Renal impairment 29.91 17.21 78 120271 88277 63280396
Suture related complication 29.84 17.21 12 120337 188 63368485
Nocturnal dyspnoea 29.81 17.21 22 120327 1202 63367471
Wrong technique in product usage process 29.75 17.21 45 120304 62295 63306378
Sinus disorder 29.47 17.21 108 120241 24445 63344228
Cardioversion 29.24 17.21 22 120327 1238 63367435
Infusion site erosion 29.19 17.21 6 120343 3 63368670
Medical device site odour 29.19 17.21 6 120343 3 63368670
Muscular weakness 29.10 17.21 126 120223 122227 63246446
Abdominal pain upper 28.98 17.21 551 119798 205893 63162780
Skin lesion 28.91 17.21 11 120338 30710 63337963
Sickle cell anaemia 28.66 17.21 16 120333 537 63368136
Heart and lung transplant 28.56 17.21 10 120339 104 63368569
No adverse event 28.52 17.21 22 120327 41383 63327290
Pulmonary embolism 28.46 17.21 119 120230 116565 63252108
Pulmonary pain 28.27 17.21 34 120315 3456 63365217
Nasal dryness 28.27 17.21 39 120310 4542 63364131
Live birth 28.03 17.21 7 120342 25623 63343050
Disturbance in attention 27.99 17.21 19 120330 38170 63330503
Macular degeneration 27.97 17.21 6 120343 24370 63344303
Dysphagia 27.90 17.21 81 120268 88504 63280169
Decreased activity 27.87 17.21 46 120303 6274 63362399
Hypothyroidism 27.69 17.21 24 120325 42608 63326065
Drug ineffective for unapproved indication 27.68 17.21 15 120334 34048 63334625
Paranasal sinus hypersecretion 27.57 17.21 35 120314 3760 63364913
Right ventricular dilatation 27.52 17.21 22 120327 1354 63367319
Aspartate aminotransferase increased 27.39 17.21 84 120265 90193 63278480
Catheter site dermatitis 27.37 17.21 9 120340 76 63368597
Adverse drug reaction 27.27 17.21 70 120279 79644 63289029
Bone disorder 27.18 17.21 4 120345 21322 63347351
Bendopnoea 26.98 17.21 7 120342 22 63368651
Ventilation perfusion mismatch 26.88 17.21 15 120334 503 63368170
Oral herpes 26.86 17.21 8 120341 26066 63342607
Infusion site scar 26.72 17.21 15 120334 509 63368164
Ejection fraction decreased 26.66 17.21 5 120344 22327 63346346
Product administration interrupted 26.64 17.21 39 120310 4797 63363876
Dysarthria 26.60 17.21 25 120324 42686 63325987
Hyperlipidaemia 26.56 17.21 3 120346 19568 63349105
Somnolence 26.51 17.21 214 120135 178471 63190202
Incorrect drug administration rate 26.38 17.21 35 120314 3927 63364746
Therapy cessation 26.28 17.21 121 120228 30336 63338337
Hallucination, visual 26.08 17.21 3 120346 19295 63349378
Product quality issue 26.08 17.21 18 120331 35847 63332826
Intracardiac pressure increased 26.01 17.21 8 120341 53 63368620
Dyspepsia 25.86 17.21 302 120047 101894 63266779
Sickle cell anaemia with crisis 25.55 17.21 43 120306 5960 63362713
Injection site pustule 25.50 17.21 9 120340 96 63368577
Swelling 25.45 17.21 368 119981 275010 63093663
Cyanosis 25.16 17.21 80 120269 16855 63351818
Jaundice 25.09 17.21 12 120337 29239 63339434
Diplopia 24.96 17.21 7 120342 23721 63344952
Renal disorder 24.85 17.21 126 120223 32848 63335825
Skin exfoliation 24.82 17.21 27 120322 43075 63325598
Dyskinesia 24.71 17.21 15 120334 31987 63336686
Dry throat 24.32 17.21 45 120304 6720 63361953
Fracture 24.22 17.21 4 120345 19580 63349093
Haemodynamic test abnormal 24.09 17.21 7 120342 37 63368636
Platelet count decreased 23.86 17.21 126 120223 115996 63252677
Gait disturbance 23.81 17.21 227 120122 182951 63185722
Cataract 23.71 17.21 45 120304 57008 63311665
Diabetic ketoacidosis 23.62 17.21 5 120344 20500 63348173
Sleep study 23.59 17.21 6 120343 17 63368656
Influenza 23.52 17.21 312 120037 108410 63260263
Skin irritation 23.50 17.21 55 120294 9686 63358987
Eosinophilia 23.41 17.21 7 120342 22749 63345924
Platelet count increased 23.33 17.21 3 120346 17708 63350965
Transplant 23.25 17.21 16 120333 782 63367891
Respiratory tract irritation 23.24 17.21 13 120336 438 63368235
Diuretic therapy 23.23 17.21 9 120340 127 63368546
Diagnostic procedure 23.23 17.21 9 120340 127 63368546
Colitis 23.18 17.21 35 120314 48493 63320180
Erythema 23.18 17.21 217 120132 175534 63193139
Medical procedure 23.15 17.21 12 120337 346 63368327
Peripheral swelling 23.14 17.21 664 119685 265278 63103395
Malabsorption from injection site 22.86 17.21 6 120343 20 63368653
Staphylococcal infection 22.75 17.21 145 120204 41111 63327562
Catheter site cellulitis 22.73 17.21 11 120338 273 63368400
Blood pressure fluctuation 22.52 17.21 33 120316 46284 63322389
Transaminases increased 22.46 17.21 16 120333 31351 63337322
Blood calcium decreased 22.46 17.21 11 120338 26440 63342233
Altered state of consciousness 22.18 17.21 10 120339 25220 63343453
Secretion discharge 22.18 17.21 62 120287 12169 63356504
Tendonitis 22.15 17.21 5 120344 19610 63349063
Aphasia 22.14 17.21 18 120331 32982 63335691
Disability 22.13 17.21 4 120345 18343 63350330
Acute hepatic failure 22.10 17.21 4 120345 18323 63350350
Drug withdrawal syndrome 22.06 17.21 12 120337 27182 63341491
Catheter site abscess 22.01 17.21 6 120343 24 63368649
Vasculitis 21.90 17.21 4 120345 18205 63350468
Cardiac operation 21.75 17.21 29 120320 3269 63365404
Cardiogenic shock 21.62 17.21 79 120270 17853 63350820
Catheter removal 21.62 17.21 12 120337 398 63368275
Infusion site mass 21.62 17.21 23 120326 2045 63366628
Blood culture positive 21.61 17.21 35 120314 4700 63363973
Head injury 21.58 17.21 106 120243 27290 63341383
Tracheostomy malfunction 21.51 17.21 7 120342 57 63368616
Recalled product administered 21.40 17.21 13 120336 512 63368161
Coronary artery disease 21.30 17.21 18 120331 32359 63336314
Migraine 21.30 17.21 294 120055 103052 63265621
Immunodeficiency 21.26 17.21 6 120343 20248 63348425
Unevaluable device issue 21.08 17.21 4 120345 0 63368673
Device data issue 21.08 17.21 4 120345 0 63368673
Underdose 21.02 17.21 13 120336 27443 63341230
Rhinorrhoea 20.89 17.21 203 120146 65374 63303299
Spinal osteoarthritis 20.71 17.21 3 120346 16183 63352490
Product communication issue 20.70 17.21 14 120335 665 63368008
Cellulitis 20.65 17.21 242 120107 81716 63286957
Cystitis 20.62 17.21 46 120303 54945 63313728
Dysentery 20.59 17.21 16 120333 945 63367728
Orthostatic hypotension 20.44 17.21 23 120326 36137 63332536
Cardiac output decreased 20.43 17.21 16 120333 956 63367717
Carpal tunnel syndrome 20.36 17.21 7 120342 20810 63347863
Conjunctivitis 20.33 17.21 7 120342 20789 63347884
Stent placement 20.28 17.21 30 120319 3725 63364948
Visual acuity reduced 20.23 17.21 8 120341 21818 63346855
Obstructive airways disorder 20.18 17.21 7 120342 20692 63347981
Cerebrovascular accident 20.14 17.21 121 120228 107903 63260770
Blood pressure abnormal 20.08 17.21 69 120280 15129 63353544
Pulmonary haemorrhage 20.08 17.21 43 120306 7138 63361535
Hypokalaemia 20.03 17.21 115 120234 103689 63264984
Mood swings 19.92 17.21 5 120344 18243 63350430
Injection site haemorrhage 19.81 17.21 95 120254 24219 63344454
Abnormal behaviour 19.62 17.21 8 120341 21418 63347255
Cardiac pacemaker insertion 19.52 17.21 31 120318 4095 63364578
Balloon atrial septostomy 19.48 17.21 7 120342 79 63368594
Infusion site thrombosis 19.46 17.21 8 120341 133 63368540
Diet noncompliance 19.36 17.21 11 120338 382 63368291
Acne 19.31 17.21 10 120339 23283 63345390
Portopulmonary hypertension 19.30 17.21 8 120341 136 63368537
Gait inability 19.29 17.21 45 120304 52914 63315759
Hemiparesis 19.29 17.21 10 120339 23272 63345401
Pneumonitis 19.26 17.21 23 120326 35199 63333474
Pulmonary arterial pressure decreased 19.25 17.21 7 120342 82 63368591
Sciatica 19.22 17.21 22 120327 34302 63334371
Metapneumovirus infection 19.21 17.21 16 120333 1044 63367629
Pleural effusion 19.14 17.21 265 120084 92945 63275728
Supraventricular tachycardia 19.04 17.21 65 120284 14206 63354467
Night sweats 19.00 17.21 40 120309 48774 63319899
Administration site infection 18.98 17.21 5 120344 17 63368656
Tubulointerstitial nephritis 18.94 17.21 7 120342 19896 63348777
Therapeutic response unexpected 18.89 17.21 6 120343 18753 63349920
Leukocytosis 18.88 17.21 13 120336 25922 63342751
Vasodilatation 18.86 17.21 23 120326 2372 63366301
Infusion site cyst 18.85 17.21 4 120345 3 63368670
Infusion site lymphadenopathy 18.85 17.21 4 120345 3 63368670
Abdominal cavity drainage 18.75 17.21 11 120338 406 63368267
Atrial fibrillation 18.72 17.21 318 120031 116318 63252355
Unintentional medical device removal 18.71 17.21 38 120311 6077 63362596
Photosensitivity reaction 18.68 17.21 3 120346 14991 63353682
Impaired work ability 18.67 17.21 5 120344 17470 63351203
Product storage error 18.62 17.21 3 120346 14953 63353720
Urinary retention 18.56 17.21 18 120331 30283 63338390
Musculoskeletal disorder 18.44 17.21 8 120341 20636 63348037
Herpes zoster 18.36 17.21 87 120262 82375 63286298
Pericardiotomy 18.34 17.21 5 120344 20 63368653
Exposure via eye contact 18.32 17.21 4 120345 4 63368669
Systemic scleroderma 18.18 17.21 15 120334 966 63367707
Faeces soft 18.17 17.21 36 120313 5656 63363017
Rash erythematous 18.13 17.21 33 120316 42477 63326196
Jugular vein distension 18.11 17.21 15 120334 971 63367702
Amnesia 18.11 17.21 50 120299 55535 63313138
Vertigo 17.96 17.21 56 120293 59831 63308842
Blood viscosity decreased 17.91 17.21 6 120343 54 63368619
Heart rate irregular 17.83 17.21 87 120262 22334 63346339
Speech disorder 17.81 17.21 31 120318 40598 63328075
Ear congestion 17.80 17.21 24 120325 2735 63365938
Colitis ulcerative 17.79 17.21 14 120335 26077 63342596
Hypomagnesaemia 17.68 17.21 17 120332 28720 63339953
Sluggishness 17.64 17.21 34 120315 5235 63363438
Urinary tract infection 17.62 17.21 375 119974 264309 63104364
Heart valve replacement 17.54 17.21 12 120337 581 63368092
Withdrawal syndrome 17.46 17.21 8 120341 19989 63348684
Glaucoma 17.41 17.21 7 120342 18898 63349775
Pneumonia aspiration 17.40 17.21 24 120325 34516 63334157
Lip dry 17.36 17.21 4 120345 15466 63353207
Cardio-respiratory arrest 17.33 17.21 57 120292 59902 63308771
Brain oedema 17.33 17.21 3 120346 14192 63354481

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Dyspnoea 1060.03 23.10 1584 34195 375198 34545954
Infusion site pain 1004.83 23.10 300 35479 3551 34917601
Fluid retention 770.80 23.10 426 35353 26461 34894691
Right ventricular failure 665.38 23.10 272 35507 8512 34912640
Headache 661.64 23.10 913 34866 199722 34721430
Pulmonary arterial hypertension 639.47 23.10 264 35515 8475 34912677
Pulmonary hypertension 584.34 23.10 326 35453 20598 34900554
Hypervolaemia 558.35 23.10 310 35469 19399 34901753
Pain in jaw 550.18 23.10 268 35511 12772 34908380
Infusion site erythema 490.12 23.10 153 35626 2120 34919032
Oxygen saturation decreased 395.03 23.10 372 35407 53446 34867706
Flushing 370.61 23.10 289 35490 32131 34889021
Dyspnoea exertional 288.79 23.10 284 35495 42995 34878157
Infusion site infection 253.22 23.10 65 35714 414 34920738
Cough 246.45 23.10 501 35278 149639 34771513
Death 235.58 23.10 914 34865 397135 34524017
Oxygen consumption increased 221.17 23.10 74 35705 1292 34919860
Drug ineffective 216.73 23.10 99 35680 456652 34464500
Diarrhoea 216.62 23.10 878 34901 389034 34532118
Infusion site haemorrhage 205.65 23.10 65 35714 939 34920213
Device related infection 204.11 23.10 157 35622 17080 34904072
Device dislocation 192.56 23.10 104 35675 6145 34915007
Therapy change 188.52 23.10 82 35697 2995 34918157
Infusion site swelling 183.66 23.10 76 35703 2448 34918704
Drug interaction 181.51 23.10 13 35766 225933 34695219
Oedema 180.23 23.10 228 35551 45513 34875639
Toxicity to various agents 178.44 23.10 6 35773 200356 34720796
Dermatitis contact 174.25 23.10 81 35698 3465 34917687
Lung transplant 171.53 23.10 68 35711 1956 34919196
Vascular device infection 164.43 23.10 82 35697 4103 34917049
Hypoxia 163.01 23.10 239 35540 54856 34866296
Catheter site pain 160.68 23.10 58 35721 1280 34919872
Infusion site discharge 148.92 23.10 32 35747 78 34921074
Catheter site erythema 146.98 23.10 55 35724 1348 34919804
Nausea 142.63 23.10 705 35074 339203 34581949
Therapy non-responder 136.85 23.10 184 35595 38962 34882190
Dizziness 134.37 23.10 509 35270 218012 34703140
Nasal congestion 133.05 23.10 140 35639 22917 34898235
Pain in extremity 132.22 23.10 354 35425 126159 34794993
Throat irritation 122.20 23.10 95 35684 10490 34910662
Oedema peripheral 120.91 23.10 331 35448 119481 34801671
Syncope 119.80 23.10 279 35500 91172 34829980
Catheter management 112.77 23.10 41 35738 924 34920228
Infusion site warmth 105.10 23.10 25 35754 110 34921042
Pulmonary arterial pressure increased 91.73 23.10 38 35741 1227 34919925
Feeling abnormal 90.62 23.10 200 35579 63035 34858117
Product use in unapproved indication 88.10 23.10 9 35770 117490 34803662
Infusion site irritation 87.37 23.10 25 35754 251 34920901
Injection site discharge 87.23 23.10 24 35755 206 34920946
Catheter site pruritus 86.66 23.10 26 35753 312 34920840
Device infusion issue 86.57 23.10 33 35746 852 34920300
Infusion site cellulitis 85.22 23.10 20 35759 82 34921070
Hypotension 83.03 23.10 446 35333 221203 34699949
Pancytopenia 80.75 23.10 4 35775 95153 34825999
Catheter site discharge 77.69 23.10 28 35751 615 34920537
Hospitalisation 77.07 23.10 176 35603 56726 34864426
Infusion site induration 76.78 23.10 22 35757 222 34920930
Thrombocytopenia 76.67 23.10 32 35747 156215 34764937
Injection site infection 75 23.10 31 35748 995 34920157
Chest pain 74.17 23.10 291 35488 126471 34794681
Catheterisation cardiac 72.69 23.10 41 35738 2636 34918516
Catheter site rash 69.87 23.10 20 35759 201 34920951
Complication associated with device 69.52 23.10 54 35725 5952 34915200
Drug abuse 68.38 23.10 10 35769 99086 34822066
Abdominal discomfort 67.03 23.10 172 35607 59663 34861489
Catheter site swelling 66.84 23.10 22 35757 364 34920788
Acute kidney injury 64.44 23.10 135 35644 304853 34616299
Peripheral swelling 64.13 23.10 198 35581 76343 34844809
Central venous catheterisation 63.96 23.10 30 35749 1309 34919843
Catheter site infection 63.11 23.10 37 35742 2560 34918592
Haemoptysis 62.19 23.10 121 35658 34885 34886267
Catheter placement 61.36 23.10 25 35754 773 34920379
Transplant evaluation 61.00 23.10 22 35757 484 34920668
Catheterisation cardiac abnormal 60.75 23.10 14 35765 52 34921100
Infusion site abscess 59.65 23.10 12 35767 18 34921134
Device issue 57.51 23.10 60 35719 9717 34911435
Rhabdomyolysis 57.39 23.10 3 35776 68160 34852992
Infusion site discomfort 57.36 23.10 17 35762 195 34920957
Infusion site inflammation 57.34 23.10 13 35766 44 34921108
Ventilation perfusion mismatch 55.97 23.10 14 35765 79 34921073
Heart rate increased 53.75 23.10 135 35644 46208 34874944
Transfusion 52.87 23.10 54 35725 8531 34912621
White blood cell count decreased 52.84 23.10 16 35763 95429 34825723
Cardiac failure 51.33 23.10 207 35572 91041 34830111
Abdominal distension 50.55 23.10 153 35626 58339 34862813
Productive cough 50.12 23.10 116 35663 37697 34883455
Catheter site haemorrhage 49.65 23.10 30 35749 2194 34918958
Leukopenia 49.27 23.10 4 35775 62852 34858300
Infusion site reaction 49.24 23.10 22 35757 857 34920295
Infusion site rash 48.94 23.10 19 35760 516 34920636
Device breakage 48.72 23.10 30 35749 2270 34918882
Infusion site oedema 48.01 23.10 15 35764 208 34920944
Device leakage 47.26 23.10 45 35734 6530 34914622
Walking distance test abnormal 46.59 23.10 14 35765 169 34920983
Malaise 44.56 23.10 334 35445 185491 34735661
Respiratory failure 43.62 23.10 223 35556 108349 34812803
Device physical property issue 43.60 23.10 20 35759 829 34920323
Device maintenance issue 43.21 23.10 8 35771 5 34921147
Right ventricular dysfunction 43.14 23.10 22 35757 1154 34919998
Hypertension 42.69 23.10 46 35733 136397 34784755
Acute respiratory failure 42.22 23.10 96 35683 30832 34890320
Device alarm issue 42.19 23.10 18 35761 626 34920526
Palpitations 41.75 23.10 112 35667 39874 34881278
Neuropathy peripheral 40.88 23.10 17 35762 83246 34837906
Pulmonary arterial pressure abnormal 40.13 23.10 13 35766 204 34920948
Weight increased 39.42 23.10 194 35585 92839 34828313
Drug titration error 39.41 23.10 16 35763 490 34920662
Confusional state 39.39 23.10 54 35725 144106 34777046
Anaemia 39.27 23.10 116 35663 233219 34687933
Internal haemorrhage 39.11 23.10 36 35743 5005 34916147
Infusion site scar 38.72 23.10 9 35770 35 34921117
Hallucination 38.43 23.10 4 35775 51494 34869658
C-reactive protein increased 38.38 23.10 5 35774 54093 34867059
Dizziness postural 38.37 23.10 39 35740 6125 34915027
Catheter site irritation 38.30 23.10 11 35768 112 34921040
Exercise tolerance decreased 38.17 23.10 36 35743 5162 34915990
Neutrophil count decreased 38.06 23.10 4 35775 51100 34870052
Infusion site pruritus 37.96 23.10 18 35761 805 34920347
Respiration abnormal 37.72 23.10 29 35750 3147 34918005
Chest discomfort 36.66 23.10 131 35648 54399 34866753
Blood pressure decreased 36.57 23.10 126 35653 51389 34869763
Device malfunction 36.40 23.10 49 35730 10372 34910780
Terminal state 36.31 23.10 31 35748 3903 34917249
Infusion site vesicles 35.88 23.10 12 35767 209 34920943
Therapeutic product effect incomplete 35.08 23.10 5 35774 50536 34870616
Blood creatine phosphokinase increased 34.75 23.10 3 35776 44854 34876298
Product dose omission issue 34.42 23.10 225 35554 119486 34801666
Treatment failure 33.90 23.10 4 35775 46693 34874459
Rash 32.44 23.10 118 35661 222634 34698518
Haematuria 32.40 23.10 6 35773 50060 34871092
Swelling 32.17 23.10 106 35673 42260 34878892
Device related sepsis 31.92 23.10 26 35753 3067 34918085
Dizziness exertional 31.86 23.10 11 35768 212 34920940
Hyponatraemia 31.72 23.10 23 35756 82668 34838484
Overdose 31.59 23.10 28 35751 91031 34830121
Myocardial infarction 31.45 23.10 47 35732 121038 34800114
Ascites 31.40 23.10 112 35667 46459 34874693
Treatment noncompliance 30.64 23.10 80 35699 28020 34893132
Fatigue 30.03 23.10 539 35240 370114 34551038
Plasma cell myeloma 29.55 23.10 4 35775 42033 34879119
Cor pulmonale 29.16 23.10 15 35764 801 34920351
Hypoglycaemia 28.74 23.10 10 35769 54630 34866522
Intentional product misuse 28.40 23.10 6 35773 45605 34875547
Hyperkalaemia 28.35 23.10 18 35761 69371 34851781
Infusion site discolouration 28.34 23.10 9 35770 132 34921020
Blood pressure increased 28.33 23.10 29 35750 88073 34833079
Catheter removal 28.30 23.10 10 35769 207 34920945
Platelet count decreased 27.79 23.10 50 35729 119667 34801485
Agitation 27.72 23.10 12 35767 57387 34863765
Liver transplant 27.64 23.10 22 35757 2512 34918640
Cardiac output increased 27.62 23.10 7 35772 42 34921110
Hepatic function abnormal 27.29 23.10 6 35773 44357 34876795
Epistaxis 27.22 23.10 125 35654 58126 34863026
Oropharyngeal pain 27.13 23.10 89 35690 35396 34885756
Aggression 26.70 23.10 4 35775 38960 34882192
Psoriasis 26.56 23.10 4 35775 38808 34882344
Respiratory tract congestion 26.38 23.10 32 35747 6107 34915045
Device occlusion 26.33 23.10 33 35746 6512 34914640
Acute myocardial infarction 26.31 23.10 11 35768 53708 34867444
Foetal exposure during pregnancy 25.91 23.10 4 35775 38097 34883055
Asthma 25.77 23.10 6 35773 42650 34878502
Catheter site discolouration 25.68 23.10 6 35773 24 34921128
Device connection issue 25.38 23.10 11 35768 398 34920754
Deep vein thrombosis 25.22 23.10 18 35761 65230 34855922
Coronary artery disease 25.13 23.10 9 35770 48296 34872856
Oxygen saturation abnormal 25.11 23.10 17 35762 1513 34919639
Infusion site nodule 25.09 23.10 8 35771 119 34921033
Delirium 25.02 23.10 7 35772 43984 34877168
Coma 24.65 23.10 8 35771 45670 34875482
Gout 24.34 23.10 58 35721 19195 34901957
Diuretic therapy 24.27 23.10 6 35773 32 34921120
Rheumatoid arthritis 23.87 23.10 5 35774 38233 34882919
Presyncope 23.65 23.10 57 35722 19002 34902150
Blood pressure systolic decreased 23.60 23.10 26 35753 4477 34916675
Infusion site scab 23.54 23.10 4 35775 0 34921152
Prostate cancer 23.13 23.10 6 35773 39643 34881509

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Dyspnoea 3410.05 17.50 5406 123309 851619 78764054
Infusion site pain 2758.68 17.50 988 127727 13188 79602485
Fluid retention 2563.18 17.50 1523 127192 68286 79547387
Pulmonary arterial hypertension 2080.72 17.50 983 127732 27383 79588290
Hypervolaemia 1849.95 17.50 1038 127677 41652 79574021
Right ventricular failure 1849.24 17.50 855 127860 22642 79593031
Headache 1794.79 17.50 3516 125199 650256 78965417
Pulmonary hypertension 1603.80 17.50 987 127728 47093 79568580
Pain in jaw 1540.86 17.50 948 127767 45203 79570470
Infusion site erythema 1430.45 17.50 548 128167 8912 79606761
Death 1095.95 17.50 2650 126065 563864 79051809
Infusion site infection 1009.83 17.50 281 128434 1500 79614173
Dyspnoea exertional 989.37 17.50 940 127775 86133 79529540
Device related infection 968.54 17.50 634 128081 33660 79582013
Drug ineffective 921.18 17.50 302 128413 1080611 78535062
Flushing 881.52 17.50 888 127827 87380 79528293
Oxygen saturation decreased 861.16 17.50 1051 127664 127996 79487677
Infusion site swelling 815.71 17.50 347 128368 7479 79608194
Vascular device infection 792.79 17.50 369 128346 9907 79605766
Diarrhoea 713.89 17.50 3054 125661 877435 78738238
Catheter site pain 693.76 17.50 278 128437 5118 79610555
Cough 692.16 17.50 1702 127013 365087 79250586
Dizziness 601.01 17.50 2039 126676 524402 79091271
Catheter site erythema 598.51 17.50 248 128467 4992 79610681
Toxicity to various agents 555.30 17.50 31 128684 421509 79194164
Syncope 540.70 17.50 1008 127707 178441 79437232
Device dislocation 537.95 17.50 397 128318 25573 79590100
Chest pain 528.72 17.50 1307 127408 280997 79334676
Infusion site haemorrhage 510.82 17.50 201 128514 3519 79612154
Drug interaction 497.11 17.50 48 128667 415135 79200538
Nausea 490.56 17.50 2919 125796 954277 78661396
Infusion site discharge 469.87 17.50 123 128592 497 79615176
Oedema 463.57 17.50 751 127964 118829 79496844
Lung transplant 451.45 17.50 195 128520 4366 79611307
Therapy change 444.78 17.50 224 128491 7175 79608498
Hypoxia 434.07 17.50 673 128042 102570 79513103
Oxygen consumption increased 425.48 17.50 192 128523 4787 79610886
Nasal congestion 413.60 17.50 562 128153 75990 79539683
Neutropenia 409.32 17.50 12 128703 287698 79327975
Dermatitis contact 389.27 17.50 235 128480 10798 79604875
Oedema peripheral 373.60 17.50 1071 127644 251217 79364456
Hospitalisation 366.71 17.50 593 128122 93643 79522030
Febrile neutropenia 355.92 17.50 3 128712 230996 79384677
Hypotension 340.38 17.50 1509 127206 438808 79176865
Infusion related reaction 333.43 17.50 8 128707 230229 79385444
Infusion site warmth 327.11 17.50 113 128602 1342 79614331
Pulmonary arterial pressure increased 318.86 17.50 153 128562 4402 79611271
Catheter management 318.55 17.50 143 128572 3520 79612153
Catheter site pruritus 315.31 17.50 124 128591 2167 79613506
Catheter site discharge 312.59 17.50 125 128590 2287 79613386
Injection site discharge 303.60 17.50 93 128622 729 79614944
Infusion site induration 293.87 17.50 98 128617 1037 79614636
Catheter site infection 290.66 17.50 164 128551 6631 79609042
Palpitations 290.01 17.50 635 128080 125975 79489698
Device leakage 282.90 17.50 191 128524 10665 79605008
Infusion site irritation 275.09 17.50 85 128630 688 79614985
Device infusion issue 268.71 17.50 111 128604 2215 79613458
Catheterisation cardiac 263.44 17.50 145 128570 5583 79610090
Product use in unapproved indication 263.04 17.50 44 128671 250315 79365358
Catheter site haemorrhage 256.11 17.50 137 128578 4980 79610693
Infusion site abscess 252.20 17.50 61 128654 163 79615510
Throat irritation 244.78 17.50 316 128399 40630 79575043
Catheter site swelling 243.15 17.50 97 128618 1763 79613910
Feeling abnormal 239.41 17.50 680 128035 158519 79457154
Infusion site cellulitis 238.33 17.50 62 128653 243 79615430
Catheter placement 236.21 17.50 109 128606 2865 79612808
Contraindicated product administered 233.92 17.50 4 128711 157534 79458139
Rash 229.87 17.50 362 128353 577996 79037677
Rheumatoid arthritis 229.56 17.50 32 128683 208438 79407235
Therapeutic product effect decreased 228.76 17.50 8 128707 163855 79451818
Device related sepsis 220.35 17.50 133 128582 6107 79609566
Pain in extremity 218.42 17.50 1162 127553 363376 79252297
Transfusion 217.06 17.50 217 128498 21113 79594560
Injection site infection 217.04 17.50 94 128621 2118 79613555
Drug abuse 216.95 17.50 11 128704 162680 79452993
Central venous catheterisation 216.72 17.50 106 128609 3183 79612490
Complication associated with device 212.07 17.50 196 128519 17300 79598373
Treatment failure 211.11 17.50 17 128698 170469 79445204
Product dose omission issue 205.85 17.50 868 127847 246669 79369004
Therapeutic product effect incomplete 204.71 17.50 5 128710 141640 79474033
Alopecia 204.11 17.50 60 128655 231295 79384378
Drug hypersensitivity 201.66 17.50 116 128599 298800 79316873
Scleroderma 201.20 17.50 120 128595 5390 79610283
Haemoptysis 195.79 17.50 336 128379 55663 79560010
Cardiac failure 191.94 17.50 618 128097 154224 79461449
Infusion site pruritus 191.47 17.50 105 128610 4013 79611660
Arthropathy 190.77 17.50 29 128686 177082 79438591
Malaise 186.83 17.50 1391 127324 488478 79127195
Transplant evaluation 185.99 17.50 78 128637 1619 79614054
Acute kidney injury 183.57 17.50 350 128365 519054 79096619
Device issue 179.18 17.50 220 128495 26888 79588785
White blood cell count decreased 173.22 17.50 45 128670 188243 79427430
Stomatitis 172.68 17.50 18 128697 146739 79468934
Blood pressure decreased 172.61 17.50 448 128267 99018 79516655
Unevaluable event 169.27 17.50 314 128401 55271 79560402
Presyncope 168.73 17.50 265 128450 40789 79574884
Epistaxis 167.24 17.50 476 128239 111039 79504634
Hepatic enzyme increased 165.42 17.50 45 128670 182565 79433108
Abdominal distension 165.33 17.50 496 128219 119154 79496519
Hypertension 164.44 17.50 175 128540 330817 79284856
C-reactive protein increased 162.17 17.50 12 128703 129015 79486658
Pancytopenia 161.55 17.50 35 128680 165710 79449963
Chest discomfort 158.57 17.50 537 128178 137507 79478166
Catheter site rash 158.27 17.50 60 128655 945 79614728
Leukopenia 154.93 17.50 8 128707 116505 79499168
Infusion site oedema 153.45 17.50 57 128658 846 79614827
Pulmonary oedema 152.61 17.50 397 128318 87857 79527816
Rhabdomyolysis 151.52 17.50 3 128712 103128 79512545
Acute respiratory failure 149.33 17.50 310 128405 59231 79556442
Pneumonia 147.74 17.50 1671 127044 658575 78957098
Musculoskeletal stiffness 146.11 17.50 50 128665 174958 79440715
Joint swelling 142.91 17.50 153 128562 288493 79327180
Catheter site irritation 140.89 17.50 48 128667 545 79615128
Heart rate increased 139.85 17.50 471 128244 120253 79495420
Device alarm issue 139.66 17.50 68 128647 2021 79613652
Device occlusion 138.16 17.50 130 128585 11736 79603937
Intentional overdose 135.63 17.50 9 128706 105951 79509722
Respiratory failure 134.75 17.50 614 128101 180297 79435376
Thrombocytopenia 133.10 17.50 139 128576 265120 79350553
Pericardial effusion 130.63 17.50 253 128462 45984 79569689
Vomiting 130.39 17.50 1643 127072 664185 78951488
Hypersensitivity 128.70 17.50 140 128575 262099 79353574
Pruritus 121.66 17.50 287 128428 394361 79221312
Infusion site rash 121.65 17.50 58 128657 1644 79614029
Glossodynia 120.71 17.50 13 128702 103324 79512349
Neutrophil count decreased 120.20 17.50 8 128707 93951 79521722
Ascites 119.61 17.50 329 128386 75233 79540440
Pericarditis 119.53 17.50 14 128701 104222 79511451
Off label use 118.84 17.50 918 127797 906297 78709376
Confusional state 118.67 17.50 207 128508 317790 79297883
Infusion site inflammation 118.62 17.50 37 128678 310 79615363
Depressed level of consciousness 118.62 17.50 10 128705 96642 79519031
Electrocardiogram QT prolonged 117.71 17.50 7 128708 90379 79525294
Dizziness postural 116.58 17.50 117 128598 11432 79604241
Productive cough 113.43 17.50 357 128358 87974 79527699
Cardiac failure congestive 113.32 17.50 493 128222 141909 79473764
Device breakage 113.04 17.50 111 128604 10564 79605109
Therapy non-responder 113.02 17.50 367 128348 91938 79523735
Infusion site reaction 111.98 17.50 70 128645 3423 79612250
Respiration abnormal 111.77 17.50 96 128619 7692 79607981
Infusion site discolouration 110.47 17.50 42 128673 667 79615006
Device malfunction 109.04 17.50 153 128562 21295 79594378
Dyspnoea at rest 108.86 17.50 92 128623 7210 79608463
Device connection issue 107.64 17.50 46 128669 1002 79614671
Catheter site vesicles 106.95 17.50 34 128681 305 79615368
Urticaria 104.72 17.50 87 128628 185114 79430559
Catheter site inflammation 103.88 17.50 46 128669 1095 79614578
Drug titration error 103.07 17.50 46 128669 1116 79614557
Bradycardia 102.75 17.50 45 128670 135512 79480161
Intentional product use issue 101.11 17.50 60 128655 152052 79463621
Walking distance test abnormal 98.25 17.50 39 128676 699 79614974
Discomfort 97.94 17.50 40 128675 125577 79490096
Right ventricular dysfunction 97.81 17.50 58 128657 2577 79613096
Lower respiratory tract infection 97.78 17.50 43 128672 129177 79486496
Pulmonary hypertensive crisis 96.86 17.50 32 128683 328 79615345
Suicide attempt 95.43 17.50 11 128704 82921 79532752
Intentional product misuse 94.97 17.50 19 128696 95146 79520527
Anaphylactic reaction 94.17 17.50 12 128703 83731 79531942
Psoriasis 93.44 17.50 16 128699 89571 79526102
Hyponatraemia 91.67 17.50 91 128624 177757 79437916
Overdose 90.71 17.50 98 128617 184108 79431565
Infusion site nodule 90.42 17.50 30 128685 312 79615361
Metabolic acidosis 90.02 17.50 13 128702 82516 79533157
Cognitive disorder 89.31 17.50 6 128709 69920 79545753
Maternal exposure during pregnancy 89.15 17.50 55 128660 136483 79479190
Inflammation 88.92 17.50 21 128694 93732 79521941
Lactic acidosis 87.11 17.50 7 128708 70352 79545321
Cor pulmonale 87.01 17.50 51 128664 2217 79613456
Neuropathy peripheral 86.74 17.50 61 128654 141244 79474429
Blood creatine phosphokinase increased 86.41 17.50 5 128710 66085 79549588
Osteoarthritis 85.94 17.50 18 128697 87291 79528382
Helicobacter infection 83.40 17.50 8 128707 69696 79545977
Infusion site discomfort 83.38 17.50 42 128673 1345 79614328
Device physical property issue 82.54 17.50 52 128663 2578 79613095
Coma 81.85 17.50 30 128685 100619 79515054
Infusion site vesicles 81.61 17.50 31 128684 491 79615182
Catheter site warmth 80.84 17.50 26 128689 243 79615430
Angioedema 80.59 17.50 13 128702 76022 79539651
Hyperkalaemia 80.54 17.50 42 128673 114356 79501317
Oropharyngeal pain 80.51 17.50 370 128345 108983 79506690
Cardiac disorder 80.07 17.50 261 128454 65496 79550177
Thrombosis in device 77.93 17.50 67 128648 5375 79610298
Rash maculo-papular 77.32 17.50 3 128712 56075 79559598
Delirium 76.33 17.50 21 128694 84606 79531067
Folliculitis 76.23 17.50 3 128712 55377 79560296
Device maintenance issue 74.42 17.50 15 128700 9 79615664
Blood pressure systolic increased 74.35 17.50 10 128705 66976 79548697
Peripheral swelling 74.01 17.50 712 128003 268905 79346768
Blood pressure increased 73.97 17.50 143 128572 211217 79404456
Pulmonary veno-occlusive disease 73.81 17.50 41 128674 1607 79614066
Hypoglycaemia 73.46 17.50 36 128679 101558 79514115
Catheter site related reaction 73.45 17.50 37 128678 1185 79614488
Alanine aminotransferase increased 73.05 17.50 93 128622 162477 79453196
Type 2 diabetes mellitus 72.66 17.50 5 128710 57117 79558556
Cholestasis 71.13 17.50 3 128712 52106 79563567
Drug-induced liver injury 70.76 17.50 11 128704 66106 79549567
Internal haemorrhage 70.54 17.50 79 128636 8754 79606919
Agitation 69.61 17.50 37 128678 99678 79515995
Bone marrow failure 69.57 17.50 3 128712 51104 79564569
Liver injury 69.07 17.50 6 128709 56608 79559065
Depression 68.85 17.50 155 128560 216635 79399038
Dizziness exertional 68.37 17.50 28 128687 546 79615127
Impaired healing 68.17 17.50 28 128687 87627 79528046
Pulmonary arterial pressure abnormal 67.83 17.50 30 128685 712 79614961
Wound 67.62 17.50 53 128662 116126 79499547
Terminal state 67.60 17.50 59 128656 4830 79610843
Asthma 67.47 17.50 71 128644 135024 79480649
Atrial flutter 66.86 17.50 123 128592 21502 79594171
Device use error 66.34 17.50 69 128646 7032 79608641
Hyperglycaemia 66.21 17.50 16 128699 70319 79545354
Hepatic function abnormal 66.20 17.50 18 128697 73089 79542584
Acute right ventricular failure 65.82 17.50 24 128691 337 79615336
Exposure during pregnancy 65.65 17.50 41 128674 101091 79514582
Retching 65.27 17.50 108 128607 17359 79598314
Suicidal ideation 65.10 17.50 21 128694 76319 79539354
Treatment noncompliance 65.03 17.50 209 128506 52059 79563614
Arthralgia 64.97 17.50 600 128115 571203 79044470
Wrong dose 64.74 17.50 38 128677 1656 79614017
Sedation 64.70 17.50 5 128710 51890 79563783
Hepatocellular injury 64.11 17.50 3 128712 47590 79568083
Fibromyalgia 63.87 17.50 13 128702 64327 79551346
Catheter site extravasation 63.71 17.50 25 128690 434 79615239
Gamma-glutamyltransferase increased 63.54 17.50 7 128708 54673 79561000
Injury 63.18 17.50 23 128692 77473 79538200
Emergency care 62.76 17.50 32 128683 1052 79614621
Multiple sclerosis relapse 62.47 17.50 3 128712 46530 79569143
Deep vein thrombosis 62.15 17.50 62 128653 120857 79494816
Localised oedema 61.59 17.50 70 128645 7882 79607791
Infusion site pustule 61.50 17.50 15 128700 42 79615631
Plasma cell myeloma 61.43 17.50 7 128708 53252 79562421
Lung disorder 61.09 17.50 275 128440 80282 79535391
Blood potassium decreased 60.62 17.50 189 128526 46323 79569350
Hallucination 59.58 17.50 32 128683 85713 79529960
Blister 59.43 17.50 63 128652 119413 79496260
Oxygen therapy 58.53 17.50 43 128672 2747 79612926
Red blood cell sedimentation rate increased 58.49 17.50 4 128711 45938 79569735
Generalised tonic-clonic seizure 58.41 17.50 3 128712 43907 79571766
Cerebral infarction 58.09 17.50 4 128711 45672 79570001
Sleep disorder due to general medical condition, insomnia type 57.86 17.50 3 128712 43553 79572120
Brain natriuretic peptide increased 56.83 17.50 71 128644 8829 79606844
Respiratory distress 56.72 17.50 215 128500 58124 79557549
Paracentesis 56.27 17.50 32 128683 1313 79614360
Exercise tolerance decreased 55.75 17.50 71 128644 9000 79606673
Aggression 55.63 17.50 8 128707 50950 79564723
Device programming error 55.06 17.50 18 128697 178 79615495
Loss of consciousness 55.01 17.50 461 128254 167482 79448191
Catheterisation cardiac abnormal 54.84 17.50 20 128695 281 79615392
Blood glucose increased 54.58 17.50 63 128652 114912 79500761
Inappropriate schedule of product administration 54.45 17.50 82 128633 133546 79482127
Agranulocytosis 54.32 17.50 5 128710 45025 79570648
Renal impairment 54.11 17.50 108 128607 157675 79457998
Hepatotoxicity 53.93 17.50 9 128706 51343 79564330
Hepatitis 53.80 17.50 12 128703 55715 79559958
Mobility decreased 53.73 17.50 71 128644 122104 79493569
Drug intolerance 53.30 17.50 232 128483 263887 79351786
Oxygen saturation abnormal 52.96 17.50 50 128665 4532 79611141
Myelosuppression 52.83 17.50 3 128712 40293 79575380
Hypocalcaemia 51.87 17.50 9 128706 49915 79565758
Disease complication 51.65 17.50 51 128664 4886 79610787
Disease progression 51.60 17.50 489 128226 183873 79431800
Psychotic disorder 51.58 17.50 4 128711 41398 79574275
Seasonal allergy 50.32 17.50 93 128622 16313 79599360
Sickle cell anaemia with crisis 50.26 17.50 63 128652 7859 79607814
Cardiac ablation 50.17 17.50 36 128679 2217 79613456
Seizure 49.97 17.50 148 128567 188686 79426987
Abdominal pain upper 49.10 17.50 565 128150 223254 79392419
Liver transplant 48.72 17.50 47 128668 4376 79611297
Blood creatinine increased 48.30 17.50 112 128603 154945 79460728
Vascular device occlusion 48.26 17.50 19 128696 333 79615340
Swollen tongue 48.10 17.50 6 128709 42564 79573109
Disease recurrence 47.98 17.50 7 128708 44102 79571571
Drug dependence 47.93 17.50 5 128710 40764 79574909
Product administration interrupted 47.87 17.50 44 128671 3855 79611818
Respiratory tract congestion 47.81 17.50 102 128613 19852 79595821
Acute myocardial infarction 47.60 17.50 33 128682 77003 79538670
Altered state of consciousness 47.56 17.50 7 128708 43815 79571858
Haematuria 47.37 17.50 26 128689 68810 79546863
Pancreatitis acute 47.25 17.50 11 128704 49593 79566080
Dysphagia 46.87 17.50 78 128637 122058 79493615
Right-to-left cardiac shunt 46.87 17.50 17 128698 235 79615438
Sinus congestion 46.86 17.50 101 128614 19795 79595878
Tubulointerstitial nephritis 46.78 17.50 4 128711 38231 79577442
Jaundice 46.70 17.50 14 128701 53335 79562338
Diabetes mellitus 46.58 17.50 35 128680 78355 79537318
Ventilation perfusion mismatch 46.32 17.50 22 128693 618 79615055
Osteoporosis 45.94 17.50 15 128700 54097 79561576
Dysarthria 45.88 17.50 26 128689 67596 79548077
Medication error 45.70 17.50 27 128688 68615 79547058
Sickle cell anaemia 45.55 17.50 22 128693 642 79615031
Eosinophilia 45.34 17.50 9 128706 45336 79570337
Catheter site discolouration 45.23 17.50 14 128701 114 79615559
Irritable bowel syndrome 45.07 17.50 22 128693 62219 79553454
Platelet count decreased 44.98 17.50 162 128553 194502 79421171
Application site pruritus 44.85 17.50 42 128673 3768 79611905
Loss of personal independence in daily activities 44.71 17.50 60 128655 102520 79513153
Hepatic steatosis 43.43 17.50 5 128710 37733 79577940
Drug eruption 43.35 17.50 9 128706 43926 79571747
Epilepsy 43.26 17.50 7 128708 40853 79574820
Chronic respiratory failure 42.85 17.50 37 128678 2985 79612688
Gout 42.41 17.50 111 128604 24638 79591035
Diuretic therapy 42.26 17.50 15 128700 194 79615479
Paraesthesia 41.90 17.50 145 128570 176178 79439495
Coronary artery disease 41.86 17.50 27 128688 65447 79550226
Ischaemic stroke 41.85 17.50 3 128712 33128 79582545
Purulent discharge 41.50 17.50 50 128665 5989 79609684
Multiple organ dysfunction syndrome 41.49 17.50 82 128633 120164 79495509
Medical device change 41.40 17.50 19 128696 493 79615180
Device use issue 41.34 17.50 35 128680 2749 79612924
Hallucination, visual 41.23 17.50 3 128712 32726 79582947
Cardiac failure acute 41.09 17.50 93 128622 18836 79596837
General physical health deterioration 40.93 17.50 268 128447 274970 79340703
Bursitis 40.62 17.50 5 128710 35839 79579834
Viral infection 40.56 17.50 157 128558 42859 79572814
Muscular weakness 40.37 17.50 129 128586 160600 79455073
Hypothyroidism 40.31 17.50 17 128698 52375 79563298
Influenza 39.92 17.50 351 128364 129255 79486418
Ill-defined disorder 39.67 17.50 29 128686 65846 79549827
Transaminases increased 39.47 17.50 17 128698 51726 79563947
Injection site irritation 39.37 17.50 39 128676 3751 79611922
Catheter site erosion 39.32 17.50 11 128704 60 79615613
Pulmonary embolism 38.90 17.50 144 128571 171510 79444163
Myocardial infarction 38.82 17.50 159 128556 183970 79431703
Myalgia 38.65 17.50 464 128251 185177 79430496
Infusion site dryness 38.43 17.50 8 128707 7 79615666
Pneumonia aspiration 38.40 17.50 31 128684 66936 79548737
Hypoaesthesia 38.36 17.50 154 128561 179198 79436475
Pulmonary artery aneurysm 38.12 17.50 13 128702 148 79615525
Pneumonitis 37.69 17.50 26 128689 60834 79554839
Blood pressure fluctuation 37.36 17.50 32 128683 67113 79548560
Injection site bruising 37.30 17.50 10 128705 40992 79574681
Obesity 37.23 17.50 6 128709 35119 79580554
Colitis 37.19 17.50 38 128677 73269 79542404
Eczema 37.04 17.50 10 128705 40808 79574865
Infusion site injury 36.97 17.50 8 128707 10 79615663
Somnolence 36.90 17.50 230 128485 238751 79376922
Catheter site scab 36.90 17.50 14 128701 221 79615452
Prescribed overdose 36.89 17.50 8 128707 37875 79577798
Joint range of motion decreased 36.86 17.50 5 128710 33277 79582396
Prostate cancer 36.84 17.50 5 128710 33263 79582410
Catheter site nodule 36.64 17.50 10 128705 49 79615624
Aspartate aminotransferase increased 36.43 17.50 109 128606 138532 79477141
Therapeutic response decreased 35.83 17.50 33 128682 66820 79548853
Diabetic ketoacidosis 35.78 17.50 6 128709 34116 79581557
Subcutaneous drug absorption impaired 35.75 17.50 8 128707 13 79615660
Cardio-respiratory arrest 35.73 17.50 76 128639 108434 79507239
Hypercalcaemia 35.67 17.50 9 128706 38421 79577252
Urinary retention 35.33 17.50 24 128691 56606 79559067
Right ventricular systolic pressure increased 35.25 17.50 21 128694 941 79614732
Body temperature decreased 35.20 17.50 5 128710 32140 79583533
Rhinovirus infection 35.00 17.50 53 128662 7900 79607773
Fatigue 34.99 17.50 1834 126881 927893 78687780
Dialysis 34.96 17.50 86 128629 18376 79597297
Arthritis 34.95 17.50 84 128631 114796 79500877
Sinus disorder 34.72 17.50 97 128618 22367 79593306
Acute hepatic failure 34.62 17.50 4 128711 30109 79585564
Ejection fraction decreased 34.29 17.50 7 128708 34570 79581103
Infusion site haematoma 34.09 17.50 14 128701 275 79615398
Clostridium difficile infection 34.08 17.50 148 128567 42537 79573136
Catheter removal 33.93 17.50 18 128697 643 79615030
Respiratory depression 33.51 17.50 3 128712 27627 79588046
Decreased appetite 33.35 17.50 755 127960 341663 79274010
Knee arthroplasty 33.33 17.50 14 128701 43234 79572439
Aphasia 33.11 17.50 17 128698 46715 79568958
Incorrect route of product administration 32.77 17.50 8 128707 34921 79580752
Systemic lupus erythematosus 32.73 17.50 94 128621 121055 79494618
Myelodysplastic syndrome 32.51 17.50 5 128710 30296 79585377
Cyanosis 32.51 17.50 102 128613 25080 79590593
Wrong technique in product usage process 32.41 17.50 43 128672 73832 79541841
Erythema 32.39 17.50 219 128496 223071 79392602
Head discomfort 32.32 17.50 72 128643 14430 79601243
Injection site pustule 32.25 17.50 10 128705 82 79615591
Interstitial lung disease 32.19 17.50 85 128630 112515 79503158
Heart and lung transplant 31.83 17.50 12 128703 186 79615487
Flatulence 31.75 17.50 145 128570 42579 79573094
Paranasal sinus hypersecretion 31.75 17.50 35 128680 3811 79611862
Drug ineffective for unapproved indication 31.59 17.50 22 128693 51216 79564457
Inappropriate antidiuretic hormone secretion 31.53 17.50 3 128712 26310 79589363
Posterior reversible encephalopathy syndrome 31.48 17.50 3 128712 26278 79589395
Decreased activity 31.47 17.50 53 128662 8641 79607032
Proteinuria 31.37 17.50 7 128708 32495 79583178
Intracardiac pressure increased 31.24 17.50 8 128707 29 79615644
Hypokalaemia 31.23 17.50 123 128592 143917 79471756
Bacteraemia 31.11 17.50 120 128595 32704 79582969
Disturbance in attention 31.07 17.50 22 128693 50779 79564894
Infusion site scar 31.02 17.50 14 128701 349 79615324
Labelled drug-drug interaction medication error 30.99 17.50 4 128711 27646 79588027
Skin exfoliation 30.98 17.50 26 128689 55074 79560599
Device expulsion 30.85 17.50 3 128712 25858 79589815
Diplopia 30.75 17.50 8 128707 33458 79582215
Gastroenteritis viral 30.61 17.50 99 128616 24732 79590941
Catheter site dermatitis 30.49 17.50 10 128705 100 79615573
Blood pressure abnormal 30.44 17.50 78 128637 17091 79598582
Incorrect drug administration rate 30.44 17.50 35 128680 3991 79611682
Intentional medical device removal by patient 30.16 17.50 14 128701 373 79615300
Skin lesion 29.98 17.50 15 128700 41829 79573844
Ataxia 29.62 17.50 3 128712 25036 79590637
Rales 29.58 17.50 85 128630 19916 79595757
Osteonecrosis 29.41 17.50 7 128708 31088 79584585
Pulmonary arterial pressure decreased 29.24 17.50 10 128705 115 79615558
Hypomagnesaemia 29.11 17.50 20 128695 46891 79568782
Migraine 29.07 17.50 241 128474 87252 79528421
Leukocytosis 29.06 17.50 17 128698 43438 79572235
Asthenia 28.90 17.50 1053 127662 510636 79105037
Cardiac operation 28.88 17.50 38 128677 4974 79610699
Extra dose administered 28.75 17.50 50 128665 8365 79607308
Hyperlipidaemia 28.71 17.50 4 128711 26089 79589584
Cardioversion 28.37 17.50 25 128690 2073 79613600
Atrial septal defect 28.21 17.50 24 128691 1898 79613775
Weight increased 28.06 17.50 615 128100 276771 79338902
Balance disorder 27.97 17.50 75 128640 98782 79516891
Cardiac output increased 27.97 17.50 12 128703 264 79615409
Dyspepsia 27.81 17.50 283 128432 108404 79507269
Chronic obstructive pulmonary disease 27.69 17.50 234 128481 85185 79530488
Endotracheal intubation 27.67 17.50 36 128679 4661 79611012
Emotional distress 27.64 17.50 15 128700 39954 79575719
Infusion site dermatitis 27.51 17.50 6 128709 8 79615665
Brain oedema 27.50 17.50 4 128711 25259 79590414
Nocturnal dyspnoea 27.40 17.50 22 128693 1604 79614069
Infusion site erosion 27.15 17.50 5 128710 0 79615673
Unevaluable device issue 27.15 17.50 5 128710 0 79615673
Drug withdrawal syndrome 27.14 17.50 11 128704 34707 79580966
Injection site reaction 27.11 17.50 29 128686 54756 79560917
Sleep disorder 26.58 17.50 62 128653 85615 79530058
Anaemia 26.40 17.50 533 128182 444482 79171191
Orthostatic hypotension 26.40 17.50 31 128684 56133 79559540
Skin irritation 26.40 17.50 57 128658 11183 79604490
Secretion discharge 26.38 17.50 68 128647 14954 79600719
COVID-19 26.32 17.50 148 128567 157526 79458147
Melaena 26.14 17.50 36 128679 60854 79554819
Right ventricular dilatation 26.14 17.50 23 128692 1903 79613770
Nightmare 26.14 17.50 5 128710 25856 79589817
Angina pectoris 26.03 17.50 27 128688 51705 79563968
Hemiparesis 25.86 17.50 11 128704 33722 79581951
Platelet count increased 25.70 17.50 3 128712 22403 79593270
Tendonitis 25.42 17.50 4 128711 23826 79591847
Diagnostic procedure 25.41 17.50 10 128705 175 79615498
Nasal dryness 25.37 17.50 34 128681 4529 79611144
Therapy cessation 25.37 17.50 124 128591 37438 79578235
Administration site odour 25.37 17.50 7 128708 36 79615637
Dyskinesia 25.33 17.50 21 128694 44752 79570921
Visual acuity reduced 25.31 17.50 8 128707 29461 79586212
Stent placement 25.28 17.50 41 128674 6479 79609194
Administration site infection 25.09 17.50 6 128709 15 79615658
Vasculitis 25.06 17.50 5 128710 25097 79590576
Abdominal cavity drainage 25.02 17.50 16 128699 814 79614859
Renal disorder 24.95 17.50 134 128581 41971 79573702
Grip strength decreased 24.91 17.50 3 128712 21866 79593807
Concomitant disease aggravated 24.58 17.50 61 128654 13106 79602567
Contusion 24.10 17.50 141 128574 148635 79467038
Encephalopathy 24.08 17.50 45 128670 67352 79548321
Infusion site scab 24.05 17.50 7 128708 45 79615628
Sepsis 24.04 17.50 587 128128 268841 79346832
Pyrexia 24.04 17.50 875 127840 677834 78937839
Sickle cell disease 23.96 17.50 9 128706 138 79615535
Dry eye 23.92 17.50 15 128700 36916 79578757
Catheter site abscess 23.79 17.50 7 128708 47 79615626
Heart valve operation 23.78 17.50 10 128705 209 79615464
Blood culture positive 23.65 17.50 46 128669 8383 79607290
Infusion site mass 23.60 17.50 20 128695 1573 79614100
Pulmonary endarterectomy 23.56 17.50 10 128705 214 79615459
Abnormal behaviour 23.31 17.50 15 128700 36406 79579267
Injection site haemorrhage 23.30 17.50 98 128617 27772 79587901
Disorientation 23.25 17.50 41 128674 62735 79552938
Blood iron decreased 23.22 17.50 66 128649 15368 79600305
Hallucination, auditory 23.17 17.50 3 128712 20690 79594983
Product quality issue 23.09 17.50 13 128702 33927 79581746
Cellulitis 22.86 17.50 273 128442 108787 79506886
Cardiac failure high output 22.84 17.50 11 128704 319 79615354
Haemodynamic test abnormal 22.84 17.50 7 128708 55 79615618
Tracheostomy malfunction 22.79 17.50 9 128706 159 79615514
Accidental exposure to product 22.79 17.50 11 128704 31311 79584362
Dry throat 22.78 17.50 43 128672 7663 79608010
Medical procedure 22.74 17.50 11 128704 322 79615351
Ileus 22.72 17.50 7 128708 26204 79589469
Right ventricular enlargement 22.69 17.50 14 128701 669 79615004
Portopulmonary hypertension 22.54 17.50 9 128706 164 79615509
Administration site pain 22.52 17.50 13 128702 549 79615124
Thrombotic microangiopathy 22.41 17.50 3 128712 20166 79595507
Staphylococcal infection 22.35 17.50 166 128549 58129 79557544
Hyperbilirubinaemia 22.26 17.50 6 128709 24512 79591161
Diet noncompliance 22.20 17.50 13 128702 564 79615109
Metastases to liver 22.08 17.50 9 128706 28305 79587368
Joint stiffness 22.06 17.50 20 128695 40810 79574863
Rash erythematous 22.06 17.50 37 128678 57732 79557941
Conjunctivitis 22.05 17.50 7 128708 25708 79589965
Balloon atrial septostomy 21.83 17.50 8 128707 114 79615559
Medical device site odour 21.72 17.50 4 128711 0 79615673
Impaired work ability 21.69 17.50 3 128712 19678 79595995
Obstructive airways disorder 21.47 17.50 12 128703 31447 79584226
Poisoning 21.46 17.50 7 128708 25265 79590408
Pulmonary pain 21.39 17.50 31 128684 4442 79611231
Paranoia 21.33 17.50 3 128712 19429 79596244
Colitis ulcerative 21.30 17.50 15 128700 34727 79580946
Weight decreased 21.27 17.50 736 127979 354462 79261211
Vasodilatation 21.25 17.50 26 128689 3165 79612508
Supraventricular tachycardia 21.18 17.50 79 128636 21191 79594482
Multiple sclerosis 21.10 17.50 5 128710 22277 79593396
Cardiomyopathy 21.09 17.50 10 128705 28764 79586909
Right atrial pressure increased 21.02 17.50 10 128705 282 79615391
Oral herpes 20.97 17.50 9 128706 27445 79588228
Jugular vein distension 20.85 17.50 18 128697 1452 79614221
Mechanical ventilation 20.85 17.50 24 128691 2740 79612933
Cardiac discomfort 20.80 17.50 17 128698 1271 79614402
Rehabilitation therapy 20.78 17.50 20 128695 1857 79613816
Cerebrovascular accident 20.71 17.50 156 128559 155136 79460537
Speech disorder 20.67 17.50 35 128680 54410 79561263
Nephropathy toxic 20.53 17.50 4 128711 20415 79595258
Blood calcium decreased 20.50 17.50 13 128702 31806 79583867
Cardiac pacemaker insertion 20.42 17.50 35 128680 5787 79609886
Suture related complication 20.42 17.50 10 128705 301 79615372
Immunodeficiency 20.39 17.50 5 128710 21763 79593910
Patient-device incompatibility 20.38 17.50 8 128707 139 79615534
Withdrawal syndrome 20.20 17.50 9 128706 26845 79588828
Head injury 20.19 17.50 116 128599 37253 79578420
Cor pulmonale chronic 20.18 17.50 10 128705 309 79615364
White blood cell count increased 20.09 17.50 58 128657 74575 79541098
Transplant 19.95 17.50 15 128700 993 79614680
Hip arthroplasty 19.94 17.50 17 128698 35739 79579934
Lip swelling 19.86 17.50 22 128693 40889 79574784
Ear congestion 19.79 17.50 24 128691 2895 79612778
Application site hypersensitivity 19.74 17.50 10 128705 324 79615349
Hypoalbuminaemia 19.74 17.50 5 128710 21292 79594381
Infusion site bruising 19.57 17.50 24 128691 2928 79612745
Heart rate decreased 19.40 17.50 54 128661 70262 79545411
Atrial septal defect repair 19.40 17.50 11 128704 449 79615224
Critical illness 19.38 17.50 10 128705 337 79615336
Aspiration pleural cavity 19.37 17.50 18 128697 1599 79614074
Sleep study 19.34 17.50 5 128710 19 79615654
Faeces soft 19.31 17.50 42 128673 8281 79607392
Adrenal insufficiency 19.25 17.50 11 128704 28476 79587197
Cataract 19.23 17.50 45 128670 62075 79553598
Suture rupture 19.12 17.50 12 128703 591 79615082
Hernia repair 19.07 17.50 20 128695 2058 79613615
Hypertensive crisis 19.01 17.50 5 128710 20765 79594908
Tremor 19.01 17.50 179 128536 169904 79445769
Catheter site cellulitis 18.90 17.50 11 128704 472 79615201
Blood urea increased 18.86 17.50 31 128684 48759 79566914
Disseminated intravascular coagulation 18.84 17.50 18 128697 35824 79579849
Injection site cellulitis 18.80 17.50 18 128697 1660 79614013
Mydriasis 18.73 17.50 3 128712 17640 79598033
Bone disorder 18.68 17.50 4 128711 19109 79596564
Fracture 18.58 17.50 6 128709 21795 79593878
Medical device site haemorrhage 18.52 17.50 8 128707 179 79615494
Myocardial ischaemia 18.51 17.50 9 128706 25510 79590163
Abdominal discomfort 18.27 17.50 532 128183 250195 79365478
Coordination abnormal 18.25 17.50 3 128712 17309 79598364
Immunoglobulin therapy 18.07 17.50 4 128711 6 79615667
Glomerular filtration rate decreased 18.06 17.50 7 128708 22695 79592978
No adverse event 18.06 17.50 20 128695 37172 79578501
Echocardiogram abnormal 17.91 17.50 20 128695 2208 79613465
Renal tubular necrosis 17.90 17.50 9 128706 25030 79590643
Metapneumovirus infection 17.87 17.50 18 128697 1766 79613907
Photosensitivity reaction 17.68 17.50 6 128709 21121 79594552
Aphthous ulcer 17.64 17.50 3 128712 16886 79598787
Dysentery 17.62 17.50 15 128700 1187 79614486

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC B01AC21 BLOOD AND BLOOD FORMING ORGANS
ANTITHROMBOTIC AGENTS
ANTITHROMBOTIC AGENTS
Platelet aggregation inhibitors excl. heparin
FDA CS M0017817 Prostaglandins I
FDA PE N0000009909 Vasodilation
FDA EPC N0000175416 Prostacycline Vasodilator
MeSH PA D000959 Antihypertensive Agents
MeSH PA D002317 Cardiovascular Agents
CHEBI has role CHEBI:35554 cardiovascular agent
CHEBI has role CHEBI:35620 vasodilator agents
CHEBI has role CHEBI:35674 antihypertensive drugs
CHEBI has role CHEBI:50427 platelet aggregation inhibitors
CHEBI has role CHEBI:55347 vitamin K antagonists
CHEBI has role CHEBI:85234 human blood serum metabolites

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

DiseaseRelationSNOMED_IDDOID
Pulmonary arterial hypertension indication 11399002
Thromboembolic pulmonary hypertension indication 233947005
Disorder of lung contraindication 19829001 DOID:850
Low blood pressure contraindication 45007003
Blood coagulation disorder contraindication 64779008 DOID:1247
Kidney disease contraindication 90708001 DOID:557
Disease of liver contraindication 235856003 DOID:409




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 3.4 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
10MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 9199908 May 24, 2024 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE WATER FOR INJECTION OR 0.9% SODIUM CHLORIDE INJECTION PRIOR TO ADMINISTRATION
1MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 9199908 May 24, 2024 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE WATER FOR INJECTION OR 0.9% SODIUM CHLORIDE INJECTION PRIOR TO ADMINISTRATION
2.5MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 9199908 May 24, 2024 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE WATER FOR INJECTION OR 0.9% SODIUM CHLORIDE INJECTION PRIOR TO ADMINISTRATION
20MG/ML REMODULIN UNITED THERAP N021272 July 30, 2021 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 9199908 May 24, 2024 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE WATER FOR INJECTION OR 0.9% SODIUM CHLORIDE INJECTION PRIOR TO ADMINISTRATION
5MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 9199908 May 24, 2024 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE WATER FOR INJECTION OR 0.9% SODIUM CHLORIDE INJECTION PRIOR TO ADMINISTRATION
EQ 0.125MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL 9278901 May 24, 2024 USE OF ORENITRAM FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1).
EQ 0.25MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL 9278901 May 24, 2024 USE OF ORENITRAM FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1).
EQ 1MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL 9278901 May 24, 2024 USE OF ORENITRAM FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1).
EQ 2.5MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL 9278901 May 24, 2024 USE OF ORENITRAM FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1).
EQ 5MG BASE ORENITRAM UNITED THERAP N203496 Oct. 7, 2016 RX TABLET, EXTENDED RELEASE ORAL 9278901 May 24, 2024 USE OF ORENITRAM FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1).
EQ 0.125MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL 7544713 July 14, 2024 USE OF ORENITRAM FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1).
EQ 0.25MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL 7544713 July 14, 2024 USE OF ORENITRAM FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1).
EQ 1MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL 7544713 July 14, 2024 USE OF ORENITRAM FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1).
EQ 2.5MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL 7544713 July 14, 2024 USE OF ORENITRAM FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1).
EQ 5MG BASE ORENITRAM UNITED THERAP N203496 Oct. 7, 2016 RX TABLET, EXTENDED RELEASE ORAL 7544713 July 14, 2024 USE OF ORENITRAM FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1).
10MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 10695308 Dec. 16, 2024 A METHOD OF TREATING A HUMAN PATIENT SUFFERING FROM PULMONARY HYPERTENSION
10MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 9713599 Dec. 16, 2024 A METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING PARENTERALLY ADMINISTERING A FORMULATION COMPRISING A) 0.1 TO 5% W/V OF TREPROSTINIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND B) A CITRATE BUFFER
1MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 10695308 Dec. 16, 2024 A METHOD OF TREATING A HUMAN PATIENT SUFFERING FROM PULMONARY HYPERTENSION
1MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 9713599 Dec. 16, 2024 A METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING PARENTERALLY ADMINISTERING A FORMULATION COMPRISING A) 0.1 TO 5% W/V OF TREPROSTINIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND B) A CITRATE BUFFER
2.5MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 10695308 Dec. 16, 2024 A METHOD OF TREATING A HUMAN PATIENT SUFFERING FROM PULMONARY HYPERTENSION
2.5MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 9713599 Dec. 16, 2024 A METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING PARENTERALLY ADMINISTERING A FORMULATION COMPRISING A) 0.1 TO 5% W/V OF TREPROSTINIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND B) A CITRATE BUFFER
20MG/ML REMODULIN UNITED THERAP N021272 July 30, 2021 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 10695308 Dec. 16, 2024 A METHOD OF TREATING A HUMAN PATIENT SUFFERING FROM PULMONARY HYPERTENSION
20MG/ML REMODULIN UNITED THERAP N021272 July 30, 2021 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 9713599 Dec. 16, 2024 A METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING PARENTERALLY ADMINISTERING A FORMULATION COMPRISING A) 0.1 TO 5% W/V OF TREPROSTINIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND B) A CITRATE BUFFER
5MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 10695308 Dec. 16, 2024 A METHOD OF TREATING A HUMAN PATIENT SUFFERING FROM PULMONARY HYPERTENSION
5MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 9713599 Dec. 16, 2024 A METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING PARENTERALLY ADMINISTERING A FORMULATION COMPRISING A) 0.1 TO 5% W/V OF TREPROSTINIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND B) A CITRATE BUFFER
100MG/20ML (5MG/ML) REMODULIN UNITED THERAP N208276 July 30, 2018 DISCN SOLUTION INTRAVENOUS, SUBCUTANEOUS 9713599 Dec. 16, 2024 A METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING PARENTERALLY ADMINISTERING A FORMULATION COMPRISING A) 0.1 TO 5% W/V OF TREPROSTINIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND B) A CITRATE BUFFER
200MG/20ML (10MG/ML) REMODULIN UNITED THERAP N208276 July 30, 2018 DISCN SOLUTION INTRAVENOUS, SUBCUTANEOUS 9713599 Dec. 16, 2024 A METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING PARENTERALLY ADMINISTERING A FORMULATION COMPRISING A) 0.1 TO 5% W/V OF TREPROSTINIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND B) A CITRATE BUFFER
20MG/20ML (1MG/ML) REMODULIN UNITED THERAP N208276 July 30, 2018 DISCN SOLUTION INTRAVENOUS, SUBCUTANEOUS 9713599 Dec. 16, 2024 A METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING PARENTERALLY ADMINISTERING A FORMULATION COMPRISING A) 0.1 TO 5% W/V OF TREPROSTINIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND B) A CITRATE BUFFER
50MG/20ML (2.5MG/ML) REMODULIN UNITED THERAP N208276 July 30, 2018 DISCN SOLUTION INTRAVENOUS, SUBCUTANEOUS 9713599 Dec. 16, 2024 A METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING PARENTERALLY ADMINISTERING A FORMULATION COMPRISING A) 0.1 TO 5% W/V OF TREPROSTINIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND B) A CITRATE BUFFER
EQ 0.125MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL 9393203 April 27, 2026 METHOD OF TREATING PULMONARY HYPERTENSION BY ORALLY ADMINISTERING A FORMULATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF TREPROSTINIL
EQ 0.25MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL 9393203 April 27, 2026 METHOD OF TREATING PULMONARY HYPERTENSION BY ORALLY ADMINISTERING A FORMULATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF TREPROSTINIL
EQ 1MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL 9393203 April 27, 2026 METHOD OF TREATING PULMONARY HYPERTENSION BY ORALLY ADMINISTERING A FORMULATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF TREPROSTINIL
EQ 2.5MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL 9393203 April 27, 2026 METHOD OF TREATING PULMONARY HYPERTENSION BY ORALLY ADMINISTERING A FORMULATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF TREPROSTINIL
EQ 5MG BASE ORENITRAM UNITED THERAP N203496 Oct. 7, 2016 RX TABLET, EXTENDED RELEASE ORAL 9393203 April 27, 2026 METHOD OF TREATING PULMONARY HYPERTENSION BY ORALLY ADMINISTERING A FORMULATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF TREPROSTINIL
0.6MG/ML TYVASO UNITED THERAP N022387 July 30, 2009 RX SOLUTION INHALATION 10376525 May 14, 2027 METHOD OF TREATING PULMONARY HYPERTENSION BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE
0.6MG/ML TYVASO UNITED THERAP N022387 July 30, 2009 RX SOLUTION INHALATION 10716793 May 14, 2027 METHOD OF TREATING PULMONARY HYPERTENSION BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE
0.016MG/INH TYVASO DPI UNITED THERAP N214324 May 23, 2022 RX POWDER INHALATION 10716793 May 14, 2027 METHOD OF TREATING PULMONARY HYPERTENSION BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE
0.032MG/INH TYVASO DPI UNITED THERAP N214324 May 23, 2022 RX POWDER INHALATION 10716793 May 14, 2027 METHOD OF TREATING PULMONARY HYPERTENSION BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE
0.048MG/INH TYVASO DPI UNITED THERAP N214324 May 23, 2022 RX POWDER INHALATION 10716793 May 14, 2027 METHOD OF TREATING PULMONARY HYPERTENSION BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE
0.064MG/INH TYVASO DPI UNITED THERAP N214324 May 23, 2022 RX POWDER INHALATION 10716793 May 14, 2027 METHOD OF TREATING PULMONARY HYPERTENSION BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE
0.6MG/ML TYVASO UNITED THERAP N022387 July 30, 2009 RX SOLUTION INHALATION 9358240 May 5, 2028 METHOD OF TREATING PULMONARY HYPERTENSION BY ADMINISTERING TREPROSTINIL OR A SALT THEREOF BY INHALATION USING A DEVICE
10MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 8653137 Sept. 5, 2028 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
10MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 8658694 Sept. 5, 2028 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
1MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 8653137 Sept. 5, 2028 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
1MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 8658694 Sept. 5, 2028 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
2.5MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 8653137 Sept. 5, 2028 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
2.5MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 8658694 Sept. 5, 2028 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
20MG/ML REMODULIN UNITED THERAP N021272 July 30, 2021 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 8653137 Sept. 5, 2028 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
20MG/ML REMODULIN UNITED THERAP N021272 July 30, 2021 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 8658694 Sept. 5, 2028 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
5MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 8653137 Sept. 5, 2028 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
5MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 8658694 Sept. 5, 2028 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
10MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 7999007 March 29, 2029 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
1MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 7999007 March 29, 2029 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
2.5MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 7999007 March 29, 2029 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
20MG/ML REMODULIN UNITED THERAP N021272 July 30, 2021 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 7999007 March 29, 2029 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
5MG/ML REMODULIN UNITED THERAP N021272 May 21, 2002 RX INJECTABLE IV (INFUSION), SUBCUTANEOUS 7999007 March 29, 2029 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
EQ 0.125MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL 8747897 Aug. 11, 2031 A METHOD OF ORAL DELIVERY OF TREPROSTINIL COMPRISING ADMINISTERING AN ORAL OSMOTIC PHARMACEUTICAL DOSAGE FORM
EQ 0.125MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL 8747897 Aug. 11, 2031 A METHOD OF TREATING PULMONARY HYPERTENSION AND PULMONARY ARTERIAL HYPERTENSION BY ADMINISTERING AN ORAL OSMOTIC PHARMACEUTICAL DOSAGE FORM
EQ 0.25MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL 8747897 Aug. 11, 2031 A METHOD OF ORAL DELIVERY OF TREPROSTINIL COMPRISING ADMINISTERING AN ORAL OSMOTIC PHARMACEUTICAL DOSAGE FORM
EQ 0.25MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL 8747897 Aug. 11, 2031 A METHOD OF TREATING PULMONARY HYPERTENSION AND PULMONARY ARTERIAL HYPERTENSION BY ADMINISTERING AN ORAL OSMOTIC PHARMACEUTICAL DOSAGE FORM
EQ 1MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL 8747897 Aug. 11, 2031 A METHOD OF ORAL DELIVERY OF TREPROSTINIL COMPRISING ADMINISTERING AN ORAL OSMOTIC PHARMACEUTICAL DOSAGE FORM
EQ 1MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL 8747897 Aug. 11, 2031 A METHOD OF TREATING PULMONARY HYPERTENSION AND PULMONARY ARTERIAL HYPERTENSION BY ADMINISTERING AN ORAL OSMOTIC PHARMACEUTICAL DOSAGE FORM
EQ 2.5MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL 8747897 Aug. 11, 2031 A METHOD OF ORAL DELIVERY OF TREPROSTINIL COMPRISING ADMINISTERING AN ORAL OSMOTIC PHARMACEUTICAL DOSAGE FORM
EQ 2.5MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL 8747897 Aug. 11, 2031 A METHOD OF TREATING PULMONARY HYPERTENSION AND PULMONARY ARTERIAL HYPERTENSION BY ADMINISTERING AN ORAL OSMOTIC PHARMACEUTICAL DOSAGE FORM
EQ 5MG BASE ORENITRAM UNITED THERAP N203496 Oct. 7, 2016 RX TABLET, EXTENDED RELEASE ORAL 8747897 Aug. 11, 2031 A METHOD OF ORAL DELIVERY OF TREPROSTINIL COMPRISING ADMINISTERING AN ORAL OSMOTIC PHARMACEUTICAL DOSAGE FORM
EQ 5MG BASE ORENITRAM UNITED THERAP N203496 Oct. 7, 2016 RX TABLET, EXTENDED RELEASE ORAL 8747897 Aug. 11, 2031 A METHOD OF TREATING PULMONARY HYPERTENSION AND PULMONARY ARTERIAL HYPERTENSION BY ADMINISTERING AN ORAL OSMOTIC PHARMACEUTICAL DOSAGE FORM

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
0.6MG/ML TYVASO UNITED THERAP N022387 July 30, 2009 RX SOLUTION INHALATION March 31, 2024 INDICATION FOR THE TREATMENT OF PULMONARY HYPERTENSION ASSOCIATED WITH INTERSTITIAL LUNG DISEASE TO IMPROVE EXERCISE ABILITY
EQ 0.125MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL Oct. 18, 2026 INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO DELAY DISEASE PROGRESSION
EQ 0.25MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL Oct. 18, 2026 INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO DELAY DISEASE PROGRESSION
EQ 1MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL Oct. 18, 2026 INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO DELAY DISEASE PROGRESSION
EQ 2.5MG BASE ORENITRAM UNITED THERAP N203496 Dec. 20, 2013 RX TABLET, EXTENDED RELEASE ORAL Oct. 18, 2026 INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO DELAY DISEASE PROGRESSION
EQ 5MG BASE ORENITRAM UNITED THERAP N203496 Oct. 7, 2016 RX TABLET, EXTENDED RELEASE ORAL Oct. 18, 2026 INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO DELAY DISEASE PROGRESSION

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Prostacyclin receptor GPCR AGONIST EC50 8.72 IUPHAR CHEMBL
Prostaglandin E2 receptor EP1 subtype GPCR AGONIST Ki 6.70 IUPHAR
Prostaglandin E2 receptor EP3 subtype GPCR AGONIST Ki 5.60 IUPHAR
Prostaglandin E2 receptor EP2 subtype GPCR AGONIST Ki 8.40 IUPHAR
Prostaglandin E2 receptor EP4 subtype GPCR AGONIST EC50 6.70 IUPHAR
Prostaglandin D2 receptor GPCR AGONIST Ki 8.40 IUPHAR

External reference:

IDSource
4021349 VUID
N0000148769 NUI
D06213 KEGG_DRUG
289480-64-4 SECONDARY_CAS_RN
4021349 VANDF
C1145760 UMLSCUI
CHEBI:50861 CHEBI
CHEMBL1237119 ChEMBL_ID
DB00374 DRUGBANK_ID
C427248 MESH_SUPPLEMENTAL_RECORD_UI
6918140 PUBCHEM_CID
5820 IUPHAR_LIGAND_ID
C054809 MESH_SUPPLEMENTAL_RECORD_UI
8170 INN_ID
830354-48-8 SECONDARY_CAS_RN
RUM6K67ESG UNII
1927409 RXNORM
16706 MMSL
26646 MMSL
30181 MMSL
79759 MMSL
d04802 MMSL
009648 NDDF
009649 NDDF
015333 NDDF
385681001 SNOMEDCT_US
385682008 SNOMEDCT_US
443570007 SNOMEDCT_US
CHEMBL2107815 ChEMBL_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 0703-0666 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 26 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 0703-0666 INJECTION, SOLUTION 20 mg INTRAVENOUS ANDA 26 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 0703-0676 INJECTION, SOLUTION 50 mg INTRAVENOUS ANDA 26 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 0703-0676 INJECTION, SOLUTION 50 mg INTRAVENOUS ANDA 26 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 0703-0686 INJECTION, SOLUTION 100 mg INTRAVENOUS ANDA 26 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 0703-0686 INJECTION, SOLUTION 100 mg INTRAVENOUS ANDA 26 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 0703-0696 INJECTION, SOLUTION 200 mg INTRAVENOUS ANDA 26 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 0703-0696 INJECTION, SOLUTION 200 mg INTRAVENOUS ANDA 26 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 0781-3420 INJECTION 20 mg SUBCUTANEOUS ANDA 26 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 0781-3420 INJECTION 20 mg SUBCUTANEOUS ANDA 26 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 0781-3420 INJECTION 20 mg SUBCUTANEOUS ANDA 26 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 0781-3425 INJECTION 50 mg SUBCUTANEOUS ANDA 26 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 0781-3425 INJECTION 50 mg SUBCUTANEOUS ANDA 26 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 0781-3425 INJECTION 50 mg SUBCUTANEOUS ANDA 26 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 0781-3427 INJECTION 100 mg SUBCUTANEOUS ANDA 26 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 0781-3427 INJECTION 100 mg SUBCUTANEOUS ANDA 26 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 0781-3427 INJECTION 100 mg SUBCUTANEOUS ANDA 26 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 0781-3430 INJECTION 200 mg SUBCUTANEOUS ANDA 26 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 0781-3430 INJECTION 200 mg SUBCUTANEOUS ANDA 26 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 0781-3430 INJECTION 200 mg SUBCUTANEOUS ANDA 26 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 42023-206 INJECTION, SOLUTION 1 mg INTRAVENOUS ANDA 26 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 42023-206 INJECTION, SOLUTION 1 mg INTRAVENOUS ANDA 26 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 42023-207 INJECTION, SOLUTION 2.50 mg INTRAVENOUS ANDA 26 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 42023-207 INJECTION, SOLUTION 2.50 mg INTRAVENOUS ANDA 26 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 42023-208 INJECTION, SOLUTION 5 mg INTRAVENOUS ANDA 26 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 42023-208 INJECTION, SOLUTION 5 mg INTRAVENOUS ANDA 26 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 42023-209 INJECTION, SOLUTION 10 mg INTRAVENOUS ANDA 26 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 42023-209 INJECTION, SOLUTION 10 mg INTRAVENOUS ANDA 26 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 43598-646 INJECTION, SOLUTION 50 mg SUBCUTANEOUS ANDA 27 sections
Treprostinil HUMAN PRESCRIPTION DRUG LABEL 1 43598-647 INJECTION, SOLUTION 100 mg SUBCUTANEOUS ANDA 27 sections