Stem definition | Drug id | CAS RN |
---|---|---|
prostaglandins | 2720 | 81846-19-7 |
Dose | Unit | Route |
---|---|---|
4.30 | mg | P |
Property | Value | Reference |
---|---|---|
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 |
Date | Agency | Company | Orphan |
---|---|---|---|
April 3, 2020 | EMA | SciPharm Sarl | |
May 21, 2002 | FDA | UNITED THERAP |
MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
---|---|---|---|---|---|---|
Pulmonary arterial hypertension | 3384.31 | 18.02 | 1474 | 110814 | 25648 | 53211130 |
Dyspnoea | 2761.43 | 18.02 | 4617 | 107671 | 581615 | 52655163 |
Infusion site pain | 2673.77 | 18.02 | 987 | 111301 | 10846 | 53225932 |
Fluid retention | 1903.91 | 18.02 | 1269 | 111019 | 53132 | 53183646 |
Headache | 1457.54 | 18.02 | 3363 | 108925 | 533458 | 52703320 |
Right ventricular failure | 1371.91 | 18.02 | 682 | 111606 | 16161 | 53220617 |
Infusion site erythema | 1323.31 | 18.02 | 547 | 111741 | 8275 | 53228503 |
Fluid overload | 1305.46 | 18.02 | 782 | 111506 | 27049 | 53209729 |
Pulmonary hypertension | 1268.48 | 18.02 | 855 | 111433 | 36415 | 53200363 |
Pain in jaw | 1212.52 | 18.02 | 860 | 111428 | 39809 | 53196969 |
Drug ineffective | 1049.57 | 18.02 | 224 | 112064 | 817021 | 52419757 |
Infusion site infection | 1027.95 | 18.02 | 294 | 111994 | 1283 | 53235495 |
Dyspnoea exertional | 982.87 | 18.02 | 860 | 111428 | 54140 | 53182638 |
Device related infection | 862.91 | 18.02 | 559 | 111729 | 22227 | 53214551 |
Infusion site swelling | 843.53 | 18.02 | 371 | 111917 | 6583 | 53230195 |
Vascular device infection | 737.77 | 18.02 | 296 | 111992 | 4125 | 53232653 |
Flushing | 690.44 | 18.02 | 796 | 111492 | 69804 | 53166974 |
Oxygen saturation decreased | 682.35 | 18.02 | 824 | 111464 | 75901 | 53160877 |
Diarrhoea | 658.62 | 18.02 | 2825 | 109463 | 622721 | 52614057 |
Death | 638.00 | 18.02 | 1920 | 110368 | 355312 | 52881466 |
Cough | 606.53 | 18.02 | 1530 | 110758 | 255363 | 52981415 |
Catheter site pain | 596.20 | 18.02 | 247 | 112041 | 3754 | 53233024 |
Dermatitis contact | 591.43 | 18.02 | 315 | 111973 | 8637 | 53228141 |
Infusion site discharge | 573.95 | 18.02 | 153 | 112135 | 481 | 53236297 |
Rheumatoid arthritis | 525.88 | 18.02 | 35 | 112253 | 314496 | 52922282 |
Dizziness | 519.39 | 18.02 | 1840 | 110448 | 370419 | 52866359 |
Infusion site haemorrhage | 509.10 | 18.02 | 200 | 112088 | 2627 | 53234151 |
Chest pain | 499.76 | 18.02 | 1181 | 111107 | 189004 | 53047774 |
Catheter site erythema | 490.67 | 18.02 | 218 | 112070 | 3964 | 53232814 |
Syncope | 445.78 | 18.02 | 825 | 111463 | 111168 | 53125610 |
Device dislocation | 445.43 | 18.02 | 381 | 111907 | 23216 | 53213562 |
Nasal congestion | 416.96 | 18.02 | 537 | 111751 | 52750 | 53184028 |
Therapy change | 391.24 | 18.02 | 204 | 112084 | 5348 | 53231430 |
Nausea | 385.23 | 18.02 | 2809 | 109479 | 753282 | 52483496 |
Toxicity to various agents | 351.00 | 18.02 | 30 | 112258 | 219568 | 53017210 |
Oedema | 349.03 | 18.02 | 589 | 111699 | 73757 | 53163021 |
Drug interaction | 322.16 | 18.02 | 41 | 112247 | 219288 | 53017490 |
Injection site discharge | 320.51 | 18.02 | 89 | 112199 | 340 | 53236438 |
Infusion site induration | 320.38 | 18.02 | 105 | 112183 | 779 | 53235999 |
Hospitalisation | 312.84 | 18.02 | 547 | 111741 | 70465 | 53166313 |
Hypoxia | 307.52 | 18.02 | 475 | 111813 | 55205 | 53181573 |
Device infusion issue | 296.47 | 18.02 | 108 | 112180 | 1135 | 53235643 |
Alopecia | 293.74 | 18.02 | 67 | 112221 | 234516 | 53002262 |
Hypotension | 292.92 | 18.02 | 1183 | 111105 | 252893 | 52983885 |
Infusion site warmth | 292.89 | 18.02 | 113 | 112175 | 1409 | 53235369 |
Lung transplant | 292.56 | 18.02 | 138 | 112150 | 2896 | 53233882 |
Oxygen consumption increased | 291.21 | 18.02 | 147 | 112141 | 3594 | 53233184 |
Pulmonary arterial pressure increased | 291.07 | 18.02 | 144 | 112144 | 3368 | 53233410 |
Neutropenia | 286.94 | 18.02 | 11 | 112277 | 159174 | 53077604 |
Rash | 285.09 | 18.02 | 312 | 111976 | 445879 | 52790899 |
Infusion related reaction | 283.80 | 18.02 | 10 | 112278 | 155947 | 53080831 |
Catheter site pruritus | 274.93 | 18.02 | 117 | 112171 | 1907 | 53234871 |
Drug hypersensitivity | 272.13 | 18.02 | 109 | 112179 | 265133 | 52971645 |
Palpitations | 269.84 | 18.02 | 637 | 111651 | 101711 | 53135067 |
Oedema peripheral | 269.44 | 18.02 | 881 | 111407 | 169906 | 53066872 |
Infusion site pruritus | 258.43 | 18.02 | 136 | 112152 | 3634 | 53233144 |
Device leakage | 257.05 | 18.02 | 160 | 112128 | 5920 | 53230858 |
Catheter site haemorrhage | 256.36 | 18.02 | 125 | 112163 | 2830 | 53233948 |
Catheter site discharge | 252.47 | 18.02 | 110 | 112178 | 1904 | 53234874 |
Catheter management | 245.49 | 18.02 | 120 | 112168 | 2732 | 53234046 |
Treatment failure | 241.73 | 18.02 | 6 | 112282 | 128397 | 53108381 |
Infusion site irritation | 241.04 | 18.02 | 78 | 112210 | 553 | 53236225 |
Arthropathy | 224.06 | 18.02 | 20 | 112268 | 141433 | 53095345 |
Catheter site infection | 222.82 | 18.02 | 136 | 112152 | 4856 | 53231922 |
Therapeutic product effect decreased | 222.01 | 18.02 | 10 | 112278 | 125645 | 53111133 |
Infusion site abscess | 213.15 | 18.02 | 55 | 112233 | 146 | 53236632 |
Catheter site swelling | 208.59 | 18.02 | 87 | 112201 | 1345 | 53235433 |
Throat irritation | 207.62 | 18.02 | 293 | 111995 | 31388 | 53205390 |
Scleroderma | 200.63 | 18.02 | 128 | 112160 | 4947 | 53231831 |
Febrile neutropenia | 197.13 | 18.02 | 5 | 112283 | 104931 | 53131847 |
Infusion site cellulitis | 194.52 | 18.02 | 50 | 112238 | 130 | 53236648 |
Maternal exposure during pregnancy | 189.68 | 18.02 | 47 | 112241 | 155592 | 53081186 |
Joint swelling | 185.65 | 18.02 | 134 | 112154 | 234504 | 53002274 |
Catheter placement | 183.28 | 18.02 | 89 | 112199 | 1996 | 53234782 |
Device related sepsis | 182.42 | 18.02 | 107 | 112181 | 3548 | 53233230 |
Malaise | 181.89 | 18.02 | 1331 | 110957 | 356286 | 52880492 |
Catheterisation cardiac | 180.94 | 18.02 | 112 | 112176 | 4102 | 53232676 |
Glossodynia | 180.43 | 18.02 | 7 | 112281 | 100284 | 53136494 |
Blood pressure decreased | 178.32 | 18.02 | 399 | 111889 | 61470 | 53175308 |
Therapeutic product effect incomplete | 177.85 | 18.02 | 3 | 112285 | 91781 | 53144997 |
Injection site infection | 171.60 | 18.02 | 80 | 112208 | 1633 | 53235145 |
Device issue | 168.87 | 18.02 | 218 | 112070 | 21440 | 53215338 |
Transfusion | 164.24 | 18.02 | 172 | 112116 | 13515 | 53223263 |
Hepatic enzyme increased | 161.96 | 18.02 | 34 | 112254 | 126161 | 53110617 |
Hypertension | 161.67 | 18.02 | 142 | 112146 | 225289 | 53011489 |
Feeling abnormal | 161.16 | 18.02 | 637 | 111651 | 134664 | 53102114 |
White blood cell count decreased | 160.86 | 18.02 | 33 | 112255 | 124442 | 53112336 |
Central venous catheterisation | 158.26 | 18.02 | 81 | 112207 | 2040 | 53234738 |
Dyspnoea at rest | 158.08 | 18.02 | 100 | 112188 | 3807 | 53232971 |
Epistaxis | 155.95 | 18.02 | 404 | 111884 | 68306 | 53168472 |
Haemoptysis | 155.84 | 18.02 | 240 | 112048 | 27799 | 53208979 |
Presyncope | 155.22 | 18.02 | 231 | 112057 | 25963 | 53210815 |
Hypersensitivity | 154.34 | 18.02 | 130 | 112158 | 210535 | 53026243 |
Stomatitis | 152.42 | 18.02 | 15 | 112273 | 98143 | 53138635 |
Infusion site discolouration | 150.04 | 18.02 | 55 | 112233 | 589 | 53236189 |
Abdominal distension | 142.52 | 18.02 | 430 | 111858 | 79360 | 53157418 |
Product use in unapproved indication | 140.54 | 18.02 | 32 | 112256 | 112257 | 53124521 |
Infusion site oedema | 140.44 | 18.02 | 50 | 112238 | 489 | 53236289 |
Exposure during pregnancy | 140.38 | 18.02 | 44 | 112244 | 124816 | 53111962 |
Product dose omission issue | 138.42 | 18.02 | 780 | 111508 | 190840 | 53045938 |
Chest discomfort | 138.31 | 18.02 | 493 | 111795 | 99202 | 53137576 |
Therapy non-responder | 137.30 | 18.02 | 313 | 111975 | 48807 | 53187971 |
Cardiac failure | 137.09 | 18.02 | 445 | 111843 | 85399 | 53151379 |
Leukopenia | 136.11 | 18.02 | 4 | 112284 | 73459 | 53163319 |
Psoriasis | 136.03 | 18.02 | 13 | 112275 | 87076 | 53149702 |
Complication associated with device | 135.99 | 18.02 | 169 | 112119 | 15996 | 53220782 |
Infusion site reaction | 134.54 | 18.02 | 73 | 112215 | 2077 | 53234701 |
Musculoskeletal stiffness | 134.25 | 18.02 | 46 | 112242 | 123322 | 53113456 |
Pain in extremity | 134.05 | 18.02 | 1042 | 111246 | 284008 | 52952770 |
Transplant evaluation | 131.65 | 18.02 | 58 | 112230 | 1032 | 53235746 |
Pulmonary oedema | 131.40 | 18.02 | 325 | 111963 | 53398 | 53183380 |
Device occlusion | 129.18 | 18.02 | 110 | 112178 | 6655 | 53230123 |
Unevaluable event | 124.84 | 18.02 | 303 | 111985 | 49195 | 53187583 |
Pneumonia | 123.40 | 18.02 | 1354 | 110934 | 405815 | 52830963 |
Catheter site rash | 121.00 | 18.02 | 50 | 112238 | 754 | 53236024 |
Ascites | 119.81 | 18.02 | 261 | 112027 | 39474 | 53197304 |
Dizziness postural | 119.60 | 18.02 | 105 | 112183 | 6620 | 53230158 |
Pruritus | 117.08 | 18.02 | 280 | 112008 | 293552 | 52943226 |
Infusion site inflammation | 115.67 | 18.02 | 36 | 112252 | 221 | 53236557 |
C-reactive protein increased | 114.85 | 18.02 | 7 | 112281 | 67879 | 53168899 |
Acute kidney injury | 113.43 | 18.02 | 227 | 112061 | 253641 | 52983137 |
Intentional overdose | 110.55 | 18.02 | 8 | 112280 | 67197 | 53169581 |
Pericardial effusion | 109.62 | 18.02 | 202 | 112086 | 27076 | 53209702 |
Heart rate increased | 109.01 | 18.02 | 401 | 111887 | 81914 | 53154864 |
Drug abuse | 107.22 | 18.02 | 8 | 112280 | 65518 | 53171260 |
Device alarm issue | 106.55 | 18.02 | 56 | 112232 | 1492 | 53235286 |
Acute respiratory failure | 105.48 | 18.02 | 215 | 112073 | 31043 | 53205735 |
Productive cough | 105.33 | 18.02 | 310 | 111978 | 56419 | 53180359 |
Infusion site rash | 104.29 | 18.02 | 50 | 112238 | 1089 | 53235689 |
Catheter site irritation | 103.25 | 18.02 | 39 | 112249 | 457 | 53236321 |
Vomiting | 101.83 | 18.02 | 1538 | 110750 | 495601 | 52741177 |
Depression | 100.81 | 18.02 | 143 | 112145 | 182909 | 53053869 |
Lower respiratory tract infection | 98.84 | 18.02 | 34 | 112254 | 90947 | 53145831 |
Pancytopenia | 98.75 | 18.02 | 34 | 112254 | 90894 | 53145884 |
Discomfort | 98.13 | 18.02 | 39 | 112249 | 95433 | 53141345 |
Catheter site inflammation | 96.12 | 18.02 | 41 | 112247 | 672 | 53236106 |
Arthralgia | 95.30 | 18.02 | 540 | 111748 | 439243 | 52797535 |
Electrocardiogram QT prolonged | 94.86 | 18.02 | 6 | 112282 | 56397 | 53180381 |
Osteoarthritis | 94.61 | 18.02 | 17 | 112271 | 70469 | 53166309 |
Blood cholesterol increased | 94.27 | 18.02 | 4 | 112284 | 52985 | 53183793 |
Urticaria | 93.28 | 18.02 | 89 | 112199 | 135796 | 53100982 |
Drug titration error | 92.29 | 18.02 | 39 | 112249 | 624 | 53236154 |
Infusion site vesicles | 91.94 | 18.02 | 34 | 112254 | 374 | 53236404 |
Wound | 89.92 | 18.02 | 40 | 112248 | 91517 | 53145261 |
Neutrophil count decreased | 89.77 | 18.02 | 3 | 112285 | 49095 | 53187683 |
Thrombosis in device | 89.32 | 18.02 | 64 | 112224 | 3001 | 53233777 |
Infusion site discomfort | 88.45 | 18.02 | 40 | 112248 | 759 | 53236019 |
Pulmonary veno-occlusive disease | 87.71 | 18.02 | 43 | 112245 | 985 | 53235793 |
Suicide attempt | 87.44 | 18.02 | 10 | 112278 | 58158 | 53178620 |
Walking distance test abnormal | 85.29 | 18.02 | 35 | 112253 | 518 | 53236260 |
Anaphylactic reaction | 85.28 | 18.02 | 11 | 112277 | 58315 | 53178463 |
Confusional state | 84.72 | 18.02 | 176 | 112112 | 194045 | 53042733 |
Respiratory failure | 84.64 | 18.02 | 427 | 111861 | 100085 | 53136693 |
Plasma cell myeloma | 83.90 | 18.02 | 4 | 112284 | 47870 | 53188908 |
Cardiac failure congestive | 83.77 | 18.02 | 402 | 111886 | 92355 | 53144423 |
Pericarditis | 83.33 | 18.02 | 17 | 112271 | 64389 | 53172389 |
Catheter site vesicles | 82.62 | 18.02 | 29 | 112259 | 271 | 53236507 |
Respiration abnormal | 80.29 | 18.02 | 77 | 112211 | 5441 | 53231337 |
Depressed level of consciousness | 80.22 | 18.02 | 10 | 112278 | 54418 | 53182360 |
Catheter site related reaction | 80.13 | 18.02 | 38 | 112250 | 807 | 53235971 |
Bradycardia | 79.91 | 18.02 | 25 | 112263 | 71031 | 53165747 |
Device connection issue | 77.61 | 18.02 | 36 | 112252 | 726 | 53236052 |
Infusion site nodule | 77.44 | 18.02 | 41 | 112247 | 1109 | 53235669 |
Purulent discharge | 76.88 | 18.02 | 72 | 112216 | 4938 | 53231840 |
Treatment noncompliance | 75.69 | 18.02 | 195 | 112093 | 32840 | 53203938 |
Device breakage | 75.62 | 18.02 | 102 | 112186 | 10465 | 53226313 |
Asthma | 75.22 | 18.02 | 71 | 112217 | 108901 | 53127877 |
Hyponatraemia | 74.69 | 18.02 | 71 | 112217 | 108536 | 53128242 |
Device use error | 73.03 | 18.02 | 73 | 112215 | 5426 | 53231352 |
Neuropathy peripheral | 72.68 | 18.02 | 66 | 112222 | 103121 | 53133657 |
Overdose | 72.27 | 18.02 | 72 | 112216 | 107664 | 53129114 |
Suicidal ideation | 72.27 | 18.02 | 19 | 112269 | 60492 | 53176286 |
Angioedema | 72.20 | 18.02 | 4 | 112284 | 42072 | 53194706 |
Device malfunction | 71.87 | 18.02 | 124 | 112164 | 15784 | 53220994 |
Blood pressure increased | 71.28 | 18.02 | 116 | 112172 | 140363 | 53096415 |
Disease progression | 70.92 | 18.02 | 411 | 111877 | 101509 | 53135269 |
Seasonal allergy | 70.18 | 18.02 | 120 | 112168 | 15165 | 53221613 |
Right ventricular dysfunction | 69.43 | 18.02 | 43 | 112245 | 1576 | 53235202 |
Pulmonary hypertensive crisis | 69.33 | 18.02 | 23 | 112265 | 178 | 53236600 |
Coma | 69.00 | 18.02 | 22 | 112266 | 61761 | 53175017 |
Systemic lupus erythematosus | 68 | 18.02 | 99 | 112189 | 125315 | 53111463 |
Thrombocytopenia | 67.21 | 18.02 | 118 | 112170 | 138609 | 53098169 |
Alanine aminotransferase increased | 66.76 | 18.02 | 61 | 112227 | 95034 | 53141744 |
Cognitive disorder | 66.55 | 18.02 | 8 | 112280 | 44770 | 53192008 |
Decreased appetite | 66.32 | 18.02 | 718 | 111570 | 214256 | 53022522 |
Device use issue | 64.77 | 18.02 | 44 | 112244 | 1892 | 53234886 |
Infusion site pustule | 63.99 | 18.02 | 15 | 112273 | 22 | 53236756 |
Infusion site extravasation | 63.73 | 18.02 | 72 | 112216 | 6160 | 53230618 |
Catheter site warmth | 63.60 | 18.02 | 22 | 112266 | 196 | 53236582 |
Impaired healing | 63.11 | 18.02 | 28 | 112260 | 64177 | 53172601 |
Device programming error | 62.48 | 18.02 | 17 | 112271 | 59 | 53236719 |
Intentional product misuse | 61.93 | 18.02 | 14 | 112274 | 49378 | 53187400 |
Vascular device occlusion | 61.41 | 18.02 | 15 | 112273 | 29 | 53236749 |
Deep vein thrombosis | 60.84 | 18.02 | 51 | 112237 | 82862 | 53153916 |
Wrong dose | 60.63 | 18.02 | 32 | 112256 | 860 | 53235918 |
Lactic acidosis | 59.67 | 18.02 | 5 | 112283 | 37248 | 53199530 |
Brain natriuretic peptide increased | 59.27 | 18.02 | 62 | 112226 | 4863 | 53231915 |
Cor pulmonale | 59.02 | 18.02 | 42 | 112246 | 1948 | 53234830 |
Oropharyngeal pain | 58.02 | 18.02 | 330 | 111958 | 80938 | 53155840 |
Emergency care | 57.29 | 18.02 | 31 | 112257 | 877 | 53235901 |
Inflammation | 56.03 | 18.02 | 25 | 112263 | 57111 | 53179667 |
Blood pressure systolic increased | 55.59 | 18.02 | 5 | 112283 | 35172 | 53201606 |
Injury | 55.43 | 18.02 | 19 | 112269 | 50952 | 53185826 |
Atrial flutter | 54.55 | 18.02 | 83 | 112205 | 9508 | 53227270 |
Internal haemorrhage | 54.53 | 18.02 | 58 | 112230 | 4638 | 53232140 |
Retching | 54.49 | 18.02 | 102 | 112186 | 13831 | 53222947 |
Type 2 diabetes mellitus | 54.37 | 18.02 | 3 | 112285 | 31667 | 53205111 |
Product quality issue | 54.08 | 18.02 | 7 | 112281 | 37016 | 53199762 |
Seizure | 53.42 | 18.02 | 121 | 112167 | 129388 | 53107390 |
Helicobacter infection | 53.35 | 18.02 | 9 | 112279 | 39060 | 53197718 |
Metabolic acidosis | 52.90 | 18.02 | 12 | 112276 | 42230 | 53194548 |
Pulmonary arterial pressure abnormal | 52.57 | 18.02 | 24 | 112264 | 466 | 53236312 |
Agitation | 52.44 | 18.02 | 29 | 112259 | 58597 | 53178181 |
Foetal exposure during pregnancy | 52.09 | 18.02 | 6 | 112282 | 34709 | 53202069 |
Hypoglycaemia | 51.63 | 18.02 | 30 | 112258 | 58983 | 53177795 |
Bone marrow failure | 51.25 | 18.02 | 3 | 112285 | 30112 | 53206666 |
Hypoaesthesia | 51.09 | 18.02 | 129 | 112159 | 132866 | 53103912 |
Osteoporosis | 51.07 | 18.02 | 17 | 112271 | 46443 | 53190335 |
Injection site bruising | 50.68 | 18.02 | 9 | 112279 | 37637 | 53199141 |
Diabetes mellitus | 50.67 | 18.02 | 25 | 112263 | 53874 | 53182904 |
Device expulsion | 50.64 | 18.02 | 3 | 112285 | 29810 | 53206968 |
Rash maculo-papular | 50.52 | 18.02 | 3 | 112285 | 29746 | 53207032 |
Sedation | 50.37 | 18.02 | 3 | 112285 | 29672 | 53207106 |
Dizziness exertional | 49.96 | 18.02 | 22 | 112266 | 391 | 53236387 |
Gamma-glutamyltransferase increased | 49.85 | 18.02 | 6 | 112282 | 33549 | 53203229 |
Device physical property issue | 49.30 | 18.02 | 36 | 112252 | 1739 | 53235039 |
Hepatic function abnormal | 49.29 | 18.02 | 9 | 112279 | 36890 | 53199888 |
Exercise tolerance decreased | 48.82 | 18.02 | 58 | 112230 | 5237 | 53231541 |
Localised oedema | 48.70 | 18.02 | 58 | 112230 | 5251 | 53231527 |
Generalised tonic-clonic seizure | 48.53 | 18.02 | 3 | 112285 | 28755 | 53208023 |
Subcutaneous drug absorption impaired | 48.53 | 18.02 | 12 | 112276 | 25 | 53236753 |
Device maintenance issue | 48.30 | 18.02 | 10 | 112278 | 4 | 53236774 |
Blood glucose increased | 48.19 | 18.02 | 55 | 112233 | 77306 | 53159472 |
Blister | 47.96 | 18.02 | 57 | 112231 | 78696 | 53158082 |
Pulmonary embolism | 47.95 | 18.02 | 106 | 112182 | 114336 | 53122442 |
Catheter site extravasation | 47.90 | 18.02 | 20 | 112268 | 310 | 53236468 |
Paracentesis | 47.52 | 18.02 | 28 | 112260 | 936 | 53235842 |
Respiratory tract congestion | 47.11 | 18.02 | 99 | 112189 | 14600 | 53222178 |
Hypocalcaemia | 46.82 | 18.02 | 4 | 112284 | 29333 | 53207445 |
Medical device site haemorrhage | 46.20 | 18.02 | 12 | 112276 | 33 | 53236745 |
Hyperkalaemia | 45.48 | 18.02 | 29 | 112259 | 54227 | 53182551 |
Injection site erosion | 45.39 | 18.02 | 13 | 112275 | 57 | 53236721 |
Multiple sclerosis | 45.32 | 18.02 | 3 | 112285 | 27150 | 53209628 |
Lung disorder | 45.01 | 18.02 | 210 | 112078 | 47669 | 53189109 |
Paraesthesia | 44.97 | 18.02 | 129 | 112159 | 127386 | 53109392 |
Somnolence | 44.83 | 18.02 | 191 | 112097 | 167543 | 53069235 |
Sinus congestion | 44.38 | 18.02 | 96 | 112192 | 14442 | 53222336 |
Red blood cell sedimentation rate increased | 44.30 | 18.02 | 4 | 112284 | 28053 | 53208725 |
Infusion site injury | 43.80 | 18.02 | 10 | 112278 | 12 | 53236766 |
Breast cancer | 43.31 | 18.02 | 25 | 112263 | 49333 | 53187445 |
Product administration interrupted | 43.30 | 18.02 | 25 | 112263 | 804 | 53235974 |
Hallucination | 42.17 | 18.02 | 31 | 112257 | 53807 | 53182971 |
Fibromyalgia | 42.10 | 18.02 | 20 | 112268 | 44055 | 53192723 |
Rales | 41.99 | 18.02 | 79 | 112209 | 10753 | 53226025 |
Oxygen therapy | 41.93 | 18.02 | 34 | 112254 | 1920 | 53234858 |
Therapeutic response decreased | 41.87 | 18.02 | 24 | 112264 | 47545 | 53189233 |
Dysphagia | 41.58 | 18.02 | 71 | 112217 | 84326 | 53152452 |
Wrong technique in product usage process | 41.54 | 18.02 | 39 | 112249 | 59993 | 53176785 |
Cardiac failure high output | 40.98 | 18.02 | 17 | 112271 | 259 | 53236519 |
Loss of personal independence in daily activities | 40.97 | 18.02 | 52 | 112236 | 69763 | 53167015 |
Delirium | 40.82 | 18.02 | 18 | 112270 | 41411 | 53195367 |
Hepatic steatosis | 40.78 | 18.02 | 4 | 112284 | 26255 | 53210523 |
Ill-defined disorder | 40.67 | 18.02 | 27 | 112261 | 49417 | 53187361 |
Acute right ventricular failure | 40.32 | 18.02 | 15 | 112273 | 168 | 53236610 |
Hyperglycaemia | 40.16 | 18.02 | 17 | 112271 | 40067 | 53196711 |
Terminal state | 40.07 | 18.02 | 36 | 112252 | 2340 | 53234438 |
Cerebral infarction | 39.93 | 18.02 | 3 | 112285 | 24441 | 53212337 |
Oxygen saturation abnormal | 39.87 | 18.02 | 39 | 112249 | 2823 | 53233955 |
Sleep disorder due to general medical condition, insomnia type | 39.75 | 18.02 | 3 | 112285 | 24346 | 53212432 |
Injection site reaction | 39.38 | 18.02 | 30 | 112258 | 51136 | 53185642 |
Femur fracture | 39.32 | 18.02 | 17 | 112271 | 39568 | 53197210 |
Bacteraemia | 38.98 | 18.02 | 95 | 112193 | 15454 | 53221324 |
Swollen tongue | 38.58 | 18.02 | 9 | 112279 | 31071 | 53205707 |
Agranulocytosis | 38.56 | 18.02 | 3 | 112285 | 23746 | 53213032 |
Blood creatinine increased | 38.51 | 18.02 | 72 | 112216 | 82590 | 53154188 |
Rhinovirus infection | 38.41 | 18.02 | 44 | 112244 | 3821 | 53232957 |
Drug intolerance | 38.31 | 18.02 | 264 | 112024 | 205229 | 53031549 |
Dyspepsia | 38.18 | 18.02 | 287 | 112001 | 77313 | 53159465 |
Basal cell carcinoma | 38.00 | 18.02 | 3 | 112285 | 23466 | 53213312 |
Aggression | 37.87 | 18.02 | 3 | 112285 | 23400 | 53213378 |
Mobility decreased | 37.72 | 18.02 | 64 | 112224 | 76207 | 53160571 |
Renal impairment | 37.56 | 18.02 | 74 | 112214 | 83244 | 53153534 |
Intentional product use issue | 37.56 | 18.02 | 59 | 112229 | 72435 | 53164343 |
Knee arthroplasty | 37.40 | 18.02 | 12 | 112276 | 33557 | 53203221 |
No adverse event | 37.23 | 18.02 | 18 | 112270 | 39247 | 53197531 |
Product prescribing error | 37.14 | 18.02 | 3 | 112285 | 23028 | 53213750 |
Psychotic disorder | 37.13 | 18.02 | 4 | 112284 | 24381 | 53212397 |
Infusion site scar | 36.55 | 18.02 | 15 | 112273 | 222 | 53236556 |
Pulmonary artery aneurysm | 36.05 | 18.02 | 10 | 112278 | 38 | 53236740 |
Chronic respiratory failure | 35.93 | 18.02 | 30 | 112258 | 1766 | 53235012 |
Sinus disorder | 35.62 | 18.02 | 103 | 112185 | 18551 | 53218227 |
Disturbance in attention | 35.39 | 18.02 | 14 | 112274 | 34369 | 53202409 |
Peripheral swelling | 35.37 | 18.02 | 620 | 111668 | 205488 | 53031290 |
Jaundice | 35.28 | 18.02 | 10 | 112278 | 30303 | 53206475 |
Drug-induced liver injury | 35.24 | 18.02 | 9 | 112279 | 29224 | 53207554 |
Emotional distress | 35.22 | 18.02 | 12 | 112276 | 32305 | 53204473 |
Infusion site haematoma | 35.10 | 18.02 | 15 | 112273 | 247 | 53236531 |
Cardiac ablation | 34.85 | 18.02 | 26 | 112262 | 1298 | 53235480 |
Abdominal pain upper | 34.81 | 18.02 | 517 | 111771 | 165774 | 53071004 |
Dialysis | 34.72 | 18.02 | 71 | 112217 | 10271 | 53226507 |
Drug dependence | 34.07 | 18.02 | 3 | 112285 | 21469 | 53215309 |
Disease complication | 34.00 | 18.02 | 38 | 112250 | 3212 | 53233566 |
Off label use | 33.85 | 18.02 | 747 | 111541 | 471465 | 52765313 |
Drug eruption | 33.78 | 18.02 | 6 | 112282 | 25088 | 53211690 |
Cardiac disorder | 33.69 | 18.02 | 191 | 112097 | 46775 | 53190003 |
Pancreatitis acute | 33.54 | 18.02 | 7 | 112281 | 26102 | 53210676 |
Weight decreased | 33.54 | 18.02 | 687 | 111601 | 234261 | 53002517 |
Injection site irritation | 33.27 | 18.02 | 44 | 112244 | 4428 | 53232350 |
Drug withdrawal syndrome | 33.07 | 18.02 | 9 | 112279 | 28013 | 53208765 |
Disease recurrence | 33.03 | 18.02 | 3 | 112285 | 20943 | 53215835 |
Infusion site dryness | 33.00 | 18.02 | 7 | 112281 | 4 | 53236774 |
Hepatitis | 32.96 | 18.02 | 15 | 112273 | 33879 | 53202899 |
Epilepsy | 32.91 | 18.02 | 7 | 112281 | 25760 | 53211018 |
Infusion site dermatitis | 32.91 | 18.02 | 8 | 112280 | 15 | 53236763 |
Endotracheal intubation | 32.86 | 18.02 | 32 | 112256 | 2304 | 53234474 |
Hepatotoxicity | 32.82 | 18.02 | 9 | 112279 | 27871 | 53208907 |
Platelet count decreased | 32.76 | 18.02 | 117 | 112171 | 107982 | 53128796 |
Drug ineffective for unapproved indication | 32.59 | 18.02 | 3 | 112285 | 20717 | 53216061 |
Catheter site scab | 32.53 | 18.02 | 13 | 112275 | 179 | 53236599 |
Gout | 32.42 | 18.02 | 77 | 112211 | 12322 | 53224456 |
Hypercalcaemia | 32.39 | 18.02 | 6 | 112282 | 24342 | 53212436 |
Respiratory distress | 32.26 | 18.02 | 149 | 112139 | 33678 | 53203100 |
Dysarthria | 32.24 | 18.02 | 23 | 112265 | 40545 | 53196233 |
Head discomfort | 32.12 | 18.02 | 74 | 112214 | 11610 | 53225168 |
Eczema | 32.08 | 18.02 | 6 | 112282 | 24176 | 53212602 |
Metastases to liver | 31.55 | 18.02 | 4 | 112284 | 21492 | 53215286 |
Pulmonary pain | 31.50 | 18.02 | 31 | 112257 | 2261 | 53234517 |
Balance disorder | 31.32 | 18.02 | 67 | 112221 | 73140 | 53163638 |
Clostridium difficile infection | 31.28 | 18.02 | 129 | 112159 | 27764 | 53209014 |
Catheter site erosion | 31.26 | 18.02 | 10 | 112278 | 68 | 53236710 |
Aspartate aminotransferase increased | 31.11 | 18.02 | 83 | 112205 | 83946 | 53152832 |
Bursitis | 31.11 | 18.02 | 5 | 112283 | 22487 | 53214291 |
Dyskinesia | 31.10 | 18.02 | 14 | 112274 | 31819 | 53204959 |
Arthritis | 31.00 | 18.02 | 88 | 112200 | 87210 | 53149568 |
Aphasia | 30.91 | 18.02 | 13 | 112275 | 30765 | 53206013 |
Skin lesion | 30.73 | 18.02 | 11 | 112277 | 28718 | 53208060 |
Irritable bowel syndrome | 30.60 | 18.02 | 28 | 112260 | 43604 | 53193174 |
Cerebrovascular accident | 30.45 | 18.02 | 116 | 112172 | 105058 | 53131720 |
Infusion site mass | 30.41 | 18.02 | 22 | 112266 | 1047 | 53235731 |
Sleep disorder | 30.41 | 18.02 | 48 | 112240 | 58822 | 53177956 |
Liver injury | 30.38 | 18.02 | 5 | 112283 | 22098 | 53214680 |
Hypokalaemia | 30.23 | 18.02 | 103 | 112185 | 96414 | 53140364 |
Hyperlipidaemia | 30.23 | 18.02 | 3 | 112285 | 19512 | 53217266 |
Ventilation perfusion mismatch | 30.21 | 18.02 | 13 | 112275 | 218 | 53236560 |
Right ventricular enlargement | 30.06 | 18.02 | 14 | 112274 | 285 | 53236493 |
Cardiac failure acute | 30.03 | 18.02 | 62 | 112226 | 9030 | 53227748 |
Bone disorder | 29.99 | 18.02 | 4 | 112284 | 20679 | 53216099 |
Incorrect drug administration rate | 29.91 | 18.02 | 31 | 112257 | 2405 | 53234373 |
Catheter site discolouration | 29.91 | 18.02 | 11 | 112277 | 119 | 53236659 |
Medical device change | 29.81 | 18.02 | 15 | 112273 | 364 | 53236414 |
Catheterisation cardiac abnormal | 29.73 | 18.02 | 13 | 112275 | 227 | 53236551 |
Sepsis | 29.38 | 18.02 | 452 | 111836 | 145977 | 53090801 |
Altered state of consciousness | 29.27 | 18.02 | 8 | 112280 | 24828 | 53211950 |
Catheter site nodule | 29.23 | 18.02 | 9 | 112279 | 53 | 53236725 |
Administration site odour | 29.14 | 18.02 | 8 | 112280 | 29 | 53236749 |
Hallucination, visual | 28.90 | 18.02 | 3 | 112285 | 18829 | 53217949 |
Bendopnoea | 28.84 | 18.02 | 7 | 112281 | 13 | 53236765 |
Medical device site odour | 28.57 | 18.02 | 6 | 112282 | 3 | 53236775 |
Diabetic ketoacidosis | 28.53 | 18.02 | 4 | 112284 | 19911 | 53216867 |
Extra dose administered | 28.48 | 18.02 | 45 | 112243 | 5325 | 53231453 |
Intentional medical device removal by patient | 28.45 | 18.02 | 13 | 112275 | 253 | 53236525 |
Viral infection | 28.43 | 18.02 | 139 | 112149 | 32156 | 53204622 |
Ejection fraction decreased | 28.40 | 18.02 | 4 | 112284 | 19844 | 53216934 |
Sickle cell anaemia with crisis | 28.36 | 18.02 | 41 | 112247 | 4486 | 53232292 |
Cardiac output increased | 28.30 | 18.02 | 11 | 112277 | 140 | 53236638 |
Dry eye | 28.17 | 18.02 | 18 | 112270 | 33626 | 53203152 |
Paranasal sinus hypersecretion | 28.00 | 18.02 | 35 | 112253 | 3331 | 53233447 |
Cardioversion | 27.94 | 18.02 | 22 | 112266 | 1191 | 53235587 |
Coronary artery disease | 27.85 | 18.02 | 18 | 112270 | 33419 | 53203359 |
Inappropriate schedule of product administration | 27.69 | 18.02 | 74 | 112214 | 74804 | 53161974 |
Nocturnal dyspnoea | 27.66 | 18.02 | 21 | 112267 | 1077 | 53235701 |
Heart and lung transplant | 27.37 | 18.02 | 10 | 112278 | 106 | 53236672 |
Fracture | 27.32 | 18.02 | 3 | 112285 | 18016 | 53218762 |
Hypervolaemia | 27.31 | 18.02 | 28 | 112260 | 2145 | 53234633 |
Injection site pustule | 27.20 | 18.02 | 9 | 112279 | 69 | 53236709 |
Product leakage | 27.10 | 18.02 | 16 | 112272 | 537 | 53236241 |
Urinary retention | 27.06 | 18.02 | 13 | 112275 | 28453 | 53208325 |
Muscular weakness | 26.96 | 18.02 | 115 | 112173 | 100877 | 53135901 |
Right ventricular systolic pressure increased | 26.86 | 18.02 | 16 | 112272 | 546 | 53236232 |
Hypothyroidism | 26.74 | 18.02 | 22 | 112266 | 36085 | 53200693 |
Blood potassium decreased | 26.72 | 18.02 | 161 | 112127 | 40299 | 53196479 |
Nasal dryness | 26.69 | 18.02 | 36 | 112252 | 3693 | 53233085 |
Migraine | 26.34 | 18.02 | 272 | 112016 | 80145 | 53156633 |
Sickle cell anaemia | 25.89 | 18.02 | 16 | 112272 | 584 | 53236194 |
Suture related complication | 25.86 | 18.02 | 11 | 112277 | 179 | 53236599 |
Cardio-respiratory arrest | 25.79 | 18.02 | 53 | 112235 | 58705 | 53178073 |
Transaminases increased | 25.40 | 18.02 | 16 | 112272 | 30116 | 53206662 |
Colitis | 25.37 | 18.02 | 30 | 112258 | 41522 | 53195256 |
Speech disorder | 25.33 | 18.02 | 27 | 112261 | 39154 | 53197624 |
Erythema | 25.29 | 18.02 | 210 | 112078 | 156759 | 53080019 |
Flatulence | 25.18 | 18.02 | 132 | 112156 | 31385 | 53205393 |
Application site pruritus | 25.16 | 18.02 | 37 | 112251 | 4112 | 53232666 |
Cataract | 25.12 | 18.02 | 41 | 112247 | 49579 | 53187199 |
Visual acuity reduced | 25.11 | 18.02 | 8 | 112280 | 22477 | 53214301 |
Incorrect route of product administration | 25.05 | 18.02 | 5 | 112283 | 19239 | 53217539 |
Gastrointestinal haemorrhage | 25.03 | 18.02 | 269 | 112019 | 80061 | 53156717 |
Eosinophilia | 24.90 | 18.02 | 7 | 112281 | 21328 | 53215450 |
Myalgia | 24.86 | 18.02 | 407 | 111881 | 133084 | 53103694 |
Catheter site dermatitis | 24.81 | 18.02 | 8 | 112280 | 56 | 53236722 |
Cor pulmonale chronic | 24.80 | 18.02 | 11 | 112277 | 199 | 53236579 |
Oral herpes | 24.62 | 18.02 | 7 | 112281 | 21172 | 53215606 |
Gait disturbance | 24.47 | 18.02 | 215 | 112073 | 158627 | 53078151 |
Echocardiogram abnormal | 24.40 | 18.02 | 20 | 112268 | 1147 | 53235631 |
Joint stiffness | 24.28 | 18.02 | 17 | 112271 | 30266 | 53206512 |
Diagnostic procedure | 24.26 | 18.02 | 9 | 112279 | 100 | 53236678 |
Liver transplant | 24.13 | 18.02 | 28 | 112260 | 2466 | 53234312 |
Medical procedure | 24.04 | 18.02 | 12 | 112276 | 286 | 53236492 |
Abnormal behaviour | 24.03 | 18.02 | 8 | 112280 | 21858 | 53214920 |
Diuretic therapy | 23.94 | 18.02 | 9 | 112279 | 104 | 53236674 |
Diplopia | 23.89 | 18.02 | 7 | 112281 | 20758 | 53216020 |
Transplant | 23.89 | 18.02 | 16 | 112272 | 672 | 53236106 |
Product communication issue | 23.86 | 18.02 | 12 | 112276 | 291 | 53236487 |
Asthenia | 23.85 | 18.02 | 916 | 111372 | 342674 | 52894104 |
Medication error | 23.58 | 18.02 | 25 | 112263 | 36340 | 53200438 |
Intracardiac pressure increased | 23.37 | 18.02 | 7 | 112281 | 37 | 53236741 |
Haemodynamic test abnormal | 23.37 | 18.02 | 7 | 112281 | 37 | 53236741 |
Skin exfoliation | 23.18 | 18.02 | 25 | 112263 | 36058 | 53200720 |
Platelet count increased | 23.06 | 18.02 | 3 | 112285 | 15804 | 53220974 |
Tendonitis | 23.03 | 18.02 | 4 | 112284 | 17002 | 53219776 |
Right ventricular dilatation | 22.98 | 18.02 | 18 | 112270 | 967 | 53235811 |
Pneumonia aspiration | 22.90 | 18.02 | 23 | 112265 | 34278 | 53202500 |
Urinary tract infection | 22.90 | 18.02 | 361 | 111927 | 239542 | 52997236 |
Full blood count decreased | 22.80 | 18.02 | 11 | 112277 | 24018 | 53212760 |
Contusion | 22.79 | 18.02 | 138 | 112150 | 110594 | 53126184 |
Sleep study | 22.71 | 18.02 | 6 | 112282 | 18 | 53236760 |
Exposure via skin contact | 22.69 | 18.02 | 10 | 112278 | 178 | 53236600 |
Decreased activity | 22.69 | 18.02 | 41 | 112247 | 5410 | 53231368 |
Joint range of motion decreased | 22.69 | 18.02 | 5 | 112283 | 17951 | 53218827 |
Acute myocardial infarction | 22.51 | 18.02 | 22 | 112266 | 33213 | 53203565 |
Acute hepatic failure | 22.50 | 18.02 | 4 | 112284 | 16716 | 53220062 |
Rhinorrhoea | 22.44 | 18.02 | 191 | 112097 | 53387 | 53183391 |
Hip arthroplasty | 21.87 | 18.02 | 16 | 112272 | 27846 | 53208932 |
Skin irritation | 21.85 | 18.02 | 52 | 112236 | 8332 | 53228446 |
Mood swings | 21.83 | 18.02 | 5 | 112283 | 17481 | 53219297 |
Vertigo | 21.83 | 18.02 | 54 | 112234 | 56027 | 53180751 |
Spinal osteoarthritis | 21.81 | 18.02 | 3 | 112285 | 15154 | 53221624 |
Ear congestion | 21.68 | 18.02 | 24 | 112264 | 2007 | 53234771 |
Hemiparesis | 21.68 | 18.02 | 9 | 112279 | 21466 | 53215312 |
Metapneumovirus infection | 21.66 | 18.02 | 16 | 112272 | 787 | 53235991 |
Administration site infection | 21.47 | 18.02 | 5 | 112283 | 7 | 53236771 |
Malabsorption from injection site | 21.39 | 18.02 | 6 | 112282 | 24 | 53236754 |
Herpes zoster | 21.19 | 18.02 | 82 | 112206 | 73937 | 53162841 |
Leukocytosis | 21.03 | 18.02 | 13 | 112275 | 24721 | 53212057 |
Catheter removal | 21.01 | 18.02 | 12 | 112276 | 378 | 53236400 |
Dysentery | 20.98 | 18.02 | 16 | 112272 | 826 | 53235952 |
Product label confusion | 20.50 | 18.02 | 13 | 112275 | 497 | 53236281 |
Loss of consciousness | 20.44 | 18.02 | 346 | 111942 | 113866 | 53122912 |
Acne | 20.30 | 18.02 | 10 | 112278 | 21576 | 53215202 |
Haematuria | 20.16 | 18.02 | 18 | 112270 | 28371 | 53208407 |
Rash erythematous | 20.08 | 18.02 | 30 | 112258 | 37593 | 53199185 |
General physical health deterioration | 20.03 | 18.02 | 205 | 112083 | 146737 | 53090041 |
Encephalopathy | 19.99 | 18.02 | 29 | 112259 | 36779 | 53199999 |
Myocardial infarction | 19.83 | 18.02 | 125 | 112163 | 99229 | 53137549 |
Withdrawal syndrome | 19.63 | 18.02 | 8 | 112280 | 19293 | 53217485 |
Cardiac operation | 19.60 | 18.02 | 27 | 112261 | 2826 | 53233952 |
Therapeutic response unexpected | 19.55 | 18.02 | 6 | 112282 | 17264 | 53219514 |
Sinusitis | 19.50 | 18.02 | 244 | 112044 | 168320 | 53068458 |
Live birth | 19.42 | 18.02 | 4 | 112284 | 15055 | 53221723 |
Catheter site cellulitis | 19.32 | 18.02 | 10 | 112278 | 258 | 53236520 |
Photosensitivity reaction | 19.29 | 18.02 | 3 | 112285 | 13825 | 53222953 |
Cystitis | 19.28 | 18.02 | 44 | 112244 | 46944 | 53189834 |
Abdominal pain lower | 19.24 | 18.02 | 13 | 112275 | 23580 | 53213198 |
Cardiomyopathy | 19.23 | 18.02 | 6 | 112282 | 17082 | 53219696 |
Secretion discharge | 19.09 | 18.02 | 57 | 112231 | 10449 | 53226329 |
Peritonitis | 19.00 | 18.02 | 11 | 112277 | 21676 | 53215102 |
Vascular resistance pulmonary increased | 18.99 | 18.02 | 6 | 112282 | 39 | 53236739 |
Liver function test abnormal | 18.93 | 18.02 | 46 | 112242 | 48025 | 53188753 |
Portopulmonary hypertension | 18.93 | 18.02 | 8 | 112280 | 128 | 53236650 |
Infusion site thrombosis | 18.93 | 18.02 | 7 | 112281 | 77 | 53236701 |
Product substitution issue | 18.90 | 18.02 | 5 | 112283 | 15861 | 53220917 |
Faeces soft | 18.81 | 18.02 | 32 | 112256 | 4027 | 53232751 |
Cardiac pacemaker insertion | 18.78 | 18.02 | 31 | 112257 | 3806 | 53232972 |
Disseminated intravascular coagulation | 18.75 | 18.02 | 9 | 112279 | 19710 | 53217068 |
Carpal tunnel syndrome | 18.67 | 18.02 | 7 | 112281 | 17760 | 53219018 |
Balloon atrial septostomy | 18.53 | 18.02 | 7 | 112281 | 82 | 53236696 |
Obesity | 18.48 | 18.02 | 6 | 112282 | 16656 | 53220122 |
Myelodysplastic syndrome | 18.48 | 18.02 | 6 | 112282 | 16654 | 53220124 |
Pulmonary arterial pressure decreased | 18.46 | 18.02 | 7 | 112281 | 83 | 53236695 |
Infusion site cyst | 18.43 | 18.02 | 4 | 112284 | 3 | 53236775 |
Infusion site lymphadenopathy | 18.43 | 18.02 | 4 | 112284 | 3 | 53236775 |
Infusion site erosion | 18.43 | 18.02 | 4 | 112284 | 3 | 53236775 |
Hypertensive crisis | 18.41 | 18.02 | 4 | 112284 | 14502 | 53222276 |
Pain | 18.26 | 18.02 | 1033 | 111255 | 587365 | 52649413 |
Blood culture positive | 18.24 | 18.02 | 34 | 112254 | 4595 | 53232183 |
Pulmonary artery occlusion | 18.24 | 18.02 | 5 | 112283 | 18 | 53236760 |
Musculoskeletal disorder | 18.21 | 18.02 | 7 | 112281 | 17492 | 53219286 |
Influenza | 18.20 | 18.02 | 292 | 111996 | 95087 | 53141691 |
Diet noncompliance | 18.19 | 18.02 | 10 | 112278 | 292 | 53236486 |
Catheter site abscess | 18.13 | 18.02 | 6 | 112282 | 46 | 53236732 |
Pneumonitis | 18.12 | 18.02 | 23 | 112265 | 30865 | 53205913 |
Obstructive airways disorder | 18.09 | 18.02 | 7 | 112281 | 17422 | 53219356 |
Diabetes mellitus inadequate control | 18.05 | 18.02 | 4 | 112284 | 14306 | 53222472 |
Administration site discharge | 18.03 | 18.02 | 5 | 112283 | 19 | 53236759 |
MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
---|---|---|---|---|---|---|
Pulmonary arterial hypertension | 1396.22 | 23.32 | 481 | 32569 | 9340 | 32471136 |
Infusion site pain | 982.00 | 23.32 | 278 | 32772 | 2708 | 32477768 |
Dyspnoea | 945.50 | 23.32 | 1465 | 31585 | 360580 | 32119896 |
Fluid retention | 704.82 | 23.32 | 399 | 32651 | 26151 | 32454325 |
Right ventricular failure | 625.57 | 23.32 | 257 | 32793 | 8206 | 32472270 |
Pulmonary hypertension | 598.40 | 23.32 | 328 | 32722 | 20166 | 32460310 |
Headache | 569.20 | 23.32 | 837 | 32213 | 195360 | 32285116 |
Pain in jaw | 491.19 | 23.32 | 245 | 32805 | 12381 | 32468095 |
Infusion site erythema | 486.32 | 23.32 | 144 | 32906 | 1662 | 32478814 |
Fluid overload | 467.48 | 23.32 | 275 | 32775 | 19346 | 32461130 |
Oxygen saturation decreased | 361.78 | 23.32 | 336 | 32714 | 47763 | 32432713 |
Flushing | 332.80 | 23.32 | 266 | 32784 | 30861 | 32449615 |
Dyspnoea exertional | 290.60 | 23.32 | 271 | 32779 | 38690 | 32441786 |
Infusion site infection | 245.88 | 23.32 | 61 | 32989 | 334 | 32480142 |
Infusion site haemorrhage | 218.90 | 23.32 | 61 | 32989 | 556 | 32479920 |
Infusion site swelling | 199.96 | 23.32 | 74 | 32976 | 1770 | 32478706 |
Cough | 198.29 | 23.32 | 436 | 32614 | 138381 | 32342095 |
Diarrhoea | 198.24 | 23.32 | 812 | 32238 | 363990 | 32116486 |
Device related infection | 193.14 | 23.32 | 154 | 32896 | 17779 | 32462697 |
Device dislocation | 187.75 | 23.32 | 101 | 32949 | 5962 | 32474514 |
Vascular device infection | 186.52 | 23.32 | 77 | 32973 | 2483 | 32477993 |
Oxygen consumption increased | 186.45 | 23.32 | 65 | 32985 | 1301 | 32479175 |
Death | 182.78 | 23.32 | 819 | 32231 | 381698 | 32098778 |
Drug interaction | 178.42 | 23.32 | 11 | 33039 | 218174 | 32262302 |
Drug ineffective | 173.73 | 23.32 | 87 | 32963 | 383390 | 32097086 |
Therapy change | 165.65 | 23.32 | 73 | 32977 | 2772 | 32477704 |
Catheter site pain | 162.84 | 23.32 | 57 | 32993 | 1155 | 32479321 |
Oedema | 155.67 | 23.32 | 210 | 32840 | 44937 | 32435539 |
Toxicity to various agents | 155.00 | 23.32 | 6 | 33044 | 178035 | 32302441 |
Catheter site erythema | 153.85 | 23.32 | 55 | 32995 | 1188 | 32479288 |
Lung transplant | 145.76 | 23.32 | 60 | 32990 | 1920 | 32478556 |
Infusion site discharge | 143.22 | 23.32 | 31 | 33019 | 80 | 32480396 |
Dermatitis contact | 142.22 | 23.32 | 70 | 32980 | 3428 | 32477048 |
Pain in extremity | 131.18 | 23.32 | 338 | 32712 | 118563 | 32361913 |
Nasal congestion | 129.81 | 23.32 | 130 | 32920 | 20221 | 32460255 |
Hypoxia | 129.78 | 23.32 | 208 | 32842 | 51924 | 32428552 |
Nausea | 122.54 | 23.32 | 645 | 32405 | 320204 | 32160272 |
Dizziness | 122.35 | 23.32 | 478 | 32572 | 209140 | 32271336 |
Therapy non-responder | 120.39 | 23.32 | 157 | 32893 | 32497 | 32447979 |
Catheter management | 112.84 | 23.32 | 40 | 33010 | 842 | 32479634 |
Oedema peripheral | 112.33 | 23.32 | 311 | 32739 | 113780 | 32366696 |
Infusion site warmth | 108.62 | 23.32 | 25 | 33025 | 93 | 32480383 |
Syncope | 107.48 | 23.32 | 264 | 32786 | 89860 | 32390616 |
Throat irritation | 94.77 | 23.32 | 79 | 32971 | 9699 | 32470777 |
Infusion site cellulitis | 86.70 | 23.32 | 19 | 33031 | 53 | 32480423 |
Device infusion issue | 84.74 | 23.32 | 30 | 33020 | 629 | 32479847 |
Catheter site pruritus | 84.19 | 23.32 | 25 | 33025 | 291 | 32480185 |
Pulmonary arterial pressure increased | 84.09 | 23.32 | 35 | 33015 | 1152 | 32479324 |
Injection site discharge | 79.57 | 23.32 | 19 | 33031 | 86 | 32480390 |
Infusion site induration | 77.75 | 23.32 | 22 | 33028 | 213 | 32480263 |
Feeling abnormal | 77.34 | 23.32 | 182 | 32868 | 60241 | 32420235 |
Catheterisation cardiac | 76.92 | 23.32 | 40 | 33010 | 2201 | 32478275 |
Infusion site irritation | 76.66 | 23.32 | 20 | 33030 | 138 | 32480338 |
Pancytopenia | 76.29 | 23.32 | 4 | 33046 | 91231 | 32389245 |
Catheter site discharge | 76.22 | 23.32 | 27 | 33023 | 567 | 32479909 |
Hospitalisation | 75.61 | 23.32 | 159 | 32891 | 48812 | 32431664 |
Abdominal discomfort | 73.41 | 23.32 | 164 | 32886 | 52460 | 32428016 |
Catheter site rash | 71.30 | 23.32 | 20 | 33030 | 187 | 32480289 |
Injection site infection | 71.15 | 23.32 | 29 | 33021 | 904 | 32479572 |
Thrombocytopenia | 70.93 | 23.32 | 31 | 33019 | 148268 | 32332208 |
Catheter site swelling | 67.38 | 23.32 | 21 | 33029 | 291 | 32480185 |
Product use in unapproved indication | 66.59 | 23.32 | 6 | 33044 | 87198 | 32393278 |
Complication associated with device | 65.03 | 23.32 | 52 | 32998 | 6020 | 32474456 |
Peripheral swelling | 64.89 | 23.32 | 184 | 32866 | 68161 | 32412315 |
Acute kidney injury | 64.17 | 23.32 | 126 | 32924 | 293342 | 32187134 |
Infusion site discomfort | 62.69 | 23.32 | 16 | 33034 | 100 | 32480376 |
Chest pain | 62.65 | 23.32 | 271 | 32779 | 123866 | 32356610 |
Central venous catheterisation | 60.58 | 23.32 | 27 | 33023 | 1053 | 32479423 |
Transplant evaluation | 60.08 | 23.32 | 22 | 33028 | 510 | 32479966 |
Catheter placement | 59.90 | 23.32 | 24 | 33026 | 715 | 32479761 |
Hypotension | 59.29 | 23.32 | 399 | 32651 | 215711 | 32264765 |
Device leakage | 59.03 | 23.32 | 44 | 33006 | 4592 | 32475884 |
Catheter site infection | 58.76 | 23.32 | 36 | 33014 | 2718 | 32477758 |
Infusion site rash | 58.56 | 23.32 | 19 | 33031 | 302 | 32480174 |
Transfusion | 57.75 | 23.32 | 54 | 32996 | 7714 | 32472762 |
Abdominal distension | 57.64 | 23.32 | 147 | 32903 | 51148 | 32429328 |
Rhabdomyolysis | 56.06 | 23.32 | 3 | 33047 | 67262 | 32413214 |
Device issue | 55.10 | 23.32 | 56 | 32994 | 8856 | 32471620 |
Heart rate increased | 54.60 | 23.32 | 127 | 32923 | 41701 | 32438775 |
Infusion site inflammation | 54.36 | 23.32 | 12 | 33038 | 35 | 32480441 |
Ventilation perfusion mismatch | 53.88 | 23.32 | 13 | 33037 | 62 | 32480414 |
Infusion site abscess | 53.80 | 23.32 | 11 | 33039 | 19 | 32480457 |
Drug abuse | 52.81 | 23.32 | 9 | 33041 | 80234 | 32400242 |
Infusion site oedema | 52.40 | 23.32 | 15 | 33035 | 152 | 32480324 |
White blood cell count decreased | 50.47 | 23.32 | 15 | 33035 | 91183 | 32389293 |
Haemoptysis | 49.59 | 23.32 | 107 | 32943 | 33418 | 32447058 |
Productive cough | 49.45 | 23.32 | 108 | 32942 | 34008 | 32446468 |
Leukopenia | 49.12 | 23.32 | 3 | 33047 | 60119 | 32420357 |
Catheter site haemorrhage | 46.66 | 23.32 | 29 | 33021 | 2246 | 32478230 |
Catheterisation cardiac abnormal | 45.33 | 23.32 | 11 | 33039 | 54 | 32480422 |
Device breakage | 44.82 | 23.32 | 27 | 33023 | 1977 | 32478499 |
Infusion site scar | 44.60 | 23.32 | 9 | 33041 | 14 | 32480462 |
Hypertension | 44.52 | 23.32 | 41 | 33009 | 131709 | 32348767 |
Plasma cell myeloma | 43.87 | 23.32 | 4 | 33046 | 57610 | 32422866 |
Infusion site reaction | 41.67 | 23.32 | 19 | 33031 | 782 | 32479694 |
Weight increased | 41.66 | 23.32 | 182 | 32868 | 83481 | 32396995 |
Cardiac failure | 41.59 | 23.32 | 194 | 32856 | 91479 | 32388997 |
Myocardial infarction | 41.42 | 23.32 | 40 | 33010 | 125636 | 32354840 |
Infusion site pruritus | 41.40 | 23.32 | 18 | 33032 | 661 | 32479815 |
Product administration interrupted | 41.17 | 23.32 | 14 | 33036 | 259 | 32480217 |
Confusional state | 41.15 | 23.32 | 51 | 32999 | 143064 | 32337412 |
Malaise | 40.39 | 23.32 | 313 | 32737 | 176825 | 32303651 |
Exercise tolerance decreased | 40.22 | 23.32 | 35 | 33015 | 4553 | 32475923 |
Product dose omission issue | 39.38 | 23.32 | 207 | 32843 | 102368 | 32378108 |
Hallucination | 39.15 | 23.32 | 4 | 33046 | 52615 | 32427861 |
Infusion site vesicles | 38.99 | 23.32 | 12 | 33038 | 159 | 32480317 |
Walking distance test abnormal | 38.85 | 23.32 | 12 | 33038 | 161 | 32480315 |
Catheter site irritation | 38.11 | 23.32 | 11 | 33039 | 115 | 32480361 |
Device malfunction | 37.30 | 23.32 | 46 | 33004 | 8993 | 32471483 |
Right ventricular dysfunction | 37.26 | 23.32 | 19 | 33031 | 1003 | 32479473 |
Internal haemorrhage | 37.07 | 23.32 | 34 | 33016 | 4738 | 32475738 |
Drug titration error | 36.70 | 23.32 | 15 | 33035 | 471 | 32480005 |
Neutrophil count decreased | 36.64 | 23.32 | 3 | 33047 | 47136 | 32433340 |
Pulmonary arterial pressure abnormal | 36.62 | 23.32 | 12 | 33038 | 197 | 32480279 |
Respiratory failure | 36.25 | 23.32 | 209 | 32841 | 106973 | 32373503 |
Acute respiratory failure | 36.14 | 23.32 | 86 | 32964 | 28642 | 32451834 |
Device physical property issue | 35.60 | 23.32 | 17 | 33033 | 778 | 32479698 |
Anaemia | 35.53 | 23.32 | 113 | 32937 | 223511 | 32256965 |
Condition aggravated | 35.44 | 23.32 | 275 | 32775 | 155386 | 32325090 |
Neuropathy peripheral | 35.36 | 23.32 | 17 | 33033 | 76965 | 32403511 |
Palpitations | 35.24 | 23.32 | 98 | 32952 | 35871 | 32444605 |
Blood creatine phosphokinase increased | 35.05 | 23.32 | 3 | 33047 | 45473 | 32435003 |
Terminal state | 34.93 | 23.32 | 30 | 33020 | 3834 | 32476642 |
Respiration abnormal | 34.90 | 23.32 | 27 | 33023 | 2978 | 32477498 |
Device related sepsis | 34.15 | 23.32 | 25 | 33025 | 2538 | 32477938 |
Overdose | 33.25 | 23.32 | 24 | 33026 | 87053 | 32393423 |
Rash | 33.09 | 23.32 | 106 | 32944 | 209227 | 32271249 |
Psoriasis | 33.07 | 23.32 | 4 | 33046 | 46119 | 32434357 |
Chest discomfort | 32.82 | 23.32 | 119 | 32931 | 50111 | 32430365 |
C-reactive protein increased | 32.52 | 23.32 | 5 | 33045 | 48097 | 32432379 |
Ascites | 32.24 | 23.32 | 102 | 32948 | 40089 | 32440387 |
Device alarm issue | 31.93 | 23.32 | 16 | 33034 | 814 | 32479662 |
Haematuria | 30.57 | 23.32 | 6 | 33044 | 48355 | 32432121 |
Cor pulmonale | 30.25 | 23.32 | 15 | 33035 | 746 | 32479730 |
Hypoglycaemia | 29.98 | 23.32 | 9 | 33041 | 54373 | 32426103 |
Drug hypersensitivity | 29.67 | 23.32 | 19 | 33031 | 73381 | 32407095 |
Hepatic function abnormal | 29.56 | 23.32 | 5 | 33045 | 44835 | 32435641 |
Sickle cell anaemia with crisis | 29.34 | 23.32 | 23 | 33027 | 2586 | 32477890 |
Cardiac ablation | 29.33 | 23.32 | 14 | 33036 | 640 | 32479836 |
Rheumatoid arthritis | 29.29 | 23.32 | 5 | 33045 | 44539 | 32435937 |
Blood pressure decreased | 29.23 | 23.32 | 116 | 32934 | 50964 | 32429512 |
Treatment failure | 29.07 | 23.32 | 3 | 33047 | 39160 | 32441316 |
Swelling | 28.84 | 23.32 | 95 | 32955 | 38127 | 32442349 |
Therapeutic product effect incomplete | 28.64 | 23.32 | 4 | 33046 | 41337 | 32439139 |
Foetal exposure during pregnancy | 28.60 | 23.32 | 4 | 33046 | 41297 | 32439179 |
Dizziness exertional | 28.34 | 23.32 | 9 | 33041 | 133 | 32480343 |
Hyperkalaemia | 28.27 | 23.32 | 18 | 33032 | 69732 | 32410744 |
Infusion site nodule | 28.04 | 23.32 | 8 | 33042 | 80 | 32480396 |
Coronary artery disease | 27.81 | 23.32 | 8 | 33042 | 49698 | 32430778 |
Cardiac output increased | 27.67 | 23.32 | 7 | 33043 | 42 | 32480434 |
Agitation | 27.27 | 23.32 | 12 | 33038 | 57224 | 32423252 |
Acute myocardial infarction | 27.18 | 23.32 | 11 | 33039 | 55138 | 32425338 |
Platelet count decreased | 26.90 | 23.32 | 47 | 33003 | 114544 | 32365932 |
Asthma | 26.75 | 23.32 | 6 | 33044 | 44059 | 32436417 |
Delirium | 26.74 | 23.32 | 6 | 33044 | 44040 | 32436436 |
Oropharyngeal pain | 26.46 | 23.32 | 81 | 32969 | 31271 | 32449205 |
Deep vein thrombosis | 26.43 | 23.32 | 16 | 33034 | 63697 | 32416779 |
Oxygen saturation abnormal | 26.09 | 23.32 | 16 | 33034 | 1210 | 32479266 |
Catheter site discolouration | 25.72 | 23.32 | 6 | 33044 | 24 | 32480452 |
Liver transplant | 25.57 | 23.32 | 22 | 33028 | 2818 | 32477658 |
Catheter removal | 25.45 | 23.32 | 9 | 33041 | 188 | 32480288 |
Hyponatraemia | 25.37 | 23.32 | 23 | 33027 | 74490 | 32405986 |
Diuretic therapy | 25.34 | 23.32 | 6 | 33044 | 26 | 32480450 |
Presyncope | 25.32 | 23.32 | 55 | 32995 | 17246 | 32463230 |
Malignant atrophic papulosis | 25.09 | 23.32 | 5 | 33045 | 7 | 32480469 |
Gout | 24.57 | 23.32 | 57 | 32993 | 18671 | 32461805 |
Jaundice | 24.39 | 23.32 | 3 | 33047 | 34155 | 32446321 |
Blood pressure increased | 24.16 | 23.32 | 27 | 33023 | 79327 | 32401149 |
Fatigue | 23.94 | 23.32 | 494 | 32556 | 350207 | 32130269 |
Blood creatinine increased | 23.88 | 23.32 | 38 | 33012 | 96094 | 32384382 |
Infusion site scab | 23.57 | 23.32 | 4 | 33046 | 0 | 32480476 |
Device maintenance issue | 23.57 | 23.32 | 4 | 33046 | 0 | 32480476 |
Infusion site bruising | 23.55 | 23.32 | 10 | 33040 | 346 | 32480130 |
Interstitial lung disease | 23.43 | 23.32 | 19 | 33031 | 64982 | 32415494 |
Source | Code | Description |
---|---|---|
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 drugs |
CHEBI has role | CHEBI:35620 | vasodilator |
CHEBI has role | CHEBI:35674 | antihypertensive |
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 |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Pulmonary arterial hypertension | indication | 11399002 | |
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 |
Dissociation level | Dissociation constant | Type (acidic/basic) |
---|---|---|
pKa1 | 3.4 | acidic |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent 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 |
0.6MG/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 |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
---|---|---|---|---|---|---|---|---|---|
EQ 0.125MG BASE | ORENITRAM | UNITED THERAP | N203496 | Dec. 20, 2013 | RX | TABLET, EXTENDED RELEASE | ORAL | Oct. 18, 2022 | 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, 2022 | 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, 2022 | 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, 2022 | 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, 2022 | INDICATED FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO GROUP 1) TO DELAY DISEASE PROGRESSION |
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 |
Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
---|---|---|---|---|---|---|---|---|---|
Prostacyclin receptor | GPCR | AGONIST | EC50 | 8.72 | IUPHAR | CHEMBL | |||
Prostaglandin E2 receptor EP2 subtype | GPCR | AGONIST | Ki | 8.40 | IUPHAR | ||||
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 EP4 subtype | GPCR | AGONIST | EC50 | 6.70 | IUPHAR | ||||
Prostaglandin D2 receptor | GPCR | AGONIST | Ki | 8.40 | IUPHAR |
ID | Source |
---|---|
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 |
RUM6K67ESG | UNII |
1927409 | RXNORM |
16706 | MMSL |
26646 | MMSL |
79759 | MMSL |
d04802 | MMSL |
009648 | NDDF |
009649 | NDDF |
015333 | NDDF |
385681001 | SNOMEDCT_US |
385682008 | SNOMEDCT_US |
443570007 | SNOMEDCT_US |
CHEMBL2107815 | ChEMBL_ID |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
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 | 0703-0686 | 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 | 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 | 0781-3427 | 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 | 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 | 42023-208 | 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 | 62332-514 | INJECTION, SOLUTION | 20 mg | INTRAVENOUS | ANDA | 26 sections |
Treprostinil | Human Prescription Drug Label | 1 | 62332-515 | INJECTION, SOLUTION | 50 mg | INTRAVENOUS | ANDA | 26 sections |
Treprostinil | Human Prescription Drug Label | 1 | 62332-516 | INJECTION, SOLUTION | 100 mg | INTRAVENOUS | ANDA | 26 sections |
Treprostinil | Human Prescription Drug Label | 1 | 62332-517 | INJECTION, SOLUTION | 200 mg | INTRAVENOUS | ANDA | 26 sections |
Remodulin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 66302-101 | INJECTION, SOLUTION | 20 mg | INTRAVENOUS | NDA | 28 sections |
Remodulin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 66302-102 | INJECTION, SOLUTION | 50 mg | INTRAVENOUS | NDA | 28 sections |
Remodulin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 66302-105 | INJECTION, SOLUTION | 100 mg | INTRAVENOUS | NDA | 28 sections |
Remodulin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 66302-110 | INJECTION, SOLUTION | 200 mg | INTRAVENOUS | NDA | 28 sections |
Remodulin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 66302-120 | INJECTION, SOLUTION | 400 mg | INTRAVENOUS | NDA | 28 sections |
TYVASO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 66302-206 | INHALANT | 1.74 mg | ORAL | NDA | 33 sections |
Orenitram | HUMAN PRESCRIPTION DRUG LABEL | 1 | 66302-300 | TABLET, EXTENDED RELEASE | 0.13 mg | ORAL | NDA | 31 sections |
Orenitram | HUMAN PRESCRIPTION DRUG LABEL | 1 | 66302-302 | TABLET, EXTENDED RELEASE | 0.25 mg | ORAL | NDA | 31 sections |
Orenitram | HUMAN PRESCRIPTION DRUG LABEL | 1 | 66302-310 | TABLET, EXTENDED RELEASE | 1 mg | ORAL | NDA | 31 sections |
Orenitram | HUMAN PRESCRIPTION DRUG LABEL | 1 | 66302-325 | TABLET, EXTENDED RELEASE | 2.50 mg | ORAL | NDA | 31 sections |
Orenitram | HUMAN PRESCRIPTION DRUG LABEL | 1 | 66302-350 | TABLET, EXTENDED RELEASE | 5 mg | ORAL | NDA | 31 sections |