tadalafil Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| inhibitors of phosphodiesterase PDE5 with vasodilator action | 2553 | 171596-29-5 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
A carboline derivative and PHOSPHODIESTERASE 5 INHIBITOR that is used primarily to treat ERECTILE DYSFUNCTION; BENIGN PROSTATIC HYPERPLASIA and PRIMARY PULMONARY HYPERTENSION.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 10 | mg | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 2 | Benet LZ, Broccatelli F, Oprea TI |
| MRTD (Maximum Recommended Therapeutic Daily Dose) | 0.73 µM/kg/day | Contrera JF, Matthews EJ, Kruhlak NL, Benz RD |
| BA (Bioavailability) | 16 % | Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Nov. 21, 2003 | FDA | LILLY |
FDA Adverse Event Reporting System (Female)
| 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 | 1957.13 | 15.13 | 960 | 86570 | 24968 | 46573564 |
| Dyspnoea | 1670.74 | 15.13 | 3236 | 84294 | 512312 | 46086220 |
| Pain in jaw | 1437.09 | 15.13 | 895 | 86635 | 37477 | 46561055 |
| Fluid retention | 1321.12 | 15.13 | 946 | 86584 | 50100 | 46548432 |
| Headache | 1144.64 | 15.13 | 2658 | 84872 | 475694 | 46122838 |
| Dyspnoea exertional | 925.04 | 15.13 | 761 | 86769 | 49528 | 46549004 |
| Drug ineffective | 753.83 | 15.13 | 176 | 87354 | 677662 | 45920870 |
| Right ventricular failure | 719.68 | 15.13 | 421 | 87109 | 15672 | 46582860 |
| Pulmonary hypertension | 698.12 | 15.13 | 562 | 86968 | 35431 | 46563101 |
| Flushing | 643.91 | 15.13 | 696 | 86834 | 63918 | 46534614 |
| Fluid overload | 595.14 | 15.13 | 456 | 87074 | 26729 | 46571803 |
| Nasal congestion | 564.96 | 15.13 | 566 | 86964 | 47547 | 46550985 |
| Infusion site pain | 509.63 | 15.13 | 286 | 87244 | 9821 | 46588711 |
| Catheter site erythema | 501.72 | 15.13 | 211 | 87319 | 3772 | 46594760 |
| Hospitalisation | 501.44 | 15.13 | 606 | 86924 | 62779 | 46535753 |
| Transfusion | 448.26 | 15.13 | 290 | 87240 | 12941 | 46585591 |
| Catheter site pain | 440.89 | 15.13 | 190 | 87340 | 3616 | 46594916 |
| Diarrhoea | 436.41 | 15.13 | 2133 | 85397 | 557469 | 46041063 |
| Catheter management | 416.48 | 15.13 | 167 | 87363 | 2628 | 46595904 |
| Death | 409.09 | 15.13 | 1468 | 86062 | 334080 | 46264452 |
| Oxygen saturation decreased | 404.74 | 15.13 | 570 | 86960 | 68594 | 46529938 |
| Device related infection | 375.16 | 15.13 | 313 | 87217 | 20728 | 46577804 |
| Catheter site pruritus | 372.09 | 15.13 | 140 | 87390 | 1839 | 46596693 |
| Rheumatoid arthritis | 340.12 | 15.13 | 30 | 87500 | 240185 | 46358347 |
| Catheter site discharge | 325.93 | 15.13 | 127 | 87403 | 1845 | 46596687 |
| Oedema | 316.71 | 15.13 | 500 | 87030 | 66571 | 46531961 |
| Vascular device infection | 309.84 | 15.13 | 145 | 87385 | 3372 | 46595160 |
| Toxicity to various agents | 272.97 | 15.13 | 37 | 87493 | 211729 | 46386803 |
| Oxygen consumption increased | 244.63 | 15.13 | 125 | 87405 | 3538 | 46594994 |
| Catheter placement | 238.36 | 15.13 | 101 | 87429 | 1840 | 46596692 |
| Infusion site erythema | 238.11 | 15.13 | 159 | 87371 | 7483 | 46591049 |
| Chest pain | 234.42 | 15.13 | 795 | 86735 | 175529 | 46423003 |
| Device leakage | 228.32 | 15.13 | 136 | 87394 | 5229 | 46593303 |
| Syncope | 227.97 | 15.13 | 564 | 86966 | 104239 | 46494293 |
| Lung transplant | 226.58 | 15.13 | 110 | 87420 | 2782 | 46595750 |
| Infusion site infection | 223.71 | 15.13 | 89 | 87441 | 1370 | 46597162 |
| Unevaluable event | 223.11 | 15.13 | 348 | 87182 | 45827 | 46552705 |
| Drug hypersensitivity | 221.65 | 15.13 | 90 | 87440 | 243735 | 46354797 |
| Drug interaction | 219.96 | 15.13 | 55 | 87475 | 203039 | 46395493 |
| Therapy change | 219.15 | 15.13 | 130 | 87400 | 4960 | 46593572 |
| Neutropenia | 216.50 | 15.13 | 13 | 87517 | 143191 | 46455341 |
| Catheter site infection | 214.11 | 15.13 | 125 | 87405 | 4628 | 46593904 |
| Completed suicide | 212.54 | 15.13 | 16 | 87514 | 145904 | 46452628 |
| Pulmonary arterial pressure increased | 211.83 | 15.13 | 110 | 87420 | 3222 | 46595310 |
| Palpitations | 211.78 | 15.13 | 517 | 87013 | 94742 | 46503790 |
| Cough | 206.16 | 15.13 | 916 | 86614 | 229333 | 46369199 |
| Dizziness | 203.48 | 15.13 | 1209 | 86321 | 339205 | 46259327 |
| Oedema peripheral | 197.36 | 15.13 | 703 | 86827 | 159003 | 46439529 |
| Scleroderma | 188.33 | 15.13 | 114 | 87416 | 4515 | 46594017 |
| Cardiac failure | 186.36 | 15.13 | 442 | 87088 | 79506 | 46519026 |
| Catheter site haemorrhage | 185.43 | 15.13 | 94 | 87436 | 2615 | 46595917 |
| Catheterisation cardiac | 183.80 | 15.13 | 107 | 87423 | 3940 | 46594592 |
| Infusion site discharge | 176.65 | 15.13 | 59 | 87471 | 532 | 46598000 |
| Dermatitis contact | 174.89 | 15.13 | 135 | 87395 | 7988 | 46590544 |
| Catheter site swelling | 173.13 | 15.13 | 72 | 87458 | 1249 | 46597283 |
| Catheter site rash | 170.08 | 15.13 | 61 | 87469 | 693 | 46597839 |
| Pneumonia | 168.71 | 15.13 | 1244 | 86286 | 375076 | 46223456 |
| Malaise | 159.39 | 15.13 | 1114 | 86416 | 330118 | 46268414 |
| Device infusion issue | 157.98 | 15.13 | 64 | 87466 | 1035 | 46597497 |
| Treatment failure | 151.93 | 15.13 | 5 | 87525 | 93082 | 46505450 |
| Infusion related reaction | 150.51 | 15.13 | 10 | 87520 | 101198 | 46497334 |
| Device alarm issue | 149.93 | 15.13 | 66 | 87464 | 1324 | 46597208 |
| Central venous catheterisation | 149.43 | 15.13 | 74 | 87456 | 1956 | 46596576 |
| Alopecia | 149.02 | 15.13 | 59 | 87471 | 162355 | 46436177 |
| Transplant evaluation | 148.99 | 15.13 | 61 | 87469 | 1015 | 46597517 |
| Infusion site swelling | 147.97 | 15.13 | 106 | 87424 | 5593 | 46592939 |
| Nausea | 145.05 | 15.13 | 1941 | 85589 | 685513 | 45913019 |
| Therapeutic product effect decreased | 140.17 | 15.13 | 3 | 87527 | 82598 | 46515934 |
| Off label use | 137.05 | 15.13 | 320 | 87210 | 379521 | 46219011 |
| Myalgia | 136.98 | 15.13 | 524 | 87006 | 122564 | 46475968 |
| Device occlusion | 135.01 | 15.13 | 102 | 87428 | 5843 | 46592689 |
| Product dose omission issue | 129.74 | 15.13 | 642 | 86888 | 167878 | 46430654 |
| Contraindicated product administered | 128.01 | 15.13 | 5 | 87525 | 79942 | 46518590 |
| Psoriasis | 122.28 | 15.13 | 6 | 87524 | 78598 | 46519934 |
| Infusion site haemorrhage | 121.88 | 15.13 | 66 | 87464 | 2108 | 46596424 |
| Hypotension | 120.45 | 15.13 | 797 | 86733 | 231792 | 46366740 |
| Device dislocation | 119.02 | 15.13 | 174 | 87356 | 21628 | 46576904 |
| Product use in unapproved indication | 118.04 | 15.13 | 15 | 87515 | 90258 | 46508274 |
| Concomitant disease aggravated | 117.68 | 15.13 | 106 | 87424 | 7776 | 46590756 |
| Therapeutic product effect incomplete | 115.37 | 15.13 | 8 | 87522 | 78145 | 46520387 |
| Pulmonary oedema | 114.13 | 15.13 | 278 | 87252 | 50827 | 46547705 |
| Catheter site inflammation | 113.10 | 15.13 | 44 | 87486 | 636 | 46597896 |
| Acute kidney injury | 113.01 | 15.13 | 167 | 87363 | 235688 | 46362844 |
| Catheter site irritation | 112.60 | 15.13 | 40 | 87490 | 441 | 46598091 |
| Hypoxia | 110.49 | 15.13 | 277 | 87253 | 51561 | 46546971 |
| Hypertension | 107.38 | 15.13 | 126 | 87404 | 196230 | 46402302 |
| Maternal exposure during pregnancy | 103.03 | 15.13 | 32 | 87498 | 102517 | 46496015 |
| Condition aggravated | 98.27 | 15.13 | 790 | 86740 | 244262 | 46354270 |
| Drug abuse | 98.11 | 15.13 | 5 | 87525 | 63403 | 46535129 |
| Leukopenia | 98.03 | 15.13 | 8 | 87522 | 68335 | 46530197 |
| Pain in extremity | 96.28 | 15.13 | 820 | 86710 | 257860 | 46340672 |
| Presyncope | 94.81 | 15.13 | 167 | 87363 | 24287 | 46574245 |
| Dyspnoea at rest | 93.75 | 15.13 | 67 | 87463 | 3521 | 46595011 |
| Intentional overdose | 92.05 | 15.13 | 8 | 87522 | 64936 | 46533596 |
| Overdose | 91.93 | 15.13 | 38 | 87492 | 101941 | 46496591 |
| Arthropathy | 91.47 | 15.13 | 23 | 87507 | 84677 | 46513855 |
| Thrombocytopenia | 89.62 | 15.13 | 64 | 87466 | 126517 | 46472015 |
| Catheter site vesicles | 87.97 | 15.13 | 29 | 87501 | 250 | 46598282 |
| Rash | 86.81 | 15.13 | 359 | 87171 | 356153 | 46242379 |
| Therapy non-responder | 86.74 | 15.13 | 219 | 87311 | 40933 | 46557599 |
| Device connection issue | 85.70 | 15.13 | 36 | 87494 | 641 | 46597891 |
| Peripheral swelling | 85.58 | 15.13 | 548 | 86982 | 157523 | 46441009 |
| White blood cell count decreased | 84.48 | 15.13 | 53 | 87477 | 112178 | 46486354 |
| Musculoskeletal stiffness | 84.40 | 15.13 | 39 | 87491 | 97954 | 46500578 |
| Seizure | 81.02 | 15.13 | 67 | 87463 | 122987 | 46475545 |
| Depression | 80.88 | 15.13 | 121 | 87409 | 169983 | 46428549 |
| Brain natriuretic peptide increased | 80.42 | 15.13 | 68 | 87462 | 4582 | 46593950 |
| Pulmonary veno-occlusive disease | 78.13 | 15.13 | 37 | 87493 | 884 | 46597648 |
| Joint swelling | 78.12 | 15.13 | 119 | 87411 | 165954 | 46432578 |
| Abdominal distension | 78.03 | 15.13 | 308 | 87222 | 73043 | 46525489 |
| Feeling abnormal | 77.45 | 15.13 | 449 | 87081 | 124611 | 46473921 |
| Ascites | 77.43 | 15.13 | 195 | 87335 | 36389 | 46562143 |
| Suicide attempt | 77.40 | 15.13 | 7 | 87523 | 55029 | 46543503 |
| Complication associated with device | 76.80 | 15.13 | 118 | 87412 | 15323 | 46583209 |
| Pericardial effusion | 75.01 | 15.13 | 155 | 87375 | 25388 | 46573144 |
| Exposure during pregnancy | 73.64 | 15.13 | 57 | 87473 | 108155 | 46490377 |
| Nasopharyngitis | 72.63 | 15.13 | 516 | 87014 | 153482 | 46445050 |
| Haemoptysis | 72.35 | 15.13 | 155 | 87375 | 26034 | 46572498 |
| Paracentesis | 71.20 | 15.13 | 35 | 87495 | 910 | 46597622 |
| Stomatitis | 70.98 | 15.13 | 20 | 87510 | 68277 | 46530255 |
| Injection site pain | 70.96 | 15.13 | 58 | 87472 | 107094 | 46491438 |
| Cardiac pacemaker insertion | 70.02 | 15.13 | 57 | 87473 | 3642 | 46594890 |
| Device related sepsis | 69.38 | 15.13 | 54 | 87476 | 3233 | 46595299 |
| Anaphylactic reaction | 68.99 | 15.13 | 9 | 87521 | 53103 | 46545429 |
| Walking distance test abnormal | 67.10 | 15.13 | 28 | 87502 | 490 | 46598042 |
| Hyponatraemia | 66.91 | 15.13 | 55 | 87475 | 101277 | 46497255 |
| Abortion spontaneous | 65.79 | 15.13 | 4 | 87526 | 43642 | 46554890 |
| Confusional state | 65.61 | 15.13 | 125 | 87405 | 159767 | 46438765 |
| Disease complication | 64.51 | 15.13 | 50 | 87480 | 2975 | 46595557 |
| Epistaxis | 64.39 | 15.13 | 265 | 87265 | 64040 | 46534492 |
| Suicidal ideation | 63.45 | 15.13 | 14 | 87516 | 56368 | 46542164 |
| Blood pressure increased | 63.25 | 15.13 | 87 | 87443 | 126579 | 46471953 |
| C-reactive protein increased | 63.07 | 15.13 | 16 | 87514 | 58574 | 46539958 |
| Osteoarthritis | 62.92 | 15.13 | 19 | 87511 | 62006 | 46536526 |
| Infusion site pruritus | 62.89 | 15.13 | 50 | 87480 | 3088 | 46595444 |
| Blood cholesterol increased | 62.39 | 15.13 | 3 | 87527 | 40010 | 46558522 |
| Glossodynia | 61.45 | 15.13 | 6 | 87524 | 44367 | 46554165 |
| Heart rate increased | 61.08 | 15.13 | 290 | 87240 | 74501 | 46524031 |
| Bradycardia | 60.89 | 15.13 | 24 | 87506 | 66274 | 46532258 |
| Infusion site irritation | 60.88 | 15.13 | 26 | 87504 | 483 | 46598049 |
| Urticaria | 60.87 | 15.13 | 79 | 87451 | 117813 | 46480719 |
| Multiple sclerosis relapse | 60.21 | 15.13 | 5 | 87525 | 42120 | 46556412 |
| Infusion site abscess | 59.81 | 15.13 | 20 | 87510 | 181 | 46598351 |
| Deep vein thrombosis | 59.57 | 15.13 | 38 | 87492 | 79735 | 46518797 |
| Plasma cell myeloma | 59.08 | 15.13 | 7 | 87523 | 44471 | 46554061 |
| Chest discomfort | 58.42 | 15.13 | 328 | 87202 | 89941 | 46508591 |
| Liver transplant | 58.30 | 15.13 | 43 | 87487 | 2374 | 46596158 |
| Injection site discharge | 57.87 | 15.13 | 23 | 87507 | 353 | 46598179 |
| Electrocardiogram QT prolonged | 57.24 | 15.13 | 13 | 87517 | 51312 | 46547220 |
| Hepatic enzyme increased | 57.02 | 15.13 | 42 | 87488 | 81745 | 46516787 |
| Agitation | 56.17 | 15.13 | 17 | 87513 | 55398 | 46543134 |
| Pruritus | 55.85 | 15.13 | 249 | 87281 | 242103 | 46356429 |
| Coma | 55.46 | 15.13 | 20 | 87510 | 58329 | 46540203 |
| Pancytopenia | 55.12 | 15.13 | 47 | 87483 | 85011 | 46513521 |
| Catheter site warmth | 54.36 | 15.13 | 19 | 87511 | 199 | 46598333 |
| Cardiac failure congestive | 53.93 | 15.13 | 325 | 87205 | 91425 | 46507107 |
| Infusion site induration | 52.48 | 15.13 | 27 | 87503 | 775 | 46597757 |
| Intentional product misuse | 52.43 | 15.13 | 12 | 87518 | 47116 | 46551416 |
| Hypersensitivity | 52.15 | 15.13 | 129 | 87401 | 150192 | 46448340 |
| Injection site reaction | 51.63 | 15.13 | 13 | 87517 | 47836 | 46550696 |
| Disease progression | 51.51 | 15.13 | 320 | 87210 | 90980 | 46507552 |
| Sinus congestion | 51.42 | 15.13 | 90 | 87440 | 13019 | 46585513 |
| Cardiac ablation | 51.19 | 15.13 | 31 | 87499 | 1228 | 46597304 |
| Paraesthesia | 50.66 | 15.13 | 89 | 87441 | 117348 | 46481184 |
| Oxygen therapy | 49.26 | 15.13 | 35 | 87495 | 1822 | 46596710 |
| Emergency care | 48.42 | 15.13 | 26 | 87504 | 816 | 46597716 |
| Wrong technique in product usage process | 47.88 | 15.13 | 21 | 87509 | 54401 | 46544131 |
| Hypoglycaemia | 47.77 | 15.13 | 21 | 87509 | 54328 | 46544204 |
| Infusion site warmth | 46.45 | 15.13 | 29 | 87501 | 1214 | 46597318 |
| Cognitive disorder | 46.14 | 15.13 | 7 | 87523 | 36876 | 46561656 |
| Angioedema | 45.85 | 15.13 | 9 | 87521 | 39333 | 46559199 |
| Foetal exposure during pregnancy | 45.80 | 15.13 | 3 | 87527 | 30744 | 46567788 |
| Atrial flutter | 45.62 | 15.13 | 70 | 87460 | 9078 | 46589454 |
| Atrial septal defect repair | 45.40 | 15.13 | 17 | 87513 | 220 | 46598312 |
| Exercise tolerance decreased | 44.96 | 15.13 | 49 | 87481 | 4528 | 46594004 |
| Neuropathy peripheral | 44.79 | 15.13 | 63 | 87467 | 90830 | 46507702 |
| Seasonal allergy | 44.04 | 15.13 | 85 | 87445 | 13249 | 46585283 |
| Bone marrow failure | 43.88 | 15.13 | 3 | 87527 | 29666 | 46568866 |
| Stent placement | 43.83 | 15.13 | 43 | 87487 | 3513 | 46595019 |
| Cardiac failure high output | 43.62 | 15.13 | 17 | 87513 | 247 | 46598285 |
| Cardiac disorder | 43.31 | 15.13 | 180 | 87350 | 43678 | 46554854 |
| Pulmonary arterial pressure abnormal | 43.09 | 15.13 | 20 | 87510 | 456 | 46598076 |
| Faeces soft | 43.07 | 15.13 | 42 | 87488 | 3406 | 46595126 |
| Dialysis | 43.03 | 15.13 | 72 | 87458 | 10044 | 46588488 |
| Somnolence | 42.91 | 15.13 | 150 | 87380 | 156371 | 46442161 |
| Blood glucose increased | 42.86 | 15.13 | 43 | 87487 | 71970 | 46526562 |
| Hypoaesthesia | 42.81 | 15.13 | 100 | 87430 | 118769 | 46479763 |
| Hallucination | 42.81 | 15.13 | 20 | 87510 | 49931 | 46548601 |
| Catheter removal | 42.37 | 15.13 | 18 | 87512 | 330 | 46598202 |
| Product quality issue | 41.87 | 15.13 | 8 | 87522 | 35640 | 46562892 |
| Drug intolerance | 41.61 | 15.13 | 139 | 87391 | 146910 | 46451622 |
| Hepatocellular injury | 40.86 | 15.13 | 4 | 87526 | 29518 | 46569014 |
| Aspiration pleural cavity | 40.74 | 15.13 | 23 | 87507 | 798 | 46597734 |
| Injury | 40.32 | 15.13 | 16 | 87514 | 44011 | 46554521 |
| Cardiac operation | 40.08 | 15.13 | 36 | 87494 | 2630 | 46595902 |
| Blood pressure systolic increased | 39.58 | 15.13 | 4 | 87526 | 28783 | 46569749 |
| Dysentery | 39.51 | 15.13 | 22 | 87508 | 743 | 46597789 |
| Mineral supplementation | 39.10 | 15.13 | 20 | 87510 | 567 | 46597965 |
| Catheter site related reaction | 38.69 | 15.13 | 22 | 87508 | 774 | 46597758 |
| Head discomfort | 37.95 | 15.13 | 69 | 87461 | 10282 | 46588250 |
| Depressed level of consciousness | 37.84 | 15.13 | 21 | 87509 | 47548 | 46550984 |
| Blood pressure decreased | 37.83 | 15.13 | 209 | 87321 | 56950 | 46541582 |
| Rehabilitation therapy | 37.61 | 15.13 | 25 | 87505 | 1167 | 46597365 |
| Productive cough | 37.36 | 15.13 | 191 | 87339 | 50524 | 46548008 |
| Catheter site erosion | 37.24 | 15.13 | 11 | 87519 | 63 | 46598469 |
| Infusion site rash | 37.07 | 15.13 | 23 | 87507 | 952 | 46597580 |
| Thrombosis in device | 36.67 | 15.13 | 36 | 87494 | 2943 | 46595589 |
| Pulmonary pain | 36.39 | 15.13 | 28 | 87502 | 1648 | 46596884 |
| Nocturnal dyspnoea | 36.31 | 15.13 | 23 | 87507 | 988 | 46597544 |
| Injection site erythema | 36.26 | 15.13 | 52 | 87478 | 74375 | 46524157 |
| Decreased appetite | 35.87 | 15.13 | 536 | 86994 | 193300 | 46405232 |
| Catheter site discolouration | 35.66 | 15.13 | 12 | 87518 | 111 | 46598421 |
| Hepatotoxicity | 35.65 | 15.13 | 3 | 87527 | 25006 | 46573526 |
| Blood creatine phosphokinase increased | 35.28 | 15.13 | 5 | 87525 | 27719 | 46570813 |
| Lactic acidosis | 35.10 | 15.13 | 10 | 87520 | 33899 | 46564633 |
| Tremor | 35.03 | 15.13 | 106 | 87424 | 115533 | 46482999 |
| Delirium | 34.97 | 15.13 | 13 | 87517 | 37215 | 46561317 |
| Device breakage | 34.76 | 15.13 | 64 | 87466 | 9628 | 46588904 |
| Pulmonary embolism | 34.74 | 15.13 | 97 | 87433 | 108488 | 46490044 |
| Paranasal sinus discomfort | 34.65 | 15.13 | 33 | 87497 | 2599 | 46595933 |
| Diabetes mellitus | 34.51 | 15.13 | 26 | 87504 | 50039 | 46548493 |
| Intentional product use issue | 34.39 | 15.13 | 29 | 87501 | 52751 | 46545781 |
| Hypokalaemia | 34.20 | 15.13 | 71 | 87459 | 87953 | 46510579 |
| Internal haemorrhage | 34.19 | 15.13 | 42 | 87488 | 4413 | 46594119 |
| Inappropriate schedule of product administration | 34.12 | 15.13 | 43 | 87487 | 64970 | 46533562 |
| Metabolic acidosis | 34.05 | 15.13 | 15 | 87515 | 38765 | 46559767 |
| Catheter site scab | 33.99 | 15.13 | 13 | 87517 | 179 | 46598353 |
| Acute respiratory failure | 33.96 | 15.13 | 126 | 87404 | 29012 | 46569520 |
| Device physical property issue | 33.21 | 15.13 | 25 | 87505 | 1424 | 46597108 |
| Dizziness postural | 33.10 | 15.13 | 50 | 87480 | 6396 | 46592136 |
| Dizziness exertional | 32.93 | 15.13 | 15 | 87515 | 327 | 46598205 |
| Hyperkalaemia | 32.87 | 15.13 | 28 | 87502 | 50681 | 46547851 |
| Respiratory failure | 32.77 | 15.13 | 296 | 87234 | 94520 | 46504012 |
| Lung disorder | 32.53 | 15.13 | 164 | 87366 | 43140 | 46555392 |
| Chemotherapy | 32.49 | 15.13 | 24 | 87506 | 1328 | 46597204 |
| Hepatitis | 32.43 | 15.13 | 10 | 87520 | 32205 | 46566327 |
| Blood iron decreased | 32.17 | 15.13 | 67 | 87463 | 11030 | 46587502 |
| Asthma | 32.17 | 15.13 | 78 | 87452 | 91464 | 46507068 |
| Osteonecrosis | 31.94 | 15.13 | 5 | 87525 | 25739 | 46572793 |
| Gastritis hypertrophic | 31.83 | 15.13 | 9 | 87521 | 43 | 46598489 |
| Treatment noncompliance | 31.72 | 15.13 | 125 | 87405 | 29606 | 46568926 |
| Cholestasis | 31.66 | 15.13 | 6 | 87524 | 26887 | 46571645 |
| N-terminal prohormone brain natriuretic peptide increased | 31.62 | 15.13 | 26 | 87504 | 1685 | 46596847 |
| Ear congestion | 31.56 | 15.13 | 26 | 87504 | 1689 | 46596843 |
| Influenza | 31.53 | 15.13 | 280 | 87250 | 88990 | 46509542 |
| Hypocalcaemia | 31.48 | 15.13 | 6 | 87524 | 26779 | 46571753 |
| Throat irritation | 31.23 | 15.13 | 122 | 87408 | 28779 | 46569753 |
| Cardioversion | 31.22 | 15.13 | 22 | 87508 | 1130 | 46597402 |
| Extra dose administered | 30.81 | 15.13 | 41 | 87489 | 4666 | 46593866 |
| Osteoporosis | 30.78 | 15.13 | 19 | 87511 | 40589 | 46557943 |
| Agranulocytosis | 30.71 | 15.13 | 3 | 87527 | 22182 | 46576350 |
| Pulmonary hypertensive crisis | 30.44 | 15.13 | 12 | 87518 | 180 | 46598352 |
| Infusion site pustule | 30.27 | 15.13 | 8 | 87522 | 28 | 46598504 |
| Drug titration error | 30.24 | 15.13 | 17 | 87513 | 585 | 46597947 |
| Acute myocardial infarction | 30.23 | 15.13 | 11 | 87519 | 31913 | 46566619 |
| Intentional dose omission | 30.21 | 15.13 | 34 | 87496 | 3256 | 46595276 |
| Stevens-Johnson syndrome | 30.13 | 15.13 | 4 | 87526 | 23293 | 46575239 |
| Emotional distress | 30.08 | 15.13 | 10 | 87520 | 30697 | 46567835 |
| Mouth ulceration | 29.51 | 15.13 | 7 | 87523 | 26825 | 46571707 |
| Medical device change | 29.31 | 15.13 | 14 | 87516 | 341 | 46598191 |
| Aggression | 29.18 | 15.13 | 4 | 87526 | 22740 | 46575792 |
| Injection site infection | 29.08 | 15.13 | 24 | 87506 | 1563 | 46596969 |
| Injection site swelling | 29.03 | 15.13 | 20 | 87510 | 40307 | 46558225 |
| Therapeutic response decreased | 28.99 | 15.13 | 23 | 87507 | 43122 | 46555410 |
| Psychotic disorder | 28.98 | 15.13 | 4 | 87526 | 22617 | 46575915 |
| Mobility decreased | 28.86 | 15.13 | 43 | 87487 | 60551 | 46537981 |
| Infusion site discolouration | 28.74 | 15.13 | 16 | 87514 | 540 | 46597992 |
| Hospice care | 28.51 | 15.13 | 42 | 87488 | 5253 | 46593279 |
| Right ventricular dilatation | 28.43 | 15.13 | 19 | 87511 | 895 | 46597637 |
| Injection site pruritus | 28.23 | 15.13 | 20 | 87510 | 39723 | 46558809 |
| Device issue | 28.14 | 15.13 | 92 | 87438 | 19888 | 46578644 |
| Impaired healing | 28.12 | 15.13 | 17 | 87513 | 36726 | 46561806 |
| Generalised tonic-clonic seizure | 28.07 | 15.13 | 8 | 87522 | 27114 | 46571418 |
| Cerebral infarction | 27.97 | 15.13 | 5 | 87525 | 23361 | 46575171 |
| Dyskinesia | 27.34 | 15.13 | 10 | 87520 | 28915 | 46569617 |
| Platelet transfusion | 27.22 | 15.13 | 17 | 87513 | 712 | 46597820 |
| Cardio-respiratory arrest | 27.07 | 15.13 | 44 | 87486 | 59825 | 46538707 |
| Systemic scleroderma | 26.93 | 15.13 | 18 | 87512 | 848 | 46597684 |
| Cor pulmonale | 26.80 | 15.13 | 25 | 87505 | 1918 | 46596614 |
| Renal disorder | 26.71 | 15.13 | 110 | 87420 | 26576 | 46571956 |
| Dysarthria | 26.46 | 15.13 | 19 | 87511 | 37479 | 46561053 |
| Concomitant disease progression | 26.38 | 15.13 | 26 | 87504 | 2136 | 46596396 |
| Swollen tongue | 26.15 | 15.13 | 11 | 87519 | 29221 | 46569311 |
| Ear discomfort | 25.97 | 15.13 | 46 | 87484 | 6715 | 46591817 |
| No adverse event | 25.97 | 15.13 | 16 | 87514 | 34215 | 46564317 |
| Oral herpes | 25.88 | 15.13 | 3 | 87527 | 19387 | 46579145 |
| Sinus disorder | 25.83 | 15.13 | 79 | 87451 | 16484 | 46582048 |
| Product use issue | 25.72 | 15.13 | 91 | 87439 | 94553 | 46503979 |
| Infusion site vesicles | 25.66 | 15.13 | 13 | 87517 | 361 | 46598171 |
| Skin lesion | 25.65 | 15.13 | 9 | 87521 | 26704 | 46571828 |
| Pulmonary arterial wedge pressure increased | 25.56 | 15.13 | 12 | 87518 | 281 | 46598251 |
| Upper respiratory tract congestion | 25.53 | 15.13 | 24 | 87506 | 1859 | 46596673 |
| Basal cell carcinoma | 25.37 | 15.13 | 4 | 87526 | 20483 | 46578049 |
| Abdominal cavity drainage | 25.27 | 15.13 | 13 | 87517 | 373 | 46598159 |
| Weight decreased | 25.12 | 15.13 | 544 | 86986 | 210305 | 46388227 |
| Hepatic steatosis | 25.05 | 15.13 | 7 | 87523 | 24035 | 46574497 |
| Disturbance in attention | 25.00 | 15.13 | 14 | 87516 | 31546 | 46566986 |
| Oxygen saturation abnormal | 24.80 | 15.13 | 28 | 87502 | 2690 | 46595842 |
| Catheterisation cardiac abnormal | 24.70 | 15.13 | 11 | 87519 | 227 | 46598305 |
| Pancreatitis acute | 24.54 | 15.13 | 8 | 87522 | 24864 | 46573668 |
| Packed red blood cell transfusion | 24.53 | 15.13 | 25 | 87505 | 2138 | 46596394 |
| Hyperglycaemia | 24.45 | 15.13 | 18 | 87512 | 35053 | 46563479 |
| Central venous catheter removal | 24.37 | 15.13 | 12 | 87518 | 313 | 46598219 |
| Haematuria | 24.20 | 15.13 | 10 | 87520 | 26848 | 46571684 |
| Skin exfoliation | 24.16 | 15.13 | 16 | 87514 | 32922 | 46565610 |
| Medication error | 24.08 | 15.13 | 14 | 87516 | 30897 | 46567635 |
| Orthopnoea | 23.88 | 15.13 | 41 | 87489 | 5839 | 46592693 |
| Right ventricular dysfunction | 23.82 | 15.13 | 21 | 87509 | 1497 | 46597035 |
| Dyspepsia | 23.78 | 15.13 | 214 | 87316 | 68258 | 46530274 |
| Transplant | 23.73 | 15.13 | 15 | 87515 | 642 | 46597890 |
| Withdrawal syndrome | 23.72 | 15.13 | 3 | 87527 | 18131 | 46580401 |
| Metapneumovirus infection | 23.71 | 15.13 | 16 | 87514 | 766 | 46597766 |
| Drug withdrawal syndrome | 23.40 | 15.13 | 11 | 87519 | 27373 | 46571159 |
| Ejection fraction decreased | 23.38 | 15.13 | 3 | 87527 | 17934 | 46580598 |
| Migraine | 23.37 | 15.13 | 217 | 87313 | 69809 | 46528723 |
| Application site pruritus | 23.32 | 15.13 | 33 | 87497 | 3980 | 46594552 |
| Cardiac flutter | 23.20 | 15.13 | 30 | 87500 | 3319 | 46595213 |
| Laboratory test abnormal | 23.16 | 15.13 | 7 | 87523 | 22840 | 46575692 |
| Disseminated intravascular coagulation | 22.89 | 15.13 | 4 | 87526 | 19001 | 46579531 |
| Inflammation | 22.86 | 15.13 | 35 | 87495 | 48746 | 46549786 |
| Epilepsy | 22.78 | 15.13 | 8 | 87522 | 23730 | 46574802 |
| Echocardiogram abnormal | 22.77 | 15.13 | 17 | 87513 | 956 | 46597576 |
| Mechanical ventilation | 22.74 | 15.13 | 19 | 87511 | 1259 | 46597273 |
| Arthritis | 22.60 | 15.13 | 72 | 87458 | 77244 | 46521288 |
| Myocardial infarction | 22.54 | 15.13 | 100 | 87430 | 97428 | 46501104 |
| Bone disorder | 22.48 | 15.13 | 5 | 87525 | 20028 | 46578504 |
| Polypectomy | 22.47 | 15.13 | 14 | 87516 | 584 | 46597948 |
| Infusion site oedema | 22.47 | 15.13 | 13 | 87517 | 473 | 46598059 |
| Blood potassium decreased | 22.45 | 15.13 | 135 | 87395 | 37928 | 46560604 |
| Abnormal behaviour | 22.18 | 15.13 | 6 | 87524 | 21052 | 46577480 |
| Hypercalcaemia | 22.16 | 15.13 | 6 | 87524 | 21040 | 46577492 |
| Hyperlipidaemia | 22.12 | 15.13 | 4 | 87526 | 18535 | 46579997 |
| Heart valve replacement | 22.07 | 15.13 | 13 | 87517 | 489 | 46598043 |
| Application site hypersensitivity | 22.04 | 15.13 | 10 | 87520 | 216 | 46598316 |
| Disorientation | 22.01 | 15.13 | 22 | 87508 | 36896 | 46561636 |
| Vomiting | 21.93 | 15.13 | 1048 | 86482 | 451746 | 46146786 |
| Catheter site induration | 21.91 | 15.13 | 7 | 87523 | 54 | 46598478 |
| Terminal state | 21.91 | 15.13 | 24 | 87506 | 2230 | 46596302 |
| Left ventricular failure | 21.87 | 15.13 | 36 | 87494 | 4954 | 46593578 |
| Osteopenia | 21.72 | 15.13 | 3 | 87527 | 16958 | 46581574 |
| Clostridium difficile infection | 21.70 | 15.13 | 99 | 87431 | 25004 | 46573528 |
| Catheter site dermatitis | 21.58 | 15.13 | 7 | 87523 | 57 | 46598475 |
| Infusion site cellulitis | 21.49 | 15.13 | 9 | 87521 | 159 | 46598373 |
| Vascular cauterisation | 21.48 | 15.13 | 7 | 87523 | 58 | 46598474 |
| Fibromyalgia | 21.43 | 15.13 | 22 | 87508 | 36441 | 46562091 |
| Abdominal pain upper | 21.36 | 15.13 | 387 | 87143 | 144918 | 46453614 |
| Ischaemic stroke | 21.32 | 15.13 | 3 | 87527 | 16719 | 46581813 |
| Wrong dose | 21.30 | 15.13 | 15 | 87515 | 770 | 46597762 |
| First bite syndrome | 21.27 | 15.13 | 5 | 87525 | 9 | 46598523 |
| Encephalopathy | 21.22 | 15.13 | 19 | 87511 | 33570 | 46564962 |
| Systemic lupus erythematosus | 21.00 | 15.13 | 58 | 87472 | 65122 | 46533410 |
| Respiratory tract congestion | 20.96 | 15.13 | 62 | 87468 | 12702 | 46585830 |
| Endotracheal intubation | 20.96 | 15.13 | 23 | 87507 | 2142 | 46596390 |
| Hepatic cirrhosis | 20.88 | 15.13 | 71 | 87459 | 15661 | 46582871 |
| Rhinorrhoea | 20.86 | 15.13 | 157 | 87373 | 47508 | 46551024 |
| Alanine aminotransferase increased | 20.86 | 15.13 | 90 | 87440 | 88361 | 46510171 |
| Multiple allergies | 20.78 | 15.13 | 44 | 87486 | 7327 | 46591205 |
| Hypomagnesaemia | 20.45 | 15.13 | 8 | 87522 | 22202 | 46576330 |
| Metastases to bone | 20.36 | 15.13 | 4 | 87526 | 17472 | 46581060 |
| Bursitis | 20.26 | 15.13 | 6 | 87524 | 19836 | 46578696 |
| Diet noncompliance | 20.17 | 15.13 | 10 | 87520 | 265 | 46598267 |
| Purulent discharge | 20.04 | 15.13 | 34 | 87496 | 4796 | 46593736 |
| Urinary retention | 20.02 | 15.13 | 12 | 87518 | 26049 | 46572483 |
| Cholecystectomy | 19.97 | 15.13 | 49 | 87481 | 8993 | 46589539 |
| Middle ear effusion | 19.96 | 15.13 | 21 | 87509 | 1864 | 46596668 |
| General physical health deterioration | 19.95 | 15.13 | 131 | 87399 | 115638 | 46482894 |
| Intracardiac pressure increased | 19.80 | 15.13 | 6 | 87524 | 38 | 46598494 |
| Pulmonary artery aneurysm | 19.67 | 15.13 | 6 | 87524 | 39 | 46598493 |
| Infusion site inflammation | 19.60 | 15.13 | 9 | 87521 | 200 | 46598332 |
| CREST syndrome | 19.58 | 15.13 | 11 | 87519 | 378 | 46598154 |
| Oropharyngeal pain | 19.56 | 15.13 | 219 | 87311 | 73949 | 46524583 |
| Therapeutic response unexpected | 19.45 | 15.13 | 3 | 87527 | 15613 | 46582919 |
| Cardiac output increased | 19.44 | 15.13 | 8 | 87522 | 135 | 46598397 |
| Arthralgia | 19.37 | 15.13 | 528 | 87002 | 364075 | 46234457 |
| Catheter culture positive | 19.33 | 15.13 | 8 | 87522 | 137 | 46598395 |
| Herpes zoster | 19.29 | 15.13 | 64 | 87466 | 67808 | 46530724 |
| Eosinophilia | 19.28 | 15.13 | 6 | 87524 | 19211 | 46579321 |
| Pneumonitis | 19.28 | 15.13 | 15 | 87515 | 28405 | 46570127 |
| Cerebrovascular accident | 19.14 | 15.13 | 111 | 87419 | 100928 | 46497604 |
| Drug eruption | 19.12 | 15.13 | 8 | 87522 | 21321 | 46577211 |
| Femur fracture | 18.86 | 15.13 | 25 | 87505 | 36972 | 46561560 |
| Full blood count decreased | 18.86 | 15.13 | 9 | 87521 | 22202 | 46576330 |
| Product prescribing error | 18.83 | 15.13 | 7 | 87523 | 20040 | 46578492 |
| Infusion site dermatitis | 18.81 | 15.13 | 5 | 87525 | 18 | 46598514 |
| Joint stiffness | 18.78 | 15.13 | 14 | 87516 | 27094 | 46571438 |
| Irritability | 18.74 | 15.13 | 16 | 87514 | 28930 | 46569602 |
| Respiratory syncytial virus infection | 18.71 | 15.13 | 33 | 87497 | 4802 | 46593730 |
| Drug ineffective for unapproved indication | 18.62 | 15.13 | 4 | 87526 | 16409 | 46582123 |
| Catheter site mass | 18.60 | 15.13 | 5 | 87525 | 19 | 46598513 |
| Cardiac resynchronisation therapy | 18.60 | 15.13 | 5 | 87525 | 19 | 46598513 |
| Lower respiratory tract infection | 18.52 | 15.13 | 48 | 87482 | 55041 | 46543491 |
| Injection site mass | 18.48 | 15.13 | 3 | 87527 | 15037 | 46583495 |
| Right ventricular systolic pressure increased | 18.40 | 15.13 | 12 | 87518 | 542 | 46597990 |
| Transaminases increased | 18.39 | 15.13 | 15 | 87515 | 27746 | 46570786 |
| Gastroenteritis viral | 18.38 | 15.13 | 75 | 87455 | 18044 | 46580488 |
| Pericardial drainage | 18.34 | 15.13 | 9 | 87521 | 233 | 46598299 |
| Colitis | 18.27 | 15.13 | 26 | 87504 | 37321 | 46561211 |
| Aphasia | 18.24 | 15.13 | 16 | 87514 | 28551 | 46569981 |
| Peritonitis | 18.20 | 15.13 | 8 | 87522 | 20706 | 46577826 |
| Metastases to liver | 18.12 | 15.13 | 7 | 87523 | 19578 | 46578954 |
| Sinus tachycardia | 18.04 | 15.13 | 9 | 87521 | 21640 | 46576892 |
| Tracheostomy | 17.88 | 15.13 | 12 | 87518 | 569 | 46597963 |
| Right-to-left cardiac shunt | 17.84 | 15.13 | 8 | 87522 | 168 | 46598364 |
| Localised oedema | 17.59 | 15.13 | 33 | 87497 | 5036 | 46593496 |
| Gout | 17.56 | 15.13 | 54 | 87476 | 11302 | 46587230 |
| Pulmonary vein occlusion | 17.18 | 15.13 | 5 | 87525 | 27 | 46598505 |
| Blood carbon monoxide increased | 17.09 | 15.13 | 4 | 87526 | 7 | 46598525 |
| Catheter site urticaria | 17.02 | 15.13 | 5 | 87525 | 28 | 46598504 |
| Palliative care | 16.57 | 15.13 | 9 | 87521 | 289 | 46598243 |
| Pregnancy test positive | 16.54 | 15.13 | 7 | 87523 | 127 | 46598405 |
| Coagulopathy | 16.49 | 15.13 | 7 | 87523 | 18492 | 46580040 |
| Medical procedure | 16.45 | 15.13 | 8 | 87522 | 203 | 46598329 |
| Hyperhidrosis | 16.44 | 15.13 | 99 | 87431 | 89209 | 46509323 |
| Vasculitis | 16.27 | 15.13 | 3 | 87527 | 13708 | 46584824 |
| Pulmonary artery dilatation | 16.20 | 15.13 | 8 | 87522 | 210 | 46598322 |
| Infusion site nodule | 16.10 | 15.13 | 14 | 87516 | 980 | 46597552 |
| Primary biliary cholangitis | 16.02 | 15.13 | 15 | 87515 | 1156 | 46597376 |
| Systemic sclerosis pulmonary | 15.86 | 15.13 | 4 | 87526 | 11 | 46598521 |
| Amnesia | 15.81 | 15.13 | 34 | 87496 | 41597 | 46556935 |
| Premature delivery | 15.81 | 15.13 | 11 | 87519 | 22058 | 46576474 |
| Accidental exposure to product | 15.79 | 15.13 | 10 | 87520 | 21071 | 46577461 |
| Obstructive airways disorder | 15.77 | 15.13 | 3 | 87527 | 13409 | 46585123 |
| Anxiety | 15.76 | 15.13 | 243 | 87287 | 181714 | 46416818 |
| Rash erythematous | 15.75 | 15.13 | 25 | 87505 | 34325 | 46564207 |
| Iron deficiency anaemia | 15.73 | 15.13 | 69 | 87461 | 17137 | 46581395 |
| Dysphagia | 15.70 | 15.13 | 83 | 87447 | 77229 | 46521303 |
| N-terminal prohormone brain natriuretic peptide | 15.61 | 15.13 | 5 | 87525 | 39 | 46598493 |
| Intervertebral disc degeneration | 15.51 | 15.13 | 3 | 87527 | 13249 | 46585283 |
| Decreased activity | 15.51 | 15.13 | 31 | 87499 | 4957 | 46593575 |
| Bendopnoea | 15.36 | 15.13 | 4 | 87526 | 13 | 46598519 |
| Colitis ulcerative | 15.34 | 15.13 | 7 | 87523 | 17725 | 46580807 |
| Female sterilisation | 15.27 | 15.13 | 11 | 87519 | 585 | 46597947 |
| Liver function test abnormal | 15.25 | 15.13 | 41 | 87489 | 46446 | 46552086 |
| Jaundice | 15.21 | 15.13 | 19 | 87511 | 28826 | 46569706 |
| Proteinuria | 15.18 | 15.13 | 6 | 87524 | 16547 | 46581985 |
FDA Adverse Event Reporting System (Male)
| 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 | 797.13 | 12.53 | 344 | 41523 | 8957 | 29901654 |
| Headache | 579.52 | 12.53 | 964 | 40903 | 181342 | 29729269 |
| Fluid retention | 433.51 | 12.53 | 324 | 41543 | 24674 | 29885937 |
| Pain in jaw | 418.41 | 12.53 | 242 | 41625 | 11914 | 29898697 |
| Dyspnoea | 347.91 | 12.53 | 1136 | 40731 | 332159 | 29578452 |
| Right ventricular failure | 317.10 | 12.53 | 175 | 41692 | 7861 | 29902750 |
| Pulmonary hypertension | 263.36 | 12.53 | 216 | 41651 | 18820 | 29891791 |
| Flushing | 242.36 | 12.53 | 250 | 41617 | 29242 | 29881369 |
| Nasal congestion | 185.22 | 12.53 | 175 | 41692 | 18391 | 29892220 |
| Fluid overload | 162.51 | 12.53 | 165 | 41702 | 18927 | 29891684 |
| Dyspnoea exertional | 154.95 | 12.53 | 218 | 41649 | 35212 | 29875399 |
| Infusion site pain | 154.37 | 12.53 | 75 | 41792 | 2575 | 29908036 |
| Vision blurred | 145.26 | 12.53 | 231 | 41636 | 41585 | 29869026 |
| Lung transplant | 141.84 | 12.53 | 64 | 41803 | 1852 | 29908759 |
| Oedema | 132.46 | 12.53 | 225 | 41642 | 42768 | 29867843 |
| Myalgia | 124.82 | 12.53 | 308 | 41559 | 76359 | 29834252 |
| Back pain | 124.72 | 12.53 | 370 | 41497 | 102226 | 29808385 |
| Transfusion | 121.00 | 12.53 | 93 | 41774 | 7368 | 29903243 |
| Pain in extremity | 118.65 | 12.53 | 381 | 41486 | 109840 | 29800771 |
| Optic ischaemic neuropathy | 117.74 | 12.53 | 57 | 41810 | 1941 | 29908670 |
| Catheterisation cardiac | 111.78 | 12.53 | 57 | 41810 | 2174 | 29908437 |
| Catheter management | 109.82 | 12.53 | 43 | 41824 | 864 | 29909747 |
| Cyanopsia | 108.93 | 12.53 | 29 | 41838 | 151 | 29910460 |
| Hospitalisation | 106.14 | 12.53 | 208 | 41659 | 44111 | 29866500 |
| Oxygen saturation decreased | 102.97 | 12.53 | 203 | 41664 | 43237 | 29867374 |
| Catheter site erythema | 101.66 | 12.53 | 44 | 41823 | 1150 | 29909461 |
| Death | 100.79 | 12.53 | 846 | 41021 | 356437 | 29554174 |
| Febrile neutropenia | 99.90 | 12.53 | 15 | 41852 | 106678 | 29803933 |
| Toxicity to various agents | 89.59 | 12.53 | 70 | 41797 | 177113 | 29733498 |
| Diarrhoea | 88.82 | 12.53 | 781 | 41086 | 333322 | 29577289 |
| Concomitant disease aggravated | 83.31 | 12.53 | 64 | 41803 | 5065 | 29905546 |
| Infusion site infection | 81.94 | 12.53 | 27 | 41840 | 321 | 29910290 |
| Device related infection | 74.79 | 12.53 | 105 | 41762 | 16910 | 29893701 |
| Acute kidney injury | 73.72 | 12.53 | 172 | 41695 | 273670 | 29636941 |
| Dizziness | 71.23 | 12.53 | 491 | 41376 | 194418 | 29716193 |
| Transplant evaluation | 70.89 | 12.53 | 27 | 41840 | 502 | 29910109 |
| Peripheral swelling | 69.16 | 12.53 | 215 | 41652 | 60859 | 29849752 |
| Thrombocytopenia | 66.91 | 12.53 | 56 | 41811 | 136988 | 29773623 |
| Infusion site erythema | 65.33 | 12.53 | 36 | 41831 | 1610 | 29909001 |
| Oxygen consumption increased | 64.79 | 12.53 | 33 | 41834 | 1255 | 29909356 |
| Feeling abnormal | 64.44 | 12.53 | 200 | 41667 | 56556 | 29854055 |
| Priapism | 61.76 | 12.53 | 52 | 41815 | 4691 | 29905920 |
| Therapy change | 59.46 | 12.53 | 40 | 41827 | 2569 | 29908042 |
| Erection increased | 58.29 | 12.53 | 24 | 41843 | 552 | 29910059 |
| Syncope | 57.41 | 12.53 | 253 | 41614 | 84650 | 29825961 |
| Malignant neoplasm progression | 55.64 | 12.53 | 16 | 41851 | 72271 | 29838340 |
| Product use in unapproved indication | 53.69 | 12.53 | 18 | 41849 | 73675 | 29836936 |
| Neutropenia | 52.94 | 12.53 | 61 | 41806 | 128479 | 29782132 |
| Catheter site pain | 52.67 | 12.53 | 27 | 41840 | 1041 | 29909570 |
| Catheter site discharge | 52.41 | 12.53 | 22 | 41845 | 532 | 29910079 |
| Drug abuse | 51.73 | 12.53 | 25 | 41842 | 82047 | 29828564 |
| Leukopenia | 50.06 | 12.53 | 9 | 41858 | 56150 | 29854461 |
| Milk-alkali syndrome | 49.64 | 12.53 | 21 | 41846 | 518 | 29910093 |
| Drug interaction | 49.20 | 12.53 | 131 | 41736 | 199437 | 29711174 |
| Rhabdomyolysis | 49.06 | 12.53 | 14 | 41853 | 63566 | 29847045 |
| Pulmonary arterial pressure increased | 48.98 | 12.53 | 26 | 41841 | 1078 | 29909533 |
| Visual impairment | 48.09 | 12.53 | 121 | 41746 | 30317 | 29880294 |
| Catheter site pruritus | 45.82 | 12.53 | 17 | 41850 | 293 | 29910318 |
| Unevaluable event | 44.73 | 12.53 | 121 | 41746 | 31664 | 29878947 |
| Dyspepsia | 43.22 | 12.53 | 116 | 41751 | 30213 | 29880398 |
| Deafness unilateral | 42.45 | 12.53 | 28 | 41839 | 1740 | 29908871 |
| Confusional state | 40.06 | 12.53 | 80 | 41787 | 134754 | 29775857 |
| Palpitations | 39.66 | 12.53 | 120 | 41747 | 33453 | 29877158 |
| Suspected counterfeit product | 39.37 | 12.53 | 15 | 41852 | 279 | 29910332 |
| Cough | 38.62 | 12.53 | 304 | 41563 | 125338 | 29785273 |
| Catheter placement | 37.71 | 12.53 | 19 | 41848 | 706 | 29909905 |
| Pancytopenia | 37.62 | 12.53 | 38 | 41829 | 85014 | 29825597 |
| Infusion related reaction | 37.25 | 12.53 | 6 | 41861 | 40558 | 29870053 |
| Vascular device infection | 37.13 | 12.53 | 26 | 41841 | 1783 | 29908828 |
| Faeces soft | 36.94 | 12.53 | 28 | 41839 | 2171 | 29908440 |
| Device alarm issue | 36.44 | 12.53 | 19 | 41848 | 759 | 29909852 |
| Cardiac pacemaker insertion | 35.42 | 12.53 | 29 | 41838 | 2516 | 29908095 |
| Erectile dysfunction | 35.15 | 12.53 | 78 | 41789 | 18024 | 29892587 |
| Hyponatraemia | 34.59 | 12.53 | 26 | 41841 | 67176 | 29843435 |
| Brain natriuretic peptide increased | 34.54 | 12.53 | 35 | 41832 | 4000 | 29906611 |
| Malaise | 34.12 | 12.53 | 370 | 41497 | 166592 | 29744019 |
| Right ventricular dysfunction | 33.92 | 12.53 | 19 | 41848 | 877 | 29909734 |
| Accommodation disorder | 33.69 | 12.53 | 12 | 41855 | 183 | 29910428 |
| Cardiac operation | 33.27 | 12.53 | 28 | 41839 | 2524 | 29908087 |
| Device dislocation | 33.15 | 12.53 | 38 | 41829 | 4993 | 29905618 |
| Fracture of penis | 33.11 | 12.53 | 12 | 41855 | 193 | 29910418 |
| Oedema peripheral | 33.02 | 12.53 | 257 | 41610 | 105575 | 29805036 |
| Haematospermia | 32.16 | 12.53 | 14 | 41853 | 371 | 29910240 |
| Sinus congestion | 31.68 | 12.53 | 36 | 41831 | 4686 | 29905925 |
| Mucosal inflammation | 31.68 | 12.53 | 3 | 41864 | 30491 | 29880120 |
| Product dose omission issue | 31.11 | 12.53 | 227 | 41640 | 91404 | 29819207 |
| Hyperkalaemia | 30.93 | 12.53 | 28 | 41839 | 65982 | 29844629 |
| Heart and lung transplant | 30.39 | 12.53 | 9 | 41858 | 73 | 29910538 |
| Pulmonary veno-occlusive disease | 30.04 | 12.53 | 14 | 41853 | 437 | 29910174 |
| Neutrophil count decreased | 29.83 | 12.53 | 11 | 41856 | 42443 | 29868168 |
| Septic shock | 29.78 | 12.53 | 27 | 41840 | 63580 | 29847031 |
| Central venous catheterisation | 29.60 | 12.53 | 18 | 41849 | 970 | 29909641 |
| Catheter site rash | 29.41 | 12.53 | 11 | 41856 | 194 | 29910417 |
| Catheter removal | 29.26 | 12.53 | 11 | 41856 | 197 | 29910414 |
| Depressed level of consciousness | 28.42 | 12.53 | 9 | 41858 | 38213 | 29872398 |
| Abdominal discomfort | 28.23 | 12.53 | 139 | 41728 | 48652 | 29861959 |
| Blindness unilateral | 27.88 | 12.53 | 31 | 41836 | 3941 | 29906670 |
| Dermatitis contact | 27.61 | 12.53 | 28 | 41839 | 3203 | 29907408 |
| Infusion site discharge | 27.56 | 12.53 | 8 | 41859 | 60 | 29910551 |
| Visual acuity reduced | 27.15 | 12.53 | 65 | 41802 | 15781 | 29894830 |
| Rheumatoid arthritis | 26.79 | 12.53 | 12 | 41855 | 41185 | 29869426 |
| Hallucination | 26.53 | 12.53 | 18 | 41849 | 49041 | 29861570 |
| Infusion site oedema | 26.51 | 12.53 | 9 | 41858 | 118 | 29910493 |
| Tinnitus | 26.50 | 12.53 | 65 | 41802 | 16023 | 29894588 |
| Blindness | 26.14 | 12.53 | 55 | 41812 | 12254 | 29898357 |
| Bone marrow failure | 26.05 | 12.53 | 5 | 41862 | 29780 | 29880831 |
| Colour blindness acquired | 25.99 | 12.53 | 8 | 41859 | 75 | 29910536 |
| Stomatitis | 25.62 | 12.53 | 10 | 41857 | 37269 | 29873342 |
| Ejaculation failure | 25.10 | 12.53 | 15 | 41852 | 783 | 29909828 |
| Overdose | 25.06 | 12.53 | 50 | 41817 | 84287 | 29826324 |
| Spontaneous penile erection | 24.95 | 12.53 | 10 | 41857 | 214 | 29910397 |
| Condition aggravated | 24.75 | 12.53 | 298 | 41569 | 137568 | 29773043 |
| Chromatopsia | 24.57 | 12.53 | 10 | 41857 | 223 | 29910388 |
| Infusion site warmth | 24.52 | 12.53 | 8 | 41859 | 92 | 29910519 |
| Drug reaction with eosinophilia and systemic symptoms | 24.46 | 12.53 | 5 | 41862 | 28483 | 29882128 |
| Hypoxia | 23.99 | 12.53 | 131 | 41736 | 47723 | 29862888 |
| Catheter site infection | 23.99 | 12.53 | 23 | 41844 | 2458 | 29908153 |
| Lactic acidosis | 23.84 | 12.53 | 7 | 41860 | 31206 | 29879405 |
| Cardiac ablation | 23.62 | 12.53 | 13 | 41854 | 580 | 29910031 |
| Haematopoietic stem cell mobilisation | 23.50 | 12.53 | 9 | 41858 | 170 | 29910441 |
| Pulmonary arterial pressure abnormal | 23.45 | 12.53 | 9 | 41858 | 171 | 29910440 |
| Treatment failure | 22.71 | 12.53 | 10 | 41857 | 34669 | 29875942 |
| Catheter site haemorrhage | 22.65 | 12.53 | 21 | 41846 | 2151 | 29908460 |
| Blindness transient | 22.51 | 12.53 | 20 | 41847 | 1939 | 29908672 |
| Seizure | 22.47 | 12.53 | 67 | 41800 | 98408 | 29812203 |
| Migraine | 22.26 | 12.53 | 53 | 41814 | 12821 | 29897790 |
| Visual brightness | 22.11 | 12.53 | 6 | 41861 | 34 | 29910577 |
| Bradycardia | 22.01 | 12.53 | 36 | 41831 | 65490 | 29845121 |
| Chest pain | 21.87 | 12.53 | 256 | 41611 | 117371 | 29793240 |
| Sepsis | 21.76 | 12.53 | 118 | 41749 | 146277 | 29764334 |
| Medical device change | 21.61 | 12.53 | 8 | 41859 | 137 | 29910474 |
| Walking distance test abnormal | 21.55 | 12.53 | 8 | 41859 | 138 | 29910473 |
| Throat irritation | 21.51 | 12.53 | 41 | 41826 | 8507 | 29902104 |
| Oxygen therapy | 21.35 | 12.53 | 13 | 41854 | 702 | 29909909 |
| Injection site discharge | 21.34 | 12.53 | 7 | 41860 | 82 | 29910529 |
| Plasma cell myeloma | 21.31 | 12.53 | 26 | 41841 | 53436 | 29857175 |
| Nasopharyngitis | 21.24 | 12.53 | 148 | 41719 | 58701 | 29851910 |
| Multiple organ dysfunction syndrome | 21.21 | 12.53 | 35 | 41832 | 63452 | 29847159 |
| Completed suicide | 21.07 | 12.53 | 70 | 41797 | 99422 | 29811189 |
| Fatigue | 20.89 | 12.53 | 591 | 41276 | 320082 | 29590529 |
| Rash | 20.81 | 12.53 | 170 | 41697 | 191719 | 29718892 |
| Suicide attempt | 20.47 | 12.53 | 13 | 41854 | 36684 | 29873927 |
| Swelling | 20.46 | 12.53 | 102 | 41765 | 35873 | 29874738 |
| Visual field defect | 20.42 | 12.53 | 28 | 41839 | 4408 | 29906203 |
| Abdominal distension | 20.20 | 12.53 | 121 | 41746 | 45588 | 29865023 |
| Gastrooesophageal reflux disease | 20.18 | 12.53 | 94 | 41773 | 32161 | 29878450 |
| Device occlusion | 20.11 | 12.53 | 33 | 41834 | 6087 | 29904524 |
| Drug hypersensitivity | 20.03 | 12.53 | 41 | 41826 | 68478 | 29842133 |
| Liver transplant | 19.89 | 12.53 | 22 | 41845 | 2780 | 29907831 |
| Product counterfeit | 19.84 | 12.53 | 8 | 41859 | 174 | 29910437 |
| Agitation | 19.81 | 12.53 | 28 | 41839 | 54045 | 29856566 |
| Counterfeit product administered | 19.80 | 12.53 | 8 | 41859 | 175 | 29910436 |
| Infusion site swelling | 19.57 | 12.53 | 17 | 41850 | 1599 | 29909012 |
| Deafness | 19.49 | 12.53 | 44 | 41823 | 10281 | 29900330 |
| General physical health deterioration | 19.37 | 12.53 | 73 | 41794 | 99871 | 29810740 |
| Platelet count decreased | 19 | 12.53 | 80 | 41787 | 106049 | 29804562 |
| Retinal detachment | 19.00 | 12.53 | 29 | 41838 | 5031 | 29905580 |
| Device infusion issue | 18.97 | 12.53 | 11 | 41856 | 543 | 29910068 |
| Metabolic acidosis | 18.63 | 12.53 | 15 | 41852 | 37446 | 29873165 |
| Viral infection | 18.61 | 12.53 | 55 | 41812 | 15130 | 29895481 |
| Ocular vascular disorder | 18.38 | 12.53 | 7 | 41860 | 130 | 29910481 |
| Delirium | 18.13 | 12.53 | 18 | 41849 | 40613 | 29869998 |
| Weight increased | 18.13 | 12.53 | 172 | 41695 | 74741 | 29835870 |
| Penis disorder | 18.11 | 12.53 | 14 | 41853 | 1118 | 29909493 |
| Hypocalcaemia | 17.84 | 12.53 | 4 | 41863 | 21372 | 29889239 |
| Gout | 17.79 | 12.53 | 59 | 41808 | 17256 | 29893355 |
| Presyncope | 17.66 | 12.53 | 56 | 41811 | 16000 | 29894611 |
| Hyperglycaemia | 17.62 | 12.53 | 14 | 41853 | 35186 | 29875425 |
| Heart rate increased | 17.43 | 12.53 | 103 | 41764 | 38618 | 29871993 |
| Catheter site inflammation | 17.22 | 12.53 | 8 | 41859 | 248 | 29910363 |
| Therapy non-responder | 17.09 | 12.53 | 84 | 41783 | 29369 | 29881242 |
| Cardiac output increased | 17.05 | 12.53 | 5 | 41862 | 39 | 29910572 |
| Blood creatinine increased | 16.90 | 12.53 | 68 | 41799 | 91307 | 29819304 |
| Haemoptysis | 16.89 | 12.53 | 87 | 41780 | 30991 | 29879620 |
| Macular degeneration | 16.29 | 12.53 | 17 | 41850 | 2011 | 29908600 |
| Pyrexia | 16.25 | 12.53 | 302 | 41565 | 294187 | 29616424 |
| Drug level increased | 16.22 | 12.53 | 3 | 41864 | 18351 | 29892260 |
| Protein-losing gastroenteropathy | 16.16 | 12.53 | 8 | 41859 | 286 | 29910325 |
| Retinal vein occlusion | 16.12 | 12.53 | 15 | 41852 | 1544 | 29909067 |
| Leukocytosis | 16.10 | 12.53 | 5 | 41862 | 21497 | 29889114 |
| Hepatic function abnormal | 16.09 | 12.53 | 21 | 41846 | 41924 | 29868687 |
| Emergency care | 16.06 | 12.53 | 7 | 41860 | 186 | 29910425 |
| Acute myeloid leukaemia | 15.79 | 12.53 | 3 | 41864 | 18003 | 29892608 |
| Aggression | 15.73 | 12.53 | 17 | 41850 | 36890 | 29873721 |
| Hepatocellular injury | 15.67 | 12.53 | 8 | 41859 | 25463 | 29885148 |
| Dialysis | 15.60 | 12.53 | 42 | 41825 | 10954 | 29899657 |
| Cancer surgery | 15.38 | 12.53 | 9 | 41858 | 452 | 29910159 |
| Mitral perforation | 15.33 | 12.53 | 4 | 41863 | 19 | 29910592 |
| Biliary catheter insertion | 15.28 | 12.53 | 5 | 41862 | 58 | 29910553 |
| White blood cell count decreased | 15.19 | 12.53 | 63 | 41804 | 83884 | 29826727 |
| Dizziness exertional | 15.17 | 12.53 | 6 | 41861 | 124 | 29910487 |
| Eosinophilia | 15.13 | 12.53 | 6 | 41861 | 22154 | 29888457 |
| Disorientation | 15.10 | 12.53 | 13 | 41854 | 31405 | 29879206 |
| Complication associated with device | 15.09 | 12.53 | 28 | 41839 | 5692 | 29904919 |
| Therapeutic product effect incomplete | 15.08 | 12.53 | 15 | 41852 | 33819 | 29876792 |
| White blood cell count increased | 15.07 | 12.53 | 20 | 41847 | 39653 | 29870958 |
| Blood pressure decreased | 15.03 | 12.53 | 115 | 41752 | 46960 | 29863651 |
| Colour blindness | 14.95 | 12.53 | 7 | 41860 | 221 | 29910390 |
| Contraindicated product administered | 14.84 | 12.53 | 3 | 41864 | 17228 | 29893383 |
| Cardiac failure | 14.81 | 12.53 | 180 | 41687 | 83238 | 29827373 |
| Myelodysplastic syndrome | 14.73 | 12.53 | 4 | 41863 | 18774 | 29891837 |
| Abdominal cavity drainage | 14.72 | 12.53 | 8 | 41859 | 348 | 29910263 |
| Creatinine renal clearance abnormal | 14.72 | 12.53 | 7 | 41860 | 229 | 29910382 |
| Hypokalaemia | 14.69 | 12.53 | 30 | 41837 | 50162 | 29860449 |
| Right ventricular dilatation | 14.55 | 12.53 | 9 | 41858 | 500 | 29910111 |
| Cardioversion | 14.49 | 12.53 | 11 | 41856 | 855 | 29909756 |
| Extra dose administered | 14.48 | 12.53 | 19 | 41848 | 2867 | 29907744 |
| Scrotal haematocoele | 14.41 | 12.53 | 4 | 41863 | 25 | 29910586 |
| Cardiac disorder | 14.19 | 12.53 | 100 | 41767 | 39793 | 29870818 |
| Chloropsia | 14.19 | 12.53 | 3 | 41864 | 4 | 29910607 |
| Lower respiratory tract infection | 14.17 | 12.53 | 10 | 41857 | 26704 | 29883907 |
| Scleroderma | 14.17 | 12.53 | 13 | 41854 | 1314 | 29909297 |
| Anaphylactic reaction | 14.17 | 12.53 | 11 | 41856 | 27971 | 29882640 |
| Terminal state | 14.02 | 12.53 | 21 | 41846 | 3583 | 29907028 |
| Diuretic therapy | 14.02 | 12.53 | 4 | 41863 | 28 | 29910583 |
| Paracentesis | 14.00 | 12.53 | 8 | 41859 | 384 | 29910227 |
| Tubulointerstitial nephritis | 13.68 | 12.53 | 4 | 41863 | 17887 | 29892724 |
| Diagnostic procedure | 13.66 | 12.53 | 4 | 41863 | 31 | 29910580 |
| Hypoglycaemia | 13.66 | 12.53 | 32 | 41835 | 50949 | 29859662 |
| Arthralgia | 13.65 | 12.53 | 266 | 41601 | 135525 | 29775086 |
| Pneumonitis | 13.64 | 12.53 | 11 | 41856 | 27443 | 29883168 |
| C-reactive protein increased | 13.58 | 12.53 | 25 | 41842 | 43448 | 29867163 |
| Acute respiratory distress syndrome | 13.53 | 12.53 | 8 | 41859 | 23464 | 29887147 |
| Immunoglobulin therapy | 13.44 | 12.53 | 3 | 41864 | 6 | 29910605 |
| Systolic hypertension | 13.39 | 12.53 | 7 | 41860 | 281 | 29910330 |
| Blood lactate dehydrogenase increased | 13.39 | 12.53 | 6 | 41861 | 20595 | 29890016 |
| Drug titration error | 13.33 | 12.53 | 8 | 41859 | 421 | 29910190 |
| Hospice care | 13.29 | 12.53 | 23 | 41844 | 4429 | 29906182 |
| Gastrointestinal cancer metastatic | 13.28 | 12.53 | 5 | 41862 | 90 | 29910521 |
| Dyskinesia | 13.22 | 12.53 | 7 | 41860 | 21827 | 29888784 |
| Pulmonary arterial wedge pressure increased | 12.93 | 12.53 | 5 | 41862 | 97 | 29910514 |
| Spinal operation | 12.92 | 12.53 | 16 | 41851 | 2280 | 29908331 |
| Shock | 12.88 | 12.53 | 8 | 41859 | 22851 | 29887760 |
| Psychotic disorder | 12.88 | 12.53 | 7 | 41860 | 21508 | 29889103 |
| Influenza like illness | 12.76 | 12.53 | 70 | 41797 | 25535 | 29885076 |
| Sinus tachycardia | 12.74 | 12.53 | 3 | 41864 | 15501 | 29895110 |
| Peritonitis | 12.73 | 12.53 | 7 | 41860 | 21368 | 29889243 |
| Infusion site haemorrhage | 12.72 | 12.53 | 8 | 41859 | 458 | 29910153 |
| Vascular stent insertion | 12.58 | 12.53 | 3 | 41864 | 9 | 29910602 |
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | C02KX52 | CARDIOVASCULAR SYSTEM ANTIHYPERTENSIVES OTHER ANTIHYPERTENSIVES Antihypertensives for pulmonary arterial hypertension |
| ATC | G04BE08 | GENITO URINARY SYSTEM AND SEX HORMONES UROLOGICALS UROLOGICALS Drugs used in erectile dysfunction |
| ATC | G04CA54 | GENITO URINARY SYSTEM AND SEX HORMONES UROLOGICALS DRUGS USED IN BENIGN PROSTATIC HYPERTROPHY Alpha-adrenoreceptor antagonists |
| FDA MoA | N0000020026 | Phosphodiesterase 5 Inhibitors |
| FDA EPC | N0000175599 | Phosphodiesterase 5 Inhibitor |
| MeSH PA | D002317 | Cardiovascular Agents |
| MeSH PA | D004791 | Enzyme Inhibitors |
| MeSH PA | D058986 | Phosphodiesterase 5 Inhibitors |
| MeSH PA | D010726 | Phosphodiesterase Inhibitors |
| MeSH PA | D064804 | Urological Agents |
| MeSH PA | D014665 | Vasodilator Agents |
| CHEBI has role | CHEBI:35620 | vasodilator |
| CHEBI has role | CHEBI:71942 | pde5 inhibitors |
Drug Use (View source of the data)
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Pulmonary hypertension | indication | 70995007 | DOID:6432 |
| Benign prostatic hyperplasia | indication | 266569009 | |
| Impotence | indication | 397803000 | |
| Induratio penis plastica | contraindication | 1335005 | DOID:8616 |
| Priapism | contraindication | 6273006 | DOID:9286 |
| Hearing loss | contraindication | 15188001 | |
| Myocardial infarction | contraindication | 22298006 | DOID:5844 |
| Alcohol intoxication | contraindication | 25702006 | |
| Fibrosis of corpus cavernosum | contraindication | 32608004 | |
| Low blood pressure | contraindication | 45007003 | |
| Chronic heart failure | contraindication | 48447003 | |
| Acute nephropathy | contraindication | 58574008 | |
| Hepatic failure | contraindication | 59927004 | |
| Aortic valve stenosis | contraindication | 60573004 | DOID:1712 |
| Blood coagulation disorder | contraindication | 64779008 | DOID:1247 |
| Leukemia, disease | contraindication | 93143009 | DOID:1240 |
| Multiple myeloma | contraindication | 109989006 | DOID:9538 |
| Hb SS disease | contraindication | 127040003 | DOID:10923 |
| Seizure disorder | contraindication | 128613002 | |
| Acute peptic ulcer | contraindication | 196682000 | |
| Cerebrovascular accident | contraindication | 230690007 | |
| Penis bent | contraindication | 249247007 | |
| Exercise-induced angina | contraindication | 300995000 | |
| Functional visual loss | contraindication | 313165001 | |
| Idiopathic hypertrophic subaortic stenosis | contraindication | 360465008 | |
| Acute coronary syndrome | contraindication | 394659003 | |
| Anterior ischemic optic neuropathy | contraindication | 404659001 | |
| Hypertensive urgency | contraindication | 443482000 | |
| Pigmentary Retinopathy | contraindication | ||
| Severe Autonomic Insufficiency | contraindication | ||
| Life-Threatening Cardiac Arrhythmias | contraindication |
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 8.3 | acidic |
Orange Book patent data (new drug applications)
None
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 10MG | CIALIS | LILLY | N021368 | Nov. 21, 2003 | RX | TABLET | ORAL | Feb. 15, 2021 | INFORMATION ADDED TO THE PEDIATRIC USE SECTION OF THE LABELING REGARDING A NEW CLINICAL TRIAL IN PATIENTS 7 TO 14 YEARS OF AGE WITH DUCHENNE MUSCULAR DYSTROPHY |
| 2.5MG | CIALIS | LILLY | N021368 | Jan. 7, 2008 | RX | TABLET | ORAL | Feb. 15, 2021 | INFORMATION ADDED TO THE PEDIATRIC USE SECTION OF THE LABELING REGARDING A NEW CLINICAL TRIAL IN PATIENTS 7 TO 14 YEARS OF AGE WITH DUCHENNE MUSCULAR DYSTROPHY |
| 20MG | CIALIS | LILLY | N021368 | Nov. 21, 2003 | RX | TABLET | ORAL | Feb. 15, 2021 | INFORMATION ADDED TO THE PEDIATRIC USE SECTION OF THE LABELING REGARDING A NEW CLINICAL TRIAL IN PATIENTS 7 TO 14 YEARS OF AGE WITH DUCHENNE MUSCULAR DYSTROPHY |
| 5MG | CIALIS | LILLY | N021368 | Nov. 21, 2003 | RX | TABLET | ORAL | Feb. 15, 2021 | INFORMATION ADDED TO THE PEDIATRIC USE SECTION OF THE LABELING REGARDING A NEW CLINICAL TRIAL IN PATIENTS 7 TO 14 YEARS OF AGE WITH DUCHENNE MUSCULAR DYSTROPHY |
| 10MG | CIALIS | LILLY | N021368 | Nov. 21, 2003 | RX | TABLET | ORAL | Aug. 15, 2021 | PEDIATRIC EXCLUSIVITY |
| 2.5MG | CIALIS | LILLY | N021368 | Jan. 7, 2008 | RX | TABLET | ORAL | Aug. 15, 2021 | PEDIATRIC EXCLUSIVITY |
| 20MG | CIALIS | LILLY | N021368 | Nov. 21, 2003 | RX | TABLET | ORAL | Aug. 15, 2021 | PEDIATRIC EXCLUSIVITY |
| 5MG | CIALIS | LILLY | N021368 | Nov. 21, 2003 | RX | TABLET | ORAL | Aug. 15, 2021 | PEDIATRIC EXCLUSIVITY |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| cGMP-specific 3',5'-cyclic phosphodiesterase | Enzyme | INHIBITOR | Ki | 8 | CHEMBL | CHEMBL | |||
| Phosphodiesterase 6 | Enzyme | IC50 | 6.01 | CHEMBL | |||||
| Potassium voltage-gated channel subfamily H member 2 | Ion channel | IC50 | 4 | CHEMBL | |||||
| Dual 3',5'-cyclic-AMP and -GMP phosphodiesterase 11A | Enzyme | IC50 | 7.48 | CHEMBL | |||||
| cGMP-specific 3',5'-cyclic phosphodiesterase | Enzyme | Ki | 8.30 | CHEMBL | |||||
| Rod cGMP-specific 3',5'-cyclic phosphodiesterase subunit alpha | Enzyme | IC50 | 5.52 | CHEMBL | |||||
| Phosphodiesterase 6 | Enzyme | IC50 | 5.29 | CHEMBL | |||||
| cGMP-specific 3',5'-cyclic phosphodiesterase | Enzyme | IC50 | 8.48 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4021415 | VUID |
| N0000148829 | NUI |
| D02008 | KEGG_DRUG |
| 4021415 | VANDF |
| C1176316 | UMLSCUI |
| CHEBI:71940 | CHEBI |
| CIA | PDB_CHEM_ID |
| CHEMBL779 | ChEMBL_ID |
| D000068581 | MESH_DESCRIPTOR_UI |
| 110635 | PUBCHEM_CID |
| 8136 | INN_ID |
| DB00820 | DRUGBANK_ID |
| 742SXX0ICT | UNII |
| 7299 | IUPHAR_LIGAND_ID |
| 303263 | RXNORM |
| 17580 | MMSL |
| 245338 | MMSL |
| 47489 | MMSL |
| d04896 | MMSL |
| 009874 | NDDF |
| 407111005 | SNOMEDCT_US |
| 407734006 | SNOMEDCT_US |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Cialis | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0002-4462 | TABLET, FILM COATED | 5 mg | ORAL | NDA | 34 sections |
| Cialis | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0002-4463 | TABLET, FILM COATED | 10 mg | ORAL | NDA | 34 sections |
| Cialis | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0002-4464 | TABLET, FILM COATED | 20 mg | ORAL | NDA | 34 sections |
| Cialis | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0002-4465 | TABLET, FILM COATED | 2.50 mg | ORAL | NDA | 34 sections |
| Tadalafil | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0093-3016 | TABLET, FILM COATED | 2.50 mg | ORAL | ANDA | 28 sections |
| Tadalafil | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0093-3017 | TABLET, FILM COATED | 5 mg | ORAL | ANDA | 28 sections |
| Tadalafil | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0093-3018 | TABLET, FILM COATED | 10 mg | ORAL | ANDA | 28 sections |
| Tadalafil | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0093-3019 | TABLET, FILM COATED | 20 mg | ORAL | ANDA | 28 sections |
| ALYQ | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0093-3334 | TABLET, FILM COATED | 20 mg | ORAL | ANDA | 27 sections |
| Tadalafil | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-6970 | TABLET, FILM COATED | 2.50 mg | ORAL | ANDA | 30 sections |
| Tadalafil | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-6972 | TABLET, FILM COATED | 10 mg | ORAL | ANDA | 30 sections |
| Tadalafil | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-6973 | TABLET, FILM COATED | 20 mg | ORAL | ANDA | 30 sections |
| Tadalafil | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-6976 | TABLET, FILM COATED | 20 mg | ORAL | ANDA | 29 sections |
| TADALAFIL | HUMAN PRESCRIPTION DRUG LABEL | 1 | 13668-565 | TABLET | 2.50 mg | ORAL | ANDA | 25 sections |
| TADALAFIL | HUMAN PRESCRIPTION DRUG LABEL | 1 | 13668-566 | TABLET | 5 mg | ORAL | ANDA | 25 sections |
| TADALAFIL | HUMAN PRESCRIPTION DRUG LABEL | 1 | 13668-567 | TABLET | 10 mg | ORAL | ANDA | 25 sections |
| TADALAFIL | HUMAN PRESCRIPTION DRUG LABEL | 1 | 13668-568 | TABLET | 20 mg | ORAL | ANDA | 25 sections |
| TADALAFIL | HUMAN PRESCRIPTION DRUG LABEL | 1 | 13668-581 | TABLET | 20 mg | ORAL | ANDA | 29 sections |
| CIALIS | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16590-905 | TABLET, FILM COATED | 10 mg | ORAL | NDA | 31 sections |
| Tadalafil | Human Prescription Drug Label | 1 | 16714-074 | TABLET, FILM COATED | 2.50 mg | ORAL | ANDA | 28 sections |
| Tadalafil | Human Prescription Drug Label | 1 | 16714-075 | TABLET, FILM COATED | 5 mg | ORAL | ANDA | 28 sections |
| Tadalafil | Human Prescription Drug Label | 1 | 16714-076 | TABLET, FILM COATED | 10 mg | ORAL | ANDA | 28 sections |
| Tadalafil | Human Prescription Drug Label | 1 | 16714-077 | TABLET, FILM COATED | 20 mg | ORAL | ANDA | 28 sections |
| Tadalafil | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-369 | TABLET, FILM COATED | 2.50 mg | ORAL | ANDA | 30 sections |
| Tadalafil | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-370 | TABLET, FILM COATED | 5 mg | ORAL | ANDA | 30 sections |
| Tadalafil | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-371 | TABLET, FILM COATED | 10 mg | ORAL | ANDA | 30 sections |
| Tadalafil | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-372 | TABLET, FILM COATED | 20 mg | ORAL | ANDA | 30 sections |
| Cialis | HUMAN PRESCRIPTION DRUG LABEL | 1 | 21695-028 | TABLET, FILM COATED | 10 mg | ORAL | NDA | 30 sections |
| Cialis | HUMAN PRESCRIPTION DRUG LABEL | 1 | 21695-029 | TABLET, FILM COATED | 20 mg | ORAL | NDA | 30 sections |
| Tadalafil | Human Prescription Drug Label | 1 | 27241-111 | TABLET | 2.50 mg | ORAL | ANDA | 29 sections |