tadalafil Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
inhibitors of phosphodiesterase PDE5 with vasodilator action 2553 171596-29-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • zalutia
  • tadalafil
  • tardenafil
  • tildenafil
  • cialis
  • IC351
A carboline derivative and PHOSPHODIESTERASE 5 INHIBITOR that is used primarily to treat ERECTILE DYSFUNCTION; BENIGN PROSTATIC HYPERPLASIA and PRIMARY PULMONARY HYPERTENSION.
  • Molecular weight: 389.41
  • Formula: C22H19N3O4
  • CLOGP: 2.58
  • LIPINSKI: 0
  • HAC: 7
  • HDO: 1
  • TPSA: 74.87
  • ALOGS: -3.19
  • ROTB: 1

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
10 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.73 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 16 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
Nov. 21, 2003 FDA LILLY

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
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:

SourceCodeDescription
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)

DiseaseRelationSNOMED_IDDOID
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 levelDissociation constantType (acidic/basic)
pKa1 8.3 acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA 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:

IDSource
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:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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