tamsulosin ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
antihypertensive substances, prazosin derivatives 2562 106133-20-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • tamsulosin
  • tamsulosin hydrochloride
  • tamsulosin HCl
  • LY-253352
A sulfonamide derivative and adrenergic alpha-1 receptor antagonist that is used to relieve symptoms of urinary obstruction caused by BENIGN PROSTATIC HYPERPLASIA.
  • Molecular weight: 408.51
  • Formula: C20H28N2O5S
  • CLOGP: 2.17
  • LIPINSKI: 0
  • HAC: 7
  • HDO: 2
  • TPSA: 99.88
  • ALOGS: -4.79
  • ROTB: 11

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.40 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 8.70 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.03 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 99 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.21 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 0.62 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.01 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 6.80 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
April 15, 1997 FDA BOEHRINGER INGELHEIM

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
Nephrolithiasis 168.39 14.70 88 7334 34605 50563097
Urinary tract infection 87.92 14.70 134 7288 223886 50373816
Multiple sclerosis relapse 70.62 14.70 55 7367 42909 50554793
Residual urine volume increased 44.38 14.70 7 7415 24 50597678
Urinary retention 44.04 14.70 34 7388 26156 50571546
Ligament pain 37.31 14.70 8 7414 182 50597520
Renal colic 34.59 14.70 11 7411 1198 50596504
Respiratory tract inflammation 33.68 14.70 9 7413 531 50597171
Multiple sclerosis 31.00 14.70 25 7397 20468 50577234
Drug ineffective 29.41 14.70 47 7375 819286 49778416
Pertussis 27.69 14.70 8 7414 630 50597072
Progressive multifocal leukoencephalopathy 26.38 14.70 18 7404 11439 50586263
Sinus pain 24.40 14.70 10 7412 2251 50595451
Disorganised speech 24.21 14.70 8 7414 983 50596719
Urinary tract obstruction 23.29 14.70 9 7413 1739 50595963
Renal stone removal 22.83 14.70 5 7417 126 50597576
Immune reconstitution inflammatory syndrome 21.18 14.70 12 7410 5504 50592198
Hydronephrosis 21.06 14.70 14 7408 8527 50589175
Chorioretinitis 20.88 14.70 6 7416 463 50597239
Flank pain 19.83 14.70 16 7406 13099 50584603
Iris disorder 19.54 14.70 4 7418 72 50597630
Rheumatoid arthritis 17.73 14.70 4 7418 202546 50395156
Fall 16.92 14.70 95 7327 334837 50262865
Central nervous system stimulation 16.79 14.70 3 7419 25 50597677
Erythropenia 16.51 14.70 4 7418 159 50597543
Heparin-induced thrombocytopenia 16.24 14.70 9 7413 3956 50593746
Hypertensive nephropathy 16.23 14.70 5 7417 491 50597211
Product use issue 15.78 14.70 53 7369 149422 50448280
Tendon pain 15.70 14.70 8 7414 2970 50594732
Orthopnoea 15.68 14.70 10 7412 5679 50592023
Central nervous system lesion 15.25 14.70 12 7410 9477 50588225
Product use in unapproved indication 14.91 14.70 44 7378 115775 50481927

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
Iris disorder 735.54 10.68 197 151041 145 29423144
Fall 354.07 10.68 1814 149424 175364 29247925
Dizziness 337.48 10.68 1881 149357 187803 29235486
Urinary retention 324.55 10.68 584 150654 31314 29391975
Cataract operation complication 248.51 10.68 71 151167 85 29423204
Orthostatic hypotension 242.62 10.68 424 150814 22205 29401084
Drug abuse 224.42 10.68 65 151173 79818 29343471
Iridocele 222.06 10.68 57 151181 27 29423262
Syncope 215.07 10.68 905 150333 80466 29342823
Toxicity to various agents 206.67 10.68 357 150881 173304 29249985
Urinary tract infection 196.87 10.68 812 150426 71542 29351747
Procedural complication 171.41 10.68 152 151086 3908 29419381
Dysuria 157.48 10.68 352 150886 22088 29401201
Floppy iris syndrome 149.33 10.68 57 151181 250 29423039
Idiopathic pulmonary fibrosis 144.61 10.68 124 151114 3044 29420245
Completed suicide 131.25 10.68 161 151077 90085 29333204
Product prescribing error 123.91 10.68 280 150958 17696 29405593
Pollakiuria 120.53 10.68 267 150971 16649 29406640
Benign prostatic hyperplasia 114.71 10.68 211 151027 11499 29411790
Fatigue 108.08 10.68 2243 148995 314578 29108711
Drug ineffective 107.22 10.68 1266 149972 361904 29061385
Off label use 101.33 10.68 1017 150221 299783 29123506
Nocturia 99.26 10.68 164 151074 8198 29415091
Multiple organ dysfunction syndrome 96.68 10.68 108 151130 63008 29360281
Micturition urgency 89.45 10.68 121 151117 5052 29418237
Retrograde ejaculation 88.78 10.68 40 151198 286 29423003
Urinary incontinence 86.26 10.68 231 151007 16250 29407039
Asthenia 83.67 10.68 1555 149683 213695 29209594
Atrial fibrillation 82.28 10.68 864 150374 104782 29318507
Drug resistance 81.21 10.68 8 151230 21532 29401757
Febrile neutropenia 78.93 10.68 301 150937 111939 29311350
Haematuria 78.23 10.68 438 150800 43701 29379588
Intentional overdose 69.39 10.68 57 151181 38471 29384818
Pupillary disorder 66.84 10.68 31 151207 239 29423050
Hallucination 66.62 10.68 424 150814 44288 29379001
Presyncope 66.31 10.68 207 151031 15882 29407407
Treatment failure 63.66 10.68 57 151181 36882 29386407
Product monitoring error 58.61 10.68 70 151168 2575 29420714
Balance disorder 58.27 10.68 350 150888 35820 29387469
Cardio-respiratory arrest 58.24 10.68 106 151132 50495 29372794
Confusional state 57.89 10.68 947 150291 126930 29296359
Cytomegalovirus infection 56.38 10.68 24 151214 23191 29400098
Hypotension 55.89 10.68 1344 149894 193010 29230279
Prostatomegaly 54.76 10.68 91 151147 4570 29418719
Urogenital haemorrhage 54.58 10.68 33 151205 457 29422832
Right atrial hypertrophy 54.01 10.68 34 151204 508 29422781
Dyspnoea 53.41 10.68 2108 149130 324624 29098665
Drug dependence 52.07 10.68 21 151217 20960 29402329
Suicide attempt 51.52 10.68 59 151179 34051 29389238
Thrombocytopenia 51.15 10.68 442 150796 134381 29288908
Labelled drug-drug interaction medication error 50.63 10.68 157 151081 12002 29411287
Prostatic disorder 50.34 10.68 68 151170 2835 29420454
Abdominal pain lower 50.26 10.68 126 151112 8512 29414777
General physical health deterioration 50.03 10.68 771 150467 102086 29321203
Miosis 49.98 10.68 120 151118 7889 29415400
Urine flow decreased 49.95 10.68 43 151195 1061 29422228
Leukopenia 47.05 10.68 136 151102 55067 29368222
Respiratory arrest 46.79 10.68 38 151200 25795 29397494
Prostatic specific antigen increased 45.78 10.68 155 151083 12409 29410880
Peripheral swelling 45.28 10.68 512 150726 63227 29360062
Pyrexia 44.41 10.68 1126 150112 286496 29136793
Bradycardia 44.30 10.68 522 150716 65107 29358182
Alanine aminotransferase increased 42.60 10.68 202 151036 70742 29352547
Ocular procedural complication 42.25 10.68 15 151223 51 29423238
Constipation 42.24 10.68 819 150419 113341 29309948
Overdose 41.35 10.68 239 150999 79580 29343709
Prostate cancer 41.10 10.68 247 150991 25280 29398009
Cardiac arrest 40.83 10.68 263 150975 85328 29337961
Memory impairment 38.79 10.68 319 150919 36151 29387138
Hypertonic bladder 38.11 10.68 42 151196 1414 29421875
Plasma cell myeloma 37.53 10.68 321 150917 36794 29386495
Aortic valve stenosis 37.19 10.68 51 151187 2157 29421132
Ejaculation failure 37.01 10.68 31 151207 736 29422553
Needle fatigue 36.98 10.68 28 151210 572 29422717
Bronchial secretion retention 36.85 10.68 37 151201 1116 29422173
Bone marrow failure 36.76 10.68 52 151186 27397 29395892
Right ventricular hypertrophy 36.64 10.68 37 151201 1124 29422165
Neutropenia 36.40 10.68 465 150773 131246 29292043
Hepatic failure 36.26 10.68 66 151172 31446 29391843
Bladder disorder 36.16 10.68 57 151181 2737 29420552
Cataract operation 36.04 10.68 36 151202 1079 29422210
Drug reaction with eosinophilia and systemic symptoms 35.56 10.68 55 151183 27937 29395352
Orbital myositis 35.56 10.68 16 151222 114 29423175
Pulmonary function test abnormal 34.94 10.68 48 151190 2034 29421255
Mucosal inflammation 34.75 10.68 68 151170 31527 29391762
Hospice care 33.87 10.68 78 151160 4990 29418299
Haematoma 33.86 10.68 219 151019 22993 29400296
Cystitis 33.54 10.68 106 151132 8186 29415103
Gait spastic 33.53 10.68 28 151210 662 29422627
Cataract 33.18 10.68 212 151026 22166 29401123
Hypoacusis 33.15 10.68 154 151084 14269 29409020
Bladder spasm 32.82 10.68 30 151208 803 29422486
Aspergillus infection 32.80 10.68 7 151231 10574 29412715
Congenital hiatus hernia 32.62 10.68 23 151215 419 29422870
Myelosuppression 32.42 10.68 11 151227 12216 29411073
Haematochezia 32.37 10.68 310 150928 36673 29386616
Bronchial wall thickening 32.24 10.68 33 151205 1019 29422270
Plasmapheresis 32.17 10.68 20 151218 292 29422997
Relapsing-remitting multiple sclerosis 32.09 10.68 28 151210 704 29422585
Full blood count decreased 31.92 10.68 164 151074 15828 29407461
Hormone receptor positive breast cancer 31.60 10.68 10 151228 21 29423268
Gait disturbance 31.59 10.68 539 150699 72810 29350479
Intentional product use issue 31.12 10.68 112 151126 42386 29380903
Lower urinary tract symptoms 30.65 10.68 17 151221 198 29423091
Haemophagocytic lymphohistiocytosis 30.49 10.68 8 151230 10496 29412793
Vitreous loss 30.39 10.68 8 151230 5 29423284
Coma 30.21 10.68 102 151136 39348 29383941
Nephrolithiasis 29.90 10.68 227 151011 25107 29398182
Product substitution issue 29.83 10.68 109 151129 9063 29414226
Graft versus host disease 28.59 10.68 7 151231 9621 29413668
Vomiting 28.54 10.68 847 150391 211413 29211876
Synovitis 28.52 10.68 10 151228 10880 29412409
Poisoning 28.27 10.68 8 151230 9985 29413304
Erectile dysfunction 28.19 10.68 173 151065 17836 29405453
Chronic obstructive pulmonary disease 28.17 10.68 327 150911 40628 29382661
Wound 27.87 10.68 129 151109 11934 29411355
Disseminated intravascular coagulation 27.61 10.68 37 151201 19943 29403346
Contusion 27.38 10.68 261 150977 30834 29392455
Obstruction 27.33 10.68 41 151197 1885 29421404
Muscular weakness 27.09 10.68 457 150781 61595 29361694
Dacryocystitis 26.98 10.68 8 151230 12 29423277
Hepatic vein dilatation 26.81 10.68 16 151222 216 29423073
Prostatitis 26.79 10.68 68 151170 4629 29418660
Seizure 26.74 10.68 326 150912 92797 29330492
Priapism 26.67 10.68 66 151172 4422 29418867
Septic shock 26.49 10.68 199 151039 62361 29360928
Adverse drug reaction 26.02 10.68 211 151027 23809 29399480
Vertigo 25.86 10.68 196 151042 21665 29401624
Ascites 25.83 10.68 98 151140 36521 29386768
Infusion related reaction 25.72 10.68 126 151112 43760 29379529
Bladder catheterisation 25.52 10.68 21 151217 486 29422803
Drug intolerance 25.50 10.68 144 151094 48235 29375054
Pancytopenia 25.48 10.68 287 150951 82881 29340408
Hot flush 25.30 10.68 146 151092 14724 29408565
Hepatic cytolysis 24.92 10.68 6 151232 8341 29414948
Hepatotoxicity 24.77 10.68 33 151205 17834 29405455
Hepatitis 24.38 10.68 43 151195 20740 29402549
Atrial septal defect 24.38 10.68 3 151235 6786 29416503
Head injury 24.24 10.68 153 151085 15928 29407361
Therapy non-responder 23.61 10.68 80 151158 30831 29392458
Milk-alkali syndrome 22.95 10.68 20 151218 502 29422787
Dementia 22.88 10.68 119 151119 11539 29411750
Muscle spasms 22.73 10.68 463 150775 64619 29358670
Nipple pain 22.49 10.68 21 151217 578 29422711
Palpitations 22.28 10.68 260 150978 32344 29390945
Pneumocystis jirovecii pneumonia 22.25 10.68 32 151206 16747 29406542
Factitious disorder 22.16 10.68 9 151229 48 29423241
Prostatic mass 22.14 10.68 8 151230 29 29423260
C-reactive protein increased 22.13 10.68 134 151104 44129 29379160
Pancreatitis 22.06 10.68 96 151142 34418 29388871
Intentional self-injury 21.74 10.68 19 151219 12442 29410847
Bladder cancer 21.72 10.68 106 151132 10021 29413268
Product use in unapproved indication 21.70 10.68 313 150925 86562 29336727
Platypnoea 21.54 10.68 8 151230 32 29423257
Loss of consciousness 21.47 10.68 513 150725 73543 29349746
Oedema peripheral 21.46 10.68 687 150551 102870 29320419
Drug hypersensitivity 21.37 10.68 235 151003 68171 29355118
Liver palpable 21.19 10.68 15 151223 275 29423014
Acute hepatic failure 21.12 10.68 18 151220 11934 29411355
Cornea verticillata 20.97 10.68 8 151230 35 29423254
Brain oedema 20.88 10.68 19 151219 12201 29411088
Immune reconstitution inflammatory syndrome 20.72 10.68 7 151231 7795 29415494
Status epilepticus 20.66 10.68 15 151223 10779 29412510
Hepatic function abnormal 20.61 10.68 117 151121 39142 29384147
Back pain 20.53 10.68 676 150562 101608 29321681
Cytomegalovirus viraemia 19.96 10.68 4 151234 6316 29416973
Hip fracture 19.84 10.68 106 151132 10386 29412903
Fractional exhaled nitric oxide increased 19.82 10.68 16 151222 360 29422929
Idiopathic interstitial pneumonia 19.70 10.68 11 151227 130 29423159
Cardiogenic shock 19.66 10.68 43 151195 19147 29404142
Lacunar stroke 19.48 10.68 11 151227 133 29423156
Blood bilirubin increased 19.46 10.68 98 151140 33795 29389494
Candida infection 19.26 10.68 30 151208 15195 29408094
Atrial enlargement 19.14 10.68 15 151223 323 29422966
Gait inability 19.14 10.68 160 151078 18215 29405074
Psychotic disorder 18.94 10.68 48 151190 20306 29402983
Agranulocytosis 18.91 10.68 48 151190 20292 29402997
Wrong schedule 18.86 10.68 11 151227 142 29423147
Post micturition dribble 18.84 10.68 6 151232 13 29423276
Dysgeusia 18.82 10.68 188 151050 22486 29400803
Aspartate aminotransferase increased 18.73 10.68 205 151033 59520 29363769
Stomal hernia 18.66 10.68 11 151227 145 29423144
Dizziness postural 18.49 10.68 65 151173 5302 29417987
Drug eruption 18.43 10.68 36 151202 16705 29406584
Sleep apnoea syndrome 18.20 10.68 153 151085 17446 29405843
Urinary tract obstruction 18.05 10.68 47 151191 3250 29420039
Diabetic neuropathy 18.04 10.68 51 151187 3702 29419587
Urosepsis 17.95 10.68 105 151133 10641 29412648
Dyspnoea exertional 17.88 10.68 274 150964 36216 29387073
Perineal pain 17.83 10.68 21 151217 761 29422528
Intentional product misuse 17.82 10.68 104 151134 34557 29388732
Blood creatine phosphokinase increased 17.82 10.68 128 151110 40516 29382773
Haematotoxicity 17.81 10.68 6 151232 6693 29416596
Hepatomegaly 17.76 10.68 13 151225 9304 29413985
Subdural haematoma 17.68 10.68 156 151082 18037 29405252
Muscle spasticity 17.57 10.68 60 151178 4823 29418466
Stress 17.54 10.68 54 151184 21436 29401853
Iris haemorrhage 17.49 10.68 5 151233 6 29423283
Rectal prolapse 17.49 10.68 13 151225 258 29423031
Ventricular fibrillation 17.47 10.68 34 151204 15799 29407490
Pathogen resistance 17.28 10.68 10 151228 8106 29415183
Bladder neck obstruction 17.15 10.68 10 151228 129 29423160
Haematospermia 17.05 10.68 14 151224 323 29422966
Therapy partial responder 17.04 10.68 3 151235 5196 29418093
Intestinal haemorrhage 16.96 10.68 44 151194 3035 29420254
Serum ferritin abnormal 16.96 10.68 12 151226 220 29423069
Myocardial infarction 16.88 10.68 432 150806 109864 29313425
Full blood count abnormal 16.87 10.68 133 151105 14880 29408409
Dry mouth 16.84 10.68 178 151060 21606 29401683
Renal failure 16.72 10.68 470 150768 118129 29305160
Thrombotic microangiopathy 16.70 10.68 12 151226 8669 29414620
Dacryostenosis acquired 16.61 10.68 11 151227 180 29423109
Resting tremor 16.50 10.68 18 151220 599 29422690
Bladder discomfort 16.44 10.68 9 151229 102 29423187
Hyponatraemic syndrome 16.41 10.68 11 151227 184 29423105
Aplastic anaemia 16.35 10.68 9 151229 7501 29415788
Akathisia 16.32 10.68 7 151231 6735 29416554
Post transplant lymphoproliferative disorder 16.30 10.68 4 151234 5489 29417800
Peritonitis 16.22 10.68 32 151206 14792 29408497
Phaeochromocytoma malignant 16.20 10.68 8 151230 72 29423217
Arteriovenous fistula 16.16 10.68 19 151219 687 29422602
Puncture site haematoma 16.08 10.68 10 151228 146 29423143
Iris atrophy 16.01 10.68 8 151230 74 29423215
Tongue dry 16.00 10.68 11 151227 192 29423097
Colitis 15.93 10.68 94 151144 31154 29392135
Bronchopulmonary aspergillosis 15.92 10.68 24 151214 12320 29410969
Genital swelling 15.91 10.68 10 151228 149 29423140
Breast tenderness 15.86 10.68 19 151219 701 29422588
Urinary hesitation 15.84 10.68 35 151203 2178 29421111
Transaminases increased 15.75 10.68 61 151177 22601 29400688
Narrow anterior chamber angle 15.71 10.68 9 151229 112 29423177
Herpes simplex 15.65 10.68 3 151235 4887 29418402
Cytokine release syndrome 15.52 10.68 27 151211 13092 29410197
Diastolic dysfunction 15.48 10.68 59 151179 5005 29418284
Burning feet syndrome 15.47 10.68 8 151230 80 29423209
Bladder outlet obstruction 15.46 10.68 10 151228 157 29423132
Blood urine present 15.45 10.68 94 151144 9661 29413628
Cystitis haemorrhagic 15.43 10.68 3 151235 4839 29418450
Tubulointerstitial nephritis 15.36 10.68 43 151195 17600 29405689
Posterior reversible encephalopathy syndrome 15.28 10.68 14 151224 8962 29414327
Flatulence 15.27 10.68 148 151090 17561 29405728
Mydriasis 15.24 10.68 6 151232 6079 29417210
Inferior vena cava dilatation 15.14 10.68 18 151220 659 29422630
Testicular swelling 15.02 10.68 25 151213 1257 29422032
Intervertebral disc degeneration 15.01 10.68 60 151178 5204 29418085
Lymphopenia 14.99 10.68 29 151209 13504 29409785
Prostatic obstruction 14.93 10.68 9 151229 124 29423165
Device dislocation 14.89 10.68 54 151184 4473 29418816
Periorbital haematoma 14.86 10.68 13 151225 328 29422961
Prostatic operation 14.83 10.68 13 151225 329 29422960
BK virus infection 14.83 10.68 3 151235 4704 29418585
Paraplegia 14.78 10.68 37 151201 2497 29420792
Nephropathy toxic 14.78 10.68 20 151218 10736 29412553
Suprapubic pain 14.57 10.68 13 151225 337 29422952
Acute respiratory distress syndrome 14.53 10.68 64 151174 22871 29400418
Disease recurrence 14.45 10.68 38 151200 15876 29407413
Faeces discoloured 14.30 10.68 117 151121 13234 29410055
Subdural hygroma 14.25 10.68 12 151226 287 29423002
Benign gastrointestinal neoplasm 14.21 10.68 9 151229 136 29423153
Respiratory distress 14.12 10.68 101 151137 32005 29391284
Taste disorder 14.08 10.68 55 151183 4721 29418568
Extrapyramidal disorder 14.03 10.68 21 151217 10810 29412479
Guillain-Barre syndrome 13.91 10.68 57 151181 5001 29418288
Tuberculosis 13.77 10.68 10 151228 7186 29416103
Blood glucose fluctuation 13.66 10.68 45 151193 3552 29419737
Bladder dysfunction 13.55 10.68 12 151226 308 29422981
Umbilical hernia 13.53 10.68 46 151192 3689 29419600
Sepsis 13.53 10.68 594 150644 142088 29281201
Transient ischaemic attack 13.50 10.68 180 151058 23090 29400199
Acquired haemophilia 13.49 10.68 19 151219 824 29422465
Blood pressure systolic 13.49 10.68 4 151234 6 29423283
Neutrophil count decreased 13.47 10.68 150 151088 43417 29379872
Bronchiectasis 13.47 10.68 68 151170 6517 29416772
Oesophageal rupture 13.45 10.68 13 151225 374 29422915
Ageusia 13.45 10.68 85 151153 8853 29414436
Arteriosclerotic gangrene 13.37 10.68 7 151231 72 29423217
Granulocytopenia 13.32 10.68 7 151231 5987 29417302
Product use issue 13.32 10.68 184 151054 51260 29372029
Aortic stenosis 13.28 10.68 47 151191 3847 29419442
Ventricular enlargement 13.22 10.68 14 151224 450 29422839
Pulmonary tuberculosis 13.08 10.68 3 151235 4312 29418977
Klebsiella infection 13.07 10.68 11 151227 7338 29415951
Vena cava injury 13.05 10.68 10 151228 208 29423081
Cardiotoxicity 13.05 10.68 4 151234 4740 29418549
Gout 12.98 10.68 138 151100 16773 29406516
Renal cyst haemorrhage 12.95 10.68 13 151225 392 29422897
Intraductal papillary mucinous neoplasm 12.92 10.68 12 151226 328 29422961
Dental restoration failure 12.91 10.68 5 151233 23 29423266
Femoral artery aneurysm 12.91 10.68 9 151229 161 29423128
Drug ineffective for unapproved indication 12.86 10.68 34 151204 14180 29409109
Renal haematoma 12.85 10.68 14 151224 465 29422824
Vertigo CNS origin 12.84 10.68 3 151235 0 29423289
Iris injury 12.84 10.68 3 151235 0 29423289
Macular degeneration 12.84 10.68 29 151209 1831 29421458
Diarrhoea 12.80 10.68 1913 149325 330785 29092504
Venoocclusive liver disease 12.74 10.68 10 151228 6907 29416382
Hepatic enzyme increased 12.70 10.68 111 151127 33688 29389601
Systemic infection 12.59 10.68 31 151207 2070 29421219
Pharyngeal cancer 12.57 10.68 5 151233 25 29423264
Hydronephrosis 12.51 10.68 82 151156 8648 29414641
Radiation inflammation 12.50 10.68 10 151228 222 29423067
Respiratory depression 12.50 10.68 32 151206 13491 29409798
SARS-CoV-2 antibody test positive 12.47 10.68 10 151228 223 29423066
Injection site pain 12.44 10.68 106 151132 32340 29390949
Monoparesis 12.40 10.68 29 151209 1874 29421415
Aggression 12.37 10.68 119 151119 35422 29387867
Cardiac disorder 12.31 10.68 263 150975 37000 29386289
Invasive ductal breast carcinoma 12.16 10.68 4 151234 10 29423279
Choroidal detachment 12.14 10.68 12 151226 355 29422934
Prostate cancer metastatic 12.14 10.68 54 151184 4912 29418377
Obstructive airways disorder 12.05 10.68 97 151141 10919 29412370
Hyperammonaemia 12.02 10.68 7 151231 5656 29417633
Tendon discomfort 11.95 10.68 10 151228 237 29423052
Accidental exposure to product 11.94 10.68 23 151215 10730 29412559
Toxic epidermal necrolysis 11.90 10.68 50 151188 18103 29405186
Wound haematoma 11.87 10.68 6 151232 57 29423232
Urinary bladder haemorrhage 11.85 10.68 26 151212 1610 29421679
Kidney transplant rejection 11.84 10.68 11 151227 6994 29416295
Stomatitis 11.78 10.68 127 151111 36986 29386303
Inadequate osteointegration 11.64 10.68 4 151234 12 29423277
Diabetes mellitus 11.59 10.68 139 151099 39692 29383597
Drug level increased 11.55 10.68 53 151185 18734 29404555
Prostatism 11.41 10.68 10 151228 253 29423036
Liver disorder 11.39 10.68 89 151149 27660 29395629
Malignant neoplasm progression 11.37 10.68 289 150949 73570 29349719
Mouth swelling 11.36 10.68 25 151213 1551 29421738
Skin laceration 11.35 10.68 96 151142 10966 29412323
Suicidal ideation 11.34 10.68 118 151120 34598 29388691
Micturition disorder 11.34 10.68 28 151210 1873 29421416
Dysstasia 11.33 10.68 92 151146 10382 29412907
Anal incontinence 11.28 10.68 65 151173 6550 29416739
Circadian rhythm sleep disorder 11.28 10.68 12 151226 388 29422901
Faecaloma 11.28 10.68 47 151191 4155 29419134
Inflammation 11.26 10.68 69 151169 22659 29400630
Wound haemorrhage 11.19 10.68 27 151211 1780 29421509
Bladder pain 11.17 10.68 13 151225 465 29422824
Metabolic acidosis 11.12 10.68 131 151107 37531 29385758
Respiratory failure 11.01 10.68 396 150842 96735 29326554
Stoma complication 10.99 10.68 9 151229 207 29423082
Alveolar bone resorption 10.97 10.68 4 151234 15 29423274
Blood chloride abnormal 10.97 10.68 4 151234 15 29423274
Lichen sclerosus 10.97 10.68 4 151234 15 29423274
Transplant rejection 10.86 10.68 19 151219 9193 29414096
Rib fracture 10.82 10.68 106 151132 12612 29410677
Food aversion 10.82 10.68 11 151227 337 29422952
Food refusal 10.80 10.68 8 151230 158 29423131
Anorectal operation 10.78 10.68 3 151235 3 29423286
Sperm concentration zero 10.78 10.68 3 151235 3 29423286
Inappropriate antidiuretic hormone secretion 10.76 10.68 94 151144 10838 29412451
Pallor 10.74 10.68 159 151079 20865 29402424
Orthostatic intolerance 10.72 10.68 15 151223 647 29422642

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Iris disorder 542.38 9.96 128 129288 213 64369103
Urinary retention 430.15 9.96 512 128904 48689 64320627
Syncope 293.90 9.96 836 128580 156799 64212517
Fall 270.04 9.96 1590 127826 415236 63954080
Dizziness 245.95 9.96 1589 127827 428574 63940742
Benign prostatic hyperplasia 228.79 9.96 171 129245 8994 64360322
Orthostatic hypotension 225.08 9.96 365 129051 46373 64322943
Drug ineffective 222.81 9.96 901 128515 839346 63529970
Idiopathic pulmonary fibrosis 221.17 9.96 121 129295 3679 64365637
Cataract operation complication 207.50 9.96 57 129359 220 64369096
Haematuria 203.60 9.96 404 129012 60067 64309249
Atrial fibrillation 178.49 9.96 748 128668 170341 64198975
Product prescribing error 176.05 9.96 280 129136 34989 64334327
Maternal exposure during pregnancy 173.04 9.96 4 129412 95880 64273436
Iridocele 169.35 9.96 36 129380 24 64369292
Synovitis 165.26 9.96 8 129408 99082 64270234
Dysuria 161.28 9.96 297 129119 41760 64327556
Drug intolerance 136.94 9.96 106 129310 187886 64181430
Prostate cancer 136.36 9.96 183 129233 19612 64349704
Rheumatoid arthritis 129.68 9.96 85 129331 164209 64205107
Alopecia 127.72 9.96 88 129328 165602 64203714
Pollakiuria 123.84 9.96 225 129191 31305 64338011
Joint swelling 123.75 9.96 150 129266 215232 64154084
Hallucination 122.05 9.96 372 129044 72416 64296900
Toxicity to various agents 120.02 9.96 354 129062 363159 64006157
Floppy iris syndrome 118.92 9.96 39 129377 306 64369010
Systemic lupus erythematosus 115.66 9.96 11 129405 77601 64291715
Hypotension 115.56 9.96 1220 128196 379754 63989562
Bradycardia 114.84 9.96 506 128910 117713 64251603
Procedural complication 113.00 9.96 103 129313 7162 64362154
Nocturia 112.34 9.96 125 129291 11040 64358276
Treatment failure 110.41 9.96 48 129368 116768 64252548
Erectile dysfunction 106.34 9.96 129 129287 12498 64356818
Drug abuse 103.75 9.96 69 129347 132305 64237011
General physical health deterioration 103.71 9.96 734 128682 203691 64165625
Drug hypersensitivity 103.56 9.96 200 129216 237615 64131701
Asthenia 98.07 9.96 1299 128117 426745 63942571
Prostatic specific antigen increased 96.72 9.96 103 129313 8657 64360659
Death 93.04 9.96 1421 127995 481284 63888032
Completed suicide 92.35 9.96 195 129221 224219 64145097
Arthropathy 88.31 9.96 68 129348 120899 64248417
Confusional state 87.07 9.96 853 128563 260291 64109025
Pemphigus 86.85 9.96 10 129406 60691 64308625
Micturition urgency 85.88 9.96 105 129311 10254 64359062
Labelled drug-drug interaction medication error 83.56 9.96 155 129261 21907 64347409
Presyncope 82.44 9.96 203 129213 34886 64334430
Right atrial hypertrophy 80.53 9.96 33 129383 512 64368804
Infusion related reaction 79.05 9.96 130 129286 164337 64204979
Nephrolithiasis 75.79 9.96 226 129190 43457 64325859
Arthralgia 73.77 9.96 552 128864 441708 63927608
Urinary incontinence 73.42 9.96 198 129218 35953 64333363
Prostatomegaly 73.25 9.96 55 129361 2912 64366404
Urinary tract infection 72.12 9.96 746 128670 230850 64138466
Product monitoring error 70.86 9.96 70 129346 5384 64363932
Urogenital haemorrhage 70.33 9.96 32 129384 648 64368668
Pain 69.48 9.96 743 128673 552768 63816548
Hypersensitivity 67.16 9.96 188 129228 196264 64173052
Prostatitis 65.84 9.96 56 129360 3550 64365766
Glossodynia 65.34 9.96 24 129392 64672 64304644
Priapism 65.12 9.96 58 129358 3912 64365404
Haematochezia 65.10 9.96 285 129131 66088 64303228
Hepatic enzyme increased 65.00 9.96 100 129316 129843 64239473
Pericarditis 63.46 9.96 23 129393 62493 64306823
Sinusitis 63.24 9.96 123 129293 145805 64223511
Therapeutic product effect decreased 62.40 9.96 84 129332 115267 64254049
Headache 61.57 9.96 723 128693 528744 63840572
Bladder cancer 58.75 9.96 90 129326 10884 64358432
Injection site pain 58.38 9.96 83 129333 111325 64257991
Discomfort 58.34 9.96 46 129370 80832 64288484
Right ventricular hypertrophy 58.00 9.96 35 129381 1285 64368031
Plasma cell myeloma 55.62 9.96 211 129205 45864 64323452
Needle fatigue 55.59 9.96 26 129390 562 64368754
Subdural haematoma 55.32 9.96 152 129264 27902 64341414
Intentional overdose 54.45 9.96 60 129356 89884 64279432
Dyspnoea 54.09 9.96 1852 127564 716822 63652494
Retrograde ejaculation 52.59 9.96 19 129397 205 64369111
Drug resistance 52.22 9.96 5 129411 35097 64334219
Pupillary disorder 52.17 9.96 23 129393 431 64368885
Pulmonary function test abnormal 51.45 9.96 46 129370 3118 64366198
Musculoskeletal stiffness 50.68 9.96 107 129309 123099 64246217
Congenital hiatus hernia 50.51 9.96 22 129394 400 64368916
Acute kidney injury 49.22 9.96 1214 128202 448026 63921290
Off label use 49.04 9.96 935 128481 631871 63737445
Injection site erythema 48.92 9.96 42 129374 70758 64298558
Migraine 48.64 9.96 33 129383 62644 64306672
Pneumonia 47.46 9.96 1463 127953 558113 63811203
Swelling 47.19 9.96 164 129252 160054 64209262
Orbital myositis 46.96 9.96 16 129400 143 64369173
Helicobacter infection 46.58 9.96 10 129406 38352 64330964
Vomiting 46.55 9.96 802 128614 550315 63819001
Stomatitis 46.09 9.96 94 129322 109511 64259805
Gait spastic 45.37 9.96 26 129390 866 64368450
Miosis 45.06 9.96 89 129327 13177 64356139
Bronchial wall thickening 44.10 9.96 34 129382 1873 64367443
Fibromyalgia 44.03 9.96 9 129407 35722 64333594
Anaemia 43.77 9.96 1031 128385 377649 63991667
Lower urinary tract symptoms 43.22 9.96 16 129400 186 64369130
Obstruction 42.78 9.96 42 129374 3206 64366110
Haematoma 42.64 9.96 195 129221 46055 64323261
Hydronephrosis 42.35 9.96 90 129326 14035 64355281
Aortic valve stenosis 42.21 9.96 49 129367 4531 64364785
Lower respiratory tract infection 41.63 9.96 79 129337 94535 64274781
Gout 41.21 9.96 115 129301 21298 64348018
Nausea 40.25 9.96 1236 128180 784564 63584752
Relapsing-remitting multiple sclerosis 40.16 9.96 26 129390 1082 64368234
Urine flow decreased 39.68 9.96 25 129391 992 64368324
Bronchial secretion retention 39.64 9.96 36 129380 2491 64366825
Hypertonic bladder 39.18 9.96 41 129375 3377 64365939
Chronic obstructive pulmonary disease 38.86 9.96 260 129156 70788 64298528
Interstitial lung disease 37.41 9.96 329 129087 97403 64271913
Hospice care 37.30 9.96 60 129356 7565 64361751
Injection site pruritus 36.59 9.96 15 129401 37811 64331505
Hepatic vein dilatation 36.59 9.96 15 129401 233 64369083
Oedema peripheral 36.53 9.96 609 128807 209708 64159608
Irritable bowel syndrome 35.86 9.96 15 129401 37354 64331962
Cerebral haemorrhage 35.55 9.96 199 129217 50891 64318425
Pallor 34.63 9.96 162 129254 38619 64330697
Plasmapheresis 34.62 9.96 19 129397 581 64368735
Ejaculation failure 34.25 9.96 16 129400 345 64368971
Contraindicated product administered 34.07 9.96 107 129309 107722 64261594
Muscular weakness 33.98 9.96 398 129018 126940 64242376
Muscle injury 33.98 9.96 6 129410 26431 64342885
Multiple organ dysfunction syndrome 33.93 9.96 98 129318 101315 64268001
Urinary tract obstruction 33.76 9.96 41 129375 3976 64365340
Suicide attempt 33.29 9.96 57 129359 70950 64298366
Injection site reaction 33.07 9.96 27 129389 46637 64322679
Nasopharyngitis 32.95 9.96 244 129172 195829 64173487
Breast cancer 32.65 9.96 9 129407 29139 64340177
Abdominal pain lower 32.59 9.96 122 129294 26347 64342969
Respiratory arrest 32.45 9.96 35 129381 52950 64316366
Liver palpable 31.75 9.96 15 129401 332 64368984
Head injury 31.42 9.96 140 129276 32702 64336614
Loss of consciousness 30.87 9.96 443 128973 147922 64221394
Hypoacusis 30.84 9.96 118 129298 25749 64343567
Guillain-Barre syndrome 30.63 9.96 55 129361 7580 64361736
Balance disorder 30.31 9.96 279 129137 83647 64285669
Vitreous loss 30.30 9.96 7 129409 10 64369306
Perineal pain 30.26 9.96 21 129395 982 64368334
Product substitution issue 29.65 9.96 91 129325 17770 64351546
Abdominal discomfort 29.63 9.96 229 129187 182093 64187223
Injection site swelling 29.22 9.96 24 129392 41329 64327987
Delirium 29.15 9.96 238 129178 68956 64300360
Constipation 29.14 9.96 633 128783 228704 64140612
Device expulsion 28.97 9.96 4 129412 21132 64348184
Bladder neck obstruction 28.91 9.96 10 129406 94 64369222
Platypnoea 28.90 9.96 8 129408 32 64369284
Dacryocystitis 28.70 9.96 8 129408 33 64369283
Umbilical hernia 27.74 9.96 39 129377 4366 64364950
Residual urine volume increased 27.62 9.96 7 129409 18 64369298
Bladder catheterisation 27.47 9.96 18 129398 765 64368551
Folliculitis 27.40 9.96 13 129403 30064 64339252
Infection 27.40 9.96 238 129178 184642 64184674
Rectal haemorrhage 27.33 9.96 215 129201 61602 64307714
Intentional product use issue 27.14 9.96 99 129317 95265 64274051
Diastolic dysfunction 27.13 9.96 57 129359 8818 64360498
Hyponatraemia 27.02 9.96 433 128983 147906 64221410
Testicular swelling 27.00 9.96 19 129397 909 64368407
Drug interaction 26.82 9.96 932 128484 361151 64008165
Idiopathic interstitial pneumonia 26.48 9.96 11 129405 177 64369139
Ejaculation disorder 26.35 9.96 15 129401 493 64368823
Prostatic disorder 26.25 9.96 24 129392 1675 64367641
Haematospermia 25.97 9.96 12 129404 252 64369064
Dementia 25.80 9.96 96 129320 20670 64348646
Cytomegalovirus infection 25.77 9.96 22 129394 37177 64332139
Inferior vena cava dilatation 25.64 9.96 17 129399 737 64368579
Faeces discoloured 25.61 9.96 111 129305 25618 64343698
Stress 25.37 9.96 52 129364 60482 64308834
Pemphigoid 25.24 9.96 70 129346 12916 64356400
Arteriovenous fistula 25.09 9.96 18 129398 888 64368428
Prostatic mass 25.05 9.96 6 129410 11 64369305
Bladder spasm 25.05 9.96 25 129391 1947 64367369
Prostate cancer metastatic 25.01 9.96 32 129384 3272 64366044
Inflammation 24.97 9.96 59 129357 65241 64304075
Dehydration 24.94 9.96 590 128826 216173 64153143
Milk-alkali syndrome 24.85 9.96 20 129396 1173 64368143
Inguinal hernia 24.72 9.96 42 129374 5539 64363777
Cardiac failure congestive 24.48 9.96 383 129033 130197 64239119
Puncture site haematoma 24.07 9.96 10 129406 161 64369155
Poisoning 24.05 9.96 7 129409 21872 64347444
Drug dependence 23.95 9.96 19 129397 33293 64336023
Urinary hesitation 23.49 9.96 32 129384 3478 64365838
Phaeochromocytoma malignant 23.43 9.96 8 129408 72 64369244
Ventricular enlargement 23.32 9.96 14 129402 509 64368807
Diabetic neuropathy 23.31 9.96 41 129375 5560 64363756
Cardio-respiratory arrest 23.12 9.96 110 129306 98283 64271033
Paraplegia 22.88 9.96 36 129380 4454 64364862
Atrial enlargement 22.73 9.96 15 129401 645 64368671
Intestinal haemorrhage 22.48 9.96 40 129376 5474 64363842
Renal cyst haemorrhage 22.26 9.96 13 129403 449 64368867
Flushing 22.15 9.96 82 129334 78566 64290750
Impaired healing 22.05 9.96 56 129360 60417 64308899
Factitious disorder 22 9.96 9 129407 139 64369177
Aortic stenosis 21.98 9.96 43 129373 6322 64362994
Transient ischaemic attack 21.98 9.96 158 129258 44024 64325292
Benign gastrointestinal neoplasm 21.94 9.96 9 129407 140 64369176
Prostatic operation 21.69 9.96 10 129406 209 64369107
Dyspnoea exertional 21.26 9.96 234 129182 73496 64295820
Vena cava injury 21.22 9.96 10 129406 220 64369096
Radiation inflammation 21.14 9.96 10 129406 222 64369094
Therapy non-responder 21.09 9.96 65 129351 65834 64303482
Psoriatic arthropathy 20.97 9.96 34 129382 43247 64326069
Tendon pain 20.84 9.96 36 129380 4812 64364504
Ageusia 20.75 9.96 68 129348 13745 64355571
Angina pectoris 20.60 9.96 158 129258 44923 64324393
Mucosal inflammation 20.55 9.96 61 129355 62523 64306793
Cerebrovascular accident 20.52 9.96 389 129027 137194 64232122
SARS-CoV-2 antibody test positive 20.47 9.96 10 129406 239 64369077
Condition aggravated 20.41 9.96 580 128836 371846 63997470
Urosepsis 20.25 9.96 93 129323 22001 64347315
Arthritis 20.10 9.96 93 129323 83721 64285595
Monoparesis 20.01 9.96 27 129389 2907 64366409
Resting tremor 19.97 9.96 19 129397 1395 64367921
Acute hepatic failure 19.92 9.96 14 129402 26098 64343218
Haemoglobin decreased 19.77 9.96 522 128894 194541 64174775
Subdural hygroma 19.75 9.96 12 129404 446 64368870
Burning feet syndrome 19.65 9.96 8 129408 122 64369194
Acquired haemophilia 19.59 9.96 20 129396 1600 64367716
Arteriosclerotic gangrene 19.50 9.96 7 129409 74 64369242
Weight increased 19.41 9.96 306 129110 213042 64156274
Thermal burns of eye 19.34 9.96 7 129409 76 64369240
Upper gastrointestinal haemorrhage 19.32 9.96 129 129287 35091 64334225
Renal haematoma 19.21 9.96 14 129402 708 64368608
Serum ferritin abnormal 18.81 9.96 11 129405 381 64368935
Product use issue 18.80 9.96 204 129212 151511 64217805
Hepatotoxicity 18.80 9.96 32 129384 39930 64329386
Dizziness postural 18.40 9.96 52 129364 9700 64359616
Inappropriate antidiuretic hormone secretion 18.38 9.96 91 129325 22198 64347118
Gastrointestinal haemorrhage 18.35 9.96 370 129046 131942 64237374
Coma 18.29 9.96 102 129314 87513 64281803
Urticaria 18.29 9.96 198 129218 147119 64222197
Vertigo 18.28 9.96 190 129226 58821 64310495
Genital swelling 18.28 9.96 10 129406 304 64369012
Testicular pain 18.21 9.96 20 129396 1740 64367576
Bladder tamponade 18.21 9.96 12 129404 515 64368801
Injection site bruising 18.17 9.96 28 129388 36345 64332971
Blood pressure decreased 18.16 9.96 258 129158 85941 64283375
Hormone receptor positive breast cancer 18.16 9.96 10 129406 308 64369008
Wrong schedule 18.04 9.96 10 129406 312 64369004
Intentional self-injury 17.99 9.96 19 129397 29025 64340291
Cardiac disorder 17.90 9.96 181 129235 55635 64313681
Choroidal detachment 17.90 9.96 12 129404 530 64368786
COVID-19 pneumonia 17.83 9.96 73 129343 16431 64352885
Cornea verticillata 17.80 9.96 7 129409 97 64369219
Alanine aminotransferase increased 17.61 9.96 186 129230 138845 64230471
Hyperkalaemia 17.59 9.96 293 129123 100836 64268480
Wrong patient received product 17.58 9.96 29 129387 3733 64365583
Hepatitis 17.57 9.96 41 129375 45541 64323775
Orthopnoea 17.52 9.96 49 129367 9085 64360231
Narrow anterior chamber angle 17.49 9.96 8 129408 164 64369152
Ill-defined disorder 17.49 9.96 39 129377 44013 64325303
Bronchiectasis 17.26 9.96 65 129351 14075 64355241
Oropharyngeal pain 17.20 9.96 106 129310 88761 64280555
Systemic infection 17.17 9.96 31 129385 4290 64365026
Pharyngeal cancer 17.16 9.96 5 129411 25 64369291
Chest X-ray abnormal 17.14 9.96 40 129376 6641 64362675
Febrile neutropenia 17.11 9.96 269 129147 187388 64181928
Bulbar palsy 17.09 9.96 9 129407 253 64369063
Prostatic obstruction 16.93 9.96 6 129410 61 64369255
Gastrointestinal disorder 16.85 9.96 108 129308 89601 64279715
Urinary bladder haemorrhage 16.69 9.96 22 129394 2316 64367000
Gait disturbance 16.67 9.96 458 128958 171697 64197619
Mydriasis 16.65 9.96 5 129411 15307 64354009
Femoral artery aneurysm 16.57 9.96 8 129408 186 64369130
Overdose 16.55 9.96 223 129193 159343 64209973
Leukopenia 16.51 9.96 127 129289 101115 64268201
Impaired work ability 16.49 9.96 5 129411 15214 64354102
Prostate infection 16.33 9.96 11 129405 490 64368826
Bone marrow failure 16.28 9.96 46 129370 47906 64321410
Cerebral haematoma 16.27 9.96 41 129375 7144 64362172
Ligament pain 16.23 9.96 8 129408 195 64369121
Iris haemorrhage 16.16 9.96 4 129412 9 64369307
Hepatic failure 16.09 9.96 57 129359 55337 64313979
Bladder outlet obstruction 16.04 9.96 7 129409 128 64369188
Graft versus host disease 15.98 9.96 4 129412 13809 64355507
Therapeutic product effect incomplete 15.86 9.96 132 129284 103350 64265966
Haematemesis 15.84 9.96 154 129262 46845 64322471
Micturition disorder 15.71 9.96 25 129391 3123 64366193
Iris injury 15.64 9.96 3 129413 0 64369316
Sperm concentration zero 15.64 9.96 3 129413 0 64369316
Orchitis 15.63 9.96 15 129401 1113 64368203
Internal haemorrhage 15.57 9.96 42 129374 7625 64361691
Memory impairment 15.55 9.96 250 129166 85432 64283884
Myelosuppression 15.43 9.96 15 129401 23815 64345501
Inadequate osteointegration 15.33 9.96 4 129412 12 64369304
Tendon discomfort 15.26 9.96 10 129406 425 64368891
Full blood count abnormal 15.14 9.96 107 129309 29650 64339666
Aspergillus infection 15.04 9.96 7 129409 16372 64352944
Forced expiratory flow decreased 14.96 9.96 8 129408 232 64369084
Candida infection 14.92 9.96 25 129391 31394 64337922
Bladder obstruction 14.87 9.96 10 129406 444 64368872
Haemorrhage urinary tract 14.86 9.96 20 129396 2149 64367167
Dysgeusia 14.82 9.96 152 129264 46895 64322421
Faecaloma 14.71 9.96 48 129368 9680 64359636
Suprapubic pain 14.69 9.96 13 129403 869 64368447
Circadian rhythm sleep disorder 14.67 9.96 11 129405 581 64368735
Oesophageal rupture 14.63 9.96 13 129403 874 64368442
Intraductal papillary mucinous neoplasm 14.59 9.96 11 129405 586 64368730
Blood glucose fluctuation 14.57 9.96 35 129381 5920 64363396
Tenosynovitis 14.54 9.96 3 129413 11830 64357486
Blood urine present 14.50 9.96 74 129342 18266 64351050
Executive dysfunction 14.48 9.96 8 129408 248 64369068
Atrioventricular block 14.48 9.96 55 129361 11960 64357356
Haematotoxicity 14.41 9.96 4 129412 12892 64356424
Arrhythmia 14.34 9.96 166 129250 52778 64316538
Gynaecomastia 14.33 9.96 35 129381 5981 64363335
Flank pain 13.99 9.96 67 129349 16122 64353194
Urinary tract infection staphylococcal 13.96 9.96 12 129404 772 64368544
Red blood cell sedimentation rate increased 13.80 9.96 26 129390 31209 64338107
Disorientation 13.79 9.96 172 129244 55656 64313660
Bladder transitional cell carcinoma 13.75 9.96 20 129396 2310 64367006
International normalised ratio increased 13.63 9.96 229 129187 78938 64290378
Renal colic 13.60 9.96 20 129396 2332 64366984
Injection site warmth 13.58 9.96 5 129411 13457 64355859
Mixed dementia 13.55 9.96 8 129408 282 64369034
Hip fracture 13.53 9.96 97 129319 27002 64342314
Fatigue 13.51 9.96 1707 127709 747023 63622293
Penis disorder 13.39 9.96 12 129404 816 64368500
Dysphagia 13.28 9.96 294 129122 106518 64262798
Muscle haemorrhage 13.21 9.96 33 129383 5720 64363596
Product prescribing issue 13.14 9.96 19 129397 2182 64367134
Posterior reversible encephalopathy syndrome 13.13 9.96 16 129400 22930 64346386
Nipple pain 13.13 9.96 10 129406 541 64368775
Food aversion 13.07 9.96 11 129405 687 64368629
Abdominal wall haemorrhage 13.06 9.96 9 129407 416 64368900
Dry eye 12.96 9.96 24 129392 28995 64340321
Gait inability 12.92 9.96 136 129280 42232 64327084
Orthostatic intolerance 12.91 9.96 16 129400 1584 64367732
Wound haemorrhage 12.86 9.96 24 129392 3407 64365909
Acute respiratory failure 12.84 9.96 155 129261 49779 64319537
Thoracic haemorrhage 12.82 9.96 7 129409 212 64369104
Drug eruption 12.76 9.96 34 129382 36102 64333214
Haemophagocytic lymphohistiocytosis 12.71 9.96 10 129406 17599 64351717
Dacryostenosis acquired 12.71 9.96 9 129407 435 64368881
Mucosal haemorrhage 12.62 9.96 19 129397 2262 64367054
Periorbital haematoma 12.58 9.96 12 129404 884 64368432
Anal incontinence 12.50 9.96 62 129354 15134 64354182
Carotid arteriosclerosis 12.49 9.96 18 129398 2061 64367255
Pain in jaw 12.48 9.96 41 129375 40714 64328602
Therapeutic response decreased 12.46 9.96 58 129358 52130 64317186
Mesenteric vascular insufficiency 12.45 9.96 6 129410 139 64369177
Knee arthroplasty 12.35 9.96 22 129394 26977 64342339
Prostatic haemorrhage 12.29 9.96 6 129410 143 64369173
Herpes simplex 12.28 9.96 3 129413 10533 64358783
Acne 12.28 9.96 17 129399 23064 64346252
Myasthenia gravis 12.23 9.96 32 129384 5706 64363610
Hyponatraemic syndrome 12.22 9.96 11 129405 752 64368564
Cardiac failure 12.21 9.96 350 129066 132023 64237293
Breath sounds abnormal 12.12 9.96 51 129365 11618 64357698
Oral herpes 12.10 9.96 16 129400 22136 64347180
Flatulence 12.09 9.96 117 129299 35549 64333767
Troponin increased 12.08 9.96 62 129354 15337 64353979
Epidermolysis 12.08 9.96 9 129407 471 64368845
Haemoptysis 12.07 9.96 151 129265 48897 64320419
Rib fracture 11.97 9.96 86 129330 23952 64345364
Basosquamous carcinoma 11.95 9.96 5 129411 82 64369234
Ear pain 11.94 9.96 20 129396 25116 64344200
Drug reaction with eosinophilia and systemic symptoms 11.94 9.96 62 129354 54155 64315161
Erection increased 11.92 9.96 8 129408 354 64368962
Respiratory tract inflammation 11.90 9.96 11 129405 779 64368537
Sedation 11.82 9.96 43 129373 41419 64327897
Renal stone removal 11.82 9.96 6 129410 156 64369160
Tandem gait test abnormal 11.82 9.96 4 129412 35 64369281
Therapy partial responder 11.79 9.96 3 129413 10245 64359071
Urinary tract disorder 11.68 9.96 22 129394 3144 64366172
Xanthelasma 11.68 9.96 6 129410 160 64369156
Hepatomegaly 11.68 9.96 10 129406 16872 64352444
Wound haematoma 11.65 9.96 6 129410 161 64369155
Malpositioned teeth 11.62 9.96 4 129412 37 64369279
Bladder dysfunction 11.57 9.96 12 129404 978 64368338
Dyspnoea paroxysmal nocturnal 11.53 9.96 17 129399 1987 64367329
Human ehrlichiosis 11.47 9.96 8 129408 377 64368939
Bladder disorder 11.46 9.96 38 129378 7729 64361587
Adenocarcinoma gastric 11.37 9.96 15 129401 1580 64367736
Full blood count decreased 11.37 9.96 81 129335 22501 64346815
Breast disorder male 11.26 9.96 3 129413 10 64369306
Peripheral artery stenosis 11.25 9.96 13 129403 1196 64368120
Atrial flutter 11.25 9.96 72 129344 19308 64350008
Adverse event 11.23 9.96 41 129375 39448 64329868
Cellulitis gangrenous 11.22 9.96 7 129409 273 64369043
Atrioventricular block first degree 11.22 9.96 47 129369 10687 64358629
Dyspnoea at rest 11.22 9.96 33 129383 6296 64363020
Weight decreased 11.19 9.96 690 128726 285049 64084267
Intervertebral disc degeneration 11.13 9.96 54 129362 13066 64356250
Foot fracture 11.11 9.96 12 129404 18145 64351171
Device difficult to use 11.02 9.96 3 129413 9795 64359521
Rash 11.00 9.96 782 128634 457767 63911549
Cytomegalovirus viraemia 10.96 9.96 4 129412 10824 64358492
Central nervous system lesion 10.95 9.96 50 129366 11799 64357517
Blood loss anaemia 10.95 9.96 56 129360 13836 64355480
Lichenoid keratosis 10.88 9.96 22 129394 3312 64366004
Nodule 10.83 9.96 12 129404 17935 64351381
Wrong patient 10.80 9.96 6 129410 188 64369128
Blister 10.79 9.96 107 129309 80860 64288456
Intentional product misuse 10.73 9.96 93 129323 72202 64297114
Subdural haemorrhage 10.72 9.96 29 129387 5274 64364042
Unemployment 10.69 9.96 4 129412 48 64369268
Mononuclear cell count abnormal 10.64 9.96 3 129413 13 64369303
Prostatic adenoma 10.61 9.96 5 129411 110 64369206
Mean cell volume increased 10.61 9.96 28 129388 5018 64364298
Disseminated Bacillus Calmette-Guerin infection 10.58 9.96 6 129410 196 64369120
Penile swelling 10.56 9.96 9 129407 572 64368744
Abnormal dreams 10.55 9.96 45 129371 10311 64359005
Urinary straining 10.54 9.96 4 129412 50 64369266
Scrotal swelling 10.42 9.96 11 129405 915 64368401
Scrotal pain 10.40 9.96 8 129408 439 64368877
Coagulation factor VII level decreased 10.38 9.96 6 129410 203 64369113
Injection site erosion 10.33 9.96 5 129411 117 64369199
Testicular infarction 10.30 9.96 3 129413 15 64369301
Human anaplasmosis 10.20 9.96 4 129412 55 64369261
Thrombotic microangiopathy 10.20 9.96 11 129405 16644 64352672
Bradyarrhythmia 10.19 9.96 23 129393 3735 64365581
Sleep apnoea syndrome 10.18 9.96 98 129318 29734 64339582
Squamous cell carcinoma of skin 10.16 9.96 49 129367 11827 64357489
Hip arthroplasty 10.13 9.96 17 129399 21334 64347982
Mantle cell lymphoma 10.11 9.96 12 129404 1136 64368180
Brain oedema 10.09 9.96 18 129398 22057 64347259
Cold sweat 10.09 9.96 62 129354 16393 64352923
Renal impairment 10.08 9.96 348 129068 134669 64234647
Cardiotoxicity 10.06 9.96 4 129412 10270 64359046
Ludwig angina 10.00 9.96 6 129410 218 64369098
Foot deformity 9.99 9.96 11 129405 16493 64352823

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC G04CA02 GENITO URINARY SYSTEM AND SEX HORMONES
UROLOGICALS
DRUGS USED IN BENIGN PROSTATIC HYPERTROPHY
Alpha-adrenoreceptor antagonists
ATC G04CA52 GENITO URINARY SYSTEM AND SEX HORMONES
UROLOGICALS
DRUGS USED IN BENIGN PROSTATIC HYPERTROPHY
Alpha-adrenoreceptor antagonists
ATC G04CA53 GENITO URINARY SYSTEM AND SEX HORMONES
UROLOGICALS
DRUGS USED IN BENIGN PROSTATIC HYPERTROPHY
Alpha-adrenoreceptor antagonists
ATC G04CA54 GENITO URINARY SYSTEM AND SEX HORMONES
UROLOGICALS
DRUGS USED IN BENIGN PROSTATIC HYPERTROPHY
Alpha-adrenoreceptor antagonists
FDA MoA N0000000099 Adrenergic alpha-Antagonists
FDA EPC N0000175553 alpha-Adrenergic Blocker
MeSH PA D018663 Adrenergic Agents
MeSH PA D058668 Adrenergic alpha-1 Receptor Antagonists
MeSH PA D000317 Adrenergic alpha-Antagonists
MeSH PA D018674 Adrenergic Antagonists
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D064804 Urological Agents
CHEBI has role CHEBI:35610 antineoplastic agents
CHEBI has role CHEBI:37890 alpha-adrenergic receptor blockaders

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

DiseaseRelationSNOMED_IDDOID
Benign prostatic hyperplasia indication 266569009
Priapism contraindication 6273006 DOID:9286
Orthostatic hypotension contraindication 28651003
Oligozoospermia contraindication 88311004
Cataract surgery contraindication 110473004
Disease of liver contraindication 235856003 DOID:409
Syncope contraindication 271594007
Pregnancy, function contraindication 289908002
Dizziness contraindication 404640003
Breastfeeding (mother) contraindication 413712001
Intraoperative floppy iris syndrome contraindication 418801006
High-Grade Prostate Cancer contraindication




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.71 acidic
pKa2 8.16 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
D(2) dopamine receptor GPCR Ki 7.89 CHEMBL
Alpha-2A adrenergic receptor GPCR Ki 7.87 CHEMBL
5-hydroxytryptamine receptor 1A GPCR Ki 9.10 CHEMBL
5-hydroxytryptamine receptor 7 GPCR Ki 7.08 CHEMBL
Alpha-1A adrenergic receptor GPCR Ki 10.54 CHEMBL
D(3) dopamine receptor GPCR Ki 9.55 CHEMBL
Alpha-2C adrenergic receptor GPCR Ki 8.10 CHEMBL
Alpha-1D adrenergic receptor GPCR Ki 10.24 CHEMBL
Alpha-1B adrenergic receptor GPCR Ki 9.21 CHEMBL
Alpha-2B adrenergic receptor GPCR Ki 8.17 CHEMBL
Alpha-1D adrenergic receptor GPCR Ki 10.15 CHEMBL
Alpha-1A adrenergic receptor GPCR Ki 9.90 CHEMBL
Alpha-1B adrenergic receptor GPCR Ki 9.70 CHEMBL
Serotonin 1 (5-HT1) receptor GPCR Ki 6.03 CHEMBL
Alpha-1A adrenergic receptor GPCR Ki 10.52 CHEMBL

External reference:

IDSource
4024076 VUID
N0000022081 NUI
D01024 KEGG_DRUG
106463-17-6 SECONDARY_CAS_RN
4021051 VANDF
4024076 VANDF
C0257343 UMLSCUI
CHEBI:9398 CHEBI
CHEMBL836 ChEMBL_ID
CHEMBL1200914 ChEMBL_ID
D000077409 MESH_DESCRIPTOR_UI
DB00706 DRUGBANK_ID
129211 PUBCHEM_CID
488 IUPHAR_LIGAND_ID
6750 INN_ID
G3P28OML5I UNII
236495 RXNORM
171693 MMSL
20642 MMSL
5541 MMSL
d04121 MMSL
006115 NDDF
006116 NDDF
108559004 SNOMEDCT_US
108560009 SNOMEDCT_US
372509005 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
FLOMAX HUMAN PRESCRIPTION DRUG LABEL 1 0024-5837 CAPSULE 0.40 mg ORAL NDA 30 sections
JALYN HUMAN PRESCRIPTION DRUG LABEL 2 0173-0809 CAPSULE 0.40 mg ORAL NDA 29 sections
Tamsulosin hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0228-2996 CAPSULE 0.40 mg ORAL ANDA 19 sections
Tamsulosin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-7995 CAPSULE 0.40 mg ORAL ANDA 26 sections
Tamsulosin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0615-8055 CAPSULE 0.40 mg ORAL ANDA 27 sections
tamsulosin hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0781-2076 CAPSULE 0.40 mg ORAL ANDA 27 sections
tamsulosin hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6401 CAPSULE 0.40 mg ORAL ANDA 27 sections
Dutasteride and Tamsulosin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 2 10370-280 CAPSULE 0.40 mg ORAL ANDA 28 sections
Tamsulosin hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10544-280 CAPSULE 0.40 mg ORAL ANDA 18 sections
TAMSULOSIN HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 10544-550 CAPSULE 0.40 mg ORAL ANDA 17 sections
TAMSULOSIN HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 16590-298 CAPSULE 0.40 mg ORAL ANDA 17 sections
FLOMAX HUMAN PRESCRIPTION DRUG LABEL 1 16590-489 CAPSULE 0.40 mg ORAL NDA 28 sections
Tamsulosin Hydrochloride Human Prescription Drug Label 1 16714-713 CAPSULE 0.40 mg ORAL ANDA 26 sections
TAMSULOSIN HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 33261-839 CAPSULE 0.40 mg ORAL ANDA 17 sections
Tamsulosin Hydrochloride Human Prescription Drug Label 1 33342-159 CAPSULE 0.40 mg ORAL ANDA 27 sections
TAMSULOSIN HYDROCHLORIDE HUMAN PRESCRIPTION DRUG LABEL 1 42254-012 CAPSULE 0.40 mg ORAL ANDA 17 sections
Tamsulosin hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 43063-264 CAPSULE 0.40 mg ORAL ANDA 19 sections
Tamsulosin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 43063-725 CAPSULE 0.40 mg ORAL ANDA 27 sections
Tamsulosin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 43063-725 CAPSULE 0.40 mg ORAL ANDA 27 sections
Tamsulosin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 43063-947 CAPSULE 0.40 mg ORAL ANDA 27 sections
Tamsulosin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 43063-947 CAPSULE 0.40 mg ORAL ANDA 27 sections
tamsulosin hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 43353-013 CAPSULE 0.40 mg ORAL ANDA 27 sections
Tamsulosin Hydrochloride Human Prescription Drug Label 1 43353-019 CAPSULE 0.40 mg ORAL ANDA 26 sections
Tamsulosin hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 43353-663 CAPSULE 0.40 mg ORAL ANDA 19 sections
Tamsulosin Hydrochloride Human Prescription Drug Label 1 50090-1846 CAPSULE 0.40 mg ORAL ANDA 27 sections
Tamsulosin Hydrochloride Human Prescription Drug Label 1 50090-3646 CAPSULE 0.40 mg ORAL ANDA 29 sections
Tamsulosin Hydrochloride Human Prescription Drug Label 1 50090-4906 CAPSULE 0.40 mg ORAL ANDA 29 sections
Tamsulosin Hydrochloride Human Prescription Drug Label 1 50090-5553 CAPSULE 0.40 mg ORAL ANDA 27 sections
Tamsulosin Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 50268-740 CAPSULE 0.40 mg ORAL ANDA 30 sections
Tamsulosin Hydrochloride Human Prescription Drug Label 1 50436-0598 CAPSULE 0.40 mg ORAL ANDA 27 sections