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

Stem definitionDrug idCAS RN
testosterone reductase inhibitors 1171 98319-26-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • finasteride
  • finastid
  • prosteride
  • prostide
  • propecia
An orally active 3-OXO-5-ALPHA-STEROID 4-DEHYDROGENASE inhibitor. It is used as a surgical alternative for treatment of benign PROSTATIC HYPERPLASIA.
  • Molecular weight: 372.55
  • Formula: C23H36N2O2
  • CLOGP: 3.01
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 2
  • TPSA: 58.20
  • ALOGS: -5.27
  • ROTB: 2

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
1 mg O
5 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.04 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 0.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.19 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 63 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 1.10 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 2.40 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.10 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 6 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
June 19, 1992 FDA MERCK

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
Exposure via body fluid 325.13 28.93 44 1081 415 50603584
Exposure during pregnancy 114.90 28.93 55 1070 120960 50483039
Abortion spontaneous 89.83 28.93 34 1091 41738 50562261
Product administration error 68.77 28.93 23 1102 19676 50584323
Abortion induced 53.83 28.93 16 1109 9328 50594671
Paternal drugs affecting foetus 52.98 28.93 7 1118 53 50603946
Exposure via father 42.51 28.93 7 1118 261 50603738
Hypertrichosis 39.07 28.93 8 1117 1001 50602998
Trans-sexualism 36.63 28.93 4 1121 3 50603996
No adverse event 33.89 28.93 16 1109 33562 50570437
Temporal lobe epilepsy 33.58 28.93 6 1119 364 50603635

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
Sexual dysfunction 2798.44 10.76 901 76325 4913 29492388
Erectile dysfunction 2469.45 10.76 1115 76111 16894 29480407
Libido decreased 1456.87 10.76 512 76714 3786 29493515
Loss of libido 1195.29 10.76 378 76848 1918 29495383
Semen volume decreased 920.35 10.76 208 77018 145 29497156
Ejaculation disorder 860.25 10.76 241 76985 727 29496574
Cognitive disorder 743.44 10.76 561 76665 22938 29474363
Depression 722.28 10.76 995 76231 84152 29413149
Ejaculation failure 543.06 10.76 160 77066 607 29496694
Anxiety 528.06 10.76 861 76365 84504 29412797
Penile size reduced 527.14 10.76 117 77109 66 29497235
Testicular pain 497.37 10.76 202 77024 2307 29494994
Gynaecomastia 450.88 10.76 276 76950 7941 29489360
Organic erectile dysfunction 444.58 10.76 107 77119 131 29497170
Hypogonadism 429.12 10.76 158 77068 1353 29495948
Post 5-alpha-reductase inhibitor syndrome 386.56 10.76 82 77144 22 29497279
Hormone level abnormal 365.24 10.76 99 77127 253 29497048
Blood testosterone decreased 360.46 10.76 185 77041 3745 29493556
Testicular atrophy 260.25 10.76 83 77143 434 29496867
Penis injury 260.13 10.76 71 77155 188 29497113
Varicocele 259.08 10.76 55 77171 15 29497286
Painful ejaculation 239.38 10.76 51 77175 15 29497286
Genital hypoaesthesia 226.41 10.76 61 77165 151 29497150
Penis disorder 211.37 10.76 87 77139 1030 29496271
Testicular failure 200.63 10.76 42 77184 8 29497293
Testicular disorder 187.11 10.76 67 77159 525 29496776
Hypogonadism male 163.80 10.76 50 77176 220 29497081
Semen analysis abnormal 163.67 10.76 34 77192 5 29497296
Male orgasmic disorder 163.45 10.76 41 77185 67 29497234
Endocrine disorder 159.37 10.76 49 77177 222 29497079
Pyrexia 154.16 10.76 326 76900 287296 29210005
Epididymal cyst 152.65 10.76 34 77192 20 29497281
Benign prostatic hyperplasia 152.34 10.76 170 77056 11540 29485761
Off label use 149.75 10.76 355 76871 300445 29196856
Infertility male 145.81 10.76 42 77184 144 29497157
Orgasm abnormal 145.48 10.76 39 77187 94 29497207
Prostatitis 143.64 10.76 110 77116 4587 29492714
Product administration error 138.92 10.76 179 77047 14131 29483170
Hair transplant 138.46 10.76 30 77196 12 29497289
Toxicity to various agents 135.92 10.76 152 77074 173509 29323792
Panic attack 135.18 10.76 136 77090 8190 29489111
Male reproductive tract disorder 129.34 10.76 33 77193 60 29497241
Androgen deficiency 126.78 10.76 38 77188 155 29497146
Anorgasmia 120.73 10.76 49 77177 558 29496743
Suicidal ideation 109.04 10.76 264 76962 34452 29462849
Sperm concentration decreased 108.26 10.76 32 77194 123 29497178
Reproductive tract disorder 103.96 10.76 21 77205 0 29497301
Prostatic pain 100.37 10.76 25 77201 39 29497262
Orgasmic sensation decreased 97.73 10.76 24 77202 34 29497267
Wrong technique in product usage process 95.51 10.76 236 76990 31192 29466109
Brain injury 94.96 10.76 93 77133 5419 29491882
Premature ejaculation 92.34 10.76 27 77199 99 29497202
Infertility 92.05 10.76 30 77196 170 29497131
Muscle atrophy 90.77 10.76 98 77128 6408 29490893
Male genital atrophy 88.86 10.76 19 77207 6 29497295
Febrile neutropenia 86.88 10.76 99 77127 112141 29385160
Drug ineffective 85.54 10.76 577 76649 362593 29134708
Vasectomy 85.20 10.76 20 77206 20 29497281
Urine flow decreased 81.55 10.76 45 77181 1059 29496242
Disturbance in attention 79.48 10.76 174 77052 21250 29476051
Disturbance in sexual arousal 78.37 10.76 24 77202 107 29497194
Vomiting 77.52 10.76 289 76937 211971 29285330
Drug abuse 76.50 10.76 58 77168 79825 29417476
Breast enlargement 74.18 10.76 32 77194 429 29496872
Tonsillectomy 73.58 10.76 29 77197 304 29496997
Penile pain 73.44 10.76 46 77180 1378 29495923
Right atrial hypertrophy 72.34 10.76 33 77193 509 29496792
Interstitial lung disease 70.79 10.76 31 77195 57687 29439614
Gastrooesophageal reflux disease 70.15 10.76 211 77015 31285 29466016
Breast cancer 69.95 10.76 26 77200 229 29497072
Hyperlipidaemia 69.60 10.76 121 77105 12469 29484832
Dysuria 67.63 10.76 168 77058 22272 29475029
Urinary retention 65.75 10.76 208 77018 31690 29465611
Pollakiuria 65.73 10.76 140 77086 16776 29480525
Multiple organ dysfunction syndrome 65.49 10.76 42 77184 63074 29434227
Melanocytic naevus 61.28 10.76 46 77180 1860 29495441
Insomnia 61.09 10.76 419 76807 88342 29408959
Nocturia 60.75 10.76 91 77135 8271 29489030
Breast tenderness 60.59 10.76 32 77194 688 29496613
Dizziness 60.29 10.76 758 76468 188926 29308375
Haematospermia 59.55 10.76 25 77201 312 29496989
Genital atrophy 59.41 10.76 12 77214 0 29497301
Penile curvature 58.86 10.76 17 77209 59 29497242
Breast mass 58.32 10.76 29 77197 547 29496754
Neutropenia 57.95 10.76 165 77061 131546 29365755
Spermatocele 56.94 10.76 14 77212 20 29497281
Male sexual dysfunction 56.74 10.76 22 77204 220 29497081
Intervertebral disc degeneration 56.09 10.76 69 77157 5195 29492106
Major depression 55.67 10.76 59 77167 3776 29493525
Lower urinary tract symptoms 55.62 10.76 21 77205 194 29497107
Generalised anxiety disorder 54.55 10.76 29 77197 632 29496669
Dihydrotestosterone decreased 54.46 10.76 11 77215 0 29497301
Sleep apnoea syndrome 54.34 10.76 133 77093 17466 29479835
Bronchial secretion retention 53.88 10.76 35 77191 1118 29496183
Oligospermia 53.24 10.76 16 77210 66 29497235
Wisdom teeth removal 52.67 10.76 16 77210 69 29497232
Fatigue 52.48 10.76 1137 76089 315684 29181617
Azoospermia 51.99 10.76 24 77202 381 29496920
Prostatomegaly 51.13 10.76 62 77164 4599 29492702
Somatic symptom disorder 50.96 10.76 26 77200 519 29496782
Sepsis 50.24 10.76 197 77029 142485 29354816
Obstruction 50.07 10.76 41 77185 1885 29495416
Body fat disorder 49.82 10.76 13 77213 27 29497274
Blood oestrogen increased 49.77 10.76 14 77212 43 29497258
Semen viscosity decreased 49.51 10.76 10 77216 0 29497301
C-reactive protein increased 49.37 10.76 27 77199 44236 29453065
Bronchial wall thickening 49.32 10.76 32 77194 1020 29496281
Product use in unapproved indication 49.27 10.76 95 77131 86780 29410521
Breast cancer male 49.05 10.76 21 77205 276 29497025
Right ventricular hypertrophy 48.82 10.76 33 77193 1128 29496173
Cardiac arrest 48.19 10.76 94 77132 85497 29411804
Condition aggravated 47.76 10.76 208 77018 146087 29351214
Dark circles under eyes 47.74 10.76 13 77213 34 29497267
Genital paraesthesia 47.32 10.76 12 77214 21 29497280
Marital problem 47.12 10.76 14 77212 55 29497246
Arthroscopy 46.78 10.76 15 77211 80 29497221
Septic shock 46.42 10.76 57 77169 62503 29434798
Knee operation 46.16 10.76 35 77191 1437 29495864
Aortic valve stenosis 45.20 10.76 41 77185 2167 29495134
Amnesia 45.15 10.76 146 77080 22497 29474804
Attention deficit hyperactivity disorder 45.06 10.76 41 77185 2176 29495125
Soft tissue injury 44.56 10.76 17 77209 162 29497139
Self esteem decreased 43.57 10.76 23 77203 494 29496807
Haematuria 43.56 10.76 229 76997 43910 29453391
Adverse event 43.48 10.76 112 77114 15179 29482122
Orthostatic hypotension 43.41 10.76 144 77082 22485 29474816
Respiratory failure 43.20 10.76 121 77105 97010 29400291
Cytomegalovirus infection 43.16 10.76 5 77221 23210 29474091
Hormone receptor positive breast cancer 43.11 10.76 11 77215 20 29497281
Nausea 42.70 10.76 517 76709 288738 29208563
Stress at work 41.99 10.76 16 77210 152 29497149
Completed suicide 41.95 10.76 110 77116 90136 29407165
Prostatic disorder 40.97 10.76 44 77182 2859 29494442
Fall 40.66 10.76 669 76557 176509 29320792
Overdose 40.46 10.76 93 77133 79726 29417575
Nipple pain 40.40 10.76 23 77203 576 29496725
Hepatic vein dilatation 40.29 10.76 17 77209 215 29497086
Secondary hypogonadism 40.03 10.76 18 77208 268 29497033
Genital pain 39.91 10.76 16 77210 176 29497125
Terminal dribbling 39.61 10.76 8 77218 0 29497301
Androgens abnormal 39.61 10.76 8 77218 0 29497301
Intentional overdose 39.46 10.76 26 77200 38502 29458799
Metabolic acidosis 39.14 10.76 25 77201 37637 29459664
Libido disorder 39.14 10.76 17 77209 232 29497069
Skin atrophy 39.08 10.76 34 77192 1700 29495601
Anogenital warts 38.93 10.76 22 77204 543 29496758
Scrotal disorder 38.63 10.76 14 77212 114 29497187
Cardio-respiratory arrest 37.64 10.76 46 77180 50555 29446746
Partner stress 37.31 10.76 14 77212 127 29497174
Mucosal inflammation 37.13 10.76 18 77208 31577 29465724
Testicular cyst 36.87 10.76 11 77215 44 29497257
Spermatozoa abnormal 36.67 10.76 11 77215 45 29497256
Radical prostatectomy 36.67 10.76 11 77215 45 29497256
Social anxiety disorder 36.53 10.76 16 77210 223 29497078
Chronic fatigue syndrome 36.37 10.76 17 77209 278 29497023
Patellofemoral pain syndrome 35.85 10.76 13 77213 106 29497195
Feeling abnormal 35.65 10.76 254 76972 54191 29443110
Epididymitis 35.61 10.76 36 77190 2179 29495122
Disseminated intravascular coagulation 35.46 10.76 5 77221 19975 29477326
Leukopenia 35.25 10.76 56 77170 55147 29442154
Prostate cancer 35.17 10.76 146 77080 25381 29471920
Treatment failure 35.11 10.76 27 77199 36912 29460389
Breast pain 34.73 10.76 28 77198 1259 29496042
Mole excision 34.65 10.76 7 77219 0 29497301
Seizure 34.42 10.76 126 77100 92997 29404304
Nasal septal operation 34.34 10.76 10 77216 36 29497265
Malignant neoplasm progression 34.34 10.76 90 77136 73769 29423532
Blood thyroid stimulating hormone decreased 34.12 10.76 32 77194 1766 29495535
Dehydroepiandrosterone decreased 34.08 10.76 9 77217 20 29497281
Arterial insufficiency 33.88 10.76 13 77213 126 29497175
Renal failure 33.79 10.76 177 77049 118422 29378879
Sexually transmitted disease 33.77 10.76 9 77217 21 29497280
Breast disorder male 33.60 10.76 8 77218 9 29497292
Persistent depressive disorder 33.26 10.76 16 77210 280 29497021
Emotional distress 32.75 10.76 95 77131 13800 29483501
Hypospermia 32.71 10.76 8 77218 11 29497290
Essential hypertension 32.56 10.76 36 77190 2417 29494884
Infusion related reaction 32.53 10.76 40 77186 43846 29453455
Irritable bowel syndrome 32.49 10.76 39 77187 2862 29494439
Muscle strain 32.42 10.76 43 77183 3490 29493811
Panic disorder 32.34 10.76 26 77200 1164 29496137
Perineal pain 32.34 10.76 22 77204 760 29496541
Tachycardia 32.33 10.76 90 77136 72320 29424981
Blood luteinising hormone decreased 32.26 10.76 12 77214 106 29497195
Pulmonary function test abnormal 31.95 10.76 33 77193 2049 29495252
Hydrocele 31.87 10.76 32 77194 1921 29495380
Bone marrow failure 31.70 10.76 16 77210 27433 29469868
Intentional product use issue 31.22 10.76 39 77187 42459 29454842
Dermal cyst 31.21 10.76 27 77199 1340 29495961
Apathy 31.14 10.76 57 77169 6114 29491187
Alanine aminotransferase increased 31.07 10.76 89 77137 70855 29426446
Semen discolouration 30.86 10.76 8 77218 16 29497285
Cardiac failure 30.82 10.76 105 77121 79182 29418119
Spermatozoa progressive motility decreased 30.60 10.76 12 77214 124 29497177
Liver palpable 30.55 10.76 15 77211 275 29497026
Nasal septum deviation 30.51 10.76 23 77203 936 29496365
Ejaculation delayed 30.29 10.76 14 77212 223 29497078
Hypotrichosis 30.22 10.76 8 77218 18 29497283
Psychosexual disorder 30.09 10.76 11 77215 92 29497209
Rhinitis allergic 29.97 10.76 36 77190 2644 29494657
Hernia repair 29.88 10.76 24 77202 1073 29496228
Drug interaction 29.74 10.76 351 76875 197034 29300267
Teratospermia 29.70 10.76 6 77220 0 29497301
Varicocele repair 29.70 10.76 6 77220 0 29497301
Testicular microlithiasis 29.64 10.76 8 77218 20 29497281
Granulomatous rosacea 29.54 10.76 12 77214 137 29497164
Emotional poverty 28.95 10.76 17 77209 452 29496849
Hypoacusis 28.75 10.76 93 77133 14330 29482971
Saliva altered 28.64 10.76 12 77214 149 29497152
Hypercholesterolaemia 28.22 10.76 60 77166 7178 29490123
Sleep disorder 27.93 10.76 132 77094 24254 29473047
Prostatic specific antigen increased 27.80 10.76 84 77142 12480 29484821
Thrombocytopenia 27.34 10.76 223 77003 134600 29362701
Urinary tract obstruction 27.04 10.76 38 77188 3259 29494042
Pneumonia 26.93 10.76 634 76592 319538 29177763
Renal impairment 26.90 10.76 115 77111 81218 29416083
Platypnoea 26.81 10.76 8 77218 32 29497269
Adenotonsillectomy 26.81 10.76 8 77218 32 29497269
Lid sulcus deepened 26.77 10.76 9 77217 57 29497244
Pelvic pain 26.72 10.76 30 77196 2049 29495252
Macular hole 26.67 10.76 12 77214 179 29497122
Vitamin D deficiency 26.56 10.76 50 77176 5479 29491822
Shoulder operation 26.55 10.76 20 77206 813 29496488
Inguinal hernia repair 26.35 10.76 13 77213 241 29497060
Drug hypersensitivity 26.30 10.76 91 77135 68315 29428986
Skin irritation 26.13 10.76 44 77182 4417 29492884
Benign neoplasm of skin 25.65 10.76 9 77217 66 29497235
Serotonin syndrome 25.60 10.76 7 77219 17505 29479796
Atrial enlargement 25.58 10.76 14 77212 324 29496977
Acute respiratory distress syndrome 25.55 10.76 14 77212 22921 29474380
Ascites 25.47 10.76 35 77191 36584 29460717
Shock 25.44 10.76 12 77214 21392 29475909
Product use issue 25.21 10.76 61 77165 51383 29445918
Primary hypogonadism 25.19 10.76 9 77217 70 29497231
Liposuction 24.75 10.76 5 77221 0 29497301
Psychogenic erectile dysfunction 24.75 10.76 5 77221 0 29497301
Leydig cell tumour of the testis 24.75 10.76 5 77221 0 29497301
Appendicectomy 24.66 10.76 19 77207 799 29496502
Rotator cuff repair 24.47 10.76 13 77213 283 29497018
Suicide attempt 24.33 10.76 32 77194 34078 29463223
Hepatic failure 24.12 10.76 28 77198 31484 29465817
Respiratory distress 24.07 10.76 29 77197 32077 29465224
Genital lesion 23.96 10.76 12 77214 230 29497071
Penile vascular disorder 23.85 10.76 6 77220 10 29497291
Osteoporosis 23.83 10.76 72 77154 10697 29486604
Injection site pain 23.60 10.76 30 77196 32416 29464885
Blood testosterone increased 23.54 10.76 20 77206 968 29496333
Seborrhoeic keratosis 23.40 10.76 19 77207 863 29496438
Hallucination 23.38 10.76 198 77028 44514 29452787
Urinary tract infection 23.26 10.76 290 76936 72064 29425237
Physical disability 23.18 10.76 22 77204 1232 29496069
Palpitations 23.04 10.76 155 77071 32449 29464852
Orchitis 23.02 10.76 23 77203 1373 29495928
Oestradiol increased 22.87 10.76 8 77218 58 29497243
Affective disorder 22.68 10.76 34 77192 3092 29494209
Respiratory depression 22.61 10.76 4 77222 13519 29483782
Ligament sprain 22.60 10.76 32 77194 2763 29494538
Renal cyst 22.56 10.76 58 77168 7849 29489452
Diabetic ketoacidosis 22.44 10.76 7 77219 16066 29481235
Radiotherapy to prostate 22.41 10.76 5 77221 3 29497298
Pneumocystis jirovecii pneumonia 22.22 10.76 8 77218 16771 29480530
Haemorrhoids 22.19 10.76 74 77152 11583 29485718
Diverticulum 21.87 10.76 50 77176 6282 29491019
Cytokine release syndrome 21.67 10.76 4 77222 13115 29484186
Stomatitis 21.54 10.76 40 77186 37073 29460228
Memory impairment 21.51 10.76 166 77060 36304 29460997
Epicondylitis 21.50 10.76 13 77213 365 29496936
Ventricular enlargement 21.47 10.76 14 77212 450 29496851
Acrochordon 21.24 10.76 12 77214 296 29497005
Feminisation acquired 21.14 10.76 7 77219 42 29497259
Lymphadenectomy 21.06 10.76 11 77215 231 29497070
Inferior vena cava dilatation 21.02 10.76 16 77210 661 29496640
Mastectomy 20.96 10.76 6 77220 20 29497281
Androgen insensitivity syndrome 20.96 10.76 6 77220 20 29497281
Diastolic dysfunction 20.94 10.76 43 77183 5021 29492280
Epilepsy 20.90 10.76 11 77215 18421 29478880
Erythema 20.87 10.76 114 77112 75492 29421809
Seasonal affective disorder 20.83 10.76 5 77221 6 29497295
Cerumen impaction 20.79 10.76 13 77213 388 29496913
Lipoma 20.74 10.76 22 77204 1409 29495892
Illusion 20.50 10.76 16 77210 686 29496615
Skin papilloma 20.39 10.76 24 77202 1725 29495576
Bladder neck obstruction 20.26 10.76 9 77217 130 29497171
Blood follicle stimulating hormone decreased 20.23 10.76 7 77219 49 29497252
Pancreatitis 20.20 10.76 37 77189 34477 29462824
Lactic acidosis 19.96 10.76 30 77196 30217 29467084
Joint injury 19.93 10.76 51 77175 6882 29490419
Testicular mass 19.88 10.76 8 77218 89 29497212
Blood follicle stimulating hormone abnormal 19.80 10.76 4 77222 0 29497301
Benign tumour excision 19.80 10.76 4 77222 0 29497301
Keratomileusis 19.80 10.76 4 77222 0 29497301
Late onset hypogonadism syndrome 19.80 10.76 4 77222 0 29497301
Pelvic floor muscle weakness 19.80 10.76 4 77222 0 29497301
Oestrogenic effect 19.80 10.76 4 77222 0 29497301
Anhedonia 19.71 10.76 52 77174 7148 29490153
Soft tissue mass 19.67 10.76 15 77211 621 29496680
Hepatic function abnormal 19.67 10.76 46 77180 39213 29458088
Invasive ductal breast carcinoma 19.63 10.76 5 77221 9 29497292
Prostatic calcification 19.34 10.76 8 77218 96 29497205
Seborrhoea 19.27 10.76 10 77216 207 29497094
Rheumatoid arthritis 19.24 10.76 34 77192 32118 29465183
Rash maculo-papular 19.22 10.76 21 77205 24268 29473033
Agranulocytosis 19.16 10.76 15 77211 20325 29476976
Cystitis 18.87 10.76 56 77170 8236 29489065
Neutrophil count decreased 18.81 10.76 55 77171 43512 29453789
Seborrhoeic dermatitis 18.73 10.76 21 77205 1432 29495869
Bladder outlet obstruction 18.68 10.76 9 77217 158 29497143
Myocardial infarction 18.62 10.76 191 77035 110105 29387196
Cholecystectomy 18.56 10.76 27 77199 2390 29494911
Extrapyramidal disorder 18.56 10.76 3 77223 10828 29486473
Limb operation 18.44 10.76 14 77212 576 29496725
Tinnitus 18.23 10.76 85 77141 15529 29481772
Alveolar bone resorption 18.11 10.76 5 77221 14 29497287
Psychiatric symptom 18.11 10.76 31 77195 3153 29494148
Genital burning sensation 18.11 10.76 5 77221 14 29497287
Blood testosterone free decreased 18.05 10.76 7 77219 70 29497231
Retrograde ejaculation 18 10.76 11 77215 315 29496986
Drug-induced liver injury 17.95 10.76 18 77208 21637 29475664
Neurotoxicity 17.67 10.76 8 77218 14605 29482696
Toxic epidermal necrolysis 17.59 10.76 13 77213 18140 29479161
Asthenospermia 17.59 10.76 6 77220 40 29497261
Testis discomfort 17.57 10.76 4 77222 3 29497298
Rhinoplasty 17.57 10.76 4 77222 3 29497298
Hypothalamo-pituitary disorder 17.52 10.76 15 77211 734 29496567
Prostatic operation 17.52 10.76 11 77215 331 29496970
Rosacea 17.36 10.76 17 77209 990 29496311
Back injury 17.35 10.76 32 77194 3452 29493849
Disease recurrence 17.32 10.76 10 77216 15904 29481397
Sprue-like enteropathy 17.30 10.76 12 77214 428 29496873
Fat tissue increased 17.28 10.76 11 77215 339 29496962
Inner ear disorder 17.19 10.76 9 77217 190 29497111
Oxygen saturation decreased 17.12 10.76 60 77166 44877 29452424
Muscle disorder 17.12 10.76 25 77201 2221 29495080
Aspartate aminotransferase increased 17.06 10.76 89 77137 59636 29437665
Melanocytic hyperplasia 17.04 10.76 4 77222 4 29497297
Genital cyst 17.04 10.76 4 77222 4 29497297
Plica syndrome 17.04 10.76 4 77222 4 29497297
Depression suicidal 16.94 10.76 19 77207 1296 29496005
Micturition urgency 16.94 10.76 40 77186 5133 29492168
Stress 16.92 10.76 105 77121 21385 29475916
Impaired fasting glucose 16.89 10.76 9 77217 197 29497104
Flat affect 16.79 10.76 15 77211 777 29496524
Sex hormone binding globulin decreased 16.76 10.76 5 77221 20 29497281
Groin pain 16.70 10.76 38 77188 4760 29492541
Drug resistance 16.63 10.76 19 77207 21521 29475780
Chest X-ray abnormal 16.62 10.76 33 77193 3761 29493540
Thinking abnormal 16.62 10.76 40 77186 5196 29492105
Malpositioned teeth 16.56 10.76 5 77221 21 29497280
Varicose vein 16.53 10.76 17 77209 1050 29496251
Mental impairment 16.49 10.76 57 77169 9084 29488217
Chlamydial infection 16.48 10.76 8 77218 143 29497158
Xanthopsia 16.43 10.76 8 77218 144 29497157
Type V hyperlipidaemia 16.38 10.76 14 77212 683 29496618
Chills 16.30 10.76 114 77112 71186 29426115
Nephropathy toxic 16.29 10.76 4 77222 10752 29486549
Hypoxia 16.27 10.76 66 77160 47313 29449988
Balance disorder 16.26 10.76 155 77071 36015 29461286
Facial bones fracture 16.20 10.76 25 77201 2332 29494969
Acute kidney injury 16.19 10.76 549 76677 264718 29232583
Pelvic discomfort 16.15 10.76 4 77222 6 29497295
Penile prosthesis insertion 16.15 10.76 4 77222 6 29497295
Benign breast neoplasm 16.15 10.76 4 77222 6 29497295
Prostatic dysplasia 16.15 10.76 4 77222 6 29497295
Asthenia 16.03 10.76 701 76525 214549 29282752
Peripheral coldness 16.03 10.76 44 77182 6192 29491109
Prostatic specific antigen decreased 16.02 10.76 7 77219 97 29497204
Eczema 15.95 10.76 75 77151 13751 29483550
Blunted affect 15.89 10.76 10 77216 302 29496999
Zinc deficiency 15.77 10.76 4 77222 7 29497294
Respiratory arrest 15.74 10.76 27 77199 25806 29471495
Dissociation 15.73 10.76 17 77209 1112 29496189
Meniscus injury 15.70 10.76 22 77204 1881 29495420
Lung disorder 15.68 10.76 35 77191 30327 29466974
Gingival recession 15.58 10.76 11 77215 404 29496897
Agoraphobia 15.54 10.76 9 77217 233 29497068
Drug reaction with eosinophilia and systemic symptoms 15.52 10.76 31 77195 27961 29469340
Haemorrhoid operation 15.39 10.76 5 77221 28 29497273
Post-traumatic stress disorder 15.28 10.76 20 77206 1602 29495699
Penile exfoliation 15.23 10.76 7 77219 110 29497191
Decreased interest 15.15 10.76 23 77203 2115 29495186
Sex hormone binding globulin increased 15.11 10.76 4 77222 9 29497292
Product name confusion 14.97 10.76 6 77220 66 29497235
Pancytopenia 14.88 10.76 142 77084 83026 29414275
Testis cancer 14.88 10.76 15 77211 905 29496396
Fixed eruption 14.86 10.76 17 77209 1185 29496116
Scar excision 14.85 10.76 3 77223 0 29497301
Blood oestrogen abnormal 14.85 10.76 3 77223 0 29497301
Genital disorder 14.85 10.76 3 77223 0 29497301
Penile repair 14.85 10.76 3 77223 0 29497301
Biotin deficiency 14.85 10.76 3 77223 0 29497301
Sigmoidectomy 14.85 10.76 3 77223 0 29497301
Urinary bladder suspension 14.85 10.76 3 77223 0 29497301
Uvulopalatopharyngoplasty 14.85 10.76 3 77223 0 29497301
Penile wart 14.85 10.76 3 77223 0 29497301
Prostate tenderness 14.85 10.76 3 77223 0 29497301
Eyelid cyst 14.85 10.76 3 77223 0 29497301
Genital injury 14.85 10.76 3 77223 0 29497301
Benign breast lump removal 14.85 10.76 3 77223 0 29497301
Lipoma excision 14.85 10.76 3 77223 0 29497301
Semen liquefaction 14.85 10.76 3 77223 0 29497301
Varicose vein operation 14.85 10.76 3 77223 0 29497301
Cryotherapy 14.85 10.76 3 77223 0 29497301
Pseudohermaphroditism male 14.85 10.76 3 77223 0 29497301
Plastic surgery 14.85 10.76 3 77223 0 29497301
Dermatitis artefacta 14.85 10.76 3 77223 0 29497301
Sclerotherapy 14.85 10.76 3 77223 0 29497301
Mammoplasty 14.82 10.76 4 77222 10 29497291
Exostosis of external ear canal 14.82 10.76 4 77222 10 29497291
Transplant rejection 14.81 10.76 3 77223 9209 29488092
Adrenal disorder 14.78 10.76 14 77212 782 29496519
Hypertrophy 14.76 10.76 11 77215 440 29496861
Nasal discomfort 14.75 10.76 17 77209 1195 29496106
Vitreous floaters 14.71 10.76 28 77198 3093 29494208
Genital herpes 14.70 10.76 12 77214 549 29496752
Blood follicle stimulating hormone increased 14.58 10.76 7 77219 122 29497179
Bronchopulmonary aspergillosis 14.55 10.76 7 77219 12337 29484964
Bronchiectasis 14.54 10.76 44 77182 6541 29490760
Death 14.51 10.76 738 76488 341346 29155955
Dry eye 14.50 10.76 47 77179 7249 29490052
Hair texture abnormal 14.47 10.76 9 77217 266 29497035
Creatinine urine decreased 14.45 10.76 5 77221 35 29497266
Dementia Alzheimer's type 14.34 10.76 10 77216 360 29496941
Anxiety disorder 14.30 10.76 19 77207 1545 29495756
Genital rash 14.29 10.76 11 77215 462 29496839
Urinary straining 14.29 10.76 4 77222 12 29497289
Dandruff 14.27 10.76 7 77219 128 29497173
Inguinal hernia 14.13 10.76 44 77182 6644 29490657
Daydreaming 14.11 10.76 11 77215 471 29496830
Hyperbilirubinaemia 14.08 10.76 11 77215 14923 29482378
Exposure to communicable disease 14.03 10.76 7 77219 133 29497168
Abnormal loss of weight 14.02 10.76 30 77196 3604 29493697
Infusion site induration 13.99 10.76 8 77218 202 29497099
Adverse drug reaction 13.97 10.76 109 77117 23911 29473390
Intervertebral disc protrusion 13.89 10.76 52 77174 8618 29488683
Peritonitis 13.87 10.76 11 77215 14813 29482488
Xerophthalmia 13.87 10.76 6 77220 81 29497220
Premature ageing 13.87 10.76 6 77220 81 29497220
Hypoglycaemia 13.83 10.76 72 77154 48274 29449027
Red blood cell analysis abnormal 13.82 10.76 4 77222 14 29497287
Disease progression 13.76 10.76 142 77084 81774 29415527
Acute hepatic failure 13.75 10.76 7 77219 11945 29485356
Gingival disorder 13.72 10.76 17 77209 1289 29496012
Acne 13.70 10.76 54 77172 9166 29488135
Glomerular filtration rate abnormal 13.65 10.76 13 77213 731 29496570
Dyshidrotic eczema 13.62 10.76 7 77219 142 29497159
Hyperglycaemia 13.59 10.76 45 77181 34242 29463059
Floppy iris syndrome 13.57 10.76 9 77217 298 29497003
Rhabdomyolysis 13.52 10.76 98 77128 60710 29436591
Obsessive-compulsive disorder 13.51 10.76 34 77192 4542 29492759
Fear of crowded places 13.41 10.76 4 77222 16 29497285
Electrocardiogram QT prolonged 13.27 10.76 49 77177 36088 29461213
Prostatic haemorrhage 13.22 10.76 8 77218 225 29497076
Contraindicated product administered 13.17 10.76 17 77209 18249 29479052
Atrioventricular block first degree 13.15 10.76 37 77189 5282 29492019
Hepatocellular injury 13.13 10.76 22 77204 21221 29476080
Abdominal pain 13.06 10.76 262 76964 135095 29362206
Transurethral prostatectomy 13.05 10.76 9 77217 318 29496983
Beta globulin increased 13.03 10.76 4 77222 18 29497283
Cortisol increased 12.99 10.76 7 77219 157 29497144
Orchidectomy 12.98 10.76 5 77221 49 29497252
Sinus polyp 12.95 10.76 7 77219 158 29497143
Emotional disorder 12.88 10.76 35 77191 4896 29492405
Gamma-glutamyltransferase increased 12.86 10.76 32 77194 26705 29470596
Reproductive tract hypoplasia, male 12.86 10.76 4 77222 19 29497282
Sexual relationship change 12.86 10.76 4 77222 19 29497282
Neuroleptic malignant syndrome 12.74 10.76 14 77212 16134 29481167
Drug dependence 12.72 10.76 22 77204 20959 29476342
Otosalpingitis 12.69 10.76 4 77222 20 29497281
Alpha 2 globulin decreased 12.69 10.76 4 77222 20 29497281
Faecal calprotectin 12.69 10.76 4 77222 20 29497281
Bladder stenosis 12.69 10.76 4 77222 20 29497281
Enterococcal infection 12.67 10.76 3 77223 8265 29489036
Hyposmia 12.60 10.76 7 77219 167 29497134
Urinary tract disorder 12.59 10.76 20 77206 1912 29495389
Free androgen index decreased 12.53 10.76 4 77222 21 29497280
Radiotherapy 12.50 10.76 9 77217 341 29496960
Mitral valve prolapse 12.46 10.76 11 77215 561 29496740
Psoriatic arthropathy 12.42 10.76 12 77214 14679 29482622
Hair colour changes 12.37 10.76 18 77208 1593 29495708
Viral acanthoma 12.37 10.76 4 77222 22 29497279
Posterior reversible encephalopathy syndrome 12.37 10.76 4 77222 8972 29488329
Anaphylactic shock 12.35 10.76 10 77216 13326 29483975
Nipple disorder 12.34 10.76 7 77219 174 29497127
Plantar fascial fibromatosis 12.32 10.76 3 77223 4 29497297
Nasal operation 12.22 10.76 4 77222 23 29497278
Social avoidant behaviour 12.18 10.76 25 77201 2917 29494384
Adjustment disorder 12.11 10.76 14 77212 987 29496314
Umbilical hernia repair 12.08 10.76 4 77222 24 29497277
Sinus tachycardia 11.96 10.76 13 77213 15056 29482245
Urine calcium/creatinine ratio increased 11.94 10.76 4 77222 25 29497276
Snoring 11.94 10.76 24 77202 2760 29494541
Bladder trabeculation 11.92 10.76 3 77223 5 29497296
Exposure via body fluid 11.89 10.76 6 77220 117 29497184
Thyroid hormones increased 11.87 10.76 5 77221 63 29497238
Device related infection 11.85 10.76 14 77212 15622 29481679
General physical health deterioration 11.84 10.76 193 77033 102664 29394637
White blood cell count increased 11.81 10.76 54 77172 37462 29459839
Pelvic fracture 11.75 10.76 21 77205 2210 29495091
Musculoskeletal stiffness 11.75 10.76 54 77172 37404 29459897
Thrombotic microangiopathy 11.73 10.76 4 77222 8677 29488624
N-terminal prohormone brain natriuretic peptide abnormal 11.72 10.76 7 77219 192 29497109
Iron metabolism disorder 11.68 10.76 4 77222 27 29497274
Thyroid cyst 11.68 10.76 4 77222 27 29497274
Stenosis 11.67 10.76 14 77212 1027 29496274
Mood altered 11.65 10.76 47 77179 8064 29489237
Body height decreased 11.65 10.76 27 77199 3423 29493878
Tension headache 11.63 10.76 16 77210 1345 29495956
Synovitis 11.63 10.76 7 77219 10883 29486418
Delusion of replacement 11.62 10.76 6 77220 123 29497178
Alpha globulin increased 11.57 10.76 3 77223 6 29497295
Pudendal canal syndrome 11.57 10.76 3 77223 6 29497295
Brain oedema 11.52 10.76 9 77217 12211 29485090
Prostatic obstruction 11.44 10.76 6 77220 127 29497174
Blood testosterone free increased 11.44 10.76 4 77222 29 29497272
Therapy non-responder 11.29 10.76 42 77184 30869 29466432
On and off phenomenon 11.27 10.76 19 77207 1909 29495392
Cystitis radiation 11.27 10.76 5 77221 72 29497229
Spermatozoa morphology abnormal 11.26 10.76 3 77223 7 29497294
Pituitary tumour benign 11.24 10.76 12 77214 774 29496527
Seasonal allergy 11.18 10.76 34 77192 5068 29492233
Pneumothorax 11.16 10.76 15 77211 15827 29481474
Wrist surgery 11.15 10.76 6 77220 134 29497167
Urinary retention postoperative 11.15 10.76 5 77221 74 29497227
Myotonic dystrophy 11.15 10.76 5 77221 74 29497227
Blood bilirubin increased 11.15 10.76 48 77178 33845 29463456
Scrotal pain 11.12 10.76 12 77214 784 29496517
Bradyphrenia 11.10 10.76 30 77196 4184 29493117
Proteinuria 11.09 10.76 15 77211 15789 29481512
Blood testosterone abnormal 11.09 10.76 8 77218 304 29496997
Anaphylactic reaction 11.06 10.76 36 77190 27537 29469764
Blood pressure fluctuation 11.05 10.76 22 77204 19872 29477429
Painful erection 11.05 10.76 7 77219 214 29497087
Arthroscopic surgery 10.98 10.76 3 77223 8 29497293
Anti factor Xa activity decreased 10.98 10.76 3 77223 8 29497293
Uterine haemorrhage 10.98 10.76 3 77223 8 29497293
Seminoma 10.93 10.76 7 77219 218 29497083
Hair disorder 10.92 10.76 6 77220 140 29497161
Hand fracture 10.90 10.76 17 77209 1600 29495701
Tendon operation 10.89 10.76 4 77222 34 29497267
Immunodeficiency common variable 10.88 10.76 6 77220 141 29497160
Neoplasm progression 10.85 10.76 20 77206 18592 29478709
Testicular swelling 10.85 10.76 15 77211 1267 29496034
Vision blurred 10.82 10.76 156 77070 40020 29457281
Generalised oedema 10.81 10.76 8 77218 11157 29486144

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
Erectile dysfunction 625.48 10.43 266 49226 12361 64436879
Post 5-alpha-reductase inhibitor syndrome 431.50 10.43 73 49419 22 64449218
Libido decreased 344.71 10.43 132 49360 4652 64444588
Loss of libido 261.80 10.43 90 49402 2314 64446926
Testicular pain 247.94 10.43 80 49412 1680 64447560
Penile size reduced 216.02 10.43 38 49454 24 64449216
Gynaecomastia 206.13 10.43 98 49394 5918 64443322
Semen volume decreased 154.35 10.43 29 49463 39 64449201
Depression 131.02 10.43 372 49120 182919 64266321
Benign prostatic hyperplasia 124.04 10.43 81 49411 9084 64440156
Ejaculation disorder 122.81 10.43 35 49457 473 64448767
Organic erectile dysfunction 117.86 10.43 24 49468 61 64449179
Right atrial hypertrophy 111.58 10.43 33 49459 512 64448728
Penis disorder 109.98 10.43 36 49456 792 64448448
Sexual dysfunction 104.61 10.43 64 49428 6407 64442833
Haematuria 97.30 10.43 170 49322 60301 64388939
Genital hypoaesthesia 95.57 10.43 23 49469 151 64449089
Infertility male 95.32 10.43 21 49471 87 64449153
Urinary retention 94.81 10.43 150 49342 49051 64400189
Drug ineffective 84.93 10.43 345 49147 839902 63609338
Right ventricular hypertrophy 82.99 10.43 33 49459 1287 64447953
Ejaculation failure 78.92 10.43 23 49469 338 64448902
Dizziness 77.66 10.43 580 48912 429583 64019657
Blood testosterone decreased 77.05 10.43 36 49456 2089 64447151
Testicular atrophy 75.70 10.43 22 49470 320 64448920
Obstruction 70.77 10.43 39 49453 3209 64446031
Prostate cancer 69.82 10.43 81 49411 19714 64429526
Suicidal ideation 68.29 10.43 155 49337 66387 64382853
Bronchial secretion retention 68.21 10.43 35 49457 2492 64446748
Bronchial wall thickening 68.19 10.43 32 49460 1875 64447365
Exposure via body fluid 67.99 10.43 19 49473 238 64449002
Rheumatoid arthritis 67.54 10.43 21 49471 164273 64284967
Orthostatic hypotension 65.77 10.43 124 49368 46614 64402626
Drug hypersensitivity 65.37 10.43 52 49440 237763 64211477
Atrial fibrillation 65.12 10.43 282 49210 170807 64278433
Azoospermia 63.18 10.43 16 49476 133 64449107
Breast cancer male 61.50 10.43 17 49475 204 64449036
Hallucination 61.22 10.43 157 49335 72631 64376609
Male reproductive tract disorder 59.66 10.43 12 49480 28 64449212
Semen analysis abnormal 59.11 10.43 10 49482 3 64449237
Haematospermia 58.51 10.43 17 49475 247 64448993
Prostatic pain 56.53 10.43 11 49481 20 64449220
Aortic valve stenosis 55.99 10.43 38 49454 4542 64444698
Fall 55.95 10.43 526 48966 416300 64032940
Pulmonary function test abnormal 55.55 10.43 33 49459 3131 64446109
Synovitis 54.85 10.43 6 49486 99084 64350156
Testicular disorder 53.97 10.43 15 49477 184 64449056
Hepatic vein dilatation 50.70 10.43 15 49477 233 64449007
Muscle atrophy 50.56 10.43 49 49443 9709 64439531
Vomiting 50.18 10.43 235 49257 550882 63898358
Toxicity to various agents 49.15 10.43 131 49361 363382 64085858
Panic attack 49.08 10.43 70 49422 20883 64428357
Joint swelling 48.79 10.43 56 49436 215326 64233914
Penile pain 48.12 10.43 20 49472 875 64448365
Pyrexia 47.52 10.43 244 49248 558400 63890840
Liver palpable 45.74 10.43 15 49477 332 64448908
Off label use 45.45 10.43 292 49200 632514 63816726
Drug intolerance 44.64 10.43 47 49445 187945 64261295
Prostatic disorder 44.33 10.43 23 49469 1676 64447564
Prostatitis 44.28 10.43 30 49462 3576 64445664
Anorgasmia 43.70 10.43 19 49473 930 64448310
Prostatic specific antigen increased 43.54 10.43 43 49449 8717 64440523
Syncope 43.50 10.43 237 49255 157398 64291842
Nausea 43.50 10.43 390 49102 785410 63663830
Breast tenderness 42.99 10.43 24 49468 2025 64447215
Infusion related reaction 42.67 10.43 38 49454 164429 64284811
International normalised ratio increased 41.97 10.43 145 49347 79022 64370218
Acute kidney injury 41.76 10.43 527 48965 448713 64000527
Maternal exposure during pregnancy 41.71 10.43 11 49481 95873 64353367
Diastolic dysfunction 41.23 10.43 42 49450 8833 64440407
Granulomatous rosacea 39.94 10.43 12 49480 197 64449043
Treatment failure 39.69 10.43 20 49472 116796 64332444
Cardiac failure congestive 39.23 10.43 201 49291 130379 64318861
Anxiety 39.16 10.43 278 49214 202371 64246869
Male orgasmic disorder 39.14 10.43 9 49483 47 64449193
Breast disorder male 38.89 10.43 7 49485 6 64449234
Contraindicated product administered 38.88 10.43 17 49475 107812 64341428
Systemic lupus erythematosus 37.60 10.43 7 49485 77605 64371635
Hypospermia 37.43 10.43 7 49485 9 64449231
Intervertebral disc degeneration 37.05 10.43 48 49444 13072 64436168
Semen viscosity decreased 37.04 10.43 6 49486 0 64449240
Pain 36.91 10.43 261 49231 553250 63895990
Hypoacusis 36.85 10.43 69 49423 25798 64423442
Platypnoea 36.54 10.43 8 49484 32 64449208
Ventricular enlargement 36.13 10.43 14 49478 509 64448731
Swelling 35.90 10.43 42 49450 160176 64289064
Death 35.42 10.43 543 48949 482162 63967078
Wrong technique in product usage process 35.31 10.43 120 49372 64854 64384386
Scrotal disorder 34.60 10.43 8 49484 43 64449197
Testis cancer 34.47 10.43 15 49477 736 64448504
Inferior vena cava dilatation 34.41 10.43 15 49477 739 64448501
Asthenia 33.92 10.43 488 49004 427556 64021684
Skin atrophy 33.91 10.43 29 49463 4891 64444349
Disturbance in attention 33.91 10.43 88 49404 40986 64408254
Dysuria 33.59 10.43 89 49403 41968 64407272
Chest X-ray abnormal 33.58 10.43 33 49459 6648 64442592
Urine flow decreased 33.11 10.43 16 49476 1001 64448239
Dehydroepiandrosterone decreased 33.05 10.43 7 49485 23 64449217
Atrial enlargement 32.98 10.43 14 49478 646 64448594
Spermatozoa abnormal 32.89 10.43 6 49486 6 64449234
Injection site pain 32.33 10.43 23 49469 111385 64337855
Headache 32.27 10.43 256 49236 529211 63920029
Emotional poverty 32.02 10.43 14 49478 695 64448545
Gastrointestinal haemorrhage 31.95 10.43 192 49300 132120 64317120
Pericarditis 31.68 10.43 5 49487 62511 64386729
Gout 31.60 10.43 58 49434 21355 64427885
Apathy 31.58 10.43 41 49451 11191 64438049
Plasma cell myeloma 31.37 10.43 92 49400 45983 64403257
Hypogonadism male 31.35 10.43 9 49483 125 64449115
Hormone receptor positive breast cancer 31.14 10.43 11 49481 307 64448933
Dark circles under eyes 31.11 10.43 12 49480 431 64448809
Leydig cell tumour of the testis 30.87 10.43 5 49487 0 64449240
Pollakiuria 30.74 10.43 72 49420 31458 64417782
Upper gastrointestinal haemorrhage 30.67 10.43 77 49415 35143 64414097
Hypotension 30.03 10.43 434 49058 380540 64068700
Lid sulcus deepened 30 10.43 9 49483 147 64449093
Pemphigoid 29.85 10.43 43 49449 12943 64436297
Libido disorder 29.57 10.43 10 49482 244 64448996
Body fat disorder 29.56 10.43 9 49483 155 64449085
Hepatic enzyme increased 29.17 10.43 34 49458 129909 64319331
Genital paraesthesia 28.95 10.43 7 49485 47 64449193
Sleep apnoea syndrome 28.95 10.43 68 49424 29764 64419476
Androgen deficiency 28.72 10.43 8 49484 99 64449141
Blood thyroid stimulating hormone decreased 28.49 10.43 27 49465 5203 64444037
Saliva altered 28.13 10.43 11 49481 410 64448830
Stomatitis 27.62 10.43 26 49466 109579 64339661
Discomfort 27.24 10.43 14 49478 80864 64368376
Sperm concentration decreased 27.14 10.43 7 49485 63 64449177
Hypogonadism 26.97 10.43 14 49478 1021 64448219
Musculoskeletal stiffness 26.85 10.43 33 49459 123173 64326067
Somatic symptom disorder 26.48 10.43 17 49475 1851 64447389
Bladder cancer 26.20 10.43 37 49455 10937 64438303
Therapeutic product effect decreased 26.09 10.43 30 49462 115321 64333919
Confusional state 25.77 10.43 310 49182 260834 64188406
Faeces discoloured 25.35 10.43 59 49433 25670 64423570
Orgasmic sensation decreased 25.25 10.43 6 49486 37 64449203
Hypersensitivity 24.87 10.43 73 49419 196379 64252861
Hepatitis cholestatic 24.71 10.43 38 49454 12117 64437123
Reproductive tract hypoplasia, male 24.69 10.43 4 49488 0 64449240
Late onset hypogonadism syndrome 24.69 10.43 4 49488 0 64449240
Perineal pain 24.52 10.43 13 49479 990 64448250
C-reactive protein increased 24.52 10.43 22 49470 94887 64354353
Alopecia 24.46 10.43 57 49435 165633 64283607
Bronchiectasis 24.37 10.43 41 49451 14099 64435141
Fixed eruption 24.24 10.43 17 49475 2142 64447098
Sinusitis 24.22 10.43 47 49445 145881 64303359
Condition aggravated 24.10 10.43 177 49315 372249 64076991
On and off phenomenon 24.10 10.43 18 49474 2501 64446739
Illusion 24.03 10.43 15 49477 1555 64447685
Penile exfoliation 24.01 10.43 7 49485 103 64449137
Floppy iris syndrome 23.00 10.43 9 49483 336 64448904
Soft tissue mass 22.84 10.43 12 49480 897 64448343
Testicular swelling 22.61 10.43 12 49480 916 64448324
Agitation 22.46 10.43 130 49362 88237 64361003
Trans-sexualism 22.46 10.43 4 49488 3 64449237
Nipple pain 22.06 10.43 10 49482 541 64448699
Plica syndrome 21.92 10.43 4 49488 4 64449236
Prostatic haemorrhage 21.92 10.43 7 49485 142 64449098
Glomerular filtration rate abnormal 21.76 10.43 13 49479 1246 64447994
Cerebrovascular accident 21.67 10.43 180 49312 137403 64311837
Prostatomegaly 21.50 10.43 18 49474 2949 64446291
Interstitial lung disease 21.48 10.43 26 49466 97706 64351534
Sprue-like enteropathy 21.45 10.43 12 49480 1017 64448223
Injection site erythema 21.36 10.43 14 49478 70786 64378454
Myopathy 21.35 10.43 44 49448 17636 64431604
Hallucination, visual 21.32 10.43 58 49434 27776 64421464
Daydreaming 21.23 10.43 11 49481 799 64448441
Atrioventricular block first degree 21.04 10.43 33 49459 10701 64438539
Splenomegaly 20.87 10.43 44 49448 17917 64431323
Intentional overdose 20.77 10.43 23 49469 89921 64359319
Nasopharyngitis 20.61 10.43 79 49413 195994 64253246
Product administration error 20.57 10.43 57 49435 27586 64421654
Malpositioned teeth 20.37 10.43 5 49487 36 64449204
Xanthopsia 20.29 10.43 8 49484 305 64448935
Arthropathy 20.03 10.43 39 49453 120928 64328312
Depression suicidal 20 10.43 16 49476 2459 64446781
Stenosis 19.70 10.43 14 49478 1801 64447439
Exostosis of external ear canal 19.69 10.43 4 49488 10 64449230
Helicobacter infection 19.59 10.43 3 49489 38359 64410881
Product use issue 19.47 10.43 56 49436 151659 64297581
Melanocytic hyperplasia 19.42 10.43 4 49488 11 64449229
Oligospermia 19.16 10.43 4 49488 12 64449228
Varicocele 19.16 10.43 4 49488 12 64449228
Balance disorder 19.12 10.43 120 49372 83806 64365434
Completed suicide 19.01 10.43 98 49394 224316 64224924
Hypertrophy 19.00 10.43 10 49482 750 64448490
Semen discolouration 18.92 10.43 4 49488 13 64449227
Suicide attempt 18.90 10.43 16 49476 70991 64378249
Cytomegalovirus infection 18.79 10.43 3 49489 37196 64412044
Teratospermia 18.52 10.43 3 49489 0 64449240
Biotin deficiency 18.52 10.43 3 49489 0 64449240
Androgens abnormal 18.52 10.43 3 49489 0 64449240
Blood oestrogen abnormal 18.52 10.43 3 49489 0 64449240
Androgen insensitivity syndrome 18.47 10.43 4 49488 15 64449225
Fear of crowded places 18.47 10.43 4 49488 15 64449225
Red blood cell analysis abnormal 18.47 10.43 4 49488 15 64449225
Penile curvature 18.27 10.43 4 49488 16 64449224
N-terminal prohormone brain natriuretic peptide abnormal 18.26 10.43 7 49485 247 64448993
Skin irritation 17.66 10.43 28 49464 9166 64440074
Delusion of replacement 17.65 10.43 6 49486 149 64449091
Parkinsonism 17.62 10.43 36 49456 14337 64434903
Abdominal discomfort 17.57 10.43 76 49416 182246 64266994
Subdural haemorrhage 17.54 10.43 21 49471 5282 64443958
Haemorrhage urinary tract 17.48 10.43 14 49478 2155 64447085
Ageusia 17.42 10.43 35 49457 13778 64435462
Product name confusion 17.31 10.43 6 49486 158 64449082
Coronary artery stenosis 17.27 10.43 31 49461 11217 64438023
Alveolar bone resorption 17.25 10.43 5 49487 72 64449168
Bradycardia 17.21 10.43 152 49340 118067 64331173
Feeling abnormal 17.05 10.43 167 49325 133435 64315805
Muscle disorder 17.02 10.43 20 49472 4931 64444309
Febrile neutropenia 17.02 10.43 80 49412 187577 64261663
Haemoglobin decreased 16.86 10.43 226 49266 194837 64254403
Nipple disorder 16.70 10.43 6 49486 176 64449064
Cognitive disorder 16.67 10.43 85 49407 55002 64394238
Muscular weakness 16.66 10.43 160 49332 127178 64322062
Iron metabolism disorder 16.65 10.43 4 49488 26 64449214
Dermatitis artefacta 16.44 10.43 3 49489 3 64449237
Seminoma 16.30 10.43 6 49486 189 64449051
Iris disorder 16.27 10.43 7 49485 334 64448906
Psychiatric symptom 16.25 10.43 22 49470 6251 64442989
Bradyphrenia 15.84 10.43 27 49465 9379 64439861
Intentional product use issue 15.57 10.43 31 49461 95333 64353907
Ludwig angina 15.49 10.43 6 49486 218 64449022
Retrograde ejaculation 15.49 10.43 6 49486 218 64449022
Drug abuse 15.46 10.43 51 49441 132323 64316917
Arthralgia 15.29 10.43 243 49249 442017 64007223
Cardiac failure chronic 15.29 10.43 26 49466 9015 64440225
Alcohol intolerance 15.23 10.43 7 49485 391 64448849
Urinary tract obstruction 15.11 10.43 17 49475 4000 64445240
Flat affect 15.00 10.43 12 49480 1845 64447395
Ophthalmoplegia 14.81 10.43 14 49478 2688 64446552
Blunted affect 14.75 10.43 7 49485 421 64448819
Myasthenia gravis 14.68 10.43 20 49472 5718 64443522
Haemorrhage intracranial 14.67 10.43 46 49446 23838 64425402
Subdural haematoma 14.53 10.43 51 49441 28003 64421237
Serotonin syndrome 14.46 10.43 6 49486 39276 64409964
Immunodeficiency common variable 14.38 10.43 6 49486 265 64448975
Patellofemoral pain syndrome 14.37 10.43 7 49485 446 64448794
Hospice care 14.34 10.43 23 49469 7602 64441638
Cataract operation complication 14.26 10.43 6 49486 271 64448969
Hyperkalaemia 14.19 10.43 129 49363 101000 64348240
Anhedonia 14.13 10.43 32 49460 13674 64435566
Dementia Alzheimer's type 13.99 10.43 9 49483 983 64448257
Mood altered 13.98 10.43 35 49457 15944 64433296
Phlebosclerosis 13.94 10.43 5 49487 146 64449094
Genital cyst 13.84 10.43 4 49488 57 64449183
Bone marrow failure 13.78 10.43 10 49482 47942 64401298
Breast enlargement 13.76 10.43 10 49482 1332 64447908
Zinc deficiency 13.71 10.43 4 49488 59 64449181
Inflammation 13.69 10.43 18 49474 65282 64383958
Lower respiratory tract infection 13.60 10.43 33 49459 94581 64354659
Spermatozoa progressive motility decreased 13.59 10.43 4 49488 61 64449179
Mental impairment 13.47 10.43 35 49457 16308 64432932
Blood luteinising hormone decreased 13.45 10.43 5 49487 162 64449078
Hypotrichosis 13.42 10.43 5 49487 163 64449077
Glossodynia 13.39 10.43 18 49474 64678 64384562
Social avoidant behaviour 13.38 10.43 17 49475 4540 64444700
Withdrawal hypertension 13.30 10.43 6 49486 321 64448919
Blood testosterone abnormal 13.28 10.43 5 49487 168 64449072
C-reactive protein abnormal 13.28 10.43 3 49489 29044 64420196
Premature ejaculation 13.24 10.43 4 49488 67 64449173
Testicular microlithiasis 13.16 10.43 3 49489 15 64449225
Sex hormone binding globulin decreased 13.16 10.43 3 49489 15 64449225
Alpha 2 globulin decreased 13.16 10.43 3 49489 15 64449225
Otosalpingitis 13.16 10.43 3 49489 15 64449225
Paternal drugs affecting foetus 13.16 10.43 3 49489 15 64449225
Viral acanthoma 13.00 10.43 3 49489 16 64449224
Free androgen index decreased 13.00 10.43 3 49489 16 64449224
Borderline personality disorder 12.94 10.43 8 49484 816 64448424
Strangury 12.90 10.43 5 49487 182 64449058
Ventricular extrasystoles 12.90 10.43 36 49456 17493 64431747
Infusion site induration 12.86 10.43 8 49484 825 64448415
Bladder stenosis 12.84 10.43 3 49489 17 64449223
Anti factor Xa activity decreased 12.84 10.43 3 49489 17 64449223
Haematuria traumatic 12.82 10.43 5 49487 185 64449055
Fat tissue increased 12.77 10.43 8 49484 835 64448405
Obstructive airways disorder 12.75 10.43 43 49449 23142 64426098
Sinus rhythm 12.59 10.43 7 49485 586 64448654
Affective disorder 12.58 10.43 20 49472 6560 64442680
Nocturia 12.56 10.43 27 49465 11138 64438102
Weight increased 12.56 10.43 104 49388 213244 64235996
Listless 12.51 10.43 14 49478 3276 64445964
Blood oestrogen increased 12.48 10.43 4 49488 82 64449158
Exposure via father 12.48 10.43 4 49488 82 64449158
Nasal discomfort 12.48 10.43 16 49476 4312 64444928
Basosquamous carcinoma 12.44 10.43 4 49488 83 64449157
Mucosal inflammation 12.37 10.43 18 49474 62566 64386674
Gastrointestinal disorder 12.34 10.43 32 49460 89677 64359563
Faecal calprotectin 12.30 10.43 3 49489 21 64449219
Haemorrhagic stroke 12.29 10.43 25 49467 9926 64439314
Mitochondrial cytopathy 12.25 10.43 6 49486 387 64448853
Asthenospermia 12.18 10.43 3 49489 22 64449218
Prostatic operation 12.13 10.43 5 49487 214 64449026
Peritoneal neoplasm 12.05 10.43 4 49488 92 64449148
Peyronie's disease 11.95 10.43 3 49489 24 64449216
Multiple organ dysfunction syndrome 11.89 10.43 39 49453 101374 64347866
Renal atrophy 11.86 10.43 10 49482 1654 64447586
Injection site reaction 11.83 10.43 11 49481 46653 64402587
Altered state of consciousness 11.83 10.43 59 49433 37843 64411397
Leukopenia 11.83 10.43 39 49453 101203 64348037
Disseminated intravascular coagulation 11.81 10.43 5 49487 32343 64416897
Dyspnoea at rest 11.78 10.43 19 49473 6310 64442930
Dissociation 11.77 10.43 13 49479 2998 64446242
Bundle branch block right 11.75 10.43 25 49467 10244 64438996
Overdose 11.71 10.43 73 49419 159493 64289747
Vitreous floaters 11.68 10.43 19 49473 6354 64442886
Insomnia 11.67 10.43 215 49277 197621 64251619
Metabolic acidosis 11.64 10.43 23 49469 70935 64378305
Myxoedema coma 11.63 10.43 7 49485 680 64448560
Gingivitis 11.62 10.43 21 49471 7638 64441602
Wound 11.53 10.43 26 49466 76451 64372789
Renal cyst 11.49 10.43 28 49464 12542 64436698
Full blood count abnormal 11.26 10.43 49 49443 29708 64419532
Sexually inappropriate behaviour 11.26 10.43 6 49486 462 64448778
Obsessive-compulsive disorder 11.14 10.43 16 49476 4802 64444438
Myalgia 11.03 10.43 177 49315 158440 64290800
Cryptorchism 11.01 10.43 3 49489 34 64449206
Feminisation acquired 11.01 10.43 3 49489 34 64449206
Product dispensing error 11.00 10.43 26 49466 11424 64437816
Genital burning sensation 10.92 10.43 5 49487 277 64448963
Fibromyalgia 10.87 10.43 7 49485 35724 64413516
Tendon calcification 10.84 10.43 4 49488 127 64449113
Injection site pruritus 10.72 10.43 8 49484 37818 64411422
Skin fragility 10.67 10.43 7 49485 791 64448449
Gingival disorder 10.66 10.43 13 49479 3331 64445909
Meibomian gland dysfunction 10.63 10.43 4 49488 134 64449106
Heparin-induced thrombocytopenia test positive 10.63 10.43 4 49488 134 64449106
Hypertrichosis 10.53 10.43 8 49484 1140 64448100
Irritable bowel syndrome 10.47 10.43 8 49484 37361 64411879
Mesenteric vascular insufficiency 10.44 10.43 4 49488 141 64449099
Prostate examination abnormal 10.44 10.43 4 49488 141 64449099

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC D11AX10 DERMATOLOGICALS
OTHER DERMATOLOGICAL PREPARATIONS
OTHER DERMATOLOGICAL PREPARATIONS
Other dermatologicals
ATC G04CA51 GENITO URINARY SYSTEM AND SEX HORMONES
UROLOGICALS
DRUGS USED IN BENIGN PROSTATIC HYPERTROPHY
Alpha-adrenoreceptor antagonists
ATC G04CB01 GENITO URINARY SYSTEM AND SEX HORMONES
UROLOGICALS
DRUGS USED IN BENIGN PROSTATIC HYPERTROPHY
Testosterone-5-alpha reductase inhibitors
FDA MoA N0000000126 5-alpha Reductase Inhibitors
CHEBI has role CHEBI:35497 antiandrogen
CHEBI has role CHEBI:50781 5alpha-reductase inhibitors
CHEBI has role CHEBI:59844 antihyperplasia drugs
FDA EPC N0000175836 5-alpha Reductase Inhibitor
MeSH PA D058891 5-alpha Reductase Inhibitors
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D006727 Hormone Antagonists
MeSH PA D065088 Steroid Synthesis Inhibitors
MeSH PA D064804 Urological Agents

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

DiseaseRelationSNOMED_IDDOID
Benign prostatic hyperplasia indication 266569009
Male Patterned Baldness indication
Hidradenitis suppurativa off-label use 59393003 DOID:2280
Disease of liver contraindication 235856003 DOID:409
Pregnancy, function contraindication 289908002
Breastfeeding (mother) contraindication 413712001
High-Grade Prostate Cancer contraindication
Breast Carcinoma in Males 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 13.26 acidic

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
3-oxo-5-alpha-steroid 4-dehydrogenase 2 Enzyme INHIBITOR IC50 8.26 WOMBAT-PK DRUG LABEL
3-oxo-5-alpha-steroid 4-dehydrogenase 1 Enzyme INHIBITOR IC50 7.58 WOMBAT-PK DRUG LABEL
3 beta-hydroxysteroid dehydrogenase/Delta 5-->4-isomerase type 1 Enzyme Ki 4.96 CHEMBL
Cytochrome P450 2C9 Enzyme IC50 5.70 DRUG MATRIX
Cytochrome P450 2C19 Enzyme IC50 6 DRUG MATRIX
3-oxo-5-alpha-steroid 4-dehydrogenase 1 Enzyme Ki 8.17 CHEMBL
Steroid 5-alpha-reductase Enzyme Ki 7.26 CHEMBL
3-oxo-5-alpha-steroid 4-dehydrogenase 2 Enzyme IC50 9.55 CHEMBL

External reference:

IDSource
4020167 VUID
N0000148118 NUI
D00321 KEGG_DRUG
4020167 VANDF
C0060389 UMLSCUI
CHEBI:5062 CHEBI
FIT PDB_CHEM_ID
CHEMBL710 ChEMBL_ID
DB01216 DRUGBANK_ID
D018120 MESH_DESCRIPTOR_UI
57363 PUBCHEM_CID
6818 IUPHAR_LIGAND_ID
6539 INN_ID
57GNO57U7G UNII
219462 RXNORM
11509 MMSL
4728 MMSL
82773 MMSL
d00563 MMSL
003665 NDDF
109035006 SNOMEDCT_US
386963006 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
PROPECIA HUMAN PRESCRIPTION DRUG LABEL 1 0006-0071 TABLET, FILM COATED 1 mg ORAL NDA 28 sections
PROSCAR HUMAN PRESCRIPTION DRUG LABEL 1 0006-0072 TABLET, FILM COATED 5 mg ORAL NDA 28 sections
Finasteride HUMAN PRESCRIPTION DRUG LABEL 1 0093-7355 TABLET, FILM COATED 5 mg ORAL ANDA 27 sections
Finasteride HUMAN PRESCRIPTION DRUG LABEL 1 0093-7355 TABLET, FILM COATED 5 mg ORAL ANDA 27 sections
Finasteride HUMAN PRESCRIPTION DRUG LABEL 1 0904-6830 TABLET, FILM COATED 5 mg ORAL ANDA 26 sections
Finasteride HUMAN PRESCRIPTION DRUG LABEL 1 16729-089 TABLET, FILM COATED 1 mg ORAL ANDA 28 sections
Finasteride HUMAN PRESCRIPTION DRUG LABEL 1 16729-090 TABLET, FILM COATED 5 mg ORAL ANDA 26 sections
Finasteride HUMAN PRESCRIPTION DRUG LABEL 1 17856-0090 TABLET, FILM COATED 5 mg ORAL ANDA 26 sections
Finasteride HUMAN PRESCRIPTION DRUG LABEL 1 31722-525 TABLET, FILM COATED 5 mg ORAL ANDA 22 sections
Finasteride HUMAN PRESCRIPTION DRUG LABEL 1 31722-525 TABLET, FILM COATED 5 mg ORAL ANDA 22 sections
Finasteride Human Prescription Drug Label 1 31722-526 TABLET, FILM COATED 1 mg ORAL ANDA 26 sections
Finasteride HUMAN PRESCRIPTION DRUG LABEL 1 33261-833 TABLET 5 mg ORAL ANDA 27 sections
Finasteride Human Prescription Drug Label 1 35573-400 TABLET, FILM COATED 1 mg ORAL ANDA 26 sections
Finasteride HUMAN PRESCRIPTION DRUG LABEL 1 43598-303 TABLET, FILM COATED 5 mg ORAL ANDA 26 sections
Finasteride HUMAN PRESCRIPTION DRUG LABEL 1 43598-390 TABLET, FILM COATED 1 mg ORAL ANDA 25 sections
Finasteride Human Prescription Drug Label 1 47335-714 TABLET, FILM COATED 1 mg ORAL ANDA 26 sections
Finasteride HUMAN PRESCRIPTION DRUG LABEL 1 50090-1718 TABLET, FILM COATED 5 mg ORAL ANDA 26 sections
Finasteride Human Prescription Drug Label 1 50090-1936 TABLET, FILM COATED 5 mg ORAL ANDA 26 sections
Finasteride Human Prescription Drug Label 1 50090-1936 TABLET, FILM COATED 5 mg ORAL ANDA 26 sections
Finasteride HUMAN PRESCRIPTION DRUG LABEL 1 50090-3942 TABLET, FILM COATED 1 mg ORAL ANDA 27 sections
Finasteride Human Prescription Drug Label 1 50090-4648 TABLET, COATED 1 mg ORAL ANDA 25 sections
Finasteride Human Prescription Drug Label 1 50090-4697 TABLET, FILM COATED 5 mg ORAL ANDA 25 sections
Finasteride HUMAN PRESCRIPTION DRUG LABEL 1 50268-314 TABLET, FILM COATED 5 mg ORAL ANDA 26 sections
Finasteride HUMAN PRESCRIPTION DRUG LABEL 1 50268-314 TABLET, FILM COATED 5 mg ORAL ANDA 26 sections
Finasteride HUMAN PRESCRIPTION DRUG LABEL 1 50436-0089 TABLET, FILM COATED 1 mg ORAL ANDA 27 sections
Finasteride Human Prescription Drug Label 1 50436-0455 TABLET, COATED 1 mg ORAL ANDA 25 sections
Finasteride Human Prescription Drug Label 1 50436-0927 TABLET, FILM COATED 1 mg ORAL ANDA 26 sections
PROPECIA HUMAN PRESCRIPTION DRUG LABEL 1 54868-4120 TABLET, FILM COATED 1 mg ORAL NDA 29 sections
Finasteride HUMAN PRESCRIPTION DRUG LABEL 1 54868-5636 TABLET, FILM COATED 5 mg ORAL ANDA 14 sections
Finasteride HUMAN PRESCRIPTION DRUG LABEL 1 55111-171 TABLET, FILM COATED 1 mg ORAL ANDA 26 sections