All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

finasteride 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
testosterone reductase inhibitors	1171	98319-26-7

Description:

Molecule	Description
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:

Dose	Unit	Route
1	mg	O
5	mg	O

ADMET properties:

Property	Value	Reference
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 µM/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:

Date	Agency	Company	Orphan
June 19, 1992	FDA	MERCK

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
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:

Source	Code	Description
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|

Disease	Relation	SNOMED_ID	DOID
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

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	13.26	acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
3-oxo-5-alpha-steroid 4-dehydrogenase 2	Enzyme	P31213	S5A2_HUMAN	INHIBITOR	IC50	8.26		WOMBAT-PK	DRUG LABEL
3-oxo-5-alpha-steroid 4-dehydrogenase 1	Enzyme	P18405	S5A1_HUMAN	INHIBITOR	IC50	7.58		WOMBAT-PK	DRUG LABEL
3 beta-hydroxysteroid dehydrogenase/Delta 5-->4-isomerase type 1	Enzyme	P14060	3BHS1_HUMAN		Ki	4.96		CHEMBL
Cytochrome P450 2C9	Enzyme	P11712	CP2C9_HUMAN		IC50	5.70		DRUG MATRIX
Cytochrome P450 2C19	Enzyme	P33261	CP2CJ_HUMAN		IC50	6		DRUG MATRIX
3-oxo-5-alpha-steroid 4-dehydrogenase 1	Enzyme		S5A1_RAT		Ki	8.17		CHEMBL
Steroid 5-alpha-reductase	Enzyme		S5A1_RAT S5A2_RAT		Ki	7.26		CHEMBL
3-oxo-5-alpha-steroid 4-dehydrogenase 2	Enzyme		S5A2_RAT		IC50	9.55		CHEMBL

External reference:

ID	Source
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:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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