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

Stem definition	Drug id	CAS RN
androgens/anabolic steroids	2607	58-22-0

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: testosterone 17beta-Testosterone	A potent androgenic steroid and major product secreted by the LEYDIG CELLS of the TESTIS. Its production is stimulated by LUTEINIZING HORMONE from the PITUITARY GLAND. In turn, testosterone exerts feedback control of the pituitary LH and FSH secretion. Depending on the tissues, testosterone can be further converted to DIHYDROTESTOSTERONE or ESTRADIOL. Molecular weight: 288.43 Formula: C19H28O2 CLOGP: 3.41 LIPINSKI: 0 HAC: 2 HDO: 1 TPSA: 37.30 ALOGS: -3.94 ROTB: 0 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

testosterone
17beta-Testosterone

A potent androgenic steroid and major product secreted by the LEYDIG CELLS of the TESTIS. Its production is stimulated by LUTEINIZING HORMONE from the PITUITARY GLAND. In turn, testosterone exerts feedback control of the pituitary LH and FSH secretion. Depending on the tissues, testosterone can be further converted to DIHYDROTESTOSTERONE or ESTRADIOL.

Molecular weight: 288.43
Formula: C19H28O2
CLOGP: 3.41
LIPINSKI: 0
HAC: 2
HDO: 1
TPSA: 37.30
ALOGS: -3.94
ROTB: 0

Status: OFP

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

Drug dosage:

Dose	Unit	Route
0.12	g	O
18	mg	P
0.12	g	R
60	mg	SL
50	mg	TD
3	mg	TD

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	0.02 mg/mL	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	2.97 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability)	4 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution)	0.35 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	24.50 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.06 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	0.17 hours	Lombardo F, Berellini G, Obach RS

Approvals:

Date	Agency	Company	Orphan
July 13, 1972	FDA	ACTIENT PHARMS

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
Blood testosterone increased	291.11	20.64	40	3410	110	50601564
Accidental exposure to product	201.81	20.64	71	3379	22986	50578688
Virilism	157.57	20.64	20	3430	21	50601653
Expulsion of medication	140.27	20.64	17	3433	7	50601667
Enlarged clitoris	130.86	20.64	20	3430	136	50601538
Precocious puberty	117.16	20.64	19	3431	197	50601477
Hair growth abnormal	109.39	20.64	27	3423	2534	50599140
Accidental exposure to product by child	70.81	20.64	16	3434	1024	50600650
Off label use	70.81	20.64	120	3330	474306	50127368
Metaplasia	48.55	20.64	10	3440	412	50601262
Adnexal torsion	47.71	20.64	9	3441	234	50601440
Hirsutism	44.97	20.64	11	3439	992	50600682
Skin laceration	44.71	20.64	23	3427	18819	50582855
Idiopathic intracranial hypertension	44.34	20.64	13	3437	2336	50599338
Apocrine breast carcinoma	42.97	20.64	5	3445	0	50601674
Atherosclerotic plaque rupture	42.97	20.64	5	3445	0	50601674
Priapism	42.77	20.64	7	3443	77	50601597
Renal infarct	41.65	20.64	11	3439	1349	50600325
Borderline serous tumour of ovary	39.51	20.64	5	3445	5	50601669
Self-destructive behaviour	39.51	20.64	5	3445	5	50601669
Infertility	39.40	20.64	9	3441	604	50601070
Ovarian endometrioid carcinoma	38.59	20.64	5	3445	7	50601667
Hormone level abnormal	36.67	20.64	11	3439	2138	50599536
Vaginal disorder	33.16	20.64	8	3442	681	50600993
Acne	32.82	20.64	19	3431	19576	50582098
Blood testosterone decreased	31.27	20.64	5	3445	47	50601627
Renal artery fibromuscular dysplasia	30.71	20.64	4	3446	6	50601668
Intraductal proliferative breast lesion	30.71	20.64	10	3440	2540	50599134
Vocal cord atrophy	29.37	20.64	4	3446	10	50601664
Dissociative identity disorder	28.99	20.64	5	3445	77	50601597
Performance enhancing product use	28.36	20.64	4	3446	14	50601660
Papilloedema	27.68	20.64	10	3440	3463	50598211
Chorioretinopathy	26.82	20.64	7	3443	819	50600855
Ovarian necrosis	26.32	20.64	4	3446	26	50601648
Gender dysphoria	25.78	20.64	3	3447	0	50601674
Ovarian cancer stage II	25.48	20.64	4	3446	33	50601641
Product packaging difficult to open	23.68	20.64	4	3446	54	50601620
Focal segmental glomerulosclerosis	23.47	20.64	7	3443	1334	50600340
Breast cancer	23.37	20.64	21	3429	42869	50558805
Osteonecrosis	23.07	20.64	16	3434	22501	50579173
Growth accelerated	21.89	20.64	3	3447	8	50601666
Product quality issue	20.66	20.64	17	3433	30841	50570833

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
Blood testosterone decreased	634.76	11.48	218	33386	3712	29537211
Blood testosterone increased	503.42	11.48	133	33471	855	29540068
Polycythaemia	298.18	11.48	101	33503	1643	29539280
Product administered at inappropriate site	256.75	11.48	90	33514	1630	29539293
Product deposit	251.63	11.48	60	33544	235	29540688
Application site rash	233.85	11.48	69	33535	695	29540228
Deep vein thrombosis	190.96	11.48	278	33326	57121	29483802
Expulsion of medication	172.06	11.48	32	33572	16	29540907
Blood testosterone abnormal	163.71	11.48	43	33561	269	29540654
Incorrect dose administered	159.51	11.48	192	33412	32792	29508131
Precocious puberty	140.02	11.48	32	33572	99	29540824
Haematocrit increased	137.65	11.48	57	33547	1651	29539272
Product quality issue	127.37	11.48	121	33483	15774	29525149
Poor quality product administered	123.65	11.48	52	33552	1567	29539356
Application site pain	121.82	11.48	52	33552	1627	29539296
Implant site pain	116.84	11.48	27	33577	89	29540834
Pulmonary embolism	116.60	11.48	264	33340	76270	29464653
Application site erythema	113.78	11.48	53	33551	2046	29538877
Prescribed overdose	108.00	11.48	85	33519	8598	29532325
Testicular atrophy	104.59	11.48	34	33570	483	29540440
Toxicity to various agents	103.93	11.48	34	33570	173627	29367296
Multiple use of single-use product	86.35	11.48	24	33580	191	29540732
Insulin-like growth factor increased	85.90	11.48	36	33568	1075	29539848
Infertility male	85.08	11.48	23	33581	163	29540760
Application site pruritus	83.75	11.48	37	33567	1260	29539663
Death	77.99	11.48	171	33433	341913	29199010
Product odour abnormal	77.55	11.48	29	33575	636	29540287
Product packaging quantity issue	77.12	11.48	30	33574	735	29540188
Libido decreased	75.92	11.48	52	33552	4246	29536677
Pituitary tumour benign	72.84	11.48	29	33575	757	29540166
Device delivery system issue	71.79	11.48	23	33581	311	29540612
Application site reaction	70.85	11.48	24	33580	390	29540533
Injection site pain	70.83	11.48	130	33474	32316	29508607
Oestradiol increased	69.89	11.48	16	33588	50	29540873
Clear cell renal cell carcinoma	68.92	11.48	30	33574	985	29539938
Blood testosterone free decreased	67.43	11.48	16	33588	61	29540862
Febrile neutropenia	67.04	11.48	22	33582	112218	29428705
Neutropenia	66.97	11.48	33	33571	131678	29409245
Craniopharyngioma	66.37	11.48	21	33583	272	29540651
Erectile dysfunction	62.37	11.48	89	33515	17920	29523003
Device expulsion	62.35	11.48	14	33590	39	29540884
Gynaecomastia	61.00	11.48	60	33544	8157	29532766
Application site exfoliation	57.08	11.48	15	33589	94	29540829
General physical health deterioration	56.61	11.48	23	33581	102834	29438089
Feeling abnormal	55.97	11.48	162	33442	54283	29486640
Secondary hypogonadism	54.59	11.48	18	33586	268	29540655
Product dose omission issue	54.18	11.48	235	33369	96148	29444775
Application site irritation	53.95	11.48	22	33582	612	29540311
Haemoglobin increased	53.55	11.48	36	33568	2850	29538073
Prostatic specific antigen increased	52.46	11.48	68	33536	12496	29528427
Azoospermia	52.16	11.48	19	33585	386	29540537
Mesenteric vein thrombosis	51.88	11.48	20	33584	478	29540445
Osteonecrosis	51.57	11.48	70	33534	13449	29527474
Application site dryness	51.38	11.48	12	33592	42	29540881
Sleep apnoea syndrome	50.97	11.48	80	33524	17519	29523404
Completed suicide	49.95	11.48	20	33584	90226	29450697
Muscle mass	49.83	11.48	16	33588	218	29540705
Thrombocytopenia	49.65	11.48	48	33556	134775	29406148
Hypogonadism	49.12	11.48	27	33577	1484	29539439
Pyrexia	48.75	11.48	166	33438	287456	29253467
Hair growth abnormal	47.92	11.48	21	33583	701	29540222
Application site vesicles	46.78	11.48	19	33585	523	29540400
Red blood cell count increased	45.60	11.48	25	33579	1367	29539556
Wrong technique in product usage process	45.11	11.48	106	33498	31322	29509601
Product container issue	45.00	11.48	19	33585	578	29540345
Acute myocardial infarction	44.00	11.48	138	33466	48300	29492623
Liquid product physical issue	43.74	11.48	16	33588	329	29540594
Implant site bruising	43.71	11.48	8	33596	3	29540920
Anaemia	43.57	11.48	103	33501	200848	29340075
Lymphoproliferative disorder	43.28	11.48	30	33574	2497	29538426
Performance enhancing product use	43.00	11.48	11	33593	61	29540862
Hyperoestrogenism	42.37	11.48	8	33596	5	29540918
Focal segmental glomerulosclerosis	42.07	11.48	26	33578	1781	29539142
Implant site infection	41.68	11.48	21	33583	965	29539958
Blood oestrogen increased	40.46	11.48	10	33594	47	29540876
Thrombosis	40.35	11.48	124	33480	42921	29498002
Insulin-like growth factor decreased	39.85	11.48	14	33590	255	29540668
Drug interaction	39.80	11.48	105	33499	197280	29343643
Application site discolouration	38.39	11.48	13	33591	211	29540712
Headache	37.54	11.48	331	33273	173676	29367247
Acne	37.09	11.48	49	33555	9171	29531752
Pancytopenia	36.33	11.48	25	33579	83143	29457780
Cerebrovascular accident	36.14	11.48	178	33426	76733	29464190
Infertility	35.83	11.48	12	33592	188	29540735
Depression	35.79	11.48	191	33413	84956	29455967
Interstitial lung disease	34.99	11.48	11	33593	57707	29483216
Acute kidney injury	34.89	11.48	169	33435	265098	29275825
Acne fulminans	34.73	11.48	11	33593	143	29540780
Spinal cord abscess	34.60	11.48	12	33592	210	29540713
Product physical consistency issue	34.58	11.48	14	33590	382	29540541
Septic shock	34.39	11.48	14	33590	62546	29478377
Portal vein thrombosis	34.01	11.48	29	33575	3280	29537643
Product physical issue	33.92	11.48	24	33580	2064	29538859
Product administration error	33.33	11.48	59	33545	14251	29526672
Myocardial infarction	33.33	11.48	227	33377	110069	29430854
Breast cancer	32.98	11.48	12	33592	243	29540680
Application site urticaria	32.91	11.48	9	33595	67	29540856
Prostate cancer	32.27	11.48	82	33522	25445	29515478
Drug abuse	32.09	11.48	177	33427	79706	29461217
Product storage error	31.79	11.48	38	33566	6432	29534491
Drug ineffective	30.87	11.48	581	33023	362589	29178334
Blood follicle stimulating hormone decreased	30.74	11.48	8	33596	48	29540875
Fatigue	30.13	11.48	516	33088	316305	29224618
Blood testosterone free increased	29.64	11.48	7	33597	26	29540897
Blood luteinising hormone decreased	28.99	11.48	9	33595	109	29540814
Virilism	28.91	11.48	5	33599	0	29540923
Implant site swelling	28.75	11.48	8	33596	64	29540859
Expired product administered	27.60	11.48	24	33580	2787	29538136
Muscle hypertrophy	27.49	11.48	7	33597	38	29540885
Stubbornness	26.91	11.48	6	33598	16	29540907
Implant site haemorrhage	26.15	11.48	8	33596	92	29540831
Left ventricular hypertrophy	26.01	11.48	35	33569	6668	29534255
Coronary artery disease	25.75	11.48	109	33495	44081	29496842
Pneumonia	25.48	11.48	237	33367	319935	29220988
Drug-disease interaction	25.39	11.48	11	33593	357	29540566
Renal infarct	25.30	11.48	16	33588	1141	29539782
Malignant neoplasm progression	25.23	11.48	28	33576	73831	29467092
Melaena	25.03	11.48	3	33601	31173	29509750
Leukopenia	24.90	11.48	16	33588	55187	29485736
Pituitary tumour	24.88	11.48	12	33592	501	29540422
Platelet count decreased	24.82	11.48	51	33553	104621	29436302
Therapeutic response unexpected	24.63	11.48	39	33565	8599	29532324
Pituitary tumour recurrent	24.62	11.48	7	33597	61	29540862
Acromegaly	24.31	11.48	6	33598	28	29540895
Hyperhidrosis	23.93	11.48	140	33464	64400	29476523
Disease progression	23.89	11.48	35	33569	81881	29459042
Multiple organ dysfunction syndrome	23.76	11.48	22	33582	63094	29477829
Incorrect product administration duration	23.68	11.48	26	33578	4015	29536908
Hypercoagulation	23.63	11.48	15	33589	1077	29539846
Idiopathic intracranial hypertension	23.19	11.48	12	33592	583	29540340
Anger	22.95	11.48	43	33561	10847	29530076
Application site dermatitis	22.78	11.48	6	33598	38	29540885
Hypotension	22.61	11.48	129	33475	194225	29346698
Hormone level abnormal	22.59	11.48	10	33594	342	29540581
Cholelithiasis	22.58	11.48	59	33545	18613	29522310
Implant site erythema	22.38	11.48	6	33598	41	29540882
Intentional overdose	22.20	11.48	8	33596	38520	29502403
Phaeochromocytoma	22.03	11.48	8	33596	161	29540762
Hypogonadism male	21.72	11.48	9	33595	261	29540662
Neoplasm recurrence	21.71	11.48	18	33586	1959	29538964
Pre-existing condition improved	21.65	11.48	19	33585	2234	29538689
Insulin resistance	21.48	11.48	11	33593	523	29540400
Loss of libido	21.34	11.48	19	33585	2277	29538646
Decreased appetite	21.21	11.48	89	33515	145253	29395670
C-reactive protein increased	21.12	11.48	12	33592	44251	29496672
Renal artery thrombosis	20.95	11.48	9	33595	286	29540637
Product complaint	20.63	11.48	28	33576	5377	29535546
Aortic aneurysm	20.45	11.48	30	33574	6190	29534733
Sepsis	20.44	11.48	88	33516	142594	29398329
Intentional product misuse	19.81	11.48	85	33519	34576	29506347
Application site paraesthesia	19.47	11.48	4	33600	6	29540917
Glucose tolerance decreased	19.30	11.48	6	33598	73	29540850
Underdose	19.21	11.48	42	33562	11827	29529096
Mucosal inflammation	19.18	11.48	6	33598	31589	29509334
Treatment failure	19.13	11.48	9	33595	36930	29503993
Prostatomegaly	19.10	11.48	25	33579	4636	29536287
Oligospermia	19.08	11.48	6	33598	76	29540847
Irritability	19.08	11.48	62	33542	22090	29518833
Myocardial fibrosis	19.04	11.48	13	33591	1055	29539868
Needle issue	19.01	11.48	25	33579	4658	29536265
Bone marrow failure	18.99	11.48	4	33600	27445	29513478
Blood thyroid stimulating hormone decreased	18.98	11.48	16	33588	1782	29539141
Renal failure	18.97	11.48	70	33534	118529	29422394
Product colour issue	18.93	11.48	9	33595	364	29540559
No adverse event	18.90	11.48	53	33551	17425	29523498
Cardiac death	18.62	11.48	12	33592	884	29540039
Accidental exposure to product by child	18.46	11.48	14	33590	1340	29539583
Implant site mass	18.42	11.48	4	33600	9	29540914
Breast tenderness	18.41	11.48	11	33593	709	29540214
Amnesia	18.28	11.48	62	33542	22581	29518342
Testicular pain	18.02	11.48	18	33586	2491	29538432
Blood growth hormone increased	17.90	11.48	8	33596	280	29540643
Chorioretinopathy	17.90	11.48	14	33590	1402	29539521
Acne conglobata	17.85	11.48	4	33600	11	29540912
Application site inflammation	17.57	11.48	6	33598	100	29540823
Nipple pain	17.56	11.48	10	33594	589	29540334
Growth hormone-producing pituitary tumour	17.44	11.48	5	33599	45	29540878
Anorgasmia	17.43	11.48	10	33594	597	29540326
Angiofibroma	17.34	11.48	3	33601	0	29540923
Borderline ovarian tumour	17.34	11.48	3	33601	0	29540923
Circumstance or information capable of leading to medication error	16.99	11.48	14	33590	1510	29539413
Cardiac failure	16.85	11.48	41	33563	79246	29461677
Application site burn	16.83	11.48	7	33597	205	29540718
Thyroxine decreased	16.75	11.48	6	33598	116	29540807
Neutrophil count decreased	16.61	11.48	15	33589	43552	29497371
Oxygen saturation decreased	16.51	11.48	16	33588	44921	29496002
Growth accelerated	16.51	11.48	4	33600	17	29540906
Transient ischaemic attack	16.45	11.48	61	33543	23209	29517714
Confusional state	16.45	11.48	82	33522	127795	29413128
Stomatitis	16.40	11.48	11	33593	37102	29503821
Cardio-respiratory arrest	16.40	11.48	20	33584	50581	29490342
Bradycardia	16.39	11.48	31	33573	65598	29475325
Gastrointestinal haemorrhage	16.22	11.48	42	33562	79491	29461432
Implant site cellulitis	16.15	11.48	4	33600	19	29540904
Skin irritation	15.37	11.48	22	33582	4439	29536484
Hyperkalaemia	15.33	11.48	29	33575	61363	29479560
Implant site necrosis	15.27	11.48	3	33601	3	29540920
Dermal absorption impaired	15.27	11.48	3	33601	3	29540920
Sperm concentration zero	15.27	11.48	3	33601	3	29540920
Thyrotoxic periodic paralysis	15.25	11.48	5	33599	73	29540850
Thyroid mass	15.03	11.48	8	33596	412	29540511
Testis discomfort	14.81	11.48	3	33601	4	29540919
Blood cholesterol increased	14.67	11.48	45	33559	15550	29525373
Small airways disease	14.48	11.48	4	33600	31	29540892
Device extrusion	14.41	11.48	3	33601	5	29540918
Asthma exercise induced	14.29	11.48	5	33599	90	29540833
Androgen deficiency	14.07	11.48	6	33598	187	29540736
Accidental exposure to product	14.06	11.48	35	33569	10718	29530205
Implant site rash	14.06	11.48	3	33601	6	29540917
Penis disorder	14.03	11.48	11	33593	1106	29539817
Carpal tunnel syndrome	13.75	11.48	20	33584	4094	29536829
Back pain	13.73	11.48	177	33427	102107	29438816
Alopecia	13.47	11.48	50	33554	19034	29521889
Coma	13.42	11.48	15	33589	39435	29501488
Ophthalmic vein thrombosis	13.32	11.48	4	33600	43	29540880
Sleep disorder	13.32	11.48	59	33545	24327	29516596
Hepatic adenoma	13.15	11.48	4	33600	45	29540878
Electrocardiogram QT prolonged	13.12	11.48	13	33591	36124	29504799
Gamma-glutamyltransferase increased	13.11	11.48	7	33597	26730	29514193
Haemoglobin decreased	13.09	11.48	71	33533	108304	29432619
Empty sella syndrome	13.07	11.48	4	33600	46	29540877
Retinal vein occlusion	12.96	11.48	12	33592	1513	29539410
Lower respiratory tract infection	12.91	11.48	7	33597	26495	29514428
Factor V Leiden mutation	12.85	11.48	4	33600	49	29540874
Hyponatraemia	12.83	11.48	37	33567	67596	29473327
Drug withdrawal syndrome	12.59	11.48	47	33557	17937	29522986
Muscle spasms	12.56	11.48	121	33483	64961	29475962
Injection site bruising	12.47	11.48	27	33577	7553	29533370
Cardiomyopathy	12.39	11.48	41	33563	14746	29526177
Eye colour change	12.39	11.48	6	33598	253	29540670
Respiratory distress	12.30	11.48	11	33593	32095	29508828
Hyperglycaemic hyperosmolar nonketotic syndrome	12.29	11.48	10	33594	1060	29539863
Impulsive behaviour	12.26	11.48	13	33591	1930	29538993
Cortisol decreased	12.24	11.48	9	33595	822	29540101
Eosinophilia	12.10	11.48	5	33599	22156	29518767
Metabolic acidosis	12.08	11.48	15	33589	37647	29503276
Gastric hypomotility	12.04	11.48	4	33600	61	29540862
Lactic acidosis	12.03	11.48	10	33594	30237	29510686
Cerebral venous thrombosis	11.94	11.48	8	33596	630	29540293
Inappropriate schedule of product administration	11.93	11.48	89	33515	44383	29496540
Sperm concentration decreased	11.91	11.48	5	33599	150	29540773
Skin odour abnormal	11.81	11.48	9	33595	867	29540056
Haematuria	11.78	11.48	20	33584	44119	29496804
Obesity	11.75	11.48	31	33573	9832	29531091
Weight increased	11.73	11.48	136	33468	76531	29464392
Cortisol increased	11.64	11.48	5	33599	159	29540764
Anxiety	11.57	11.48	148	33456	85217	29455706
Depressed level of consciousness	11.55	11.48	15	33589	36927	29503996
Arterial occlusive disease	11.55	11.48	18	33586	3916	29537007
Pneumonitis	11.49	11.48	9	33595	28035	29512888

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
Blood testosterone increased	549.33	11.29	113	26422	673	64471524
Blood testosterone decreased	314.24	11.29	87	26448	2038	64470159
Polycythaemia	301.44	11.29	83	26452	1904	64470293
Expulsion of medication	232.87	11.29	36	26499	14	64472183
Deep vein thrombosis	199.84	11.29	231	26304	104951	64367246
Precocious puberty	190.61	11.29	40	26495	266	64471931
Virilism	146.67	11.29	23	26512	12	64472185
Pulmonary embolism	141.71	11.29	232	26303	146124	64326073
Product administered at inappropriate site	116.53	11.29	45	26490	3065	64469132
Acute myocardial infarction	101.46	11.29	134	26401	69584	64402613
Haematocrit increased	99.57	11.29	41	26494	3304	64468893
Idiopathic intracranial hypertension	98.87	11.29	38	26497	2555	64469642
Application site rash	94.14	11.29	34	26501	1920	64470277
Blood testosterone abnormal	92.85	11.29	20	26515	153	64472044
Erectile dysfunction	89.61	11.29	59	26476	12568	64459629
Testicular atrophy	89.30	11.29	22	26513	320	64471877
Enlarged clitoris	84.13	11.29	13	26522	5	64472192
Clear cell renal cell carcinoma	79.76	11.29	31	26504	2148	64470049
Gynaecomastia	73.81	11.29	40	26495	5976	64466221
Craniopharyngioma	71.93	11.29	19	26516	370	64471827
Application site pain	71.67	11.29	35	26500	4213	64467984
Product deposit	71.45	11.29	19	26516	380	64471817
Focal segmental glomerulosclerosis	70.74	11.29	31	26504	2913	64469284
Prostatic specific antigen increased	69.73	11.29	44	26491	8716	64463481
Product quality issue	66.03	11.29	71	26464	29728	64442469
Insulin-like growth factor increased	65.82	11.29	25	26510	1627	64470570
Accidental exposure to product by child	65.72	11.29	28	26507	2457	64469740
Drug abuse	63.89	11.29	157	26378	132217	64339980
Secondary hypogonadism	63.88	11.29	17	26518	341	64471856
Prescribed overdose	62.73	11.29	58	26477	20273	64451924
Acne fulminans	61.11	11.29	14	26521	146	64472051
Infertility male	60.87	11.29	13	26522	95	64472102
Hair growth abnormal	60.55	11.29	26	26509	2326	64469871
Myocardial infarction	59.24	11.29	176	26359	165645	64306552
Coronary artery disease	58.65	11.29	96	26439	60337	64411860
Toxicity to various agents	58.36	11.29	39	26496	363474	64108723
Renal infarct	56.68	11.29	25	26510	2386	64469811
Oestradiol increased	56.39	11.29	12	26523	86	64472111
Product odour abnormal	55.31	11.29	20	26515	1133	64471064
Pituitary tumour benign	54.63	11.29	24	26511	2269	64469928
Lymphoproliferative disorder	54.58	11.29	31	26504	5072	64467125
Application site erythema	54.27	11.29	30	26505	4659	64467538
Completed suicide	52.03	11.29	14	26521	224400	64247797
Osteonecrosis	51.84	11.29	61	26474	28168	64444029
Cerebrovascular accident	49.10	11.29	146	26389	137437	64334760
Thrombosis	47.86	11.29	96	26439	70546	64401651
Left ventricular hypertrophy	47.84	11.29	36	26499	9470	64462727
Portal vein thrombosis	47.22	11.29	28	26507	4963	64467234
Prostate cancer	47.11	11.29	49	26486	19746	64452451
Accidental exposure to product	46.81	11.29	56	26479	26308	64445889
Performance enhancing product use	46.14	11.29	10	26525	79	64472118
Hypogonadism	46.11	11.29	17	26518	1018	64471179
Mesenteric vein thrombosis	45.81	11.29	18	26517	1284	64470913
Libido decreased	45.69	11.29	27	26508	4757	64467440
Neutropenia	45.22	11.29	21	26514	239603	64232594
Application site pruritus	44.72	11.29	24	26511	3515	64468682
Muscle mass	43.56	11.29	13	26522	400	64471797
Chorioretinopathy	42.85	11.29	20	26515	2177	64470020
Ovarian endometrioid carcinoma	41.37	11.29	7	26528	10	64472187
Haemoglobin increased	41.08	11.29	26	26509	5175	64467022
General physical health deterioration	38.43	11.29	18	26517	204407	64267790
Implant site infection	38.25	11.29	17	26518	1652	64470545
Ophthalmic vein thrombosis	37.46	11.29	10	26525	203	64471994
Spinal cord abscess	36.36	11.29	11	26524	355	64471842
Blood oestrogen increased	35.41	11.29	8	26527	78	64472119
Oligospermia	34.90	11.29	6	26529	10	64472187
Acne	34.53	11.29	45	26490	23036	64449161
Priapism	34.27	11.29	21	26514	3949	64468248
Apocrine breast carcinoma	33.98	11.29	5	26530	0	64472197
Atherosclerotic plaque rupture	33.98	11.29	5	26530	0	64472197
Sleep apnoea syndrome	33.95	11.29	51	26484	29781	64442416
Growth accelerated	33.87	11.29	6	26529	13	64472184
Red blood cell count increased	33.78	11.29	20	26515	3535	64468662
Rheumatoid arthritis	33.22	11.29	13	26522	164281	64307916
Febrile neutropenia	33.06	11.29	18	26517	187639	64284558
Implant site haemorrhage	32.65	11.29	9	26526	207	64471990
Incorrect dose administered	32.45	11.29	75	26460	60690	64411507
Metaplasia	30.92	11.29	10	26525	403	64471794
Borderline serous tumour of ovary	30.52	11.29	5	26530	5	64472192
Poor quality product administered	30.32	11.29	18	26517	3197	64469000
Neoplasm recurrence	30.31	11.29	19	26516	3720	64468477
Aortic aneurysm	30.18	11.29	25	26510	7549	64464648
Blood luteinising hormone decreased	30.13	11.29	8	26527	159	64472038
Implant site pain	30.10	11.29	15	26520	1885	64470312
Irritability	29.90	11.29	54	26481	36692	64435505
Blood testosterone free increased	29.61	11.29	5	26530	7	64472190
Feeling abnormal	29.53	11.29	121	26414	133481	64338716
Blood follicle stimulating hormone decreased	29.50	11.29	7	26528	86	64472111
Application site vesicles	28.81	11.29	13	26522	1309	64470888
Infertility	28.63	11.29	10	26525	512	64471685
Blood testosterone free decreased	28.45	11.29	6	26529	41	64472156
Drug-disease interaction	28.33	11.29	11	26524	760	64471437
Product administration error	28.29	11.29	45	26490	27598	64444599
Depression	27.99	11.29	149	26386	183142	64289055
Muscle hypertrophy	27.62	11.29	7	26528	115	64472082
Treatment failure	27.61	11.29	7	26528	116809	64355388
Product dose omission issue	27.51	11.29	155	26380	194592	64277605
Vocal cord atrophy	27.31	11.29	5	26530	14	64472183
Multiple use of single-use product	27.23	11.29	10	26525	592	64471605
Anger	27.23	11.29	33	26502	15708	64456489
Pituitary tumour recurrent	26.91	11.29	7	26528	128	64472069
Myocardial fibrosis	26.60	11.29	13	26522	1567	64470630
Contraindicated product administered	26.39	11.29	6	26529	107823	64364374
Azoospermia	26.23	11.29	7	26528	142	64472055
Hormone level abnormal	25.57	11.29	13	26522	1704	64470493
Glucose tolerance decreased	25.12	11.29	6	26529	76	64472121
Application site exfoliation	24.72	11.29	8	26527	323	64471874
Self-destructive behaviour	24.42	11.29	4	26531	4	64472193
Adnexal torsion	24.36	11.29	7	26528	188	64472009
Insulin-like growth factor decreased	24.25	11.29	9	26526	549	64471648
Penis disorder	24.14	11.29	10	26525	818	64471379
Loss of libido	24.09	11.29	14	26521	2390	64469807
Hyperandrogenism	23.52	11.29	4	26531	6	64472191
Infusion related reaction	23.33	11.29	20	26515	164447	64307750
Device delivery system issue	23.12	11.29	8	26527	398	64471799
Product container issue	23.01	11.29	10	26525	921	64471276
Cardiac death	22.58	11.29	11	26524	1317	64470880
Testicular pain	22.42	11.29	12	26523	1748	64470449
Intentional product misuse	22.32	11.29	73	26462	72222	64399975
Renal artery thrombosis	22.26	11.29	8	26527	445	64471752
Product complaint	22.22	11.29	26	26509	11928	64460269
Hypogonadism male	22.20	11.29	6	26529	128	64472069
Hyperhidrosis	22.19	11.29	106	26429	124814	64347383
Gender dysphoria	21.92	11.29	5	26530	51	64472146
Growth hormone-producing pituitary tumour	21.92	11.29	5	26530	51	64472146
Vaginal disorder	21.45	11.29	8	26527	495	64471702
Insulin resistance	21.41	11.29	10	26525	1090	64471107
Dissociative identity disorder	21.26	11.29	5	26530	59	64472138
Product physical consistency issue	21.16	11.29	8	26527	514	64471683
Coronary artery occlusion	20.65	11.29	27	26508	13864	64458333
Spontaneous cerebrospinal fluid leak syndrome	20.39	11.29	3	26532	0	64472197
Hyperoestrogenism	20.39	11.29	3	26532	0	64472197
Renal artery fibromuscular dysplasia	20.39	11.29	3	26532	0	64472197
Suicidal ideation	20.37	11.29	67	26468	66475	64405722
Cardiomyopathy	20.29	11.29	37	26498	25319	64446878
Impulsive behaviour	20.26	11.29	13	26522	2650	64469547
Phaeochromocytoma	20.22	11.29	8	26527	581	64471616
Renal cell carcinoma	19.97	11.29	18	26517	6086	64466111
Lower respiratory tract infection	19.93	11.29	7	26528	94607	64377590
Blood growth hormone increased	19.80	11.29	8	26527	614	64471583
Acne conglobata	19.71	11.29	4	26531	22	64472175
Thrombocytopenia	19.62	11.29	39	26496	223762	64248435
Anaemia	19.39	11.29	85	26450	378595	64093602
Cortisol increased	18.75	11.29	7	26528	434	64471763
Pyrexia	18.65	11.29	144	26391	558500	63913697
Needle issue	18.64	11.29	21	26514	9251	64462946
Stomatitis	18.60	11.29	11	26524	109594	64362603
Implant site bruising	18.57	11.29	6	26529	241	64471956
Application site inflammation	18.41	11.29	7	26528	457	64471740
Congestive cardiomyopathy	18.40	11.29	22	26513	10322	64461875
Aggression	18.34	11.29	51	26484	46181	64426016
Uterine cervical metaplasia	18.31	11.29	3	26532	3	64472194
Oestrone increased	18.31	11.29	3	26532	3	64472194
Death	18.26	11.29	120	26415	482585	63989612
Drug withdrawal syndrome	18.24	11.29	40	26495	31251	64440946
Drug intolerance	18.04	11.29	31	26504	187961	64284236
Hypercoagulation	17.99	11.29	12	26523	2611	64469586
Intraductal proliferative breast lesion	17.61	11.29	11	26524	2140	64470057
Nasopharyngitis	17.33	11.29	34	26501	196039	64276158
Stubbornness	17.22	11.29	6	26529	305	64471892
Hyperglycaemic hyperosmolar nonketotic syndrome	17.20	11.29	10	26525	1709	64470488
Transient ischaemic attack	16.80	11.29	48	26487	44134	64428063
Interstitial lung disease	16.31	11.29	10	26525	97722	64374475
Pancytopenia	16.31	11.29	21	26514	143288	64328909
Eye colour change	16.10	11.29	6	26529	370	64471827
Septic shock	15.98	11.29	12	26523	105425	64366772
Application site paraesthesia	15.82	11.29	4	26531	65	64472132
Empty sella syndrome	15.33	11.29	4	26531	74	64472123
Application site irritation	15.32	11.29	9	26526	1567	64470630
Intentional overdose	15.29	11.29	9	26526	89935	64382262
Wrong technique in product usage process	15.26	11.29	60	26475	64914	64407283
Diastolic hypertension	15.23	11.29	4	26531	76	64472121
Acromegaly	15.04	11.29	4	26531	80	64472117
Product physical issue	15.04	11.29	12	26523	3437	64468760
Bone marrow oedema syndrome	14.71	11.29	3	26532	17	64472180
Hidradenitis	14.41	11.29	10	26525	2319	64469878
Blood thyroid stimulating hormone decreased	14.37	11.29	14	26521	5216	64466981
Retinal vein occlusion	14.34	11.29	11	26524	2977	64469220
Thyrotoxic periodic paralysis	14.31	11.29	4	26531	97	64472100
Mucosal inflammation	14.31	11.29	4	26531	62580	64409617
Wolff-Parkinson-White syndrome	14.26	11.29	5	26530	259	64471938
Amnesia	14.24	11.29	48	26487	48221	64423976
Asthma exercise induced	14.12	11.29	4	26531	102	64472095
Oxygen saturation decreased	14.05	11.29	14	26521	107162	64365035
Nipple pain	13.88	11.29	6	26529	545	64471652
Papilloedema	13.77	11.29	14	26521	5491	64466706
Ovarian necrosis	13.70	11.29	3	26532	25	64472172
Anorgasmia	13.60	11.29	7	26528	942	64471255
Leukopenia	13.53	11.29	13	26522	101229	64370968
Atrial fibrillation	13.40	11.29	118	26417	170971	64301226
Device extrusion	13.40	11.29	3	26532	28	64472169
Small airways disease	13.40	11.29	3	26532	28	64472169
Angiofibroma	13.22	11.29	4	26531	129	64472068
Factor V Leiden mutation	13.22	11.29	4	26531	129	64472068
Ovarian cancer stage II	13.21	11.29	3	26532	30	64472167
Malignant melanoma	13.12	11.29	21	26514	12943	64459254
Melaena	13.06	11.29	3	26532	53545	64418652
Hypothalamo-pituitary disorder	12.97	11.29	7	26528	1037	64471160
Gastric hypomotility	12.91	11.29	4	26531	140	64472057
Expired product administered	12.79	11.29	14	26521	5973	64466224
Hepatic artery aneurysm	12.71	11.29	3	26532	36	64472161
Pituitary tumour	12.59	11.29	7	26528	1099	64471098
Nocturia	12.57	11.29	19	26516	11146	64461051
Thalamic infarction	12.55	11.29	7	26528	1105	64471092
Pericarditis	12.54	11.29	5	26530	62511	64409686
Cardiovascular disorder	12.49	11.29	23	26512	15858	64456339
Application site reaction	12.39	11.29	6	26529	709	64471488
Prostatic disorder	12.20	11.29	8	26527	1691	64470506
Renal embolism	12.19	11.29	4	26531	169	64472028
Injection site pain	12.15	11.29	83	26452	111325	64360872
Nephropathy	12	11.29	16	26519	8370	64463827
Libido increased	11.82	11.29	8	26527	1782	64470415
C-reactive protein increased	11.76	11.29	13	26522	94896	64377301
Large intestine polyp	11.58	11.29	18	26517	10819	64461378
Diabetes mellitus	11.50	11.29	56	26479	66418	64405779
Astrocytoma	11.45	11.29	4	26531	205	64471992
Malignant neoplasm progression	11.39	11.29	18	26517	112853	64359344
Therapeutic response unexpected	11.38	11.29	23	26512	16978	64455219
Fibromuscular dysplasia	11.34	11.29	4	26531	211	64471986
Disease progression	11.32	11.29	26	26509	141654	64330543

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	G03BA03	GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM ANDROGENS 3-oxoandrosten (4) derivatives
ATC	G03EA02	GENITO URINARY SYSTEM AND SEX HORMONES SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM ANDROGENS AND FEMALE SEX HORMONES IN COMBINATION Androgens and estrogens
FDA CS	M0001109	Androstanes
FDA MoA	N0000000146	Androgen Receptor Agonists
MeSH PA	D000728	Androgens
MeSH PA	D006728	Hormones
FDA EPC	N0000175824	Androgen
CHEBI has role	CHEBI:50113	androgene
CHEBI has role	CHEBI:75771	Mus musculus metabolites
CHEBI has role	CHEBI:77746	Homo sapiens metabolite
CHEBI has role	CHEBI:83056	Daphnia magna metabolites

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

Disease	Relation	SNOMED_ID	DOID
Hypogonadotropic hypogonadism	indication	33927004
Deficiency of testosterone biosynthesis	indication	38825009
Inhibition of lactation procedure	indication	43141007
Male hypogonadism	indication	48723006
Hypopituitarism	indication	74728003	DOID:9406
Menopausal flushing	indication	198436008
Undescended testicle	indication	204878001	DOID:11383
Bilateral orchidectomy	indication	386634006
Delayed puberty	indication	400003000
Klinefelter's syndrome, XXY	indication	405769009
Hormone receptor positive malignant neoplasm of breast	indication	417181009
Primary Hypogonadism due to Bilateral Torsion	indication
Primary Hypogonadism due to Orchitis	indication
LHRH Deficiency	indication
Chemotherapy-Induced Hypogonadism	indication
Bilateral Anorchia	indication
Noonan's syndrome	off-label use	205824006	DOID:3490
Hyperlipoproteinemia	contraindication	3744001	DOID:1168
Gynecomastia	contraindication	4754008	DOID:12698
Hypocalcemia	contraindication	5291005
Hypercholesterolemia	contraindication	13644009
Myocardial infarction	contraindication	22298006	DOID:5844
Chloasma	contraindication	36209000
Migraine	contraindication	37796009	DOID:6364
Hypertensive disorder	contraindication	38341003	DOID:10763
Disorder of gallbladder	contraindication	39621005	DOID:0060262
Hypothyroidism	contraindication	40930008	DOID:1459
Body fluid retention	contraindication	43498006
Thrombosis of retinal vein	contraindication	46085004
Humoral hypercalcemia of malignancy	contraindication	47709007
Chronic heart failure	contraindication	48447003
Dementia	contraindication	52448006
Hepatic porphyria	contraindication	55056006	DOID:3133
Systemic lupus erythematosus	contraindication	55464009	DOID:9074
Heart disease	contraindication	56265001	DOID:114
Thrombophlebitis	contraindication	64156001	DOID:3875
Intermenstrual bleeding - irregular	contraindication	64996003
Hypercalcemia	contraindication	66931009	DOID:12678
Arteriosclerotic vascular disease	contraindication	72092001
Diabetes mellitus	contraindication	73211009	DOID:9351
Sleep apnea	contraindication	73430006	DOID:0050847
Heart failure	contraindication	84114007	DOID:6000
Epilepsy	contraindication	84757009	DOID:1826
Breast lump	contraindication	89164003
Kidney disease	contraindication	90708001	DOID:557
Uterine leiomyoma	contraindication	95315005	DOID:13223
Magnetic resonance imaging	contraindication	113091000
Neoplasm of liver	contraindication	126851005	DOID:3571
Neoplasm of prostate	contraindication	126906006	DOID:10283
Deep venous thrombosis	contraindication	128053003
Endometriosis	contraindication	129103003
Mammography abnormal	contraindication	168750009
Asthma	contraindication	195967001	DOID:2841
Cerebrovascular accident	contraindication	230690007
Pulmonary thromboembolism	contraindication	233935004
Thrombophilia	contraindication	234467004	DOID:2452
Disease of liver	contraindication	235856003	DOID:409
Endometrial carcinoma	contraindication	254878006	DOID:2871
Benign prostatic hyperplasia	contraindication	266569009
Edema	contraindication	267038008
Chorea	contraindication	271700006
Pregnancy, function	contraindication	289908002
Hypertriglyceridemia	contraindication	302870006
Functional visual loss	contraindication	313165001
Malignant tumor of ovary	contraindication	363443007	DOID:2394
Thromboembolic disorder	contraindication	371039008
Cardiovascular event risk	contraindication	395112001
Breastfeeding (mother)	contraindication	413712001
Chronic lung disease	contraindication	413839001
Disorder of coronary artery	contraindication	414024009
Obesity	contraindication	414916001	DOID:9970
Estrogen receptor positive tumor	contraindication	416053008
Family history of malignant neoplasm of breast	contraindication	429740004
Hypertensive urgency	contraindication	443482000
Carcinoma of female breast	contraindication	447782002
Smokes tobacco daily	contraindication	449868002
Breast Carcinoma in Males	contraindication

🐶 Veterinary Drug Use

Species	Use	Relation
Cattle	To increase rate of weight gain	Indication
Cattle	To improve feed efficiency	Indication

🐶 Veterinary products

Product	Applicant	Ingredients
Component E-H with Tylan	Elanco US Inc.	3

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
50MG/5GM PACKET	TESTIM	AUXILIUM PHARMS LLC	N021454	Oct. 31, 2002	RX	GEL	TRANSDERMAL	7608605	April 21, 2023	METHOD FOR ADMINISTRATION OF TESTOSTERONE
50MG/5GM PACKET	TESTIM	AUXILIUM PHARMS LLC	N021454	Oct. 31, 2002	RX	GEL	TRANSDERMAL	7608606	April 21, 2023	METHOD FOR ADMINISTRATION OF TESTOSTERONE
50MG/5GM PACKET	TESTIM	AUXILIUM PHARMS LLC	N021454	Oct. 31, 2002	RX	GEL	TRANSDERMAL	7608607	April 21, 2023	METHOD FOR ADMINISTRATION OF TESTOSTERONE
50MG/5GM PACKET	TESTIM	AUXILIUM PHARMS LLC	N021454	Oct. 31, 2002	RX	GEL	TRANSDERMAL	7608608	April 21, 2023	METHOD FOR ADMINISTRATION OF TESTOSTERONE
50MG/5GM PACKET	TESTIM	AUXILIUM PHARMS LLC	N021454	Oct. 31, 2002	RX	GEL	TRANSDERMAL	7608609	April 21, 2023	METHOD FOR ADMINISTRATION OF TESTOSTERONE
50MG/5GM PACKET	TESTIM	AUXILIUM PHARMS LLC	N021454	Oct. 31, 2002	RX	GEL	TRANSDERMAL	7608610	April 21, 2023	METHOD FOR ADMINISTRATION OF TESTOSTERONE
50MG/5GM PACKET	TESTIM	AUXILIUM PHARMS LLC	N021454	Oct. 31, 2002	RX	GEL	TRANSDERMAL	7935690	April 21, 2023	METHOD FOR ADMINISTRATION OF TESTOSTERONE
50MG/5GM PACKET	TESTIM	AUXILIUM PHARMS LLC	N021454	Oct. 31, 2002	RX	GEL	TRANSDERMAL	8063029	April 21, 2023	METHOD FOR ADMINISTRATION OF TESTOSTERONE
30MG/1.5ML ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	AXIRON	ELI LILLY AND CO	N022504	Nov. 23, 2010	DISCN	SOLUTION, METERED	TRANSDERMAL	8784878	July 13, 2023	A METHOD OF TRANSDERMALLY DELIVERING TESTOSTERONE
5.5MG/0.122GM ACTUATION	NATESTO	ACERUS	N205488	May 28, 2014	RX	GEL, METERED	NASAL	8784882	Feb. 4, 2024	A METHOD OF TESTOSTERONE REPLACEMENT THERAPY COMPRISING THE STEP OF NASALLY ADMINISTERING TO A PATIENT IN NEED OF SUCH TREATMENT AN EFFECTIVE AMOUNT OF TESTOSTERONE GEL FORMULATION.
5.5MG/0.122GM ACTUATION	NATESTO	ACERUS	N205488	May 28, 2014	RX	GEL, METERED	NASAL	8877230	Feb. 4, 2024	NASAL ADMINISTRATION OF A TESTOSTERONE GEL TO A PATIENT TO TREAT THE PATIENT FOR A CONDITION ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
50MG/5GM PACKET	TESTIM	AUXILIUM PHARMS LLC	N021454	Oct. 31, 2002	RX	GEL	TRANSDERMAL	7320968	Jan. 18, 2025	METHOD FOR ADMINISTRATION OF TESTOSTERONE
30MG/1.5ML ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	AXIRON	ELI LILLY AND CO	N022504	Nov. 23, 2010	DISCN	SOLUTION, METERED	TRANSDERMAL	8993520	June 2, 2026	A METHOD OF INCREASING THE TESTOSTERONE BLOOD LEVEL OF AN ADULT MALE SUBJECT IN NEED THEREOF
30MG/1.5ML ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	AXIRON	ELI LILLY AND CO	N022504	Nov. 23, 2010	DISCN	SOLUTION, METERED	TRANSDERMAL	9180194	June 2, 2026	A METHOD OF INCREASING THE TESTOSTERONE BLOOD LEVEL OF AN ADULT MALE SUBJECT IN NEED THEREOF
1.62% (20.25MG/1.25GM ACTUATION)	ANDROGEL	ABBVIE	N022309	April 29, 2011	RX	GEL, METERED	TRANSDERMAL	8466137	Oct. 12, 2026	TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
1.62% (20.25MG/1.25GM ACTUATION)	ANDROGEL	ABBVIE	N022309	April 29, 2011	RX	GEL, METERED	TRANSDERMAL	8466138	Oct. 12, 2026	TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
1.62% (20.25MG/1.25GM ACTUATION)	ANDROGEL	ABBVIE	N022309	April 29, 2011	RX	GEL, METERED	TRANSDERMAL	8741881	Oct. 12, 2026	TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
1.62% (20.25MG/1.25GM PACKET)	ANDROGEL	ABBVIE	N022309	Sept. 7, 2012	DISCN	GEL	TRANSDERMAL	8466137	Oct. 12, 2026	TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
1.62% (20.25MG/1.25GM PACKET)	ANDROGEL	ABBVIE	N022309	Sept. 7, 2012	DISCN	GEL	TRANSDERMAL	8466138	Oct. 12, 2026	TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
1.62% (20.25MG/1.25GM PACKET)	ANDROGEL	ABBVIE	N022309	Sept. 7, 2012	DISCN	GEL	TRANSDERMAL	8741881	Oct. 12, 2026	TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
1.62% (40.5MG/2.5GM PACKET)	ANDROGEL	ABBVIE	N022309	Sept. 7, 2012	DISCN	GEL	TRANSDERMAL	8466137	Oct. 12, 2026	TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
1.62% (40.5MG/2.5GM PACKET)	ANDROGEL	ABBVIE	N022309	Sept. 7, 2012	DISCN	GEL	TRANSDERMAL	8466138	Oct. 12, 2026	TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
1.62% (40.5MG/2.5GM PACKET)	ANDROGEL	ABBVIE	N022309	Sept. 7, 2012	DISCN	GEL	TRANSDERMAL	8741881	Oct. 12, 2026	TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
30MG/1.5ML ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	AXIRON	ELI LILLY AND CO	N022504	Nov. 23, 2010	DISCN	SOLUTION, METERED	TRANSDERMAL	8419307	Feb. 26, 2027	A METHOD OF INCREASING THE TESTOSTERONE BLOOD LEVEL OF A PERSON IN NEED THEREOF
30MG/1.5ML ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	AXIRON	ELI LILLY AND CO	N022504	Nov. 23, 2010	DISCN	SOLUTION, METERED	TRANSDERMAL	8807861	Feb. 26, 2027	A METHOD OF TRANSDERMAL ADMINISTRATION OF A PHYSIOLOGICALLY ACTIVE AGENT TO A SUBJECT.
30MG/1.5ML ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	AXIRON	ELI LILLY AND CO	N022504	Nov. 23, 2010	DISCN	SOLUTION, METERED	TRANSDERMAL	9289586	Feb. 26, 2027	A METHOD OF INCREASING THE TESTOSTERONE BLOOD LEVEL OF AN ADULT MALE SUBJECT IN NEED THEREOF
30MG/1.5ML ACTUATION Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	AXIRON	ELI LILLY AND CO	N022504	Nov. 23, 2010	DISCN	SOLUTION, METERED	TRANSDERMAL	8435944	Sept. 27, 2027	A METHOD OF INCREASING THE TESTOSTERONE BLOOD LEVEL OF AN ADULT MALE SUBJECT IN NEED THEREOF
12.5MG/1.25GM ACTUATION	VOGELXO	UPSHER SMITH LABS	N204399	June 4, 2014	RX	GEL, METERED	TRANSDERMAL	8785426	Feb. 11, 2034	METHOD FOR TRANSDERMAL DELIVERY OF TESTOSTERONE
12.5MG/1.25GM ACTUATION	VOGELXO	UPSHER SMITH LABS	N204399	June 4, 2014	RX	GEL, METERED	TRANSDERMAL	9295675	Feb. 11, 2034	METHOD FOR TRANSDERMAL DELIVERY OF TESTOSTERONE
12.5MG/1.25GM ACTUATION	VOGELXO	UPSHER SMITH LABS	N204399	June 4, 2014	RX	GEL, METERED	TRANSDERMAL	9662340	Feb. 11, 2034	METHOD FOR TRANSDERMAL DELIVERY OF TESTOSTERONE
50MG/5GM PACKET	VOGELXO	UPSHER SMITH LABS	N204399	June 4, 2014	RX	GEL	TRANSDERMAL	8785426	Feb. 11, 2034	METHOD FOR TRANSDERMAL DELIVERY OF TESTOSTERONE
50MG/5GM PACKET	VOGELXO	UPSHER SMITH LABS	N204399	June 4, 2014	RX	GEL	TRANSDERMAL	9295675	Feb. 11, 2034	METHOD FOR TRANSDERMAL DELIVERY OF TESTOSTERONE
50MG/5GM PACKET	VOGELXO	UPSHER SMITH LABS	N204399	June 4, 2014	RX	GEL	TRANSDERMAL	9662340	Feb. 11, 2034	METHOD FOR TRANSDERMAL DELIVERY OF TESTOSTERONE
5.5MG/0.122GM ACTUATION	NATESTO	ACERUS	N205488	May 28, 2014	RX	GEL, METERED	NASAL	11090312	March 17, 2034	NASAL ADMINISTRATION OF A TESTOSTERONE GEL TO A PATIENT TO TREAT THE PATIENT FOR A CONDITION ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Androgen receptor	Nuclear hormone receptor	P10275	ANDR_HUMAN	AGONIST	EC50	9.20	WOMBAT-PK	CHEMBL
Glucocorticoid receptor	Nuclear hormone receptor	P04150	GCR_HUMAN		Ki	5.84	DRUG MATRIX
Aromatase	Enzyme	P11511	CP19A_HUMAN		Ki	6.22	CHEMBL
Corticosteroid-binding globulin	Secreted	P08185	CBG_HUMAN		Ki	6.72	CHEMBL
Sex hormone-binding globulin	Secreted	P04278	SHBG_HUMAN		Kd	9.20	CHEMBL
Lanosterol 14-alpha demethylase	Enzyme	Q16850	CP51A_HUMAN		IC50	4.30	CHEMBL
Sigma non-opioid intracellular receptor 1	Membrane receptor	Q99720	SGMR1_HUMAN		Ki	5.92	CHEMBL
Alpha-synuclein	Transporter	P37840	SYUA_HUMAN		IC50	4.01	CHEMBL
Androgen receptor	Transcription factor		ANDR_RAT		Ki	8.85	CHEMBL
Progesterone receptor	Transcription factor		Q690N0_BOVIN		Ki	6.60	DRUG MATRIX
C-8 sterol isomerase	Enzyme		ERG2_YEAST		Ki	5.11	CHEMBL
Steroid 5-alpha-reductase	Enzyme		S5A1_RAT S5A2_RAT		IC50	5.72	CHEMBL
Constitutive androstane receptor	Nuclear hormone receptor		NR1I3_MOUSE		IC50	4.52	CHEMBL

External reference:

ID	Source
4017484	VUID
N0000145872	NUI
D00075	KEGG_DRUG
4017484	VANDF
C0039601	UMLSCUI
CHEBI:17347	CHEBI
TES	PDB_CHEM_ID
CHEMBL386630	ChEMBL_ID
CHEMBL1201101	ChEMBL_ID
DB00624	DRUGBANK_ID
D013739	MESH_DESCRIPTOR_UI
6013	PUBCHEM_CID
2858	IUPHAR_LIGAND_ID
1900	INN_ID
3XMK78S47O	UNII
10379	RXNORM
2966	MMSL
5552	MMSL
d00558	MMSL
001245	NDDF
109033004	SNOMEDCT_US
43688007	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Androderm	HUMAN PRESCRIPTION DRUG LABEL	1	0023-5990	PATCH	2 mg	TRANSDERMAL	NDA	34 sections
Androderm	HUMAN PRESCRIPTION DRUG LABEL	1	0023-5992	PATCH	4 mg	TRANSDERMAL	NDA	34 sections
Androgel	HUMAN PRESCRIPTION DRUG LABEL	1	0051-8425	GEL	10 mg	TRANSDERMAL	NDA	37 sections
Androgel	HUMAN PRESCRIPTION DRUG LABEL	1	0051-8450	GEL	10 mg	TRANSDERMAL	NDA	37 sections
Androgel	HUMAN PRESCRIPTION DRUG LABEL	1	0051-8462	GEL	16.20 mg	TRANSDERMAL	NDA	37 sections
Androgel	HUMAN PRESCRIPTION DRUG LABEL	1	0051-8488	GEL	10 mg	TRANSDERMAL	NDA	37 sections
Vogelxo	HUMAN PRESCRIPTION DRUG LABEL	1	0245-0871	GEL	50 mg	TOPICAL	NDA	37 sections
Vogelxo	HUMAN PRESCRIPTION DRUG LABEL	1	0245-0872	GEL, METERED	12.50 mg	TOPICAL	NDA	37 sections
Testosterone	HUMAN PRESCRIPTION DRUG LABEL	1	0591-2114	SOLUTION	30 mg	TOPICAL	ANDA	33 sections
Testosterone	HUMAN PRESCRIPTION DRUG LABEL	1	0591-2363	GEL, METERED	10 mg	TOPICAL	ANDA	33 sections
Testosterone	HUMAN PRESCRIPTION DRUG LABEL	1	0591-2921	GEL	10 mg	TOPICAL	ANDA	32 sections
Testosterone	HUMAN PRESCRIPTION DRUG LABEL	1	0591-2924	GEL	16.20 mg	TRANSDERMAL	ANDA	32 sections
Testosterone	HUMAN PRESCRIPTION DRUG LABEL	1	0591-2925	GEL	16.20 mg	TRANSDERMAL	ANDA	32 sections
Testosterone	HUMAN PRESCRIPTION DRUG LABEL	1	0591-2926	GEL	16.20 mg	TRANSDERMAL	ANDA	32 sections
Testosterone	HUMAN PRESCRIPTION DRUG LABEL	1	0591-3216	GEL	10 mg	TOPICAL	ANDA	32 sections
Testosterone	HUMAN PRESCRIPTION DRUG LABEL	1	0591-3217	GEL	10 mg	TOPICAL	ANDA	32 sections
Testosterone	HUMAN PRESCRIPTION DRUG LABEL	1	0591-3524	GEL	50 mg	TRANSDERMAL	ANDA	30 sections
Testosterone	HUMAN PRESCRIPTION DRUG LABEL	1	0591-3524	GEL	50 mg	TRANSDERMAL	ANDA	30 sections
Testosterone	HUMAN PRESCRIPTION DRUG LABEL	1	0603-7831	GEL, METERED	10 mg	TOPICAL	NDA authorized generic	33 sections
Testosterone	HUMAN PRESCRIPTION DRUG LABEL	1	0832-1120	GEL	50 mg	TOPICAL	NDA authorized generic	35 sections
Testosterone	HUMAN PRESCRIPTION DRUG LABEL	1	0832-1121	GEL, METERED	12.50 mg	TOPICAL	NDA authorized generic	35 sections
Testim	HUMAN PRESCRIPTION DRUG LABEL	1	16590-853	GEL	50 mg	TOPICAL	NDA	13 sections
testosterone	HUMAN PRESCRIPTION DRUG LABEL	1	16714-967	GEL	20.25 mg	TOPICAL	ANDA	33 sections
testosterone	HUMAN PRESCRIPTION DRUG LABEL	1	16714-968	GEL	20.25 mg	TOPICAL	ANDA	33 sections
testosterone	HUMAN PRESCRIPTION DRUG LABEL	1	16714-969	GEL	40.50 mg	TOPICAL	ANDA	33 sections
Androgel	HUMAN PRESCRIPTION DRUG LABEL	1	21695-112	GEL	10 mg	TRANSDERMAL	NDA	18 sections
Testosterone Gel, 1%	HUMAN PRESCRIPTION DRUG LABEL	1	21922-019	GEL	10 mg	TRANSDERMAL	ANDA	34 sections
Testosterone	HUMAN PRESCRIPTION DRUG LABEL	1	24979-078	GEL	16.20 mg	TRANSDERMAL	ANDA	29 sections
testosterone	HUMAN PRESCRIPTION DRUG LABEL	1	24979-130	SOLUTION	30 mg	TOPICAL	ANDA	32 sections
testosterone	HUMAN PRESCRIPTION DRUG LABEL	1	24979-130	SOLUTION	30 mg	TOPICAL	ANDA	32 sections