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

Stem definitionDrug idCAS RN
androgens/anabolic steroids 2607 58-22-0

Description:

MoleculeDescription

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:

DoseUnitRoute
0.12 g O
18 mg P
0.12 g R
60 mg SL
50 mg TD
3 mg TD

ADMET properties:

PropertyValueReference
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 ยตM/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:

DateAgencyCompanyOrphan
July 13, 1972 FDA ACTIENT PHARMS

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
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
Atherosclerotic plaque rupture 42.97 20.64 5 3445 0 50601674
Apocrine breast carcinoma 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
Self-destructive behaviour 39.51 20.64 5 3445 5 50601669
Borderline serous tumour of ovary 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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
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 termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
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:

SourceCodeDescription
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 (View source of the data)

DiseaseRelationSNOMED_IDDOID
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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

ProductApplicantIngredients
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 strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent 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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Androgen receptor Nuclear hormone receptor AGONIST EC50 9.20 WOMBAT-PK CHEMBL
Glucocorticoid receptor Nuclear hormone receptor Ki 5.84 DRUG MATRIX
Aromatase Enzyme Ki 6.22 CHEMBL
Corticosteroid-binding globulin Secreted Ki 6.72 CHEMBL
Sex hormone-binding globulin Secreted Kd 9.20 CHEMBL
Lanosterol 14-alpha demethylase Enzyme IC50 4.30 CHEMBL
Sigma non-opioid intracellular receptor 1 Membrane receptor Ki 5.92 CHEMBL
Alpha-synuclein Transporter IC50 4.01 CHEMBL
Androgen receptor Transcription factor Ki 8.85 CHEMBL
Progesterone receptor Transcription factor Ki 6.60 DRUG MATRIX
C-8 sterol isomerase Enzyme Ki 5.11 CHEMBL
Steroid 5-alpha-reductase Enzyme IC50 5.72 CHEMBL
Constitutive androstane receptor Nuclear hormone receptor IC50 4.52 CHEMBL

External reference:

IDSource
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:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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