testosterone 🐶 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 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:

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 299.60 19.16 42 4586 128 63484266
Idiopathic intracranial hypertension 256.40 19.16 56 4572 2875 63481519
Metaplasia 197.07 19.16 34 4594 490 63483904
Accidental exposure to product 188.63 19.16 72 4556 27333 63457061
Prostatic disorder 179.01 19.16 24 4604 46 63484348
Virilism 156.22 19.16 20 4608 21 63484373
Expulsion of medication 137.76 19.16 17 4611 9 63484385
Enlarged clitoris 136.74 19.16 21 4607 137 63484257
Off label use 129.44 19.16 198 4430 674264 62810130
Precocious puberty 114.85 19.16 19 4609 209 63484185
Hair growth abnormal 103.50 19.16 27 4601 2954 63481440
Papilloedema 86.89 19.16 25 4603 3935 63480459
Accidental exposure to product by child 67.55 19.16 16 4612 1177 63483217
Cervix carcinoma stage IV 64.74 19.16 10 4618 68 63484326
Adnexal torsion 52.92 19.16 11 4617 443 63483951
Borderline serous tumour of ovary 52.70 19.16 7 4621 12 63484382
Breast hyperplasia 44.86 19.16 9 4619 303 63484091
Apocrine breast carcinoma 42.64 19.16 5 4623 0 63484394
Hirsutism 40.64 19.16 11 4617 1384 63483010
Atherosclerotic plaque rupture 40.29 19.16 5 4623 3 63484391
Renal infarct 40.24 19.16 11 4617 1436 63482958
Skin laceration 39.23 19.16 23 4605 22685 63461709
Priapism 38.73 19.16 7 4621 133 63484261
Ovarian endometrioid carcinoma 38.26 19.16 5 4623 7 63484387
Blood testosterone decreased 37.45 19.16 6 4622 53 63484341
Infertility 36.63 19.16 9 4619 772 63483622
Self-destructive behaviour 35.96 19.16 5 4623 14 63484380
Endometrial hyperplasia 35.57 19.16 9 4619 871 63483523
Hormone level abnormal 34.37 19.16 11 4617 2472 63481922
Acne 33.56 19.16 21 4607 23272 63461122
Vaginal disorder 31.76 19.16 8 4620 760 63483634
Multiple use of single-use product 30.86 19.16 9 4619 1483 63482911
Renal artery fibromuscular dysplasia 30.44 19.16 4 4624 6 63484388
Vocal cord atrophy 29.10 19.16 4 4624 10 63484384
Intraductal proliferative breast lesion 28.64 19.16 10 4618 2935 63481459
Dissociative identity disorder 28.36 19.16 5 4623 82 63484312
Performance enhancing product use 28.09 19.16 4 4624 14 63484380
Chorioretinopathy 26.25 19.16 7 4621 832 63483562
Ovarian necrosis 26.05 19.16 4 4624 26 63484368
Breast cancer 25.60 19.16 24 4604 48359 63436035
Gender dysphoria 25.58 19.16 3 4625 0 63484394
Product preparation error 24.76 19.16 11 4617 6081 63478313
Focal segmental glomerulosclerosis 22.38 19.16 7 4621 1461 63482933
Ovarian cancer stage II 22.28 19.16 4 4624 73 63484321
Product quality issue 21.33 19.16 19 4609 35846 63448548
Product packaging difficult to open 21.12 19.16 4 4624 99 63484295
Growth accelerated 20.96 19.16 3 4625 11 63484383
Osteonecrosis 20.87 19.16 16 4612 24514 63459880
Therapeutic response unexpected 19.95 19.16 14 4614 18745 63465649
Intracranial pressure increased 19.85 19.16 9 4619 5218 63479176
Uterine cervical metaplasia 19.74 19.16 3 4625 18 63484376

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 654.20 11.64 225 36902 4132 34915672
Blood testosterone increased 515.86 11.64 141 36986 1132 34918672
Polycythaemia 391.71 11.64 126 37001 1859 34917945
Product deposit 369.52 11.64 86 37041 322 34919482
Product administered at inappropriate site 243.26 11.64 91 37036 2145 34917659
Application site rash 239.31 11.64 71 37056 786 34919018
Poor quality product administered 231.02 11.64 84 37043 1823 34917981
Deep vein thrombosis 189.36 11.64 286 36841 64962 34854842
Expulsion of medication 175.01 11.64 33 37094 24 34919780
Blood testosterone abnormal 161.23 11.64 45 37082 393 34919411
Incorrect dose administered 159.98 11.64 206 36921 40309 34879495
Precocious puberty 143.18 11.64 33 37094 117 34919687
Haematocrit increased 142.75 11.64 61 37066 2052 34917752
Product quality issue 134.85 11.64 125 37002 16910 34902894
Implant site pain 121.98 11.64 28 37099 97 34919707
Application site pain 118.80 11.64 52 37075 1856 34917948
Application site erythema 114.85 11.64 54 37073 2282 34917522
Pulmonary embolism 113.20 11.64 276 36851 89470 34830334
Toxicity to various agents 106.35 11.64 40 37087 200322 34719482
Testicular atrophy 106.32 11.64 35 37092 557 34919247
Multiple use of single-use product 104.86 11.64 30 37097 289 34919515
Prescribed overdose 99.86 11.64 86 37041 10561 34909243
Insulin-like growth factor increased 94.39 11.64 39 37088 1204 34918600
Liquid product physical issue 91.45 11.64 30 37097 472 34919332
Injection site pain 87.19 11.64 152 36975 38853 34880951
Infertility male 86.14 11.64 23 37104 167 34919637
Application site pruritus 85.71 11.64 38 37089 1399 34918405
Death 83.16 11.64 188 36939 397861 34521943
Mesenteric vein thrombosis 83.13 11.64 32 37095 817 34918987
Libido decreased 82.04 11.64 55 37072 4641 34915163
Clear cell renal cell carcinoma 80.42 11.64 34 37093 1113 34918691
Product packaging quantity issue 80.33 11.64 32 37095 897 34918907
Febrile neutropenia 78.32 11.64 24 37103 136825 34782979
Device delivery system issue 75.66 11.64 26 37101 475 34919329
Neutropenia 75.61 11.64 36 37091 156742 34763062
Product odour abnormal 75.09 11.64 29 37098 747 34919057
Application site reaction 71.82 11.64 24 37103 401 34919403
Pituitary tumour benign 71.53 11.64 29 37098 852 34918952
Oestradiol increased 70.72 11.64 16 37111 51 34919753
Blood testosterone free decreased 68.51 11.64 16 37111 61 34919743
Craniopharyngioma 67.35 11.64 21 37106 278 34919526
General physical health deterioration 67.33 11.64 26 37101 128243 34791561
Product dose omission issue 66.15 11.64 277 36850 119434 34800370
Erectile dysfunction 63.40 11.64 93 37034 20544 34899260
Haemoglobin increased 62.14 11.64 41 37086 3368 34916436
Feeling abnormal 58.96 11.64 174 36953 63061 34856743
Muscle mass 57.20 11.64 18 37109 246 34919558
Gynaecomastia 57.13 11.64 62 37065 10118 34909686
Application site irritation 56.84 11.64 23 37104 672 34919132
Device expulsion 56.55 11.64 14 37113 72 34919732
Product container issue 56.09 11.64 23 37104 696 34919108
Secondary hypogonadism 54.82 11.64 18 37109 284 34919520
Idiopathic intracranial hypertension 53.24 11.64 22 37105 679 34919125
Osteonecrosis 52.99 11.64 72 37055 14818 34904986
Retinal neovascularisation 52.85 11.64 15 37112 140 34919664
Lymphoproliferative disorder 52.29 11.64 34 37093 2725 34917079
Application site exfoliation 51.83 11.64 15 37112 151 34919653
Azoospermia 51.83 11.64 19 37108 422 34919382
Sleep apnoea syndrome 51.79 11.64 84 37043 20237 34899567
Wrong technique in product usage process 49.98 11.64 115 37012 35871 34883933
Pyrexia 49.84 11.64 184 36943 332829 34586975
Thrombocytopenia 49.28 11.64 56 37071 156191 34763613
Anaemia 48.73 11.64 110 37017 233225 34686579
Prostatic specific antigen increased 47.78 11.64 68 37059 14612 34905192
Hair growth abnormal 46.81 11.64 21 37106 795 34919009
Red blood cell count increased 46.80 11.64 26 37101 1563 34918241
Application site dryness 46.09 11.64 12 37115 78 34919726
Focal segmental glomerulosclerosis 46.02 11.64 28 37099 1997 34917807
Hypogonadism 45.73 11.64 29 37098 2226 34917578
Application site vesicles 45.49 11.64 19 37108 603 34919201
Pituitary tumour recurrent 44.26 11.64 12 37115 93 34919711
Implant site bruising 44.25 11.64 8 37119 3 34919801
Performance enhancing product use 43.00 11.64 11 37116 66 34919738
Hyperoestrogenism 42.91 11.64 8 37119 5 34919799
Drug interaction 42.85 11.64 112 37015 225834 34693970
Acute myocardial infarction 42.82 11.64 140 36987 53579 34866225
Product physical consistency issue 42.38 11.64 18 37109 596 34919208
Headache 41.11 11.64 358 36769 200277 34719527
Implant site infection 41.02 11.64 21 37106 1069 34918735
Insulin-like growth factor decreased 40.57 11.64 14 37113 259 34919545
Blood oestrogen increased 40.46 11.64 10 37117 51 34919753
Pancytopenia 39.84 11.64 26 37101 95131 34824673
Depression 39.81 11.64 206 36921 96892 34822912
Acne 38.60 11.64 53 37074 11013 34908791
Completed suicide 38.23 11.64 29 37098 98139 34821665
Myocardial infarction 37.27 11.64 238 36889 120847 34798957
Product storage error 36.34 11.64 44 37083 8078 34911726
Interstitial lung disease 36.33 11.64 12 37115 65270 34854534
Cerebrovascular accident 36.20 11.64 182 36945 84629 34835175
No adverse event 36.04 11.64 77 37050 22850 34896954
Infertility 35.56 11.64 12 37115 207 34919597
Thrombosis 35.38 11.64 126 37001 50332 34869472
Application site discolouration 35.37 11.64 13 37114 291 34919513
Septic shock 35.35 11.64 16 37111 71818 34847986
Acute kidney injury 35.00 11.64 186 36941 304802 34615002
Renal infarct 33.79 11.64 20 37107 1356 34918448
Spinal cord abscess 33.68 11.64 12 37115 245 34919559
Product physical issue 33.36 11.64 25 37102 2516 34917288
Application site urticaria 33.28 11.64 9 37118 69 34919735
Product administration error 33.05 11.64 61 37066 16283 34903521
Disease progression 32.69 11.64 40 37087 108037 34811767
Portal vein thrombosis 32.31 11.64 29 37098 3759 34916045
Breast cancer 32.30 11.64 12 37115 277 34919527
Acne fulminans 32.11 11.64 11 37116 199 34919605
Drug abuse 31.86 11.64 197 36930 98899 34820905
Renal artery thrombosis 31.30 11.64 12 37115 303 34919501
Blood follicle stimulating hormone decreased 31.27 11.64 8 37119 48 34919756
Fatigue 31.05 11.64 559 36568 370094 34549710
Coronary artery disease 30.82 11.64 117 37010 48188 34871616
Blood testosterone free increased 30.11 11.64 7 37120 26 34919778
Hypogonadism male 30.07 11.64 12 37115 338 34919466
Blood luteinising hormone decreased 29.44 11.64 9 37118 111 34919693
Expired product administered 29.34 11.64 26 37101 3315 34916489
Virilism 29.24 11.64 5 37122 0 34919804
Platelet count decreased 28.73 11.64 52 37075 119665 34800139
Implant site swelling 28.65 11.64 8 37119 70 34919734
Malignant neoplasm progression 28.34 11.64 31 37096 88015 34831789
Drug ineffective 28.10 11.64 658 36469 456093 34463711
Multiple organ dysfunction syndrome 28.08 11.64 24 37103 76542 34843262
Muscle hypertrophy 27.80 11.64 7 37120 39 34919765
Pituitary tumour 27.46 11.64 13 37114 558 34919246
Left ventricular hypertrophy 26.96 11.64 38 37089 8092 34911712
Stubbornness 26.55 11.64 6 37121 19 34919785
Leukopenia 26.54 11.64 17 37110 62839 34856965
Product delivery mechanism issue 26.47 11.64 9 37118 159 34919645
Incorrect product administration duration 26.47 11.64 29 37098 4782 34915022
Pneumonia 26.06 11.64 253 36874 362374 34557430
Implant site haemorrhage 26.00 11.64 8 37119 101 34919703
Therapeutic response unexpected 25.77 11.64 41 37086 9716 34910088
Device malfunction 25.09 11.64 42 37085 10379 34909425
Phaeochromocytoma 24.80 11.64 9 37118 194 34919610
Melaena 24.63 11.64 4 37123 35376 34884428
C-reactive protein increased 23.71 11.64 14 37113 54084 34865720
Anger 23.58 11.64 44 37083 11840 34907964
Hypotension 23.30 11.64 139 36988 221510 34698294
Drug-disease interaction 23.10 11.64 11 37116 478 34919326
Decreased appetite 22.85 11.64 95 37032 166297 34753507
Application site dermatitis 22.79 11.64 6 37121 41 34919763
Loss of libido 22.69 11.64 20 37107 2532 34917272
Pre-existing condition improved 22.42 11.64 20 37107 2572 34917232
Blood growth hormone increased 22.30 11.64 10 37117 378 34919426
Acromegaly 22.18 11.64 6 37121 46 34919758
Hypercoagulation 22.08 11.64 15 37112 1293 34918511
Implant site erythema 22.07 11.64 6 37121 47 34919757
Application site inflammation 21.96 11.64 7 37120 100 34919704
Hormone level abnormal 21.75 11.64 10 37117 401 34919403
Product complaint 21.74 11.64 29 37098 5861 34913943
Mucosal inflammation 21.66 11.64 7 37120 38615 34881189
Product colour issue 21.54 11.64 11 37116 557 34919247
Cholelithiasis 21.43 11.64 60 37067 21088 34898716
Growth hormone-producing pituitary tumour 21.04 11.64 6 37121 57 34919747
Myocardial fibrosis 20.86 11.64 14 37113 1183 34918621
Prostatomegaly 20.80 11.64 27 37100 5314 34914490
Neoplasm recurrence 20.75 11.64 18 37109 2231 34917573
Needle issue 20.71 11.64 29 37098 6136 34913668
Steatocystoma multiplex 20.63 11.64 4 37123 4 34919800
Injection site mass 20.54 11.64 30 37097 6596 34913208
Sepsis 20.52 11.64 99 37028 166462 34753342
Pyomyositis 20.47 11.64 8 37119 213 34919591
Accidental exposure to product by child 20.45 11.64 15 37112 1461 34918343
Hyperhidrosis 20.39 11.64 144 36983 75548 34844256
Application site burn 20.22 11.64 8 37119 220 34919584
Underdose 20.19 11.64 45 37082 13735 34906069
Product gel formation 20.16 11.64 4 37123 5 34919799
Circumstance or information capable of leading to medication error 20.07 11.64 16 37111 1763 34918041
Aortic aneurysm 20.02 11.64 30 37097 6749 34913055
Insulin resistance 20.02 11.64 11 37116 647 34919157
Neutrophil count decreased 20.01 11.64 15 37112 51089 34868715
Optic ischaemic neuropathy 19.89 11.64 17 37110 2065 34917739
Application site paraesthesia 19.74 11.64 4 37123 6 34919798
Glucose tolerance decreased 19.70 11.64 6 37121 73 34919731
Cardiac death 19.68 11.64 13 37114 1070 34918734
Irritability 19.35 11.64 64 37063 24626 34895178
Treatment failure 19.21 11.64 13 37114 46684 34873120
Blood thyroid stimulating hormone decreased 18.85 11.64 16 37111 1925 34917879
Implant site mass 18.69 11.64 4 37123 9 34919795
Stomatitis 18.64 11.64 11 37116 42503 34877301
Breast tenderness 18.40 11.64 11 37116 760 34919044
Renal failure 18.25 11.64 74 37053 130483 34789321
Gastrointestinal haemorrhage 18.18 11.64 42 37085 88435 34831369
Chorioretinopathy 18.08 11.64 14 37113 1479 34918325
Hyponatraemia 18.02 11.64 38 37089 82653 34837151
Accidental exposure to product 17.86 11.64 41 37086 12761 34907043
Acne conglobata 17.62 11.64 4 37123 13 34919791
Borderline ovarian tumour 17.55 11.64 3 37124 0 34919804
Endometrial hyperplasia 17.55 11.64 3 37124 0 34919804
Cervix carcinoma stage IV 17.55 11.64 3 37124 0 34919804
Angiofibroma 17.55 11.64 3 37124 0 34919804
Oligospermia 17.54 11.64 6 37121 108 34919696
Device dislocation 17.53 11.64 27 37100 6222 34913582
Hepatic adenoma 17.31 11.64 5 37122 50 34919754
Testicular pain 17.29 11.64 18 37109 2800 34917004
Cardio-respiratory arrest 17.19 11.64 20 37107 55253 34864551
Injection site bruising 17.09 11.64 32 37095 8631 34911173
Intentional overdose 16.86 11.64 13 37114 43661 34876143
Prostate cancer 16.84 11.64 85 37042 39564 34880240
Intentional product misuse 16.79 11.64 94 37033 45517 34874287
Growth accelerated 16.78 11.64 4 37123 17 34919787
Amnesia 16.65 11.64 64 37063 26499 34893305
Thyroid mass 16.56 11.64 9 37118 518 34919286
Testicular failure 16.33 11.64 5 37122 62 34919742
Cerebral venous thrombosis 16.05 11.64 10 37117 744 34919060
Coma 15.92 11.64 15 37112 45663 34874141
Hyperkalaemia 15.88 11.64 31 37096 69358 34850446
Carpal tunnel syndrome 15.53 11.64 22 37105 4704 34915100
Skin irritation 15.51 11.64 24 37103 5553 34914251
Implant site necrosis 15.47 11.64 3 37124 3 34919801
Dermal absorption impaired 15.47 11.64 3 37124 3 34919801
Sperm concentration zero 15.47 11.64 3 37124 3 34919801
Cardiomyopathy 15.40 11.64 46 37081 16762 34903042
Skin odour abnormal 15.24 11.64 11 37116 1045 34918759
Bone marrow failure 15.21 11.64 6 37121 29247 34890557
Injection site swelling 15.08 11.64 36 37091 11491 34908313
Testis discomfort 15.01 11.64 3 37124 4 34919800
Anorgasmia 14.88 11.64 10 37117 847 34918957
Confusional state 14.82 11.64 91 37036 144069 34775735
Electrocardiogram QT prolonged 14.81 11.64 13 37114 40939 34878865
Haemoglobin decreased 14.74 11.64 72 37055 120700 34799104
Small airways disease 14.64 11.64 4 37123 32 34919772
Bradycardia 14.55 11.64 37 37090 75381 34844423
Renal cell carcinoma 14.43 11.64 22 37105 5026 34914778
Eosinophilia 14.27 11.64 5 37122 26217 34893587
Implant site rash 14.26 11.64 3 37124 6 34919798
Sleep disorder 14.21 11.64 69 37058 31619 34888185
Oxygen saturation decreased 14.17 11.64 22 37105 53796 34866008
Nipple pain 14.07 11.64 10 37117 927 34918877
Androgen deficiency 14.03 11.64 6 37121 202 34919602
Asthma exercise induced 13.99 11.64 5 37122 103 34919701
Lactic acidosis 13.88 11.64 10 37117 34762 34885042
Depressed level of consciousness 13.87 11.64 15 37112 42826 34876978
Cardiac failure 13.85 11.64 50 37077 91198 34828606
Implant site cellulitis 13.85 11.64 4 37123 40 34919764
Gastric hypomotility 13.77 11.64 5 37122 108 34919696
Transient ischaemic attack 13.76 11.64 62 37065 27551 34892253
Thyroxine decreased 13.73 11.64 6 37121 213 34919591
Recalled product administered 13.64 11.64 8 37119 533 34919271
Gamma-glutamyltransferase increased 13.63 11.64 7 37120 29224 34890580
Ophthalmic vein thrombosis 13.59 11.64 4 37123 43 34919761
Needle track marks 13.50 11.64 4 37123 44 34919760
Drug withdrawal syndrome 13.44 11.64 49 37078 19785 34900019
Penis disorder 13.41 11.64 11 37116 1262 34918542
Anxiety 13.40 11.64 163 36964 99265 34820539
Product closure issue 13.40 11.64 3 37124 9 34919795
Device extrusion 13.40 11.64 3 37124 9 34919795
Respiratory distress 13.29 11.64 11 37116 35654 34884150
Pneumonitis 13.19 11.64 10 37117 33868 34885936
Product adhesion issue 13.16 11.64 12 37115 1588 34918216
Product tampering 12.82 11.64 4 37123 53 34919751
Body height decreased 12.79 11.64 18 37109 3825 34915979
Lower respiratory tract infection 12.75 11.64 9 37118 31628 34888176
Injection site abscess 12.61 11.64 9 37118 840 34918964
Orchidectomy 12.56 11.64 4 37123 57 34919747
Empty sella syndrome 12.49 11.64 4 37123 58 34919746
Back pain 12.46 11.64 190 36937 121599 34798205
Thyrotoxic periodic paralysis 12.42 11.64 5 37122 144 34919660
Retinal vein occlusion 12.42 11.64 12 37115 1707 34918097
Metabolic acidosis 12.34 11.64 17 37110 43663 34876141
Eye colour change 12.26 11.64 6 37121 277 34919527
Sperm concentration decreased 12.20 11.64 5 37122 151 34919653
Intentional misuse of drug delivery system 12.19 11.64 3 37124 15 34919789
Autoimmune thyroiditis 12.07 11.64 10 37117 1164 34918640
Pollakiuria 12.00 11.64 47 37080 19627 34900177
Toxic epidermal necrolysis 12 11.64 4 37123 21642 34898162
Open angle glaucoma 11.96 11.64 5 37122 159 34919645
Muscle spasms 11.93 11.64 127 37000 74874 34844930
Impulsive behaviour 11.84 11.64 13 37114 2149 34917655
Hepatic function abnormal 11.81 11.64 18 37109 44345 34875459
Mood swings 11.80 11.64 26 37101 7875 34911929
Haematuria 11.77 11.64 22 37105 50044 34869760
Hypokalaemia 11.66 11.64 28 37099 58186 34861618

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 554.33 11.21 118 30039 934 79713297
Polycythaemia 414.54 11.21 108 30049 2176 79712055
Idiopathic intracranial hypertension 350.98 11.21 102 30055 3120 79711111
Blood testosterone decreased 330.22 11.21 91 30066 2286 79711945
Expulsion of medication 238.62 11.21 37 30120 20 79714211
Deep vein thrombosis 200.94 11.21 238 29919 120681 79593550
Metaplasia 196.24 11.21 45 30112 517 79713714
Precocious puberty 196.12 11.21 41 30116 294 79713937
Virilism 148.61 11.21 23 30134 12 79714219
Pulmonary embolism 144.53 11.21 244 29913 171410 79542821
Prostatic disorder 124.32 11.21 42 30115 2118 79712113
Product administered at inappropriate site 113.02 11.21 46 30111 3919 79710312
Haematocrit increased 105.48 11.21 44 30113 3990 79710241
Acute myocardial infarction 101.33 11.21 135 30022 76901 79637330
Product deposit 98.34 11.21 26 30131 555 79713676
Application site rash 97.80 11.21 35 30122 2097 79712134
Clear cell renal cell carcinoma 94.94 11.21 36 30121 2540 79711691
Testicular atrophy 94.44 11.21 23 30134 348 79713883
Erectile dysfunction 93.28 11.21 62 30095 14602 79699629
Blood testosterone abnormal 92.74 11.21 21 30136 227 79714004
Enlarged clitoris 91.34 11.21 14 30143 6 79714225
Mesenteric vein thrombosis 76.36 11.21 28 30129 1799 79712432
Focal segmental glomerulosclerosis 76.14 11.21 33 30124 3288 79710943
Insulin-like growth factor increased 75.49 11.21 28 30129 1858 79712373
Gynaecomastia 73.13 11.21 42 30115 7639 79706592
Craniopharyngioma 72.99 11.21 19 30138 381 79713850
Application site pain 70.77 11.21 35 30122 4712 79709519
Drug abuse 69.67 11.21 175 29982 162516 79551715
Myocardial infarction 69.59 11.21 189 29968 183940 79530291
Renal infarct 69.18 11.21 29 30128 2662 79711569
Lymphoproliferative disorder 68.04 11.21 36 30121 5579 79708652
Coronary artery disease 67.26 11.21 102 30055 65372 79648859
Accidental exposure to product by child 66.84 11.21 29 30128 2897 79711334
Product quality issue 66.79 11.21 73 30084 33867 79680364
Prostatic specific antigen increased 66.26 11.21 44 30113 10342 79703889
Cervix carcinoma stage IV 65.53 11.21 13 30144 69 79714162
Secondary hypogonadism 64.79 11.21 17 30140 352 79713879
Acne fulminans 62.94 11.21 15 30142 206 79714025
Infertility male 61.84 11.21 13 30144 96 79714135
Hair growth abnormal 58.44 11.21 26 30131 2758 79711473
Toxicity to various agents 57.71 11.21 45 30112 421495 79292736
Oestradiol increased 56.35 11.21 12 30145 95 79714136
Retinal neovascularisation 55.21 11.21 13 30144 169 79714062
Application site erythema 54.22 11.21 30 30127 5080 79709151
Product odour abnormal 53.96 11.21 20 30137 1324 79712907
Pituitary tumour benign 53.88 11.21 24 30133 2552 79711679
Osteonecrosis 52.88 11.21 62 30095 31033 79683198
Muscle mass 51.90 11.21 15 30142 449 79713782
Neutropenia 51.76 11.21 22 30135 287688 79426543
General physical health deterioration 51.22 11.21 20 30137 275218 79439013
Accidental exposure to product 50.86 11.21 61 30096 31261 79682970
Libido decreased 50.40 11.21 29 30128 5292 79708939
Left ventricular hypertrophy 49.66 11.21 38 30119 11153 79703078
Pituitary tumour recurrent 49.30 11.21 12 30145 181 79714050
Poor quality product administered 48.84 11.21 25 30132 3620 79710611
Cerebrovascular accident 48.59 11.21 149 30008 155143 79559088
Performance enhancing product use 46.98 11.21 10 30147 79 79714152
Haemoglobin increased 46.59 11.21 29 30128 6103 79708128
Portal vein thrombosis 45.39 11.21 28 30129 5799 79708432
Hypogonadism 45.35 11.21 19 30138 1741 79712490
Thrombosis 45.30 11.21 99 30058 84001 79630230
Application site pruritus 44.96 11.21 24 30133 3786 79710445
Chorioretinopathy 44.16 11.21 20 30137 2211 79712020
Ovarian endometrioid carcinoma 41.96 11.21 7 30150 10 79714221
Papilloedema 41.20 11.21 27 30130 6206 79708025
Borderline serous tumour of ovary 41.18 11.21 7 30150 12 79714219
Contraindicated product administered 39.85 11.21 6 30151 157532 79556699
Prescribed overdose 38.87 11.21 59 30098 37824 79676407
Febrile neutropenia 37.95 11.21 20 30137 230979 79483252
Completed suicide 37.90 11.21 23 30134 245744 79468487
Implant site infection 37.81 11.21 17 30140 1848 79712383
Rheumatoid arthritis 37.39 11.21 16 30141 208454 79505777
Steatocystoma multiplex 37.13 11.21 6 30151 6 79714225
Ophthalmic vein thrombosis 37.11 11.21 10 30147 230 79714001
Priapism 35.99 11.21 22 30135 4483 79709748
Blood oestrogen increased 35.63 11.21 8 30149 83 79714148
Spinal cord abscess 35.10 11.21 11 30146 436 79713795
Red blood cell count increased 34.78 11.21 21 30136 4187 79710044
Acne 34.73 11.21 47 30110 27143 79687088
Apocrine breast carcinoma 34.40 11.21 5 30152 0 79714231
Multiple use of single-use product 34.37 11.21 13 30144 911 79713320
Treatment failure 34.07 11.21 11 30146 170475 79543756
Renal artery thrombosis 33.91 11.21 11 30146 488 79713743
Device delivery system issue 33.53 11.21 12 30145 719 79713512
Growth accelerated 33.49 11.21 6 30151 16 79714215
Product dose omission issue 32.75 11.21 182 29975 247355 79466876
Irritability 32.60 11.21 57 30100 41087 79673144
Implant site haemorrhage 32.54 11.21 9 30148 229 79714002
Adnexal torsion 32.49 11.21 10 30147 373 79713858
Incorrect dose administered 32.32 11.21 82 30075 76548 79637683
Infusion related reaction 32.21 11.21 24 30133 230213 79484018
Sleep apnoea syndrome 32.16 11.21 53 30104 36425 79677806
Atherosclerotic plaque rupture 32.05 11.21 5 30152 3 79714228
Prostate cancer 31.60 11.21 50 30107 33218 79681013
Endometrial hyperplasia 31.29 11.21 11 30146 625 79713606
Feeling abnormal 31.13 11.21 131 30026 159068 79555163
Anger 30.48 11.21 35 30122 17127 79697104
Blood luteinising hormone decreased 30.38 11.21 8 30149 168 79714063
Blood testosterone free increased 30.03 11.21 5 30152 7 79714224
Intracranial pressure increased 29.97 11.21 25 30132 8297 79705934
Implant site pain 29.90 11.21 15 30142 2082 79712149
Neoplasm recurrence 29.69 11.21 19 30138 4195 79710036
Aortic aneurysm 29.64 11.21 25 30132 8421 79705810
Myocardial fibrosis 29.64 11.21 14 30143 1704 79712527
Oligospermia 29.34 11.21 6 30151 38 79714193
Loss of libido 29.14 11.21 16 30141 2669 79711562
Blood testosterone free decreased 28.95 11.21 6 30151 41 79714190
Application site vesicles 28.79 11.21 13 30144 1427 79712804
Depression 28.40 11.21 159 29998 216631 79497600
Muscle hypertrophy 27.87 11.21 7 30150 121 79714110
Vocal cord atrophy 27.73 11.21 5 30152 14 79714217
Product container issue 26.91 11.21 12 30145 1279 79712952
Blood follicle stimulating hormone decreased 26.86 11.21 7 30150 141 79714090
Stomatitis 26.73 11.21 11 30146 146746 79567485
Growth hormone-producing pituitary tumour 26.65 11.21 6 30151 63 79714168
Infertility 26.57 11.21 10 30147 691 79713540
Suicidal ideation 26.47 11.21 76 30081 76264 79637967
Product administration error 26.38 11.21 45 30112 31801 79682430
Renal cell carcinoma 26.29 11.21 21 30136 6557 79707674
Azoospermia 26.10 11.21 7 30150 158 79714073
Cardiomyopathy 25.62 11.21 42 30115 28732 79685499
Glucose tolerance decreased 25.62 11.21 6 30151 76 79714155
Drug-disease interaction 25.57 11.21 11 30146 1076 79713155
Drug intolerance 25.22 11.21 38 30119 264081 79450150
Optic ischaemic neuropathy 25.05 11.21 15 30142 2946 79711285
Hormone level abnormal 24.72 11.21 13 30144 1989 79712242
Cardiac death 24.64 11.21 12 30145 1562 79712669
Insulin-like growth factor decreased 24.58 11.21 9 30148 576 79713655
Pericarditis 24.12 11.21 5 30152 104231 79610000
Product physical consistency issue 24.09 11.21 10 30147 895 79713336
Hyperandrogenism 23.86 11.21 4 30153 6 79714225
Penis disorder 23.77 11.21 10 30147 926 79713305
Phaeochromocytoma 23.43 11.21 9 30148 658 79713573
Product complaint 23.33 11.21 27 30130 13322 79700909
Lower respiratory tract infection 23.03 11.21 10 30147 129210 79585021
Application site inflammation 22.57 11.21 8 30149 466 79713765
Blood growth hormone increased 22.57 11.21 9 30148 727 79713504
Gender dysphoria 22.34 11.21 5 30152 51 79714180
Breast hyperplasia 21.87 11.21 6 30151 148 79714083
Injection site pain 21.72 11.21 102 30055 129736 79584495
Application site exfoliation 21.61 11.21 8 30149 528 79713703
Dissociative identity disorder 21.60 11.21 5 30152 60 79714171
Testicular pain 21.57 11.21 12 30145 2053 79712178
Vaginal disorder 21.54 11.21 8 30149 533 79713698
Device malfunction 21.43 11.21 33 30124 21415 79692816
Aggression 20.93 11.21 54 30103 50904 79663327
Borderline ovarian tumour 20.90 11.21 4 30153 17 79714214
Hypogonadism male 20.69 11.21 6 30151 182 79714049
Spontaneous cerebrospinal fluid leak syndrome 20.64 11.21 3 30154 0 79714231
Hyperoestrogenism 20.64 11.21 3 30154 0 79714231
Renal artery fibromuscular dysplasia 20.64 11.21 3 30154 0 79714231
Needle issue 20.48 11.21 25 30132 13043 79701188
Pyomyositis 20.41 11.21 8 30149 617 79713614
Coronary artery occlusion 20.36 11.21 27 30130 15288 79698943
Impulsive behaviour 20.24 11.21 13 30144 2887 79711344
Anaemia 20.23 11.21 93 30064 444922 79269309
Stubbornness 20.08 11.21 7 30150 388 79713843
Insulin resistance 20.06 11.21 10 30147 1369 79712862
Glossodynia 20.06 11.21 7 30150 103330 79610901
Drug withdrawal syndrome 19.98 11.21 42 30115 34676 79679555
Self-destructive behaviour 19.61 11.21 4 30153 25 79714206
Atrial fibrillation 19.54 11.21 135 30022 197751 79516480
Pyrexia 19.35 11.21 164 29993 678545 79035686
Acne conglobata 19.34 11.21 4 30153 27 79714204
Nasopharyngitis 19.33 11.21 42 30115 253839 79460392
Thrombocytopenia 19.29 11.21 45 30112 265214 79449017
Intentional product misuse 19.13 11.21 79 30078 95086 79619145
Hyperhidrosis 19.10 11.21 110 30047 151382 79562849
Uterine cervical metaplasia 18.56 11.21 3 30154 3 79714228
Oestrone increased 18.56 11.21 3 30154 3 79714228
Septic shock 18.22 11.21 12 30145 122789 79591442
Implant site bruising 18.10 11.21 6 30151 285 79713946
Cortisol increased 17.88 11.21 7 30150 538 79713693
Wrong technique in product usage process 17.85 11.21 65 30092 73810 79640421
Pancytopenia 17.67 11.21 22 30135 165723 79548508
Congestive cardiomyopathy 17.60 11.21 22 30135 11758 79702473
Hypercoagulation 17.44 11.21 12 30145 2988 79711243
Pseudoprecocious puberty 17.35 11.21 3 30154 6 79714225
C-reactive protein increased 17.34 11.21 14 30143 129013 79585218
Intraductal proliferative breast lesion 16.98 11.21 11 30146 2480 79711751
Interstitial lung disease 16.71 11.21 11 30146 112589 79601642
Gastric hypomotility 16.23 11.21 5 30152 187 79714044
Eye colour change 16.08 11.21 6 30151 405 79713826
Application site paraesthesia 15.99 11.21 4 30153 68 79714163
Needle track marks 15.72 11.21 4 30153 73 79714158
Death 15.64 11.21 138 30019 566376 79147855
Liquid product physical issue 15.58 11.21 8 30149 1166 79713065
Hypothalamo-pituitary disorder 15.45 11.21 8 30149 1186 79713045
Intentional misuse of drug delivery system 15.44 11.21 3 30154 14 79714217
Off label use 15.35 11.21 450 29707 906765 78807466
Diastolic hypertension 15.28 11.21 4 30153 82 79714149
Hyperglycaemic hyperosmolar nonketotic syndrome 15.28 11.21 10 30147 2293 79711938
Pituitary tumour 15.27 11.21 8 30149 1214 79713017
Application site irritation 15.18 11.21 9 30148 1735 79712496
Empty sella syndrome 14.89 11.21 4 30153 91 79714140
Mucosal inflammation 14.88 11.21 5 30152 75575 79638656
Myalgia 14.58 11.21 120 30037 185521 79528710
Shunt malfunction 14.54 11.21 5 30152 266 79713965
Blood thyroid stimulating hormone decreased 14.32 11.21 14 30143 5702 79708529
Acromegaly 14.31 11.21 4 30153 106 79714125
Transient ischaemic attack 14.14 11.21 48 30109 52647 79661584
Retinal vein occlusion 14.12 11.21 11 30146 3312 79710919
Libido increased 14.04 11.21 9 30148 1992 79712239
Wolff-Parkinson-White syndrome 13.99 11.21 5 30152 298 79713933
Ovarian necrosis 13.95 11.21 3 30154 25 79714206
Hypopituitarism 13.90 11.21 11 30146 3388 79710843
Product physical issue 13.89 11.21 12 30145 4173 79710058
Therapeutic response unexpected 13.72 11.21 26 30131 19920 79694311
Cerebral venous thrombosis 13.67 11.21 10 30147 2743 79711488
Prostatomegaly 13.67 11.21 11 30146 3472 79710759
Disease progression 13.62 11.21 31 30126 184331 79529900
Expired product administered 13.58 11.21 15 30142 7036 79707195
Device extrusion 13.55 11.21 3 30154 29 79714202
Small airways disease 13.55 11.21 3 30154 29 79714202
Malignant neoplasm progression 13.53 11.21 19 30138 135971 79578260
Injection site mass 13.51 11.21 26 30131 20158 79694073
Angiofibroma 13.47 11.21 4 30153 132 79714099
Prostate infection 13.38 11.21 6 30151 648 79713583
Endometrial adenocarcinoma 13.33 11.21 7 30150 1068 79713163
Large intestine polyp 13.33 11.21 20 30137 12688 79701543
Asthma exercise induced 13.27 11.21 4 30153 139 79714092
Vein collapse 13.01 11.21 7 30150 1121 79713110
Coronary artery dissection 12.92 11.21 7 30150 1137 79713094
Leukopenia 12.91 11.21 15 30142 116498 79597733
Thyrotoxic periodic paralysis 12.80 11.21 4 30153 157 79714074
Viral diarrhoea 12.78 11.21 5 30152 384 79713847
Hidradenitis 12.77 11.21 10 30147 3034 79711197
Malignant melanoma 12.43 11.21 21 30136 14720 79699511
Bone marrow oedema syndrome 12.40 11.21 3 30154 44 79714187
Exaggerated startle response 12.40 11.21 3 30154 44 79714187
Application site reaction 12.40 11.21 6 30151 770 79713461
Renal embolism 12.34 11.21 4 30153 177 79714054
Anorgasmia 12.32 11.21 7 30150 1247 79712984
Hepatic artery aneurysm 12.28 11.21 3 30154 46 79714185
Nocturia 12.22 11.21 20 30137 13661 79700570
Factor V Leiden mutation 12.17 11.21 4 30153 185 79714046
Open angle glaucoma 12.11 11.21 5 30152 442 79713789
Thalamic infarction 12.05 11.21 7 30150 1300 79712931
Melaena 12.03 11.21 4 30153 60886 79653345
Decreased appetite 12.00 11.21 78 30079 342340 79371891
Diabetes mellitus 11.96 11.21 60 30097 78330 79635901
Recalled product administered 11.90 11.21 6 30151 841 79713390
Cardiovascular disorder 11.79 11.21 23 30134 18002 79696229
Amnesia 11.63 11.21 51 30106 63006 79651225
Helicobacter infection 11.49 11.21 6 30151 69698 79644533
Nipple pain 11.40 11.21 6 30151 920 79713311
Astrocytoma 11.38 11.21 4 30153 227 79714004
Product contamination microbial 11.28 11.21 6 30151 940 79713291
Cardiac disorder 11.24 11.21 52 30105 65705 79648526

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 | Suggest Off label Use Form| |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




🐶 Veterinary Drug Use

SpeciesUseRelation
Cattle To increase rate of weight gain Indication
Cattle To improve feed efficiency Indication

🐶 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 BESINS HLTHCARE 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 BESINS HLTHCARE 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 BESINS HLTHCARE 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) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ANDROGEL BESINS HLTHCARE 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) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ANDROGEL BESINS HLTHCARE 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) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ANDROGEL BESINS HLTHCARE 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) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ANDROGEL BESINS HLTHCARE 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) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ANDROGEL BESINS HLTHCARE 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) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** ANDROGEL BESINS HLTHCARE 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 36 sections
Androderm HUMAN PRESCRIPTION DRUG LABEL 1 0023-5990 PATCH 2 mg TRANSDERMAL NDA 36 sections
Androderm HUMAN PRESCRIPTION DRUG LABEL 1 0023-5990 PATCH 2 mg TRANSDERMAL NDA 36 sections
Androderm HUMAN PRESCRIPTION DRUG LABEL 1 0023-5992 PATCH 4 mg TRANSDERMAL NDA 36 sections
Androderm HUMAN PRESCRIPTION DRUG LABEL 1 0023-5992 PATCH 4 mg TRANSDERMAL NDA 36 sections
Androderm HUMAN PRESCRIPTION DRUG LABEL 1 0023-5992 PATCH 4 mg TRANSDERMAL NDA 36 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 0051-8462 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 0245-0871 GEL 50 mg TOPICAL NDA 37 sections
Vogelxo HUMAN PRESCRIPTION DRUG LABEL 1 0245-0872 GEL, METERED 12.50 mg TOPICAL NDA 37 sections
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 0591-2114 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 0591-2363 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 0591-2921 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 0591-3216 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 0591-3217 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