testosterone 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 3.107 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 0.780 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 79.799 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 64.269 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 7.890 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 12.550 % High 1
herg hERG pIC50 4.513 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 14.791 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 27.925 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 5.630 % High 1
kinase-safety-class ACVR2B,BRAF,CDK5,EIF2AK3,ERBB2,GRK2,ITK,NTRK2,PDK1,PDK2,PDK4,PRKDC 12
kinase-selectivity-class EIF2AK3,GRK2 2
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 0.590 High 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 2.371 High 1
mh-clint Mouse hepatocyte intrinsic clearance 228.560 High 1
mppb Mouse plasma protein binding (% unbound) 10.090 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 4.955 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 10.870 % High 1
rat-kpuu-brain Rat brain Kpuu 0.861 % High 1
rh-clint Rat hepatocyte intrinsic clearance 258.821 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 45.920 % High 1
rppb Rat plasma protein binding (% unbound) 10.670 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 81.658 uM High 1

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 375.42 18.64 53 5743 204 90622447
Idiopathic intracranial hypertension 263.51 18.64 58 5738 3523 90619128
Off label use 209.64 18.64 300 5496 1101952 89520699
Accidental exposure to product 197.46 18.64 81 5715 42285 90580366
Virilism 169.56 18.64 22 5774 35 90622616
Enlarged clitoris 155.89 18.64 23 5773 128 90622523
Expulsion of medication 133.53 18.64 17 5779 21 90622630
Precocious puberty 124.60 18.64 21 5775 300 90622351
Hair growth abnormal 106.14 18.64 28 5768 3648 90619003
Papilloedema 90.79 18.64 26 5770 4589 90618062
Accidental exposure to product by child 78.46 18.64 18 5778 1315 90621336
Breathing-related sleep disorder 74.09 18.64 12 5784 132 90622519
Cervix carcinoma stage IV 64.84 18.64 10 5786 78 90622573
Metaplasia 64.61 18.64 13 5783 508 90622143
Hirsutism 63.90 18.64 16 5780 1694 90620957
Breast hyperplasia 57.49 18.64 11 5785 330 90622321
Borderline serous tumour of ovary 55.76 18.64 7 5789 7 90622644
Adnexal torsion 52.57 18.64 11 5785 523 90622128
Endometrial adenocarcinoma 46.46 18.64 12 5784 1438 90621213
Blood testosterone decreased 43.74 18.64 7 5789 71 90622580
Mesonephric duct cyst 43.29 18.64 5 5791 0 90622651
Hepatic adenoma 42.97 18.64 9 5787 430 90622221
Ovarian endometrioid carcinoma 40.94 18.64 5 5791 3 90622648
Breast cancer 40.67 18.64 31 5765 53730 90568921
Renal infarct 40.46 18.64 11 5785 1604 90621047
Skin laceration 39.09 18.64 23 5773 26012 90596639
Atherosclerotic plaque rupture 38.14 18.64 5 5791 9 90622642
Acne 37.17 18.64 23 5773 28484 90594167
Infertility 36.87 18.64 9 5787 858 90621793
Endometrial hyperplasia 35.78 18.64 9 5787 970 90621681
Endometrial cancer 35.65 18.64 12 5784 3600 90619051
Blood testosterone free increased 34.63 18.64 4 5792 0 90622651
Ovarian granulosa cell tumour 33.86 18.64 5 5791 28 90622623
Priapism 33.28 18.64 6 5790 129 90622522
Invasive ductal breast carcinoma 33.17 18.64 14 5782 7804 90614847
Renal artery fibromuscular dysplasia 30.97 18.64 4 5792 6 90622645
Apocrine breast carcinoma 30.97 18.64 4 5792 6 90622645
Gender dysphoria 30.24 18.64 4 5792 8 90622643
Hormone level abnormal 30.16 18.64 10 5786 2863 90619788
Polycythaemia 29.11 18.64 8 5788 1215 90621436
Dissociative identity disorder 28.90 18.64 5 5791 84 90622567
Performance enhancing product use 28.62 18.64 4 5792 14 90622637
Suicidal ideation 28.40 18.64 29 5767 73826 90548825
Intraductal proliferative breast lesion 28.36 18.64 10 5786 3443 90619208
Vaginal disorder 28.07 18.64 7 5789 729 90621922
Hyperandrogenism 27.37 18.64 5 5791 116 90622535
Cerebrospinal fluid leakage 27.15 18.64 8 5788 1559 90621092
Exposure via partner 27.05 18.64 5 5791 124 90622527
Anxiety 26.44 18.64 60 5736 309712 90312939
Transgender hormonal therapy 25.97 18.64 3 5793 0 90622651
Prostatic disorder 24.78 18.64 4 5792 43 90622608
Ovarian necrosis 24.69 18.64 4 5792 44 90622607
Osteonecrosis 24.06 18.64 17 5779 26224 90596427
Dermatitis atopic 23.38 18.64 16 5780 23456 90599195
Ovarian cancer stage II 22.96 18.64 4 5792 70 90622581
Vocal cord atrophy 22.68 18.64 3 5793 6 90622645
Libido increased 22.09 18.64 7 5789 1737 90620914
Chorioretinopathy 22.07 18.64 6 5790 874 90621777
Focal segmental glomerulosclerosis 21.68 18.64 7 5789 1844 90620807
Product preparation error 20.68 18.64 11 5785 10250 90612401
Product packaging difficult to open 20.48 18.64 4 5792 134 90622517
Self-destructive behaviour 20.39 18.64 5 5791 486 90622165
Solar lentigo 20.33 18.64 6 5790 1174 90621477
Growth accelerated 20.28 18.64 3 5793 17 90622634
Uterine cervical metaplasia 19.61 18.64 3 5793 22 90622629
Loss of libido 19.46 18.64 6 5790 1361 90621290
Biliary dyskinesia 19.35 18.64 7 5789 2592 90620059
Porphyria 18.84 18.64 4 5792 204 90622447
Cervix disorder 18.76 18.64 5 5791 676 90621975

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
Polycythaemia 789.13 11.63 228 39231 2658 42579218
Blood testosterone decreased 623.46 11.63 216 39243 4686 42577190
Blood testosterone increased 561.47 11.63 153 39306 1414 42580462
Deep vein thrombosis 222.25 11.63 313 39146 76644 42505232
Application site rash 199.09 11.63 62 39397 947 42580929
Product deposit 189.72 11.63 50 39409 401 42581475
Expulsion of medication 186.82 11.63 35 39424 32 42581844
Product administered at inappropriate site 175.99 11.63 76 39383 3022 42578854
Precocious puberty 171.57 11.63 37 39422 106 42581770
Blood testosterone abnormal 155.70 11.63 45 39414 524 42581352
Haematocrit increased 142.63 11.63 62 39397 2505 42579371
Insulin-like growth factor increased 137.13 11.63 53 39406 1578 42580298
Drug abuse 132.86 11.63 297 39162 104474 42477402
Pulmonary embolism 130.87 11.63 320 39139 119292 42462584
Implant site pain 130.05 11.63 30 39429 127 42581749
Incorrect dose administered 126.25 11.63 197 39262 52777 42529099
Secondary hypogonadism 125.04 11.63 41 39418 745 42581131
Mesenteric vein thrombosis 122.06 11.63 42 39417 890 42580986
Testicular atrophy 117.04 11.63 37 39422 595 42581281
Febrile neutropenia 111.37 11.63 19 39440 185684 42396192
Hepatic adenoma 106.27 11.63 22 39437 48 42581828
Application site pain 106.23 11.63 49 39410 2280 42579596
Application site erythema 101.71 11.63 49 39410 2517 42579359
Neutropenia 100.42 11.63 30 39429 199401 42382475
Toxicity to various agents 97.72 11.63 45 39414 229091 42352785
Prescribed overdose 89.77 11.63 83 39376 12844 42569032
Infertility male 89.03 11.63 23 39436 169 42581707
Clear cell renal cell carcinoma 88.07 11.63 36 39423 1245 42580631
Product quality issue 87.62 11.63 95 39364 17787 42564089
Application site pruritus 87.30 11.63 38 39421 1540 42580336
Focal segmental glomerulosclerosis 87.12 11.63 44 39415 2504 42579372
Product delivery mechanism issue 86.16 11.63 24 39435 242 42581634
Libido decreased 84.81 11.63 55 39404 5043 42576833
Death 82.55 11.63 198 39261 470987 42110889
Oestradiol increased 78.49 11.63 17 39442 50 42581826
Product odour abnormal 74.11 11.63 29 39430 893 42580983
Osteonecrosis 73.76 11.63 82 39377 15783 42566093
Application site reaction 71.45 11.63 23 39436 393 42581483
Blood growth hormone increased 69.00 11.63 25 39434 619 42581257
Cardiomyopathy 68.96 11.63 87 39372 19123 42562753
Pituitary tumour benign 68.34 11.63 28 39431 974 42580902
Craniopharyngioma 68.19 11.63 20 39439 246 42581630
Haemoglobin increased 67.17 11.63 48 39411 5158 42576718
Acute myocardial infarction 67.14 11.63 159 39300 58006 42523870
Erectile dysfunction 66.91 11.63 98 39361 24815 42557061
Poor quality product administered 65.01 11.63 35 39424 2273 42579603
Muscle mass 64.32 11.63 19 39440 240 42581636
Toxic cardiomyopathy 62.44 11.63 21 39438 414 42581462
General physical health deterioration 62.43 11.63 31 39428 151215 42430661
Blood testosterone free decreased 58.95 11.63 14 39445 69 42581807
Portal vein thrombosis 58.82 11.63 42 39417 4507 42577369
Renal artery thrombosis 58.68 11.63 19 39440 331 42581545
Feeling abnormal 58.25 11.63 169 39290 69617 42512259
Azoospermia 58.23 11.63 21 39438 513 42581363
Thrombocytopenia 57.32 11.63 55 39404 190224 42391652
Device expulsion 56.22 11.63 14 39445 87 42581789
Idiopathic intracranial hypertension 55.95 11.63 23 39436 807 42581069
Lymphoproliferative disorder 55.80 11.63 36 39423 3271 42578605
Retinal neovascularisation 54.99 11.63 15 39444 139 42581737
Renal infarct 54.29 11.63 29 39430 1854 42580022
Injection site pain 54.17 11.63 146 39313 57652 42524224
Blood follicle stimulating hormone decreased 53.78 11.63 13 39446 70 42581806
Self-medication 53.75 11.63 35 39424 3231 42578645
Pancytopenia 53.52 11.63 21 39438 117722 42464154
Anaemia 52.82 11.63 113 39346 280165 42301711
Hypogonadism 52.53 11.63 31 39428 2403 42579473
Prostatic specific antigen increased 51.99 11.63 71 39388 16854 42565022
Gynaecomastia 51.74 11.63 61 39398 12506 42569370
Application site irritation 51.57 11.63 21 39438 719 42581157
Device delivery system issue 51.02 11.63 23 39436 1014 42580862
Intentional product misuse 50.79 11.63 149 39310 61751 42520125
Performance enhancing product use 49.66 11.63 14 39445 148 42581728
Red blood cell count increased 48.88 11.63 27 39432 1845 42580031
Implant site infection 48.54 11.63 23 39436 1138 42580738
Left ventricular hypertrophy 48.27 11.63 51 39408 9268 42572608
Product packaging quantity issue 48.13 11.63 24 39435 1329 42580547
Hyperoestrogenism 47.89 11.63 8 39451 0 42581876
Pyrexia 47.41 11.63 196 39263 393846 42188030
Product container issue 47.29 11.63 21 39438 893 42580983
Pituitary tumour recurrent 46.96 11.63 12 39447 84 42581792
Insulin-like growth factor decreased 46.29 11.63 15 39444 262 42581614
Growth hormone-producing pituitary tumour 46.24 11.63 13 39446 136 42581740
Myocardial infarction 46.19 11.63 232 39227 123777 42458099
Implant site bruising 45.34 11.63 8 39451 3 42581873
Hair growth abnormal 45.05 11.63 21 39438 1001 42580875
Breast cancer 43.94 11.63 15 39444 310 42581566
Wrong technique in product usage process 42.27 11.63 110 39349 42525 42539351
Septic shock 42.23 11.63 16 39443 91656 42490220
Phaeochromocytoma 42.16 11.63 14 39445 265 42581611
Sleep apnoea syndrome 41.54 11.63 73 39386 21535 42560341
Hypercoagulation 40.46 11.63 22 39437 1457 42580419
Andropause 40.12 11.63 11 39448 104 42581772
Device malfunction 39.82 11.63 53 39406 12274 42569602
Optic ischaemic neuropathy 39.09 11.63 27 39432 2748 42579128
Interstitial lung disease 39.08 11.63 12 39447 78450 42503426
Blood luteinising hormone decreased 38.38 11.63 11 39448 124 42581752
Coronary artery disease 38.18 11.63 123 39336 53597 42528279
Headache 37.01 11.63 361 39098 239008 42342868
Pneumonia 36.60 11.63 235 39224 421914 42159962
Infertility 36.49 11.63 12 39447 220 42581656
Polycythaemia vera 36.43 11.63 14 39445 410 42581466
Cerebrovascular accident 36.32 11.63 182 39277 96978 42484898
Disease progression 36.17 11.63 48 39411 143608 42438268
Anger 36.10 11.63 52 39407 12966 42568910
Product physical issue 35.64 11.63 27 39432 3172 42578704
Prescription drug used without a prescription 34.83 11.63 25 39434 2705 42579171
Application site urticaria 34.39 11.63 9 39450 70 42581806
Hypogonadism male 34.35 11.63 13 39446 365 42581511
Acne 34.23 11.63 52 39407 13592 42568284
Multiple organ dysfunction syndrome 34.21 11.63 24 39435 97011 42484865
Malignant neoplasm progression 34.19 11.63 30 39429 108370 42473506
Implant site swelling 34.17 11.63 9 39450 72 42581804
Cardiac death 33.94 11.63 18 39441 1134 42580742
Product physical consistency issue 33.85 11.63 17 39442 956 42580920
Acne fulminans 33.71 11.63 12 39447 282 42581594
Muscle hypertrophy 33.59 11.63 8 39451 40 42581836
Gastric hypomotility 33.28 11.63 11 39448 205 42581671
Application site vesicles 33.15 11.63 15 39444 667 42581209
Acute kidney injury 33.10 11.63 202 39257 367135 42214741
Acromegaly 32.36 11.63 8 39451 48 42581828
Blood oestrogen increased 32.22 11.63 8 39451 49 42581827
Application site dryness 32.02 11.63 9 39450 94 42581782
Blood testosterone free increased 31.97 11.63 7 39452 22 42581854
Application site discolouration 31.44 11.63 12 39447 345 42581531
Platelet count decreased 31.26 11.63 50 39409 138531 42443345
Needle track marks 31.06 11.63 8 39451 58 42581818
Depression 30.59 11.63 192 39267 111171 42470705
Stubbornness 30.47 11.63 7 39452 29 42581847
Shunt malfunction 30.45 11.63 11 39448 270 42581606
Sepsis 30.03 11.63 90 39369 199244 42382632
Application site exfoliation 29.93 11.63 10 39449 193 42581683
Virilism 29.93 11.63 5 39454 0 42581876
Graft overgrowth 29.93 11.63 5 39454 0 42581876
Endometrial adenocarcinoma 29.93 11.63 5 39454 0 42581876
Steatocystoma multiplex 29.93 11.63 5 39454 0 42581876
Hypotension 29.77 11.63 130 39329 257501 42324375
Myocardial fibrosis 29.53 11.63 17 39442 1258 42580618
Viral diarrhoea 28.86 11.63 11 39448 315 42581561
Spinal cord abscess 28.85 11.63 12 39447 434 42581442
Accidental exposure to product by child 28.78 11.63 18 39441 1549 42580327
Therapeutic response unexpected 28.02 11.63 43 39416 11338 42570538
C-reactive protein increased 27.79 11.63 12 39447 63548 42518328
Liquid product physical issue 27.75 11.63 14 39445 795 42581081
Palmoplantar pustulosis 27.64 11.63 12 39447 483 42581393
Implant site haemorrhage 27.38 11.63 8 39451 97 42581779
Product storage error 27.30 11.63 42 39417 11098 42570778
Leukopenia 26.99 11.63 18 39441 74728 42507148
Implant site erythema 26.91 11.63 7 39452 53 42581823
Myelosuppression 26.90 11.63 3 39456 40458 42541418
Hyponatraemic seizure 26.78 11.63 9 39450 177 42581699
No adverse event 26.51 11.63 88 39371 38933 42542943
Stomatitis 26.35 11.63 7 39452 50322 42531554
Infection parasitic 26.23 11.63 11 39448 406 42581470
Drug interaction 26.06 11.63 143 39316 266856 42315020
Product dose omission issue 25.91 11.63 237 39222 154128 42427748
Device dislocation 25.80 11.63 34 39425 7797 42574079
Pituitary tumour 25.66 11.63 12 39447 576 42581300
Coronary artery dissection 25.61 11.63 10 39449 306 42581570
Mucosal inflammation 25.60 11.63 7 39452 49367 42532509
Portal vein cavernous transformation 25.16 11.63 5 39454 8 42581868
Thyroxine decreased 25.14 11.63 9 39450 215 42581661
Neutrophil count decreased 24.67 11.63 14 39445 63401 42518475
Completed suicide 24.51 11.63 32 39427 96433 42485443
Needle issue 24.40 11.63 35 39424 8692 42573184
Breast tenderness 24.35 11.63 13 39446 830 42581046
Product administration error 24.32 11.63 53 39406 18290 42563586
Mood swings 24.10 11.63 35 39424 8791 42573085
Cervix carcinoma stage IV 23.94 11.63 4 39455 0 42581876
Endometrial cancer 23.94 11.63 4 39455 0 42581876
Prostate cancer 23.79 11.63 93 39366 44550 42537326
Fatigue 23.58 11.63 548 38911 435093 42146783
Thrombosis 23.28 11.63 125 39334 68386 42513490
Melaena 23.11 11.63 4 39455 38742 42543134
Cholelithiasis 22.89 11.63 60 39399 23286 42558590
Oxygen saturation decreased 22.79 11.63 16 39443 64671 42517205
Blood thyroid stimulating hormone decreased 22.40 11.63 18 39441 2305 42579571
Hyperhidrosis 22.37 11.63 152 39307 90360 42491516
Expired product administered 21.95 11.63 23 39436 4140 42577736
Aortic aneurysm 21.63 11.63 31 39428 7692 42574184
Hormone level abnormal 21.58 11.63 10 39449 470 42581406
Decreased appetite 21.36 11.63 99 39360 193038 42388838
Coronary artery occlusion 20.94 11.63 37 39422 10960 42570916
Gastrointestinal bacterial infection 20.93 11.63 11 39448 680 42581196
Foreign body reaction 20.75 11.63 6 39453 70 42581806
Glucose tolerance decreased 20.59 11.63 6 39453 72 42581804
Pre-existing condition improved 20.52 11.63 19 39440 2944 42578932
Hepatic angiosarcoma 20.30 11.63 6 39453 76 42581800
Osteopenia 20.29 11.63 27 39432 6251 42575625
Secondary hypertension 19.97 11.63 7 39452 157 42581719
Loss of libido 19.94 11.63 19 39440 3051 42578825
Neoplasm recurrence 19.90 11.63 18 39441 2706 42579170
Inflammatory pain 19.86 11.63 10 39449 565 42581311
Postprandial hypoglycaemia 19.81 11.63 6 39453 83 42581793
Pyomyositis 19.67 11.63 8 39451 273 42581603
Hyperprolactinaemia 19.52 11.63 16 39443 2107 42579769
Chorioretinopathy 19.48 11.63 14 39445 1517 42580359
Simple partial seizures 19.27 11.63 9 39450 431 42581445
May-Thurner syndrome 19.24 11.63 4 39455 9 42581867
Skin irritation 19.19 11.63 29 39430 7545 42574331
Brugada syndrome 19.10 11.63 12 39447 1041 42580835
Hypothalamic pituitary adrenal axis suppression 19.09 11.63 8 39451 295 42581581
Application site paraesthesia 18.94 11.63 4 39455 10 42581866
Embolism venous 18.87 11.63 15 39444 1891 42579985
Oligospermia 18.67 11.63 6 39453 102 42581774
Device extrusion 18.67 11.63 4 39455 11 42581865
Renal cell carcinoma 18.25 11.63 24 39435 5493 42576383
Implant site mass 18.17 11.63 4 39455 13 42581863
Respiratory distress 18.11 11.63 8 39451 41812 42540064
Infrequent bowel movements 18.02 11.63 12 39447 1150 42580726
Hypokalaemia 18.00 11.63 24 39435 71697 42510179
Penis disorder 18.00 11.63 13 39446 1420 42580456
White blood cell count decreased 17.97 11.63 48 39411 110348 42471528
Blood gonadotrophin decreased 17.96 11.63 3 39456 0 42581876
Borderline ovarian tumour 17.96 11.63 3 39456 0 42581876
Hyperandrogenism 17.96 11.63 3 39456 0 42581876
Endometrial hyperplasia 17.96 11.63 3 39456 0 42581876
Growth accelerated 17.94 11.63 4 39455 14 42581862
Drug-disease interaction 17.93 11.63 11 39448 915 42580961
Confusional state 17.89 11.63 87 39372 167510 42414366
High density lipoprotein decreased 17.86 11.63 20 39439 3877 42577999
Injection site mass 17.83 11.63 30 39429 8545 42573331
Food craving 17.66 11.63 9 39450 522 42581354
Accidental exposure to product 17.59 11.63 50 39409 20343 42561533
Asthma exercise induced 17.58 11.63 6 39453 124 42581752
Application site burn 17.57 11.63 7 39452 226 42581650
Pulmonary oil microembolism 17.47 11.63 5 39454 56 42581820
Unmasking of previously unidentified disease 17.41 11.63 12 39447 1217 42580659
Myalgia 17.38 11.63 150 39309 95930 42485946
Congestive cardiomyopathy 17.35 11.63 30 39429 8734 42573142
Androgen deficiency 17.35 11.63 7 39452 234 42581642
Cardiac ventricular thrombosis 17.32 11.63 14 39445 1808 42580068
Arthralgia 17.14 11.63 276 39183 204962 42376914
Breath odour 17.12 11.63 11 39448 992 42580884
Circumstance or information capable of leading to medication error 17.10 11.63 16 39443 2512 42579364
Adrenocortical insufficiency acute 16.90 11.63 15 39444 2200 42579676
Shunt occlusion 16.88 11.63 11 39448 1016 42580860
Product complaint 16.75 11.63 24 39435 5953 42575923
Cerebral venous thrombosis 16.75 11.63 11 39448 1030 42580846
Testicular failure 16.66 11.63 5 39454 67 42581809
Insulin resistance 16.62 11.63 10 39449 803 42581073
Autoimmune pancreatitis 16.60 11.63 8 39451 411 42581465
Pneumonitis 16.52 11.63 9 39450 41709 42540167
Cardio-respiratory arrest 16.43 11.63 18 39441 58618 42523258
Renal failure 16.28 11.63 73 39386 143653 42438223
Lactic acidosis 16.20 11.63 11 39448 45250 42536626
Thrombocytosis 16.15 11.63 21 39438 4754 42577122
Prostatomegaly 16.15 11.63 24 39435 6153 42575723
Irritability 16.14 11.63 60 39399 28068 42553808
Sperm concentration zero 15.88 11.63 3 39456 3 42581873
Implant site necrosis 15.88 11.63 3 39456 3 42581873
Injection site haemorrhage 15.66 11.63 34 39425 11702 42570174
Nephropathy 15.47 11.63 25 39434 6886 42574990
Product substitution issue 15.40 11.63 33 39426 11257 42570619
Diarrhoea 15.34 11.63 318 39141 460531 42121345
Implant site discharge 15.30 11.63 4 39455 31 42581845
Application site inflammation 15.04 11.63 5 39454 95 42581781
Hair texture abnormal 14.95 11.63 7 39452 337 42581539
Bradycardia 14.81 11.63 36 39423 85448 42496428
Implant site cellulitis 14.77 11.63 4 39455 36 42581840
Cerebral venous sinus thrombosis 14.74 11.63 9 39450 742 42581134
Eosinophilia 14.72 11.63 6 39453 32893 42548983
Treatment failure 14.68 11.63 22 39437 62602 42519274
Implant site rash 14.67 11.63 3 39456 6 42581870
Dermal absorption impaired 14.67 11.63 3 39456 6 42581870
Astrocytoma 14.50 11.63 6 39453 214 42581662
Acne conglobata 14.48 11.63 4 39455 39 42581837
Coma 14.40 11.63 17 39442 53537 42528339
Hepatic function abnormal 14.26 11.63 16 39443 51551 42530325
Electrocardiogram QT prolonged 14.25 11.63 14 39445 47931 42533945
Epistaxis 14.23 11.63 25 39434 66801 42515075
Anxiety 14.18 11.63 170 39289 118390 42463486
Amnesia 14.15 11.63 58 39401 28379 42553497
Drug withdrawal syndrome 14.10 11.63 48 39411 21501 42560375
Gastrointestinal haemorrhage 14.07 11.63 45 39414 97681 42484195
Factor V Leiden mutation 14.05 11.63 6 39453 232 42581644
Gender dysphoria 13.96 11.63 4 39455 45 42581831
Small airways disease 13.96 11.63 4 39455 45 42581831
Product solubility abnormal 13.85 11.63 8 39451 596 42581280
Blood glucose increased 13.82 11.63 116 39343 73583 42508293
Product residue present 13.75 11.63 15 39444 2826 42579050
Product adhesion issue 13.72 11.63 12 39447 1727 42580149
Application site dermatitis 13.58 11.63 4 39455 50 42581826
Hepatic cytolysis 13.55 11.63 4 39455 26840 42555036
Lower respiratory tract infection 13.48 11.63 11 39448 41195 42540681
Toxic epidermal necrolysis 13.48 11.63 4 39455 26746 42555130
Ophthalmic vein thrombosis 13.37 11.63 4 39455 53 42581823
Renal-limited thrombotic microangiopathy 13.24 11.63 6 39453 268 42581608
Hypoxia 13.21 11.63 28 39431 69758 42512118
Insomnia 13.04 11.63 167 39292 118086 42463790
Eye colour change 13.03 11.63 6 39453 278 42581598
Ventricular hypertrophy 13.00 11.63 19 39440 4797 42577079
Blood lactate dehydrogenase increased 12.96 11.63 4 39455 26077 42555799
Gamma-glutamyltransferase increased 12.89 11.63 7 39452 32490 42549386
Empty sella syndrome 12.85 11.63 4 39455 61 42581815
Skin odour abnormal 12.80 11.63 10 39449 1229 42580647
Autoimmune thyroiditis 12.65 11.63 11 39448 1571 42580305
Hypoaesthesia 12.62 11.63 111 39348 71352 42510524
Hypervolaemia 12.52 11.63 3 39456 23122 42558754
Atrial fibrillation 12.51 11.63 190 39269 139403 42442473
Strabismus 12.43 11.63 13 39446 2335 42579541
Hepatocellular carcinoma 12.40 11.63 25 39434 8169 42573707
Retinal vein occlusion 12.38 11.63 12 39447 1969 42579907
Carpal tunnel syndrome 12.35 11.63 20 39439 5519 42576357
Haemoglobin decreased 12.33 11.63 72 39387 132399 42449477
Blindness transient 12.25 11.63 14 39445 2775 42579101
Aspartate aminotransferase increased 12.21 11.63 34 39425 77129 42504747
Injection site abscess 12.14 11.63 9 39450 1023 42580853
Adrenal haemorrhage 12.14 11.63 6 39453 326 42581550
Intentional overdose 12.13 11.63 18 39441 51438 42530438
Muscle necrosis 12.04 11.63 9 39450 1036 42580840
Suicidal ideation 11.96 11.63 81 39378 48080 42533796
Bone marrow failure 11.90 11.63 8 39451 33085 42548791
Pneumonia haemophilus 11.90 11.63 9 39450 1055 42580821
Invasive ductal breast carcinoma 11.89 11.63 4 39455 79 42581797
Cortisol decreased 11.87 11.63 10 39449 1368 42580508
Aortic thrombosis 11.85 11.63 9 39450 1061 42580815
Infusion related reaction 11.85 11.63 24 39435 60782 42521094
Psychiatric symptom 11.84 11.63 17 39442 4224 42577652
Blood triglycerides increased 11.84 11.63 37 39422 15859 42566017
Tumour lysis syndrome 11.81 11.63 3 39456 22228 42559648
Dyspnoea 11.77 11.63 316 39143 442305 42139571
Nephroangiosclerosis 11.76 11.63 5 39454 191 42581685
Transient ischaemic attack 11.75 11.63 62 39397 33677 42548199
Nocturia 11.74 11.63 31 39428 12081 42569795
Hair follicle tumour benign 11.74 11.63 3 39456 21 42581855
Blood pressure increased 11.68 11.63 145 39314 101783 42480093
Right ventricular dysfunction 11.67 11.63 10 39449 1399 42580477
Penile contusion 11.67 11.63 5 39454 195 42581681
Thyroid mass 11.64 11.63 8 39451 807 42581069

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
Polycythaemia 882.29 11.65 205 34490 3070 110551534
Blood testosterone increased 702.27 11.65 146 34549 1256 110553348
Blood testosterone decreased 340.02 11.65 93 34602 2755 110551849
Idiopathic intracranial hypertension 305.58 11.65 92 34603 3860 110550744
Deep vein thrombosis 256.10 11.65 265 34430 139622 110414982
Expulsion of medication 241.26 11.65 38 34657 40 110554564
Drug abuse 230.36 11.65 281 34414 177130 110377474
Precocious puberty 213.87 11.65 44 34651 357 110554247
Pulmonary embolism 213.52 11.65 298 34397 214176 110340428
Virilism 165.93 11.65 24 34671 4 110554600
Secondary hypogonadism 160.11 11.65 40 34655 823 110553781
Acute myocardial infarction 144.79 11.65 154 34541 83623 110470981
Hepatic adenoma 135.15 11.65 31 34664 436 110554168
Focal segmental glomerulosclerosis 133.80 11.65 50 34645 4095 110550509
Insulin-like growth factor increased 133.58 11.65 43 34652 2253 110552351
Mesenteric vein thrombosis 122.80 11.65 39 34656 1956 110552648
Testicular atrophy 117.11 11.65 27 34668 389 110554215
Haematocrit increased 114.77 11.65 47 34648 4912 110549692
Enlarged clitoris 113.08 11.65 16 34679 0 110554604
Clear cell renal cell carcinoma 106.64 11.65 38 34657 2718 110551886
Erectile dysfunction 102.57 11.65 67 34628 18489 110536115
Cardiomyopathy 99.05 11.65 83 34612 33442 110521162
Renal infarct 98.92 11.65 38 34657 3357 110551247
Application site rash 88.11 11.65 32 34663 2418 110552186
Blood testosterone abnormal 84.96 11.65 20 34675 317 110554287
Myocardial infarction 84.12 11.65 186 34509 191897 110362707
Coronary artery disease 84.05 11.65 108 34587 71582 110483022
Left ventricular hypertrophy 83.59 11.65 52 34643 13192 110541412
Toxic cardiomyopathy 81.48 11.65 23 34672 766 110553838
Portal vein thrombosis 80.90 11.65 41 34654 7017 110547587
Accidental exposure to product by child 79.82 11.65 32 34663 3166 110551438
Blood growth hormone increased 78.86 11.65 24 34671 1044 110553560
Cervix carcinoma stage IV 78.83 11.65 15 34680 77 110554527
Osteonecrosis 78.60 11.65 73 34622 33668 110520936
Product administered at inappropriate site 75.78 11.65 36 34659 5357 110549247
Endometrial adenocarcinoma 74.90 11.65 24 34671 1239 110553365
Craniopharyngioma 72.58 11.65 18 34677 359 110554245
Gynaecomastia 72.16 11.65 42 34653 9448 110545156
Application site pain 72.09 11.65 35 34660 5464 110549140
Lymphoproliferative disorder 71.45 11.65 38 34657 7180 110547424
Prostatic specific antigen increased 71.17 11.65 46 34649 12465 110542139
Intentional product misuse 67.80 11.65 137 34558 132767 110421837
General physical health deterioration 66.73 11.65 25 34670 425270 110129334
Product deposit 65.84 11.65 19 34676 686 110553918
Renal artery thrombosis 65.67 11.65 18 34677 537 110554067
Retinal neovascularisation 63.59 11.65 15 34680 240 110554364
Oestradiol increased 63.57 11.65 13 34682 102 110554502
Infertility male 63.46 11.65 13 34682 103 110554501
Muscle mass 63.40 11.65 17 34678 466 110554138
Acne fulminans 61.78 11.65 15 34680 273 110554331
Accidental exposure to product 61.24 11.65 77 34618 49931 110504673
Hypogonadism 60.54 11.65 23 34672 1971 110552633
Neutropenia 60.50 11.65 21 34674 374599 110180005
Infusion related reaction 60.47 11.65 22 34673 381140 110173464
Hair growth abnormal 60.30 11.65 27 34668 3510 110551094
Growth hormone-producing pituitary tumour 59.70 11.65 13 34682 142 110554462
Blood testosterone free increased 58.43 11.65 9 34686 7 110554597
Performance enhancing product use 58.28 11.65 13 34682 160 110554444
Brugada syndrome 58.07 11.65 21 34674 1567 110553037
Libido decreased 58.06 11.65 31 34664 5904 110548700
Haemoglobin increased 57.94 11.65 36 34659 9111 110545493
Cerebrovascular accident 57.41 11.65 155 34540 181129 110373475
Papilloedema 56.89 11.65 33 34662 7376 110547228
Stomatitis 55.68 11.65 9 34686 270233 110284371
Febrile neutropenia 54.26 11.65 16 34679 316751 110237853
Contraindicated product administered 54.10 11.65 7 34688 248260 110306344
Pituitary tumour benign 52.62 11.65 23 34672 2824 110551780
Andropause 51.96 11.65 11 34684 104 110554500
Anger 51.93 11.65 45 34650 18962 110535642
Pituitary tumour recurrent 51.85 11.65 12 34683 176 110554428
Rheumatoid arthritis 51.56 11.65 15 34680 299598 110255006
Application site erythema 51.24 11.65 28 34667 5582 110549022
Self-medication 51.17 11.65 29 34666 6203 110548401
Product odour abnormal 50.74 11.65 19 34676 1564 110553040
Blood follicle stimulating hormone decreased 50.53 11.65 12 34683 198 110554406
Optic ischaemic neuropathy 50.20 11.65 25 34670 4122 110550482
Unmasking of previously unidentified disease 49.23 11.65 22 34673 2846 110551758
Implant site infection 48.90 11.65 20 34675 2083 110552521
Polycythaemia vera 48.36 11.65 14 34681 511 110554093
Pericarditis 48.17 11.65 6 34689 219108 110335496
Breathing-related sleep disorder 47.75 11.65 12 34683 253 110554351
Coronary artery dissection 47.50 11.65 17 34678 1231 110553373
Application site pruritus 47.20 11.65 24 34671 4136 110550468
Ovarian endometrioid carcinoma 46.98 11.65 7 34688 3 110554601
Cardiac death 45.92 11.65 18 34677 1678 110552926
Glossodynia 44.39 11.65 8 34687 221996 110332608
Lower respiratory tract infection 44.03 11.65 11 34684 243095 110311509
Chorioretinopathy 43.91 11.65 19 34676 2276 110552328
Prescription drug used without a prescription 43.58 11.65 25 34670 5471 110549133
Myocardial fibrosis 43.09 11.65 18 34677 1977 110552627
Atrial fibrillation 43.07 11.65 164 34531 229478 110325126
Steatocystoma multiplex 42.40 11.65 6 34689 0 110554604
Blood luteinising hormone decreased 42.28 11.65 10 34685 162 110554442
Suicidal ideation 42.26 11.65 92 34603 93845 110460759
Phaeochromocytoma 41.80 11.65 14 34681 831 110553773
Toxicity to various agents 41.46 11.65 54 34641 480501 110074103
Prostate cancer 41.45 11.65 55 34640 37586 110517018
Gastric hypomotility 41.29 11.65 11 34684 294 110554310
Exposure during pregnancy 40.97 11.65 3 34692 167421 110387183
Thrombosis 40.70 11.65 99 34596 108563 110446041
Red blood cell count increased 40.69 11.65 23 34672 4895 110549709
Device malfunction 40.66 11.65 45 34650 25513 110529091
Gender dysphoria 39.56 11.65 8 34687 59 110554545
Shunt malfunction 39.18 11.65 11 34684 359 110554245
Coronary artery occlusion 38.43 11.65 35 34660 15737 110538867
Ovarian granulosa cell tumour 38.42 11.65 7 34688 27 110554577
Ophthalmic vein thrombosis 38.13 11.65 10 34685 251 110554353
Treatment failure 37.64 11.65 20 34675 277214 110277390
Metaplasia 37.53 11.65 12 34683 615 110553989
Hypercoagulation 37.18 11.65 19 34676 3307 110551297
Acne 36.94 11.65 49 34646 33471 110521133
Hyperandrogenism 36.91 11.65 6 34689 9 110554595
Needle track marks 36.77 11.65 8 34687 87 110554517
Needle issue 36.62 11.65 36 34659 17804 110536800
Borderline serous tumour of ovary 36.52 11.65 6 34689 10 110554594
Endometrial cancer 36.24 11.65 17 34678 2459 110552145
Device delivery system issue 35.46 11.65 16 34679 2117 110552487
Mesonephric duct cyst 35.34 11.65 5 34690 0 110554604
Cardiac ventricular thrombosis 35.25 11.65 18 34677 3129 110551475
Implant site haemorrhage 34.95 11.65 9 34686 210 110554394
Feeling abnormal 34.65 11.65 130 34565 180581 110374023
Viral diarrhoea 34.05 11.65 11 34684 583 110554021
Poor quality product administered 33.86 11.65 20 34675 4621 110549983
C-reactive protein increased 33.83 11.65 13 34682 217906 110336698
Drug intolerance 33.71 11.65 47 34648 406465 110148139
Adnexal torsion 33.06 11.65 10 34685 426 110554178
Spinal cord abscess 32.92 11.65 11 34684 648 110553956
Irritability 32.80 11.65 56 34639 47753 110506851
Growth accelerated 32.76 11.65 6 34689 24 110554580
Hepatocellular carcinoma 32.40 11.65 26 34669 9854 110544750
Endometrial hyperplasia 32.24 11.65 11 34684 691 110553913
Palmoplantar pustulosis 32.21 11.65 12 34683 974 110553630
Hyperhidrosis 32.06 11.65 130 34565 187168 110367436
Implant site pain 31.78 11.65 15 34680 2200 110552404
Renal cell carcinoma 31.71 11.65 23 34672 7507 110547097
Penis disorder 31.70 11.65 12 34683 1018 110553586
Breast hyperplasia 31.38 11.65 8 34687 179 110554425
Oligospermia 31.34 11.65 6 34689 32 110554572
Sleep apnoea syndrome 31.27 11.65 50 34645 40397 110514207
Wheezing 31.02 11.65 21 34674 255209 110299395
Hypogonadism male 30.35 11.65 8 34687 205 110554399
Aortic aneurysm 30.24 11.65 25 34670 9879 110544725
Congestive cardiomyopathy 29.76 11.65 29 34666 14190 110540414
Insulin-like growth factor decreased 29.71 11.65 10 34685 603 110554001
Infection parasitic 29.64 11.65 11 34684 883 110553721
Loss of libido 29.62 11.65 16 34679 3117 110551487
Neoplasm recurrence 29.17 11.65 19 34676 5213 110549391
Cerebrospinal fluid leakage 29.15 11.65 14 34681 2134 110552470
Azoospermia 28.83 11.65 8 34687 250 110554354
Muscle hypertrophy 28.75 11.65 7 34688 129 110554475
Incorrect dose administered 28.28 11.65 84 34611 103557 110451047
Helicobacter infection 27.98 11.65 11 34684 181866 110372738
Hormone level abnormal 27.79 11.65 14 34681 2366 110552238
High density lipoprotein decreased 27.59 11.65 19 34676 5714 110548890
Infertility 27.32 11.65 10 34685 772 110553832
Invasive ductal breast carcinoma 27.31 11.65 20 34675 6626 110547978
Glucose tolerance decreased 26.81 11.65 6 34689 75 110554529
Product container issue 26.74 11.65 12 34683 1568 110553036
Wound 26.27 11.65 21 34674 234416 110320188
Blister 25.94 11.65 20 34675 227356 110327248
Nasopharyngitis 25.86 11.65 53 34642 394308 110160296
Pancytopenia 25.80 11.65 17 34678 209596 110345008
Blood oestrogen increased 25.73 11.65 7 34688 203 110554401
Mobility decreased 25.70 11.65 22 34673 237400 110317204
Fibromyalgia 25.22 11.65 11 34684 170898 110383706
Liver injury 25.01 11.65 8 34687 150405 110404199
Gastrointestinal bacterial infection 24.73 11.65 11 34684 1407 110553197
Hepatic angiosarcoma 24.67 11.65 6 34689 110 110554494
Myalgia 24.61 11.65 136 34559 222245 110332359
Apocrine breast carcinoma 24.61 11.65 4 34691 6 110554598
Stubbornness 24.60 11.65 8 34687 433 110554171
Pyrexia 24.57 11.65 173 34522 898092 109656512
Prostatic disorder 24.25 11.65 13 34682 2496 110552108
Hyponatraemic seizure 24.16 11.65 9 34686 730 110553874
Blood testosterone free decreased 24.15 11.65 5 34690 42 110554562
Off label use 24.14 11.65 628 34067 1499557 109055047
Injection site pain 23.99 11.65 115 34580 177807 110376797
Atherosclerotic plaque rupture 23.84 11.65 5 34690 45 110554559
Application site vesicles 23.70 11.65 11 34684 1553 110553051
Nephropathy 23.68 11.65 25 34670 13442 110541162
Vocal cord atrophy 23.56 11.65 4 34691 9 110554595
Pulmonary oil microembolism 23.45 11.65 5 34690 49 110554555
Ill-defined disorder 23.30 11.65 10 34685 156843 110397761
Bursitis 23.28 11.65 6 34689 129912 110424692
Acromegaly 23.06 11.65 6 34689 146 110554458
Dissociative identity disorder 22.61 11.65 5 34690 59 110554545
Shunt occlusion 22.60 11.65 11 34684 1726 110552878
Musculoskeletal stiffness 22.54 11.65 33 34662 279789 110274815
Hirsutism 22.45 11.65 11 34684 1752 110552852
Postprandial hypoglycaemia 22.39 11.65 6 34689 164 110554440
Product quality issue 22.38 11.65 64 34631 77235 110477369
Product administration error 22.19 11.65 41 34654 37176 110517428
Adrenocortical insufficiency acute 22.05 11.65 15 34680 4425 110550179
Therapeutic response unexpected 22 11.65 32 34663 23811 110530793
Confusional state 21.62 11.65 75 34620 468605 110085999
Impaired healing 21.56 11.65 18 34677 196699 110357905
Drug withdrawal syndrome 21.54 11.65 41 34654 38013 110516591
Drug-disease interaction 21.47 11.65 11 34684 1925 110552679
Simple partial seizures 21.22 11.65 9 34686 1027 110553577
Transgender hormonal therapy 21.20 11.65 3 34692 0 110554604
Graft overgrowth 21.20 11.65 3 34692 0 110554604
Hyperoestrogenism 21.20 11.65 3 34692 0 110554604
Blood gonadotrophin decreased 21.20 11.65 3 34692 0 110554604
Product complaint 21.19 11.65 24 34671 13948 110540656
Hypothalamic pituitary adrenal axis suppression 21.19 11.65 8 34687 674 110553930
Breath odour 21.17 11.65 11 34684 1981 110552623
Decreased appetite 20.73 11.65 78 34617 475768 110078836
Inflammatory pain 20.71 11.65 10 34685 1543 110553061
Product dose omission issue 20.68 11.65 172 34523 321610 110232994
Blood triglycerides increased 20.48 11.65 31 34664 23895 110530709
Septic shock 20.46 11.65 12 34683 157516 110397088
Embolism venous 20.38 11.65 15 34680 5008 110549596
Pyomyositis 20.34 11.65 8 34687 752 110553852
Wound infection 20.34 11.65 3 34692 96462 110458142
Thrombocytopenia 20.33 11.65 50 34645 348835 110205769
Wrong technique in product usage process 20.33 11.65 67 34628 87281 110467323
Arthropathy 20.27 11.65 37 34658 287485 110267119
Infrequent bowel movements 20.27 11.65 11 34684 2164 110552440
Porphyria 20.25 11.65 6 34689 238 110554366
Exposure via partner 20.09 11.65 4 34691 27 110554577
Product administration interrupted 19.92 11.65 21 34674 11271 110543333
Cerebral venous sinus thrombosis 19.88 11.65 12 34683 2883 110551721
Myelosuppression 19.74 11.65 3 34692 94337 110460267
Acne conglobata 19.72 11.65 4 34691 30 110554574
Large intestine polyp 19.66 11.65 24 34671 15093 110539511
Vaginal disorder 19.57 11.65 7 34688 506 110554098
Abdominal discomfort 19.56 11.65 61 34634 393797 110160807
Autoimmune pancreatitis 19.51 11.65 8 34687 838 110553766
Blood thyroid stimulating hormone decreased 19.49 11.65 17 34678 7222 110547382
Thrombocytosis 19.46 11.65 20 34675 10424 110544180
Anaemia 19.36 11.65 97 34598 546989 110007615
Intracranial pressure increased 19.31 11.65 20 34675 10515 110544089
Factor V Leiden mutation 19.23 11.65 6 34689 284 110554320
Uterine cervical metaplasia 19.12 11.65 3 34692 3 110554601
Oestrone increased 19.12 11.65 3 34692 3 110554601
Renal artery fibromuscular dysplasia 19.12 11.65 3 34692 3 110554601
Lung disorder 19.10 11.65 17 34678 180030 110374574
Device extrusion 18.97 11.65 4 34691 37 110554567
Application site exfoliation 18.85 11.65 7 34688 563 110554041
Portal vein cavernous transformation 18.79 11.65 5 34690 133 110554471
Breast cancer 18.77 11.65 39 34656 38503 110516101
Coronary artery thrombosis 18.63 11.65 12 34683 3232 110551372
Secondary hypertension 18.47 11.65 7 34688 596 110554008
Product physical consistency issue 18.38 11.65 9 34686 1431 110553173
Implant site bruising 18.30 11.65 6 34689 333 110554271
Food craving 18.30 11.65 10 34685 1993 110552611
Gait inability 18.26 11.65 10 34685 136366 110418238
Cortisol increased 18.13 11.65 7 34688 627 110553977
Abdominal pain upper 18.10 11.65 53 34642 349058 110205546
Aggression 18.10 11.65 50 34645 59160 110495444
Breast cancer male 18.10 11.65 6 34689 345 110554259
Plantar fasciitis 17.97 11.65 14 34681 5087 110549517
Strabismus 17.80 11.65 12 34683 3487 110551117
Myocarditis 17.78 11.65 33 34662 30022 110524582
Swelling 17.69 11.65 54 34641 350987 110203617
Interstitial lung disease 17.55 11.65 11 34684 139323 110415281
Aortic thrombosis 17.50 11.65 10 34685 2173 110552431
Nocturia 17.45 11.65 24 34671 16966 110537638
Intraductal proliferative breast lesion 17.31 11.65 11 34684 2894 110551710
Completed suicide 17.26 11.65 31 34664 242350 110312254
Gastrointestinal disorder 17.18 11.65 31 34664 241921 110312683
Injection site mass 17.10 11.65 29 34666 24584 110530020
Alopecia 17.07 11.65 58 34637 364695 110189909
Foreign body reaction 17.03 11.65 5 34690 192 110554412
Diabetes mellitus 17.01 11.65 69 34626 99312 110455292
Hyperprolactinaemia 16.83 11.65 15 34680 6560 110548044
Insulin resistance 16.80 11.65 9 34686 1725 110552879
Injection site haemorrhage 16.77 11.65 34 34661 32994 110521610
Left ventricular dysfunction 16.75 11.65 28 34667 23465 110531139
Hair follicle tumour benign 16.56 11.65 6 34689 450 110554154
Device dislocation 16.53 11.65 33 34662 31671 110522933
May-Thurner syndrome 16.51 11.65 4 34691 72 110554532
Testicular pain 16.51 11.65 10 34685 2419 110552185
Pituitary tumour 16.50 11.65 8 34687 1245 110553359
Application site inflammation 16.49 11.65 6 34689 456 110554148
Visual field defect 16.48 11.65 18 34677 10054 110544550
Adrenal haemorrhage 16.45 11.65 7 34688 805 110553799
Cerebral venous thrombosis 16.15 11.65 11 34684 3251 110551353
Asthma exercise induced 16.12 11.65 5 34690 232 110554372
Libido increased 16.10 11.65 10 34685 2529 110552075
Blindness transient 16.07 11.65 14 34681 5942 110548662
Cardiovascular disorder 16.06 11.65 27 34668 22733 110531871
Pseudoprecocious puberty 16.00 11.65 3 34692 14 110554590
Impulsive behaviour 15.99 11.65 11 34684 3304 110551300
Joint swelling 15.96 11.65 78 34617 442767 110111837
Ventricular hypertrophy 15.94 11.65 15 34680 7030 110547574
Primary hypogonadism 15.93 11.65 5 34690 241 110554363
Application site irritation 15.87 11.65 9 34686 1928 110552676
Breast tenderness 15.74 11.65 10 34685 2630 110551974
Hepatic enzyme increased 15.72 11.65 50 34645 320842 110233762
Application site paraesthesia 15.71 11.65 4 34691 89 110554515
Eye colour change 15.69 11.65 6 34689 523 110554081
Malignant neoplasm progression 15.67 11.65 19 34676 174548 110380056
Astrocytoma 15.66 11.65 5 34690 255 110554349
Thyroxine decreased 15.61 11.65 7 34688 913 110553691
Vomiting 15.58 11.65 197 34498 910478 109644126
Depression 15.52 11.65 160 34535 317175 110237429
Renal-limited thrombotic microangiopathy 15.49 11.65 6 34689 542 110554062
Inflammation 15.35 11.65 23 34672 193215 110361389
Brain neoplasm 15.32 11.65 14 34681 6323 110548281
Blood glucose increased 15.30 11.65 82 34613 132414 110422190
Intentional misuse of drug delivery system 15.23 11.65 3 34692 19 110554585
Drug hypersensitivity 15.22 11.65 82 34613 454008 110100596
Mania 15.11 11.65 25 34670 20771 110533833
Hyperlipidaemia 14.87 11.65 34 34661 35814 110518790
Stress 14.86 11.65 69 34626 105279 110449325
Peripheral venous disease 14.85 11.65 4 34691 84113 110470491
Joint range of motion decreased 14.83 11.65 10 34685 121822 110432782
Malignant melanoma 14.62 11.65 22 34673 16869 110537735
Bipolar disorder 14.57 11.65 16 34679 8991 110545613
Hyperglycaemic hyperosmolar nonketotic syndrome 14.55 11.65 10 34685 2999 110551605
Mucosal inflammation 14.48 11.65 6 34689 96135 110458469
Acute coronary syndrome 14.46 11.65 26 34669 23086 110531518
Liver disorder 14.41 11.65 14 34681 142229 110412375
Priapism 14.27 11.65 13 34682 5848 110548756
Drug dose omission by device 14.15 11.65 20 34675 14496 110540108
Anxiety 14.14 11.65 168 34527 344910 110209694
Retinal vein occlusion 14.12 11.65 11 34684 3996 110550608
Cervix disorder 14.09 11.65 5 34690 353 110554251
Hypersensitivity 14.07 11.65 72 34623 403926 110150678
Urticaria 14.05 11.65 52 34643 318805 110235799
Urine albumin/creatinine ratio 14.02 11.65 3 34692 30 110554574
Transient ischaemic attack 13.93 11.65 48 34647 63934 110490670
Pulmonary microemboli 13.93 11.65 3 34692 31 110554573
Product physical issue 13.91 11.65 12 34683 5024 110549580
Exaggerated startle response 13.84 11.65 3 34692 32 110554572
Expired product administered 13.84 11.65 15 34680 8305 110546299
Muscle necrosis 13.79 11.65 8 34687 1789 110552815
Brain injury 13.78 11.65 19 34676 13457 110541147
Empty sella syndrome 13.71 11.65 4 34691 150 110554454
Leukopenia 13.56 11.65 16 34679 148775 110405829
Mood swings 13.43 11.65 25 34670 22787 110531817
Wolff-Parkinson-White syndrome 13.36 11.65 5 34690 411 110554193
Red blood cell sedimentation rate increased 13.31 11.65 4 34691 78298 110476306
Vein collapse 13.27 11.65 7 34688 1300 110553304
Hypopituitarism 13.23 11.65 11 34684 4379 110550225
Left ventricular failure 13.09 11.65 17 34678 11372 110543232
Pneumonia haemophilus 13.07 11.65 9 34686 2706 110551898
Thalamic infarction 13.05 11.65 7 34688 1345 110553259
Ovarian necrosis 13.03 11.65 3 34692 43 110554561
Injection site abscess 12.97 11.65 8 34687 1998 110552606
Application site reaction 12.97 11.65 6 34689 841 110553763
Sudden cardiac death 12.75 11.65 12 34683 5625 110548979
Therapeutic product effect decreased 12.72 11.65 37 34658 244279 110310325
Growth hormone deficiency 12.70 11.65 5 34690 472 110554132
Panic attack 12.62 11.65 28 34667 28912 110525692
Blood pressure increased 12.50 11.65 130 34565 258243 110296361
Feeling of despair 12.47 11.65 10 34685 3788 110550816
Osteoarthritis 12.43 11.65 24 34671 182599 110372005
Ischaemic cerebral infarction 12.41 11.65 9 34686 2936 110551668
Renal embolism 12.38 11.65 4 34691 212 110554392
Skin irritation 12.38 11.65 20 34675 16299 110538305
Mental status changes 12.36 11.65 52 34643 76070 110478534
Implant site swelling 12.33 11.65 5 34690 509 110554095
Cardiac disorder 12.30 11.65 52 34643 76228 110478376
Orgasm abnormal 12.29 11.65 4 34691 217 110554387
Fracture of penis 12.22 11.65 4 34691 221 110554383
Neutrophil count decreased 12.14 11.65 12 34683 120929 110433675
Prescribed overdose 12.08 11.65 57 34638 87524 110467080
Product substitution issue 12.02 11.65 24 34671 23037 110531567
Death 12.01 11.65 151 34544 698718 109855886
Disease progression 11.96 11.65 38 34657 243996 110310608
Obsessive-compulsive disorder 11.95 11.65 13 34682 7228 110547376
Arterial thrombosis 11.95 11.65 9 34686 3110 110551494
Adverse event 11.87 11.65 10 34685 108799 110445805
Bone marrow oedema syndrome 11.86 11.65 3 34692 65 110554539
Application site urticaria 11.84 11.65 4 34691 244 110554360
Drug effect less than expected 11.84 11.65 13 34682 7307 110547297
Open angle glaucoma 11.80 11.65 5 34690 569 110554035
Ovarian cancer stage II 11.77 11.65 3 34692 67 110554537
Anorgasmia 11.77 11.65 7 34688 1639 110552965
Taste disorder 11.75 11.65 3 34692 65384 110489220
Borderline ovarian tumour 11.73 11.65 3 34692 68 110554536
Affective disorder 11.73 11.65 16 34679 11225 110543379
Implant site erythema 11.70 11.65 5 34690 581 110554023

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:35480 analgesic
CHEBI has role CHEBI:35554 cardiovascular drug
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35620 vasodilator agent
CHEBI has role CHEBI:35705 immunosuppressive agent
CHEBI has role CHEBI:50113 androgen
CHEBI has role CHEBI:50779 appetite enhancer
CHEBI has role CHEBI:50864 insulin-sensitizing drug
CHEBI has role CHEBI:74518 anti-obesity agent
CHEBI has role CHEBI:75771 mouse metabolite
CHEBI has role CHEBI:77746 human metabolite
CHEBI has role CHEBI:83056 <em>Daphnia magna</em> metabolite
CHEBI has role CHEBI:176497 geroprotector
CHEBI has role CHEBI:231911 renoprotective agent

Related Drugs by ATC class:

G03BA 3-oxoandrosten (4) derivatives 2 drugs
fluoxymesteronemethyltestosterone
G03EA Androgens and estrogens 2 drugs
methyltestosteroneprasterone

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
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 RX 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 RX 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 RX 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 RX 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 RX 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 RX 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
5.5MG/0.122GM ACTUATION NATESTO ACERUS N205488 May 28, 2014 RX GEL, METERED NASAL 11744838 March 17, 2034 TREATING HYPOGONADOTROPIC HYPOGONADISM BY ADMINISTERING TO A MALE WITH ALLERGIC OR SEASONAL RHINITIS 5.5MG TESTOSTERONE IN 0.122G TESTOSTERONE GEL IN EACH NOSTRIL 3 TIMES DAILY VIA A METERED DOSE PUMP ACTUATABLE 60 TIMES AND CONTAINING 11 G GEL
5.5MG/0.122GM ACTUATION NATESTO ACERUS N205488 May 28, 2014 RX GEL, METERED NASAL 11744838 March 17, 2034 TREATING PRIMARY HYPOGONADISM BY ADMINISTERING TO A MALE WITH ALLERGIC OR SEASONAL RHINITIS 5.5MG TESTOSTERONE IN 0.122G TESTOSTERONE GEL IN EACH NOSTRIL 3 TIMES DAILY VIA A METERED DOSE PUMP ACTUATABLE 60 TIMES AND CONTAINING 11 G GEL

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
Sigma non-opioid intracellular receptor 1 Membrane receptor Ki 5.92 CHEMBL
Glucocorticoid receptor Nuclear hormone receptor Ki 5.84 DRUG MATRIX
Aromatase Enzyme Ki 6.22 CHEMBL
Sex hormone-binding globulin Secreted Kd 9.20 CHEMBL
Lanosterol 14-alpha demethylase Enzyme IC50 4.30 CHEMBL
Corticosteroid-binding globulin Secreted Ki 6.72 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
Androgen receptor Transcription factor IC50 7.96 CHEMBL
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
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
3XMK78S47O INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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 34 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 33 sections
Testosterone HUMAN PRESCRIPTION DRUG LABEL 1 0591-2924 GEL 16.20 mg TRANSDERMAL ANDA 33 sections
Testosterone HUMAN PRESCRIPTION DRUG LABEL 1 0591-2925 GEL 16.20 mg TRANSDERMAL ANDA 33 sections
Testosterone HUMAN PRESCRIPTION DRUG LABEL 1 0591-2926 GEL 16.20 mg TRANSDERMAL ANDA 33 sections
Testosterone HUMAN PRESCRIPTION DRUG LABEL 1 0591-3216 GEL 10 mg TOPICAL ANDA 33 sections
Testosterone HUMAN PRESCRIPTION DRUG LABEL 1 0591-3217 GEL 10 mg TOPICAL ANDA 33 sections
Testosterone HUMAN PRESCRIPTION DRUG LABEL 1 0591-3524 GEL 50 mg TRANSDERMAL ANDA 30 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 16714-968 GEL 20.25 mg TOPICAL ANDA 34 sections
testosterone HUMAN PRESCRIPTION DRUG LABEL 1 16714-969 GEL 40.50 mg TOPICAL ANDA 34 sections
AndroGel HUMAN PRESCRIPTION DRUG LABEL 1 17139-501 GEL 10 mg TRANSDERMAL NDA 38 sections
AndroGel HUMAN PRESCRIPTION DRUG LABEL 1 17139-525 GEL 10 mg TRANSDERMAL NDA 38 sections
AndroGel HUMAN PRESCRIPTION DRUG LABEL 1 17139-550 GEL 10 mg TRANSDERMAL NDA 38 sections
AndroGel HUMAN PRESCRIPTION DRUG LABEL 1 17139-562 GEL 16.20 mg TRANSDERMAL NDA 38 sections
AndroGel HUMAN PRESCRIPTION DRUG LABEL 1 17139-562 GEL 16.20 mg TRANSDERMAL NDA 38 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 Gel, 1% Human Prescription Drug Label 1 21922-019 GEL 10 mg TRANSDERMAL ANDA 34 sections
TESTOSTERONE Human Prescription Drug Label 1 21922-030 GEL 16.20 mg TRANSDERMAL ANDA 33 sections
TESTOSTERONE Human Prescription Drug Label 1 21922-030 GEL 16.20 mg TRANSDERMAL ANDA 33 sections
Testosterone HUMAN PRESCRIPTION DRUG LABEL 1 21922-109 SOLUTION 30 mg TOPICAL ANDA 33 sections
Testosterone HUMAN PRESCRIPTION DRUG LABEL 1 24979-078 GEL 16.20 mg TRANSDERMAL ANDA 29 sections
Natestonasal gel HUMAN PRESCRIPTION DRUG LABEL 1 42667-5511 GEL, METERED 5.50 mg NASAL NDA 37 sections
Testosterone HUMAN PRESCRIPTION DRUG LABEL 1 43598-304 GEL, METERED 1.62 mg TRANSDERMAL ANDA 31 sections