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

Stem definitionDrug idCAS RN
androgens/anabolic steroids 4454 58-20-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • testosterone cypionate
  • testosterone cyclopentylpropionate
cypionate ester of the androgenic hormone testosterone
  • Molecular weight: 412.61
  • Formula: C27H40O3
  • CLOGP: 6.97
  • LIPINSKI: 1
  • HAC: 3
  • HDO: 0
  • TPSA: 43.37
  • ALOGS: -5.98
  • ROTB: 5
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

PropertyValueReference
BA (Bioavailability) 4 %

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 4.726 Moderate 0.75
caco2-efflux Caco-2 efflux ratio (BA/AB) 0.760 Moderate 0.75
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 22.284 10^-6 cm/s Moderate 0.75
dh-clint Dog hepatocyte intrinsic clearance 132.130 uL/min/10^6 cells Moderate 0.75
dppb Dog plasma protein binding (% unbound) 0.240 % Moderate 0.75
fcs-ppb Fetal calf serum protein binding (% unbound) 0.350 % Moderate 0.75
herg hERG pIC50 4.992 pIC50 Moderate 0.75
hh-clint Human hepatocyte intrinsic clearance 149.624 uL/min/10^6 cells Moderate 0.75
hlm-clint Human liver microsomal intrinsic clearance 128.825 uL/min/mg protein Moderate 0.75
hppb Human plasma protein binding (% unbound) 0.300 % Moderate 0.75
kinase-safety-class ACVR2B,AXL,BRAF,CAMK2D,CDK5,CDK9,EIF2AK3,EPHB4,ERBB2,GRK2,ITK,MAPK10,MAPK7,MAPKAPK2,NTRK2,PDK1,PDK2,PDK4,PRKDC,TEK,TGFBR1 21
kinase-selectivity-class EIF2AK3,GRK2 2
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 0.077 Moderate 0.75
mh-clint Mouse hepatocyte intrinsic clearance 317.687 Moderate 0.75
mppb Mouse plasma protein binding (% unbound) 0.420 Moderate 0.75
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 0.143 Moderate 0.75
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 0.890 % Moderate 0.75
rh-clint Rat hepatocyte intrinsic clearance 274.157 uL/min/10^6 cells Moderate 0.75
rh-fuinc Rat hepatocyte fraction unbound in incubation 2.850 % Moderate 0.75
rppb Rat plasma protein binding (% unbound) 0.340 % Moderate 0.75
solubility-dd Solubility at pH 7.4 in DMSO 1.346 uM Moderate 0.75

Approvals:

DateAgencyCompanyOrphan
June 23, 1978 FDA WATSON LABS

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
Metaplasia 299.61 39.29 36 542 485 90627384
Prostatic disorder 213.69 39.29 21 557 26 90627843
Product use issue 72.26 39.29 37 541 329882 90297987
Idiopathic intracranial hypertension 63.32 39.29 12 566 3569 90624300
Multiple use of single-use product 44.34 39.29 8 570 1815 90626054
Vaginal disorder 44.20 39.29 7 571 729 90627140
Vaginal lesion 39.54 39.29 6 572 472 90627397

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
Product deposit 675.09 18.86 107 6719 344 42614165
Poor quality product administered 592.79 18.86 123 6703 2185 42612324
Liquid product physical issue 428.22 18.86 79 6747 730 42613779
Injection site pain 172.27 18.86 110 6716 57688 42556821
Multiple use of single-use product 158.75 18.86 31 6795 396 42614113
Product dose omission issue 155.52 18.86 155 6671 154210 42460299
Product quality issue 131.77 18.86 62 6764 17820 42596689
Blood testosterone increased 109.05 18.86 29 6797 1538 42612971
Polycythaemia 108.39 18.86 33 6793 2853 42611656
Product gel formation 85.14 18.86 11 6815 0 42614509
Blood testosterone decreased 83.81 18.86 31 6795 4871 42609638
Injection site swelling 67.69 18.86 39 6787 16934 42597575
Haematocrit increased 54.27 18.86 19 6807 2548 42611961
Blood testosterone abnormal 41.83 18.86 11 6815 558 42613951
Product packaging quantity issue 40.45 18.86 13 6813 1340 42613169
Recalled product administered 39.19 18.86 11 6815 714 42613795
Incorrect product administration duration 39.05 18.86 19 6807 5861 42608648
Product colour issue 35.98 18.86 10 6816 626 42613883
Product contamination physical 33.97 18.86 7 6819 119 42614390
Product administered at inappropriate site 33.27 18.86 14 6812 3084 42611425
Suspected product tampering 32.89 18.86 5 6821 11 42614498
Pre-existing condition improved 30.52 18.86 13 6813 2950 42611559
Injection site infection 30.34 18.86 10 6816 1116 42613393
Injection site mass 29.71 18.86 18 6808 8557 42605952
Injection site erythema 29.40 18.86 25 6801 20170 42594339
Product storage error 27.75 18.86 19 6807 11121 42603388
Cardiac valve fibroelastoma 27.40 18.86 5 6821 43 42614466
Product closure issue 27.30 18.86 4 6822 6 42614503
Haemoglobin increased 26.34 18.86 14 6812 5192 42609317
Toxicity to various agents 26.27 18.86 3 6823 229133 42385376
Oestradiol increased 25.73 18.86 5 6821 62 42614447
Secondary hypogonadism 25.35 18.86 8 6818 778 42613731
Product administration interrupted 24.13 18.86 13 6813 4953 42609556
Intentional dose omission 23.99 18.86 16 6810 8970 42605539
Expired product administered 20.51 18.86 11 6815 4152 42610357
Feeling abnormal 19.73 18.86 38 6788 69748 42544761
Fatigue 19.70 18.86 128 6698 435513 42178996
Product contamination 19.64 18.86 7 6819 988 42613521
Glucose tolerance decreased 19.09 18.86 4 6822 74 42614435

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
Metaplasia 300.16 18.79 47 5116 580 110583556
Product deposit 251.42 18.79 41 5122 664 110583472
Idiopathic intracranial hypertension 186.32 18.79 42 5121 3910 110580226
Poor quality product administered 184.89 18.79 43 5120 4598 110579538
Prostatic disorder 142.14 18.79 31 5132 2478 110581658
Liquid product physical issue 138.09 18.79 28 5135 1572 110582564
Polycythaemia 133.92 18.79 31 5132 3244 110580892
Blood testosterone increased 111.94 18.79 23 5140 1379 110582757
Injection site pain 87.88 18.79 70 5093 177852 110406284
Product dose omission issue 81.33 18.79 87 5076 321695 110262441
Blood testosterone decreased 60.80 18.79 16 5147 2832 110581304
Product quality issue 59.96 18.79 40 5123 77259 110506877
Multiple use of single-use product 46.30 18.79 11 5152 1285 110582851
Product use issue 45.59 18.79 64 5099 311631 110272505
Product use in unapproved indication 39.50 18.79 73 5090 447304 110136832
Hepatic adenoma 39.27 18.79 8 5155 459 110583677
Injection site swelling 36.32 18.79 27 5136 61763 110522373
Haematocrit increased 35.62 18.79 12 5151 4947 110579189
Acute myocardial infarction 35.10 18.79 30 5133 83747 110500389
Product administered at inappropriate site 34.63 18.79 12 5151 5381 110578755
Secondary hypogonadism 34.38 18.79 8 5155 855 110583281
Product gel formation 33.65 18.79 4 5159 3 110584133
Vaginal disorder 32.77 18.79 7 5156 506 110583630
Cardiac valve fibroelastoma 32.61 18.79 5 5158 53 110584083
Priapism 29.92 18.79 11 5152 5850 110578286
Vaginal lesion 29.16 18.79 6 5157 362 110583774
Intracranial pressure increased 26.84 18.79 12 5151 10523 110573613
Drug abuse 25.25 18.79 36 5127 177375 110406761
Haemoglobin increased 25.17 18.79 11 5152 9136 110575000
Injection site mass 24.70 18.79 15 5148 24598 110559538
Cardiac ventricular thrombosis 24.13 18.79 8 5155 3139 110580997
Glucose tolerance decreased 23.86 18.79 4 5159 77 110584059
Pulmonary embolism 22.77 18.79 38 5125 214436 110369700
Oestradiol increased 22.46 18.79 4 5159 111 110584025
Polycythaemia vera 21.62 18.79 5 5158 520 110583616
Injection site infection 21.53 18.79 7 5156 2586 110581550
Performance enhancing product use 20.83 18.79 4 5159 169 110583967
Intentional dose omission 19.54 18.79 12 5151 20068 110564068

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
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:35610 antineoplastic agent
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:35554 cardiovascular drug
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

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

DiseaseRelationSNOMED_IDDOID
Deficiency of testosterone biosynthesis indication 38825009
Male hypogonadism indication 48723006
Menopausal flushing indication 198436008
Undescended testicle indication 204878001 DOID:11383
Delayed puberty indication 400003000
Klinefelter's syndrome, XXY indication 405769009
Hormone receptor positive malignant neoplasm of breast indication 417181009
LHRH Deficiency indication
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
Diabetes mellitus contraindication 73211009 DOID:9351
Sleep apnea contraindication 73430006 DOID:0050847
Epilepsy contraindication 84757009 DOID:1826
Breast lump contraindication 89164003
Kidney disease contraindication 90708001 DOID:557
Uterine leiomyoma contraindication 95315005 DOID:13223
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

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

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 CHEMBL CHEMBL

External reference:

IDSource
D00957 KEGG_DRUG
4017483 VUID
N0000179263 NUI
4017483 VANDF
4017484 VANDF
CHEBI:9463 CHEBI
TES PDB_CHEM_ID
CHEMBL1201101 ChEMBL_ID
DB13943 DRUGBANK_ID
M0XW1UBI14 UNII
441404 PUBCHEM_CID
DB00624 DRUGBANK_ID
10379 RXNORM
2966 MMSL
2990 MMSL
399961 MMSL
5552 MMSL
5553 MMSL
d00558 MMSL
001245 NDDF
001246 NDDF
109033004 SNOMEDCT_US
109034005 SNOMEDCT_US
43688007 SNOMEDCT_US
C0076181 UMLSCUI
C0039601 UMLSCUI
6013 PUBCHEM_CID
1900 INN_ID
D013739 MESH_DESCRIPTOR_UI
CHEBI:17347 CHEBI
M0XW1UBI14 INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Depo-Testosterone HUMAN PRESCRIPTION DRUG LABEL 1 0009-0085 INJECTION, SOLUTION 100 mg INTRAMUSCULAR ANDA 28 sections
Depo-Testosterone HUMAN PRESCRIPTION DRUG LABEL 1 0009-0086 INJECTION, SOLUTION 200 mg INTRAMUSCULAR ANDA 28 sections
Depo-Testosterone HUMAN PRESCRIPTION DRUG LABEL 1 0009-0347 INJECTION, SOLUTION 100 mg INTRAMUSCULAR ANDA 28 sections
Depo-Testosterone HUMAN PRESCRIPTION DRUG LABEL 1 0009-0417 INJECTION, SOLUTION 200 mg INTRAMUSCULAR ANDA 28 sections
Testosterone Cypionate HUMAN PRESCRIPTION DRUG LABEL 1 0143-9005 INJECTION 200 mg INTRAMUSCULAR ANDA 25 sections
Testosterone Cypionate HUMAN PRESCRIPTION DRUG LABEL 1 0143-9659 INJECTION 200 mg INTRAMUSCULAR ANDA 25 sections
Testosterone Cypionate HUMAN PRESCRIPTION DRUG LABEL 1 0143-9726 INJECTION 200 mg INTRAMUSCULAR ANDA 25 sections
Testosterone Cypionate HUMAN PRESCRIPTION DRUG LABEL 1 0409-6557 INJECTION, SOLUTION 100 mg INTRAMUSCULAR ANDA 28 sections
Testosterone Cypionate HUMAN PRESCRIPTION DRUG LABEL 1 0409-6562 INJECTION, SOLUTION 200 mg INTRAMUSCULAR ANDA 28 sections
Testosterone Cypionate HUMAN PRESCRIPTION DRUG LABEL 1 0517-1830 INJECTION, SOLUTION 200 mg INTRAMUSCULAR ANDA 26 sections
Testosterone Cypionate HUMAN PRESCRIPTION DRUG LABEL 1 0574-0820 INJECTION, SOLUTION 200 mg INTRAMUSCULAR ANDA 25 sections
Testosterone Cypionate HUMAN PRESCRIPTION DRUG LABEL 1 0574-0827 INJECTION, SOLUTION 200 mg INTRAMUSCULAR ANDA 25 sections
AZMIRO Human Prescription Drug Label 1 24338-055 INJECTION, SOLUTION 200 mg INTRAMUSCULAR NDA 30 sections
AZMIRO Human Prescription Drug Label 1 24338-056 INJECTION, SOLUTION 200 mg INTRAMUSCULAR NDA 30 sections
testosterone cypionate HUMAN PRESCRIPTION DRUG LABEL 1 47781-910 INJECTION, SOLUTION 200 mg INTRAMUSCULAR ANDA 25 sections
testosterone cypionate HUMAN PRESCRIPTION DRUG LABEL 1 47781-910 INJECTION, SOLUTION 200 mg INTRAMUSCULAR ANDA 25 sections
testosterone cypionate HUMAN PRESCRIPTION DRUG LABEL 1 47781-911 INJECTION, SOLUTION 200 mg INTRAMUSCULAR ANDA 25 sections
testosterone cypionate HUMAN PRESCRIPTION DRUG LABEL 1 47781-911 INJECTION, SOLUTION 200 mg INTRAMUSCULAR ANDA 25 sections
Testosterone Cypionate HUMAN PRESCRIPTION DRUG LABEL 1 50090-4147 INJECTION, SOLUTION 200 mg INTRAMUSCULAR ANDA 26 sections
Testosterone Cypionate Human Prescription Drug Label 1 50090-4446 INJECTION, SOLUTION 200 mg INTRAMUSCULAR ANDA 26 sections
Testosterone Cypionate HUMAN PRESCRIPTION DRUG LABEL 1 50090-4920 INJECTION, SOLUTION 200 mg INTRAMUSCULAR ANDA 25 sections
Testosterone Cypionate HUMAN PRESCRIPTION DRUG LABEL 1 50090-4921 INJECTION, SOLUTION 200 mg INTRAMUSCULAR ANDA 25 sections
Testosterone Cypionate HUMAN PRESCRIPTION DRUG LABEL 1 50090-7435 INJECTION 200 mg INTRAMUSCULAR ANDA 27 sections
testosterone cypionate HUMAN PRESCRIPTION DRUG LABEL 1 50090-7584 INJECTION, SOLUTION 200 mg INTRAMUSCULAR ANDA 26 sections
testosterone cypionate HUMAN PRESCRIPTION DRUG LABEL 1 50090-7585 INJECTION, SOLUTION 200 mg INTRAMUSCULAR ANDA 27 sections
Testosterone Cypionate HUMAN PRESCRIPTION DRUG LABEL 1 52536-625 INJECTION 200 mg INTRAMUSCULAR ANDA 28 sections
Depo-Testosterone HUMAN PRESCRIPTION DRUG LABEL 1 54868-0216 INJECTION, SOLUTION 200 mg INTRAMUSCULAR ANDA 26 sections
Testosterone Cypionate HUMAN PRESCRIPTION DRUG LABEL 1 54868-3618 INJECTION, SOLUTION 200 mg INTRAMUSCULAR ANDA 25 sections
Testosterone Cypionate HUMAN PRESCRIPTION DRUG LABEL 1 54868-3669 INJECTION, SOLUTION 100 mg INTRAMUSCULAR ANDA 26 sections
Testosterone Cypionate HUMAN PRESCRIPTION DRUG LABEL 1 55045-2092 INJECTION, SOLUTION 200 mg INTRAMUSCULAR ANDA 15 sections