Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Testosterone enanthate
Drug ID BADD_D02172
Description Testosterone enanthate is an esterified variant of testosterone that comes as an injectable compound with a slow-release rate. This slow release is achieved by the presence of the enanthate ester functional group attached to the testosterone molecule.[A31615] This testosterone derivative was first approved on December 24, 1953.[L8941] In 2017, about 6.5 million retail prescriptions for testosterone therapy were filled [L4659]. The majority of the prescriptions written were for injectable (66%) and topical (32%) testosterone products. As recent as 1 October 2018, the US FDA approved Antares Pharma Inc.'s Xyosted - a subcutaneous testosterone enanthate product for once-weekly, at-home self-administration with an easy-to-use, single dose, disposable autoinjector [L4659]. As the first subcutaneous autoinjector product designed for testosterone replacement therapy, this innovative formulation removes transfer concerns commonly associated with testosterone gels and potentially reduces the need for in-office/in-clinic injection procedures that may inconvenience patients with frequent visits to the clinic [L4659].
Indications and Usage In females, testosterone enanthate is indicated to be used secondarily in presence of advanced inoperable metastatic mammary cancer in women who are from one to five years postmenopausal. It has also been used in premenopausal women with breast cancer who have benefited from oophorectomy and are considered to have a hormone-responsive tumor.[FDA label]
Marketing Status Prescription; Discontinued
ATC Code G03BA03
DrugBank ID DB13944
KEGG ID D00958
MeSH ID C004648
PubChem ID 9416
TTD Drug ID Not Available
NDC Product Code 0395-8150; 54436-275; 62991-2700; 63275-9938; 54436-250; 64025-0020; 48087-0137; 60870-0266; 0143-9750; 51552-1336; 43647-567; 54436-200; 22552-0014; 12875-9951; 49803-005
Synonyms testosterone enanthate | testosterone heptanoate | testosterone heptylate | Primoteston Depot | Testosteron Depot-Rotexmedica | Testosteron-Depot Eifelfango | Delatestryl | Testrin P.A. | Theramex | Andropository | Durathate | Testosteron-Depot Jenapharm
Chemical Information
Molecular Formula C26H40O3
CAS Registry Number 315-37-7
SMILES CCCCCCC(=O)OC1CCC2C1(CCC3C2CCC4=CC(=O)CCC34C)C
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Incontinence20.02.02.004; 17.05.01.006; 07.01.06.011--Not Available
Increased appetite08.01.09.027; 14.03.01.003--Not Available
Injection site inflammation12.07.03.009; 08.02.03.008--Not Available
Injection site pain12.07.03.011; 08.02.03.010--Not Available
Insomnia17.15.03.002; 19.02.01.002--
Irritability19.04.02.013; 08.01.03.011--
Jaundice cholestatic09.01.01.005--Not Available
Leukopenia01.02.02.001--Not Available
Libido decreased21.03.02.005; 19.08.03.001--
Libido increased19.08.03.002; 21.03.02.007--
Liver function test abnormal13.03.01.013--Not Available
Malaise08.01.01.003--
Menstruation irregular21.01.01.005; 05.05.01.008--
Myalgia15.05.02.001--
Myocardial infarction24.04.04.009; 02.02.02.007--
Nausea07.01.07.001--
Nervous system disorder17.02.10.001--Not Available
Oedema14.05.06.010; 08.01.07.006--Not Available
Oligospermia21.03.03.005--
Paraesthesia17.02.06.005--
Peliosis hepatis09.01.07.010--Not Available
Personality disorder19.05.02.002--Not Available
Polycythaemia01.07.01.001--Not Available
Priapism21.03.01.005--Not Available
Pruritus23.03.12.001--
Rash23.03.13.001--Not Available
Rash pustular23.03.10.003; 11.01.12.002--
Seborrhoeic dermatitis23.03.04.018--Not Available
Skin disorder23.03.03.007--Not Available
Sleep apnoea syndrome17.15.05.001; 22.02.01.013; 19.02.05.002--
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