Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Testosterone undecanoate
Drug ID BADD_D02174
Description Testosterone undecanoate is the ester prodrug of testosterone and has a midchain fatty acid at the 17Beta position. [A176753] It is available as an intramuscular injection and as an oral capsule, and is indicated for treatment of testosterone deficiency. [F4247][FDA Label] It should be noted that testosterone undecanoate is only indicated for treatment of hypogonadal conditions with structural or genetic etiologies and should not be used to manage "age-related hypogonadism". [FDA Label]
Indications and Usage Testosterone undecanoate is indicated as a testosterone replacement therapy in adult males that present conditions of deficiency or absence of endogenous testosterone. The approved conditions for the use of testosterone undecanoate are 1) primary hypogonadism, defined as a testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy or toxic damage from alcohol or heavy metals: or 2) hypogonadotropic hypogonadism caused by idiopathic gonadotropin or luteinizing hormone-releasing hormone deficiency or pituitary-hypothalamic injuries from tumors, trauma or radiation.[FDA label]
Marketing Status Prescription
ATC Code G03BA03
DrugBank ID DB13946
KEGG ID D06087
MeSH ID C010792
PubChem ID 65157
TTD Drug ID D02AXG
NDC Product Code 11014-0385; 69087-237; 60722-0009; 60870-0465; 11014-0386; 51552-1598; 49803-003; 48087-0135; 54436-112; 22552-0013; 11014-0387; 60722-3007; 69087-158; 0009-5036; 69087-198; 67979-511
Synonyms testosterone undecanoate | testosterone undecylate | Andriol | Restandol | Pantestone | Nebido | Undestor
Chemical Information
Molecular Formula C30H48O3
CAS Registry Number 5949-44-0
SMILES CCCCCCCCCCC(=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)
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.003--
Acne23.02.01.001--Not Available
Aggression19.05.01.001-Not Available
Agitation19.06.02.001; 17.02.05.012--
Alanine aminotransferase increased13.03.01.003--
Alopecia23.02.02.001-
Anaphylactic reaction24.06.03.006; 10.01.07.001-
Anaphylactic shock24.06.02.004; 10.01.07.002-Not Available
Anaphylactoid reaction24.06.03.007; 10.01.07.003--Not Available
Anger19.04.02.001--Not Available
Angina pectoris24.04.04.002; 02.02.02.002--
Angioedema10.01.05.009; 23.04.01.001--Not Available
Anxiety19.06.02.002-
Application site erythema23.03.06.005; 12.07.01.001; 08.02.01.001--Not Available
Application site pain12.07.01.004; 08.02.01.004--Not Available
Application site rash08.02.01.016; 23.03.13.008; 12.07.01.016--Not Available
Arthralgia15.01.02.001--
Aspartate aminotransferase13.03.01.032--Not Available
Aspartate aminotransferase increased13.03.01.006--
Asthenia08.01.01.001-Not Available
Asthma22.03.01.002; 10.01.03.010-Not Available
Azoospermia21.03.03.001--
Back pain15.03.04.005-
Benign prostatic hyperplasia21.04.02.001--Not Available
Blood bilirubin increased13.03.01.008--
Blood cholesterol increased13.12.01.002--
Blood creatine phosphokinase increased13.04.01.001--
Blood glucose increased13.02.02.002--Not Available
Blood pressure fluctuation24.06.01.002-Not Available
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