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 for replacement therapy in adult males with conditions that are linked with an absence or deficiency in endogenous testosterone production. [F4247][FDA Label]
Marketing Status approved; investigational
ATC Code Not Available
DrugBank ID DB13946
KEGG ID D06087
MeSH ID C010792
PubChem ID 65157
TTD Drug ID D02AXG
NDC Product Code 80603-103; 10745-1444; 49803-003; 69087-158; 69087-237; 0009-5036; 11014-0386; 60722-3007; 67979-511; 69087-198; 80603-105; 60722-0009; 22552-0013; 60870-0465; 73774-008; 54436-112; 11014-0385; 48087-0135; 51552-1598; 80603-101; 11014-0387
UNII H16A5VCT9C
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
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Tremor17.01.06.002--
Upper respiratory tract infection22.07.03.011; 11.01.13.009--
Urethral disorder20.07.01.002--Not Available
Urinary retention20.02.02.011--
Urinary tract disorder20.08.01.001--Not Available
Urine flow decreased20.02.02.012--Not Available
Urticaria23.04.02.001; 10.01.06.001--
Vomiting07.01.07.003--
Weight increased13.15.01.006--
Application site vesicles23.03.01.009; 12.07.01.009; 08.02.01.009--Not Available
Peripheral swelling08.01.03.053; 02.05.04.015-Not Available
Osteopenia15.02.03.003; 14.04.04.004--Not Available
Erythropoiesis abnormal01.07.02.010--Not Available
Muscle strain15.05.07.002; 12.01.07.004--Not Available
Reversible ischaemic neurological deficit17.08.01.074; 24.04.06.012--Not Available
Prostate infection21.09.01.002; 11.01.19.001--
Musculoskeletal chest pain22.09.01.001; 15.03.04.012--
Deep vein thrombosis24.01.02.003-Not Available
Prostatomegaly21.04.01.002--Not Available
Lymphatic disorder01.09.01.003--Not Available
Musculoskeletal stiffness15.03.05.027--Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Blood testosterone free increased13.10.05.013--Not Available
Injection site discomfort12.07.03.019; 08.02.03.018--Not Available
Transaminases increased13.03.04.036--Not Available
Prostate examination abnormal13.15.01.026--Not Available
Haemorrhage24.07.01.002--Not Available
Prostate induration21.04.01.006--Not Available
Cognitive disorder19.21.02.001; 17.03.03.003--
Precocious puberty05.05.03.001; 21.03.02.009--
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