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)
Gynaecomastia21.05.04.003; 05.05.02.003--
Haematocrit increased13.01.05.002--Not Available
Haematuria21.10.01.018; 24.07.01.047; 20.02.01.006--
Haemoglobin13.01.05.018--Not Available
Haemoglobin increased13.01.05.004--
Headache17.14.01.001--
Hepatic neoplasm16.07.03.001; 09.04.03.001--Not Available
Hirsutism23.02.04.001; 05.05.01.005--
Hostility19.05.01.003--Not Available
Hypercholesterolaemia14.08.01.001--Not Available
Hyperhidrosis23.02.03.004; 08.01.03.028-
Hyperparathyroidism14.04.01.020; 05.04.01.001--
Hypersensitivity10.01.03.003-
Hypersensitivity vasculitis01.01.04.008; 24.12.04.013; 23.06.02.005; 10.02.02.017--Not Available
Hypertension24.08.02.001--
Hypertriglyceridaemia14.08.02.001--
Hyperventilation22.02.01.006; 19.01.02.004--Not Available
Hypoglycaemia05.06.03.001; 14.06.03.001--
Immune system disorder10.02.01.001--Not Available
Incontinence17.05.01.006; 07.01.06.011; 20.02.02.004--Not Available
Increased appetite14.03.01.003; 08.01.09.027--Not Available
Influenza22.07.02.001; 11.05.03.001--Not Available
Injection site abscess12.07.03.021; 08.02.03.021; 11.01.08.023--Not Available
Injection site erythema23.03.06.015; 12.07.03.001; 08.02.03.001-Not Available
Injection site haematoma24.07.01.009; 12.07.03.004; 08.02.03.004--Not Available
Injection site irritation12.07.03.027; 08.02.03.027--Not Available
Injection site pain12.07.03.011; 08.02.03.010-Not Available
Injection site pruritus23.03.12.007; 12.07.03.014; 08.02.03.013-Not Available
Injection site reaction12.07.03.015; 08.02.03.014--
Insomnia17.15.03.002; 19.02.01.002--
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