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)
Intraocular pressure increased13.07.04.002---
Irritability08.01.03.011; 19.04.02.013--
Jaundice01.06.04.004; 09.01.01.004; 23.03.03.030---
Jaundice cholestatic09.01.01.005---
Joint swelling15.01.02.004--
Laryngeal pain22.12.03.010--
Leukopenia01.02.02.001---
Libido decreased19.08.03.001; 21.03.02.005-
Libido increased19.08.03.002; 21.03.02.007--
Lip swelling07.05.04.005; 10.01.05.005; 23.04.01.007--
Lipids abnormal13.12.02.001---
Liver function test abnormal13.03.04.030---
Loss of consciousness17.02.04.004--
Lymphadenopathy01.09.01.002--
Malaise08.01.01.003-
Male orgasmic disorder19.08.01.006; 21.03.02.019---
Menopausal symptoms21.02.02.002---
Migraine17.14.02.001; 24.03.05.003---
Mitral valve incompetence02.07.01.002--
Mood altered19.04.02.007---
Mood swings19.04.03.001---
Muscle spasms15.05.03.004--
Musculoskeletal pain15.03.04.007--
Myalgia15.05.02.001--
Myocardial infarction02.02.02.007; 24.04.04.009-
Nasopharyngitis11.01.13.002; 22.07.03.002---
Nausea07.01.07.001--
Nephrolithiasis20.04.01.002--
Nephropathy20.05.03.001---
Nervous system disorder17.02.10.001---
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