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)
Nervousness19.06.02.003--Not Available
Night sweats23.02.03.006; 08.01.03.031-Not Available
Nocturia20.02.03.001--Not Available
Oedema14.05.06.010; 08.01.07.006--Not Available
Oedema peripheral08.01.07.007; 02.05.04.007; 14.05.06.011--
Oestradiol increased13.10.05.014--Not Available
Oligospermia21.03.03.005--
Orthostatic hypotension24.06.03.004; 17.05.01.020-Not Available
Osteoporosis15.02.03.002; 14.04.04.002--
Pain08.01.08.004--
Pain in extremity15.03.04.010--
Pallor24.03.04.001; 23.03.03.031; 08.01.03.032-Not Available
Palpitations02.11.04.012-
Paraesthesia23.03.03.094; 17.02.06.005-
Peliosis hepatis09.01.07.010--Not Available
Personality disorder19.05.02.002--Not Available
Pharyngeal oedema23.04.01.016; 22.04.05.003; 10.01.05.016--Not Available
Pleural effusion22.05.02.002-
Pollakiuria20.02.02.007--
Polycythaemia01.07.01.001-Not Available
Priapism24.04.12.007; 21.03.01.005--Not Available
Productive cough22.02.03.005-
Prostatic disorder21.04.01.001--Not Available
Prostatic specific antigen increased13.23.01.003--Not Available
Prostatitis21.09.01.001--Not Available
Pruritus23.03.12.001-
Pulmonary embolism24.01.06.001; 22.06.02.001-Not Available
Pulmonary hypertension24.08.03.002; 22.06.01.001-
Pulmonary microemboli24.01.06.006; 22.06.02.006-Not Available
Rash23.03.13.001--Not Available
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