FDA label 216a5bc2-69ad-0a00-e063-6394a90ac5ed

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
593ebdf5-54c6-7fae-e053-2991aa0a8e4a
SPL ID
216a5bc2-69ad-0a00-e063-6394a90ac5ed
Version
10
Effective date
2024-09-05
Source export date
2026-09-28
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:17:59

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings and cautions

Before you are given Testosterone Implants Do not use Testosterone Implants if you: - are allergic (hypersensitive) to testosterone - have prostate cancer or breast cancer Take special care with Testosterone Implants: Extra supervision by your doctor may be necessary in some cases: particularly the elderly. -> Tell your doctor if you have ever had: - heart disease - kidney disease - liver disease - high blood pressure - epilepsy - migraine - cancer of the bone - sleep apnea (temporary stopping of breathing during your sleep), If this gets worse during treatment you should also tell your doctor. Blood tests may be affected. Children and adolescents Safety and efficacy have not been adequately determined in children and adolescents. Extra supervision by the doctor is necessary in the treatment of young boys since male hormones may cause early sexual development and delay growth. Testosterone implants should not be used to enhance ability in sports as it carries serious health risks.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.