Testosterone: Side Effects, Uses & Monitoring
INDICATIONS AND USAGETestim® is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquire
- Data source
- FDA labeling via NIH DailyMed (label 0d90cadf…)
- Label version
- current
- Last reviewed
- 2026
Reported adverse reactions
Reactions listed in current FDA labeling, with the highest frequency reported across summarized placebo-controlled trials.
| Adverse reaction (as reported in labeling) | Reported frequency* |
|---|---|
| Application site reactions | 4% |
| Hematocrit/hemoglobin increased | 2% |
| Benign prostatic hyperplasia | 1% |
| Blood pressure diastolic decreased | 1% |
| Blood pressure increased | 1% |
| Gynecomastia | 1% |
| Headache | 1% |
| Hot flushes | 1% |
| Insomnia | 1% |
| Lacrimation increased | 1% |
| Mood swings | 1% |
| Smell disorder | 1% |
| Spontaneous penile erection | 1% |
| Taste disorder | 1% |
*Highest percentage reported for the active moiety across placebo-controlled trial tables in current FDA labeling. Values reflect trial reporting, not your individual risk.
Labeled uses (from FDA prescribing information)
INDICATIONS AND USAGETestim® is indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired): testicular failure due to cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's syndrome, chemotherapy, or toxic damage from alcohol or heavy metals. These men usually have low serum testosterone levels and gonadotropins (FSH, LH) above the normal range. Hypogonadotropic hypogonadism (congenital or acquired): idiopathic gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation. These men have low testosterone serum levels but have gonadotropins in the normal or low range. Testim® has not been clinically evaluated in males under 18 years of age.
Conditions associated with Testosterone in labeling
Frequently Asked Questions
What is Testosterone used for?
FDA labeling lists the approved uses shown above under "Labeled uses." This summary is informational; only a qualified prescriber can determine whether a medication is appropriate for you.
What are the most commonly reported side effects of Testosterone?
The table above shows adverse reactions and the highest frequencies reported in placebo-controlled trials summarized in current FDA labeling for Testosterone. Individual risk varies.
Does Testosterone require lab monitoring?
Monitoring needs vary. Ask your healthcare provider whether any lab tests apply while taking Testosterone.
Where does this information come from?
All clinical facts on this page were extracted from the current FDA-registered product labeling for this ingredient, published by manufacturers through NIH DailyMed. See the source link below.
Medical disclaimer: Educational content extracted from public FDA labeling. Not medical advice. Always consult a qualified healthcare professional before starting, stopping, or changing any medication.