Drug profile
Testosterone
Adult, child, renal, hepatic, pregnancy and breastfeeding information, with the source named on every line.
DRUG INFORMATION
ADULT
- Starting dose of testosterone gel 1.62% is 40.5 mg of testosterone (2 pump
actuations or a single 40.5 mg packet), applied topically once daily in the
morning.
Source: US FDA label for testosterone (Testosterone), section 'dosage and
administration', retrieved 2026-08-29
- ( 2.2 , 12.3 ) Dose adjustment: Testosterone gel 1.62% can be dose adjusted
between a minimum of 20.25 mg of testosterone (1 pump actuation) and a maximum of
81 mg of testosterone (4 pump actuations).
Source: US FDA label for testosterone (Testosterone), section 'dosage and
administration', retrieved 2026-08-29
- ( 2.2 ) 2.1 Dosing and Dose Adjustment The recommended starting dose of
testosterone gel 1.62% is 40.5 mg of testosterone (2 pump actuations or a single
40.5 mg packet) applied topically once daily in the morning to the shoulders and
upper arms.
Source: US FDA label for testosterone (Testosterone), section 'dosage and
administration', retrieved 2026-08-29
CHILD
- The safety and effectiveness of testosterone gel 1.62% in pediatric patients less
than 18 years old has not been established. Improper use may result in
acceleration of bone age and premature closure of epiphyses.
Source: US FDA label for testosterone (Testosterone), section 'pediatric use',
retrieved 2026-08-29
- Administration Instructions Testostrone gel 1.62% should be applied to clean, dry,
intact skin of the upper arms and shoulders. Do not apply testostrone gel 1.62% to
any other parts of the body, including the abdomen, genitals, chest, armpits
(axillae), or knees [see Clinical Pharmacology ( 12.3 )] . Area of application
should be limited to the area that will be covered by the patient's short sleeve
t-shirt.
Source: US FDA label for testosterone (Testosterone), section 'dosage and
administration', retrieved 2026-08-29
RENAL IMPAIRMENT
- Geriatric patients treated with androgens may also be at risk for worsening of
signs and symptoms of BPH. 8.6 Renal Impairment No studies were conducted
involving patients with renal impairment. 8.7 Hepatic Impairment No studies were
conducted in patients with hepatic impairment.
Source: US FDA label for testosterone (Testosterone), section 'use in specific
populations', retrieved 2026-08-29
HEPATIC IMPAIRMENT
- Geriatric patients treated with androgens may also be at risk for worsening of
signs and symptoms of BPH. 8.6 Renal Impairment No studies were conducted
involving patients with renal impairment. 8.7 Hepatic Impairment No studies were
conducted in patients with hepatic impairment.
Source: US FDA label for testosterone (Testosterone), section 'use in specific
populations', retrieved 2026-08-29
PREGNANCY [ AVOID ]
The label says not to use it. Read the quote below before deciding.
- Risk Summary Testosterone gel 1.62% is contraindicated in pregnant women.
Source: US FDA label for testosterone (Testosterone), section 'pregnancy',
retrieved 2026-08-29
- Testosterone is teratogenic and may cause fetal harm when administered to a
pregnant woman based on data from animal studies and its mechanism of action [see
Contraindications ( 4 ) and Clinical Pharmacology ( 12.1 )] .
Source: US FDA label for testosterone (Testosterone), section 'pregnancy',
retrieved 2026-08-29
- Exposure of a female fetus to androgens may result in varying degrees of
virilization.
Source: US FDA label for testosterone (Testosterone), section 'pregnancy',
retrieved 2026-08-29
BREASTFEEDING
- Infertility Testis disorder, testicular atrophy, and oligospermia have been
identified during use of AndroGel 1.62% [see Adverse Reactions ( 6.1 , 6.2 )] .
Source: US FDA label for testosterone (Testosterone), section 'nursing mothers',
retrieved 2026-08-29
- During treatment with large doses of exogenous androgens, including AndroGel
1.62%, spermatogenesis may be suppressed through feedback inhibition of the
hypothalamic-pituitary-testicular axis [see Warnings and Precautions ( 5.8 )] .
Source: US FDA label for testosterone (Testosterone), section 'nursing mothers',
retrieved 2026-08-29
- Reduced fertility is observed in some men taking testosterone replacement therapy.
Source: US FDA label for testosterone (Testosterone), section 'nursing mothers',
retrieved 2026-08-29