What it isAndrogen-receptor agonist and principal endogenous androgen; replacement for hypogonadism.
Why this oneTopical gels and depot injections trade level stability against convenience and transfer risk.
What limits itIt suppresses spermatogenesis, so discuss fertility first; monitor hematocrit, and prevent skin transfer from gels.
FDA-approved for
FDA label
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| FDA dosing | Population | Start | Target | Max |
| Hypogonadism (primary or hypogonadotropic) in adult men | Adult men | 237 mg BID (morning and evening, with food) | 158–396 mg BID, titrated to serum testosterone | 396 mg BID |
Renal Undefined
Hepatic Undefined
Instructions
- Take with food, morning and evening
- Confirm hypogonadism with morning serum testosterone below normal on ≥2 separate days before starting
- Measure serum testosterone 6h after morning dose, ≥7 days after start or dose change, then periodically; adjust per dosing table
- Monitor hematocrit ~every 3 months, blood pressure, PSA, and lipids periodically
- Not recommended in uncontrolled hypertension
Contraindications
- Men with breast carcinoma or known/suspected prostate carcinoma
- Women who are pregnant (virilization of female fetus)
Cautions
- Polycythemia — monitor hematocrit
- Venous thromboembolism (DVT/PE)
- Worsening BPH and potential prostate cancer risk
- Blood pressure increases — can raise cardiovascular risk
- Abuse potential (anabolic androgenic steroid)
- May suppress spermatogenesis/impair fertility
- Hepatic adverse effects; edema (esp. cardiac/renal/hepatic disease)
- Sleep apnea; hypercalcemia in cancer patients
- Depression and suicidal ideation
Adverse reactions
- Polycythemia / increased hematocrit
- Hypertension
- Headache
- Nausea
- Diarrhea
- Dyspepsia
- Peripheral edema
- Prostatomegaly
Pregnancy Contraindicated — teratogenic; may cause virilization of a female fetus
Lactation Not indicated for use in women
⚠ BOXED WARNINGS
- Blood pressure increases
- Secondary exposure in children
Cost, est. cash$300–$5,000/dose or month
Generic entry2041 est.
Classes and tags
Clinical profile
Therapeutic safety burden2 / 4
Overdose danger2 / 4
Weight-gain liability0 / 4
Sedation liability0 / 4
QT / Torsades0 / 4
Direct muscarinic antagonism0 / 4
Embryofetal risk4 / 4
Legacy pregnancy categoryX
Defining liabilityErythrocytosis, infertility, hepatic/lipid effects and mood or misuse concerns.
Mechanism of action: Testosterone ballicule
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Memory aids: mascots and interaction avatars
Testosterone mnemonic
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