Testosterone: What to Know Before You Take It
Also known as Depo-Testosterone, Xyosted
Other names: testosterone, depo-testosterone
Testosterone cypionate is an FDA-approved injectable androgen ester used for testosterone replacement therapy (TRT) in males with documented hypogonadism. It is classified as a DEA Schedule III controlled substance. Testosterone is also used off-label in gender-affirming care under specialist supervision.
In plain language
What Testosterone is used for
- Male hypogonadism (primary or hypogonadotropic)
- Transgender hormone therapy (masculinizing HRT)
- Delayed puberty in males (short-term use)
Taking this medicine
How it is administered
- Intramuscular injection
- Subcutaneous injection when prescribed off-label
Read before you decide
Risks and precautions
Risks and warnings
- Erythrocytosis (excess red blood cell production)
- Acne, oily skin
- Mood changes, irritability
- Suppression of natural testosterone/sperm production
- Sleep apnea exacerbation
- Deepening of voice, clitoral enlargement (in females)
- Gynecomastia (if excess aromatization to estrogen)
Who should not take it
- Prostate cancer or breast cancer
- Polycythemia
- Severe untreated sleep apnea
- Pregnancy (absolute contraindication — virilization of fetus)
Medication review
Testosterone drug interactions
FDA safety data
Most-reported side effects
Based on 51,927 FAERS reports. Reports do not prove the drug caused the effect.
Regulatory record
FDA recalls (20)
Defective Container - A defect in the side-seal which allows leakage of product.
Recalling firm: Teva Pharmaceuticals USA, Inc
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Recalling firm: Eugia US LLC
Presence of foreign substance: Presence of Benzene.
Recalling firm: Strides Pharma, Inc.
Presence of foreign substance: Presence of Benzene.
Recalling firm: Strides Pharma, Inc.
Superpotent Drug
Recalling firm: Teva Pharmaceuticals USA, Inc
OOS for viscosity
Recalling firm: Teva Pharmaceuticals USA, Inc
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Recalling firm: Azurity Pharmaceuticals, Inc.
Superpotent Drug: Out of specification assay result was obtained during stability testing.
Recalling firm: Teva Pharmaceuticals USA Inc
cGMP - Water leakage
Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INC
Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion
Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INC
CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery.
Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INC
CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification for impurities.
Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INC
Common questions
Patient questions
Is testosterone a controlled substance?
Yes. Testosterone is a DEA Schedule III controlled substance. It requires a prescription from a licensed provider with DEA prescribing authority. Telehealth prescribing of Schedule III substances is subject to federal and state-specific restrictions.
What monitoring is required during testosterone replacement therapy?
Routine monitoring typically includes serum testosterone levels, hematocrit/hemoglobin (erythrocytosis risk), PSA (prostate), lipid panel, and estradiol. Frequency and specific tests depend on your provider's protocol and your individual health history.
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This information is educational — not medical advice.
This page is provided for general educational purposes and summarizes publicly available data from sources such as the U.S. Food & Drug Administration. It is not a substitute for the judgment of a licensed clinician and should not be used to start, stop, or change any medication. It may be incomplete or out of date, and individual circumstances vary. Always talk with your prescriber or pharmacist about your specific medications and health conditions. If you think you may have a medical emergency, call 911.
Sources & References
- FDA structured product labeling for Testosterone
- U.S. Food & Drug Administration — openFDA Drug Labeling API
- U.S. National Library of Medicine — RxNorm drug nomenclature
- FDA: Testosterone and Other Anabolic Steroids
- DailyMed: Testosterone cypionate injection labels
- DEA: Anabolic Steroids — Schedule III
Learn more about where our data comes from and how we write and review medical content.