Depo-Testosterone Side Effects: What the FDA Label Lists
[Side effects · Depo-Testosterone]

Depo-Testosterone side effects

testosterone cypionate · intramuscular injection · Label checked

Short answer: The Depo-Testosterone label lists side effects seen with androgens without giving percentages: breast enlargement, frequent or long erections, acne, oily skin, male-pattern hair loss, fluid retention, nausea, a rise in red blood cells (polycythemia), headache, mood changes, and pain at the injection site. Its warnings cover blood clots, blood pressure, heart risk, liver tumors with long high-dose use, and abuse. It has no boxed warning.

What Depo-Testosterone is approved for: Depo-Testosterone is approved as testosterone replacement in males with symptoms from low or absent natural testosterone due to primary hypogonadism (testicular failure) or hypogonadotropic hypogonadism (a pituitary or hypothalamus cause). The label says safety and effectiveness in men with age-related ("late-onset") hypogonadism have not been established (Indications and Usage).

Source
DEPO-Testosterone (testosterone cypionate) injection, prescribing information. Pfizer (Pharmacia & Upjohn). DailyMed, version published August 20, 2026. DailyMed setid cfbb53d4-b868-4a28-8436-f9112eb01c39

Does Depo-Testosterone have a boxed warning?

No. The current Depo-Testosterone label has no boxed warning.

What are the most common Depo-Testosterone side effects?

These are the label's own numbers from the Adverse Reactions section. Where the label compares with placebo (a dummy treatment), both columns are shown, so you can see how much more often a reaction happened on Depo-Testosterone.

Listed in the Adverse Reactions section (no frequencies given) [Adverse Reactions]
Body systemReactions the label lists
Endocrine and urogenitalGynecomastia and excessive frequency and duration of penile erections. Oligospermia may occur at high dosages.
Skin and appendagesHirsutism, male pattern of baldness, seborrhea, and acne.
Cardiovascular Disordersmyocardial infarction, stroke.
Fluid and electrolyte disturbancesRetention of sodium, chloride, water, potassium, calcium, and inorganic phosphates.
GastrointestinalNausea, cholestatic jaundice, alterations in liver function tests, rarely hepatocellular neoplasms and peliosis hepatis.
HematologicSuppression of clotting factors II, V, VII, and X, bleeding in patients on concomitant anticoagulant therapy, and polycythemia.
Nervous systemIncreased or decreased libido, headache, anxiety, depression, and generalized paresthesia.
AllergicHypersensitivity, including skin manifestations and anaphylactoid reactions.
Vascular disordersVenous thromboembolism.
Special sensesRare cases of central serous chorioretinopathy (CSCR).
MiscellaneousInflammation and pain at the site of intramuscular injection.

The label says these reactions "have occurred with some androgens" in males. It gives no percentages and no placebo comparison.

Other numbers in the Adverse Reactions section

  • Precautions

    Hemoglobin and hematocrit (to detect polycythemia, too many red blood cells) should be checked periodically with long-term use. Serum cholesterol may increase.

  • Precautions

    Oligospermia (low sperm count) may occur after prolonged use or excessive dosage. If it, priapism or urine blockage from an enlarged prostate appears, the label says the androgen should be stopped and, if restarted, given at a lower dose.

What serious risks does the Depo-Testosterone label warn about?

The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.

  • Warnings

    Blood clots. Deep vein thrombosis and pulmonary embolism have been reported with testosterone products. Leg pain, swelling, warmth or redness, or sudden shortness of breath are checked for clots, and testosterone is stopped if one is suspected.

  • Warnings

    Heart risk. Long-term trials of heart outcomes have not been done, and studies so far are inconclusive about the risk of heart attack, stroke and heart-related death with testosterone.

  • Warnings

    Blood pressure. Testosterone can raise blood pressure, which can raise heart risk over time. Blood pressure is checked periodically, and testosterone is not recommended with uncontrolled high blood pressure.

  • Warnings

    Liver tumors. Long use of high doses of androgens (mainly the oral 17-alpha alkyl type) has been linked to liver adenomas, liver cancer and peliosis hepatis, all potentially life-threatening.

  • Warnings

    High calcium. Calcium can rise in people who are immobilized; if it does, the drug is stopped.

  • Warnings

    Prostate in older men. Older men on androgens may have a higher risk of prostate enlargement and prostate cancer, though the label says conclusive evidence is lacking.

  • Warnings

    Fluid retention. Swelling, with or without heart failure, can be a serious problem in people with existing heart, kidney or liver disease.

  • Warnings

    Breast enlargement. Gynecomastia may develop and sometimes persists.

  • Warnings

    Abuse. Testosterone has been abused at doses above those approved, often with other anabolic steroids, which can cause serious heart and mental health problems.

  • Warnings

    Benzyl alcohol. The preservative benzyl alcohol has been linked to "gasping syndrome" and death in infants. Normal doses deliver much less, but the label flags it.

  • Warnings

    Teen growth. In young people with delayed puberty, androgens can speed bone maturation and reduce final height, so bone age is checked every 6 months.

  • Warnings

    Not for athletic performance. The label says it has not been shown to be safe and effective for enhancing athletic performance and should not be used for that.

When does the label say to call your doctor?

From the Information for patients (Precautions) that comes with Depo-Testosterone:

  • Nausea or vomiting.
  • Changes in skin color.
  • Ankle swelling.
  • Erections that are too frequent or last too long.
  • From the Warnings: leg pain, swelling, warmth or redness, or sudden shortness of breath are the signs the label says are checked for blood clots.

How do I keep track of side effects in Dose Track?

Dose Track has a side-effect log. Each entry records the symptom, a severity (none, mild, moderate, severe or life-threatening), the date and an optional note, and can be tied to a specific dose or logged on its own. The history screen shows what you logged over time, which makes it easier to tell your prescriber when a reaction started and whether it is easing. The app records what you enter; it does not judge whether a symptom is serious. For anything on the label's call-your-doctor list, call your doctor.

This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.

Side effects for similar medicines

Frequently asked questions

What are the most common Depo-Testosterone side effects?+
The label does not give percentages. It lists androgen side effects including breast enlargement, frequent or long erections, acne, oily skin, male-pattern hair loss, fluid retention, nausea, polycythemia, headache, libido changes, anxiety, depression and injection-site pain (Adverse Reactions).
Does Depo-Testosterone have a boxed warning?+
No. The current Depo-Testosterone label has no boxed warning. Its Warnings section covers blood clots, blood pressure, heart risk, liver tumors with long high-dose androgen use, fluid retention and abuse.
Does Depo-Testosterone raise red blood cells?+
It can. Polycythemia is listed as a side effect, and the label says hemoglobin and hematocrit should be checked periodically in people on long-term androgens (Adverse Reactions; Precautions, Laboratory tests).
Can Depo-Testosterone affect fertility?+
The label says oligospermia (low sperm count) may occur at high dosages or after prolonged use (Adverse Reactions; Precautions).