TRT safety and monitoring
Testosterone therapy has known risks: it can raise blood pressure and red blood cell count, lower sperm production and fertility, and it needs prostate and blood-level monitoring. This page lists what the labels and guidelines say, who should not start, and how your provider watches for problems while you're on treatment.
What the label says first
Testosterone labels limit who it is approved for and list risks that apply to every patient, so your provider starts there.
Testosterone is FDA-approved for men with low testosterone caused by certain medical conditions. Its safety and effectiveness for low testosterone due to aging alone have not been established. Testosterone can raise blood pressure and red blood cell count, reduce sperm production and fertility, and requires monitoring of the prostate and blood levels. Your provider will review the benefits and risks and monitor you with regular labs. Important Safety Information for testosterone
The label also says a diagnosis should be confirmed with testosterone measured in the morning on at least two separate days, with results below the normal range, before treatment starts.1 In June 2026 FDA asked makers to remove the limitation for age-related hypogonadism and to revise prostate wording. The current labels have not changed yet.6
Risks your provider monitors
Each risk below has a check, and your provider can change the dose, pause or stop treatment based on what the check shows.
| Risk | What the label or guideline says | What your provider checks |
|---|---|---|
| Blood pressure | Testosterone can raise blood pressure, which can raise cardiovascular risk over time; it is not recommended with uncontrolled high blood pressure1,2 | Blood pressure at visits and readings you share |
| Red blood cell count | Testosterone can raise red blood cell production; hemoglobin and hematocrit should be checked periodically1 | Blood count (hematocrit) on follow-up labs |
| Prostate | Not used with known or suspected prostate cancer; prostate risk is evaluated in the first year of treatment1,3 | PSA and prostate risk review |
| Sperm production and fertility | Testosterone can suppress the pituitary signals behind sperm production1 | Your plans for children, before you start |
| Blood clots | Clots in the legs and lungs have been reported with testosterone1 | Symptoms you report, at any time |
| Testosterone level | Guidelines aim for the mid-normal range on treatment3 | Testosterone on follow-up labs |
The schedule for these checks is on the follow-up lab schedule page.
What the heart-safety trial found
TRAVERSE, an FDA-required trial in more than 5,200 men with or at high risk of heart disease, found about the same rate of heart attack, stroke and cardiovascular death with testosterone as with placebo.5,6
The same trial found more atrial fibrillation, acute kidney injury and pulmonary embolism in the testosterone group.5 The Endocrine Society notes it also found more bone fractures, that long-term safety is not established, and that careful monitoring remains essential.4 After TRAVERSE, FDA recommended removing the boxed-warning language about cardiovascular outcomes and required blood-pressure warnings on all testosterone products.2
Who should not start
Guidelines and the label list conditions in which testosterone is not started, or is started only after more evaluation. Your provider checks for these at your first visit.1,3
- Plans to have children in the near term
- Breast cancer, or known or suspected prostate cancer
- A prostate lump or hardened area, or a raised PSA, without further urology evaluation
- A high red blood cell count (elevated hematocrit)
- Untreated severe obstructive sleep apnea
- Severe lower urinary tract symptoms
- Uncontrolled heart failure, or a heart attack or stroke in the past 6 months
- Thrombophilia, a tendency to form blood clots
- Serious heart, liver or kidney disease
- An allergy to the medication
Misuse, dependence and stopping
Testosterone is a controlled substance because it can be misused. Abuse and dependence have been reported, mostly at doses above those prescribed, and stopping high doses abruptly can cause withdrawal symptoms such as low mood, fatigue and trouble sleeping. Take it only as your provider directs.1
Visits are at our offices, or by secure video with a provider licensed in your state where your state allows. Testosterone is a Schedule III controlled substance. Depending on your state, and on federal telemedicine rules that are currently set to change after December 31, 2026, an in-person exam may be required before or during treatment. Services are available only in states where our providers are licensed.
The federal rule is the fourth temporary extension of telemedicine flexibilities, in effect through December 31, 2026.7 Read more about the DEA telehealth deadline.
Symptoms to report right away
Contact your provider promptly, or call 911 in an emergency, if you notice any of these.1
- Pain, swelling, warmth or redness in a leg
- Sudden shortness of breath
- An erection that lasts too long or keeps coming back
- Ankle swelling, changes in skin color, nausea or vomiting
Your coordinator has a direct line and can get your message to your provider.
How monitoring fits your care
Your coordinator books follow-up labs, your provider reviews the results with you, and each new supply needs your provider's prescription and your OK.
If a result is out of range, your provider can adjust the dose, pause or stop treatment. If treatment isn't right for you at any point, nothing more is prescribed.
Prescription treatment requires an evaluation by a licensed healthcare provider, who decides whether treatment is appropriate for you. Not everyone qualifies. Completing an assessment, booking a visit, or paying a fee does not guarantee a prescription.
Providers who treat this
Questions
What are the most common side effects of TRT?
Testosterone labels list acne and oily skin, male-pattern hair loss, breast enlargement, changes in libido, fluid retention, headache and excess hair growth, along with the risks that need monitoring: higher blood pressure, a rising red blood cell count and lower sperm production. Which ones matter for you depends on your health and the medication your provider chooses.1
Is TRT safe for my heart?
The answer depends on your own heart health. In the TRAVERSE trial, men with or at high risk of heart disease had about the same rate of heart attack, stroke and cardiovascular death on testosterone as on placebo, and more atrial fibrillation, acute kidney injury and pulmonary embolism. Testosterone also raises blood pressure, so your provider checks it during treatment.2,5,6
What happens if my red blood cell count goes too high?
Does TRT cause prostate cancer?
Will TRT affect my fertility?
Can I stop TRT once I start?
Yes. Talk to your provider first so they can plan it with you. Testosterone treatment suppresses your body's own production, and stopping high doses abruptly can cause withdrawal symptoms.1
Which symptoms should I report right away?
Leg pain, swelling, warmth or redness, or sudden shortness of breath (possible blood clots), and an erection that won't go away. Also tell your provider about ankle swelling, changes in skin color, nausea or vomiting. If it's an emergency, call 911.1
Sources
- DailyMed. Testosterone cypionate, prescribing information: indications, contraindications, warnings, precautions (laboratory tests, information for patients), adverse reactions, drug abuse and dependence (Pharmacia & Upjohn; label effective 2026-08-21) dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cfbb53d4-b868-4a28-8436-f9112eb01c39
- FDA. FDA issues class-wide labeling changes for testosterone products. February 28, 2025 www.fda.gov/drugs/drug-alerts-and-statements/fda-issues-class-wide-labeling-changes-testosterone-products
- Bhasin S, et al. Testosterone Therapy in Men With Hypogonadism: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2018;103(5):1715-1744 (abstract) pubmed.ncbi.nlm.nih.gov/29562364/
- Endocrine Society. Statement on Testosterone Replacement Therapy. July 16, 2026 www.endocrine.org/news-and-advocacy/news-room/2026/statement-on-testosterone-replacement-therapy
- Lincoff AM, et al. Cardiovascular Safety of Testosterone-Replacement Therapy (TRAVERSE). N Engl J Med. 2023;389:107-117 (abstract) pubmed.ncbi.nlm.nih.gov/37326322/
- FDA. Testosterone Information (content current as of 06/23/2026) www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/testosterone-information
- DEA and HHS. Fourth Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications. FR Doc. 2025-24123 www.federalregister.gov/d/2025-24123
Medical services are provided by independently licensed physicians, nurse practitioners and physician assistants of affiliated professional corporations and their affiliated professional entities. Vitality Testosterone Replacement Therapy provides administrative and technology support and does not practice medicine. All treatment decisions are made at the sole discretion of the treating provider. Medications are dispensed by licensed pharmacies. This website is an advertisement for medical services and is not medical advice. If you have a medical emergency, call 911.