TRT Side Effects: Hematocrit, Blood Pressure, PSA and Fertility
Testosterone therapy side effects from FDA labels and the TRAVERSE trial: red blood cells, blood pressure, PSA, fertility and heart risk, with label dates. Sourced.
By Julian Caraulani · Last updated
Safety
Below: the label numbers, what changed on testosterone labels in 2025, the monitoring each label asks for, and where to ask a clinician. We do not give doses or protocols.
TRT side effects vs placebo (label table)
Most testosterone labels report open-label studies with no placebo group. AndroGel 1.62% is the exception: its label has a 182-day placebo-controlled trial, and it was the drug used in TRAVERSE, the cardiovascular safety trial now summarised on every testosterone label.
| Side effect | Testosterone | Placebo | Study | Source |
|---|---|---|---|---|
| PSA increased | 11.1% | 0% | 182-day trial (N=234 vs 40) | AndroGel 1.62% label, revised 10/2025 |
| Emotional lability (mood swings, anger) | 2.6% | 0% | 182-day trial | Same label, Table 4 |
| Hypertension | 2.1% | 0% | 182-day trial | Same label, Table 4 |
| Hematocrit or hemoglobin increased | 2.1% | 0% | 182-day trial | Same label, Table 4 |
| Contact dermatitis | 2.1% | 0% | 182-day trial | Same label, Table 4 |
| Heart attack, stroke or CV death (MACE) | 7.0% | 7.3% | TRAVERSE (5,198 men) | Same label, section 6.1 |
| Nonfatal arrhythmia needing intervention | 5.2% | 3.3% | TRAVERSE | Same label, section 6.1 |
| Atrial fibrillation | 3.5% | 2.4% | TRAVERSE | Same label, section 6.1 |
| Bone fracture | 3.5% | 2.5% | TRAVERSE | Same label, section 6.1 |
| Acute kidney injury | 2.3% | 1.5% | TRAVERSE | Same label, section 6.1 |
| Venous blood clots (VTE) | 1.7% | 1.2% | TRAVERSE | Same label, section 5.3 |
| Pulmonary embolism | 0.9% | 0.5% | TRAVERSE | Same label, section 5.3 |
Injections show a similar pattern without a placebo arm. In a one-year study of Xyosted, a weekly testosterone autoinjector, hematocrit increased in 14.0% of men, hypertension in 12.7% and PSA in 12.0% (DailyMed: Xyosted label, revised 7/2025).
Hematocrit: the red blood cell rise
Testosterone raises red blood cell mass, which thickens the blood. The AndroGel 1.62% label says "Check hematocrit prior to initiating treatment" and "If hematocrit becomes elevated, stop therapy until hematocrit decreases to an acceptable concentration", because "An increase in red blood cell mass may increase the risk of thromboembolic events" (DailyMed: AndroGel 1.62% label). How often to test, and what level is too high, is the prescriber's call.
- FDA-approved and compounded
- No FDA warning letter found
- No state list published
Blood pressure, and what changed in 2025
On February 28, 2025, after TRAVERSE and a set of 24-hour blood pressure studies, the FDA announced "removing language from the Boxed Warning related to an increased risk of adverse cardiovascular outcomes for all testosterone products" and "adding a new warning about increased blood pressure for testosterone products which currently do not have such a warning in their labeling" (FDA: class-wide labeling changes for testosterone products).
Some products had carried a boxed warning about blood pressure. Two of them now list it as removed: the Xyosted label shows the blood pressure boxed warning "Removed 03/2025" (DailyMed: Xyosted label), and the oral capsule Jatenzo shows it as removed in 07/2025 (DailyMed: Jatenzo label, revised 9/2025). The warning itself stays. The AndroGel 1.62% label still says "Blood pressure increases can increase cardiovascular (CV) risk over time" and that it "is not recommended for use in patients with uncontrolled hypertension" (DailyMed: AndroGel 1.62% label).
What TRAVERSE found on heart risk
TRAVERSE enrolled men aged 45 to 80 with low testosterone and existing heart disease or a high risk of it. The authors concluded that "testosterone-replacement therapy was noninferior to placebo with respect to the incidence of major adverse cardiac events", and also that "A higher incidence of atrial fibrillation, of acute kidney injury, and of pulmonary embolism was observed in the testosterone group" (Lincoff et al., NEJM 2023, PubMed). Noninferior means the trial ruled out a large increase in risk, not that the risk is zero.
Prostate, PSA and BPH
Testosterone labels list breast cancer and known or suspected prostate cancer as contraindications. The AndroGel 1.62% label says "Patients with BPH treated with androgens are at an increased risk for worsening of signs and symptoms of BPH" and tells prescribers to "Evaluate patients for prostate cancer prior to initiating and during treatment with androgens" (DailyMed: AndroGel 1.62% label). That is why programs order a PSA test before and during therapy.
Fertility
Testosterone from outside the body tells the brain to stop signalling the testes, which can shut down sperm production. The Xyosted label says "Reduced fertility is observed in some men taking testosterone replacement therapy. The impact on fertility may be irreversible." (DailyMed: Xyosted label) Men who want children should say so at the first visit; some programs offer enclomiphene instead, which is compared in our enclomiphene vs TRT guide.
Other label warnings
Labels also list sleep apnea, swelling (edema), acne, lipid changes and mood effects. Gels carry a boxed warning of their own: "Virilization has been reported in children who were secondarily exposed to testosterone gel" (DailyMed: AndroGel 1.62% label). Testosterone cypionate injections are FDA-approved generics; testosterone creams made by compounding pharmacies are compounded and not FDA-approved.
What the videos show
Doctors and men on TRT discuss side effects on YouTube, from hematocrit to acne. These are individual accounts, not evidence, and many come from clinics that sell therapy. Use them for questions to ask, not answers. Our TRT video hub has the full list.
Urologists answer your questions about testosterone replacement therapy | TRTRena Malik, M.D., December 7, 2021
Testosterone & Testosterone Replacement Therapy (TRT) | Dr. Peter Attia & Dr. Andrew HubermanHuberman Lab Clips, August 19, 2022
Is Testosterone Safe for Your Heart?! Things You Should KnowRena Malik, M.D., July 14, 2023
Videos belong to their channels; our summary is on each video's page. All 8 Testosterone therapy (TRT) videos.
Which programs let you message a clinician
TRT needs ongoing blood work and someone to read it. This table shows which testosterone programs let you message a clinician between visits, from each program's own pages.
| Program | Message a clinician | Cost | Lowest price |
|---|---|---|---|
| Rugiet | Yes: You can message your doctor anytime in the portal, and unlimited follow-ups with your doctor are included in the price. source, 2026-10-31 | Included | $99 |
| Henry Meds | Yes: You and your provider exchange messages in a secure patient portal, and ongoing care is part of the plan price. source, 2026-10-31 | Included | $129 |
| Brightmeds | Yes: A licensed doctor is one message away for your whole treatment, at no extra cost. source, 2026-10-31 | Included | $191 |
| Rex MD | Yes: Follow-ups are free once treatment starts; you message your assigned provider through the member portal any time. source, 2026-10-31 | Included | $18 |
| Hims | Yes: You can message a provider with questions at any time, for free. source, 2026-10-31 | Included | $22 |
| Maximus | Yes: Every protocol includes 24/7 messaging with your care team at no additional cost. source, 2026-10-31 | Included | $24.99 |
| MangoRx | Yes: Unlimited access to licensed providers for any concerns, with ongoing provider support listed in the monthly plan; the page does not name the channel. source, 2026-10-31 | Included | $59 |
| PeterMD | Yes: Unlimited free consultations and 24/7 access to your medical team; the page says access and consults, not messaging by name. source, 2026-10-31 | Included | See review |
| Hone Health | Yes: Unlimited messaging with your care team, plus a clinician meeting every 3 months, as part of the membership. source, 2026-10-31 | Included in the paid Hone membership | See review |
| Male Excel | Yes: The Medical Membership required for HRT gives unlimited access to medical providers for health questions. source, 2026-10-31 | Part of the required Medical Membership (price not stated on the page) | See review |
| Taurus Meds | Not found: The site says it offers online access to licensed clinicians who adjust dosages, but never says you can message one. | Not stated | See review |
From each program's own page, read 2026-10-31.
What it costs
The cheapest testosterone plan we track is Rugiet at $99, as checked October 31, 2026. Lab work is often extra; see our testosterone test cost guide. Every plan is on our TRT price page, and the overall ranking is on Best men's health programs.
Questions
FAQ
What are the most common side effects of TRT?
On the labels: a rise in PSA, higher hematocrit, higher blood pressure, skin reactions with gels, and injection-site bruising with injections. In a one-year Xyosted study, hematocrit rose in 14.0% of men and blood pressure in 12.7%.
Does testosterone therapy cause heart attacks?
In TRAVERSE, heart attacks, strokes and cardiovascular deaths occurred in 7.0% of men on testosterone gel and 7.3% on placebo. The FDA then removed the cardiovascular outcomes language from the boxed warning on all testosterone products. Atrial fibrillation, kidney injury and pulmonary embolism were more common on testosterone.
Does TRT raise blood pressure?
It can. Labels now carry a blood pressure warning and ask for periodic checks. The boxed warning on blood pressure that some products carried has been removed, but the warning itself remains.
Why does hematocrit go up on TRT?
Testosterone stimulates red blood cell production. Labels ask for a hematocrit check before starting and during treatment, and say to stop until it falls if it gets too high.
Does TRT make you infertile?
It can suppress sperm production, and the Xyosted label says the effect on fertility may be irreversible. Tell the prescriber if you plan to have children.
Does TRT cause prostate cancer?
Labels say men on androgens may be at increased risk and should be checked for prostate cancer before and during treatment. Known or suspected prostate cancer is a contraindication.
Is TRT safe for age-related low testosterone?
The labels say safety and efficacy in men with age-related hypogonadism have not been established. A clinician decides based on symptoms and repeated morning blood tests.