Does TRT raise blood pressure? What the FDA label change means

By Marcus Renshaw · · updated

Two things happened to every testosterone product label in the same announcement, and almost everyone reported one of them. The FDA took the cardiovascular boxed warning off. It also added a warning that testosterone raises your blood pressure. The first half traveled as “TRT cleared of heart risk.” The second half is the part that changes what you should be doing on a Tuesday morning with a cuff on your arm.

In February 2025 the FDA recommended removing the cardiovascular boxed warning from all testosterone products after the TRAVERSE trial found no increase in major cardiac events. In the same action it required adding a class wide blood pressure warning. The heart risk was not erased. It was made specific, and blood pressure is the number to track.

What did the FDA actually change?

On February 28, 2025, the FDA told sponsors of every testosterone product to make several labeling changes at once. The wording of that notice repays a careful read, because the agency used two different verbs.

Led by the TRAVERSE results, the FDA said it was recommending three changes: adding the trial results to all labels, retaining the “Limitation of Use” language for age related hypogonadism, and removing the boxed warning language about increased cardiovascular risk. Led by the ambulatory blood pressure studies, it said it was requiring two more: product specific information about increased blood pressure where those studies were done, and a new blood pressure warning for every product that did not already carry one.

The good news was a recommendation. The blood pressure finding was a requirement. That is not decoration, it is the difference between guidance a sponsor may follow and a change a sponsor must make.

The history behind it matters too. The boxed warning existed because of reports of stroke, heart attack, and death that prompted a January 2014 safety communication and a September 2014 advisory committee meeting. That meeting produced the recommendation for an industry wide trial, which became TRAVERSE. Separately, in 2016 and 2017 the FDA asked for ambulatory blood pressure studies during premarket development of two products given by two different routes, subcutaneous injection and oral. The results were consistent enough to raise concern that in March 2018 the agency required ambulatory studies for all testosterone products. Those are the studies that came back and confirmed a rise class wide.

The loosening did not stop there, and it came in two more steps through 2026. On April 20, 2026, the FDA published a Federal Register notice inviting sponsors to apply for a new indication: treating low libido in men with decreased libido associated with idiopathic hypogonadism, a group that sits outside the labeled uses today. It is an invitation, not an approval. The agency said it had reviewed promising published evidence and asked interested sponsors to make contact by April 30, 2026 about a supplemental application, with any approval still resting on a full risk benefit review. Nothing in that notice lets a man be prescribed testosterone today for an indication that does not yet exist on a label.

Then, on June 18, 2026, HHS and the FDA requested a further round of label updates: removing the 2015 limitation on age related hypogonadism, narrowing the prostate cancer contraindication to metastatic disease only, and softening the warnings around benign prostatic hyperplasia. As of this writing that round is a request, not a finalized label.

Read these moves together and the direction is clear. The regulator is loosening who can be prescribed testosterone while tightening what has to be monitored on it. More men will qualify. The thing they need to watch is not the one the old boxed warning pointed at.

What did TRAVERSE find?

TRAVERSE is the reason the boxed warning came off, and it is a serious trial. It randomized 5,246 men aged 45 to 80 who had hypogonadal symptoms, two fasting testosterone readings under 300 ng/dL, and either existing cardiovascular disease or high risk of it. They received transdermal testosterone gel 1.62% or placebo gel, with a mean follow up of 33 months.

The primary endpoint, cardiovascular death plus nonfatal heart attack plus nonfatal stroke, landed at 182 events (7.0 percent) on testosterone against 190 events (7.3 percent) on placebo. Hazard ratio 0.96, confidence interval 0.78 to 1.17. Testosterone was noninferior to placebo. For a drug class that carried a boxed cardiovascular warning for a decade, that is a real result and the label change follows from it.

The trial was not uniformly reassuring, and the secondary findings deserve their numbers rather than a wave of the hand. Atrial fibrillation ran 3.5 percent against 2.4 percent. Nonfatal arrhythmias warranting intervention ran 5.2 percent against 3.3 percent. Acute kidney injury ran 2.3 percent against 1.5 percent. Pulmonary embolism ran 0.9 percent against 0.5 percent. A TRAVERSE subtrial also found a 43 percent increase in all clinical fractures, which is a counterintuitive result for a hormone that builds bone density and remains unexplained.

None of that was the primary endpoint, so each carries less statistical weight. But “no increase in major adverse cardiac events” is a narrower claim than “safe,” and the gap between those two sentences is where most of the reporting went wrong.

If TRAVERSE was clean, where did the blood pressure warning come from?

This is the part worth slowing down on, because the answer is a measurement story and it maps onto everything else on this site.

TRAVERSE did not flag a blood pressure signal. The manufacturer run ambulatory studies did. The difference is how they measured. TRAVERSE assessed blood pressure the way a clinic does, at study visits. The postmarket studies the FDA required were ambulatory blood pressure monitoring studies, where a cuff reads you automatically every 20 or 30 minutes across a full 24 hours, sleep included.

The cleanest demonstration is that one of those studies used the same formulation as TRAVERSE. A single arm study of testosterone gel 1.62%, the exact product TRAVERSE randomized, put 24 hour monitors on the participants and found mean systolic pressure rose 1.9 mmHg over 16 weeks. Same molecule, same formulation, same dose range. One measurement method found nothing, the other found a consistent rise.

That is the same gap between office readings and continuous readings that makes home measurement worth doing properly in the first place, and the same reason a morning surge sits invisible inside a normal looking clinic number. A study visit gives you a handful of readings taken in the least representative environment of your week. Twenty four hour monitoring gives you the shape of the thing.

So the honest summary is not “TRT raises your blood pressure and the trial hid it.” It is that the effect is small enough to vanish under clinic measurement and consistent enough to show up whenever anyone measures properly.

Does TRT raise blood pressure, and by how much?

Small on average, and the studies were not able to prove it was small enough to ignore.

Each of these trials set itself a noninferiority margin in advance: the upper bound of the 95 percent confidence interval on the change in 24 hour systolic pressure had to come in under 3.0 mmHg. That is the manufacturer’s own definition of “small enough not to matter.” Here is what came back.

FormulationAnalyzedDuration24h systolic changeUnder the 3.0 mmHg margin
Gel 1.62%16916 weeks+1.9 mmHg (0.6 to 3.1)No
Transdermal patch6216 weeks+3.5 mmHg (1.2 to 5.8)No
Oral undecanoate155180 days+1.8 mmHg (0.3 to 3.2)Not stated

The point estimates are modest. Not one of them cleared the bar its own sponsor set. That is a more honest reading than either “TRT is fine for your heart” or “TRT will give you hypertension.”

The subgroup split in the oral undecanoate study is the number that matters most for the reader here. In men already taking antihypertensive medication, mean systolic rose 3.4 mmHg at day 120 and 3.1 mmHg at day 180. In men not on antihypertensives it was 0.7 and 1.0 mmHg. The men whose blood pressure was already a managed problem got roughly four times the increase of the men whose was not.

That is the practical shape of this risk. If your pressure is 115/70 and you start testosterone, the label change is a note in your file. If you are already medicated, or already sitting at the top of the range, the same intervention pushes on the exact system that is already under strain. Averages are not the unit you live in.

NOTE

These are single arm studies, meaning everyone got the drug and there was no placebo group. That design cannot separate a drug effect from regression to the mean or seasonal drift, which is part of why the FDA treated them as a signal requiring a warning rather than a precise effect size. The class wide conclusion rests on their consistency across routes: oral, gel, patch, and the subcutaneous injection data that triggered the requirement in the first place.

Can you take TRT if you already have high blood pressure?

Existing hypertension is not listed as a contraindication on the label. The warning asks prescribers to check your pressure before starting and to keep checking it, not to rule you out. So this is a question for the person writing the prescription, and the honest answer is that it depends on where your pressure sits and how well it is controlled.

What the data does say is that this group is the one carrying most of the effect. In the oral undecanoate study, men already on antihypertensive medication saw mean systolic rise 3.4 mmHg at day 120, against 0.7 mmHg in men who were not. The average across everyone is small precisely because it is averaging the men with nothing to lose here against the men who have something to lose. If you are already medicated or already sitting near the top of the range, you are in the second group, and the useful move is to arrive at that conversation with your own data rather than a single reading taken in a waiting room.

That means a seven day block of morning and evening readings before you start, so that whatever happens next has something to be compared against. Starting testosterone without a baseline is the one version of this that cannot be fixed later, because you can always measure your pressure next month but you cannot go back and measure what it was before.

What should you be tracking if you are on testosterone?

Two numbers, and neither of them is testosterone.

Blood pressure is the first, and it is the cheapest safety marker you will ever own. A validated upper arm cuff is a one time purchase in the low hundreds of SEK and it works for years. The clinical floor here is a reading at whatever appointment cadence your prescriber uses, which is the measurement modality that missed this signal entirely.

The floor is lower than you might expect. The VA’s January 2026 clinical recommendations for managing men on testosterone are current, detailed, and specify testosterone, hemoglobin and hematocrit, and PSA at three to six months after initiation and again at twelve months. Blood pressure is not in the monitoring schedule. The document does not mention blood pressure, hypertension, or ambulatory monitoring anywhere in its text, eleven months after the FDA required a class wide blood pressure warning on the drugs it covers. Guidance takes years to absorb a label change. That lag is yours to cover.

The optimization version is a seven day block of morning and evening readings at baseline before you start, another block six to eight weeks in, and another after any dose change. Know which threshold you are using, because the two major guideline systems disagree. The European framework pairs an office threshold of 140/90 with a home threshold of 135/85. The American one sets a single number for both: the 2025 ACC/AHA guideline keeps hypertension at 130/80 whether measured in a clinic or at home, and treats home monitoring as the preferred way to confirm a diagnosis. A reading of 134/84 is normal under one system and stage 1 hypertension under the other, so pick your reference and stay with it rather than switching to whichever looks better.

Hematocrit is the second. Testosterone reliably raises red cell mass, enough that hemoglobin rose by 1.0 g/dL in between a third and a half of the men in the T-Trials and TRAVERSE. Thicker blood is a clotting concern in its own right and a plausible contributor to the pressure rise, alongside effects on sodium and fluid handling. The VA guidance adjusts the dose above 51 percent and stops testosterone above 54 percent. The Endocrine Society guideline sets the same 54 percent stopping point, and adds a step worth noticing: when hematocrit crosses it, evaluate the patient for hypoxia and sleep apnea rather than treating the number as a pure drug effect.

Here is where the guideline is the floor rather than the answer. Clinical monitoring is built around catching a problem before it becomes an event, in a patient taking one doctor managed drug. You are likely running a stack, and a stack makes attribution hard. Tadalafil lowers blood pressure. Topical minoxidil lowers it. Meaningful weight loss on a GLP-1 lowers it substantially. Testosterone nudges it up. Run three of those at once and your blood pressure is a net figure, not a signal from any one compound, and you cannot decompose it after the fact if you did not log what changed and when. The same logic applies to the retest interval for hematocrit: three to six months is a reasonable steady state cadence and a poor one for the first months of a new dose, when the trajectory is the information.

What if you are on a SERM instead?

Worth naming, because the label change does not obviously transfer. The FDA’s action applies to exogenous testosterone products. Enclomiphene and similar SERMs raise your own testosterone by acting on the hypothalamic pituitary gonadal axis rather than supplying hormone from outside, and they carry no equivalent warning.

That is not the same as evidence of safety. The ambulatory studies that produced the warning were a postmarket requirement attached to approved testosterone products. Enclomiphene is not an approved testosterone product, so nobody was ever required to run them, and no one volunteered. An absent warning reflects what regulators demanded, not what is true about the molecule. If the pressure rise is mediated partly through raised hematocrit, a SERM that raises testosterone into the same range has a plausible path to some of the same effect, and hematocrit is a marker worth watching on a SERM for exactly that reason.

I run enclomiphene rather than testosterone, and I track blood pressure daily anyway, because I arrived at this from the other direction. My unmedicated readings sat in the mid 140s over mid 80s in the morning and drifted down through the day, which is how I found out I was hypertensive at all. Medicated at bedtime, the mornings settle into the mid 130s. That baseline existed before the SERM did, so a 2 mmHg class effect is not my main problem. It is also exactly why I would see one. The value of a daily log is not any single reading, it is that a small persistent shift becomes visible against a year of your own numbers instead of hiding inside normal variation.

None of this replaces the person who writes your prescription. Blood pressure and hematocrit are the two markers where a self-experimenter can genuinely see a problem coming, and they are also the two where the right response is a conversation rather than a solo dose adjustment.

If you are on testosterone and cannot say what your blood pressure did in the eight weeks after you started, that is the gap this label change is pointing at. Take a seven day block of morning and evening readings this week and you will at least know where you are standing.

FAQ

Does TRT raise blood pressure?

Yes, modestly. The FDA required a class wide blood pressure warning on all testosterone products after ambulatory monitoring studies confirmed an increase across formulations. Mean 24 hour systolic rises reported in those studies run from about 1.8 to 3.5 mmHg. The increase was roughly four times larger in men already taking blood pressure medication than in men who were not.

Can you take TRT if you have high blood pressure?

Existing hypertension is not a labeled contraindication, so it is a decision for your prescriber rather than an automatic no. It does put you in the group that saw the larger rise: 3.4 mmHg mean systolic at day 120 in men on antihypertensives, against 0.7 mmHg in men who were not. Take a seven day block of morning and evening readings before you start, so the comparison exists later.

Can TRT lower blood pressure?

Not on the current evidence. Every formulation with published ambulatory data moved 24 hour systolic upward, and none of the three studies cleared the noninferiority margin its own sponsor had set. If your pressure falls after starting testosterone, look at what else changed, since weight loss, a GLP-1, tadalafil and topical minoxidil all push the other way and can easily outweigh a 2 mmHg class effect.

What is normal blood pressure on testosterone?

The same target as anyone else, since being on testosterone does not move the threshold. Know which system you are using, because they disagree. The 2025 ACC/AHA guideline sets 130/80 for both office and home readings, while the European framework pairs an office 140/90 with a home 135/85. A reading of 134/84 is normal under one and stage 1 hypertension under the other, so pick one reference and stay with it.

Why did the FDA remove the boxed warning from testosterone?

Because the TRAVERSE trial, which randomized 5,246 men with or at high risk of cardiovascular disease, found no increase in major adverse cardiac events. Events occurred in 7.0 percent on testosterone versus 7.3 percent on placebo, a hazard ratio of 0.96. In February 2025 the FDA recommended removing the cardiovascular language from the boxed warning on that basis.

Did the FDA say testosterone is safe for the heart?

No. It concluded the specific claim in the old boxed warning, an increased risk of major cardiac events, was not supported. In the same action it required a blood pressure warning. TRAVERSE itself reported higher rates of atrial fibrillation, acute kidney injury, and pulmonary embolism, and a subtrial found more clinical fractures. The risk profile was revised, not cleared.

Why did TRAVERSE not detect the blood pressure increase?

Measurement method. TRAVERSE assessed blood pressure at clinic study visits. The studies that found the increase used ambulatory monitoring, where a cuff reads automatically every 20 to 30 minutes over 24 hours including sleep. One ambulatory study used testosterone gel 1.62%, the same formulation TRAVERSE randomized, and found a rise. Same drug, different method, different answer.

How often should you check blood pressure on testosterone?

More often than clinical guidance suggests, since some current guidance does not schedule it at all. A practical approach is a seven day block of morning and evening home readings before starting, another block six to eight weeks in, and another after any dose change, then periodic blocks. Decide in advance whether you are using the 130/80 or the 135/85 home threshold.

What hematocrit is too high on testosterone?

Both Endocrine Society and current VA guidance set 54 percent as the level at which testosterone should be stopped, with the VA adjusting dose above 51 percent. Endocrine Society guidance adds that a hematocrit crossing that threshold should prompt evaluation for hypoxia and sleep apnea rather than being treated as a drug effect alone.

Does enclomiphene raise blood pressure like testosterone does?

Unknown rather than no. The FDA warning applies to approved testosterone products, and enclomiphene raises your own testosterone through the HPG axis instead. It carries no equivalent warning, but the ambulatory studies behind that warning were a postmarket requirement on testosterone products and were never run on SERMs. No warning reflects what was studied and mandated, not proof of no effect.

Is the FDA expanding who can be prescribed testosterone?

Two 2026 actions point that way, though neither is final. In April 2026 the FDA published a Federal Register notice inviting sponsors to seek a new indication, treating low libido in men with idiopathic hypogonadism, and asked them to make contact by April 30. In June 2026 HHS and the FDA requested label updates removing the age related hypogonadism limitation and narrowing the prostate restrictions. Both are steps in a process rather than approvals, so as of mid 2026 no new indication is on any label.

What changed in the June 2026 FDA testosterone proposal?

HHS and the FDA requested three further label updates: removing the 2015 limitation of use for age related hypogonadism, narrowing the prostate cancer contraindication to metastatic disease only, and revising the warnings on benign prostatic hyperplasia. It is a request rather than a finalized label, and it would widen who can be prescribed testosterone.

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