Does Jatenzo still have a boxed warning?

No. The current SPL has no boxed-warning section, and its Recent Major Changes table records "Boxed Warning, Increases in Blood Pressure Removed" along with the removal of the "age related hypogonadism" contraindication and the Cardiovascular Risk warning at 5.3. The table gives two different dates for all of that in the same document — 03/2025 in the section body and 07/2025 in the Highlights excerpt — so this page reports both. Section 5.4 still carries the finding: +4.9/2.5 mm Hg at four months, 5.4/3.2 mm Hg in men on antihypertensives, and "Average blood pressures had not plateaued at the end of the trial."

What is the starting dose of Jatenzo?

237 mg twice daily with food, morning and evening — one orange 237 mg capsule each time. From there Table 1 moves one rung on a serum testosterone drawn 6 hours after the morning dose, at least 7 days after starting or after any change: up if the level is below 425 ng/dL, down if it is above 970 ng/dL, unchanged between. The rungs are 158 mg, 198 mg, 237 mg, 316 mg, 396 mg twice daily, with 316 mg made from two 158 mg capsules and 396 mg from two 198 mg capsules.

Why does Jatenzo have to be taken with food?

Because absorption depends on fat, and the label puts a number on it. Section 12.3: "the bioavailability with the 30 g fat, 45 g fat, and high-calorie high-fat breakfasts was comparable, but there was a food effect with the 15 g fat breakfast compared to the 30 g fat breakfast. The 15 g fat breakfast had a 25% decrease in testosterone exposure compared to the 30 g fat breakfast." A quarter of the exposure is enough to move a titration decision, so the meal is part of the dose — and the 6-hour level Table 1 adjusts on reflects what was eaten as much as what was swallowed.

How much does Jatenzo raise blood pressure?

More than any other testosterone product states for itself. Ambulatory monitoring over 24 hours at baseline and Day 139, in 135 evaluable patients, gave a mean rise of +4.9 mm Hg systolic (95% CI 3.5, 6.4) and +2.5 mm Hg diastolic (95% CI 1.5, 3.6). In men with a history of hypertension on antihypertensive therapy it was 5.4/3.2 mm Hg (n=67); in men with no history, 4.4/1.8 (n=63). For comparison: Tlando +4.3/1.4 at about 16 weeks, Xyosted +3.9/1.5 at 12 weeks, AndroGel 1.62% +1.9/1.3 at 16 weeks. Jatenzo's label adds that the average had not plateaued when the trial ended.

What is the difference between Jatenzo, Kyzatrex and Tlando?

Three capsules of one ester with three regimens. Jatenzo: 237 mg twice daily to start, five rungs from 158 to 396 mg twice daily, level drawn 6 hours after the morning dose. Kyzatrex: 200 mg twice daily to start, floor of 100 mg once daily in the morning, ceiling of 400 mg twice daily, level drawn 3 to 5 hours after the morning dose. Tlando: 225 mg twice daily, fixed, with no titration table — its pivotal studies were run without dose titration. Kyzatrex and Tlando both state in section 2 that they are not substitutable with other oral testosterone undecanoate products; Jatenzo's label does not contain that sentence.

Is Jatenzo bad for the liver?

The label addresses that assumption directly and separates itself from the drug class it comes from. "Prolonged use of high doses of orally active 17-alpha-alkyl androgens (e.g., methyltestosterone) has been associated with serious hepatic adverse effects (peliosis hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice)… JATENZO is not known to cause these adverse effects. Nonetheless, patients should be instructed to report any signs or symptoms of hepatic dysfunction (e.g. jaundice)." Testosterone undecanoate is not 17-alpha-alkylated and is absorbed largely through the lymphatics, which is why the oral capsule exists at all.

Is Jatenzo approved for low testosterone from ageing?

No, and the direction of travel is worth knowing. The current label lists it as a Limitation of Use — "Safety and efficacy of JATENZO in men with “age-related hypogonadism” have not been established" — but the Recent Major Changes table records that men with "age related hypogonadism" were removed from Contraindications in 2025. It used to be a contraindication on this product; now it is an absence of evidence. The approved indications remain primary hypogonadism and hypogonadotropic hypogonadism, both defined by structural or genetic cause.

When should the blood test be drawn on Jatenzo?

Six hours after the morning dose, at least seven days after starting or after any dose change, and the tube matters: "measure serum testosterone concentrations 6 hours after the morning dose in plain tubes, clotted at room temperature for 30 minutes prior to centrifugation." Table 1 then reads that number against 425 ng/dL and 970 ng/dL. Kyzatrex uses 3 to 5 hours after the morning dose instead, and its pivotal trial measured NaF/EDTA plasma rather than serum — so a level drawn on one product's schedule and read against the other's table is the wrong number at the wrong time.

Brand — one of three oral testosterone undecanoates

Jatenzo

Testosterone undecanoate you swallow twice a day with food, titrated on a level drawn six hours after the morning dose. Its blood-pressure boxed warning was removed in 2025 — and section 5.4 still reports +4.9/2.5 mm Hg that had not plateaued at four months.

Molecule: testosterone undecanoate
Manufacturer: TOLMAR Inc.
Products under this name: 1
Last reviewed: September 2026

Why "oral testosterone undecanoate" does not identify a regimen

Testosterone undecanoate is sold in the United States as four products and they have almost nothing in common. Three are capsules — JATENZO, KYZATREX and TLANDO — and one, AVEED, is a 3 mL intramuscular oil depot given at week 0, week 4 and then every ten weeks in a healthcare setting, under a REMS, with the patient observed for thirty minutes after every injection because of pulmonary oil microembolism and anaphylaxis. Same ester, same hormone; one is a bottle of 120 capsules and one is a restricted-distribution clinic procedure with a boxed warning.

The three capsules do not agree with each other either. JATENZO starts at 237 mg twice daily and titrates through 158 mg, 198 mg, 237 mg, 316 mg, 396 mg against a level drawn six hours after the morning dose. KYZATREX starts at 200 mg twice daily, can go down to a single 100 mg morning dose or up to 400 mg twice daily, and draws its level three to five hours after the morning dose. TLANDO is 225 mg twice daily and does not titrate at all — its pivotal studies were run "without dose titration", and its label offers no adjustment table, only a decision to continue or discontinue. Two of those three labels then state in section 2 that they are "not substitutable with other oral testosterone undecanoate products"; JATENZO's label contains no such sentence.

None of this belongs to the molecule. Testosterone undecanoate has no starting dose, no monitoring hour, no food requirement and no boxed-warning status — each is a property of a product, and in JATENZO's case of a product whose label was substantially rewritten in 2025. Its Recent Major Changes table records a boxed warning about blood pressure removed, a contraindication for "age related hypogonadism" removed, and a cardiovascular-risk warning removed. What it does not record is any change to the number in section 5.4.

What is true of Jatenzo and not of testosterone undecanoate

Each row is something a reader would reasonably assume belongs to the molecule, and does not. These are the facts that change when the brand name on the carton changes, while the drug inside it does not.

Attribute	Jatenzo	Elsewhere, same molecule
How the same ester is givenTwo products of one ester, one of which is 730 self-administered capsules a year and the other five supervised clinic visits under a restricted distribution programme. Any statement beginning "testosterone undecanoate is…" is describing one of them and not the other.	A liquid-filled capsule swallowed twice a day with food, from a bottle of 120, self-administered at home.	AVEED is testosterone undecanoate as a 3 mL intramuscular oil depot, 750 mg at week 0, 750 mg at week 4, then 750 mg every 10 weeks — administered in a healthcare setting, with the patient observed for 30 minutes after every injection, available only through a restricted REMS programme, and opening with "WARNING: SERIOUS PULMONARY OIL MICROEMBOLISM (POME) REACTIONS AND ANAPHYLAXIS".
The food requirement, and what it is worthA man on this capsule who eats a light breakfast is taking a materially lower dose than the same capsule with a proper one, and the effect is large enough to move a titration decision. The 6-hour level that Table 1 adjusts on is a measurement of what he ate as much as what he swallowed, which is why the specimen timing and the meal are both in section 2.2.	"Take JATENZO with food", stated in the Highlights, in section 2.2 and again in the patient counselling section. Section 12.3 puts a number on it: a 15 g fat breakfast produced "a 25% decrease in testosterone exposure compared to the 30 g fat breakfast", while 30 g, 45 g and a high-calorie high-fat breakfast were comparable.	KYZATREX and TLANDO are also taken with food, but neither quantifies a fat threshold. The injectable, topical, nasal and subcutaneous testosterones have no food statement at all, because absorption does not go through the gut.
The ladder, and whether there is oneThree oral products of one ester with three starting doses, two different blood-draw windows and, in one case, no dose adjustment on offer. A level drawn on KYZATREX's three-to-five-hour schedule and read against JATENZO's Table 1 is the wrong number at the wrong time, and the result is a dose change neither label authorised.	Five rungs — 158 mg, 198 mg, 237 mg, 316 mg, 396 mg — twice daily, starting at 237 mg, moving one rung on a level drawn 6 hours after the morning dose, against a window of 425 to 970 ng/dL.	KYZATREX starts at 200 mg twice daily, floors at 100 mg once daily in the morning and ceilings at 400 mg twice daily, and draws its level 3 to 5 hours after the morning dose. TLANDO is 225 mg twice daily with no titration table at all — its pivotal studies were conducted "without dose titration" and its label directs only "Monitor serum testosterone after initiating TLANDO to determine if TLANDO should be continued or discontinued."
Whether the label forbids substituting another oralThe absence is not permission. Two of the three manufacturers have been asked and answered, and their answer is about this class of product rather than about their own — so the sentence on the KYZATREX label already covers JATENZO from the other direction. A page that noted only JATENZO's silence would leave a reader with exactly the wrong impression.	JATENZO's label contains no such sentence. Section 2 covers confirmation of hypogonadism, dosing and dose adjustment, and never addresses substitution.	Both of the other oral undecanoates open section 2 with it. KYZATREX: "KYZATREX® is not substitutable with other oral testosterone undecanoate products." TLANDO: "TLANDO is not substitutable with other oral testosterone undecanoate products." Both AndroGels and TESTIM carry the topical equivalent.
How much it raises blood pressureThis is the largest ambulatory rise stated on any US testosterone label, in the shortest-running trial of the four, and the only one whose label says the curve was still climbing when the study ended. A reader comparing routes on blood pressure should know the gel figure and the capsule figure come from studies of different lengths as well as different products.	+4.9/2.5 mm Hg after 4 months of treatment in a clinical trial (Day 139, n=135), rising to 5.4/3.2 mm Hg in men already on antihypertensive therapy — and the clause that matters most: "Average blood pressures had not plateaued at the end of the trial."	+4.3/1.4 mm Hg at approximately 16 weeks for TLANDO. XYOSTED: +3.9/1.5 mm Hg at 12 weeks. AndroGel 1.62%: +1.9/1.3 mm Hg at 16 weeks. The intramuscular oil vials state no ambulatory figure of their own at all, only the class sentence inside WARNINGS.
What the 2025 labelling changes took off, and whenThe one thing not in dispute is that there is no boxed warning in the current document. The month is, in the source itself, and this page prints both dates rather than choosing. Anyone citing a single date for "when FDA removed the testosterone blood-pressure boxed warnings" is flattening a staged set of changes across at least two quarters.	A boxed warning about increases in blood pressure, a contraindication for men with "age related hypogonadism", and the Cardiovascular Risk warning at 5.3. The Recent Major Changes section dates all six of its entries twice — 03/2025 in the section body and 07/2025 in the Highlights excerpt of the same section, in the same document.	XYOSTED dates its identical removals 03/2025, unambiguously. TLANDO and KYZATREX date theirs 07/2025, unambiguously — and KYZATREX's removed contraindication is worded differently again, "Hypogonadal conditions not associated with structural or genetic etiologies". AVEED's box was not removed, because it is about POME and anaphylaxis rather than blood pressure.
Whether depression and suicide appear as a warningTwo of the three oral undecanoates carry nothing here and one carries a named warning, which reflects what each programme observed rather than a difference between the capsules. The strongest version of this warning in the class belongs to a subcutaneous enanthate autoinjector, not to any oral product.	Section 5.15, Risk of Depression and Suicide: "Depression and suicidal ideation has been reported in patients treated with JATENZO in clinical trials."	KYZATREX and TLANDO have no such section, despite being the same ester by the same route. XYOSTED has a 5.15 with the same heading and stronger wording — "Depression and suicidal ideation and behavior, including completed suicide, have occurred during clinical trials in patients treated with XYOSTED."
What the Highlights say the approval date isThe single field a reader is most likely to take as "how long has this been around" is the one field on the page that is not about this product. Seventy years of testosterone experience is not seventy years of experience with an oral undecanoate capsule, and the four-month trial behind section 5.4 is the actual duration of evidence here.	The Highlights header reads "Initial U.S. Approval: 1953" — on a liquid-filled oral capsule approved under NDA 206089 in 2019.	AndroGel 1% and 1.62% carry the same 1953, and so does every other testosterone product: it is the date the active moiety was first approved in the United States, not the date this product was. KYZATREX holds NDA 213953, TLANDO NDA 208088, AVEED NDA 022219 — all with their own approval years and the same 1953 in the header.

JATENZO capsules

Dosage form: Capsule, liquid filled — CIII
Route: Oral, twice daily with food, morning and evening
Marketing category: NDA — NDA206089
Label read: SPL version 14, effective September 30, 2025

What this product is approved to treat

—JATENZO (testosterone undecanoate) is an androgen indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.
—Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter syndrome, chemotherapy, or toxic damage from alcohol or heavy metals.
—Hypogonadotropic hypogonadism (congenital or acquired): gonadotropin or luteinizing hormone-releasing hormone (LHRH) deficiency or pituitary-hypothalamic injury from tumors, trauma, or radiation.
—Limitation of use: "Safety and efficacy of JATENZO in men with “age-related hypogonadism” have not been established." This is a downgrade, not a constant — the Recent Major Changes table records "Contraindications, Men with “age related hypogonadism” (4) Removed" in 2025. It used to be a contraindication.
—Limitation of use: "Safety and efficacy of JATENZO in males less than 18 years old have not been established."

The labelled ladder

When	Dose	What the label attaches to this step
Before the first capsule	None	Section 2.1: "Prior to initiating JATENZO, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these testosterone concentrations are below the normal range."
Day 1 onward	237 mg twice daily, with food	Section 2.2: "The recommended starting dose is 237 mg taken orally twice daily, once in the morning and once in the evening. Take JATENZO with food." The food requirement is not a tolerability suggestion — see the administration notes for what a low-fat breakfast costs in exposure.
Day 7 at the earliest, 6 hours after the morning dose	Unchanged, pending the result	"Wait seven days after starting treatment or adjusting the dose before checking the serum testosterone concentration." And the specimen handling is part of the instruction: "measure serum testosterone concentrations 6 hours after the morning dose in plain tubes, clotted at room temperature for 30 minutes prior to centrifugation."
Minimum the label names	158 mg twice daily	"The minimum recommended dose is 158 mg twice daily." Below this the table says "Discontinue Treatment" rather than naming a smaller dose. Table 1 moves one rung up if the 6-hour level is less than 425 ng/dL, one rung down if it is more than 970 ng/dL, and not at all between. "Administer the same dose in the morning and evening."
Titration rung	198 mg twice daily	A rung of the Table 1 adjustment scheme, not a scheduled step — you arrive here only if a level sends you here. Table 1 moves one rung up if the 6-hour level is less than 425 ng/dL, one rung down if it is more than 970 ng/dL, and not at all between. "Administer the same dose in the morning and evening."
Starting dose	237 mg twice daily	A rung of the Table 1 adjustment scheme, not a scheduled step — you arrive here only if a level sends you here. Table 1 moves one rung up if the 6-hour level is less than 425 ng/dL, one rung down if it is more than 970 ng/dL, and not at all between. "Administer the same dose in the morning and evening."
Titration rung	316 mg twice daily (two 158 mg capsules)	A rung of the Table 1 adjustment scheme, not a scheduled step — you arrive here only if a level sends you here. Table 1 moves one rung up if the 6-hour level is less than 425 ng/dL, one rung down if it is more than 970 ng/dL, and not at all between. "Administer the same dose in the morning and evening."
Maximum the label names	396 mg twice daily (two 198 mg capsules)	"The maximum recommended dose is 396 mg (two 198 mg capsules) twice daily." Above this the label's own table has only one instruction left: at 396 mg twice daily with a level still over 970 ng/dL, step down to 316 mg. Table 1 moves one rung up if the 6-hour level is less than 425 ng/dL, one rung down if it is more than 970 ng/dL, and not at all between. "Administer the same dose in the morning and evening."
Thereafter	Whatever the last level set	"Thereafter, periodically monitor serum testosterone concentrations 6 hours after the morning dose." Blood pressure is monitored periodically alongside it, and section 17 tells the patient what to do with a rise: "If BP increases while on JATENZO, antihypertensive medications may need to be started, added, or adjusted to control BP, or JATENZO may need to be discontinued."

Ceiling. Stated plainly in section 2.2: "The maximum recommended dose is 396 mg (two 198 mg capsules) twice daily" — 792 mg of testosterone undecanoate a day. The minimum is equally explicit, "The minimum recommended dose is 158 mg twice daily", and below it Table 1 has no smaller rung: it says "Discontinue Treatment". KYZATREX names a higher ceiling for the same ester, 400 mg twice daily, and a lower floor, 100 mg once daily in the morning.

How it is supplied

Presentation	Total strength	Concentration	Delivers
opaque red liquid-filled gelatin capsule imprinted with “158” in white ink — bottles of 120, child-resistant cap, induction-sealed	158 mg of testosterone undecanoate per capsule	Not applicable — a capsule has no concentration	One capsule twice daily is a labelled dose (158 mg BID). Two of these make the 316 mg rung.
opaque white liquid-filled gelatin capsule imprinted with “198” in red ink — bottles of 120, child-resistant cap, induction-sealed	198 mg of testosterone undecanoate per capsule	Not applicable — a capsule has no concentration	One capsule twice daily is a labelled dose (198 mg BID). Two of these make the 396 mg maximum.
opaque orange liquid-filled gelatin capsule imprinted with “237” in white ink — bottles of 120, child-resistant cap, induction-sealed	237 mg of testosterone undecanoate per capsule	Not applicable — a capsule has no concentration	One capsule twice daily is a labelled dose (237 mg BID). The starting dose — one capsule, morning and evening, with food.

Administration, as the label words it

—"Take JATENZO with food." The label quantifies why in section 12.3: "When JATENZO was dosed with different breakfasts containing various amounts of fat, the bioavailability with the 30 g fat, 45 g fat, and high-calorie high-fat breakfasts was comparable, but there was a food effect with the 15 g fat breakfast compared to the 30 g fat breakfast. The 15 g fat breakfast had a 25% decrease in testosterone exposure compared to the 30 g fat breakfast."
—"Administer the same dose in the morning and evening." The label has no asymmetric regimen, unlike KYZATREX, whose minimum dose is a single morning capsule.
—Monitoring, with the specimen handling specified: "To ensure proper dose adjustment, measure serum testosterone concentrations 6 hours after the morning dose in plain tubes, clotted at room temperature for 30 minutes prior to centrifugation. Adjust the JATENZO dose based on this serum testosterone measurement as shown in Table 1. Wait seven days after starting treatment or adjusting the dose before checking the serum testosterone concentration."
—Section 5.4, the content that outlived the boxed warning: "JATENZO can increase blood pressure. Ambulatory blood pressure monitoring (ABPM) demonstrated JATENZO increased systolic/diastolic BP by an average of 4.9/2.5 mm Hg from baseline after 4 months of treatment in a clinical trial. In patients with hypertension on antihypertensive therapy, JATENZO increased the mean systolic/diastolic BP by 5.4/3.2 mm Hg from baseline. Average blood pressures had not plateaued at the end of the trial." And: "JATENZO is not recommended for use in patients with uncontrolled hypertension."
—Section 5.15, Risk of Depression and Suicide: "Depression and suicidal ideation has been reported in patients treated with JATENZO in clinical trials. Advise patients and caregivers to seek medical attention for manifestations of new onset or worsening depression, suicidal ideation or behavior, anxiety, or other mood changes."
—Section 5, on the hepatic risk this product is most often assumed to share: "Prolonged use of high doses of orally active 17-alpha-alkyl androgens (e.g., methyltestosterone) has been associated with serious hepatic adverse effects… JATENZO is not known to cause these adverse effects. Nonetheless, patients should be instructed to report any signs or symptoms of hepatic dysfunction (e.g. jaundice)."
—Section 4: contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate, in women who are pregnant, and in men with known hypersensitivity to JATENZO or any of its ingredients.

Storage

Bottle of 120 capsules: "Store at 20°C to 25ºC (68°F to 77ºF), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF). Avoid exposing the capsules to moisture (store in a dry place)."; Until the expiration date on the bottle
Around children: "Keep JATENZO out of reach of children." The bottles ship with white polypropylene child-resistant caps and an induction-sealed liner.; No child access at any time

Children and adolescents

"The safety and efficacy of JATENZO in pediatric patients less than 18 years old have not been established. Improper use may result in acceleration of bone age and premature closure of epiphyses." Section 8.5 is thinner still at the other end: "No patients over 65 years of age were enrolled in the 4-month efficacy and safety clinical study utilizing JATENZO."

This statement belongs to JATENZO capsules. It is not a statement about testosterone undecanoate, and another brand of the same molecule may say the opposite.

The same molecule under other brand names

Everything below is testosterone undecanoate. None of it is Jatenzo, and a dose from one column carried into another is not a smaller or larger version of the same instruction — it is a different product’s schedule.

Brand	Form	Approved for	Ladder	Maximum
Kyzatrex	Oral testosterone undecanoate capsule, liquid filled — NDA 213953, Marius Pharmaceuticals	The same two hypogonadism indications. Its section 2 opens "KYZATREX® is not substitutable with other oral testosterone undecanoate products"; its boxed warning about blood pressure was removed 07/2025	200 mg twice daily to start; minimum 100 mg once daily in the morning, maximum 400 mg twice daily, adjusted on a level drawn 3 to 5 hours after the morning dose	The maximum recommended dose is 400 mg twice daily
Tlando	Oral testosterone undecanoate capsule, liquid filled — NDA 208088, Verity Pharmaceuticals	The same two indications, with no dose-adjustment table at all: "Monitor serum testosterone after initiating TLANDO to determine if TLANDO should be continued or discontinued." Boxed warning removed 07/2025	225 mg twice daily with food, fixed — the pivotal studies were run without dose titration	No higher dose is named; 225 mg twice daily is the only dose
Aveed	Intramuscular testosterone undecanoate, 750 mg/3 mL in castor oil — NDA 022219, Endo USA	The same two indications, boxed for serious pulmonary oil microembolism reactions and anaphylaxis, with 30 minutes of observation after every injection and availability only through the AVEED REMS Program	750 mg at week 0, 750 mg at week 4, then 750 mg every 10 weeks	No dose above 750 mg per administration is named

Switching between products

The sentence JATENZO does not carry, from the label that does

KYZATREX® is not substitutable with other oral testosterone undecanoate products.

Kyzatrex — the other titratable oral undecanoate

And again, from the third product in the class

TLANDO is not substitutable with other oral testosterone undecanoate products.

Tlando

What the removed boxed warning left behind

JATENZO can increase blood pressure. Ambulatory blood pressure monitoring (ABPM) demonstrated JATENZO increased systolic/diastolic BP by an average of 4.9/2.5 mm Hg from baseline after 4 months of treatment in a clinical trial. In patients with hypertension on antihypertensive therapy, JATENZO increased the mean systolic/diastolic BP by 5.4/3.2 mm Hg from baseline. Average blood pressures had not plateaued at the end of the trial.

JATENZO — section 5.4, after the box came off

What the label tells the patient to do about a rise

Instruct patients about the importance of monitoring BP periodically while on JATENZO. If BP increases while on JATENZO, antihypertensive medications may need to be started, added, or adjusted to control BP, or JATENZO may need to be discontinued.

JATENZO — section 17, patient counselling

What this page does not tell you

Price — list, cash or copay: No price appears anywhere on this page, and no price is emitted in its structured data. There is no generic oral testosterone undecanoate, so every capsule in this class is a single-source brand whose cost to a patient turns on formulary placement and manufacturer assistance rather than on an acquisition figure. Our TRT cost calculator does work from a dated national acquisition-cost snapshot with its as-of date attached, and it records which products that file cannot price at all — which is the only form in which we will state a number.
The month the boxed warning was removed: The source contradicts itself and this page will not resolve it by choosing. JATENZO's Recent Major Changes section lists six entries twice over in the same SPL: the section body dates every one of them 03/2025 and the Highlights excerpt of that same section dates every one 07/2025. The removal itself is not in question — there is no boxed-warning section anywhere in the document — and neither is what was removed: the blood-pressure box, the "age related hypogonadism" contraindication and the Cardiovascular Risk warning at 5.3. Only the month is uncertain, and both dates are printed above so a reader can see the discrepancy rather than inherit a guess.
A conversion to or from another testosterone product: There is none on any label, and this class is where a conversion table would be most tempting and least defensible. The three oral undecanoates start at 237, 200 and 225 mg twice daily — near enough that a row of equivalences would look plausible — but they were titrated against different target windows, on levels drawn at different hours after the dose, and one of them has no titration at all. Two of the three labels state that they are not substitutable with each other. A milligram equivalence to an injection or a gel is further outside the evidence again, since those bypass first-pass metabolism entirely.
Long-term safety, in this label's own words: The evidence behind section 5.4 is four months long. The ABPM substudy ran to Day 139 in 135 evaluable patients, and it ended with average blood pressures that "had not plateaued at the end of the trial" — so where the curve goes after four months is not something this label reports. Section 8.5 adds that no patients over 65 were enrolled in that study at all, and that there is insufficient long-term safety data in geriatric patients to assess the potentially increased risk of cardiovascular disease and prostate cancer. This page states the four-month figure with its duration attached and does not extrapolate it.

Frequently asked questions

Does Jatenzo still have a boxed warning?: No. The current SPL has no boxed-warning section, and its Recent Major Changes table records "Boxed Warning, Increases in Blood Pressure Removed" along with the removal of the "age related hypogonadism" contraindication and the Cardiovascular Risk warning at 5.3. The table gives two different dates for all of that in the same document — 03/2025 in the section body and 07/2025 in the Highlights excerpt — so this page reports both. Section 5.4 still carries the finding: +4.9/2.5 mm Hg at four months, 5.4/3.2 mm Hg in men on antihypertensives, and "Average blood pressures had not plateaued at the end of the trial."
What is the starting dose of Jatenzo?: 237 mg twice daily with food, morning and evening — one orange 237 mg capsule each time. From there Table 1 moves one rung on a serum testosterone drawn 6 hours after the morning dose, at least 7 days after starting or after any change: up if the level is below 425 ng/dL, down if it is above 970 ng/dL, unchanged between. The rungs are 158 mg, 198 mg, 237 mg, 316 mg, 396 mg twice daily, with 316 mg made from two 158 mg capsules and 396 mg from two 198 mg capsules.
Why does Jatenzo have to be taken with food?: Because absorption depends on fat, and the label puts a number on it. Section 12.3: "the bioavailability with the 30 g fat, 45 g fat, and high-calorie high-fat breakfasts was comparable, but there was a food effect with the 15 g fat breakfast compared to the 30 g fat breakfast. The 15 g fat breakfast had a 25% decrease in testosterone exposure compared to the 30 g fat breakfast." A quarter of the exposure is enough to move a titration decision, so the meal is part of the dose — and the 6-hour level Table 1 adjusts on reflects what was eaten as much as what was swallowed.
How much does Jatenzo raise blood pressure?: More than any other testosterone product states for itself. Ambulatory monitoring over 24 hours at baseline and Day 139, in 135 evaluable patients, gave a mean rise of +4.9 mm Hg systolic (95% CI 3.5, 6.4) and +2.5 mm Hg diastolic (95% CI 1.5, 3.6). In men with a history of hypertension on antihypertensive therapy it was 5.4/3.2 mm Hg (n=67); in men with no history, 4.4/1.8 (n=63). For comparison: Tlando +4.3/1.4 at about 16 weeks, Xyosted +3.9/1.5 at 12 weeks, AndroGel 1.62% +1.9/1.3 at 16 weeks. Jatenzo's label adds that the average had not plateaued when the trial ended.
What is the difference between Jatenzo, Kyzatrex and Tlando?: Three capsules of one ester with three regimens. Jatenzo: 237 mg twice daily to start, five rungs from 158 to 396 mg twice daily, level drawn 6 hours after the morning dose. Kyzatrex: 200 mg twice daily to start, floor of 100 mg once daily in the morning, ceiling of 400 mg twice daily, level drawn 3 to 5 hours after the morning dose. Tlando: 225 mg twice daily, fixed, with no titration table — its pivotal studies were run without dose titration. Kyzatrex and Tlando both state in section 2 that they are not substitutable with other oral testosterone undecanoate products; Jatenzo's label does not contain that sentence.
Is Jatenzo bad for the liver?: The label addresses that assumption directly and separates itself from the drug class it comes from. "Prolonged use of high doses of orally active 17-alpha-alkyl androgens (e.g., methyltestosterone) has been associated with serious hepatic adverse effects (peliosis hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice)… JATENZO is not known to cause these adverse effects. Nonetheless, patients should be instructed to report any signs or symptoms of hepatic dysfunction (e.g. jaundice)." Testosterone undecanoate is not 17-alpha-alkylated and is absorbed largely through the lymphatics, which is why the oral capsule exists at all.
Is Jatenzo approved for low testosterone from ageing?: No, and the direction of travel is worth knowing. The current label lists it as a Limitation of Use — "Safety and efficacy of JATENZO in men with “age-related hypogonadism” have not been established" — but the Recent Major Changes table records that men with "age related hypogonadism" were removed from Contraindications in 2025. It used to be a contraindication on this product; now it is an absence of evidence. The approved indications remain primary hypogonadism and hypogonadotropic hypogonadism, both defined by structural or genetic cause.
When should the blood test be drawn on Jatenzo?: Six hours after the morning dose, at least seven days after starting or after any dose change, and the tube matters: "measure serum testosterone concentrations 6 hours after the morning dose in plain tubes, clotted at room temperature for 30 minutes prior to centrifugation." Table 1 then reads that number against 425 ng/dL and 970 ng/dL. Kyzatrex uses 3 to 5 hours after the morning dose instead, and its pivotal trial measured NaF/EDTA plasma rather than serum — so a level drawn on one product's schedule and read against the other's table is the wrong number at the wrong time.

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Educational reference, not medical advice. Testosterone undecanoate is a Schedule III controlled substance and a prescription-only medicine, contraindicated in pregnancy and in men with breast or suspected prostate carcinoma. This page reports what the FDA label states, including what was removed from it and the dates the document gives; it does not recommend a dose or a product.