Does Xyosted still have a boxed warning?

No. Its Recent Major Changes table records "Boxed Warnings, Blood Pressure Increases — Removed 03/2025", along with "Warnings and Precautions, Cardiovascular Risk (5.4) — Removed 03/2025". But the blood-pressure content was moved rather than deleted: section 5.4 still opens "XYOSTED can increase blood pressure", still reports a mean ambulatory rise of 3.9/1.5 mm Hg at 12 weeks, and still closes "XYOSTED is not recommended for use in patients with uncontrolled hypertension." The same removal happened across the class in 2025 — Jatenzo, Tlando and Kyzatrex all lost the same box.

How much does Xyosted raise blood pressure?

Section 5.4 and section 6.1 give the figure from 24-hour ambulatory monitoring in the six-month study: among 62 patients with acceptable recordings at baseline and week 12, mean systolic rose 3.9 mm Hg (95% CI 1.4–6.4) and diastolic 1.5 mm Hg (95% CI 0.4–2.6). In men already on antihypertensive therapy it was 3.9/1.3 mm Hg (n=33); in men with no history of hypertension, 4.1/1.9 mm Hg (n=28). Separately, hypertension was the second most common adverse reaction in the one-year study — 19 of 150 patients, 12.7%.

Where do you inject Xyosted?

The abdomen, and only the abdomen. Section 2.3 states "XYOSTED is for subcutaneous injection in the abdominal region only. Avoid intramuscular or intravascular injection", and the Instructions for Use narrow it to "Only use the left or right side of the abdomen (belly) for injection sites." The technique is also specified: squeeze the site to raise the skin, hold the autoinjector at 90 degrees, push firmly and keep holding after the click. This is the opposite of every other approved enanthate product, which directs slow deep injection into the gluteal muscle.

What doses does Xyosted come in?

Three, all in the same 0.5 mL autoinjector: 50 mg, 75 mg, 100 mg. Because the fill is constant, those are three concentrations — 100 mg/mL, 150 mg/mL, 200 mg/mL — and only the 100 mg device matches the 200 mg/mL concentration of a generic enanthate vial. Everyone starts on 75 mg weekly, and the label adjusts by 25 mg in either direction based on a trough drawn after 6 weeks, so 50, 75 and 100 mg is the entire reachable set. There is no larger device and no instruction to give two.

How is the Xyosted dose adjusted?

On one number, measured at one time. "Measure total testosterone trough concentrations (measured 7 days after the most recent dose) following 6 weeks of dosing, following 6 weeks after dose adjustment, and periodically while on treatment." Then: decrease by 25 mg if the trough is ≥650 ng/dL, increase by 25 mg if it is <350 ng/dL, hold if it sits between. The label explains why that window: a trough between 350 and 650 ng/dL "generally provides testosterone exposures in the normal range during the entire dosing interval", and steady state is reached by week 6.

Is Xyosted the same as testosterone enanthate from a vial?

Same molecule, same oil, almost nothing else. The vial is 200 mg/mL multiple-dose with 5 mg of chlorobutanol per mL as preservative, injected deeply into the gluteal muscle at 50 to 400 mg every two to four weeks, with no titration target and no incidence figures on its label. XYOSTED is preservative-free, single-dose, sealed, subcutaneous into the abdomen at a fixed 75 mg weekly, titrated against a trough, with a counted adverse-reaction table and a Risk of Depression and Suicide section. Sesame oil is a contraindication on both, and it is the only inactive ingredient in XYOSTED.

Can Xyosted be refrigerated?

No, and section 16.2 opens with the prohibition rather than the storage range: "Do Not refrigerate or freeze. Use at room temperature." The range itself is 20 °C to 25 °C with excursions permitted to 15 °C to 30 °C, and the label adds "Protect from light (keep in carton until time of use)." There is no in-use period because there is no second use — each autoinjector is single-dose and the label directs discarding the unused portion.

Why does Xyosted have a suicide warning?

Because it came out of this product's own clinical programme. Section 5.15 states: "Depression and suicidal ideation and behavior, including completed suicide, have occurred during clinical trials in patients treated with XYOSTED. Advise patients and caregivers to seek medical attention for manifestations of suicidal ideation or behavior, new onset or worsening depression, anxiety, or other mood changes." It is the strongest psychiatric language on any US testosterone label. Jatenzo carries a section with the same heading but reports only ideation; Kyzatrex and Tlando, the other oral undecanoates, carry none, and neither do the vial labels.

Brand — the only weekly, subcutaneous testosterone

Xyosted

Q: Is Xyosted the same as testosterone enanthate from a vial?

Same molecule, same oil, almost nothing else. The vial is 200 mg/mL multiple-dose with 5 mg of chlorobutanol per mL as preservative, injected deeply into the gluteal muscle at 50 to 400 mg every two to four weeks, with no titration target and no incidence figures on its label. XYOSTED is preservative-free, single-dose, sealed, subcutaneous into the abdomen at a fixed 75 mg weekly, titrated against a trough, with a counted adverse-reaction table and a Risk of Depression and Suicide section. Sesame oil is a contraindication on both, and it is the only inactive ingredient in XYOSTED.

Q: Can Xyosted be refrigerated?

No, and section 16.2 opens with the prohibition rather than the storage range: "Do Not refrigerate or freeze. Use at room temperature." The range itself is 20 °C to 25 °C with excursions permitted to 15 °C to 30 °C, and the label adds "Protect from light (keep in carton until time of use)." There is no in-use period because there is no second use — each autoinjector is single-dose and the label directs discarding the unused portion.

Q: Why does Xyosted have a suicide warning?

Because it came out of this product's own clinical programme. Section 5.15 states: "Depression and suicidal ideation and behavior, including completed suicide, have occurred during clinical trials in patients treated with XYOSTED. Advise patients and caregivers to seek medical attention for manifestations of suicidal ideation or behavior, new onset or worsening depression, anxiety, or other mood changes." It is the strongest psychiatric language on any US testosterone label. Jatenzo carries a section with the same heading but reports only ideation; Kyzatrex and Tlando, the other oral undecanoates, carry none, and neither do the vial labels.

The one US testosterone product labelled weekly, the one labelled subcutaneous, and the one whose label forbids the intramuscular route. Its blood-pressure boxed warning was removed in March 2025 — and section 5.4 still carries the 3.9/1.5 mm Hg finding that put it there.

Molecule: testosterone enanthate
Manufacturer: Antares Pharma, Inc.
Products under this name: 1
Last reviewed: September 2026

Why this is the one testosterone the label will not let you inject into muscle

Testosterone enanthate has been given intramuscularly in the United States since the 1950s, and every generic vial of it still is: "Care should be taken to slowly inject the preparation deeply into the gluteal muscle", at 50 to 400 mg every two to four weeks. XYOSTED is the same ester and it inverts all of that. Section 2.3 reads "XYOSTED is for subcutaneous injection in the abdominal region only. Avoid intramuscular or intravascular injection", and the dose is a fixed 75 mg once every 7 days. It is the only approved testosterone product of any ester labelled weekly and the only one labelled subcutaneous, which means "weekly subcutaneous testosterone" describes exactly one product in the country and describes common clinical practice with a vial of something else.

The device is the second thing the molecule does not explain. XYOSTED is a preservative-free single-dose syringe pre-assembled in a pressure-assisted autoinjector, sold in three strengths — 50 mg, 75 mg, 100 mg — all holding 0.5 mL. Work the concentration out and those are 100 mg/mL, 150 mg/mL, 200 mg/mL, three different concentrations under one product name, only the largest of which matches the 200 mg/mL vial people compare it to. Because every device is single-dose and sealed, a dose change is a device change: the label's "Decrease the dose by 25 mg" means dispensing a different product code, not drawing less.

And the third thing is a regulatory event rather than a pharmacological one. XYOSTED launched with a boxed warning about blood pressure, and its Recent Major Changes table records "Boxed Warnings, Blood Pressure Increases — Removed 03/2025". The same table, the same month, also records "Warnings and Precautions, Blood Pressure Increases (5.4)" as changed. The warning did not disappear; it moved down. Section 5.4 still states the ambulatory monitoring result — +3.9/1.5 mm Hg after 12 weeks of treatment in clinical trials (n=62 with acceptable recordings) — and still ends "XYOSTED is not recommended for use in patients with uncontrolled hypertension." None of this is a property of testosterone enanthate. It is a property of a document that was revised.

What is true of Xyosted and not of testosterone enanthate

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	Xyosted	Elsewhere, same molecule
The route, and what is forbiddenOne ester, two opposite routes, decided by the device. A man who learned to inject enanthate into a glute and is handed an autoinjector is being asked to unlearn it, and the label's own wording is "Avoid intramuscular" rather than a preference.	Section 2.3: "XYOSTED is for subcutaneous injection in the abdominal region only. Avoid intramuscular or intravascular injection." The Instructions for Use narrow it further: "Only use the left or right side of the abdomen (belly) for injection sites."	Every other approved testosterone enanthate is the opposite. The Hikma vial (ANDA 091120) directs "Care should be taken to slowly inject the preparation deeply into the gluteal muscle, being sure to follow the usual precautions for intramuscular administration, such as the avoidance of intravascular injection." So does the Eugia vial. AVEED, the injectable undecanoate, is intramuscular only.
The interval"Weekly testosterone" names one product and describes a great deal of practice with others. Our injection schedule planner classifies any interval as inside the two-to-four-week vial window, XYOSTED-only, or not labelled at all, rather than accepting all three as equivalent: Weekly is labelled for one product only — XYOSTED, a sealed subcutaneous autoinjector. It is not the interval on either oil vial.	75 mg once every 7 days, fixed. This is the only approved testosterone product in the United States labelled weekly, of any ester or route.	Both enanthate vials: 50 to 400 mg every 2 to 4 weeks. DEPO-Testosterone: the identical sentence for cypionate. AVEED: 750 mg at week 0, week 4, then every 10 weeks. AndroGel and Jatenzo are daily; Natesto is three times a day.
What a dose change physically isThe reachable doses here are a property of what is manufactured, not of what is safe or effective. There is no 125 mg autoinjector, so the label's single "increase by 25 mg" step from 75 mg has no successor, and a man whose trough is still under 350 ng/dL on 100 mg has run out of ladder rather than run into a ceiling.	Three sealed single-dose autoinjectors — 50 mg, 75 mg, 100 mg — all holding 0.5 mL, so three concentrations: 100 mg/mL, 150 mg/mL, 200 mg/mL. "Discard unused portion." A 25 mg adjustment means dispensing a different device.	The enanthate vial is one strength, 200 mg/mL, multiple-dose, preserved with 5 mg of chlorobutanol per mL, and any dose is whatever volume is drawn. Nothing about it constrains the dose to a set of three numbers.
Whether there is a boxed warningWhether a testosterone product has a box, and what the box is about, tracks the delivery system and the year the label was last revised — not the hormone. "The boxed warning was removed" and "the risk was withdrawn" are different statements, and only the first is true here: the ambulatory monitoring result and the recommendation against use in uncontrolled hypertension both survived the removal intact.	There was and there is not. Recent Major Changes: "Boxed Warnings, Blood Pressure Increases — Removed 03/2025", alongside "Warnings and Precautions, Cardiovascular Risk (5.4) — Removed 03/2025". The same table records section 5.4 itself as revised 03/2025, and 5.4 still carries the finding: +3.9/1.5 mm Hg after 12 weeks of treatment in clinical trials (n=62 with acceptable recordings).	The 2025 removals swept the class, at different dates: JATENZO, TLANDO and KYZATREX all lost the same blood-pressure box, the oral products in 07/2025. AVEED kept its box, because its box is about pulmonary oil microembolism and anaphylaxis rather than blood pressure, and it kept its REMS with it. Both AndroGels keep a box about secondary exposure to children. The enanthate vial never had one.
Whether depression and suicide are on the labelThis is the strongest psychiatric language on any US testosterone label, and it is attached to one brand because it came out of that brand's own trials. It is not transferable evidence about the hormone, and its absence from a competitor's label is not evidence of absence either.	Section 5.15, Risk of Depression and Suicide: "Depression and suicidal ideation and behavior, including completed suicide, have occurred during clinical trials in patients treated with XYOSTED."	No testosterone enanthate vial label has such a section — the pre-PLR format has no numbered warnings at all. Among the newer products, JATENZO has a 5.15 with the same heading but weaker wording ("Depression and suicidal ideation has been reported in patients treated with JATENZO"), while KYZATREX and TLANDO, the other two oral undecanoates, have no such section.
Whether adverse reactions come with a rateThe comparison people want — is the autoinjector safer than the vial — cannot be made from the labels, because only one of them counts. A 12.7% hypertension rate looks alarming next to a vial label that reports no rate for anything, and the difference is documentary rather than clinical.	Counted, in 150 patients over a year: hematocrit increased 21 (14.0%), hypertension 19 (12.7%), PSA increased 18 (12.0%), injection site bruising 10 (6.7%), headache 8 (5.3%). Hypertension is the second most common adverse reaction in the pivotal study of this product.	The enanthate and cypionate vial labels list adverse reactions by organ system with no numbers at all — "Gynecomastia and excessive frequency and duration of penile erections", "Hirsutism, male pattern of baldness, seborrhea, and acne" — because the pre-PLR format does not require incidence tables.
Whether a half-life is statedEvery "enanthate half-life is about 4.5 to 8 days" table on the internet is sourcing that number from somewhere other than an FDA label, because no enanthate label contains one. What XYOSTED does give is more useful for dosing anyway — a median peak inside half a day and steady state at six weeks, which is exactly why the label draws its first trough at week 6.	Nowhere. Section 12.3 reports that serum testosterone peaks at a median of 11.9 hours post-dose (range 5.8 to 168.7 hours) and that "Steady state serum testosterone concentration was achieved by Week 6", and gives no half-life for the ester.	DEPO-Testosterone states one for its ester in a single sentence: "The half-life of testosterone cypionate when injected intramuscularly is approximately eight days." The Hikma enanthate vial gives only free testosterone's, "ranging from 10 to 100 minutes", which is not the ester either.
The oil, and where it appearsA sesame allergy rules out both enanthate products and neither cypionate one; a cottonseed sensitivity does the reverse. Because XYOSTED is preservative-free and single-dose it is the only one of the four with no benzyl compound in it at all, which matters to anyone who has reacted to an injection site rather than to the hormone.	Sesame oil, and it is the only inactive ingredient — "Inactive ingredients: sesame oil". It is also named in Contraindications: "Men with known hypersensitivity to XYOSTED or any of its ingredients (testosterone enanthate and sesame oil)." Preservative-free.	The enanthate vial is also sesame oil but adds 5 mg of chlorobutanol per mL as a preservative, because it is multiple-dose. DEPO-Testosterone is cottonseed oil with benzyl benzoate and 9.45 mg of benzyl alcohol. AVEED is castor oil with benzyl benzoate. Four injectable testosterones, three different oils.

XYOSTED autoinjector

Dosage form: Injection, solution in a single-dose autoinjector — in sesame oil, preservative-free, CIII
Route: Subcutaneous, abdominal region only, once weekly
Marketing category: NDA — NDA209863
Label read: SPL version 16, effective July 1, 2025

What this product is approved to treat

—XYOSTED (testosterone enanthate) injection 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 cryptorchidism, bilateral torsion, orchitis, vanishing testis syndrome, orchiectomy, Klinefelter's 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 XYOSTED in men with “age-related hypogonadism” has not been established."
—Limitation of use: "Safety and efficacy of XYOSTED 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 dose	None	Section 2.1: "Prior to initiating XYOSTED, 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 serum testosterone concentrations are below the normal range." Section 5.1 adds a second precondition: "Check that hematocrit is not elevated prior to initiating XYOSTED."
Week 1 onward	75 mg once weekly	Section 2.2: "The starting dose of XYOSTED is 75 mg, administered subcutaneously in the abdominal region once a week." Every patient starts here; there is no lower initiation rung. Weekly is labelled for one product only — XYOSTED, a sealed subcutaneous autoinjector. It is not the interval on either oil vial.
Week 6	75 mg once weekly, pending the result	The first decision point. "Measure total testosterone trough concentrations (measured 7 days after the most recent dose) following 6 weeks of dosing, following 6 weeks after dose adjustment, and periodically while on treatment with XYOSTED. A trough concentration between 350 ng/dL and 650 ng/dL generally provides testosterone exposures in the normal range during the entire dosing interval." Section 12.3 adds that steady state is reached by week 6.
Week 7, if the trough is high	50 mg once weekly	"Decrease the dose by 25 mg if the total testosterone trough concentration (Ctrough) is ≥650 ng/dL." That is a device swap rather than a dial adjustment — the 50 mg autoinjector is a different product code.
Week 7, if the trough is low	100 mg once weekly	"Increase the dose by 25 mg if the total testosterone Ctrough is <350 ng/dL." This is the top: no autoinjector above 100 mg exists, so there is no second increase to make. The reachable set is 50 mg, 75 mg, 100 mg and nothing else.
In range	Unchanged	"Maintain the same dose if the total testosterone Ctrough is ≥350 ng/dL and <650 ng/dL." Then re-measure 6 weeks after any adjustment and periodically thereafter, plus hematocrit "approximately every 3 months" and blood pressure periodically.

Ceiling. The label names no "maximum recommended dosage", but the product supplies one by construction: the largest autoinjector is 100 mg and the titration rule moves 25 mg at a time from a 75 mg start, so 50 mg, 75 mg, 100 mg is the whole reachable set. There is no 125 mg device and no instruction to give two. In the pivotal studies "All patients were started on 75 mg weekly, then the dose was titrated to 50 mg or 100 mg weekly, as needed, to achieve pre-dose total testosterone concentrations of ≥350 ng/dL and <650 ng/dL."

How it is supplied

Presentation	Total strength	Concentration	Delivers
Single-dose pressure-assisted autoinjector, 0.5 mL — carton of 4, or a single autoinjector	50 mg/0.5 mL	100 mg/mL — derived from the strength and the fill, which the label never prints as a concentration	50 mg subcutaneously, abdomen only. Preservative-free and single-dose: "Do not use XYOSTED if the seal is broken. Discard unused portion." There is no partial dose — a change of dose is a change of device.
Single-dose pressure-assisted autoinjector, 0.5 mL — carton of 4, carton of 1, or a single autoinjector	75 mg/0.5 mL	150 mg/mL — derived from the strength and the fill, which the label never prints as a concentration	75 mg subcutaneously, abdomen only. Preservative-free and single-dose: "Do not use XYOSTED if the seal is broken. Discard unused portion." There is no partial dose — a change of dose is a change of device.
Single-dose pressure-assisted autoinjector, 0.5 mL — carton of 4, carton of 1, or a single autoinjector	100 mg/0.5 mL	200 mg/mL — derived from the strength and the fill, which the label never prints as a concentration. This is the only one of the three that matches the 200 mg/mL enanthate vial	100 mg subcutaneously, abdomen only. Preservative-free and single-dose: "Do not use XYOSTED if the seal is broken. Discard unused portion." There is no partial dose — a change of dose is a change of device.

Administration, as the label words it

—Section 2.3: "XYOSTED is for subcutaneous injection in the abdominal region only. Avoid intramuscular or intravascular injection."
—Instructions for Use: "Only use the left or right side of the abdomen (belly) for injection sites." "Gently squeeze the abdomen injection site to create a raised area and hold that area firmly until after the injection is complete." "Keep the Auto-Injector straight at a 90 degree angle to the abdomen injection site." "Firmly push the Auto-Injector down on the abdomen site and continue to hold down after you hear the “CLICK”."
—Section 2.3: "Visually inspect XYOSTED for particulate matter and discoloration prior to administration. Do not use if the liquid is cloudy or if visible particles are present." "Do not use XYOSTED if the seal is broken. Discard unused portion."
—Section 5.4, the content that was demoted out of the boxed warning rather than deleted: "XYOSTED can increase blood pressure. Ambulatory blood pressure monitoring (ABPM) demonstrated XYOSTED increased systolic/diastolic BP by an average of 3.9/1.5 mm Hg from baseline after 12 weeks of treatment in clinical trials. In patients with hypertension on antihypertensive therapy, XYOSTED increased the mean systolic/diastolic BP by 3.9/1.3 mm Hg from baseline." And: "XYOSTED is not recommended for use in patients with uncontrolled hypertension."
—Section 5.15, Risk of Depression and Suicide: "Depression and suicidal ideation and behavior, including completed suicide, have occurred during clinical trials in patients treated with XYOSTED. Advise patients and caregivers to seek medical attention for manifestations of suicidal ideation or behavior, new onset or worsening depression, anxiety, or other mood changes."
—Section 5.1: "Evaluate hematocrit approximately every 3 months while the patient is on XYOSTED. If hematocrit becomes elevated, stop XYOSTED until the hematocrit decreases to an acceptable level. If XYOSTED is restarted and again causes hematocrit to become elevated, stop XYOSTED permanently."
—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 XYOSTED or any of its ingredients (testosterone enanthate and sesame oil)". The oil is named in the contraindication.

Storage

Autoinjector, in its carton: Section 16.2 opens with the prohibition rather than the instruction: "Do Not refrigerate or freeze. Use at room temperature." Then "Store at controlled room temperature, 20°C to 25°C (68°F - 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F)."; Until the expiration date; no in-use period, because there is no second use
Light exposure: "Protect from light (keep in carton until time of use)."; Keep in the carton until the moment of injection

Children and adolescents

"Safety and effectiveness of XYOSTED 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 nearly as thin at the other end: of the 283 patients in the pivotal studies, 49 (17%) were over 65, and "there are insufficient long-term safety data in geriatric patients to assess the potentially increased risk of cardiovascular disease and prostate cancer."

This statement belongs to XYOSTED autoinjector. It is not a statement about testosterone enanthate, and another brand of the same molecule may say the opposite.

The same molecule under other brand names

Everything below is testosterone enanthate. None of it is Xyosted, 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
Testosterone Enanthate Injection, USP (Hikma)	Intramuscular oil solution, 200 mg/mL multiple-dose vial, sesame oil with chlorobutanol — ANDA 091120	Replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone, with the same age-related-hypogonadism limitation. No boxed warning; no incidence figures anywhere	50–400 mg every 2 to 4 weeks, slowly and deeply into the gluteal muscle	No maximum stated; no titration target, no trough window
Testosterone Enanthate Injection, USP (Eugia)	Intramuscular oil solution, sesame oil — a second ANDA of the same vial	The same indications on the same pre-PLR template, with the same class blood-pressure paragraph inside WARNINGS	50–400 mg every 2 to 4 weeks, intramuscular	No maximum stated
Aveed	Intramuscular testosterone undecanoate, 750 mg/3 mL in castor oil — NDA 022219	The same two hypogonadism indications, but boxed for serious pulmonary oil microembolism reactions and anaphylaxis, with 30 minutes of observation in the healthcare setting 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

Everyone starts at the same dose, whatever they were on before

The starting dose of XYOSTED is 75 mg, administered subcutaneously in the abdominal region once a week.

XYOSTED

The route is a prohibition, not a preference

XYOSTED is for subcutaneous injection in the abdominal region only. Avoid intramuscular or intravascular injection.

XYOSTED

What the removed boxed warning left behind

XYOSTED can increase blood pressure. Ambulatory blood pressure monitoring (ABPM) demonstrated XYOSTED increased systolic/diastolic BP by an average of 3.9/1.5 mm Hg from baseline after 12 weeks of treatment in clinical trials. In patients with hypertension on antihypertensive therapy, XYOSTED increased the mean systolic/diastolic BP by 3.9/1.3 mm Hg from baseline. Monitor blood pressure periodically in men using XYOSTED, especially men with hypertension. XYOSTED is not recommended for use in patients with uncontrolled hypertension.

XYOSTED — section 5.4, after the box came off

The same ester, the opposite instruction

Care should be taken to slowly inject the preparation deeply into the gluteal muscle, being sure to follow the usual precautions for intramuscular administration, such as the avoidance of intravascular injection. Testosterone products are not recommended for use in patients with uncontrolled hypertension.

The enanthate vial — the product people switch from

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. XYOSTED is a single-source brand dispensed in cartons of four and of one at three strengths, and what a patient pays turns on formulary tier, prior authorisation, manufacturer copay assistance and whether the prescriber has already tried the generic vial — none of which we can cite and re-verify the way every label quote here is cited. A stale figure here would be repeated as a reason to choose or reject a treatment, so the field is absent rather than estimated.
An equivalent dose of the enanthate vial, or of cypionate: No label supplies one, and the difference is not only the arithmetic. The vial is intramuscular at 50 to 400 mg every two to four weeks; XYOSTED is subcutaneous at a fixed 75 mg weekly with a different absorption profile, a different peak and a titration target the vial label does not have. Writing "75 mg weekly is about 150 mg fortnightly" would be dividing one product's regimen into another's calendar and presenting the quotient as a labelled dose. The label's own answer to "what should I switch to" is that everyone starts at 75 mg and is measured at week 6.
A half-life for testosterone enanthate: There is not one on this label or on any enanthate label read for this page. XYOSTED's section 12.3 gives a median time to maximum concentration of 11.9 hours with a range of 5.8 to 168.7 hours, and states that steady state is reached by week 6; the Hikma vial offers only free testosterone's 10 to 100 minutes, which is a different quantity. The eight-day figure that circulates for injectable testosterone comes from the cypionate label and belongs to the other ester. This page prints the peak and the steady-state week instead, because those are what the label actually measured and what the week-6 trough rule is built on.
Whether the removed boxed warning means the blood-pressure risk was reduced: Not a question this page will answer, because the label does not and the distinction matters clinically. What is documented is that the box came off in 03/2025, that the cardiovascular-risk warning at 5.4 came off with it, and that the blood-pressure content stayed as a Warning and Precaution with its numbers intact. The evidence FDA had in front of it included TRAVERSE — 5,198 hypogonadal men with cardiovascular disease or multiple risk factors, MACE 7% on topical testosterone gel against 7.3% on placebo — which is a study of a gel rather than of this product. Reading across from that to "XYOSTED is now known to be cardiovascularly safe" is a step neither the label nor the trial takes.

Frequently asked questions

Does Xyosted still have a boxed warning?: No. Its Recent Major Changes table records "Boxed Warnings, Blood Pressure Increases — Removed 03/2025", along with "Warnings and Precautions, Cardiovascular Risk (5.4) — Removed 03/2025". But the blood-pressure content was moved rather than deleted: section 5.4 still opens "XYOSTED can increase blood pressure", still reports a mean ambulatory rise of 3.9/1.5 mm Hg at 12 weeks, and still closes "XYOSTED is not recommended for use in patients with uncontrolled hypertension." The same removal happened across the class in 2025 — Jatenzo, Tlando and Kyzatrex all lost the same box.
How much does Xyosted raise blood pressure?: Section 5.4 and section 6.1 give the figure from 24-hour ambulatory monitoring in the six-month study: among 62 patients with acceptable recordings at baseline and week 12, mean systolic rose 3.9 mm Hg (95% CI 1.4–6.4) and diastolic 1.5 mm Hg (95% CI 0.4–2.6). In men already on antihypertensive therapy it was 3.9/1.3 mm Hg (n=33); in men with no history of hypertension, 4.1/1.9 mm Hg (n=28). Separately, hypertension was the second most common adverse reaction in the one-year study — 19 of 150 patients, 12.7%.
Where do you inject Xyosted?: The abdomen, and only the abdomen. Section 2.3 states "XYOSTED is for subcutaneous injection in the abdominal region only. Avoid intramuscular or intravascular injection", and the Instructions for Use narrow it to "Only use the left or right side of the abdomen (belly) for injection sites." The technique is also specified: squeeze the site to raise the skin, hold the autoinjector at 90 degrees, push firmly and keep holding after the click. This is the opposite of every other approved enanthate product, which directs slow deep injection into the gluteal muscle.
What doses does Xyosted come in?: Three, all in the same 0.5 mL autoinjector: 50 mg, 75 mg, 100 mg. Because the fill is constant, those are three concentrations — 100 mg/mL, 150 mg/mL, 200 mg/mL — and only the 100 mg device matches the 200 mg/mL concentration of a generic enanthate vial. Everyone starts on 75 mg weekly, and the label adjusts by 25 mg in either direction based on a trough drawn after 6 weeks, so 50, 75 and 100 mg is the entire reachable set. There is no larger device and no instruction to give two.
How is the Xyosted dose adjusted?: On one number, measured at one time. "Measure total testosterone trough concentrations (measured 7 days after the most recent dose) following 6 weeks of dosing, following 6 weeks after dose adjustment, and periodically while on treatment." Then: decrease by 25 mg if the trough is ≥650 ng/dL, increase by 25 mg if it is <350 ng/dL, hold if it sits between. The label explains why that window: a trough between 350 and 650 ng/dL "generally provides testosterone exposures in the normal range during the entire dosing interval", and steady state is reached by week 6.
Is Xyosted the same as testosterone enanthate from a vial?: Same molecule, same oil, almost nothing else. The vial is 200 mg/mL multiple-dose with 5 mg of chlorobutanol per mL as preservative, injected deeply into the gluteal muscle at 50 to 400 mg every two to four weeks, with no titration target and no incidence figures on its label. XYOSTED is preservative-free, single-dose, sealed, subcutaneous into the abdomen at a fixed 75 mg weekly, titrated against a trough, with a counted adverse-reaction table and a Risk of Depression and Suicide section. Sesame oil is a contraindication on both, and it is the only inactive ingredient in XYOSTED.
Can Xyosted be refrigerated?: No, and section 16.2 opens with the prohibition rather than the storage range: "Do Not refrigerate or freeze. Use at room temperature." The range itself is 20 °C to 25 °C with excursions permitted to 15 °C to 30 °C, and the label adds "Protect from light (keep in carton until time of use)." There is no in-use period because there is no second use — each autoinjector is single-dose and the label directs discarding the unused portion.
Why does Xyosted have a suicide warning?: Because it came out of this product's own clinical programme. Section 5.15 states: "Depression and suicidal ideation and behavior, including completed suicide, have occurred during clinical trials in patients treated with XYOSTED. Advise patients and caregivers to seek medical attention for manifestations of suicidal ideation or behavior, new onset or worsening depression, anxiety, or other mood changes." It is the strongest psychiatric language on any US testosterone label. Jatenzo carries a section with the same heading but reports only ideation; Kyzatrex and Tlando, the other oral undecanoates, carry none, and neither do the vial labels.

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Compare online testosterone providersWho will write an autoinjector, who insists on a vial, and what each one requires before they will.Check whether your interval is on a labelEnter a frequency and see whether it is inside the vial window, XYOSTED-only, or not labelled for any product.

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