Natesto: The Definitive Guide

What is Natesto?

Natesto is a prescription testosterone gel for the nose. A small pump places the gel on the inside wall of each nostril, and the testosterone passes through the nasal lining into the blood. Unlike injections, it has no chemical tail to slow it down, so each dose rises and falls within hours and has to be repeated during the day. [1], [2]

It is labeled for adult men with hypogonadism (low testosterone from a medical cause): either primary hypogonadism, where the testicles fail, or hypogonadotropic hypogonadism, where the brain and pituitary do not send enough signal. Like every US testosterone label, it still says that safety and benefit in "age-related" low testosterone have not been established. [1]

[1], [2], [3], [4], [5], [50], [51]

Natesto is the only FDA-approved nasal testosterone, and the FDA's Orange Book lists no generic version (checked September 2026). It is used far less than injections or gels: Medicare Part D paid for 634 Natesto prescriptions for 160 people in 2024. [4], [5], [53]

Because it is testosterone, it is a controlled substance: Schedule III in the United States. [55] Compounded nasal testosterone products also exist; they are not covered by the label or the studies described here. [80]

Typical Natesto Protocols

Every source uses the same 11 mg dose, one pump in each nostril. They differ only on how many doses a day: the US label says three, while Canada's label and published practice series start at two and add a third if needed. The Canadian urology guideline lists twice a day, and the Endocrine Society allows either. [1], [2], [13], [14], [16], [17]

Titration Adjusting the dose in steps

The US label has no dose steps: it checks total testosterone "periodically, starting as soon as one month," stops treatment if the level is consistently above 1,050 ng/dL (36.4 nmol/L) and suggests another treatment if it stays below 300 ng/dL (10.4 nmol/L). Canada starts at twice a day and adds the third dose if one blood draw 20 minutes to 2 hours after a morning dose is below 300 ng/dL, or symptoms are not treated within 90 days. The American Urological Association (AUA) checks nasal testosterone 2 to 4 weeks after starting, with the gel used on the day of the test. [1], [2], [15] See why draw timing matters.

Breaks and cycles

Not applicable. Testosterone replacement is continuous treatment; no label or guideline describes planned breaks or cycles. The US label does say to pause Natesto during a bout of severe rhinitis (a badly inflamed, runny or blocked nose) until it settles (colds and allergies). Stopping is a separate decision (what happens when you stop). [1]

Read the units. Natesto is counted in pumps, not millilitres or syringe units. One dose is 2 pumps, one in each nostril, which delivers 11 mg. An 11 g pump holds 60 pumps, or 30 doses: that is 10 days at three doses a day, or 15 days at two. The amount each time and the daily total are different numbers: 11 mg three times a day is 33 mg a day, or 231 mg a week. Those milligrams cannot be compared one for one with an injection or a skin gel, because each form absorbs differently. Doserly's TRT dose calculator can still show daily and weekly totals. [1]

These are labeled and guideline doses; prescribers adjust them using blood tests and symptoms. The schedules above are for adult men. For women, see testosterone therapy for women, which uses different products and far smaller doses.

Cautions for every schedule above. The US label rules out testosterone with breast or known or suspected prostate cancer and in women who are pregnant or breastfeeding. Natesto is not recommended with a history of nose or sinus disorders, past nose or sinus surgery, a recent nasal fracture or uncontrolled high blood pressure (who should be cautious). It can lower sperm production (fertility), and hematocrit, blood pressure and PSA (prostate-specific antigen, a prostate blood test) need checking (monitoring). [1], [2]

Where schedules differ: two or three doses a day, when to draw blood, fertility, and colds and allergies ↓

What do practice series and trial protocols use?

Both start at twice a day, as Canada's label does, and add the third dose only when needed. In the US series only 1 of 27 men needed it; in the Canadian study 37% were raised, without a further gain in symptom scores. [16], [17]

What is Natesto commonly used for?

Its approved use is replacing testosterone in men whose bodies cannot make enough because of a medical condition, either testicular failure or a missing signal from the brain or pituitary. Diagnosis needs symptoms and low morning testosterone on at least two separate days. [1], [15]

What does Natesto improve?

The pivotal trial measured blood levels, not symptoms: its goal was an average testosterone level in the normal range at day 90, and 90% of men on three doses a day reached it. Symptom data come from smaller open-label studies without a placebo group, where men knew they were being treated. [1], [11]

• Sexual desire. In a single-group study of 60 men, sexual desire and overall satisfaction scores improved. In a practice series of 41 men switched from clomiphene, 38 reported better libido after 3 months. [22], [27]
• Symptom scores. In the maker's Canadian study of 117 men, 77% were in the normal range at the end; for the 37% whose dose was raised to three times a day, symptom scores did not change significantly at the higher dose. [17]
• Erections. In a randomized trial comparing Natesto with cypionate injections, erectile function scores improved only in the injection group. [29]

What testosterone does in general is better known from larger trials of other forms: mainly better sexual desire and activity, with small effects on mood and energy symptoms. See the results timeline guide and the evidence section. [69], [71]

How long does Natesto take to work?

Blood levels rise within about 40 minutes of each dose. Symptoms change more slowly, and there are no Natesto-specific data on how long that takes. For testosterone in general, the Canadian Urological Association tells men to expect changes in libido, energy and sexual function after 3 months or longer, and in body composition and bone after 6 months or more. The AUA suggests discussing whether to stop after 3 to 6 months if levels are normal but symptoms have not improved. [1], [14], [15]

Where do Natesto protocols differ?

The label is strict and the rest of the literature is looser. Most real disagreements are about how many doses a day, when to draw blood, whether it protects fertility and what to do with a cold or allergies.

Twice or three times a day?

The US label says three times a day because only that schedule passed FDA's test. In the trial, 228 men were randomly assigned to start twice a day (some later moved to three times) and 78 to three times a day from the start. FDA wrote that the results "did not reach the pre-determined success threshold" for the twice-daily approach, while "efficacy was shown for the TID-only, fixed-dose regimen" (TID means three times a day). The maker then changed its application to three doses a day for everyone. [7], [8]

The per-protocol numbers show the gap: the average level was in range for 76 of 102 men (75%) on twice a day, 43 of 68 (63%) who were moved up from twice to three times a day, and 61 of 67 (91%) on three times a day from the start. [12]

Canada approved the same product with a twice-daily start, and the Endocrine Society lists "two or three times daily." In practice many men stay on two doses: 60 of 77 previously treated men in the maker's Canadian study, and 26 of 27 in one US practice. The real disagreement is whether twice a day works for enough men to be the labeled start, and the answer differs by country. [2], [13], [19], [16]

When should blood be drawn on Natesto?

It matters more than with most forms, because the level changes within minutes of a dose. On three doses a day, the average level at day 90 was 421 ng/dL (about 14.6 nmol/L), but the peak averaged 1,044 ng/dL and the lowest point 215 ng/dL, all in the same men on the same day. A draw 45 minutes after a dose and a draw 6 hours after it describe the same treatment. [1], [8]

[1], [2], [15], [16]

No source recommends waiting for a trough (the lowest level before the next dose), although the earlier version of this guide suggested it. On Natesto a trough mostly shows how fast one dose wears off. Whatever timing a prescriber uses, recording the time of the last dose before the draw makes results comparable. See TRT blood work for the wider picture.

Doserly

A day on Natesto: doses, levels and blood-draw timing

A day on three doses

Doses

11 mg (one pump in each nostril) three times a day, 6 to 8 hours apart, for example 7 am, 2 pm and 9 pm.

When blood is drawn

Canadian label: one draw 20 minutes to 2 hours after the morning dose (shaded). US practice series (2022): 1 hour after the morning dose. US label: testosterone is checked from about 1 month after starting, with no time of day named.

Day-90 averages: 69 men on 3 doses a day

Total testosterone, mean ± SD. Shaded: the 300–1,050 ng/dL range used in the approval trial.

Peak

1,044 ± 378 ng/dL (about 36.2 nmol/L)

Average

421 ± 116 ng/dL (about 14.6 nmol/L)

Lowest

215 ± 74 ng/dL (about 7.5 nmol/L)

Peak about 40 minutes after a dose (median 0.65 hours). About 16% of these men had a peak above 1,500 ng/dL. In range for an average of 16 hours a day (FDA).

Record the time of the last dose: on average, the peak was nearly five times the lowest level of the day.

Does Natesto protect fertility?

Guidelines genuinely disagree, and no one promises it. The small studies suggest nasal testosterone lowers the brain's signals to the testicles less than long-acting forms (details). Guideline bodies read that evidence differently:

• Canadian Urological Association (2021): nasal testosterone "may represent a treatment option for symptomatic hypogonadal men who desire to maintain fertility potential." [14]
• AUA and American Society for Reproductive Medicine (2020, amended 2024): in two studies it "was associated with preserved spermatogenesis," but "given the lack of long-term data, this agent, like other forms of exogenous testosterone, should not be routinely used by males attempting to conceive." [21]
• European Association of Urology (2026): "Preliminary results suggest" less suppression of these signals and a lower risk of hematocrit rises; it still advises against testosterone for men wishing to become fathers. [20]

Suppression can still happen. In one practice, a man switched from clomiphene to Natesto twice a day saw his hormone signals and semen results fall; they recovered after his dose was lowered, while 48 other men in the same practice stayed stable. [28] Men who want children now or soon should discuss fertility-first options; see TRT and fertility and the hCG guide.

What if I have a cold or allergies?

The US label says to pause Natesto during a bout of severe rhinitis and to consider another treatment if it persists. For milder symptoms the data are mixed but reassuring: [1]

• In an allergy-chamber study of 18 men, symptoms did not change how much of the dose was absorbed, but the men's own testosterone before the dose was 21–25% lower while they had symptoms. [34]
• FDA's analysis of the same study found total exposure about 21% higher without symptoms than with untreated symptoms, and the US label reports levels 21–24% lower during allergy symptoms. The two views differ in what they count; both describe lower totals while symptomatic. [8], [1]
• A decongestant spray, oxymetazoline, used 30 minutes before Natesto barely changed absorption (2.6% lower overall exposure). The label names no required gap. [1]

The pivotal trial excluded men with active allergies, asthma or regular nasal medicines, so evidence in those groups is thin. [8]

What happens when you stop Natesto?

The drug itself wears off within hours; what happens next has not been studied. Each dose peaks within about 40 minutes and fades within hours, so soon after the last dose your blood level reflects only your own production. [1], [8]

• Your own testosterone. No study has followed men after stopping Natesto. In men with a lasting cause of hypogonadism, low testosterone and its symptoms are expected to return. The Canadian Urological Association says no taper is needed when stopping testosterone. [14]
• Sperm. No study has measured sperm recovery after stopping Natesto. The only related data come from a practice series of 27 men who switched from long-acting testosterone to Natesto: all 27 had sperm in their semen afterwards, and one couple conceived. Only 10 of them had a documented zero sperm count beforehand, and the series did not compare switching with simply stopping. [16]
• When it does not help. The Canadian Urological Association advises stopping testosterone if symptoms have not improved after about 3 months despite normal levels, and the AUA suggests discussing stopping after 3 to 6 months. [14], [15]

See stopping TRT for the full picture, including fertility recovery after other forms.

How does a nasal dose behave in the body?

It is a short-acting form: testosterone itself, absorbed quickly and cleared quickly. That is the main difference from injections, gels on the skin and long-acting pellets, and it explains both its advantages and its three-times-a-day schedule. [1], [13]

How long does one dose last?

The US label says levels peak about 40 minutes after a dose; the Canadian monograph says within 45 minutes; FDA's review gives a median of 0.65 hours, with a range of 0.3 to 6.1 hours. Testosterone released into the blood is cleared quickly: the labels quote a half-life of 10 to 100 minutes, which FDA noted is a range from the medical literature rather than a Natesto measurement. [1], [2], [8], [10]

At day 90 on three doses a day, FDA found levels stayed within 300–1,050 ng/dL for an average of 16 hours a day, and noted that Natesto keeps testosterone "generally in the lower one-half of the reference range." About 16% of men had a peak above 1,500 ng/dL, and 1.4% peaked between 1,800 and 2,500 ng/dL; at day 90, no man taking three doses a day peaked above 2,500 ng/dL, although one man still on twice a day did (at day 30, three men had: two on twice a day and one on three times). [7], [1]

Does Natesto mimic the body's natural rhythm?

That claim is weaker than it sounds. It comes from a 2008 computer model of an earlier nasal formulation, which suggested nasal dosing "can be used to mimic the normal diurnal pattern," and from a later analysis led by the maker's employees. No study compares how "natural" different testosterone forms are. What the data do show is short peaks after each dose with lower levels in between. [26], [25]

How is it different from gels and injections?

• No transfer by touch. Testosterone gels on the skin carry a boxed warning about passing testosterone to children and partners. FDA noted that, compared with transdermal products (absorbed through the skin), nasal gel has "no risk of skin reactions or transfer to others," and Natesto has no boxed warning. [95], [7], [1]
• No needles and no liver first pass. It avoids injections, and absorption through the nose bypasses the liver on the way in (first-pass metabolism). [13]
• More doses a day. The Endocrine Society lists the drawbacks plainly: "Multiple daily intranasal dosing required; local nasal side effects, not appropriate for men with nasal disorders." [13]
• Lower levels. Its average level at day 90 (421 ng/dL) sat in the lower half of the trial's range. In a randomized comparison, testosterone rose by an average 283 ng/dL on Natesto and 511 ng/dL on cypionate injections every 2 weeks. [1], [7], [29]

How do you use the pump?

The label's instructions, in short: [1]

1. Before first use, prime the pump by pressing it 10 times.
2. Blow your nose.
3. Put the tip into one nostril, tilted toward the outer side wall, and press the pump fully once. Repeat in the other nostril.
4. Gently press and massage the outside of the nose to spread the gel.
5. Do not blow your nose or sniff for 1 hour after a dose.
6. Replace the pump when the piston reaches the arrow on the side of the dispenser.

Canada adds that each dose should be at least 6 hours after the previous one and at least 1 hour before going to bed. [2]

How should Natesto be stored?

Store it at room temperature. Neither label gives a separate in-use period after first use; the pump is used until empty. Each product's label sets its own rules, so the leaflet in your box is the final word. [1], [2]

[1], [2]

For carrying it on a trip, see traveling with testosterone.

What does Natesto do to fertility, estrogen and red blood cells?

These three effects come with every form of testosterone; each has its own hub guide. Here is what is specific to Natesto. The studies are small, mostly open-label and mostly from one university group, one urology practice or the maker, so they suggest a difference rather than prove one.

Fertility. The Natesto label warns that it can suppress sperm production. Four studies give the form-specific picture:

• The main fertility study. In a single-group study of 60 men aged 18 to 55 on 11 mg three times a day, total motile sperm count stayed above 5 million in 93.9% of men evaluated at 6 months, and LH (luteinizing hormone) stayed normal in 72.7% and FSH (follicle-stimulating hormone) in 81.8%. [22]
• Its limits. Only 33 of the 60 men were evaluated at 6 months. The trial registry lists 1 man who developed no sperm at all (azoospermia) and 3 with severely low counts. [22], [23]
• A comparison from injections. In a World Health Organization trial in a different population, weekly 200 mg enanthate injections made 65% of healthy men azoospermic within 6 months (a cumulative rate; 157 of the 271 men reached it). [74]
• Hormone signals across forms. A review co-written with the maker and its former US partner found nasal gel lowered FSH by 37.8% and LH by 47.3%, against 86.3% and 71.8% for long-acting injections. The nasal figure came from a single study. [24]

See TRT and fertility. [1]

Estrogen. Some testosterone is converted into estradiol. In the randomized comparison, estradiol rose by about 22.9 pg/mL on cypionate injections and 1.1 pg/mL on Natesto, and a practice series found estradiol lower after men switched from long-acting forms. FDA found estradiol changes consistent with testosterone dosing. See estrogen on TRT. [30], [16], [8]

Red blood cells. Two small studies found less effect than injections, but not none:

• Randomized trial. Over 4 months, cypionate 200 mg every 2 weeks raised average hematocrit from 42.7% to 46.6%, while Natesto caused no significant change. [29]
• Cross-sectional comparison. Among 30 men on each, none on Natesto reached 50%, against 10 of 30 on cypionate (3 reached 54% or more). [31]
• The approval trial. 7 men had a hematocrit above 54% at some point, all starting above average, and 4 of 306 went above 55%. [8], [1]

The largest analysis of hematocrit by form, a network meta-analysis of 29 randomized trials, did not include nasal gel. See hematocrit on TRT. [73]

Doserly

Hematocrit on Natesto vs injections: small studies

Rivero 2023: randomized, 4 months

81 men randomized, 54 finished; one university group.

Cypionate injections, 200 mg every 2 weeks

Average hematocrit 42.7% to 46.6%

Natesto, 11 mg 3 times a day

Started at 44.4%: no significant change

Best 2021: cross-sectional, 30 vs 30 men

Filled dots: 50% or higher (darkest: 54% or higher).

Cypionate, 100–200 mg weekly

10 of 30 at 50% or higher; 3 of them at 54% or higher

Natesto, 11 mg 3 times a day

0 of 30 at 50% or higher

Reddy 2023: matched cohort, 78 men, 16 weeks

Average change in hematocrit, percentage points. The nasal group started higher.

Injections (cypionate)

+4.4

Pellets

+1.7

Natesto (nasal)

−0.8

Natesto approval trial: 306 men, up to 1 year

Above 54% at some point

7 men, all of whom started above average (FDA review)

Above 55%

4 of 306 (starting values 48% and 51%); none above 58% (US label)

Small studies, mostly from one university group; not randomized except Rivero 2023. They compare groups, not individual risk.

What do we actually know about Natesto in people?

That it raises testosterone into the normal range for most men is established; it is approved for that. How it compares with other forms over years is not known. The evidence is one pivotal trial without placebo and a set of small studies, many by the same two groups.

Which studies used Natesto itself?

Most post-approval studies come from one university group in Miami or were run or funded by the maker; the pooled 17-hydroxyprogesterone analysis was also funded in part by a compounding pharmacy. [33] Reviews from 2025 describe nasal testosterone as a possible option for men who want to preserve fertility; one notes that "its efficacy has so far only been demonstrated in small sample sizes." [36], [78], [37]

What is still being studied?

• Blood pressure. A 24-hour blood-pressure study of Natesto, planned with about 218 men, has not posted results, and its status has been unknown since 2022. [39]
• Sperm recovery. A small University of Florida study of Natesto in men whose sperm counts fell on earlier testosterone therapy was completed in April 2025 with 13 men and has no posted results. [40]
• Teenagers. A pilot study in boys was stopped after enrolling 8, for lack of patients and commercial reasons. Use under 18 is specialist care only. [41]

What did the large trials of other forms find?

TRAVERSE, a trial of about 5,200 men on a daily skin gel, is covered in full below. Its substudies found that testosterone increased sexual activity and desire but not erections in men with low libido, did not significantly slow progression from prediabetes to diabetes, and did not improve persistent depressive disorder in the 49 men who had it. Whether those results apply to short nasal doses is not known; no trial has tested Natesto on heart, bone or prostate outcomes. [66], [69], [70], [71]

How does Natesto work?

Once absorbed through the nasal lining, the testosterone is the same hormone the body makes. In many tissues it acts after being converted to dihydrotestosterone (DHT), and some is converted to estradiol. In the blood, about 40% is bound to sex hormone-binding globulin (SHBG), about 2% is free and the rest is loosely bound to albumin and other proteins. The label notes that no specific pharmacodynamic studies (studies of the drug's effects on the body) were done with Natesto. [1]

Why it may switch off your own production less. The brain senses testosterone from any source and turns down its LH and FSH signals to the testicles when levels are high. One proposed explanation for Natesto's smaller effect is that levels fall between doses, giving the pituitary time without a strong signal. That is a hypothesis from an analysis led by the maker's employees, not something measured directly; the same analysis found LH fell more in men who started with higher testosterone. [25]

What are the risks and unanswered questions?

Is Natesto safe?

For men with a confirmed diagnosis and regular monitoring, it is an approved treatment with a clear set of risks: nose problems, the usual testosterone risks (red blood cells, blood clots, blood pressure, prostate effects, lower sperm production) and limited long-term nasal safety data. The evidence on its own safety comes from about a year of follow-up in a few hundred men; what remains unknown is long-term nasal safety and how it compares with other forms on heart and prostate outcomes. [1], [9]

What side effects do the labels list?

The nose comes first. Across all 306 men in the approval program, followed for up to a year, the most common reactions were: [1]

[1]

In the three-times-daily group over 90 days, a rise in PSA was the most common reaction (5.1%), and nine others each affected 3 of 78 men (3.8%): headache, runny nose, nosebleed, nasal discomfort, cold-like nose and throat inflammation, bronchitis, upper respiratory tract infection, sinusitis and nasal scab. Six of the 306 men stopped because of side effects. On average, PSA rose by 0.2 ng/mL over a year. [1]

What the nose exams showed. Every man in the trial had a monthly ear, nose and throat exam that included looking inside the nose with a camera. FDA reviewed 245 men with 6 months and 55 with 12 months of exposure. There were two reports of nasal ulcers and no holes in the central wall of the nose (septal perforation). A changed sense of smell was the most common nose symptom judged treatment-related (2.6% at day 90). Nasal side effects rose over the first 30 days, then eased and levelled off. No formal smell tests or tissue samples were done, and the label warns that long-term nasal safety data are limited. [9], [7], [1]

The labels also list the usual testosterone effects: a rise in red blood cells (polycythemia), breast enlargement (gynecomastia), fluid retention, liver problems (rare), changes in cholesterol, higher calcium in men with cancer, sleep apnea and changes in thyroid-binding protein test results. [1]

Does Natesto affect the heart?

The best evidence comes from TRAVERSE, a randomized trial of about 5,200 men aged 45 to 80 with heart disease or high heart risk, given a daily testosterone gel on the skin or a placebo gel. No such trial has used Natesto. Among the 2,596 men who used testosterone gel and the 2,602 who used placebo gel, it found:

• Heart attack, stroke or heart death: 182 men (7.0%) on testosterone vs 190 (7.3%) on placebo; hazard ratio 0.96, with a 95% confidence interval of 0.78 to 1.17. The top of that range stayed below the trial's safety margin of 1.5, so a large rise in risk was ruled out. [66], [1]
• Heart rhythm: atrial fibrillation 3.5% vs 2.4%; nonfatal rhythm problems needing treatment 5.2% vs 3.3%. [1]
• Kidneys: acute kidney injury 2.3% vs 1.5%. [1]
• Clots: venous clots 1.7% vs 1.2%, including pulmonary embolism 0.9% vs 0.5%. [1]
• Fractures: 91 of 2,601 men (3.50%) vs 64 of 2,603 (2.46%), counting every randomized man. [67]
• Blood pressure: systolic pressure rose 1.0 mm Hg on testosterone and fell 0.5 mm Hg on placebo by 36 months. [1]

Doserly

TRAVERSE: absolute results

Testosterone gel (2,596 men)Placebo gel (2,602 men)

Heart attack, stroke or heart death

Testosterone 7.0% vs placebo 7.3% (182 vs 190 men; hazard ratio 0.96, 95% CI 0.78–1.17; met the 1.5 safety margin)

Nonfatal rhythm problems needing treatment

Testosterone 5.2% vs placebo 3.3%

Atrial fibrillation

Testosterone 3.5% vs placebo 2.4%

Clinical fracture

Testosterone 3.5% vs placebo 2.5% (91 of 2,601 vs 64 of 2,603 in the full analysis set)

Acute kidney injury

Testosterone 2.3% vs placebo 1.5%

Venous clots (all)

Testosterone 1.7% vs placebo 1.2%

Pulmonary embolism

Testosterone 0.9% vs placebo 0.5%

About 5,200 men aged 45–80 at high heart risk; daily gel; mean treatment 21.7 months; about 61% stopped their study gel. A trial of a gel on the skin, not of nasal gel.

Its limits matter for Natesto. TRAVERSE tested only a skin gel, the average man used it for 21.7 months, about 61% stopped their study gel early, and it enrolled men at high heart risk. A 2025 meta-analysis of 23 trials lasting at least a year found no increase in death, heart attack or stroke, but about 50% more heart-rhythm problems (risk ratio 1.53). The Endocrine Society's July 2026 statement says long-term safety, including prostate cancer, is still not established. [66], [1], [72], [77]

What the Natesto label says now. A 2015 label change added a warning about a possible increase in heart attacks and strokes. In July 2025 that warning was removed and replaced with the TRAVERSE results and a class-wide blood-pressure warning, after FDA's February 2025 action for all testosterone products. FDA found that testosterone products as a class can raise blood pressure; no Natesto-specific 24-hour blood-pressure result has been published. [42], [44], [63], [39]

See TRT and heart health for the full picture.

What about blood clots, sleep apnea and fluid retention?

• Blood clots. The label reports clots in the legs (deep vein thrombosis) and lungs (pulmonary embolism) after marketing, a warning present since at least 2016, and now the TRAVERSE figures. Leg pain, swelling, warmth or redness, or sudden shortness of breath need urgent assessment. [1], [45]
• Sleep apnea. Testosterone may worsen sleep apnea; men with sleep apnea were excluded from the approval trial. [1], [8]
• Fluid retention. Swelling, with or without heart failure, can be serious in people with heart, kidney or liver disease. [1]

Could Natesto affect the prostate?

Testosterone can enlarge the prostate and raise PSA slightly. On Natesto, PSA rose by 0.2 ng/mL on average over a year. US labels contraindicate it in known or suspected prostate cancer and warn that men with an enlarged prostate may develop urinary blockage. In TRAVERSE, which excluded men with PSA above 3.0 ng/mL, high-grade prostate cancer occurred in 5 of 2,596 men on testosterone (0.19%) vs 3 of 2,602 on placebo (0.12%), a difference that was not significant. [1], [68] See TRT and the prostate.

Is Natesto legal? Is it FDA approved?

Checked September 2026. Rules differ by country and change often.

United States. Natesto is an FDA-approved prescription medicine, and testosterone is a Schedule III controlled substance. The key steps:

• Approval. FDA approved Natesto on May 28, 2014, through its 505(b)(2) pathway, which relies partly on published information about testosterone. It remains marketed, with patents listed until March 17, 2034, and no generic. [6], [4], [5]
• Holders. The approval went to Trimel Biopharma; later label changes were addressed to Endo's Auxilium (2015), Aytu BioScience (2016) and Acerus (2025), the current holder. [6], [42], [43], [44]
• Class label changes. In 2015 the label added the "age-related" limitation; in 2016 a warning on abuse and dependence; in July 2025 the TRAVERSE results and blood-pressure wording. Natesto has no boxed warning and no special safety program. [42], [43], [44], [7]
• June 18, 2026. The Department of Health and Human Services (HHS) announced that FDA is requesting label changes for testosterone products: removing the age-related limitation, contraindicating testosterone only in metastatic prostate cancer, and revising the prostate-enlargement warning. These are requests: the current Natesto label still carries the old wording. [62], [1]
• Telehealth. Temporary rules let clinicians prescribe controlled medicines such as testosterone without an in-person visit through December 31, 2026; a permanent Drug Enforcement Administration (DEA) special-registration rule is still under review. [64], [65]
• Compounded nasal testosterone. Compounded nasal products are not FDA-approved and were not tested in the studies above. The AUA advises commercially made testosterone over compounded products when possible. [15]

Canada. Testosterone is a Schedule IV controlled substance and prescription-only. Natesto has been sold in Canada since May 2016. The 2021 Canadian urology guideline described it as "currently unavailable due to a manufacturing modification"; it has been listed as marketed again since September 15, 2022. [56], [3], [14]

United Kingdom. Testosterone is a Class C controlled drug, prescription-only. No Natesto or other nasal testosterone product has UK product information on the electronic medicines compendium, and the British Society for Sexual Medicine describes Natesto as a US product. [57], [50], [49]

Australia. Testosterone is a Schedule 4 (prescription-only) medicine with extra controls on possession. Natesto is not among Australia's current testosterone product information documents. [58], [51]

European Union. The European Academy of Andrology wrote in 2020 that nasal preparations "are not currently available in Europe," and the 2026 EAU guideline names the United States and Canada as places where it is sold. National registers were not checked for this guide. [48], [20] See TRT in Europe.

Is Natesto banned in sport? Does it show up on a drug test?

Yes. Testosterone in any form is on the World Anti-Doping Agency (WADA) Prohibited List in class S1, banned in and out of competition, with no exception for the nasal route, and the 2027 list keeps that from January 1, 2027. Athletes with a medical need can apply for a therapeutic use exemption, which WADA grants only when low testosterone has an organic cause (such as a testicular or pituitary disorder), not for age, obesity or earlier steroid use. In a study of 5 healthy men using Natesto three times a day for 4 weeks, it was detectable with standard anti-doping tests. [59], [60], [61], [35]

Who should be especially cautious?

• Men with nose or sinus problems. The label does not recommend Natesto with a history of nasal disorders, a history of nose or sinus surgery, a nasal fracture in the past 6 months or one that left a deviated septum, inflammatory conditions of the nasal lining (such as Sjögren's syndrome) or sinus disease. [1]
• Men who want children now or soon. Guidelines disagree on nasal testosterone, and none recommends it routinely to men trying to conceive (details). [21], [14]
• Men with prostate or breast cancer. Contraindicated on current US labels (known or suspected prostate cancer). [1]
• High hematocrit or a history of clots. Several guidelines treat a high starting hematocrit or unexplained clots as reasons not to start; the approval trial excluded men with hematocrit above 54%. [13], [47], [8]
• Heart, kidney or liver disease, sleep apnea or high blood pressure. Fluid retention and blood-pressure rises can worsen these. The label does not recommend Natesto for men with uncontrolled high blood pressure. [1]
• Men with a body mass index above 35, or aged 65 and over. Safety and benefit above a body mass index of 35 have not been established, and only 60 of the 306 trial men were 65 or older (9 were 75 or older). [1]
• Women and children. Testosterone is contraindicated in pregnancy and breastfeeding and can harm an unborn baby; these guides are for men. Use in teenagers is specialist care only. [1], [41]
• Drug-tested athletes. Banned at all times. [59]

Can Natesto be taken with other medicines?

The labels list three interactions that apply to all testosterone, plus one specific to the nose:

• Other nasal sprays. Natesto "is not recommended for use with nasally administered drugs other than sympathomimetic decongestants" (sprays such as oxymetazoline that shrink swollen nasal tissue), because no other nasal medicines were studied. That includes steroid and antihistamine sprays: they have not been shown to change absorption, but they were never tested. [1], [9]
• Blood thinners (oral anticoagulants such as warfarin). Testosterone can change their effect, so clotting tests (INR) are checked more often. [1]
• Insulin and diabetes medicines. Testosterone can lower blood sugar and insulin needs. [1]
• Corticosteroids. Together they can increase fluid retention. [1]

Guidelines discuss hCG, clomiphene and aromatase inhibitors alongside testosterone for fertility or estrogen questions; see TRT and fertility and estrogen on TRT. Bring a full list of everything you take, including nasal sprays and supplements, to a pharmacist or doctor.

Is Natesto available, and what does it cost?

Checked September 2026.

In the United States it is marketed but little used: Medicare Part D paid for 634 prescriptions for 160 people in 2024, at a total gross cost of about $489,500. FDA's drug shortage data lists no testosterone shortage (updated September 26, 2026), although people in public forums describe pharmacies that could not order it in 2025 and 2026 (what people report). [53], [76]

There is no single US price. As a reference point, the average price US pharmacies paid for Natesto in September 2026 was $41.28 per gram, or about $454 for one 11 g pump, which lasts 10 days at three doses a day. What you pay depends on the pharmacy, insurance and any fees. No generic exists to lower the price. [52], [5]

In Canada, Alberta's drug price list sets a base price of CAD 8.41 per gram, about CAD 92.50 per pump (effective September 14, 2026); that list is for pricing only and does not show whether a plan covers it. [54]

What should be monitored while using Natesto?

The label asks for testosterone checks from 1 month, hematocrit before treatment, at 3 to 6 months and then yearly, prostate checks, blood pressure and cholesterol, and a report of any nose symptoms. It gives no numeric hematocrit limit. The numbers come from guidelines. Use this summary to prepare questions for your prescriber; it is not a personal testing plan. [1]

[1], [13], [15], [47], [75]

The Canadian Urological Association uses its own hematocrit trigger of 55%, and the European urology guideline monitors testosterone and hematocrit at 3, 6 and 12 months and then yearly. [14], [20] See TRT blood work and hematocrit on TRT.

Write down the timing. For every testosterone result, note the time of your last dose and how many doses a day you take. On Natesto, a result without its timing is almost impossible to interpret.

What do people in public communities report?

Public forums hold every kind of Natesto story: men who feel better within days, men who feel nothing and have sore noses, and many who simply cannot get it filled. The accounts below come from public Reddit threads, most from the past year, and are described without identifying anyone.

What do the positive reports look like?

Better energy, mood and sex drive are the usual good news. A man in his 20s with a morning level of 253 noticed more motivation, energy and sexual function about 10 days after starting, before any follow-up blood test; replies pointed out that muscle changes would depend on training. Another man, who had switched after years of injections and a cream, felt much better, especially sexually, and said his hematocrit moved from 49–54% on injections to the low to mid 40s on Natesto. [79], [80]

Some reports run longer. A man in his 20s said Natesto worked well for about two years, with levels around 950 ng/dL, before cost made him stop; two years later his symptoms returned and he started weekly injections. Another said Natesto improved his mood and brought his level into the normal range, until a supply problem ended treatment after about two months. [81], [82]

Does everyone respond?

No. One man in his 20s, who started with a level of 294, had no relief from tiredness or low mood after about five weeks and instead had a dry, cracked, blocked nose, nosebleeds about weekly, and an unpleasant taste and throat itch. A man who used Natesto for about a year found three daily applications messy and felt the brief rise in testosterone never fully relieved his symptoms; after switching to injections with hCG he described much better energy, sleep and sexual function, with several things changed at once. [86], [88]

One commenter used half the prescribed dose and described getting about two-thirds of the benefit he hoped for on most days, until refills became unavailable. [83]

What unwanted effects come up?

• Nose and throat. Blockage, dryness, nosebleeds and the taste of gel in the throat come up repeatedly, as in the account above. One man who otherwise did well mentioned an occasional taste of gel. [86], [80]
• Too strong a sex drive. After about a week, one man with a starting level of 168 described a sex drive so much stronger than before that it affected his concentration at work, with frequent unplanned erections; he did not report whether it settled. [85]
• The routine itself. Two accounts describe the three daily doses as a burden: one man found them messy, and another planned to switch to a once-daily cream for convenience. [88], [89]

Why do blood results confuse people?

Timing again. One man in his 20s who started at 294 had a result of 119 after about two months and was switched to a skin gel by his doctor. Replies raised absorption, suppression and the timing of the draw, but the post did not say how long after a dose the blood was taken, so the result cannot be read either way. [87] See when blood should be drawn.

What do people report about getting it?

Access dominates the discussion:

• Pharmacies. People in Texas, California and elsewhere describe pharmacies that could not fill Natesto, in one case because suppliers had no stock; some found it elsewhere after several attempts, including a man with secondary hypogonadism who was prescribed it because he and his partner wanted more children. [80], [84], [90], [91]
• Prescribers. One man could not find a clinician in his area willing to prescribe it. [92]
• Canada and elsewhere. A Canadian commenter said a local pharmacy ordered it after receiving the prescription; another said the price had recently doubled. A question about nasal testosterone in the UK and Europe went unanswered. [93], [84], [94]
• Compounded versions. When Natesto could not be filled, one man tried a compounded nasal product and felt it was only about a quarter to a third as effective. [80]

How can you judge a Natesto story?

Ask: Was it Natesto or a compounded nasal product? How many doses a day, and were any missed? How long after a dose was blood drawn? Had the person used other testosterone, hCG or clomiphene before, and what else changed at the same time? Did they have allergies or a cold? What happened a few months later?

These selected discussions show what people experience and the questions research should answer. They are not a survey of all users, a success rate or a substitute for the studies.

How does Natesto compare with other testosterone forms?

These are the forms most often weighed against Natesto. Status was checked in September 2026.

No trial ranks these forms on long-term outcomes. The practical differences are how often you dose, how much levels swing, how much hematocrit rises and whether someone else can be exposed. [36], [38] Men focused on fertility may also be weighing medicines that are not testosterone, such as enclomiphene and clomiphene; see hCG vs gonadorelin vs enclomiphene.

Common questions about Natesto

How many times a day do you use Natesto?

In the United States, three times a day: 11 mg (one pump in each nostril) in the morning, afternoon and evening, 6 to 8 hours apart, for 33 mg a day. In Canada the label starts at twice a day, at least 6 hours apart, and adds a third dose if a blood test or symptoms call for it. [1], [2] See typical protocols.

Does Natesto shut down your natural testosterone and fertility?

Less than long-acting forms in small studies, but not never. In a 60-man study, LH stayed normal in 72.7% and FSH in 81.8% of those evaluated at 6 months, so about 18–27% were outside the normal range. The label still warns that it can suppress sperm production, and one man in that study developed azoospermia. Guidelines disagree on using it while trying to conceive: the Canadian urology guideline calls it a possible option, and the US male infertility guideline says it should not be routinely used. [22], [23], [1], [14], [21] See fertility.

When should I get my blood drawn on Natesto?

Ask your prescriber, and write down when your last dose was. The US label gives no time; Canada's label uses a single draw 20 minutes to 2 hours after a morning dose; the AUA says to use the gel on the test day. A level drawn long after a dose can look low even when treatment is working. [1], [2], [15] See blood-test timing.

Can I use Flonase or other nasal sprays with Natesto?

The label does not recommend other nasal medicines except decongestants such as oxymetazoline, because they were not studied together; oxymetazoline 30 minutes before Natesto barely changed absorption. Steroid sprays like fluticasone (Flonase) were never tested, so ask your prescriber or pharmacist before combining them. [1] See interactions.

What should I do if I miss a dose?

The Canadian monograph says to skip the missed dose and take the next one at its usual time, not to double up. The US label gives no missed-dose instruction, so check with your pharmacist. If a blood test is due, tell the prescriber about any missed doses. [2]

Is there a generic Natesto, and why is it so expensive?

No. It is the only FDA-approved nasal testosterone, with patents listed until 2034 and no generic. In September 2026 pharmacies paid about $454 on average for one pump, which lasts 10 days at three doses a day; what you pay depends on insurance and the pharmacy. [5], [52] See cost.

Is Natesto better than injections?

Neither is better for everyone. Natesto avoids needles and, in small studies, raised hematocrit and estradiol less and suppressed the brain's signals less, but it gives lower average levels, needs doses two or three times a day and causes nose side effects, and in public forums people describe trouble getting it filled. In the one randomized comparison, erectile function improved only on injections. [29], [30], [31], [1] See how Natesto compares.

Glossary

Plain explanations of the medical, dosing and research terms used in this guide. Underlined terms in the text link here.

Actuation (pump)

One press of the Natesto pump. Each press delivers 5.5 mg of testosterone; one dose is two presses, one in each nostril.

Azoospermia

No sperm at all in a semen sample.

Controlled substance

A medicine whose prescribing and possession are restricted by law because it can be misused. Testosterone is Schedule III in the US, Schedule IV in Canada and Class C in the UK.

Controlled trial

A study that compares people who receive a treatment with a similar group who receive a placebo, no treatment or a different treatment. Randomly assigning people to each group makes the comparison fairer.

Epistaxis

A nosebleed. It is one of the most common side effects of nasal testosterone.

Ester

A chemical tail joined to testosterone that makes it dissolve in oil and release slowly after injection. Natesto has no ester; it is plain testosterone, which is why each dose is short-lived.

Estradiol

The main form of estrogen. In men it is made mostly from testosterone, so it rises when testosterone rises.

First-pass metabolism

The breakdown of a medicine by the liver before it reaches the rest of the body, as happens with many swallowed drugs. Absorption through the nose avoids it.

FSH (follicle-stimulating hormone)

A pituitary hormone that acts on the cells supporting sperm production. Testosterone therapy lowers it.

Gynecomastia

Growth of breast tissue in men, often tender at first. It is linked to a higher estrogen-to-testosterone balance.

Half-life

The time it takes for the level of a substance in the blood to fall by half. Testosterone itself is cleared within minutes to about an hour, which is why a nasal dose fades within hours.

Hematocrit

The share of the blood made up of red blood cells. Testosterone raises it, and most guidelines act when it reaches about 54%.

Hypogonadotropic hypogonadism

Low testosterone because the brain and pituitary send too little LH and FSH to the testicles. It can be present from birth or start later. Also called secondary hypogonadism.

Hypogonadism

Low testosterone caused by a problem in the testicles or in the brain and pituitary signals that control them, confirmed with symptoms and repeated morning blood tests.

Intranasal

Given inside the nose. Natesto is placed on the outer side wall of each nostril and absorbed through the nasal lining.

LH (luteinizing hormone)

A pituitary hormone that tells the testicles to make testosterone. Testosterone therapy turns it down.

Nasal lining (mucosa)

The moist tissue that lines the inside of the nose. It has many small blood vessels, so medicines placed on it can reach the blood quickly.

Open-label study

A study in which the participants and researchers know who is getting which treatment. It is more prone to bias than a blinded, placebo-controlled trial.

Parosmia

A changed or distorted sense of smell, where familiar smells seem different. It was reported in about 5% of men on Natesto.

Per-protocol analysis

Results counting only the people who followed the study plan. An intention-to-treat analysis counts everyone assigned to a group and usually gives lower success rates.

Placebo

A dummy treatment with no active ingredient, used as a comparison in studies.

Polycythemia (erythrocytosis)

Too many red blood cells, shown by a high hematocrit. Testosterone therapy is a common cause.

Primary hypogonadism

Low testosterone because the testicles themselves do not work well, even though the pituitary sends plenty of LH and FSH.

PSA (prostate-specific antigen)

A blood test for a protein made by the prostate. It rises slightly on testosterone and is used to decide whether prostate checks are needed.

Rhinitis

Inflammation of the nasal lining, causing a runny, blocked or itchy nose, from a cold or allergies. The labels say to pause Natesto during severe rhinitis.

Rhinorrhea

A runny nose.

SHBG (sex hormone-binding globulin)

A blood protein that carries testosterone. Testosterone bound to it is not immediately available to tissues, so SHBG affects how much free testosterone there is.

Total motile sperm count

The number of moving sperm in a whole semen sample. Above about 5 million is often used as a practical marker of fertility potential.

Titration

Adjusting a dose in steps, usually based on blood tests and symptoms.

Trough level

The lowest level of a drug in the blood, measured just before the next dose. No source recommends judging Natesto by it.

TRT (testosterone replacement therapy)

Prescribed testosterone, by injection, gel or other forms, for men with low testosterone.

WADA

The World Anti-Doping Agency, which publishes the list of substances banned in sport. Testosterone is banned at all times.

How this guide was researched

This guide is built from a thorough review of the sources cited throughout it: the US and Canadian product labels, FDA's approval review documents and letters, clinical guidelines from the United States, Canada, the United Kingdom and Europe, published clinical trials and studies, trial registry records and regulatory and pricing records. We also reviewed public online forums where people describe their own experiences with Natesto.

The guide cites 100 sources, including 9 product labels and monographs, 8 FDA review documents and letters, 10 guidelines and position statements, 22 original studies in people, 7 trial registry records and 16 public community threads. Each type of source answers a different question. Labels, FDA reviews, guidelines and trials show what was approved and measured. Practice papers show how prescribers typically use it. Personal accounts show what individual people experienced. Every numbered citation links to its entry below, labeled by source type.

How this guide was made

Research and drafting were AI-assisted. Every cited source was checked against the original, and the guide was reviewed and edited by Doserly before publication. It has not had an independent clinical review, and Doserly does not currently have medical reviewers. Doserly makes a medication and health-tracking app and runs Doserly Academy, both of which are promoted in this guide. Read our editorial policy for how guides are researched, updated and corrected.

This guide is for educational purposes. It summarizes what the reviewed sources report so the research is easier to understand; it is not medical advice. For a deeper dive, or to check any point for yourself, go straight to the cited sources.

Explore the sources