Testosterone rules in Canada, the US, Europe and Australia

Testosterone rules in Canada are set by product monographs, not by a recent regulatory review. Those monographs require deficiency confirmed by two separate validated biochemical assays on morning testosterone, and Health Canada has issued nothing on testosterone since its Information Update of 15 July 2014. The United States, Europe and Australia have each moved differently.

Key takeaways

• Health Canada’s most recent statement on testosterone is dated 15 July 2014, so Canada has published no regulatory response to TRAVERSE or to either American label change that followed it.
• Testosterone is a Schedule IV controlled substance under Canada’s Controlled Drugs and Substances Act, while Canadian monographs still carry the legacy phrase “Schedule G controlled substance as defined by the Food and Drugs Act.”
• The US Food and Drug Administration issued class-wide labelling changes on 28 February 2025 that removed the cardiovascular boxed warning language, added the TRAVERSE results and added blood pressure warnings.
• On 18 June 2026, the US Department of Health and Human Services and the FDA requested removal of the age-related hypogonadism limitation of use and narrowing of the prostate cancer contraindication to metastatic disease. These are requested changes, not completed ones.

Every position summarised here applies to men with confirmed low testosterone. It does not apply to men whose testosterone is normal, and no regulator on this page has approved testosterone for that purpose. What testing your own case needs is a decision for your doctor or nurse practitioner.

What are the testosterone rules in Canada?

Canada regulates testosterone through approved labelling and through drug control law, and neither has changed recently. Canadian product monographs carry the indication “indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone (male hypogonadism).”

The monograph for oral testosterone undecanoate capsules, authorized 12 December 2025, requires deficiency to be “clearly demonstrated by clinical features and confirmed by two separate validated biochemical assays (morning testosterone),” and states it should not be used “to treat non-specific symptoms suggestive of hypogonadism if testosterone deficiency has not been demonstrated.” Safety and efficacy for age-related hypogonadism are not established. Its warnings cover blood pressure increases and venous thromboembolism, with no boxed warning. The diagnostic standard is set out in how low testosterone is diagnosed in Canada.

The older monograph for testosterone cypionate, revised 12 July 2018, uses the same indication wording and advises cardiovascular risk assessment before starting.

Is testosterone a controlled substance in Canada?

Yes. Testosterone is listed in Schedule IV of the Controlled Drugs and Substances Act, where item 23 covers anabolic steroids and their derivatives and sub-item (40) is testosterone. Canadian monographs still describe it as a “Schedule G controlled substance as defined by the Food and Drugs Act,” which is legacy wording from an earlier framework. Both appear in Canadian documents; the statute is the current authority.

What testosterone products are marketed in Canada?

Health Canada’s Drug Product Database listed 13 marketed human testosterone drug identification numbers as of 13 September 2026. Delatestryl and Depo-Testosterone are no longer in Marketed status, so any Canadian page still listing them as current options is out of date.

When did Health Canada last speak on testosterone?

15 July 2014. That day Health Canada published a Summary Safety Review on testosterone and cardiovascular risk, which examined 35 Canadian reports received to 31 August 2013 and concluded that post-market studies suggest an increased risk of serious cardiovascular problems that may be linked to these products. The Information Update issued the same day advises against use for non-specific symptoms where laboratory tests have not confirmed a low level and other causes have not been excluded. Nothing further has been issued since.

What changed in the United States?

The United States has moved twice since 2015, both times by changing labels. The first is recorded in the FDA supplement approval letter for Striant, NDA 021543/S-011, dated 11 May 2015, which documents the class labelling change that added the age-related hypogonadism limitation of use and the cardiovascular warning.

On 28 February 2025 the FDA issued class-wide labelling changes with four elements: removal of the boxed warning language on increased cardiovascular risk; addition of the TRAVERSE finding of no increase in the risk of adverse cardiovascular outcomes in men using testosterone for hypogonadism; addition of product-specific blood pressure information from ambulatory monitoring studies; and a new blood pressure warning for products that previously lacked one. The FDA stated that those studies “confirmed an increase in blood pressure with use of all testosterone products, class-wide.”

On 18 June 2026 the US Department of Health and Human Services announced that the FDA had requested further updates: removal of the limitation of use stating that safety and effectiveness in age-related hypogonadism have not been established, narrowing of the prostate cancer contraindication to metastatic disease only, and, for benign prostatic hyperplasia, continued monitoring rather than exclusion. It cited TRAVERSE, described as more than 5,200 men with “no meaningful increase in the risk of major adverse cardiovascular events.”

Are the June 2026 US changes in force?

Not uniformly. They are requested changes, and labels update on their own schedule. The most recent US label verified here, the testosterone enanthate prescribing information revised July 2025, still carries the age-related limitation. Its boxed warning is now “WARNING: BLOOD PRESSURE INCREASES,” and it reports major adverse cardiovascular events in 7 percent on testosterone gel versus 7.3 percent on placebo, a mean systolic rise of 1.0 mm Hg from baseline to 36 months, and ambulatory increases averaging 3.9 mm Hg systolic and 1.5 mm Hg diastolic at 12 weeks. The trial behind those numbers is covered in what the TRAVERSE trial found.

Does the US position apply in Canada?

No. Canada has made no equivalent change to either the February 2025 or the June 2026 American positions. The age-related limitation the FDA has asked American manufacturers to remove is still the Canadian position: the monograph authorized 12 December 2025 states that safety and efficacy for age-related hypogonadism are not established. A reader who sees an American article saying the restriction has been lifted is reading about a different regulatory system.

What does Europe say?

Europe reviewed testosterone in 2014 and has not returned to it. The European Medicines Agency referral on testosterone-containing medicines, with a PRAC recommendation of 9 October 2014 and a CMDh position of 8 January 2015, concluded that “there is no consistent evidence of an increased risk of heart problems with testosterone medicines in men who lack the hormone.”

The EMA also states that testosterone medicines are licensed in the EU to treat men with abnormally low levels and “are not approved in the EU for use to boost testosterone levels in healthy older men.” Treatment begins only when low testosterone is confirmed by signs, symptoms and appropriate laboratory tests, with regular monitoring of hemoglobin, hematocrit, liver function and lipids, and caution in pre-existing hypertension. Those requirements underpin the page on monitoring during testosterone therapy.

A clotting disorders warning followed, adopted in September 2016 with implementation by 28 December 2016, advising caution in patients with thrombophilia. Europe has not re-reviewed testosterone cardiovascular risk since TRAVERSE and has not mirrored the FDA’s 2025 or 2026 changes.

Separately, the European Association of Urology guideline on male hypogonadism, 2026 edition with a limited update in March 2026, is a professional society document, not a regulatory one. It recommends a diagnostic threshold of 12 nmol/L total testosterone (3.5 ng/mL), measured fasting between 07:00 and 10:00 and confirmed on two separate occasions, and states that no increased cardiovascular risk has been demonstrated up to three years, citing TRAVERSE.

What does Australia require?

Australia is the only jurisdiction here that writes exclusions into a funding rule. The Therapeutic Goods Administration Medicines Safety Update, Volume 8, Number 2, April to May 2017, notes that registered Australian indications are variants of “androgen replacement therapy for confirmed testosterone deficiency in males,” advises that testosterone “should only be prescribed to males who meet the clinical criteria for confirmed testosterone deficiency, and are under the care of a specialist medical practitioner,” and states that “testosterone levels decline naturally with age and most men do not require testosterone replacement therapy.”

The Pharmaceutical Benefits Scheme listing for testosterone undecanoate, item 10205D, retrieved 13 September 2026, sets two Authority Required pathways. With an established pituitary or testicular disorder, treatment must be by or in consultation with a specialist endocrinologist, urologist, pediatrician or Fellow of the Australasian Chapter of Sexual Health Medicine. Without established organic disease, the patient must be 40 or older, the condition “must not be due to age, obesity, cardiovascular diseases, infertility or drugs,” and androgen deficiency means testosterone below 6 nmol/L, or 6 to 15 nmol/L with high LH (above 1.5 times the upper limit of the young-men reference range, or above 14 IU/L, whichever is higher), on at least two morning samples taken on different mornings.

The Endocrine Society of Australia position statement of 2016 states that “testosterone replacement therapy is warranted in men with pathological hypogonadism, regardless of age,” and says there are limited high-quality randomized data to justify treatment for age-related decline without disease. It predates both T4DM and TRAVERSE.

What does the World Health Organization say?

Very little. Testosterone is on the WHO Model List of Essential Medicines, 24th list, published 5 September 2025, under ATC code G03BA03 in the Androgens section, as a parenteral intramuscular 200 mg/mL enantate preparation, for the indication “Testicular dysfunction or testosterone-related disorders,” for adolescents and adults, on the core list. It was first added in 1977.

That entry carries no clinical criteria, no threshold and no statement of benefits: it is a procurement and availability recommendation. Site-restricted searching of who.int found no WHO guideline, position statement or fact sheet on testosterone replacement therapy or male hypogonadism. WHO has not issued guidance on it.

How do the rules compare side by side?

What the evidence does not show

A label change is not evidence that testosterone benefits men with normal levels, and the trials behind these changes carry findings that go both ways.

• TRAVERSE, published in the New England Journal of Medicine in 2023, enrolled 5,246 men aged 45 to 80 with existing or high cardiovascular risk and two fasting testosterone levels below 300 ng/dL. It found testosterone non-inferior to placebo for cardiovascular death, non-fatal myocardial infarction and non-fatal stroke combined, with major adverse cardiovascular events in 7 percent versus 7.3 percent per the current US label. It also found more atrial fibrillation, acute kidney injury and pulmonary embolism on testosterone.
• Fractures did not fall. Snyder 2024, in the New England Journal of Medicine, followed 5,204 men for a median of 3.19 years and found clinical fracture in 91 (3.50 percent) on testosterone versus 64 (2.46 percent) on placebo, hazard ratio 1.43 (95% CI 1.04 to 1.97).
• TRAVERSE did not show diabetes prevention. Bhasin 2024, in JAMA Internal Medicine, studied 1,175 men with prediabetes and 3,880 with diabetes and found progression to diabetes did not differ between groups. The authors state testosterone alone should not be used to prevent or treat diabetes, a contrast discussed in what testosterone therapy actually does.
• Blood pressure rises. The FDA’s February 2025 review confirmed a class-wide increase in blood pressure with all testosterone products, and the boxed warning on at least one US product is now specifically about blood pressure.
• No regulator has approved testosterone for men with normal levels. The EMA states that testosterone medicines are not approved in the EU to boost levels in healthy older men.

Frequently asked questions

Did Canada remove the cardiovascular boxed warning the way the United States did?

No. The FDA removed the cardiovascular boxed warning language class-wide on 28 February 2025. Health Canada has issued nothing on testosterone since 15 July 2014, so there is no Canadian equivalent of that decision. Canadian labels continue to reflect the monographs, including the cypionate monograph revised 12 July 2018.

Can testosterone be prescribed in Canada for age-related low testosterone?

The Canadian monograph for oral testosterone undecanoate, authorized 12 December 2025, states that safety and efficacy for age-related hypogonadism are not established. The FDA requested removal of the equivalent American limitation on 18 June 2026, but Canada has made no matching change. Speak with your doctor or pharmacist about your own situation.

What did the FDA request on 18 June 2026?

The US Department of Health and Human Services announced that the FDA had asked manufacturers to remove the limitation of use stating that safety and effectiveness in age-related hypogonadism have not been established, to narrow the prostate cancer contraindication to metastatic disease only, and to move benign prostatic hyperplasia from exclusion to continued monitoring. The announcement cited TRAVERSE, described as more than 5,200 men.

Does the World Health Organization recommend testosterone replacement therapy?

WHO has issued no guidance on testosterone replacement therapy. Testosterone is listed on the WHO Model List of Essential Medicines, 24th list, published 5 September 2025, for “Testicular dysfunction or testosterone-related disorders,” on the core list, first added in 1977. That listing is a procurement recommendation and carries no clinical criteria and no threshold.

Are Delatestryl and Depo-Testosterone still marketed in Canada?

No. As of 13 September 2026, Health Canada’s Drug Product Database shows Delatestryl and Depo-Testosterone as no longer in Marketed status, while 13 marketed human testosterone drug identification numbers remain listed. Content naming those two brands as current Canadian options is out of date. Ask your pharmacist what is available.

References

1. Health Canada. Summary Safety Review, Testosterone Replacement Products, Cardiovascular Risk. 15 July 2014. https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SSR00058
2. Health Canada. Information Update, Possible cardiovascular problems associated with testosterone products. 15 July 2014. https://recalls-rappels.canada.ca/en/alert-recall/information-update-possible-cardiovascular-problems-associated-testosterone-products
3. Health Canada. Product Monograph, JATENZO (testosterone undecanoate oral capsules). Authorized 12 December 2025. https://pdf.hres.ca/dpd_pm/00082762.PDF
4. Health Canada. Product Monograph, DEPO-TESTOSTERONE (testosterone cypionate). Revised 12 July 2018. https://pdf.hres.ca/dpd_pm/00046306.PDF
5. Health Canada. Drug Product Database. Retrieved 13 September 2026. https://health-products.canada.ca/dpd-bdpp/search/
6. Government of Canada. Controlled Drugs and Substances Act, Schedule IV. https://laws-lois.justice.gc.ca/eng/acts/c-38.8/page-12.html
7. US Food and Drug Administration. FDA issues class-wide labeling changes for testosterone products. 28 February 2025. https://www.fda.gov/drugs/drug-alerts-and-statements/fda-issues-class-wide-labeling-changes-testosterone-products
8. US Department of Health and Human Services. HHS Announces Requested Updates to Testosterone Therapy Product Labels. 18 June 2026. https://www.hhs.gov/press-room/fda-requests-updates-testosterone-therapy-labeling.html
9. US Food and Drug Administration. Testosterone Information. Last updated 23 June 2026. https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/testosterone-information
10. US Food and Drug Administration. XYOSTED (testosterone enanthate) prescribing information. Revised July 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209863s020lbl.pdf
11. US Food and Drug Administration. Supplement approval letter, Striant, NDA 021543/S-011. 11 May 2015. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021543Orig1s011ltr.pdf
12. European Medicines Agency. Testosterone-containing medicines referral. PRAC recommendation 9 October 2014, press release 21 November 2014, CMDh position 8 January 2015. https://www.ema.europa.eu/en/medicines/human/referrals/testosterone-containing-medicines
13. European Medicines Agency. No consistent evidence of an increased risk of heart problems with testosterone medicines. 21 November 2014. https://www.ema.europa.eu/en/news/no-consistent-evidence-increased-risk-heart-problems-testosterone-medicines
14. European Medicines Agency and CMDh. PSUSA on testosterone, clotting disorders. Adopted September 2016, implementation by 28 December 2016. https://www.ema.europa.eu/en/documents/psusa/testosterone-all-formulations-apart-topical-use-and-testosterone-undecanoate-injection-cmdh-scientific-conclusions-and-grounds-variation-amendments-product-information-and-timetable-implementa_en.pdf
15. European Association of Urology. Guidelines on Sexual and Reproductive Health, male hypogonadism chapter. 2026 edition, limited update March 2026. https://uroweb.org/guidelines/sexual-and-reproductive-health/chapter/male-hypogonadism
16. Therapeutic Goods Administration, Australia. Medicines Safety Update, Volume 8, Number 2, April to May 2017. https://www.tga.gov.au/sites/default/files/medicines-safety-update-volume-8-number-2-april-may-2017.pdf
17. Pharmaceutical Benefits Scheme, Australia. Testosterone undecanoate, item 10205D. Schedule retrieved 13 September 2026. https://www.pbs.gov.au/medicine/item/10205D
18. Endocrine Society of Australia. Position statement on male hypogonadism, part 1. 2016. https://endocrinesociety.org.au/resources/ESA%20Position%20Statement%20Part%201%20Yeap%20et%20al%20MJA%202016.pdf
19. World Health Organization. The selection and use of essential medicines, WHO Model List of Essential Medicines, 24th list. 5 September 2025. https://www.who.int/publications/i/item/B09474
20. Lincoff 2023. Cardiovascular Safety of Testosterone-Replacement Therapy. New England Journal of Medicine. PMID 37326322. DOI: https://doi.org/10.1056/NEJMoa2215025
21. Snyder 2024. New England Journal of Medicine. Full title unknown in the source list used for this page; cited for the fracture result. PMID 38231621. DOI: https://doi.org/10.1056/NEJMoa2308836
22. Bhasin 2024. JAMA Internal Medicine. Full title unknown in the source list used for this page; cited for the diabetes progression result. PMID 38315466. DOI: https://doi.org/10.1001/jamainternmed.2023.7862

This page is educational information, not medical advice. Testosterone is a prescription medication and a controlled substance in Canada. Talk to your doctor or pharmacist about your own situation.