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AndroGel Regulatory Status: US, EU, Canada, and UK Approvals Explained

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At a glance

  • US status / Prescription testosterone gel approved only for hypogonadism with a medical cause [1]
  • Age-related low testosterone / Label limitation says not established; FDA asked in June 2026 to remove it [1][3]
  • US scheduling / Schedule III controlled substance [3]
  • AndroGel 1% label / Boxed warning: secondary exposure and virilization in children [3]
  • EU position / CMDh found no consistent evidence of increased heart risk and called for product-information updates [2]
  • Canada / Three AndroGel products in the Health Canada Drug Product Database: 2.5 g and 5 g packets, 1% metered-dose pump [5]

What is AndroGel's US regulatory status?

The FDA says testosterone products are approved only for men who lack or have low testosterone along with an associated medical condition, such as testicular failure or a pituitary or hypothalamic disorder; none is approved for low testosterone without such a condition [1]. The AndroGel 1% label names primary and hypogonadotropic hypogonadism and says safety and efficacy in age-related hypogonadism have not been established [3]. In June 2026 the FDA requested removal of that limitation [1]; the AndroGel 1% label, revised July 2025, still carries the old text [3].

Is testosterone gel a controlled substance?

Yes. The AndroGel 1% label states that testosterone is a Schedule III controlled substance under the Controlled Substances Act [3].

What changed in the FDA's labeling actions?

On 28 February 2025 the FDA informed sponsors of class-wide labeling changes. It recommended adding TRAVERSE results, retaining the age-related limitation of use, and removing boxed-warning language about an increased risk of adverse cardiovascular outcomes; it also required product-specific blood pressure information and a new blood pressure warning for products without one [4]. The FDA says the completed ABPM studies confirmed a blood pressure increase with all testosterone products, class-wide [4]. The AndroGel 1% label's boxed warning is about secondary exposure: virilization has been reported in children exposed to testosterone gel, and children should avoid contact with unwashed or unclothed application sites [3].

What is the EU position?

The EMA's Pharmacovigilance Risk Assessment Committee review, endorsed by the CMDh, found no consistent evidence of an increased risk of heart problems with testosterone medicines in men with hypogonadism. EU product information is to be updated with current safety evidence, including warnings that low testosterone should be confirmed by signs, symptoms and laboratory tests before treating men, and restoring testosterone levels in healthy older men is not an authorised use. The EMA notes that testosterone can increase blood pressure [2].

What about Canada and the UK?

Health Canada's Drug Product Database lists AndroGel products under three entries: a 2.5 g gel packet, a 5 g gel packet and a 1% metered-dose pump [5]. UK approval details for AndroGel are not covered on this page.

Frequently asked questions

Is AndroGel FDA-approved?
AndroGel is a testosterone gel, and FDA-approved testosterone products are approved only for men whose low testosterone comes with an associated medical condition [1]. The AndroGel 1% label says safety and efficacy in age-related hypogonadism have not been established [3], and in June 2026 the FDA asked for that limitation to be removed [1].
Do testosterone gels carry a boxed warning?
The AndroGel 1% label carries a boxed warning about secondary exposure: virilization has been reported in children exposed to testosterone gel, and children should avoid contact with unwashed or unclothed application sites [3]. In February 2025 the FDA recommended removing boxed-warning language about adverse cardiovascular outcomes from testosterone products [4].
What did the EU review conclude?
The CMDh agreed there was no consistent evidence of an increased risk of heart problems with testosterone medicines in men with hypogonadism, and called for product information to be updated with current safety evidence and with warnings that low testosterone should be confirmed by signs, symptoms and laboratory tests before treatment [2].
Is AndroGel listed in Canada?
Health Canada's Drug Product Database lists AndroGel as a 2.5 g gel packet, a 5 g gel packet and a 1% metered-dose pump [5].

References

  1. Testosterone Information | FDA. Testosterone Information | FDA
  2. Testosterone-containing medicines - referral | European Medicines Agency (EMA). Testosterone-containing medicines - referral | European Medicines Agency (EMA)
  3. U.S. Food and Drug Administration, Drugs@FDA. AndroGel (testosterone gel) 1% prescribing information, NDA 021015, supplement 047, July 2025. AndroGel 1% prescribing information
  4. FDA issues class-wide labeling changes for testosterone products | FDA. FDA issues class-wide labeling changes for testosterone products | FDA
  5. Health Canada. Drug Product Database: AndroGel product listing (DINs 02245345, 02245346, 02249499). Health Canada Drug Product Database: AndroGel
Evidence overview for AndroGel Regulatory Status: US, EU, Canada, and UK Approvals Explained