Testosterone replacement therapy (TRT) is prescription testosterone, given by injection, gel, oral capsule, cream or pellet, for men diagnosed with low testosterone from a medical cause.
- Label change
- Feb 28, 2025: cardiovascular boxed warning removed; blood pressure warning added class-wide [1]
- Approved use
- Primary or hypogonadotropic hypogonadism, not age-related low T [2]
- Diagnosis threshold (AUA)
- Total testosterone below 300 ng/dL on two tests, plus symptoms or signs [3]
- TRAVERSE result
- Major heart events 7.0% vs 7.3% on placebo in 5,204 men [4]
- Generic injection
- About $20 to $31 per 1 mL vial with coupon (Oct 17, 2026) [5]
What the February 2025 label change did
- Removed boxed-warning language about increased cardiovascular risk [1].
- Added the results of TRAVERSE, a large heart-safety trial [1].
- Kept the Limitation of Use: testosterone is not established as safe and effective for age-related low testosterone [1].
- Added a blood pressure warning to products that did not already have one, after ambulatory blood pressure studies confirmed increases across all testosterone products [1].
Other boxed warnings remain. Gels such as AndroGel 1.62% keep a boxed warning about secondary exposure, because children who touched application sites developed virilization [2]. The oral testosterone undecanoate products (Jatenzo, Kyzatrex, Tlando) lost their blood pressure boxed warning in July 2025, though blood pressure increases still appear in Warnings and Precautions [6]. Testosterone is also a Schedule III controlled substance under the Controlled Substances Act, as the AndroGel label states [2].
Who TRT is for
The American Urological Association supports a diagnosis of testosterone deficiency when total testosterone is below 300 ng/dL on two separate measurements, and treats a man as a candidate only when low levels come with symptoms or signs [3]. FDA labels go further: testosterone is approved for low or absent testosterone tied to a medical condition, primary hypogonadism or hypogonadotropic hypogonadism [2].
What TRAVERSE found
TRAVERSE (New England Journal of Medicine, 2023) randomized 5,204 men aged 45 to 80 with low testosterone (two fasting levels below 300 ng/dL) and existing heart disease or high heart risk to testosterone gel or placebo. Major adverse cardiac events occurred in 7.0% of the testosterone group and 7.3% of the placebo group (hazard ratio 0.96), meeting the trial's test for noninferiority. The testosterone group had more pulmonary embolism (0.9% vs 0.5%), atrial fibrillation and acute kidney injury [4].
Forms of testosterone and what they cost
| Form | Example | FDA status | Price | Source |
|---|---|---|---|---|
| Injection | Generic testosterone cypionate 200 mg/mL | FDA-approved | About $20 to $31 per 1 mL vial with coupon (Oct 17, 2026) | GoodRx [5] |
| Gel | AndroGel 1.62% | FDA-approved; boxed warning for secondary exposure | Not collected | Label [2] |
| Oral | Jatenzo, Kyzatrex, Tlando | FDA-approved | Not confirmed; see oral testosterone cost | Label [6] |
| Cream (telehealth) | Fountain TRT daily cream | Not confirmed | As low as $199 a month with visits (Oct 17, 2026) | Fountain TRT [7] |
| Pellets | Offered at Gameday Men's Health clinics | Depends on product | Not listed | Gameday [8] |
| Enclomiphene (not testosterone) | Compounded | Not FDA-approved | From $99 a month on a 10-month prepaid plan at Hims, which we rate avoid | Hims [9] |
Full breakdown on TRT cost per month. Enclomiphene is covered on enclomiphene: cost and legal status and enclomiphene vs TRT.
Clinic, online program or your own doctor
You can get testosterone from a primary care doctor or urologist, an in-person men's clinic, or a telehealth program. Online programs charge from $99 a month at TRT Nation, with labs extra [10], to as low as $199 a month at Fountain TRT with medication and visits included [7]. Compare them on online TRT clinics, or see how to find a TRT clinic near you.
Safety note
The 2025 class-wide label change added a blood pressure warning to testosterone products that lacked one, after studies confirmed that testosterone raises blood pressure [1]. Testosterone gels carry a boxed warning because children who touched application sites have developed signs of male puberty [2]. In TRAVERSE, the testosterone group had more pulmonary embolism (0.9% vs 0.5%), atrial fibrillation and acute kidney injury [4]. Call 911 for chest pain, sudden shortness of breath or other emergencies.
Every TRT guide on this site
- TRT cost per month
- Find a TRT clinic near you
- Online TRT clinics compared
- Oral testosterone cost: Jatenzo, Kyzatrex, Tlando
- Enclomiphene: cost, online access and legal status
- Enclomiphene vs TRT
- Reviews: TRT Nation, Hone Health, Fountain TRT, Defy Medical, Marek Health, Gameday Men's Health, Blue Sky MD, Maximus, Hims testosterone
- For women: menopause hormone therapy
In this section
Costs and prices
- Cost guideOral testosterone cost: Jatenzo, Kyzatrex, Tlando
- Cost guideTRT cost per month: clinic, online and pharmacy prices
Online programs
Guides
Finding care
Questions people ask
Did FDA say testosterone is safe for the heart?
FDA removed boxed-warning language on increased cardiovascular risk on February 28, 2025, and added TRAVERSE results [1]. In TRAVERSE, major heart events occurred in 7.0% on testosterone vs 7.3% on placebo, but the testosterone group had more pulmonary embolism, atrial fibrillation and acute kidney injury [4].
Who qualifies for testosterone replacement therapy?
How much does TRT cost?
Is testosterone approved for age-related low testosterone?
Does testosterone raise blood pressure?
Yes. FDA said in 2025 that ambulatory blood pressure studies confirmed increased blood pressure across all testosterone products, and it added a blood pressure warning to products that lacked one [1].
What is hormone replacement therapy for men?
It usually means testosterone replacement therapy: prescription testosterone for men with low testosterone from a medical cause, given as an injection, gel, oral product or other form [2].
Is testosterone a controlled substance?
Yes. Testosterone is a Schedule III controlled substance under the Controlled Substances Act, as the AndroGel label states [2]. It requires a prescription from a licensed clinician.
Sources
10 cited
- FDA issues class-wide labeling changes for testosterone products. U.S. Food and Drug Administration, Feb 28, 2025.
- AndroGel 1.62% prescribing information. Drugs.com (FDA label text), Oct 2025.
- Testosterone deficiency diagnostic algorithm. American Urological Association, 2018.
- Cardiovascular safety of testosterone-replacement therapy (TRAVERSE). New England Journal of Medicine, Jun 2023.
- Testosterone cypionate prices. GoodRx, Oct 17, 2026.
- Kyzatrex prescribing information. Drugs.com (FDA label text), Aug 2026.
- Fountain TRT home page. Fountain TRT, Oct 17, 2026.
- Gameday Men's Health home page. Gameday Men's Health, Oct 17, 2026.
- Hims testosterone page. Hims, Oct 17, 2026.
- TRT Nation home page and pricing. TRT Nation, Oct 17, 2026.
This page is general information, not medical advice. Talk with a licensed clinician about your own care.