AndroGel® / Xyosted® / Testim® / Axiron® / Natesto®
Testosterone
Version 2025-04 · Last reviewed April 1, 2025 · Methodology
List Price
$500
With Insurance
$30-80
FDA Black Box Warning
SECONDARY EXPOSURE (GEL) & ABUSE POTENTIAL
Topical testosterone can transfer to others through skin contact — causing virilization in women and premature puberty in children. Testosterone is a Schedule III controlled substance with abuse potential, particularly by athletes and bodybuilders. Misuse can cause serious cardiovascular harm.
Strict Contraindications
How It Works
Testosterone is the primary androgen hormone produced in men (primarily by the testes) and at much lower levels in women (by the ovaries and adrenal glands). It acts by binding to androgen receptors (AR) found in muscle, bone, brain, skin, reproductive organs, and many other tissues. Once bound, the testosterone-androgen receptor complex regulates gene expression affecting muscle protein synthesis, bone density, red blood cell production, mood, libido, and secondary sexual characteristics.
Why the side effects happen
Most testosterone side effects follow directly from its mechanism. Erythrocytosis (high red blood cells) comes from its EPO-stimulating effect. Acne and hair loss come from DHT production in skin. Testicular atrophy occurs because exogenous testosterone suppresses LH and FSH — the signals that stimulate the testes to produce testosterone and sperm. Gynecomastia occurs from aromatization to estradiol. Mood changes can result from both the direct neurological effects and from dose-related hormonal fluctuations.
When Will I Feel It?
Testosterone's effects unfold over a wide time range — sexual function may improve within weeks, while body composition changes take months, and full effects on bone density are seen at 1-2 years.
Libido and energy may begin to improve within days of reaching therapeutic levels. Acne can appear early.
Mood and motivation improvements are often reported in this window. Erythrocytosis begins developing — hematocrit check at 3 months is standard.
Sexual function typically improved. Lean body mass begins increasing; fat redistribution starts. PSA levels stabilize (checked at this point in men).
Muscle mass and strength continue building with exercise. Bone density effects begin accumulating. Testicular volume continues to decrease.
Full bone density effects established. Hematocrit and PSA are monitored annually. Fertility suppression is ongoing as long as testosterone is taken.
Adherence Note
Injection formulations produce peaks and troughs in testosterone levels that can cause mood fluctuations. Many patients find transdermal gel provides more stable levels and more consistent mood and energy. Consistency of application (same time, same site) matters for gel formulations.
Medical Disclaimer
The information on this page is compiled from publicly available clinical trial data, FDA prescribing information, and peer-reviewed literature. It is provided for educational purposes only and does not constitute medical advice, diagnosis, or treatment recommendations. Individual responses to medications vary. Always consult a qualified healthcare provider before starting, stopping, or changing any medication.
Common Side Effects
While taking this medication, you may experience the following common side effects. We've included tips on how to manage them.
Acne
10-15%Dose-dependent; often improves with dose reduction. Topical retinoids and non-comedogenic skincare may help.
Erythrocytosis (high red blood cell count)
5-15%Elevated hematocrit increases blood viscosity and clot risk — monitored routinely with CBC. Dose reduction or blood donation may be recommended.
Testicular atrophy (men)
Very commonExogenous testosterone suppresses the HPG axis, reducing natural testosterone production and sperm count — causing testicular shrinkage. HCG co-prescription is used to partially mitigate this.
Reduced sperm count / infertility (men)
Common with extended useTestosterone suppresses FSH and LH, markedly reducing sperm production. This effect may be reversible but can take months to years to recover — important to discuss before starting if future fertility matters.
Mood changes / irritability
5-10%Particularly with large dose fluctuations (injection peaks and troughs). More stable delivery (gel, patch) may reduce mood swings.
Sleep apnea worsening
5-10%Testosterone can worsen existing OSA; screen for sleep apnea before starting in at-risk patients
Hair thinning / male-pattern baldness
Genetically determinedDHT (dihydrotestosterone, converted from testosterone) drives hair follicle miniaturization in those genetically susceptible
Breast tissue growth (gynecomastia)
3-5%Results from aromatization of testosterone to estradiol; dose reduction or an aromatase inhibitor may help
Serious Adverse Effects
- • Polycythemia (dangerously high red blood cell count) — increases stroke and clot risk
- • Cardiovascular events — evidence on long-term risk remains an active area of research; higher risk in older men with pre-existing cardiovascular disease
- • Prostate growth — regular PSA and prostate monitoring required in men
- • Liver toxicity — primarily with oral testosterone (17-alpha alkylated forms); injectable and transdermal largely avoid this
- • Severe acne / cystic acne at high doses
- • Secondary exposure harm to partners and children (with topical formulations)
Drug Interactions
Major Interactions (Avoid)
Moderate Interactions (Caution)
Food Interactions
When to Contact Your Doctor
This medication requires ongoing medical supervision. The following situations warrant a prompt conversation with your prescribing physician — do not wait for your next scheduled appointment.
Contact soon if you notice
- Polycythemia (dangerously high red blood cell count) — increases stroke and clot risk
- Cardiovascular events — evidence on long-term risk remains an active area of research; higher risk in older men with pre-existing cardiovascular disease
- Prostate growth — regular PSA and prostate monitoring required in men
- Liver toxicity — primarily with oral testosterone (17-alpha alkylated forms); injectable and transdermal largely avoid this
- Profound fatigue or depressive symptoms within days of stopping
Also discuss if you want to
- Review whether this medication is still appropriate for you
- Consider dosage adjustments based on response
- Explore lifestyle or non-drug alternatives
- Understand stopping or tapering options
- Plan monitoring labs and follow-up
In the US, call 911 or go to the nearest emergency room for severe symptoms. Poison Control: 1-800-222-1222.
Special Populations
Safety classifications for specific groups — discuss with your provider before use.
Testosterone causes virilization of a female fetus. Women who are pregnant or may become pregnant must not use testosterone — gel exposure is also a risk for female partners.
Testosterone is not appropriate during breastfeeding.
Testosterone is not FDA-approved for women, but international menopause societies (ISSWSH, IMS) support its off-label use at low physiological doses for hypoactive sexual desire disorder (HSDD) in postmenopausal women. A 2019 Lancet Diabetes & Endocrinology systematic review found benefit for sexual function. Women are prescribed compounded low-dose testosterone creams or gels — at doses approximately 1/10th of male doses. Side effects at these doses are generally mild but include acne and mild hair changes.
The TOM trial in men over 65 was stopped early due to excess cardiovascular events. The TRAVERSE trial in a different older population found non-inferiority for cardiovascular events. Individual risk assessment — particularly cardiovascular history, prostate health, and hematocrit — is essential in older men.
Testosterone may worsen fluid retention in renal impairment. Monitor closely.
FDA Adverse Event Reports
Patient-filed reports from the FDA FAERS database · refreshed daily
Community Reports
User-reported experiences — anonymous & anecdotal
Medical Disclaimer
The information on this page is compiled from publicly available clinical trial data, FDA prescribing information, and peer-reviewed literature. It is provided for educational purposes only and does not constitute medical advice, diagnosis, or treatment recommendations. Individual responses to medications vary. Always consult a qualified healthcare provider before starting, stopping, or changing any medication.
Metabolic & Lifestyle Alternatives
Lifestyle Factors That Support Testosterone Levels
Testosterone levels are significantly influenced by lifestyle. Several well-studied factors affect endogenous testosterone production — these are important to evaluate and address before or alongside any pharmacological intervention, as they represent root causes rather than symptoms.
Important context: Evidence quality varies across these approaches. Some are well-studied with randomized controlled trial data; others are based on observational or smaller studies. These interventions are not guaranteed to replace medication for all patients. Discuss with your doctor whether any of these are appropriate for your clinical situation.
Resistance training (3-4×/week)
Compound movements (squat, deadlift, press) are associated with acute and chronic increases in testosterone and growth hormone in men
Studies suggest 15-40% increases in testosterone levels with consistent resistance training programs; effects are largest in previously sedentary individuals
Sleep optimization (7-9 hours)
The majority of daily testosterone secretion occurs during sleep — particularly during slow-wave sleep. Sleep restriction significantly suppresses morning testosterone.
A JAMA Internal Medicine study found 1 week of sleep restriction (5hrs/night) reduced daytime testosterone by 10-15% in healthy young men
Body weight management
Adipose tissue (particularly visceral fat) converts testosterone to estrogen via aromatase. Excess adiposity is associated with lower testosterone and higher estradiol in men.
Studies show testosterone levels correlate inversely with body fat percentage; weight loss of 5-10% may raise testosterone meaningfully in overweight hypogonadal men
Zinc and Vitamin D adequacy
Zinc is required for testosterone synthesis; vitamin D receptors are expressed in testicular Leydig cells. Deficiency of either is associated with lower testosterone.
Supplementation in deficient individuals — not those with adequate levels — shows testosterone-supporting effects in multiple studies
Key Studies
How It Compares
Testosterone is the primary clinically used androgen. It differs significantly between formulations (injection vs. gel vs. patch) in terms of delivery stability, convenience, and cost. For women, only low-dose compounded testosterone is used — no FDA-approved formulation exists for women in the US.
Strengths
- Well-established efficacy for true hypogonadism in men — improves sexual function, bone density, mood, and energy
- Multiple formulations allow individualized delivery
- Low-dose use in postmenopausal women supported by international menopause societies for HSDD
- Generic testosterone cypionate injection is very affordable
- Increasingly understood metabolic benefits in men with true hypogonadism (insulin sensitivity, body composition)
Weaknesses
- Schedule III controlled substance — prescribing restrictions and abuse potential
- Significant fertility implications — often not adequately communicated to younger men
- No FDA-approved product for women — compounding required
- TOM trial raised safety concerns in older men with limited mobility
- "Low T" marketing significantly expanded prescribing beyond men with true clinical hypogonadism
- Long-term cardiovascular data (TRAVERSE) shows non-inferiority but also increased PE and AFib risk
Clinically Preferred Alternatives
Global Prescribing & Pricing
US testosterone prescribing tripled between 2000-2013, driven significantly by direct-to-consumer marketing; other countries did not see comparable increases
United States
$80–300/mo
Highest testosterone prescribing rate in the world; "Low T" marketing significantly expanded the diagnosed population in 2000s-2010s
FDA requires cardiovascular warning label added in 2015; ongoing monitoring of prescribing appropriateness
Often covered with hypogonadism diagnosis; may require prior authorization
United Kingdom
~$10–30/mo
NICE guidance requires confirmed biochemical hypogonadism (morning testosterone, repeated) before prescribing
NHS restricts prescribing to specialists (endocrinology, urology); GP prescribing for "Low T" is not standard practice
Covered by NHS with confirmed diagnosis
Germany
~$15–40/mo
Requires two confirmed low testosterone readings before prescribing; prescribing rate much lower than US
German Endocrine Society guidelines emphasize confirming true hypogonadism vs. age-related decline
Covered by GKV with diagnosis
Australia
~$10–35/mo
TGA monitoring identified a prescribing increase; Endocrine Society of Australia guidelines require documentation of symptoms + biochemical confirmation
Australia approved testosterone for women (Androfeme 1%) — the only country with a specifically approved female testosterone product
PBS subsidized for confirmed hypogonadism
Canada
~$20–60/mo
Lower prescribing rate than the US; no direct-to-consumer advertising of prescription drugs
Canada bans DTC pharmaceutical advertising — no "Low T" TV campaigns; prescribing driven by clinical presentation
Provincial coverage varies
The US testosterone prescribing surge was directly correlated with a $194M/year marketing campaign. Canada and the UK, which ban or limit direct-to-consumer pharmaceutical advertising, did not see comparable increases — suggesting the prescribing expansion was at least partially marketing-driven rather than purely clinically driven.
Clinical Trials & Funding
Understanding who funds research helps contextualize results. Industry-funded trials are not automatically invalid — they undergo the same FDA review — but declared conflicts and sponsor effects are worth knowing. All linked trials can be verified on ClinicalTrials.gov.
Funding Sources
AbbVie spent approximately $194 million marketing AndroGel in 2012 alone and funded multiple prescribing education campaigns through "Low T" disease awareness efforts. The TRAVERSE trial (cardiovascular safety of testosterone in men) was FDA-mandated and co-funded by AbbVie, Endo Pharmaceuticals, and other manufacturers — with significant FDA oversight to ensure independence. For women's testosterone: the LibiGel and Intrinsa FDA applications were funded by BioSante Pharmaceuticals and Watson Pharmaceuticals respectively — both were declined by FDA.
Declared Conflicts of Interest
The "Low T" marketing campaign (primarily AbbVie/Abbott) significantly expanded the diagnosed population of men with "testosterone deficiency" in the 2000s-2010s. Endocrinology societies received pharmaceutical funding during the period when testosterone prescribing guidelines were being written. For women: there is no FDA-approved testosterone product — women using testosterone are on off-label compounded preparations, which creates a different regulatory and evidence gap.
Key Efficacy Results
TOM trial: Stopped early — excess cardiovascular events in older men on testosterone vs. placebo. TRAVERSE: Testosterone non-inferior to placebo for major cardiovascular events in hypogonadal men with or at high risk for cardiovascular disease. Women: systematic review found benefit for sexual function at physiological doses; long-term safety data limited.
Referenced Studies
Each study carries a Cochrane RoB-2 risk-of-bias badge — tap the badge for details.
Evidence & Transparency
Cochrane RoB-2 (Risk of Bias)
Badges reflect an editorial assessment using Cochrane's RoB-2 tool domains: randomization, intervention deviation, missing data, outcome measurement, and selective reporting. These are not certified Cochrane reviews. Learn more ↗
CMS Open Payments
Manufacturer payment disclosures are reported via the CMS Sunshine Act. Disclosure is legally required and does not imply bias or misconduct. Language uses "may," "suggests," or "appears" — never definitive clinical claims. CMS Open Payments ↗
Live Clinical Trials
Live from ClinicalTrials.gov · refreshed every 4 hours
Currently enrolling, active, and recently completed studies involving Testosterone. Data is pulled directly from the U.S. National Library of Medicine.
Recent Research
Live from PubMed · peer-reviewed literature · refreshed every 4 hours
Most recently indexed clinical trials and systematic reviews mentioning Testosterone in PubMed.
Source Documentation
Structured citations for referenced clinical trials
Each referenced trial is listed with its registry ID, funding source, and bias assessment. Use the copy button to generate a formatted citation.
| Trial | Registry ID | Cite |
|---|---|---|
| TOM Trial — Older Men (NEJM 2010) | NCT00240981 | |
| TRAVERSE Trial — Cardiovascular Safety | NCT03518034 | |
| Testosterone in Women — Systematic Review (Lancet DE 2019) | PMID:34762252 |
Bias ratings use Cochrane RoB-2 methodology. Editorial assessment — not a certified Cochrane review.
Our MethodologyMedical Disclaimer
The information on this page is compiled from publicly available clinical trial data, FDA prescribing information, and peer-reviewed literature. It is provided for educational purposes only and does not constitute medical advice, diagnosis, or treatment recommendations. Individual responses to medications vary. Always consult a qualified healthcare provider before starting, stopping, or changing any medication.
Stopping This Medication Safely
Exogenous testosterone suppresses the hypothalamic-pituitary-gonadal (HPG) axis. Stopping abruptly leaves the body without either the exogenous testosterone OR its natural production for weeks to months — causing significant hypogonadism: profound fatigue, low mood, and loss of libido that can persist until the axis recovers. Recovery is not guaranteed in all patients, particularly with long-term use.
What Published Research Shows About Stopping This Medication
This summarizes what published research documents — it is not personal medical advice. Any changes to your medication require discussion with your prescribing physician.
- ·Research documents that abrupt discontinuation causes significant hypogonadism — medical supervision during stopping is consistently supported
- ·Published protocols describe using clomiphene citrate or HCG to stimulate natural testosterone production during the transition
- ·Research supports gradual gel dose reduction over 6-12 weeks; for injections, progressively increasing the interval between doses is documented
- ·Research recommends monitoring morning testosterone levels throughout to assess HPG axis recovery
- ·Research documents full HPG axis recovery typically taking 3-6 months, with longer timelines in patients with years of use
Warning Symptoms — Contact Your Doctor If You Experience:
- Profound fatigue or depressive symptoms within days of stopping
- Severe loss of libido
- Mood changes or irritability
- Morning testosterone level remaining very low at 3-month check
- Testicular pain — potential sign of testicular recovery effort
Never change or stop a medication without consulting your prescribing physician.
Questions for Your Doctor
Questions to Ask
- 1.Has my testosterone been measured at least twice in the morning — and was it below the established reference range for my age?
- 2.Has the cause of low testosterone been investigated — is it primary (testicular) or secondary (pituitary) hypogonadism?
- 3.If I want to preserve fertility, have we discussed that testosterone suppresses sperm production — and options like HCG?
- 4.What monitoring schedule do you use — hematocrit, PSA, and testosterone levels?
- 5.For women: what dose and formulation are we using, and how will we monitor for signs of excess androgen?
Lab Tests to Request
- Morning testosterone (8-10 AM, fasted — two readings)
- LH and FSH (to distinguish primary vs. secondary hypogonadism)
- Hematocrit/hemoglobin (baseline and every 3-6 months)
- PSA (men over 40)
- Lipid panel
- Sleep apnea screening if not already evaluated
- Bone density (DEXA) if low-normal testosterone long-term
Medical Disclaimer
The information on this page is compiled from publicly available clinical trial data, FDA prescribing information, and peer-reviewed literature. It is provided for educational purposes only and does not constitute medical advice, diagnosis, or treatment recommendations. Individual responses to medications vary. Always consult a qualified healthcare provider before starting, stopping, or changing any medication.
Frequently Asked Questions About AndroGel® / Xyosted® / Testim® / Axiron® / Natesto®
- What is AndroGel® / Xyosted® / Testim® / Axiron® / Natesto® used for?
- AndroGel® / Xyosted® / Testim® / Axiron® / Natesto® (Testosterone) is a Androgen / Sex Hormone manufactured by AbbVie (AndroGel) / Antares Pharma (Xyosted) / Endo (Testim) / Various Generic. FDA-approved indications include: Male hypogonadism (FDA-approved); Delayed puberty in boys (FDA-approved); Metastatic breast cancer in women (FDA-approved — rarely used); Hypoactive sexual desire disorder in postmenopausal women (off-label); Gender-affirming therapy (off-label); Low energy and mood in age-related hypogonadism (off-label).
- What are the common side effects of AndroGel® / Xyosted® / Testim® / Axiron® / Natesto®?
- Common side effects of AndroGel® / Xyosted® / Testim® / Axiron® / Natesto® include: Acne (10-15%); Erythrocytosis (high red blood cell count) (5-15%); Testicular atrophy (men) (Very common); Reduced sperm count / infertility (men) (Common with extended use); Mood changes / irritability (5-10%).
- How much does AndroGel® / Xyosted® / Testim® / Axiron® / Natesto® cost?
- AndroGel® / Xyosted® / Testim® / Axiron® / Natesto® list price is approximately $500. With insurance it typically costs $30-80; without insurance approximately $80-300.
- Who funded the clinical trials for AndroGel® / Xyosted® / Testim® / Axiron® / Natesto®?
- AbbVie spent approximately $194 million marketing AndroGel in 2012 alone and funded multiple prescribing education campaigns through "Low T" disease awareness efforts. The TRAVERSE trial (cardiovascular safety of testosterone in men) was FDA-mandated and co-funded by AbbVie, Endo Pharmaceuticals, and other manufacturers — with significant FDA oversight to ensure independence. For women's testosterone: the LibiGel and Intrinsa FDA applications were funded by BioSante Pharmaceuticals and Watson Pharmaceuticals respectively — both were declined by FDA.
- How strong is the clinical evidence for AndroGel® / Xyosted® / Testim® / Axiron® / Natesto®?
- Key studies: TOM Trial (men), TRAVERSE Trial (men), Xyosted REMS study (subcutaneous enanthate), LibiGel & Intrinsa (women — FDA rejected). TOM trial: Stopped early — excess cardiovascular events in older men on testosterone vs. placebo. TRAVERSE: Testosterone non-inferior to placebo for major cardiovascular events in hypogonadal men with or at high risk for cardiovascular disease. Women: systematic review found benefit for sexual function at physiological doses; long-term safety data limited. Potential conflicts of interest: The "Low T" marketing campaign (primarily AbbVie/Abbott) significantly expanded the diagnosed population of men with "testosterone deficiency" in the 2000s-2010s. Endocrinology societies received phar.
- Are there non-drug alternatives to AndroGel® / Xyosted® / Testim® / Axiron® / Natesto®?
- Testosterone levels are significantly influenced by lifestyle. Several well-studied factors affect endogenous testosterone production — these are important to evaluate and address before or alongside any pharmacological intervention, as they represent root causes rather than symptoms. See the Alternatives tab for full details.
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