AndroGel Geriatric (65+) Safety: What Older Men and Their Doctors Need to Know

Is AndroGel approved for men over 65?

Testosterone products are FDA-approved for men who lack or have low testosterone together with an associated medical condition: testicular failure from causes such as chemotherapy or genetic problems, or a pituitary or hypothalamic disorder. FDA states that none of the approved testosterone products are approved for men with low testosterone who lack an associated condition [1]. Labels carry a Limitation of Use saying safety and efficacy in age-related, or late-onset, hypogonadism have not been established [1].

In February 2025 FDA told sponsors to keep that limitation while adding TRAVERSE results to labels and removing boxed-warning language about adverse cardiovascular outcomes [5]. In June 2026 FDA requested further updates, including removing the age-related limitation and revising prostate cancer and benign prostatic hyperplasia safety information [1]. Those are requests: the testosterone gel 1% label (effective September 2025) still carries the older limitation text [6].

What TRAVERSE found in men aged 45 to 80

TRAVERSE randomized 5,246 men aged 45 to 80 who had symptoms of hypogonadism, two fasting testosterone levels below 300 ng/dL, and existing or high risk of cardiovascular disease to daily 1.62% testosterone gel or placebo gel [2]. Over a mean treatment duration of 21.7 months and mean follow-up of 33.0 months, the primary composite of cardiovascular death, nonfatal myocardial infarction or nonfatal stroke occurred in 182 men (7.0%) on testosterone and 190 (7.3%) on placebo, hazard ratio 0.96 (95% CI 0.78 to 1.17), which met the noninferiority margin [2]. FDA reviewed the results and said TRAVERSE did not demonstrate a new safety signal or trend in adverse cardiovascular outcomes [1].

Secondary findings were mixed. Nonfatal arrhythmias needing intervention occurred in 5.2% versus 3.3%, atrial fibrillation in 3.5% versus 2.4%, acute kidney injury in 2.3% versus 1.5%, and bone fracture in 3.5% versus 2.5% [2]. In TRAVERSE, venous thromboembolism was reported in 1.7% on testosterone gel versus 1.2% on placebo, including deep vein thrombosis in 0.6% versus 0.5% and pulmonary embolism in 0.9% versus 0.5%, as the testosterone gel 1% label records it [6]. That label also says there are insufficient long-term safety data in geriatric patients to assess cardiovascular disease and prostate cancer risk [6].

Blood pressure rises with every testosterone product

FDA's February 2025 action also followed ambulatory blood pressure monitoring studies. FDA says results from the completed studies confirmed an increase in blood pressure with all testosterone products, class-wide, and required a new blood pressure warning for products that did not have one [5]. In TRAVERSE, mean systolic blood pressure rose 1.0 mm Hg from baseline to 36 months on testosterone gel, against a mean fall of 0.5 mm Hg on placebo [2]. The testosterone gel 1% label says the product is not recommended for men with uncontrolled hypertension [6].

Coronary plaque: a substudy signal

A substudy of the Testosterone Trials sent 170 of the 788 enrolled men for coronary CT angiography; 138 scans were analyzable (73 on testosterone, 65 on placebo), with a mean age of 71.2 [7]. Noncalcified coronary plaque volume rose from a median of 204 mm3 to 232 mm3 on testosterone versus 317 mm3 to 325 mm3 on placebo, an estimated difference of 41 mm3 (95% CI 14 to 67; P=0.003). Total plaque volume rose from 272 mm3 to 318 mm3 versus 499 mm3 to 541 mm3, a difference of 47 mm3 (95% CI 13 to 80; P=0.006) [7]. Plaque volume is a surrogate measurement, not a count of heart attacks.

Hematocrit and erythrocytosis

Testosterone raises red cell mass, and the size of the rise depends partly on the formulation. A network meta-analysis of 29 placebo-controlled randomized trials covering 3,393 men found mean hematocrit increases versus placebo of 3.0% with gel (95% CI 1.8 to 4.3) and 4.0% with intramuscular enanthate or cypionate (95% CI 2.9 to 5.1), with short-acting injectables rising significantly more than patch [3]. A review of testosterone replacement in aging men reported a 315% greater risk of erythrocytosis, defined as hematocrit above 0.52, compared with controls [8].

The Endocrine Society guideline recommends monitoring hematocrit during the first year of treatment [9]. The testosterone gel 1% label says to check hematocrit before starting, re-evaluate it 3 to 6 months after starting and then annually, and stop therapy if hematocrit becomes elevated until it falls to an acceptable concentration; it also notes that increased red cell mass may raise the risk of thromboembolic events [6].

Prostate and BPH

The Endocrine Society recommends against starting testosterone therapy in men with breast or prostate cancer [9]. The testosterone gel 1% label says men treated with androgens may be at increased risk for prostate cancer, that patients should be evaluated for prostate cancer before and during treatment, and that men with BPH should be monitored for worsening signs and symptoms [6]. FDA asked in June 2026 for revised prostate cancer and BPH safety information [1].

Other cautions from the guideline and label

The Endocrine Society also recommends against starting testosterone in men with elevated hematocrit, untreated severe sleep apnea, uncontrolled heart failure, or a heart attack or stroke within the past 6 months [9]. The testosterone gel 1% label warns that edema, with or without congestive heart failure, may occur in patients with pre-existing cardiac, renal or hepatic disease [6].

The testosterone gel 1% label lists three interactions. It says androgens can change anticoagulant activity, so more frequent INR and prothrombin time monitoring is recommended, especially at the start and end of therapy. Androgens may lower blood glucose and insulin requirements. Combined with corticosteroids or ACTH, they may increase fluid retention [6].

Strength, bone and falls

The Testosterone Trials studied men 65 and older for one year. A separate three-year trial in healthy men 60 and older found modest improvements in muscle strength and stair-climbing power [10]. In that trial, men with total testosterone of 100 to 400 ng/dL or free testosterone below 50 pg/mL took 7.5 g of 1% testosterone gel or placebo daily; stair-climbing power, chest-press strength and lean mass all improved modestly more on testosterone [10].

In the one-year Testosterone Trials, 790 men aged 65 or older with testosterone below 275 ng/dL and symptoms were randomized to gel or placebo. Sexual activity, sexual desire and erectile function improved (P<0.001), mood improved slightly, and there was no benefit for vitality. Walking distance improved only when all three trials were pooled (20.5% versus 12.6%, P=0.003), and adverse event rates were similar between groups. The investigators cautioned that the number of participants was too few to draw conclusions about the risks of testosterone treatment [4].

Bone density moved in the same direction. Among 211 men with a mean age of 72.3, one year of testosterone gel raised spine trabecular volumetric bone density by 7.5% versus 0.8% on placebo, and estimated spine strength by 10.8% versus 2.4% [11]. The authors of the three-year trial said the clinical meaning of its effects, and their impact on disability, remains to be studied [10].

Secondary exposure at home

The boxed warning on the testosterone gel 1% label is about other people, not the patient. Virilization has been reported in children secondarily exposed to testosterone gel, and the label says children should avoid contact with unwashed or unclothed application sites [6]. Reported signs include enlargement of the penis or clitoris, pubic hair, increased erections and libido, aggressive behavior and advanced bone age; most regressed once exposure was removed, but in a few cases enlarged genitalia did not fully return to age-appropriate size [6]. The same label contraindicates use in women who are pregnant, because exposure of a female fetus to androgens may cause virilization [6].