androgel
Androgel (Testosterone) is an androgen used to treat Breast Neoplasms, Hypogonadism, Delayed Puberty.
Testosterone · by Besins Hlthcare
Key facts
- Active ingredient
- Testosterone
- Drug class
- Androgen
- Form
- Topical
- Strength
- Testosterone 12.5MG/1.25GM Actuation · Testosterone 25MG/2.5GM Packet · Testosterone 50MG/5GM Packet
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- breast neoplasms, hypogonadism, delayed puberty
- Manufacturer
- Besins Hlthcare
- Half-life
- about 10 to 100 minutes (how long it stays in your system)
- What the pharmacy pays
- ~$0.65 per gm — not your price
- FDA application
- NDA021015
- FDA boxed warning
- Yes — see the boxed warning
What is Androgel?
From the FDA label:Testosterone gel 1% is a clear, colorless hydroalcoholic gel containing testosterone. The active pharmacologic ingredient in testosterone gel 1% is testosterone, an androgen. Testosterone USP is a white to practically white crystalline powder chemically described as 17-beta hydroxyandrost-4-en-3-one. The structural formula is: Pharmacologically inactive ingredients in testosterone gel 1% are carbomer 980, ethanol 67.0%, isopropyl myristate, purified water, and sodium hydroxide. These ingredients are not pharmacologically active. Chem
How to use
Dosage and Administration for testosterone gel 1% differs from testosterone gel 1.62%. For dosage and administration of testosterone gel 1.62% refer to its full prescribing information. ( 2 ) Prior to initiating testosterone gel 1%, confirm the diagnosis of hypogonadism by ensuring that serum testosterone concentrations have been measured in the morning on at least two separate days and that these serum testosterone concentrations are below the normal range. Dosage and Administration for testosterone gel 1% differs from testosterone gel 1.62%. For dosage and administration of testosterone gel 1.62% refer to its full prescribing information. ( 2 ) Prior to initiating testosterone gel 1%, confirm the diagnosis of hypogonadism by ensuring that serum testosterone has been measured in the morning on at least two separate days and that these concentrations are below the normal range ( 2 ). Starting dose of testosterone gel 1% is 50 mg of testosterone (4 pump actuations, two 25 mg packets or one 50 mg packet), applied once daily in the morning. ( 2.1 ) Apply to clean, dry, intact skin of shoulders and upper arms and/or abdomen. Do NOT apply testosterone gel 1% to any other parts of the body including the genitals, chest, armpits (axillae), knees, or back. ( 2.2 ) Dose adjustment: testosterone gel 1% can be dose adjusted using 50 mg, 75 mg, or 100 mg of testosterone on the basis of…
Side effects
Most common adverse reactions (incidence ≥ 5%) are acne, application site reaction, abnormal lab tests, and prostatic disorders. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Prasco Laboratories at 1-866-525-0688 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trials in Hypogonadal Men Table 2 shows the incidence of all adverse events judged by the investigator to be at least possibly related to treatment with testosterone gel 1% and reported by >1% of patients in a 180 Day, Phase 3 study. Table 2 : Adverse Events Possibly, Probably or Definitely Related to Use of Testosterone Gel 1% in the 180 Day Controlled Clinical Trial Adverse Event Dose of Testosterone Gel 1% 50 mg 75 mg 100 mg N = 77 N = 40 N = 78 Acne 1% 3% 8% Alopecia 1% 0% 1% Application Site Reaction 5% 3% 4% Asthenia 0% 3% 1% Depression 1% 0% 1% Emotional Lability 0% 3% 3% Gynecomastia 1% 0% 3% Headache 4% 3% 0% Hypertension 3% 0% 3% Lab Test Abnormal* 6% 5% 3% Libido Decreased 0% 3% 1% Nervousness 0% 3% 1% Pain Breast 1% 3% 1% Prostate Disorder** 3% 3% 5% Testis Disorder*** 3% 0% 0% * Lab test abnormal…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
Virilization has been reported in children who were secondarily exposed to testosterone gel [see Warnings and Precautions ( 5.2 ) and Adverse Reactions ( 6.2 )] . Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel [see Dosage and Administration ( 2.2 ) and Warnings and Precautions ( 5.2 )] . Healthcare providers should advise patients to strictly adhere to recommended instructions for use [see Dosage and Administration ( 2.2 ), Warnings and Precautions ( 5.2 ) and Patient Counseling Information ( 17 )] . WARNING: SECONDARY EXPOSURE TO TESTOSTERONE See full prescribing information for complete boxed warning. Virilization has been reported in children who were secondarily exposed to testosterone gel. ( 5.2 , 6.2 ) Children should avoid contact with unwashed or unclothed application sites in men using testosterone gel. ( 2.2 , 5.2 ) Healthcare providers should advise patients to strictly adhere to recommended instructions for use. ( 2.2 , 5.2 , 17 )
Warnings
Important safety information
Monitor patients with benign prostatic hyperplasia (BPH) for worsening of signs and symptoms of BPH. ( 5.1 ) Avoid unintentional exposure of women or children to testosterone gel 1%. Secondary exposure to testosterone can produce signs of virilization. Testosterone gel 1% should be discontinued until the cause of virilization is identified. ( 5.2 ) Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients using testosterone products. Evaluate patients with signs or symptoms consistent with DVT or PE. ( 5.4 ) Some postmarketing studies have shown an increased risk of myocardial infarction and stroke associated with use of testosterone replacement therapy. ( 5.5 ) Exogenous administration of androgens may lead to azoospermia. ( 5.8 ) Edema, with or without congestive heart failure (CHF), may be a complication in patients with preexisting cardiac, renal, or hepatic disease. ( 5.10 , 6.2 ) Sleep apnea may occur in those with risk factors. ( 5.12 ) Monitor serum testosterone, prostate specific antigen (PSA), hemoglobin, hematocrit, liver function tests, and lipid concentrations periodically. ( 5.1 , 5.3 , 5.9 , 5.13 ) Testosterone gel 1% is flammable until dry. ( 5.16 ) 5.1 Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer Patients with BPH treated with androgens are at an increased risk for worsening of signs and symptoms of BPH. Monitor patients with BPH for worsening signs and symptoms. Patients treated with androgens may be at increased risk for prostate cancer. Evaluate patients for prostate cancer prior to initiating and during treatment with androgens [see Contraindications ( 4 ), Adverse Reactions ( 6.1 ) and Nonclinical Toxicology ( 13.1 )] . 5.2 Potential for Secondary Exposure to Testosterone Cases of secondary exposure resulting in virilization of children have been reported in postmarketing surveillance. Signs and symptoms have included enlargement of the penis or clitoris, development of pubic hair, increased erections and libido, aggressive behavior, and advanced bone age. In most cases, these signs and symptoms regressed with removal of the exposure to testosterone gel. In a few cases, however, enlarged genitalia did not fully return to age-appropriate normal size, and bone age remained modestly greater than chronological age. The risk of transfer was increased in some of these cases by not adhering to precautions for the appropriate use of the topical testosterone product. Children and women should avoid contact with unwashed or unclothed application sites in men using testosterone gel 1% [see Dosage and Administration ( 2.2 ), Use in Specific Populations ( 8.1 ) and Clinical Pharmacology ( 12.3 )] . Inappropriate changes in genital size or development of pubic hair or libido in children, or changes in body hair distribution, significant increase in acne, or other signs of virilization in adult women should be brought to the attention of a physician and the possibility of secondary exposure to testosterone gel should also be brought to the attention of a physician. Testosterone gel should be promptly discontinued until the cause of virilization has been identified. 5.3 Polycythemia Increases in hematocrit, reflective of increases in red blood cell mass, may require lowering or discontinuation of testosterone. Check hematocrit prior to initiating treatment. It would also be appropriate to re-evaluate the hematocrit 3 to 6 months after starting treatment, and then annually. If hematocrit becomes elevated, stop therapy until hematocrit decreases to an acceptable concentration. An increase in red blood cell mass may increase the risk of thromboembolic events. 5.4 Venous Thromboembolism There have been postmarketing reports of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone products such as testosterone gel 1%. Evaluate patients who report symptoms of pain, edema, warmth and erythema in the lower extremity for DVT and those who present with acute shortness of breath for PE. If a venous thromboembolic event is suspected, discontinue treatment with testosterone gel 1% and initiate appropriate workup and management [see Adverse Reactions ( 6.2 )] . 5.5 Cardiovascular Risk Long term clinical safety trials have not been conducted to assess the cardiovascular outcomes of testosterone replacement therapy in men. To date, epidemiologic studies and randomized controlled trials have been inconclusive for determining the risk of major adverse cardiovascular events (MACE), such as non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death, with the use of testosterone compared to non-use. Some studies, but not all, have reported an increased risk of MACE in association with use of testosterone replacement therapy in men. Patients should be informed of this possible risk when deciding whether to use or to continue to use testosterone gel 1%. 5.6 Abuse of Testosterone and Monitoring of Serum Testosterone Concentrations Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids. Anabolic androgenic steroid abuse can lead to serious cardiovascular and psychiatric adverse reactions [see Drug Abuse and Dependence ( 9 )] . If testosterone abuse is suspected, check serum testosterone concentrations to ensure they are within therapeutic range. However, testosterone levels may be in the normal or subnormal range in men abusing synthetic testosterone derivatives. Counsel patients concerning the serious adverse reactions associated with abuse of testosterone and anabolic androgenic steroids. Conversely, consider the possibility of testosterone and anabolic androgenic steroid abuse in suspected patients who present with serious cardiovascular or psychiatric adverse events. 5.7 Use in Women Due to lack of controlled evaluations in women and potential virilizing effects, testosterone gel 1% is not indicated for use in women [see Contraindications ( 4 ) and Use in Specific Populations ( 8.1 , 8.2 )]. 5.8 Potential for Adverse Effects on Spermatogenesis With large doses of exogenous androgens, including testosterone gel 1%, spermatogenesis may be suppressed through feedback inhibition of pituitary follicle-stimulating hormone (FSH) which could possibly lead to adverse effects on semen parameters including sperm count. 5.9 Hepatic Adverse Effects Prolonged use of high doses of orally active 17-alpha-alkyl androgens (e.g., methyltestosterone) has been associated with serious hepatic adverse effects (peliosis hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice). Peliosis hepatis can be a life-threatening or fatal complication. Long-term therapy with intramuscular testosterone enanthate has produced multiple hepatic adenomas. testosterone gel 1% is not known to cause these adverse effects. 5.10 Edema Androgens, including testosterone gel 1%, may promote retention of sodium and water. Edema, with or without congestive heart failure, may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease [see Adverse Reactions ( 6.2 )]. 5.11 Gynecomastia Gynecomastia may develop and persist in patients being treated with androgens, including testosterone gel 1%, for hypogonadism. 5.12 Sleep Apnea The treatment of hypogonadal men with testosterone may potentiate sleep apnea in some patients, especially those with risk factors such as obesity or chronic lung diseases [see Adverse Reactions ( 6.2 )] . 5.13 Lipids Changes in serum lipid profile may require dose adjustment or discontinuation of testosterone therapy. 5.14 Hypercalcemia Androgens, including testosterone gel 1%, should be used with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria). Regular monitoring of serum calcium concentrations is…
Who should not take Androgel
Testosterone gel 1% is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate [see Warnings and Precautions ( 5.1 ), Adverse Reactions ( 6.1 ), and Nonclinical Toxicology ( 13.1 )] . Testosterone gel 1% is contraindicated in women who are pregnant. Testosterone gel 1% can cause virilization of the female fetus when administered to a pregnant woman. Pregnant women need to be aware of the potential for transfer of testosterone from men treated with testosterone gel 1%. If a pregnant woman is exposed to testosterone gel 1%, she should be apprised of the potential hazard to the fetus [see Warnings and Precautions ( 5.2 ) and Use in Specific Populations ( 8.1 )] . Men with carcinoma of the breast or known or suspected prostate cancer. ( 4 , 5.1 ) Women who are pregnant. Testosterone may cause fetal harm. ( 4 , 8.1 )
Overdose — what happens if you take too much
There is one report of acute overdosage with use of an approved injectable testosterone product: this subject had serum testosterone concentrations of up to 11,400 ng/dL with a cerebrovascular accident. Treatment of overdosage would consist of discontinuation of testosterone gel 1%, washing the application site with soap and water, and appropriate symptomatic and supportive care.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Androgens may decrease blood glucose and therefore may decrease insulin requirements in diabetic patients. ( 7.1 ) Changes in anticoagulant activity may be seen with androgens. More frequent monitoring of INR and prothrombin time is recommended. ( 7.2 ) Use of testosterone with adrenocorticotrophic hormone (ACTH) or corticosteroids may result in increased fluid retention. Use with caution, particularly in patients with cardiac, renal, or hepatic disease. ( 7.3 ) 7.1 Insulin Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, may decrease insulin requirements. 7.2 Oral Anticoagulants Changes in anticoagulant activity may be seen with androgens, therefore more frequent monitoring of international normalized ratio (INR) and prothrombin time are recommended in patients taking anticoagulants, especially at the initiation and termination of androgen therapy. 7.3 Corticosteroids The concurrent use of testosterone with adrenocorticotropic hormone (ACTH) or corticosteroids may result in increased fluid retention and requires careful monitoring particularly in patients with cardiac, renal or hepatic disease.
How long does Testosterone stay in your body?
The elimination half-life of testosterone is about 10 to 100 minutes — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the half-life of the natural testosterone hormone itself. The FDA label notes "considerable variation... ranging from 10 to 100 minutes," reflecting how quickly free testosterone is cleared. Two caveats matter for "how long it stays in your system": (1) Formulation dominates. Injectable esters are slow-release depots that far outlast the hormone's own half-life — testosterone cypionate ~8 days, enanthate ~4.5 days, undecanoate weeks — and oral testosterone undecanoate (Jatenzo, Kyzatrex) is a prodrug cleaved to testosterone. The 10-100 minute figure is the hormone's intrinsic clearance, not the duration of a shot. (2) Testosterone converts to active metabolites — dihydrotestosterone (DHT) and estradiol — that circulate on their own timelines. Inactivation occurs primarily in the liver, so hepatic impairment can slow clearance; ~90% is excreted in urine as conjugates. Half-life is not the drug-test detection window: anti-doping tests use the testosterone/epitestosterone ratio and isotope analysis and can flag use for far longer than clearance of the hormone.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: AndroGel (testosterone gel) FDA label, DailyMed — Clinical Pharmacology.
Drug class
How this class works, per Physiology, Testosterone - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
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Dosage forms
Topical
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- What does Androgel treat?
- Androgel (Testosterone) may be used to treat breast neoplasms, hypogonadism, delayed puberty, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Androgel work?
- Androgel is a androgen. Androgens such as testosterone are male sex hormones that enter cells and bind the androgen receptor, switching on genes that drive male traits, muscle and bone growth, and reproductive function. Some testosterone is also converted in tissues to the more potent DHT.
- How much does Androgel cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.65 per gm, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Androgel?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Androgel. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Androgel?
- Androgel is marketed by Besins Hlthcare. You can see Besins Hlthcare's full profile, rating, and other products on pharmaranks.
- Is Androgel a brand-name or generic drug?
- Androgel is a brand-name product with the active ingredient Testosterone.
- Is Androgel available over the counter?
- No. Androgel is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Androgel come in?
- Androgel is currently marketed as topical, per the FDA's National Drug Code Directory.
- What class of drug is Androgel?
- Androgel is classified as androgen, per the FDA's Established Pharmacologic Class.
- Is Androgel FDA-registered?
- Androgel is on record with the U.S. FDA under application number NDA021015. You can verify this on its official FDA label.
- Is Androgel safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Androgel. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Androgel?
- Androgel's side effects are taken directly from its FDA label. From the label: Most common adverse reactions (incidence ≥ 5%) are acne, application site reaction, abnormal lab tests, and prostatic disorders. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Prasco Laboratories at 1-866-525-0688 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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