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AndroGel contains testosterone, a naturally occurring male hormone necessary for many processes in the body. It works by replacing or supplementing the testosterone that is naturally made in the body.
AndroGel is used to treat conditions in men that result from a lack of natural testosterone.
AndroGel will not enhance athletic performance and should not be used for this purpose.
You should not use AndroGel if you have prostate cancer, male breast cancer, are pregnant, or are breastfeeding.
Testosterone can cause birth defects in an unborn baby. A pregnant woman should avoid coming into contact with this medicine, or with a man's skin where the medicine has been applied.
Topical testosterone is absorbed through the skin and can cause side effects or symptoms of male features in a child or woman who comes into contact with this medicine. Call your doctor if a person who has close contact with you develops enlarged genitals, premature pubic hair, increased libido, aggressive behavior, male-pattern baldness, excessive body hair growth, increased acne, irregular menstrual periods, or any signs of male characteristics.
Misuse of AndroGel can cause dangerous or irreversible effects. Never use more than your prescribed dose. Do not share this medicine with another person.
You should not use Androgel if you are allergic to testosterone patches or gels, or if you have;
prostate cancer; or
male breast cancer.
To make sure AndroGel is safe for you, tell your doctor if you have ever had:
cancer;
enlarged prostate, urination problems;
sleep apnea (breathing stops during sleep);
high blood pressure, heart disease, heart attack, or stroke;
a blood clot;
diabetes; or
liver disease or kidney disease.
Older men who use AndroGel may have an increased risk of prostate enlargement or cancer. If you are over 65, talk with your doctor about your specific risk.
AndroGel should not be used by a woman. Testosterone can cause birth defects in an unborn baby. A pregnant woman should avoid coming into contact with testosterone gel, or with a man's skin areas where the gel has been applied. If contact does occur, wash with soap and water right away.
Do not use AndroGel on anyone younger than 18 years old.
Use AndroGel exactly as it was prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than prescribed.
Misuse of AndroGel can cause dangerous or irreversible effects, such as enlarged breasts, small testicles, infertility, high blood pressure, heart attack, stroke, liver disease, bone growth problems, addiction, and mental effects such as aggression and violence.
Do not share this medicine with another person.
This medicine comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.
Apply AndroGel only to your shoulders, upper arms, and/or abdomen that will be covered by a short sleeve t-shirt. Wash your hands right away with soap and water after applying the gel. Keep the area covered until you have washed the application area well or have showered. If you expect to have skin-to-skin contact with another person, first wash the application area well with soap and water.
Do not apply AndroGel to your penis or scrotum.
Apply testosterone gel to dry skin after showering or bathing. Allow the medicine to dry for at least 5 minutes before you dress. Avoid showering, swimming or bathing for at least 2 hours after you application.
Cover treated skin areas with clothing to keep from getting this medicine on other people. If someone else does come into contact with a treated skin area, they must wash the contact area right away with soap and water.
While using AndroGel, you may need frequent blood tests.
Use AndroGel regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
Store at room temperature away from moisture and heat.
Apply the gel as soon as you remember. Skip the missed dose if it is almost time to apply your next dose. Do not use extra gel to make up the missed dose.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Do not apply this medicine to your penis or your scrotum.
Avoid swimming, bathing, or showering for 2 to 5 hours after applying testosterone gel. Follow the directions provided with your specific brand.
Testosterone gel may be flammable. Avoid using near open flame, and do not smoke until the gel has completely dried on your skin.
Get emergency medical help if you have any signs of an allergic reaction to Androgel: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using AndroGel and call your doctor at once if you have:
increased urination (many times per day), loss of bladder control;
painful or difficult urination;
breast pain or swelling;
painful or bothersome erections;
swelling, rapid weight gain, shortness of breath during sleep;
chest pain or pressure, pain spreading to your jaw or shoulder;
liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
signs of a blood clot in the lung - chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
signs of a blood clot in your leg - pain, swelling, warmth, or redness in one or both legs.
Topical testosterone is absorbed through the skin and can cause symptoms of male features in a woman or child who comes into contact with the medication. Call your doctor if your female partner has male-pattern baldness, excessive body hair growth, increased acne, irregular menstrual periods, or any other signs of male characteristics.
Common Androgel side effects may include:
redness, itching, burning, hardened skin or other irritation where the medicine was applied;
headache, mood changes;
increased red blood cells (may cause dizziness, itching, redness in your face, or muscle pain);
vomiting, diarrhea;
strange dreams;
frequent or prolonged erections; or
high blood pressure - severe headache, blurred vision, pounding in your neck or ears.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Tell your doctor about all your current medicines and any you start or stop using during your treatment with AndroGel, especially:
insulin;
a blood thinner; (warfarin, Coumadin, Jantoven); or
a steroid medicine; methylprednisolone (Medrol), prednisone (Sterapred), and others.
This list is not complete. Other drugs may interact with testosterone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Further informationRemember, keep this and all other medicines out of the reach of children, never share your medicines with others, and AndroGel only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Androgel (www.drugs.com/androgel.html).
Note: This document contains side effect information about testosterone. Some of the dosage forms listed on this page may not apply to the brand name AndroGel.
For the ConsumerApplies to testosterone: buccal patch extended release
Other dosage forms:
Along with its needed effects, testosterone (the active ingredient contained in AndroGel) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking testosterone:
Incidence not known
Get emergency help immediately if any of the following symptoms of overdose occur while taking testosterone:
Symptoms of overdose
Some side effects of testosterone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Less common
For Healthcare Professionals
Applies to testosterone: buccal film extended release, compounding powder, intramuscular solution, nasal gel, subcutaneous implant, subcutaneous solution, transdermal cream, transdermal film extended release, transdermal gel, transdermal ointment, transdermal solution
GeneralThe most frequently reported side effects with this drug are edema, acne, site pain, injection site erythema, cough or dyspnea during or immediately after injection.
The most frequently reported side effects with testosterone (the active ingredient contained in AndroGel) topical are skin reaction (16.1%) and allergic contact dermatitis (up to 37%).
DermatologicVery common (10% or more): Testosterone topical: Skin reaction (16.1%), burn-like blisters (12%), itching, allergic contact dermatitis (up to 37%)
Common (1% to 10%): Acne, induration, burning
Uncommon (0.1% to 1%): Alopecia, erythema, rash (including rash popular), pruritus, dry skin, folliculitis (testosterone (the active ingredient contained in AndroGel) topical)
Frequency not reported: Seborrhea, urticaria, male pattern baldness, hirsutism injection site inflammation
Postmarketing reports: Angioedema, angioneurotic edema, hyperhidrosis, discolored hair, leukocytoclastic vasculitis
EndocrineVery common (10% or more): Accelerated growth
Common (1% to 10%): Increased estradiol, hypogonadism
Uncommon (0.1% to 1%): Increased blood testosterone (the active ingredient contained in AndroGel) Frequency not reported: Signs of virilization in women (e.g., hoarseness, acne, hirsutism, menstrual irregularity, clitoral enlargement, and alopecia), precocious puberty (in prepubertal males)
Postmarketing reports: Hyperparathyroidism, prolactin increased, testosterone increased
GastrointestinalVery common (10% or more): Testosterone (the active ingredient contained in AndroGel) buccal film: Gingivitis (32.6%)
Common (1% to 10%): Diarrhea, oily stools (due to IM injection oily solvent); Testosterone topical: Gastroesophageal reflux disease, gastrointestinal bleeding, gum or mouth irritation (9.2%), taste bitter, gum pain, gum tenderness, gum edema, taste perversion
Uncommon (0.1% to 1%): Nausea
Rare (less than 0.1%): Abdominal pain
Frequency not reported: Abdominal disorder, intraabdominal hemorrhage
Postmarketing reports: Vomiting; Testosterone buccal film: Dry mouth, gingival swelling, lip swelling, mouth ulceration, stomatitis
The majority of gum-related adverse events were transient.
LocalVery common (10% or more): Testosterone topical: Application site pruritus (up to 37%), application site blistering (12%)
Common (1% to 10%): Injection site pain, injection site discomfort, injection site pruritus, erythema, injection site hematoma, injection site irritation, injection site inflammation; injection site reaction; Topical testosterone (the active ingredient contained in AndroGel) Application site erythema, application site warmth, application site irritation, application site vesicles, application site exfoliation, application site burning, application site induration, bullae at application site, mechanical irritation at application site, rash at application site, contamination of application site
Postmarketing reports: Injection site abscess, procedural pain, application site swelling (topical testosterone)
CardiovascularCommon (1% to 10%): Hot flush, hypertension
Uncommon (0.1% to 1%): Cardiovascular disorder
Frequency not reported: Venous thromboembolism
Postmarketing reports: Angina pectoris, cardiac arrest, cardiac failure, coronary artery disease, coronary artery occlusion, myocardial infarction, tachycardia, cerebral infarction, cerebrovascular accident, circulatory collapse, deep venous thrombosis, syncope, thromboembolism, thrombosis, venous insufficiency, stroke
GenitourinaryCommon (1% to 10%): Abnormal prostate examination, benign prostate hyperplasia (BPH), ejaculation disorder, prostatitis
Uncommon (0.1% to 1%): Prostate induration, prostatic disorder, testicular pain, decreased urine flow, urinary retention, urinary tract disorder, nocturia, dysuria
Rare (less than 0.1%): Micturition disorders, epididymitis, bladder irritability, impotence, inhibition of testicular function and testicular atrophy
Frequency not reported: Oligospermia, priapism, benign prostatic hyperplasia (prostatic growth to eugonadal state), excessive frequency and duration of erections; Pediatrics: Precocious sexual development, an increased frequency of erections, phallic enlargement
Postmarketing reports: Prostate infection, calculus urinary, dysuria, hematuria, urinary tract disorder, pollakiuria, azoospermia
HematologicCommon (1% to 10%): Polycythemia, hematocrit increased
Uncommon (0.1% to 1%): Increased red blood cell count, increased hemoglobin, prolonged activated partial thromboplastin time, prolonged prothrombin time
Frequency not reported: Blood and lymphatic system disorders, suppression of clotting factors II, V, VII, and X, bleeding in patients on concomitant anticoagulant therapy
Postmarketing reports: Thrombocytopenia, anemia
MetabolicCommon (1% to 10%): Weight increased, appetite increased, fluid retention (sodium, chloride, water, potassium, calcium, and inorganic phosphates)
Uncommon (0.1% to 1%): Increased glycosylated hemoglobin, hypercholesterolemia, increased triglyceride
Frequency not reported: Abnormal lipids (decrease in serum LDL, HDL, and triglycerides), metabolism and nutrition disorders, hypercalcemia
Postmarketing reports: Hypoglycemia, diabetes mellitus, fluid retention, hyperlipidemia, hypertriglyceridemia, blood glucose increased
MusculoskeletalCommon (1% to 10%): Back pain, hemarthrosis (testosterone (the active ingredient contained in AndroGel) topical)
Uncommon (0.1% to 1%): Arthralgia, pain in extremity, muscle spasm, muscle strain, myalgia, musculoskeletal stiffness, increased creatine phosphokinase
Frequency not reported: Pediatrics: Premature epiphyseal closure, increased bone formation
Postmarketing reports: Musculoskeletal chest pain, musculoskeletal pain, myalgia, osteopenia, osteoporosis, systemic lupus erythematosus
Nervous systemCommon (1% to 10%): Headache, vertigo (topical testosterone (the active ingredient contained in AndroGel)
Uncommon (0.1% to 1%): Migraine, tremor, dizziness
Frequency not reported: Nervousness, paresthesia
Postmarketing reports: Cerebrovascular insufficiency, reversible ischemic neurological deficiency, transient ischemic attack, amnesia
OncologicCommon (1% to 10%): Prostatic specific antigen (PSA) increased, prostate cancer
Uncommon (0.1% to 1%): Prostatic intraepithelial neoplasia
Rare (less than 0.1%): Neoplasms benign, malignant, and unspecified (including cysts and polyps)
OtherCommon (1% to 10%): Fatigue, hyperhidrosis; chills, body pain, smell disorder
Uncommon (0.1% to 1%): Breast induration, breast pain, sensitive nipples, gynecomastia, increased estradiol, increased testosterone (the active ingredient contained in AndroGel) asthenia, night sweats
Rare (less than 0.1%): Fever, malaise
Frequency not reported: Edema
Postmarketing reports: Sudden hearing loss, tinnitus, Influenza like illness
PsychiatricCommon (1% to 10%): Irritability, insomnia, mood swings, aggression,
Uncommon (0.1% to 1%): Depression, emotional disorder, restlessness, increased libido, decreased libido
Frequency not reported: Hostility, anxiety
Postmarketing reports: Korsakoff's psychosis nonalcoholic, male orgasmic disorder, restlessness, sleep disorder
RespiratoryCommon (1% to 10%): Sinusitis, nasopharyngitis, upper respiratory tract infection, bronchitis
Uncommon (0.1% to 1%): Cough, dyspnea, snoring, dysphonia
Rare (less than 0.1%): Pulmonary microembolism (POME) (cough, dyspnea, malaise, hyperhidrosis, chest pain, dizziness, paresthesia, or syncope) caused by oily solutions
Frequency not reported: Sleep apnea
Postmarketing reports: Chest pain, asthma, chronic obstructive pulmonary disease, hyperventilation, obstructive airway disorder, pharyngeal edema, pharyngolaryngeal pain, pulmonary embolism, respiratory distress, rhinitis, sleep apnea syndrome
Signs and symptoms of pulmonary microemboli may occur during or immediately after the injections and are reversible.
HepaticUncommon (0.1% to 1%): Abnormal LFT, increased AST
Rare (less than 0.1%): Abnormal hepatic function
Frequency not reported: Jaundice, benign liver tumor, malignant liver tumor, liver enlargement, peliosis hepatitis
Postmarketing reports: ALT increased, AST increased, bilirubin increased, transaminases increased, gamma-glutamyltransferase increased
HypersensitivityUncommon (0.1% to 1%): Hypersensitivity reactions
Frequency not reported: Anaphylactic reactions
Postmarketing reports: Anaphylactic shock
OcularUncommon (0.1% to 1%): Testosterone (the active ingredient contained in AndroGel) topical: Lacrimation increased
Postmarketing reports: Testosterone topical: Intraocular pressure increased, vitreous detachment
RenalPostmarketing reports: Nephrolithiasis, renal colic, renal pain
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Androgel (www.drugs.com/androgel.html).
December 16, 2020
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