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Testosterone is a naturally occurring sex hormone produced in a man's testicles. Small amounts of testosterone are also produced in a woman's ovaries and adrenal system.
Depo-Testosterone is used in men and boys to treat conditions caused by a lack of this hormone, such as delayed puberty, impotence, or other hormonal imbalances. This medicine is not for use in treating low testosterone without certain medical conditions or due to getting older.
Testosterone enanthate is used in women to treat breast cancer that has spread to other parts of the body (metastatic) and cannot be treated with surgery.
Testosterone will not enhance athletic performance and should not be used for that purpose.
Depo-Testosterone may also be used for purposes not listed in this medication guide.
You should not be treated with testosterone if you have prostate cancer, male breast cancer, a serious heart condition, severe liver or kidney disease, or an allergy to castor oil or sesame oil. Depo-Testosterone is not for use in treating low testosterone without certain medical conditions or due to getting older. Testosterone should not be used to enhance athletic performance.
Depo-Testosterone is not for use in women who are pregnant.
Testosterone can increase your risk of heart attack, stroke, or death. You may need to stop using testosterone or start taking blood pressure medication.
Misuse of testosterone can cause dangerous or irreversible effects. Do not share this medicine with another person.
You should not be treated with this medicine if you are allergic to testosterone, or if you have:
male breast cancer;
prostate cancer;
serious heart problems;
severe liver disease;
severe kidney disease; or
an allergy to castor oil or sesame oil.
Depo-Testosterone is not for use in women who are pregnant. This medicine can harm an unborn baby or cause birth defects.
Tell your doctor if you have ever had:
high blood pressure;
heart problems, coronary artery disease (clogged arteries);
a heart attack or stroke;
sleep apnea;
an enlarged prostate and urination problems;
high cholesterol or triglycerides;
cancer;
depression, anxiety, a mood disorder, suicidal thoughts or actions;
diabetes;
high red blood cell (RBC) counts; or
liver or kidney disease.
Using testosterone may increase your risk of developing prostate cancer, liver problems, or heart problems (including heart attack, stroke, or death). Ask your doctor about these risks.
Women using testosterone should not breastfeed.
Testosterone should not be given to a child younger than 12 years old. Some types of this medicine are not approved for use by anyone younger than 18 years old.
Testosterone is injected under the skin or into a muscle, usually given every 2 to 4 weeks. Depo-Testosterones should be given only by a healthcare professional.
The length of treatment with Depo-Testosterone will depend on the condition being treated.
Testosterone can raise your blood pressure, which could increase your risk of heart attack, stroke, or death. Your blood pressure will need to be checked often. You may need to stop using testosterone or start taking blood pressure medication.
You will need frequent blood tests.
Testosterone can affect bone growth in boys who are treated for delayed puberty. Bone development may need to be checked with x-rays every 6 months during treatment.
Depo-Testosterone can affect the results of certain medical tests. Tell any doctor who treats you that you are using testosterone.
Misuse of testosterone 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. Stealing, selling, or giving away this medicine is against the law.
If you have used too much testosterone, stopping the medicine may caused unpleasant withdrawal symptoms, such as depression, tiredness, irritability, loss of appetite, sleep problems, or decreased libido.
Call your doctor for instructions if you miss an appointment for your Depo-Testosterone.
Since Depo-Testosterone is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Tell your caregivers right away if you have a tight feeling in your throat, a sudden urge to cough, or if you feel light-headed or short of breath during or shortly after receiving the injection.
You will be watched closely for at least 30 minutes to make sure you do not have a reaction to the injection.
Call your doctor at once if you have:
chest pain or pressure, pain spreading to your jaw or shoulder;
shortness of breath, breathing problems at night (sleep apnea);
swelling in your ankles or feet, rapid weight gain;
a seizure;
unusual changes in mood or behavior;
increased or ongoing erection of the penis, ejaculation problems, decreased amounts of semen, decrease in testicle size;
painful or difficult urination, increased urination at night, loss of bladder control;
high levels of calcium in the blood--stomach pain, constipation, increased thirst or urination, muscle pain or weakness, joint pain, confusion, and feeling tired or restless; or
high potassium level--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement;
liver problems--right-sided upper stomach pain, vomiting, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes).
signs of a blood clot deep in the body--swelling, warmth, or redness in an arm or leg;
signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
signs of a stroke--sudden numbness or weakness (especially on one side of the body), severe headache, slurred speech, balance problems.
Women receiving testosterone may develop male characteristics, which could be irreversible if treatment is continued. Call your doctor at once if you notice any of these signs of excess testosterone:
acne;
changes in your menstrual periods (including missed periods);
male-pattern hair growth (such as on the chin or chest);
hoarse or deepened voice; or
enlarged clitoris.
Your Depo-Testosterones may be delayed or permanently discontinued if you have certain side effects.
Common side effects (in men or women) may include:
breast swelling;
acne, increased facial or body hair growth, male-pattern baldness;
increased or decreased interest in sex;
headache, anxiety, depressed mood;
increased blood pressure;
numbness or tingly feeling;
abnormal liver function tests;
high red blood cell counts (hematocrit or hemoglobin);
increased PSA (prostate-specific antigen); or
pain, bruising, bleeding, redness, or a hard lump where the medicine was injected.
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 other medicines, especially:
insulin or oral diabetes medicine;
medicine to treat pain, cough, or cold symptoms;
a blood thinner--warfarin, Coumadin, Jantoven; or
steroid medicine--prednisone, dexamethasone, and others.
This list is not complete. Other drugs may affect testosterone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication 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 1/1/2020.
Source: Drugs.com Depo-testosterone (www.drugs.com/mtm/depo-testosterone.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 Depo-Testosterone.
Applies to testosterone: buccal patch extended release
Other dosage forms:
Along with its needed effects, testosterone (the active ingredient contained in Depo-Testosterone) 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
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
The 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 Depo-Testosterone) topical are skin reaction (16.1%) and allergic contact dermatitis (up to 37%).
Very 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 Depo-Testosterone) topical)
Frequency not reported: Seborrhea, urticaria, male pattern baldness, hirsutism injection site inflammation
Postmarketing reports: Angioedema, angioneurotic edema, hyperhidrosis, discolored hair, leukocytoclastic vasculitis
Very 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 Depo-Testosterone) 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
Very common (10% or more): Testosterone (the active ingredient contained in Depo-Testosterone) 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.
Very 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 Depo-Testosterone) 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)
Common (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
Common (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
Common (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
Common (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
Common (1% to 10%): Back pain, hemarthrosis (testosterone (the active ingredient contained in Depo-Testosterone) 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
Common (1% to 10%): Headache, vertigo (topical testosterone (the active ingredient contained in Depo-Testosterone)
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
Common (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)
Common (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 Depo-Testosterone) asthenia, night sweats
Rare (less than 0.1%): Fever, malaise
Frequency not reported: Edema
Postmarketing reports: Sudden hearing loss, tinnitus, Influenza like illness
Common (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
Common (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.
Uncommon (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
Uncommon (0.1% to 1%): Hypersensitivity reactions
Frequency not reported: Anaphylactic reactions
Postmarketing reports: Anaphylactic shock
Uncommon (0.1% to 1%): Testosterone (the active ingredient contained in Depo-Testosterone) topical: Lacrimation increased
Postmarketing reports: Testosterone topical: Intraocular pressure increased, vitreous detachment
Postmarketing reports: Nephrolithiasis, renal colic, renal pain
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Depo-testosterone (www.drugs.com/mtm/depo-testosterone.html).
July 7, 2020
July 7, 2020
July 7, 2020
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