Depo-testosterone

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:

• implant, oil, solution
• nasal gel/jelly
• transdermal patch extended release

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

• Pain, redness, or swelling in the arm or leg
• trouble breathing

Get emergency help immediately if any of the following symptoms of overdose occur while taking testosterone:

Symptoms of overdose

• Blurred vision
• headache
• seizures
• slurred speech
• sudden and severe inability to speak
• temporary blindness
• weakness in the arm or leg on one side of the body, sudden and severe

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

• Gum or mouth irritation

Less common

• Bad, unusual, or unpleasant (after) taste
• bleeding gums
• blemishes on the skin
• breast pain
• change in taste
• cough
• crying
• depersonalization
• diarrhea
• discouragement
• dizziness
• dry mouth
• dysphoria
• enlarged breasts
• euphoria
• fear or nervousness
• feeling sad or empty
• gum pain or blisters
• hoarseness
• indigestion
• irritability
• itching skin
• loss of appetite
• loss of interest or pleasure
• lower back or side pain
• mouth ulcers
• nausea
• noisy breathing
• painful or difficult urination
• paranoia
• passing of gas
• pounding in the ears
• quick to react or overreact emotionally
• rapidly changing moods
• redness and swelling of the gums
• slow or fast heartbeat
• stinging of the lips
• stomach cramps, pain, fullness, or discomfort
• swelling of the gums
• swelling of the nose
• tiredness
• toothache
• trouble concentrating
• trouble sleeping
• unusual tiredness or weakness
• vomiting

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