Note: This document contains side effect information about testosterone. Some dosage forms listed on this page may not apply to the brand name Jatenzo.

Applies to testosterone: oral capsule liquid filled. Other dosage forms:

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

Serious side effects of Jatenzo

Along with its needed effects, testosterone (the active ingredient contained in Jatenzo) 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:

Less common

• Bleeding from the gums or nose
• bloating or swelling of the face, arms, hands, lower legs, or feet
• blurred vision
• bone or muscle pain
• discouragement
• dizziness
• enlarged prostate
• eye pain
• feeling sad or empty
• headache
• irritability
• lack of appetite
• loss of interest or pleasure
• nervousness
• painful or difficult urination
• pounding in the ears
• ringing in the ears
• slow or fast heartbeat
• stomach pain
• tingling of the hands or feet
• trouble concentrating
• trouble sleeping
• unusual tiredness or weakness
• unusual weight gain or loss

Rare

• Changes in behavior
• thoughts of killing oneself

Incidence not known

• Chest pain or discomfort
• confusion
• difficulty breathing
• difficulty in speaking
• double vision
• inability to move the arms, legs, or facial muscles
• inability to speak
• nausea
• pain in the chest, groin, or legs, especially the calves
• pain or discomfort in the arms, jaw, back, or neck
• severe, sudden headache
• slow or slurred speech
• sudden loss of coordination
• sudden, severe weakness or numbness in the arm or leg
• sweating
• vision changes
• vomiting

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

Symptoms of overdose

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

Other side effects of Jatenzo

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:

Less common

• Belching
• bloated, full feeling
• diarrhea
• excess air or gas in the stomach
• heartburn
• indigestion
• runny or stuffy nose
• sore throat
• stomach discomfort or upset

For Healthcare Professionals

Applies to testosterone: buccal film extended release, compounding powder, intramuscular solution, nasal gel, oral capsule, subcutaneous implant, subcutaneous solution, transdermal cream, transdermal film extended release, transdermal gel, transdermal ointment, transdermal solution.

General

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 Jatenzo) topical are skin reaction (16.1%) and allergic contact dermatitis (up to 37%).^[Ref]

Dermatologic

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 Jatenzo) topical)

Frequency not reported: Seborrhea, urticaria, male pattern baldness, hirsutism injection site inflammation

Postmarketing reports: Angioedema, angioneurotic edema, hyperhidrosis, discolored hair, leukocytoclastic vasculitis^[Ref]

Endocrine

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 Jatenzo) 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^[Ref]

Gastrointestinal

Very common (10% or more): Testosterone (the active ingredient contained in Jatenzo) 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^[Ref]

The majority of gum-related adverse events were transient.^[Ref]

Local

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 Jatenzo) 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)^[Ref]

Cardiovascular

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^[Ref]

Genitourinary

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^[Ref]

Hematologic

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^[Ref]

Metabolic

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^[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, hemarthrosis (testosterone (the active ingredient contained in Jatenzo) 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^[Ref]

Nervous system

Common (1% to 10%): Headache, vertigo (topical testosterone (the active ingredient contained in Jatenzo)

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^[Ref]

Oncologic

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)^[Ref]

Other

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 Jatenzo) asthenia, night sweats

Rare (less than 0.1%): Fever, malaise

Frequency not reported: Edema

Postmarketing reports: Sudden hearing loss, tinnitus, Influenza like illness^[Ref]

Psychiatric

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^[Ref]

Respiratory

Signs and symptoms of pulmonary microemboli may occur during or immediately after the injections and are reversible.^[Ref]

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^[Ref]

Hepatic

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^[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity reactions

Frequency not reported: Anaphylactic reactions

Postmarketing reports: Anaphylactic shock^[Ref]

Ocular

Uncommon (0.1% to 1%): Testosterone (the active ingredient contained in Jatenzo) topical: Lacrimation increased

Postmarketing reports: Testosterone topical: Intraocular pressure increased, vitreous detachment^[Ref]

Renal

Postmarketing reports: Nephrolithiasis, renal colic, renal pain^[Ref]