Jatenzo Side Effects
Generic name: testosterone
Note: This document provides detailed information about Jatenzo Side Effects associated with testosterone. Some dosage forms listed on this page may not apply specifically to the brand name Jatenzo.
Applies to testosterone: oral capsule liquid filled.
Other dosage forms:
Important warnings
This medicine can cause some serious health issues
Oral route (capsule)
Warning: Blood Pressure Increases. Testosterone undecanoate can cause blood pressure (BP) increases that can increase the risk of major adverse cardiovascular events (MACE), including non-fatal myocardial infarction, non-fatal stroke and cardiovascular death.
Before initiating testosterone undecanoate, consider the patient’s baseline cardiovascular risk and ensure blood pressure is adequately controlled.
Periodically monitor for and treat new-onset hypertension or exacerbations of pre-existing hypertension and re-evaluate whether the benefits of testosterone undecanoate outweigh its risks in patients who develop cardiovascular risk factors or cardiovascular disease on treatment.
Due to this risk, use testosterone undecanoate only for the treatment of men with hypogonadal conditions associated with structural or genetic etiologies.
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, 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 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
- 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]
Signs and symptoms of pulmonary microemboli may occur during or immediately after the injections and are reversible.[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]
References
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Further information
Jatenzo side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.