For the Consumer
Applies to testosterone: buccal patch extended release
Along with its needed effects, 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:
Get emergency help immediately if any of the following symptoms of overdose occur while taking testosterone:
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:
Applies to testosterone: buccal film extended release, compounding powder, intramuscular solution, nasal gel, subcutaneous implant, 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 topical are skin reaction (16.1%) and allergic contact dermatitis (up to 37%).[Ref]
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, burningUncommon (0.1% to 1%): Alopecia, erythema, rash (including rash popular), pruritus, dry skin, folliculitis (testosterone topical)Frequency not reported: Seborrhea, urticaria, male pattern baldness, hirsutism injection site inflammationPostmarketing reports: Angioedema, angioneurotic edema, hyperhidrosis, discolored hair, leukocytoclastic vasculitis[Ref]
Very common (10% or more): Accelerated growthCommon (1% to 10%): Increased estradiol, hypogonadismUncommon (0.1% to 1%): Increased blood testosteroneFrequency 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]
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 perversionUncommon (0.1% to 1%): NauseaRare (less than 0.1%): Abdominal painFrequency not reported: Abdominal disorder, intraabdominal hemorrhagePostmarketing 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]
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: 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 sitePostmarketing reports: Injection site abscess, procedural pain, application site swelling (topical testosterone)[Ref]
Common (1% to 10%): Hot flush, hypertensionUncommon (0.1% to 1%): Cardiovascular disorderFrequency not reported: Venous thromboembolismPostmarketing 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]
Common (1% to 10%): Abnormal prostate examination, benign prostate hyperplasia (BPH), ejaculation disorder, prostatitisUncommon (0.1% to 1%): Prostate induration, prostatic disorder, testicular pain, decreased urine flow, urinary retention, urinary tract disorder, nocturia, dysuriaRare (less than 0.1%): Micturition disorders, epididymitis, bladder irritability, impotence, inhibition of testicular function and testicular atrophyFrequency 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 enlargementPostmarketing reports: Prostate infection, calculus urinary, dysuria, hematuria, urinary tract disorder, pollakiuria[Ref]
Common (1% to 10%): Polycythemia, hematocrit increasedUncommon (0.1% to 1%): Increased red blood cell count, increased hemoglobin, prolonged activated partial thromboplastin time, prolonged prothrombin timeFrequency not reported: Blood and lymphatic system disorders, suppression of clotting factors II, V, VII, and X, bleeding in patients on concomitant anticoagulant therapyPostmarketing reports: Thrombocytopenia, anemia[Ref]
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 triglycerideFrequency not reported: Abnormal lipids (decrease in serum LDL, HDL, and triglycerides), metabolism and nutrition disorders, hypercalcemiaPostmarketing reports: Hypoglycemia, diabetes mellitus, fluid retention, hyperlipidemia, hypertriglyceridemia, blood glucose increased[Ref]
Common (1% to 10%): Back pain, hemarthrosis (testosterone topical)Uncommon (0.1% to 1%): Arthralgia, pain in extremity, muscle spasm, muscle strain, myalgia, musculoskeletal stiffness, increased creatine phosphokinaseFrequency not reported: Pediatrics: Premature epiphyseal closure, increased bone formationPostmarketing reports: Musculoskeletal chest pain, musculoskeletal pain, myalgia, osteopenia, osteoporosis, systemic lupus erythematosus[Ref]
Common (1% to 10%): Headache, vertigo (topical testosterone)Uncommon (0.1% to 1%): Migraine, tremor, dizzinessFrequency not reported: Nervousness, paresthesiaPostmarketing reports: Cerebrovascular insufficiency, reversible ischemic neurological deficiency, transient ischemic attack, amnesia[Ref]
Common (1% to 10%): Prostatic specific antigen (PSA) increased, prostate cancerUncommon (0.1% to 1%): Prostatic intraepithelial neoplasiaRare (less than 0.1%): Neoplasms benign, malignant, and unspecified (including cysts and polyps)[Ref]
Common (1% to 10%): Fatigue, hyperhidrosis; chills, body pain, smell disorderUncommon (0.1% to 1%): Breast induration, breast pain, sensitive nipples, gynecomastia, increased estradiol, increased testosterone, asthenia, night sweats Rare (less than 0.1%): Fever, malaiseFrequency not reported: EdemaPostmarketing reports: Sudden hearing loss, tinnitus, Influenza like illness[Ref]
Common (1% to 10%): Irritability, insomnia, mood swings, aggression,Uncommon (0.1% to 1%): Depression, emotional disorder, restlessness, increased libido, decreased libidoFrequency not reported: Hostility, anxietyPostmarketing reports: Korsakoff's psychosis nonalcoholic, male orgasmic disorder, restlessness, sleep disorder[Ref]
Common (1% to 10%): Sinusitis, nasopharyngitis, upper respiratory tract infection, bronchitisUncommon (0.1% to 1%): Cough, dyspnea, snoring, dysphoniaRare (less than 0.1%): Pulmonary microembolism (POME) (cough, dyspnea, malaise, hyperhidrosis, chest pain, dizziness, paresthesia, or syncope) caused by oily solutionsFrequency not reported: Sleep apneaPostmarketing 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]
Uncommon (0.1% to 1%): Abnormal LFT, increased ASTRare (less than 0.1%): Abnormal hepatic functionFrequency not reported: Jaundice, benign liver tumor, malignant liver tumor, liver enlargement, peliosis hepatitisPostmarketing reports: ALT increased, AST increased, bilirubin increased, transaminases increased, gamma-glutamyltransferase increased[Ref]
Uncommon (0.1% to 1%): Hypersensitivity reactionsFrequency not reported: Anaphylactic reactionsPostmarketing reports: Anaphylactic shock[Ref]
Uncommon (0.1% to 1%): Testosterone topical: Lacrimation increasedPostmarketing reports: Testosterone topical: Intraocular pressure increased, vitreous detachment[Ref]
Postmarketing reports: Nephrolithiasis, renal colic, renal pain[Ref]
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Some side effects of testosterone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
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Testosterone Side Effects in Detail - Drugs.com
