Testosterone Side Effects
Medically reviewed by Drugs.com. Last updated on Sep 29, 2023.
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 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 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
- 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: 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 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)
- 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, 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 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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2. (2002) "Product Information. Testopel (testosterone)." Bartor Pharmacal Co, Inc
3. Cerner Multum, Inc. "UK Summary of Product Characteristics."
4. Cerner Multum, Inc. "Australian Product Information."
5. (2014) "Product Information. Depo-Testosterone (testosterone)." Pfizer U.S. Pharmaceuticals Group
6. (2014) "Product Information. Testosterone Enanthate (testosterone)." West Ward Pharmaceutical Corporation
7. (2014) "Product Information. Aveed (testosterone)." Endo Pharmaceuticals Solutions Inc
8. (2015) "Product Information. Testim (testosterone)." A-S Medication Solutions
9. (2015) "Product Information. Fortesta (testosterone)." Endo Pharmaceuticals (formally Indevus Pharmaceuticals Inc)
10. (2015) "Product Information. Axiron (testosterone)." Lilly, Eli and Company
11. Traupe H, von Muhlendahl KE, Bramswig J, Happle R (1988) "Acne of the fulminans type following testosterone therapy in three excessively tall boys." Arch Dermatol, 124, p. 414-7
12. Bates GW, Cornwell CE (1991) "Iatrogenic causes of hirsutism." Clin Obstet Gynecol, 34, p. 848-51
13. Fyrand O, Fiskaadal HJ, Trygstad O (1992) "Acne in pubertal boys undergoing treatment with androgens." Acta Derm Venereol, 72, p. 148-9
14. O'Driscoll JB, August PJ (1990) "Exacerbation of psoriasis precipitated by an oestradiol-testosterone implant." Clin Exp Dermatol, 15, p. 68-9
15. Bennett NJ (1998) "A burn-like lesion caused by a testosterone transdermal system." Burns, 24, p. 478-80
16. Buckley DA, Wilkinson SM, Higgins EM (1998) "Contact allergy to a testosterone patch." Contact Dermatitis, 39, p. 91-2
17. Wu FC, Farley TM, Peregoudov A, Waites GM (1996) "Effects of testosterone enanthate in normal men: experience from a multicenter contraceptive efficacy study. World Health Organizatio Task Force on Methods for the Regulation of Male Fertility." Fertil Steril, 65, p. 626-36
18. DeSanctis V, Vullo C, Urso L, Rigolin F, Cavallini A, Caramelli K, Daugherty C, Mazer N (1998) "Clinical experience using the Androderm (R) testosterone transdermal system in hypogonadal adolescents and young men with beta-thalassemia major." J Pediatr Endocrinol Metab, 11, p. 891-900
19. Dobs AS, Meikle AW, Arver S, Sanders SW, Caramelli KE, Mazer NA (1999) "Pharmacokinetics, efficacy, and safety of a permeation-enhanced testosterone transdermal system in comparison with bi-weekly injections of testosterone enanthate for the treatment of hypogonadal men." J Clin Endocrinol Metab, 84, p. 3469-78
20. Matsumoto AM (1990) "Effects of chronic testosterone administration in normal men: safety and efficacy of high dosage testosterone and parallel dose-dependent suppression of luteinizing hormone, follicle-stimulating hormone, and sperm production." J Clin Endocrinol Metab, 70, p. 282-7
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Testosterone 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.