Testopel Side Effects

Generic Name: testosterone

Note: This page contains side effects data for the generic drug testosterone. It is possible that some of the dosage forms included below may not apply to the brand name Testopel.

It is possible that some side effects of Testopel may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to testosterone: buccal patch extended release

As well as its needed effects, testosterone (the active ingredient contained in Testopel) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking testosterone, check with your doctor immediately:

Incidence not known
  • Pain, redness, or swelling in the arm or leg
  • trouble breathing

If any of the following symptoms of overdose occur while taking testosterone, get emergency help immediately:

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 testosterone side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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

For Healthcare Professionals

Applies to testosterone: buccal film extended release, compounding powder, intramuscular solution, subcutaneous implant, 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 Testopel) 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 Testopel) 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 Testopel) 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 Testopel) 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 Testopel) 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[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[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 Testopel) 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 Testopel)
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 Testopel) 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 Testopel) topical: Lacrimation increased
Postmarketing reports: Testosterone topical: Intraocular pressure increased, vitreous detachment[Ref]

Renal

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

References

1. "Product Information. Fortesta (testosterone)." Endo Pharmaceuticals (formally Indevus Pharmaceuticals Inc), Lexington, MA.

2. "Product Information. AndroGel (testosterone)." Unimed Pharmaceuticals, Buffalo Grove, IL.

3. Cerner Multum, Inc. "Australian Product Information." O 0

4. "Product Information. Testosterone Enanthate (testosterone)." West-Ward Pharmaceutical Corporation, Eatontown, NJ.

5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

6. "Product Information. Axiron (testosterone)." Lilly, Eli and Company, Indianapolis, IN.

7. "Product Information. Testopel (testosterone)." Bartor Pharmacal Co, Inc, Rye, NY.

8. "Product Information. Aveed (testosterone)." Endo Pharmaceuticals Solutions Inc, Malvern, PA.

9. "Product Information. Testim (testosterone)." A-S Medication Solutions, Chicago, IL.

10. "Product Information. Androderm (testosterone topical)." SmithKline Beecham, Philadelphia, PA.

11. "Product Information. Depo-Testosterone (testosterone)." Pfizer U.S. Pharmaceuticals Group, New York, NY.

12. Bates GW, Cornwell CE "Iatrogenic causes of hirsutism." Clin Obstet Gynecol 34 (1991): 848-51

13. O'Driscoll JB, August PJ "Exacerbation of psoriasis precipitated by an oestradiol-testosterone implant." Clin Exp Dermatol 15 (1990): 68-9

14. Dobs AS, Meikle AW, Arver S, Sanders SW, Caramelli KE, Mazer NA "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 (1999): 3469-78

15. Traupe H, von Muhlendahl KE, Bramswig J, Happle R "Acne of the fulminans type following testosterone therapy in three excessively tall boys." Arch Dermatol 124 (1988): 414-7

16. Fyrand O, Fiskaadal HJ, Trygstad O "Acne in pubertal boys undergoing treatment with androgens." Acta Derm Venereol 72 (1992): 148-9

17. Wu FC, Farley TM, Peregoudov A, Waites GM "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 (1996): 626-36

18. Bennett NJ "A burn-like lesion caused by a testosterone transdermal system." Burns 24 (1998): 478-80

19. Buckley DA, Wilkinson SM, Higgins EM "Contact allergy to a testosterone patch." Contact Dermatitis 39 (1998): 91-2

20. DeSanctis V, Vullo C, Urso L, Rigolin F, Cavallini A, Caramelli K, Daugherty C, Mazer N "Clinical experience using the Androderm (R) testosterone transdermal system in hypogonadal adolescents and young men with beta-thalassemia major." J Pediatr Endocrinol Metab 11 (1998): 891-900

21. Cefalu WT, Pardridge WM, Premachandra BN "Hepatic bioavailability of thyroxine and testosterone in familial dysalbuminemic hyperthyroxinemia." J Clin Endocrinol Metab 61 (1985): 783-6

22. Matsumoto AM "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 (1990): 282-7

23. Tripathy D, Shah P, Lakshmy R, Reddy KS "Effect of testosterone replacement on whole body glucose utilisation and other cardiovascular risk factors in males with idiopathi hypogonadotrophic hypogonadism." Horm Metab Res 30 (1998): 642-5

24. Becker U, Gluud C, Bennett P "The effect of oral testosterone on serum TBG levels in alcoholic cirrhotic men." Liver 8 (1988): 219-24

25. Ferrera PC, Putnam DL, Verdile VP "Anabolic steroid use as the possible precipitant of dilated cardiomyopathy." Cardiology 88 (1997): 218-20

26. Jackson JA, Waxman J, Spiekerman AM "Prostatic complications of testosterone replacement therapy." Arch Intern Med 149 (1989): 2365-6

27. Zelissen PM, Stricker BH "Severe priapism as a complication of testosterone substitution therapy." Am J Med 85 (1988): 273-4

28. Wang C, Leung A, Superlano L, Steiner B, Swerdloff RS "Oligozoospermia induced by exogenous testosterone is associated with normal functioning residual spermatozoa." Fertil Steril 68 (1997): 149-53

29. Endres W, Shin YS, Rieth M, Block T, Schmiedt E, Knorr D "Priapism in Fabry's disease during testosterone treatment." Klin Wochenschr 65 (1987): 925

30. Parker LU, Bergfeld WF "Virilization secondary to topical testosterone." Cleve Clin J Med 58 (1991): 43-6

31. Zhang GY, Gu YQ, Wang XH, Cui YG, Bremner WJ "A clinical trial of injectable testosterone undecanoate as a potential male contraceptive in normal Chinese men." J Clin Endocrinol Metab 84 (1999): 3642-7

32. Anderson FH, Francis RM, Faulkner K "Androgen supplementation in eugonadal men with osteoporosis-effects of 6 months of treatment on bone mineral density and cardiovascula risk factors." Bone 18 (1996): 171-7

33. Bhasin S, Storer TW, Javanbakht M, et al. "Testosterone replacement and resistance exercise in HIV-infected men with weight loss and low testosterone levels." JAMA 283 (2000): 763-70

34. Bagatell CJ, Heiman JR, Matsumoto AM, Rivier JE, Bremner WJ "Metabolic and behavioral effects of high-dose, exogenous testosterone in healthy men." J Clin Endocrinol Metab 79 (1994): 561-7

35. Lajarin F, Zaragoza R, Tovar I, Martinezhernandez P "Evolution of serum lipids in two male bodybuilders using anabolic steroids." Clin Chem 42 (1996): 970-2

36. Zmuda JM, Thompson PD, Dickenson R, Bausserman LL "Testosterone decreases lipoprotein(a) in men." Am J Cardiol 77 (1996): 1244

37. Stannard JP, Bucknell AL "Rupture of the triceps tendon associated with steroid injections." Am J Sports Med 21 (1993): 482-5

38. Pollard M "Tumorigenic effect of testosterone." Lancet 336 (1990): 1518

39. Uzych L "Anabolic-androgenic steroids and psychiatric-related effects: a review." Can J Psychiatry 37 (1992): 23-8

40. Nuzzo JL, Manz HJ, Maxted WC "Peliosis hepatis after long-term androgen therapy." Urology 25 (1985): 518-9

41. Carrasco D, Prieto M, Pallardo L, Moll JL, Cruz JM, Munoz C, Berenguer J "Multiple hepatic adenomas after long-term therapy with testosterone enanthate. Review of the literature." J Hepatol 1 (1985): 573-8

42. Yu MW, Chen CJ "Elevated serum testosterone levels and risk of hepatocellular carcinoma." Cancer Res 53 (1993): 790-4

43. Falk H, Thomas LB, Popper H, Ishak KG "Hepatic angiosarcoma associated with androgenic-anabolic steroids." Lancet 2 (1979): 1120-3

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

Hide
(web1)