Andro LA 200 Side Effects

Generic Name: testosterone

Note: This page contains information about the side effects of testosterone. Some of the dosage forms included on this document may not apply to the brand name Andro LA 200.

Not all side effects for Andro LA 200 may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to testosterone: buccal patch extended release

In addition to its needed effects, some unwanted effects may be caused by testosterone (the active ingredient contained in Andro LA 200). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking testosterone:

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 of the side effects that can occur with testosterone may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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

Cardiovascular

Cardiovascular side effects have included hypertension, and edema with and without congestive heart failure.[Ref]

Endocrine

Endocrine side effects have included gynecomastia as a frequent and sometimes persistent side effect. Cautious use is recommended in patients with existing gynecomastia.

During exogenous administration of androgens, endogenous testosterone (the active ingredient contained in Andro LA 200) release is inhibited through feedback inhibition of pituitary luteinizing hormone (LH). Large doses of exogenous androgens may suppress spermatogenesis through inhibition of pituitary follicle stimulating hormone (FSH).

Androgens may decrease levels of thyroxin binding globulin resulting in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged and there is no clinical evidence of thyroid dysfunction.

Changes in insulin sensitivity or glycemic control may occur in patients treated with androgens. In diabetic patients, the metabolic effects of androgens may decrease blood glucose and, therefore, insulin requirements.

Virilization of children has been reported due to secondary exposure to testosterone. Signs and symptoms have included inappropriate enlargement of the penis or clitoris, premature development of pubic hair, increased erections and libido, aggressive behavior, and advanced bone age. In most cases, these signs and symptoms regressed with removal of the exposure to testosterone. In a few cases, however, enlarged genitalia did not fully return to age-appropriate normal size and bone age remained modestly greater than chronological age.[Ref]

Renal

Renal side effects have included retention of nitrogen, sodium, potassium, chloride, water and phosphorus, and decreased urinary excretion of calcium.[Ref]

Hepatic

Hepatic side effects have included life-threatening peliosis hepatitis and hepatic abnormalities including hepatic neoplasms and hepatocellular carcinomas following prolonged therapy with high doses of androgen. Tumor regression did not occur in all cases following medication withdrawal.

Cholestatic hepatitis, jaundice, and abnormal liver function tests have occurred during androgen therapy. Drug-induced jaundice is usually reversible following drug discontinuation.[Ref]

Genitourinary

Genitourinary side effects following chronic administration and/or large dosages of testosterone (the active ingredient contained in Andro LA 200) have included oligospermia and decreased ejaculatory volume. Elderly male patients have experienced prostatic enlargement resulting in urinary obstruction. Priapism and excessive stimulation has developed. Other urinary side effects have included nocturia, urinary hesitancy, urinary incontinence, urinary retention, urinary urgency, and weak urinary system.

In female patients the use of androgens has resulted in virilization including deepening voice, hirsutism, acne, clitomegaly (not reversible), and menstrual abnormalities. Discontinuation of testosterone at signs of mild virilization may prevent irreversible virilization.[Ref]

Metabolic

Metabolic side effects have included osteolytic-induced hypercalcemia in immobilized patients or those with metastatic breast disease. Increased cholesterol levels and acute intermittent porphyria have been reported.[Ref]

Other

Other side effects have included virilization in female patients. Virilization included deepening voice, hirsutism, acne, clitomegaly (not reversible), and menstrual abnormalities.

Female sexual partners of men using topical testosterone (the active ingredient contained in Andro LA 200) (residual on skin) have reported virilization.[Ref]

Dermatologic

Discontinuation rates for transdermal testosterone (the active ingredient contained in Andro LA 200) were as follows: due to chronic skin irritation (5%), allergic dermal reactions (4%), and burn-like, usually a single site (0%).

Triamcinolone 1% cream applied sparingly to skin under the reservoir reduced irritation and did not interfere with testosterone absorption. Ointment formulations reduce testosterone absorption.[Ref]

Dermatologic side effects have included hirsutism, acne, male-patterned baldness and seborrhea. Dermal reactions have been the most commonly reported side effects for transdermal testosterone and occur primarily at the site of application. Dermal effects have included 3 types: irritation including mild to moderate erythema (to 6%), induration (3%), itching (12%), and burning (3%); allergic contact dermatitis including pruritus (to 37%), vesicles (6%), and rash (2%); and burn-like blisters (12%).[Ref]

Gastrointestinal

Gastrointestinal side effects have included nausea and vomiting.[Ref]

Musculoskeletal

Testosterone is involved in termination of linear bone growth by closure of the epiphyseal growth centers. Appropriate monitoring of bone age is recommended during testosterone (the active ingredient contained in Andro LA 200) use in healthy males with delayed puberty.[Ref]

Musculoskeletal side effects have included myalgia and pain.[Ref]

Hematologic

Hematologic side effects have included alteration in clotting factors II, V, VII and X and polycythemia due to increased red cell production. Anemia has also been reported.[Ref]

Hypersensitivity

Hypersensitivity side effects have included rash and anaphylactoid reactions.[Ref]

Local

Local side effects have included inflammation and pain at injection or dermal application site.[Ref]

Nervous system

Nervous system side effects have included altered libido (increased/decreased), headache (to 5%), anxiety, depression, generalized paresthesia, or sleep apnea syndrome.[Ref]

Oncologic

Oncologic side effects have included carcinoma of the prostate, hepatic neoplasms, and hepatocellular carcinomas.[Ref]

Respiratory

Respiratory side effects have included reports of potentiation of sleep apnea, particularly in obese patients or those with chronic lung disease. There have been rare postmarketing reports of transient reactions involving urge to cough, coughing fits, and respiratory distress immediately after the injection of testosterone (the active ingredient contained in Andro LA 200) enanthate, an oil-based depot preparation.[Ref]

References

1. 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

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

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

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

5. 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

6. 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

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

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

9. 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

10. 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

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

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

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

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

15. 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

16. 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

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

18. 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

19. 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

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

21. 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

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

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

24. 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

25. 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

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

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

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

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

30. 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

31. 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

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

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