Tostrelle Side effects

• Side effects of Tostrelle in details
• Tostrelle contraindications
• Tostrelle reviews

What are the possible side effects of Tostrelle?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using Tostrelle topical and call your doctor at once if you have any of these serious side effects:

• burn-like blistering of the skin where the transdermal patch is worn;
• skin irritation with patch-wearing that does not get better with time;
• problems with urination;
• swelling of your ankles;
• frequent, prolonged, or bothersome erections; or
• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Topical Tostrelle is absorbed through the skin and can cause symptoms of male features in a woman or child who comes into contact with the medication. Call your doctor if your female partner has male-pattern baldness, excessive body hair growth, increased acne, irregular menstrual periods, or any other signs of male characteristics.

Less serious side effects may include:

• redness, itching, burning, or hardened skin where the skin patch is worn;
• breast swelling or tenderness;
• increased acne or hair growth;
• headache, depressed mood; or
• changes in your sex drive.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Tostrelle in details

Adverse events are reported in this section by product. Adverse events reported during use of a given product may occur in patients who are treated with any Tostrelle (Tostrelle (transdermal)) product.

Adverse Events with Tostrelle (Tostrelle (transdermal)) TTS

In clinical studies of 457 participants (116 hypogonadal males and 341 healthy adult males) treated for up to 6 weeks with Tostrelle (Tostrelle (transdermal)) TTS, the most commonly reported adverse events were application site reactions of transient itching (12%) and moderate or severe erythema (3%).

Adverse events reported by less than 1% of Tostrelle (Tostrelle (transdermal)) TTS users in clinical trials that were of probable or unknown relationship to drug were:

Body as a Whole: abdominal pain, back pain, infection;

Cardiovascular System: congestive heart failure, hypertension, tachycardia;

Digestive System: diarrhea, nausea;

Metabolic and Nutritional System: hyperglycemia, hyperlipemia, hyponatremia;

Musculoskeletal System: arthralgia;

Nervous System: nervousness, depression, dizziness, dry mouth, insomnia, decreased libido, personality disorder, CNS stimulation;

Respiratory System: bronchitis;

Skin System: application site reactions--papules/pustules, edema, vesicles, pain, other--, acne, alopecia, hirsutism;

Urogenital System: abnormal ejaculation, breast pain, dysuria, urinary tract infection, and impaired urination.

Topical Reactions

Of 457 study participants, 3 men (1%) discontinued prematurely because of application site reactions.

There were no clinically significant differences in skin tolerability in younger (<65 years old) and older (³ 65 years old) subjects.

A contact sensitization rate of 0.5% for Tostrelle (Tostrelle (transdermal)) TTS was observed in a 6-week study of 233 normal male volunteers.

In one study with 14 days of daily use, 42% of patients reported 3 or more detachments of their Tostrelle (Tostrelle (transdermal)) TTS; of these detachments, 33% occurred during exercise.

Adverse Events with Tostrelle (Tostrelle (transdermal))

In clinical studies of 104 patients treated with Tostrelle (Tostrelle (transdermal)), the most common adverse effects reported were local effects. In US clinical trials, most of the 72 patients filling out a daily questionnaire reported scrotal itching, discomfort, or irritation at some time during therapy. Of all the daily questionnaire responses, 7% reported itching, 4% discomfort, and 2% irritation. All topical reactions decreased with duration of use.

The following adverse effects (greater than 1%) were reported in association with Tostrelle (Tostrelle (transdermal)) therapy in 104 patients using the product for up to three years. These effects are listed in decreasing frequency of occurrence with the percentages of patients reporting the effect in parentheses: Gynecomastia (5%), acne (4%), prostatitis/urinary tract infection (4%), breast tenderness (3%), stroke (2%). For this same patient population, the following adverse effects were reported by 1% of users: memory loss, pupillary dilation, abnormal liver enzymes, scrotal cellulitis, deep vein phlebitis, benign prostatic hyperplasia, rectal mucosal lesion over prostate, hematuria/bladder cancer, papilloma on scrotum, and congestive heart failure.

Adverse Events with Tostrelle (Tostrelle (transdermal)) WITH ADHESIVE

In a pharmacokinetic study in 50 normal men, skin assessment scores following a single 24-hour application of Tostrelle (Tostrelle (transdermal)) WITH ADHESIVE to scrotal skin were similar to those for Tostrelle (Tostrelle (transdermal)). Other adverse events reported during the study were headache (6%), dizziness (6%), back pain, pain, nausea, and pustular rash (1% each).

General Adverse Events with Androgen Replacement Therapy

Skin and Appendages: Hirsutism, male pattern baldness, seborrhea, and acne.

Endocrine and Urogenital: Gynecomastia and excessive frequency and duration of penile erections. Oligospermia may occur at high doses.

Fluid and Electrolyte Disturbances: Retention of sodium, chloride, water, potassium, calcium, and inorganic phosphates.

Gastrointestinal: Nausea, cholestatic jaundice, alterations in liver function tests. Rare instances of hepatocellular neoplasms and peliosis hepatis have occurred.

Hematologic: Suppression of clotting factors II, V, VII, and X, bleeding in patients on concomitant anticoagulant therapy, and polycythemia.

Nervous System: Increased or decreased libido, headache, anxiety, depression, and generalized paresthesia.

Metabolic: Increased serum cholesterol.

Miscellaneous: Rarely, anaphylactoid reactions.

DRUG ABUSE AND DEPENDENCE

The Tostrelle (Tostrelle (transdermal)) products contain a Schedule III controlled substance as defined by the Anabolic Steroids Control Act.

Tostrelle (Tostrelle (transdermal)) TTS is designed for application to arm, back or upper buttocks skin.

Tostrelle (Tostrelle (transdermal)) and Tostrelle (Tostrelle (transdermal)) WITH ADHESIVE are designed for application to scrotal skin only. Because scrotal skin is at least five times more permeable to Tostrelle than other skin sites, Tostrelle (Tostrelle (transdermal)) or Tostrelle (Tostrelle (transdermal)) WITH ADHESIVE will not produce adequate serum Tostrelle concentrations if applied to non-scrotal skin.

Ingestion of Tostrelle, or the contents of any of the Tostrelle (Tostrelle (transdermal)) products will not result in clinically significant serum Tostrelle concentrations due to extensive first-pass metabolism. In addition, an intramuscular injection of Tostrelle from any of the Tostrelle (Tostrelle (transdermal)) products will not produce adequate serum Tostrelle levels due to its short half-life (about 10 minutes).

What is the most important information I should know about Tostrelle?

• Tell your doctor or dentist that you take Tostrelle patch before you receive any medical or dental care, emergency care, or surgery.
• Blood clots have happened in patients using Tostrelle products such as Tostrelle patch. Tell your doctor if you have ever had a blood clot. Call your doctor right away if you have symptoms of a blood clot (eg, swelling, warmth, numbness, change of color, or pain in a leg or arm; chest pain; shortness of breath; coughing up blood).
• Skin burns may occur if this patch is worn during a magnetic resonance imaging (MRI) scan. If you will be having an MRI, tell your doctor that you use Tostrelle patch. You will need to remove the patch before having an MRI.
• Diabetes patients - Tostrelle patch may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Tostrelle patch may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Tostrelle patch.
• Lab tests, including liver function, blood cell counts, blood cholesterol, prostate-specific antigen, and blood Tostrelle, may be performed while you use Tostrelle patch. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Tostrelle patch with caution in the ELDERLY; they may be more sensitive to its effects, especially an enlarged prostate or prostate cancer.
• Tostrelle patch should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Using Tostrelle patch while pregnant may cause harm to the fetus. It is not known if Tostrelle patch is found in breast milk. Tostrelle patch should not be used by women.

Tostrelle contraindications

• Tostrelle Gel 1% is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate.

• Tostrelle Gel 1% is contraindicated in women who are or may become pregnant, or who are breastfeeding. Tostrelle Gel 1% may cause fetal harm when administered to a pregnant woman. Tostrelle Gel 1% may cause serious adverse reactions in nursing infants. Exposure of a female fetus or nursing infant to androgens may result in varying degrees of virilization. Pregnant women or those who may become pregnant need to be aware of the potential for transfer of Tostrelle from men treated with Tostrelle Gel 1%. If a pregnant woman is exposed to Tostrelle Gel 1%, she should be apprised of the potential hazard to the fetus.

References

1. DailyMed. "TESTOSTERONE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. European Chemicals Agency - ECHA. "Testosterone: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
3. HSDB. "Testosterone". https://toxnet.nlm.nih.gov/cgi-bin/s... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Tostrelle are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Tostrelle. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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Information checked by Dr. Sachin Kumar, MD Pharmacology