Malerone Side effects

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What are the possible side effects of Malerone?

Get emergency medical help if you have any signs of an allergic reaction to Malerone: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Malerone and call your doctor at once if you have any of these serious side effects:

  • increased urination (many times per day), loss of bladder control;

  • painful or difficult urination;

  • breast pain or swelling;

  • painful or bothersome erections;

  • swelling, rapid weight gain, shortness of breath during sleep;< /p>

  • chest pain or pressure, pain spreading to your jaw or shoulder;

  • liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • signs of a blood clot in the lung - chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or

  • signs of a blood clot in your leg - pain, swelling, warmth, or redness in one or both legs.

Topical Malerone 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.

Common Malerone side effects may include:

  • redness, itching, burning, hardened skin or other irritation where the medicine was applied or where the skin patch was worn;

  • headache, mood changes;

  • increased red blood cells (may cause dizziness, itching, redness in your face, or muscle pain);

  • vomiting, diarrhea;

  • strange dreams;

  • frequent or prolonged erections; or

  • high blood pressure - severe headache, blurred vision, pounding in your neck or ears.

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 Malerone in details

infoA side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.

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 Malerone (Malerone (transdermal)) product.

Adverse Events with Malerone (Malerone (transdermal)) TTS

In clinical studies of 457 participants (116 hypogonadal males and 341 healthy adult males) treated for up to 6 weeks with Malerone (Malerone (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 Malerone (Malerone (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 Malerone (Malerone (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 Malerone (Malerone (transdermal)) TTS; of these detachments, 33% occurred during exercise.

Adverse Events with Malerone (Malerone (transdermal))

In clinical studies of 104 patients treated with Malerone (Malerone (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 Malerone (Malerone (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 Malerone (Malerone (transdermal)) WITH ADHESIVE

In a pharmacokinetic study in 50 normal men, skin assessment scores following a single 24-hour application of Malerone (Malerone (transdermal)) WITH ADHESIVE to scrotal skin were similar to those for Malerone (Malerone (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.


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

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

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

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

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

  • Do NOT take more than the recommended dose without checking with your doctor.
  • Patients who use androgens (such as Malerone) may have an increased risk of prostate cancer. Check with your doctor if you have questions about your risk of prostate cancer while you use Malerone solution.
  • Do not allow others, especially children and women, to come into contact with the medicine, the unclothed or unwashed application site, or any unwashed clothing that may have touched the application site. If someone else comes into contact with Malerone solution, have them wash the area with soap and water right away.
  • Contact your doctor right away if a child you are in close contact with develops enlarged genitals, pubic hair, or increased sex drive, or if your female partner develops a change in hair distribution, an increase in acne, or any masculine signs.
  • Malerone solution is flammable. Avoid fire, an open flame, or smoking after application until Malerone solution has dried.
  • Do not switch between other topical Malerone products and Malerone solution without talking to your doctor.
  • Tell your doctor or dentist that you take Malerone solution before you receive any medical or dental care, emergency care, or surgery.
  • Blood clots have happened in patients using Malerone products such as Malerone solution. 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).
  • Malerone solution may interfere with certain lab tests. Be sure your doctor and lab personnel know you are using Malerone solution.
  • Diabetes patients - Malerone solution may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Large doses of Malerone solution may lower your sperm count. Discuss any questions or concerns with your doctor.
  • Lab tests, including liver function, complete blood cell counts, blood cholesterol, prostatic specific antigen (PSA) levels, and blood Malerone, may be performed while you use Malerone solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Malerone solution with caution in the ELDERLY; they may be more sensitive to its effects, especially an enlarged prostate or prostate cancer.
  • Malerone solution should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Malerone solution may cause harm to the fetus. If you think you may be pregnant, contact your doctor right away. It is not known if Malerone solution is found in breast milk. Malerone solution is not approved for use in women.

Malerone contraindications

infoContraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.

  • Malerone 1% is contraindicated in men with carcinoma of the breast or known or suspected carcinoma of the prostate.
  • Malerone 1% is contraindicated in women who are or may become pregnant, or who are breastfeeding. Malerone 1% may cause fetal harm when administered to a pregnant woman. Malerone 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 Malerone from men treated with Malerone 1%. If a pregnant woman is exposed to Malerone 1%, she should be apprised of the potential hazard to the fetus.


  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).". (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. ". (accessed September 17, 2018).
  3. HSDB. "Testosterone". (accessed September 17, 2018).


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Information checked by Dr. Sachin Kumar, MD Pharmacology

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