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Side Effects

Get emergency help immediately if any of the following symptoms of overdose occur:

  • Blurred vision
  • Headache
  • Sudden and severe inability to speak
  • Seizures
  • Slurred speech
  • Temporary blindness
  • Weakness in arm and/or leg on one side of the body, sudden and severe

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

  • Gum or mouth irritation

Less common

  • Abnormal liver function test
  • Abnormal renal function
  • Bad unusual or unpleasant (after) taste
  • Bleeding gums
  • Blemishes on the skin, pimples
  • Blurred vision
  • Breast enlargement
  • Breast pain
  • Buccal inflammation
  • Change in taste
  • Cough
  • Crying
  • Depersonalization
  • Diarrhea
  • Difficulty breathing
  • Discouragement
  • Dry mouth
  • Dizziness
  • Dysphoria
  • Euphoria
  • Fear
  • Feeling sad or empty
  • Fever or chills
  • Gum blister
  • Gum pain
  • Headache
  • Hoarseness
  • Indigestion
  • Irritability;
  • Itching skin
  • Loss of appetite
  • Loss of interest or pleasure
  • Lower back or side pain
  • Mental depression
  • Mouth ulcers
  • Nausea
  • Nervousness
  • Noisy breathing
  • Paranoia
  • Painful or difficult urination
  • Passing of gas
  • Pounding in the ears
  • Quick to react or overreact emotionally
  • Rapidly changing moods
  • Redness and swelling of gums
  • Shortness of breath
  • Slow or fast heartbeat
  • Stomach cramps
  • Stomach pain, fullness or discomfort
  • Stinging of lips
  • Swelling of gums
  • Swelling or inflammation of the mouth
  • Swelling of the nose
  • Taste bitter
  • Tightness in chest
  • Tiredness
  • Toothache
  • Trouble concentrating
  • Trouble sleeping
  • Unusual tiredness or weakness
  • Vomiting
  • Wheezing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.


If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits to check your progress during therapy.

For patients with diabetes mellitus (sugar diabetes), this medicine may lower blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

Tell your doctor if you have too frequent or persistent erections of the penis.

Tell your doctor if you have any nausea, vomiting, changes in skin color or swelling of the ankles.

Tell your doctor if you experience any breathing problems, including those while you sleep.

Regularly check your gums where the buccal system is applied to check for any abnormalities and report findings to your doctor.

Proper Use

Importance of reading the patient directions carefully before using the buccal system

Proper administration technique

Proper dosing. Use this medicine only as directed.

Proper storage


The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For buccal dosage form:
    • For testosterone hormone replacement in men
      • Adults—30 milligrams (mg) applied to your upper gum above the left or right incisor twice a day

Missed Dose

Call your doctor or pharmacist for instructions.

If the buccal system fails to properly adhere to the gum or should fall off during the 12-hour dosing interval, the old one should be removed and a new buccal system applied. If the old one falls out within 4 hours before the next dose, a new system should be applied and it may remain in place until the time of the next regularly scheduled dosing. Do not double doses.


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Studies on this medicine have been done only on adult patients, and there is no specific information comparing use of testosterone in children with use in other age groups


This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults. However older men may be at increased risk for development of prostatic hyperplasia and prostatic cancer.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Anisindione
  • Bupropion
  • Dicumarol
  • Paclitaxel
  • Paclitaxel Protein-Bound
  • Phenprocoumon
  • Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Licorice

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Breast cancer (in males) or
  • Prostate cancer—Androgens can cause growth of these tumors.
  • Diabetes mellitus (sugar diabetes)—Testosterone may decrease blood sugar levels. Careful monitoring of blood glucose should be done.
  • Heart disease or
  • Kidney disease or
  • Liver disease—These conditions can be worsened by the fluid retention (keeping too much water in the body) that can be caused by androgens. Also, liver disease can prevent the body from removing the medicine from the bloodstream as fast as it normally would. This could increase the chance of side effects occurring.
  • Sleep apnea—This condition may become worse, especially in patients with risk factors such as obesity or chronic lung disease.


Testosterone are male hormones. Some are naturally produced in the body and are responsible for the growth and development of male sex organs

This medicine is available only with your doctor’s prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, testosterone is used in certain patients with the following medical conditions:

  • Female-to-male transsexualism in patients with gender identity disorder, (person who is born as a woman but adapts to a man’s lifestyle, sees herself as a man, and feels like a man instead of a woman)