Important Safety Information: Testosterone | Compounded Buccal Troche
What is this?
This Important Safety Information summarizes key warnings and precautions for Testosterone 8 mg Troche, a compounded buccal formulation designed to support men diagnosed with low testosterone levels. Testosterone is an androgen hormone responsible for energy, libido, muscle mass, mood stability, and overall metabolic function.
This compounded troche is intended for buccal administration, meaning it dissolves slowly in the mouth and is absorbed through the oral mucosa. This formulation has not been reviewed or approved by the U.S. Food and Drug Administration (FDA) for safety or efficacy. It should only be used exactly as directed by a licensed healthcare provider. This summary does not include all available information. Always follow your provider’s instructions and read your medication label carefully.
Most Serious Warnings
Testosterone therapy can cause:
Severe allergic reactions, including swelling of the face, lips, tongue, or throat
Blood clots, including pain, swelling, warmth, or redness in the arms or legs
Increased risk of heart attack, stroke, or cardiovascular complications
Worsening of prostate enlargement or stimulation of prostate cancer
Liver problems, including dark urine, yellowing of the skin or eyes, or abdominal pain
Mood or behavioral changes, including depression or suicidal thoughts
Dependence and misuse risk due to anabolic steroid properties
Compounded testosterone products may carry sterility, potency, or formulation variability risks due to limited FDA oversight.
Who Should NOT Take Testosterone Troche
Do not take this medication if you:
Have a known allergy to testosterone or any ingredient in the formulation
Have male breast cancer or known or suspected prostate cancer
Are a woman who is pregnant, planning pregnancy, or breastfeeding
Are a child or adolescent
Have uncontrolled heart, liver, or kidney disease without provider clearance
Before Taking Testosterone, Tell Your Healthcare Provider if You:
Have a history of heart disease, stroke, or high blood pressure
Have sleep apnea or breathing problems
Have an enlarged prostate or difficulty urinating
Have a history of blood clots
Have diabetes or high cholesterol
Have liver disease
Have a history of depression, mood disorders, or substance misuse
Are trying to father a child, as testosterone may reduce sperm production
Take any prescription, over the counter, herbal, or supplement products
Possible Side Effects
Common (mild to moderate):
Headache
Acne or oily skin
Emotional changes or mood swings
Fatigue or weakness
Trouble sleeping
Irritation in the mouth at the site of troche placement
Mild fluid retention
Serious (seek medical care immediately):
Signs of an allergic reaction such as rash, swelling, or trouble breathing
Chest pain, shortness of breath, or coughing up blood
Sudden weakness on one side of the body, slurred speech, or vision changes
Pain, warmth, redness, or swelling in a leg or arm
Severe or persistent erections
Difficulty urinating or inability to control urination
Significant mood changes, depression, or thoughts of self harm
Yellowing of the skin or eyes, dark urine, or severe abdominal pain
Rapid weight gain or swelling of the arms or legs
While Taking Testosterone Troche
Tell your healthcare provider immediately if you:
Notice worsening urinary symptoms
Experience breast tenderness or enlargement
Develop shortness of breath or swelling
Have daytime sleepiness or worsening sleep apnea
Experience persistent mood or behavior changes
Do not notice improvement in symptoms after an appropriate trial period
Pregnancy and Fertility
Testosterone is not approved for use in women and must not be used during pregnancy. Exposure during pregnancy may cause harm to an unborn baby.
In men, testosterone therapy may decrease sperm production and impair fertility. Discuss fertility goals with your provider before starting therapy.
Overdose
Symptoms of testosterone overdose may include:
Severe mood changes
Persistent or painful erections
Severe swelling or fluid retention
Nausea or vomiting
Signs of blood clots or cardiovascular complications
If overdose is suspected, seek emergency medical attention or contact Poison Control immediately.
Missed Dosage
If you miss a dose:
Take the missed dose as soon as you remember unless it is close to your next scheduled dose
Do not double doses
Resume your regular schedule as directed by your provider
Storage
Store at room temperature unless otherwise directed on your label
Keep away from heat and moisture
Keep out of reach of children and pets
Dispose of unused or expired medication according to local hazardous waste regulations
Medication Disposal
Dispose of unused or expired medication in accordance with local medication disposal guidelines. Do not flush medication unless instructed. Contact your pharmacy or local waste authority for safe disposal options.
Provider Oversight and Order Review
This compounded testosterone medication requires review and oversight by a licensed Superior Health & Wellness provider. Dosing is individualized based on symptoms, laboratory results, and treatment goals. Regular lab monitoring and follow up appointments are required to ensure safety and effectiveness.
Telemedicine Disclosure
This prescription may have been issued via telemedicine. If you experience severe or concerning symptoms, contact your prescribing clinician immediately or seek emergency medical care.
Disclaimer
This summary does not include all information about Testosterone 8 mg Troche and should not replace medical guidance. Always consult your healthcare provider for complete safety information, potential interactions, and individualized recommendations. This compounded medication has not been evaluated or approved by the FDA for safety or efficacy.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1 800 FDA 1088.
