Important Safety Information: Testosterone Injectable, Topical, Oral, & Blends

What is this?

This Important Safety Information summarizes key warnings and precautions for testosterone therapy prescribed through Superior. Testosterone is an androgen hormone used to treat clinically low testosterone levels in men and, at lower doses, selected hormone imbalances in women when determined appropriate by a licensed provider.

• Formulations may include:

• Injectable testosterone cypionate or cypionate/propionate blends

• Testosterone Cyp/Prop (175/25 mg)

• Testosterone Cypionate 200 mg (commercial)

• Testosterone Cypionate 200 mg/mL in MCT oil (compounded)

• Testosterone Cypionate 210 mg/mL in sesame oil (compounded)

• Testosterone Cypionate 40 mg/mL (compounded)

• Topical testosterone creams

• Female: Testosterone 10 mg/mL (1%) cream, 90 g

• Male: Testosterone 200 mg/mL (20%) cream, 90 g

• Buccal or sublingual testosterone troches

• Female: Testosterone 8 mg troches

• Male: Testosterone 50 mg troches

• Oral Test Booster capsules (enclomiphene, DHEA, progesterone, anastrozole) used as adjunctive therapy in select protocols

Commercial testosterone products are FDA approved for specific uses. Compounded formulations are prepared by a pharmacy for individualized dosing and are not reviewed or approved by the FDA for safety or efficacy. This summary does not include all possible information. Always follow your prescription label and your provider’s instructions.

Most Serious Warnings

Testosterone therapy can cause serious side effects, including:

• Heart and blood vessel problems: Increased risk of heart attack, stroke, blood clots, and worsening of existing heart disease, especially in the first 6–12 months of therapy

• Blood clots (venous and arterial): Deep vein thrombosis or pulmonary embolism, which may present as leg pain or swelling, chest pain, or sudden shortness of breath

• Elevated red blood cell count (erythrocytosis): Can thicken the blood, increasing the risk of clots, heart attack, or stroke

• Worsening prostate disease in men: Can worsen benign prostate enlargement and may stimulate growth of existing prostate cancer

• Liver problems: Certain formulations and misuse can contribute to liver injury

• Serious mood or behavior changes: Depression, irritability, aggression, mania, or suicidal thoughts, especially at high doses or with non-medical use

• Hormone-sensitive cancer risk: Potential stimulation of hormone-sensitive or androgen-dependent tumors

For topical testosterone, accidental transfer to others (especially women and children) through skin contact can cause unwanted virilizing effects. For some long-acting injectable testosterone products, there is a risk of severe breathing problems and allergic reactions requiring monitored administration. Your provider will advise you if a specialized program or observation period applies to your medication.

Who Should NOT Use Testosterone

Do not use testosterone therapy if you:

• Have a known allergy to testosterone or any ingredient in the formulation

• Are a man with known or suspected prostate cancer or male breast cancer

• Are a woman who is pregnant, may become pregnant, or is breastfeeding

• Have a history of testosterone or anabolic steroid misuse and are not under close medical supervision

• Have significantly elevated red blood cell or hematocrit levels that have not been cleared by your provider

• Have uncontrolled severe heart failure, severe sleep apnea, or are otherwise advised by a provider to avoid testosterone

Women who can become pregnant should not handle topical testosterone or contact skin where testosterone products have been applied unless appropriate precautions are taken.

Before Using Testosterone, Tell Your Healthcare Provider if You:

Tell your Superior provider about all medical conditions and medications before starting or continuing testosterone. This includes if you:

• Have or have ever had:

• Heart disease, prior heart attack, stroke, or high blood pressure

• High cholesterol or triglycerides

• History of blood clots, clotting disorders, or a strong family history of clots

• Sleep apnea or other breathing problems during sleep

• Enlarged prostate (benign prostatic hyperplasia, BPH) or urinary symptoms

• Prostate nodules, abnormal PSA levels, or prior prostate procedures

• Liver, kidney, or lung disease

• Diabetes or insulin resistance

• Depression, bipolar disorder, anxiety, or other mental health conditions

• Seizure disorder or migraine headaches

• Are using:

• Blood thinners (anticoagulants) such as warfarin

• Blood pressure medications

• Insulin or other diabetes medications

• Corticosteroids or other hormone therapies

• Cholesterol-lowering medications

• Supplements or over-the-counter products that affect hormones

Also tell your provider if you are:

• Planning to conceive in the near future

• Undergoing evaluation for infertility

• Using any other hormone therapy, including estrogen, progesterone, or DHEA

Possible Side Effects

Not everyone experiences side effects. Some may be mild and manageable, while others require immediate medical attention.

Common (mild to moderate) – All Patients

• Acne or oily skin

• Increased facial or body hair

• Headache

• Injection site pain, redness, or swelling

• Mild fluid retention or weight gain

• Changes in mood, irritability, or fluctuations in energy

• Increased sweating or body odor

Additional Effects More Common in Men

• Increased red blood cell count (erythrocytosis)

• Breast tenderness or enlargement

• Worsening of sleep apnea

• Increased or decreased libido

• Changes in fertility and sperm count

Additional Effects More Common in Women

• Acne or new facial hair growth

• Thinning scalp hair or male-pattern hair loss

• Voice deepening or hoarseness

• Changes in menstrual cycle or cessation of periods

• Clitoral enlargement

Some changes in women, such as voice deepening and clitoral enlargement, may be irreversible, even if therapy is stopped.

Serious (seek medical care immediately)

Stop the medication and contact your provider or seek emergency care if you experience:

• Chest pain, pressure, or discomfort

• Sudden shortness of breath, coughing up blood, or difficulty breathing

• Pain, swelling, warmth, or redness in one leg

• Sudden weakness or numbness of the face, arm, or leg, especially on one side

• Sudden trouble speaking, confusion, or difficulty understanding speech

• Sudden vision changes or severe headache

• Rapid weight gain, severe swelling of legs, ankles, feet, or abdomen

• Yellowing of the skin or eyes, dark urine, or severe upper right abdominal pain

• Very frequent or prolonged erections (men)

• New or worsening depression, severe anxiety, agitation, or thoughts of self-harm

• Signs of a serious allergic reaction, including rash, hives, itching, swelling of the face or throat, or trouble breathing

While Using Testosterone

Call your provider right away if you:

• Notice significant mood changes, irritability, or aggression

• Develop new or worsening urinary problems, such as difficulty starting urine, weak stream, or blood in urine

• Experience frequent nighttime urination or pelvic discomfort

• Have symptoms of blood clots, including leg pain or swelling, chest pain, or sudden shortness of breath

• Develop persistent headaches, visual changes, or neurologic symptoms

• Notice increased bruising or bleeding, particularly if on blood thinners

Your provider may periodically order lab tests that can include:

• Total and free testosterone levels

• Complete blood count (CBC) to assess hematocrit and hemoglobin

• Lipid panel and metabolic labs

• Liver and kidney function tests

• PSA and prostate evaluations for men

• Other hormone panels depending on your protocol

Do not adjust your dose, change your route, or stop therapy without consulting your provider.

Men: Monitoring and Special Considerations

For male patients:

• Routine prostate monitoring may be recommended, especially if you are age 40 or older or have risk factors

• Hematocrit and hemoglobin are checked regularly to watch for erythrocytosis

• Testosterone can lower sperm count and may impair fertility, particularly at higher doses or with long-term use

• If fertility is a current or future goal, discuss this with your provider before starting or adjusting therapy

Women: Monitoring and Special Considerations

For female patients:

• Therapy is prescribed at significantly lower doses than in men, using creams or low-dose troches when appropriate

• Providers closely monitor for virilizing side effects, including voice changes, unwanted hair growth, and menstrual changes

• Testosterone is not recommended during pregnancy or breastfeeding; therapy should be discontinued and your provider contacted if pregnancy occurs or is planned

• Women should not handle topical testosterone or contact treated skin areas unless precautions are taken to prevent exposure

Pregnancy, Breastfeeding, and Fertility

• Testosterone can harm an unborn baby and is contraindicated in pregnancy.

• Women who are pregnant, may become pregnant, or are breastfeeding should not use testosterone therapies.

• Men treated with testosterone may experience reduced sperm count and fertility. If having biological children is a priority, discuss options with your provider before starting treatment.

Overdose

Symptoms of testosterone overdose or serious reaction may include:

• Severe shortness of breath or chest pain

• Confusion, extreme fatigue, or sudden behavior changes

• Very frequent or prolonged erections (men)

• Severe swelling, rapid weight gain, or worsening heart symptoms

• Severe abdominal pain, nausea, or jaundice

If overdose is suspected:

• Call Poison Control at 1-800-222-1222, or use the online resource at poisonhelp.org.

• If the person collapses, has a seizure, has trouble breathing, or cannot be awakened, call 911 immediately.

Missed Dosage

If you miss a dose:

• Injectable testosterone: Take the missed dose as soon as you remember unless it is close to your next scheduled injection. Do not take two injections at once. Contact your provider if you are unsure how to adjust your schedule.

• Creams and troches: Apply or use the missed dose as soon as you remember on the same day. If it is almost time for your next dose, skip the missed dose. Do not double the dose to catch up.

Follow the dosing instructions on your prescription label and ask your provider or pharmacy team if you have questions.

Storage

• Store testosterone vials, creams, and troches at room temperature unless your pharmacy label states otherwise.

• Keep products away from direct light, heat, and moisture. Do not store in the bathroom.

• Do not freeze injectable or topical formulations.

• Keep all medications tightly closed and out of sight and reach of children and pets.

For topical products:

• After applying, allow the product to dry fully and cover the area with clothing to reduce transfer risk.

• Wash hands thoroughly with soap and water after application.

Medication Disposal

Do not flush testosterone products down the toilet or pour them into drains unless specifically instructed. Use community medication take-back programs where available, or follow local disposal guidance. Ask your pharmacy for instructions on safe disposal of unused or expired medication and sharps containers for needles and syringes when applicable.

Provider Oversight and Order Review

Testosterone therapy, including compounded products and combination capsules such as the Test Booster (enclomiphene, DHEA, progesterone, anastrozole), requires careful review and ongoing supervision by a licensed Superior provider.

• Dosing is based on your medical history, lab results, symptoms, and treatment goals.

• Therapy may be adjusted, paused, or discontinued if lab values change, side effects occur, or risks outweigh benefits.

• Additional safety information may apply to adjunctive agents such as enclomiphene, DHEA, progesterone, or anastrozole. Your provider will review these with you if they are part of your protocol.

Telemedicine Disclosure

This prescription was issued via telemedicine. If you experience any concerning or severe symptoms, contact your prescribing clinician immediately or seek emergency medical care.

Disclaimer

This Important Safety Information is a summary and does not include every possible risk, side effect, interaction, or instruction related to testosterone therapy or adjunctive medications. It does not replace medical advice from your provider. Always:

• Review the medication guides and pharmacy inserts provided with your prescription

• Discuss any questions or concerns with your Superior provider or pharmacist

• Inform your healthcare team about all medications, supplements, and therapies you use

Compounded medications described here are not evaluated or approved by the U.S. Food and Drug Administration (FDA) for safety or efficacy.

You are encouraged to report negative side effects of prescription drugs to the FDA MedWatch program at 1-800-FDA-1088 or online through the MedWatch website.