Important Safety Information: DHEA (Dehydroepiandrosterone)/Pregnenolone | Compounded Oral Capsule

What is this?

This Important Safety Information summarizes key warnings and precautions for DHEA (Dehydroepiandrosterone) and Pregnenolone, two endogenous steroid hormones involved in adrenal and sex hormone production. DHEA is a precursor to testosterone and estrogen, while pregnenolone is a neurosteroid and upstream hormone involved in steroid synthesis and cognitive signaling pathways.

DHEA has been studied for adrenal insufficiency, mood disorders, bone density concerns, sexual dysfunction, and metabolic health. Pregnenolone has been evaluated for potential cognitive and neurosteroidal effects, though robust long-term human data are limited.

This sustained-release compounded oral capsule 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 read your medication label and follow your provider’s instructions.

Most Serious Warnings

Product can cause:

• Severe allergic reactions, including swelling of the face, lips, tongue, or throat

• Hormonal imbalances or excessive androgen or estrogen conversion

• Mood instability, including agitation, anxiety, mania, or hypomania

• Increased blood pressure

• Decreased HDL cholesterol

• Erythrocytosis (elevated red blood cell levels)

• Potential stimulation of hormone-sensitive cancers

• Seizure risk in susceptible individuals (pregnenolone)

Compounded hormone therapies may carry formulation variability due to limited FDA oversight.

Who Should NOT Take This Medication

Do not take this medication if you:

• Have a known allergy to DHEA, pregnenolone, or any ingredient in the formulation

• Have breast cancer, prostate cancer, or other hormone-sensitive cancers

• Have androgen-dependent tumors

• Have epilepsy or a seizure disorder (pregnenolone precaution)

• Are pregnant or breastfeeding without provider supervision

Before Taking This Medication, Tell Your Healthcare Provider if You:

• Have a history of psychiatric disorders, including depression, bipolar disorder, or anxiety

• Have liver dysfunction

• Have diabetes or insulin resistance

• Have polycystic ovarian syndrome (PCOS)

• Have high blood pressure or cardiovascular disease

• Have abnormal cholesterol levels

• Are taking estrogen, testosterone, or other hormone therapies

• Take prescription, over-the-counter, or herbal medications

• Are undergoing fertility treatment

• Are planning pregnancy

DHEA supplementation may interfere with progesterone laboratory testing and may falsely elevate measured progesterone levels.

Possible Side Effects

Common (mild to moderate):

• Acne or oily skin

• Increased facial or body hair (hirsutism)

• Breast tenderness or gynecomastia

• Mood changes

• Headache

• Sleep changes

Serious (seek medical care immediately):

• Rash, hives, swelling, or difficulty breathing

• Severe mood changes, paranoia, or suicidal thoughts

• Chest pain or significant blood pressure elevation

• Signs of blood thickening such as headaches, dizziness, or visual changes

• Seizures

• Sudden abdominal pain

While Taking This Medication

Tell your healthcare provider immediately if you:

• Experience worsening mood, agitation, or behavioral changes

• Develop new or worsening acne, hair growth, or hormonal symptoms

• Notice significant changes in blood pressure

• Experience symptoms of liver dysfunction such as yellowing of the skin or eyes

• Develop symptoms of elevated red blood cell count such as headaches or flushing

Bloodwork monitoring may be required to assess hormone levels and ensure appropriate dosing.

Pregnancy and Fertility

Safety data in pregnancy and lactation are limited. DHEA has been studied in certain fertility protocols under medical supervision. This medication should only be used during fertility care if directed by a licensed healthcare provider.

Overdose

Symptoms of overdose may include:

• Severe mood changes or agitation

• Significant hormonal imbalance symptoms

• Elevated blood pressure

• Nausea or vomiting

If overdose is suspected, seek emergency medical attention or contact Poison Control immediately.

Missed Dosage

If you miss a scheduled dose:

• Do not double the next dose

• Take the missed dose when remembered unless it is near the next scheduled dose

• Contact your provider if you are unsure how to resume therapy

Storage

• Store in the original labeled container

• Store at controlled room temperature

• Protect from excessive heat and moisture

• Keep out of reach of children and pets

Medication Disposal

Dispose of unused or expired medication according to local medication disposal guidelines. Do not flush medication or dispose of it in household drains.

Provider Oversight and Order Review

This compounded medication requires review and oversight by licensed Superior Health & Wellness providers. Dosing and sustained-release hormone therapy must be individualized and monitored with appropriate lab testing. Orders may be adjusted based on lab results, clinical goals, or symptom response.

Telemedicine Disclosure

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

Disclaimer

This summary does not include all information about DHEA and pregnenolone and should not replace medical guidance. Always consult your healthcare provider or pharmacist for complete safety information, potential interactions, and individualized treatment 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 or call 1-800-FDA-1088.