Important Safety Information: Glutathione | Compounded Injectable

What is this?

This Important Safety Information summarizes key warnings and precautions for Glutathione, a mass-produced compounded injectable formulation often referred to as the “Master Antioxidant.” Glutathione supports detoxification, liver health, immune function, and protection against oxidative stress. Naturally produced by the body, levels decline with age, chronic stress, and illness. This compounded injectable is not customized for individual patients and has not been reviewed or approved by the U.S. Food and Drug Administration (FDA) for safety or efficacy. It should only be used as directed under appropriate clinical supervision. This summary does not include all possible information. Always read your product label and follow your healthcare provider’s instructions.

Most Serious Warnings

Product can cause:

• Severe allergic reactions, including anaphylaxis (swelling, rash, or difficulty breathing)

• Hypotension or fainting during or shortly after injection

• Liver or kidney toxicity with prolonged or high-dose use

• Severe skin reactions, including Stevens-Johnson Syndrome (rare)

• Respiratory distress in patients with asthma or sulfur sensitivity

• Unknown long-term safety when used outside approved indications

The FDA has expressed concern regarding compounded injectable glutathione due to limited clinical data and potential sterility or formulation risks.

Who Should NOT Take Glutathione

Do not take this medication if you:

• Have a known allergy to glutathione or sulfur-containing compounds

• Have a history of severe allergic or anaphylactic reactions to antioxidant therapies

• Have asthma or a chronic respiratory condition that could worsen with antioxidant therapy

• Are pregnant or breastfeeding, due to insufficient safety data

• Have been advised by your clinician to avoid detoxification or antioxidant-based therapies

Before Taking Glutathione, Tell Your Healthcare Provider if You:

• Have liver disease, kidney disease, or respiratory illness

• Have a history of sulfa or sulfur sensitivity

• Are taking chemotherapy, immunosuppressants, or medications affecting liver function

• Have experienced neurological symptoms, or severe drug-related skin reactions

• Are pregnant, breastfeeding, or planning pregnancy

Possible Side Effects

Common (mild to moderate):

• Redness, swelling, itching, or burning at the injection site

• Mild headache or dizziness

• Nausea, bloating, or abdominal discomfort

• Temporary fatigue or lightheadedness

• Mild skin lightening or pigmentation changes with long-term use

Serious (seek medical care immediately):

• Severe allergic reaction (hives, facial or throat swelling, difficulty breathing)

• Severe abdominal pain, jaundice (yellowing of skin or eyes), or dark urine

• Decreased urination, swelling, or signs of fluid retention

• Widespread rash, blistering, or skin peeling

• Sudden dizziness, fainting, or irregular heartbeat

While Taking Glutathione

Tell your healthcare provider immediately if you:

• Develop shortness of breath, wheezing, or chest tightness

• Notice yellowing of skin or eyes

• Have swelling, reduced urination, or unexplained fatigue

• Experience widespread rash, itching, or pain at injection site

• Develop neurological changes, confusion, or tremors

Pregnancy and Fertility

The safety of injectable glutathione during pregnancy and breastfeeding has not been established. Use is not recommended in these populations unless deemed medically necessary by a healthcare provider. There is no evidence supporting its use for fertility enhancement or prenatal benefits in injectable form.

Overdose

Human data on glutathione overdose are limited. Potential symptoms may include:

• Nausea, vomiting, or severe abdominal pain

• Jaundice or dark urine (liver strain)

• Fatigue, weakness, or confusion

• Decreased urine output or swelling (kidney strain)

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

Missed Dosage

If you miss a scheduled dose, do not double up. Contact your prescribing clinician or pharmacy to reschedule. Follow your individualized administration instructions carefully.

Storage

• Store refrigerated at 36–46°F (2–8°C).

• Protect from light.

• Do not freeze.

• Keep out of reach of children.

• Discard after the beyond-use date indicated on the pharmacy label.

Medication Disposal

Dispose of unused or expired medication in accordance with local regulations for hazardous or compounded medications. Do not flush or throw into household trash. Ask your pharmacy about an approved medication take-back program.

Provider Oversight and Order Review

While provider approval is not required for this order, all requests are reviewed and processed under the supervision of Superior’s Medical Assistants. Orders may be subject to provider review and approval in accordance with medical guidelines and patient eligibility.

Individual results may vary. Promotional savings are valid for a limited time only.

Telemedicine Disclosure

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

Disclaimer

This summary does not include all information about Glutathione and should not replace medical advice. Consult your healthcare provider or pharmacist for complete guidance, potential interactions, and individualized recommendations.

This compounded medication has not been evaluated or approved by the FDA for safety or efficacy. All treatment decisions are made based on clinical judgment and patient suitability under provider supervision.