Use of an oxygen–ozone gas mixture by methods such as major autohemotherapy, topical application, or insufflation. Ozone is toxic when inhaled, is not FDA-approved to treat disease in the U.S., and should never be injected directly as gas into a vein.
Ozone therapy uses a calibrated oxygen–ozone (O₂–O₃) gas mixture by several very different routes: blood is exposed outside the body in major autohemotherapy (MAH); ozone may be applied topically in a sealed bag or ozonated oil; or gas may be insufflated into a body cavity under a protocol. Ozone is a strong oxidant. It is toxic to lungs when inhaled and is not FDA-approved to prevent or treat disease in the United States.
Methods are not interchangeable
MAH draws a limited amount of blood, exposes it to ozone outside the body, and reinfuses it. EBOO uses a continuous extracorporeal circuit and is more invasive. Prolozone is a local injection practice. Ozonated saline and insufflation are separate approaches. Direct intravenous injection of ozone gas is unsafe because gas embolism can be fatal.
Evidence and limits
Laboratory and small clinical studies examine antimicrobial effects and oxidative signaling, but evidence quality and protocols vary widely. Claims involving chronic infection, autoimmune disease, cancer, detoxification, or anti-aging are not established indications. The FDA regulation on ozone describes it as a toxic gas with no known useful medical application in specific, adjunctive, or preventive therapy. Patients should not stop proven treatment for ozone.
Safety
Route determines risk. Blood procedures add infection, vascular-access, anticoagulation, and air/gas hazards. Inhalation can injure airways and lungs. Rectal or other insufflation can irritate tissue. Compounding and device claims do not substitute for regulatory authorization or high-quality outcome data.
Bring diagnoses, medications, anticoagulants, pulmonary history, pregnancy status, and the clinic’s written route/concentration. Ask whether the proposed use is FDA-approved (ozone therapy is not approved to treat disease in the U.S.).
Recovery varies by route. Blood procedures may cause fatigue, bruising, or lightheadedness. Respiratory symptoms after any exposure require prompt assessment.
Pulmonary injury from inhalation; gas embolism from direct IV gas; infection, bleeding, hemolysis, line complications, anticoagulant reactions, tissue irritation, oxidative injury, and delayed evidence-based treatment. EBOO adds extracorporeal-circuit risks.
21 CFR § 801.415. Maximum acceptable level of ozone.
https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-801/subpart-H/section-801.415U.S. EPA. Health effects of ozone pollution.
https://www.epa.gov/ground-level-ozone-pollution/health-effects-ozone-pollutionFDA. Consumer warnings regarding fraudulent ozone-related treatment claims.
https://www.fda.gov/consumers/consumer-updates/beware-fraudulent-coronavirus-tests-vaccines-and-treatmentsCDC. Injection Safety.
https://www.cdc.gov/injection-safety/© 2026 Longevity Clinic Finder. All rights reserved.
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