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LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-.

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LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet].

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Last Update: September 8, 2021.



OxyELITE Pro is the commercial name for a variety of multi-ingredient dietary supplements (MIDS) marketed for weight loss and body building. In 2013, one of the OxyELITE Pro products called “Super Thermogenic” was withdrawn from use in the United States after it was implicated in more than 50 cases of acute hepatitis including several instances of fatal, acute liver failure.


OxyELITE Pro is the proprietary name of a series of multi-ingredient nutritional supplements that are typically marketed as weight loss, body building, “fat burning” and performance enhancement aids. Initial ingredients in the products included caffeine and dimethylamylamine (DMAA) which in animal studies led to weight loss. Small phase 1 studies demonstrated that both blood pressure and pulse were increased with OxyELITE Pro, which was attributed to the effects of DMAA. In 2013, the FDA banned the use of DMAA in nutritional supplements and the composition of OxyELITE Pro was altered, with removal of DMAA and addition of aegeline, an herbal derivative that was believed to cause weight loss. Shortly thereafter reports of severe hepatitis were reported in persons taking “OxyELITE Pro Super Thermogenic”, some of which were severe enough to warrant emergency liver transplantation and some of which were fatal. In October 2013, under pressure from the FDA, the sponsor of OxyELITE Pro withdrew it from the market and requested retrieval of products already in distribution.

Aegeline is a component present in the fruit of the bael tree, Aegle marmelos that is native to India and is found throughout Southeast Asia. The bael tree is considered sacred in much of India and its fruit is used both as food and in Ayurvedic medicine. Extracts of bael leaves and fruit have had many uses in traditional medicine including treatment of digestive complaints and diarrhea. Its active ingredients include tannins, fatty oils, furocoumarins and furoquinolin alkaloids. The aegeline added to OxyELITE Pro was suspected to be a synthetic product, the purity of which was not clear. Other components in the OxyELITE product included caffeine (100 mg/capsule) and a propriety blend of Bauhinia purpurea leaf and pod extract, Bacopa monnieri leaf extract, dimethylamylamine (DMAA), Cirsium oligophyllum extract and Pausinystalia yohimbe bark extract (Yohimbe); none of these, however, have been implicated convincingly in causing liver injury.


OxyELITE Pro has been associated with at least 50 instances of clinically apparent acute liver injury. The onset of injury was usually within 2 to 20 weeks of starting regular use or of switching to the altered formulation of OxyELITE Pro products. The typical presenting symptoms were fatigue, nausea, and abdominal pain followed by dark urine and jaundice. The pattern of liver injury was hepatocellular and serum aminotransferase levels ranged to as high as several thousand U/L while alkaline phosphatase levels tended to be normal or minimally elevated (less than 3 times ULN). Liver biopsies showed an acute hepatitis-like picture and severe cases were associated with confluent, submassive or massive necrosis. Immunoallergic and features were not common, but autoantibodies were often detected. Indeed, instances of an autoimmune hepatitis-like pattern of injury occurred in a proportion of cases, some of which led to a chronic hepatitis and required long term immune suppressive therapy despite prompt withdrawal of the agent. The mortality rate overall was approximately 10% among cases with jaundice. In most non-fatal cases, symptoms resolved within 1 to 8 weeks and laboratory tests returned to normal by two to three months.

Likelihood score: A (well documented cause of clinically apparent liver injury).

Mechanism of Injury

The cause of acute liver injury associated with OxyELITE Pro has been attributed to aegeline, which was added to the commercial product in early 2013. Aegeline is a derivative of the fruit and other components of the bael tree and is a commonly used herbal agent in Southeast Asia, employed in Ayurvedic medicine for digestive complains. Cases of acute liver injury have not been previously reported with aegeline use. The aegeline used in OxyELITE Pro implicated in liver injury, however, was a synthetic product produced in China and may have included contaminants, synthetic precursors, metabolic derivatives, or racemic forms of the chemical that are toxic or immunogenic.

Drug Class: Herbal and Dietary Supplements, ◦Multi-Ingredient Nutritional Supplements





Herbal and Dietary Supplements


Product labeling at DailyMed, National Library of Medicine, NIH


Aegeline 456-12-2 C18-H19-N-O3 image 165224873 in the ncbi pubchem database
105-41-9 C7-H17-N image 134970998 in the ncbi pubchem database


References updated: 8 September 2021

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    (Expert review of hepatotoxicity published in 1999; OxyELITE Pro, aegeline and MDAA are not discussed).
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    (Review of hepatotoxicity of herbal and dietary supplements [HDS]; OxyELITE Pro, aegeline and MDAA are not mentioned).
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    (Extensive review of liver injury due to HDS mentions that OxyELITE Pro products have been implicated in more than 30 cases of liver injury resulting in liver transplantation in 4 and death in one patient).
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    (Search from several databases for instances of acute liver injury following use of muscle building or weight reducing dietary supplements occurring between April and December 2013, identified 40 cases, 27 of which were linked to use of OxyElite Pro).
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    (Review of reports of liver injury attributed to dietary supplements used for weight loss [such as green tea extract, Hydroxycut, Herbalife products and OxyELITE Pro] found that nonalcoholic liver disease was rarely considered responsible for the liver injury rather than the dietary supplement).
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