Bael

• Aegeline supplements are a separate and serious safety issue. Aegeline is a compound found in bael leaf and fruit. In 2013 the weight-loss and muscle-gain supplement OxyELITE Pro, reformulated in early 2013 to contain aegeline in place of 1,3-dimethylamylamine, was linked by CDC, FDA and Hawaii investigators to a cluster of severe liver injury, including liver failure, transplants and at least one death. The causing ingredient was never established, and one group disputes the link. Eating bael fruit or taking bael leaf is a different exposure, but products that list aegeline should be avoided. Case series ^{2 15 3 14 16 21}
• No human safety data for the fruit or leaf themselves. The reviews report no human toxicity or adverse-effect data for bael fruit or leaf and ask for clinical trials to confirm safety. One review says the plants were safe in long-term use but gives no trial; we treat that as an unproven claim. Not having data is not proof of safety. Systematic review ^{19 23 12}
• Possible low blood sugar with diabetes medicines. Because bael is promoted for lowering glucose, people taking diabetes medicine should tell their prescriber. No documented case or human interaction study was found; this is reasoned from animal and lab claims. Pharmacological theory ^{19 12}
• Bowel effects: constipation and loose stools. Traditionally the unripe or dried unripe fruit is used to stop diarrhea and the ripe fruit as a laxative. So the unripe fruit could cause constipation, and ripe fruit could loosen stools. These are traditional-use expectations from our summary; no trial or case report of either was found. Traditional use ^{6 13}
• Lab signal for some medicines handled by CYP3A4 and CYP1A2. In human liver microsomes a bael fruit extract and its compound marmelosin inhibited CYP3A4 and CYP1A2. The authors say it is unknown whether eating bael changes drug levels in people. Laboratory research ¹⁷

Bael fruit and leaf: no liver injury case report was found. Aegeline products: serious injury is documented. During 2013 CDC, Hawaii Department of Health and FDA investigated acute hepatitis linked to OxyELITE Pro (Hawaii: 44 cases met the definition and 36 had used the product; 40 cases across 23 states; FDA received 55 reports of non-viral liver disease, with 3 transplants). In a US liver-injury network series of 7 patients, median peak ALT was 2242 U/L, 3 developed liver failure and 2 had a transplant. The FDA noted the 2013 reformulation swapped 1,3-dimethylamylamine for aegeline and that its lab found no drugs, poisons, toxic metals or other known liver toxins in the products. Investigators did not identify which ingredient was responsible, and one group (Teschke and Eickhoff) argues many cases had other causes. LiverTox has an OxyELITE Pro entry (NOT verified, page blocked; search summary says the aegeline used was synthetic and the cause unknown). A lab study suggests aegeline can be turned into a reactive product by the enzyme CYP2C19 in rat liver cells. ^{2 15 3 14 16 21 22 7}

How often. Unknown. The number of people who took the product safely is not known.

Monitoring. Liver blood tests are the standard check for unexplained jaundice or dark urine; no agency advice specific to bael was found.

• . 7 patients, median use 18 weeks; 6 hospitalised, 3 liver failure, 2 transplants.
• . Hawaii 2013: 36 of 44 cases exposed; 2 transplants and 1 death among exposed.
• . FDA MedWatch: 55 of 114 reports non-viral liver disease; 33 hospitalised; 3 transplants.

This is a safety connection. It is not evidence that Bael supports liver health.

Summary. No human toxicity data for bael fruit or leaf. Animal toxicity detail was not re-opened. Aegeline had liver toxicity signals in lab work and in a human outbreak linked to a product containing it.

Animal. Mice absorbed aegeline within 30 minutes and cleared it with a half-life of about 1.3 to 1.4 hours (30 and 300 mg/kg). The LiverTox search summary also mentions deaths in mice given OxyELITE Pro (NOT verified).

Human doses studied. Human trials were tiny: unripe fruit powder (16 men) and a two-herb mix for 6 weeks.

High dose or long term signals. OxyELITE Pro cases had used it for a median of 18 weeks in one series; excessive dosing was not reported in Hawaii.

Overdose response. No overdose case found.

Genotoxicity. Not assessed in the sources read.

Toxic plant parts. None known from the sources read. NOT verified from a regulator.

Aegeline itself was not found contaminated in FDA lab tests of OxyELITE Pro, which found no drugs, toxic metals or common liver toxins. LiverTox (search summary only, NOT verified) says the aegeline used was synthetic and may have contained impurities or other forms. Bael fruit and leaf herbal products: no adulteration report found.

Natural bael versus aegeline in supplements. Aegeline is found in bael leaf and fruit, but the supplement ingredient was reported by LiverTox (unverified) to be synthetic. We cannot say whether natural fruit or leaf would behave the same. ^{7 16 22}

• Yellow skin or eyes, dark urine, pale stools, severe tiredness or belly pain after taking a supplement
• Persistent nausea or vomiting with weight-loss or muscle-building supplements
• Shakiness, sweating, confusion or fainting (low blood sugar) if you take diabetes medicine
• Diarrhea with blood, high fever or signs of dehydration
• No bowel movement with severe belly pain or swelling

Stop the supplement and contact a clinician or emergency service. In the US, Poison Control is 1-800-222-1222.