Safety

Adverse effects

Slight increases in the serum concentrations of the liver enzyme, alanine aminotransferase (ALT) were observed in two women who took unspecified doses of I3C supplements for four weeks. One person reported a skin rash while taking 375 mg/day of I3C. High doses of I3C (800 mg/day) have been associated with symptoms of disequilibrium and tremor, which resolved when the dose was decreased. In a phase I study in women at high risk for breast cancer, 5 out of 20 participants had gastrointestinal symptoms with single doses ≥600 mg, although others had no adverse effects with single doses up to 1,200 mg. No adverse effects were reported with daily consumption of 400 mg of I3C for four weeks.

Pregnancy and lactation

The safety of I3C or DIM supplements during pregnancy or lactation has not been established.

Drug interactions

No drug interactions with I3C or DIM supplementation in humans have been reported. However, preliminary evidence that I3C and DIM can increase the activity of CYP1A2suggests the potential for I3C or DIM supplementation to decrease serum concentrations of medications metabolized by CYP1A2. Both I3C and DIM modestly increase the activity of CYP3A4 in rats when administered chronically. This observation raises the potential for adverse drug interactions in humans since CYP3A4 is involved in the metabolism of approximately 60% of therapeutic drugs.

The acidic environment of the stomach allows I3C molecules to condense and generate a number of biologically active I3C oligomers. Drugs that block the production of stomach acids, like antacids, Histamine2 (H2) receptor antagonists, and proton-pump inhibitors, would likely prevent the generation of DIM and ICZ. However, it is not known whether these drugs limit the biological activities attributed to I3C and its derivatives.

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