The U.S. Food and Drug Administration does not strictly regulate herbs and supplements. There is no guarantee of strength, purity or safety of products, and effects may vary. You should always read product labels. If you have a medical condition, or are taking other drugs, herbs, or supplements, you should speak with a qualified healthcare provider before starting a new therapy. Consult a healthcare provider immediately if you experience side effects.
Avoid lycopene in individuals with a known allergy/hypersensitivity to lycopene or tomatoes.
Side Effects and Warnings
The safety of lycopene supplements has not been thoroughly studied. Review of available scientific literature finds tomatoes, tomato-based products, and lycopene supplements generally well tolerated. However, rare reports of diarrhea, nausea, stomach pain or cramps, gas, vomiting, and loss of appetite have been reported. Tomatoes and tomato-based products may be acidic and irritate stomach ulcers. Lycopene has been associated with death from a cancer-related hemorrhage, although causality is unclear.
Pregnancy and Breastfeeding
There is not enough scientific research to recommend the use of lycopene supplements during pregnancy and breastfeeding. Amounts of lycopene found in foods are usually assumed to be safe. Tomato consumption has been shown to increase lycopene concentrations in breast milk and plasma of breastfeeding women.