Sexual-enhancement dietary supplement products marketed to help with erectile dysfunction or enhance sexual function, even ones marketed as “all natural,” sometimes contain prescription drug ingredients, controlled substances, or other unstudied ingredients not listed on product labels. In fact, the Food and Drug Administration (FDA) has found that such products can contain “undeclared” active ingredients that could be harmful. Hidden drug ingredients could interact with other medications, such as nitrates (which might lead to dangerously low blood pressure), or cause other side effects that range from mild to serious. Such effects include headache, diarrhea, dizziness or lightheadedness, chest pain, muscle pain, blurred or sudden loss of vision, sudden decrease or loss of hearing, and an erection that is painful or lasts longer than 4 hours.

To date, FDA has identified more than 400 sexual-enhancement dietary supplement products tainted with hidden ingredients. For a list of these products, see FDA’s “Tainted Sexual Enhancement Products.” In addition, please see FDA’s Tainted Products widget on the OPSS home page for other dietary supplement products—including ones marketed for muscle building and weight loss—found to contain hidden drug ingredients.

 

Updated 6 March 2019

References

MedlinePlus. (2016). Tadalafil. Retrieved 6 March 2019 from https://medlineplus.gov/druginfo/meds/a604008.html

MedlinePlus. (2018). Sildenafil. Retrieved 6 March 2019 from https://medlineplus.gov/druginfo/meds/a699015.html

Tucker, J., Fischer, T., Upjohn, L., Mazzera, D., & Kumar, M. (2018). Unapproved pharmaceutical ingredients included in dietary supplements associated with US Food and Drug Administration warnings. JAMA Network Open, 1(6), e183337. doi:10.1001/jamanetworkopen.2018.3337

U.S. Food & Drug Administration. (2018a). Public Notification: On Demand contains hidden drug ingredient. Medication Health Fraud. Retrieved 6 March 2019 from https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm628056.htm

U.S. Food & Drug Administration. (2018b). Public Notification: Willy Go Wild contains hidden drug ingredients. Medication Health Fraud. Retrieved 6 March 2019 from https://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm627259.htm

U.S. Food & Drug Administration. (2019). Tainted products marketed as dietary supplements_CDER. FDA's Medication Health Fraud Page. Retrieved 6 March 2019 from https://www.accessdata.fda.gov/scripts/sda/sdNavigation.cfm?filter=&sortColumn=5a&sd=tainted_supplements_cder&displayAll=false&page=10