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FDA Drug Safety Podcast: FDA Warns Consumers to Avoid TimeOut Capsules

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On August 26, 2010, the Food and Drug Administration (FDA) issued an alert, warning consumers about TimeOut Capsules.

I am Yolanda Fultz-Morris from F-D-A's Center for Drug Evaluation and Research. 

FDA is warning consumers not to take TimeOut Capsules, a product marketed as a dietary supplement for sexual enhancement. TimeOut contains a chemical similar to the active ingredient in Viagra. This chemical may interact with prescription drugs, such as nitrates, including nitroglycerin, and cause dangerously low blood pressure.

When blood pressure drops suddenly, the brain is deprived of an adequate blood supply, which can lead to dizziness or lightheadedness. FDA is especially concerned that consumers may mistakenly assume that this product is harmless and poses no health risk because TimeOut is labeled as "100 percent natural."

FDA is not aware of any adverse events associated with the use of this product. The product is distributed on Internet sites and online marketplaces. As of the date of this posting, these Internet sites and online marketplaces are still operating, but further compliance action may be pending.

We urge consumers who have experienced any negative side effects to consult a health care professional and to discard the product. Consumers and health care professionals should report adverse events to the FDA's MedWatch Adverse Event Reporting program by phone at 1-800-F-D-A-ten-88 or by the Internet at W-W-W dot F-D-A dot GOV slash M-E-D-W-A-T-C-H.

Updated information about drugs with emerging safety concerns is available 24 hours a day at our Web site W-W-W dot F-D-A dot GOV slash D-R-U-G-S.




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