Objective: With the withdrawal of Zelnorm, recall of products such as Ranbaxy's generic gabapentin, and the increase in FDA safety communications related to highly prescribed products including the thiazolidinediones and bisphosphonates in 2007, information on drug safety was present weekly, if not daily, in the newspaper and on television. To assist consumers in understanding their risk of developing serious side effects and put into context the relative risk of their various medications, we have developed a 5-color drug risk rating system. Methods: The iGuard Risk Rating system is a patented process for summarizing serious adverse events contained in each medication's Prescribing Information. Specifically, we focus on: 1) the severity of the reaction (serious disability or death); 2) the likelihood of the reaction (e.g., >1 in 10,000); and 3) proportion of the population affected (e.g., 0-15%). We also adjust for lack of experience with a product on the market: <1,000,000 prescriptions or <2 years post-launch. Our iGuard Risk Ratings, from lowest to highest, are as follows: 1) Green: Low Risk–Suitable for widespread use; 2) Blue: General Risk–Use under normal care of a doctor; 3) Yellow: Guarded–Be on the lookout for safety events; 4) Orange: Elevated Risk–Create a personal risk reduction plan with your doctor; and 5) Red: High Risk–Requires careful consideration of risk versus benefit. Results: To date, we have rated 106 medications. Risk Ratings associated with individual medications are available on the project website at www.iguard.org. A total of 80 of 106 medications (75%) were rated Level 2/Blue: General Risk. An additional 20% were rated Level 4/Orange: Elevated Risk. Ratings across molecules within a therapeutic class are very similar. Conclusion: Consumer feedback on the iGuard Risk Ratings has been very positive, especially in understanding which of their medications they need to be most diligent in monitoring.