In 2009 SFJDC was approved as prescription medicine by the Chinese Food and Drug Administration and in 2021 SFJDC got the approval to be sold as OTC medication in in China. Since the approval of SFJDC 78 randomized controlled trials (RCT) which involved 8793 patients were conducted. A team of the University in Southampton (UK) analyzed 64 of the published RTC and two years of adverse event data which were supplied from the Chinese pharmacovigilance system including safety data from over 20 million SFJDC boxes sold in China. The analyses of the RTC´s and pharmacovigilance data showed that no serious adverse events appeared. The main adverse reaction which were reported could be categorized as minor adverse reaction and include diarrhea, nausea and gastrointestinal discomfort. However, the side effects disappeared as soon as the drug treatment was stopped.

Furthermore, the University in Southampton analyzed SFJDC for potential interaction with western drugs and found no evidence for such an interaction in the existing data. Based on a theoretical phytochemical analyses of the ingredients of SFJDC some concerns for the safe use of SFJDC with taking anticoagulants, hypotensive, diuretic or antidiabetic medication alongside SFJD were raised and patients taking those western medicine should be monitored by a doctor when taking SFJDC. Additionally, four constituents of SFJDC (saikosaponins, lignans, resveratrol and glycyrrhizin) might have a potential effect on platelets, blood pressure, potassium and blood glucose, however those effects did not appear in the clinical trials.

There was insufficient information within the clinical studies and the pharmacovigilance data concerning the safety of Shufeng Jiedu Capsules for the treatment of pregnant and lactating women. There, pregnant and lactating women should only be treated with Shufeng Jiedu if the benefit of the treatment is higher than the risk.

In conclusion, Shufeng Jiedu capsules could be used safely in a clinical setting for the treatment of adults and children if the specified maximum dosage and duration of use are not exceeded.