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Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS) between January – March 2013

The table below lists the names of products and potential signals of serious risks/new safety information that were identified for these products during the period January - March 2013 in the FAERS database. The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but does not mean that FDA has identified a causal relationship between the drug and the listed risk. If after further evaluation the FDA determines that the drug is associated with the risk, it may take a variety of actions including requiring changes to the labeling of the drug, requiring development of a Risk Evaluation and Mitigation Strategy (REMS), or gathering additional data to better characterize the risk.

FDA wants to emphasize that the listing of a drug and a potential safety issue on this Web site does not mean that FDA is suggesting prescribers should not prescribe the drug or that patients taking the drug should stop taking the medication. Patients who have questions about their use of the identified drug should contact their health care provider. FDA will complete its evaluation of each potential signal/new safety information and issue additional public communications as appropriate.

Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS) January - March 2013

Product Name: Active Ingredient (Trade) or Product ClassPotential Signal of a Serious Risk / New Safety InformationAdditional Information
(as of July 26, 2016)

Metoprolol succinate extended release products

Lack of therapeutic effect, possibly related to product quality issues


FDA decided that no action is necessary at this time based on available information.

Serotonin-3 (5-HT3) receptor antagonist products:

  • Ondansetron Hydrochloride (Zofran) IV Injection, Tablet, and Oral Solution
  • Palonosetron Hydrochloride (Aloxi) IV Intravenous and Capsule
  • Ondansetron (Zuplenz) Oral Soluble Film

Serotonin syndrome


The “Warnings and Precautions,” “Drug Interactions,” and “Overdosage” sections of the labeling for 5-HT3 receptor antagonist products were updated September 2014 to include information about serotonin syndrome.

Zofran Injection Drug Safety Labeling Information

Zofran Tablets Drug Safety Labeling

Zofran Oral Solution Drug Safety Labeling

Aloxi Injection Drug Safety Labeling

Aloxi Capsule Drug Safety Labeling Information

Zuplenz Drug Safety Labeling Information


Page Last Updated: 01/13/2017
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