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  5. FDA's Adverse Event Reporting System (FAERS)
  6. October - December 2023 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
  1. FDA's Adverse Event Reporting System (FAERS)

October - December 2023 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

The drug product(s) included in any of the potential signals of serious risks/new safety information listed below may also include the generic version of the drug product(s), if there are generic versions approved for use by the FDA at the time of this publication.
Product Name: Trade (Active Ingredient) or Product Class Potential Signal of a Serious Risk / New Safety Information Additional Information
(as of March 15, 2024)

Acetaminophen-containing products

 

Metabolic acidosis

FDA is evaluating the need for regulatory action.

Certain adenosine injection (generic product)

Certain amiodarone hydrochloride injection (generic product)

Look alike container labels that contribute to wrong drug errors

FDA is evaluating the need for regulatory action.

Alecensa (alectinib)

Xalkori (crizotinib)

Acute pancreatitis

FDA is evaluating the need for regulatory action.

Aplenzin (bupropion hydrobromide)

Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride)

Contrave (naltrexone hydrochloride and bupropion hydrochloride)

Forfivo XL (bupropion hydrochloride)

Wellbutrin (bupropion hydrochloride)

Wellbutrin SR (bupropion hydrochloride)

Wellbutrin XL (bupropion hydrochloride extended release)

Meningitis aseptic

FDA is evaluating the need for regulatory action.

Aplenzin (bupropion hydrobromide)

Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride)

Contrave (naltrexone hydrochloride and bupropion hydrochloride)

Forfivo XL (bupropion hydrochloride)

Wellbutrin (bupropion hydrochloride)

Wellbutrin SR (bupropion hydrochloride)

Wellbutrin XL (bupropion hydrochloride extended release)

 

Brugada syndrome

The “Postmarketing Experience” section of the labeling for Contrave was updated in November 2023 to include Brugada pattern/syndrome.

Contrave labeling

 

FDA is evaluating the need for regulatory action for the other drug products.

Beyfortus (nirsevimab-alip)

Hypersensitivity

The “Warnings and Precautions” section of the labeling was updated in February 2024 to include risk of serious hypersensitivity reactions following Beyfortus administration.

Beyfortus labeling

 

Braftovi (encorafenib)

Zelboraf (vemurafenib)

Haemophagocytic lymphohistiocytosis

FDA is evaluating the need for regulatory action.

Central Nervous System (CNS) stimulants

Electrocardiogram QT prolonged

FDA is evaluating the need for regulatory action.

Gilotrif (afatinib)

Iressa (gefitinib)

Tarceva (erlotinib)

Cardiac failure

FDA is evaluating the need for regulatory action.

Gonadotropin releasing hormone (GnRH) agonists

  • Fensolvi (leuprolide acetate)
  • Lupron Depot (leuprolide acetate for depot suspension)
  • Lupron Depot-Ped (leuprolide acetate for depot suspension)
  • Lupaneta Pack (leuprolide acetate for depot suspension, for injection; norethindrone acetate tablets)
  • Supprelin LA (histrelin acetate)
  • Synarel (nafarelin acetate)
  • Triptodur (triptorelin)

Severe cutaneous adverse reactions

FDA is evaluating the need for regulatory action.

Imcivree (setmelanotide)

Hypersensitivity

The “Contraindications”, “Warnings and Precautions”, and “Postmarketing Experience” sections of the labeling were updated in November 2023 to include hypersensitivity reactions.

Imcivree labeling

 

Liptruzet (ezetimibe and atorvastatin)

Nexlizet (bempedoic acid and ezetimibe)

Roszet (rosuvastatin and ezetimibe)

Vytorin (ezetimibe and simvastatin)

Zetia (ezetimibe)

Drug-induced liver injury

The “Postmarketing Experience” section of the labeling for Zetia was updated in February 2024 regarding liver transaminases.

Zetia Labeling

 

FDA is evaluating the need for regulatory action for the other drug products.

 

Liptruzet (ezetimibe and atorvastatin)

Nexlizet (bempedoic acid and ezetimibe)

Roszet (rosuvastatin and ezetimibe)

Vytorin (ezetimibe and simvastatin)

Zetia (ezetimibe)

Severe cutaneous adverse reaction

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

Lupkynis (voclosporin)

Hypersensitivity

FDA is evaluating the need for regulatory action.

Systemic (oral/intravenous) metronidazole-containing products

Hearing impairment

FDA is evaluating the need for regulatory action.

Oncaspar (pegaspargase)

Rylaze (asparaginase erwinia chrysanthemi (recombinant)- rywn)

Veno-occlusive liver disease

The “Warnings and Precautions” section of the labeling for Oncaspar was updated in March 2024 to include the risk of hepatic veno-occlusive disease.

Oncaspar labeling

 

FDA is evaluating the need for regulatory action for Rylaze.

 

Rybrevant (amivantamab-vmjw)

Anaphylactic reaction

FDA is evaluating the need for regulatory action.

Sphingosine 1-phosphate receptor (S1PR) modulators

  • Mayzent (siponimod)
  • Ponvory (ponesimod)
  • Velsipity (etrasimod)
  • Zeposia (ozanimod)

Drug-induced liver injury

FDA is evaluating the need for regulatory action.

Turalio (pexidartinib)

Posterior reversible encephalopathy syndrome

FDA is evaluating the need for regulatory action.

Veozah (fezolinetant)

Drug-induced liver injury

FDA is evaluating the need for regulatory action.
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