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  5. FDA's Adverse Event Reporting System (FAERS)
  6. April - June 2024 | 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)

April - June 2024 | 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 September 20, 2024)

Belsomra (suvorexant)

Dayvigo (lemborexant)

Quviviq (daridorexant)

 

Paradoxical drug reaction

FDA is evaluating the need for regulatory action.

Breyna (budesonide and formoterol fumarate) inhalation aerosol

Drug ineffective

FDA is evaluating the need for regulatory action.

Carbaglu (carglumic acid)

Product physical issue that may contribute to clogged feeding tubes

FDA is evaluating the need for regulatory action.

Certain flecainide acetate (generic product)

Certain prasugrel hydrochloride (generic product)

Look alike container labels that may contribute to wrong drug errors

The prasugrel container labels were revised in August 2024 to differentiate the products.

 

Certain tiotropium inhalation powder (generic product)

Device difficult to use

FDA is evaluating the need for regulatory action.

Copaxone (glatiramer acetate)

Anaphylactic reaction

FDA is evaluating the need for regulatory action.

Epinephrine injection (authorized generic for Adrenaclick)

Device use confusion (mismatch between the pen device and Instructions for Use)

FDA is evaluating the need for regulatory action.

Fetroja (cefiderocol)

Chromaturia

FDA is evaluating the need for regulatory action.

Gemtesa (vibegron)

Hypersensitivity

FDA is evaluating the need for regulatory action.

Janus kinase (JAK) inhibitors

Hypoglycemia

FDA is evaluating the need for regulatory action.

Kalydeco (ivacaftor)

Orkambi (lumacaftor and ivacaftor)

Symdeko (tezacaftor/ivacaftor)

Trikafta (elexacaftor, tezacaftor, and ivacaftor)

Increased intracranial pressure disorders

FDA is evaluating the need for regulatory action.

Mekinist (trametinib)

Acute febrile neutrophilic dermatosis

FDA is evaluating the need for regulatory action.

Potassium Phosphates Injection

Sodium Chloride 0.9% Injection

Look alike containers that may contribute to wrong drug errors

FDA is evaluating the need for regulatory action.

Pyzchiva (ustekinumab-ttwe)

Stelara (ustekinumab)

Selarsdi (ustekinumab-aekn)

Wezlana (ustekinumab-auub)

Hepatobiliary disorders

FDA is evaluating the need for regulatory action.

Singulair (montelukast sodium)

Psychiatric disorders

FDA is evaluating the need for regulatory action.

Tafinlar (dabrafenib)

Zelboraf (vemurafenib)

Acute febrile neutrophilic dermatosis

FDA is evaluating the need for regulatory action.

Tazverik (tazemetostat)

Blood glucose abnormal

FDA is evaluating the need for regulatory action.

Thrombin-JMI (thrombin, topical [bovine])

 

Inadvertent intravenous (IV) administration causing thrombosis

FDA is evaluating the need for regulatory action.
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