U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Drugs
  3. Guidance, Compliance, & Regulatory Information
  4. Surveillance: Post Drug-Approval Activities
  5. FDA's Adverse Event Reporting System (FAERS)
  6. October - December 2022 | 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 2022 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Product Name: Trade (Active Ingredient) or Product Class Potential Signal of a Serious Risk / New Safety Information Additional Information
(as of March 17, 2023)

Apretude (cabotegravir extended-release injectable suspension)

Cabenuva (cabotegravir extended-release injectable suspension; rilpivirine extended-release injectable suspension), co-packaged for intramuscular use

Vocabria (cabotegravir)

 

Anaphylactic reaction

The “Adverse Reactions:  Postmarketing Experience” subsection of the labeling was updated in February 2023 to include hypersensitivity reactions (including angioedema and urticaria).

 

Apretude labeling

 

Cabenuva labeling

 

Vocabria labeling

 

Atypical antipsychotics

  • Abilify (aripiprazole)
  • Abilify Mycite (aripiprazole)
  • Abilify Maintena (aripiprazole)
  • Aristada (aripiprazole lauroxil)
  • Caplyta (lumateperone)
  • Clozaril (clozapine)
  • Fanapt (iloperidone)
  • Geodon (ziprasidone)
  • Geodon (ziprasidone mesylate)
  • Invega (paliperidone)
  • Invega Hafyera (paliperidone palmitate)
  • Invega Trinza (paliperidone palmitate)
  • Latuda (lurasidone hydrochloride)
  • Lybalvi (olanzapine and samidorphan)
  • Nuplazid (pimavanserin)
  • Rexulti (brexpiprazole)
  • Risperdal (risperidone)
  • Risperdal Consta (risperidone)
  • Rykindo (risperidone)
  • Perseris (risperidone)
  • Saphris (asenapine)
  • Secuado (asenapine)
  • Seroquel (quetiapine)
  • Seroquel XR (quetiapine)
  • Symbyax (olanzapine and fluoxetine)
  • Versacloz (clozapine)
  • Vraylar (cariprazine)
  • Zyprexa (olanzapine)
  • Zyprexa Relprevv (olanzapine)
  • Zyprexa Zydis (olanzapine)

Generic products containing atypical antipsychotics

Faecal incontinence

FDA is evaluating the need for regulatory action.

Avonex (interferon beta-1a)

Betaseron (interferon beta-1b)

Extavia (interferon beta-1b)

Plegridy (peginterferon beta-1a)

Rebif (interferon beta-1a)

 

Pulmonary hypertension

FDA is evaluating the need for regulatory action.

Clenpiq (sodium picosulfate, magnesium oxide, and anhydrous citric acid)

Prepopik (sodium picosulfate, magnesium oxide, and anhydrous citric acid)

 

Syncope

FDA is evaluating the need for regulatory action.

Definity (perflutren lipid microsphere)

Lumason (sulfur hexafluoride lipid-type A microspheres)

Optison (perflutren protein-type A microspheres)

Sickle cell anaemia with crisis

FDA is evaluating the need for regulatory action.

Eliquis (apixaban)

Savaysa (edoxaban)

Pradaxa (dabigatran etexilate mesylate)

Xarelto (rivaroxaban)

 

Acute kidney injury

FDA is evaluating the need for regulatory action.

Certain glipizide extended-release product (generic product for the trade name Glucotrol XL)

Certain chlorpromazine hydrochloride product (generic product)

 

Similar tablet appearance that may contribute to wrong drug errors

FDA is evaluating the need for regulatory action.

Hydroxychloroquine sulfate

Plaquenil (hydroxychloroquine sulfate)

Generic products containing hydroxychloroquine sulfate or chloroquine phosphate

Hepatotoxicity

FDA is evaluating the need for regulatory action.

Hydroxychloroquine sulfate

Primaquine (primaquine phosphate)

Plaquenil (hydroxychloroquine sulfate)

Generic products containing hydroxychloroquine sulfate, chloroquine phosphate, or primaquine phosphate

 

Neuropsychiatric symptoms

FDA is evaluating the need for regulatory action.

Kalydeco (ivacaftor)

Orkambi (lumacaftor and ivacaftor)

Symdeko (tezacaftor/ivacaftor)

Trikafta (elexacaftor, tezacaftor, and ivacaftor)

Acute pancreatitis

FDA is evaluating the need for regulatory action.

Nexletol (bempedoic acid)

Nexlizet (bempedoic acid and ezetimibe)

Rhabdomyolysis

FDA is evaluating the need for regulatory action.

Non-steroidal anti-inflammatory drugs (NSAIDs)

 

Generalised bullous fixed drug eruption

FDA is evaluating the need for regulatory action.

Prolia (denosumab)

Hypocalcaemia

FDA is evaluating the need for regulatory action.

Drug Safety Communication (11/22/2022):  FDA investigating risk of severe hypocalcemia in patients on dialysis receiving osteoporosis medicine Prolia (denosumab)

Semglee (insulin glargine)

Device malfunction

FDA is evaluating the need for regulatory action.

Spravato (esketamine)

Respiratory depression

FDA is evaluating the need for regulatory action.

Tivdak (tisotumab vedotin-tftv)

Stevens-Johnson syndrome

FDA is evaluating the need for regulatory action.
Back to Top