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  6. January - March 2021 | 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)

January - March 2021 | 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 June 16, 2021)

Addyi (flibanserin)

Drug hypersensitivity

FDA is evaluating the need for regulatory action.

Adlyxin (lixisenatide)
Bydureon (exenatide)
Bydureon BCise (exenatide)
Byetta (exenatide)
Ozempic (semaglutide)
Rybelsus (semaglutide)
Saxenda (liraglutide)
Soliqua (insulin glargine and lixisenatide)
Trulicity (dulaglutide)
Victoza (liraglutide)
Xultophy (insulin degludec and liraglutide)

Drug-induced liver injury

FDA is evaluating the need for regulatory action.

Alcohol-based hand sanitizers

Exposure via inhalation

FDA is evaluating the need for regulatory action.

Amlodipine and Levamlodipine Products

  • Azor (amlodipine and olmesartan medomoxil)
  • Caduet (amlodipine besylate and atorvastatin calcium)
  • Conjupri (levamlodipine maleate)
  • Consensi (amlodipine besylate and celecoxib)
  • Exforge (amlodipine and valsartan)
  • Exforge HCT (amlodipine/valsartan and hydrochlorothiazide)
  • Lotrel (amlodipine besylate and benazepril hydrochloride)
  • Katerzia (amlodipine benzoate)
  • Norvasc (amlodipine besylate)
  • Prestalia (amlodipine besylate and perindopril arginine)
  • Tribenzor (amlodipine besylate/olmesartan medoxomil and hydrochlorothiazide)
  • Twynsta (amlodipine and telmisartan)

Non-cardiogenic pulmonary oedema

FDA is evaluating the need for regulatory action.

Avonex (interferon beta-1a)
Betaseron (interferon beta-1b)
Extavia (interferon beta-1b)
Plegridy (pegylated interferon beta-1a)
Rebif (interferon beta-1a)

Injection site abscess

FDA is evaluating the need for regulatory action.

Bavencio (avelumab)
Imfinzi (durvalumab)
Keytruda (pembrolizumab)
Libtayo (cemiplimab-rwlc)
Opdivo (nivolumab)
Tecentriq (atezolizumab)

Scleroderma

FDA is evaluating the need for regulatory action.

Bavencio (avelumab)
Imfinzi (durvalumab)
Keytruda (pembrolizumab)
Libtayo (cemiplimab-rwlc)
Opdivo (nivolumab)
Tecentriq (atezolizumab)

Cholangitis sclerosing

FDA is evaluating the need for regulatory action.

Chloroquine

Phospholipidosis

FDA is evaluating the need for regulatory action.

Eliquis (apixaban)
Pradaxa (dabigatran etexilate mesylate)
Savaysa (edoxaban tosylate)
Xarelto (ribaroxaban)
Generic products containing dabigatran etexilate mesylate
Generic products containing ribaroxaban

Menorrhagia

The “Use in Specific Populations” section was updated April 2021 to add language to describe the risk of clinically significant uterine bleeding in females of reproductive potential.
Eliquis label
Pradaxa label
Savaysa label
Xarelto label

Depakote (divalproex sodium)
Depakote ER (divalproex sodium)
Stavzor (valproic acid)
Generic products containing divalproex sodium
Generic products containing valproic acid

Tubulointerstitial nephritis

FDA is evaluating the need for regulatory action.

Dupixent (dupilumab)

Alopecias

FDA is evaluating the need for regulatory action.

H.P. Acthar Gel (corticotropin)

Anaphylactic and anaphylactoid responses

FDA is evaluating the need for regulatory action.

H.P. Acthar Gel (corticotropin)

Cardiac arrhythmias

FDA is evaluating the need for regulatory action.

Ibrance (palbociclib)
Kisqali (ribociclib)
Kisqali Fermara Co-Pack (letrozole and ribociclib)
Verzenio (abemaciclib)

Second primary malignancy

FDA is evaluating the need for regulatory action.

Lynparza (olaparib)

Drug-induced liver injury

FDA is evaluating the need for regulatory action.

Ocrevus (ocrelizumab)

Autoimmune colitis

FDA is evaluating the need for regulatory action.

Poteligeo (mogamulizumab-kpkc)

Acute kidney injury

FDA is evaluating the need for regulatory action.

Ravicti (glycerol phenylbutyrate)

Product labeling issue regarding stability and instructions for administration

FDA is evaluating the need for regulatory action.

Spravato (esketamine)

Hypertensive crisis

FDA is evaluating the need for regulatory action.

Tremfya (guselkumab)

Device use errors resulting in possible missed or partial doses

FDA is evaluating the need for regulatory action.

Trulance (plecanatide)

Drug hypersensitivity

The “Adverse Reactions” section of the Trulance labeling was updated April 2021 to include skin itching, hives, and rash.
Trulance Label

Trulance (plecanatide)

Vomiting

The “Adverse Reactions” section of the Trulance labeling was updated April 2021 to include vomiting.
Trulance Label

 

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