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  6. October - December 2020 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
  1. Questions and Answers on FDA's Adverse Event Reporting System (FAERS)

October - December 2020 | 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 23, 2021)

Acetaminophen

Stevens-Johnson Syndrome

FDA is evaluating the need for regulatory action.

Ajovy (fremanezumab)

Vyepti (eptinezumab)

Anaphylactic reaction

FDA is evaluating the need for regulatory action.

Albuterol sulfate inhaler

Product quality issue due to device malfunctions/failure to dispense

FDA is evaluating the need for regulatory action.

Alunbrig (brigatinib)

Xalkori (crizotinib)

Zykadia (ceritinib)

Photosensitivity reaction

FDA is evaluating the need for regulatory action.

Ameluz (aminolevulinic acid hydrochloride)

Gleolan (aminolevulinic acid hydrochloride)

Levulan Kerastick (5-aminolevulinic acid hydrochloride)

Metvixia (methyl aminolevulinate hydrochloride)

Generic products containing aminolevulinic acid hydrochloride

Hypersensitivity

FDA is evaluating the need for regulatory action.

Benznidazole tablets

Flagyl (metronidazole)

Flagyl ER (metronidazole)

Helidac Therapy (bismuth subsalicylate, metronidazole, and tetracycline hydrochloride)

Metronidazole oral and intravenous

Pylera (bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride)

Solosec (secnidazole)

Tindamax (tinidazole)

Generic products containing metronidazole (oral and intravenous)

Hepatic failure

FDA is evaluating the need for regulatory action.

Carac (fluorouracil)

Efudex (fluorouracil)

Fluoroplex (fluorouracil)

Tolak (fluorouracil)

Product storage error

FDA is evaluating the need for regulatory action.

Definity (perflutren lipid microsphere)

Definity RT (perflutren lipid microsphere)

Lumason (sulfur hexafluoride lipid-type A microspheres)

Allergy to chemicals

FDA is evaluating the need for regulatory action.

 

Farxiga (dapagliflozin)

Glyxambi (empagliflozin and linagliptin)

Invokana (canagliflozin)

Invokamet (canagliflozin and metformin hydrochloride)

Invokamet XR (canagliflozin and metformin hydrochloride)

Jardiance (empagliflozin)

Qtern (saxagliptin and dapagliflozin)

Qternmet XR (dapagliflozin, saxagliptin, and metformin hydrochloride)

Segluromet (ertugliflozin and metformin hydrochloride)

Steglatro (ertugliflozin)

Steglujan (ertugliflozin and sitagliptin)

Synjardy (empagliflozin and metformin hydrochloride)

Synjardy XR (empagliflozin and metformin hydrochloride)

Trijardy XR (empagliflozin, linagliptin, and metformin hydrochloride)

Xigduo XR (dapagliflozin and metformin)

Diabetic ketoacidosis in patients with Type 1 diabetes mellitus

FDA is evaluating the need for regulatory action.

GoLytely (polyethylene glycol 3350 and electrolytes)

MiraLAX (polyethylene glycol 3350)

MoviPrep (polyethylene glycol 3350, ascorbic acid, sodium ascorbate, sodium chloride, sodium sulfate, and potassium chloride)

NuLytely (polyethylene glycol 3350, potassium chloride, sodium bicarbonate, sodium chloride and sodium sulfate)

Plenvu (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride, and potassium chloride)

Aspiration

FDA is evaluating the need for regulatory action.

Nplate (romiplostim)

Wrong dose

FDA is evaluating the need for regulatory action.

PADCEV (enfortumab vendotin-ejfv)

Stevens-Johnson Syndrome

FDA is evaluating the need for regulatory action.

Piqray (alpelisib)

Colitis

FDA is evaluating the need for regulatory action.

Pitocin (oxytocin)

Generic products containing oxytocin

Accidental overdose

FDA is evaluating the need for regulatory action

Prolia (denosumab)

 

Hypersensitivity vasculitis

FDA is evaluating the need for regulatory action.

Sarclisa (isatuximab)

Anaphylactic reaction

FDA is evaluating the need for regulatory action.

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