U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Guidance, Compliance, & Regulatory Information
  4. Surveillance: Post Drug-Approval Activities
  5. Questions and Answers on FDA's Adverse Event Reporting System (FAERS)
  6. October - December 2018 | 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 2018 | 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 December 13, 2022)

Aimovig (erenumab-aooe) injection

Hypersensitivity events

The “Contraindications” and “Warnings and Precautions” sections of the labeling were updated to include information about hypersensitivity reactions.
Aimovig labeling

  • Abilify (aripiprazole)
  • Abilify Discmelt (aripiprazole) tablet
  • Abilify Maintena (aripiprazole) injection
  • Abilify MyCite (aripiprazole tablets with sensor) tablet
  • Aristada (aripiprazole lauroxil)
  • Generic products containing aripiprazole

Acute generalized exanthematous pustulosis, Drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome, and toxic epidermal necrolysis

FDA is evaluating the need for regulatory action.

  • Anoro Ellipta (umeclidinium and vilanterol)
  • Arnuity Ellipta (fluticasone furoate)
  • Breo Ellipta (fluticasone furoate and vilanterol)
  • Incruse Ellipta (umeclidinium)
  • Trelegy Ellipta (fluticasone furoate, vilanterol, and umeclidinium)

Medication errors: wrong drug

Updated

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

  • Antara (fenofibrate) capsule
  • Fenoglide (fenofibrate) tablet
  • Fibricor (fenofibric acid) tablet
  • Lipofen (fenofibrate) capsule
  • TriCor (fenofibrate) tablet
  • TriCor NFE (fenofibrate) tablet
  • Triglide (fenofibrate) tablet
  • Trilipix (fenofibric acid) capsule
  • Generic products containing fenofibrate

Interstitial lung disease

Updated

The “Adverse Reactions” section of the fenofibrate labeling was updated between March 2019 and May 2019 to include interstitial lung disease.

Example: Antara labeling

  • Belbuca (buprenorphine hydrochloride) film
  • Bunavail (buprenorphine hydrochloride and naloxone hydrochloride) film
  • Cassipa (buprenorphine hydrochloride and naloxone hydrochloride) film
  • Suboxone (buprenorphine and naloxone) tablet
  • Suboxone (buprenorphine and naloxone) film
  • Subutex (buprenorphine hydrochloride) tablet
  • Zubsolv (buprenorphine hydrochloride and naloxone hydrochloride) tablet
  • Generic oral products containing buprenorphine hydrochloride or buprenorphine hydrochloride and naloxone hydrochloride

Drug-induced dental caries

FDA is evaluating the need for regulatory action.

Bosulif (bosutinib monohydrate) film

Cardiac failure

Updated

The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the Bosulif labeling were updated in October 2019 to include cardiac failure.

Bosulif labeling

Chlorpromazine hydrochloride

Drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome, and toxic epidermal necrolysis

FDA is evaluating the need for regulatory action.

Cinvanti (aprepitant) injection

Hypersensitivity reactions, including anaphylaxis

The “Contraindications” and “Warnings and Precautions” sections of the labeling were updated to reflect information about hypersensitivity reactions.

Cinvanti labeling

  • Clozaril (clozapine) tablet
  • FazaClo ODT (clozapine) tablet
  • Versacloz (clozapine) suspension
  • Generic products containing clozapine

Stevens-Johnson syndrome and toxic epidermal necrolysis

FDA decided that no action is necessary at this time.

Gilenya (fingolimod) capsule

Hemolytic anemia

Updated

The “Adverse Reactions” section of the Gilenya labeling was updated in December 2019 to include hemolytic anemia.

Gilenya labeling

  • Gralise (gabapentin) tablet
  • Horizant (gabapentin encarbil) tablet
  • Lyrica (pregabalin) capsule
  • Lyrica (pregabalin) solution
  • Lyrica CR (pregabalin) tablet
  • Neurontin (gabapentin)
  • Generic products containing gabapentin or pregabalin

Respiratory depression

FDA is evaluating the need for regulatory action.

  • Gralise (gabapentin) tablet
  • Horizant (gabapentin encarbil) tablet
  • Lyrica (pregabalin) capsule
  • Lyrica (pregabalin) solution
  • Lyrica CR (pregabalin) tablet
  • Neurontin (gabapentin)
  • Generic products containing gabapentin or pregabalin

Bullous pemphigoid

FDA is evaluating the need for regulatory action.

  • Haldol (haloperidol) injection
  • Haldol (haloperidol) decanoate injection
  • Haloperidol injection

Acute generalized exanthematous pustulosis, Drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome, and toxic epidermal necrolysis

Updated

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

  • Inlyta (axitinib) tablet
  • Coumadin (warfarin sodium) tablet
  • Generic products containing warfarin sodium

 

Drug interaction between axitinib and warfarin

Updated

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

  • Invega (paliperidone) tablet
  • Invega Sustenna (paliperidone palmitate) suspension
  • Invega Trinza (paliperidone)
  • Generic products containing paliperidone

Drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome, and toxic epidermal necrolysis

Updated

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

  • Lithium carbonate capsule
  • Lithium carbonate tablet
  • Lithium citrate syrup
  • Lithobid (lithium carbonate) tablet
  • Generic products containing lithium carbonate and lithium citrate

Acute generalized exanthematous pustulosis, Drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome and toxic epidermal necrolysis

Updated

The “Adverse Reactions” section of the lithium labeling was updated in February 2020 to include drug reaction with eosinophilia and systemic symptoms.

Example: Lithobid labeling

 

  • Lovenox (enoxaparin sodium) injection
  • Generic products containing enoxaparin sodium

Device malfunction

FDA is evaluating the need for regulatory action.

  • Risperdal Consta (risperidone) injection
  • Risperdal M-tab (risperidone) tablet
  • Generic products containing risperidone

Acute generalized exanthematous pustulosis, Drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome and toxic epidermal necrolysis

FDA is evaluating the need for regulatory action.

  • Rituxan (rituximab) solution
  • Rituxan Hycela (hyaluronidase human and rituximab) injection

Pyoderma gangrenosum

Updated

The “Adverse Reactions” section of the rituximab labeling was updated between November 2019 and December 2019 to include pyoderma gangrenosum.

Rituxan labeling

Rituxan Hycela labeling

  • Sensipar (cinacalcet hydrochloride) capsule
  • Parsabiv (etelcalcetide) injection
  • Prolia (denosumab) injection
  • Xgeva (denosumab) injection

Drug interaction between calcimimetics (i.e. cinacalcet hydrochloride or etelcalcetide) and denosumab

Updated

The “Dosage and Administration” and “Warnings and Precautions” sections of the Sensipar labeling were updated in March 2019 to include that the concomitant use of other serum calcium lowering drugs may worsen hypocalcemia risk.

Sensipar labeling

The “Warnings and Precautions” and “Adverse Reactions” sections of the Parsabiv labeling were updated in March 2019 to include that the concomitant use of other serum calcium lowering drugs may worsen hypocalcemia risk.

Parsabiv labeling

The “Warnings and Precautions” section of the denosumab labeling was updated between April 2019 and February 2020 include that the concomitant use of calcimimetic drugs may worsen hypocalcemia risk.

Prolia labeling

The “Warnings and Precautions” section of the Xgeva labeling was updated in February 2020 to include that the concomitant use of calcimimetic drugs may worsen hypocalcemia risk.

Xgeva labeling

  • Seroquel (quetiapine fumarate) tablet
  • Seroquel XR (quetiapine fumarate) tablet
  • Generic products containing quetiapine

Acute generalized exanthematous pustulosis, Drug reaction with eosinophilia and systemic symptoms, Stevens-Johnson syndrome and toxic epidermal necrolysis

Updated

The “Adverse Reactions” section of the quetiapine labeling was updated in February 2020 to include acute generalized exanthematous pustulosis.

Seroquel labeling

Seroquel XR labeling

Stivarga (regorafenib) tablet

Cardiac failure

Updated

The “Adverse Reactions” section of the Stivarga labeling was updated in July 2019 to include cardiac failure.

Stivarga labeling

  • Sutent (sunitinib) capsule
  • Inlyta (axitinib) tablet
  • Nexavar (sorafenib tosylate) tablet
  • Votrient (pazopanib) tablet

Aortic dissection

Updated

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

(See the January – March 2020 posting for safety information related to VEGF inhibitors and Aneurysm and Artery Dissection)

Tagrisso (osimertinib) tablet

Severe cutaneous adverse events (SCAR):  Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, and bullous pemphigoid

Updated

The “Dosage and Administration”, “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the Tagrisso labeling were updated in December 2019 to include Stevens-Johnson syndrome and erythema multiforme.

Tagrisso labeling

  • Zyprexa (olanzapine) tablet
  • Zyprexa Zydis (olanzapine) tablet
  • Zyprexa (olanzapine) injection
  • Zyprexa Relprevv (olanzapine) injection
  • Generic products containing olanzapine

Acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis

Updated

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

  • Zytiga (abiraterone acetate)
  • Yonsa (abiraterone acetate)
  • Generic products containing abiraterone

QT prolongation

Updated

The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the Zytiga and Yonsa  labeling were updated in June 2019 and September 2020, respectively, to include QT prolongation.

Zytiga labeling

Yonsa labeling

 

 
Back to Top