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. January - March 2019 | Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS)
  1. Questions and Answers on FDA's Adverse Event Reporting System (FAERS)

January - March 2019 | Potential Signals of Serious Risks/New Safety Information Identified from 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 July 17, 2019)

  • Afinitor (everolimus)
  • Afinitor Disperz (everolimus)
  • Nexavar (sorafenib toxylate)
Thrombotic microangiopathy FDA is evaluating the need for regulatory action.
  • Aimovig (erenumab-aooe) injection
  • Aljovy (fremanezumab-vfrm) injection
  • Emgality (galcanezumab-gnlm) injection
Constipation FDA is evaluating the need for regulatory action.
  • Amoxil (amoxicillin)
  • Augmentin (amoxicillin and clavulanate potassium)
  • Moxatag (amoxicillin)
  • Omeclamox-Oak (omeprazole, amoxicillin, and clarithromycin)
  • Prevpac (amoxicillin, clarithromycin, and lansoprazole)
  • Generic products containing amoxicillin; amoxicillin and clavulanate potassium; omeprazole, amoxicillin, and clarithromycin; and amoxicillin, clarithromycin, and lansoprazole
Aseptic meningitis FDA is evaluating the need for regulatory action.
  • Bavencio (avelumab)
  • Imfinzi (durvalumab)
  • Opdivo (nivolumab)
  • Tecentriq (atezolizumab)
Solid organ transplant rejection FDA is evaluating the need for regulatory action.
Rubidium Rb 82 generators
  • CardioGen 82
  • Ruby-Fill
Excess radiation exposure to the patient due to elution of the generator with an incorrect solution containing calcium The “Boxed Warning”, “Dosing and Administration,” “Contraindications,” and “Warnings and Precautions,” sections on labeling were updated to include information about using the correct solution to elute the generator and carefully following daily safety procedures for the system.  Rubidium Rb 82 generator Drug Safety Communication (4/29/19)
  • Daklinza (daclatasvir dihydrochloride) tablet
  • Epclusa (sofosbuvir and velpatisvir) tablet
  • Harvoni (ledipasvir and sofosbuvir) tablet
  • Mavyret (glecaprevir and pibrentasvir) tablet
  • Sovaldi (sofosbuvir) tablets
  • Technivie (ombitsavir, paritaprevir, and ritonavir)
  • Viekira Pak (dasabuvir, ombitasvir, paritaprevir, and ritonavir) tablet
  • Viekira XR (dasabuvir, ombitasvir, paritaprevir, and ritonavir) tablet
  • Vosevi (sofosbuvir, velpatasvir, and voxilaprevir) tablet
  • Zepatier (elbasvir and grazoprevir) tablet
Dysglycemia FDA is evaluating the need for regulatory action.
Esbriet (pirfenidone) Drug Induced Liver Injury FDA is evaluating the need for regulatory action.
Forteo (teriparatide) Cutaneous calcification, including calciphylaxis FDA is evaluating the need for regulatory action.
  • Fulphila (pegfilgrastim-jbdb)
  • Neulasta (pegfilgrastim)
Wrong dose errors in pediatric patients FDA is evaluating the need for regulatory action.
  • Gilenya (fingolimod) capsule
  • Generic products containing fingolimod
Serious hepatotoxicity FDA is evaluating the need for regulatory action.
  • Lamictal (lamotrigine)
  • Generic products containing lamotrigine
Brugada Syndrome FDA is evaluating the need for regulatory action.
  • Mavyret (glecaprevir and pibrentasvir) tablet
  • Vosevi (Sofosbuvir, Velpatasvir, and Voxilaprevir) tablet
  • Zepatier (Elbasvir and Grazoprevir) tablet
Hepatic decompensation and hepatic failure FDA is evaluating the need for regulatory action.
Non-steroidal anti-inflammatory drugs (NSAIDs) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) FDA is evaluating the need for regulatory action.
Pomalyst (pomalidomide) Thyroid disorders FDA is evaluating the need for regulatory action.
  • Signifor (pasireotide)
  • Signifor LAR (pasireotide)
Ketoacidosis FDA is evaluating the need for regulatory action.
  • Sustiva (efavirenz)
  • Symfi Lo (efavirenz, lamivudine, tenofovir disoproxil fumarate)
  • Symfi (efavirenz, lamivudine, tenofovir disoproxil fumarate)
  • Atripla (efavirenz, emtricitabine, tenofovir disoproxil fumarate)
  • Generic products containing efavirenz
Ataxia and encephalopathy FDA is evaluating the need for regulatory action.
  • Tygacil (tigecycline)
  • Generic products containing tigecycline
Hypofibrinogenemia FDA is evaluating the need for regulatory action.
  • Vidaza (azacitidine)
  • Generic products containing azacitidine
Differentiation syndrome FDA is evaluating the need for regulatory action.
Zydelig (idelalisib) Heart failure FDA decided that no action is necessary at this time based on available information.