Epalrestat Safety Information and Side Effects

Epalrestat Safety Information

  • FDA Side Effects: 2
  • Deaths: 2
  • Life-threatening: 1
  • Disabled: 1
  • Hospitalized: 1
  • Safety Alerts:N/A

Gastrointestinal Haemorrhage ( 2 reports)    ➢ More

Septic Shock, Melaena, Coagulopathy, Disseminated Intravascular Coagulation, Shock Haemorrhagic, Necrotising Colitis, Gastrointestinal Haemorrhage

This case suggests a potential Epalrestat Gastrointestinal Haemorrhage side effect(s) that can have serious consequences. A patient from JAPAN (weight:NA) was diagnosed with the following health condition(s): diabetic neuropathy,diabetes mellitus,hyperlipidaemia,atrial fibrillation,hyperuricaemia,hypertension and used Epalrestat (dosage: 150 Mg) starting Apr 13, 2011. Soon after starting Epalrestat the patient began experiencing various side effects, including:
  • Septic Shock
  • Melaena
  • Coagulopathy
  • Disseminated Intravascular Coagulation
  • Shock Haemorrhagic
  • Necrotising Colitis
  • Gastrointestinal Haemorrhage
Drugs used concurrently:
  • Nesina (25 Mg)
  • Lipidil (200 Mg)
  • Pradaxa (300 Mg)
  • Allopurinol (100 Mg)
  • Losartan Potassium And Hydrochlorothiazide
  • Pradaxa (300 Mg)
  • Miglitol (150 Mg)
  • Rozerem (8 Mg)
  • The patient was hospitalized and became disabled. Although Epalrestat demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Gastrointestinal Haemorrhage, may still occur.

    Necrotising Colitis ( 2 reports)    ➢ More

    Septic Shock, Melaena, Coagulopathy, Disseminated Intravascular Coagulation, Shock Haemorrhagic, Necrotising Colitis, Gastrointestinal Haemorrhage

    Adverse event was reported on Oct 18, 2011 by a male taking Epalrestat (Dosage: 150 Mg) was diagnosed with and. Location: JAPAN , weighting 163.1 lb, Directly after treatment started, patient experienced the unwanted or unexpected Epalrestat side effects: septic shock, melaena, coagulopathy, disseminated intravascular coagulation, shock haemorrhagic, necrotising colitis, gastrointestinal haemorrhage.
    Associated medications used:
    • Nesina (25 Mg)
    • Lipidil (200 Mg)
    • Pradaxa (300 Mg)
    • Allopurinol (100 Mg)
    • Losartan Potassium And Hydrochlorothiazide
    • Pradaxa (300 Mg)
    • Miglitol (150 Mg)
    • Rozerem (8 Mg)
    The patient was hospitalized and became disabled.

    Septic Shock ( 2 reports)    ➢ More

    Septic Shock, Melaena, Coagulopathy, Disseminated Intravascular Coagulation, Shock Haemorrhagic, Necrotising Colitis, Gastrointestinal Haemorrhage

    This Septic Shock problem was reported by a physician from JAPAN. A patient (weight: NA) was diagnosed with the following medical condition(s): diabetic neuropathy,diabetes mellitus,hyperlipidaemia,atrial fibrillation,hyperuricaemia,hypertension.On Apr 13, 2011 a consumer started treatment with Epalrestat (dosage: 150 Mg). The following health products were being taken at the same time:
  • Nesina (25 Mg)
  • Lipidil (200 Mg)
  • Pradaxa (300 Mg)
  • Allopurinol (100 Mg)
  • Losartan Potassium And Hydrochlorothiazide
  • Pradaxa (300 Mg)
  • Miglitol (150 Mg)
  • Rozerem (8 Mg)
  • When commencing Epalrestat, the patient experienced the following unwanted symptoms /side effects:
    • Septic Shock
    • Melaena
    • Coagulopathy
    • Disseminated Intravascular Coagulation
    • Shock Haemorrhagic
    • Necrotising Colitis
    • Gastrointestinal Haemorrhage
    The patient was hospitalized and became disabled. Although all health products are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as Septic Shock, may become evident only after a product is in use by the general population.

    Coagulopathy ( 1 reports)    ➢ More

    Septic Shock, Melaena, Coagulopathy, Disseminated Intravascular Coagulation, Shock Haemorrhagic, Necrotising Colitis, Gastrointestinal Haemorrhage

    A case of a patient (weight: NA) from JAPAN was presented. The patient developed the following symptoms/conditions: diabetic neuropathy,diabetes mellitus,hyperlipidaemia,atrial fibrillation,hyperuricaemia,hypertension and was treated with Epalrestat (dosage: 150 Mg) starting Apr 13, 2011. Concurrently used drugs:
  • Nesina (25 Mg)
  • Lipidil (200 Mg)
  • Pradaxa (300 Mg)
  • Allopurinol (100 Mg)
  • Losartan Potassium And Hydrochlorothiazide
  • Pradaxa (300 Mg)
  • Miglitol (150 Mg)
  • Rozerem (8 Mg)
  • Soon after that, the subject experienced the following of symptoms:
    • Septic Shock
    • Melaena
    • Coagulopathy
    • Disseminated Intravascular Coagulation
    • Shock Haemorrhagic
    • Necrotising Colitis
    • Gastrointestinal Haemorrhage
    The patient was hospitalized and became disabled. This opens a possibility that Epalrestat could cause Coagulopathy and that some subjects may be more susceptible.

    Disseminated Intravascular Coagulation ( 1 reports)    ➢ More

    Septic Shock, Melaena, Coagulopathy, Disseminated Intravascular Coagulation, Shock Haemorrhagic, Necrotising Colitis, Gastrointestinal Haemorrhage

    on Oct 18, 2011 a male from JAPAN , weighting 163.1 lb, was diagnosed with and was treated with Epalrestat. Directly after treatment started, patient experienced the unwanted or unexpected Epalrestat side effects: septic shock, melaena, coagulopathy, disseminated intravascular coagulation, shock haemorrhagic, necrotising colitis, gastrointestinal haemorrhage. Epalrestat dosage: 150 Mg.
    Associated medications used:
    • Nesina (25 Mg)
    • Lipidil (200 Mg)
    • Pradaxa (300 Mg)
    • Allopurinol (100 Mg)
    • Losartan Potassium And Hydrochlorothiazide
    • Pradaxa (300 Mg)
    • Miglitol (150 Mg)
    • Rozerem (8 Mg)
    The patient was hospitalized and became disabled.

    Common Epalrestat Side Effects

    Click to view detailed reports:

    Gastrointestinal Haemorrhage (3)
    Septic Shock (2)
    Coagulopathy (2)
    Necrotising Colitis (2)
    Shock Haemorrhagic (1)
    Disseminated Intravascular Coagulation (1)
    Melaena (1)

    ➢ More



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