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Epalrestat Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Septic Shock, Melaena, Coagulopathy, Disseminated Intravascular Coagulation, Shock Haemorrhagic, Necrotising Colitis, Gastrointestinal Haemorrhage (7828792-X)
on Oct 18, 2011 Male from JAPAN , weighting 163.1 lb, was diagnosed with
  • diabetic neuropathy
  • diabetes mellitus
  • hyperlipidaemia
  • atrial fibrillation
  • hyperuricaemia
  • hypertension
and was treated with Epalrestat. Directly after, 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)
Patient was hospitalized and became disabled.

Gastrointestinal Haemorrhage, Septic Shock, Necrotising Colitis (7757296-8)
Patient was taking Epalrestat. Patient felt the following Epalrestat side effects: gastrointestinal haemorrhage, septic shock, necrotising colitis on Sep 14, 2011 from JAPAN Additional patient health information: Male , weighting 162.0 lb, was diagnosed with
  • diabetic neuropathy
  • hyperlipidaemia
  • hyperuricaemia
  • hypertension
  • atrial fibrillation
and. Epalrestat dosage: 150 Mg.
Multiple prescriptions taken:
  • Lipidil (200 Mg)
  • Allopurinol (100 Mg)
  • Losartan Potassium And Hydrochlorothiazide
  • Pradaxa (300 Mg)
  • Pradaxa (300 Mg)
  • Nesina (25 Mg)
  • Miglitol (150 Mg)
  • Rozerem (80 Mg)


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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Epalrestat Information

More About Epalrestat

Side Effects reported to FDA: 2. View Epalrestat Adverse Reports

Epalrestat safety alerts: No

Reported deaths: 2

Reported hospitalizations: 1

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