Epalrestat Side Effects

Common Epalrestat Side Effects

The most commonly reported Epalrestat side effects (click to view or check a box to report):

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

If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Epalrestat Side Effects Reported to FDA

The following Epalrestat reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

The appearance of Epalrestat on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Septic Shock, Melaena, Coagulopathy, Disseminated Intravascular Coagulation, Shock Haemorrhagic, Necrotising Colitis, Gastrointestinal Haemorrhage
on Oct 18, 2011 Male from JAPAN , weighting 163.1 lb, was diagnosed with 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
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 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)

Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:


    Side Effects


    Date & Time

    Other Medicine(s) or Treatment(s)





    Scale: 1 = very mild to 10 = very bad

    Track Online

  • User Sign In
  • Register to track your side effects

  • 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.

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    Safety Alerts, Active Ingredients, Usage Information

    More About Epalrestat

    Side Effects reported to FDA: 2

    Epalrestat safety alerts: No

    Reported deaths: 2

    Reported hospitalizations: 1

    Latest Epalrestat clinical trials

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