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.

Epalrestat Side Effects Reported to FDA

Epalrestat Side Effect Report#7828792-X
Septic Shock, Melaena, Coagulopathy, Disseminated Intravascular Coagulation, Shock Haemorrhagic, Necrotising Colitis, Gastrointestinal Haemorrhage
This is a report of a male patient (weight: NA) from Japan, suffering from the following health symptoms/conditions: diabetic neuropathy,diabetes mellitus,hyperlipidaemia,atrial fibrillation,hyperuricaemia,hypertension, who was treated with Epalrestat (dosage: 150 Mg, start time:
Apr 13, 2011), combined with:
  • 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)
and developed a serious reaction and side effect(s): Septic Shock, Melaena, Coagulopathy, Disseminated Intravascular Coagulation, Shock Haemorrhagic, Necrotising Colitis, Gastrointestinal Haemorrhage after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Epalrestat treatment in male patients, resulting in Septic Shock side effect. The patient was hospitalized and became disabled.
Epalrestat Side Effect Report#7757296-8
Gastrointestinal Haemorrhage, Septic Shock, Necrotising Colitis
This report suggests a potential Epalrestat Gastrointestinal Haemorrhage side effect(s) that can have serious consequences. A male patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: diabetic neuropathy,hyperlipidaemia,hyperuricaemia,hypertension,atrial fibrillation and used Epalrestat (dosage: 150 Mg) starting
Jul 14, 2001. After starting Epalrestat the patient began experiencing various side effects, including: Gastrointestinal Haemorrhage, Septic Shock, Necrotising ColitisAdditional drugs used concurrently:
  • 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)
Although Epalrestat demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Gastrointestinal Haemorrhage, may still occur.

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.

What are common Epalrestat Side Effects for Women?

Women Side Effects Reports

What are common Epalrestat Side Effects for Men?

Men Side Effects Reports
Gastrointestinal Haemorrhage 2
Necrotising Colitis 2
Septic Shock 2
Coagulopathy 1
Disseminated Intravascular Coagulation 1
Melaena 1
Shock Haemorrhagic 1

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health 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 Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    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.

    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 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.

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    More About Epalrestat

    Side Effects reported to FDA: 2

    Epalrestat safety alerts: No

    Reported deaths: 2

    Reported hospitalizations: 1

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