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Spagulax Side Effects

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Common Spagulax Side Effects


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

Depression (1)
Fatigue (1)
Cytolytic Hepatitis (1)
Cholestasis (1)
Toxicity To Various Agents (1)
Headache (1)
Paraesthesia (1)
Skin Lesion (1)
Tinnitus (1)
Renal Failure Acute (1)
Pyrexia (1)
Pruritus (1)
Blood Glucose Increased (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.

Spagulax Side Effects Reported to FDA


Spagulax Side Effect Report#8255091-7
Skin Lesion, Pruritus
This is a report of a 36-year-old female patient (weight: NA) from France, suffering from the following health symptoms/conditions: NA, who was treated with Spagulax (dosage: Unk, start time:
Jun 01, 2011), combined with:
  • Keppra (2.5 G, Qd)
  • Fenofibrate (145 Mg,qd)
  • Levothyroxine Sodium (25 A?g, Qd)
  • Repaglinide ((2 Mg In Morning, 2 Mg At Noon And 2 Mg At Evening))
  • Vimpat (Unk Unk, Bid)
  • Transulose
  • Meteospasmyl /01017401/ (Unk)
  • Levemir (25 Ui At Morning)
and developed a serious reaction and side effect(s): Skin Lesion, Pruritus after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Spagulax treatment in female patients, resulting in Skin Lesion side effect. The patient was hospitalized.
Spagulax Side Effect Report#8231149-3
Cytolytic Hepatitis, Cholestasis, Renal Failure Acute
This report suggests a potential Spagulax Cytolytic Hepatitis side effect(s) that can have serious consequences. A 76-year-old female patient (weight: NA) from France was diagnosed with the following symptoms/conditions: NA and used Spagulax (dosage: Unk) starting
Nov 01, 2011. After starting Spagulax the patient began experiencing various side effects, including: Cytolytic Hepatitis, Cholestasis, Renal Failure AcuteAdditional drugs used concurrently:
  • Lyrica (150 Mg Daily)
  • Atenolol (50 Mg Daily)
  • Micardis (40 Mg Daily)
  • Pantoprazole (Unk)
  • Diosmine (Unk)
The patient was hospitalized. Although Spagulax demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cytolytic Hepatitis, may still occur.
Spagulax Side Effect Report#7978736-5
Pyrexia, Headache, Fatigue, Blood Glucose Increased, Tinnitus, Depression, Paraesthesia, Toxicity To Various Agents
This Pyrexia problem was reported by a physician from France. A male patient (weight: NA) was diagnosed with the following symptoms/conditions: constipation,renal transplant. On
Feb 21, 2011 this consumer started treatment with Spagulax (dosage: Unk). The following drugs were being taken at the same time:
  • Tacrolimus
  • Prograf
  • Mycophenolate Mofetil (Unk)
  • Tacrolimus
  • Myfortic
  • Prograf
  • Nasacort
When using Spagulax, the patient experienced the following unwanted symptoms/side effects: Pyrexia, Headache, Fatigue, Blood Glucose Increased, Tinnitus, Depression, Paraesthesia, Toxicity To Various AgentsAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pyrexia, may become evident only after a product is in use by the general population.



The appearance of Spagulax 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.

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What are common Spagulax Side Effects for Women?

Women Side EffectsReports
Cholestasis 1
Cytolytic Hepatitis 1
Pruritus 1
Renal Failure Acute 1
Skin Lesion 1

What are common Spagulax Side Effects for Men?

Men Side EffectsReports
Blood Glucose Increased 1
Depression 1
Fatigue 1
Headache 1
Paraesthesia 1
Pyrexia 1
Tinnitus 1
Toxicity To Various Agents 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.

    Spagulax 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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    Spagulax Safety Alerts, Active Ingredients, Usage Information

    More About Spagulax

    Side Effects reported to FDA: 3

    Spagulax safety alerts: No

    Reported hospitalizations: 2

    Latest Spagulax clinical trials

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