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Sibelium Side Effects

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Common Sibelium Side Effects


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

Speech Disorder (2)
Somnolence (2)
Muscular Weakness (2)
Blood Glucose Decreased (2)
Blood Pressure Decreased (2)
Back Pain (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.

Sibelium Side Effects Reported to FDA


Sibelium Side Effect Report#8332617-6
Back Pain
This is a report of a male patient (weight: NA) from China, suffering from the following health symptoms/conditions: NA, who was treated with Sibelium (dosage: NA, start time:
Jun 12, 2011), combined with: NA. and developed a serious reaction and side effect(s): Back Pain after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Sibelium treatment in male patients, resulting in Back Pain side effect.
Sibelium Side Effect Report#6221500-8
Blood Glucose Decreased, Blood Pressure Decreased, Muscular Weakness, Somnolence, Speech Disorder
This report suggests a potential Sibelium Blood Glucose Decreased side effect(s) that can have serious consequences. A 53-year-old female patient (weight: NA) from Brazil was diagnosed with the following symptoms/conditions: labyrinthitis and used Sibelium (dosage: NA) starting NS. After starting Sibelium the patient began experiencing various side effects, including: Blood Glucose Decreased, Blood Pressure Decreased, Muscular Weakness, Somnolence, Speech DisorderAdditional drugs used concurrently:
  • Stugeron
Although Sibelium demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Blood Glucose Decreased, may still occur.
Sibelium Side Effect Report#6047682-9
Blood Glucose Decreased, Blood Pressure Decreased, Muscular Weakness, Somnolence, Speech Disorder
This Blood Glucose Decreased problem was reported by a consumer or non-health professional from Brazil. A 53-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: labyrinthitis. On NS this consumer started treatment with Sibelium (dosage: NA). The following drugs were being taken at the same time:
  • Stugeron
  • Tylenol
  • Tylenol
When using Sibelium, the patient experienced the following unwanted symptoms/side effects: Blood Glucose Decreased, Blood Pressure Decreased, Muscular Weakness, Somnolence, Speech DisorderAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Blood Glucose Decreased, may become evident only after a product is in use by the general population.



The appearance of Sibelium 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 Sibelium Side Effects for Women?

Women Side EffectsReports
Blood Glucose Decreased 2
Blood Pressure Decreased 2
Muscular Weakness 2
Somnolence 2
Speech Disorder 2

What are common Sibelium Side Effects for Men?

Men Side EffectsReports
Back Pain 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.

    Sibelium 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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