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Stresam Side Effects

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Common Stresam Side Effects


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

Epilepsy (2)
Lung Disorder (1)
Hallucination, Visual (1)
Confusional State (1)
Abnormal Withdrawal Bleeding (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.

Stresam Side Effects Reported to FDA


Stresam Side Effect Report#8511180-0
Abnormal Withdrawal Bleeding
This is a report of a 34-year-old female patient (weight: NA) from France, suffering from the following health symptoms/conditions: NA, who was treated with Stresam (etifoxine) (dosage: 1 Df;tid;po, start time:
Jan 01, 2009), combined with:
  • Desogestrel And Ethinyl Estradiol (1 Df;qd;po ; 1 Df;qd;po)
and developed a serious reaction and side effect(s): Abnormal Withdrawal Bleeding after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Stresam (etifoxine) treatment in female patients, resulting in Abnormal Withdrawal Bleeding side effect.
Stresam Side Effect Report#8210743-X
Epilepsy
This report suggests a potential Stresam Epilepsy side effect(s) that can have serious consequences. A 50-year-old female patient (weight: NA) from France was diagnosed with the following symptoms/conditions: NA and used Stresam (dosage: NA) starting
Mar 01, 2009. After starting Stresam the patient began experiencing various side effects, including: EpilepsyAdditional drugs used concurrently:
  • Tysabri
  • Clonazepam
  • Ixel
  • Praxinor
The patient was hospitalized. Although Stresam demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Epilepsy, may still occur.
Stresam Side Effect Report#8110550-2
Epilepsy
This Epilepsy problem was reported by a physician from France. A 50-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Nov 01, 2011 this consumer started treatment with Stresam (dosage: NA). The following drugs were being taken at the same time:
  • Clonazepam
  • Praxinor
  • Tysabri
  • Ixel
When using Stresam, the patient experienced the following unwanted symptoms/side effects: EpilepsyThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Epilepsy, may become evident only after a product is in use by the general population.
Stresam Side Effect Report#7511951-3
Lung Disorder, Confusional State, Hallucination, Visual
This Lung Disorder side effect was reported by a physician from France. A 89-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Stresam (drug dosage: NA), which was initiated on
Mar 18, 2011. Concurrently used drugs:
  • Rabeprazole Sodium
  • Zolpidem
  • Paroxetine Hcl
  • Mirtazapine (15 Mg; Qd; Po)
  • Motilium
  • Transipeg
  • Ramipril
  • Arixtra
.After starting to take Stresam the consumer reported adverse symptoms, such as: Lung Disorder, Confusional State, Hallucination, VisualThese side effects may potentially be related to Stresam. The patient was hospitalized.



The appearance of Stresam 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 Stresam Side Effects for Women?

Women Side EffectsReports
Epilepsy 2
Abnormal Withdrawal Bleeding 1
Confusional State 1
Hallucination, Visual 1
Lung Disorder 1

What are common Stresam Side Effects for Men?

Men Side EffectsReports

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.

    Stresam 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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    Stresam Safety Alerts, Active Ingredients, Usage Information

    More About Stresam

    Side Effects reported to FDA: 4

    Stresam safety alerts: No

    Reported hospitalizations: 3

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