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Stresam Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Abnormal Withdrawal Bleeding (8511180-0)
on Jun 19, 2012 Female from FRANCE , 34 years of age, was treated with Stresam (etifoxine). Directly after, patient experienced the unwanted or unexpected Stresam side effects: abnormal withdrawal bleeding. Stresam (etifoxine) dosage: 1 Df;tid;po.
Associated medications used:
  • Desogestrel And Ethinyl Estradiol (1 Df;qd;po ; 1 Df;qd;po)


Epilepsy (8210743-X)
Patient was taking Stresam. Patient felt the following Stresam side effects: epilepsy on Mar 08, 2012 from FRANCE Additional patient health information: Female , 50 years of age, . Stresam dosage: N/A.
Multiple prescriptions taken:
  • Tysabri
  • Clonazepam
  • Ixel
  • Praxinor
Patient was hospitalized.

Epilepsy (8110550-2)
Adverse event was reported on Jan 24, 2012 by a Female taking Stresam (Dosage: N/A) . Location: FRANCE , 50 years of age, After Stresam was administered, patient encountered several Stresam side effects: epilepsy.
Multiple concurrent drugs taken:
  • Clonazepam
  • Praxinor
  • Tysabri
  • Ixel
Patient was hospitalized.

Lung Disorder, Confusional State, Hallucination, Visual (7511951-3)
on May 12, 2011 Female from FRANCE , 89 years of age, was treated with Stresam. Directly after, patient experienced the unwanted or unexpected Stresam side effects: lung disorder, confusional state, hallucination, visual. Stresam dosage: N/A.
Associated medications used:
  • Rabeprazole Sodium
  • Zolpidem
  • Paroxetine Hcl
  • Mirtazapine (15 Mg; Qd; Po)
  • Motilium
  • Transipeg
  • Ramipril
  • Arixtra
Patient was hospitalized.

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

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 Information

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