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

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Dyspnoea, Rales, Rash (8015792-2)
on Oct 20, 2011 Male from POLAND , 30 years of age, was treated with Biseptol. Directly after, patient experienced the unwanted or unexpected Biseptol side effects: dyspnoea, rales, rash. Biseptol dosage: N/A.
Associated medications used:
  • Ganciclovir
  • Voriconazole
Patient was hospitalized.

Anal Inflammation, Body Temperature Increased, Pneumonia Fungal (7825573-8)
Patient was taking Biseptol. Patient felt the following Biseptol side effects: anal inflammation, body temperature increased, pneumonia fungal on Oct 11, 2011 from SLOVAKIA (Slovak Republic) Additional patient health information: Female , 65 years of age, was diagnosed with
  • prophylaxis
and. Biseptol dosage: N/A.
Multiple prescriptions taken:
  • Mycomax
  • Vidaza


Face Oedema, Erythema, Erythema Of Eyelid, Cheilitis (7750207-0)
Adverse event was reported on Sep 14, 2011 by a Female taking Biseptol (Dosage: N/A) . Location: POLAND , child 12 years of age, weighting 119.0 lb, After Biseptol was administered, patient encountered several Biseptol side effects: face oedema, erythema, erythema of eyelid, cheilitis.
Multiple concurrent drugs taken:
  • Midazolam
  • Atropine
  • Ketamine Hcl (150 Mg, Unk)


Transplant Rejection, Urinary Tract Infection (7726027-X)
on Aug 23, 2011 Male from UNITED STATES , 59 years of age, weighting 180.8 lb, was treated with Biseptol. Directly after, patient experienced the unwanted or unexpected Biseptol side effects: transplant rejection, urinary tract infection. Biseptol dosage: N/A.
Associated medications used:
  • Cellcept
  • Cyclosporine (75 Mg In The Morning And 50 Mg In The Evening)
  • Bisoprolol Fumarate
  • Doxazosin Mesylate
  • Cyclosporine (100 Mg In Morning And 75 Mg In Evening)
  • Cyclosporine (125 Mg In The Morning And 100 Mg In The Evening.)
  • Prednisone
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.

Biseptol Information

More About Biseptol

Side Effects reported to FDA: 4. View Biseptol Adverse Reports

Biseptol safety alerts: No

Reported deaths: 1

Reported hospitalizations: 2

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