Biseptol Side Effects

Common Biseptol Side Effects

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

Dyspnoea (1)
Erythema (1)
Cheilitis (1)
Body Temperature Increased (1)
Urinary Tract Infection (1)
Erythema Of Eyelid (1)
Face Oedema (1)
Transplant Rejection (1)
Rash (1)
Rales (1)
Pneumonia Fungal (1)
Anal Inflammation (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.

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.

Biseptol Side Effects Reported to FDA

The following Biseptol 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.

The appearance of Biseptol 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.
Dyspnoea, Rales, Rash
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
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 and. Biseptol dosage: N/A.
Multiple prescriptions taken:
  • Mycomax
  • Vidaza

Face Oedema, Erythema, Erythema Of Eyelid, Cheilitis
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
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.

Keep Track of Side Effects

Note Your Observations

It is really important to keep of your 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


    Date & Time

    Other Medicine(s) or Treatment(s)





    Scale: 1 = very mild to 10 = very bad

    Track Online

  • User Sign In
  • Register to track your side effects

  • 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.

    Discuss Biseptol Side Effects

    Did You Have a Biseptol Side Effect?

    Yes, Severe
    Yes, Moderate
    Yes, Minor

    How Effective is Biseptol for You?

    Exceeded Expectations
    Somewhat Effective
    Not Effective

    Safety Alerts, Active Ingredients, Usage Information

    More About Biseptol

    Side Effects reported to FDA: 4

    Biseptol safety alerts: No

    Reported deaths: 1

    Reported hospitalizations: 2

    Latest Biseptol clinical trials

    Biseptol Reviews

    No reviews, be a first to report a side effect via side effect reporting form