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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
This is a report of a 30-year-old male patient (weight: NA) from POLAND, suffering from the following symptoms/conditions: NA, who was treated with Biseptol (dosage: NA, start time: NS), combined with:
  • Ganciclovir
  • Voriconazole
and developed a serious reaction and side effect(s). The consumer presented with:
  • Dyspnoea
  • Rales
  • Rash
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Biseptol treatment in male patients, resulting in dyspnoea side effect. The patient was hospitalized.

Anal Inflammation, Body Temperature Increased, Pneumonia Fungal
This report suggests a potential Biseptol Anal Inflammation, Body Temperature Increased, Pneumonia Fungal side effect(s) that can have serious consequences. A 65-year-old female patient (weight: NA) from SLOVAKIA (Slovak Republic) was diagnosed with the following symptoms/conditions: prophylaxis and used Biseptol (dosage: NA) starting Jul 12, 2010. Soon after starting Biseptol the patient began experiencing various side effects, including:
  • Anal Inflammation
  • Body Temperature Increased
  • Pneumonia Fungal
Drugs used concurrently:
  • Mycomax
  • Vidaza
Although Biseptol demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as anal inflammation, may still occur.

Face Oedema, Erythema, Erythema Of Eyelid, Cheilitis
This Face Oedema, Erythema, Erythema Of Eyelid, Cheilitis problem was reported by a health professional from POLAND. A 12-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On Aug 17, 2011 this consumer started treatment with Biseptol (dosage: NA). The following drugs were being taken at the same time:
  • Midazolam
  • Atropine
  • Ketamine Hcl (150 Mg, Unk)
When commencing Biseptol, the patient experienced the following unwanted symptoms/side effects:
  • Face Oedema
  • Erythema
  • Erythema Of Eyelid
  • Cheilitis
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as face oedema, may become evident only after a product is in use by the general population.

Transplant Rejection, Urinary Tract Infection
This is a report of a 59-year-old male patient (weight: NA) from UNITED STATES. The patient developed the following symptoms/conditions: NA and was treated with Biseptol (dosage: NA) starting Oct 07, 2009. Concurrently used drugs:
  • 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
Soon after that, the consumer experienced the following side effects:
  • Transplant Rejection
  • Urinary Tract Infection
The patient was hospitalized. This opens a possibility that Biseptol treatment could cause the above reactions, including transplant rejection, and some male subjects may be more susceptible.



Top 10 Biseptol Side Effects for Women

Women Side EffectsReports
Anal Inflammation 1
Body Temperature Increased 1
Cheilitis 1
Erythema 1
Erythema Of Eyelid 1
Face Oedema 1
Pneumonia Fungal 1

Top 10 Biseptol Side Effects for Men

Men Side EffectsReports
Dyspnoea 1
Rales 1
Rash 1
Transplant Rejection 1
Urinary Tract Infection 1

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 Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    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

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    Biseptol 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

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