Common Gelclair Side Effects


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

Fatigue (2)
Dysuria (2)
Infection (2)
Oral Candidiasis (2)
Rectal Haemorrhage (2)
Performance Status Decreased (2)
Stomatitis (2)


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.

Gelclair Side Effects Reported to FDA


Gelclair Side Effect Report#7394933-4
Fatigue, Rectal Haemorrhage, Oral Candidiasis, Stomatitis, Performance Status Decreased, Infection, Dysuria
This is a report of a male patient (weight: NA) from United Kingdom, suffering from the following health symptoms/conditions: stomatitis,nausea,renal cell carcinoma, who was treated with Gelclair (dosage: 1u Three Times Per Day, start time:
Oct 22, 2010), combined with:
  • Cyclizine (50mg Three Times Per Day)
  • Pazopanib (800mg Per Day)
and developed a serious reaction and side effect(s): Fatigue, Rectal Haemorrhage, Oral Candidiasis, Stomatitis, Performance Status Decreased, Infection, Dysuria after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Gelclair treatment in male patients, resulting in Fatigue side effect. The patient was hospitalized.
Gelclair Side Effect Report#7293716-3
Stomatitis, Oral Candidiasis, Fatigue, Performance Status Decreased, Infection, Rectal Haemorrhage, Dysuria
This report suggests a potential Gelclair Stomatitis side effect(s) that can have serious consequences. A male patient (weight: NA) from United Kingdom was diagnosed with the following symptoms/conditions: stomatitis,renal cell carcinoma,nausea and used Gelclair (dosage: NA) starting
Jan 25, 2011. After starting Gelclair the patient began experiencing various side effects, including: Stomatitis, Oral Candidiasis, Fatigue, Performance Status Decreased, Infection, Rectal Haemorrhage, DysuriaAdditional drugs used concurrently:
  • Pazopanib (800mg Per Day)
  • Cyclizine (50mg Three Times Per Day)
The patient was hospitalized. Although Gelclair demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Stomatitis, may still occur.



The appearance of Gelclair 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.

What are common Gelclair Side Effects for Women?

Women Side Effects Reports

What are common Gelclair Side Effects for Men?

Men Side Effects Reports
Dysuria 2
Fatigue 2
Infection 2
Oral Candidiasis 2
Performance Status Decreased 2
Rectal Haemorrhage 2
Stomatitis 2

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.

    Gelclair 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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    Gelclair Safety Alerts, Active Ingredients, Usage Information

    More About Gelclair

    Side Effects reported to FDA: 2

    Gelclair safety alerts: No

    Reported hospitalizations: 2

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