DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Xolegel (Ketoconazole Topical) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Clinical Trial Experiences

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

In the 3 safety and efficacy trials, 65 of 933 subjects (7%) experienced at least one treatment-related adverse event. The most common treatment-related adverse reaction was application site burning (4%). Treatment-related application site reactions that were reported in < 1% of subjects were: dermatitis, discharge, dryness, erythema, irritation, pain, pruritus, and pustules. Other treatment-related adverse reactions that were reported in < 1% of subjects were: eye irritation, eye swelling, keratoconjunctivitis sicca, impetigo, pyogenic granuloma, dizziness, headache, paresthesia, acne, nail discoloration, facial swelling.

Post-marketing Experience

Adverse events identified during post approval use with XOLEGEL include burning sensation, pain, skin irritation, and erythema. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.



REPORTS OF SUSPECTED XOLEGEL SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Xolegel. The information is not vetted and should not be considered as verified clinical evidence.

Possible Xolegel side effects / adverse reactions in 55 year old female

Reported by a physician from United States on 2012-03-29

Patient: 55 year old female

Reactions: Application Site Warmth, Drug Ineffective, Basal Cell Carcinoma, Application Site Swelling, Application Site Burn, Application Site Erythema

Suspect drug(s):
Locoid Lipocream
    Dosage: bid, topically
    Administration route: Topical
    Indication: Blepharitis
    Start date: 2011-01-27
    End date: 2011-01-01

Locoid Lipocream
    Dosage: apply every other week, alternating with promiseb, topically
    Administration route: Topical
    Indication: Dermatitis
    Start date: 2011-06-01
    End date: 2011-07-12

Locoid Lipocream
    Dosage: topically
    Administration route: Topical
    Indication: Blepharitis
    Start date: 2011-06-13
    End date: 2011-01-01

Locoid Lipocream
    Dosage: apply every other week, alternating with locoid lipocream, topically
    Administration route: Topical
    Indication: Dermatitis
    Start date: 2011-01-01
    End date: 2011-07-01

Xolegel
    Dosage: topically
    Indication: Blepharitis
    Start date: 2011-07-14

Other drugs received by patient: Topamax



See index of all Xolegel side effect reports >>

Drug label data at the top of this Page last updated: 2011-06-22

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017