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
|