" Allergy medications overview
The arsenal of allergy drugs includes dozens of medications that relieve allergy symptoms when confronted with a trigger known as an allergen. That trigger could be something from a plant, such as polle"...
Clinical Trial Experience
In 2 multicenter vehicle-controlled clinical trials of once-daily application of CUTIVATE® Lotion by 196 adult and 242 pediatric patients, the total incidence of adverse reactions considered drug related by investigators was approximately 4%. Events were local cutaneous events, usually mild and self-limiting, and consisted primarily of burning/stinging (2%). All other drug-related events occurred with an incidence of less than 1%, and inclusively were contact dermatitis, exacerbation of atopic dermatitis, folliculitis of legs, pruritus, pustules on arm, rash, and skin infection.
The incidence of drug-related events on drug compared to vehicle (4% and 5%, respectively) was similar. The incidence of drug-related events between study populations of 242 pediatric patients (age 3 months to < 17 years) and 196 adult patients (17 years or older) (4% and 5%, respectively) was also similar.
In an open-label study of 44 pediatric patients applying CUTIVATE® Lotion to at least 35% of body surface area twice daily for 3 or 4 weeks, the overall incidence of drug-related adverse events was 14%. Events were local, cutaneous, and inclusively were dry skin (7%), stinging at application site (5%), and excoriation (2%).
Table 2: Drug Related Adverse Events from Controlled Clinical
|Adverse Events||CUTIVATE® Lotion
|Burning/Stinging skin||4 (2%)||3 (1%)|
|Contact Dermatitis||0||1 ( < 1%)|
|Exacerbation of Atopic dermatitis||0||1 ( < 1%)|
|Folliculitis of legs||2 ( < 1%)||0|
|Irritant Contact Dermatitis||0||1 ( < 1%)|
|Pruritus||1 ( < 1%)||1 ( < 1%)|
|Pustules on Arms||1 ( < 1%)||0|
|Rash||1 ( < 1%)||2 ( < 1%)|
|Skin Infection||0||3 (1%)|
Table 3: Drug Related Adverse Events From Pediatric Open
Label Trial (n=44)
|Adverse Events||CUTIVATE® Lotion Twice Daily|
|Dry skin at multiple sites||3 (7%)|
|Stinging at Application Sites||2 (5%)|
The table below summarizes all adverse events by body system that occurred in at least 1% of patients in either the drug or vehicle group in controlled clinical trials.
Table 4: Adverse Events Occurring in ≥ 1% of Patients
from Either Arm from Controlled Clinical Trials (n=438)
N = 221
N = 217
|Any Adverse Event||77 (35%)||82 (38%)|
|Burning and Stinging||4 (2%)||3 (1%)|
|Pruritus||3 (1%)||5 (2%)|
|Rash||2 (<1%)||3 (1%)|
|Skin Infection||0||3 (1%)|
|Ear, Nose, Throat|
|Common Cold||9 (4%)||5 (2%)|
|Ear Infection||3 (1%)||3 (1%)|
|Nasal Sinus Infection||2 (<1%)||4 (2%)|
|Rhinitis||1 (<1%)||3 (1%)|
|Upper Respiratory Tract Infection||6 (3%)||7 (3%)|
|Normal Tooth Eruption||2 (< 1%)||3 (1%)|
|Vomiting||3 (1%)||2 (<1%)|
|Cough||7 (3%)||6 (3%)|
|Headache||4 (2%)||5 (2%)|
|Fever||8 (4%)||8 (4%)|
|Seasonal Allergy||2 ( < 1%)||3 (1%)|
During the clinical trials, eczema herpeticum occurred in a 33-year-old male patient treated with CUTIVATE® Lotion. Additionally, a 4-month-old patient treated with CUTIVATE® Lotion in the open-label trial had marked elevations of the hepatic enzymes AST and ALT.
Post Marketing Experience
Systemic adverse events with CUTIVATE® Cream and CUTIVATE® Ointment have included: immunosuppression/Pneumocystis carinii pneumonia/leukopenia/thrombocytopenia; hyperglycemia/ glycosuria; Cushing syndrome; generalized body edema/blurred vision; and acute urticarial reaction (edema, urticaria, pruritus, and throat swelling).
The following localized adverse reactions have been reported during post approval use of CUTIVATE® Lotion: erythema, edema/swelling, bleeding, and a reported lack of efficacy.
Because these reactions 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.
Read the Cutivate Lotion (fluticasone propionate lotion) Side Effects Center for a complete guide to possible side effects »
No information provided.
Last reviewed on RxList: 6/16/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Cutivate Lotion Information
Report Problems to the Food and Drug Administration
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.
Find out what women really need.