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Fluticasone (Fluticasone Propionate Topical) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Clinical Trial Experience: In 2 multicenter vehicle-controlled clinical trials of once-daily application of Fluticasone Propionate 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 Fluticasone Propionate 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 Trials (n=438)
Adverse Events      Fluticasone Propionate Lotion Vehicle
     N=221 N=217
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 Fluticasone Propionate Lotion Twice Daily
Dry skin at multiple sites 3 (7%)
Stinging at Application Sites 2 (5%)
Excoriation 1 (2%)

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)
Body System      Fluticasone Propionate Lotion      Vehicle Lotion
     N = 221      N = 217
Any Adverse Event      77 (35%)      82 (38%)
Skin
     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%)
Gastrointestinal
     Normal Tooth Eruption      2 (< 1%)      3 (1%)
     Diarrhea      3 (1%)      0
     Vomiting      3 (1%)      2 (<1%)
Lower Respiratory
     Cough      7 (3%)      6 (3%)
     Influenza      5 (2%)      0
     Wheeze      0      3 (1%)
Neurology
     Headache      4 (2%)      5 (2%)
Non-Site Specific
     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 Fluticasone Propionate Lotion. Additionally, a 4-month-old patient treated with Fluticasone Propionate Lotion in the open-label trial had marked elevations of the hepatic enzymes AST and ALT.

Post Marketing Experience: Systemic adverse events with Fluticasone Propionate Cream and Fluticasone Propionate 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 Fluticasone Propionate 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.



REPORTS OF SUSPECTED FLUTICASONE SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Fluticasone side effects / adverse reactions in 62 year old female

Reported by a physician from United States on 2012-01-11

Patient: 62 year old female

Reactions: Toxicity TO Various Agents

Adverse event resulted in: death

Suspect drug(s):
Pepcid
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Docusate Sodium
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Mevacor
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Albuterol
    Indication: Product Used FOR Unknown Indication

Gabapentin
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Citalopram
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Metolazone
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Furosemide
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Amlodipine
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Clonidine
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Omeprazole
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Insulin
    Indication: Product Used FOR Unknown Indication

Fluticasone
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Iron (Unspecified)
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Metformin HCL
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Metoprolol
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication



Possible Fluticasone side effects / adverse reactions in 62 year old female

Reported by a physician from United States on 2012-01-23

Patient: 62 year old female

Reactions: Toxicity TO Various Agents

Adverse event resulted in: death

Suspect drug(s):
Mevacor
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Furosemide
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Gabapentin
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Pepcid
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Fluticasone
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Metolazone
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Clonidine
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Metformin HCL
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Amlodipine
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Albuterol
    Indication: Product Used FOR Unknown Indication

Docusate Sodium
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Iron (Unspecified)
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Citalopram
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Omeprazole
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Metoprolol
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Insulin
    Indication: Product Used FOR Unknown Indication



Possible Fluticasone side effects / adverse reactions in 36 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-06-20

Patient: 36 year old female

Reactions: Drug Interaction, Cushing's Syndrome

Suspect drug(s):
Verapamil HCL
    Dosage: unk
    Indication: Hypertension

Fluticasone
    Dosage: 1500 ug, qd



See index of all Fluticasone side effect reports >>

Drug label data at the top of this Page last updated: 2013-03-07

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