April 26, 2017
Recommended Topic Related To:

Qvar

"Sublingual immunotherapy lengthened the time to first moderate or severe exacerbation during a period of corticosteroid reduction among patients with house dust miteā€“related asthma, according to a multicenter randomized study published in the Apr"...

A A A

Qvar




Side Effects
Interactions

SIDE EFFECTS

Systemic and local corticosteroid use may result in the following:

Clinical Trials Experience

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 practice.

The following reporting rates of common adverse experiences are based upon 4 clinical trials in which 1196 patients (671 female and 525 male adults previously treated with as-needed bronchodilators and/or inhaled corticosteroids) were treated with QVAR (doses of 40, 80, 160, or 320 mcg twice daily) or CFC-BDP (doses of 42, 168, or 336 mcg twice daily) or placebo. Table 3 below includes all events reported by patients taking QVAR (whether considered drug related or not) that occurred at a rate over 3% for QVAR. In considering these data, difference in average duration of exposure and clinical trial design should be taken into account.

Table 3 Adverse Events Reported by at Least 3% of the Patients for QVAR by Treatment and Daily Dose

Adverse
Events
Placebo
(N=289)
%
QVAR
Total
(N=624)
%
80-160
mcg
(N=233)
%
320
mcg
(N=335)
%
640
mcg
(N=56)
%
HEADACHE 9 12 15 8 25
PHARYNGITIS 4 8 6 5 27
UPPER RESP
TRACT
INFECTION
11 9 7 11 5
RHINITIS 9 6 8 3 7
INCREASED
ASTHMA
SYMPTOMS
18 3 2 4 0
ORAL SYMPTOMS
INHALATION
ROUTE
2 3 3 3 2
SINUSITIS 2 3 3 3 0
PAIN <1 2 1 2 5
BACK PAIN 1 1 2 <1 4
DYSPHONIA 2 <1 1 0 4

Other adverse events that occurred in these clinical trials using QVAR with an incidence of 1% to 3% and which occurred at a greater incidence than placebo were nausea, dysmenorrhea, and coughing. Oropharyngeal candidiasis occurred in <1% of patients in both QVAR and placebo treatment groups.

Pediatric Studies

In two 12-week placebo-controlled studies in steroid naive pediatric patients 5 to 12 years of age, no clinically relevant differences were found in the pattern, severity, or frequency of adverse events compared with those reported in adults, with the exception of conditions which are more prevalent in a pediatric population generally.

Postmarketing Experience

In addition to adverse reactions experienced in the clinical trials, the following adverse events have been reported during post-approval use of QVAR. Because they 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.

Local Effects: Localized infections with Candida albicans have occurred in patients treated with QVAR or other orally inhaled corticosteroids [see WARNINGS AND PRECAUTIONS].

Psychiatric and Behavioral Changes: Aggression, depression, sleep disorders, psychomotor hyperactivity, and suicidal ideation have been reported (primarily in children).

Read the Qvar (beclomethasone dipropionate hfa) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

No Information Provided

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 10/10/2016

Side Effects
Interactions

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.


Allergies & Asthma

Improve treatments & prevent attacks.