March 29, 2017
Recommended Topic Related To:

Qvar

"The European Medicines Agency (EMA) has approved mepolizumab (Nucala, GlaxoSmithKline) as an add-on treatment for severe refractory eosinophilic asthma in adults in the 31 European countries covered by the EMA, according to a company state"...

A A A

Qvar




Qvar Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 10/5/2016

Qvar (beclomethasone dipropionate) is a steroid used to prevent asthma attacks. Qvar will not treat an asthma attack that has already begun. Qvar is available in generic form. Common side effects of Qvar include:

  • stomach upset,
  • nausea,
  • vomiting,
  • headache,
  • sore throat,
  • stuffy nose,
  • sinus pain,
  • cough,
  • dryness in your mouth/nose/throat after use,
  • unpleasant taste in the mouth,
  • hoarseness, or
  • deepened voice.

The recommended dose of Qvar is 40 to 320 mcg twice daily for adults and 40 to 80 mg twice daily for children. If you are also using a bronchodilator, use it first before using the beclomethasone inhaler. There may be other drugs that can interact with Qvar. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Qvar should be used only when prescribed during pregnancy. There are rare reports of harm to a fetus when the mother took other corticosteroids. Infants born to mothers who have been using high doses of beclomethasone for an extended time may have hormone problems. Tell your doctor if you notice symptoms such as persistent nausea/vomiting, severe diarrhea, or weakness in your newborn. It is not known if this medication passes into breast milk. Consult your doctor before breastfeeding.

Our Qvar (beclomethasone dipropionate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Qvar in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • weakness, tired feeling, nausea, loss of appetite, weight loss;
  • white patches or sores inside your mouth or on your lips;
  • wheezing, choking, or other breathing problems after using this medication;
  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness;
  • changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist);
  • blurred vision, eye pain, or seeing halos around lights; or
  • worsening asthma symptoms.

Common side effects may include:

  • headache;
  • dryness in your mouth, nose, or throat after use;
  • stuffy nose, sinus pain, sore throat, cough; or
  • hoarseness or deepened voice.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Qvar (Beclomethasone Dipropionate HFA)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Qvar FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 entire FDA prescribing information for Qvar (Beclomethasone Dipropionate HFA)

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.