Adverse reactions : תופעות לוואי

4.8.    Undesirable effects

A serious hypersensitivity reaction including oedema of the eye, face, lips and throat (angioedema) has been reported rarely.

As with other inhalation therapy, paradoxical bronchospasm may occur after dosing.
Immediate treatment with a short-acting bronchodilator should be initiated, Qvar should be discontinued immediately and an alternative prophylactic treatment introduced.

Systemic effects of inhaled corticosteroids may occur, particularly with high doses prescribed for prolonged periods. These include adrenal suppression, growth retardation in children and adolescents, decrease in bone mineral density and the occurrence of cataract and glaucoma.

Commonly, when taking Qvar, hoarseness and candidiasis of the throat and mouth may occur.
To reduce the risk of hoarseness and candida infection, patients are advised to rinse their mouth after using their inhaler.

Based on the MedDra system organ class and frequencies, adverse events are listed in the table below according to the following frequency estimate: very common ( 1/10); common (1/100 to <1/10); Uncommon (1/1,000 to <1/100); rare (1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).


MedDra – system organ class                         Frequency and Symptom Infections and infestations                         Common: Candidiasis in mouth and throat

Immune system disorders                             Rare: Allergic reactions, angioedema in eyes, throat, lips and face

Endocrine disorders                                 Very rare: Cushing's syndrome, cushingoid features, adrenal suppression*, growth retardation * (in children and
QVAR Solution for Inhalation-metered dose-IG-SPC-Notification 10-2024_CLEAN adolescents), bone density decreased*

Psychiatric Disorders                               Unknown: Psychomotor hyperactivity, sleep disorders, anxiety, depression,
aggression, behavioural changes
(predominantly in children)

Nervous system disorders                            Uncommon: Headache, vertigo, tremor 
Eye disorders                                       Uncommon: Vision, blurred (see also section 4.4)

Very rare: Cataract,* glaucoma*

Not known: Central serous retinopathy
Respiratory, thoracic and mediastinal               Common: Hoarseness, pharyngitis disorders
Uncommon: Cough, increased asthma symptoms

Rare: Paradoxical bronchospasm

Gastrointestinal disorders                          Common: Taste disturbances 
Uncommon: Nausea

Skin and subcutaneous tissue disorders              Uncommon: Urticaria, rash, pruritus, erythema, purpura

Musculoskeletal and connective tissue        Very rare: Decrease bone mineral density disorders
*Systemic reactions are a possible response to inhaled corticosteroids, especially when a high dose is prescribed for a prolonged time (see section 4.4 Special warnings and precautions for use).

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il