Adverse reactions : תופעות לוואי

4.8.   Undesirable Effects

Adverse events are listed below by system organ class and frequency.
Frequencies are defined as: very common (1/10), common (1/100 and 1/10), uncommon (1/1000 and 1/100), rare (1/10,000 and 1/1000) and very rare (1/10,000). Very common and common events were generally determined from clinical trial data. Rare, very rare and unknown events were generally determined from spontaneous data.

Immune system disorders
Very rare:    Hypersensitivity reactions including angioedema, urticaria, bronchospasm, hypotension and collapse.

Metabolism and nutrition disorders

Rare:         Hypokalaemia.
Potentially serious hypokalaemia may result from beta-agonist therapy.

Unknown:      Lactic acidosis (see section 4.4)

Nervous system disorders

Very common:          Tremor.

Common:               Headache.
Very rare:            Hyperactivity.

Cardiac disorders

Very common:          Tachycardia.
Common:               Palpitations.

Rare:                 Cardiac arrhythmias including atrial fibrillation, supraventricular tachycardia and extrasystoles.

Unknown:              Myocardial ischaemia* ( see section 4.4) 

Vascular disorders
Rare:                 Peripheral vasodilatation.

Gastrointestinal disorders

Unknown:              Nausea, vomiting *.
Musculoskeletal and connective tissue disorders

Common:               Muscle cramps.

Injury, poisoning and procedural complications
Unknown:              Slight pain or stinging on intramuscular use of undiluted injection*.

* reported spontaneously in post-marketing data therefore frequency regarded as unknown.

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
Additionally, you should also report to GSK Israel (il.safety@gsk.com).