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 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000), very rare (<1/10000), not known (cannot be estimated from the available data). Some of the symptoms reported as undesirable effects may be associated symptoms of migraine.

Clinical Trial Data

Nervous System Disorders
Common:                  Dizziness, drowsiness, sensory disturbance including paraesthesia and hypoaesthesia.

Vascular Disorders
Common:                       Transient increases in blood pressure arising soon after treatment. Flushing.

Respiratory, Thoracic and Mediastinal Disorders
Common                    Dyspnoea.

Gastrointestinal Disorders
Common:                    Nausea and vomiting occurred in some patients but it is unclear if this is related to sumatriptan or the underlying condition.


Musculoskeletal and Connective Tissue Disorders
Common:                   Sensations of heaviness (usually transient and may be intense and can affect any part of the body including the chest and throat). Myalgia.

General Disorders and Administration Site Conditions
Very common:             Transient injection site pain. Injection site stinging/burning, swelling, erythema, bruising and bleeding have also been reported.
Common:                  Pain, sensations of heat or cold, pressure or tightness (these events are usually transient and may be intense and can affect any part of the body including the chest and throat).
Feelings of weakness, fatigue (both events are mostly mild to moderate in intensity and transient).

Although direct comparisons are not available, flushing, paraesthesia and sensations of heat, pressure, and heaviness may be more common after sumatriptan injection.

Conversely, nausea, vomiting and fatigue appear to be less frequent with subcutaneous administration of sumatriptan injection than with tablets.

Investigations
Very rare:                   Minor disturbances in liver function tests have occasionally been observed

Post-Marketing Data

Immune System Disorders
Not known:              Hypersensitivity reactions ranging from cutaneous hypersensitivity to anaphylaxis.

Nervous System Disorders
Not known:               Seizures, although some have occurred in patients with either a history of seizures or concurrent conditions predisposing to seizures there are also reports in patients where no such predisposing factors are apparent.
Tremor, dystonia, nystagmus, scotoma.

Eye Disorders
Not known:                   Flickering, diplopia, reduced vision. Loss of vision including reports of permanent defects.
However, visual disorders may also occur during a migraine attack itself.

Cardiac Disorders

Not known:                    Bradycardia, tachycardia, palpitations, cardiac arrhythmias, transient ischaemic ECG changes,
coronary artery vasospasm, angina, myocardial infarction (see sections 4.3 and 4.4).

Vascular Disorders
Not known:                    Hypotension, Raynaud’s phenomenon.

Gastrointestinal Disorders
Not known:                 Ischaemic colitis, diarrhoea, dysphagia.
Musculoskeletal, Connective Tissue and Bone Disorders
Not known:                 Neck stiffness.
Arthralgia.

General Disorders and Administration Site Conditions
Not known:               Pain trauma activated, pain inflammation activated.

Psychiatric disorders
Not known:                    Anxiety.

Skin and subcutaneous tissue disorders
Not known:                 Hyperhidrosis.
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)