Imigran FDT Adverse Reactions

Adverse events are listed as follows by system organ class and frequency. Frequencies are defined as: Very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10,000, <1/1000) and very rare (<1/10,000) including isolated reports. The data from clinical trials are estimates. It should be noted that the background rate in comparator groups was not taken into account. Post-marketing data refer to reporting rate rather than true frequency.
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 the relationship to sumatriptan is not clear.
Musculoskeletal and Connective Tissue Disorders: The following symptom is usually transient and may be intense and can affect any part of the body including the chest and throat: Common: Sensations of heaviness.
General Disorders and Administration Site Conditions: The following symptoms are usually transient and may be intense and can affect any part of the body including the chest and throat: Common: Pain, sensations of heat or cold, pressure or tightness.
The following symptoms are mostly mild to moderate in intensity and transient: Common: Feelings of weakness, fatigue.
Investigations: Very Rare: Minor disturbances in liver function tests have occasionally been observed.
Post-Marketing Data: Immune System Disorders: Very Rare: Hypersensitivity reactions ranging from cutaneous hypersensitivity to anaphylaxis.
Nervous System Disorders: Very Rare: 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: Very Rare: Flickering, diplopia, reduced vision. Loss of vision (usually transient). However, visual disorders may also occur during a migraine attack itself.
Cardiac Disorders: Very Rare: Bradycardia, tachycardia, palpitations, cardiac arrhythmias, transient ischaemic ECG changes, coronary artery vasospasm, angina, myocardial infarction (see Contraindications and Precautions).
Vascular Disorders: Very Rare: Hypotension, Raynaud's phenomenon.
Gastrointestinal Disorders: Very Rare: Ischaemic colitis.