Adverse reactions : תופעות לוואי

4.8 Undesirable effects

These side effects are generally mild, of short duration (usually less than 1 minute) and well tolerated by the patient. However severe reactions can occur.

Methylxanthines, such as IV aminophylline or theophylline have been used to terminate persistent side effects (50 – 125 mg by slow intravenous injection).

Adverse events are ranked under the heading of the frequency: Very common (> 1/10), common (> 1/100, < 1/10), uncommon (> 1/1000, < 1/100), rare (> 1/10000, < 1/1000), very rare (< 1/10000), not known (cannot be estimated from available data).

Immune system disorders:
Not known: anaphylactic reaction (including angioedema and skin reactions such as urticaria and rash) 
Cardiac disorders:
Very common: bradycardia, sinus pause, skipped beats, atrial extrasystoles, Atrio-Ventricular block, ventricular excitability disorders such as ventricular extrasystoles, non-sustained ventricular tachycardia Uncommon: sinus tachycardia, palpitations
Very rare: atrial fibrillation, severe bradycardia not corrected by atropine and possibly requiring temporary pacing, ventricular excitability disorders, including ventricular fibrillation and torsade de pointes (see section 4.4)
Not known: asystole/cardiac arrest, sometimes fatal especially in patients with underlying ischemic heart disease /cardiac disorder (see section 4.4)
Vascular disorders:
Very common: flushing
Not known: hypotension (sometimes severe) (see section 4.4)

Nervous system disorders:
Common: headache, dizziness, light-headedness, paraesthesia
Uncommon: head pressure
Very rare: transient and spontaneously rapidly reversible worsening of intracranial hypertension Not known: loss of consciousness/syncope, convulsions, especially in predisposed patients (see section 4.4)

Eye disorders:
Uncommon: blurred vision

Respiratory, thoracic and mediastinal disorders:
Very common: dyspnea (or the urge to take a deep breath)
Uncommon: hyperventilation
Very rare: bronchospasm (see section 4.4)
Not known: respiratory failure (see section 4.4), apnea/respiratory arrest Cases of respiratory failure, bronchospasm, apnea, and respiratory arrest with fatal outcome have been reported.

Gastrointestinal disorders:
Common: nausea
Uncommon: metallic taste
Not known: vomiting

Psychiatric disorders:
Common: nervousness
General disorders and administration site conditions:
Very common: chest pain or pressure, feeling of thoracic constriction/oppression Uncommon: sweating, discomfort in the leg, arm or back, feeling of general discomfort, weakness/pain Very rare: injection site reactions


Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization 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/