Isoket IV Adverse Reactions

Adverse drug reactions (ADRs) are listed as follows by MedDRA system organ class and by 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).
Nervous system disorders: Very common: headache. Common: dizziness, somnolence.
Cardiac disorders: Common: tachycardia. Uncommon: angina pectoris aggravated.
Vascular disorders: Common: orthostatic hypotension. Uncommon: circulatory collapse (sometimes accompanied by bradyarrhythmia and syncope). Not known: hypotension.
Severe hypotensive responses have been reported for organic nitrates including nausea, vomiting, restlessness, pallor, and excessive perspiration.
Respiratory, thoracic and mediastinal disorders: Not known: hypoxaemia (see Precautions).
During treatment with isosorbide dinitrate, temporary hypoxemia may occur due to a relative redistribution of the blood flow in hypoventilated alveolar areas. Particularly in patients with coronary artery disease, this may lead to myocardial hypoxia.
Gastrointestinal disorders: Uncommon: nausea, vomiting. Very rare: heartburn.
Skin and subcutaneous tissue disorders: Uncommon: allergic skin reactions (e.g. rash), flushing. Very rare: angioedema, Stevens-Johnson Syndrome. Not known: exfoliative dermatitis.
General disorders and administration site conditions: Common: asthenia.