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Adverse reaction information concerning intravenous dipyridamole is derived from a study of 3911 patients in which intravenous dipyridamole was used as an adjunct to thallium myocardial perfusion imaging and from spontaneous reports of adverse reactions and the published literature.

Serious adverse events (cardiac death, fatal and non-fatal myocardial infarction, ventricular fibrillation, asystole, sinus node arrest, symptomatic ventricular tachycardia, stroke, transient cerebral ischemia, seizures, anaphylactoid reaction and bronchospasm) are described above (see WARNINGS).

In the study of 3911 patients, the most frequent adverse reactions were: chest pain/angina pectoris (19.7%), electrocar-diographic changes (most commonly ST-T changes)(15.9%), headache (12.2%), and dizziness (11.8%).

Adverse reactions occurring in greater than 1% of the patients in the study are shown in the following table:

  Incidence (%) of Drug-Related Adverse Events
Chest pain/angina pectoris 19.7
Headache 12.2
Dizziness 11.8
Electrocardiographic Abnormalities/ST-T changes 7.5
Electrocardiographic Abnormalities/Extrasystoles 5.2
Hypotension 4.6
Nausea 4.6
Flushing 3.4
Electrocardiographic Abnormalities/Tachycardia 3.2
Dyspnea 2.6
Pain Unspecified 2.6
Blood Pressure Lability 1.6
Hypertension 1.5
Paresthesia 1.3
Fatigue 1.2

Less common adverse reactions occurring in 1% or less of the patients within the study included:

Cardiovascular System: Electrocardiographic abnormalities unspecified (0.8%), arrhythmia unspecified (0.6%), palpitation (0.3%), ventricular tachycardia (0.2% see WARNINGS), bradycardia (0.2%), myocardial infarction (0.1% see WARNINGS), AV block (0.1%), syncope (0.1%), orthostatic hypotension (0.1%), atrial fibrillation (0.1%), supraventricular tachycardia (0.1%), ventricular arrhythmia unspecified (0.03% see WARNINGS), heart block unspecified (0.03%), cardiomyopathy (0.03%), edema (0.03%).

Central and Peripheral Nervous System: Hypothesia (0.5%), hypertonia (0.3%), nervousness/anxiety (0.2%), tremor (0.1%), abnormal coordination (0.03%), somnolence (0.03%), dysphonia (0.03%), migraine (0.03%), vertigo (0.03%).

Gastrointestinal System: Dyspepsia (1%), dry mouth (0.8%), abdominal pain (0.7%), flatulence (0.6%), vomiting (0.4%), eructation (0.1%), dysphagia (0.03%), tenesmus (0.03%), appetite increased (0.03%).

Respiratory System: Pharyngitis (0.3%), bronchospasm (0.2% see WARNINGS), hyperventilation (0.1%), rhinitis (0.1%), coughing (0.03%), pleural pain (0.03%).

Other: Myalgia (0.9%), back pain (0.6%), injection site reaction unspecified (0.4%), diaphoresis (0.4%), asthenia (0.3%), malaise (0.3%), arthralgia (0.3%), injection site pain (0.1%), rigor (0.1%), earache (0.1%), tinnitus (0.1%), vision abnormalities unspecified (0.1%), dysgeusia (0.1%), thirst (0.03%), depersonalization (0.03%), eye pain (0.03%), renal pain (0.03%), perineal pain (0.03%), breast pain (0.03%), intermittent claudication (0.03%), leg cramping (0.03%). In additional postmarketing experience, there have been rare reports of allergic reaction including urticaria, pruritus, dermatitis and rash.