Last updated on MDtodate: 10/10/2022

SIDE EFFECTS

Adverse reaction information concerning intravenous Persantine^® (dipyridamole USP) is derived from a study of 3911 patients in which intravenous Persantine^® 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, angioedema and bronchospasm) are described above. In the study of 3911 patients, the most frequent adverse reactions were: chest pain/angina pectoris (19.7%), electrocardiographic changes (most commonly ST-T changes) (15.9%), headache (12.2%), and dizziness (11.8%).

Adverse reactions occuring in greater than 1% of the patients in the study are shown in Table 1:

Table 1 Drug-Related Adverse Reactions (%) Occurring in Greater than 1% of Patients

 

	Incidence (%) of Drug-Related
Adverse Reaction	Adverse Reactions
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 (0.8%), arrhythmia (0.6%), palpitation (0.3%), ventricular tachycardia, bradycardia (0.2%), myocardial infarction, AV block (0.1%), syncope (0.1%), orthostatic hypotension (0.1%), atrial fibrillation (0.1%), supraventricular tachycardia (0.1%), ventricular arrhythmia , heart block (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 (1.0%), 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 , 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 diarrhea, allergic reaction including urticaria, pruritus, dermatitis and rash. Mesenteric ischemia and mesenteric infarction have also been observed in association with intravenous Persantine^® (dipyridamole USP) administration.