Persantine IV
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Persantine IV
Please Note: This Brand Name drug is no longer available in the US.(Generic versions may still be available.)
Persantine IV Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Persantine IV FDA Prescribing Information: Side Effects
(Adverse Reactions)
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 (see WARNINGS). 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 |
| 4.6 | |
| 4.6 | |
| Flushing | 3.4 |
| Electrocardiographic Abnormalities/Tachycardia | 3.2 |
| 2.6 | |
| Pain Unspecified | 2.6 |
| 1.6 | |
| 1.5 | |
| 1.3 | |
| 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 (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 (0.03% see WARNINGS), 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 (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 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.
Read the entire FDA prescribing information for Persantine IV (Persantine) »
Additional Persantine IV Information
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