Dipyridamole Side Effects

Brand Names: Persantine

Please note - some side effects for Dipyridamole may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Dipyridamole - for the Consumer

Dipyridamole

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Dipyridamole:

Dizziness; fatigue; flushing; headache; nausea.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; confusion; fast, irregular, or slow heartbeat; one-sided weakness; seizures; slurred speech.

Dipyridamole Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Dipyridamole Tablets:

Diarrhea; dizziness; flushing; headache; itching; stomach pain; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; fast heartbeat; hepatitis; pounding in the chest; swelling of throat.

Dipyridamole Side Effects - for the Professional

Dipyridamole

Adverse reactions at therapeutic doses are usually minimal and transient. On long-term use of Dipyridamole tablets USP initial side effects usually disappear.

The following reactions in Table 1 were reported in two heart valve replacement trials comparing Dipyridamole tablets USP and warfarin therapy to either warfarin alone or warfarin and placebo:

Other reactions from uncontrolled studies include diarrhea, vomiting, flushing and pruritus. In addition, angina pectoris has been reported rarely and there have been rare reports of liver dysfunction. On those uncommon occasions when adverse reactions have been persistent or intolerable, they have ceased on withdrawal of the medication.

When Dipyridamole tablets USP were administered concomitantly with warfarin, bleeding was no greater in frequency or severity than that observed when warfarin was administered alone. In rare cases, increased bleeding during or after surgery has been observed.

In post-marketing reporting experience, there have been rare reports of hypersensitivity reactions (such as rash, urticaria, severe bronchospasm, and angioedema), larynx edema, fatigue, malaise, myalgia, arthritis, nausea, dyspepsia, paresthesia, hepatitis, thrombocytopenia, alopecia, cholelithiasis, hypotension, palpitation, and tachycardia.

Dipyridamole Injection

Adverse reaction information concerning intravenous Dipyridamole Injection 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.

In a 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 occurring in greater than 1% of the patients in the study are shown in the following table:

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 increase (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.

Side Effects by Body System

General

Generally, oral administration of dipyridamole has been well tolerated. Adverse effects during intravenous (IV) administration have occurred in 40% to 55% of patients. The majority of dipyridamole-induced adverse effects resulting from IV administration can be reversed by intravenous aminophylline.

Cardiovascular

Cardiovascular symptoms have been the most frequently reported adverse effects associated with dipyridamole, particularly when given intravenously. Ischemia and angina have been reported following oral administration. Intravenous administration has been associated with chest pain (20% to 25%), ST segment depression (8% to 20%), facial flushing (2%), and severe ischemia (2.5%). Atrial and ventricular premature beats, ventricular tachycardia, ventricular fibrillation, bradycardia, asystole, sinus arrest, and myocardial infarction have also been reported. Hypotension may occur, with an average decrease in mean arterial pressure of 5% to 10%.

Chest pain, ischemia, and myocardial infarction associated with dipyridamole may be due to a phenomenon known as coronary "steal". Coronary steal involves shunting of blood flow away from an ischemic area where diseased vessels are already maximally dilated, to non-diseased areas when dipyridamole administration has resulted in vasodilation. Myocardial infarction has been reported in patients with unstable angina.

Aminophylline, an adenosine-receptor antagonist, may be used to reverse some of the effects of dipyridamole, including chest pain and bronchospasm. Intravenous aminophylline should be available during myocardial imaging.

Nervous system

Nervous system effects have occurred following intravenous and oral administration of dipyridamole and included headache (12.2%), lightheadedness or dizziness (11.8%), and paresthesias (1.3%). Cerebrovascular accident following intravenous administration also has been reported.

Respiratory

In one case report, a patient with asthma developed sudden bronchospasm with wheezing, coughing, and dyspnea immediately after receiving IV dipyridamole during thallium stress testing. Symptoms and hypoxemia resolved within 5 minutes after administration of IV aminophylline.

Respiratory tract adverse effects may occur, especially in patients with pre-existing asthma or chronic obstructive pulmonary disease. Dyspnea, bronchospasm, and respiratory arrest have been reported.

Gastrointestinal

Gastrointestinal disturbances associated with dipyridamole therapy have included nausea and vomiting in up to 5% of patients. Gallstones containing dipyridamole have been reported in patients on long-term dipyridamole therapy.

Hematologic

Hematologic abnormalities have included rare bleeding complications due to the platelet inhibitory effects of dipyridamole.

Renal

In one small study, dipyridamole induced a marked but reversible reduction in glomerular filtration rate in patients with elevated renin-angiotensin activity and ascites due to cirrhosis. Sodium and free water excretion were reduced as well.

Hypersensitivity

Hypersensitivity reactions have been reported rarely and included angioedema and anaphylaxis.

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