Applies to dipyridamole: solution, tablet.

Serious side effects of Dipyridamole

Along with its needed effects, dipyridamole may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur while taking dipyridamole:

Rare

• Chest pain
• gallstones
• tightness or swelling of neck
• yellow eyes or skin

Other side effects of Dipyridamole

Some side effects of dipyridamole may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abdominal or stomach cramps
• diarrhea
• dizziness or lightheadedness

Less common

• Flushing
• headache
• nausea or vomiting
• weakness

Rare

• General discomfort and/or unusual tiredness or weakness
• hair loss
• joint pain or swelling
• muscle pain
• runny nose
• sneezing

For Healthcare Professionals

Applies to dipyridamole: compounding powder, intravenous solution, oral tablet.

General

The most frequent adverse reactions were chest pain/angina pectoris, electrocardiographic changes (mostly ST-T changes), headache, and dizziness.^[Ref]

Cardiovascular

Very common (10% or more): Chest pain/angina pectoris (19.7%), electrocardiographic changes (15.9%)

Common (1% to 10%): Electrocardiographic abnormalities/ST-T changes, electrocardiographic abnormalities/extrasystoles, hypotension, flushing, electrocardiographic abnormalities/tachycardia, blood pressure lability, hypertension, angina pectoris, bleeding

Uncommon (0.1% to 1%): Myocardial infarction, electrocardiographic abnormalities unspecified, arrhythmia unspecified, palpitation, ventricular tachycardia, bradycardia, atrioventricular block, orthostatic hypotension, atrial fibrillation, supraventricular tachycardia

Rare (0.01% to 0.1%): Fatal myocardial infarction, nonfatal myocardial infarction, ventricular arrhythmia unspecified, heart block unspecified, cardiomyopathy, intermittent claudication

Very rare (less than 0.01%): Asystole, sustained ventricular tachycardia or ventricular fibrillation

Frequency not reported: Bleeding during or after surgery, cardiac death, ventricular fibrillation, symptomatic ventricular tachycardia, sinus node arrest, sinus node depression, conduction block, tachycardia, post procedural hemorrhage, operative hemorrhage, cardiac arrest, sinus arrest

Postmarketing reports: Palpitation^[Ref]

Respiratory

Common (1% to 10%): Dyspnea

Uncommon (0.1% to 1%): Severe bronchospasm, pharyngitis, bronchospasm, hyperventilation, rhinitis

Rare (0.01% to 0.1%): Dysphonia, coughing, pleural pain

Very rare (less than 0.01%): Pulmonary edema

Frequency not reported: Laryngospasm

Postmarketing reports: Larynx edema^[Ref]

Nervous system

Very common (10% or more): Headache (up to 37.2%), dizziness (up to 30.1%)

Common (1% to 10%): Paresthesia

Uncommon (0.1% to 1%): Hypoesthesia, hypertonia, tremor, tinnitus, dysgeusia

Rare (less than 0.1%): Abnormal coordination, somnolence, migraine, vertigo, transient ischemic attack

Frequency not reported: Stroke, transient cerebral ischemia, seizures, cerebrovascular accident, syncope, cerebral seizure/grand mal seizure^[Ref]

Gastrointestinal

Very common (10% or more): Dyspepsia (up to 16.6%), diarrhea (up to 15.4%), nausea (up to 14.8%), gastric pain (up to 14.5%)

Common (1% to 10%): Abdominal distress, vomiting

Uncommon (0.1% to 1%): Dry mouth, abdominal pain, flatulence, eructation

Rare (less than 0.1%): Dysphagia, tenesmus

Frequency not reported: Gastroduodenal ulcer^[Ref]

Other

Common (1% to 10%): Pain unspecified, fatigue

Uncommon (0.1% to 1%): Asthenia, malaise, earache

Rare (less than 0.1%): Death, any complication^[Ref]

Musculoskeletal

Common (1% to 10%): Myalgia

Uncommon (0.1% to 1%): Back pain, arthralgia, rigor

Rare (less than 0.1%): Leg cramping

Postmarketing reports: Arthritis^[Ref]

Dermatologic

Common (1% to 10%): Rash

Uncommon (0.1% to 1%): Diaphoresis

Frequency not reported: Pruritus, urticaria

Postmarketing reports: Alopecia^[Ref]

Immunologic

Uncommon (0.1% to 1%): Hypersensitivity reaction

Frequency not reported: Anaphylactoid reaction, angioedema

Postmarketing reports: Allergic reaction, urticaria, pruritus, dermatitis, rash^[Ref]

Psychiatric

Uncommon (0.1% to 1%): Nervousness/anxiety

Rare (less than 0.1%): Depersonalization^[Ref]

Ocular

Uncommon (0.1% to 1%): Vision abnormalities unspecified

Rare (less than 0.1%): Eye pain^[Ref]

Local

Uncommon (0.1% to 1%): Injection site reaction unspecified, injection site pain^[Ref]

Metabolic

Rare (less than 0.1%): Edema, appetite increased, thirst^[Ref]

Endocrine

Rare (less than 0.1%): Breast pain^[Ref]

Genitourinary

Rare (less than 0.1%): Perineal pain^[Ref]

Renal

Rare (less than 0.1%): Renal pain^[Ref]

Hematologic

Frequency not reported: Thrombocytopenia, anemia^[Ref]

Hepatic

Frequency not reported: Liver dysfunction

Postmarketing reports: Hepatitis, cholelithiasis^[Ref]

Hypersensitivity

Postmarketing reports: Rash, urticaria, severe bronchospasm, angioedema^[Ref]