Safety

• Aggrenox®/Asasantin® is well tolerated with few serious adverse events
• Dipyridamole does not increase the bleeding risk inherent to ASA 
• Dipyridamole-induced headache disappears rapidly (3-5 days) following initial dosing
• The safety of oral ER-DP is not considered a barrier to treatment of patients with both cerebrovascular disease and stable angina

Prescribing Information arising from ESPS 2

Study investigators for ESPS 2 actively questioned all respondents for possible adverse events at each and every follow-up visit.
The most common adverse event with Aggrenox®/Asasantin® was headache (39.2% vs. 32.9% for placebo), which occurred more often at the onset of therapy. Differences in rates of headache among the four treatment groups disappeared over time.
After 3 months of treatment, the rate of headache with dipyridamole fell to that of placebo, and remained at placebo level for the duration of the 24-month trial.

The incidence of gastrointestinal bleeding reported in patients taking Aggrenox®/Asasantin® vs. placebo, was 4.1% vs. 2.1%, and 4% vs. 8% for ASA vs. non-ASA, respectively.
Due to the ASA component, Aggrenox®/Asasantin® is contraindicated in patients with known allergy to ASA and nonsteroidal anti-inflammatory drug products.

Patients should be counselled about bleeding risks with chronic, heavy alcohol use while taking ASA. Even low doses of ASA inhibit platelet function leading to an increase in bleeding time. Physicians should remain alert for signs of GI ulceration and bleeding. Patients with a history of active peptic ulcer should avoid using ASA.
ASA can increase bleeding risk when used in conjunction with warfarin or heparin.