What the label lists and what reports show
Aspirin and dipyridamole side effects
Aspirin and dipyridamole's FDA label: “The most frequently reported adverse reactions (>10% and greater than placebo) were headache, dyspepsia, abdominal pain, nausea, and diarrhea ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA …” FAERS holds 239 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is cerebrovascular accident (16 reports).
- Generic listed
Check it at the source: the aspirin and dipyridamole FDA label on DailyMed (effective January 5, 2026, Glenmark Pharmaceuticals Inc., USA); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of Aspirin and Extended-Release Dipyridamole Capsules?Aspirin and extended-release dipyridamole capsules may cause serious side effects, including: • increased risk of bleeding. You may bleed more easily during aspirin and extended-release dipyridamole capsules treatment, and it may take longer than usual for bleeding to stop. This can include: o bleeding into your brain (intracranial hemorrhage). This can be a medical emergency. Get medical help right away if you have any of these symptoms while taking aspirin and extended-release dipyridamole capsules: ▪ severe headache with drowsiness ▪ confusion or memory change ▪ pass out (become unconscious) o bleeding in your stomach or intestine. ▪ stomach pain ▪ heartburn or nausea ▪ vomiting blood or vomit looks like "coffee grounds" ▪ red or bloody stools ▪ black stools that look like tar • new or worsening chest pain in some people with heart disease. […]
Source: FDA drug label, Glenmark Pharmaceuticals Inc., USA, effective January 5, 2026 (SPL set 467d6ce3-bc05-4aa1-87cc-3214fd628d39), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most frequently reported adverse reactions (>10% and greater than placebo) were headache, dyspepsia, abdominal pain, nausea, and diarrhea ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Table 1 Incidence of Adverse Events in ESPS2 a
| Body System/Preferred Term | Aspirin and Extended-Release Dipyridamole n (%/year) b | ER-DP Alone n (%/year) b | ASA Alone n (%/year) b | Placebo n (%/year) b |
|---|---|---|---|---|
| Total Number of Patients | 1650 | 1654 | 1649 | 1649 |
| Headache | 647 (28.25) | 634 (27.91) | 558 (22.10) | 543 (22.29) |
| Dyspepsia | 303 (13.23) | 288 (12.68) | 299 (11.84) | 275 (11.29) |
| Abdominal Pain | 289 (12.62) | 255 (11.22) | 262 (10.38) | 239 (9.81) |
| Nausea | 264 (11.53) | 254 (11.18) | 210 (8.32) | 232 (9.53) |
| Diarrhea | 210 (9.17) | 257 (11.31) | 112 (4.44) | 161 (6.61) |
| Vomiting | 138 (6.03) | 129 (5.68) | 101 (4) | 118 (4.84) |
| Hemorrhage NOS | 52 (2.27) | 24 (1.06) | 46 (1.82) | 24 (0.99) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are discussed elsewhere in the labeling: • Hypersensitivity [ see Contraindications (4.1) ] • Allergy [ see Contraindications (4.2) ] • Risk of Bleeding [ see Warnings and Precautions (5.1) ] • The most frequently reported adverse reactions (>10% and greater than placebo) were headache, dyspepsia, abdominal pain, nausea, and diarrhea ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The efficacy and safety of aspirin and extended-release dipyridamole was established in the European Stroke Prevention Study-2 (ESPS2). ESPS2 was a double-blind, placebo-controlled study that evaluated 6602 patients over the age of 18 years who had a previous ischemic stroke or transient ischemic attack within ninety days prior to entry. Patients were randomized to either aspirin and extended-release dipyridamole, aspirin, ER-DP, or placebo [ see Clinical Studies (14) ]; primary endpoints included stroke (fatal or nonfatal) and death from all causes.
Source: FDA drug label, Glenmark Pharmaceuticals Inc., USA, effective January 5, 2026 (SPL set 467d6ce3-bc05-4aa1-87cc-3214fd628d39), via openFDA; the full label on DailyMed
What do FAERS reports show?
239 reports list aspirin and dipyridamole among the medicines taken, each a report of something that happened, not proof the medicine caused it; 19 are coded as a death and 111 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 24 reactions below, 11 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Aspirin and dipyridamole: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions