What the label lists and what reports show
Dipyridamole side effects
Dipyridamole's FDA label lists its adverse reactions in its own words. FAERS holds 3,743 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 fall (550 reports).
- Generic listed
Check it at the source: the dipyridamole FDA label on DailyMed (effective September 16, 2023, Zydus Pharmaceuticals USA Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsAdverse reactions at therapeutic doses are usually minimal and transient. On long-term use of dipyridamole tablets initial side effects usually disappear. The following reactions in Table 1 were reported in two heart valve replacement trials comparing dipyridamole tablets and warfarin therapy to either warfarin alone or warfarin and placebo: Table 1 Adverse Reactions Reported in 2 Heart Valve Replacement Trials Adverse Reaction Dipyridamole Tablets/ Placebo/ Warfarin Warfarin Number of patients 147 170 Dizziness 13.6% 8.2% Abdominal distress 6. 1% 3.5% Headache 2.3% 0.0% Rash 2.3% 1.1% 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. …
Table 1. Adverse Reactions Reported in 2 Heart Valve Replacement Trials
This table is printed in the Dipyridamole label published by Oxford Pharmaceuticals, LLC of March 29, 2021; the label quoted above does not print one.
| Adverse Reaction | Dipyridamole Tablets/ Warfarin | Placebo/ Warfarin |
|---|---|---|
| Number of patients | 147 | 170 |
| Dizziness | 13.6% | 8.2% |
| Abdominal distress | 6.1% | 3.5% |
| Headache | 2.3% | 0.0% |
| Rash | 2.3% | 1.1% |
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.
Source: FDA drug label, Zydus Pharmaceuticals USA Inc., effective September 16, 2023 (SPL set 004bada0-dbf7-4a94-8792-6833d7eeda2b), via openFDA; the full label on DailyMed
What do FAERS reports show?
3,743 reports list dipyridamole among the medicines taken, each a report of something that happened, not proof the medicine caused it; 461 are coded as a death and 1,931 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 21 reactions below, 6 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.
Reports received each year
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?
- 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