Dipyridamole: adverse event reports filed with FDA

1,695

reports as suspect product

0% of all reports · about 75 a year

48

reports, 12 months to June 2026

39 in the 12 months before

96.3%

marked serious by the reporter

87.3% across the class

11.5%

record death among outcomes, as reported

195 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Dipyridamole reports recording the termmedian drug in platelet aggregation inhibitor

1. Cognitive disorderproblems with thinking or memory27.7%469
2. Falla fall27.6%467
3. Hypotensionlow blood pressure26.7%452
4. Depressed level of consciousness26.6%451
5. Painpain, site not specified25.6%434
6. Sedation complication25.5%433
7. Orthostatic hypotension25.4%430
8. Balance disorderproblems with balance25.1%426
9. Mobility decreasedreduced ability to move about24.8%421
10. Constipationconstipation24.8%420
11. Sedationdrowsiness from a medicine24.8%420
12. Blood calcium decreased24.5%416
13. Creatinine renal clearance decreased24.5%416
14. Toxicity to various agentspoisoning or toxic effect of one or more substances22.5%382
15. Off label useused for a purpose or in a way not on the label7.8%132
16. Drug interactionan interaction between medicines7.2%122
17. Dyspnoeashortness of breath7.1%121
18. Product use in unapproved indicationused for a purpose not on the label5.5%93
19. Drug ineffectivethe medicine did not work as expected5.1%86
20. Renal function test abnormal4%67
21. Multiple drug therapy3.9%66
22. Overdosea dose above the recommended amount3.9%66
23. Drug abusemisuse of a medicine3.7%63
24. Creatinine renal clearance increased3.3%56
25. Cerebral haemorrhage3%51
26. Headachehead pain3%51
27. Gastrointestinal haemorrhagebleeding in the stomach or bowel2.9%50
28. Dizzinesslight-headedness or unsteadiness2.9%49
29. Cerebrovascular accidentstroke2.4%40
30. Ischaemic stroke2.2%37

Top 30 of 381 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 3 drugs in the platelet aggregation inhibitor class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 4,639 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 16.8% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 1,695 reports.

Drugs most often listed in the same reports

Other products listed in reports where Dipyridamole is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the platelet aggregation inhibitor class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Dipyridamole as a suspect or interacting product; reports listing it only as a concomitant medication (2,084) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.