FDA label 4eac07e2-a24d-4b04-b6a9-a93db459bcbf

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
1b82871b-f60b-4485-9a45-026aeb18b484
SPL ID
4eac07e2-a24d-4b04-b6a9-a93db459bcbf
Version
9
Effective date
2010-11-24
Source export date
2026-09-28
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:19:43

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 2 matching rows.

adverse reactions

ADVERSE REACTIONS Adverse 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/ 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% 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. On those uncommon occasions when adverse reactions have been persistent or intolerable, they have ceased on withdrawal of the medication. When dipyridamole tablets were administered concomitantly with warfarin, bleeding was no greater in frequency or severity than that observed when warfarin was administered alone. In rare cases, increased bleeding during or after surgery has been observed. In post-marketing reporting experience, there have been rare reports of hypersensitivity reactions (such as rash, urticaria, severe bronchospasm, and angioedema), larynx edema, fatigue, malaise, myalgia, arthritis, nausea, dyspepsia, paresthesia, hepatitis, thrombocytopenia, alopecia, cholelithiasis, hypotension, palpitation, and tachycardia.

adverse reactions table

<table><caption>Table 1. Adverse Reactions Reported in 2 Heart Valve Replacement Trials</caption><col/><col/><col/><thead><tr><th align="center" valign="top" styleCode=" Botrule"> Adverse Reaction</th><th align="center" valign="top" styleCode=" Botrule"> Dipyridamole Tablets/ Warfarin</th><th align="center" valign="top" styleCode=" Botrule"> Placebo/ Warfarin</th></tr><tr><th align="center" valign="top"> Number of patients</th><th align="center" valign="top"> 147</th><th align="center" valign="top"> 170</th></tr></thead><tbody><tr><td align="center" valign="top" styleCode=" Botrule"> Dizziness</td><td align="center" valign="top" styleCode=" Botrule"> 13.6%</td><td align="center" valign="top" styleCode=" Botrule"> 8.2%</td></tr><tr><td align="center" valign="top" styleCode=" Botrule"> Abdominal distress</td><td align="center" valign="top" styleCode=" Botrule"> 6.1%</td><td align="center" valign="top" styleCode=" Botrule"> 3.5%</td></tr><tr><td align="center" valign="top" styleCode=" Botrule"> Headache</td><td align="center" valign="top" styleCode=" Botrule"> 2.3%</td><td align="center" valign="top" styleCode=" Botrule"> 0.0%</td></tr><tr><td align="center" valign="top"> Rash</td><td align="center" valign="top"> 2.3%</td><td align="center" valign="top"> 1.1%</td></tr></tbody></table>

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.