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

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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
2026-08-01
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/2026-08-01/8ac060fefb6f4d67c41cc2c9e4330286ca93c48094c18386c11bf706a1d8bd34/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:29:50

Adverse reactions cross-check#

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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>