FDA label 02f9d37a-99f4-3275-e063-6294a90a9fb5

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
d89ee09f-ae57-028b-e053-2a95a90a3550
SPL ID
02f9d37a-99f4-3275-e063-6294a90a9fb5
Version
2
Effective date
2023-08-15
Source export date
2026-11-06
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/bbdc0a42bf44145a63c3752991067bece7e2a518be6cc14943d33c4987faa012/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 07:12:02

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 width="100%"><col width="29%"/><col width="32%"/><col width="25%"/><tbody><tr styleCode="Toprule"><td styleCode="Botrule " valign="bottom"><paragraph><content styleCode="bold">Adverse Reaction</content></paragraph></td><td styleCode="Botrule " valign="bottom"><paragraph><content styleCode="bold">Dipyridamole Tablets / Warfarin</content></paragraph></td><td styleCode="Botrule " valign="bottom"><paragraph><content styleCode="bold">Placebo/ Warfarin</content></paragraph></td></tr><tr><td styleCode="Toprule Botrule " valign="top"><paragraph>Number of patients</paragraph></td><td styleCode="Toprule Botrule " valign="top"><paragraph>147</paragraph></td><td styleCode="Toprule Botrule " valign="top"><paragraph>170</paragraph></td></tr><tr><td styleCode="Toprule Botrule " valign="top"><paragraph>Dizziness</paragraph></td><td styleCode="Toprule Botrule " valign="top"><paragraph>13.6%</paragraph></td><td styleCode="Toprule Botrule " valign="top"><paragraph>8.2%</paragraph></td></tr><tr><td styleCode="Toprule Botrule " valign="top"><paragraph>Abdominal distress</paragraph></td><td styleCode="Toprule Botrule " valign="top"><paragraph>6.1%</paragraph></td><td styleCode="Toprule Botrule " valign="top"><paragraph>3.5%</paragraph></td></tr><tr><td styleCode="Toprule Botrule " valign="top"><paragraph>Headache</paragraph></td><td styleCode="Toprule Botrule " valign="top"><paragraph>2.3%</paragraph></td><td styleCode="Toprule Botrule " valign="top"><paragraph>0.0%</paragraph></td></tr><tr styleCode="Botrule"><td styleCode="Botrule Toprule " valign="top"><paragraph>Rash</paragraph></td><td styleCode="Botrule Toprule " valign="top"><paragraph>2.3%</paragraph></td><td styleCode="Botrule Toprule " valign="top"><paragraph>1.1%</paragraph></td></tr></tbody></table>

Reported adverse events (FAERS/openFDA)#

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