FDA label 30ecc1bf-1917-45a8-9460-583ceb0901eb

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
ae7585ec-1280-40fe-b888-613b8a0e6ef6
SPL ID
30ecc1bf-1917-45a8-9460-583ceb0901eb
Version
3
Effective date
2018-08-13
Source export date
2026-10-12
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 03:01:31

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

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 war- farin 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 USP 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 reac- tions (such as rash, urticaria, severe bronchospasm, and angioedema), larynx edema, fatigue, malaise, myalgia, arthritis, nausea, dyspepsia, paresthesia, hepatitis, thrombocytopenia, alo- pecia, cholelithiasis, hypotension, palpitation, and tachycardia.

adverse reactions table

<table ID="_RefID65EFE2D60AE748C7BDE794C80720B870" width="100%"> <caption>Table 1 Adverse Reactions Reported in 2 Heart Valve Replacement Trials </caption> <col width="22%"/> <col width="23%"/> <col width="25%"/> <tbody> <tr> <td styleCode="Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Adverse Reaction</content> </paragraph> </td> <td align="center" styleCode="Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Dipyridamole Tablets/Warfarin</content> </paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule Toprule " valign="top"> <paragraph> <content styleCode="bold">Placebo/Warfarin</content> </paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph>Number of Patients</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>147</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>170</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph>Dizziness</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>13.6%</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>8.2%</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph>Abdominal distress</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>6.1%</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>3.5%</paragraph> </td> </tr> <tr> <td styleCode="Lrule Botrule " valign="top"> <paragraph>Headache</paragraph> </td> <td align="center" styleCode="Lrule Botrule " valign="top"> <paragraph>2.3%</paragraph> </td> <td align="center" styleCode="Rrule Lrule Botrule " valign="top"> <paragraph>0.0%</paragraph> </td> </tr> <tr> <td styleCode="Botrule Lrule " valign="top"> <paragraph>Rash</paragraph> </td> <td align="center" styleCode="Botrule Lrule " valign="top"> <paragraph>2.3%</paragraph> </td> <td align="center" styleCode="Rrule Botrule Lrule " 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.