FDA label 6e11c897-845d-06fe-e053-2a91aa0abf3c

openFDA label record#

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

SPL set ID
22b9ebcd-bfbf-4455-a4df-1aefbb473ec9
SPL ID
6e11c897-845d-06fe-e053-2a91aa0abf3c
Version
3
Effective date
2018-06-07
Source export date
2026-10-12
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:50:37

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 USP 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% 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 postmarketing 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="0.000" ID="id_14473837-e9ff-43ff-aa56-d8283d2773a7"> <caption ID="id_64ab28d1-646e-4fda-82dd-3599f116ae1a">Table 1: Adverse Reactions Reported in 2 Heart Valve Replacement Trials</caption> <col/> <col/> <col/> <tbody> <tr ID="id_f9359b06-cb13-41c7-8637-e96bbb431819"> <td align="center" styleCode="Botrule Toprule Rrule Lrule" valign="top"> <content styleCode="bold">Adverse Reaction</content> </td> <td align="center" styleCode="Botrule Rrule" valign="top"> <content styleCode="bold">Dipyridamole Tablets/ Warfarin</content> </td> <td align="center" styleCode="Botrule Rrule" valign="top"> <content styleCode="bold">Placebo/Warfarin</content> </td> </tr> <tr ID="id_5b964102-8508-46dc-91c7-34e33f708188"> <td align="left" styleCode="Lrule Botrule Rrule" valign="top">Number of patients</td> <td align="center" styleCode="Botrule Rrule" valign="top">147</td> <td align="center" styleCode="Botrule Rrule" valign="top">170</td> </tr> <tr ID="id_07c5d014-9a6f-47ea-8d0a-3bd0f9535a21"> <td align="left" styleCode="Lrule Botrule Rrule" valign="top">Dizziness</td> <td align="center" styleCode="Botrule Rrule" valign="top">13.6%</td> <td align="center" styleCode="Botrule Rrule" valign="top">8.2%</td> </tr> <tr ID="id_21a5bd56-b84f-4ead-bc81-32a7aaa21fb5"> <td align="left" styleCode="Lrule Botrule Rrule" valign="top">Abdominal distress</td> <td align="center" styleCode="Botrule Rrule" valign="top">6.1%</td> <td align="center" styleCode="Botrule Rrule" valign="top">3.5%</td> </tr> <tr ID="id_60e87e16-2685-4d7a-becf-de9c908ae45a"> <td align="left" styleCode="Lrule Botrule Rrule" valign="top">Headache</td> <td align="center" styleCode="Botrule Rrule" valign="top">2.3%</td> <td align="center" styleCode="Botrule Rrule" valign="top">0%</td> </tr> <tr ID="id_566e1749-4d66-4676-b994-62de72444a82"> <td align="left" styleCode="Lrule Botrule Rrule" valign="top">Rash</td> <td align="center" styleCode="Rrule" valign="top">2.3%</td> <td align="center" styleCode="Botrule Rrule" valign="top">1.1%</td> </tr> </tbody> </table>

Reported adverse events (FAERS/openFDA)#

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