pharmacopeia
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/api/v1/drug/dipyridamole

Mechanism of action

Sourced from openFDA

Dipyridamole inhibits the uptake of adenosine into platelets, endothelial cells and erythrocytes in vitro and in vivo ; the inhibition occurs in a dose-dependent manner at therapeutic concentrations (0.5 to 1.9 mcg/mL). This inhibition results in an increase in local concentrations of adenosine which acts on the platelet A 2 -receptor thereby stimulating platelet adenylate cyclase and increasing platelet cyclic-3',5'-adenosine monophosphate (cAMP) levels.

Adenosine DeaminaseAdenosine ReceptorPhosphodiesterase

Indications

Sourced from openFDA
  • Dipyridamole tablets are indicated as an adjunct to coumarin anticoagulants in the prevention of postoperative thromboembolic complications of cardiac valve replacement.

Contraindications

Sourced from openFDA
  • Hypersensitivity to dipyridamole and any of the other components.contraindicated

Dosage & administration

Sourced from openFDA

Adjunctive Use in Prophylaxis of Thromboembolism after Cardiac Valve Replacement The recommended dose is 75 to 100 mg four times daily as an adjunct to the usual warfarin therapy. Please note that aspirin is not to be administered concomitantly with coumarin anticoagulants.

Adverse reactions

Sourced from openFDA

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/ Placebo/ Warfarin 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.

Use in specific populations

Sourced from openFDA

Pregnancy Teratogenic Effects: PREGNANCY CATEGORY B Reproduction studies have been performed in mice, rabbits and rats at oral dipyridamole doses of up to 125 mg/kg, 40 mg/kg and 1000 mg/kg, respectively (about 1 1/2 , 2 and 25 times the maximum recommended daily human oral dose, respectively, on a mg/m 2 basis) and have revealed no evidence of harm to the fetus due to dipyridamole. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, dipyridamole tablets should be used during pregnancy only if clearly needed.

Overdosage

Sourced from openFDA

In case of real or suspected overdose, seek medical attention or contact a Poison Control Center immediately. Careful medical management is essential. Based upon the known hemodynamic effects of dipyridamole, symptoms such as warm feeling, flushes, sweating, restlessness, feeling of weakness and dizziness may occur. A drop in blood pressure and tachycardia might also be observed. Symptomatic treatment is recommended, possibly including a vasopressor drug. Gastric lavage should be considered. Administration of xanthine derivatives (e.g., aminophylline) may reverse the hemodynamic effects of dipyridamole overdose. Since dipyridamole is highly protein bound, dialysis is not likely to be of benefit.

Approval history

Sourced from openFDA
  • Oct 18, 1996ANDAANDA074521Hikma
  • Apr 21, 2006ANDAANDA040542Oxford Pharms
  • Jul 18, 2007ANDAANDA040782Impax Labs
  • Jan 28, 2008ANDAANDA040874Zydus Pharms Usa Inc
  • Mar 8, 2016ANDAANDA206392Amneal Pharms
  • Jan 18, 2017ANDAANDA207944Ph Health
  • Oct 10, 2018ANDAANDA209048Dr Reddys
  • May 24, 2019ANDAANDA210318Glenmark Speclt

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
3,949 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Fall55514%
  2. 2Hypotension54014%
  3. 3Pain52413%
  4. 4Cognitive Disorder50113%
  5. 5Depressed Level Of Consciousness47412%
  6. 6Constipation47112%
  7. 7Balance Disorder46812%
  8. 8Orthostatic Hypotension46712%
  9. 9Sedation Complication45211%
  10. 10Blood Calcium Decreased44411%
  11. 11Creatinine Renal Clearance Decreased44411%
  12. 12Mobility Decreased44311%
  13. 13Sedation43711%
  14. 14Toxicity To Various Agents39410.0%
  15. 15Dyspnoea2536.4%

Literature

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Recent PubMed references pinned to Dipyridamole as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 106 ClinicalTrials.gov registrations naming Dipyridamole as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Dipyridamole work?
Dipyridamole inhibits the uptake of adenosine into platelets, endothelial cells and erythrocytes in vitro and in vivo ; the inhibition occurs in a dose-dependent manner at therapeutic concentrations (0.5 to 1.9 mcg/mL). This inhibition results in an increase in local concentrations of adenosine which acts on the platelet A 2 -receptor thereby stimulating platelet adenylate cyclase and increasing platelet cyclic-3',5'-adenosine monophosphate (cAMP) levels.
What is Dipyridamole used for?
According to FDA labeling, Dipyridamole carries indications including: Dipyridamole tablets are indicated as an adjunct to coumarin anticoagulants in the prevention of postoperative thromboembolic complications of cardiac valve replacement.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Dipyridamole?
Dipyridamole is classified as Platelet aggregation inhibitors excl. heparin, Platelet Aggregation Inhibitor, Adenosine Deaminase Inhibitors, Adenosine Receptor Antagonists, Phosphodiesterase Inhibitors, Coronary Arterial Vasodilation, Decreased Platelet Aggregation.
What are the contraindications for Dipyridamole?
Dipyridamole labeling lists contraindications including: Hypersensitivity to dipyridamole and any of the other components.. Always consult the full prescribing information and a clinician.
Note. Data for dipyridamole is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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