{"id":"dipyridamole","rwe":[{"pmid":"41899397","year":"2026","title":"Extracellular Adenosine Contributes to the Hydrogen Peroxide-Induced Calcification of Cultured Tendon Cells.","finding":"","journal":"Current issues in molecular biology","studyType":"Clinical Study"},{"pmid":"41848559","year":"2026","title":"Impact of Coronary Microvascular Dysfunction on Left Ventricular Function After Percutaneous Coronary Intervention: Assessment With Combined Dipyridamole-Exercise Stress and Myocardial Strain/Work.","finding":"","journal":"Echocardiography (Mount Kisco, N.Y.)","studyType":"Clinical Study"},{"pmid":"41833979","year":"2026","title":"Synergistic effects of HDAC inhibitor tucidinostat and ENT inhibitor dipyridamole in T-cell malignancies.","finding":"","journal":"Scientific reports","studyType":"Clinical Study"},{"pmid":"41812856","year":"2026","title":"Normal values of myocardial blood flow and flow reserve with rubidium-82 positron emission tomography in low-risk patients.","finding":"","journal":"Journal of nuclear cardiology : official publication of the American Society of Nuclear Cardiology","studyType":"Clinical Study"},{"pmid":"41809869","year":"2026","title":"Design and rationale of the AIR-NET trial: a randomised, open-label, multifactorial, multicentre, adaptive platform trial using a range of repurposed anti-inflammatory treatments to improve outcomes in patients with bronchiectasis within the EMBARC clinical research network.","finding":"","journal":"ERJ open research","studyType":"Clinical Study"}],"_fda":{"id":"8b638b19-214a-4a58-a336-656d690130e3","set_id":"004bada0-dbf7-4a94-8792-6833d7eeda2b","openfda":{"nui":["N0000008832","N0000175578"],"unii":["64ALC7F90C"],"route":["ORAL"],"rxcui":["197622","309952","309955"],"spl_id":["8b638b19-214a-4a58-a336-656d690130e3"],"brand_name":["Dipyridamole"],"spl_set_id":["004bada0-dbf7-4a94-8792-6833d7eeda2b"],"package_ndc":["68382-187-01","68382-187-05","68382-187-10","68382-187-77","68382-188-01","68382-188-05","68382-188-10","68382-188-77","68382-189-01","68382-189-05","68382-189-10","68382-189-77"],"product_ndc":["68382-187","68382-188","68382-189"],"generic_name":["DIPYRIDAMOLE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"pharm_class_pe":["Decreased Platelet Aggregation [PE]"],"substance_name":["DIPYRIDAMOLE"],"pharm_class_epc":["Platelet Aggregation Inhibitor [EPC]"],"manufacturer_name":["Zydus Pharmaceuticals USA Inc."],"application_number":["ANDA040874"],"is_original_packager":[true]},"version":"10","pregnancy":["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":["OVERDOSAGE 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."],"description":["DESCRIPTION Dipyridamole is a platelet inhibitor chemically described as 2,2',2'',2'''-[(4,8-Dipiperidinopyrimido[5,4- d ]pyrimidine-2,6-diyl)dinitrilo]-tetraethanol. It has the following structural formula: C 24 H 40 N 8 O 4 Mol. Wt. 504.63 Dipyridamole, USP is intensely yellow crystalline powder or needles. It is very soluble in methanol, in alcohol, and in chloroform; slightly soluble in water; very slightly soluble in acetone and in ethyl acetate. Each dipyridamole tablet intended for oral administration contains 25 mg or 50 mg or 75 mg of dipyridamole. In addition, each tablet contains the following inactive ingredients: corn starch, hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone and titanium dioxide. structured formula for dipyridamole"],"precautions":["PRECAUTIONS General Coronary Artery Disease Dipyridamole has a vasodilatory effect and should be used with caution in patients with severe coronary artery disease (e.g., unstable angina or recently sustained myocardial infarction). Chest pain may be aggravated in patients with underlying coronary artery disease who are receiving dipyridamole. Hepatic Insufficiency Elevations of hepatic enzymes and hepatic failure have been reported in association with dipyridamole administration. Hypotension Dipyridamole should be used with caution in patients with hypotension since it can produce peripheral vasodilation. Stress Testing with Intravenous Dipyridamole and Other Adenosinergic Agents Clinical experience suggests that patients being treated with dipyridamole tablets who also require pharmacological stress testing with intravenous dipyridamole or other adenosinergic agents (e.g. adenosine, regadenoson) should interrupt dipyridamole tablets for 48 hours prior to stress testing. Intake of dipyridamole tablets within 48 hours prior to stress testing with intravenous dipyridamole or other adenosinergic agents may increase the risk for cardiovascular side effects of these agents and may impair the sensitivity of the test. Laboratory Tests Dipyridamole has been associated with elevated hepatic enzymes. Drug Interactions No pharmacokinetic drug-drug interaction studies were conducted with dipyridamole tablets. The following information was obtained from the literature. Adenosinergic agents (e.g., adenosine, regadenoson) Dipyridamole has been reported to increase the plasma levels and cardiovascular effects of adenosine. Adjustment of adenosine dosage may be necessary. Dipyridamole also increases the cardiovascular effects of regadenoson, an adenosine A 2A -receptor agonist. The potential risk of cardiovascular side effects with intravenous adenosinergic agents may be increased during the testing period when dipyridamole is not held 48 hours prior to stress testing. Cholinesterase Inhibitors Dipyridamole may counteract the anticholinesterase effect of cholinesterase inhibitors, thereby potentially aggravating myasthenia gravis. Carcinogenesis, Mutagenesis, Impairment of Fertility In studies in which dipyridamole was administered in the feed to mice (up to 111 weeks in males and females) and rats (up to 128 weeks in males and up to 142 weeks in females), there was no evidence of drug-related carcinogenesis. The highest dose administered in these studies (75 mg/kg/day) was, on a mg/m 2 basis, about equivalent to the maximum recommended daily human oral dose (MRHD) in mice and about twice the MRHD in rats. Mutagenicity tests of dipyridamole with bacterial and mammalian cell systems were negative. There was no evidence of impaired fertility when dipyridamole was administered to male and female rats at oral doses up to 500 mg/kg/day (about 12 times the MRHD on a mg/m 2 basis). A significant reduction in number of corpora lutea with consequent reduction in implantations and live fetuses was, however, observed at 1250 mg/kg (more than 30 times the MRHD on a mg/m 2 basis). 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. Nursing Mothers As dipyridamole is excreted in human milk , caution should be exercised when dipyridamole tablets are administered to a nursing woman. Pediatric Use Safety and effectiveness in the pediatric population below the age of 12 years have not been established."],"how_supplied":["HOW SUPPLIED Dipyridamole Tablets USP, 25 mg are light yellow, round, biconvex, film-coated tablets debossed with 'ZE 43' on one side and plain on the other side are supplied as follows: NDC 68382-187-01 in bottle of 100 tablets NDC 68382-187-05 in bottle of 500 tablets NDC 68382-187-10 in bottle of 1000 tablets NDC 68382-187-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Dipyridamole Tablets USP, 50 mg are light yellow, round, biconvex, beveled-edge, film-coated tablets debossed with 'ZE 49' on one side and plain on the other side are supplied as follows: NDC 68382-188-01 in bottle of 100 tablets NDC 68382-188-05 in bottle of 500 tablets NDC 68382-188-10 in bottle of 1000 tablets NDC 68382-188-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Dipyridamole Tablets USP, 75 mg are light yellow, round, biconvex, beveled-edge, film-coated tablets debossed with 'ZE 50' on one side and plain on the other side are supplied as follows: NDC 68382-189-01 in bottle of 100 tablets NDC 68382-189-05 in bottle of 500 tablets NDC 68382-189-10 in bottle of 1000 tablets NDC 68382-189-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets"],"pediatric_use":["Pediatric Use Safety and effectiveness in the pediatric population below the age of 12 years have not been established."],"effective_time":"20230916","nursing_mothers":["Nursing Mothers As dipyridamole is excreted in human milk , caution should be exercised when dipyridamole tablets are administered to a nursing woman."],"laboratory_tests":["Laboratory Tests Dipyridamole has been associated with elevated hepatic enzymes."],"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/ 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."],"contraindications":["CONTRAINDICATIONS Hypersensitivity to dipyridamole and any of the other components."],"drug_interactions":["Drug Interactions No pharmacokinetic drug-drug interaction studies were conducted with dipyridamole tablets. The following information was obtained from the literature. Adenosinergic agents (e.g., adenosine, regadenoson) Dipyridamole has been reported to increase the plasma levels and cardiovascular effects of adenosine. Adjustment of adenosine dosage may be necessary. Dipyridamole also increases the cardiovascular effects of regadenoson, an adenosine A 2A -receptor agonist. The potential risk of cardiovascular side effects with intravenous adenosinergic agents may be increased during the testing period when dipyridamole is not held 48 hours prior to stress testing. Cholinesterase Inhibitors Dipyridamole may counteract the anticholinesterase effect of cholinesterase inhibitors, thereby potentially aggravating myasthenia gravis."],"mechanism_of_action":["Mechanism of Action 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. Via this mechanism, platelet aggregation is inhibited in response to various stimuli such as platelet activating factor (PAF), collagen and adenosine diphosphate (ADP). Dipyridamole inhibits phosphodiesterase (PDE) in various tissues. While the inhibition of cAMP-PDE is weak, therapeutic levels of dipyridamole inhibit cyclic-3',5'-guanosine monophosphate-PDE (cGMP-PDE), thereby augmenting the increase in cGMP produced by EDRF (endothelium-derived relaxing factor, now identified as nitric oxide)."],"storage_and_handling":["STORAGE Store at 20°C to 25°C (68°F to 77°F) [ See USP Controlled Room Temperature ]. Keep out of reach of children. Dispense in a tight, light-resistant container. Package insert available at www.zydususa.com/products or call 1-877-993-8779."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY It is believed that platelet reactivity and interaction with prosthetic cardiac valve surfaces, resulting in abnormally shortened platelet survival time, is a significant factor in thromboembolic complications occurring in connection with prosthetic heart valve replacement. Dipyridamole tablets have been found to lengthen abnormally shortened platelet survival time in a dose-dependent manner. In three randomized controlled clinical trials involving 854 patients who had undergone surgical placement of a prosthetic heart valve, dipyridamole tablets, in combination with warfarin, decreased the incidence of postoperative thromboembolic events by 62 to 91% compared to warfarin treatment alone. The incidence of thromboembolic events in patients receiving the combination of dipyridamole tablets and warfarin ranged from 1.2 to 1.8%. In three additional studies involving 392 patients taking dipyridamole tablets and coumarin-like anticoagulants, the incidence of thromboembolic events ranged from 2.3 to 6.9%. In these trials, the coumarin anticoagulant was begun between 24 hours and 4 days postoperatively, and the dipyridamole tablets were begun between 24 hours and 10 days postoperatively. The length of follow-up in these trials varied from 1 to 2 years. Dipyridamole tablets do not influence prothrombin time or activity measurements when administered with warfarin. Mechanism of Action 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. Via this mechanism, platelet aggregation is inhibited in response to various stimuli such as platelet activating factor (PAF), collagen and adenosine diphosphate (ADP). Dipyridamole inhibits phosphodiesterase (PDE) in various tissues. While the inhibition of cAMP-PDE is weak, therapeutic levels of dipyridamole inhibit cyclic-3',5'-guanosine monophosphate-PDE (cGMP-PDE), thereby augmenting the increase in cGMP produced by EDRF (endothelium-derived relaxing factor, now identified as nitric oxide). Hemodynamics In dogs intraduodenal doses of dipyridamole of 0.5 to 4.0 mg/kg produced dose-related decreases in systemic and coronary vascular resistance leading to decreases in systemic blood pressure and increases in coronary blood flow. Onset of action was in about 24 minutes and effects persisted for about 3 hours. Similar effects were observed following intravenous dipyridamole in doses ranging from 0.025 to 2.0 mg/kg. In man the same qualitative hemodynamic effects have been observed. However, acute intravenous administration of dipyridamole may worsen regional myocardial perfusion distal to partial occlusion of coronary arteries. Pharmacokinetics and Metabolism Following an oral dose of dipyridamole tablets, the average time to peak concentration is about 75 minutes. The decline in plasma concentration following a dose of dipyridamole tablets fits a two-compartment model. The alpha half-life (the initial decline following peak concentration) is approximately 40 minutes. The beta half-life (the terminal decline in plasma concentration) is approximately 10 hours. Dipyridamole is highly bound to plasma proteins. It is metabolized in the liver where it is conjugated as a glucuronide and excreted with the bile."],"indications_and_usage":["INDICATIONS AND USAGE Dipyridamole tablets are indicated as an adjunct to coumarin anticoagulants in the prevention of postoperative thromboembolic complications of cardiac valve replacement."],"adverse_reactions_table":["
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%
"],"spl_unclassified_section":["Manufactured by: Zydus Lifesciences Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 Rev.: 12/22"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION 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."],"spl_product_data_elements":["Dipyridamole Dipyridamole DIPYRIDAMOLE DIPYRIDAMOLE FERRIC OXIDE YELLOW HYPROMELLOSE 2910 (6 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL 3350 POVIDONE K30 TITANIUM DIOXIDE STARCH, CORN LIGHT YELLOW ROUND ZE;43 Dipyridamole Dipyridamole DIPYRIDAMOLE DIPYRIDAMOLE FERRIC OXIDE YELLOW HYPROMELLOSE 2910 (6 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE K30 TITANIUM DIOXIDE STARCH, CORN LIGHT YELLOW ROUND ZE;49 Dipyridamole Dipyridamole DIPYRIDAMOLE DIPYRIDAMOLE FERRIC OXIDE YELLOW HYPROMELLOSE 2910 (6 MPA.S) LACTOSE MONOHYDRATE MAGNESIUM STEARATE POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE K30 TITANIUM DIOXIDE STARCH, CORN LIGHT YELLOW ROUND ZE;50"],"package_label_principal_display_panel":["PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 68382-187-05 in bottle of 500 tablets Dipyridamole Tablets USP, 25 mg R x only 500 tablets NDC 68382-188-05 in bottle of 500 tablets Dipyridamole Tablets USP, 50 mg R x only 500 tablets NDC 68382-189-05 in bottle of 500 tablets Dipyridamole Tablets USP, 75 mg R x only 500 tablets Dipyridamole tablets, 25 mg Dipyridamole Tablets, 50 mg Dipyridamole Tablets, 75 mg"]},"tags":[{"label":"Platelet Aggregation Inhibitor","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Equilibrative nucleoside transporter 1","category":"target"},{"label":"SLC29A1","category":"gene"},{"label":"SLC28A1","category":"gene"},{"label":"PDE6A","category":"gene"},{"label":"B01AC07","category":"atc"},{"label":"Intravenous","category":"route"},{"label":"Oral","category":"route"},{"label":"Capsule","category":"form"},{"label":"Injection","category":"form"},{"label":"Solution","category":"form"},{"label":"Tablet","category":"form"},{"label":"Off-Patent","category":"patent"},{"label":"Generic Available","category":"availability"},{"label":"Established","category":"status"},{"label":"Atrial fibrillation","category":"indication"},{"label":"Chronic heart failure","category":"indication"},{"label":"Myocardial Perfusion Imaging Adjunct","category":"indication"},{"label":"Platelet Aggregation Inhibition","category":"indication"},{"label":"Prevention of Cerebral Thrombosis","category":"indication"},{"label":"Boehringer Ingelheim","category":"company"},{"label":"Approved 1960s","category":"decade"},{"label":"Cardiovascular Agents","category":"pharmacology"},{"label":"Enzyme Inhibitors","category":"pharmacology"},{"label":"Hematologic Agents","category":"pharmacology"},{"label":"Phosphodiesterase Inhibitors","category":"pharmacology"},{"label":"Platelet Aggregation Inhibitors","category":"pharmacology"},{"label":"Vasodilator Agents","category":"pharmacology"}],"phase":"marketed","safety":{"boxedWarnings":[],"safetySignals":[{"llr":1618.681,"date":"","count":399,"signal":"Sedation complication","source":"DrugCentral FAERS","actionTaken":"Reported 399 times (LLR=1619)"},{"llr":1531.95,"date":"","count":398,"signal":"Creatinine renal clearance decreased","source":"DrugCentral FAERS","actionTaken":"Reported 398 times (LLR=1532)"},{"llr":1329.527,"date":"","count":404,"signal":"Blood calcium decreased","source":"DrugCentral FAERS","actionTaken":"Reported 404 times (LLR=1330)"},{"llr":1149.46,"date":"","count":412,"signal":"Orthostatic hypotension","source":"DrugCentral FAERS","actionTaken":"Reported 412 times (LLR=1149)"},{"llr":1128.053,"date":"","count":404,"signal":"Sedation","source":"DrugCentral FAERS","actionTaken":"Reported 404 times (LLR=1128)"},{"llr":1117.663,"date":"","count":437,"signal":"Cognitive disorder","source":"DrugCentral FAERS","actionTaken":"Reported 437 times (LLR=1118)"},{"llr":995.436,"date":"","count":424,"signal":"Depressed level of consciousness","source":"DrugCentral FAERS","actionTaken":"Reported 424 times (LLR=995)"},{"llr":909.499,"date":"","count":420,"signal":"Balance disorder","source":"DrugCentral FAERS","actionTaken":"Reported 420 times (LLR=909)"},{"llr":767.718,"date":"","count":402,"signal":"Mobility decreased","source":"DrugCentral FAERS","actionTaken":"Reported 402 times (LLR=768)"},{"llr":539.71,"date":"","count":504,"signal":"Hypotension","source":"DrugCentral FAERS","actionTaken":"Reported 504 times (LLR=540)"},{"llr":514.777,"date":"","count":430,"signal":"Constipation","source":"DrugCentral FAERS","actionTaken":"Reported 430 times (LLR=515)"},{"llr":430.402,"date":"","count":483,"signal":"Fall","source":"DrugCentral FAERS","actionTaken":"Reported 483 times (LLR=430)"},{"llr":309.521,"date":"","count":364,"signal":"Toxicity to various agents","source":"DrugCentral FAERS","actionTaken":"Reported 364 times (LLR=310)"},{"llr":188.271,"date":"","count":433,"signal":"Pain","source":"DrugCentral FAERS","actionTaken":"Reported 433 times (LLR=188)"},{"llr":100.123,"date":"","count":34,"signal":"Multiple drug therapy","source":"DrugCentral FAERS","actionTaken":"Reported 34 times (LLR=100)"}],"drugInteractions":[{"url":"/drug/p-glycoprotein-substrates","drug":"P-glycoprotein Substrates","action":"Use caution","effect":"P-glycoprotein Inhibitors - P-glycoprotein Substrates","source":"DrugCentral","drugSlug":"p-glycoprotein-substrates"}],"commonSideEffects":[{"effect":"ST-T changes","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"headache","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"dizziness","drugRate":"","severity":"common","_validated":false,"_confidence":0.3},{"effect":"hypertonia","drugRate":"","severity":"mild","_validated":false,"_confidence":0.3},{"effect":"dyspepsia","drugRate":"1%","severity":"common","_validated":true},{"effect":"myalgia","drugRate":"","severity":"mild","_validated":false,"_confidence":0.3},{"effect":"abdominal pain","drugRate":"","severity":"mild","_validated":false,"_confidence":0.3},{"effect":"flatulence","drugRate":"","severity":"mild","_validated":false,"_confidence":0.3},{"effect":"back pain","drugRate":"","severity":"mild","_validated":false,"_confidence":0.3},{"effect":"hyperventilation","drugRate":"","severity":"mild","_validated":false,"_confidence":0.3},{"effect":"nervousness/anxiety","drugRate":"","severity":"mild","_validated":false,"_confidence":0.3},{"effect":"vomiting","drugRate":"","severity":"mild","_validated":false,"_confidence":0.3},{"effect":"diaphoresis","drugRate":"","severity":"mild","_validated":false,"_confidence":0.3},{"effect":"arthralgia","drugRate":"","severity":"mild","_validated":false,"_confidence":0.3},{"effect":"asthenia","drugRate":"","severity":"mild","_validated":false,"_confidence":0.3},{"effect":"malaise","drugRate":"","severity":"mild","_validated":false,"_confidence":0.3},{"effect":"palpitation","drugRate":"","severity":"mild","_validated":false,"_confidence":0.3},{"effect":"hypertension","drugRate":"reported","severity":"unknown"},{"effect":"hypersensitivity","drugRate":"reported","severity":"unknown"},{"effect":"allergic reaction","drugRate":"reported","severity":"unknown"},{"effect":"urticaria","drugRate":"reported","severity":"unknown"},{"effect":"pruritus","drugRate":"reported","severity":"unknown"},{"effect":"dermatitis","drugRate":"reported","severity":"unknown"},{"effect":"rash","drugRate":"reported","severity":"unknown"}],"contraindications":["Acute coronary syndrome","Acute erosive gastritis","Acute nephropathy","Alcoholism","Anemia","Anemia due to enzyme deficiency","Atrioventricular block","Breastfeeding (mother)","Constrictive pericarditis","Cor pulmonale","Disease of liver","Factor II deficiency","Gastrointestinal hemorrhage","Gastrointestinal ulcer","Gout","Hemophilia","Hypercalcemia","Hypokalemia","Hypomagnesemia","Idiopathic hypertrophic subaortic stenosis","Kidney disease","Low blood pressure","Myocardial infarction","Myocarditis","Myxedema"],"specialPopulations":{"Pregnancy":"There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of harm to the fetus due to dipyridamole. Teratogenic EffectsReproduction 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 1/2 2 and 25 times the maximum recommended daily human oral dose, respectively, on mg/m basis) and have revealed no evidence of harm to the fetus due to dipyridamole.","Paediatric use":"Safety and effectiveness in the pediatric population below the age of 12 years have not been established."}},"trials":[],"aliases":[],"company":"Boehringer Ingelheim","patents":[],"pricing":[{"market":"United States","source":"CMS National Average Drug Acquisition Cost (NADAC)","asOfDate":"2024-01-03","unitCost":"$0.4742/EA","priceType":"NADAC","sourceUrl":"https://data.medicaid.gov/dataset/4j6z-xnwq","annualCost":"$173","description":"DIPYRIDAMOLE 75 MG TABLET","retrievedDate":"2026-04-07"}],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=DIPYRIDAMOLE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:47:00.705542+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:47:06.439003+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=DIPYRIDAMOLE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:47:06.840769+00:00"},"mechanism.drugClass":{"url":"https://api.fda.gov/drug/label.json","method":"deterministic","source":"FDA Label (EPC)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:46:59.599439+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:46:59.599531+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:46:59.599538+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: 3',5'-cyclic phosphodiesterase inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:47:07.929001+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL932/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:47:07.581544+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA040874","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T03:46:59.599542+00:00"}},"allNames":"persantine","offLabel":[],"synonyms":["dipyridamole","cardoxil","cardoxin","cleridium","dipyridamine","dipyridamol","dipyridan","peridamol","persantin","stenocardil","stimolcardio"],"timeline":[{"date":"1961-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from BOEHRINGER INGELHEIM to Boehringer Ingelheim"},{"date":"1961-12-06","type":"positive","source":"DrugCentral","milestone":"FDA approval (Boehringer Ingelheim)"},{"date":"1986-12-22","type":"positive","source":"FDA Orange Book","milestone":"Persantine approved — 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**"},{"date":"1998-04-13","type":"neutral","source":"FDA Orange Book","milestone":"Generic entry — 10 manufacturers approved"}],"aiSummary":"Persantine (Dipyridamole) is a small molecule platelet aggregation inhibitor developed by Boehringer Ingelheim, targeting the equilibrative nucleoside transporter 1. It was first approved by the FDA in 1961 for various indications, including atrial fibrillation, chronic heart failure, and myocardial perfusion imaging adjunct. Persantine is now off-patent, with 17 generic manufacturers available. Key safety considerations include its potential to cause vasodilation and myocardial ischemia. As a platelet aggregation inhibitor, Persantine works by inhibiting platelet activation and aggregation, thereby reducing the risk of thrombosis.","approvals":[{"date":"1961-12-06","orphan":false,"company":"BOEHRINGER INGELHEIM","regulator":"FDA"}],"brandName":"Persantine","ecosystem":[{"indication":"Atrial fibrillation","otherDrugs":[{"name":"acetyldigitoxin","slug":"acetyldigitoxin","company":"Novartis"},{"name":"bisoprolol","slug":"bisoprolol","company":"Teva Womens"},{"name":"clopidogrel","slug":"clopidogrel","company":"Sanofi Aventis Us"},{"name":"digoxin","slug":"digoxin","company":"Eurohlth Intl Sarl"}],"globalPrevalence":59000000},{"indication":"Chronic heart failure","otherDrugs":[{"name":"candesartan cilexetil","slug":"candesartan-cilexetil","company":"Astrazeneca"},{"name":"captopril","slug":"captopril","company":"Par Pharm"},{"name":"carvedilol","slug":"carvedilol","company":"Smithkline Beecham"},{"name":"chlorothiazide","slug":"chlorothiazide","company":"Oak Pharms Akorn"}],"globalPrevalence":64000000},{"indication":"Myocardial Perfusion Imaging Adjunct","otherDrugs":[{"name":"adenosine","slug":"adenosine","company":"Astellas"},{"name":"ganciclovir","slug":"ganciclovir","company":"Roche Palo"},{"name":"regadenoson","slug":"regadenoson","company":"Astellas"}],"globalPrevalence":null},{"indication":"Platelet Aggregation Inhibition","otherDrugs":[],"globalPrevalence":null},{"indication":"Prevention of Cerebral Thrombosis","otherDrugs":[{"name":"apraclonidine","slug":"apraclonidine","company":"Alcon"},{"name":"dicoumarol","slug":"dicoumarol","company":"Abbvie"},{"name":"ticlopidine","slug":"ticlopidine","company":""}],"globalPrevalence":null}],"mechanism":{"target":"Equilibrative nucleoside transporter 1","novelty":"Follow-on","targets":[{"gene":"SLC29A1","source":"DrugCentral","target":"Equilibrative nucleoside transporter 1","protein":"Equilibrative nucleoside transporter 1"},{"gene":"SLC28A1","source":"DrugCentral","target":"Sodium/nucleoside cotransporter 1","protein":"Sodium/nucleoside cotransporter 1"},{"gene":"PDE6A","source":"DrugCentral","target":"Phosphodiesterase 6","protein":"Rod cGMP-specific 3',5'-cyclic phosphodiesterase subunit alpha"},{"gene":"PDE6B","source":"DrugCentral","target":"Phosphodiesterase 6","protein":"Rod cGMP-specific 3',5'-cyclic phosphodiesterase subunit beta"},{"gene":"PDE6C","source":"DrugCentral","target":"Phosphodiesterase 6","protein":"Cone cGMP-specific 3',5'-cyclic phosphodiesterase subunit alpha'"},{"gene":"PDE6D","source":"DrugCentral","target":"Phosphodiesterase 6","protein":"Retinal rod rhodopsin-sensitive cGMP 3',5'-cyclic phosphodiesterase subunit delta"},{"gene":"PDE6G","source":"DrugCentral","target":"Phosphodiesterase 6","protein":"Retinal rod rhodopsin-sensitive cGMP 3',5'-cyclic phosphodiesterase subunit gamma"},{"gene":"PDE6H","source":"DrugCentral","target":"Phosphodiesterase 6","protein":"Retinal cone rhodopsin-sensitive cGMP 3',5'-cyclic phosphodiesterase subunit gamma"},{"gene":"PDE11A","source":"DrugCentral","target":"Dual 3',5'-cyclic-AMP and -GMP phosphodiesterase 11A","protein":"Dual 3',5'-cyclic-AMP and -GMP phosphodiesterase 11A"},{"gene":"PDE5A","source":"DrugCentral","target":"cGMP-specific 3',5'-cyclic phosphodiesterase","protein":"cGMP-specific 3',5'-cyclic phosphodiesterase"}],"modality":"Small Molecule","drugClass":"Platelet Aggregation Inhibitor [EPC]","explanation":"Mechanism of Action. Dipyridamole inhibits the uptake of adenosine into platelets, endothelial cells and erythrocytes in vitro and in vivo; the inhibition occurs in dose-dependent manner at therapeutic concentrations (0.5-1.9 ug/mL). This inhibition results in an increase in local concentrations of adenosine which acts on the platelet 2-receptor thereby stimulating platelet adenylate cyclase and increasing platelet cyclic-3,5- adenosine monophosphate (cAMP) levels. Via this mechanism, platelet aggregation is inhibited in response to various stimuli such as platelet activating factor (PAF), collagen and adenosine diphosphate (ADP). Dipyridamole inhibits phosphodiesterase (PDE) in various tissues. While the inhibition of cAMP-PDE is weak, therapeutic levels of dipyridamole inhibit cyclic-3,5-guanosine monophosphate-PDE (cGMP- PDE), thereby augmenting the increase in cGMP produced by EDRF (endothelium-derived relaxing factor, now identified as nitric oxide).","oneSentence":"Persantine works by inhibiting platelet activation and aggregation by blocking the equilibrative nucleoside transporter 1.","technicalDetail":"Persantine (Dipyridamole) acts as a non-competitive inhibitor of the equilibrative nucleoside transporter 1 (ENT1), which is responsible for the uptake of adenosine and other nucleosides into platelets. By blocking ENT1, Persantine increases the concentration of adenosine in the extracellular space, leading to vasodilation and inhibition of platelet activation and aggregation.","_target_confidence":0.5},"commercial":{"launchDate":"1961","_launchSource":"DrugCentral (FDA 1961-12-06, BOEHRINGER INGELHEIM)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/924","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=DIPYRIDAMOLE","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=DIPYRIDAMOLE","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange Book"}],"_enrichedAt":"2026-03-30T10:42:14.193881","_validation":{"fieldsValidated":0,"lastValidatedAt":"2026-04-20T03:47:11.381719+00:00","fieldsConflicting":17,"overallConfidence":0.8},"biosimilars":[],"competitors":[{"drugName":"clopidogrel","drugSlug":"clopidogrel","fdaApproval":"1997-11-17","genericCount":23,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"ticlopidine","drugSlug":"ticlopidine","fdaApproval":"1991-10-31","genericCount":8,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"acetylsalicylic acid","drugSlug":"acetylsalicylic-acid","fdaApproval":"1950-04-12","relationship":"same-class"},{"drugName":"epoprostenol","drugSlug":"epoprostenol","fdaApproval":"1995-09-20","patentExpiry":"Mar 15, 2027","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"iloprost","drugSlug":"iloprost","fdaApproval":"2004-12-29","patentExpiry":"Jul 18, 2044","patentStatus":"Patent 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Reinfarction Prevention","source":"DrugCentral","drugName":"DIPYRIDAMOLE","evidenceCount":14,"evidenceLevel":"moderate"},{"name":"Thromboembolic disorder","source":"DrugCentral","drugName":"DIPYRIDAMOLE","evidenceCount":364,"evidenceLevel":"strong"},{"name":"Transient ischemic attack","source":"DrugCentral","drugName":"DIPYRIDAMOLE","evidenceCount":390,"evidenceLevel":"strong"}],"pipeline":[]},"currentOwner":"Boehringer Ingelheim","drugCategory":"established","labelChanges":[],"patentStatus":"Off-patent — no active Orange Book patents","relatedDrugs":[{"drugId":"clopidogrel","brandName":"clopidogrel","genericName":"clopidogrel","approvalYear":"1997","relationship":"same-class"},{"drugId":"ticlopidine","brandName":"ticlopidine","genericName":"ticlopidine","approvalYear":"1991","relationship":"same-class"},{"drugId":"acetylsalicylic-acid","brandName":"acetylsalicylic acid","genericName":"acetylsalicylic 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Endovascular Treatment of Asymptomatic Carotid Artery Stenosis","status":"RECRUITING","sponsor":"Beijing Tiantan Hospital","startDate":"2024-10-18","conditions":["Asymptomatic Carotid Artery Stenosis"],"enrollment":982,"completionDate":"2028-07"},{"nctId":"NCT04645550","phase":"PHASE4","title":"Apixaban, Warfarin and Aspirin Prevents Portal Vein Thrombosis in Patients After Laparoscopic Splenectomy（ESAWAAPT）","status":"COMPLETED","sponsor":"Northern Jiangsu People's Hospital","startDate":"2020-11-22","conditions":["Cirrhosis","Splenectomy; Status","Venous Thrombosis","Hypertension, Portal"],"enrollment":120,"completionDate":"2023-12-31"},{"nctId":"NCT04410328","phase":"PHASE3","title":"Aggrenox To Treat Acute Covid-19","status":"COMPLETED","sponsor":"Rutgers, The State University of New Jersey","startDate":"2020-10-21","conditions":["Covid19"],"enrollment":98,"completionDate":"2021-10-15"},{"nctId":"NCT06824454","phase":"PHASE2","title":"Evaluation of Dipyridamole in Preventing Post-Transplant Hypophosphatemia in Kidney Transplant Recipients","status":"NOT_YET_RECRUITING","sponsor":"Stanford University","startDate":"2025-03","conditions":["Hypophosphatemia","Kidney Transplantation"],"enrollment":90,"completionDate":"2026-03"},{"nctId":"NCT00129038","phase":"PHASE4","title":"Modified-release Dipyridamole/Aspirin (200mg/25mg bd) Versus Aspirin (75mg) in Aspirin-resistant Patients","status":"COMPLETED","sponsor":"Boehringer Ingelheim","startDate":"2004-04-01","conditions":["Coronary Arteriosclerosis"],"enrollment":11,"completionDate":""},{"nctId":"NCT04666454","phase":"PHASE4","title":"BROKEN-SWEDEHEART- Optimized Pharmacological Treatment for Broken Heart (Takotsubo) Syndrome.","status":"RECRUITING","sponsor":"Vastra Gotaland Region","startDate":"2020-12-14","conditions":["Takotsubo Syndrome"],"enrollment":1000,"completionDate":"2028-12"},{"nctId":"NCT05763862","phase":"NA","title":"Genotype Guided Antiplatelet Therapy in Ischemic 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Hospital, School of Medicine, Zhejiang University","startDate":"2023-09-15","conditions":["Acute Ischemic Stroke","Thrombocytopenia"],"enrollment":1200,"completionDate":"2026-01-01"},{"nctId":"NCT03354273","phase":"PHASE3","title":"An International Study to Evaluate Diagnostic Efficacy of Flurpiridaz (18F) Injection PET MPI in the Detection of Coronary Artery Disease (CAD)","status":"COMPLETED","sponsor":"GE Healthcare","startDate":"2018-06-05","conditions":["Coronary Artery Disease (CAD)"],"enrollment":730,"completionDate":"2022-05-05"},{"nctId":"NCT04424901","phase":"PHASE2","title":"Trial of Open Label Dipyridamole- In Hospitalized Patients With COVID-19","status":"TERMINATED","sponsor":"UConn Health","startDate":"2020-05-03","conditions":["COVID-19 Pneumonia","Vascular Complications"],"enrollment":41,"completionDate":"2022-04-24"},{"nctId":"NCT05637333","phase":"","title":"Sonazoid in Myocardial Perfusion Imaging","status":"WITHDRAWN","sponsor":"London North West Healthcare NHS 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