Prescription medicine

Aspirin and dipyridamole First approved as Aggrenox

Aspirin and dipyridamole (Aggrenox) is a prescription medicine with an FDA approval on record since 1999. FDA's NDC Directory lists it from 9 generic labelers, and pharmacies paid $0.559 per unit (Aspirin-dipyridam ER 25-200 mg) in the October 7, 2026 NADAC survey.

Generic listed

Check it at the source: the aspirin and dipyridamole FDA label on DailyMed (effective January 5, 2026, Glenmark Pharmaceuticals Inc., USA); the NDA 20884 record on Drugs@FDA; every aspirin and dipyridamole label on DailyMed.

Highlights of the record

FDA label of January 5, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026

Used for

From the label: indications and usage
Aspirin and extended-release dipyridamole capsules are indicated to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis.

Forms and strengths

25 mg / 200 mg

Capsule; extended-release capsule.

On the market

Earliest approval on file: November 22, 1999 Aggrenox, Boehringer Ingelheim; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: 11 first August 14, 2009; 8 with a marketed status in Drugs@FDA
Labelers listed (NDC): 9 of which 9 under generic applications, 0 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC): $0.559 per unit Aspirin-dipyridam ER 25-200 mg
Shortage (FDA): No current entry
Recalls by its makers (FDA): 2 since 2013 0 Class I among all firms' recalls; latest June 29, 2022; 1 more by firms not listed as its makers
FAERS reports: 239 through July 30, 2026

What is aspirin and dipyridamole used for?

From the label: indications and usage
Aspirin and extended-release dipyridamole capsules are indicated to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis.
Aspirin and extended-release dipyridamole capsules are a combination of aspirin and dipyridamole, antiplatelet agents, indicated to reduce the risk of stroke in patients who have had transient ischemia of the brain or completed ischemic stroke due to thrombosis

Conditions named in the indications of aspirin and dipyridamole's FDA labels, with every medicine labeled for each:

Stroke prevention

FDA pharmacologic class: Nonsteroidal Anti-inflammatory Drug and Platelet Aggregation Inhibitor.

Source: FDA drug label (ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE), Glenmark Pharmaceuticals Inc., USA, effective January 5, 2026 (SPL set 467d6ce3-bc05-4aa1-87cc-3214fd628d39), via openFDA; the full label on DailyMed

What does the patient leaflet for aspirin and dipyridamole say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What should I avoid while using Aspirin and Extended-Release Dipyridamole Capsules?
• heavy alcohol use. People who drink three or more alcoholic drinks every day have a higher risk of bleeding during treatment with aspirin and extended-release dipyridamole capsules, because it contains aspirin.

From the patient leaflet: How should I store Aspirin and Extended-Release Dipyridamole Capsules?
Store aspirin and extended-release dipyridamole capsules at room temperature 59ºF to 86ºF (15ºC to 30ºC). • Keep aspirin and extended-release dipyridamole capsules dry. Keep aspirin and extended-release dipyridamole capsules and all medicines out of the reach of children.

Is there a generic for aspirin and dipyridamole (Aggrenox)?

The FDA approved the first generic aspirin and dipyridamole on August 14, 2009. 11 generic applications are approved; 8 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.

FDA's NDC Directory lists aspirin and dipyridamole from 9 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

1999 earliest approval on file
2009 first generic approved
red ticks recalls

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What do pharmacies pay for aspirin and dipyridamole (Aggrenox)?

In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.559 per unit (Aspirin-dipyridam ER 25-200 mg), down 2% from $0.572 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.

Aspirin-dipyridam ER 25-200 mg (generic)

$0.776

$0.556

January 2024October 2026

NADAC per unit, October 7, 2026
Strength and form	Brand or generic	Pharmacy cost	30 tablets, or one pen or vial	12-month change
Aspirin-dipyridam ER 25-200 mg	Generic	$0.559 per unit	n/a	-2%

Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price

Has aspirin and dipyridamole been recalled?

The FDA's Enforcement Report lists 3 recalls naming aspirin and dipyridamole since 2013: 0 Class I (the most serious), 2 Class II, 1 Class III; 1 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of aspirin and dipyridamole and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.

Started	Class	Company	Reason
June 29, 2022	Class III	Glenmark Pharmaceuticals Inc., USA	Failed Tablet/Capsule Specification : Capsule breakage
March 1, 2019	Class II	American Health Packaging	Failed Impurities/Degradation Specifications; out of specification result for an unknown impurity in stability samples.
July 2, 2013	Class II	Aidapak Services, LLC not a listed maker	Labeling: Label Mixup: ASPIRIN/ER DIPYRIDAMOLE, Capsule, 25 mg/200 mg may have potentially been mislabeled as the following drug: THIAMINE HCL, Tablet, 100 mg …

Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026

What does the aspirin and dipyridamole label say about other medicines?

The aspirin and dipyridamole label names 12 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine named	Section	What the label says
Acetazolamide	drug interactions	Acetazolamide Concurrent use of aspirin and acetazolamide can lead to high serum concentrations of acetazolamide (and toxicity) due to competition at the renal tubule for secretion.
Adenosine	drug interactions	Adenosinergic agents (e.g. adenosine, regadenoson) Dipyridamole has been reported to increase the plasma levels and cardiovascular effects of adenosine.
Anagrelide	drug interactions	Anagrelide Patients taking aspirin in combination with anagrelide are at an increased risk of bleeding.
Divalproex	drug interactions	Anticonvulsants Salicylic acid can displace protein-bound phenytoin and valproic acid, leading to a decrease in the total concentration of phenytoin and an increase in serum valproic acid levels.
Heparin	drug interactions	Aspirin can increase the anticoagulant activity of heparin, increasing bleeding risk.
Methotrexate	drug interactions	Methotrexate Salicylate can inhibit renal clearance of methotrexate, leading to bone marrow toxicity, especially in the elderly or renal impaired.
Phenytoin	drug interactions	Anticonvulsants Salicylic acid can displace protein-bound phenytoin and valproic acid, leading to a decrease in the total concentration of phenytoin and an increase in serum valproic acid levels.
Probenecid	drug interactions	Uricosuric Agents (probenecid and sulfinpyrazone) Salicylates antagonize the uricosuric action of uricosuric agents.
Regadenoson	drug interactions	Adenosinergic agents (e.g. adenosine, regadenoson) Dipyridamole has been reported to increase the plasma levels and cardiovascular effects of adenosine.
Salicylic acid	drug interactions	Anticonvulsants Salicylic acid can displace protein-bound phenytoin and valproic acid, leading to a decrease in the total concentration of phenytoin and an increase in serum valproic acid levels.
Valproic acid	drug interactions	Anticonvulsants Salicylic acid can displace protein-bound phenytoin and valproic acid, leading to a decrease in the total concentration of phenytoin and an increase in serum valproic acid levels.
Warfarin	drug interactions	Aspirin can displace warfarin from protein binding sites, leading to prolongation of both the prothrombin time and the bleeding time.

Check aspirin and dipyridamole against other medicines

What do FAERS reports show for aspirin and dipyridamole?

The FDA Adverse Event Reporting System holds 239 reports that list aspirin and dipyridamole among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 19 are coded as a death and 111 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

The most reported reactions

Cerebrovascular Accident16
Nausea (named in the label)15
Vomiting (named in the label)14
Pain In Extremity12
Diarrhoea (named in the label)11
Dizziness (named in the label)10
Fatigue10
Headache (named in the label)10

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What next?

Other NSAIDs: the pharmacologic class, with prices and generics
Aspirin and dipyridamole side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other