"July 25, 2014 -- When the blood-thinner drug Pradaxa (dabigatran) was FDA-approved in 2010 to prevent stroke in people at high risk, a major selling point was that it doesn't require frequent blood tests like the old standby drug, warfarin.
Aggrenox Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Aggrenox (aspirin, extended-release dipyridamole) is used to reduce the risk of stroke in people who have had blood clots or a "mini-stroke" (also called a transient ischemic attack or TIA). Aggrenox is a combination of aspirin, a salicylate, and dipyridamole, a platelet aggregation inhibitor. This medication may be available in generic form. Common side effects include headache, nausea, and heartburn.
The recommended dose of Aggrenox is one 25 mg/200 mg capsule given orally twice daily, one in the morning and one in the evening. Aggrenox may interact with acetazolamide, methotrexate, diabetes medications taken orally, gout medications, ACE inhibitors, Alzheimer medications, beta-blockers, diuretics (water pills), seizure medication, aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs). Tell your doctor all medications you are taking. Aspirin is not recommended for use during pregnancy. This medication should be used only when prescribed during the first 6 months of pregnancy. Do not use this medication during the last 3 months of pregnancy because of possible harm to the fetus or problems during delivery. This medication passes into breast milk. Breast-feeding while using this drug is not recommended.
Our Aggrenox (aspirin, extended-release dipyridamole) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Aggrenox in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using this medication and call your doctor at once if you have any of these serious side effects:
- weakness or fainting;
- black, bloody, or tarry stools;
- coughing up blood or vomit that looks like coffee grounds;
- severe nausea, vomiting, or stomach pain;
- fever lasting longer than 3 days;
- swelling, or pain lasting longer than 10 days; or
- hearing problems, ringing in your ears.
Less serious side effects may include:
- upset stomach, mild heartburn, nausea, vomiting, diarrhea;
- joint pain;
- drowsiness; or
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Aggrenox (Aspirin, Extended-Release Dipyridamole Capsules)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Aggrenox Overview - Patient Information: Side Effects
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: easy bleeding/bruising, uncontrolled bleeding from gums or nose, fast/slow/irregular heartbeat, loss of appetite, dark urine, yellowing eyes/skin, unusual tiredness, unusual weakness.
This drug may infrequently cause serious bleeding from the stomach or intestines. If you notice any of the following serious side effects, stop taking this medication and consult your doctor or pharmacist right away: black stools, vomit that looks like coffee grounds, persistent stomach/abdominal pain.
Get medical help right away if you have any very serious side effects, including: fainting, symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating), signs of bleeding in the brain or stroke (such as weakness on one side of the body, slurred speech, sudden vision changes, confusion).
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Aggrenox (Aspirin, Extended-Release Dipyridamole Capsules)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Aggrenox FDA Prescribing Information: Side Effects
The following adverse reactions are discussed elsewhere in the labeling:
- Hypersensitivity [see CONTRAINDICATIONS].
- Allergy [see CONTRAINDICATIONS].
- Risk of Bleeding [see WARNINGS AND PRECAUTIONS].
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The efficacy and safety of AGGRENOX was established in the European Stroke Prevention Study-2 (ESPS2). ESPS2 was a double-blind, placebo controlled study that evaluated 6602 patients over the age of 18 years who had a previous ischemic stroke or transient ischemic attack within ninety days prior to entry. Patients were randomized to either AGGRENOX, aspirin, ER-DP, or placebo [see Clinical Studies]; primary endpoints included stroke (fatal or nonfatal) and death from all causes.
This 24-month, multicenter, double-blind, randomized study (ESPS2) was conducted to compare the efficacy and safety of AGGRENOX with placebo, extendedrelease dipyridamole alone and aspirin alone. The study was conducted in a total of 6602 male and female patients who had experienced a previous ischemic stroke or transient ischemia of the brain within three months prior to randomization.
Table 1 presents the incidence of adverse events that occurred in 1% or more of patients treated with AGGRENOX where the incidence was also greater than in those patients treated with placebo. There is no clear benefit of the dipyridamole/aspirin combination over aspirin with respect to safety.
Table 1 : Incidence of Adverse Events in ESPS2*
|Body System/Preferred Term||Individual Treatment Group|
|AGGRENOX||ER-DP Alone||ASA Alone||Placebo|
|Total Number of Patients||1650||1654||1649||1649|
|Total Number (%) of Patients With at Least|
|One On-Treatment Adverse Event||1319 (80%)||1305 (79%)||1323 (80%)||1304 (79%)|
|Central and Peripheral Nervous System Disorders|
|Headache||647 (39%)||634 (38%)||558 (34%)||543 (33%)|
|Convulsions||28 (2%)||15 (1%)||28 (2%)||26 (2%)|
|Gastrointestinal System Disorders|
|Dyspepsia||303 (18%)||288 (17%)||299 (18%)||275 (17%)|
|Abdominal Pain||289 (18%)||255 (15%)||262 (16%)||239 (14%)|
|Nausea||264 (16%)||254 (15%)||210 (13%)||232 (14%)|
|Diarrhea||210 (13%)||257 (16%)||112 (7%)||161 (10%)|
|Vomiting||138 (8%)||129 (8%)||101 (6%)||118 (7%)|
|Hemorrhage Rectum||26 (2%)||22 (1%)||16 (1%)||13 (1%)|
|Melena||31 (2%)||10 (1%)||20 (1%)||13 (1%)|
|Hemorrhoids||16 (1%)||13 (1%)||10 (1%)||10 (1%)|
|GI Hemorrhage||20 (1%)||5 (0%)||15 (1%)||7 (0%)|
|Body as a Whole - General Disorders|
|Pain||105 (6%)||88 (5%)||103 (6%)||99 (6%)|
|Fatigue||95 (6%)||93 (6%)||97 (6%)||90 (5%)|
|Back Pain||76 (5%)||77 (5%)||74 (4%)||65 (4%)|
|Accidental Injury||42 (3%)||24 (1%)||51 (3%)||37 (2%)|
|Malaise||27 (2%)||23 (1%)||26 (2%)||22 (1%)|
|Asthenia||29 (2%)||19 (1%)||17 (1%)||18 (1%)|
|Syncope||17 (1%)||13 (1%)||16 (1%)||8 (0%)|
|Amnesia||39 (2%)||40 (2%)||57 (3%)||34 (2%)|
|Confusion||18 (1%)||9 (1%)||22 (1%)||15 (1%)|
|Anorexia||19 (1%)||17 (1%)||10 (1%)||15 (1%)|
|Somnolence||20 (1%)||13 (1%)||18 (1%)||9 (1%)|
|Musculoskeletal System Disorders|
|Arthralgia||91 (6%)||75 (5%)||91 (6%)||76 (5%)|
|Arthritis||34 (2%)||25 (2%)||17 (1%)||19 (1%)|
|Arthrosis||18 (1%)||22 (1%)||13 (1%)||14 (1%)|
|Myalgia||20 (1%)||16 (1%)||11 (1%)||11 (1%)|
|Respiratory System Disorders|
|Coughing||25 (2%)||18 (1%)||32 (2%)||21 (1%)|
|Upper Respiratory Tract Infection||16 (1%)||9 (1%)||16 (1%)||14 (1%)|
|Cardiovascular Disorders, General|
|Cardiac Failure||26 (2%)||17 (1%)||30 (2%)||25 (2%)|
|Platelet, Bleeding and Clotting Disorders|
|Hemorrhage NOS||52 (3%)||24 (1%)||46 (3%)||24 (1%)|
|Epistaxis||39 (2%)||16 (1%)||45 (3%)||25 (2%)|
|Purpura||23 (1%)||8 (0%)||9 (1%)||7 (0%)|
|Neoplasm NOS||28 (2%)||16 (1%)||23 (1%)||20 (1%)|
|Red Blood Cell Disorders|
|Anemia||27 (2%)||16 (1%)||19 (1%)||9 (1%)|
|* Reported by ≥ 1% of patients during AGGRENOX treatment
where the incidence was greater than in those treated with placebo.
Note: ER-DP = extended-release dipyridamole 200 mg; ASA = aspirin 25 mg. The dosage regimen for all treatment groups is BID
NOS = not otherwise specified.
Discontinuation due to adverse events in ESPS2 was 25% for AGGRENOX, 25% for extended-release dipyridamole, 19% for aspirin, and 21% for placebo (refer to Table 2)
Table 2 : Incidence of Adverse Events that Led to the
Discontinuation of Treatment: Adverse Events with an Incidence of ≥ 1%
in the AGGRENOX Group
|Total Number of Patients||1650||1654||1649||1649|
|Patients with at least one Adverse Event that led to treatment discontinuation||417 (25%)||419 (25%)||318 (19%)||352 (21%)|
|Headache||165 (10%)||166 (10%)||57 (3%)||69 (4%)|
|Dizziness||85 (5%)||97 (6%)||69 (4%)||68 (4%)|
|Nausea||91 (6%)||95 (6%)||51 (3%)||53 (3%)|
|Abdominal Pain||74 (4%)||64 (4%)||56 (3%)||52 (3%)|
|Dyspepsia||59 (4%)||61 (4%)||49 (3%)||46 (3%)|
|Vomiting||53 (3%)||52 (3%)||28 (2%)||24 (1%)|
|Diarrhea||35 (2%)||41 (2%)||9 ( < 1%)||16 ( < 1%)|
|Stroke||39 (2%)||48 (3%)||57 (3%)||73 (4%)|
|Transient Ischemic Attack||35 (2%)||40 (2%)||26 (2%)||48 (3%)|
|Angina Pectoris||23 (1%)||20 (1%)||16 ( < 1%)||26 (2%)|
|Note: ER-DP = extended-release dipyridamole 200 mg; ASA = aspirin 25 mg. The dosage regimen for all treatment groups is BID|
Headache was most notable in the first month of treatment.
Other Adverse Events
Adverse reactions that occurred in less than 1% of patients treated with AGGRENOX in the ESPS2 study and that were medically judged to be possibly related to either dipyridamole or aspirin are listed below.
Body as a Whole: Allergic reaction, fever
Hearing and Vestibular Disorders: Tinnitus, and deafness. Patients with high frequency hearing loss may have difficulty perceiving tinnitus. In these patients, tinnitus cannot be used as a clinical indicator of salicylism
Metabolic and Nutritional Disorders: Hyperglycemia, thirst
Platelet, Bleeding and Clotting Disorders: Hematoma, gingival bleeding
Psychiatric Disorders: Agitation
Reproductive: Uterine hemorrhage
Special Senses Other Disorders: Taste loss
Urogenital: Renal insufficiency and failure, hematuria
Vascular (Extracardiac) Disorders: Flushing
Over the course of the 24-month study (ESPS2), patients treated with AGGRENOX showed a decline (mean change from baseline) in hemoglobin of 0.25 g/dL, hematocrit of 0.75%, and erythrocyte count of 0.13x106/mm³.
The following is a list of additional adverse reactions that have been reported either in the literature or are from post-marketing spontaneous reports for either dipyridamole or aspirin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or establish a causal relationship to drug exposure. Decisions to include these reactions in labeling are typically based on one or more of the following factors: (1) seriousness of the reaction, (2) frequency of reporting, or (3) strength of causal connection to AGGRENOX.
Body as a Whole: Hypothermia, chest pain
Cardiovascular: Angina pectoris
Central Nervous System: Cerebral edema
Hearing and Vestibular Disorders: Hearing loss
Immune System Disorders: Hypersensitivity, acute anaphylaxis, laryngeal edema
Liver and Biliary System Disorders: Hepatitis, hepatic failure
Metabolic and Nutritional Disorders: Hypoglycemia, dehydration
Reproductive: Prolonged pregnancy and labor, stillbirths, lower birth weight infants, antepartum and postpartum bleeding
Urogenital: Interstitial nephritis, papillary necrosis, proteinuria
Vascular (Extracardiac Disorders): Allergic vasculitis
Read the entire FDA prescribing information for Aggrenox (Aspirin, Extended-Release Dipyridamole Capsules)
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