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Aggrenox

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Aggrenox

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
  • headache.

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

SIDE EFFECTS: Headache, nausea, and heartburn may occur. Talk with your doctor if you have a severe headache when you first start taking this medication. Your doctor may change your dose for the first week to lessen headache. If any of these effects persist or worsen, contact your doctor or pharmacist promptly.

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 immediately if any of these unlikely but serious side effects occur: easy bleeding/bruising, uncontrolled bleeding from gums or nose, fast/slow/irregular heartbeat, dark urine, yellowing eyes/skin.

This drug may infrequently cause serious bleeding (especially from the stomach or intestines). If you notice any of the following rare but serious side effects, stop taking this medication and consult your doctor or pharmacist immediately: bloody/black/tarry stools, fainting, pale/bluish skin color, unusual weakness, vomit with blood or that looks like coffee grounds, persistent stomach/abdominal pain.

Get medical help right away if any of these rare but serious side effects occur: 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: severe 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
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions are discussed elsewhere in the labeling:

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%)
Psychiatric Disorders
  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
  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

  Treatment Groups
AGGRENOX ER-DP ASA Placebo
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

Cardiovascular: Hypotension

Central Nervous System: Coma, dizziness, paresthesia, cerebral hemorrhage, intracranial hemorrhage, subarachnoid hemorrhage

Gastrointestinal: Gastritis, ulceration and perforation

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

Heart Rate and Rhythm Disorders: Tachycardia, palpitation, arrhythmia, supraventricular tachycardia

Liver and Biliary System Disorders: Cholelithiasis, jaundice, hepatic function abnormal

Metabolic and Nutritional Disorders: Hyperglycemia, thirst

Platelet, Bleeding and Clotting Disorders: Hematoma, gingival bleeding

Psychiatric Disorders: Agitation

Reproductive: Uterine hemorrhage

Respiratory: Hyperpnea, asthma, bronchospasm, hemoptysis, pulmonary edema

Special Senses Other Disorders: Taste loss

Skin and Appendages Disorders: Pruritus, urticaria

Urogenital: Renal insufficiency and failure, hematuria

Vascular (Extracardiac) Disorders: Flushing

Laboratory Changes

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.

Post-Marketing Experience

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

Fluid and Electrolyte: Hyperkalemia, metabolic acidosis, respiratory alkalosis, hypokalemia

Gastrointestinal: Pancreatitis, Reye syndrome, hematemesis

Hearing and Vestibular Disorders: Hearing loss

Immune System Disorders: Hypersensitivity, acute anaphylaxis, laryngeal edema

Liver and Biliary System Disorders: Hepatitis, hepatic failure

Musculoskeletal: Rhabdomyolysis

Metabolic and Nutritional Disorders: Hypoglycemia, dehydration

Platelet, Bleeding and Clotting Disorders: Prolongation of the prothrombin time, disseminated intravascular coagulation, coagulopathy, thrombocytopenia

Reproductive: Prolonged pregnancy and labor, stillbirths, lower birth weight infants, antepartum and postpartum bleeding

Respiratory: Tachypnea, dyspnea

Skin and Appendages Disorders: Rash, alopecia, angioedema, Stevens-Johnson syndrome, skin hemorrhages such as bruising, ecchymosis, and hematoma

Urogenital: Interstitial nephritis, papillary necrosis, proteinuria

Vascular (Extracardiac Disorders): Allergic vasculitis

Other adverse events: anorexia, aplastic anemia, migraine, pancytopenia, thrombocytosis.

Read the entire FDA prescribing information for Aggrenox (Aspirin, Extended-Release Dipyridamole Capsules) »

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Aggrenox - User Reviews

Aggrenox User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Aggrenox sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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