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Aggrenox

Last reviewed on RxList: 11/27/2018
Aggrenox Side Effects Center

Last reviewed on RxList 11/27/2018

Aggrenox (aspirin, extended-release dipyridamole) is a combination of a salicylate and a platelet aggregation inhibitor 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 may be available in generic form. Common side effects of Aggrenox include:

Tell your doctor if you have serious side effects of Aggrenox including:

  • easy bleeding or bruising,
  • uncontrolled bleeding from gums or nose,
  • fast/slow/irregular heartbeat,
  • loss of appetite,
  • dark urine,
  • yellowing eyes or skin,
  • unusual tiredness, or
  • unusual weakness.

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. Breastfeeding 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.

SLIDESHOW

Stroke Causes, Symptoms, and Recovery See Slideshow
Aggrenox Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • new or worsening chest pain;
  • a light-headed feeling, like you might pass out;
  • hearing problems, ringing in your ears;
  • liver problems--upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • signs of stomach bleeding--stomach pain, severe heartburn, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds; or
  • signs of bleeding in the brain--confusion, memory problems, severe headache, fainting.

Common side effects may include:

  • headache;
  • heartburn, upset stomach;
  • nausea, stomach pain; or
  • diarrhea.

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.

Read the entire detailed patient monograph for Aggrenox (Aspirin, Extended-Release Dipyridamole Capsules)

QUESTION

What is a stroke? See Answer
Aggrenox Professional Information

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 annualized event rate for adverse events that occurred in 1%/year or more of patients treated with AGGRENOX where the incidence was also at least 1%/year 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 ESPS2a

  Individual Treatment Group
Body System/Preferred Term AGGRENOX ER-DP Alone ASA Alone Placebo
n (%/year)b n (%/year)b n (%/year)b n (%/year)b
Total Number of Patients 1650 1654 1649 1649
Central and Peripheral Nervous System Disorders
  Headache 647 (28.25) 634 (27.91) 558 (22.10) 543 (22.29)
Gastrointestinal System Disorders
  Dyspepsia 303 (13.23) 288 (12.68) 299 (11.84) 275 (11.29)
  Abdominal Pain 289 (12.62) 255 (11.22) 262 (10.38) 239 (9.81)
  Nausea 264 (11.53) 254 (11.18) 210 (8.32) 232 (9.53)
  Diarrhea 210 (9.17) 257 (11.31) 112 (4.44) 161 (6.61)
  Vomiting 138 (6.03) 129 (5.68) 101 (4.00) 118 (4.84)
Platelet, Bleeding and Clotting Disorders
  Hemorrhage NOS 52 (2.27) 24 (1.06) 46 (1.82) 24 (0.99)
a Reportedby ≥1%/year of patients during AGGRENOX treatment where the incidence was at least 1%/year greater than in those treated with placebo.
bAnnual event rate per 100 pt-years = 100* number of subjects with event/subject-years. Subject-years is defined as cumulative number of days on treatment divided by 365.25.
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 Treatmenta

  Treatment Groups
AGGRENOX ER-DP ASA Placebo
n (%/year)b n (%/year)b n (%/year)b n (%/year)b
Total Number of Patients 1650 1654 1649 1649
Patients with at least one Adverse Event that led to treatment discontinuation 417 (18.21) 419 (18.44) 318 (12.59) 352 (14.45)
Headache 165 (7.20) 166 (7.31) 57 (2.26) 69 (2.83)
Nausea 91 (3.97) 95 (4.18) 51 (2.02) 53 (2.18)
Abdominal Pain 74 (3.23) 64 (2.82) 56 (2.22) 52 (2.13)
Vomiting 53 (2.31) 52 (2.29) 28 (1.11) 24 (0.99)
aReported by ≥1%/year of patients during AGGRENOX treatment where the incidence was at least 1%/year greater than in those treated with placebo.
bAnnual event rate per 100 pt-years = 100* number of subjects with event/subject-years. Subject-years is defined as cumulative number of days on treatment divided by 365.25.
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.

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, allergic reaction, syncope

Cardiovascular: Angina pectoris, hypotension

Central Nervous System: Cerebral edema, dizziness, cerebral hemorrhage, intracranial hemorrhage, subarachnoid hemorrhage

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

Gastrointestinal: Pancreatitis, Reye syndrome, hematemesis, gastritis, ulceration and perforation, hemorrhage rectum, melena, GI hemorrhage

Hearing and Vestibular Disorders: Hearing loss

Heart Rate and Rhythm Disorders: Tachycardia, palpitation

Immune System Disorders: Hypersensitivity, acute anaphylaxis, laryngeal edema

Liver and Biliary System Disorders: Hepatitis, hepatic failure, cholelithiasis, jaundice, hepatic function abnormal

Musculoskeletal: Rhabdomyolysis, myalgia

Metabolic and Nutritional Disorders: Hypoglycemia, dehydration

Platelet, Bleeding and Clotting Disorders: Prolongation of the prothrombin time, disseminated intravascular coagulation, coagulopathy, thrombocytopenia, hematoma, gingival bleeding, epistaxis, purpura

Psychiatric Disorders: Confusion, agitation

Respiratory: Tachypnea, dyspnea, hemoptysis

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

Urogenital: Interstitial nephritis, papillary necrosis, proteinuria, renal insufficiency and failure, hematuria

Vascular (Extracardiac) Disorders: Allergic vasculitis, flushing

Other Adverse Events: Anorexia, aplastic anemia, migraine, pancytopenia, thrombocytosis.

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

Related Resources for Aggrenox

Read the Aggrenox User Reviews »

© Aggrenox Patient Information is supplied by Cerner Multum, Inc. and Aggrenox Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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