Aggrenox Side Effects

Generic Name: aspirin / dipyridamole

Note: This page contains information about the side effects of aspirin / dipyridamole. Some of the dosage forms included on this document may not apply to the brand name Aggrenox.

Not all side effects for Aggrenox may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to aspirin / dipyridamole: oral capsule, oral capsule extended release

In addition to its needed effects, some unwanted effects may be caused by aspirin / dipyridamole. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking aspirin / dipyridamole:

More common
  • Abdominal or stomach pain
  • vomiting
Less common
  • Bleeding from the rectum
  • bloody mucous or unexplained nosebleeds
  • bloody or black, tarry stools
  • confusion
  • convulsions (seizures)
  • difficulty with breathing
  • difficulty with speaking
  • double vision
  • inability to move the arms, legs, or facial muscles
  • inability to speak
  • memory loss
  • pale skin
  • purple or red spots on skin
  • slow speech
  • tightness in the chest
  • troubled breathing (exertional)
  • unusual bleeding or bruising
  • vomiting of blood or material that looks like coffee grounds
Rare
  • Abdominal or stomach fullness
  • blood in the urine
  • chills
  • clay-colored stools
  • collection of blood under the skin
  • cough
  • deep, dark purple bruise
  • gaseous abdominal or stomach pain
  • itching, pain, redness, or swelling of the eye or eyelid
  • loss of appetite
  • nausea
  • noisy breathing
  • recurrent fever
  • skin rash or hives (severe)
  • watering of the eyes
  • yellow eyes or skin

If any of the following symptoms of overdose occur while taking aspirin / dipyridamole, get emergency help immediately:

Symptoms of overdose
  • Blurred vision
  • continuing ringing or buzzing or other unexplained noise in the ears
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fast or irregular heartbeat
  • flushes
  • hearing loss
  • restlessness
  • sweating
  • unusual tiredness or weakness
  • warm feeling

Some of the side effects that can occur with aspirin / dipyridamole may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Acid or sour stomach
  • belching
  • diarrhea
  • difficulty with moving
  • headache
  • heartburn
  • indigestion
  • muscle pain or stiffness
  • pain, swelling, or redness in the joints
  • stomach discomfort or upset
Less common or rare
  • Back pain
  • burning feeling in the chest or stomach
  • loss of strength or energy
  • rectal pain or swelling
  • sleepiness or unusual drowsiness
  • taste loss
  • tenderness in the stomach area

For Healthcare Professionals

Applies to aspirin / dipyridamole: oral capsule extended release

General

Adverse events associated with aspirin-dipyridamole and causing discontinuation during clinical trials included headache 10%, dizziness 5%, nausea 6%, abdominal pain 4%, dyspepsia 4%, vomiting 3%, diarrhea 2%, stroke 2%, transient ischemic attack (TIA) 2%, and angina pectoris 1%. Stroke, TIA, and angina pectoris occurred more frequently in the placebo group and at a rate of 4%, 3%, and 2%, respectively. No clear safety benefit was noted for the use of aspirin-dipyridamole over aspirin alone.[Ref]

Generally, aspirin-dipyridamole adverse effects most commonly affected the gastrointestinal (GI) and hematologic systems. Headache has been the single most frequently reported adverse effect. During clinical trials, the percent of patients reporting at least one adverse event was 79.9% in the aspirin-dipyridamole group and 79.1% in the placebo group. Discontinuation occurred in the treatment and placebo groups at a rate of 25% and 21%, respectively.

General adverse events affecting the body as a whole, occurring at a rate equal to or greater than 1% in patients receiving aspirin-dipyridamole, and more frequently than in the placebo group (treatment vs. placebo, respectively) included pain 6.4% vs. 6.0%, fatigue 5.8% vs. 5.5%, accidental injury 2.5% vs. 0.2%, malaise 1.6% vs. 1.3%, asthenia 1.8% vs. 1.1%, and syncope 1.0% vs. 0.5%. Hypothermia has been reported in medical literature or postmarketing reports for either dipyridamole or aspirin.[Ref]

Gastrointestinal

Gastrointestinal (GI) symptoms were the most frequently reported side effects noted during clinical trials. The following adverse effects occurred at a rate equal to or greater than 1% in patients receiving aspirin-dipyridamole and more frequently than in the placebo group (treatment vs. placebo, respectively): dyspepsia 18.4% vs. 16.7%, abdominal pain 17.5% vs. 14.5%, nausea 16.0% vs. 14.1%, diarrhea 12.7% vs. 9.8%, vomiting 8.4% vs. 7.2%, rectal bleeding 1.6% vs. 0.8%, melena 1.9% vs. 0.8%, hemorrhoids 1.0% vs. 0.6%, and GI bleeding 1.2% vs. 0.4%.

Adverse events occurring at a rate of less than 1% and considered possibly related to either dipyridamole or aspirin included taste loss, gingival bleeding, gastritis, ulceration, perforation and cholelithiasis. Adverse reactions reported in medical literature or postmarketing reports for either dipyridamole or aspirin have included pancreatitis and hematemesis.[Ref]

Nervous system

Nervous system side effects occurring at a rate equal to or greater than 1% in patients receiving aspirin-dipyridamole and more frequently than in the placebo group (treatment vs. placebo, respectively) included: headache 39.2% vs. 32.9% and convulsions 1.7% vs. 1.6%. Headache is typically the most frequently occurring adverse effect reported during clinical trials, but it may be more noticeable during the first month of treatment. Adverse events occurring at a rate of less than 1% and considered possibly related to either dipyridamole or aspirin included coma, dizziness, paresthesia, cerebral hemorrhage, intracranial hemorrhage, subarachnoid hemorrhage. Cerebral edema has been reported in medical literature or postmarketing reports for either dipyridamole or aspirin.[Ref]

Cardiovascular

Cardiovascular adverse effects presenting as cardiac failure occurred in 1.6% of patients receiving aspirin-dipyridamole compared to 1.5% of patients in the placebo group. Hypotension, flushing, tachycardia, palpitation, and arrhythmia occurred at a rate of less than 1% and were considered possibly related to dipyridamole. Adverse reactions reported in medical literature or postmarketing reports for either dipyridamole or aspirin have included chest pain and angina pectoris.[Ref]

Hematologic

Hematologic side effects occurring at a rate equal to or greater than 1% in patients receiving aspirin-dipyridamole and more frequently than in the placebo group (treatment vs. placebo, respectively) included hemorrhage 3.2% vs. 1.5%, epistaxis 2.4% vs. 1.5%, purpura 1.4% vs. 0.4%, anemia 1.6% vs. 0.5%. Hematoma occurred at a rate of less than 1% and was considered possibly related to either dipyridamole or aspirin.

Adverse reactions reported in medical literature or postmarketing reports for either dipyridamole or aspirin have included prolongation of the prothrombin time, disseminated intravascular coagulation, coagulopathy, and thrombocytopenia. Although reported for either dipyridamole or aspirin a causal relationship has not been established for aplastic anemia, pancytopenia, and thrombocytosis.[Ref]

Hepatic

Hepatic adverse events occurring at a rate of less than 1% and considered possibly related to either dipyridamole or aspirin included jaundice and abnormal hepatic function. Hepatitis and hepatic failure associated with either dipyridamole or aspirin have been reported in medical literature or postmarketing reports.[Ref]

Metabolic

Metabolic adverse events occurring at a rate of less than 1% and considered possibly related to either dipyridamole or aspirin included hyperglycemia and thirst. Adverse reactions reported in medical literature or postmarketing reports for either dipyridamole or aspirin have included hyperkalemia, metabolic acidosis, respiratory alkalosis, hypokalemia, hypoglycemia, and dehydration. Salicylates have been reported to displace triiodothyronine (T3) and thyroxine (T4) from protein binding sites. The initial effect is an increase in serum free T4 concentrations.[Ref]

Other

Tinnitus cannot be used as a clinical indicator of salicylism in patients with high frequency hearing loss as these patients may have difficulty perceiving tinnitus.[Ref]

Otic adverse effects of tinnitus and deafness occurred at a rate of less than 1% and were considered possibly related to either dipyridamole or aspirin. Hearing loss has been reported in medical literature or postmarketing reports associated with either dipyridamole or aspirin.

Reye's syndrome associated with aspirin has been reported in medical literature or postmarketing reports.[Ref]

Musculoskeletal

Musculoskeletal side effects occurring at a rate equal to or greater than 1% in patients receiving aspirin-dipyridamole and more frequently than in the placebo group (treatment vs. placebo, respectively) included: arthralgia 5.5% vs. 4.6%, arthritis 2.1% vs. 1.2%, arthrosis 1.1% vs. 0.8%, back pain 4.6% vs. 3.9%, and myalgia 1.2% vs. 0.7%. Rhabdomyolysis has been reported in medical literature or postmarketing reports for either dipyridamole or aspirin.[Ref]

Hypersensitivity

Hypersensitivity reactions reported in medical literature or postmarketing reports for either dipyridamole or aspirin have included acute anaphylaxis, allergic vasculitis, and laryngeal edema.[Ref]

Oncologic

Oncologic adverse events occurring at a rate equal to or greater than 1% in patients receiving aspirin-dipyridamole and more frequently than in the placebo group were reported as unspecified neoplasms, 1.7% vs. 1.2% (treatment vs. placebo, respectively).[Ref]

Respiratory

Respiratory side effects occurring at a rate equal to or greater than 1% in patients receiving aspirin-dipyridamole and more frequently than in the placebo group (treatment vs. placebo, respectively) included: coughing 1.5% vs. 1.3% and upper respiratory tract infection 1% vs. 0.8%. Hyperpnea, asthma, bronchospasm, hemoptysis, pulmonary edema occurred at a rate of less than 1% and were considered possibly related to either dipyridamole or aspirin. Tachypnea and dyspnea have been reported in medical literature or postmarketing reports for either dipyridamole or aspirin.[Ref]

Renal

Renal insufficiency and failure occurred at a rate of less than 1% and were considered possibly related to either dipyridamole or aspirin. Adverse reactions reported in medical literature or postmarketing reports for either dipyridamole or aspirin have included interstitial nephritis and papillary necrosis.[Ref]

Genitourinary

Genitourinary side effects of uterine hemorrhage and hematuria occurred at a rate of less than 1% and were considered possibly related to either dipyridamole or aspirin. Proteinuria associated with either dipyridamole or aspirin has been reported in medical literature or postmarketing reports.[Ref]

Dermatologic

Dermatologic symptoms of pruritus and urticaria occurred in less than 1% of treatment patients and were considered possibly related to either dipyridamole or aspirin. Adverse reactions reported in medical literature or postmarketing reports for either dipyridamole or aspirin have included rash, alopecia, angioedema, and Stevens-Johnson syndrome.[Ref]

Psychiatric

Psychiatric side effects occurring at a rate equal to or greater than 1% in patients receiving aspirin-dipyridamole and more frequently than in the placebo group (treatment vs. placebo, respectively) included amnesia 2.4% vs. 2.1%, confusion 1.1% vs. 0.9%, anorexia 1.2% vs. 0.9%, and somnolence 1.2% vs. 0.5%. Agitation has occurred at a rate of less than 1% and was considered possibly related to either dipyridamole or aspirin. Although reported either in medical literature or postmarketing reports for either dipyridamole or aspirin a causal relationship has not been established for anorexia.[Ref]

References

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2. Silagy CA, McNeil JJ, Donnan GA, Tonkin AM, Worsam B, Campion K "Adverse effects of low-dose aspirin in a healthy elderly population." Clin Pharmacol Ther 54 (1993): 84-9

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6. Diener HC, Cunha L, Forbes C, Sivenius J, Smets P, Lowenthal A "European stroke prevention study 2. Dipyridamole and acetylsalicylic acid in the secondary prevention of stroke." J Neurol Sci 143 (1996): 1-13

7. Dickinson JP, Prentice CRM "Aspirin: benefit and risk in thromboprophylaxis." Qjm Mon J Assoc Physician 91 (1998): 523-38

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15. Petty GW, Brown RD, Whisnant JP, Sicks JD, O'Fallon WM, Wiebers DO "Frequency of major complications of aspirin, warfarin, and intravenous heparin for secondary stroke prevention: a population study." Ann Intern Med 130 (1999): 14-22

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19. Shibata T, Kubota I, Ikeda K, Yamaki M, Hanashima K, Tsuiki K, Yasui S "Relation between the incidence of arrhythmias and ischemic ST-segment depression during dipyridamole electrocardiography test in patients with coronary artery disease." Jpn Heart J 32 (1991): 751-8

20. Mukerji V, Alpert MA, Flaker GC, Beach CL, Weber RD "Cardiac conduction abnormalities and atrial arrhythmias associated with salicylate toxicity." Pharmacotherapy 6 (1986): 41-3

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