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Drug Profile

The information on this site is intended to supplement and enhance, not replace, the advice of a physician who is familiar with your medical history. Decisions about your health should always be made ONLY after detailed conversation with your doctor.

Generic drug name: aspirin (AS pir in)
Brand name(s): AGGRENOX, DURLAZA, EASPRIN, ECOTRIN, EMPIRIN, EXCEDRIN [MIGRAINE], GENUINE BAYER ASPIRIN, LANORINAL, VAZALORE
GENERIC: available FAMILY: Salicylates
Find the drug label by searching at DailyMed.

Pregnancy and Breast-feeding Warnings [top]

Pregnancy Warning

NSAIDs have caused serious harm to human infants born to mothers taking these drugs during pregnancy, particularly the third trimester of pregnancy. Such infants have been born with damage to the heart, blood vessels, kidney, and gastrointestinal tract. Tell your doctor if you are pregnant or thinking of becoming pregnant before you take these drugs.

Breast-feeding Warning

Many NSAIDs are excreted in human milk. Because of the potential for adverse effects in nursing infants, you should not take these drugs while nursing.

Safety Warnings For This Drug [top]

FDA BLACK-BOX WARNINGS

Cardiovascular Risk

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, including heart attack and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
  • NSAIDs are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft surgery.

Gastrointestinal Risk

  • NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk of serious gastrointestinal events. (See WARNINGS)

Aspirin/Reye's Syndrome Alert

Do not use this product for treating chicken pox, flu, or flulike illness if you are under 40. It will increase the risk of contracting Reye’s syndrome, a rare but often fatal disease.

Facts About This Drug [top]

Aspirin belongs to a family of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). It often is used to treat arthritis in older adults. Aspirin also is prescribed as a preventive medicine for illnesses such as heart disease. The Food and Drug Administration (FDA) has approved the use of aspirin for patients who have had a previous heart attack or unstable chest pain (angina) to reduce the risk of death and nonfatal heart attacks; patients with chronic stable angina to reduce the risk...

Aspirin belongs to a family of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). It often is used to treat arthritis in older adults. Aspirin also is prescribed as a preventive medicine for illnesses such as heart disease. The Food and Drug Administration (FDA) has approved the use of aspirin for patients who have had a previous heart attack or unstable chest pain (angina) to reduce the risk of death and nonfatal heart attacks; patients with chronic stable angina to reduce the risk of heart attacks and sudden death; patients who have undergone revascularization procedures, such as the placement of a stent, for a preexisting condition; patients with a suspected acute heart attack to reduce vascular mortality; and patients who have had ischemic stroke or transient ischemia of the brain due to fibrin platelet emboli (clots) to reduce death and nonfatal stroke.

The use of aspirin in the aforementioned situations is known as secondary prevention because the patient already has a preexisting cardiovascular condition.

However, aspirin should not be used for the primary prevention of heart attacks in patients without preexisting heart disease for two reasons. First, there is no convincing evidence that aspirin offers any benefit in the primary prevention of heart attacks. Second, aspirin increases the risk of bleeding.

There are several forms of aspirin available: plain aspirin, enteric-coated aspirin and buffered aspirin. In previous editions of Worst Pills, Best Pills News, we recommended the use of enteric-coated aspirin over plain or buffered aspirin because enteric coating was once thought to reduce the overall risk of bleeding in the gastrointestinal (GI) tract, as this form of aspirin does not dissolve in the stomach. The weight of the evidence now indicates that the risk of GI bleeding is similar among plain, enteric-coated and buffered aspirin.[1],[2],[3],[4] This is probably at least partially due to the fact that once aspirin is absorbed into the blood it can cause GI bleeding not related to local irritation but due to its effects on diminishing the natural protection of the GI tract and blood clotting.

We have listed buffered aspirin (ASCRIPTIN, BUFFERIN) as a Do Not Use drug because it is no better than plain aspirin and is more costly.

Adverse effects

NSAIDs can cause serious harm, including death, from bleeding in the stomach or intestines. Bleeding can occur at any time and without warning, and older people are more likely to experience adverse effects from bleeding. Combining aspirin with the antiplatelet drug clopidogrel (PLAVIX) further increases the risk of gastrointestinal bleeding.[5]

Older adults are also more likely to have reduced liver and kidney function. Some doctors believe people over age 70 should be started on half the usual dose.[6]

Interactions

A 2013 study published in Circulation, the journal of the American Heart Association, found that patients with atrial fibrillation who were receiving oral anticoagulants (blood thinners for preventing blood clots) as well as aspirin had an increased risk of bleeding compared with patients who were receiving only oral anticoagulant therapy with no aspirin.[7]

A study published in JAMA Internal Medicine in 2014 showed that the risk of major bleeding in patients with venous thromboembolism (VTE; blood clots in large veins which can break off and travel to the lung) using anticoagulants increased significantly when the patient also took NSAIDs or aspirin.[8]

Studies show...

One meta-analysis (a study that combines data from many other studies) studied the risks and benefits of adding aspirin therapy to the drug regimen of patients who were already taking an oral anticoagulant such as warfarin (COUMADIN), including patients with atrial fibrillation or with mechanical heart valves. This study demonstrated that there is little support in the published literature for the common clinical practice of adding aspirin to oral anticoagulant therapy except in select patients with a mechanical heart valve. The additional risk of bleeding was not thought to be warranted.[9]

Another study examined the effects of long-term, low-dose aspirin therapy in VTE in healthy women. The study found that aspirin therapy is not effective in primary prevention of VTE in women with low-to-moderate risk of VTE.[10]

According to a study in the Annals of Internal Medicine, taking 75 to 81 milligrams of aspirin a day (one low-dose aspirin tablet) could be the safest, most effective way to prevent heart disease in patients who require aspirin therapy.

The study also found that taking doses of aspirin larger than 100 milligrams a day does not have any clear benefit for preventing heart disease — and it may actually be harmful to patients' health.[11]

The Archives of Internal Medicine published a meta-analysis in 2012 in which the authors aimed to assess whether the benefits of aspirin for those without known cardiovascular disease would outweigh aspirin's increased risk of serious bleeding. The study found that aspirin, taken daily or every other day in low doses for primary prevention of cardiovascular death in patients without existing cardiovascular disease, was not effective in reducing cardiovascular death or death from cancer. Aspirin did, however, increase clinically important bleeding events.[12]

Patients who frequently use medication to relieve headache pain may develop a condition known as medication overuse headache (MOH). According to a 2004 review published in the medical journal Lancet Neurology,[13] there is substantial evidence that all headache drugs can cause MOH in patients who use these drugs excessively.

The March 2013 issue of Worst Pills, Best Pills News discussed two recent studies dealing with MOH. In the first study, the treatment for MOH was simple: basic information tailored to the individual patient, including a discussion with the patient’s doctor of both the role of drugs in developing MOH and the likelihood that stopping painkiller overuse would lead to an improvement. The second study involved a review of MOH treatment guidelines, including evidence concerning the manner in which the previously overused painkillers were discontinued.

Based on the results of both studies, patients should discuss with their doctors the important details of MOH and, depending on their individual case, the type of withdrawal from the MOH-causing drugs that is best for them.[14]

Results of a major government-funded clinical trial, called ASPREE, published in the New England Journal of Medicine (NEJM) in 2018 demonstrated that long-term daily use of low-dose aspirin in elderly adults who did not have cardiovascular disease, dementia or physical disability did not decrease the risk of heart attack, stroke or other serious cardiovascular disease. However, it did increase the risk of major bleeding.[15],[16],[17]

Results of another major study, called ASCEND, also published in the NEJM in 2018, showed that daily aspirin use in diabetic patients who had never had cardiovascular disease led to a lower risk of serious heart disease, but this benefit was offset by an increased risk of major bleeding.[18]

A third major study, called ARRIVE, published in Lancet in 2018, found that long-term daily use of low-dose aspirin in adults (average age 64 years) without prior cardiovascular disease or diabetes who had low 10-year risk of developing cardiovascular disease, although the researchers had aimed to enroll subjects with moderate risk.[19] After a median of five years of follow-up, the two groups had similar rates of adverse cardiovascular events, but 1% of the aspirin group subjects experienced gastrointestinal bleeding compared with only 0.5% of the placebo group subjects, a difference that was statistically significant.

Regulatory actions surrounding aspirin

2003: Bayer, the producer of Genuine Bayer Aspirin, petitioned the FDA to allow the use of aspirin to reduce the risk of a first heart attack in patients with a coronary heart disease risk of 10% or greater over 10 years. This is known as primary prevention.

On Dec. 8, 2003, the FDA's Cardio-Renal Drugs Advisory Committee met to evaluate the results of five published clinical trials[20],[21],[22],[23],[24] submitted by Bayer to support their petition. The committee refused to recommend aspirin for primary prevention. The official concerns of the FDA were:

In only one[24] of the five studies submitted by Bayer was there a reduction in fatal heart attacks. In this study there was a larger, though not statistically significant, increase in fatal sudden death, strokes or other fatal cardiovascular events.

The lack of efficacy [prevention of cardiovascular events, primarily a first heart attack] in the face of associated morbidity (i.e., bleeding) prevents the recommendation of use of aspirin for the primary prevention of cardiovascular morbidity and mortality.[25]

2020: The FDA and Health Canada (an agency in Canada similar to the FDA) warned that use NSAIDs at about 20 weeks or later in pregnancy rarely causes serious kidney problems in an unborn baby.[26],[27] These kidney problems can lead to oligohydramnios, a condition in which there are low levels of amniotic fluid surrounding the baby. Amniotic fluid normally provides a protective cushion and plays an important role in the development of a baby’s lungs, digestive system and muscles. Oligohydramnios in turn can lead to decreased range of motion in a baby’s arms and legs and delayed lung maturation.

Before You Use This Drug [top]

Do not use if you have or have had:

  • bleeding ulcers
  • other bleeding problems
  • severe sensitivity reaction to aspirin or other NSAIDs (for aspirin only)
  • nasal polyps associated with asthma (for aspirin only)
  • poor kidney function (for choline and magnesium salicylates)
  • are breast-feeding

Tell your doctor if you have or have had:

  • mild allergic reaction to aspirin or other NSAIDs
  • bleeding problems
  • vitamin K deficiency
  • ulcer or other stomach problems
  • kidney, liver, or heart problems
  • asthma (for aspirin only)
  • anemia
  • glucose-6-phosphate dehydrogenase deficiency
  • gout
  • overactive thyroid
  • high blood pressure
  • symptoms of nasal polyps

Tell your doctor about any other drugs you take, including aspirin, herbs, vitamins, and other nonprescription products.

When You Use This Drug [top]

  • Get regular checkups when you take the drug for a long time.
  • Caution if you take other aspirin or salicylate drugs at the same time to avoid overdose.
  • If taking for pain and pain lasts longer than ten days for adults or five days for children, contact your doctor.
  • If taking for fever and fever lasts longer than three days or you get worse, new symptoms, redness, or swelling, contact your doctor.
  • If taking for sore throat and sore throat is severe, persists longer than two days, or there is fever, headache, rash, nausea, or vomiting, contact your doctor.
  • Do not drink alcohol. This combination increases the risk of stomach or intestinal bleeding.
  • Never take more than the amount prescribed by your doctor or recommended on the package label.
  • Caution diabetics: see Diabetes Prevention and Treatment.
  • If you are treating yourself, call your doctor if your symptoms do not improve or if you have a fever that lasts more than three days or returns.
  • Do not take aspirin for five days before any surgery, unless your doctor tells you otherwise. Aspirin interferes with your body’s ability to stop bleeding.
  • Never place aspirin directly on teeth or gums because it irritates these tissues.
  • Do not chew aspirin within one week after you have had any type of surgery in your mouth.

How to Use This Drug [top]

  • If you miss a dose, take it as soon as you remember, but skip it if it is almost time for the next dose. Do not take double doses.
  • Do not share your medication with others.
  • Take the drug at the same time(s) each day.
  • Take tablets with food and a full glass (eight ounces) of water. Do not break, chew, or crush long-acting forms of this drug. Do not lie down for 30 minutes.
  • Store at room temperature with lid on tightly. Do not store in the bathroom. Do not expose to heat, moisture, or strong light. Keep out of reach of children.

Interactions with Other Drugs [top]

The following drugs, biologics (e.g., vaccines, therapeutic antibodies), or foods are listed in Evaluations of Drug Interactions 2003 as causing “highly clinically significant” or “clinically significant” interactions when used together with any of the drugs in this section. In some sections with multiple drugs, the interaction may have been reported for one but not all drugs in this section, but we include the interaction because the drugs in this section are similar to one another. We have also included potentially serious interactions listed in the drug’s FDA-approved professional package insert or in published medical journal articles. There may be other drugs, especially those in the families of drugs listed below, that also will react with this drug to cause severe adverse effects. Make sure to tell your doctor and pharmacist the drugs you are taking and tell them if you are taking any of these interacting drugs:

acetazolamide, AGGRASTAT, alcohol, aluminum hydroxide/magnesium hydroxide, AMARYL, CAPOTEN, captopril, chlorpropamide, COUMADIN, danaparoid, DEPAKEN/DEPAKOTE, DIABINESE, DIAMOX, GARAMYCIN, gentamicin, glimepiride, heparin, ketorolac, MAALOX, MAALOX TC, MEDROL, methotrexate, methylprednisolone, MEXATE, nadroparin, reteplase, TREXALL DOSE PACK, TICLID, ticlopidine, tirofiban, TORADOL, valproic acid, warfarin.

Adverse Effects [top]

Call your doctor immediately if you experience:

  • an allergic reaction: bluish discoloration or flushing or redness of skin, coughing, difficulty swallowing, dizziness or lightheadedness, skin rash, hives, or itching, stuffy nose, swelling of eyelids, face, or lips, tightness in chest, trouble breathing and/or wheezing
  • vomiting material that looks bloody or like coffee grounds
  • unusual tiredness or weakness (aspirin only)
  • skin rash, hives, or itching
  • bloody or black, tarry stools
  • severe stomach pain
  • wheezing, tightness in chest, or trouble breathing
  • fainting or dizzy spells

Call your doctor if these symptoms continue:

  • heartburn, indigestion, nausea with or without vomiting, or mild stomach pain
  • abnormal weakness or fatigue

Signs of overdose (mild):

  • continued ringing or buzzing in ears or hearing loss
  • confusion
  • extreme drowsiness
  • nausea or vomiting
  • stomach pain and/or headache
  • dizziness or lightheadedness
  • abnormally fast or deep breathing, or trouble breathing
  • abnormal or uncontrolled flapping of hands
  • nervousness or excitement

Signs of overdose (severe):

  • bloody urine
  • convulsions
  • hallucinations
  • severe nervousness, excitement, or confusion
  • shortness of breath or troubled breathing
  • unexplained fever

If you suspect an overdose, call this number to contact your poison control center: (800) 222-1222.

Periodic Tests[top]

Ask your doctor which of these tests should be done periodically while you are taking this drug:

  • liver function tests
  • hematocrit determinations
  • salicylate concentrations
  • serum magnesium levels (for choline and magnesium salicylates)

last reviewed February 28, 2021