OTC Pain Relievers & Fever Reducers: Safety

Safety of Over-the-Counter (OTC) Pain Relievers and Fever Reducers

The active ingredients found in nonprescription pain relievers and fever reducers (acetaminophen, aspirin, ibuprofen, ketoprofen, naproxen sodium) are similarly effective. However, some patients may be at risk for side effects from these medications, including gastrointestinal side effects and effects on the heart, kidneys, and liver.

Gastrointestinal Side Effects

Aspirin, ibuprofen, ketoprofen. and naproxen sodium can cause gastrointestinal side effects such as heartburn, nausea, upset stomach, or stomach pain. Some patients develop ulcers that can interrupt the lining of the gut and result in bleeding. Even though they are considered safe, complications from these medications result in more than 100,000 hospitalizations and thousands of deaths each year. Researchers have identified several factors that increase the risk for developing gastrointestinal side effects. These risk factors include:

  • Older age (>65 years)
  • History of gastrointestinal problems such as ulcers or bleeding
  • Use of “high” doses of aspirin, ibuprofen, ketoprofen, and naproxen sodium; either separately or in combination (even doses within the recommended dosing range can cause gastrointestinal problems)
  • Use of aspirin, ibuprofen, ketoprofen, or naproxen sodium with oral corticosteroid drugs such as prednisone
  • Use of aspirin, ibuprofen, ketoprofen, or naproxen sodium with drugs that prolong bleeding such as warfarin (Coumadin2)
  • Chronic alcohol use (ingestion of more than 3 drinks per day)

Even low doses of aspirin, such as those taken to protect against heart attacks, can cause gastrointestinal side effects in “at-risk” individuals (those with any of the listed risk factors). Contrary to popular belief, “buffered” or “enteric-coated” products do not decrease these risks.

The risk for gastrointestinal side effects with acetaminophen is very small.

Effects on the Kidneys and Heart

Aspirin has been shown to protect against heart attacks and strokes in people with certain risk factors (for example, people who have had a heart attack or stroke in the past). The dose of aspirin used to prevent heart attacks and strokes is lower than that usually used to treat pain or fever. Common doses are 81 mg (one “baby aspirin”) daily or 165 mg (one-half of a regular strength aspirin tablet) daily. No other nonprescription pain relievers have been shown to prevent heart attacks or strokes when administered at recommended doses. People who take aspirin for this purpose should talk to their health-care provider before taking any additional nonprescription pain relievers because these other agents may reduce the protective effect of aspirin on the heart.

Individuals with no underlying health problems are at low risk for experiencing side effects related to the function of their kidneys or heart. However, people who have high blood pressure, heart failure, or reduced kidney function may retain fluids and experience swelling and increases in blood pressure when they use aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, ketoprofen or naproxen sodium. Acetaminophen does not affect the function of the kidneys or heart and should be used instead in such patients.

Effects on the Liver

Excessive doses of acetaminophen can cause liver damage in some patients. Doses most often associated with liver damage are much higher than the maximum recommended adult dose of 4000 mg daily. (8 tablets of “extra strength” acetaminophen)

People with liver disease should talk to their healthcare providers before starting any new medicines. Acetaminophen can be used by people who have liver disease, and at recommended doses does not increase the risk for side effects in such patients. Aspirin should be used with caution in people with liver disease, as their risk for toxicity and side effects such as bleeding is greater than that of people who do not have liver disease.

Use With Alcohol

It is generally wise to avoid drinking alcohol when taking any medicine. People who drink alcohol regularly have an increased risk for developing gastrointestinal side effects from aspirin or other NSAIDs such as ibuprofen, ketoprofen, or naproxen sodium. Acetaminophen, when taken at recommended doses, is not likely to produce harmful effects, even among patients who regularly drink alcohol.

Co-Sponsorship provided ay the American Pharmacists Association and SynerMed® Communications
Supported by an educational grant from McNeil Consumer & Specialty Pharmaceuticals

US Pharmacist