Though there are many brands of over-the-counter (OTC) pain relievers, there are two basic types: acetaminophen (such as Tylenol) and NSAIDs (nonsteroidal anti-inflammatory drugs), all available in generic form. These nonprescription NSAIDs are aspirin, ibuprofen (such as Motrin and Advil) and naproxen (such as Aleve). Some NSAIDs are also sold by prescription.
For many people, pain relievers are wonder drugs, allowing them to carry on with their lives despite disabling arthritis, for instance, or recurrent headaches. But all pain relievers, whether sold OTC or by prescription, have potential risks. Recent studies have amplified the concerns.
The most recent news came from the FDA, which announced in July 2015 that most NSAIDs will have to carry a stronger warning on their labels about their cardiovascular risks.
The following issues relate primarily to people who take pain relievers at least several times a week:
• Cardiovascular risk. Over the years studies have linked NSAIDs to an increased risk of heart attacks and strokes, especially when taken long term, at higher doses, or by people who had previously had a heart attack (or had cardiac risk factors). Over-the-counter NSAIDs have been required to warn about this in the small print since 2011, as have prescription NSAIDs such as celecoxib and diclofenac. The tougher FDA warning is based on a review of newer research and will appear on all NSAIDs except aspirin. It strengthens the old warning and adds, among other things, that the risks include heart failure and that they can occur as early as the first weeks of NSAID use.
• Blood pressure. NSAIDs can raise blood pressure. This may be at least partly responsible for the increased risk of heart attack and stroke. The evidence about acetaminophen is inconsistent.
• Gastrointestinal (GI) bleeding. NSAIDs can damage the stomach lining and cause bleeding and ulcers. This has long been considered their major drawback, as the labels warn. The risk is greatest in long-term users, those over 60, heavy drinkers, those with a history of GI bleeding or ulcers and those taking certain medications, such as blood-thinning drugs or steroids.
• Liver damage. Acetaminophen, the leading nonprescription pain reliever, does not cause GI bleeding, but long-term frequent use or even large single doses can cause severe liver damage. In fact, acetaminophen overdosing is the most common cause of acute liver failure in the U.S., often as the result of suicide attempts. Most people are unaware of this risk and don’t realize that acetaminophen is in hundreds of OTC cold, allergy and headache products and some prescription pain relievers. Check labels for acetaminophen, and don’t take more than 4 grams—equal to eight Extra Strength Tylenol tablets—a day from all sources. Alcohol (three drinks or more at a time) and certain other drugs increase the risk. Heavy drinkers and those with liver disease should avoid, or at least limit, acetaminophen. Taking the drug while fasting also increases the risk.
• Kidney damage. NSAIDs (and acetaminophen to a lesser extent) can damage the kidneys. If you have kidney disease, talk to your doctor about pain reliever safety.
Advice on using pain relievers safely
For healthy people who take OTC pain relievers as directed, the risks are relatively small. However, because these drugs are so popular, thousands of Americans are adversely affected every year. Don’t let these concerns prevent you from taking the drugs if you need them, but do follow this advice, especially if you take pain relievers often:
• Try nondrug treatments for chronic pain first. For arthritis or back pain, for instance, that means physical therapy, exercise, weight loss, and heat or cold therapy. It’s easier to pop a pill, but these treatments may work just as well or even better.
• Talk to your doctor about which pain reliever is best for you to take regularly. Weigh the potential risks and benefits, especially if have heart disease (or are at high risk for it) or uncontrolled hypertension, or if you drink moderately or heavily.
• Consider acetaminophen first, then naproxen. But the best choice depends on the cause and severity of your pain, along with your medical history. Acetaminophen is safest for the GI tract, though it may not provide enough relief, since unlike NSAIDs it doesn’t reduce inflammation. Your doctor may recommend a prescription drug instead of long-term use or high doses of OTC products. Celebrex should be used only as a last resort.
• Take the lowest effective dose for the shortest time possible, whatever the pain reliever.
• Do not exceed the doses listed on the labels or take for more than 10 days, unless your doctor has instructed otherwise.
• Consult your doctor before starting aspirin therapy to protect your heart reduce the risk of colon cancer. Ibuprofen can block aspirin’s anti-clotting effect, so don’t take it during the eight hours before or half hour after you take low-dose aspirin, the FDA advises.
Originally published August 2011. Updated January 2013 and August 2015.