Over-the-Counter Meds Have Risks Too

NSAIDs and acetaminophen, alone or in combo, can lead side effects.


Your dose of ibuprofen doesn’t completely alleviate your joint pain, so you take a couple of acetaminophen tablets for added relief. Or, maybe ibuprofen is working well for your aching joints, but you come down with a cold and take an over-the-counter (OTC) cold medicine for your cough and sore throat.  In either case, if you are not careful, you could be setting yourself up for problems. Even OTC drugs carry a risk of side effects, and by taking two or more together you could be increasing that risk or even putting yourself in danger of an overdose.

Combining NSAIDs and Acetaminophen

Adding acetaminophen to nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen or naproxen, can be an effective way to improve pain relief. In fact, in Europe there are products that combine the two. But one study shows the combination could potentially increase the risk of gastrointestinal bleeding.

In a British study published in the Annals of the Rheumatic Diseases, 900 patients were assigned to one of four treatment groups -- acetaminophen only, ibuprofen only, a low dose of both acetaminophen and ibuprofen, and high dose of acetaminophen and ibuprofen – and then evaluated after 10 days and again after three months.

While the group taking the high-dose combination pill experienced the biggest improvements in pain relief, stiffness, function and quality of life at both check-ups, that pain relief came at a cost. At the end of the 13-week trial, 38.4 percent of patients in the high-dose combination group saw their hemoglobin levels drop compared with 24.1 percent in the group taking low-dose combination pills, 20.3 percent on acetaminophen alone and 19.6 percent on ibuprofen alone. Hemoglobin is the main component of red blood cells, and a drop in hemoglobin can be a sign of gastrointestinal bleeding; however, the study results didn’t conclusively link the drop to hemoglobin to GI bleeding.

The researchers write that they are concerned that there may be a synergistic – and not just additive – effect between ibuprofen and acetaminophen in the combination pills that potentially leads to GI bleeding.

“The significance of this article is that it points out the possible complications of taking over-the-counter medications without knowing the exact dosages or side effects,” says Terry L. Moore, MD, director of the division of rheumatology and pediatric rheumatology at Saint Louis University Medical Center. Dr. Moore was not involved with the study.

Combining Seemingly Unrelated Products

But knowingly combining two different pain relievers is not the only risky practice. If you are taking an NSAID for arthritis and take a cold medicine or other OTC product not realizing it also contains an NSAID, you could inadvertently get an overdose. Taking higher than the recommended dosage of NSAIDs can increase your risk of stomach ulcers and GI bleeding.

The same goes for acetaminophen, which can be found in a number of OTC cold formulations, headache remedies and cough medicines.  Consuming high doses of acetaminophen – long believed not to irritate the GI system – also can cause GI bleeding, the British study found.

Perhaps more disturbing is that an acetaminophen overdose can also lead to acute liver damage, which could be deadly. The risk was so concerning that in 2011 the FDA asked manufacturers of prescription drugs to limit the amount of acetaminophen to 325 mg per tablet or capsule. The FDA set the maximum 24-hour dose of acetaminophen at 4,000 mg. Many believe the daily limit should be lower – 3,000 mg per day. But keeping within the limits – or even keeping up with how much you are consuming – can be difficult if you are taking more than one acetaminophen-containing product.

So, what does that mean for consumers? Know all you can about the medications you are taking. When purchasing an OTC product, read the label for ingredients. You should also tell your doctor about all medications you take, including over-the-counter drugs, plus when and how often you take them.

“If we don’t know what other drugs you are taking, we won’t be able to warn you or look out for additional side effects,” says Elaine Husni, MD, director of the arthritis and musculoskeletal center at the Cleveland Clinic and vice chair of the department of rheumatologic and immunologic diseases.

“The take home for patients is, they should know the medication and the dosage they are taking, and in most cases not exceed 1 to 2 grams [1,000 mg to 2,000 mg] of acetaminophen a day, and lower doses NSAIDs if possible,” Dr. Moore says. “All pain and anti-inflammatory medications should be followed with blood work every four months to ensure [there’s] no development of toxicity.”