Potential Risks and Complications of NSAIDs

While nonsteroidal anti-inflammatory medications, known as NSAIDs, have been widely and successfully used to ease back pain, it is important to be aware of potential drawbacks, including greater risks of serious cardiovascular, gastrointestinal, and kidney problems.

Risks and complications are typically greater for those taking the medications for a long period. The U.S. Food and Drug Administration recommends that people taking an NSAID for more than 10 days should see the doctor, and that NSAIDs be used in the smallest effective dose for the shortest possible time.3

See NSAIDs: Non-Steroidal Anti-Inflammatory Drugs

As with other medications, there is a risk of allergic and skin reactions. Swelling in the face, wheezing, and hives or a skin rash are all common signs of an allergic response. Blisters, a reddened face, and a skin rash are signs of a skin reaction.

Anyone having trouble breathing should go to an emergency room immediately. The doctor should be advised of any reactions or side effects, even if they do not appear serious.

People with cardiovascular or gastrointestinal risk factors should consult the doctor or pharmacist before taking an NSAID.

See Potential Risks and Complications of Celecoxib

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Heart-Related Risks

Citing research on the heart-related risks of NSAIDs, the U.S. Food and Drug Administration has emphasized that patients using these medications are at added risk of a heart attack or stroke.4,5

The FDA noted the increased risk:

  • Can develop as soon as the first weeks of NSAID use
  • Is most serious for people who have experienced a heart attack, have other heart problems or have risk factors for heart events, but others are also affected
  • Appears to be most significant with higher doses of medication

Research into NSAIDs’ risks includes an analysis of multiple studies. The analysis found the risk of heart attack or stroke was raised by one third when high doses of the NSAID diclofenac were taken.2

The risk was similar with celecoxib (Celebrex) and ibuprofen (Advil, Motrin). Naproxen (Aleve, Naprosyn) did not show an increase in heart attacks or stroke. The risk of heart failure doubled, however, with all four NSAIDs studied—diclofenac, ibuprofen, celecoxib, and naproxen.

See About Celebrex (Celecoxib), a COX-2 Inhibitor

Both ibuprofen and naproxen can cause some additional cardiovascular problems. They thin the blood, and too much blood thinning may lead to bleeding. Because of this thinning effect, individuals taking oral blood thinners or anticoagulants should avoid ibuprofen and naproxen. Ibuprofen and naproxen also can reduce the effectiveness of some blood pressure medications and diuretics (water pills).

Some research points to an even greater risk of cardiovascular problems with celecoxib (Celebrex).6,7 The FDA does not consider any type of NSAID to be more risky than another, but the American Heart Association advises that for people already at risk for cardiovascular events, celecoxib use is best confined to those with no better alternatives.8 The American Heart Association further recommends that individuals using celecoxib should have their blood pressure and kidney function monitored as a precaution.

See Safe Use of COX-2 Inhibitors and Other NSAIDs

Stopping NSAIDs Suddenly Poses Risk

While learning about the risks may prompt some individuals to immediately stop taking an NSAID, the medication should not be halted abruptly.

The body’s reaction to such a cutoff could make blood clots more likely, adding to the risk of heart attack or stroke. Instead, a person who is regularly using NSAIDs should talk with his or her doctor about the best way to taper off.

Stomach-Related Risks

Individuals with ulcers or sensitive stomachs are advised to avoid NSAIDs because of the risk of bleeding in the gastrointestinal tract, including the stomach. It is recommended that all oral NSAIDs be taken with food. A doctor and/or pharmacist may recommend adding another medication to protect your stomach when taking NSAIDs as well.

People older than 65 and those taking blood thinners or corticosteroids, are at extra risk of gastrointestinal problems. Difficulties can include stomach upset, ulcers, and stomach bleeding. Drinking alcohol can increase the risk.

See Oral Steroids

Researchers have found some evidence that celecoxib is easier on the stomach in the short term, but the evidence over the long term is not definitive.

Risks of Kidney Damage

Taking high doses of NSAIDs increases the risk of kidney damage, and the added risk continues even after the medication has been stopped. Using NSAIDs has also been shown to speed the advance of kidney disease. Even short-term use poses added risk.

NSAIDs can reduce the amount of blood reaching the kidneys, slowing kidney function. Water and salt retention, high blood pressure, and electrolyte imbalances have been linked to NSAIDs’ effect on the kidneys. In rare cases, kidney failure can result.

Individuals whose kidney function is impaired should not take NSAIDs without consulting a doctor.

Additional Safety Concerns

People with chronic conditions and those who are pregnant or breastfeeding are advised to discuss their medical history and current status with the doctor before taking NSAIDs. As a class, NSAIDs are pregnancy category C, however celecoxib, diclofenac, fenoprofen, ibuprofen injection, indomethacin (Tivorbex only), and meloxicam (starting at 30 weeks’ gestation) are pregnancy category D. The FDA’s pregnancy safety ranking for medications runs from A through X, with A being the safest.

See Management of Back Pain in Pregnancy

The long-term use of NSAIDs in women of reproductive age may be associated with infertility that is reversible upon discontinuation of the medication.9,10

This is not a comprehensive list of potential risks and complications associated with NSAIDs. Anyone taking NSAIDs should consult their treating physician and/or pharmacist regarding their individual situation.


  1. Bhala N, et al. Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomized trials. The Lancet, Vol. 382, No. 9894, p769-779, 31 August 2013.
  2. Sharon Hertz, M.D. The Benefits and Risks of Pain Relievers: Q & A on NSAIDs. U.S. Food and Drug Administration. Sept. 24, 2015.
  3. FDA Drug Safety Communication: FDA strengthens warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) can cause heart attacks or strokes. July 9, 2015.

Complete Listing of References

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