Potential Risks and Complications of NSAIDs

Nonsteroidal anti-inflammatory medications, known as NSAIDs, are widely and often successfully used to ease back and neck pain, however, they do have some drawbacks. Some people may experience serious side effects, including cardiovascular, gastrointestinal, and kidney problems.

See Medications for Back Pain and Neck Pain

Risks and complications are typically greater for people who take NSAIDs for a long period—daily use for weeks, months or even years. The U.S. Food and Drug Administration recommends people taking an over-the-counter NSAID for more than 10 days see a doctor, and that NSAIDs be used in the smallest effective dose for the shortest possible time. ¹ Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs). October 2016

Heart-Related Risks

Citing research on the heart-related risks of NSAIDs, the U.S. Food and Drug Administration has emphasized that some people using these medications are at added risk of a heart attack or stroke. ¹ Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs). October 2016 ^{, 2} FDA Drug Safety Communication: FDA strengthens warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) can cause heart attacks or strokes. July 9, 201

• 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
• Appears to be most significant with higher doses of medication

Research into NSAIDs’ risks includes an analysis of multiple studies. There were several important findings from the analysis:

• The risk of heart attack or stroke was raised by one-third when high doses of the NSAID diclofenac were taken. ³ Coxib and traditional NSAID Trialists' (CNT) Collaboration., Bhala N, Emberson J, Merhi A, Abramson S, Arber N, Baron JA, Bombardier C, Cannon C, Farkouh ME, FitzGerald GA, Goss P, Halls H, Hawk E, Hawkey C, Hennekens C, Hochberg M, Holland LE, Kearney PM, Laine L, Lanas A, Lance P, Laupacis A, Oates J, Patrono C, Schnitzer TJ, Solomon S, Tugwell P, Wilson K, Wittes J, Baigent C. Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials. Lancet. 2013 Aug 31;382(9894):769-79. doi: 10.1016/S0140-6736(13)60900-9. Epub 2013 May 30. PubMed PMID: 23726390; PubMed Central PMCID: PMC3778977.
• The risk was similar with celecoxib (Celebrex) and ibuprofen (Advil, Motrin). ³ Coxib and traditional NSAID Trialists' (CNT) Collaboration., Bhala N, Emberson J, Merhi A, Abramson S, Arber N, Baron JA, Bombardier C, Cannon C, Farkouh ME, FitzGerald GA, Goss P, Halls H, Hawk E, Hawkey C, Hennekens C, Hochberg M, Holland LE, Kearney PM, Laine L, Lanas A, Lance P, Laupacis A, Oates J, Patrono C, Schnitzer TJ, Solomon S, Tugwell P, Wilson K, Wittes J, Baigent C. Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials. Lancet. 2013 Aug 31;382(9894):769-79. doi: 10.1016/S0140-6736(13)60900-9. Epub 2013 May 30. PubMed PMID: 23726390; PubMed Central PMCID: PMC3778977.
• Naproxen (Aleve, Naprosyn) did not show an increase in heart attacks or stroke. ³ Coxib and traditional NSAID Trialists' (CNT) Collaboration., Bhala N, Emberson J, Merhi A, Abramson S, Arber N, Baron JA, Bombardier C, Cannon C, Farkouh ME, FitzGerald GA, Goss P, Halls H, Hawk E, Hawkey C, Hennekens C, Hochberg M, Holland LE, Kearney PM, Laine L, Lanas A, Lance P, Laupacis A, Oates J, Patrono C, Schnitzer TJ, Solomon S, Tugwell P, Wilson K, Wittes J, Baigent C. Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials. Lancet. 2013 Aug 31;382(9894):769-79. doi: 10.1016/S0140-6736(13)60900-9. Epub 2013 May 30. PubMed PMID: 23726390; PubMed Central PMCID: PMC3778977.
• he risk of heart failure doubled with all four NSAIDs studied—diclofenac, ibuprofen, celecoxib, and naproxen.

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

Both ibuprofen and naproxen can cause 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). ³ Coxib and traditional NSAID Trialists' (CNT) Collaboration., Bhala N, Emberson J, Merhi A, Abramson S, Arber N, Baron JA, Bombardier C, Cannon C, Farkouh ME, FitzGerald GA, Goss P, Halls H, Hawk E, Hawkey C, Hennekens C, Hochberg M, Holland LE, Kearney PM, Laine L, Lanas A, Lance P, Laupacis A, Oates J, Patrono C, Schnitzer TJ, Solomon S, Tugwell P, Wilson K, Wittes J, Baigent C. Vascular and upper gastrointestinal effects of non-steroidal anti-inflammatory drugs: meta-analyses of individual participant data from randomised trials. Lancet. 2013 Aug 31;382(9894):769-79. doi: 10.1016/S0140-6736(13)60900-9. Epub 2013 May 30. PubMed PMID: 23726390; PubMed Central PMCID: PMC3778977.

See Potential Risks and Complications of Celecoxib

The FDA does not consider any type of NSAID to be riskier than another, but the American Heart Association advises people already at risk for cardiovascular events to only use celecoxib if there are no better alternatives. ⁴ American Heart Association Website, Use of Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): An Update for Clinicians. https://professional.heart.org/professional/ScienceNews/UCM_464574_Use-of-Nonsteroidal-Anti-Inflammatory-Drugs-NSAIDs-An-Update-for-Clinicians.jsp. February 27, 2007 The American Heart Association further recommends that individuals using celecoxib should have their blood pressure and kidney function monitored as a precaution.

See Understanding COX-2 Inhibitor Side Effects

Stopping NSAIDs Suddenly Poses Heart-Related Risks

Despite the risks associated with taking NSAIDs daily, people who have been taking NSAIDs daily for long periods of time should not stop taking them abruptly.

See Safe Use of COX-2 Inhibitors and Other NSAIDs

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 a doctor about the best way to taper off.

Risk of Stomach Problems

Individuals with ulcers or sensitive stomachs are advised to avoid NSAIDs because of the risk of bleeding in the gastrointestinal tract, including the stomach.

People older than 65 and those taking blood thinners or corticosteroids are particularly at risk of gastrointestinal problems. These problems include:

• Upset stomach
• Ulcers
• Stomach bleeding

Drinking alcohol can increase the risk of stomach problems.

It is recommended that anyone using oral NSAIDs take them with food. A doctor and/or pharmacist may recommend adding another medication to protect the stomach when taking NSAIDs.

Risks of Kidney Damage

This increased risk exists because 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.

Allergic Reactions to NSAIDs

As with other medications, there is a risk of allergic reaction. Signs of allergic reaction include:

• Swelling in the face
• Wheezing
• Hives or a skin rash
• Blisters
• Reddened face

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.

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 a doctor before taking NSAIDs.

See Management of Back Pain in Pregnancy

The FDA’s pregnancy safety ranking for medications runs from A through X, with A being the safest. 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 long-term use of some NSAIDs in women of reproductive age is associated with infertility that may be reversible upon discontinuation of the medication. ⁵ Skomsvoll JF, Rødevand E, Koksvik HS, et al. Reversible infertility from nonsteroidal anti-inflammatory drugs. Skomsvoll JF, Rødevand E, Koksvik HS, et al. Tidsskr Nor Laegeforen. 2005 Jun 2;125(11):1476-8. ^{, 6} Micu MC, Micu R, Ostensen M. Luteinized unruptured follicle syndrome increased by inactive disease and selective cyclooxygenase 2 inhibitors in women with inflammatory arthropathies. Arthritis Care Res (Hoboken). 2011 Sep;63(9):1334-8. doi: 10.1002/acr.20510.

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.