NSAIDs Side Effects --
A Bloody Price to Pay for Pain

NSAIDs side effects of GI bleeding, ulcers and liver failure are causing 100,000 hospitalizations and 17,000 deaths annually in the U.S. yet studies show the majority of American consumers remain unaware of the seriousness of these risks. This medical predicament-- described as a “silent epidemic”--has been given scant publicity and no one appears to be tracking the numbers.

A 1999 study in The New England Journal of Medicine concerning NSAIDs side effects, concluded that if deaths from GI toxic effects from NSAIDs were tabulated separately in the National Vital Statistics reports, these effects would constitute the 15th most common cause of death in the United States. Yet these toxic effects remain mainly a "silent epidemic," with many physicians and most patients unaware of the magnitude of the problem. Furthermore the mortality statistics do not include deaths ascribed to the use of over-the-counter NSAIDS.(1)

Deaths and hospitalizations from NSAIDs side effects not being tracked

In fact, the estimated number of hospitalizations and deaths has remained unchanged over an eleven-year period between two bookend studies conducted in 1998 and 2009. The reason? No one is actually sure what the numbers really are.

A study published in The American Journal of Medicine in July, 1998 observed: "Conservative calculations estimate that approximately 107,000 patients are hospitalized annually for nonsteroidal anti-inflammatory drug (NSAID)-related gastrointestinal (GI) complications and at least 16,500 NSAID-related deaths occur each year among arthritis patients alone. The figures of all NSAID users would be overwhelming, yet the scope of this problem is generally under-appreciated."(1A)

A 2009 study in Therapeutics and Clinical Risk Management cited that the number of deaths and hospitalizations from GI bleeding due to NSAIDs has remained unchanged over more than a decade, and are annually responsible for over 100,000 hospitalizations, 17,000 deaths and $2 billion in healthcare costs in the U.S. Regarding major NSAIDs side effects, the study noted, “Despite improvements in the available medications to aid in healing and treatment of NSAID-associated complications, the number of hospitalizations and deaths has remained unchanged in the US in the last decade."(2)

Non-steroidal anti-inflammatory drugs (NSAIDs) are prescribed extensively for a variety of pain and health issues. The widespread use and accessibility of NSAIDs may allow consumers to erroneously assume the safety of these medications. This problem is largely a consequence of NSAIDs' regular use by more than 60 million Americans (3) resulting in clinically significant upper GI events in 1–2% (up to 1,200,000) of users (4).

Pharmaceutical companies market and promote worldwide sales. Yet American government agencies have done nothing of substance to alert the public concerning NSAIDs side effects.

Plant-based natural supplements provide safe, effective pain relief alternative

If you could achieve the relief you need safely, without worrying about NSAIDs side effects, wouldn’t it be worth a try?

In my opinion, the six-minute video Gastrointestinal Risk with NSAIDs, produced by the American Gastroenterology Association (AGA) provides factual reason enough to consider switching from NSAIDs to plant-based pain relief.

Natural pain management is nothing new. For centuries, nature has contained the answers for pain relief. There are many botanical and herbal substances that have proven effective, safe and without any NSAIDs side effects.

Here are three trusted high quality natural products that may be helpful in attaining back pain and joint pain relief from injury, surgery or arthritis:

  1. Pain Relief Complex: Dietary supplement caplets consisting of patent-pending safflower extract and clinically-proven boswellia extract. Contains no aspirin and is gentle on the stomach. Use as a complement or potential replacement to existing medications as it’s a natural anti-inflammatory with minimal side effects and without NSAIDs side effects of GI bleeding.

  2. New Advanced Joint Health Complex: Contains natural, fast-acting key joint nutrients to help bring joint comfort and mobility. Two coated caplets daily help build cartilage to promote joint health and flexibility, consisting of glucosamine hydrochloride and clinically-proven patent-pending boswellia extract for faster relief in as few as five days.

  3. Joint & Muscle Pain Cream: A natural blend of plant extracts with pain-relieving, cooling menthol that provides temporary but a very deep pain relief rub for pain associated with arthritis, bruises, muscle strains and sprains. This product alone may reduce your dependency on NSAID dosage as its relief is immediate and lasts up to four hours.

For complete background information and our personal testimonies on each, click on the following link: Three natural pain products.

Non prescription NSAIDs are not risk free; don’t over medicate--FDA

“Non-prescription NSAIDS join more than 700 other over-the-counter (OTC) drugs that would have required a prescription only 20 years ago, according to the Consumer Healthcare Products Association (CHPA), which represents the leading manufacturers and distributors of OTC medicines and nutritional supplements,” as quoted in the Food and Drug Administration (FDA) publication, Now Available Without a Prescription.

“These products are now available without a prescription because the FDA, in cooperation with panels of outside experts, determined they could be used safely and effectively without a doctor's supervision. If you do choose OTC treatment, heed this warning: Drugs aren't candy; they aren't risk-free. You have to follow the label and take appropriate responsibility for your own self-care.”(5)

The FDA publication continues:” “Today's emphasis on self-care fuels the popularity of nonprescription drugs. But OTC products are intended to supplement the medical options of the consumer, not substitute for a prescriber's medical knowledge. If a health problem persists or worsens while using an OTC drug, consult a health care provider.”

“People must be in a partnership with their health care providers for optimal health. Many situations aren't appropriate for self-treatment, and others may require professional guidance for self-treatment.”

What are NSAIDs side effects?

NSAIDs side effects have been extensively published and are included with the packaging of each non-prescription NSAID product, or pharmaceutical information sheets with each filled prescription.

Because NSAIDs comprise a large variety of drugs, both over-the-counter (OTC) and prescription, it is complicated to lump their side effects into one box with a neat ribbon. Associated risk factors such as product strength, chronic use, frequency and amount of regular use, over age 65, alcohol intake, obesity, diabetes, and cardiovascular disease or hypertension are factors that must be considered on an individual case basis.

According to the American College of Gastroenterology (ACG), gastrointestinal (GI) bleeding and ulcers is an important and potentially serious condition. It can arise initially with few if any symptoms. While damage may occur with modest, short-term doses, problems are more likely to arise in regular NSAID users, and increase with the magnitude of use—more frequent use and/or higher dosages.(6, 6A)

NSAIDs side effects can be separated into three general categories: Temporary, Serious and Toxic Overdose:

  1. Temporary NSAIDs Side Effects. The more common of these temporary side effects include dyspepsia or nausea, heartburn or acid indigestion, dizziness, nasal congestion, headaches, back pain, throat burning sensation, insomnia, gas and a nasal drip. Less common temporary side effects include excessive tearing, anxiety, bleeding stool, hair loss, motion difficulties when walking, joint pain, nervousness, vocal changes among others. Rare temporary side effects may include crying, inability to concentrate, moods that change quickly, euphoria or dysphoria, paranoia and depression. Tell your doctor about any of these that persist.

  2. Serious NSAIDs Side Effects. Serious side effects may occur when taking NSAIDs, whether they are by prescription or purchased OTC. They include more common serious side effects such as wheezing or breathing difficulties, unaccounted itching, swelling, belching, chest tightness, bruising, stomach pain, shortness of breath, headaches and skin eruptions, among others. Less common serious side effects, may include tunnel vision, tar-like stool, mouth inflammation or swelling, cloudy urine, constipation, severe pain or cramping or burning in the stomach, double vision, color perception irregularities, appetite loss and night blindness. Rare serious side effects include anxiety, confusion, vision decreases, cold sweats, depression, diarrhea, skin blisters, blindness, dizziness, eye pain, fainting, skin cracks, extreme fatigue or even a coma. Other rare effects include seizures, slurred speech, weight gain, sneezing, throat soreness, nosebleeds, breathing difficulties (labored, or fast and shallow), eye irritation, bodily heat loss, lightheadedness, tachycardia, arrhythmia, nightmares and nervousness, among many others. Check with your doctor for any of these immediately.

  3. Toxic Overdose NSAIDs Side Effects. Exceeding the recommended dosage (especially chronically) can cause toxic overdose. Check with your physician immediately if you experience side effects such as sudden fainting, skin or lips turning blue, stomach cramping, sleeping problems, hallucinations, disorientation, muscle tremors, drowsiness or restlessness. More serious signs may include a kidney or liver failure, coma, bradycardia and arrhythmia.

What are the common brand names of NSAID products?

Some of the OTC brands of NSAIDs include:

  • Aspirin. Anacin, Bayher, Bufferin, Ecotrin
  • Ibuprofen. Advil, Motrin, Nuprin
  • Naproxen. Aleve, Naproxen
  • Keptoprofen. Actron, Orudis

The prescription brand of NSAID is:

  • Celecoxib. Celebrex

Study: people not aware of harmful effects of painkillers

Over-the-counter and prescription painkiller drugs are often used inappropriately and there’s a substantial number of people who are not aware of the potential side effects, according to a study published in the November, 2005 issue of the Journal of Rheumatology.(7)

The study, People Unaware of Harmful Effects of Painkillers, is the first to look at the characteristics, attitudes and behaviors of the population who frequently use non-prescription and prescription NSAIDs.

“This study shows just how common these medications are used and highlights the lack of insight into their potential dangers,” said C. Mel Wilcox, MD, lead study author from the University of Alabama at Birmingham. “The findings paint a clear picture of the need for patient and physician education efforts and interventions to help prevent unnecessary complications from painkillers.”

Fifty-four percent of the 807 people surveyed in the study were not aware of the potential side effects of these drugs and 18 percent had previously experienced side effects. Those who used over-the-counter painkillers commonly experienced side effects such as stomach pain, internal bleeding and ulcers.

Nearly 30 percent of these people did not consider themselves at risk for any side effects associated with painkiller use. The study found similar numbers in people who exclusively used prescription painkillers.

AGA estimates 36 million take NSAIDS with 25% exceeding recommended dosage

The above study was supported by the American Gastroenterological Association (AGA), which estimates that every day more than 36 million people take over-the-counter and prescription NSAIDs for pain relief, headaches and arthritis, with nearly 25 percent exceeding the recommended dosage.(7)

The AGA observed that long-term use of NSAIDs in high doses can provide great benefit in terms of anti-inflammatory effects, pain relief and cardio-protective effects but the risk can be great.

With increased dosage, there’s increased risk of gastrointestinal complications ranging from stomach pain to ulcers, hemorrhage and severe and potentially deadly gastrointestinal problems.

Study: taking two different NSAIDs at same time is risky

A study published in the European Journal of Clinical Pharmacology and research presented at the 2007 Annual Scientific Meeting of the American College of Gastroenterology concluded that the risk of severe drug reactions causing injury to the liver and acute renal failure was 6 to 7 times higher in reported cases of simultaneous use of two NSAIDs.(8)

NSAIDS are commonly prescribed medications used to treat arthritis. However, they’re available both by prescription and over the counter. Some patients may take two separate drugs because of inadequate pain relief or because they don’t realize both drugs are in the same therapeutic drug class.

Survey results have shown that patients under-report or fail to report their use of over-the-counter NSAIDs because they believe the drugs are insignificant since they’re available without a prescription.

You do not want to become a statistic. Use NSAIDs safely and appropriately. If you already take a prescription NSAID, check with your doctor before taking over-the-counter medications at the same time.

Study: “Many take more NSAIDs that recommended

Forty-four percent of Americans said they took more than the recommended dose of NSAID pain relievers in 2003, up from 26 percent in 1997, according to a study released by the American Gastroenterological Association May, 23, 2004. (9)

Researchers compared findings of two consumer surveys—one conducted in 1997 and another in 2003—to measure consumer awareness levels of side effects associated with over-the-counter analgesics.

The comparison study found that 59 percent of respondents were concerned about side effects in 2003, up from only 18 percent in 1997.

The study concluded that despite increasing evidence of the seriousness of NSAIDs side effects associated with indiscriminate use of store-bought pharmaceuticals, U.S. adults continue to use the medications incorrectly, putting themselves at risk for life-threatening side effects.

NSAIDs side effects are serious for those with inappropriate use

"Because these drugs are easily accessible and can be very effective, there is a misperception out there that they have no risks," said Byron Cryer, M.D., lead investigator on the study and an associate professor of medicine at the University of Texas Southwestern Medical School in Dallas, Texas. "In reality, there are serious side effects associated with inappropriate use that patients need to recognize."

"There is no medical test to determine who will develop side effects, and there usually are no warning signs. Education is imperative to help patients recognize the risk factors and have discussions with their physicians," said Cryer.(9)

NSAIDs, including the pain medications aspirin, ibuprofen and naproxen, are one of the leading causes of stomach ulcers and have been associated with NSAIDs side effects ranging from stomach upset to stomach bleeding, which can be life threatening.

Risk factors of painkiller drugs

In an effort to reduce risk factors, the American Gastroenterological Association has established the REDUCE (Risk Education to Decrease Ulcer Complications and their Effects from NSAIDS) online Patient Center, as part of their educational program to raise awareness about NSAIDs side effects.(10)

Surveys have found that more than one-third of consumers considered it safe to combine over-the-counter analgesics and prescription NSAIDs, putting them at risk for complications. Other risk factors include:

  • Age 60 or over
  • History of previous ulcer(s)
  • Exceeding recommended dosages
  • Extended treatment periods
  • Combining a NSAID with blood thinners or steroid medications

Relationship between NSAIDs side effects and rheumatoid arthritis patients

Doctors often prescribe higher doses of NSAIDs for rheumatoid arthritis sufferers because the condition leads to a significant degree of heat, swelling, and stiffness in the joints.

Early, aggressive treatment is important for rheumatoid arthritis sufferers in order to prevent further damage. Lower doses are typically adequate for osteoarthritis and muscle injuries, since there is less swelling and no warmth in the joints.

Painkiller drug manufacturers revised their labels to include more information on potential heart attack and stomach bleeding risks associated with NSAIDs side effects.


1. Wolfe M. MD, Lichtenstein D. MD, and Singh Gurkirpal, MD, "Gastrointestinal Toxicity of Nonsteroidal Anti-inflammatory Drugs", The New England Journal of Medicine, June 17, 1999, Vol. 340, No. 24, pp. 1888-1889

1A. Singh Gurkirpal, MD, Recent Considerations in Nonsteroidal Anti-Inflammatory Drug Gastropathy, The American Journal of Medicine, July 27, 1998, p. 31S

2. Edward J. Frech and Mae F. Go, Treatment and chemoprevention of NSAID-associated gastrointestinal complications, Therapeutics and Clinical Risk Management, 2009, pp. 65-73

3. Dai, C, Stafford, RS, Alexander, GC. National trends in cyclooxygenase-2 inhibitor use since market release: Nonselective diffusion of a selectively cost-effective innovation. Arch Intern Med 2005;165: 171–177.

4. Silverstein, FE, Faich, G, Goldstein, JL, et al. Gastrointestinal toxicity with celecoxib vs. Nonsteroidal anti-inflammatory drugs for osteoarthritis and rheumatoid arthritis: The CLASS study: A randomized controlled trial. Celecoxib long-term arthritis safety study. JAMA 2000;284: 1247–1255.

5. Current publication, Now Available Without a Prescription, U.S. Food and Drug Administration (FDA) http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm143547.htm

6. Printable online patient handout ,The Dangers of Aspirin and NSAIDS, , American College of Gastroenterology (ACG). http://www.acg.gi.org/patients/women/asprin.asp

6A. Understanding GI Bleeding (ACG), a consumer education brochure, The American College of Gastroenterology. http://www.acg.gi.org/patients/gibleeding/index.asp

7. C. Mel Wilcox, MD, People Unaware Of Harmful Effects of Painkillers, Journal of Rheumatology, Nov. 2005. Study supported by American Gastroenterology Association (AGA). http://www.sciencedaily.com/releases/2005/11/051121165432.htm

8. François Clinard, et. al. Association between concomitant use of several systemic NSAIDs and an excess risk of adverse drug reaction. European Journal of Clinical Pharmacology. April 21, 2004. http://www.springerlink.com/content/ubprtwrb07xntmew

9. Byron Cryer, M.D., Many take more NSAIDS than recommended, presentation at Digestive Disease Week, New Orleans, LA. American Gastroenterology Association (AGA), May 23, 2004 http://alcoholism.about.com/od/prescription/a/blaga040522.htm

10. Patient Center, Non Steroidal Anti Inflammatory Drugs, American Gastroenterology Association (AGA), April 24, 2010 http://www.gastro.org/patient-center/diet-medications/nonsteriodal-anti-inflammatory-drugs-nsaids

Video Gastrointestinal Risks with NSAIDS, American Gastroenterology Association (AGA) 6:13 http://www.youtube.com/watch?feature=player_detailpage&v=MJ9pamb9lhc

NSAIDs Side Effects Disclaimer: Health statements on this MSAIDs side effects page have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease

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