Ibuprofen, one of the most widely used painkillers for arthritis and many other pain disorders, may not be as safe as originally thought when taken in standard and high dosages. A succession of clinical studies from 2005-2018 has implicated the drug for increased risk for fibrillation, stroke and heart
attack on top of its gastrointestinal side effects of bleeding, ulcers and death.
Does this risky drug beg natural pain relief alternatives that are effective, but without side effects? If this idea appeals to you, the information on this site is based on evidence gleaned from hundreds of clinical studies on pain--not from our opinion.
First, let’s look at the problem:
The risk of heart attack and stroke with non-steroidal anti-inflammatory drugs (NSAIDs), either of which can lead to death, was first addressed in 2005 by the Food and Drug Administration (FDA) in the Boxed Warning and Warnings and Precautions section of prescription drug labels.
On July 9, 2015, influenced by mounting evidence from subsequent studies, the Food and Drug Administration (FDA) announced update requirements for stronger wording on ibuprofen's risk of stroke and heart attacks for all non-prescription and prescription outer package labels. 1
The updates include, but are not limited to, the following heart-related warnings:
Ibuprofen is identified most commonly with the brand names Advil and Motrin. Other members of this class of drugs include aspirin (Bayer), naproxen (Aleve) indomethacin (Indocin), celecoxib (Celebrex) and several others.
It is available over-the-counter (OTC) and by prescription at greater strength or in combination with another drug, such as hydrocodone (Vicoprefen, Represain, Xylon).
Pain, fever and inflammation are promoted by the release in the body of chemicals called prostaglandins. Ibuprofen blocks the enzyme that makes prostaglandins (cyclooxygenase), resulting in lower levels of prostaglandins, reducing the symptoms.
It’s used to reduce fever and treat mild to moderate pain or inflammation caused by many conditions such as various types of arthritis, back pain, headache, toothache, menstrual cramps, minor injury and diverse diseases. Like all pharmaceuticals, it has side effects, which are increasingly implicated for stroke and cardiac arrest.
More than 100 million Americans suffer from some sort of chronic pain. Fifty-four million have doctor-diagnosed arthritis, a figure the Arthritis Foundation says is more like 91 million, when considering those who have arthritis symptoms but not yet diagnosed. 2
NSAIDs have been the cornerstone of managing pain in patients with osteoarthritis and other painful conditions.
To provide a more reliable estimate of the cardiovascular risks of NSAIDs, researchers in Switzerland performed a comprehensive analysis of all randomized controlled trials comparing any NSAID with other NSAIDs or placebo. They included 31 trials and 116,429 patients taking seven different NSAIDs or placebo and found ibuprofen was associated with more than three times the risk of stroke and 1.3 times greater risk of a heart attack compared to placebo.
Naproxen was the least harmful in terms of cardiovascular safety of the seven drugs.3
The study authors concluded, “Although uncertainty remains, little evidence exists to suggest that any of the investigated drugs are safe in cardiovascular terms, a risk that needs to be taken into account when prescribing any NSAID.” The study was published January 12, 2011 in the British Medical Journal,.
Painkillers considered harmless by the public, including OTC's, are associated with increased risk of cardiac arrest, according to research published in the European Heart Journal—Cardiovascular Pharmacotherapy, March 2017. The study recommended limiting daily intake of ibuprofen and naproxen to 1200 mg and 500 mg, respectively.4
Previous studies have linked NSAIDs to increased cardiovascular risk. To investigate the link between NSAID use and cardiac arrest, researchers in Denmark studied 28,947 patients who had an out-of-hospital cardiac arrest in that country during a ten-year period between 2001-2010. Of these 3,376 were treated with an NSAID up to 30 days before the event.
Ibuprofen was the most commonly used NSAID making up 51% of
the total. The study found that the drug was associated with a 31% increased risk, which was also the average percent increase from use of any NSAID, although diclofenac had a 50% risk increase.
"Allowing these drugs to be purchased without a prescription, and without any advice or restrictions, sends a message to the public that they must be safe," said author Professor Gunnar H. Gislason, professor of cardiology at Copenhagen University Hospital Gentofte, Denmark.
“The findings are a stark reminder that NSAIDs are not harmless.” He added that “ibuprofen and diclofenac, both commonly used drugs, were associated with significantly increased risk of cardiac arrest. NSAIDS should be used with caution and for a valid indication. They should probably be avoided in patients with cardiovascular disease or many cardiovascular risk factors.”
Professor Gislason said he was opposed to NSAIDs being sold in supermarkets where there is no professional advice on how to use them. “Over-the-counter NSAIDS should only be available at pharmacies, in limited quantities, and in low doses,” he cautioned.
“Do not take more than 1200 mg of ibuprofen per day,” he continued. “Naproxen is probably the safest NSAID and we can take up to 500 mg a day and diclofenac should be avoided”
Prescription-strength ibuprofen and naproxen may be linked to a 30% risk of irregular heartbeat, a condition that can increase risk of stroke and heart failure, according to new research.5
Previous studies found use of these drugs to increase risk of stroke, heart attack and death. To determine whether there is an association between taking NSAIDS and the risk of atrial fibrillation (AF), researchers used national data sets of 57,000 patients in Taiwan older than age 45 from 2000, 2005 and 2010. They compared those with AF to those without AF of similar age, sex, and medical conditions. They concluded the participants who used NSAIDs had a significantly elevated risk of AF by 30 percent. The drugs studied both selective (Celebrex and Mobic) and non-selective NSAIDs (aspirin, diclofenac, ibuprofen and naproxen).
Study authors summarized: “Based on these findings it will certainly be important for physicians who prescribe NSAIDs to do so cautiously, especially among those at high risk for AF. Benefits and risks of NSAID use should be carefully evaluated when delivered in clinical practice.” They said their findings deserve further investigation.
The study was published in the British Journal of Clinical Pharmacology on March 20, 2018.
A five-year study has found that OTC drugs Advil, Motrin, and Aleve increase cardiovascular safety more than prescription Celebrex.
Ibuprofen and naproxen are typically used without prescription for backaches and headaches, and at higher OTC doses can reduce inflammation behind chronic conditions like osteoarthritis or rheumatoid arthritis.
Celecoxib is a NSAID COX-2 inhibitor drug that, unlike ibuprofen and naproxen, is easy on the stomach. Previously, the two other COX-2’s, Vioxx and Bextra, were removed from the market because studies showed they were linked to higher risk of heart attack and stroke. Celebrex survived but the heart concerns led the Food and Drug Administration (FDA) to require its maker, Pfizer, to pay for additional studies to ensure that celecoxib did not put people at increased risk of heart trouble.
The study, called PRECISION, involved more than 24,000 people with heart problems who needed to take an NSAID to treat conditions like arthritis and rheumatoid arthritis. They were randomly assigned to take non-prescription Advil, Motrin or Aleve or prescription Celebrex for nearly two years and followed for another three years for heart attacks, stroke or death.
The study did not include people who take higher doses of any of the three drugs. They were assigned standard doses for chronic arthritis pain of 600 mg ibuprofen three times a day, 375 mg naproxen twice a day, and 100 mg celecoxib twice a day.
Results of the study surprised its authors. Researchers and physicians did not expect that celecoxib would not lead to higher rates of heart events than ibuprofen or naproxen. In fact, it was discovered that celecoxib may even cause fewer kidney problems than the other two NSAIDS.
In the intention to treat analysis, a primary outcome event occurred in 2.3% of the celecoxib group, compared with 2.5% of the naproxen group and 2.7% of the ibuprofen group. The on-treatment analysis found a primary outcome event occurred in 1.7% of the celecoxib group, 1.8% of the naproxen group, and 1.9% of the ibuprofen group.
The risk of gastrointestinal events, typical side effects of ibuprofen and naproxen, was significantly lower with celecoxib, and the risk of renal events was significantly lower with celecoxib compared with ibuprofen.
"In summary," the researchers conclude, "the PRECISION trial showed the noninferiority of moderate doses of celecoxib, as compared with naproxen or ibuprofen with regard to the primary [Antiplatelet Trialists Collaboration] cardiovascular outcome."
The study was published in the New England Journal of Medicine (JAMA) December 29, 2016. It was funded by Pfizer.6
High-dose NSAIDs, widely used to manage pain for arthritis and other inflammatory disorders, have been linked since inception to increased risk of gastrointestinal complications. However, the vascular effects at considered high doses has not been clear.
A large meta-analysis, Coxib and Traditional NSAID Trialists’ Collaboration consisting of 639 trials and more than 353,000 participants, compared coxibs and NSAIDS with each other or with placebo. Researchers discovered that ibuprofen at 2400 mg daily more than doubled (2.22 rate ratio) major coronary events of stroke, mortality, heart failure and upper GI complications, but not major vascular events of non-fatal myocardial infarction, non-fatal stroke or vascular death. Naproxen did not significantly increase major vascular events or vascular deaths.7
The main drugs studied were COX-2’s (celecoxib. rofecoxib), and traditional NSAIDs ibuprofen, naproxen at 1000 mg daily, and diclofenac at 150 mg daily.
Heart failure risk was roughly doubled by all NSAIDs and all NSAID regimens increased upper GI complications, with rate ratios of 1.81 for coxibs, 1.89 for diclofenac, 3.07 for ibuprofen and 4.22 for naproxen.
On the positive side, high-dose naproxen seemed to be associated with less hazard, although it's "unclear" if that's true of the lower doses most commonly used in clinical practice, they reported.
In an accompanying commentary on the study, Marie Griffin, MD, of Vanderbilt University Medical Center in Nashville, said the analysis “offers considerable certainty” about high dosage risks of commonly used NSAIDs, She argued that the study has some major gaps—the risks associated with lower doses, longer durations of use, and residual effects after stopping treatment.
“Clinical trials are not the whole story,” she noted. “The bottom line is that identification of safe and effective strategies for chronic pain is sorely needed.” Until those are worked out, “long-term use of high-dose NSAIDs should be reserved for those who receive considerable symptomatic benefit from the treatment and understand the risks,” she concluded.
The study was published in Lancet August 31, 2013.
Listed below are the serious Motrin and Advil side effects (if you have any of these symptoms, stop taking the
medication and seek medical attention or call your doctor at once):
This medicine can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking ibuprofen. Older adults may have an even greater risk of these serious gastrointestinal side effects.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Less serious side effects may include:
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.
If you take ibuprofen for a long period of time, your doctor may want to check you on a regular basis to make sure the medication doesn’t cause harmful effects. The medicine is available only in 200 mg tablets or liquid gels. High per tablet dosage are available only by prescription. It is generally regarded as safe when used for short durations of 10 days or less.
The following are the usual dosages for age 12 through adult:
(Recent studies are now suggesting 1200 mg per day).
Have painkillers like ibuprofen for chronic pain forced you into a corner? Can't live with them but can't survive without them?
You've waded into the middle of an American dilemma that, for some, cries out, “Do pain drugs cause more harm than good?”
That's why we developed this site. Arthritis-Relief-Naturally
explores plant-based clini-cally-proven alternatives for pain relief that safely shut the door on harmful side effects from pharmaceutical drugs.
What's in it for you? Natural pain relief products protect your health and won't tear it down. Benefits flourish into a healthier, restored quality of life. If you could achieve the arthritis pain relief you need safely, without total reliance on drugs, wouldn’t it be worth a try?
Now, let’s look at the solution.
As you can see in this report, ibuprofen has potential serious side effects from over use or long-term treatment.
Do you have pain that requires non-prescription or prescription medication as many as five days a week? If so, you may wonder about the potential damage this drug has on your gastrointestinal tract, kidneys, heart or other organs.
It’s possible to free yourself completely (or cut back substantially) from pain relief medications by switching to natural alternatives.
The recommended products below contain the power to deliver pain relief long-term and have proved extremely safe. For information on three available options, please click on the Pain Trio link below:
Nature’s pharmacy: Three Natural Pain Products (The Pain Trio). Scroll this to access #1 Natural Nutrition Company in the U.S., Pain Is A Warning, and My Arthritis Story.
Arthritis is a chronic pain condition. It is with you every day. In some, every hour.
One of the three natural pain relief products in the link above has completely replaced ibuprofen and made a remarkable difference in the treatment of my husband and my osteoarthritis, as well as my recurrent neck and back pain (click the blue link below for product information):
As a clinically-tested natural dietary supplement in tablet form, it consists of a patented blend of 1000 mg of clinically proven boswellia extract [resin] (standardized to 40% total boswellic acid) and 150 mg of safflower extract.
It provides pain relief for overworked joints, promotes flexibility and overall comfortable movement and is gentle on the stomach. It is gluten free, contains no aspirin, sweeteners, colors, artificial flavors, preservatives, is not habit-forming and is completely safe.
I highly recommend it from the personal experience of taking 3 tablets every day for many years without side effects of any kind. The longer you take it the more your pain subsides.
It is not recommended for children or pregnant/nursing women.
1 Drug Safety Announcement, FDA strengthens warning that non-aspirin NSAIDs can cause heart attacks or strokes. Food & Drug Administration, July 9, 2015. https://www.fda.gov/Drugs/DrugSafety/ucm451800.htm
2 Arthritis by the numbers, pdf. Arthritis Foundation, 2018 edition, https://www.arthritis.org/Documents/Sections/About-Arthritis/arthritis-facts-stats-figures.pdf
3 Article, Dangers of over-the-counter pain medication: safety tips, Doctor Oz, January 29, 2013, accessed May 16, 2018. https://www.doctoroz.com/article/dangers-over-counter-pain-medication-safety-tips
3A Study Common painkillers linked to increased risk of heart problems, Source: BMJ/ScienceDaily, January 12, 2011 https://www.sciencedaily.com/releases/2011/01/110111184132.htm
4 Pirani, F., Article, Common painkillers increase risk of heart attack by one-third, new study finds. Atlanta Journal-Constitution, July 10, 2017, https://www.ajc.com/news/local/common-painkillers-increase-risk-heart-attack-one-third-new-study-finds/Q5m8BfdzaZlFZQlDKh8MXN/
5 Pirani, F., Article, Common painkillers linked to increased heart risks, new study finds, Atlanta Journal-Constitution, March 22, 2018. https://www.ajc.com/news/health-med-fit-science/common-painkillers-linked-increased-heart-risks-new-study-finds/oNxYqON7S34AtmHCCZF6lL/
6 Nissen, S., MD, Study, Cardiovascular safety of celecoxib, naproxen, or ibuprofen for arthritis. New Engl J. Med (NEJM), DOI: 10.1056/NEJMoa1611593, December 29, 2016 https://www.nejm.org/doi/full/10.1056/NEJMoa1611593
7 Bhala, N., et al. meta-analysis: Vascular and upper GI effects of NSAIDs, Lancet, August 31, 2013; 382(9894):769-79. doi: 10.1016/S0140-6736(13)60900-9, PubMed: https://www.ncbi.nlm.nih.gov/pubmed/23726390
8 Daily Med, Ibuprofen, Dosage and Administration, U.S. National Library of Medicine,(NLM) National Institutes of Health (NIH), accessed May 20, 2018. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=69fbfd9b-5a75-486c-bf29-b63745cdfc7d
Disclaimer: Health statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease.
Arthritis Products 3 safe natural products scientifically designed to fight pain and reduce dependency on pharmaceutical medicines. Each unique for rapid relief and joint health …. Click here for details
Find Best Company. 30 questions concerning standards of excellence help find the best dietary supplement company. One company stands out with 90 published studies in prestigious medical journals, the gold standard for natural health products. Click here for more information
Natural Arthritis Pain Relief. Millions choosing herbal supplements when conventional treatments are of concern or haven’t provided acceptable results. How to find the best pain relief….Click here for more
Herbal Pain Relief. In the last twenty years in the United States, the public has become increasingly dissatisfied with the cost and side effect risks of prescription medications. This, combined with an interest in returning to natural or organic remedies, has... Click here for background on herbal medicine
Chronic Pain Relief Naturally. Natural treatments not only relieve chronic pain, they can help the body rebuild. An estimated 50 million Americans are aggravated by the frustration of chronic pain. Click here for more information
Joint Pain Relief. Wouldn't it be great if you could have a drug-free future with no harmful side effects and have complete control over your joint pain? It's not a dream--all of this is possible.... Click here for more on natural joint pain relief
Vitamin Supplements There are no vitamin supplements proven to reduce symptoms of arthritis, a debilitating disease. A natural multivitamin can improve overall health and vitality. Click here for recommended multivitamin.