Do NOT stop taking this or any drug without the advice of your physician. Some drugs can cause severe adverse effects when they are stopped suddenly.
Generic drug name:
flurbiprofen
(flure BY proe fen)
Brand name(s):
GENERIC:
available
FAMILY:
Nonsteroidal Anti-inflammatory Drugs (NSAID)
Find the drug label by
searching at DailyMed.
Generic drug name:
ketoprofen
(kee toe PROE fen)
Brand name(s):
GENERIC:
available
FAMILY:
Nonsteroidal Anti-inflammatory Drugs (NSAID)
Find the drug label by
searching at DailyMed.
Generic drug name:
naproxen
(na PROX en)
Brand name(s):
ALEVE,
ANAPROX DS,
EC-NAPROSYN,
NAPRELAN,
NAPROSYN,
TREXIMET
GENERIC:
available
FAMILY:
Nonsteroidal Anti-inflammatory Drugs (NSAID)
Find the drug label by
searching at DailyMed.
Limited Use
[what does this mean?]
Generic drug name:
diclofenac [topical]
Brand name(s):
PENNSAID TOPICAL SOLUTION,
SOLARAZE TOPICAL GEL,
VOLTAREN GEL
GENERIC:
not available
FAMILY:
Nonsteroidal Anti-inflammatory Drugs (NSAID)
Find the drug label by
searching at DailyMed.
Limited Use
[what does this mean?]
Generic drug name:
etodolac
(ee TOE doe lak)
Brand name(s):
GENERIC:
available
FAMILY:
Nonsteroidal Anti-inflammatory Drugs (NSAID)
Find the drug label by
searching at DailyMed.
Limited Use
[what does this mean?]
Generic drug name:
fenoprofen
(fen oh PROE fen)
Brand name(s):
NALFON
GENERIC:
available
FAMILY:
Nonsteroidal Anti-inflammatory Drugs (NSAID)
Find the drug label by
searching at DailyMed.
Limited Use
[what does this mean?]
Generic drug name:
meclofenamate
(me kloe FEN am ate)
Brand name(s):
GENERIC:
available
FAMILY:
Nonsteroidal Anti-inflammatory Drugs (NSAID)
Find the drug label by
searching at DailyMed.
Limited Use
[what does this mean?]
Generic drug name:
mefenamic acid
(me fe NAM ik)
Brand name(s):
PONSTEL
GENERIC:
not available
FAMILY:
Nonsteroidal Anti-inflammatory Drugs (NSAID)
Find the drug label by
searching at DailyMed.
Limited Use
[what does this mean?]
Generic drug name:
nabumetone
(na BYOO me tone)
Brand name(s):
GENERIC:
available
FAMILY:
Nonsteroidal Anti-inflammatory Drugs (NSAID)
Find the drug label by
searching at DailyMed.
Limited Use
[what does this mean?]
Generic drug name:
oxaprozin
(ox a PRO zin)
Brand name(s):
DAYPRO
GENERIC:
available
FAMILY:
Nonsteroidal Anti-inflammatory Drugs (NSAID)
Find the drug label by
searching at DailyMed.
Limited Use
[what does this mean?]
Generic drug name:
sulindac
(syl IN dak)
Brand name(s):
GENERIC:
available
FAMILY:
Nonsteroidal Anti-inflammatory Drugs (NSAID)
Find the drug label by
searching at DailyMed.
Limited Use
[what does this mean?]
Generic drug name:
tolmetin
(TOLE me tin)
Brand name(s):
GENERIC:
available
FAMILY:
Nonsteroidal Anti-inflammatory Drugs (NSAID)
Find the drug label by
searching at DailyMed.
Do Not Use
[what does this mean?]
Generic drug name:
diclofenac [oral]
(dye KLOE fen ak)
Brand name(s):
CAMBIA,
CATAFLAM,
VOLTAREN,
ZIPSOR,
ZORVOLEX
GENERIC:
available
FAMILY:
Nonsteroidal Anti-inflammatory Drugs (NSAID)
Find the drug label by
searching at DailyMed.
Pregnancy and Breast-feeding Warnings [top]
Pregnancy Warning
NSAIDs have caused serious harm to human infants born to mothers taking these drugs during pregnancy, particularly the third trimester of pregnancy. Such infants have been born with damage to the heart, blood vessels, kidney, and gastrointestinal tract. Tell your doctor if you are pregnant or thinking of becoming pregnant before you take these drugs.
Breast-feeding Warning
Many NSAIDs are excreted in human milk. Because of the potential for adverse effects in nursing infants, you should not take these drugs while nursing.
Safety Warnings For This Drug [top]
FDA BLACK-BOX WARNINGS
Cardiovascular Risk
Gastrointestinal Risk
Facts About This Drug [top]
The medications discussed in this profile belong to the family of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). These medications are used to treat several conditions, including mild-to-moderate pain, rheumatoid arthritis, osteoarthritis and spondylitis (an inflammation of the vertebra, the bones that form the spine).
Refer to the drug label for each medication for specific indications of use.
Older adults are more likely to suffer the adverse effects of NSAIDs because...
The medications discussed in this profile belong to the family of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). These medications are used to treat several conditions, including mild-to-moderate pain, rheumatoid arthritis, osteoarthritis and spondylitis (an inflammation of the vertebra, the bones that form the spine).
Refer to the drug label for each medication for specific indications of use.
Older adults are more likely to suffer the adverse effects of NSAIDs because they are more likely to have reduced liver and kidney function. Some doctors believe people over age 70 should be started on half the usual dose of drugs in this group.[1] Patients over age 60 (especially those with decreased kidney function) also should take less than the usual adult dose of these drugs.
Public Citizen lists the following as Limited Use drugs: etodolac (generic only), fenoprofen (NALFON), meclofenamate (generic only), mefenamic acid (PONSTEL), nabumetone (generic only), oxaprozin (DAYPRO), sulindac (generic only) and tolmetin (generic only). We list the oral form of diclofenac (CAMBIA, VOLTAREN, ZIPSOR, ZORVOLEX) as a Do Not Use drug because it has a higher risk of adverse cardiovascular events than other NSAIDs.
Adverse effects
NSAIDs can cause serious harm, and even death, from bleeding in the stomach or intestines. Bleeding can occur at any time and without warning, and older people are more likely to experience adverse effects from bleeding. There is a potential for liver problems associated with the use of all diclofenac-containing products, including liver toxicity, jaundice and liver failure.
The British Medical Journal (BMJ) published a meta-analysis (a study that combines data from many other studies) looking at the use of NSAIDs and cardiovascular safety. The authors of the article stated that there is a risk of cardiovascular adverse effects associated with these drugs, and this risk must be considered when treating patients.[2]
Information from another article in the BMJ found that the use of NSAIDs was associated with the occurrence of abnormal heart rhythms called atrial fibrillation or flutter.[3]
In 2013, the manufacturer of diclofenac in the U.K., in agreement with the European Medicines Agency and the U.K. Medicines and Healthcare products Regulatory Agency (an agency in the U.K. similar to the Food and Drug Administration [FDA]), issued information to the public on restrictions on the use of diclofenac-containing products and cardiovascular safety concerns. Data from a Europe-wide review showed that there is an increased risk of cardiovascular adverse effects associated with diclofenac use, and new contraindications were added to the drug product information based on these data.[4]
Data from a study published in The Lancet in 2013 added to the mounting evidence that NSAIDs may endanger heart health and prompted us to reclassify the pill form of diclofenac from Limited Use to Do Not Use. The study analyzed data from 639 studies in which more than 300,000 patients were randomized to receive an NSAID or a placebo (or, in some studies, another NSAID). The researchers found that high doses of diclofenac increased the risk of major vascular events (nonfatal heart attack, nonfatal stroke or vascular death). The study also showed that high-dose naproxen (NAPROSYN, ALEVE) is not associated with these increased risks.[5]
NSAIDs rarely can cause serious adverse skin reactions such as Stevens-Johnson Syndrome and toxic epidermal necrolysis, which can be fatal.[6]
There have been reports of patients taking NSAIDs developing a potentially fatal disorder known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS can lead to fever; rash; swollen lymph glands; and inflammation in the liver, kidneys, heart and other organs.[6]
In October 2014, Health Canada, a regulatory agency similar to the FDA, also issued a warning that products containing diclofenac are associated with an increased risk of cardiovascular adverse effects.[7]
In 2016, Pancreatology published a study showing that the risk of sudden inflammation of the pancreas (acute pancreatitis) may be increased with use of nabumetone.[8]
Interactions
Studies suggest a possible harmful interaction between NSAIDs and a class of osteoporosis drugs called bisphosphonates. Patients need to be alert to the fact that the combination can result in an increased risk of ulcers and other gastrointestinal adverse effects. Read more in the July 2010 issue of Worst Pills, Best Pills News.
Combining NSAIDs with anticoagulants (blood thinners for preventing blood clots) increases the risk of serious bleeding complications.[9]
When not to use NSAIDs
In patients with advanced kidney disease, treatment with NSAIDs is not recommended. However, if NSAID therapy must be initiated, close monitoring of the patient’s kidney function is advisable.
Patients in whom aspirin or other nonsteroidal anti-inflammatory/analgesic drugs induce the syndrome of asthma, rhinitis and nasal polyps should not use these drugs. These reactions have the potential to be fatal. Therefore, it is important that you discuss with your physician whether you have asthma, nasal polyps, urticaria (hives) and low blood pressure associated with NSAIDs before starting therapy. In addition, if such symptoms occur during therapy, stop taking the NSAIDs.
Better options available
Among the NSAIDs, evidence shows that ibuprofen (ADVIL, MEDIPREN, MOTRIN, NUPRIN) is less toxic than other drugs in this family to the gastrointestinal tract, which is one of the main safety concerns with NSAIDs.[10],[11],[12],[13],[14]
Aspirin (EASPRIN, ECOTRIN, EMPIRIN, GENUINE BAYER ASPIRIN) is just as effective as and less costly than other NSAIDs and is the drug of choice to treat pain, fever and inflammation in people who do not have ulcers, gastritis (inflammation of the stomach) or an allergy to aspirin. Some rheumatologists prefer aspirin to other NSAIDs for treatment of rheumatoid arthritis.[15]
Regulatory actions surrounding NSAIDs
2005: The FDA requested that manufacturers of NSAIDs, both prescription and over-the-counter, revise the drugs’ labels to include the potentially increased risks of cardiovascular events (read the information noted with COX-2 inhibitors) and gastrointestinal bleeding (see “Warnings” box at top of page). The FDA also required that a Medication Guide be provided to patients with each dispensed prescription.
2007: The FDA approved a diclofenac patch (FLECTOR) for topical treatment of acute pain due to minor strains, sprains and contusions. The Medical Letter on Drugs and Therapeutics published an article on FLECTOR. It concluded that there was not much evidence that the patch was more effective than a placebo and that there was no evidence that it was as effective as an oral analgesic.[16]
The FDA also approved a diclofenac gel (VOLTAREN GEL) for the treatment of osteoarthritis. The Medical Letter published an article on VOLTAREN GEL and concluded that it “might be modestly effective in decreasing pain in patients with osteoarthritis of the hand or knee.” According to the article, it has not yet been determined how the gel would compare to oral NSAIDs in terms of efficacy.[17]
2009: In December, the FDA and drug manufacturer Novartis issued information that there is a potential for liver problems, including liver toxicity, jaundice and liver failure, associated with the use of all diclofenac-containing products. This information was based on postmarketing reports of hepatotoxicity associated with diclofenac drug use. The advisory stated that the cases were reported within the first month of drug use but can occur at any time during treatment.[18]
2015: The FDA announced that the agency is strengthening the existing warning for all non-aspirin NSAIDs concerning an increased risk of heart attack and stroke.[19]
2020: The FDA and Health Canada (an agency in Canada similar to the FDA) warned that use of NSAIDs at about 20 weeks or later in pregnancy rarely causes serious kidney problems in an unborn baby.[20],[21] These kidney problems can lead to oligohydramnios, a condition in which there are low levels of amniotic fluid surrounding the baby. Amniotic fluid normally provides a protective cushion and plays an important role in the development of a baby’s lungs, digestive system and muscles. Oligohydramnios in turn can lead to decreased range of motion in a baby’s arms and legs and delayed lung maturation.
Before You Use This Drug [top]
Do not use if you have or have had:
Tell your doctor if you have or have had:
Tell your doctor about any other drugs you take, including aspirin, herbs, vitamins, and other nonprescription products.
When You Use This Drug [top]
How to Use This Drug [top]
Interactions with Other Drugs [top]
The following drugs, biologics (e.g., vaccines, therapeutic antibodies), or foods are listed in Evaluations of Drug Interactions 2003 as causing “highly clinically significant” or “clinically significant” interactions when used together with any of the drugs in this section. In some sections with multiple drugs, the interaction may have been reported for one but not all drugs in this section, but we include the interaction because the drugs in this section are similar to one another. We have also included potentially serious interactions listed in the drug’s FDA-approved professional package insert or in published medical journal articles. There may be other drugs, especially those in the families of drugs listed below, that also will react with this drug to cause severe adverse effects. Make sure to tell your doctor and pharmacist the drugs you are taking and tell them if you are taking any of these interacting drugs:
abciximab, alendronate, ardeparin, bendroflumethiazide, CAPOTEN, captopril, certoparin, clopidogrel, COUMADIN, cyclosporine, digoxin, DILANTIN, DYAZIDE, DYRENIUM, enoxaparin, eptifibatide, FOLEX, FOSAMAX, GARAMYCIN, gentamicin, gold sodium thiomalate, INDERAL, INDERAL LA, INTEGRILIN, ketorolac, LANOXICAPS, LANOXIN, lithium, LITHOBID, LITHONATE, LOVENOX, MAXZIDE, methotrexate, MEXATE, MINIPRESS, MYOCHRYSINE, nadroparin, NATURETIN, NEORAL, NORVIR, phenytoin, PLAVIX, prazosin, propranolol, ritonavir, SANDIMMUNE, TORADOL, TREXALL DOSE PACK, triamterene, triamterene and hydrocholorothiazide, warfarin.
The NSAIDs may diminish the blood-pressure-lowering effect of the angiotensin converting enzyme (ACE) inhibitors. See the table in our discussion on high blood pressure for a listing of ACE inhibitors.
The NSAIDs may reduce the effect of furosemide (LASIX).
The NSAIDs may reduce the effect of the thiazide diuretics (water pills). See the table in our discussion on high blood pressure for a listing of thiazide diuretics.
Adverse Effects [top]
Call your doctor immediately if you experience:
Call your doctor if these symptoms continue:
Periodic Tests[top]
Ask your doctor which of these tests should be done periodically while you are taking this drug:
last reviewed August 31, 2024
Worst Pills, Best Pills is a project of Public Citizen's Health Research Group Group. As an independent, nonprofit organization, we take no corporate or government contributions and accept no advertising. Copyright © 2024 Public Citizen's Health Research Group. All rights reserved.
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