This drug may rarely cause serious (rarely fatal) bleeding from the stomach or intestines. This side effect can occur without warning at any time during treatment with diflunisal. The elderly are at increased risk for serious stomach/intestinal bleeding.
Drugs related to diflunisal have rarely caused blood clots to form, resulting in serious (possibly fatal) heart attacks and strokes. This medication might also rarely cause similar problems. The risk of these serious side effects may increase if you have heart disease and with longer use of this medication. Talk to your doctor or pharmacist about the benefits and risks of treatment, as well as other possible medication choices.
Stop taking diflunisal and seek immediate medical attention if you notice any of the following rare but very serious side effects: black stools, persistent stomach/abdominal pain, vomit that looks like coffee grounds, chest pain, shortness of breath, weakness on one side of the body, sudden vision changes, slurred speech.
This medication should not be used right before or after heart bypass surgery.Who should not take diflunisal?
Diflunisal is used to relieve mild to moderate pain from various conditions. It also reduces pain, swelling, and joint stiffness caused by arthritis. Reducing these symptoms helps you do more of your normal daily activities. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID).
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
This medication may also be used to treat gout attacks.
Read the Medication Guide provided by your pharmacist before you start using diflunisal and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.
Take this medication by mouth with a full glass of water (8 ounces or 240 milliliters) unless your doctor directs you otherwise. Do not lie down for at least 10 minutes after taking this drug. Take this medication with food/milk or right after meals to prevent stomach upset.
Swallow this medication whole. Do not crush or chew the tablets. Doing so may increase side effects.
Dosage is based on your medical condition and response to therapy. Do not take more than 1,500 milligrams per day. To minimize side effect risks (e.g., stomach bleeding), use this medication at the lowest effective dose for the shortest possible length of time. Do not increase your dose or take it more often than prescribed. For ongoing conditions such as arthritis, continue taking it as directed by your doctor. Discuss the risks and benefits with your doctor or pharmacist.
In certain conditions (e.g., arthritis), it may take up to 2 weeks of regular use before the full benefits of this drug take effect.
If you are taking this drug on an "as needed" basis (not on a regular schedule), remember that pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has significantly worsened, the medicine may not work as well.
Inform your doctor if your condition worsens.
See also Warning section.
Upset stomach, heartburn, headache, tiredness, drowsiness, or dizziness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if any of these unlikely but serious side effects occur: stomach pain, swelling of the hands/feet, sudden/unexplained weight gain, vision changes, hearing changes (e.g., ringing in the ears), mental/mood changes (e.g., confusion, hallucinations), fast/pounding heartbeat, persistent/severe headache, fainting, difficult/painful swallowing.
Tell your doctor right away if any of these rare but very serious side effects occur: signs of kidney problems (such as change in the amount of urine), easy bruising/bleeding, signs of infection (e.g., fever, persistent sore throat), unexplained stiff neck.
This drug may rarely cause serious (possibly fatal) liver disease. If you notice any of the following rare but very serious side effects, stop taking diflunisal and tell your doctor right away: yellowing eyes/skin, dark urine, unusual/extreme tiredness, severe stomach/abdominal pain, persistent nausea/vomiting.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
See also Warning section.
Before taking diflunisal, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other salicylates (e.g., choline salicylate), or other NSAIDs (e.g., ibuprofen, naproxen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: asthma (including a history of worsening breathing after taking aspirin or other NSAIDs), liver disease, poorly controlled diabetes, stomach/intestine/esophagus problems (e.g., bleeding, ulcers), heart disease (e.g., history of heart attack), stroke, high blood pressure, swelling (edema, fluid retention), blood disorders (e.g., anemia), bleeding or clotting problems, growths in the nose (nasal polyps).
Kidney problems can sometimes occur with the use of NSAID medications, including diflunisal. Problems are more likely to occur if you are dehydrated, have heart failure or kidney disease, are an older adult, or if you take certain medications (see also Drug Interactions section). Drink plenty of fluids as directed by your doctor to prevent dehydration and tell your doctor right away if you have a change in the amount of urine.
Before having surgery, tell your doctor or dentist that you are using this medication.
This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely.
This medicine may cause stomach bleeding. Daily use of alcohol and tobacco may increase your risk for stomach bleeding, especially when combined with this medicine. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information.
The elderly may be more sensitive to the side effects of this drug, especially stomach/intestinal bleeding and kidney problems.
This medication is not recommended for use in children under 12 years of age. In addition, since diflunisal is related to aspirin, children and teenagers should not take diflunisal if they have chickenpox, influenza, or any undiagnosed illness without first consulting a doctor about Reye's syndrome, a rare but serious illness.
Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks (such as miscarriage, trouble getting pregnant). Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It is not recommended for use during the first and last trimesters of pregnancy due to possible harm to the unborn baby and interference with normal labor/delivery.
This drug passes into breast milk. Therefore, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Some products that may interact with this drug include: aliskiren, ACE inhibitors (such as captopril, lisinopril), angiotensin II receptor blockers (such as losartan, valsartan), antacids (regular use), cidofovir, corticosteroids (e.g., prednisone), digoxin, live influenza vaccine, lithium, methotrexate, pemetrexed, probenecid, "water pills" (diuretics such as furosemide, hydrochlorothiazide, triamterene).
This medication may increase the risk of bleeding when taken with other drugs that also may cause bleeding. Examples include anti-platelet drugs such as clopidogrel, "blood thinners" such as dabigatran/enoxaparin/warfarin, among others.
Check all prescription and nonprescription medicine labels carefully since many contain pain relievers/fever reducers (NSAIDs such as aspirin, ibuprofen, indomethacin, ketorolac or naproxen) which if taken together with diflunisal may increase your risk for side effects. Low-dose aspirin, as prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention (usually at dosages of 81-325 milligrams per day), should be continued. Consult your doctor or pharmacist for more details.
This medication can affect the results of certain lab tests. Make sure laboratory personnel and your doctors know you use this drug.
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include severe stomach pain, vomit that looks like coffee grounds, extreme drowsiness, fast breathing, confusion, loss of consciousness.
Do not share this medication with others.
Laboratory and/or medical tests (e.g., complete blood count, liver and kidney function tests) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
Non-drug treatment for arthritis that is approved by your doctor (e.g., weight loss if needed, strengthening and conditioning exercises) may help improve your flexibility, range of motion, and joint function. Consult your doctor for specific instructions.
If you are prescribed this drug on a regular schedule (not just "as needed") and you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.
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