Dolobid Side Effects

Generic Name: diflunisal

Note: This document contains side effect information about diflunisal. Some of the dosage forms listed on this page may not apply to the brand name Dolobid.

Some side effects of Dolobid may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to diflunisal: oral tablet

Along with its needed effects, diflunisal (the active ingredient contained in Dolobid) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking diflunisal:

More common
  • Stomach cramps or pain
Less common
  • Back or leg pains
  • bleeding gums
  • blistering, peeling, loosening of skin
  • bloody or black, tarry stools
  • bloody or cloudy urine
  • blurred or loss of vision
  • burning feeling in chest or stomach
  • burning while urinating
  • clay-colored stools
  • constipation
  • cough or hoarseness
  • cracks in the skin
  • dark-colored urine
  • diarrhea
  • difficult or painful urination
  • difficulty breathing
  • difficulty swallowing
  • disturbed color perception
  • dizziness
  • double vision
  • facial swelling
  • fast heartbeat
  • feeling of warmth
  • fever with or without chills
  • flu-like symptoms
  • general body swelling
  • general feeling of tiredness or weakness
  • greatly decreased frequency of urination or amount of urine
  • halos around lights
  • headache
  • hives
  • increased blood pressure
  • increased thirst
  • indigestion
  • itching
  • joint or muscle pain
  • large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs
  • light-colored stools
  • liver function abnormalities
  • loss of appetite
  • loss of heat from the body
  • lower back or side pain
  • muscle aches, pains, or weakness
  • nausea or vomiting
  • night blindness
  • noisy breathing
  • nosebleeds
  • overbright appearance of lights
  • pale skin
  • pinpoint red spots on skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
  • red, irritated eyes
  • redness of the face, neck, arms and occasionally, upper chest
  • red skin lesions, often with a purple center
  • red, swollen skin
  • scaly skin
  • severe or continuing stomach pain
  • shortness of breath
  • skin rash
  • sores, ulcers, or white spots in mouth or on lips
  • sore throat
  • stomach upset
  • swelling of face, fingers, feet or lower legs
  • swollen lymph nodes
  • tenderness in stomach area
  • tightness in chest
  • troubled breathing
  • tunnel vision
  • unpleasant breath odor
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • upper right abdominal pain
  • vomiting of blood or material that looks like coffee grounds
  • weight gain
  • wheezing
  • yellow eyes or skin
Symptoms of overdose
  • Change in consciousness
  • confusion about identity, place, and time
  • continuing ringing or buzzing or other unexplained noise in ears
  • decreased awareness or responsiveness
  • deep or fast breathing with dizziness
  • fast, pounding, or irregular heartbeat or pulse
  • hearing loss
  • loss of consciousness
  • numbness of feet, hands, and around mouth
  • severe sleepiness
  • sweating

Some side effects of diflunisal may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Acid or sour stomach
  • belching
  • heartburn
  • indigestion
  • stomach discomfort or upset
Less common
  • Bloated, full feeling
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • discouragement
  • dry mucous membranes
  • excess air or gas in stomach or intestines
  • feeling of constant movement of self or surroundings
  • feeling sad or empty
  • increased sensitivity of skin to sunlight
  • irritability
  • lack or loss of strength
  • lightheadedness
  • loss of interest or pleasure
  • mood or mental changes
  • nervousness
  • passing gas
  • seeing, hearing, or feeling things that are not there
  • sensation of spinning
  • severe sunburn
  • sleeplessness
  • swelling or inflammation of the mouth
  • tiredness
  • trouble concentrating
  • trouble sleeping
  • unable to sleep
  • weight loss

For Healthcare Professionals

Applies to diflunisal: compounding powder, oral tablet

Gastrointestinal

Diflunisal doses of 500 to 1000 mg per day have not been associated with an increase in fecal blood loss. In one study, diflunisal (the active ingredient contained in Dolobid) 2000 mg per day was associated with a 3-fold increase in fecal blood loss while aspirin 1300 mg per day was associated with a 6-fold increase in fecal blood loss compared to placebo.

Despite these results, serious, sometimes fatal, gastrointestinal events are reported. Gastrointestinal ulcers, bleeding, and perforation occur in 2% to 4% of patients treated for up to one year.

Patients with a history of serious gastrointestinal events or alcohol abuse are at increased risk for severe gastrointestinal side effects. Diflunisal should be used with caution in these patients.

Gastrointestinal side effects may occur in up to 20% of patients treated with diflunisal and include nausea (3% to 9%), dyspepsia (3% to 9%), gastrointestinal pain (3% to 9%), diarrhea (3% to 9%), vomiting, constipation, and flatulence. Peptic ulceration, gastrointestinal bleeding, and perforation have also been reported.

Renal

Diflunisal (the active ingredient contained in Dolobid) may impair the ability of the kidney to cope with low renal blood flow states due to inhibition of prostaglandin-dependent afferent arteriolar vasodilation. Renal function may be further compromised in patients with heart failure, hypovolemia, cirrhosis, nephrotic syndrome, or hypoalbuminemia. Additional risk factors for diflunisal-induced renal insufficiency are advanced age and concomitant use of diuretics.

Renal side effects include acute renal failure due to interstitial nephritis, nephrotic syndrome, hematuria, and proteinuria. Renal decompensation has also been reported.

Hematologic

Diflunisal inhibits platelet prostaglandin synthetase in a dose-dependent manner. Doses of 250 mg twice a day had no effect on platelet function. Doses of 500 mg twice a day has a slight inhibitory effect. Doses of 1000 mg twice a day significantly inhibited platelet function. Unlike aspirin, diflunisal (the active ingredient contained in Dolobid) inhibition of platelet function is reversible.

Hematologic side effects have included a dose-dependent inhibition of platelet function by diflunisal, thrombocytopenia, agranulocytosis, and hemolytic anemia. A case of febrile neutropenia has also been described in the literature.

Dermatologic

Dermatologic side effects have included rash (3% to 9%), erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, fixed drug eruption, pruritus, dry mucous membranes, stomatitis, and photosensitivity. In addition, a case of lichenoid photoreactive epidermal necrosis has been reported.

Hepatic

Hepatic side effects have included reports of liver function abnormalities, jaundice, cholestasis, and hepatitis.

Hepatic side effects include elevations in liver function tests in up to 15% of patients. Significant elevations (three times normal values) occur in 1% of patients. Rare cases of cholestasis and hepatitis have been reported.

Hypersensitivity

A multisystem hypersensitivity syndrome has been described by the manufacturer. Fever, chills, and dermatologic findings are noted. In addition, elevations in liver function test, jaundice, leukopenia, thrombocytopenia, eosinophilia, disseminated intravascular coagulation, and renal dysfunction as well as arthralgia, myalgia, malaise, anorexia, and disorientation may be present. In the event that a hypersensitivity syndrome is suspected, diflunisal (the active ingredient contained in Dolobid) should be discontinued.

Hypersensitivity side effects have included anaphylactoid reactions with bronchospasm, angioedema, and flushing in less than 1% of patients, and hypersensitivity vasculitis. In addition, a hypersensitivity syndrome, which may be life-threatening, has been reported.

Other

Necrotizing fasciitis has been reported rarely and may be fatal. The presence of Group A beta-hemolytic streptococcus may be a contributing factor in these cases.

Cardiovascular

Cardiovascular side effects have been reported rarely, and direct causality could not be established. These have included chest pain, palpitation, and syncope.

Metabolic

Metabolic abnormalities include a case report of pseudoporphyria. Salicylates have been reported to displace triiodothyronine (T3) and thyroxine (T4) from protein binding sites. The initial effect is an increase in serum free T4 concentrations.

Psychiatric

Psychiatric side effects have included reports of somnolence, insomnia, nervousness, depression, hallucinations, confusion, and disorientation.

Nervous system

Nervous system side effects have included reports of dizziness, headache, vertigo, light-headedness, and paresthesias.

Musculoskeletal

Musculoskeletal side effects have included rare reports of muscle cramps, asthenia, fatigue and tiredness.

Rare reports of fulminant necrotizing fasciitis, sometimes with fatal outcomes, have been described in persons with group A beta-hemolytic streptococcus, who are also receiving nonsteroidal anti-inflammatory drugs, including diflunisal.

Ocular

Ocular side effects have included transient visual disturbances including blurred vision.

Respiratory

Respiratory side effects have included reports of dyspnea.

Genitourinary

Genitourinary side effects have included reports of dysuria.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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