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

Get emergency medical help if you have any of these signs of an allergic reaction while taking diflunisal (the active ingredient contained in Dolobid) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking diflunisal and call your doctor at once if you have any of these serious side effects:

• chest pain, slurred speech, problems with vision or balance, and feeling weak or short of breath;

• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• fever, chills, body aches, flu symptoms;

• pale or yellowed skin, dark colored urine, confusion;

• swelling or rapid weight gain;

• urinating less than usual or not at all;

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• skin rash, bruising, severe tingling, numbness, pain, muscle weakness;

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or

• the first sign of any skin rash, no matter how mild.

Less serious side effects of diflunisal may include:

• mild nausea, stomach pain, vomiting, upset stomach;

• diarrhea, constipation, gas;

• dizziness, drowsiness, headache, tired feeling;

• sleep problems (insomnia); or

• ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

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.

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