Dolobid Side Effects
Generic Name: diflunisal
Note: This page contains information about the side effects of diflunisal. Some of the dosage forms included on this document may not apply to the brand name Dolobid.
Not all side effects for Dolobid may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.
For the Consumer
Applies to diflunisal: oral tablet
In addition to its needed effects, some unwanted effects may be caused by diflunisal (the active ingredient contained in Dolobid). In the event that any of these side effects do occur, they may require medical attention.
You should check with your doctor immediately if any of these side effects occur when taking diflunisal:More common
- Stomach cramps or pain
- 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
- cough or hoarseness
- cracks in the skin
- dark-colored urine
- difficult or painful urination
- difficulty breathing
- difficulty swallowing
- disturbed color perception
- 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
- increased blood pressure
- increased thirst
- 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
- 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
- yellow eyes or skin
- 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
Some of the side effects that can occur with diflunisal may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:More common
- Acid or sour stomach
- stomach discomfort or upset
- Bloated, full feeling
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- 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
- lack or loss of strength
- loss of interest or pleasure
- mood or mental changes
- passing gas
- seeing, hearing, or feeling things that are not there
- sensation of spinning
- severe sunburn
- swelling or inflammation of the mouth
- trouble concentrating
- trouble sleeping
- unable to sleep
- weight loss
For Healthcare Professionals
Applies to diflunisal: compounding powder, oral tablet
Gastrointestinal side effects may occur in up to 20% of patients treated with diflunisal (the active ingredient contained in Dolobid) 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.
Diflunisal doses of 500 to 1000 mg per day have not been associated with an increase in fecal blood loss. In one study, diflunisal 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.
Renal side effects include acute renal failure due to interstitial nephritis, nephrotic syndrome, hematuria, and proteinuria. Renal decompensation has also been reported.
Diflunisal 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.
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 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 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.
Hepatic side effects have included reports of liver function abnormalities, jaundice, cholestasis, and hepatitis.
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.
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 side effects have been reported rarely, and direct causality could not be established. These have included chest pain, palpitation, and syncope.
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 side effects have included reports of somnolence, insomnia, nervousness, depression, hallucinations, confusion, and disorientation.
Nervous system side effects have included reports of dizziness, headache, vertigo, light-headedness, and paresthesias.
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 (the active ingredient contained in Dolobid)
Musculoskeletal side effects have included rare reports of muscle cramps, asthenia, fatigue and tiredness.
Ocular side effects have included transient visual disturbances including blurred vision.
Respiratory side effects have included reports of dyspnea.
Genitourinary side effects have included reports of dysuria.
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