Applies to diflunisal: oral tablet.

Serious side effects of Diflunisal

Along with its needed effects, diflunisal 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
• greatly decreased frequency of urination or amount of urine
• halos around lights
• headache
• hives, itching, skin rash
• increased blood pressure
• increased thirst
• indigestion
• joint or muscle pain
• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs
• light-colored stools
• 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
• sores, ulcers, or white spots in mouth or on lips
• sore throat
• stomach upset, tenderness
• swelling of the face, fingers, feet or lower legs
• swollen lymph nodes
• tightness in chest
• trouble breathing
• tunnel vision
• unpleasant breath odor
• unusual bleeding or bruising
• unusual tiredness or weakness
• upper right stomach pain
• vomiting of blood or material that looks like coffee grounds
• weight gain
• 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

Other side effects of Diflunisal

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.

General

The most frequently reported side effects were gastrointestinal in nature and included nausea, vomiting, dyspepsia, gastrointestinal pain, diarrhea, constipation, and flatulence.^[Ref]

Gastrointestinal

Common (1% to 10%): Gastrointestinal (GI) pain, dyspepsia, diarrhea, nausea, vomiting, constipation, flatulence

Frequency not reported: Peptic ulcer, GI perforation, GI bleeding, gastritis, hematemesis, melena, ulcerative stomatitis, colitis exacerbated, Crohn's disease exacerbated, eructation, GI perforation^[Ref]

Cardiovascular

Frequency not reported: Palpitation, hypertension, cardiac failure, flushing, myocardial infarction^[Ref]

Dermatologic

Common (1% to 10%): Rash

Frequency not reported: Pruritus, sweating, dry mucous membranes, stomatitis, photosensitivity, urticaria, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, angioedema, sweating, dry mucous membranes, stomatitis, photosensitivity^[Ref]

Nervous system

Common (1% to 10%): Headache, dizziness, somnolence

Frequency not reported: Lightheadedness, paresthesia, syncope, stroke

Hematologic

Frequency not reported: Thrombocytopenia, neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia

Hepatic

Frequency not reported: Jaundice, cholestasis, liver function abnormal, hepatitis

Renal

Frequency not reported: Renal impairment, renal failure, interstitial nephritis, nephritic syndrome

Hypersensitivity

Frequency not reported: Hypersensitivity vasculitis, hypersensitivity syndrome^[Ref]

Other

Common (1% to 10%): Tinnitus, fatigue

Frequency not reported: Vertigo, asthenia, edema, chest pain, fulminant necrotizing fasciitis, hearing loss^[Ref]

Metabolic

Frequency not reported: Anorexia^[Ref]

Psychiatric

Common (1% to 10%): Insomnia

Frequency not reported: Nervousness, depression, hallucination, confusion, disorientation^[Ref]

Musculoskeletal

Frequency not reported: Muscle cramp^[Ref]

Ocular

Frequency not reported: Blurred vision, transient visual disturbance^[Ref]

Respiratory

Frequency not reported: Bronchospasm, dyspnea

Genitourinary

Frequency not reported: Dysuria, hematuria, proteinuria^[Ref]

Immunologic

Frequency not reported: Acute anaphylaxis^[Ref]