Flurbiprofen Side Effects

Brand Names: Ansaid

Please note - some side effects for Flurbiprofen may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Flurbiprofen - for the Consumer

Flurbiprofen

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Flurbiprofen:

Constipation; diarrhea; dizziness; drowsiness; gas; headache; heartburn; nausea; stomach upset; stuffy nose.

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.

Flurbiprofen Drops

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Flurbiprofen Drops:

Sensitivity of the eyes to light; temporary burning, irritation, itching, pain, redness, stinging, or swelling of the eye.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bleeding of the eye; sensitivity to light; severe burning, irritation, itching, redness, stinging, or swelling of the eye; vision changes.

Flurbiprofen Side Effects - for the Professional

Flurbiprofen

Flurbiprofen Tablets

Adverse reaction information was derived from patients who received Flurbiprofen in blinded-controlled and open-label clinical trials, and from worldwide marketing experience and from publications. In the description below, rates of the more common events (greater than 1%) and many of the less common events (less than 1%) represent clinical study results. For rarer events that were derived principally from worldwide marketing experience and the literature (printed in italics), accurate rate estimates are generally impossible.

Of the 4123 patients in premarketing studies, 2954 were treated for at least 1 month, 1448 for at least 3 months, 948 for at least 6 months, 356 for at least 1 year, and 100 for at least 2 years. Of the 4123 patients, 9.4% dropped out of the studies because of an adverse drug reaction, principally involving the gastrointestinal tract (5.8%), central nervous system and special senses (1.4%), skin (0.6%) and genitourinary tract (0.5%).

Incidence Greater Than 1%

An asterisk after a reaction identifies reactions which occurred in 3-9% of patients treated with Flurbiprofen. Reactions occurring in 1-3% of the patients are unmarked.

Gastrointestinal: Dyspepsia*, diarrhea*, abdominal pain*, nausea*, constipation, GI bleeding, flatulence, elevated liver enzymes, and vomiting.

Central Nervous System: Headache*, nervousness, and other manifestations of CNS “stimulation” (e.g., anxiety, insomnia, reflexes increased, and tremor), and symptoms associated with CNS “inhibition” (e.g., amnesia, asthenia, somnolence, malaise, and depression).

Respiratory: Rhinitis.

Dermatological: Rash.

Special Senses: Dizziness, tinnitus, and changes in vision.

Genitourinary: Signs and symptoms suggesting urinary tract infection*.

Body as a Whole: Edema*.

Metabolic/Nutritional: Body weight changes.

Incidence Less Than 1% (Causal Relationship Probable)

The reactions listed in this category occurred in <1% of patients in the clinical trials or were reported during postmarketing experience from other countries. Adverse reactions reported only in worldwide postmarketing experience or the literature (which presumably indicates that they are rarer) are italicized.

Gastrointestinal: Peptic ulcer disease Ulcerations, Bleeding and Perforation with Nonsteroidal Anti-inflammatory Therapy), gastritis, bloody diarrhea, stomatitis, esophageal disease, hematemesis, and hepatitis; cholestatic and non-cholestatic jaundice.

Central Nervous System: Ataxia, cerebrovascular ischemia, confusion, paresthesia, and twitching.

Hematologic: Decrease in hemoglobin and hematocrit, iron deficiency anemia, hemolytic anemia and aplastic anemia; leukopenia; eosinophilia; ecchymosis and thrombocytopenia.

Respiratory: Asthma and epistaxis.

Dermatological: Angioedema, urticaria, eczema, and pruritus; photosensitivity, toxic epidermal necrolysis, and exfoliative dermatitis.

Special Senses: Conjunctivitis and parosmia.

Genitourinary: Hematuria and renal failure; interstitial nephritis.

Body as a Whole: Chills and fever; anaphylactic reaction.

Metabolic/Nutritional: Hyperuricemia.

Cardiovascular: Heart failure, hypertension, vascular diseases and vasodilation.

Incidence Less Than 1% (Causal Relationship Unknown)

The following reactions have been reported in patients taking Flurbiprofen under circumstances that do not permit a clear attribution of the reaction to Flurbiprofen. These reactions are being included as alerting information for physicians. Adverse reactions reported only in worldwide postmarketing experience or the literature (which presumably indicates that they are rarer) are italicized.

Gastrointestinal: Periodontal abscess, appetite changes, cholecystitis, and dry mouth.

Central Nervous System: Convulsion, meningitis, hypertonia, cerebrovascular accident, emotional lability, and subarachnoid hemorrhage.

Hematologic: Lymphadenopathy.

Respiratory: Bronchitis, laryngitis, dyspnea, pulmonary embolism, pulmonary infarct, and hyperventilation.

Dermatological: Alopecia, nail disorder, herpes simplex, zoster, dry skin, and sweating.

Special Senses: Ear disease, corneal opacity, glaucoma, retrobulbar neuritis, changes in taste, and transient hearing loss; retinal hemorrhage.

Genitourinary: Menstrual disturbances, vaginal and uterine hemorrhage, vulvovaginitis, and

prostate disease.

Metabolic/Nutritional: Hyperkalemia.

Cardiovascular: Arrhythmias, angina pectoris, and myocardial infarction.

Musculoskeletal: Myasthenia.

Side Effects by Body System

Gastrointestinal

In one safety review, serious gastrointestinal side effects were reported in 1.1% of patients. Duodenal ulcer occurred in 10/4123 patients (0.2%). Clinical gastrointestinal hemorrhage occurred in 5/4123 patients (0.1%). Duration of therapy in these cases was not specified in the review. However, as with other nonsteroidal anti-inflammatory agents, the risk of serious gastrointestinal effects is expected to increase with prolonged duration of therapy.

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

Gastrointestinal side effects have included dyspepsia (8.7%), diarrhea (7.2%), nausea (5.8%), abdominal pain (4.8%), constipation (3.3%), vomiting, gastritis, and flatulence. More serious gastrointestinal effects include ulcer, gastrointestinal hemorrhage, and bloody diarrhea.

Hepatic

Hepatic side effects have included elevations in liver function tests which may occur in up to 15% of patients. In addition, hepatitis as well as cholestatic and noncholestatic jaundice have been reported.

Elevations in liver function tests to three times normal values occur in approximately 1.1% of patients.

Renal

Renal side effects have included elevations in creatinine and blood urea nitrogen, signs and symptoms of urinary tract infection, hematuria, renal calculi, hemorrhagic cystitis, renal failure, interstitial nephritis, and renal papillary necrosis.

In one safety review, significant elevations in serum creatinine and blood urea nitrogen were reported in 11/3802 (0.3%) patients.

Flurbiprofen 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 factor for flurbiprofen-induced renal insufficiency are advanced age and concomitant use of diuretics.

A case-control study suggested that patients who consumed 5000 or more pills containing NSAIDs during their lifetime may be at increased risk of end-stage renal disease.

Hypersensitivity

Hypersensitivity side effects have included urticaria, bronchospasm, angioedema, cutaneous vasculitis, and anaphylaxis.

A 21-year-old female developed a pruritic maculopapular rash 48 hours after taking flurbiprofen 200 mg for a sore throat. Two days later, the patient further developed angioedema and hypotension. After treatment with intravenous methylprednisolone for 6 days, the affected skin underwent desquamation and healed. Flurbiprofen patch testing produced positive results 48 and 72 hours after application suggesting a type IV hypersensitivity.

Dermatologic

Dermatologic side effects have been reported rarely. These have included rash, pruritus, eczema, photosensitivity, exfoliative dermatitis, and toxic epidermal necrolysis.

Hematologic

Hematologic side effects have included reductions in hemoglobin and hematocrit, iron deficiency anemia, leukopenia, eosinophilia, ecchymoses, and thrombocytopenia. Aplastic anemia and hemolytic anemia have also been reported.

Nervous system

Nervous system side effects have included headache (2.9%), nervousness, insomnia, asthenia, somnolence, malaise, amnesia, depression, confusion, paresthesia, and twitching. Seizures, meningitis, cerebrovascular accident, and subarachnoid hemorrhage have also been reported rarely although causality is unknown. Flurbiprofen has also been implicated in a case of acute Parkinsonism.

Cardiovascular

Cardiovascular side effects have included edema (3% to 9%). In addition, blood pressure may be elevated by flurbiprofen which may have clinical relevance in patients with other comorbid illnesses.

Nonsteroidal anti-inflammatory drugs (NSAIDs) may elevate blood pressure and increase the risk for the initiation of antihypertensive therapy. Furthermore, NSAIDs may antagonize the blood pressure lowering effect of antihypertensive medications in patients already being treated with antihypertensive drugs.

Other

Other side effects have included tinnitus (1% to 3%), deafness (0.1%), and parosmia (altered sense of smell).

Ocular

Ocular side effects have included visual disturbances and conjunctivitis,

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