Ansaid Side Effects

Generic Name: flurbiprofen

Note: This page contains information about the side effects of flurbiprofen. Some of the dosage forms included on this document may not apply to the brand name Ansaid.

Not all side effects for Ansaid 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 flurbiprofen: oral capsule extended release, oral tablet

In addition to its needed effects, some unwanted effects may be caused by flurbiprofen (the active ingredient contained in Ansaid). 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 flurbiprofen:

Less common
  • Abdominal or stomach pain
  • bladder pain
  • bloody or black, tarry stools
  • bloody or cloudy urine
  • constipation
  • difficult, burning, or painful urination
  • frequent urge to urinate
  • lower back or side pain
  • rash
  • severe stomach pain
  • swelling
  • vomiting of blood or material that looks like coffee grounds
Rare
  • Back or leg pains
  • bleeding gums
  • blistering, peeling, or loosening of the skin
  • bloody diarrhea
  • bloody nose
  • blurred vision
  • burning feeling in the chest or stomach
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chest pain
  • chills
  • clay-colored stools
  • cough
  • cracks in the skin
  • dark urine
  • decreased urine output
  • difficulty breathing
  • difficulty swallowing
  • dilated neck veins
  • dizziness
  • extreme fatigue
  • fast heartbeat
  • feeling faint, dizzy, or lightheaded
  • feeling of warmth or heat
  • fever with or without chills
  • flushing or redness of the skin, especially on the face and neck
  • general feeling of tiredness or weakness
  • greatly decreased frequency of urination
  • headache
  • high fever
  • hives
  • hoarseness
  • increased blood pressure
  • increased sensitivity of the skin to sunlight
  • increased thirst
  • indigestion
  • irregular breathing
  • irregular heartbeat
  • itching
  • joint pain, stiffness, or swelling
  • large, flat, blue, or purplish patches in the skin
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • light-colored stools
  • loss of appetite
  • loss of heat from the body
  • muscle pain
  • nausea
  • nervousness
  • noisy breathing
  • nosebleeds
  • pale skin
  • pinpoint red or purple spots on the skin
  • pounding in the ears
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • red, swollen skin
  • redness or other discoloration of the skin
  • redness, swelling, or soreness of the tongue
  • scaly skin
  • severe or continuing stomach pain
  • severe sunburn
  • shakiness and unsteady walk
  • shortness of breath
  • skin rash, encrusted, scaly and oozing
  • slow or fast heartbeat
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • stomach bloating or cramping
  • stomach upset
  • sweating
  • swelling of the face, fingers, feet, or lower legs
  • swelling or inflammation of the mouth
  • swollen or painful glands
  • tenderness in the stomach area
  • tightness in the chest
  • troubled breathing
  • unpleasant breath odor
  • unsteadiness, trembling, or other problems with muscle control or coordination
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • upper right abdominal or stomach pain
  • vomiting
  • weight gain
  • weight loss
  • wheezing
  • yellow eyes or skin

If any of the following symptoms of overdose occur while taking flurbiprofen, get emergency help immediately:

Symptom of overdose
  • Change in consciousness
  • fast or slow, or shallow breathing
  • heartburn
  • loss of consciousness
  • pain or discomfort in the chest, upper stomach, or throat
  • pale or blue lips, fingernails, or skin
  • unusual drowsiness, dullness, or feeling of sluggishness

Some of the side effects that can occur with flurbiprofen 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:

Less common
  • Acid or sour stomach
  • belching
  • changes in vision
  • continuing ringing or buzzing or other unexplained noise in the ear
  • diarrhea
  • discouragement
  • excess air or gas in the stomach or intestines
  • fear
  • feeling of constant movement of self or surroundings
  • feeling sad or empty
  • full feeling
  • general feeling of discomfort or illness
  • hearing loss
  • irritability
  • lack of appetite
  • lack or loss of strength
  • lightheadedness
  • loss of interest or pleasure
  • loss of memory
  • passing gas
  • problems with memory
  • runny nose
  • sensation of spinning
  • sleepiness
  • sleeplessness
  • sneezing
  • stomach discomfort
  • stuffy nose
  • tremor
  • trouble concentrating
  • trouble sleeping
  • unable to sleep
Rare
  • Burning, dry, or itching eyes
  • confusion
  • discharge or excessive tearing
  • redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
  • transient, mild, pleasant aromatic odor
  • twitching

For Healthcare Professionals

Applies to flurbiprofen: compounding powder, oral tablet

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 (the active ingredient contained in Ansaid) should be used with caution in these patients.[Ref]

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.[Ref]

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.[Ref]

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

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.[Ref]

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.[Ref]

Hypersensitivity

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

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.[Ref]

Dermatologic

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

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.[Ref]

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 (the active ingredient contained in Ansaid) has also been implicated in a case of acute Parkinsonism.[Ref]

Cardiovascular

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

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.[Ref]

Other

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

Ocular

Ocular side effects have included visual disturbances and conjunctivitis,[Ref]

References

1. Brooks CD, Linet OI, Schellenberg D, Turner LF, Defesche CL, Teoh KW, Johnson JH, Assenzo JR "Clinical safety of flurbiprofen." J Clin Pharmacol 30 (1990): 342-51

2. Singh G, Ramey DR, Morfeld D, Fries JF "Comparative toxicity of non-steroidal anti-inflammatory agents." Pharmacol Ther 62 (1994): 175-91

3. "Product Information. Ansaid (flurbiprofen)." Pharmacia and Upjohn, Kalamazoo, MI.

4. Kaufhold J, Wilkowski M, McCabe K "Flurbiprofen-associated acute tubulointerstitial nephritis." Am J Nephrol 11 (1991): 144-6

5. Perneger TV, Whelton PK, Klag MJ "Risk of kidney failure associated with the use of acetaminophen, aspirin, and nonsteroidal antiinflammatory drugs." N Engl J Med 331 (1994): 1675-9

6. Colome Nafria E, Solans R, Espinach J, Delgadillo J, Fonollosa V "Renal papillary necrosis induced by flurbiprofen ." DICP 25 (1991): 870-1

7. Murray MD, Greene PK, Brater DC, et al "Effects of flurbiprofen on renal function in patients with moderate renal insufficiency." Br J Clin Pharmacol 33 (1992): 385-93

8. Cohen RD, Bateman ED, Potgieter PD "Near-fatal bronchospasm in an asthmatic patient following ingestion of flurbiprofen. A case report." S Afr Med J 61 (1982): 803

9. Romano A, Pietrantonio F "Delayed hypersensitivity to flurbiprofen." J Intern Med 241 (1997): 81-3

10. Enevoldson TP, Wiles CM "Acute parkinsonism associated with flurbibrofen." BMJ 300 (1990): 540-1

11. Johnson AG, Nguyen TV, Day RO "Do nonsteroidal anti-inflammatory drugs affect blood pressure? A meta-analysis." Ann Intern Med 121 (1994): 289-300

12. Gurwitz JH, Avron J, Bohn RL, Glynn RJ, Monane M, Mogun H "Initiation of antihypertensive treatment during nonsteroidal anti-inflammatory drug therapy." JAMA 272 (1994): 781-6

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.

Hide
(web4)