Ansaid Side Effects
Generic Name: flurbiprofen,flurbiprofen sodium
Please note - some side effects for Ansaid may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects of Ansaid - for the Consumer
Ansaid
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 Ansaid:
Seek medical attention right away if any of these SEVERE side effects occur when using Ansaid: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.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopAnsaid Side Effects - for the Professional
Ansaid
| Reported in patients treated with Ansaid | |||
|---|---|---|---|
| Incidence of 1% or greater* | Incidence < 1% - Causal Relationship Probable† | Incidence < 1% - Causal Relationship Unknown† | Reported in patients treated with other products but not Ansaid |
| BODY AS A WHOLE | |||
| edema | anaphylactic reaction chills fever |
< 1%: death infection sepsis |
|
| CARDIOVASCULAR SYSTEM | |||
| congestive heart failure hypertension vascular diseases vasodilation |
angina pectoris arrhythmias myocardial infarction |
< 1%: hypotension palpitations syncope tachycardia vasculitis |
|
| DIGESTIVE SYSTEM | |||
| abdominal pain constipation diarrhea dyspepsia/heartburn elevated liver enzymes flatulence GI bleeding nausea vomiting |
bloody diarrhea esophageal disease gastric/peptic ulcer disease gastritis jaundice (cholestatic and noncholestatic) hematemesis hepatitis stomatitis/glossitis |
appetite changes cholecystitis colitis dry mouth exacerbation of inflammatory bowel disease periodontal abscess small intestine inflammation with loss of blood and protein |
> 1%: GI perforation GI ulcers (gastric/duodenal) < 1%: eructation liver failure pancreatitis |
| HEMIC AND | |||
| LYMPHATIC SYSTEM | aplastic anemia (including agranulocytosis or pancytopenia) decrease in hemoglobin and hematocrit ecchymosis/purpura eosinophilia hemolytic anemia iron deficiency anemia leukopenia thrombocytopenia |
lymphadenopathy | > 1%: anemia increased bleeding time < 1%: melena rectal bleeding |
| METABOLIC AND NUTRITIONAL SYSTEM | |||
| body weight changes | hyperuricemia | hyperkalemia | < 1%: hyperglycemia |
| NERVOUS SYSTEM | |||
| headache nervousness and other manifestations of central nervous system (CNS) stimulation (eg, anxiety, insomnia, increased reflexes, tremor) symptoms associated with CNS inhibition (eg, amnesia, asthenia, depression, malaise, somnolence) |
ataxia cerebrovascular ischemia confusion paresthesia twitching |
convulsion cerebrovascular accident emotional lability hypertonia meningitis myasthenia subarachnoid hemorrhage |
< 1%: coma dream abnormalities drowsiness hallucinations |
| RESPIRATORY SYSTEM | |||
| rhinitis | asthma epistaxis |
bronchitis dyspnea hyperventilation laryngitis pulmonary embolism pulmonary infarct |
< 1%: pneumonia respiratory depression |
| SKIN AND APPENDAGES | |||
| rash | angioedema eczema exfoliative dermatitis photosensitivity pruritus toxic epidermal necrolysis urticaria |
alopecia dry skin herpes simplex/zoster nail disorder sweating |
< 1%: erythema multiforme Stevens Johnson syndrome |
| SPECIAL SENSES | |||
| changes in vision dizziness/vertigo tinnitus |
conjunctivitis parosmia |
changes in taste corneal opacity ear disease glaucoma retinal hemorrhage retrobulbar neuritis transient hearing loss |
> 1%: pruritus < 1%: hearing impairment |
| UROGENITAL SYSTEM | |||
| signs and symptoms suggesting urinary tract infection | hematuria interstitial nephritis renal failure |
menstrual disturbances prostate disease vaginal and uterine hemorrhage vulvovaginitis |
> 1%: abnormal renal function < 1%: dysuria oliguria polyuria proteinuria |
Side Effects by Body System - for Healthcare Professionals
Gastrointestinal
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.
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.
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
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.
Hypersensitivity side effects have included urticaria, bronchospasm, angioedema, cutaneous vasculitis, and anaphylaxis.
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
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.
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.
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,
TopMore Ansaid resources
- Ansaid Concise Consumer Information (Cerner Multum)
- Ansaid MedFacts Consumer Leaflet (Wolters Kluwer)
- Ansaid Monograph (AHFS DI)
- Ansaid Prescribing Information (FDA)
- Ansaid Advanced Consumer (Micromedex) - Includes Dosage Information
- Flurbiprofen Professional Patient Advice (Wolters Kluwer)
- Flurbiprofen Sodium eent Monograph (AHFS DI)
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