TABLE 2: Reported adverse events in patients receiving ANSAID (flurbiprofen)
or other nonsteroidal anti-inflammatory drugs
|Reported in patients treated with ANSAID||Reported in patients treated with other products but not ANSAID|
|Incidence of 1% or greater †||Incidence < 1% - Causal Relationship Probable ‡||Incidence < 1% - Causal Relationship Unknown ‡|
|BODY AS A WHOLE
| < 1%:
|CARDIOVASCULAR SYSTEM||congestive heart failure
| < 1%:
elevated liver enzymes
jaundice (cholestatic and
inflammation with loss of
blood and protein
| > 1%:
|HEMIC AND LYMPHATIC SYSTEM||aplastic anemia
decrease in hemoglobin
iron deficiency anemia
|lymphadenopathy|| > 1%:
increased bleeding time
|METABOLIC AND NUTRITIONAL SYSTEM
body weight changes
|hyperuricemia||hyperkalemia|| < 1%:
nervousness and other manifestations of entral nervous system (CNS) stimulation (eg, anxiety, insomnia, increased reflexes, tremor)
symptoms associated with CNS inhibition (eg, amnesia, asthenia, depression,
| < 1%:
| < 1%:
|SKIN AND APPENDAGES
| < 1%:
changes in vision
|changes in taste
transient hearing loss
| > 1%:
signs and symptoms
suggesting urinary tract infection
vaginal and uterine
| > 1%:
abnormal renal function
|† from clinical trials
‡ from clinical trials, post-marketing surveillance, or literature
Read the Ansaid (flurbiprofen) Side Effects Center for a complete guide to possible side effects »
Reports suggest that nonsteroidal anti-inflammatory drugs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking nonsteroidal antiinflammatory drugs concomitantly with ACE-inhibitors.
The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone. The physician should be cautious when administering ANSAID (flurbiprofen) to patients taking warfarin or other anticoagulants.
Concurrent administration of aspirin lowers serum flurbiprofen concentrations (see CLINICAL PHARMACOLOGY, Drug-Drug Interactions). The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of flurbiprofen and aspirin is not generally recommended because of the potential for increased adverse effects.
Beta-adrenergic blocking agents
Flurbiprofen attenuated the hypotensive effect of propranolol but not atenolol (see CLINICAL PHARMACOLOGY, Drug-Drug Interactions). The mechanism underlying this interference is unknown. Patients taking both flurbiprofen and a beta-blocker should be monitored to ensure that a satisfactory hypotensive effect is achieved.
Clinical studies, as well as post marketing observations, have shown that ANSAID (flurbiprofen) can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure (see WARNINGS, Renal Effects), as well as diuretic efficacy.
NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. The mean minimum lithium concentration increased 15% and the renal clearance was decreased by approximately 20%.
These effects have been attributed to inhibition of renal prostaglandin synthesis by the nonsteroidal anti-inflammatory drug. Thus, when nonsteroidal anti-inflammatory drugs and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity.
Nonsteroidal anti-inflammatory drugs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when nonsteroidal anti-inflammatory drugs are administered concomitantly with methotrexate.
Last reviewed on RxList: 9/10/2010
This monograph has been modified to include the generic and brand name in many instances.
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