Ansaid
SIDE EFFECTS
TABLE 2. Reported adverse events in patients receiving ANSAID
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 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 diseasegastric/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 headachenervousness 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 |
| † from clinical trials ‡ from clinical trials, post-marketing surveillance, or literature |
|||
DRUG INTERACTIONS
ACE-inhibitors
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 anti-inflammatory drugs concomitantly with ACEinhibitors.
Anticoagulants
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 to patients taking warfarin or other anticoagulants.
Aspirin
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.
Diuretics
Clinical studies, as well as post marketing observations, have shown that ANSAID 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.
Lithium
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.
Methotrexate:
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 antiinflammatory drugs are administered concomitantly with methotrexate.
Generic Name: Flurbiprofen
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