| Reported in patients treated with flurbiprofen tablets | Reported in patients treated with other products but not flurbiprofen tablets |
| 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 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%: eru ctation 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 mainifestations of central nervous system (CNS) stimulation (e.g., anxiety, insomnia, increased reflexes, tremor) symptoms associated with CNS inhibition (e.g., 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%: h e aring 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%: dy suria oliguria polyuria proteinuria |
