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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
  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 entral 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