A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Ansaid Side Effects, and Drug Interactions - Flurbiprofen
Ansaid Side Effects, and Drug Interactions - Flurbiprofen
SIDE EFFECTS
Adverse reaction information
was derived from patients who received flurbiprofen in blind-controlled
and open-label clinical
trials, and from worldwide marketing experience
and from publications. In
the description below, rates of the more common events (greater
than 1%) and many of the less common events (less than 1%) represent
clinical study results.
For rarer events that were derived principally from worldwide marketing
experience and the literature (printed in italics), accurate rate
estimates are generally impossible.
Of the 4,123 patients in premarketing studies, 2,954 were treated
for at least 1 month, 1,448 for at least 3 months, 948 for at least
6 months, 356 for at least 1 year, and 100 for at least 2 years.
Of the 4,123 patients, 9.4% dropped out of the studies because of
an adverse drug reaction,
principally involving the gastrointestinal
tract (5.8%), central
nervous system
and special senses (1.4%), skin
(0.6%) and genitourinary
tract (0.5%).
Incidence Greater Than 1%
An asterisk after a reaction
identifies reactions which occurred in 3-9% of patients treated
with flurbiprofen. Reactions occurring in l-3% of the patients are
unmarked.
- Gastrointestinal: Dyspepsia*, diarrhea*, abdominal
pain*, nausea*, constipation, GI
bleeding, flatulence,
elevated liver enzymes,
and vomiting.
- Central Nervous system: Headache, nervousness, and other
manifestations of CNS
“stimulation” (e.g., anxiety,
insomnia, reflexes
increased, and tremor), and symptoms associated with CNS
"inhibition" (e.g., amnesia asthenia,
somnolence, malaise,
and depression).
- Respiratory: Rhinitis.
- Dermatological: Rash.
- Special Senses: Dizziness and changes in vision
tinnitus.
- Genitourinary: Signs and symptoms suggesting urinary
tract infection.
- Body as a Whole: Edema.
- Metabolic/Nutritional : Body weight
changes.
Incidence Less Than 1% (Causal Relationship Probable)
The reactions listed in this category occurred in <1% of patients
in the clinical trials
or were reported during postmarketing experience from other countries.
Adverse reactions reported only in worldwide postmarketing experience
or the literature (which presumably indicates that they are rarer)
are italicized.
- Gastrointestinal: Peptic ulcer
disease (see also
WARNINGS, Risk of
Gastrointestinal (GI) Ulceration's, Bleeding and Perforation with
Non-steroidal Anti-inflammatory Therapy), gastritis,
bloody diarrhea, stomatitis, esophageal
disease, hematemesis,
and hepatitis cholestatic
and non-cholestatic jaundice.
- Central Nervous System: Ataxia, cerebrovascular
ischemia, confusion
paresthesia, and twitching.
- Hematologic: Decrease in hemoglobin
and hematocrit,
iron deficiency anemia,
hemolylic anemia and
aplastic anemia, leukopenia,
eosinophilia, ecchymosis and thrombocytopenia
(See also PRECAUTIONS,
Effect on Platelets and coagulation).
- Respiratory: Asthma and epistaxis.
- Dermatological: Angioedema, urticaria,
eczema, and pruritus, photosensitivity, toxic
epidermal necrolysis
and exloliative dermatitis.
- Special Senses: Conjunctivitis and parosmia.
- Genitourinary: Hematuria and renal
failure, interstitial
nephritis.
- Body as a Whole: Chills and fever
anaphylactic reaction.
- Metabolic/Nutritional: Hyperuricemia.
- Cardiovascular: Heart failure, hypertension. vascular
diseases and vasodilation.
Incidence Less Than 1% (Causal Relationship Unknown)
The following reactions have been reported in patients taking flurbiprofen
under circumstances that do not permit a clear attribution of the
reaction to flurbiprofen. These reactions are being included as
alerting information for physicians. Adverse reactions reported
only in worldwide postmarketing experience or the literature (which
presumably indicates that they are rarer) are italicized.
- Gastrointestinal: Periodontal abscess
appetite changes,
cholecystitis, and dry mouth.
- Central Nervous System Convulsion meningitis,
hypertonia, cerebrovascular
accident, emotional lability, and subarachnoid
hemorrhage.
- Hematologic: Cymphadenopathy.
- Respiratory: Bronchitis, laryngitis
dyspnea, pulmonary
embolism, pulmonary infarct, and hyperventilation.
- Dermatological: Alopecia, nail
disorder, herpes simplex,
zoster, dry skin and
sweating.
- Special Senses: Ear disease,
corneal opacity, glaucoma,
retrobulbar neuritis, changes in taste, and transient
hearing loss, retinal
hemorrhage.
- Genitourinary: Menstrual disturbances vaginal
and uterine hemorrhage,
vulva-vaginitis, and prostate
disease.
- Metabolic/Nutritional: Hyperkalemia.
- Cardiovascular: Arrhythmia's, angina
pectoris, and myocardial infarction.
- Musculoskeletal: Myasthenia.
DRUG ABUSE AND DEPENDENCE
No drug abuse
or drug dependence
has been observed with flurbiprofen.
DRUG INTERACTIONS
Antacids: Administration of flurbiprofen to volunteers under
fasting conditions, or with antacid
suspension yielded
similar serum flurbiprofen
time profiles in young subjects (n=12). In
geriatric subjects (n=7) there was a reduction
in the rate but not the
extent of flurbiprofen absorption.
Anticoagulants: Flurbiprofen like other nonsteroidal anti-inflammatory
drugs, has been shown to affect
bleeding parameters
in patients receiving anti-coagulants, and serious clinical
bleeding has been reported.
The physician should be cautious when administering flurbiprofen
to patients taking anticoagulants.
Aspirin: Concurrent administration
of aspirin and flurbiprofen
resulted in 50% lower serum
flurbiprofen concentrations. This effect
of aspirin (which also lowers serum
concentrations of other nonsteroidal anti-inflammatory drugs given
with it) has been demonstrated in patients with rheumatoid arthritis
(n= 15) as well as normal
volunteers (n= 16). Concurrent use of flurbiprofen and aspirin
is therefore not recommended.
Beta-adrenergic Blocking Agents: The effect
of flurbiprofen on blood pressure
response to propranolol
and atenolol was evaluated
in men with mild uncomplicated hypertension
(n = 10). Flurbiprofen pretreatment attenuated the hypotensive
effect of a single dose
of propranolol but not atenolol. Flurbiprofen did not appear to
affect the beta-blocker-mediated
reduction in heart rate.
Flurbiprofen did not affect
the pharmacokinetic profile of either drug,
and the mechanism
under lying the interference with propranolol's hypotensive
effect is unknown. Patients
taking both flurbiprofen and a beta-blocker should be monitored
to ensure that a satisfactory hypotensive effect
is achieved.
Cimetidine, Ranitidine: In
normal volunteers (n=9),
pretreatment with cimetidine
or ranitidine did not affect
flurbiprofen pharmacokinetics except that a small (13 %) but statistically
significant increase
in the area under the serum
concentration
curve of flurbiprofen
resulted with cimetidine.
Digoxin: Studies of concomitant
administration
of flurbiprofen and digoxin
to healthy men (n= 14)
did not show a change in
the steady state serum
levels of either drug.
Diuretics: Studies in normal
volunteers have shown that flurbiprofen like other nonsteroidal
anti-inflammatory
drugs, can interfere with the effects of furosemide. Although results
have varied from study to study, effects have been shown on furosemide-stimulated
diuresis, natriuresis,
and kaliuresis. Other nonsteroidal anti-inflammatory
drugs that inhibit prostaglandin synthesis
have been shown to interfere with thiazide diuretics in some studies
and with potassium-sparing diuretics. Patients receiving flurbiprofen
and furosemide or
other diuretics should be observed closely to determine if the desired
effect is obtained.
Oral Hypoglycemic Agents: In
one study, flurbiprofen was given to adult
diabetics who were already receiving glyburide
(n=4), metformin (n=2) chlorpropamide
with phenformin (n= 3) or glyburide
with phenformin (n=6). Although there was a slight reduction
in blood sugar
concentrations during concomitant
administration
of flurbiprofen and hypoglycemic agents, there were no
signs or symptoms of hypoglycemia.
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