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
Anaprox Side Effects, and Drug Interactions - Naproxen Sodium
Anaprox Side Effects, and Drug Interactions - Naproxen Sodium
SIDE EFFECTS
As with all drugs in this class, the frequency
and severity of adverse events depends on several factors: the dose
of the drug and duration
of treatment; the age, the sex, physical condition
of the patient; any concurrent medical
diagnoses or individual risk
factors.
The following adverse reactions are divided into three parts based
on frequency and whether
or not the possibility exists of a causal relationship between drug
usage and these adverse events. In
those reactions listed as "Probable Causal Relationship"
there is at least one case
for each adverse reaction
where there is evidence to suggest that there is a causal relationship
between drug usage and
the reported event.
The adverse reactions reported were based on the results from two
double-blind controlled clinical
trials of three months duration
with an additional nine month open-label extension. A total of 542
patients received Naprelan either in the double-blind period or
in the nine month open-label extension. Of these 542 patients, 232
received Naprelan, 167 were initially treated with Naprosyn and
143 were initially treated with placebo. Adverse reactions
reported by patients who received Naprelan are shown by body
system. Those adverse reactions observed with naproxen but not reported
in controlled trials with Naprelan are italicized.
The most frequent adverse events from the double-blind and open-label
clinical trials were
headache (15%), followed by dyspepsia
(14%), and flu syndrome
(10%). The incidence of other adverse events occurring in 3% - 9%
of the patients are marked with an asterisk.
Those reactions occurring in less than 3% of the patients are unmarked.
Incidence Greater Than 1% (Probable Causal Relationship)
Body as a Whole—Pain (back)*, pain*, infection*,
fever, injury
(accident), asthenia,
pain chest,
headache (15%), flu syndrome
(10%).
Gastrointestinal—Nausea*, diarrhea*, constipation*,
abdominal pain*, flatulence,
gastritis, vomiting,
dysphagia, dyspepsia
(14%), heartburn*, stomatitis.
Hematologic—Anemia, ecchymosis.
Respiratory—Pharyngitis*, rhinitis*, sinusitis*,
bronchitis, cough
increased.
Renal—Urinary tract
infection*, cystitis.
Dermatologic—Skin rash*, skin eruptions*,
ecchymoses*, purpura.
Metabolic and Nutrition—Peripheral edema, hyperglycemia.
Central Nervous System—Dizziness, paresthesia, insomnia,
drowsiness*, lightheadedness.
Cardiovascular—Hypertension, edema*, dyspnea*,
palpitations.
Musculoskeletal—Cramps (leg), myalgia, arthralgia,
joint disorder, tendon
disorder.
Special Senses—Tinnitus*, hearing disturbances,
visual disturbances.
General—Thirst.
Incidence Less Than 1% (Probable Causal Relationship)
Body as a Whole—Abscess, monilia, neck
rigid, pain neck, abdomen
enlarged, carcinoma,
cellulitis, edema general, LE syndrome,
malaise, mucous
membrane disorder,
allergic reaction, pain
pelvic.
Gastrointestinal—Anorexia, cholecystitis, cholelithiasis,
eructation, GI
hemorrhage, rectal
hemorrhage, stomatitis aphthous,
stomatitis ulcer,
ulcer mouth,
ulcer stomach,
periodontal abscess, cardiospasm, colitis,
esophagitis, gastroenteritis,
GI disorder, rectal disorder,
tooth disorder, hepatosplenomegaly,
liver function
abnormality, melena, ulcer
esophagus, hematemesis, jaundice,
pancreatitis, necrosis.
Renal—Dysmenorrhea, dysuria, kidney function
abnormality, nocturia,
prostate disorder,
pyelonephritis, carcinoma breast,
urinary incontinence,
kidney calculus, kidney
failure, menorrhagia, metrorrhagia, neoplasm
breast, nephrosclerosis,
hematuria, pain kidney,
pyuria, urine abnormal,
urinary frequency, urinary
retention, uterine spasm,
vaginitis, glomerular
nephritis, hyperkalemia,
interstitial nephritis, nephrotic
syndrome, renal
disease, renal
failure, renal papillary
necrosis.
Hematologic—Leukopenia, bleeding time
increased, eosinophilia,
abnormal RBC, abnormal
WBC, thrombocytopenia, agranulocytosis, granulocytopenia.
Central Nervous System—Depression, anxiety, hypertonia,
nervousness, neuralgia,
neuritis, vertigo,
amnesia, confusion, co-ordination, abnormal
diplopia, emotional
lability, hematoma subdural, paralysis,
dream abnormalities, inability to concentrate, muscle weakness.
Dermatologic—Angiodermatitis, herpes simplex, dry
skin, sweating, ulcer
skin, acne,
alopecia, dermatitis
contact, eczema, herpes
zoster, nail disorder,
skin necrosis,
subcutaneous nodule, pruritus,
urticaria, neoplasm
skin, photosensitive
dermatitis, photosensitivity reactions resembling porphyria
cutaneous tarda, epidermolysis
bullosa.
Special Senses—Amblyopia, scleritis, cataract, conjunctivitis,
deaf, ear disorder, keratoconjunctivitis,
lacrimation disorder, otitis
media, pain eye.
Cardiovascular—Angina pectoris, coronary artery
disease, myocardial
infarction, deep thrombophlebitis,
vasodilation, vascular
anomaly, arrhythmia,
bundle branch
block, abnormal ECG, heart
failure right, hemorrhage,
migraine, aortic
stenosis, syncope,
tachycardia, congestive heart
failure.
Respiratory—Asthma, dyspnea, lung edema,
laryngitis, lung
disorder, epistaxis,
pneumonia, respiratory
distress, respiratory
disorder, eosinophilic pneumonitis.
Musculoskeletal—Myasthenia, bone disorder, spontaneous
bone fracture, fibrotendinitis,
bone pain,
ptosis, spasm general, bursitis.
Metabolic and Nutrition—Creatinine increase, glucosuria,
hypercholesteremia, albuminuria,
alkalosis, BUN
increased, dehydration, edema,
glucose tolerance
decrease, hyperuricemia,
hypokalemia, SGOT increase, SGPT
increase, weight decrease.
General—Anaphylactoid reactions, angioneurotic
edema, menstrual disorders,
hypoglycemia, pyrexia
(chills and fevers).
Incidence Less Than 1% (Probable Causal Relationship)
Other adverse reactions listed in the naproxen package label, but
not reported by those who received Naprelan are shown in italics.
These observations are being listed as alerting information to the
physician.
Hematologic—Aplastic anemia, hemolytic
anemia.
Central Nervous System—Aseptic meningitis,
cognitive dysfunction.
Dermatologic—Epidermal necrolysis, erythema
multiforme, Stevens-Johnson syndrome.
Gastrointestinal—Non-peptic GI ulceration, ulcerative
stomatitis.
Cardiovascular—Vasculitis.
DRUG INTERACTIONS
The use of NSAIDs in
patients who are receiving ACE
inhibitors may potentiate
renal disease
states (See PRECAUTIONS—Renal
Effects).
In vitro studies have shown that naproxen anion, because
of its affinity for
protein, may displace
from their binding sites other drugs which are also albumin-bound
(see CLINICAL PHARMACOLOGY—Pharmacokinetics).
Theoretically, the naproxen anion itself could likewise be displaced.
Short-term controlled studies failed to show
that taking the drug significantly
affects prothrombin
times when administered to individuals on coumarin-type anticoagulants.
Caution is advised nonetheless, since interactions have been seen
with other nonsteroidal agents of this class. Similarly, patients
receiving the drug and
a hydantoin, sulfonamide or sulfonylurea
should be observed for signs of toxicity
to these drugs.
Concomitant administration of naproxen and aspirin
is not recommended because naproxen is displaced from its binding
sites during the concomitant
administration
of aspirin, resulting in lower plasma
concentrations and peak plasma
levels.
The natriuretic
effect of furosemide
has been reported to be inhibited by some drugs of this class. Inhibition
of renal lithium
clearance leading
to increases in plasma
lithium concentrations has also been reported. Naproxen and other
NSAIDs can reduce the
antihypertensive
effect of propranolol
and other beta-blockers.
Probenecid given concurrently increases naproxen anion
plasma levels and extends
its plasma half-life
significantly.
Caution should be used if naproxen is administered concomitantly
with methotrexate. Naproxen, naproxen sodium and other NSAIDs
have been reported to reduce
the tubular secretion
of methotrexate
in an animal model, possibly
increasing the toxicity
of methotrexate.
Drug/Laboratory Test Interactions
Naproxen may decrease platelet aggregation and prolong bleeding
time. This effect should
be kept in mind when bleeding
times are determined. The administration
of naproxen may result in increased urinary
values for 17-ketogenic steroids because of an interaction between
the drug and/or its metabolites
with m-dinitrobenzene used in this assay. Although 17-hydroxy-corticosteroid
measurements (Porter-Silber test) do not appear to be artifactually
altered, it is suggested that therapy with naproxen be temporarily
discontinued 72 hours before adrenal
function tests are performed if the Porter-Silber test
is to be used.
Naproxen may interfere with some urinary
assays of 5-hydroxy indoleacetic acid
(5HIAA).
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