Dermatologic

Dermatologic side effects have included Stevens-

Johnson syndrome and a lichenoid eruption. In
addition, isolated cases of unilateral aquagenic
wrinkling of the palms and papuloerythroderma have
been associated with aspirin therapy.[Ref]
Hepatic
Hepatic side effects have included hepatotoxicity and
cholestatic hepatitis.[Ref]
Oncologic
Oncologic side effects have included reports of
pancreatic cancer. Several epidemiologic studies
have suggested that chronic aspirin use may
decrease the risk of large bowel neoplasms.
However, other studies have not found such a
beneficial effect.[Ref]
Metabolic
Metabolic side effects have included dehydration and
hyperkalemia. Respiratory alkalosis and metabolic
acidosis, particularly during salicylate toxicity, have
been reported. A case of hypoglycemia has been
reported in a patient on hemodialysis. Salicylates
have also been reported to displace triiodothyronine
(T3) and thyroxine (T4) from protein binding sites.
The initial effect is an increase in serum free T4
concentrations.[Ref]
Cardiovascular
A 29-year-old female with a history of migraine
developed chest pain, tachycardia and orthopnea
following aspirin consumption at doses of 1500 mg
per day for several days. After discontinuation of
aspirin therapy, the patient's symptoms promptly
resolved. The patient consented to a pharmacological
challenge test which once again triggered the
symptoms.[Ref]
Cardiovascular side effects have included salicylate-
induced variant angina, ventricular ectopy,
conduction abnormalities, and hypotension,
particularly during salicylate toxicity. In addition, at
least one case of fluid retention simulating acute
congestive heart failure has been reported during
aspirin therapy. Antiplatelet therapy has also been
associated with acute deterioration of intracerebral
hemorrhage.[Ref]
Nervous system
Central nervous system side effects have included
agitation, cerebral edema, coma, confusion,
dizziness, headache, cranial hemorrhage, lethargy
and seizures. Tinnitus and subjective hearing loss (or
both) may occur. Some investigators have reported
that modest doses may result in decreased
frequency selectivity and may therefore impair
hearing performance, particularly in the setting of
background noise.[Ref]

For Healthcare Professionals

Applies to aspirin: compounding powder, oral capsule
extended release, oral delayed release capsule, oral
delayed release tablet, oral gum, oral powder for
reconstitution, oral tablet, oral tablet chewable, oral
tablet disintegrating, oral tablet dispersible, oral
tablet extended release, rectal suppository
Gastrointestinal
Endoscopically identifiable gastric mucosal lesions
occur in most patients who receive a single dose of
aspirin. Clinically evident gastrointestinal bleeding
has been reported in as many as 3% of treated
elderly patients. Anorectal ulceration and rectal
stenosis have been reported in patients who abuse
aspirin-containing rectal suppositories. One case-
controlled study has suggested that an association
between aspirin (and other NSAID) consumption and
appendicitis may exist.

The risk of developing dyspeptic events (i.e.,

epigastric pain, heartburn, nausea, ulcers) is low in
rheumatic patients with no prior gastrointestinal
symptoms who receive low-dose (less than 650
mg/day) aspirin therapy.[Ref]
Gastrointestinal side effects have included epigastric
distress (in as many as 83% of patients treated with
regular aspirin), abdominal discomfort or pain,
endoscopically identifiable gastric mucosal lesions,
nausea, and vomiting. More serious gastrointestinal
effects include hemorrhage, peptic ulcers,
perforation, small bowel enteropathy, and
esophageal ulcerations.[Ref]
Renal
The mechanism of an aspirin-induced decrease in
renal function may be related to inhibition of renal
prostaglandin synthesis with consequent decreases
in renal blood flow. Vasodilating renal prostaglandins
may be particularly important in patients who exhibit
arterial underfilling (i.e. heart failure, cirrhosis). The
administration of high doses of NSAIDs to such
patients has produced acute renal failure in rare
instances.[Ref]
Renal side effects have included reduction in
glomerular filtration rate (particularly in patients who
are sodium restricted or who exhibit diminished
 effective arterial blood volume, such as patients with
advanced heart failure or cirrhosis), interstitial
nephritis, papillary necrosis, elevations in serum
creatinine, elevations in blood urea nitrogen,
proteinuria, hematuria, and renal failure.[Ref]
Hematologic
Hematologic side effects have included increased
blood fibrinolytic activity. In addition,
hypoprothrombinemia, thrombocytopenia,
thrombocyturia, megaloblastic anemia, and
pancytopenia have been reported rarely. Aplastic
anemia and eosinophilia have also been reported.
[Ref]
Hypersensitivity
The mechanism of aspirin-induced hypersensitivity
may be related to an up-regulation of the 5-
lipoxygenase pathway of arachidonic acid
metabolism with a resulting increase in the products
of 5-lipoxygenase (such as leukotrienes).[Ref]
Hypersensitivity side effects have included
bronchospasm, rhinitis, conjunctivitis, urticaria,
angioedema, and anaphylaxis. Approximately 10%
to 30% of asthmatics are aspirin-sensitive (with the
clinical triad of aspirin sensitivity, bronchial
asthma, and nasal polyps).[Ref]
upper right abdominal or stomach
vomiting of blood or material that looks like coffee
grounds
weakness or heaviness of the legs
weight gain
yellow eyes and skin
Aspirin side effects
Get emergency medical help if you have signs of an
allergic reaction to aspirin: hives; difficult
 breathing; swelling of your face, lips, tongue, or
throat.
Stop using this medicine and call your doctor at once
if you have:
ringing in your ears, confusion, hallucinations, rapid
breathing, seizure (convulsions);
severe nausea, vomiting, or stomach pain;
bloody or tarry stools, coughing up blood or vomit
that looks like coffee grounds;
fever lasting longer than 3 days; or
swelling, or pain lasting longer than 10 days.
Common aspirin side effects may include:
upset stomach, heartburn;
drowsiness; or
mild headache.
This is not a complete list of side effects and others
may occur. Call your doctor for medical advice about
side effects. You may report side effects to FDA at 1-
800-FDA-1088.
See also: Side effects (in more detail)
What other drugs will affect
aspirin?
Ask your doctor before using aspirin if you take an
antidepressant such as citalopram, escitalopram,
fluoxetine (Prozac), fluvoxamine, paroxetine,
sertraline (Zoloft), trazodone, or vilazodone. Taking
any of these medicines with an NSAID may cause
you to bruise or bleed easily.
Ask a doctor or pharmacist if it is safe for you to use
aspirin if you are also using any of the following
drugs:
a blood thinner (warfarin, Coumadin, Jantoven), or
other medication used to prevent blood clots; or
 other salicylates such as Nuprin Backache Caplet,
Kaopectate, KneeRelief, Pamprin Cramp Formula,
Pepto-Bismol, Tricosal, Trilisate, and others.
This list is not complete. Other drugs may interact
with aspirin, including prescription and over-the-
counter medicines, vitamins, and herbal products.
Not all possible interactions are listed in this
medication guide
If you use the orally disintegrating tablet or the
dispersible tablet, follow all dosing instructions
provided with your medicine.
If you need surgery, tell the surgeon ahead of time
that you are using this medicine. You may need to
stop using it for a short time.
Do not take this medicine if you smell a strong
vinegar odor in the bottle. The medicine may no
longer be effective.
Store at room temperature away from moisture and
heat.
See also: Dosage Information (in more detail)
What happens if I miss a dose?
Since aspirin is used when needed, you may not be
on a dosing schedule. If you are on a schedule, use
the missed dose as soon as you remember. Skip the
missed dose if it is almost time for your next
scheduled dose. Do not use extra medicine to make
up the missed dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison
Help line at 1-800-222-1222.
Overdose symptoms may include temporary hearing
loss, seizure (convulsions), or coma.
What should I avoid while
 taking aspirin?
Avoid drinking alcohol while you are taking aspirin.
Alcohol may increase your risk of stomach bleeding.
If you are taking this medicine to prevent heart
attack or stroke, avoid also taking ibuprofen (Advil,
Motrin). Ibuprofen may make this medicine less
effective. If you must use both medications, take the
ibuprofen at least 8 hours before or 30 minutes after
you take the aspirin (non-enteric coated form).
Ask a doctor or pharmacist before using any cold,
allergy, or pain medication. Many medicines
available over the counter contain aspirin or an
NSAID. Taking certain products together can cause
you to get too much of this type of medication.
Check the label to see if a medicine contains aspirin,
ibuprofen, ketoprofen, naproxen, or an NSAID.

You should not use aspirin if you are allergic to it, or if

you have:
a recent history of stomach or intestinal bleeding;
a bleeding disorder such as hemophilia; or
if you have ever had an asthma attack or severe
allergic reaction after taking aspirin or an NSAID
(non-steroidal anti-inflammatory drug) such as Advil,
Motrin, Aleve, Orudis, Indocin, Lodine, Voltaren,
Toradol, Mobic, Relafen, Feldene, and others.
To make sure this medicine is safe for you, tell your
doctor if you have:
asthma or seasonal allergies;
stomach ulcers;
liver disease;
kidney disease;
a bleeding or blood clotting disorder;
gout; or
 heart disease, high blood pressure, or congestive
heart failure.
Taking aspirin during late pregnancy may
cause bleeding in the mother or the baby
during delivery. Tell your doctor if you are pregnant
or plan to become pregnant.
Aspirin can pass into breast milk and may harm a
nursing baby. You should not breast-feed while using
this medicine.

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How should I take aspirin?
Take aspirin exactly as directed on the label, or as
prescribed by your doctor. Do not use in larger or
smaller amounts or for longer than recommended.
Take with food if aspirin upsets your stomach.
Do not crush, chew, break, or open an enteric-
coated or delayed-release pill. Swallow it whole.
The chewable tablet form must be chewed before
swallowing.
What is aspirin?
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Aspirin is a salicylate (sa-LIS-il-ate). It works by
reducing substances in the body that cause pain,
fever, and inflammation.
Aspirin is used to treat pain, and reduce fever or
inflammation. It is sometimes used to treat or
prevent heart attacks, strokes, and chest pain
(angina).
Aspirin should be used for cardiovascular conditions
only under the supervision of a doctor.
Important information
You should not use aspirin if you have a bleeding
disorder such as hemophilia, a recent history of
stomach or intestinal bleeding, or if you are allergic
to an NSAID (non-steroidal anti-inflammatory drug)
such as Advil, Motrin, Aleve, Orudis, Indocin, Lodine,
Voltaren, Toradol, Mobic, Relafen, Feldene, and
others.

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Looking Ahead: Pharma Projections for 2016 - And
Beyond
Do not give this medication to a child or teenager
with a fever, flu symptoms, or chicken pox.
Salicylates can cause Reye's syndrome, a
serious and sometimes fatal condition in
children.