Bayer Oral

It is very important that your doctor check your progress while you are using this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

This medicine can not be used for treatment of a heart attack. Use an immediate-release aspirin in such an event.

Make sure your doctor knows if you are pregnant or breastfeeding. Do not use this medicine during the later part of a pregnancy unless your doctor tells you to.

This medicine may increase risk for bleeding problems, including stomach ulcers or bleeding. This usually occurs if you are taking aspirin with certain medicines (eg, NSAIDs, blood thinner). Check with your doctor right away if you have black, tarry stools, severe or continuing stomach pain, unusual bleeding, bruising, or weakness, or vomiting of blood or material that looks like coffee grounds.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Abdominal or stomach pain, cramping, or burning
• black, tarry stools
• bloody or cloudy urine
• change in consciousness
• chest pain or discomfort
• confusion
• constipation
• convulsions, severe or continuing
• dark urine
• decreased frequency or amount of urine
• diarrhea
• difficult breathing
• drowsiness
• fainting
• fast breathing
• feeling that something terrible will happen
• fever
• general tiredness and weakness
• greatly decreased frequency of urination or amount of urine
• headache
• heartburn
• increased thirst
• indigestion
• irregular heartbeat
• light-colored stools
• loss of appetite
• loss of consciousness
• lower back or side pain
• muscle cramping and weakness
• muscle tremors
• nausea or vomiting
• nervousness
• numbness or tingling in the hands, feet, or lips
• panic
• rapid, deep breathing
• restlessness
• seizures
• skin rash
• stomach cramps
• swelling of the face, fingers, or lower legs
• unusual bleeding or bruising
• unusual tiredness or weakness
• 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

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Acid or sour stomach
• anxiety
• belching
• dizziness
• dry mouth
• hyperventilation
• irritability
• shaking
• stomach discomfort, upset, or pain
• trouble sleeping
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

More frequent side effects include: dyspepsia, epigastric distress, heartburn, and nausea. See below for a comprehensive list of adverse effects.

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

Common (1% to 10%): Dyspepsia,
Frequency not reported: GI bleeding, ulceration, perforation, nausea, vomiting, pancreatitis, gastric irritation, GI erosions, gastritis, melena, hematemesis, gingival bleeding[Ref]

Renal

Frequency not reported: Interstitial nephritis, papillary necrosis, renal insufficiency and failure[Ref]

Hematologic

Common (1% to 10%): Increased bleeding tendencies
Rare (0.01% to 0.1%): Aplastic anemia agranulocytosis, thrombocytopenia
Frequency not reported: Prolongation of prothrombin time, disseminated intravascular coagulation, coagulopathy, antepartum and postpartum bleeding, anemia[Ref]

Hypersensitivity

Rare (0.01% to 0.1%): Anaphylactic reactions including shock
Frequency not reported: Urticaria, angioedema, skin rashes[Ref]

Dermatologic

Uncommon (0.1% to 1%): Urticaria
Rare (0.01% to 0.1%): Steven-Johnson syndrome, Lyell's syndrome, erythema nodosum, erythema multiforme
Frequency not reported: Purpura, hives[Ref]

Hepatic

Frequency not reported: Transient elevations of hepatic enzymes, hepatitis, Reye's syndrome, hepatic insufficiency[Ref]

Metabolic

Frequency not reported: Thirst, dehydration, hyperkalemia, metabolic acidosis, respiratory alkalosis, hypoglycemia, hyperglycemia, hyperuricemia, salt and water retention[Ref]

Cardiovascular

Rare (0.01% to 0.1%): Hemorrhagic vasculitis
Frequency not reported: Dysrhythmias, hypotension, tachycardia[Ref]

Nervous system

Frequency not reported: Cerebral edema, coma headache, subdural or intracranial hemorrhage, seizures, lethargy, dizziness[Ref]

Other

Frequency not reported: Fever, hypothermia, hearing loss, tinnitus (at high doses), hearing disturbances[Ref]

Musculoskeletal

Frequency not reported: Rhabdomyolysis[Ref]

Respiratory

Frequency not reported: Hyperpnea, pulmonary edema, tachypnea, epistaxis, dyspnea, bronchospasm, asthma[Ref]

General

The more commonly experienced adverse effects include indigestion, dyspepsia, bleeding, and bruising.[Ref]

Genitourinary

Rare (0.01% to 0.1%): Menorrhagia
Frequency not reported: Proteinuria[Ref]

Psychiatric

Frequency not reported: Agitation, confusion[Ref]

Some side effects of Bayer Aspirin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.