Applies to aspirin / omeprazole: oral tablet delayed release.

Serious side effects

Along with its needed effects, aspirin/omeprazole 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 while taking aspirin / omeprazole:

More common

• Burning feeling in the chest or stomach
• indigestion
• stomach upset or tenderness

Less common

• Black, tarry stools
• chest pain
• diarrhea
• vomiting of blood or material that looks like coffee grounds

Incidence not known

• Blistering, peeling, or loosening of the skin
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody or cloudy urine
• blurred vision
• chest tightness
• chills
• confusion
• constipation
• continuing vomiting
• cough
• darkened urine
• decreased frequency or amount of urine
• difficulty breathing
• difficulty swallowing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast, pounding, or irregular heartbeat or pulse
• fever
• general feeling of discomfort or illness
• hair loss
• headache
• heartburn
• hives, itching, skin rash
• increased thirst
• indigestion
• joint or muscle pain
• loss of appetite
• lower back or side pain
• mood or mental changes
• muscle or joint pain
• muscle spasms (tetany) or twitching
• nausea
• nervousness
• nosebleed
• numbness or tingling in the hands, feet, or lips
• pain or swelling in the arms or legs without any injury
• painful or difficult urination
• pains in the stomach, side, or abdomen, possibly radiating to the back
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid weight gain
• red skin lesions, often with a purple center
• red, irritated eyes
• seizures
• severe stomach cramps and pain
• slow heartbeat
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• stomach pain, cramping, tenderness, or burning
• swelling of the face, fingers, or lower legs
• swollen glands
• trembling
• trouble breathing
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss
• vomiting
• watery and severe diarrhea, which may also be bloody
• weakness or heaviness of the legs
• weight gain
• yellow eyes or skin

Other side effects

Some side effects of aspirin / omeprazole 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:

Incidence not known

• Bad unusual or unpleasant (after) taste
• belching
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in taste
• double vision
• heartburn
• increased sensitivity of the skin to sunlight
• loss or thinning of the hair
• redness or discoloration of the skin
• severe sunburn
• swelling of the breasts or breast soreness in both females and males
• swelling or inflammation of the mouth

For Healthcare Professionals

Applies to aspirin / omeprazole: oral delayed release tablet.

General

The most frequently reported side effects were gastritis, nausea, diarrhea, gastric polyps, and non-cardiac chest pain.^[Ref]

Gastrointestinal

Very common (10% or more): Gastritis (18%)

Common (1% to 10%): Nausea, diarrhea, gastric polyp

Frequency not reported: Gastric bleeding, duodenal bleeding, hematochezia, large intestinal hemorrhage, small bowel obstruction

Aspirin:

-Very common (10% or more): Gastritis (16%)

-Common (1% to 10%): Nausea, diarrhea, gastric polyp

-Postmarketing reports: Dyspepsia, gastrointestinal (GI) bleeding, GI ulceration, GI perforation, vomiting, pancreatitis

Omeprazole:

-Postmarketing reports: Pancreatitis, colon irritable, fecal discoloration, stomatitis, abdominal swelling, dry mouth, microscopic colitis^[Ref]

Cardiovascular

Aspirin:

-Postmarketing reports: Dysrhythmia, hypotension, tachycardia

Omeprazole:

-Postmarketing reports: Chest pain/angina, tachycardia, bradycardia, palpitation, blood pressure elevated^[Ref]

Dermatologic

Aspirin:

-Postmarketing reports: Urticaria, angioedema

Omeprazole:

-Postmarketing reports: Urticaria, angioedema, toxic epidermal necrolysis, Stevens-Johnson syndrome, cutaneous lupus erythematosus, erythema multiforme, photosensitivity, rash, skin inflammation, pruritus, petechiae, purpura, alopecia, dry skin, hyperhidrosis^[Ref]

Hematologic

Aspirin:

-Postmarketing reports: Prothrombin time prolonged, disseminated intravascular coagulation, coagulopathy, thrombocytopenia

Omeprazole:

-Postmarketing reports: Agranulocytosis, hemolytic anemia, pancytopenia, neutropenia, anemia, thrombocytopenia, leukopenia, leukocytosis^[Ref]

Other

Common (1% to 10%): Non-cardiac chest pain

Aspirin:

-Common (1% to 10%): Noncardiac chest pain

-Postmarketing reports: Fever, hypothermia, thirst, pregnancy prolonged, labor prolonged, stillbirth, low birth weight infant, antepartum bleeding, postpartum bleeding, hearing loss, tinnitus

Omeprazole:

-Postmarketing reports: Fever, pain, fatigue, malaise, esophageal candidiasis, mucosal atrophy of tongue, clostridium difficile-associated diarrhea, weight gain, vertigo, tinnitus, peripheral edema^[Ref]

Genitourinary

Aspirin:

-Postmarketing reports: Proteinuria

Omeprazole:

-Postmarketing reports: Hematuria, proteinuria, microscopic pyuria, urinary tract infection, glycosuria, urinary frequency, testicular pain^[Ref]

Hepatic

Aspirin:

-Postmarketing reports: Reye's Syndrome, hepatitis, hepatic enzymes elevated

Omeprazole:

-Postmarketing reports: Liver disease, hepatic failure, liver necrosis, hepatic encephalopathy, hepatocellular disease, cholestatic disease, mixed hepatitis, jaundice, ALT increased, AST increased, bilirubin increased, alkaline phosphatase increased, gamma-glutamyl transferase increased^[Ref]

Metabolic

Aspirin:

-Postmarketing reports: Dehydration, hyperkalemia, metabolic acidosis, hypoglycemia, hyperglycemia

Omeprazole:

-Postmarketing reports: Anorexia, hypoglycemia, hypomagnesemia, hypocalcemia, hypokalemia, hyponatremia^[Ref]

Musculoskeletal

Aspirin:

-Postmarketing reports: Rhabdomyolysis

Omeprazole:

-Postmarketing reports: Systemic lupus erythematosus, muscle weakness, myalgia, muscle cramps, joint pain, leg pain, bone fracture^[Ref]

Nervous system

Aspirin:

-Postmarketing reports: Cerebral edema, coma, dizziness, headache, subdural hemorrhage, intracranial hemorrhage, lethargy, seizure

Omeprazole:

-Postmarketing reports: Paresthesia, tremor, taste perversion, optic neuritis^[Ref]

Endocrine

Omeprazole:

-Postmarketing reports: Gynecomastia^[Ref]

Oncologic

Omeprazole:

-Postmarketing reports: Benign gastric fundic gland polyp, gastroduodenal carcinoid^[Ref]

Psychiatric

Aspirin:

-Postmarketing reports: Agitation, confusion

Omeprazole:

-Postmarketing reports: Depression, agitation, aggression, hallucination, confusion, insomnia, nervousness, apathy, somnolence, anxiety, abnormal dream^[Ref]

Renal

Aspirin:

-Postmarketing reports: Interstitial nephritis, papillary necrosis, renal impairment, renal failure

Omeprazole:

-Postmarketing reports: Interstitial nephritis, serum creatinine increased^[Ref]

Respiratory

Aspirin:

-Postmarketing reports: Respiratory alkalosis, laryngeal edema, bronchospasm, asthma, hyperpnea, pulmonary edema, tachypnea

Omeprazole:

-Postmarketing reports: Bronchospasm, epistaxis, pharyngeal pain^[Ref]

Ocular

Omeprazole:

-Postmarketing reports: Optic atrophy, anterior ischemic optic neuropathy, dry eye syndrome, ocular irritation, blurred vision, double vision^[Ref]

Immunologic

Aspirin:

-Postmarketing reports: Acute anaphylaxis

Omeprazole:

-Postmarketing reports: Hypersensitivity reaction, anaphylaxis, anaphylactic shock^[Ref]