Aspirin / Omeprazole Side Effects
Medically reviewed by Drugs.com. Last updated on Jul 7, 2023.
Applies to aspirin / omeprazole: oral tablet delayed release.
Precautions
It is important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood, urine, and other laboratory tests may be needed to check for unwanted effects.
Do not use this medicine if you are also using medicines containing rilpivirine (Edurant®, Complera®, Odefsey®). Using these medicines together may cause unwanted side effects.
Tell your doctor if you are of Asian descent, such as Filipino, Chinese, Japanese, Korean, or Taiwanese. You may need a lower dose of this medicine.
Serious stomach conditions may occur while using this medicine. Check with your doctor immediately if you have stomach cramps, bloated feeling, watery and severe diarrhea which may also be bloody sometimes, fever, nausea or vomiting, or unusual tiredness or weakness.
Check with your doctor right away if you have a bloody urine, change in frequency of urination or amount of urine, a fever, joint pain, loss of appetite, skin rash, swelling of the body, feet, or ankles, unusual tiredness or weakness, or unusual weight gain after using this medicine. These may be symptoms of a serious kidney problem called acute tubulointerstitial nephritis.
This medicine may increase your risk of having fractures of the hip, wrist, and spine. This is more likely if you are 50 years of age and older, if you receive high doses of this medicine, or use it for one year or more.
Cutaneous or systemic lupus erythematosus may occur or gets worse in lupus patients and are taking PPI. Call your doctor right away if you have a joint pain or skin rash on your cheeks or arms that gets worse when exposed in the sun.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
Drinking alcohol while using this medicine may increase your risk of liver damage. If you drink 3 or more alcoholic drinks every day, tell your doctor.
Taking this medicine for a long time may make it harder for your body to absorb vitamin B12. Tell your doctor if you have concerns about vitamin B12 deficiency.
This medicine may cause hypomagnesemia (low magnesium in the blood). This is more likely to occur if you are taking this medicine for more than one year, or if you are taking this medicine together with digoxin (Lanoxin®) or certain diuretics or "water pills". Check with your doctor right away if you have convulsions (seizures), fast, racing, or uneven heartbeat, muscle spasms (tetany), tremors, or unusual tiredness or weakness.
This medicine may increase your risk for fundic gland polyps (abnormal tissue growth in the upper part of your stomach). This is more likely if you are receiving this medicine for more than 1 year. Talk to your doctor if you have concerns.
Do not stop using this medicine suddenly without asking your doctor. You may need to slowly decrease your dose before stopping it completely.
Using this medicine during the later part of pregnancy can harm your unborn baby. If you think you have become pregnant while using this medicine, tell your doctor right away.
This medicine may cause a delay in ovulation for women and may affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.
This medicine may cause serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, and drug reaction with eosinophilia and systemic symptoms (DRESS). Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.
Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before you have medical tests.
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 (eg, St. John's wort) or vitamin supplements.
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 side effects
- burning feeling in the chest or stomach
- indigestion
- stomach upset or tenderness
Less common side effects
- 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
- decreased interest in sexual intercourse
- double vision
- heartburn
- inability to have or keep an erection
- increased sensitivity of the skin to sunlight
- loss in sexual ability, desire, drive, or performance
- 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 adverse events
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]
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References
1. (2016) "Product Information. Yosprala (aspirin-omeprazole)." Aralez Pharmaceuticals
More about aspirin / omeprazole
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Further information
Aspirin/omeprazole side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.