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Yosprala Side Effects

Generic Name: aspirin / omeprazole

Medically reviewed by Last updated on Feb 13, 2020.

Note: This document contains side effect information about aspirin / omeprazole. Some of the dosage forms listed on this page may not apply to the brand name Yosprala.

For the Consumer

Applies to aspirin / omeprazole: oral tablet delayed release

Side effects requiring immediate medical attention

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

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
  • 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
  • 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 abdominal or 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
  • tightness in the chest
  • trembling
  • troubled breathing
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • vomiting
  • vomiting of blood or material that looks like coffee grounds
  • watery and severe diarrhea, which may also be bloody
  • weakness or heaviness of the legs
  • weight gain
  • yellow eyes or skin

Side effects not requiring immediate medical attention

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
  • 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


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


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


-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


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



-Postmarketing reports: Dysrhythmia, hypotension, tachycardia


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



-Postmarketing reports: Urticaria, angioedema


-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]



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


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


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


-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


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



-Postmarketing reports: Proteinuria


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



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


-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]



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


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



-Postmarketing reports: Rhabdomyolysis


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

Nervous system


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


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



-Postmarketing reports: Gynecomastia[Ref]



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



-Postmarketing reports: Agitation, confusion


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



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


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



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


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



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



-Postmarketing reports: Acute anaphylaxis


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


1. "Product Information. Yosprala (aspirin-omeprazole)." Aralez Pharmaceuticals, New York, NY.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.