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Yosprala Side Effects

Generic Name: aspirin / omeprazole

Note: This page contains side effects data for the generic drug aspirin / omeprazole. It is possible that some of the dosage forms included below may not apply to the brand name Yosprala.

For the Consumer

Applies to aspirin / omeprazole: oral tablet delayed release

As well as its needed effects, aspirin / omeprazole may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking aspirin / omeprazole, check with your doctor or nurse immediately:

Incidence not known:
  • Abdominal or stomach pain, cramping, or burning
  • abdominal or stomach tenderness
  • black, tarry stools blisters, hives, or itching
  • bloody urine
  • chest pain
  • constipation
  • decreased frequency or amount of urine
  • diarrhea
  • drowsiness
  • fever and chills
  • general feeling of discomfort or illness
  • hair loss
  • headaches
  • heartburn
  • increased thirst
  • indigestion
  • loss of appetite
  • lower back or side pain
  • mood or mental changes
  • muscle or joint pain
  • muscle spasms (tetany) or twitching
  • nausea or vomiting
  • pain or swelling in the arms or legs without any injury
  • seizures
  • severe abdominal or stomach cramps and pain
  • skin rash
  • sore throat
  • swelling of the face, fingers, or lower legs
  • swollen glands
  • trembling
  • troubled breathing
  • unusual tiredness or weakness
  • vomiting of blood or material that looks like coffee grounds
  • watery and severe diarrhea, which may also be bloody
  • weight gain

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]

References

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

It is possible that some side effects of Yosprala may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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