Yosprala

Last updated on RxList: 12/14/2020
Yosprala Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Yosprala?

Yosprala (aspirin and omeprazole) delayed-release is a combination of an anti-platelet agent and a proton pump inhibitor (PPI) indicated for patients who require aspirin for secondary prevention of cardiovascular and cerebrovascular events and who are at risk of developing aspirin associated gastric ulcers.

What Are Side Effects of Yosprala?

Common side effects of Yosprala include:

  • stomach pain or discomfort caused by gastritis,
  • nausea,
  • diarrhea,
  • gastric polyps, and
  • non-cardiac chest pain.

Dosage for Yosprala

The recommended dosage of Yosprala is one tablet daily taken at least 60 minutes before a meal.

What Drugs, Substances, or Supplements Interact with Yosprala?

Yosprala may interact with antiretroviral drugs, heparin, warfarin, methotrexate, clopidogrel, citalopram, cilostazol, phenytoin, diazepam, ticagrelor, digoxin, iron salts, erlotinib, dasatinib, nilotinib, mycophenolate, mofetil, azole antifungals, tacrolimus, ACE inhibitors, beta-blockers, diuretics, nonsteroidal anti-inflammatory drugs (NSAIDs), oral hypoglycemics, acetazolamide, probenecid, valproic acid, St. John's Wort, and rifampin. Tell your doctor all medications and supplements you use.

Yosprala During Pregnancy and Breastfeeding

Use of NSAIDs, including Yosprala, during the third trimester of pregnancy can cause harm to the fetus. Avoid use of NSAIDs, including Yosprala, in pregnant women starting at 30 weeks of gestation (third trimester). It is unknown if Yosprala passes into breast milk. Breastfeeding is not recommended while using Yosprala.

Additional Information

Our Yosprala (aspirin and omeprazole) delayed-release tablets Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Yosprala Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: sneezing, runny or stuffy nose; wheezing or trouble breathing; hives; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe nausea, vomiting, stomach pain, or diarrhea that is watery or bloody;
  • bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • easy bruising, unusual bleeding (such as a nosebleed), or any bleeding that will not stop;
  • sudden pain or trouble moving your hip, wrist, or back;
  • kidney problems--fever, rash, nausea, loss of appetite, joint pain, urinating less than usual, blood in your urine, weight gain;
  • liver problems--stomach pain, itching, dark urine, jaundice (yellowing of the skin or eyes);
  • low magnesium--dizziness, fast or irregular heart rate, tremors (shaking) or jerking muscle movements, feeling jittery, muscle cramps, muscle spasms in your hands and feet, cough or choking feeling; or
  • new or worsening symptoms of lupus--joint pain, and a skin rash on your cheeks or arms that worsens in sunlight.

Taking this medicine long-term may cause you to develop stomach growths called fundic gland polyps. Talk with your doctor about this risk.

If you use this medicine for longer than 3 years, you could develop a vitamin B-12 deficiency. Talk to your doctor about how to manage this condition if you develop it.

Common side effects may include:

  • heartburn, stomach pain, indigestion;
  • nausea, diarrhea; or
  • chest pain (may happen when you eat).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Yosprala (Aspirin and Omeprazole Tablets)

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Yosprala Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

  • Coagulation Abnormalities [see WARNINGS AND PRECAUTIONS]
  • Gastrointestinal Adverse Reactions [see WARNINGS AND PRECAUTIONS]
  • Bleeding Risk with Use of Alcohol [see WARNINGS AND PRECAUTIONS]
  • Interaction with Clopidogrel [see WARNINGS AND PRECAUTIONS]
  • Interaction with Ticagrelor [see WARNINGS AND PRECAUTIONS]
  • Renal Failure [see WARNINGS AND PRECAUTIONS]
  • Presence of Gastric Malignancy [see WARNINGS AND PRECAUTIONS]
  • Acute Tubulointerstitial Nephritis [see WARNINGS AND PRECAUTIONS]
  • Clostridium difficile-Associated Diarrhea [see WARNINGS AND PRECAUTIONS]
  • Bone Fracture [see WARNINGS AND PRECAUTIONS]
  • Cutaneous and Systemic Lupus Erythematosus [see WARNINGS AND PRECAUTIONS]
  • Hepatic Impairment [see WARNINGS AND PRECAUTIONS]
  • Cyanocobalamin (Vitamin B-12) Deficiency [see WARNINGS AND PRECAUTIONS]
  • Hypomagnesemia [see WARNINGS AND PRECAUTIONS]
  • Reduced Effect of Omeprazole with St. John's Wort or Rifampin [see WARNINGS AND PRECAUTIONS]
  • Interactions with Diagnostic Investigations for Neuroendocrine Tumors [see WARNINGS AND PRECAUTIONS]
  • Interaction with Methotrexate [see WARNINGS AND PRECAUTIONS]
  • Fetal Toxicity [see WARNINGS AND PRECAUTIONS]
  • Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) [see WARNINGS AND PRECAUTIONS]
  • Abnormal Laboratory Tests [see WARNINGS AND PRECAUTIONS]
  • Fundic Gland Polyps [see WARNINGS AND PRECAUTIONS]

Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

YOSPRALA 325 mg/40 mg was studied primarily in two randomized, double-blind controlled clinical trials (n=524) of 6 months duration. Table 1 lists adverse reactions that occurred in >2% of patients in the YOSPRALA arm and were more common than in the control arm, consisting of 325 mg of enteric coated (EC)-aspirin.

Table 1: Most Common Adverse Reactions in Study 1 and Study 2*

Preferred Term YOSPRALA 325 mg/40 mg once daily
(n=521) %
EC-Aspirin 325 mg once daily
(n=524) %
Gastritis 18 16
Nausea 3 2
Diarrhea 3 2
Gastric polyps 2 1
Non-cardiac chest pain 2 1
*Adverse reactions occurring in ≥2% of YOSPRALA-treated patients and more common than in the control arm

In Study 1 and Study 2 combined, 7% of patients taking YOSPRALA discontinued due to adverse reactions compared to 11% of patients taking EC-aspirin alone. The most common reasons for discontinuations due to adverse reactions in the YOSPRALA treatment group were upper abdominal pain (<1%, n=2), diarrhea (<1%, n=2) and dyspepsia (<1%, n=2).

Less Common Adverse Reactions

In YOSPRALA-treated patients in the clinical trials there were 2 patients with upper GI bleeding (gastric or duodenal) and 2 patients with lower GI bleeding (hematochezia and large intestinal hemorrhage) and one additional patient experienced obstruction in the small bowel.

See also the full prescribing information of aspirin and omeprazole products for additional adverse reactions.

Post-Marketing Experience

The following adverse reactions have been identified during post-approval use of aspirin and omeprazole separately. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Aspirin

Body as a Whole: Fever, hypothermia, thirst

Cardiovascular: Dysrhythmias, hypotension, tachycardia

Central Nervous System: Agitation, cerebral edema, coma, confusion, dizziness, headache, subdural or intracranial hemorrhage, lethargy, seizures

Fluid and Electrolyte: Dehydration, hyperkalemia, metabolic acidosis, respiratory alkalosis

Gastrointestinal: Dyspepsia, GI bleeding, ulceration and perforation, nausea, vomiting, transient elevations of hepatic enzymes, hepatitis, Reye's Syndrome [see CONTRAINDICATIONS], pancreatitis

Hematologic: Prolongation of the prothrombin time, disseminated intravascular coagulation, coagulopathy, thrombocytopenia

Hypersensitivity: Acute anaphylaxis, angioedema, asthma, bronchospasm, laryngeal edema, urticaria

Musculoskeletal: Rhabdomyolysis

Metabolism: Hypoglycemia (in pediatrics), hyperglycemia

Reproductive: Prolonged pregnancy and labor, stillbirths, lower birth weight infants, antepartum and postpartum bleeding

Respiratory: Hyperpnea, pulmonary edema, tachypnea

Special Senses: Hearing loss, tinnitus. Patients with high frequency hearing loss may have difficulty perceiving tinnitus. In these patients, tinnitus cannot be used as a clinical indicator of salicylism.

Urogenital: Interstitial nephritis, papillary necrosis, proteinuria, renal impairment and failure

Omeprazole

Body As a Whole: Hypersensitivity reactions including anaphylaxis, a naphylactic shock, angioedema, bronchospasm [see CONTRAINDICATIONS], interstitial nephritis, urticaria (see also Skin below), systemic lupus erythematosus, fever, pain, fatigue, malaise

Cardiovascular: Chest pain or angina, tachycardia, bradycardia, palpitations, elevated blood pressure, peripheral edema

Endocrine: Gynecomastia

Gastrointestinal: Pancreatitis (some fatal), anorexia, irritable colon, fecal discoloration, esophageal candidiasis, mucosal atrophy of the tongue, stomatitis, abdominal swelling, dry mouth, microscopic colitis, fundic gland polyps.

Gastroduodenal carcinoids have been reported in patients with Zollinger-Ellison syndrome on long-term treatment with omeprazole. This finding is believed to be a manifestation of the underlying condition, which is known to be associated with such tumors.

Hematologic: Agranulocytosis (some fatal), hemolytic anemia, pancytopenia, neutropenia, anemia, thrombocytopenia, leukopenia, leukocytosis

Hepatic: Liver disease including hepatic failure (some fatal), liver necrosis (some fatal), hepatic encephalopathy hepatocellular disease, cholestatic disease, mixed hepatitis, jaundice, and elevations of liver function tests [ALT, AST, GGT, alkaline phosphatase, and bilirubin]

Infections and Infestations: Clostridium difficile-associated diarrhea [see WARNINGS AND PRECAUTIONS]

Metabolism and Nutritional disorders: Hypoglycemia, hypomagnesemia, with or without hypocalcemia and/or hypokalemia, hyponatremia, weight gain

Musculoskeletal: Muscle weakness, myalgia, muscle cramps, joint pain, leg pain, bone fracture Nervous System/Psychiatric: Psychiatric and sleep disturbances including depression, agitation, aggression, hallucinations, confusion, insomnia, nervousness, apathy, somnolence, anxiety, and dream abnormalities; tremors, paresthesia; vertigo

Respiratory: Epistaxis, pharyngeal pain

Skin: Severe generalized skin reactions including toxic epidermal necrolysis (some fatal), Stevens-Johnson syndrome, cutaneous lupus erythematosus and erythema multiforme; photosensitivity; urticaria; rash; skin inflammation; pruritus; petechiae; purpura; alopecia; dry skin; hyperhidrosis

Special Senses: Tinnitus, taste perversion

Ocular: Optic atrophy, anterior ischemic optic neuropathy, optic neuritis, dry eye syndrome, ocular irritation, blurred vision, double vision

Urogenital: Interstitial nephritis, hematuria, proteinuria, elevated serum creatinine, microscopic pyuria, urinary tract infection, glycosuria, urinary frequency, testicular pain

DRUG INTERACTIONS

Tables 2 and 3 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with YOSPRALA and instructions for preventing or managing them.

Consult the labeling of concomitantly used drugs to obtain further information about interactions with omeprazole or aspirin.

Table 2: Clinically Relevant Interactions Affecting Drugs Co-Administered with YOSPRALA and Interaction with Diagnostics

Antiretrovirals
Clinical Impact: The effect of PPIs, such as omeprazole, on antiretroviral drugs is variable. The clinical importance and the mechanisms behind these interactions are not always known.
  • Decreased exposure of some antiretroviral drugs (e.g., rilpivirine, atazanavir and nelfinavir) when used concomitantly with omeprazole may reduce antiviral effect and promote the development of drus resistance [see CLINICAL PHARMACOLOGY].
  • Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with omeprazole may increase toxicity [see CLINICAL PHARMACOLOGY].
  • There are other antiretroviral drugs which do not result in clinically relevant interactions with omeprazole.
Intervention: Rilpivirine-containing products: Concomitant use with Y OSPRALA is contraindicated [see CONTRAINDICATIONS].
Atazanavir: Avoid concomitant use with YOSPRALA. See prescribing information for atazanavir for dosing information.
Nelfinavir: Avoid concomitant use with YOSPRALA. See prescribing information for nelfinavir.
Saquinavir: See the prescribing information for saquinavir for monitoring of potential saquinavir-related toxicities.
Other antiretrovirals: See prescribing information for specific antiretroviral drugs.
Heparin and Warfarin
Clinical Impact: Increased INR and prothrombin time in patients receiving PPIs, including omeprazole, and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death.
Aspirin can increase the anticoagulant activity of heparin and warfarin, increasing bleeding risk.
Intervention: Monitor INR and prothrombin time and adjust the dose of warfarin, if needed, to maintain target INR range.
Monitor and adjust the dose of heparin and warfarin as needed.
Methotrexate
Clinical Impact: Concomitant use of omeprazole with methotrexate (primarily at high dose) may elevate and prolong serum concentrations of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to methotrexate toxicities. No formal drug interaction studies of high-dose methotrexate with PPIs, such as omeprazole, have been conducted [see WARNINGS AND PRECAUTIONS].
Intervention: A temporary withdrawal of YOSPRALA may be considered in some patients receiving high-dose methotrexate.
CYP2C19 Substrates (e.g., clopidogrel, citalopram, cilostazol, phenytoin,diazepam)
Clopidogrel
Clinical Impact: Concomitant use of omeprazole 80 mg results in reduced plasma concentrations of the active metabolite of clopidogrel and a reduction in platelet inhibition [see CLINICAL PHARMACOLOGY]. There are no adequate combination studies of a lower dose of omeprazole or a higher dose of clopidogrel in comparison with the approved dose of clopidogrel.
Intervention: Avoid concomitant use with YOSPRALA. Consider use of alternative antiplatelet therapy [see WARNINGS AND PRECAUTIONS].
Citalopram
Clinical Impact: Concomitant use of omeprazole results in increased exposure of citalopram leading to an increased risk of QT prolongation [see CLINICAL PHARMACOLOGY].
Intervention: Limit the dose of citalopram to a maximum of 20 mg per day. See prescribing information for citalopram.
Cilostazol
Clinical Impact: Concomitant use of omeprazole results in increased exposure of one of the active metabolites of cilostazol (3,4-dihydro-cilostazol).
Intervention: Reduce the dose of cilostazol to 50 mg twice daily. See prescribing information for cilostazol.
Phenytoin
Clinical Impact: Potential for increased exposure of phenytoin with concomitant omeprazole. Aspirin can displace protein-bound phenytoin leading to a decrease in the total concentration of phenytoin.
Intervention: Monitor phenytoin serum concentrations. Dose adjustment may be needed to maintain therapeutic drug concentrations. See prescribing information for phenytoin.
Diazepam
Clinical Impact: Increased exposure of diazepam with concomitant omeprazole [see CLINICAL PHARMACOLOGY].
Intervention: Monitor patients for increased sedation and reduce the dose of diazepam as needed.
Ticagrelor
Clinical Impact: Maintenance doses of aspirin above 100 mg reduce the effectiveness of ticagrelor.
Intervention: Avoid concomitant use of ticagrelor with the 325 mg/40 mg tablet strength of YOSPRALA [see WARNINGS AND PRECAUTIONS].
Digoxin
Clinical Impact: Potential for increased exposure of digoxin with concomitant omeprazole [see CLINICAL PHARMACOLOGY].
Intervention: Monitor digoxin concentrations. Dose adjustment may be needed to maintain therapeutic drug concentrations. See digoxin prescribing information.
Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole)
Clinical Impact: Omeprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity.
Intervention: Mycophenolate mofetil (MMF): Co-administration of omeprazole in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid (MPA), possibly due to a decrease in MMF solubility at an increased gastric pH. The clinical relevance of reduced MPA exposure on organ rejection has not been established in transplant patients receiving omeprazole and MMF. Use Yosprala with caution in transplant patients receiving MMF [see CLINICAL PHARMACOLOGY].
See the prescribing information for other drugs dependent on gastric pH for absorption.
Tacrolimus
Clinical Impact: Potential for increased exposure of tacrolimus with concomitant omeprazole, especially in transplant patients who are intermediate or poor metabolizers of CYP2C19.
Intervention: Monitor tacrolimus whole blood concentrations. Dose adjustment may be needed to maintain therapeutic drug concentrations. See prescribing information for tacrolimus.
ACE-Inhibitors
Clinical Impact: Aspirin may diminish the antihypertensive effect of ACE-inhibitors.
Intervention: Monitor blood pressure as needed.
Beta Blockers
Clinical Impact: The hypotensive effects of beta blockers may be diminished by the concomitant administration of aspirin.
Intervention: Monitor blood pressure as needed in patients taking YOSPRALA concomitantly with beta blockers for hypertension.
Diuretics
Clinical Impact: The effectiveness of diuretics in patients with underlying renal or cardiovascular disease may be diminished by the concomitant administration of aspirin.
Intervention: Monitor blood pressure as needed.
NSAIDs
Clinical Impact: The concurrent use of NSAIDs and aspirin may increase the risk of serious adverse events, including increased bleeding or decreased renal function.
Intervention: Monitor for signs and symptoms of bleeding or decreased renal function.
Oral Hypoglycemics
Clinical Impact: Moderate doses of aspirin may increase the effectiveness of oral hypoglycemic drugs, leading to hypoglycemia.
Intervention: Monitor blood sugar as needed.
Acetazolamide
Clinical Impact: Concurrent use of aspirin and acetazolamide can lead to high serum concentrations of acetazolamide (and toxicity).
Intervention: Adjust the dose of acetazolamide if signs of toxicity occur.
Uricosuric Agents (Probenecid)
Clinical Impact: Aspirin antagonizes the uricosuric action of uricosuric agents.
Intervention: Monitor serum uric acid levels as needed.
Valproic Acid
Clinical Impact: Concomitant use of aspirin can displace protein-bound valproic acid, leading to an increase in serum concentrations of valproic acid.
Intervention: Monitor valproic acid serum concentrations. Dose adjustment may be needed to maintain therapeutic drug concentrations. See prescribing information for valproic acid.
Interactions with Investigations of Neuroendocrine Tumors
Clinical Impact: Serum chromogranin A (CgA) levels increase secondary to omeprazole-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors [see WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY].
Intervention: Temporarily stop YOSPRALA treatment at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high. If serial tests are performed (e.g., for monitoring), the same commercial laboratory should be used for testing, as reference ranges between tests may vary.
Interaction with Secretin Stimulation Test
Clinical Impact: Omeprazole can cause a hyper-response in gastrin secretion in response to secretin stimulation test, falsely suggesting gastrinoma.
Intervention: Temporarily stop YOSPRALA treatment at least 14 days before assessing to allow gastrin levels to return to baseline [see CLINICAL PHARMACOLOGY].
False Positive Urine Tests for THC
Clinical Impact: There have been reports of false positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving PPIs such as omeprazole.
Intervention: An alternative confirmatory method should be considered to verify positive results.
Other
Clinical Impact: There have been clinical reports of interactions with other drugs metabolized via the cytochrome P450 system (e.g., cyclosporine, disulfiram) with omeprazole.
Intervention: Monitor patients to determine if it is necessary to adjust the dosage of these other drugs when taken concomitantly with YOSPRALA.

Table 3: Clinically Relevant Interactions Affecting YOSPRALA When Co-Administered with Other Drugs

CYP2C19 or CYP3A4 Inducers
Clinical Impact: Decreased exposure of omeprazole when used concomitantly with strong inducers [see CLINICAL PHARMACOLOGY].
Intervention: St. John’s Wort, rifampin: Avoid concomitant use with YOSPRALA [see WARNINGS AND PRECAUTIONS ]. Ritonavir-containing products: See prescribing information for specific drugs.
CYP2C19 or CYP3A4 Inhibitors
Clinical Impact: Increased exposure of omeprazole [see CLINICAL PHARMACOLOGY].
Intervention: Voriconazole: Avoid concomitant use with YOSPRALA.

Read the entire FDA prescribing information for Yosprala (Aspirin and Omeprazole Tablets)

© Yosprala Patient Information is supplied by Cerner Multum, Inc. and Yosprala Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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