Medical Editor: John P. Cunha, DO, FACOEP
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. Common side effects of Yosprala include:
- stomach pain or discomfort caused by gastritis,
- gastric polyps, and
- non-cardiac chest pain.
The recommended dosage of Yosprala is one tablet daily taken at least 60 minutes before a meal. 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. 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.
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.
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
|Preferred Term||YOSPRALA 325 mg/ 40 mgonce daily
|EC-Aspirin 325 mg oncedaily
|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.
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.
Body as a Whole: Fever, hypothermia, thirst
Reproductive: Prolonged pregnancy and labor, stillbirths, lower birth weight infants, antepartum and postpartum bleeding
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.
Body As a Whole: Hypersensitivity reactions including anaphylaxis, anaphylactic shock, angioedema, bronchospasm [see CONTRAINDICATIONS], interstitial nephritis, urticaria (see also Skin below), systemic lupus erythematosus, fever, pain, fatigue, malaise
Gastrointestinal: Pancreatitis (some fatal), anorexia, irritable colon, fecal discoloration, esophageal candidiasis, mucosal atrophy of the tongue, stomatitis, abdominal swelling, dry mouth, microscopic colitis
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.
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]
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
Read the entire FDA prescribing information for Yosprala (Aspirin and Omeprazole Tablets)