YOSPRALA SIDE EFFECTS
- Generic Name: aspirin and omeprazole tablets
- Brand Name: Yosprala
- Drug Class: NSAIDs, Proton Pump Inhibitors
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Coagulation Abnormalities
- Gastrointestinal Adverse Reactions
- Bleeding Risk with Use of Alcohol
- Interaction with Clopidogrel
- Interaction with Ticagrelor
- Renal Failure
- Presence of Gastric Malignancy
- Acute Tubulointerstitial Nephritis
- Clostridium difficile-Associated Diarrhea
- Bone Fracture
- Severe Cutaneous Adverse Reactions
- Cutaneous and Systemic Lupus Erythematosus
- Hepatic Impairment
- Cyanocobalamin (Vitamin B-12) Deficiency
- Hypomagnesemia and Mineral Metabolism
- Reduced Effect of Omeprazole with St. John’s Wort or Rifampin
- Interactions with Diagnostic Investigations for Neuroendocrine Tumors
- Interaction with Methotrexate
- Fetal Toxicity
- Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
- Abnormal Laboratory Tests
- Fundic Gland Polyps
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*
325 mg/40 mg
|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
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 , pancreatitis
Hematologic: Prolongation of the prothrombin time, disseminated intravascular coagulation, coagulopathy, thrombocytopenia
Hypersensitivity: Acute anaphylaxis, angioedema, asthma, bronchospasm, laryngeal edema, urticaria
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
Body As a Whole: Hypersensitivity reactions including anaphylaxis, anaphylactic shock, angioedema, bronchospasm , 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, 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.
Metabolism and Nutritional disorders: Hypoglycemia, hypomagnesemia, hypocalcemia, 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 SJS/TEN, DRESS and AGEP 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.
SRC: NLM .