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adverse reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in labeling: Acute Interstitial Nephritis [see WARNINGS AND PRECAUTIONS(5.2 )] Clostridium difficile- Associated Diarrhea [see WARNINGS AND PRECAUTIONS (5.4 )] Bone Fracture [see WARNINGS AND PRECAUTIONS (5.5 )] Cutaneous and Systemic Lupus Erythematosus [see WARNINGS AND PRECAUTIONS (5.6 )] Cyanocobalamin (Vitamin B-12) Deficiency [see WARNINGS AND PRECAUTIONS (5.8 )] Hypomagnesemia [see WARNINGS AND PRECAUTIONS (5.9) ] Fundic Gland Polyps [see WARNINGS AND PRECAUTIONS (5.13 )] Most common adverse reactions (≥ 2%) are: Headache, abdominal pain, nausea, diarrhea, vomiting, and flatulence (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Par Pharmaceutical at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials 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. The safety of omeprazole and sodium bicarbonate has been established, in part, based on oral studies of an oral delayed-release omeprazole product. Clinical Trials with Omeprazole In the U.S. clinical trial population of 465 adult patients, the adverse reactions summarized in Table 3 were reported to occur in 1% or more of patients on therapy with omeprazole. Table 3: Adverse Reactions Occurring in 1% or More of Adult Patients in US Clinical Trials of Omeprazole Therapy Omeprazole % (n = 465) Placebo % (n = 64) Ranitidine % (n = 195) Headache 7 6 8 Diarrhea 3 3 2 Abdominal Pain 2 3 3 Nausea 2 3 4 Upper Respiratory Infection (URI) 2 2 3 Dizziness 2 0 3 Vomiting 2 5 2 Rash 2 0 0 Constipation 1 0 0 Cough 1 0 2 Asthenia 1 2 2 Back Pain 1 0 1 Table 4 summarizes the adverse reactions that occurred in 1% or more of omeprazole-treated patients from international double-blind, and open-label clinical trials in which 2,631 patients and subjects received omeprazole. Table 4: Adverse Reactions Occurring in 1% or More of Adult Patients in International Clinical Trials of Omeprazole Therapy Omeprazole % (N = 2631) Placebo % (N = 120) Abdominal Pain 5.2 3.3 Nausea 4.0 6.7 Diarrhea 3.7 2.5 Vomiting 3.2 10.0 Headache 2.9 2.5 Flatulence 2.7 5.8 Acid Regurgitation 1.9 3.3 Constipation 1.5 0.8 Asthenia 1.3 0.8 Clinical Trial of 40 mg Omeprazole and Sodium Bicarbonate for Oral Suspension Adverse reactions reported in at least 3% of critically ill adult patients in a clinical trial of 40 mg Omeprazole and Sodium Bicarbonate for oral suspension compared to intravenous cimetidine for up to 14 days are presented in Table 5 . Table 5: Common Adverse Reactions 1 by Body System and Preferred Term in a Randomized Controlled Trial of Critically Ill Adult Patients Treated up to 14 Days Body System Preferred Term Omeprazole and Sodium Bicarbonate 40 mg for oral suspension once daily % (N=178) Intravenous Cimetidine 1,200 mg per day % (N=181) Blood and Lymphatic System Disorders Anemia NOS 7.9 7.7 Anemia NOS Aggravated 2.2 3.9 Thrombocytopenia 10.1 6.1 Cardiac Disorders Atrial Fibrillation 6.2 3.9 Bradycardia NOS 3.9 2.8 Supraventricular Tachycardia 3.4 1.1 Tachycardia NOS 3.4 3.3 Ventricular Tachycardia 4.5 3.3 Gastrointestinal Disorders 2 Constipation 4.5 4.4 Diarrhea NOS 3.9 8.3 Gastric Hypomotility 1.7 3.3 General Disorders and Administration Site Conditions Hyperpyrexia 4.5 1.7 Edema NOS 2.8 6.1 Pyrexia 20.2 16.0 Infections and Infestations Candidal Infection NOS 1.7 3.9 Oral Candidiasis 3.9 0.6 Sepsis NOS 5.1 5.0 Urinary Tract Infection 2.2 3.3 Investigations Liver Function Tests NOS Abnormal 1.7 3.3 Metabolism and Nutrition Disorders Fluid Overload 5.1 7.7 Hyperglycemia NOS 10.7 11.6 Hyperkalemia 2.2 3.3 Hypernatremia 1.7 5.0 Hypocalcemia 6.2 5.5 Hypoglycemia NOS 3.4 4.4 Hypokalemia 12.4 13.3 Hypomagnesemia 10.1 9.9 Hyponatremia 3.9 2.8 Hypophosphatemia 6.2 3.9 Psychiatric Disorders Agitation 3.4 8.8 Respiratory, Thoracic and Mediastinal Disorders Acute Respiratory Distress Syndrome 3.4 3.9 Nosocomial Pneumonia 11.2 9.4 Pneumothorax NOS 0.6 4.4 Respiratory Failure 1.7 3.3 Skin and Subcutaneous Tissue Disorders Decubitus Ulcer 3.4 2.8 Rash NOS 5.6 6.1 Vascular Disorders Hypertension NOS 7.9 3.3 Hypotension NOS 9.6 6.6 NOS = not otherwise specified 1 reported in at least 3% of patients in either treatment group. 2 In this trial, clinically significant upper gastrointestinal bleeding was considered a serious adverse reaction, but it is not included in this table. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of omeprazole and sodium bicarbonate. 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. Omeprazole Body as a Whole: Hypersensitivity reactions, including anaphylaxis, anaphylactic shock, angioedema, bronchospasm, interstitial nephritis, urticaria (see also Skin below), fever, pain, fatigue, malaise, systemic lupus erythematosus. Cardiovascular: Chest pain or angina, tachycardia, bradycardia, palpitation, elevated blood pressure, and peripheral edema. Gastrointestinal: Pancreatitis (some fatal), anorexia, irritable colon, flatulence, fecal discoloration, esophageal candidiasis, mucosal atrophy of the tongue, dry mouth, stomatitis, abdominal swelling and 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. Hepatic: Mild and, rarely, marked elevations of liver function tests [ALT (SGPT), AST (SGOT), γ -glutamyl transpeptidase, alkaline phosphatase, and bilirubin (jaundice)]. In rare instances, overt liver disease has occurred, including hepatocellular, cholestatic, or mixed hepatitis, liver necrosis (some fatal), hepatic failure (some fatal), and hepatic encephalopathy. Infections and Infestations : Clostridium difficile -associated diarrhea. Metabolism and Nutritional Disorders: Hyponatremia, hypoglycemia, hypomagnesemia, and weight gain. Musculoskeletal: Muscle cramps, myalgia, muscle weakness, joint pain, bone fracture, and leg pain. Nervous System/Psychiatric: Psychic disturbances including depression, agitation, aggression, hallucinations, confusion, insomnia, nervousness, tremors, apathy, somnolence, anxiety, dream abnormalities; vertigo; paresthesia; and hemifacial dysesthesia. Respiratory: Epistaxis, pharyngeal pain. Skin: Severe generalized skin reactions including toxic epidermal necrolysis (TEN; some fatal), Stevens-Johnson syndrome, cutaneous lupus erythematosus and erythema multiforme (some severe); purpura and/or petechiae (some with rechallenge); skin inflammation, urticaria, angioedema, pruritus, photosensitivity, alopecia, dry skin, and hyperhidrosis. Special Senses: Tinnitus, taste perversion. Ocular: Blurred vision, ocular irritation, dry eye syndrome, optic atrophy, anterior ischemic optic neuropathy, optic neuritis and double vision. Urogenital: Interstitial nephritis (some with positive rechallenge), urinary tract infection, microscopic pyuria, urinary frequency, elevated serum creatinine, proteinuria, hematuria, glycosuria, testicular pain, and gynecomastia. Hematologic: Rare instances of pancytopenia, agranulocytosis (some fatal), thrombocytopenia, neutropenia, leukopenia, anemia, leukocytosis, and hemolytic anemia have been reported. Sodium Bicarbonate metabolic alkalosis, seizures, and tetany