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<code code="34084-4" codeSystem="2.16.840.1.113883.6.1" displayName="ADVERSE REACTIONS SECTION"/>
<title>6 ADVERSE REACTIONS</title>
<text>
<paragraph>The following serious adverse reactions are described below and elsewhere in labeling:</paragraph>
<list listType="unordered">
<item>
<caption>•</caption>Acute Tubulointerstitial Nephritis <content styleCode="italics">[see </content>
<content styleCode="italics">
<linkHtml href="#_5.2_Acute_Interstitial">Warnings and Precautions (5.2)</linkHtml>
</content>
<content styleCode="italics">]</content>
</item>
<item>
<caption>•</caption>Clostridium difficile-Associated Diarrhea <content styleCode="italics">[see <linkHtml href="#ID_6b0e1800-d077-49ac-851c-d3422efeaa8f">Warnings and Precautions (5.3)</linkHtml>]</content>
</item>
<item>
<caption>•</caption>Bone Fracture <content styleCode="italics">[see <linkHtml href="#williamsonbk1282066915764">Warnings and Precautions (5.4)</linkHtml>]</content>
</item>
<item>
<caption>•</caption>Severe Cutaneous Adverse Reactions <content styleCode="italics">[see <linkHtml href="#ID_c09cafc9-6f77-41db-b9f1-49d1e10f1e02">Warnings and Precautions (5.5)</linkHtml>]</content>
</item>
<item>
<caption>•</caption>Cutaneous and Systemic Lupus Erythematosus <content styleCode="italics">[see </content>
<content styleCode="italics">
<linkHtml href="#ID_9c98abad-7d2d-45c4-9b79-952629467d42">Warnings and Precautions (5.6)</linkHtml>
</content>
<content styleCode="italics">]</content>
</item>
<item>
<caption>•</caption>Cyanocobalamin (Vitamin B-12) Deficiency <content styleCode="italics">[see </content>
<content styleCode="italics">
<linkHtml href="#ID_b13ac510-713a-4b92-b387-61a7d97aefd7">Warnings and Precautions (5.8)</linkHtml>
</content>
<content styleCode="italics">]</content>
</item>
<item>
<caption>•</caption>Hypomagnesemia and Mineral Metabolism <content styleCode="italics">[see </content>
<content styleCode="italics">
<linkHtml href="#ID_99eafb44-c0ea-451c-9dba-722cfeaf9050">Warnings and Precautions (5.9)</linkHtml>
</content>
<content styleCode="italics">]</content>
</item>
<item>
<caption>•</caption>Fundic Gland Polyps <content styleCode="italics">[see </content>
<content styleCode="italics">
<linkHtml href="#ID_de20c6c5-b74b-4584-8269-7fd7c150b3bb">Warnings and Precautions (5.13)</linkHtml>
</content>
<content styleCode="italics">]</content>
</item>
</list>
</text>
<effectiveTime value="20230718"/>
<excerpt>
<highlight>
<text>
<paragraph/>
<paragraph>Most common adverse reactions <linkHtml href="#williamsonbk1185474323706">(6.1)</linkHtml>:</paragraph>
<list listType="unordered">
<item>
<caption>•</caption>Adults (≥ 18 years) (<content styleCode="underline">></content>1%) are: headache, diarrhea, nausea, flatulence, abdominal pain, constipation, and dry mouth. </item>
<item>
<caption>•</caption>Pediatrics (1 to 17 years) (<content styleCode="underline">></content>2%) are: headache, diarrhea, abdominal pain, nausea, and somnolence. </item>
<item>
<caption>•</caption>Pediatrics (1 month to less than 1 year) (>1%) are: abdominal pain, regurgitation, tachypnea, and increased ALT. </item>
</list>
<paragraph>
<content styleCode="bold">To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or <linkHtml href="http://www.fda.gov/medwatch">www.fda.gov/medwatch.</linkHtml>
</content>
</paragraph>
</text>
</highlight>
</excerpt>
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<section ID="williamsonbk1185474323706">
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<code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
<title>6.1 Clinical Trials Experience</title>
<text>
<paragraph>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.</paragraph>
<paragraph>
<content styleCode="underline">Adults</content>
</paragraph>
<paragraph>The safety of NEXIUM delayed-release capsules was evaluated in over 15,000 patients (aged 18 to 84 years) in clinical trials worldwide including over 8,500 patients in the United States and over 6,500 patients in Europe and Canada. Over 2,900 patients were treated in long-term studies for up to 6 to 12 months. </paragraph>
<paragraph>The safety in the treatment of healing of EE in adults was assessed in four randomized comparative clinical trials, which included 1,240 patients who received NEXIUM 20 mg once daily, 2,434 patients on NEXIUM 40 mg once daily, and 3,008 patients on omeprazole 20 mg once daily. The most frequently occurring adverse reactions (at least 1%) in all three groups were headache (5.5%, 5%, and 3.8%, respectively) and diarrhea (no difference among the three groups). Nausea, flatulence, abdominal pain, constipation, and dry mouth occurred at similar rates among patients taking NEXIUM or omeprazole.</paragraph>
<paragraph>Less common adverse reactions with an incidence of less than 1% are listed below by body system:</paragraph>
<paragraph>
<content styleCode="italics">Body as a Whole:</content> abdomen enlarged, allergic reaction, asthenia, back pain, chest pain, substernal chest pain, facial edema, peripheral edema, hot flushes, fatigue, fever, flu-like disorder, generalized edema, leg edema, malaise, pain, rigors; </paragraph>
<paragraph>
<content styleCode="italics">Cardiovascular:</content> flushing, hypertension, tachycardia; </paragraph>
<paragraph>
<content styleCode="italics">Endocrine:</content> goiter; </paragraph>
<paragraph>
<content styleCode="italics">Gastrointestinal:</content> bowel irregularity, constipation aggravated, dyspepsia, dysphagia, dysplasia GI, epigastric pain, eructation, esophageal disorder, frequent stools, gastroenteritis, GI hemorrhage, GI symptoms not otherwise specified, hiccup, melena, mouth disorder, pharynx disorder, rectal disorder, serum gastrin increased, tongue disorder, tongue edema, ulcerative stomatitis, vomiting; </paragraph>
<paragraph>
<content styleCode="italics">Hearing:</content> earache, tinnitus; </paragraph>
<paragraph>
<content styleCode="italics">Hematologic:</content> anemia, anemia hypochromic, cervical lymphadenopathy, epistaxis, leukocytosis, leukopenia, thrombocytopenia;</paragraph>
<paragraph>
<content styleCode="italics">Hepatic:</content> bilirubinemia, hepatic function abnormal, SGOT increased, SGPT increased; </paragraph>
<paragraph>
<content styleCode="italics">Metabolic/Nutritional:</content> glycosuria, hyperuricemia, hyponatremia, increased alkaline phosphatase, thirst, vitamin B12 deficiency, weight increase, weight decrease; </paragraph>
<paragraph>
<content styleCode="italics">Musculoskeletal:</content> arthralgia, arthritis aggravated, arthropathy, cramps, fibromyalgia syndrome, hernia, polymyalgia rheumatica; </paragraph>
<paragraph>
<content styleCode="italics">Nervous System/Psychiatric:</content> anorexia, apathy, appetite increased, confusion, depression aggravated, dizziness, hypertonia, nervousness, hypoesthesia, impotence, insomnia, migraine, migraine aggravated, paresthesia, sleep disorder, somnolence, tremor, vertigo, visual field defect; </paragraph>
<paragraph>
<content styleCode="italics">Reproductive:</content> dysmenorrhea, menstrual disorder, vaginitis; </paragraph>
<paragraph>
<content styleCode="italics">Respiratory:</content> asthma aggravated, coughing, dyspnea, larynx edema, pharyngitis, rhinitis, sinusitis; </paragraph>
<paragraph>
<content styleCode="italics">Skin and Appendages:</content> acne, angioedema, dermatitis, pruritus, pruritus ani, rash, rash erythematous, rash maculo-papular, skin inflammation, sweating increased, urticaria; </paragraph>
<paragraph>
<content styleCode="italics">Special Senses:</content> otitis media, parosmia, taste loss, taste perversion; </paragraph>
<paragraph>
<content styleCode="italics">Urogenital: </content> abnormal urine, albuminuria, cystitis, dysuria, fungal infection, hematuria, micturition frequency, moniliasis, genital moniliasis, polyuria; </paragraph>
<paragraph>
<content styleCode="italics">Visual:</content> conjunctivitis, vision abnormal.</paragraph>
<paragraph>The following potentially clinically significant laboratory changes in clinical trials, irrespective of relationship to NEXIUM, were reported in 1% or less of patients: increased creatinine, uric acid, total bilirubin, alkaline phosphatase, ALT, AST, hemoglobin, white blood cell count, platelets, serum gastrin, potassium, sodium, thyroxine and thyroid stimulating hormone <content styleCode="italics">[see </content>
<content styleCode="italics">
<linkHtml href="#williamsonbk1310048423179">Clinical Pharmacology (12.2)</linkHtml>
</content>
<content styleCode="italics">]</content>. Decreases were seen in hemoglobin, white blood cell count, platelets, potassium, sodium, and thyroxine.</paragraph>
<paragraph>Endoscopic findings that were reported as adverse reactions include: duodenitis, esophagitis, esophageal stricture, esophageal ulceration, esophageal varices, gastric ulcer, gastritis, hernia, benign polyps or nodules, Barrett’s esophagus, and mucosal discoloration.</paragraph>
<paragraph>The incidence of adverse reactions during 6-month trials for the maintenance of healing of EE with NEXIUM 20 mg once daily was similar to placebo. There were no differences in types of adverse reactions seen during maintenance treatment up to 12 months compared to short-term treatment.</paragraph>
<paragraph>Two placebo-controlled studies were conducted in 710 adult patients for the treatment of symptomatic GERD. The most common adverse reactions that were reported were: diarrhea (4%), headache (4%), and abdominal pain (4%).</paragraph>
<paragraph>
<content styleCode="italics">Combination Treatment with NEXIUM, Amoxicillin and Clarithromycin</content>
</paragraph>
<paragraph>In clinical trials of <content styleCode="italics">H. pylori</content> eradication of to reduce duodenal ulcer recurrence, no additional adverse reactions specific to the combination of NEXIUM delayed-release capsules, amoxicillin and clarithromycin were observed and were similar to those observed with NEXIUM, amoxicillin, or clarithromycin alone. The most frequently reported adverse reactions for patients who received NEXIUM, amoxicillin and clarithromycin for 10 days were diarrhea (9%), taste perversion (4%), and abdominal pain (4%). No adverse reactions were observed at higher rates with NEXIUM, amoxicillin and clarithromycin than were observed with NEXIUM alone.</paragraph>
<paragraph>In clinical trials using of NEXIUM, amoxicillin and clarithromycin, no additional increased laboratory abnormalities particular to these drug combinations were observed.</paragraph>
<paragraph>For more information on adverse reactions and laboratory changes with amoxicillin or clarithromycin, refer to Adverse Reactions section of the respective prescribing information.</paragraph>
<paragraph>
<content styleCode="underline">Pediatrics</content>
</paragraph>
<paragraph>
<content styleCode="italics">1 Year to 17 Years of Age</content>
</paragraph>
<paragraph>The safety of NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension was evaluated in 316 pediatric and adolescent patients aged 1 year to 17 years in four clinical trials for the treatment of symptomatic GERD <content styleCode="italics">[see <linkHtml href="#williamsonbk1185473675741">Clinical Studies (14.3)</linkHtml>]</content>. In 109 pediatric patients aged 1 year to 11 years, the most frequently reported (at least 1%) treatment-related adverse reactions in these patients were diarrhea (3%), headache (2%) and somnolence (2%). In 149 pediatric patients aged 12 years to 17 years the most frequently reported adverse reactions (at least 2%) were headache (8%), abdominal pain (3%), diarrhea (2%), and nausea (2%).</paragraph>
<paragraph>
<content styleCode="italics">1 Month to Less Than 1 Year of Age</content>
</paragraph>
<paragraph>The safety of esomeprazole magnesium was evaluated in 167 infants from 1 month to less than 1 year of age with GERD in three clinical trials <content styleCode="italics">[see <linkHtml href="#ID_8f087c07-d7fe-4224-a1cc-fb2272cacf4e">Use in Specific Populations (8.4)</linkHtml>]</content>. In a study that included 43 pediatric patients, the most frequently reported adverse reactions (at least 5%) with esomeprazole magnesium were irritability and vomiting. In a study that included 98 pediatric patients, administered esomeprazole magnesium for up to 6 weeks (including 39 patients randomized to the withdrawal phase), reported adverse reactions were: abdominal pain (1%), regurgitation (1%),</paragraph>
<paragraph>tachypnea (1%), and increased ALT (1%).</paragraph>
</text>
<effectiveTime value="20230718"/>
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<section ID="ID_36bfd923-1437-491d-9487-ae5a769721c3">
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<code code="42229-5" codeSystem="2.16.840.1.113883.6.1" displayName="SPL UNCLASSIFIED SECTION"/>
<title>6.2 Postmarketing Experience</title>
<text>
<paragraph>The following adverse reactions have been identified during post-approval use of esomeprazole. 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. These reports are listed below by body system:</paragraph>
<paragraph>
<content styleCode="italics">Blood and Lymphatic: </content> agranulocytosis, pancytopenia;</paragraph>
<paragraph>
<content styleCode="italics">Eye: </content>blurred vision;</paragraph>
<paragraph>
<content styleCode="italics">Gastrointestinal:</content> pancreatitis; stomatitis; microscopic colitis; fundic gland polyps;</paragraph>
<paragraph>
<content styleCode="italics">Hepatobiliary:</content> hepatic failure, hepatitis with or without jaundice; </paragraph>
<paragraph>
<content styleCode="italics">Immune System:</content> anaphylactic reaction/shock; systemic lupus erythematosus;</paragraph>
<paragraph>
<content styleCode="italics">Infections and Infestations:</content> GI candidiasis; <content styleCode="italics">Clostridium difficile-</content>associated diarrhea;</paragraph>
<paragraph>
<content styleCode="italics">Metabolism and nutritional disorders:</content> hypomagnesemia (may lead to hypocalcemia and/or hypokalemia) <content styleCode="italics">[see <linkHtml href="#ID_99eafb44-c0ea-451c-9dba-722cfeaf9050">Warnings and Precautions (5.9)</linkHtml>]</content>;</paragraph>
<paragraph>
<content styleCode="italics">Musculoskeletal and Connective Tissue:</content> muscular weakness, myalgia, bone fracture;</paragraph>
<paragraph>
<content styleCode="italics">Nervous System:</content> hepatic encephalopathy, taste disturbance; </paragraph>
<paragraph>
<content styleCode="italics">Psychiatric:</content> aggression, agitation, depression, hallucination; </paragraph>
<paragraph>
<content styleCode="italics">Renal and Urinary:</content> interstitial nephritis; </paragraph>
<paragraph>
<content styleCode="italics">Reproductive System and Breast:</content> gynecomastia, erectile dysfunction; </paragraph>
<paragraph>
<content styleCode="italics">Respiratory, Thoracic, and Mediastinal:</content> bronchospasm; </paragraph>
<paragraph>
<content styleCode="italics">Skin and Subcutaneous Tissue:</content> alopecia, erythema multiforme, hyperhidrosis, photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis (some fatal), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), cutaneous lupus erythematosus.</paragraph>
<paragraph>Adverse reactions associated with omeprazole may also be expected to occur with esomeprazole. See the full prescribing information for omeprazole for complete safety information.</paragraph>
</text>
<effectiveTime value="20230718"/>
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