Adult (> 18 years) use (incidence > 1%):

Headache, diarrhea, nausea, flatulence, abdominal pain, constipation, and dry mouth (6.1)
Pediatric (1 - 17 years) use (incidence > 1–2%):

Headache, diarrhea, abdominal pain, nausea, and somnolence (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
May affect plasma levels of antiretroviral drugs – use with atazanavir and nelfinavir is not recommended; if saquinavir is used with NEXIUM, monitor for toxicity and consider saquinavir dose reduction (7.1)

May interfere with drugs for which gastric pH affects bioavailability (e.g., ketoconazole, iron salts, and digoxin) Patients treated with NEXIUM and digoxin may need to be monitored for digoxin toxicity. (7.2)

Combined inhibitor of CYP 2C19 and 3A4 may raise esomeprazole levels (7.3)

May increase systemic exposure of cilostazol and an active metabolite. Consider dose reduction (7.3)

Tacrolimus: NEXIUM may increase serum levels of tacrolimus (7.4)
USE IN SPECIFIC POPULATIONS
Severe liver impairment – do not exceed dose of 20 mg (2)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling 

Revised: 06/2011
Back to Highlights and TabsFULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed 

Recent Major Changes
1 INDICATIONS AND USAGE
1.1 Treatment of Gastroesophageal Reflux Disease (GERD)
1.2 Risk Reduction of NSAID-Associated Gastric Ulcer
1.3 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
1.4 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Concurrent Gastric Malignancy
5.2 Atrophic Gastritis
5.3 Bone Fracture
5.4 Risks of Amoxicillin (as Part of H. pylori Triple Therapy)
5.5 Risks of Clarithromycin (as Part of H. pylori Triple Therapy)
5.6Hypomagnesemia
5.7 Concomitant use of NEXIUM with St John’s Wort or Rifampin
5.8 Interactions with Investigations for Neuroendocrine Tumors
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Combination Treatment with Amoxicillin and Clarithromycin
6.3 Postmarketing Experience
7 DRUG INTERACTIONS
7.1 Interference with Antiretroviral Therapy
7.2 Drugs for Which Gastric pH Can Affect Bioavailability
7.3 Effects on Hepatic Metabolism/Cytochrome P-450 Pathways
7.4 Interactions With Investigations of Neuroendocrine Tumors
7.5 Tacrolimus
7.6 Combination Therapy with Clarithromycin
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.3Nursing Mothers
8.4Pediatric Use
8.5Geriatric Use
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
12.4 Microbiology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
13.2 Animal Toxicology and/or Pharmacology
14 CLINICAL STUDIES
14.1 Healing of Erosive Esophagitis
14.2 Symptomatic Gastroesophageal Reflux Disease (GERD)
14.3 Pediatric Gastroesophageal Reflux Disease (GERD)
14.