Nexium Side Effects Center

SIDE EFFECTS

The following serious adverse reactions are described below and elsewhere in labeling:

• Acute Tubulointerstitial Nephritis [see WARNINGS AND PRECAUTIONS]
• Clostridium difficile-Associated Diarrhea [see WARNINGS AND PRECAUTIONS]
• Bone Fracture [see WARNINGS AND PRECAUTIONS]
• Severe Cutaneous Adverse Reactions [see WARNINGS AND PRECAUTIONS]
• Cutaneous and Systemic Lupus Erythematosus [see WARNINGS AND PRECAUTIONS]
• Hypomagnesemia and Mineral Metabolism [see WARNINGS AND PRECAUTIONS]
• Fundic Gland Polyps [see WARNINGS AND PRECAUTIONS]

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.

Symptomatic GERD And EE

Adults

The safety of NEXIUM I.V. is based on results from clinical trials conducted in four different populations including healthy subjects (n=204) and patients with bleeding gastric or duodenal ulcers (n=375). The data described below reflect exposure to NEXIUM I.V. in 359 patients in actively-controlled trials: symptomatic GERD with or without a history of EE (n=199) and patients with EE (n=160). The population was 18 to 77 years of age; 45% Male, 52% Caucasian, 17% Black, 3% Asian, and 28% other race. Most patients received doses of either 20 or 40 mg either as an infusion or an injection. Adverse reactions occurring in at least 1% of patients are listed below in Table 3:

Table 3: Adverse Reactions¹ in the NEXIUM I.V. Group in Active Controlled Trials of Symptomatic GERD with or without EE

Intravenous treatment with NEXIUM I.V. 20 and 40 mg-administered as an injection or as an infusion was found to have a safety profile similar to that of oral esomeprazole.

Pediatrics

A randomized, open-label, multi-national study to evaluate the pharmacokinetics of repeated intravenous doses of once daily NEXIUM I.V. in pediatric patients 1 month to 17 years old, inclusive was performed [see CLINICAL PHARMACOLOGY]. The safety results are consistent with the known safety profile of esomeprazole and no unexpected safety signals were identified.

Risk Reduction Of Rebleeding Of Gastric Or Duodenal Ulcers In Adults

The data described in Table 4 below reflect exposure to NEXIUM I.V. in 375 patients who presented with endoscopically confirmed gastric or duodenal ulcer bleeding in a placebo-controlled trial. The population was 18 to 98 years old; 68% Male, 87% Caucasian, 1% Black, 7% Asian, and 4% other race. Following endoscopic hemostasis, patients received either placebo or 80 mg NEXIUM I.V. as an intravenous infusion over 30 minutes followed by a continuous infusion of 8 mg/hour for a total treatment duration of 72 hours. After the initial 72-hour period, all patients received an oral PPI for 27 days.

Table 4: Adverse Reactions¹ Occurring within 72 Hours after Start of Treatment in Patients with Endoscopically Confirmed Bleeding Ulcers

With the exception of injection site reactions described above, intravenous treatment with NEXIUM I.V. administered as an injection or as an infusion was found to have a safety profile similar to that of oral esomeprazole.

Postmarketing Experience

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.

Blood and Lymphatic System Disorders: agranulocytosis, pancytopenia;

Eye Disorders: blurred vision;

Gastrointestinal Disorders: pancreatitis; stomatitis; microscopic colitis; fundic gland polyps;

Hepatobiliary Disorders: hepatic failure, hepatitis with or without jaundice;

Immune System Disorders: anaphylactic reaction/shock; systemic lupus erythematosus;

Infections and Infestations: GI candidiasis;

Metabolism and nutritional disorders: hypomagnesemia (may lead to hypocalcemia and/or hypokalemia) [see WARNINGS AND PRECAUTIONS], hyponatremia;

Musculoskeletal and Connective Tissue Disorders: muscular weakness, myalgia, bone fracture;

Nervous System Disorders: hepatic encephalopathy, taste disturbance;

Psychiatric Disorders: aggression, agitation, depression, hallucination;

Renal and Urinary Disorders: interstitial nephritis;

Reproductive System and Breast Disorders: gynecomastia;

Respiratory, Thoracic and Mediastinal Disorders: bronchospasm;

Skin and Subcutaneous Tissue Disorders: alopecia, erythema multiforme, hyperhidrosis, photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN, some fatal), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), cutaneous lupus erythematosus.

Adverse reactions associated with omeprazole may also be expected to occur with NEXIUM I.V. See the full prescribing information for oral omeprazole for complete safety information.

DRUG INTERACTIONS

Tables 5 and 6 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with esomeprazole and instructions for preventing or managing them.

Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs.

Table 5: Clinically Relevant Interactions Affecting Drugs Co-Administered with Esomeprazole and Interaction with Diagnostics

Table 6: Clinically Relevant Interactions Affecting Esomeprazole When Co-Administered with Other Drugs

Read the entire FDA prescribing information for Nexium (Esomeprazole Magnesium)