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Nexium

Last reviewed on RxList: 8/28/2018
Nexium Side Effects Center

Pharmacy Editor: Eni Williams, PharmD

Last reviewed on RxList 8/28/2018

Nexium (esomeprazole magnesium) is a proton pump inhibitor (PPI) that blocks acid production in the stomach and is used to treat stomach and duodenal ulcers, gastroesophageal reflux disease (GERD), and Zollinger-Ellison syndrome. Nexium is available as a generic. Common side effects of Nexium include

Nexium dosage depends on the condition being treated. Drug interactions include Valium (diazepam), Nizoral (ketoconazole), Lanoxin (digoxin), Invirase (saquinavir), Viracept (nelfinavir), Reyataz (atazanavir), Plavix (clopidogrel), and Pletal (cilostazol). Nexium should be used during pregnancy only if clearly needed. For breastfeeding mothers, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Our Nexium Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Nexium Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe stomach pain, diarrhea that is watery or bloody;
  • seizure (convulsions);
  • joint pain or swelling with fever, swollen glands, and skin rash on your cheeks or arms (worsens in sunlight);
  • kidney problems--urinating more or less than usual, blood in your urine, swelling, rapid weight gain; or
  • low magnesium--dizziness, irregular heartbeats, feeling jittery, muscle cramps, muscle spasms, cough or choking feeling.

Taking esomeprazole long-term may cause you to develop stomach growths called fundic gland polyps. Talk with your doctor about this risk.

Common side effects may include:

  • headache, drowsiness;
  • mild diarrhea;
  • nausea, stomach pain, gas, constipation; or
  • dry mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Nexium (Esomeprazole Magnesium)

Nexium Professional Information

SIDE EFFECTS

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

  • Acute Interstitial Nephritis [see WARNINGS AND PRECAUTIONS]
  • Clostridium difficile-Associated Diarrhea [see WARNINGS AND PRECAUTIONS]
  • Bone Fracture [see WARNINGS AND PRECAUTIONS]
  • Cutaneous and Systemic Lupus Erythematosus [see WARNINGS AND PRECAUTIONS]
  • Hypomagnesemia [see WARNINGS AND PRECAUTIONS]
  • Fundic Gland Polyps [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience With Intravenous NEXIUM

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.

Adults

The safety of intravenous esomeprazole is based on results from clinical trials conducted in four different populations including patients having symptomatic GERD with or without a history of erosive esophagitis (n=199), patients with erosive esophagitis (n=160), healthy subjects (n=204) and patients with bleeding gastric or duodenal ulcers (n=375).

Symptomatic GERD And Erosive Esophagitis Trials

The data described below reflect exposure to NEXIUM I.V. for Injection in 359 patients. NEXIUM I.V. for Injection was studied only in actively-controlled trials. The population was 18 to 77 years of age; 45% Male, 52% Caucasian, 17% Black, 3% Asian, 28% Other, and had either erosive reflux esophagitis (44%) or GERD (56%). Most patients received doses of either 20 or 40 mg either as an infusion or an injection. Adverse reactions occurring in ≥1% of patients treated with intravenous esomeprazole (n=359) in clinical trials are listed below:

Table 2: Adverse Reactions Occurring at an Incidence ≥ 1% in the NEXIUM I.V. Group

Adverse Reactions % of patients Esomeprazole Intravenous
(n=359)
Headache 10.9
Flatulence 10.3
Nausea 6.4
Abdominal pain 5.8
Diarrhea 3.9
Mouth dry 3.9
Dizziness/vertigo 2.8
Constipation 2.5
Injection site reaction 1.7
Pruritus 1.1

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

Pediatric

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

Risk Reduction Of Rebleeding Of Gastric Or Duodenal Ulcers In Adults

The data described below reflect exposure to NEXIUM I.V. for Injection in 375 patients. NEXIUM I.V. for Injection was studied in a placebo-controlled trial. Patients were randomized to receive NEXIUM I.V. for Injection (n=375) or placebo (n=389). The population was 18 to 98 years old; 68% Male, 87% Caucasian, 1% Black, 7% Asian, 4% other, who presented with endoscopically confirmed gastric or duodenal ulcer bleeding. Following endoscopic hemostasis, patients received either 80 mg esomeprazole as an intravenous infusion over 30 minutes followed by a continuous infusion of 8 mg per hour or placebo for a total treatment duration of 72 hours. After the initial 72-hour period, all patients received oral proton pump inhibitor (PPI) for 27 days.

Table 3: Incidence (%) of Adverse Reactions that Occurred in Greater than 1 % of Patients within 72 Hours after Start of Treatment1

  Number (%) of patients
Esomeprazole
(n=375)
Placebo
(n=389)
Duodenal ulcer hemorrhage 16 (4.3%) 16 (4.1%)
Injection site reaction2 16 (4.3%) 2 (0.5%)
Pyrexia 13 (3.5%) 11 (2.8%)
Cough 4 (1.1%) 1 (0.3%)
Dizziness 4 (1.1%) 3 (0.8%)
1 Incidence ≥1% in the esomeprazole group and greater than placebo group safety population
2 Injection site reactions included erythema, swelling, inflammation, pruritus, phlebitis, thrombophlebitis and superficial phlebitis.

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

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of NEXIUM. 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.

Postmarketing Reports - There have been spontaneous reports of adverse events with postmarketing use of esomeprazole. These reports occurred rarely and are listed below by body system:

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 with or without hypocalcemia and/or hypokalemia; 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), cutaneous lupus erythematosus.

Other adverse events not observed with NEXIUM, but occurring with omeprazole can be found in the omeprazole package insert, ADVERSE REACTIONS section.

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

Related Resources for Nexium

Read the Nexium User Reviews »

© Nexium Patient Information is supplied by Cerner Multum, Inc. and Nexium Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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