Nexium Side Effects Center

Last updated on RxList: 3/22/2022
Nexium Side Effects Center

Pharmacy Editor: Eni Williams, PharmD

What Is Nexium?

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.

What Are Side Effects of Nexium?

Common side effects of Nexium include

Dosage for Nexium

Nexium dosage depends on the condition being treated.

What Drugs, Substances, or Supplements Interact with Nexium?

Drug interactions include Valium (diazepam), Nizoral (ketoconazole), Lanoxin (digoxin), Invirase (saquinavir), Viracept (nelfinavir), Reyataz (atazanavir), Plavix (clopidogrel), and Pletal (cilostazol).

Nexium During Pregnancy and Breastfeeding

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.

Additional Information

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.

SLIDESHOW

Digestive Disorders: Common Misconceptions See Slideshow
Nexium Consumer Information

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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);
  • kidney problems-- fever, rash, nausea, loss of appetite, joint pain, urinating less than usual, blood in your urine, weight gain;
  • low magnesium--dizziness, fast or irregular heart rate, tremors (shaking) or jerking muscle movements, feeling jittery, muscle cramps, muscle spasms in your hands and feet, cough or choking feeling; or
  • new or worsening symptoms of lupus--joint pain, and a skin rash on your cheeks or arms that worsens in sunlight.

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

If you use esomeprazole for longer than 3 years, you could develop a vitamin B-12 deficiency. Talk to your doctor about how to manage this condition if you develop it.

Common side effects may include:

  • headache;
  • 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.

Nexium Professional Information

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

Adverse Reactions % of patients NEXIUM I.V.
(n=359)
Headache 11
Flatulence 10
Nausea 6
Abdominal pain 6
Diarrhea 4
Mouth dry 4
Dizziness/vertigo 3
Constipation 3
Injection site reaction 2
Pruritus 1
1 Incidence of at least 1% in the NEXIUM I.V. group

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

% of patients
NEXIUM I.V.
(n=375)
Placebo
(n=389)
Duodenal ulcer hemorrhage 4 4
Injection site reaction2 4 1
Pyrexia 4 3
Cough 1 0.3
Dizziness 1 1
1Incidence ≥1% in the NEXIUM I.V. group and greater than placebo group
2Injection site reactions included erythema, swelling, inflammation, pruritus, phlebitis, thrombophlebitis and superficial phlebitis.

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

Antiretrovirals
Clinical Impact: The effect of PPIs on antiretroviral drugs is variable. The clinical importance and the mechanisms behind these interactions are not always known.
  • Decreased exposure of some antiretroviral drugs (e.g., rilpivirine atazanavir, and nelfinavir) when used concomitantly with esomeprazole may reduce antiviral effect and promote the development of drug resistance [see CLINICAL PHARMACOLOGY].
  • Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with esomeprazole may increase toxicity [see CLINICAL PHARMACOLOGY].
  • There are other antiretroviral drugs which do not result in clinically relevant interactions with esomeprazole.
Intervention: Rilpivirine-containing products: Concomitant use with NEXIUM I.V. is contraindicated [see CONTRAINDICATIONS].
Atazanavir: See prescribing information for atazanavir for dosing information.
Nelfinavir: Avoid concomitant use with NEXIUM I.V. See prescribing information for nelfinavir.
Saauinavir: See the prescribing information for saauinavir for monitoring of potential saquinavir-related toxicities.
Other antiretrovirals: See prescribing information for specific antiretroviral drugs
Warfarin
Clinical Impact: Increased INR and prothrombin time in patients receiving PPIs, including esomeprazole, and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death.
Intervention: Monitor INR and prothrombin time and adjust the dose of warfarin, if needed, to maintain the target INR range.
Methotrexate
Clinical Impact: Concomitant use of esomeprazole with methotrexate (primarily at high dose) may elevate and prolong serum concentrations of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to methotrexate toxicities. No formal drug interaction studies of high-dose methotrexate with PPIs have been conducted [see WARNINGS AND PRECAUTIONS].
Intervention: A temporary withdrawal of NEXIUM I.V. may be considered in some patients receiving high-dose methotrexate.
2C19 Substrates (e.g., clopidogrel, citalopram, cilostazol, diazepam)
Clopidogrel
Clinical Impact: Concomitant use of esomeprazole 40 mg resulted in reduced plasma concentrations of the active metabolite of clopidogrel and a reduction in platelet inhibition [see CLINICAL PHARMACOLOGY]. There are no adequate combination studies of a lower dose of esomeprazole or a higher dose of clopidogrel in comparison with the approved dose of clopidogrel.
Intervention: Avoid concomitant use with NEXIUM I.V. Consider use of alternative anti-platelet therapy [see WARNINGS AND PRECAUTIONS].
Citalopram
Clinical Impact: Increased exposure of citalopram leading to an increased risk of QT prolongation [see CLINICAL PHARMACOLOGY].
Intervention: Limit the dose of citalopram to a maximum of 20 mg per day. See prescribing information for citalopram.
Cilostazol
Clinical Impact: Increased exposure of cilostazol and one of its active metabolites (3,4-dihydro-cilostazol) [see CLINICAL PHARMACOLOGY].
Intervention: Consider reducing the dose of cilostazol to 50 mg twice daily. See prescribing information for cilostazol.
Digoxin
Clinical Impact: Potential for increased exposure of digoxin [see CLINICAL PHARMACOLOGY].
Intervention: Monitor digoxin concentrations and adjust the dose, if needed, to maintain therapeutic drug concentrations. See prescribing information for digoxin.
Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole)
Clinical Impact: Esomeprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity
Intervention: Mycophenolate mofetil (MMF): Co-administration of omeprazole, of which esomeprazole is an enantiomer, in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid (MPA), possibly due to a decrease in MMF solubility at an increased gastric pH. The clinical relevance of reduced MPA exposure on organ rejection has not been established in transplant patients receiving NEXIUM I.V. and MMF. Use NEXIUM I.V. with caution in transplant patients receiving MMF [see CLINICAL PHARMACOLOGY].
See the prescribing information for other drugs dependent on gastric pH for absorption.
Tacrolimus
Clinical Impact: Potentially increased exposure of tacrolimus, especially in transplant patients who are intermediate or poor metabolizers of CYP2C19.
Intervention: Monitor tacrolimus whole blood concentrations and consider reducing the dose, if needed, to maintain therapeutic drug concentrations. See prescribing information for tacrolimus.
Interactions with Investigations of Neuroendocrine Tumors
Clinical Impact: Serum chromogranin A (CgA) levels increase secondary to PPI-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors [see WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY].
Intervention: Discontinue NEXIUM I.V. at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high. If serial tests are performed (e.g. for monitoring), the same commercial laboratory should be used for testing, as reference ranges between tests may vary.
Interaction with Secretin Stimulation Test
Clinical Impact: Hyper-response in gastrin secretion in response to secretin stimulation test, falsely suggesting gastrinoma.
Intervention: Discontinue NEXIUM I.V. 4 weeks prior to testing [see CLINICAL PHARMACOLOGY]

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

CYP2C19 or CYP3A4 Inducers
Clinical Impact: Decreased exposure of esomeprazole when used concomitantly with strong inducers [see CLINICAL PHARMACOLOGY].
Intervention: St. John’s Wort, rifampin: Avoid concomitant use with NEXIUM I.V. [see WARNINGS AND PRECAUTIONS]. Ritonavir-containing products: see prescribing information for specific drugs
Voriconazole
Clinical Impact: Increased exposure of esomeprazole [see CLINICAL PHARMACOLOGY].
Intervention: Dose adjustment of NEXIUM I.V. is not normally required. See prescribing information for voriconazole.

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

© 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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