"The U.S. Food and Drug Administration today approved the first generic versions of Aciphex (rabeprazole sodium) delayed-release tablets, used to treat gastroesophageal reflux disease (GERD) in adults and adolescents (ages 12 and up).
Nexium IV Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Nexium I.V. (esomeprazole sodium) is used to treat symptoms of gastroesophageal reflux disease (GERD) and other conditions involving excessive stomach acid such as Zollinger-Ellison syndrome. It is also used to promote healing of erosive esophagitis (damage to your esophagus caused by stomach acid), and may also be given to prevent gastric ulcer caused by infection with helicobacter pylori (H. pylori), or by the use of nonsteroidal anti-inflammatory drugs (NSAIDs). It is a proton pump inhibitor that inhibits gastric acid secretion. Common side effects include headache, diarrhea, nausea, stomach pain, gas, constipation, or dry mouth.
The recommended adult dose of Nexium I.V. is either 20 mg or 40 mg given once daily by intravenous injection (no less than 3 minutes) or intravenous infusion (10 minutes to 30 minutes). Pediatric dose is determined by the child's weight. Nexium I.V. may interact with clopidogrel, digoxin, diazepam, ketoconazole, HIV or AIDS medications, iron, or blood thinners. Tell your doctor all medications and supplements you use. During pregnancy, Nexium I.V. is not expected to be harmful to a fetus. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.
Our Nexium I.V. (esomeprazole sodium) 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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Nexium IV in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using esomeprazole and call your doctor at once if you have symptoms of low magnesium such as:
- dizziness, confusion;
- fast or uneven heart rate;
- jerking muscle movements;
- jittery feeling;
- diarrhea that is watery or bloody;
- muscle cramps, muscle weakness or limp feeling;
- cough or choking feeling; or
- seizure (convulsions).
Less serious side effects may include:
- headache, drowsiness;
- mild diarrhea;
- nausea, stomach pain, gas, constipation; or
- dry mouth.
Read the entire detailed patient monograph for Nexium IV (Esomeprazole Sodium) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Nexium IV FDA Prescribing Information: Side Effects
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.
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)|
|Injection site reaction||1.7|
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.
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
|Duodenal ulcer haemorrhage||16 (4.3%)||16 (4.1%)|
|Injection site reaction#||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%)|
|*Incidence ≥ 1% in the esomeprazole group and greater than placebo
group safety population
#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.
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:
Eye Disorders: blurred vision;
Immune System Disorders: anaphylactic reaction/shock;
Infections and Infestations: GI candidiasis;
Metabolism and nutritional disorders: hypomagnesemia;
Nervous System Disorders: hepatic encephalopathy, taste disturbance;
Psychiatric Disorders: aggression, agitation, depression, hallucination;
Reproductive System and Breast Disorders: gynecomastia;
Respiratory, Thoracic and Mediastinal Disorders: bronchospasm;
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 IV (Esomeprazole Sodium) »
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