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Side Effects of Nexium (Esomeprazole Magnesium) Drug Center

Openmedi.orgNexium side effects


8/20/2014
04:22 | Author: Emma Coleman

Nexium side effects
Side Effects of Nexium (Esomeprazole Magnesium) Drug Center

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. These reports are listed below by body system:

What is Patient Information Overview?

Read the FDA Approves First Generic Versions of Aciphex to treat GERD article »

Musculoskeletal: arthralgia, arthritis aggravated, arthropathy, cramps, fibromyalgia syndrome, hernia, polymyalgia rheumatica ;

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Additional adverse reactions that were reported as possibly or probably related to NEXIUM with an incidence < 1% are listed below by body system:

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.

Less serious side effects may include:

Body as a Whole: abdomen enlarged, allergic reaction, asthenia, back pain, chest pain, substernal chest pain, facial edema, peripheral edema, hot flushes, fatigue, fever, flu-like disorder, generalized edema, leg edema, malaise, pain, rigors;

Read the Nexium User Reviews » Share this Article:

Gastrointestinal: bowel irregularity, constipation aggravated, dyspepsia, dysphagia, dysplasia GI, epigastric pain, eructation, esophageal disorder, frequent stools, gastroenteritis, GI hemorrhage, GI symptoms not otherwise specified, hiccup, melena, mouth disorder, pharynx disorder, rectal disorder, serum gastrin increased, tongue disorder, tongue edema, ulcerative stomatitis, vomiting;

Skin and Subcutaneous Tissue: alopecia, erythema multiforme, hyperhidrosis, photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis (some fatal).

Infections and Infestations: GI candidiasis ; Clostridium difficile associated diarrhea;

What is Patient Information in Detail?

Immune System: anaphylactic reaction/ shock ;

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.

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

For more information on adverse reactions with amoxicillin or clarithromycin, refer to their package inserts, Adverse Reactions sections.

Nervous System/Psychiatric: anorexia, apathy, appetite increased, confusion, depression aggravated, dizziness, hypertonia, nervousness, hypoesthesia, impotence, insomnia, migraine, migraine aggravated, paresthesia, sleep disorder, somnolence, tremor, vertigo, visual field defect;

Reproductive System and Breast: gynecomastia ;

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Report Problems to the Food and Drug Administration.

Metabolism and nutritional disorders: hypomagnesemia.

The incidence of treatment-related adverse reactions during 6-month maintenance treatment was similar to placebo. There were no differences in types of related adverse reactions seen during maintenance treatment up to 12 months compared to short-term treatment.

Cardiovascular: flushing, hypertension, tachycardia ; Endocrine: goiter ;

For more information on laboratory changes with amoxicillin or clarithromycin, refer to their package inserts, Adverse Reactions section.

Endoscopic findings that were reported as adverse reactions include: duodenitis, esophagitis, esophageal stricture, esophageal ulceration, esophageal varices, gastric ulcer, gastritis, hernia, benign polyps or nodules, Barrett's esophagus, and mucosal discoloration.

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.

Visual: conjunctivitis, vision abnormal.

Hepatic: bilirubinemia, hepatic function abnormal, SGOT increased, SGPT increased;

The most frequently reported drug-related adverse reactions for patients who received triple therapy for 10 days were diarrhea (9.2%), taste perversion (6.6%), and abdominal pain (3.7%). No treatment-emergent adverse reactions were observed at higher rates with triple therapy than were observed with NEXIUM alone.

Skin and Appendages: acne, angioedema, dermatitis, pruritus, pruritus ani, rash, rash erythematous, rash maculo- papular, skin inflammation, sweating increased, urticaria ;

Get the latest treatment options.

FDA Approves First Generic Versions of Aciphex to treat GERD »

Pharmacy Editor: Eni Williams, PharmD.

Blood And Lymphatic: agranulocytosis, pancytopenia ; Eye: blurred vision;

Hearing: earache, tinnitus ;

Stop using esomeprazole and call your doctor at once if you have symptoms of low magnesium such as:

No new safety concerns were identified in pediatric patients.

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.

The safety of NEXIUM was evaluated in 167 pediatric patients from birth to < 1 year of age in three clinical trials. In a study that included 26 pediatric patients aged birth to 1 month there were no treatment related adverse reactions. In a study that included 43 pediatric patients age 1 to 11 months, inclusive the most frequently reported (at least 5%) adverse reactions, irrespective of causality, were irritability and vomiting. In a study that included 98 pediatric patients, age 1 to 11 months, inclusive exposed to esomeprazole for up to 6 weeks (including 39 patients randomized to the withdrawal phase), there were 4 treatment-related adverse reactions: abdominal pain (1%), regurgitation (1%), tachypnea (1%), and increased ALT (1%).

In clinical trials using combination therapy with NEXIUM plus amoxicillin and clarithromycin, no additional adverse reactions specific to these drug combinations were observed. Adverse reactions that occurred were limited to those observed when using NEXIUM, amoxicillin, or clarithromycin alone.

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

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

Special Senses: otitis media, parosmia, taste loss, taste perversion;

A concise overview of the drug for the patient or caregiver from First DataBank.

Headache or abdominal pain may occur. If any of these effects persist or worsen, l your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. l your doctor right away if you have any serious side effects, including: symptoms of a low magnesium blood level (such as unusually fast/slow/irregular heartbeat, persistent muscle spasms, seizures). This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of bacteria. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. l your doctor right away if you develop: persistent diarrhea, abdominal or stomach pain/cramping, fever, blood/mucus in your stool. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at. Read the entire patient information overview for Nexium (Esomeprazole Magnesium) »

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

What is Prescribing information?

Here is a collection of user reviews for the medication Nexium sorted by most helpful.

Psychiatric: aggression, agitation, depression, hallucination ;

The safety of NEXIUM was evaluated in over 15,000 patients (aged 18 to 84 years) in clinical trials worldwide including over 8,500 patients in the United States and over 6,500 patients in Europe and Canada. Over 2,900 patients were treated in long-term studies for up to 6-12 months. In general, NEXIUM was well tolerated in both short and long-term clinical trials.

"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). GE".

The safety in the treatment of healing of erosive esophagitis was assessed in four randomized comparative clinical trials, which included 1,240 patients on NEXIUM 20 mg, 2,434 patients on NEXIUM 40 mg, and 3,008 patients on omeprazole 20 mg daily. The most frequently occurring adverse reactions ( ≥ 1%) in all three groups were headache (5.5, 5, and 3.8, respectively) and diarrhea (no difference among the three groups). Nausea, flatulence, abdominal pain, constipation, and dry mouth occurred at similar rates among patients taking NEXIUM or omeprazole.

Hematologic: anemia, anemia hypochromic, cervical lymphadenopathy, epistaxis, leukocytosis, leukopenia, thrombocytopenia ;

Two placebo-controlled studies were conducted in 710 patients for the treatment of symptomatic gastroesophageal reflux disease. The most common adverse reactions that were reported as possibly or probably related to NEXIUM were diarrhea (4.3%), headache (3.8%), and abdominal pain (3.8%).

Nervous System: hepatic encephalopathy, taste disturbance;

Nexium (esomeprazole magnesium) belongs to a class of medications called proton pump inhibitors (PPIs) that block acid production in the stomach. It is available as a generic. It is used to treat stomach and duodenal ulcers, gastroesophageal reflux disease (GERD) and the Zollinger-Ellison syndrome. The most common side effects are diarrhea, nausea, vomiting, headaches, rash and dizziness.

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

Urogenital: abnormal urine, albuminuria, cystitis, dysuria, fungal infection, hematuria, micturition frequency, moniliasis, genital moniliasis, polyuria ;

The following potentially clinically significant laboratory changes in clinical trials, irrespective of relationship to NEXIUM, were reported in ≤ 1% of patients: increased creatinine, uric acid, total bilirubin, alkaline phosphatase, ALT, AST, hemoglobin, white blood cell count, plaets, serum gastrin, potassium, sodium, thyroxine and thyroid stimulating hormone. Decreases were seen in hemoglobin, white blood cell count, plaets, potassium, sodium, and thyroxine.

The safety of NEXIUM was evaluated in 316 pediatric and adolescent patients aged 1 to 17 years in four clinical trials for the treatment of symptomatic GERD. In 109 pediatric patients aged 1 to 11 years, the most frequently reported (at least 1%) treatment-related adverse reactions in these patients were diarrhea (2.8%), headache (1.9%) and somnolence (1.9%). In 149 pediatric patients aged 12 to 17 years the most frequently reported (at least 2%) treatment-related adverse reactions in these patients were headache (8.1%), abdominal pain (2.7%), diarrhea (2%), and nausea (2%).

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.

In clinical trials using combination therapy with NEXIUM plus amoxicillin and clarithromycin, no additional increased laboratory abnormalities particular to these drug combinations were observed.

Renal and Urinary: interstitial nephritis ;

Hepatobiliary: hepatic failure, hepatitis with or without jaundice ;

Gastrointestinal: pancreatitis ; stomatitis; microscopic colitis.

Respiratory: asthma aggravated, coughing, dyspnea, larynx edema, pharyngitis, rhinitis, sinusitis ;

Respiratory, Thoracic, and Mediastinal: bronchospasm;

Reproductive: dysmenorrhea, menstrual disorder, vaginitis ;

Metabolic/Nutritional: glycosuria, hyperuricemia, hyponatremia, increased alkaline phosphatase, thirst, vitamin B12 deficiency, weight increase, weight decrease;


Nexium side effects