Medical Editor: John P. Cunha, DO, FACOEP
Esomeprazole Magnesium delayed-release capsules are a proton pump inhibitor indicated for treatment of gastroesophageal reflux disease (GERD), risk reduction of nonsteroidal anti-inflammatory drug (NSAID)-associated gastric ulcer, and pathological hypersecretory conditions, including Zollinger-Ellison Syndrome. Esomeprazole magnesium is available in generic form. Common side effects of esomeprazole magnesium include:
- abdominal pain,
- dry mouth, and
The adult dosage of esomeprazole magnesium ranges from 20 mg to 40 mg, for 4 to 8 weeks, depending on the condition being treated. Esomeprazole magnesium may interact with antiretroviral drugs, ketoconazole, iron salts, erlotinib, digoxin, mycophenolate mofetil, St. John's Wort, rifampin, diuretics, clopidogrel, cilostazol, tacrolimus, and methotrexate. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before taking esomeprazole magnesium; it may harm a fetus. Esomeprazole magnesium likely passes into breast milk. Consult your doctor before breastfeeding.
Our Esomeprazole Magnesium Delayed-Release Capsule 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.
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]
- Cyanocobalamin (Vitamin B-12) Deficiency [see WARNINGS AND PRECAUTIONS]
- Hypomagnesemia [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.
The safety of esomeprazole magnesium delayed-release capsules 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 to 12 months. In general, esomeprazole magnesium delayed-release capsules were well tolerated in both short and long-term clinical trials.
The safety in the treatment of healing of erosive esophagitis was assessed in four randomized comparative clinical trials, which included 1,240 patients on esomeprazole magnesium delayed-release capsules 20 mg, 2,434 patients on esomeprazole magnesium delayed-release capsules 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 esomeprazole magnesium delayed-release capsules or omeprazole.
Additional adverse reactions that were reported as possibly or probably related to esomeprazole magnesium delayed-release capsules with an incidence < 1% are listed below by body system:
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;
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;
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: dysmenorrhea, menstrual disorder, vaginitis;
Special Senses: otitis media, parosmia, taste loss, taste perversion;
Visual: conjunctivitis, vision abnormal.
The following potentially clinically significant laboratory changes in clinical trials, irrespective of relationship to esomeprazole magnesium delayed-release capsules, were reported in ≤ 1% of patients: increased creatinine, uric acid, total bilirubin, alkaline phosphatase, ALT, AST, hemoglobin, white blood cell count, platelets, serum gastrin, potassium, sodium, thyroxine and thyroid stimulating hormone [see CLINICAL PHARMACOLOGY]. Decreases were seen in hemoglobin, white blood cell count, platelets, potassium, sodium, and thyroxine.
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.
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.
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 esomeprazole magnesium delayed-release capsules were diarrhea (4.3%), headache (3.8%), and abdominal pain (3.8%).
The safety of esomeprazole magnesium delayed-release capsules was evaluated in 316 pediatric and adolescent patients aged 1 to 17 years in four clinical trials for the treatment of symptomatic GERD [see Clinical Studies]. 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%).
No new safety concerns were identified in pediatric patients.
The following adverse reactions have been identified during post-approval use of esomeprazole magnesium delayed-release capsules. 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:
Eye: blurred vision;
Gastrointestinal: pancreatitis; stomatitis; microscopic colitis;
Infections and Infestations: GI candidiasis; Clostridium difficile-associated diarrhea;
Musculoskeletal and Connective Tissue: muscular weakness, myalgia, bone fracture;
Nervous System: hepatic encephalopathy, taste disturbance;
Psychiatric: aggression, agitation, depression, hallucination;
Renal and Urinary: interstitial nephritis;
Reproductive System and Breast: gynecomastia;
Respiratory, Thoracic, and Mediastinal: bronchospasm;
Read the entire FDA prescribing information for Esomeprazole Magnesium (esomeprazole magnesium)