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Esomeprazole is a proton pump inhibitor that decreases the amount of acid produced in the stomach.
Esomeprazole is used to treat symptoms of gastroesophageal reflux disease (GERD) and other conditions involving excessive stomach acid such as Zollinger-Ellison syndrome. Esomeprazole is also used to promote healing of erosive esophagitis (damage to your esophagus caused by stomach acid).
Esomeprazole 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).
Esomeprazole is not for immediate relief of heartburn symptoms.
Esomeprazole may also be used for purposes not listed in this medication guide.
Esomeprazole can cause kidney problems. Tell your doctor if you are urinating less than usual, or if you have blood in your urine.
Diarrhea may be a sign of a new infection. Call your doctor if you have diarrhea that is watery or has blood in it.
Esomeprazole may cause new or worsening symptoms of lupus. Tell your doctor if you have joint pain and a skin rash on your cheeks or arms that worsens in sunlight.
You may be more likely to have a broken bone while taking esomeprazole long term or more than once per day.
Heartburn can mimic early symptoms of a heart attack. Get emergency medical help if you have chest pain that spreads to your jaw or shoulder and you feel anxious or light-headed.
You should not use this medicine if you are allergic to esomeprazole or to similar medicines such as lansoprazole, omeprazole, pantoprazole, rabeprazole, Dexilant, Nexium, Prevacid, Protonix, and others.
Tell your doctor if you have ever had:
severe liver disease;
lupus;
osteoporosis or low bone mineral density (osteopenia); or
low levels of magnesium in your blood.
You may be more likely to have a broken bone in your hip, wrist, or spine while taking a proton pump inhibitor long-term or more than once per day. Talk with your doctor about ways to keep your bones healthy.
Ask a doctor before using this medicine if you are pregnant or breast-feeding.
Use exactly as directed on the label, or as prescribed by your doctor.
Take each dose with a full glass (8 ounces) of water.
Esomeprazole should be taken at least one hour before a meal.
Swallow the pill whole and do not crush, chew, break, or open it.
If you cannot swallow a capsule whole, open it and sprinkle the medicine into a spoonful of pudding or applesauce. Swallow the mixture right away without chewing. Do not save it for later use.
The esomeprazole capsule can be given through a nasogastric (NG) feeding tube. Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.
Esomeprazole is usually given for 4 to 8 weeks only. Your doctor may recommend a second course of treatment if you need additional healing time.
Use esomeprazole for the full prescribed length of time, even if your symptoms quickly improve.
Call your doctor if your symptoms do not improve or if they get worse while you are taking this medicine.
This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using esomeprazole.
Some conditions are treated with a combination of esomeprazole and antibiotics. Use all medications as directed.
Store at room temperature away from moisture and heat.
Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
esomeprazole can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor before using anti-diarrhea medicine.
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--little or no urination, blood in your urine, swelling, rapid 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, 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.
Tell your doctor about all your current medicines. Many drugs can affect esomeprazole, especially:
cilostazol;
clopidogrel;
diazepam;
digoxin;
erlotinib;
iron-containing medicines (ferrous fumarate, ferrous gluconate, ferrous sulfate, and others);
methotrexate;
mycophenolate mofetil;
rifampin;
St. John's wort;
tacrolimus;
warfarin (Coumadin, Jantoven);
antifungal medication--ketoconazole, voriconazole; or
HIV/AIDS medication--atazanavir, nelfinavir, saquinavir.
This list is not complete and many other drugs may affect esomeprazole. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Further informationRemember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Esomeprazole Magnesium (www.drugs.com/mtm/esomeprazole.html).
Applies to esomeprazole: oral capsule delayed release, oral packet, oral tablet delayed release
Other dosage forms:
Along with its needed effects, esomeprazole may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking esomeprazole:
Incidence not known
Some side effects of esomeprazole may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Less common
Rare
Incidence not known
For Healthcare Professionals
Applies to esomeprazole: intravenous powder for injection, oral delayed release capsule, oral delayed release tablet, oral powder for reconstitution delayed release
GeneralThe most frequently occurring adverse reactions were headache and diarrhea.
The most frequently reported adverse reactions for patients who received triple therapy for 10 days were diarrhea, taste perversion, and abdominal pain.
Nervous systemVery Common (10% or more): Headache (up to 10.9%)
Common (1% to 10%): Dizziness, somnolence, taste disturbance/perversion, vertigo
Uncommon (0.1% to 1%): Paresthesia
Very rare (less than 0.01%): Hepatic encephalopathy
Frequency not reported: Hypertonia, hypoesthesia, migraine/aggravated migraine, parosmia, taste loss, tremor
GastrointestinalVery common (10% or more): Flatulence (up to 10.3%)
Common (1% to 10%): Abdominal pain, benign fundic gland polyps, constipation/constipation aggravated, diarrhea, dry mouth, duodenal ulcer hemorrhage, epigastric pain/aggravated epigastric pain, gastritis/aggravated gastritis, nausea/aggravated nausea, regurgitation, tooth disorder, vomiting/aggravated vomiting
Rare (0.01% to 0.1%): Gastrointestinal (GI) candidiasis, stomatitis
Very rare (less than 0.01%): Microscopic colitis
Frequency not reported: Barrett's esophagus, benign polyps or nodules, bowel irregularity, duodenitis, dyspepsia, dysphagia, dysplasia GI, enlarged abdomen, eructation, esophagitis, esophageal disorder, esophageal stricture, esophageal ulceration, esophageal varices, frequent stools, gastric ulcer, gastroenteritis, GI hemorrhage, GI symptoms not otherwise specified, hernia, hiccup, melena, mouth disorder, mucosal discoloration, pharynx disorder, rectal disorder, tongue disorder, tongue edema, ulcerative stomatitis
Postmarketing reports: Clostridium difficile associated diarrhea, fundic gland polyps, hemorrhagic necrotic gastritis (in children), pancreatitis
RespiratoryCommon (1% to 10%): Cough, respiratory infection, sinusitis, tachypnea (in pediatrics)
Uncommon (0.1% to 1%): Epistaxis
Rare (0.01% to 0.1%): Bronchospasm
Frequency not reported: Asthma aggravated, dyspnea, larynx edema, pharyngitis, rhinitis
OtherCommon (1% to 10%): Accident or injury, fever/pyrexia
Rare (0.01% to 0.1%): Malaise
Frequency not reported: Asthenia, earache, facial edema, fatigue, leg edema, otitis media, pain, rigors, tinnitus
DermatologicCommon (1% to 10%): Pruritus
Uncommon (0.1% to 1%): Dermatitis, rash, urticaria
Rare (0.01% to 0.1%): Alopecia, increased sweating/hyperhidrosis, photosensitivity
Very rare (less than 0.01): Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN)/ fatal TEN
Frequency not reported: Acne, erythema, pruritus ani, rash erythematous, rash maculo-papular, skin inflammation, subacute cutaneous lupus erythematosus (SCLE)
Postmarketing reports: Cutaneous lupus erythematosus, systemic lupus erythematosus
CardiovascularCommon (1% to 10%): Hypertension/aggravated hypertension
Uncommon (0.1% to 1%): Peripheral edema
Frequency not reported: Chest pain, flushing, generalized edema/swelling/inflammation, hot flush, hypertension, irregular heartbeat, phlebitis, substernal chest pain, superficial phlebitis, tachycardia, thrombophlebitis
MusculoskeletalCommon (1% to 10%): Back pain
Uncommon (0.1% to 1%): Fracture of the hip, wrist or spine
Rare (0.01% to 0.1%): Arthralgia, myalgia
Very rare (less than 0.01%): Muscular weakness
Frequency not reported: Arthritis aggravated, arthropathy, cramps, fibromyalgia syndrome, hernia, hyperuricemia/increased uric acid, polymyalgia rheumatica
Postmarketing reports: Bone fracture
An increased risk of hip fracture has been reported in a cohort study. The risk was significantly increased among patients prescribed long-term high PPIs.
EndocrineCommon (1% to 10%): Increased serum gastrin
Very rare (less than 0.01%): Gynecomastia
Frequency not reported: Decreased/increased thyroxine, goiter, increased thyroid stimulating hormone
LocalCommon (1% to 10%): Administration/injection site reactions
Postmarketing reports: Tissue inflammatory reaction
ImmunologicCommon (1% to 10%): Viral infection
Frequency not reported: Flu-like disorder, fungal infection
HepaticCommon (1% to 10%): ALT increased
Uncommon (0.1% to 1%): Increased liver enzymes
Rare (0.01% to 0.1%): Hepatitis with/without jaundice
Very rare (less than 0.01%): Hepatic failure
Frequency not reported: Abnormal hepatic function, AST increased, bilirubinemia, increased alkaline phosphatase, increased total bilirubin
OcularUncommon (0.1% to 1%): Blurred vision
Rare (0.01% to 0.1%): Visual accommodation disorder/disturbances, visual field defect
Frequency not reported: Abnormal vision, conjunctivitis
Postmarketing reports: Irreversible visual impairment, loss of vision
PsychiatricUncommon (0.1% to 1%): Insomnia, irritability
Rare (0.01% to 0.1%): Agitation, confusion, depression/aggravated depression
Very rare (less than 0.01%): Aggression, hallucinations
Frequency not reported: Apathy, nervousness, sleep disorder
HematologicRare (0.01% to 0.1%): Leukopenia, thrombocytopenia
Very rare (less than 0.01%): Agranulocytosis, pancytopenia
Frequency not reported: Anemia, anemia hypochromic, cervical lymphadenopathy, decreased/increased hemoglobin, decreased/increased platelets, decreased/increased white blood cell count, leukocytosis
MetabolicRare (0.01% to 0.1%): Hyponatremia
Very rare (less than 0.01%): Hypomagnesemia with or without hypocalcemia and/or hypokalemia, severe hypomagnesemia
Frequency not reported: Anorexia, decreased/increased potassium, increased sodium, increased appetite, vitamin B12 (cyanocobalamin) deficiency, thirst, weight decrease/increase
HypersensitivityRare (0.01% to 0.1%): Anaphylactic reaction/shock, angioedema, hypersensitivity reactions
Frequency not reported: Allergic reaction
RenalVery rare (less than 0.01%): Interstitial nephritis with/without renal failure
Frequency not reported: Glycosuria
Postmarketing reports: Acute interstitial nephritis, impaired renal function, increased creatinine, nephrosis
GenitourinaryFrequency not reported: Abnormal urine, albuminuria, cystitis, dysmenorrhea, dysuria, genital moniliasis, hematuria, impotence, menstrual disorder, micturition frequency, moniliasis, polyuria, vaginitis
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Esomeprazole Magnesium (www.drugs.com/mtm/esomeprazole.html).
October 19, 2020
October 19, 2020
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