About Esomeprazole

What is esomeprazole?

Nexium (esomeprazole) is a proton pump inhibitor that decreases the amount of acid produced in the stomach.

Nexium 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 erosiveesophagitis (damage to your esophagus caused by stomach acid).

Nexium 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).

Nexium is not for immediate relief of heartburn symptoms.

Important information

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

You should not use Nexium if you are allergic to esomeprazole or to similar medicines such as lansoprazole (Prevacid), omeprazole (Prilosec, Zegerid), pantoprazole (Protonix), or rabeprazole (AcipHex).

Heartburn is often confused with the first symptoms of a heart attack. Seek emergency medical attention if you have chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, and a general ill feeling.

To make sure Nexium is safe for you, tell your doctor if you have:

• severe liver disease;
• osteoporosis;
• low bone mineral density (osteopenia); or
• low levels of magnesium in your blood.

Taking a proton pump inhibitor such as Nexium may increase your risk of bone fracture in the hip, wrist, or spine. This effect has occurred mostly in people who have taken the medicine long term or at high doses, and in those who are age 50 and older. It is not clear whether Nexium is the actual cause of an increased risk of fracture.

It is not known whether Nexium will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether esomeprazole passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I take Nexium?

Take Nexium exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

This medicine is usually given for 4 to 8 weeks only. Your doctor may recommend a second course of treatment if you need additional healing time.

Take each dose with a full glass (8 ounces) of water.

Nexium should be taken at least one hour before a meal.

Do not crush or chew a delayed-release capsule. However to make swallowing easier, you may open the Nexium capsule and sprinkle the medicine into a spoonful of pudding or applesauce. Swallow right away without chewing. Do not save the mixture for later use.

Nexium can be given through a nasogastric (NG) feeding tube. Open the capsule and sprinkle the medicine into a 60-milliliter syringe. Mix in 50 milliliters of water. Place the plunger into the syringe and shake the mixture well. Make sure there are no medicine granules stuck in the tip of the syringe. Attach the syringe to the NG tube and push the plunger down to empty the syringe into the tube. Then flush the tube with more water to wash the contents down.

Take this medicine for the full prescribed length of time. Your symptoms may improve before the condition is fully treated.

If you use Nexium 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.

Call your doctor if your symptoms do not improve or if they get worse while you are taking this medicine.

Nexium can cause unusual results with certain medical tests, and you may need to stop using the medicine for a short time before a test. Tell any doctor who treats you that you are using this medicine.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Nexium?

This medicine can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Nexium side effects

Get emergency medical help if you have signs of an allergic reaction to Nexium: 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 - urinating more or less than usual, blood in your urine, swelling, rapid weight gain; or
• symptoms of low magnesium - dizziness, confusion; fast or uneven heart rate; tremors (shaking) or jerking muscle movements; feeling jittery;muscle cramps, muscle spasms in your hands and feet; cough or choking feeling.

Common Nexium 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.

See also: Side effects (in more detail)

What other drugs will affect Nexium?

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Nexium, 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 other drugs may interact with esomeprazole. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor

It is possible that some side effects of Nexium may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to esomeprazole: oral capsule delayed release, oral packet

Other dosage forms:

• oral capsule delayed release
• intravenous powder for solution

As well as its needed effects, esomeprazole (the active ingredient contained in Nexium) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking esomeprazole, check with your doctor immediately:

Incidence not known

• Blistering, peeling, or loosening of the skin
• bloating
• chills
• constipation
• cough
• darkened urine
• difficulty with swallowing
• dizziness
• drowsiness
• fast heartbeat
• fever
• indigestion
• joint or muscle pain
• loss of appetite
• mood or mental changes
• muscle spasms (tetany) or twitching
• nausea
• pains in the stomach, side, or abdomen, possibly radiating to the back
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red skin lesions, often with a purple center
• red, irritated eyes
• seizures
• skin rash, hives, itching
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• tightness in the chest
• trembling
• unusual tiredness or weakness
• vomiting
• yellow eyes or skin

Some esomeprazole side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common

• Bad, unusual, or unpleasant (after) taste
• change in taste

Less common

• Sleepiness or unusual drowsiness

Rare

• Acne
• back pain

Incidence not known

• Agitation
• dry mouth
• excess air or gas in the stomach or intestines
• full feeling
• hair loss or thinning of the hair
• muscular weakness
• passing gas
• seeing, hearing, or feeling things that are not there
• swelling of the breasts or breast soreness in both females and males
• swelling or inflammation of the mout

  For Healthcare Professionals

  Applies to esomeprazole: intravenous powder for injection, oral delayed release capsule, oral powder for reconstitution delayed release

  General

  The 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.^[Ref]

  Gastrointestinal

  Common (1% to 10%): Diarrhea, headache, abdominal pain, nausea, vomiting, regurgitation
  Uncommon (0.1% to 1%): Abdomen enlargement, 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
  Frequency not reported: Duodenitis, esophagitis, esophageal stricture, esophageal ulceration, esophageal varices, gastric ulcer, gastritis, hernia, benign polyps or nodules, Barrett's esophagus, and mucosal discoloration
  Postmarketing reports: Pancreatitis; stomatitis; microscopic colitis, GI candidiasis, Clostridium difficile associated diarrhea^[Ref]

  Hepatic

  Common (1% to 10%): Increased liver enzymes
  Uncommon (0.1% to 1%): Bilirubinemia, hepatic function abnormal, SGOT increased, SGPT increased
  Postmarketing reports: Hepatic failure, hepatitis with or without jaundice^[Ref]

  Respiratory

  Common (1% to 10%): Tachypnea (in pediatrics)
  Uncommon (0.1% to 1%): Asthma aggravated, coughing, dyspnea, larynx edema, pharyngitis, rhinitis, sinusitis, chest pain, substernal chest pain
  Postmarketing reports: Bronchospasm^[Ref]

  Cardiovascular

  Uncommon (0.1% to 1%): Flushing, hypertension, tachycardia
  Frequency not reported: Irregular heartbeat^[Ref]

  Dermatologic

  Uncommon (0.1% to 1%): Acne, angioedema, dermatitis, pruritus, pruritus ani, rash, rash erythematous, rash maculo-papular, skin inflammation, sweating increased, urticaria
  Postmarketing reports: Alopecia, erythema multiforme, hyperhidrosis, photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis (some fatal)^[Ref]

  Endocrine

  Uncommon (0.1% to 1%): Goiter^[Ref]

  Genitourinary

  Uncommon (0.1% to 1%): Abnormal urine, albuminuria, dysuria, hematuria, micturition frequency, polyuria, impotence, vaginitis, cystitis, fungal infection, moniliasis, genital moniliasis, dysmenorrhea, menstrual disorder
  Postmarketing reports: Gynecomastia^[Ref]

  Hematologic

  Uncommon (0.1% to 1%): Anemia, anemia hypochromic, cervical lymphadenopathy, epistaxis, leukocytosis, leukopenia, thrombocytopenia
  Postmarketing reports: Agranulocytosis, pancytopenia^[Ref]

  Hypersensitivity

  Uncommon (0.1% to 1%): Allergic reaction
  Postmarketing reports: Anaphylactic reaction/shock^[Ref]

  Metabolic

  Uncommon (0.1% to 1%): Glycosuria, hyperuricemia, hyponatremia, increased alkaline
  phosphatase, thirst, vitamin B12 deficiency, weight increase, weight decrease, appetite increased, anorexia
  Postmarketing reports: Hypomagnesemia, with or without hypocalcemia and/or hypokalemia^[Ref]

  Musculoskeletal

  Uncommon (0.1% to 1%): Arthralgia, arthritis aggravated, arthropathy, cramps, fibromyalgia syndrome, hernia, polymyalgia rheumatic, back pain, fracture of the hip, wrist or spine
  Postmarketing reports: Muscular weakness, myalgia, bone fracture^[Ref]
  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.^[Ref]

  Nervous system

  Uncommon (0.1% to 1%):Dizziness, hypertonia, nervousness, hypoesthesia, migraine, migraine aggravated, paresthesia, somnolence, tremor, visual field defect, parosmia, taste loss, taste perversion
  Postmarketing reports: Hepatic encephalopathy, taste disturbance^[Ref]

  Ocular

  Uncommon (0.1% to 1%): Conjunctivitis, abnormal vision
  Postmarketing reports: Blurred vision^[Ref]

  Other

  Uncommon (0.1% to 1%): Earache, tinnitus, facial edema, peripheral edema, fatigue, fever, flu-like disorder, generalized edema, leg edema, malaise, pain, rigors, fatigue, asthenia, vertigo, otitis media^[Ref]

  Psychiatric

  Uncommon (0.1% to 1%): Depression aggravated, apathy, confusion, insomnia, sleep disorder
  Postmarketing reports: Aggression, agitation, depression, hallucination^[Ref]

  Renal

  Very rare (less than 0.01%): Interstitial nephritis concomitantly with renal failure
  Postmarketing reports: Interstitial nephritis^[Ref]

  References

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

  2. "Product Information. Esomeprazole Strontium (esomeprazole)." Amneal Pharmaceuticals, Glasgow, KY.

  3. Cerner Multum, Inc. "Australian Product Information." O 0

  4. "Product Information. Nexium (esomeprazole)" Astra-Zeneca Pharmaceuticals, Wilmington, DE.

  5. "Product Information. NexIUM I.V. (esomeprazole)." Astra-Zeneca Pharmaceuticals, Wilmington, DE.

  6. Mennecier D, Ceppa F, Gidenne S, Vergeau B "Hyponatremia with consciousness disturbance associated with esomeprazole." Ann Pharmacother 39 (2005): 774-5

  7. Yang YX, Lewis JD, Epstein S, Metz DC "Long-term proton pump inhibitor therapy and risk of hip fracture." JAMA 296 (2006): 2947-53

  8. Rosenshein B, Flockhart DA, Ho H "Induction of Testosterone Metabolism by Esomeprazole in a CYP2C19*2 Heterozygote." Am J Med Sci 327 (2004): 289-293

  9. Geevasinga N, Kairaitis L, Rangan GK, Coleman PL "Acute interstitial nephritis secondary to esomeprazole." Med J Aust 182 (2005): 235-6
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