Generic Name: esomeprazole (ES-oh-MEP-ra-zole)
Brand Name: Nexium I.V.
Short-term treatment of gastroesophageal reflux disease (GERD) in patients with irritation and swelling of the esophagus when medicine cannot be taken by mouth. It is also used to reduce the risk of bleeding ulcers after a certain procedure (endoscopy). It may also be used for other conditions as determined by your doctor.
Nexium I.V. is a proton pump inhibitor (PPI). It works by decreasing the amount of acid produced in the stomach.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Nexium I.V.. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Nexium I.V.. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Nexium I.V. may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Nexium I.V. as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Nexium I.V..
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Constipation; drowsiness; dry mouth; gas; headache; mild diarrhea or stomach pain; nausea.Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest or throat; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bloody or watery stools; bone pain; chest pain; confusion; dark urine; difficult or painful urination; fast heartbeat; fever, chills, or persistent sore throat; mental or mood changes (eg, depression); pain, swelling, or redness at the injection site; red, swollen, blistered, or peeling skin; severe or persistent diarrhea or stomach pain; severe or persistent nausea or vomiting; shortness of breath; sluggishness; sore joints; stomach cramps; swelling of the hands, ankles, or feet; symptoms of kidney problems (eg, not able to pass urine, change in the amount of urine produced, blood in the urine, a big weight gain); unexplained weight loss; unusual bruising or bleeding; unusual tiredness or weakness; vision changes; yellowing of the eyes or skin.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of Nexium I.V.:
Nexium I.V. is usually handled and stored by a health care provider. If you are using Nexium I.V. at home, store Nexium I.V. as directed by your pharmacist or health care provider. Keep Nexium I.V. out of the reach of children and away from pets.
This information should not be used to decide whether or not to take Nexium I.V. or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Nexium I.V.. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Nexium I.V.. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Nexium I.V..
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.
Note: This page contains side effects data for the generic drug esomeprazole. It is possible that some of the dosage forms included below may not apply to the brand name Nexium IV.
It is possible that some side effects of Nexium IV may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.
Applies to esomeprazole: oral capsule delayed release, oral packet
As well as its needed effects, esomeprazole (the active ingredient contained in Nexium IV) 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
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
Applies to esomeprazole: intravenous powder for injection, oral delayed release capsule, oral powder for reconstitution delayed release
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]
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]
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]
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]
Uncommon (0.1% to 1%): Flushing, hypertension, tachycardia
Frequency not reported: Irregular heartbeat[Ref]
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]
Uncommon (0.1% to 1%): Goiter[Ref]
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]
Uncommon (0.1% to 1%): Anemia, anemia hypochromic, cervical lymphadenopathy, epistaxis, leukocytosis, leukopenia, thrombocytopenia
Postmarketing reports: Agranulocytosis, pancytopenia[Ref]
Uncommon (0.1% to 1%): Allergic reaction
Postmarketing reports: Anaphylactic reaction/shock[Ref]
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]
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]
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]
Uncommon (0.1% to 1%): Conjunctivitis, abnormal vision
Postmarketing reports: Blurred vision[Ref]
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]
Uncommon (0.1% to 1%): Depression aggravated, apathy, confusion, insomnia, sleep disorder
Postmarketing reports: Aggression, agitation, depression, hallucination[Ref]
Very rare (less than 0.01%): Interstitial nephritis concomitantly with renal failure
Postmarketing reports: Interstitial nephritis[Ref]
US: This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus. AU: This drug should be used only if clearly needed. UK: Caution is recommended. AU TGA pregnancy category: B3 US FDA pregnancy category: C
Animal studies have failed to reveal evidence of teratogenicity or fetal harm at therapeutic doses. However, changes in bone morphology were observed in offspring of rats, dosed through most of the pregnancy and lactation, at doses equal to or greater than 33.6 times an oral human dose of 40 mg. There are no controlled data in human pregnancy. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Esomeprazole is the S-isomer of omeprazole and limited data indicate that maternal doses of omeprazole 20 mg daily produce low levels in human milk. No studies in lactating women have been performed. Esomeprazole strontium: Studies showed effects of esomeprazole strontium on developing bone in rats, at high doses.
AU, UK: Use is not recommended. US: Caution is recommended. Esomeprazole Strontium: US: A decision should be made to discontinue breastfeeding or discontinue this drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: The effects in the nursing infant are unknown.