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Nexium Side Effects

Generic Name: esomeprazole

Note: This document contains side effect information about esomeprazole. Some of the dosage forms listed on this page may not apply to the brand name Nexium.

For the Consumer

Applies to esomeprazole: oral capsule delayed release, oral packet, oral tablet delayed release

Along with its needed effects, esomeprazole (the active ingredient contained in Nexium) 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
  • 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 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
  • 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 mouth
  • swollen joints

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]

Nervous system

Very Common (10% or more): Headache (up to 10.9%)
Common (1% to 10%): Dizziness, somnolence, vertigo
Uncommon (0.1% to 1%): Paresthesia
Rare (0.01% to 0.1%): Taste disturbance
Very rare (less than 0.01%): Hepatic encephalopathy
Frequency not reported: Hypertonia, hypoesthesia, migraine/aggravated migraine, parosmia, taste loss/perversion, tremor[Ref]

Gastrointestinal

Very common (10% or more): Flatulence (up to 10.3%)
Common (1% to 10%): Abdominal pain, benign fundic gland polyps, constipation, 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%): GI candidiasis, stomatitis
Very rare (less than 0.01%): Microscopic colitis
Frequency not reported: Barrett's esophagus, benign polyps or nodules, bowel irregularity, constipation aggravated, duodenitis, dyspepsia, dysphagia, dysplasia gastrointestinal (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, hemorrhagic necrotic gastritis, pancreatitis[Ref]

Respiratory

Common (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[Ref]

Other

Common (1% to 10%): Accident or injury, fever/pyrexia
Rare (0.01% to 0.1%): Malaise
Frequency not reported: Asthenia, earache, facial edema, fatigue, flu-like disorder, leg edema, otitis media, pain, rigors, thirst, tinnitus[Ref]

Dermatologic

Common (1% to 10%): Pruritus
Uncommon (0.1% to 1%): Dermatitis, rash, urticaria
Rare (0.01% to 0.1%): Alopecia, increased sweating, photosensitivity
Very rare (less than 0.01): Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN)/ fatal TEN
Frequency not reported: Acne, pruritus ani, rash erythematous, rash maculopapular, skin inflammation, subacute cutaneous lupus erythematosus, sweating increased/hyperhidrosis
Postmarketing reports: Cutaneous lupus erythematosus, systemic lupus erythematosus[Ref]

Cardiovascular

Common (1% to 10%): Hypertension/aggravated hypertension
Uncommon (0.1% to 1%): Peripheral edema
Frequency not reported: Chest pain, flushing, generalized edema, hot flush, hypertension, irregular heartbeat, substernal chest pain, tachycardia[Ref]

Musculoskeletal

Common (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, increased alkaline phosphatase, polymyalgia rheumatic
Postmarketing reports: 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]

Endocrine

Common (1% to 10%): Increased serum gastrin
Very rare (less than 0.01%): Gynecomastia
Frequency not reported: Decreased/increased thyroxine, goiter, increased thyroid stimulating hormone[Ref]

Local

Common (1% to 10%): Administration/injection site reactions
Postmarketing reports: Tissue inflammatory reaction[Ref]

Immunologic

Common (1% to 10%): Viral infection[Ref]

Hepatic

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, ALT/AST increased, bilirubinemia, increased total bilirubin[Ref]

Ocular

Uncommon (0.1% to 1%): Blurred vision
Rare (0.01% to 0.1%): Visual accommodation disorder, visual field defect
Frequency not reported: Abnormal vision, conjunctivitis
Postmarketing reports: Irreversible visual impairment, loss of vision[Ref]

Psychiatric

Uncommon (0.1% to 1%): Insomnia
Rare (0.01% to 0.1%): Agitation, confusion, depression/aggravated depression
Very rare (less than 0.01%): Aggression, hallucinations
Frequency not reported: Apathy, irritability, nervousness, sleep disorder[Ref]

Hematologic

Rare (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[Ref]

Metabolic

Rare (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, decreased/increased sodium, increased appetite, vitamin B12 deficiency, weight decrease/increase[Ref]

Hypersensitivity

Rare (0.01% to 0.1%): Anaphylactic reaction/shock, angioedema, hypersensitivity reactions
Frequency not reported: Allergic reaction[Ref]

Renal

Very rare (less than 0.01%): Interstitial nephritis with/without renal failure
Frequency not reported: Glycosuria
Postmarketing reports: Impaired renal function, increased creatinine, nephrosis[Ref]

Genitourinary

Frequency not reported: Abnormal urine, albuminuria, cystitis, dysmenorrhea, dysuria, fungal infection, genital moniliasis, hematuria, menstrual disorder, micturition frequency, moniliasis, polyuria, vaginitis
Postmarketing reports: Impotence[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.

Some side effects of Nexium may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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