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Nexium Side Effects

Generic name: esomeprazole

Medically reviewed by Drugs.com. Last updated on Jan 3, 2024.

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

For Healthcare Professionals

Applies to esomeprazole: intravenous powder for injection, oral delayed release capsule, oral delayed release tablet, 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, 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[Ref]

Gastrointestinal

Very 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: Aggravated acid-related symptoms, 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, rebound hypersecretion, rectal disorder, tongue disorder, tongue edema, ulcerative stomatitis

Postmarketing reports: Clostridium difficile associated diarrhea, fundic gland polyps, hemorrhagic necrotic gastritis (in children), 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, leg edema, otitis media, pain, rigors, 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/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[Ref]

Cardiovascular

Common (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[Ref]

Musculoskeletal

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]

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, polymyalgia rheumatica

Postmarketing reports: Bone fracture[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

Frequency not reported: Flu-like disorder, fungal infection[Ref]

Hepatic

Common (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[Ref]

Ocular

Uncommon (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[Ref]

Psychiatric

Uncommon (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[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, increased sodium, increased appetite, vitamin B12 (cyanocobalamin) deficiency, thirst, 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: Acute interstitial nephritis, impaired renal function, increased creatinine, nephrosis[Ref]

Genitourinary

Frequency not reported: Abnormal urine, albuminuria, cystitis, dysmenorrhea, dysuria, genital moniliasis, hematuria, impotence, menstrual disorder, micturition frequency, moniliasis, polyuria, vaginitis[Ref]

Frequently asked questions

References

1. Product Information. Nexium (esomeprazole). Astra-Zeneca Pharmaceuticals. 2001;PROD.

2. Cerner Multum, Inc. UK Summary of Product Characteristics.

3. Cerner Multum, Inc. Australian Product Information.

4. Product Information. NexIUM I.V. (esomeprazole). Astra-Zeneca Pharmaceuticals. 2014.

5. Product Information. Esomeprazole Strontium (esomeprazole). Amneal Pharmaceuticals. 2014.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.