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
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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.