Esomeprazole Side Effects
Medically reviewed by Drugs.com. Last updated on Mar 19, 2024.
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 adverse events
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
- 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]
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
- 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]
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References
1. (2001) "Product Information. Nexium (esomeprazole)." Astra-Zeneca Pharmaceuticals
2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
3. Cerner Multum, Inc. "Australian Product Information."
4. (2014) "Product Information. NexIUM I.V. (esomeprazole)." Astra-Zeneca Pharmaceuticals
5. (2014) "Product Information. Esomeprazole Strontium (esomeprazole)." Amneal Pharmaceuticals
Frequently asked questions
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Other brands
Nexium, Nexium 24HR, Nexium IV
Professional resources
- Esomeprazole monograph
- Esomeprazole (FDA)
- Esomeprazole Capsules (FDA)
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Further information
Esomeprazole side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.