Esomeprazole and naproxen Side Effects

Please note - some side effects for Esomeprazole and naproxen may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects by Body System - for Healthcare Professionals

Applies to: oral delayed release tablet

Gastrointestinal

Gastrointestinal side effects have included erosive gastritis, dyspepsia, gastritis, diarrhea, gastric ulcer, upper abdominal pain, nausea, hiatus hernia, abdominal distension, flatulence, esophagitis, constipation, abdominal pain, erosive duodenitis, lower abdominal pain, duodenitis, hemorrhagic gastritis, gastroesophageal reflux disease, duodenal ulcer, and erosive esophagitis. Postmarketing reports have included gastrointestinal bleeding and/or perforation, hematemesis, pancreatitis, vomiting, colitis, exacerbation of inflammatory bowel disease (ulcerative colitis, Crohn's disease), nonpeptic gastrointestinal ulceration, ulcerative stomatitis, esophagitis, microscopic colitis, and peptic ulceration.

Cardiovascular

Cardiovascular side effects have included congestive heart failure, vasculitis, hypertension, pulmonary edema, and peripheral edema.

Respiratory

Respiratory side effects have included upper respiratory tract infection, bronchitis, bronchospasm, sinusitis, cough and nasopharyngitis. Postmarketing reports have included eosinophilic pneumonitis and asthma.

Musculoskeletal

Musculoskeletal side effects have included muscle spasm (tetany), arthralgia, aggravation of arthritis, arthropathy, cramps, fibromyalgia syndrome, hernia, hypertonia, polymyalgia rheumatica, and back pain. Myalgia and bone fracture have also been reported.

Nervous system

Nervous system side effects have included headache, dizziness, and dysgeusia. Postmarketing reports have included inability to concentrate, depression, dream abnormalities, insomnia, malaise, myalgia, muscle weakness, aseptic meningitis, cognitive dysfunction, hepatic encephalopathy, taste disturbance, and seizures.

Hepatic

Hepatic side effects have included jaundice, abnormal liver function tests, and hepatitis (some cases have been fatal).

Hematologic

Hematologic side effects have included eosinophilia, leucopenia, melena, thrombocytopenia, agranulocytosis, granulocytopenia, pancytopenia, hemolytic anemia, and aplastic anemia.

Dermatologic

Dermatologic side effects have included alopecia, urticaria, skin rashes, hyperhidrosis, toxic epidermal necrolysis, erythema multiforme, erythema nodosum, fixed drug eruption, lichen planus, pustular reaction, systemic lupus erythematosus, bullous reactions, including Stevens-Johnson syndrome, photosensitive dermatitis, photosensitivity reactions, including rare cases resembling porphyria cutanea tarda (pseudoporphyria) or epidermolysis bullosa, and toxic epidermal necrolysis (some fatal).

Hypersensitivity

Hypersensitivity side effects have included anaphylactoid reactions, shock, and angioneurotic edema.

Endocrine

Endocrine side effects have included hyperglycemia and hypoglycemia.

Ocular

Ocular side effects have included blurred vision, corneal opacity, papillitis, retrobulbar optic neuritis, and papilledema.

Renal

Renal side effects have included glomerular nephritis, hematuria, hyperkalemia, interstitial nephritis, nephrotic syndrome, renal disease, renal failure, raised serum creatinine, and renal papillary necrosis.

Genitourinary

Genitourinary side effects have included infertility, gynecomastia, and menstrual disorders.

General

General side effects have included pyrexia (chills and fever).

Psychiatric

Psychiatric side effects have included aggression, agitation, depression, and hallucination.

Metabolic

FDA warns that prescription proton pump inhibitor (PPI) drugs may cause low serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time (in most cases, longer than one year).

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