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.

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.

For the Consumer

Applies to esomeprazole: oral delayed release capsule, oral powder for reconstitution delayed release

Get emergency medical help if you have any of these signs of an allergic reaction while taking esomeprazole (the active ingredient contained in Nexium) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using esomeprazole and call your doctor at once if you have symptoms of low magnesium such as:

• dizziness, confusion;

• fast or uneven heart rate;

• jerking muscle movements;

• jittery feeling;

• diarrhea that is watery or bloody;

• muscle cramps, muscle weakness or limp feeling;

• cough or choking feeling; or

• seizure (convulsions).

Less serious side effects of esomeprazole may include:

• headache, drowsiness;

• mild diarrhea;

• nausea, stomach pain, gas, constipation; or

• dry mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to esomeprazole: intravenous powder for injection, oral delayed release capsule, oral powder for reconstitution delayed release

Gastrointestinal

Gastrointestinal (GI) side effects have included bowel irregularity, aggravated constipation, dyspepsia, dysphagia, dysplasia, epigastric pain, eructation, esophageal disorder, frequent stools, gastroenteritis, GI hemorrhage, rectal disorder, increased appetite, anorexia, ulcerative stomatitis, and vomiting. Pancreatitis has also been reported. Postmarketing reports of microscopic colitis have been received.

Nervous system

Nervous system side effects have included confusion, dizziness, hypoesthesia, insomnia, migraine aggravation, paresthesia, sleep disorder, somnolence, tremor, vertigo, and seizures.

Cardiovascular

Cardiovascular side effects have included hypertension, angioedema, tachycardia, chest pain, irregular heartbeat, and substernal chest pain.

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.

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.

Hematologic

Hematologic side effects have included anemia, hypochromic anemia, cervical lymphadenopathy, epistaxis, leukocytosis, leukopenia, and thrombocytopenia. Agranulocytosis and pancytopenia have also been reported.

Hepatic

Hepatic side effects have included bilirubinemia, abnormal hepatic function, and increase in SGOT and SGPT. Hepatitis, with or without jaundice, has also been reported.

Metabolic

Metabolic side effects have included glycosuria, hyperuricemia, hyponatremia, increased alkaline phosphatase, excessive thirst, vitamin B12 deficiency, and weight increase/decrease. 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).

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). Patients who develop hypomagnesemia may experience seizures, dizziness, abnormal or fast heart beat, or skipped heartbeat, jitteriness, jerking movements or tremors, muscle weakness, spasms of the hands and feet, cramps or muscle aches, and spasm of the voice box.

Genitourinary

Genitourinary side effects have included abnormal urine, albuminuria, cystitis, dysuria, hematuria, micturition frequency, moniliasis, genital moniliasis, impotence, dysmenorrhea, menstrual disorder, vaginitis, and polyuria.

Psychiatric

A 42-year-old female with previously normal sexual function experienced loss of libido during esomeprazole (the active ingredient contained in Nexium) therapy. She had been prescribed 40 mg esomeprazole twice daily for one month for symptoms of acid reflux disease. Over a 10 week period, she experienced a decline in sexual function until she could no longer respond sexually. After discontinuation of esomeprazole, her symptoms improved but did not return to what she considered normal.

Psychiatric side effects have included apathy, confusion, aggravated depression, and nervousness. At least one case of loss of libido has been reported.

Respiratory

Respiratory side effects have included aggravated asthma, coughing, dyspnea, larynx edema, pharyngitis, rhinitis, and sinusitis.

General

General side effects including hot flushes, fatigue, fever, flu-like disorder, leg edema, malaise, pain, earache, tinnitus, otitis, parosmia, taste loss, taste perversion, and enlarged abdomen have been reported.

Ocular

Ocular side effects have included abnormal vision, conjunctivitis, and visual field defect. Blurred vision has also been reported.

Dermatologic

Dermatologic side effects have included acne, dermatitis, pruritus, erythematous rash, maculopapular rash, skin inflammation, and increased sweating. Alopecia and erythema multiforme have also been reported. Duodenitis, esophagitis, esophageal stricture, esophageal ulceration, esophageal varices, gastric ulcer, gastritis, hernia, benign polyps or nodules, Barrett's esophagus, and mucosal discoloration have also been reported.

Endocrine

Endocrine side effects have included goiter.

Hypersensitivity

Hypersensitivity side effects have rarely included allergic reactions (less than 1%). Toxic epidermal necrolysis (some cases fatal) and Stevens-Johnson syndrome have also been reported.

Immunologic

Immunologic side effects have included anaphylactic reaction or shock.

Renal

A 63-year-old female with dyspepsia experienced acute interstitial nephritis coincident with esomeprazole (the active ingredient contained in Nexium) therapy. She presented to the hospital with a 1-month history of nausea and intermittent vomiting. Three weeks before presentation, she was empirically prescribed esomeprazole for the treatment of dyspepsia. A week before presentation, she stopped taking this drug, as she suspected it was exacerbating the malaise, nauseas, and vomiting. On day 4 of admission, a renal biopsy showed acute interstitial nephritis. Prednisolone therapy was continued for 4 weeks. Supportive dialysis was needed for 4 days, by which time renal function had improved. However, at follow-up 8 months later, serum creatinine levels remained abnormal.

Renal side effects including at least two cases of interstitial nephritis have been reported.

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