Nexium Side Effects

Generic Name: esomeprazole,esomeprazole magnesium

Please note - some side effects for Nexium 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 of Nexium - for the Consumer

Nexium I.V.

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Nexium I.V.:

Constipation; diarrhea; drowsiness; dry mouth; gas; headache; nausea; stomach pain.

Seek medical attention right away if any of these SEVERE side effects occur when using Nexium I.V.:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bone pain; chest pain; dark urine; fast heartbeat; fever, chills, or sore throat; pain, swelling, or redness at the injection site; red, swollen, blistered, or peeling skin; severe diarrhea; severe stomach cramps or pain; unusual bruising or bleeding; unusual tiredness or weakness; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Nexium Delayed-Release Capsules

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Nexium Delayed-Release Capsules:

Constipation; diarrhea; drowsiness; dry mouth; gas; headache; nausea; stomach pain.

Seek medical attention right away if any of these SEVERE side effects occur when using Nexium Delayed-Release Capsules:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bone pain; chest pain; dark urine; fast heartbeat; fever or chills; persistent sore throat; red, swollen, blistered, or peeling skin; severe diarrhea; severe stomach pain or cramps; unusual bruising or bleeding; unusual tiredness; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Nexium Delayed-Release Oral Suspension

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Nexium Delayed-Release Oral Suspension:

Constipation; diarrhea; drowsiness; dry mouth; gas; headache; nausea; stomach pain.

Seek medical attention right away if any of these SEVERE side effects occur when using Nexium Delayed-Release Oral Suspension:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest or throat; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bone pain; chest pain; dark urine; fast heartbeat; fever or chills; persistent sore throat; red, swollen, blistered, or peeling skin; severe diarrhea; severe stomach pain or cramps; unusual bruising or bleeding; unusual tiredness or weakness; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Nexium Side Effects - for the Professional

Nexium

Clinical Trials Experience with Intravenous Nexium

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Adults

The safety of intravenous esomeprazole is based on results from clinical trials conducted in three different populations including patients having symptomatic GERD with or without a history of erosive esophagitis (n=199), patients with erosive esophagitis (n=160), and healthy subjects (n=204). Adverse experiences occurring in >1% of patients treated with intravenous esomeprazole (n=359) in trials are listed below by body system:

Symptomatic GERD and Erosive Esophagitis Trials

The data described below reflect exposure to Nexium I.V for Injection in 359 patients. Nexium I.V. for Injection was studied only in actively-controlled trials. The population was 18 to 77 years of age; 45% Male, 52% Caucasian, 17% Black, 3% Asian, 28% Other, and had either erosive reflux esophagitis (44%) or GERD (56%). Most patients received doses of either 20 or 40 mg either as an infusion or an injection.

Table 2

Adverse reactions occurring at an incidence ≥ 1% in the Nexium I.V. group

Adverse Reactions	% of patients Esomeprazole Intravenous (n=359)
Headache	10.9
Flatulence	10.3
Nausea	6.4
Abdominal pain	5.8
Diarrhea	3.9
Mouth dry	3.9
Dizziness/vertigo	2.8
Constipation	2.5
Injection site reaction	1.7
Pruritus	1.1

Intravenous treatment with esomeprazole 20 and 40 mg administered as an injection or as an infusion was found to have a safety profile similar to that of oral administration of esomeprazole.

Pediatric

In a randomized, open-label, multi-national study to evaluate the pharmacokinetics of repeated intravenous doses of once daily esomeprazole, esomeprazole was well tolerated in pediatric patients 1 month to 17 years old, inclusive. The safety results are consistent with the known safety profile of esomeprazole and no unexpected safety signals were identified. [See Clinical Pharmacology (12.3)]

Clinical Trials Experience with Oral Nexium

Adult

The safety of oral Nexium was evaluated in over 15,000 patients (aged 18 to 84 years) in clinical trials worldwide including over 8,500 patients in the United States and over 6,500 patients in Europe and Canada. Over 2,900 patients were treated in long-term studies for up to 6-12 months. In general, Nexium was well tolerated in both short and long-term clinical trials.

The safety in the treatment of healing of erosive esophagitis was assessed in four randomized comparative clinical trials, which included 1,240 patients on Nexium 20 mg, 2,434 patients on Nexium 40 mg, and 3,008 patients on omeprazole 20 mg daily. The most frequently occurring adverse events (≥1%) in all three groups were headache (5.5, 5.0, and 3.8, respectively) and diarrhea (no difference among the three groups). Nausea, flatulence, abdominal pain, constipation, and dry mouth occurred at similar rates among patients taking Nexium or omeprazole.

Additional adverse events that were reported as possibly or probably related to Nexium with an incidence <1% are listed below by body system:

Body as a Whole: abdomen enlarged, allergic reaction, asthenia, back pain, chest pain, chest pain substernal, facial edema, peripheral edema, hot flushes, fatigue, fever, flu-like disorder, generalized edema, leg edema, malaise, pain, rigors;Cardiovascular: flushing, hypertension, tachycardia; Endocrine: goiter; Gastrointestinal: bowel irregularity, constipation aggravated, dyspepsia, dysphagia, dysplasia GI, epigastric pain, eructation, esophageal disorder, frequent stools, gastroenteritis, GI hemorrhage, GI symptoms not otherwise specified, hiccup, melena, mouth disorder, pharynx disorder, rectal disorder, serum gastrin increased, tongue disorder, tongue edema, ulcerative stomatitis, vomiting; Hearing: earache, tinnitus; Hematologic: anemia, anemia hypochromic, cervical lymphadenopathy, epistaxis, leukocytosis, leukopenia, thrombocytopenia; Hepatic: bilirubinemia, hepatic function abnormal, SGOT increased, SGPT increased; Metabolic/Nutritional: glycosuria, hyperuricemia, hyponatremia, increased alkaline phosphatase, thirst, vitamin B12 deficiency, weight increase, weight decrease; Musculoskeletal: arthralgia, arthritis aggravated, arthropathy, cramps, fibromyalgia syndrome, hernia, polymyalgia rheumatica; Nervous System/Psychiatric: anorexia, apathy, appetite increased, confusion, depression aggravated, dizziness, hypertonia, nervousness, hypoesthesia, impotence, insomnia, migraine, migraine aggravated, paresthesia, sleep disorder, somnolence, tremor, vertigo, visual field defect; Reproductive: dysmenorrhea, menstrual disorder, vaginitis; Respiratory: asthma aggravated, coughing, dyspnea, larynx edema, pharyngitis, rhinitis, sinusitis; Skin and Appendages: acne, angioedema, dermatitis, pruritus, pruritus ani, rash, rash erythematous, rash maculo-papular, skin inflammation, sweating increased, urticaria; Special Senses: otitis media, parosmia, taste loss, taste perversion; Urogenital: abnormal urine, albuminuria, cystitis, dysuria, fungal infection, hematuria, micturition frequency, moniliasis, genital moniliasis, polyuria; Visual: conjunctivitis, vision abnormal.

Endoscopic findings that were reported as adverse events include: duodenitis, esophagitis, esophageal stricture, esophageal ulceration, esophageal varices, gastric ulcer, gastritis, hernia, benign polyps or nodules, Barrett’s esophagus, and mucosal discoloration.

The incidence of treatment-related adverse events during 6- month maintenance treatment was similar to placebo. There were no differences in types of related adverse events seen during maintenance treatment up to 12 months compared to short-term treatment.

Two placebo-controlled studies were conducted in 710 patients for the treatment of symptomatic gastroesophageal reflux disease. The most common adverse events that were reported as possibly or probably related to Nexium were diarrhea (4.3%), headache (3.8%), and abdominal pain (3.8%).

The following potentially clinically significant laboratory changes in clinical trials, irrespective of relationship to Nexium, were reported in ≤ 1% of patients: increased creatinine, uric acid, total bilirubin, alkaline phosphatase, ALT, AST, hemoglobin, white blood cell count, platelets, serum gastrin, potassium, sodium, thyroxine and thyroid stimulating hormone [see Clinical Pharmacology, Endocrine Effects (12.2) for further information on thyroid effects]. Decreases were seen in hemoglobin, white blood cell count,platelets, potassium, sodium, and thyroxine.

Pediatric

The safety of oral Nexium was evaluated in 316 pediatric and adolescent patients aged 1 to 17 years in four clinical trials for the treatment of symptomatic GERD [see Clinical Studies (14.2)]. In 109 pediatric patients aged 1 to 11 years, the most frequently reported (at least 1%) treatment-related adverse reactions in these patients were diarrhea (2.8%), headache (1.9%) and somnolence (1.9%). In 149 pediatric patients aged 12 to 17 years the most frequently reported (at least 2%) treatment-related adverse reactions in these patients were headache (8.1%), abdominal pain (2.7%), diarrhea (2%), and nausea (2%). No new safety concerns were identified in pediatric patients.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Nexium. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Postmarketing Reports - There have been spontaneous reports of adverse events with postmarketing use of esomeprazole. These reports occurred rarely and are listed below by body system:

Blood And Lymphatic System Disorders: agranulocytosis, pancytopenia; Eye Disorders: blurred vision; Gastrointestinal Disorders: pancreatitis; stomatitis; Hepatobiliary Disorders: hepatic failure, hepatitis with or without jaundice; Immune System Disorders: anaphylactic reaction/shock; Infections and Infestations: GI candidiasis; Metabolism and nutritional disorders: hypomagnesemia; Musculoskeletal And Connective Tissue Disorders: muscular weakness, myalgia, bone fracture; Nervous System Disorders: hepatic encephalopathy, taste disturbance; Psychiatric Disorders: aggression, agitation, depression, hallucination; Renal and Urinary Disorders: interstitial nephritis; Reproductive System and Breast Disorders: gynecomastia; Respiratory, Thoracic and Mediastinal Disorders: bronchospasm; Skin and Subcutaneous Tissue Disorders: alopecia, erythema multiforme, hyperhidrosis, photosensitivity, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN, some fatal).

Other adverse events not observed with Nexium, but occurring with omeprazole can be found in the omeprazole package insert, ADVERSE REACTIONS section.

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Side Effects by Body System - for Healthcare Professionals

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.

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 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 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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