Applies to esomeprazole: oral capsule delayed release, oral packet, oral tablet delayed release. Other dosage forms:

• oral capsule delayed release
• intravenous powder for solution

Serious side effects of Esomeprazole

Along with its needed effects, esomeprazole may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking esomeprazole:

Incidence not known

• Black, tarry stools
• blistering, peeling, or loosening of the skin
• bloating
• chest pain or tightness
• chills
• confusion
• constipation
• cough
• darkened urine
• decreased urine
• difficulty with swallowing
• dizziness
• drowsiness
• dry mouth
• fast heartbeat
• fever
• indigestion
• joint or muscle pain
• loss of appetite
• mood or mental changes
• muscle cramps in the hands, arms, feet, legs, or face
• muscle spasms (tetany) or twitching
• nausea
• numbness and tingling around the mouth, fingertips, or feet
• painful or difficult urination
• pains in the stomach, side, or abdomen, possibly radiating to the back
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red skin lesions, often with a purple center
• red, irritated eyes
• seizures
• skin rash, hives, itching
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• stomach cramps
• swollen glands
• trouble breathing
• trembling
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting
• yellow eyes or skin

Other side effects of Esomeprazole

Some side effects of esomeprazole may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Bad, unusual, or unpleasant (after) taste
• change in taste

Less common

• Sleepiness or unusual drowsiness

Rare

• Acne
• back pain

Incidence not known

• Agitation
• excess air or gas in the stomach or bowels
• full feeling
• increased sensitivity of the skin to sunlight
• loss or thinning of the hair
• muscular weakness
• passing gas
• redness or other discoloration of the skin
• seeing, hearing, or feeling things that are not there
• severe sunburn
• swelling of the breasts or breast soreness in both females and males
• swelling or inflammation of the mouth
• swollen joints

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]