Applies to esomeprazole: oral capsule delayed release, oral packet, oral tablet delayed release

Other dosage forms:

• oral capsule delayed release
• intravenous powder for solution

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

• Blistering, peeling, or loosening of the skin
• bloating
• chills
• constipation
• cough
• darkened urine
• difficulty with swallowing
• dizziness
• drowsiness
• fast heartbeat
• fever
• indigestion
• joint or muscle pain
• loss of appetite
• mood or mental changes
• muscle spasms (tetany) or twitching
• nausea
• 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
• tightness in the chest
• trembling
• unusual tiredness or weakness
• vomiting
• yellow eyes or skin

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
• dry mouth
• excess air or gas in the stomach or bowels
• full feeling
• hair loss or thinning of the hair
• muscular weakness
• passing gas
• seeing, hearing, or feeling things that are not there
• swelling of the breasts or breast soreness in both females and males
• swelling or inflammation of the mouth
• swollen joints

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

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.

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

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: 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, rectal disorder, tongue disorder, tongue edema, ulcerative stomatitis

Postmarketing reports: Clostridium difficile associated diarrhea, fundic gland polyps, hemorrhagic necrotic gastritis (in children), pancreatitis

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

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

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

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

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

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.

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

Common (1% to 10%): Administration/injection site reactions

Postmarketing reports: Tissue inflammatory reaction

Common (1% to 10%): Viral infection

Frequency not reported: Flu-like disorder, fungal infection

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

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

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

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

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

Rare (0.01% to 0.1%): Anaphylactic reaction/shock, angioedema, hypersensitivity reactions

Frequency not reported: Allergic reaction

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

Frequency not reported: Abnormal urine, albuminuria, cystitis, dysmenorrhea, dysuria, genital moniliasis, hematuria, impotence, menstrual disorder, micturition frequency, moniliasis, polyuria, vaginitis