Applies to omeprazole: oral delayed-release capsules, oral immediate-release capsules, oral powder for delayed-release or immediate-release suspension, oral tablets for.

Side effects include:

In adults, diarrhea, nausea, constipation, abdominal pain, vomiting, headache, flatulence.

In pediatric patients, respiratory effects, fever (in children 1–2 years of age), accidental injuries (in children 2–16 years of age); otherwise, adverse effects generally similar to those in adults.

For Healthcare Professionals

Applies to omeprazole: compounding powder, oral delayed release capsule, oral delayed release tablet, oral powder for reconstitution, oral powder for reconstitution delayed release, oral suspension, oral tablet disintegrating delayed release.

General

The most commonly reported side effects included headache, abdominal pain, nausea, and diarrhea.^[Ref]

Other

Otitis media occurred most frequently in patients 1 month to less than 1 year of age.

Fever most commonly occurred in patients 1 to less than 2 years of age.

Accidental injury most commonly occurred in patients 2 to 16 years of age.^[Ref]

Very common (10% or more): Fever (up to 33%), otitis media (up to 22%)

Common (1% to 10%): Accidental injury, asthenia

Uncommon (0.1% to 1%): Malaise

Very rare (less than 0.01%): Elevated body temperature

Postmarketing reports: Pain, fatigue, tinnitus^[Ref]

Respiratory

Patients 1 to less than 2 years of age had the highest frequency of adverse reactions of the respiratory system, followed by patients 1 month to less than 1 year and patients 2 to 16 years of age.^[Ref]

Very common (10% or more): Respiratory system reactions (up to 75%)

Common (1% to 10%): Cough, pharyngitis/pharyngeal pain, rhinitis, upper respiratory infection

Rare (0.01% to 0.1%): Bronchospasm

Very rare (less than 0.01%): Dyspnea

Postmarketing reports: Epistaxis^[Ref]

Nervous system

Lightheadedness occurred predominantly in severely ill or elderly patients.

Taste disturbance usually resolved when treatment was stopped.

Taste perversion most commonly occurred in patients given concomitant treatment with clarithromycin.

Hepatic encephalopathy occurred in patients with preexisting liver disease.^[Ref]

Very common (10% or more): Taste perversion (up to 15%)

Common (1% to 10%): Dizziness, drowsiness, headache, somnolence

Uncommon (0.1% to 1%): Paresthesia, taste disturbances, vertigo

Rare (0.01% to 0.1%): Hepatic encephalopathy, lightheadedness

Postmarketing reports: Tremor^[Ref]

Gastrointestinal

Hemorrhagic necrotic gastritis has been reported in pediatric patients.

Diarrhea most commonly occurred in patients given concomitant treatment with clarithromycin and amoxicillin.

Benign gastric fundic gland polyps appeared to be reversible when omeprazole was discontinued.^[Ref]

Very common (10% or more): Diarrhea (Up to 14%)

Common (1% to 10%): Abdominal pain, acid regurgitation, benign fundic gland polyps, constipation, flatulence, nausea, tongue discoloration, vomiting

Rare (0.01% to 0.1%): Dry mouth, gastrointestinal candidiasis, microscopic colitis, stomatitis

Very rare (less than 0.01%): Dyspepsia, hemorrhagic necrotic gastritis

Postmarketing reports: Abdominal swelling, Clostridium difficile associated diarrhea, esophageal candidiasis, fecal discoloration, fundic gland polyps, irritable colon, mucosal atrophy of the tongue, pancreatitis (sometimes fatal)^[Ref]

Dermatologic

Common (1% to 10%): Rash

Uncommon (0.1% to 1%): Alopecia, dermatitis, erythema multiforme, increased sweating, pruritus, photosensitivity, skin eruptions, urticaria

Rare (0.01% to 0.1%): Allergic vasculitis, Stevens-Johnson syndrome, toxic epidermal necrolysis (some fatal)

Frequency not reported: Subacute cutaneous lupus erythematosus

Postmarketing reports: Cutaneous lupus erythematosus, dry skin, hyperhidrosis, petechia, skin inflammation, severe generalized skin reactions, systemic lupus erythematosus^[Ref]

Musculoskeletal

Common (1% to 10%): Back pain

Uncommon (0.1% to 1%): Fracture of the hip/wrist/spine

Rare (0.01% to 0.1%): Arthralgia, joint pain, muscular weakness, myalgia

Postmarketing reports: Bone fracture, leg pain, muscle cramps^[Ref]

Psychiatric

Confusion, agitation, aggression, depression, and hallucinations occurred predominantly in severely ill or elderly patients.^[Ref]

Common (1% to 10%): Insomnia

Rare (0.01% to 0.1%): Aggression, agitation, confusion/reversible mental confusion, depression, hallucinations

Postmarketing reports: Anxiety, apathy, dream abnormalities, nervousness, psychiatric and sleep disturbances^[Ref]

Immunologic

Common (1% to 10%): Flu syndrome^[Ref]

Hepatic

Uncommon (0.1% to 1%): Increased liver enzymes (ALT, alkaline phosphatase, AST, bilirubin, gamma glutamyl transferase)

Rare (0.01% to 0.1%): Hepatic failure, hepatitis with/without jaundice

Postmarketing reports: Cholestatic disease, fatal hepatic failure, hepatocellular disease, jaundice, liver disease, liver necrosis (some fatal), mixed hepatitis^[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Peripheral edema

Postmarketing reports: Bradycardia, chest pain/angina, elevated blood pressure/hypertension, palpitations, tachycardia^[Ref]

Peripheral edema usually resolved when treatment was stopped.^[Ref]

Hematologic

Rare (0.01% to 0.1%): Agranulocytosis, hypochromic/microcytic anemia, leukopenia, pancytopenia, thrombocytopenia

Postmarketing reports: Anemia, fatal agranulocytosis, hemolytic anemia, leukocytosis, neutropenia, purpura^[Ref]

Hypersensitivity

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

Postmarketing reports: Anaphylaxis^[Ref]

Metabolic

Rare (0.01% to 0.1%): Hyponatremia

Very rare (less than 0.01%): Hypocalcemia, hypokalemia, hypomagnesemia with/without hypocalcemia and/or hypokalemia, weight increase

Postmarketing reports: Anorexia, cyanocobalamin (vitamin B12) deficiency, hypoglycemia^[Ref]

Severe hypomagnesemia may result in hypocalcemia, and this condition may be associated with hypokalemia.

Hypokalemia was reported in pediatric patients.^[Ref]

Renal

Rare (0.01% to 0.1%): Interstitial nephritis

Very rare (less than 0.01%): Impaired renal function, nephrosis

Postmarketing reports: Elevated serum creatinine, glycosuria^[Ref]

Ocular

Rare (0.01% to 0.1%): Blurred vision

Frequency not reported: Irreversible visual impairment

Postmarketing reports: Anterior ischemic optic neuropathy, double vision, dry eye syndrome, ocular irritation, optic atrophy, optic neuritis^[Ref]

Irreversible visual impairment has been reported in critically ill patients who generally received high doses of the IV formulation as a bolus; however, no causal relationship has been established.^[Ref]

Endocrine

Rare (0.01% to 0.1%): Gynecomastia^[Ref]

Genitourinary

Very rare (less than 0.01%): Impotence

Postmarketing reports: Hematuria, microscopic pyuria, proteinuria, testicular pain, urinary frequency, urinary tract infection^[Ref]

A causal relationship between this drug and impotence has not been established.^[Ref]

Oncologic

Postmarketing reports: Gastroduodenal carcinoids^[Ref]

Gastroduodenal carcinoids have been reported in patients with Zollinger-Ellison syndrome on long-term therapy. This condition may be a manifestation of the underlying condition, which is known to be associated with tumors.^[Ref]