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]
