Summary

More frequently reported side effects include: congenital anomalies and abdominal pain. Continue reading for a comprehensive list of adverse effects.

Applies to omeprazole / sodium bicarbonate: oral capsule, oral packet, oral powder for suspension.

Serious side effects

Along with its needed effects, omeprazole/sodium bicarbonate 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 omeprazole / sodium bicarbonate:

More common

• Black, tarry stools
• bleeding gums
• blood in the urine or stools
• blurred vision
• chest pain or tightness
• confusion
• cough
• decreased urine
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drowsiness
• dry mouth
• fainting
• fast or irregular heartbeat
• fever or chills
• headache
• increased thirst
• lightheadedness
• loss of appetite
• muscle pain, cramps, spasms, or twitching
• nausea or vomiting
• nervousness
• numbness or tingling in the hands, feet, or lips
• pale skin
• pinpoint red spots on the skin
• pounding in the ears
• rapid, shallow breathing
• seizures
• slow heartbeat
• sneezing
• sore throat
• sweating
• trembling
• trouble breathing
• unusual bleeding or bruising
• unusual tiredness or weakness

Less common

• Bladder pain
• blue lips, fingernails, or skin
• bone pain
• chest discomfort
• cloudy urine
• coma
• decreased urine output
• difficult, burning, or painful urination
• fast, pounding, or irregular heartbeat or pulse
• frequent urge to urinate
• headache
• irregular, fast or slow, or shallow breathing
• irritability
• lower back or side pain
• muscle cramps in the hands, arms, feet, legs, or face
• restlessness
• stomach cramps or pain
• swelling of the face, feet, lower legs, ankles, or hands
• weakness or heaviness of the legs

Rare

• Severe pain in the chest
• sudden onset of severe breathing difficulty

Incidence not known

• Arm, back, or jaw pain
• blistering, peeling, or loosening of the skin
• bloating or swelling of the face, arms, hands, lower legs, or feet
• chest tightness or heaviness
• constipation
• cough or hoarseness
• dark-colored urine
• diarrhea
• difficulty with swallowing
• fever with or without chills
• general body swelling
• general feeling of tiredness or weakness
• greatly decreased frequency of urination or amount of urine
• high fever
• hives or skin rash
• indigestion
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• light-colored stools
• mood or mental changes
• noisy breathing
• nosebleeds
• pain with swallowing
• 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
• rapid weight gain
• red skin lesions, often with a purple center
• red, irritated eyes
• sores, ulcers, or white spots on the lips or in the mouth
• stomach pain, continuing
• sweating
• swollen glands
• unexplained bleeding or bruising
• unusual weight gain or loss
• weight gain
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking omeprazole / sodium bicarbonate:

Symptoms of overdose

• Feeling of warmth
• increased sweating
• redness of the face, neck, arms, and occasionally, upper chest

Other side effects

Some side effects of omeprazole / sodium bicarbonate 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:

Less common

• Agitation
• cold sweats
• cool, pale skin
• depression
• excess air or gas in the stomach or intestines
• flushed, dry skin
• fruit-like breath odor
• full feeling
• increased hunger
• increased thirst
• increased urination
• lack or loss of strength
• nightmares
• passing gas
• shakiness
• slurred speech
• white patches in the mouth or throat or on the tongue
• white patches with diaper rash

Incidence not known

• Abnormal dreams
• attack, assault, or force
• bad, unusual, or unpleasant (after) taste
• blindness
• blue-yellow color blindness
• change in taste
• continuing ringing or buzzing or other unexplained noise in the ears
• decreased vision
• double vision
• dry eyes or skin
• eye pain
• feeling of constant movement of self or surroundings
• general feeling of discomfort or illness
• hair loss or thinning of the hair
• hearing loss
• hives or welts
• increased sensitivity of the skin to sunlight
• itching, redness, tearing, or other sign of eye irritation not present before use of this medicine or becoming worse during use
• lack of feeling or emotion
• pain in the testes
• pinpoint red or purple spots on the skin
• redness or other discoloration of the skin
• seeing, hearing, or feeling things that are not there
• sensation of spinning
• severe sunburn
• sleepiness or unusual drowsiness
• sugar in the urine
• swelling of the breasts or breast soreness in both females and males
• swelling or inflammation of the mouth
• trouble sleeping
• uncaring

For Healthcare Professionals

Applies to omeprazole / sodium bicarbonate: oral capsule, oral powder for reconstitution, oral suspension.

Other

Very common (10% or more): Pyrexia (Up to 20.2%)

Common (1% to 10%): Hyperpyrexia

Omeprazole:

Common (1% to 10%): Asthenia

Postmarketing reports: Fatigue, fever, malaise, pain, tinnitus^[Ref]

Metabolic

Very common (10% or more): Hypokalemia (Up to 12.4%), hyperglycemia NOS (Up to 10.7%), hypomagnesemia (Up to 10.1%)

Common (1% to 10%): Fluid overload, hyperkalemia, hypernatremia, hypocalcemia, hypoglycemia NOS, hyponatremia, hypophosphatemia

Frequency not reported: Cyanocobalamin (vitamin B-12) deficiency

Omeprazole:

Postmarketing reports: Anorexia, hypoglycemia, hypomagnesemia, hyponatremia, weight gain

Sodium Bicarbonate:

Postmarketing reports: Metabolic acidosis, tetany^[Ref]

Respiratory

Very common (10% or more): Nosocomial pneumonia (Up to 11.2%)

Common (1% to 10%): Acute respiratory distress syndrome, respiratory failure

Uncommon (0.1% to 1%): Pneumothorax NOS

Omeprazole:

Common (1% to 10%): Cough, upper respiratory infection

Postmarketing reports: Bronchospasm, epistaxis, pharyngeal pain^[Ref]

Hematologic

Very common (10% or more): Thrombocytopenia (Up to 10.1%)

Common (1% to 10%): Anemia NOS, anemia NOS aggravated

Omeprazole:

Postmarketing reports: Agranulocytosis/fatal agranulocytosis, anemia, hemolytic anemia, leukocytosis, leukopenia, neutropenia, pancytopenia, thrombocytopenia^[Ref]

Cardiovascular

Common (1% to 10%): Atrial fibrillation, bradycardia not otherwise specified (NOS), edema NOS, hypertension NOS, hypotension NOS, supraventricular tachycardia, tachycardia NOS, ventricular tachycardia

Omeprazole:

Postmarketing reports: Bradycardia, chest pain/angina, elevated blood pressure, palpitation, peripheral edema, tachycardia^[Ref]

Gastrointestinal

Common (1% to 10%): Constipation, diarrhea NOS, gastric hypomobility, oral candidiasis

Frequency not reported: Clostridium difficile-associated diarrhea, fundic gland polyps, upper gastrointestinal bleeding

Omeprazole:

Common (1% to 10%): Abdominal pain, acid regurgitation, constipation, diarrhea, flatulence, nausea, vomiting

Postmarketing reports: Abdominal swelling, Clostridium difficile associated diarrhea, dry mouth, esophageal candidiasis, fecal discoloration, gastric fundic gland polyps, irritable colon, mucosal atrophy of the tongue, pancreatitis/fatal pancreatitis, stomatitis^[Ref]

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

Dermatologic

Common (1% to 10%): Decubitus ulcer, rash NOS

Frequency not reported: Cutaneous lupus erythematosus, systemic lupus erythematosus

Omeprazole:

Common (1% to 10%): Rash

Postmarketing reports: Alopecia, cutaneous lupus erythematosus, dry skin, erythema multiforme/severe erythema multiforme, hyperhidrosis, photosensitivity, pruritus, purpura and/or petechia with/without rechallenge, severe generalized skin reactions, skin inflammation, Stevens-Johnson syndrome, systemic lupus erythematosus, toxic epidermal necrolysis (TEN)/fatal TEN, urticaria^[Ref]

Hepatic

Common (1% to 10%): Abnormal liver function tests NOS

Omeprazole:

Postmarketing reports: Hepatocellular/cholestatic/mixed hepatitis, jaundice, liver failure/fatal liver failure, liver necrosis/fatal liver necrosis, mild to marked elevation of liver function tests (alkaline phosphatase, ALT, AST, gamma-glutamyl transpeptidase), overt liver disease^[Ref]

Immunologic

Common (1% to 10%): Candidal infection NOS, sepsis NOS^[Ref]

Psychiatric

Common (1% to 10%): Agitation

Omeprazole:

Postmarketing reports: Abnormal dreams, aggression, agitation, anxiety, apathy, confusion, depression, hallucinations, insomnia, nervousness, psychiatric disturbances^[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection, urinary tract infection NOS

Omeprazole:

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

Nervous system

Omeprazole:

Common (1% to 10%): Headache, dizziness

Postmarketing reports: Hemifacial dysesthesia, hepatic encephalopathy, paresthesia, somnolence, taste perversion, tremors, vertigo

Sodium Bicarbonate:

Postmarketing reports: Seizures^[Ref]

Musculoskeletal

Frequency not reported: Bone fracture

Omeprazole:

Common (1% to 10%): Back pain

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

Ocular

Omeprazole:

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

Hypersensitivity

Omeprazole:

Postmarketing reports: Anaphylactic shock, anaphylaxis, angioedema, hypersensitivity reactions^[Ref]

Renal

Frequency not reported: Acute interstitial nephritis

Omeprazole:

Postmarketing reports: Elevated serum creatinine, glycosuria, interstitial nephritis with/without positive rechallenge^[Ref]

Oncologic

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 these tumors.^[Ref]

Omeprazole:

Postmarketing reports: Gastroduodenal carcinoids^[Ref]

Endocrine

Omeprazole:

Postmarketing reports: Gynecomastia^[Ref]