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Zegerid Side Effects

Generic Name: omeprazole / sodium bicarbonate

Note: This document contains side effect information about omeprazole / sodium bicarbonate. Some of the dosage forms listed on this page may not apply to the brand name Zegerid.

In Summary

More frequent side effects include: congenital anomalies and abdominal pain. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to omeprazole / sodium bicarbonate: oral capsule, oral packet

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
  • confusion
  • convulsions
  • 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 or cramps
  • muscle spasms (tetany) 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
  • tightness in the chest
  • trembling
  • troubled breathing
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness

Less Common

  • Abdominal or stomach cramps or pain
  • bladder pain
  • blue lips, fingernails, or skin
  • bone pain
  • chest discomfort
  • cloudy urine
  • coma
  • decreased urine output
  • difficult or troubled breathing
  • 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
  • swelling
  • 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
  • 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

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

Other

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

Common (1% to 10%): Hyperpyrexia, candida infection NOS, sepsis NOS

Omeprazole:

Common (1% to 10%): Asthenia

Postmarketing reports: Fever, pain, fatigue, malaise, 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, hyponatremia, hypoglycemia NOS, hypophosphatemia

Omeprazole:

Postmarketing reports: Anorexia, hyponatremia, hypoglycemia, hypomagnesemia, 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%): Upper respiratory infection, cough

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: Pancytopenia, agranulocytosis/fatal agranulocytosis, thrombocytopenia, neutropenia, leukopenia, anemia, leukocytosis, hemolytic anemia[Ref]

Cardiovascular

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

Omeprazole:

Postmarketing reports: Chest pain/angina, tachycardia, bradycardia, palpitation, elevated blood pressure, peripheral edema[Ref]

Gastrointestinal

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

Frequency not reported: Upper gastrointestinal bleeding

Omeprazole:

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

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

Omeprazole:

Common (1% to 10%): Rash

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

Hepatic

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

Omeprazole:

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

Psychiatric

Common (1% to 10%): Agitation

Omeprazole:

Postmarketing reports: Psychiatric disturbances, depression, agitation, aggression, hallucinations, confusion, insomnia, nervousness, apathy, anxiety, abnormal dreams[Ref]

Genitourinary

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

Omeprazole:

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

Nervous system

Omeprazole:

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

Postmarketing reports: Hepatic encephalopathy, tremors, somnolence, vertigo, paresthesia, hemifacial dysesthesia, taste perversion

Sodium Bicarbonate:

Postmarketing reports: Seizures[Ref]

Musculoskeletal

Omeprazole:

Common (1% to 10%): Back pain

Postmarketing reports: Muscle cramps, myalgia, muscle weakness, joint pain, bone fracture, leg pain[Ref]

Ocular

Omeprazole:

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

Hypersensitivity

Omeprazole:

Postmarketing reports: Hypersensitivity reactions, anaphylaxis, anaphylactic shock, angioedema[Ref]

Renal

Omeprazole:

Postmarketing reports: Interstitial nephritis with/without positive rechallenge, elevated serum creatinine, glycosuria[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]

References

1. "Product Information. Zegerid (omeprazole-sodium bicarbonate)." Santarus Inc, San Diego, CA.

2. "Product Information. Zegerid (omeprazole)." Santarus Inc, San Diego, CA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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