Zegerid

What Is Zegerid?

Zegerid (omeprazole/sodium bicarbonate) is a combination of a proton-pump inhibitor (PPI) and an antacid used to treat ulcers, gastroesophageal reflux disease (GERD), and other conditions involving excessive stomach acid production. Zegerid may be available in generic form.

What Are Side Effects of Zegerid?

Common side effects of Zegerid include:

• headache stomach or abdominal pain,
• nausea,
• gas, or
• diarrhea.

Tell your doctor if you have unlikely but serious side effects of Zegerid including:

• swelling of the hands or feet,
• symptoms of a low magnesium blood level (such as unusually fast/slow/irregular heartbeat, persistent muscle spasms, seizures), or
• sudden weight gain.

Dosage for Zegerid

Dose and duration of treatment with Zegerid depends on the condition being treated. For ulcers, GERD, erosive esophagitis and eradication of H. pylori the usual recommended dose for adults is 20-40 mg daily. Follow instructions from your doctor.

What Drugs, Substances, or Supplements Interact with Zegerid?

Zegerid may interact with bosentan, citalopram, clopidogrel, cyclosporine, diazepam or similar sedatives, digoxin, digitalis, disulfiram, Antabuse, methotrexate, rifabutin, rifampin, rifapentine, sodium polystyrene sulfonate, St. John's wort, tacrolimus, antibiotics, antifungals, blood thinners, calcium supplements or iron supplements (including ferrous fumarate, ferrous gluconate, ferrous sulfonate), diuretics (water pills), HIV medicines, or seizure medications. Tell your doctor all medications and supplements you use.

Zegerid During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant while using Zegerid; it is unknown if Zegerid will harm a fetus. Zegerid can pass into breast milk and may harm a nursing baby. Breastfeeding while using Zegerid is not recommended.

Additional Information

Our Zegerid (omeprazole/sodium bicarbonate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Zegerid Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody;
• new or unusual pain in your wrist, back, hip, or thigh;
• muscle twitching or tremor;
• numbness or tingling in your face, arms, or legs;
• confusion, dizziness;
• a seizure;
• low magnesium--dizziness, irregular heartbeats, feeling jittery, muscle cramps, muscle spasms, cough or choking feeling;
• kidney problems--fever, rash, nausea, loss of appetite, joint pain, urinating less than usual, blood in your urine, weight gain;
• new or worsening symptoms of lupus--joint pain, and a skin rash on your cheeks or arms that worsens in sunlight; or
• vitamin B12 deficiency--shortness of breath, feeling lightheaded, irregular heartbeats, muscle weakness, pale skin, tiredness, mood changes.

Taking this medicine long-term may cause you to develop stomach growths called fundic gland polyps. Talk with your doctor about this risk.

If you use omeprazole and sodium bicarbonate for longer than 3 years, you could develop a vitamin B-12 deficiency. Talk to your doctor about how to manage this condition if you develop it.

Common side effects may include:

• headache;
• nausea, vomiting, stomach pain, gas; or
• diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Zegerid (Omeprazole, Sodium Bicarbonate)

 

Zegerid Professional Information

SIDE EFFECTS

The following serious adverse reactions are described below and elsewhere in labeling:

• Acute Interstitial Nephritis [see WARNINGS AND PRECAUTIONS]
• Clostridium difficile-Associated Diarrhea [see WARNINGS AND PRECAUTIONS]
• Bone Fracture [see WARNINGS AND PRECAUTIONS]
• Cutaneous and Systemic Lupus Erythematosus [see WARNINGS AND PRECAUTIONS]
• Cyanocobalamin (Vitamin B-12) Deficiency [see WARNINGS AND PRECAUTIONS]
• Hypomagnesemia [see WARNINGS AND PRECAUTIONS]
• Fundic Gland Polyps [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of ZEGERID has been established, in part, based on oral studies of an oral delayed-release omeprazole product.

Clinical Trials With Omeprazole

In the U.S. clinical trial population of 465 adult patients, the adverse reactions summarized in Table 3 were reported to occur in 1% or more of patients on therapy with omeprazole.

Table 3: Adverse Reactions Occurring in 1% or More of Adult Patients in US Clinical Trials ofOmeprazole Therapy

	Omeprazole % (n = 465)	Placebo % (n = 64)	Ranitidine % (n = 195)
Headache	7	6	8
Diarrhea	3	3	2
Abdominal Pain	2	3	3
Nausea	2	3	4
Upper Respiratory Infection (URI)	2	2	3
Dizziness	2	0	3
Vomiting	2	5	2
Rash	2	0	0
Constipation	1	0	0
Cough	1	0	2
Asthenia	1	2	2
Back Pain	1	0	1

Table 4 summarizes the adverse reactions that occurred in 1% or more of omeprazole-treated patients from international double-blind and open-label clinical trials in which 2,631 patients and subjects received omeprazole.

Table 4: Adverse Reactions Occurring in 1% or More of Adult Patients in International Clinical Trials ofOmeprazole Therapy

	Omeprazole % (n = 465)	Placebo % (n = 64)
Abdominal Pain	5.2	3.3
Nausea	4.0	6.7
Diarrhea	3.7	2.5
Vomiting	3.2	10.0
Headache	2.9	2.5
Flatulence	2.7	5.8
Acid Regurgitation	1.9	3.3
Constipation	1.5	0.8
Asthenia	1.3	0.8

Clinical Trial Of 40 mg ZEGERID For Oral Suspension

Adverse reactions reported in at least 3% of critically ill adult patients in a clinical trial of 40 mg ZEGERID for oral suspension compared to intravenous cimetidine for up to 14 days are presented in Table 5.

Table 5: Common Adverse Reactions¹ by Body System and Preferred Term in a Randomized ControlledTrial of Critically Ill Adult Patients Treated up to 14 Days

Body System Preferred Term	ZEGERID 40 mg for oral suspension once daily % (N=178)	Intravenous Cimetidine 1,200 mg per day % (N=181)
Blood and Lymphatic System Disorders
Anemia NOS	7.9	7.7
Anemia NOS Aggravated	2.2	3.9
Thrombocytopenia	10.1	6.1
Cardiac Disorders
Atrial Fibrillation	6.2	3.9
Bradycardia NOS	3.9	2.8
Supraventricular Tachycardia	3.4	1.1
Tachycardia NOS	3.4	3.3
Ventricular Tachycardia	4.5	3.3
Gastrointestinal Disorders2
Constipation	4.5	4.4
Diarrhea NOS	3.9	8.3
Gastric Hypomotility	1.7	3.3
General Disorders and Administration Site Conditions
Hyperpyrexia	4.5	1.7
Edema NOS	2.8	6.1
Pyrexia	20.2	16.0
Infections and Infestations
Candidal Infection NOS	1.7	3.9
Oral Candidiasis	3.9	0.6
Sepsis NOS	5.1	5.0
Urinary Tract Infection	2.2	3.3
Investigations
Liver Function Tests NOS Abnormal	1.7	3.3
Metabolism and Nutrition Disorders
Fluid Overload	5.1	7.7
Hyperglycemia NOS	10.7	11.6
Hyperkalemia	2.2	3.3
Hypernatremia	1.7	5.0
Hypocalcemia	6.2	5.5
Hypoglycemia NOS	3.4	4.4
Hypokalemia	12.4	13.3
Hypomagnesemia	10.1	9.9
Hyponatremia	3.9	2.8
Hypophosphatemia	6.2	3.9
Psychiatric Disorders
Agitation	3.4	8.8
Respiratory, Thoracic and Mediastinal Disorders
Acute Respiratory Distress Syndrome	3.4	3.9
Nosocomial Pneumonia	11.2	9.4
Pneumothorax NOS	0.6	4.4
Respiratory Failure	1.7	3.3
Skin and Subcutaneous Tissue Disorders
Decubitus Ulcer	3.4	2.8
Rash NOS	5.6	6.1
Vascular Disorders
Hypertension NOS	7.9	3.3
Hypotension NOS	9.6	6.6
NOS = not otherwise specified 1 reported in at least 3% of patients in either treatment group. 2 In this trial, clinically significant upper gastrointestinal bleeding was considered a serious adverse reaction, but it is not included in this table.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of omeprazole and sodium bicarbonate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Omeprazole

Body as a Whole: Hypersensitivity reactions, including anaphylaxis, anaphylactic shock, angioedema, bronchospasm, interstitial nephritis, urticaria (see also Skin below), fever, pain, fatigue, malaise, and systemic lupus erythematosus.

Cardiovascular: Chest pain or angina, tachycardia, bradycardia, palpitation, elevated blood pressure, and peripheral edema.

Gastrointestinal: Pancreatitis (some fatal), anorexia, irritable colon, flatulence, fecal discoloration, esophageal candidiasis, mucosal atrophy of the tongue, dry mouth, stomatitis, abdominal swelling and fundic gland polyps. Gastroduodenal carcinoids have been reported in patients with Zollinger-Ellison syndrome on long-term treatment with omeprazole. This finding is believed to be a manifestation of the underlying condition, which is known to be associated with such tumors.

Hepatic: Mild and, rarely, marked elevations of liver function tests [ALT (SGPT), AST (SGOT), γ-glutamyl transpeptidase, alkaline phosphatase, and bilirubin (jaundice)]. In rare instances, overt liver disease has occurred, including hepatocellular, cholestatic, or mixed hepatitis, liver necrosis (some fatal), hepatic failure (some fatal), and hepatic encephalopathy.

Infections and Infestations: Clostridium difficile-associated diarrhea.

Metabolism and Nutritional Disorders: Hyponatremia, hypoglycemia, hypomagnesemia, and weight gain.

Musculoskeletal: Muscle cramps, myalgia, muscle weakness, joint pain, bone fracture, and leg pain.

Nervous System/Psychiatric: Psychic disturbances including depression, agitation, aggression, hallucinations, confusion, insomnia, nervousness, tremors, apathy, somnolence, anxiety, dream abnormalities; vertigo; paresthesia; and hemifacial dysesthesia.

Respiratory: Epistaxis, pharyngeal pain.

Skin: Severe generalized skin reactions including toxic epidermal necrolysis (TEN; some fatal), Stevens-Johnson syndrome, cutaneous lupus erythematosus and erythema multiforme (some severe); purpura and/or petechiae (some with rechallenge); skin inflammation, urticaria, angioedema, pruritus, photosensitivity, alopecia, dry skin, and hyperhidrosis.

Special Senses: Tinnitus, taste perversion.

Ocular: Blurred vision, ocular irritation, dry eye syndrome, optic atrophy, anterior ischemic optic neuropathy, optic neuritis, and double vision.

Urogenital: Interstitial nephritis (some with positive rechallenge), urinary tract infection, microscopic pyuria, urinary frequency, elevated serum creatinine, proteinuria, hematuria, glycosuria, testicular pain, and gynecomastia.

Hematologic: Rare instances of pancytopenia, agranulocytosis (some fatal), thrombocytopenia, neutropenia, leukopenia, anemia, leukocytosis, and hemolytic anemia have been reported.

Sodium Bicarbonate

metabolic alkalosis, seizures, and tetany.

Read the entire FDA prescribing information for Zegerid (Omeprazole, Sodium Bicarbonate)