Medical Editor: John P. Cunha, DO, FACOEP
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.
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.
SLIDESHOW
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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.
SIDE EFFECTS
The following serious adverse reactions are described below and elsewhere in labeling:
- Acute Tubulointerstitial Nephritis [see WARNINGS AND PRECAUTIONS]
- Clostridium difficile-Associated Diarrhea [see WARNINGS AND PRECAUTIONS]
- Bone Fracture [see WARNINGS AND PRECAUTIONS]
- Severe Cutaneous Adverse Reactions [see WARNINGS AND PRECAUTIONS]
- Cutaneous and Systemic Lupus Erythematosus [see WARNINGS AND PRECAUTIONS]
- Cyanocobalamin (Vitamin B-12) Deficiency [see WARNINGS AND PRECAUTIONS]
- Hypomagnesemia and Mineral Metabolism [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 of Omeprazole 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 of Omeprazole Therapy
| Omeprazole % (N = 2631) |
Placebo % (N = 120) |
|
| 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 Controlled Trial 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 | 1.7 | 3.3 |
| Abnormal | ||
| 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 1reported 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, 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: Hypomagnesemia, hypocalcemia, hypokalemia [see WARNINGS AND PRECAUTIONS], hyponatremia, hypoglycemia, 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 TEN (some fatal), SJS, DRESS, AGEP, 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: Tubulointerstitial nephritis, 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.
DRUG INTERACTIONS
Tables 6 and 7 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with omeprazole and instructions for preventing or managing them.
Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs.
Table 6: Clinically Relevant Interactions Affecting Drugs Co-Administered with Omeprazole and Interaction with Diagnostics
| Antiretrovirals | |
| Clinical Impact: | The effect of PPIs on antiretroviral drugs is variable. The clinical importance and the mechanisms behind these interactions are not always known.
|
| Intervention: | Rilpivirine-containing products: Concomitant use with ZEGERID is contraindicated [see CONTRAINDICATIONS]. Atazanavir: Avoid concomitant use with ZEGERID. See prescribing information for atazanavir for dosing information. Nelfinavir: Avoid concomitant use with ZEGERID. See prescribing information for nelfinavir. Saquinavir: See the prescribing information for saquinavir for monitoring of potential saquinavir-related toxicities. Other antiretrovirals: See prescribing information for specific antiretroviral drugs. |
| Warfarin | |
| Clinical Impact: | Increased INR and prothrombin time in patients receiving PPIs, including omeprazole, and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. |
| Intervention: | Monitor INR and prothrombin time and adjust the dose of warfarin, if needed, to maintain target INR range. |
| Methotrexate | |
| Clinical Impact: | Concomitant use of omeprazole with methotrexate (primarily at high dose) may elevate and prolong serum concentrations of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to methotrexate toxicities. No formal drug interaction studies of high-dose methotrexate with PPIs have been conducted [see WARNINGS AND PRECAUTIONS]. |
| Intervention: | A temporary withdrawal of ZEGERID may be considered in some patients receiving high-dose methotrexate. |
| CYP2C19 Substrates (e.g., clopidogrel, citalopram, cilostazol, phenytoin, diazepam) | |
| Clopidogrel | |
| Clinical Impact: | Concomitant use of omeprazole 80 mg results in reduced plasma concentrations of the active metabolite of clopidogrel and a reduction in platelet inhibition [see CLINICAL PHARMACOLOGY]. There are no adequate combination studies of a lower dose of omeprazole or a higher dose of clopidogrel in comparison with the approved dose of clopidogrel. |
| Intervention: | Avoid concomitant use with ZEGERID. Consider use of alternative antiplatelet therapy [see WARNINGS AND PRECAUTIONS]. |
| Citalopram | |
| Clinical Impact: | Increased exposure of citalopram leading to an increased risk of QT prolongation [see CLINICAL PHARMACOLOGY]. |
| Intervention: | Limit the dose of citalopram to a maximum of 20 mg per day. See prescribing information for citalopram. |
| Cilostazol | |
| Clinical Impact: | Increased exposure of one of the active metabolites of cilostazol (3,4-dihydro-cilostazol) [see CLINICAL PHARMACOLOGY]. |
| Intervention: | Reduce the dose of cilostazol to 50 mg twice daily. See prescribing information for cilostazol. |
| Phenytoin | |
| Clinical Impact: | Potential for increased exposure of phenytoin. |
| Intervention: | Monitor phenytoin serum concentrations. Dose adjustment may be needed to maintain therapeutic drug concentrations. See prescribing information for phenytoin. |
| Diazepam | |
| Clinical Impact: | Increased exposure of diazepam [see CLINICAL PHARMACOLOGY]. |
| Intervention: | Monitor patients for increased sedation and reduce the dose of diazepam as needed. |
| Digoxin | |
| Clinical Impact: | Potential for increased exposure of digoxin [see CLINICAL PHARMACOLOGY]. |
| Intervention: | Monitor digoxin concentrations. Dose adjustment may be needed to maintain therapeutic drug concentrations. See digoxin prescribing information. |
| Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole) | |
| Clinical Impact: | Omeprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. |
| Intervention: | Mycophenolate mofetil (MMF): Co-administration of omeprazole in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid (MPA), possibly due to a decrease in MMF solubility at an increased gastric pH. The clinical relevance of reduced MPA exposure on organ rejection has not been established in transplant patients receiving ZEGERID and MMF. Use ZEGERID with caution in transplant patients receiving MMF [see CLINICAL PHARMACOLOGY]. See the prescribing information for other drugs dependent on gastric pH for absorption. |
| Tacrolimus | |
| Clinical Impact: | Potential for increased exposure of tacrolimus, especially in transplant patients who are intermediate or poor metabolizers of CYP2C19. |
| Intervention: | Monitor tacrolimus whole blood concentrations. Dose adjustment may be needed to maintain therapeutic drug concentrations. See prescribing information for tacrolimus. |
| Interactions with Investigations of Neuroendocrine Tumors | |
| Clinical Impact: | Serum chromogranin A (CgA) levels increase secondary to PPI-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY]. |
| Intervention: | Temporarily stop PRILOSEC treatment at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high. If serial tests are performed (e.g., for monitoring), the same commercial laboratory should be used for testing, as reference ranges between tests may vary. |
| Interaction with Secretin Stimulation Test | |
| Clinical Impact: | Hyper-response in gastrin secretion in response to secretin stimulation test, falsely suggesting gastrinoma. |
| Intervention: | Temporarily stop ZEGERID treatment at least 14 days before assessing to allow gastrin levels to return to baseline [see CLINICAL PHARMACOLOGY]. |
| False Positive Urine Tests for THC | |
| Clinical Impact: | There have been reports of false positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving PPIs. |
| Intervention: | An alternative confirmatory method should be considered to verify positive results. |
| Other | |
| Clinical Impact: | There have been clinical reports of interactions with other drugs metabolized via the cytochrome P450 system (e.g., cyclosporine, disulfiram). |
| Intervention: | Monitor patients to determine if it is necessary to adjust the dosage of these other drugs when taken concomitantly with ZEGERID. |
Table 7: Clinically Relevant Interactions Affecting Omeprazole When Co-Administered with Other Drugs
| CYP2C19 or CYP3A4 Inducers | |
| Clinical Impact: | Decreased exposure of omeprazole when used concomitantly with strong inducers [see CLINICAL PHARMACOLOGY]. |
| Intervention: | St. John’s wort, rifampin: Avoid concomitant use with ZEGERID [see Warnings and Precautions (5.10)]. Ritonavir-containing products: See prescribing information for specific drugs. |
| CYP2C19 or CYP3A4 Inhibitors | |
| Clinical Impact: | Increased exposure of omeprazole [see CLINICAL PHARMACOLOGY]. |
| Intervention: | Voriconazole: Dosage adjustment of ZEGERID is not required. |
Read the entire FDA prescribing information for Zegerid (Omeprazole, Sodium Bicarbonate)
© Zegerid Patient Information is supplied by Cerner Multum, Inc. and Zegerid Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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