Slideshows Images Quizzes


Last reviewed on RxList: 7/3/2017
Zegerid Side Effects Center

Last reviewed on RxList 7/3/2017

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. 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.

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. 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. 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.

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.

Zegerid Consumer Information

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

Call your doctor at once if you have:

  • stiffness or loss of movement in any part of your body;
  • diarrhea that is watery or bloody;
  • fast or slow heartbeats;
  • seizure (convulsions); or
  • low magnesium (dizziness, confusion, fast or uneven heart rate, jerking muscle movements, jittery feeling, muscle cramps, muscle weakness or limp feeling, cough or choking feeling).

Common side effects may include:

  • headache;
  • nausea, stomach pain, gas; or
  • mild 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


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 clinical practice.

In the U.S. clinical trial population of 465 patients, the adverse reactions summarized in Table 2 were reported to occur in 1% or more of patients on therapy with omeprazole. Numbers in parentheses indicate percentages of the adverse reactions considered by investigators as possibly, probably or definitely related to the drug.

Table 2: Adverse Reactions Occurring In 1% or More of Patients on Omeprazole Therapy

(n = 465)
(n = 64)
(n = 195)
Headache 6.9 (2.4) 6.3 7.7 (2.6)
Diarrhea 3.0 (1.9) 3.1 (1.6) 2.1 (0.5)
Abdominal Pain 2.4 (0.4) 3.1 2.1
Nausea 2.2 (0.9) 3.1 4.1 (0.5)
URI 1.9 1.6 2.6
Dizziness 1.5 (0.6) 0.0 2.6 (1.0)
Vomiting 1.5 (0.4) 4.7 1.5 (0.5)
Rash 1.5 (1.1) 0.0 0.0
Constipation 1.1 (0.9) 0.0 0.0
Cough 1.1 0.0 1.5
Asthenia 1.1 (0.2) 1.6 (1.6) 1.5 (1.0)
Back Pain 1.1 0.0 0.5

Table 3 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 3: Incidence of Adverse Reactions ≥ 1% Causal Relationship not Assessed

(n = 2631)
(n = 120)
Body as a Whole, site unspecified
  Abdominal pain 5.2 3.3
  Asthenia 1.3 0.8
Digestive System
  Constipation 1.5 0.8
  Diarrhea 3.7 2.5
  Flatulence 2.7 5.8
  Nausea 4.0 6.7
  Vomiting 3.2 10.0
  Acid regurgitation 1.9 3.3
Nervous System/Psychiatric
  Headache 2.9 2.5

A controlled clinical trial was conducted in 359 critically ill patients, comparing ZEGERID 40 mg/1680 mg suspension once daily to I.V. cimetidine 1200 mg/day for up to 14 days. The incidence and total number of AEs experienced by ≥ 3% of patients in either group are presented in Table 4 by body system and preferred term.

Table 4: Number (%) of Critically Ill Patients with Frequently Occurring ( ≥ 3%) Adverse Events by Body System and Preferred Term

Body System Preferred Term
All AEs n (%) All AEs n (%)
  Anemia NOS 14 (7.9) 14 (7.7)
  Anemia NOS Aggravated 4 (2.2) 7(3.9)
  Thrombocytopenia 18 (10.1) 11 (6.1)
  Atrial Fibrillation 11 (6.2) 7(3.9)
  Bradycardia NOS 7(3.9) 5 (2.8)
  Supraventricular Tachycardia 6 (3.4) 2(1.1)
  Tachycardia NOS 6 (3.4) 6 (3.3)
  Ventricular Tachycardia 8 (4.5) 6 (3.3)
  Constipation 8 (4.5) 8 (4.4)
  Diarrhea NOS 7(3.9) 15 (8.3)
  Gastric Hypomotility 3 (1.7) 6 (3.3)
  Hyperpyrexia 8 (4.5) 3 (1.7)
  Edema NOS 5 (2.8) 11 (6.1)
  Pyrexia 36 (20.2) 29 (16.0)
  Candidal Infection NOS  3 (1.7) 7 (3.9)
  Oral Candidiasis 7 (3.9) 1 (0.6)
  Sepsis NOS 9 (5.1) 9 (5.0)
  Urinary Tract Infection NOS 4 (2.2) 6 (3.3)
  Liver Function Tests NOS Abnormal 3 (1.7) 6 (3.3)
  Fluid Overload 9 (5.1) 14 (7.7)
  Hyperglycaemia NOS 19 (10.7) 21 (11.6)
  Hyperkalaemia 4 (2.2) 6 (3.3)
  Hypernatraemia 3 (1.7) 9 (5.0)
  Hypocalcaemia 11 (6.2) 10 (5.5)
  Hypoglycaemia NOS 6 (3.4) 8 (4.4)
  Hypokalaemia 22 (12.4) 24 (13.3)
  Hypomagnesaemia 18 (10.1) 18 (9.9)
  Hyponatraemia 7(3.9) 5 (2.8)
  Hypophosphataemia 11 (6.2) 7(3.9)
  Agitation 6 (3.4) 16 (8.8)
  Acute Respiratory Distress Syndrome   6 (3.4) 7 (3.9)
  Nosocomial Pneumonia 20 (11.2) 17 (9.4)
  Pneumothorax NOS 1 (0.6) 8 (4.4)
  Respiratory Failure 3 (1.7) 6 (3.3)
  Decubitus Ulcer 6 (3.4) 5 (2.8)
  Rash NOS 10 (5.6) 11 (6.1)
  Hypertension NOS 14 (7.9) 6 (3.3)
  Hypotension NOS 17 (9.6) 12 (6.6)
* Clinically significant upper gastrointestinal bleeding was considered a serious adverse event but it is not included in this table.
NOS = Not otherwise specified.

Postmarketing Experience

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

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

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 and abdominal swelling. During treatment with omeprazole, gastric fundic gland polyps have been noted rarely. These polyps are benign and appear to be reversible when treatment is discontinued. 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, 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, leucocytosis, and hemolytic anemia have been reported.

The incidence of clinical adverse experiences in patients greater than 65 years of age was similar to that in patients 65 years of age or less.

Additional adverse reactions that could be caused by sodium bicarbonate include metabolic alkalosis, seizures, and tetany.

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

Related Resources for Zegerid

Related Health

Read the Zegerid User Reviews »

© 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.

Health Solutions From Our Sponsors