"The U.S. Food and Drug Administration today approved the first generic versions of Aciphex (rabeprazole sodium) delayed-release tablets, used to treat gastroesophageal reflux disease (GERD) in adults and adolescents (ages 12 and up).
Zegerid Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
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.
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Zegerid in Detail - Patient Information: Side Effects
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:
- nausea, stomach pain, gas; or
- mild diarrhea.
Read the entire detailed patient monograph for Zegerid (Omeprazole, Sodium Bicarbonate)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Zegerid Overview - Patient Information: Side Effects
Headache or abdominal pain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
If your doctor has directed you to use this product, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: swelling of the hands/feet, symptoms of a low magnesium blood level (such as unusually fast/slow/irregular heartbeat, persistent muscle spasms, seizures), sudden weight gain.
When taken with sodium bicarbonate, large doses of calcium from your diet, medications, or supplements can rarely cause a serious problem called milk-alkali syndrome. Ask your doctor or pharmacist about using calcium products safely while you are using this medication. Tell your doctor immediately if any of these rare but serious side effects occur: dizziness, muscle aches/spasms, mental/mood changes (such as confusion, irritability, memory problems), vomiting, weakness.
This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of bacteria. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor right away if you develop: persistent diarrhea, abdominal or stomach pain/cramping, fever, blood/mucus in your stool.
Rarely, proton pump inhibitors (such as omeprazole) have caused vitamin B-12 deficiency. The risk is increased if they are taken every day for a long time (3 years or longer). Tell your doctor right away if you develop symptoms of vitamin B-12 deficiency (such as unusual weakness, sore tongue, or numbness/tingling of the hands/feet).
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, kidney problems (such as change in the amount of urine).
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Zegerid (Omeprazole, Sodium Bicarbonate)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Zegerid FDA Prescribing Information: Side Effects
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)|
|Dizziness||1.5 (0.6)||0.0||2.6 (1.0)|
|Vomiting||1.5 (0.4)||4.7||1.5 (0.5)|
|Asthenia||1.1 (0.2)||1.6 (1.6)||1.5 (1.0)|
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|
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 (%)|
|BLOOD AND LYMPHATIC SYSTEM DISORDERS|
|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)|
|GASTROINTESTINAL DISORDERS *|
|Constipation||8 (4.5)||8 (4.4)|
|Diarrhea NOS||7(3.9)||15 (8.3)|
|Gastric Hypomotility||3 (1.7)||6 (3.3)|
|GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS|
|Hyperpyrexia||8 (4.5)||3 (1.7)|
|Edema NOS||5 (2.8)||11 (6.1)|
|Pyrexia||36 (20.2)||29 (16.0)|
|INFECTIONS AND INFESTATIONS|
|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)|
|METABOLISM AND NUTRITION DISORDERS|
|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)|
|Agitation||6 (3.4)||16 (8.8)|
|RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS|
|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)|
|SKIN AND SUBCUTANEOUS TISSUE DISORDERS|
|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.
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.
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.
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.
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.
Urogenital: Interstitial nephritis (some with positive rechallenge), urinary tract infection, microscopic pyuria, urinary frequency, elevated serum creatinine, proteinuria, hematuria, glycosuria, testicular pain, and gynecomastia.
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.
Read the entire FDA prescribing information for Zegerid (Omeprazole, Sodium Bicarbonate)
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