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Side Effects of Zegerid (Omeprazole, Sodium Bicarbonate) Drug

Openmedi.orgOmeprazole side effects weight gain


03/15/2015
12:08 | Author: David Perry

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Side Effects of Zegerid (Omeprazole, Sodium Bicarbonate) Drug

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.

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.

Table 2: Adverse Reactions Occurring In 1% or More of Patients on Omeprazole Therapy Omeprazole (n = 465) Placebo (n = 64) Ranitidine (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.

Headache or abdominal pain may occur. If any of these effects persist or worsen, l 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. l your doctor immediay 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. l your doctor immediay 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, change in the amount of urine. 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. l your doctor right away if you develop: persistent diarrhea, abdominal or stomach pain/cramping, fever, blood/mucus in your stool. 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. 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. Read the entire patient information overview for Zegerid (Omeprazole, Sodium Bicarbonate) »

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

Report Problems to the Food and Drug Administration.

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

Special Senses: Tinnitus, taste perversion.

Common side effects may include:

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

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.

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 ampicillin, atazanavir, clarithromycin, clopidogrel, cyclosporine, diazepam, disulfiram, iron supplements, ketoconazole, phenytoin, tacrolimus, or warfarin. l your doctor all medications you are taking. During pregnancy, Zegerid should be used only when prescribed. This medication passes into breast milk. The effects on a nursing infant are unknown. Consult your doctor before breast-feeding.

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

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 detailed patient monograph for Zegerid (Omeprazole, Sodium Bicarbonate) »

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 (omeprazole/sodium bicarbonate) is used to treat ulcers, gastroesophageal reflux disease (GERD), and other conditions involving excessive stomach acid production. Zegerid is a combination of omeprazole, a proton-pump inhibitor, and sodium bicarbonate, an antacid. This medication may be available in generic form. Common side effects include headache or abdominal pain.

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.

Table 4: Number (%) of Critically Ill Patients with Frequently Occurring ( ≥ 3%) Adverse Events by Body System and Preferred Term MedDRA Body System Preferred Term ZEGERID (N=178) Cimetidine (N=181) 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) CARDIAC DISORDERS 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) INVESTIGATIONS 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) Hyponatraemia 7(3.9) 5 (2.8) Hypophosphataemia 11 (6.2) 7(3.9) PSYCHIATRIC DISORDERS 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) VASCULAR DISORDERS 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.

Read the FDA Approves First Generic Versions of Aciphex to treat GERD article »

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

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 Overview?

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.

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Read the Zegerid User Reviews » Share this Article:

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.

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 definiy related to the drug.

Table 3: Incidence of Adverse Reactions ≥ 1% Causal Relationship not Assessed Omeprazole (n = 2631) Placebo (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.

What is Patient Information in Detail?

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.

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.

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

Medical Editor: John P. Cunha, DO, FACOEP.

A concise overview of the drug for the patient or caregiver from First DataBank.

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

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Call your doctor at once if you have:

Infections and Infestations: Clostridium difficile associated diarrhea.

"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). GE".

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

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

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.

FDA Approves First Generic Versions of Aciphex to treat GERD »

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

What is Prescribing information?

Here is a collection of user reviews for the medication Zegerid sorted by most helpful.


Omeprazole side effects weight gain