Zegerid Side Effects
Please note - some side effects for Zegerid may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects of Zegerid - for the Consumer
Zegerid
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Zegerid:
Seek medical attention right away if any of these SEVERE side effects occur when using Zegerid:Diarrhea; gas; headache; nausea; stomach pain; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bone pain; chest pain; dark urine; fast, slow, or irregular heartbeat; fever, chills, or sore throat; red, swollen, blistered, or peeling skin; seizures; severe diarrhea; severe stomach pain or cramps; swelling of the hands, ankles, or feet; unusual bruising or bleeding; unusual or sudden weight increase; unusual tiredness; vision changes; yellowing of the eyes or skin.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
Zegerid OTC
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Zegerid OTC:
Seek medical attention right away if any of these SEVERE side effects occur when using Zegerid OTC:Diarrhea; gas; headache; nausea; stomach pain; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bone pain; chest pain; dark urine; fast, slow, or irregular heartbeat; fever, chills, or sore throat; red, swollen, blistered, or peeling skin; seizures; severe diarrhea; severe stomach pain or cramps; swelling of the hands, ankles, or feet; unusual bruising or bleeding; unusual or sudden weight increase; unusual tiredness; vision changes; yellowing of the eyes or skin.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
Zegerid Powder Packets
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Zegerid Powder Packets:
Seek medical attention right away if any of these SEVERE side effects occur when using Zegerid Powder Packets:Diarrhea; gas; headache; nausea; stomach pain; vomiting.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); bone pain; chest pain; dark urine; fast, slow, or irregular heartbeat; fever, chills, or sore throat; red, swollen, blistered, or peeling skin; seizures; severe diarrhea; severe stomach pain or cramps; swelling of the hands, ankles, or feet; unusual bruising or bleeding; unusual or sudden weight increase; unusual tiredness; vision changes; yellowing of the eyes or skin.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopZegerid Side Effects - for the Professional
Zegerid
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.
| 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 |
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.
| 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 |
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.
|
* Clinically significant upper gastrointestinal bleeding was considered a serious adverse event but it is not included in this table. |
||
|
NOS = Not otherwise specified. |
||
| Zegerid® (N=178) |
Cimetidine (N=181) |
|
| MedDRA 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) |
| 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) |
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, 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.
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.
TopSide Effects by Body System - for Healthcare Professionals
Dermatologic
Dermatologic side effects have included rash.
Gastrointestinal
Gastrointestinal side effects have included diarrhea, nausea, constipation, abdominal pain, flatulence, acid regurgitation, and vomiting.
Nervous system
Nervous system side effects have included confusion, dizziness, hypoesthesia, insomnia, migraine aggravation, paresthesia, sleep disorder, somnolence, tremor, vertigo, and seizures.
Musculoskeletal
Musculoskeletal side effects have included asthenia and back pain. Postmarketing reports of increased risk of bone fracture have been reported.
Respiratory
Respiratory side effects have included cough and upper respiratory infection.
Metabolic
FDA warns that prescription proton pump inhibitor (PPI) drugs may cause low serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time (in most cases, longer than one year). Patients who develop hypomagnesemia may experience seizures, dizziness, abnormal or fast heart beat, or skipped heartbeat, jitteriness, jerking movements or tremors, muscle weakness, spasms of the hands and feet, cramps or muscle aches, and spasm of the voice box.
TopMore Zegerid resources
- Zegerid Prescribing Information (FDA)
- Zegerid Advanced Consumer (Micromedex) - Includes Dosage Information
- Zegerid MedFacts Consumer Leaflet (Wolters Kluwer)
- Zegerid Consumer Overview
- Zegerid OTC Consumer Overview
- Zegerid OTC MedFacts Consumer Leaflet (Wolters Kluwer)
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