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Zegerid (Omeprazole) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Omeprazole was generally well tolerated during domestic and international clinical trials in 3096 patients.

In the U.S. clinical trial population of 465 patients, the following adverse experiences were reported to occur in 1% or more of patients on therapy with omeprazole. Numbers in parentheses indicate percentages of the adverse experiences 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

The following adverse reactions which occurred in 1% or more of omeprazole-treated patients have been reported in international double-blind, and open-label, clinical trials in which 2,631 patients and subjects received omeprazole.

Incidence of Adverse Experiences >/= 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
Nervious System/Psychiatric
Headache 2.9 2.5

Additional adverse reactions occurring in < 1% of patients or subjects in domestic and/or international trials conducted with omeprazole, or occurring since the drug was marketed, are shown below within each body system. In many instances, the relationship to omeprazole was unclear.

Body as a Whole

Allergic reactions, including, rarely, anaphylaxis (see also Skin below), fever, pain, fatigue, malaise, abdominal swelling.

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. 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 ZE 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), (gamma)-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.

Metabolic/Nutritional

Hyponatremia, hypoglycemia, and weight gain.

Musculoskeletal

Muscle cramps, myalgia, muscle weakness, joint pain, and leg pain.

Nervous System/Psychiatric

Psychic disturbances including depression, aggression, hallucinations, confusion, insomnia, nervousness, tremors, apathy, somnolence, anxiety, dream abnormalities; vertigo; paresthesia; and hemifacial dysesthesia.

Respiratory

Epistaxis, pharyngeal pain

Skin

Rash and rarely, cases of 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, 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, 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.



REPORTS OF SUSPECTED ZEGERID SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Zegerid. The information is not vetted and should not be considered as verified clinical evidence.

Possible Zegerid side effects / adverse reactions in 69 year old male

Reported by a consumer/non-health professional from United States on 2012-04-27

Patient: 69 year old male weighing 88.9 kg (195.6 pounds)

Reactions: Abdominal Discomfort, Hypophagia, Pain, Abdominal Distension

Adverse event resulted in: hospitalization

Suspect drug(s):
Zegerid

Other drugs received by patient: Entocort EC



Possible Zegerid side effects / adverse reactions in 69 year old male

Reported by a consumer/non-health professional from United States on 2012-05-17

Patient: 69 year old male weighing 88.9 kg (195.6 pounds)

Reactions: Abdominal Discomfort, Increased Upper Airway Secretion, Pain, Hypophagia, Abdominal Distension, Unevaluable Event

Adverse event resulted in: hospitalization

Suspect drug(s):
Zegerid

Other drugs received by patient: Entocort EC



Possible Zegerid side effects / adverse reactions in 65 year old female

Reported by a consumer/non-health professional from United States on 2012-08-27

Patient: 65 year old female weighing 72.6 kg (159.7 pounds)

Reactions: Vomiting, Drug Ineffective, Hypoaesthesia, Headache, Abdominal Pain Upper, Malaise, Road Traffic Accident, Gastrointestinal Pain, Withdrawal Syndrome, Hypertension, Muscle Spasms, Neuralgia

Suspect drug(s):
Neurontin
    Dosage: unk

Lyrica
    Dosage: 100 mg, 3x/day
    Indication: Neuralgia
    Start date: 2008-01-04

Zegerid
    Dosage: unk
    Indication: Abdominal Pain Upper



See index of all Zegerid side effect reports >>

Drug label data at the top of this Page last updated: 2006-08-12

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