Zefxon Adverse Reactions

ZEFXON INJECTION (omeprazole) is generally well tolerated. Following events have occurred: headache, diarrhea, constipation, abdominal pain, nausea/vomiting and flatulence.
Rarely: Rash, urticaria and/or pruritus, dizziness, paraesthesia, somnolence, insomnia, vertigo, increased liver enzymes and malaise.
The following adverse effects occurred in 1% or more of patients: CNS: Asthenia, dizziness, headache.
GI: Abdominal pain, constipation, diarrhea, nausea, vomiting.
Miscellaneous: Back pain, cough, rash, upper respiratory tract infection.
The following adverse effects occurred in less than 1% of patients: Cardiovascular: Bradycardia, chest pain or angina, elevated blood pressure, palpitation, tachycardia.
CNS: Aggression, anxiety, apathy, confusion, depression, dream abnormalities, fatigue, hallucinations, hemifacial dysesthesia, insomnia, nervousness, paresthesia, somnolence, tremors, vertigo.
Dermatologic: Rash and rarely, cases of severe generalized skin reactions including toxic epidermal necrolysis (some fatal), Steven-Johnson syndrome and erythema multiforme (some severe), alopecia, angioedema, dry skin, hyperhidrosis, pruritus purpura and/or petechiae (some with rechallenge), skin inflammation, urticaria.
GI: Abdominal swelling, anorexia, dry mouth, esophageal candidiasis, local discoloration, flatulence, gastric fundic gland polyps (rare, reversible), irritable colon, mucosal atrophy of the tongue, pancreatitis (some fatal).
GU: Glycosuria, gynecomastia, hematuria interstitial nephritis (some with positive rechallenge), microscopic pyuria, proteinuria, testicular pain, urinary tract infection, urinary frequency.
Hematologic: Agranulocytosis (some fatal), anemia, hemolytic anemia, leukocytosis, neutropenia, pancytopenia (rare), thrombocytopenia.
Hepatic: Overt liver disease has occurred rarely, including hepatocellular, cholestatic, or mixed hepatitis, liver necrosis (some fatal), hepatic failure (some fatal), and hepatic encephalopathy.
Lab test abnormalities: Increased alkaline phosphatase, ALT, AST, bilirubin, elevated serum creatinine, γ-glutamyl transpeptidase.
Metabolic/Nutritional: Hyponatremia, hypoglycemia, peripheral edema, weight gain.
Musculoskeletal: Joint pain, leg pain, muscle cramps, muscle weakness, myalgia.
Respiratory: Epistaxis, pharyngeal pain.
Special senses: Anterior ischemia, optic neuropathy, blurred vision, double vision, dry eye syndrome, taste perversion, tinnitus, ocular irritation, optic atrophy, optic neuritis.
Miscellaneous: Allergic reactions, including, rarely anaphylaxis, fever, pain, malaise.