Esomeprazole (Nexium) Adverse Reactions
- abdominal pain
- anaphylactic shock
- anaphylactoid reactions
- anemia
- angioedema
- constipation
- diarrhea
- dizziness
- elevated hepatic enzymes
- erythema multiforme
- exfoliative dermatitis
- flatulence
- headache
- hepatitis
- hyperbilirubinemia
- injection site reaction
- jaundice
- leukocytosis
- leukopenia
- maculopapular rash
- myalgia
- nausea/vomiting
- pancreatitis
- pernicious anemia
- pruritus
- rash (unspecified)
- Stevens-Johnson syndrome
- thrombocytopenia
- toxic epidermal necrolysis
- urticaria
- vitamin B12 deficiency
- xerostomia
Esomeprazole (Nexium) Adverse Reactions
In general, oral esomeprazole has been well-tolerated in clinical trials (n > 10,000). Greater than 2900 patients have been evaluated in 6 - 12 month long studies. The types of adverse events are similar with short or long-term use, and have been comparable to placebo rates. The safety profile of esomeprazole is similar to omeprazole.
The most frequently (>=1%) reported adverse events with oral esomeprazole use were gastrointestinal (GI) in nature, including abdominal pain (3.8%), constipation, diarrhea (4.3%), flatulence (1.8%), nausea/vomiting (3.8%), and xerostomia (dry mouth). Other notable GI events that occurred in < 1% of patients, but were judged by investigators to be possibly or probably related to esomeprazole include: anorexia, bowel irregularity, dyspepsia, dysphagia, eructation, esophageal disorder, GI hemorrhage, melena, tongue edema, and ulcerative stomatitis. Intravenous esomeprazole has a safety profile similar to that of oral administration. Intravenous (IV) esomeprazole has been associated with injection site reaction (1.7%), including mild focal erythema and itching at the IV insertion site.
Headache occurred in up to 5.5% of patients using oral esomeprazole. Other notable, but rare (< 1%) central nervous system adverse events possibly or probably related to esomeprazole include: confusion, depression, dizziness, nervousness, insomnia, and migraine. Dizziness was reported in 2.5% of patients receiving intravenous esomeprazole during pre-marketing trials.
Post-marketing spontaneous reports during esomeprazole use have included anaphylactic shock or anaphylactoid reactions. Hypersensitivity reactions occurring in < 1% of patients judged by investigators during pre-approval trials as possibly or probably related to esomeprazole included: angioedema, dermatitis, pruritus, rash (unspecified), maculopapular rash, and urticaria. Rare cases of severe generalized skin reactions including toxic epidermal necrolysis (TEN) (some fatal), Stevens-Johnson syndrome and erythema multiforme have occurred. Exfoliative dermatitis has been reported with omeprazole, and could potentially occur with esomeprazole based on the similarity in dermatological reactions reported to date.
Elevated hepatic enzymes (ALT, AST and alkaline phosphatase) and hyperbilirubinemia have been rarely (< 1%) reported, both with esomeprazole and omeprazole. Rarely, hepatitis with or without jaundice has been reported with esomeprazole. Pancreatitis has also been reported in post-marketing experience.
Myalgia has been reported during post-marketing experience with esomeprazole.
Rare cardiovascular system adverse reactions with esomeprazole include chest pain, flushing, hypertension, and tachycardia. A reduction in potassium levels was noted in <= 1% of patients, but an association with hypokalemia was not made.
As with omeprazole, rare hematologic abnormalities have been reported with esomeprazole including anemia, leukocytosis, leukopenia, and thrombocytopenia. In a study of healthy volunteers, it was shown that omeprazole caused a significant reduction in cyanocobalamin absorption (vitamin B12 deficiency). Although clinical data in esomeprazole is lacking, it may be prudent to monitor patients for signs of pernicious anemia. Neurological manifestations of pernicious anemia can occur in the absence of hematologic changes.
Animal and human data have demonstrated a proliferation of enterochromaffin-like cells due to hypergastrinemia, which may be associated with the development of malignant gastric carcinoma during long-term administration of proton pump inhibitors (PPIs). In over 1,000 patients treated with esomeprazole for up to 12 months, the prevalence of ECL cell hyperplasia increased with time and dose, but no patient developed ECL cell carcinoids, dysplasia, or neoplasia in the gastric mucosa. In esomeprazole clinical trials, there were dose-related increases in mean fasting gastrin levels which reached plateaus at 2 to 3 months and returned to baseline 4 weeks after drug discontinuation. According the the manufacturer of esomeprazole, < 1% of patients were reported to have hypergastrinemia or GI dysplasia. Historically, omeprazole has been given for as long as 5 years without concern for the development of gastric neoplasia. The overall risk of carcinoid tumors during therapy with PPIs is low based on cumulative safety experience; monitoring of serum gastrin levels during PPI therapy is generally not necessary.
Other less significant and infrequently (< 1%) reported adverse reactions are detailed in the prescribing literature for oral esomeprazole.
[ Last revised: 6/12/2005 1:06:00 PM ]
References
. Marcuard SP, Albernaz L, Khazanie PG. Omeprazole therapy causes malabsorption of cyanocobalamin (vitamin B12). Ann Intern Med 1994;120:211 - 5.
. Reilly JP. Safety profile of the proton-pump inhibitors. Am J Health-Syst Pharm 1999;56(Suppl 4):S11 - 7.
. Kahrilas PJ, Falk GW, Johnson DA. Esomeprazole improves healing and symptom resolution as compared with omeprazole in reflux oesophagitis patients: a randomized controlled trial. Aliment Pharmacol Ther 2000;14:1249 - 58.)
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