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Safety profile of Nexium
PPIs are among the most-studied medicines in the world and bring benefits to millions of patients each and every day. The safety profile of Nexium is similar to that of omeprazole: it is well tolerated for short- and long-term use.[1],[2]
Long-term safety and monitoring data, including several studies and reviews, have not raised any safety concerns regarding the use of proton pump inhibitors (PPIs) including Nexium.[3],[4]
- Nexium’s safety was evaluated in over 15,000 patients (aged 18 to 84 years) in clinical trials worldwide, including over 8500 patients in the United States and over 6500 patients in Europe and Canada. In general, Nexium was well tolerated
- The safety of Nexium was evaluated in 316 pediatric patients and adolescent patients aged 1 to 17 years in 4 clinical trials for the treatment of symptomatic GERD. No new safety concerns were identified in pediatric patients
- In over 1000 patients treated with Nexium for up to 6 to 12 months, the prevalence of Enterochromaffin-like (ECL) cell hyperplasia increased with time and dose.[5] No patient developed ECL cell carcinoids, dysplasia, or neoplasia in the gastric mucosa
The most common Nexium adverse events, or side effects, associated with Nexium are headache, diarrhoea and abdominal pain. See the full prescribing information.
Nexium contraindications
Contraindications for Nexium are:
- Known hypersensitivity to esomeprazole, substituted benzimidazoles or any other constituents of the formulation.
- Esomeprazole should not be used concomitantly with nelfinavir
References
- Kahrilas PJ et al. Esomeprazole improves healing and symptom resolution as compared with omeprazole in reflux esophagitis patients: a randomised controlled trial. The Esomeprazole Study Investigators. Aliment Pharmacol Ther 2000: 14:1249-58
- Richter JE, et al. Efficacy and safety of esomeprazole compared with omeprazole in GERD patients with erosive esophagitis: a randomised controlled trial. Am J Gastroenterol 2001; 96:656-65
- AstraZeneca on file 1010; AstraZeneca on file 1011
- Maton et al. Safety and efficacy of long-term esomeprazole therapy in patients with healed erosive esophagitis. Drug Saf 2001; 24:625-35
- Prescribing Information for NEXIUM.
