Constipation Incidence with Esomeprazole
Constipation occurs in approximately 5% or more of patients taking esomeprazole, making it one of the most common adverse effects alongside upper respiratory tract infections. 1, 2
Evidence from Clinical Trials and Guidelines
The most direct evidence comes from high-quality sources indicating that constipation is reported as occurring in ≥5% of patients treated with esomeprazole across multiple dosing regimens. 1, 2 This rate is derived from pooled safety data where esomeprazole at 40 mg twice daily for 16 weeks demonstrated adverse event rates comparable to placebo, with constipation being the most frequently reported adverse effect. 1
Context from Comparative Studies
While the specific percentage for esomeprazole is approximately 5%, it's useful to note that other medications in similar therapeutic contexts show varying constipation rates:
- Eluxadoline (used for IBS-D) causes constipation in 8% of patients, which is higher than esomeprazole 3
- The constipation rate with esomeprazole appears consistent across different formulations and combination products 2
Clinical Implications
The 5% incidence rate represents a relatively low but clinically meaningful occurrence that should be discussed with patients, particularly those with pre-existing bowel disorders. 1 This is especially relevant because:
- Long-term PPI therapy (6 months) has been associated with development of new bowel symptoms including constipation, bloating (43%), and flatulence (17%) in patients with NERD 4
- Prolonged esomeprazole treatment may contribute to small intestinal bacterial overgrowth (SIBO) in 26% of patients after 6 months, which can manifest as various bowel symptoms 4
Important Caveats
Patients with concomitant irritable bowel syndrome may experience different bowel symptom patterns and have higher rates of treatment failure with PPIs. 5 Additionally, the development of bowel symptoms appears to increase with duration of therapy, suggesting that step-down or on-demand PPI strategies should be considered when appropriate to minimize gastrointestinal side effects. 4
The constipation rate is generally well-tolerated, with fewer than 3% of patients discontinuing esomeprazole due to treatment-emergent adverse events overall. 6