Possible Side Effects of Tegoprazan
Tegoprazan is generally well-tolerated with a safety profile comparable to proton pump inhibitors (PPIs), with the most common adverse events being mild-to-moderate gastrointestinal disorders (2-4.9%) and headaches (1-4.9%) that typically resolve spontaneously without medical intervention 1.
Common Side Effects (Short-to-Medium Term)
Based on the most recent clinical evidence, tegoprazan demonstrates the following adverse event profile:
Frequently Reported (Mild-to-Moderate)
- Gastrointestinal disorders: 2-4.9% of patients 1
- Headaches: 1-4.9% of patients 1
- Treatment-related adverse events: 38.2% in clinical trials, all mild-to-moderate in severity 2
These effects typically disappear spontaneously without requiring medical intervention 1.
Metabolic Effects
- Elevated serum gastrin levels: P-CABs including tegoprazan raise gastrin levels higher than PPIs, with elevations continuing throughout treatment duration and returning toward baseline within weeks after discontinuation 3
Potential Long-Term Safety Concerns
The 2024 AGA Clinical Practice Update highlights important considerations for all P-CABs, including tegoprazan 3:
Infection Risks
- Enteric infections: Due to potent acid suppression, similar associations to PPIs are expected, including increased risk of Clostridioides difficile infection (magnitude comparable to PPIs) 3
- Microbiota changes: P-CABs may alter gut microbiota, potentially decreasing defense against enteric infections 3
Theoretical Long-Term Risks
- Gastric cancer: Japanese population-based data suggest possible increased risk compared to H2-receptor antagonists (adjusted hazard ratio <2), but rates similar to PPIs 3
- Enterochromaffin-like cell hyperplasia: Infrequent and comparable to PPIs in long-term studies 3
- Gastric adenomas: Rare cases reported (similar frequency to PPIs in 5-year trials) 3
Hepatotoxicity Profile
Importantly, tegoprazan demonstrates LOWER hepatotoxicity compared to most conventional PPIs 4:
- Risk ratio of 0.73 (95% CI: 0.72-0.75) compared to six existing PPIs combined
- Lower hepatotoxicity than dexlansoprazole, esomeprazole, lansoprazole, pantoprazole, and rabeprazole
- Only omeprazole showed lower hepatotoxicity than tegoprazan
Gastric Emptying and Functional Symptoms
Unlike some PPIs, tegoprazan does not significantly affect gastric emptying or worsen dyspeptic symptoms such as postprandial fullness or early satiation 5.
Special Populations
- Pregnancy/lactation: Safety data are limited, though animal studies with P-CABs showed no maternal or developmental toxicity 3
Critical Clinical Caveats
Important Limitations
The AGA emphasizes that P-CABs including tegoprazan have less-robust long-term safety data compared to PPIs 3. The more potent acid inhibition and elevated gastrin levels with P-CABs require ongoing monitoring for potential long-term impacts 3.
Key Safety Principle
Any safety concerns related to acid inhibition with PPIs should be expected to be shared by tegoprazan and other P-CABs 3. Whether the more potent acid inhibition increases adverse effects beyond PPIs remains unknown 3.
Practical Monitoring
- Continue to assess emerging long-term safety data
- Monitor for infection risks in vulnerable populations
- Consider the balance between potent acid suppression benefits and theoretical long-term risks
- Gastrin levels normalize within weeks after discontinuation if concerns arise 3