Tegoprazan 50mg Side Effects
Tegoprazan 50mg is generally well tolerated with predominantly mild gastrointestinal side effects, most commonly headache (1-4.9%) and gastrointestinal disorders (2-4.9%) that typically resolve spontaneously without medical intervention. 1
Common Side Effects
The most frequently reported adverse events with tegoprazan include:
- Gastrointestinal disorders occurring in 2-4.9% of patients, which are typically mild and self-limiting 1
- Headache reported in 1-4.9% of patients 1
- Most adverse events are mild in intensity and resolve without sequelae 2
Safety Profile from Clinical Trials
Single and Multiple Dose Studies
- In phase I trials involving 56 healthy subjects receiving doses ranging from 50-400mg, tegoprazan was generally well tolerated 2
- Multiple dosing studies (100mg and 200mg daily for 7 days) showed no serious adverse events 2
- All reported adverse events were mild and resolved without any lasting effects 2
Metabolic and Excretion Safety
- In mass balance studies using radiolabeled tegoprazan 50mg, no serious adverse events were observed 3
- The drug is completely excreted through both urine (50.51%) and feces (47.26%), indicating efficient elimination 3
Comparative Safety Considerations
Unlike proton pump inhibitors (PPIs), tegoprazan as a potassium-competitive acid blocker (P-CAB):
- Does not require acid activation, reducing variability in response 4
- Is not affected by CYP2C19 genetic polymorphisms, which can impact PPI metabolism and side effects 4, 1
- Has a longer half-life (6-9 hours vs 1-2 hours for PPIs), allowing for more consistent acid suppression 4
Clinical Implications
- Adverse events typically disappear spontaneously without medical intervention 1
- The safety profile supports administration regardless of meal timing, as food does not significantly impact tolerability 5
- No accumulation occurs with repeated daily dosing, suggesting low risk of cumulative toxicity 2
- The orally disintegrating tablet formulation shows equivalent safety to conventional tablets 6
Important Caveats
- Current safety data is primarily from Asian populations, and more research is needed in other ethnic groups 1
- Long-term safety data beyond the clinical trial periods is still being established 1
- While gastrin levels remain relatively low with tegoprazan use, ongoing monitoring in clinical practice may be warranted 1